epidemiology.bib

Vasiljevic:2008

The assessment of health-related quality of life in relation to the body mass index value in the urban population of Belgrade
N. Vasiljevic and S. Ralevic and J. Marinkovic and N. Kocev and M. Maksimovic and G. S. Milosevic and J. Tomic
Health and Quality of Life Outcomes  6    (2008)

Background The association between excess body weight, impairment of health and different co-morbidities is well recognized; however, little is known on how excess body weight may affect the quality of life in the general population. Our study investigates the relationship between perceived health-related quality of life (HRQL) and body mass index (BMI) in the urban population of Belgrade. Methods The research was conducted during 2005 on a sample of 5,000 subjects, with a response of 63.38%. The study sample was randomly selected and included men and women over 18 years of age, who resided at the same address over a period of 10 years. Data were collected by means of a questionnaire and nutritional status was categorized using the WHO classification. HRQL was measured using the SF-36 generic score. Logistic regression analysis was used to compare HRQL between subjects with normal weight and those with different BMI values; we monitored subject characteristics and potential co-morbidity. Results The prevalence of overweight males and females was 46.6% and 22.1%, respectively. The prevalence of obesity was 7.5% in males and 8.5% in females. All aspects of health, except mental, were impaired in males who were obese. The physical and mental wellbeing of overweight males was not significantly affected; all score values were similar to those in subjects with normal weight. By contrast, obese and overweight females had lower HRQL in all aspects of physical functioning, as well as in vitality, social functioning and role-emotional. Conclusion The results of our study show that, in the urban population of Belgrade, increased BMI has a much greater impact on physical rather than on mental health, irrespective of subject gender; the effects were particularly pronounced in obese individuals.

Vries:2008

Effect of dexamethasone on quality of life in children with acute lymphoblastic leukaemia: a prospective observational study
M. de Vries and R. Litsenburg and J. Huisman and M. Grootenhuis and B. Versluys and G. Kaspers and R. Gemke
Health and Quality of Life Outcomes  6    (2008)

Background Glucocorticoids are important in the treatment of childhood acute lymphoblastic leukaemia (ALL). However, cyclic administration of high dose glucocorticoids may cause rapid and substantial changes in quality of life (QoL). The maintenance phase of the Dutch ALL-9 protocol consisted of alternating two weeks on and five weeks off dexamethasone (6 mg/m2/day). The present study was performed to assess the effect of dexamethasone on QoL during treatment for ALL according to this protocol. Methods In a multicentre prospective cohort study, QoL was assessed halfway (T1) and at the end of the two-year treatment (T2). A generic (Child Health Questionnaire) and disease specific (PedsQLTM cancer version) QoL questionnaire were used to assess QoL in two periods: on and off dexamethasone, respectively. Results 41 children (56% males) were evaluated, mean age at diagnosis was 5.6 years. The CHQ physical and psychosocial summary scores were significantly lower than population norms. At T1 and T2, overall QoL showed no significant change. However, regarding specific domains (pain, cognitive functioning, emotion/behaviour and physical functioning) QoL decreased over time. QoL was significantly more impaired during periods on dexamethasone. Conclusion Dexamethasone is associated with decreased QoL. At the end of treatment, reported QoL during dexamethasone deteriorated even more on certain scales (pain, cognitive functioning, emotion/behaviour and physical functioning). Knowledge of the specific aspects of QoL is essential to improve counselling and coping in paediatric oncology. Adverse effects of specific drugs on QoL should be taken into account when designing treatment protocols.

Klis:2008

Pictorial Representation of Illness and Self Measure Revised II (PRISM-RII) - a novel method to assess perceived burden of illness in diabetes patients
S. Klis and A. Vingerhoets and M. de Wit and N. Zandbelt and F. Snoek
Health and Quality of Life Outcomes  6    (2008)

Background The Pictorial Representation of Illness and Self Measure (PRISM) has been introduced as a visual measure of suffering. We explored the validity of a revised version, the PRISM-RII, in diabetes patients as part of the annual review. Methods Participants were 308 adult outpatients with either type 1 or type 2 diabetes. Measures: (1) the PRISM-RII, yielding Self-Illness Separation (SIS) and Illness Perception Measure (IPM); (2) the Problem Areas in Diabetes (PAID) scale, a measure of diabetes-related distress; (3) the WHO-5, Well-Being Index; (4) and a validation question on suffering (SQ). In addition, patients' complication status, comorbidity and glycemic control values(HbA1c) were recorded. Results Patients with complications did have marginally significant higher scores on IPM, compared to patients without complications. Type 2 patients had higher IPM scores than Type 1 patients. SIS and IPM showed low intercorrelation (r = -.25; p < .01). Convergent validity of PRISM-RII was demonstrated by significant correlations between IPM and PAID (r = 0.50; p < 0.01), WHO-5 (r = -.26; p < 0.01) and SQ (r = 0.36; p < 0.01). SIS showed only significant correlations with PAID (r = -0.28; p < 0.01) and SQ (r = -0.22; p < 0.01). Neither IPM nor SIS was significantly associated with HbA1c. The PRISM-RII appeared easy to use and facilitated discussion with care providers on coping with the burden of diabetes. Conclusion PRISM-RII appears a promising additional tool to assess the psychological burden of diabetes.

Briggs:2008

Impact of schizophrenia and schizophrenia treatment-related adverse events on quality of life: direct utility elicitation
A. Briggs and D. Wild and M. Lees and M. Reaney and S. Dursun and D. Parry and J. Mukherjee
Health and Quality of Life Outcomes  6    (2008)

Background To examine the impact of schizophrenia, its treatment and treatment-related adverse events related to antipsychotics, on quality of life from the perspective of schizophrenia patients and laypersons. Methods Health state descriptions for stable schizophrenia, extra pyramidal symptoms (EPS), hyperprolactinemia, diabetes, weight gain and relapse were developed based on a review of the literature and expert opinion. The quality of life impact of each health state was elicited using a time trade-off instrument administered by interview to 49 stable schizophrenia patients and 75 laypersons. Regression techniques were employed to examine the importance of subject characteristics on health-related utility scores. Results Patients and laypersons completed the interview in similar times. Stable schizophrenia had the highest mean utility (0.87 and 0.92 for laypersons and patients respectively), while relapse (0.48 and 0.60) had the lowest mean utility. Of the treatment-related adverse events, EPS had the lowest mean utility (0.57 and 0.72, respectively). Age, gender and PANSS score did not influence the utility results independently of health state. On average, patient utilities are 0.077 points higher than utilities derived from laypersons, although the ranking was similar between the two groups. Conclusions Events associated with schizophrenia and treatment of schizophrenia can bring about a significant detriment in patient quality of life, with relapse having the largest negative impact. Results indicate that patients with stable schizophrenia are less willing to trade years of life to avoid schizophrenia-related symptoms compared to laypersons. Both sets of respondents showed equal ability to complete the questionnaire.

Nagpal:2008

An exploratory study to evaluate the utility of an adapted Mother Generated Index (MGI) in assessment of postpartum quality of life in India
J. Nagpal and R. S. G. Dhar and S. Sinha and V. Bhargava and A. Sachdeva and A. Bhartia
Health and Quality of Life Outcomes  6    (2008)

Background Given the postulated advantages of mother generated index (MGI) in incorporating the patients' viewpoint and in the absence of a validated India specific postpartum quality of life assessment tool we proposed to evaluate the utility of an adapted Mother-Generated-Index in assessing postpartum quality of life (PQOL) in India. Methods The study was integrated into a community survey conducted in one district of Delhi by two-stage cluster randomized sampling to recruit women who delivered in the last 6 months. PQOL was assessed using MGI. Physical morbidity and Edinburgh- postnatal-depression-scale (EPDS) were also recorded for validation purposes. Results All subjects (249 of 282 eligible) participating in the survey were approached for the MGI evaluation which could be administered to 195 subjects due to inadequate comprehension or refusal of consent. A trend towards lower scores in lower socioeconomic stratum was observed (Primary index score-2.9, 3.7 and 4.0 in lower, middle and higher strata; Secondary Index Score-2.6, 3.2 and 3.0 in lower, middle and higher strata). 59.4% mothers had scores suggestive of possible depression (EPDS; n=172). Primary index score had a good correlation with validator scores like EPDS (p=0.024) and number of physical problems (p=0.022) while the secondary index score was only associated with EPDS score (p=0.020). Conclusion The study documents that the MGI, with its inherent advantages, is a potentially useful tool for postpartum quality of life evaluation in India especially in the absence of an alternative pre-validated tool.

Roberts:2008

The reliability and validity of the SF-8 with a conflict-affected population in Northern Uganda
B. Roberts and J. Browne and K. Ocaka and T. Oyok and E. Sondorp
Health and Quality of Life Outcomes  6    (2008)

Background The SF-8 is a health-related quality of life instrument that could provide a useful means of assessing general physical and mental health amongst populations affected by conflict. The purpose of this study was to test the validity and reliability of the SF-8 with a conflict-affected population in northern Uganda. Methods A cross-sectional multi-staged, random cluster survey was conducted with 1206 adults in camps for internally displaced persons in Gulu and Amuru districts of northern Uganda. Data quality was assessed by analysing the number of incomplete responses to SF-8 items. Response distribution was analysed using aggregate endorsement frequency. Test-retest reliability was assessed in a separate smaller survey using the intraclass correlation test. Construct validity was measured using principal component analysis, and the Pearson Correlation test for item-summary score correlation and inter-instrument correlations. Known groups validity was assessed using a two sample t-test to evaluates the ability of the SF-8 to discriminate between groups known to have, and not have, physical and mental health problems. Results The SF-8 showed excellent data quality. It showed acceptable item response distribution based upon analysis of aggregate endorsement frequencies. Test-retest showed a good intraclass correlation of 0.61 for PCS and 0.68 for MCS. The principal component analysis indicated strong construct validity and concurred with the results of the validity tests by the SF-8 developers. The SF-8 also showed strong construct validity between the 8 items and PCS and MCS summary score, moderate inter-instrument validity, and strong known groups validity. Conclusions This study provides evidence on the reliability and validity of the SF-8 amongst IDPs in northern Uganda.

Morales:2008

Psychometric properties of the Child Health Assessment Questionnaire (CHAQ) applied to children and adolescents with cerebral palsy
N. Morales and C. Funayama and V. Rangel and A. Frontarolli and R. Araujo and R. Pinto and C. Rezende and C. Silva
Health and Quality of Life Outcomes  6    (2008)

Background Cerebral palsy (CP) patients have motor limitations that can affect functionality and abilities for activities of daily living (ADL). Health related quality of life and health status instruments validated to be applied to these patients do not directly approach the concepts of functionality or ADL. The Child Health Assessment Questionnaire (CHAQ) seems to be a good instrument to approach this dimension, but it was never used for CP patients. The purpose of the study was to verify the psychometric properties of CHAQ applied to children and adolescents with CP. Methods Parents or guardians of children and adolescents with CP, aged 5 to 18 years, answered the CHAQ. A healthy group of 314 children and adolescents was recruited during the validation of the CHAQ Brazilian-version. Data quality, reliability and validity were studied. The motor function was evaluated by the Gross Motor Function Measure (GMFM). Results Ninety-six parents/guardians answered the questionnaire. The age of the patients ranged from 5 to 17.9 years (average: 9.3). The rate of missing data was low (<9.3%). The floor effect was observed in two domains, being higher only in the visual analogue scales (<35.6%). The ceiling effect was significant in all domains and particularly high in patients with quadriplegia (81.8 to 90.9%) and extrapyramidal (45.4 to 91.0%). The Cronbach alphacoefficient ranged from 0.85 to 0.95. The validity was appropriate: for the discriminant validity the correlation of the disability index with the visual analogue scales was not significant; for the convergent validity CHAQ disability index had a strong correlation with the GMFM (0.77); for the divergent validity there was no correlation between GMFM and the pain and overall evaluation scales; for the criterion validity GMFM as well as CHAQ detected differences in the scores among the clinical type of CP (p < 0.01); for the construct validity, the patients' disability index score (mean:2.16 SD:0.72) was higher than the healthy group (mean:0.12 SD:0.23)(p<0.01). Conclusion CHAQ reliability and validity were adequate to this population. However, further studies are necessary to verify the influence of the ceiling effect on the responsiveness of the instrument.

Bennett:2008

Fatness and fitness: how do they influence health-related quality of life in type 2 diabetes mellitus?
W. Bennett and P. Ouyang and A. Wu and B. Barone and K. Stewart
Health and Quality of Life Outcomes  6    (2008)

Objective We examined whether adiposity and fitness explain the decrease in health-related quality of life (HRQOL) associated with type 2 diabetes mellitus (type 2 diabetes). Methods This was a cross-sectional study using baseline data from two exercise training interventions. One study enrolled people with and the other without type 2 diabetes. We assessed aerobic fitness ("fitness") as peak oxygen uptake during treadmill testing, adiposity ("fatness") as percentage of total body fat by dual-energy x-ray absorptiometry, and HRQOL by the Medical Outcomes Study SF-36. Bivariate and multivariate linear regression analyses were used to examine determinants of HRQOL. Results There were 98 participants with and 119 participants without type 2 diabetes. Participants with type 2 diabetes had a mean hemoglobin A1c of 6.6% and, compared with participants without diabetes had lower HRQOL on the physical component summary score (P= 0.004), role-physical (P= 0.035), vitality (P= 0.062) and general health (P<0.001) scales after adjusting for age, sex and race. These associations of HRQOL with type 2 diabetes were attenuated by higher fitness, even more than reduced fatness. Only general health remained positively associated with type 2 diabetes after accounting for fatness or fitness (P=0.003). There were no significant differences between participants with and without diabetes in the mental component score. Conclusions Improved fitness, even more than reduced fatness, attenuated the association of type 2 diabetes with HRQOL. The potential to improve HRQOL may motivate patients with type 2 diabetes to engage in physical activity aimed at increasing fitness. Findings from this cross-sectional analysis will be addressed in the ongoing trial of exercise training in this cohort of participants with type 2 diabetes. Trial registration: NCT00212303

Moonesinghe:2998

Sample size requirements to detect the effect of a group of genetic variants in case-control studies
R. Moonesinghe and Q. Yang and M. Khoury
Emerging Themes in Epidemiology  5    (2998)

Background Because common diseases are caused by complex interactions among many genetic variants along with environmental risk factors, very large sample sizes are usually needed to detect such effects in case-control studies. Nevertheless, many genetic variants act in well defined biologic systems or metabolic pathways. Therefore, a reasonable first step may be to detect the effect of a group of genetic variants before assessing specific variants. Methods We present a simple method for determining approximate sample sizes required to detect the average joint effect of a group of genetic variants in a case-control study for multiplicative models. Results For a range of reasonable numbers of genetic variants, the sample size requirements for the test statistic proposed here are generally not larger than those needed for assessing marginal effects of individual variants and actually decline with increasing number of genetic variants in many situations considered in the group. Conclusions When a significant effect of the group of genetic variants is detected, subsequent multiple tests could be conducted to detect which individual genetic variants and their combinations are associated with disease risk. When testing for an effect size in a group of genetic variants, one can use our global test described in this paper, because the sample size required to detect an effect size in the group is comparatively small. Our method could be viewed as a screening tool for assessing groups of genetic variants involved in pathogenesis and etiology of common complex human diseases.

Grimaldi:2008

Indoors illumination and the seasonal changes in mood and behavior are associated with the health-related quality of life
S. Grimaldi and T. Partonen and S. Saarni and A. Aromaa and J. Lonnqvist
Health and Quality of Life Outcomes  6    (2008)

Objective Seasonal changes in mood and behavior are common in a general population, being of relevance to public health. We wanted to analyze whether the HRQoL is associated with the seasonal changes in mood and behavior. Because the shortage of exposure to daylight or artificial bright light has been linked to the occurrence of the seasonal changes, we wanted to know whether illumination indoors contributes to the HRQoL. Methods Of the sample of 7979 individuals, being representative of the Finnish general population aged 30 and over, 88% were interviewed face to face, and 84% participated in the health status examination after which the self-report assessment of the HRQoL and the seasonal changes in mood and behavior took place. The illumination levels experienced indoors were asked during the interview and the 12-item General Health Questionnaire (GHQ-12) was filled in before the health examination. Results The HRQoL was influenced by both the seasonal changes in mood and behavior (P < 0.001) and the illumination experienced indoors (P < 0.001). Greater seasonal changes (P < 0.001) and poor illumination indoors (P = 0.0035) were associated with more severe mental ill-being. Conclusion The routinely emerging seasonal changes in mood and behavior are associated with the HRQoL and mental well-being. Better illumination indoors might alleviate the season-bound symptoms and thereby enhance the HRQoL and mental well-being.

Fielding:2008

Simple imputation methods were inadequate for missing not at random (MNAR) quality of life data
S. Fielding and P. Fayers and A. McDonald and G. McPherson and M. Campbell
Health and Quality of Life Outcomes  6    (2008)

Objective QoL data were routinely collected in a randomised controlled trial (RCT), which employed a reminder system, retrieving about 50% of data originally missing. The objective was to use this unique feature to evaluate possible missingness mechanisms and to assess the accuracy of simple imputation methods. Methods Those patients responding after reminder were regarded as providing missing responses. A hypothesis test and a logistic regression approach were used to evaluate the missingness mechanism. Simple imputation procedures were carried out on these missing scores and the results compared to the actual observed scores. Results The hypothesis test and logistic regression approaches suggested the reminder data were missing not at random (MNAR). Reminder-response data showed that simple imputation procedures utilising information collected close to the point of imputation (last value carried forward, next value carried backward and last-and-next), were the best methods in this setting. However, although these methods were the best of the simple imputation procedures considered, they were not sufficiently accurate to be confident of obtaining unbiased results under imputation. Conclusion The use of the reminder data enabled the conclusion of possible MNAR data. Evaluating this mechanism was important in determining if imputation was useful. Simple imputation was shown to be inadequate if MNAR are likely and alternative strategies should be considered.

Cano:2008

The Cervical Dystonia Impact Profile: Can a Rasch developed Patient Reported Outcome Measure satisfy traditional psychometric criteria?
S. Cano and T. Warner and A. Thompson and K. Bhatia and R. Fitzpatrick and J. Hobart
Health and Quality of Life Outcomes  6    (2008)

Background The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data < 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha > 0.92, test-retest intraclass correlations > 0.83); and 5) validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.

Roizen:2008

Initial validation of the Argentinean Spanish version of the PedsQLTM 4.0 Generic Core Scales in children and adolescents with chronic diseases: Acceptability and comprehensibility in low-income settings
M. Roizen and S. Rodriguez and G. Bauer and G. Medin and S. Bevilacqua and J. Varni and V. Dussel
Health and Quality of Life Outcomes  6    (2008)

Background To validate the Argentinean Spanish version of the PedsQL(TM) 4.0 Generic Core Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of socio-demographic characteristics on the instrument's comprehensibility and acceptability. Reliability, and known-groups, and convergent validity were tested. Methods Consecutive sample of 287 children with chronic conditions and 105 healthy children, ages 2-18, and their parents. Chronically ill children were: (1) attending outpatient clinics and (2) had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease, HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy. Patients and adult proxies completed the PedsQL(TM) 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. Results The PedsQL(TM) 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete the instrument), easy to administer, completed without, or with minimal, help by most children and parents, and required a brief administration time (average 5--6 minutes). People living below the poverty line and/or low literacy needed more help to complete the instrument. Cronbach Alpha's internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of children over 8 years-old and parent-reports of children over 5 years of age. Reliability of proxy-reports of 2-4 year-olds was low but improved when school items were excluded. Internal consistency for 5-7 year-olds was low (alpha range = 0.28-0.76). Construct validity was good. Child self-report and parent proxy-report PedsQL(TM) 4.0 scores were moderately but significantly correlated (rho = 0.39, p < 0.0001) and both significantly correlated with physician's assessment of health impairment and with child self-reported overall health status. The PedsQL(TM) 4.0 discriminated between healthy and chronically ill children (72.72 and 66.87, for healthy and ill children, respectively, p = 0.01), between different chronic health conditions, and children from lower socioeconomic status. Conclusion Results suggest that the Argentinean Spanish PedsQL(TM) 4.0 is suitable for research purposes in the public health setting for children over 8 years old and parents of children over 5 years old. People with low income and low literacy need help to complete the instrument. Steps to expand the use of the Argentinean Spanish PedsQL(TM) 4.0 include an alternative approach to scoring for the 2-4 year-olds, further understanding of how to increase reliability for the 5-7 year-olds self-report, and confirmation of other aspects of validity.

Busija:2008

Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery
L. Busija and R. Osborne and A. Nilsdotter and R. Buchbinder and E. Roos
Health and Quality of Life Outcomes  6    (2008)

Background The Medical Outcomes General Health Survey (SF-36) is a widely used health status measure; however, limited evidence is available for its performance in orthopedic settings. The aim of this study was to examine the magnitude and meaningfulness of change and sensitivity of SF-36 subscales following orthopedic surgery. Methods Longitudinal data on outcomes of total hip replacement (THR, n = 255), total knee replacement (TKR, n = 103), arthroscopic partial meniscectomy (APM, n = 74) and anterior cruciate ligament reconstruction (ACL, n = 62) were used to estimate the effect sizes (ES, magnitude of change) and minimal detectable change (sensitivity) at the group and individual level. To provide context for interpreting the magnitude of changes in SF-36 scores, we also compared patients' scores with age and sex-matched population norms. The studies were conducted in Sweden. Follow-up was five years in THR and TKR studies, two years in ACL, and three months in APM. Results On average, large effect sizes (ES>0.80) were found after orthopedic surgery in SF-36 subscales measuring physical aspects (physical functioning, role physical, and bodily pain). Small (0.20-0.49) to moderate (0.50-0.79) effect sizes were found in subscales measuring mental and social aspects (role emotional, vitality, social functioning, and mental health). General health scores remained relatively unchanged during the follow-up. Despite improvements, post-surgery mean scores of patients were still below the age and sex matched population norms on physical subscales. Patients' scores on mental and social subscales approached population norms following the surgery. At the individual level, scores of a large proportion of patients were affected by floor or ceiling effects on several subscales and the sensitivity to individual change was very low. Conclusion Large to moderate meaningful changes in group scores were observed in all SF-36 subscales except General Health across the intervention groups. Therefore, in orthopedic settings, the SF-36 can be used to show changes for groups in physical, mental, and social dimensions and in comparison with population norms. However, SF-36 subscales have low sensitivity to individual change and so we caution against using SF-36 to monitor the health status of individual patients undergoing orthopedic surgery.

Lim:2008

Thai SF-36 health survey: tests of data quality, scaling assumptions, reliability and validity in healthy men and women
L. Lim and S. Seubsman and A. Sleigh
Health and Quality of Life Outcomes  6    (2008)

Background Since its translation to Thai in 2000, the SF-36 Health Survey has been used extensively in many different clinical settings in Thailand. Its popularity has increased despite the absence of published evidence that the translated instrument satisfies scoring assumptions, the psychometric properties required for valid interpretation of the SF-36 summated ratings scales. The purpose of this paper was to examine these properties and to report on the reliability and validity of the Thai SF-36 in a non-clinical general population. Methods 1345 distance-education university students who live in all areas of Thailand completed a questionnaire comprising the Thai SF-36 (Version 1). Median age was 31 years. Psychometric tests recommended by the International Quality of Life Assessment Project were used. Results Data quality was satisfactory: questionnaire completion rate was high (97.5%) and missing data rates were low (< 1.5% for all items). The ordering of item means within scales generally were clustered as hypothesized and scaling assumptions were satisfied. Known groups analysis showed good discriminant validity between subgroups of healthy persons with differing health states. However, some areas of concern were revealed. Possible translation problems of the Physical Functioning (PF) items were indicated by the comparatively low ceiling effects. High ceiling and floor effects were seen in both role functioning scales, possibly due to the dichotomous format of their response choices. The Social Functioning scale had a low reliability of 0.55, which may be due to cultural differences in the concept of social functioning. The Vitality scale correlated better with the Mental Health scale than with itself, possibly because a healthy mental state is central to the concept of vitality in Thailand. Conclusion The summated ratings method can be used for scoring the Thai SF-36. The instrument was found to be reliable and valid for use in a general non-clinical population. Version 2 of the SF-36 could improve ceiling and floor effects in the role functioning scales. Further work is warranted to refine items that measure the concepts of social functioning, vitality and mental health to improve the reliability and discriminant validity of these scales.

Machnicki:2008

Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort
G. Machnicki and J. pefaur and L. Gaite and A. Linchenko and C. Raimondi and R. Schiavelli and A. Otero and M. Margolis
Health and Quality of Life Outcomes  6    (2008)

Background Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. Patients on different immunosuppressant regimens may feel less bothered by Gastrointestinal (GI) side effects or report better health-related quality of life (HRQL). We evaluated the reliability and validity of two GI-specific outcome instruments (Gastrointestinal Symptom Rating Scale (GSRS; higher scores = increased severity) and Gastrointestinal Quality of Life Index (GIQLI; higher scores = better GI-specific HRQL)) in renal transplant patients in South America. Methods Data from 5 South American centers participating in an international, longitudinal, observational study were analyzed. Patients were > 1 month post transplant and on mycophenolate mofetil (MMF) and a calcineurin inhibitor. Patients completed the GSRS, GIQLI, and Psychological General Well-Being (PGWB; higher scores = better HRQL) Index at baseline and at 4-6 weeks. Internal consistency, test-retest reliability and construct and discriminant validity were assessed. Results Sixty-two participants were enrolled. Mean age was 42 years; mean time since transplant was 3.3 years; 57% were male; 65% received a deceased organ transplant and 68%had GI events. The GSRS and GIQLI demonstrated high internal consistency (Cronbach's alphas 0.72--0.96). Test-retest reliability was adequate (intraclass correlation coefficient > 0.6) for all GIQLI subscales and all GSRS subscales except Diarrhea and Reflux syndrome. Correlations between the GSRS and PGWB were moderate (range: -0.21 to -0.53, all p < 0.001 except 6 correlations with p < 0.05); correlations between the GIQLI and PGWB were higher (range: 0.36 to 0.71 p < 0.001), indicating good construct validity. The GSRS and GIQLI demonstrated good discriminant validity, as they clinically and statistically distinguished between patients with and without GI complaints and among patients with varying GI complication severity. Patients with GI complaints reported higher GSRS scores than patients without complaints (all p < 0.001). GIQLI scores were lower in patients with GI complaints than patients without complaints (all p < 0.001). The GSRS and GIQLI differentiated among patients with four GI severity levels (overall Kruskall-Wallis test p < 0.001, except for one scale). The GSRS and GIQLI are acceptable for use in South American renal transplant patients. These two instruments demonstrate adequate reliability and validity. Patients with GI complaints reported poor HRQL and strategies are needed to improve patients' HRQL.

Schneider:2008

Social aspects of living with rheumatoid arthritis: a qualitative descriptive study in Soweto, South Africa - a low resource context
M. Schneider and E. Manabile and M. Tikly
Health and Quality of Life Outcomes  6    (2008)

Background Rheumatoid Arthritis (RA) is a chronic illness with important functional, social and employment consequences. We therefore undertook a cross-sectional study, using the International Classification of Functioning, Disability and Health framework, to investigate the personal and social consequences of RA in women, living under largely impoverished conditions. Methods A qualitative case study design was used with a convenience sample of 60 women with RA living in Soweto, South Africa. Semi-structured in-depth interviews were conducted to cover a range of experiences including onset of disease, treatment, environmental barriers and facilitators, employment, and social inclusion in family and community life. The outcomes are described according the International Classification of Functioning, Health and Disability framework at the body, person and societal levels and looking at both personal and environmental factors. Results The main features of living with RA were pain, muscle stiffness at the body level, difficulties in doing various activities such as mobility, washing, dressing, domestic activities, using transport and obtaining and maintaining employment at the person level. At the societal level the participants described difficulties moving around, interacting socially and taking part in community activities, fulfilling social roles and earning a living. Environmental facilitators such as assistive devices and health care services improved functioning. Barriers such as physical environments, lack of transport and basic services, such as electricity, and attitudes of others lead to social exclusion, loss of a sense of self and independence. Low income, lack of sufficient public transport, and sparse basic services were poverty features that exacerbated negative experiences. Conclusion The experiences of living with RA in a low resource context are similar to those in mid- and high resource contexts, but are exacerbated by poverty and the lack of basic services. Pain and social exclusion are some of the key experiences of women with RA living in Soweto. The ICF provides a useful framework for describing and understanding the complexity of these experiences.

Jiang:2008

Patterns of health-related quality of life and patterns associated with health risks among Rhode Island adults
Y. Jiang and J. Hesser
Health and Quality of Life Outcomes  6    (2008)

Background Health-related quality of life (HRQOL) has become an important consideration in assessing the impact of chronic disease on individuals as well as in populations. HRQOL is often assessed using multiple indicators. The authors sought to determine if multiple indicators of HRQOL could be used to characterize patterns of HRQOL in a population, and if so, to examine the association between such patterns and demographic, health risk and health condition covariates. Methods Data from Rhode Island's 2004 Behavioral Risk Factor Surveillance System (BRFSS) were used for this analysis. The BRFSS is a population-based random-digit-dialed telephone survey of adults ages 18 and older. In 2004 RI's BRFSS interviewed 3,999 respondents. A latent class regression (LCR) model, using 9 BRFSS HRQOL indicators, was used to determine latent classes of HRQOL for RI adults and to model the relationship between latent class membership and covariates. Results RI adults were categorized into four latent classes of HRQOL. Class 1 (76%) was characterized by good physical and mental HRQOL; Class 2 (9%) was characterized as having physically related poor HRQOL; Class 3 (11%) was characterized as having mentally related poor HRQOL; and Class 4 (4%) as having both physically and mentally related poor HRQOL. Class 2 was associated with older age, being female, unable to work, disabled, or unemployed, no participation in leisure time physical activity, or with having asthma or diabetes. Class 3 was associated with being female, current smoking, or having asthma or disability. Class 4 was associated with almost all the same predictors of Classes 2 and 3, i.e. older age, being female, unable to work, disabled, or unemployed, no participation in leisure time physical activity, current smoking, with having asthma or diabetes, or with low income. Conclusion Using a LCR model, the authors found 4 distinct patterns of HRQOL among RI adults. The largest class was associated with good HRQOL; three smaller classes were associated with poor HRQOL. We identified the characteristics of subgroups at higher-risk for each of the three classes of poor HRQOL. Focusing interventions on the high-risk populations may be one approach to improving HRQOL in RI.

Ganova-Iolovska:2008

Satisfaction of inpatients with acute coronary syndrome in Bulgaria
M. Ganova-Iolovska and K. Kalinov and M. Geraedts
Health and Quality of Life Outcomes  6    (2008)

Background Patient satisfaction constitutes an important indicator for the quality of care. During the last years, Bulgaria changed its socialist health care system to a market-driven system. Despite the fact that the improvement of health care quality and patient satisfaction were put on top of the list of goals for the health care reforms, no studies of patient satisfaction with inpatient care have been conducted so far. Since cardiovascular diseases are amongst the major causes of death in Bulgaria, and strenuous efforts have been made to improve the quality of medical care of patients with acute coronary syndrome (ACS) during the last years, patient satisfaction in this group can be seen as an important example of the Bulgarian reforms. This study therefore investigates patient satisfaction of inpatients with ACS. Methods We performed structured face-to-face interviews with all patients with ACS, residing in a representative Bulgarian region who were discharged from hospitals in this region between September 1st and December 31st, 2004. We surveyed their socio-demographic status, overall satisfaction, change in complaints, self-perceived health status, functional possibilities in activities of daily living, satisfaction with life and self-reported condition at admission. We used descriptive methods as well as t-tests, chi-square tests, and logit models for data analysis. Results Face-to-face interviews were carried out in 394 cases, of which 53.6% were men and 46.4% were women. 24% of the patients were satisfied with inhospital treatment, 62% were satisfied to some extent, and 14% were unsatisfied. The overall satisfaction of patients with ACS was significantly associated (p < 0.05) with the type of hospital, the number of family members living together and the severity of the disease at admission. Patients treated in urban and middle-size rural hospitals, patients living together with three or more family members, and patients with more severe conditions at admission reported higher satisfaction scores. Conclusion ACS patient satisfaction with inhospital treatment in Bulgaria shows much room for improvement. Information obtained from satisfaction studies could be used at decision-making and hospital-management levels for improving new strategies and structural changes in the Bulgarian health care system.

Barton:2008

Do estimates of cost-utility based on the EQ-5D differ from those based on the mapping of utility scores?
G. Barton and T. Sach and C. Jenkinson and A. Avery and M. Doherty and K. Muir
Health and Quality of Life Outcomes  6    (2008)

Background Mapping has been used to convert scores from condition-specific measures into utility scores, and to produce estimates of cost-effectiveness. We sought to compare the QALY gains, and incremental cost per QALY estimates, predicted on the basis of mapping to those based on actual EQ-5D scores. Methods In order to compare 4 different interventions 389 individuals were asked to complete both the EQ-5D and the Western Ontartio and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 6, 12, and 24 months post-intervention. Using baseline data various mapping models were developed, where WOMAC scores were used to predict the EQ-5D scores. The performance of these models was tested by predicting the EQ-5D post-intervention scores. The preferred model (that with the lowest mean absolute error (MAE)) was used to predict the EQ-5D scores, at all time points, for individuals who had complete WOMAC and EQ-5D data. The mean QALY gain associated with each intervention was calculated, using both actual and predicted EQ-5D scores. These QALY gains, along with previously estimated changes in cost, were also used to estimate the actual and predicted incremental cost per QALY associated with each of the four interventions. Results The EQ-5D and the WOMAC were completed at baseline by 348 individuals, and at all time points by 259 individuals. The MAE in the preferred model was 0.129, and the mean QALY gains for each of the four interventions was predicted to be 0.006, 0.058, 0.058, and 0.136 respectively, compared to the actual mean QALY gains of 0.087, 0.081, 0.120, and 0.149. The most effective intervention was estimated to be associated with an incremental cost per QALY of £6,068, according to our preferred model, compared to £13,154 when actual data was used. Conclusion We found that actual QALY gains, and incremental cost per QALY estimates, differed from those predicted on the basis of mapping. This suggests that though mapping may be of value in predicting the cost-effectiveness of interventions which have not been evaluated using a utility measure, future studies should be encouraged to include a method of actual utility measurement. Trial registration Current Controlled Trials ISRCTN93206785

Garratt:2008

Development of the Knee Quality of Life (KQoL-26) 26-item questionnaire: data quality, reliability, validity and responsiveness
A. Garratt and S. Brealey and M. Robling and C. Atwell and I. Russell and W. Gillespie and D. King
Health and Quality of Life Outcomes  6    (2008)

Background This article describes the development and validation of a self-reported questionnaire, the KQoL-26, that is based on the views of patients with a suspected ligamentous or meniscal injury of the knee that assesses the impact of their knee problem on the quality of their lives. Methods Patient interviews and focus groups were used to derive questionnaire content. The instrument was assessed for data quality, reliability, validity, and responsiveness using data from a randomised trial and patient survey about general practitioners' use of Magnetic Resonance Imaging for patients with a suspected ligamentous or meniscal injury. Results Interview and focus group data produced a 40-item questionnaire designed for self-completion. 559 trial patients and 323 survey patients responded to the questionnaire. Following principal components analysis and Rasch analysis, 26 items were found to contribute to three scales of knee-related quality of life: physical functioning, activity limitations, and emotional functioning. Item-total correlations ranged from 0.60--0.82. Cronbach's alpha and test retest reliability estimates were 0.91--0.94 and 0.80--0.93 respectively. Hypothesised correlations with the Lysholm Knee Scale, EQ-5D, SF-36 and knee symptom questions were evidence for construct validity. The instrument produced highly significant change scores for 65 trial patients indicating that their knee was a little or somewhat better at six months. The new instrument had higher effect sizes (range 0.86--1.13) and responsiveness statistics (range 1.50--2.13) than the EQ-5D and SF-36. Conclusion The KQoL-26 has good evidence for internal reliability, test-retest reliability, validity and responsiveness, and is recommended for use in randomised trials and other evaluative studies of patients with a suspected ligamentous or meniscal injury.

Weiss:2008

Persisting with prevention: The importance of adherence for HIV prevention
H. Weiss and J. Wasserheit and R. Barnabas and R. Hayes and L. Abu-Raddad
Emerging Themes in Epidemiology  5    (2008)

Background Only four out of 31 completed randomized controlled trials (RCTs) of HIV prevention strategies against sexual transmission have shown significant efficacy. Poor adherence may have contributed to the lack of effect in some of these trials. In this paper we explore the impact of various levels of adherence on measured efficacy within an RCT. Analysis We used simple quantitative methods to illustrate the impact of various levels of adherence on measured efficacy by assuming a uniform population in terms of sexual behavior and the binomial model for the transmission probability per partnership. At 100% adherence the measured efficacy within an RCT is a reasonable approximation of the true biological efficacy. However, as adherence levels fall, the efficacy measured within a trial substantially under-estimates the true biological efficacy. For example, at 60% adherence, the measured efficacy can be less than half of the true biological efficacy. Conclusion Poor adherence during a trial can substantially reduce the power to detect an effect, and improved methods of achieving and maintaining high adherence within trials are needed. There are currently 12 ongoing HIV prevention trials, all but one of which require ongoing user-adherence. Attention must be given to methods of maximizing adherence when piloting and designing RCTs and HIV prevention programmes.

Phillips:2008

(Errors in Statistical Tests)^3
C. Phillips and R. MacLehose and J. Kaufman
Emerging Themes in Epidemiology  5    (2008)

In 2004, Garcia-Berthou and Alcaraz published "Incongruence between test statistics and P values in medical papers," a critique of statistical errors that received a tremendous amount of attention. One of their observations was that the final reported digit of p-values in articles published in the journal Nature departed substantially from the uniform distribution that they suggested should be expected. In 2006, Jeng critiqued that critique, observing that the statistical analysis of those terminal digits had been based on comparing the actual distribution to a uniform continuous distribution, when digits obviously are discretely distributed. Jeng corrected the calculation and reported statistics that did not so clearly support the claim of a digit preference. However delightful it may be to read a critique of statistical errors in a critique of statistical errors, we nevertheless found several aspects of the whole exchange to be quite troubling, prompting our own meta-critique of the analysis. The previous discussion emphasized statistical significance testing. But there are various reasons to expect departure from the uniform distribution in terminal digits of p-values, so that simply rejecting the null hypothesis is not terribly informative. Much more importantly, Jeng found that the original p-value of 0.043 should have been 0.086, and suggested this represented an important difference because it was on the other side of 0.05. Among the most widely reiterated (though often ignored) tenets of modern quantitative research methods is that we should not treat statistical significance as a bright line test of whether we have observed a phenomenon. Moreover, it sends the wrong message about the role of statistics to suggest that a result should be dismissed because of limited statistical precision when it is so easy to gather more data. In response to these limitations, we gathered more data to improve the statistical precision, and analyzed the actual pattern of the departure from uniformity, not just its test statistics. We found variation in digit frequencies in the additional data and describe the distinctive pattern of these results. Furthermore, we found that the combined data diverge unambiguously from a uniform distribution. The explanation for this divergence seems unlikely to be that suggested by the previous authors: errors in calculations and transcription.

Williams:2008

Hispanic Latin America, Spain and the Spanish-speaking Caribbean: a rich source of reference material for public health, epidemiology and tropical medicine
J. Williams and A. Borquez and M. Basanez
Emerging Themes in Epidemiology  5    (2008)

Anema:2008

Widespread rape does not directly appear to increase the overall HIV prevalence in conflict-affected countries: So now what?
A. Anema and M. Joffres and E. Mills and P. Spiegel
Emerging Themes in Epidemiology  5    (2008)

Background Sub-Saharan Africa (SSA) is severely affected by HIV/AIDS and conflict. Sexual violence as a weapon of war has been associated with concerns about heightened HIV incidence among women. Widespread rape by combatants has been documented in Burundi, Sierra Leone, Rwanda, Democratic Republic of Congo, Liberia, Sudan and Uganda. To examine the assertion that widespread rape may not directly increase HIV prevalence at the population level, we built a model to determine the potential impact of varying scenarios of widespread rape on HIV prevalence in the above seven African countries. Discussion Our findings show that even in the most extreme situations, where 15% of the female population was raped, where HIV prevalence among assailants was 8 times the country population prevalence, and where the HIV transmission rate was highest at 4 times the average high rate, widespread rape increased the absolute HIV prevalence of these countries by only 0.023%. These projections support the finding that widespread rape in conflict-affected countries in SSA has not incurred a major direct population-level change in HIV prevalence. However, this must not be interpreted to say that widespread rape does not pose serious problems to women's acquisition of HIV on an individual basis or in specific settings. Furthermore, direct and indirect consequences of sexual violence, such as physical and psychosocial trauma, unwanted pregnancies, and stigma and discrimination cannot be understated. Summary The conclusions of this article do not significantly change current practices in the field from an operational perspective. Proper care and treatment must be provided to every survivor of rape regardless of the epidemiological effects of HIV transmission at the population level. Sexual violence must be treated as a protection issue and not solely a reproductive health and psychosocial issue. It is worth publishing data and conclusions that could be misconstrued and may not make much of a programmatic difference in the field. Data, if collected, analysed and interpreted carefully, help to improve our understanding of complicated and nuanced situations. Ultimately, our understanding of what the outcomes of such interventions can achieve will be more realistic. It also helps decision-makers prioritise their funding and interventions.

Barakat:2008

Quality of life among adolescents with sickle cell disease: mediation of pain by internalizing symptoms and parenting stress
L. Barakat and L. Daniel and C. Patterson and C. Dampier
Health and Quality of Life Outcomes  6    (2008)

Background This study aimed to clarify associations between pain, psychological adjustment, and family functioning with health-related quality of life (HRQOL) in a sample of adolescents with sickle cell disease (SCD) utilizing teen- and parent-report. Methods Forty-two adolescents (between the ages of 12 and 18) with SCD and their primary caregivers completed paper-and-pencil measures of pain, teen's psychological adjustment, and HRQOL. In addition, primary caregivers completed a measure of disease-related parenting stress. Medical file review established disease severity. Results Pearson correlations identified significant inverse associations of pain frequency with physical and psychosocial domains of HRQOL as rated by the teen and primary caregiver. Generally, internalizing symptoms (i.e. anxiety and depression) and disease-related parenting stress were also significantly correlated with lower HRQOL. Examination of possible mediator models via a series of regression analyses confirmed that disease-related parenting stress served as a mediator between pain frequency and physical and psychosocial HRQOL. Less consistent were findings for mediation models involving internalizing symptoms. For these, parent-rated teen depression and teen anxiety served as mediators of the association of pain frequency and HRQOL. Conclusion Results are consistent with extant literature that suggests the association of pain and HRQOL and identify concomitant pain variables of internalizing symptoms and family variables as mediators. Efforts to improve HRQOL should aim to address internalizing symptoms associated with pain as well as parenting stress in the context of SCD management.

Voss:2008

Integration of immigrants into a new culture is related to poor sleep quality
U. Voss and I. Tuin
Health and Quality of Life Outcomes  6    (2008)

Background This article reports on the relationship between cultural influences on life style, coping style, and sleep in a sample of female Portuguese immigrants living in Germany. Sleep quality is known to be poorer in women than in men, yet little is known about mediating psychological and sociological variables such as stress and coping with stressful life circumstances. Migration constitutes a particularly difficult life circumstance for women if it involves differing role conceptions in the country of origin and the emigrant country. Methods The study investigated sleep quality, coping styles and level of integration in a sample of Portuguese (N = 48) and Moroccan (N = 64) immigrant women who took part in a structured personal interview. Results Sleep quality was poor in 54% of Portuguese and 39% of Moroccan women, which strongly exceeds reports of sleep complaints in epidemiologic studies of sleep quality in German women. Reports of poor sleep were associated with the degree of adoption of a German life style. Women who had integrated more into German society slept worse than less integrated women in both samples, suggesting that non-integration serves a protective function. An unusually large proportion of women preferred an information-seeking (monitoring) coping style and adaptive coping. Poor sleep was related to high monitoring in the Portuguese but not the Moroccan sample. Conclusion Sleep quality appears to be severely affected in women with a migration background. Our data suggest that non-integration may be less stressful than integration. This result points to possible benefits of non-integration. The high preference for an information-seeking coping style may be related to the process of migration, representing the attempt at regaining control over an uncontrollable and stressful life situation.

Crawford:2008

Conceptual adequacy of the neuropathic pain symptom inventory in six countries
B. Crawford and D. Bouhassira and A. Wong and E. Dukes
Health and Quality of Life Outcomes  6    (2008)

Background Neuropathic pain results from a nerve lesion or nerve damage. Because it is a subjective experience, patient-reported outcomes may measure both the symptoms and impact on the patient's life. The purpose of this study was to determine whether the Neuropathic Pain Symptom Inventory (NPSI) adequately assesses neuropathic pain symptoms in patients with diabetic peripheral neuropathy, post-herpetic neuralgia, trigeminal neuralgia, and sciatica across multiple cultures. Methods From data collected from 132 subjects in 6 countries, qualitative research methods identified their most important symptoms (and verbal descriptions) associated with neuropathic pain. A core set of commonly described symptoms spanning multiple cultures was also described. Moderators using a semi-structured discussion guide conducted focus groups consisting of patients in the U.S., Brazil, Japan, China, Finland, and Spain to elicit concepts that were most important and relevant (concept elicitation phase). Study subjects ranked the importance of each neuropathic pain symptom, completed the NPSI, and commented on its ability to capture key symptoms (face and content validation phase). Results Descriptive terms for sensations of neuropathic pain were similar in all countries; burning, electric shocks, and pins and needles were among the most-common sensations. Individuals with neuropathic pain experienced all sensations that were included in the NPSI. They also tended to describe pins and needles and numbness interchangeably, perhaps reflecting the relative number of DPN subjects on study. Conclusion Based on data from these focus groups, the NPSI is an acceptable instrument for assessing neuropathic pain.

Morton:2008a

The de Morton Mobility Index (DEMMI): an essential health index for an ageing world
N. de Morton and M. Davidson and J. Keating
Health and Quality of Life Outcomes  6    (2008)

Background Existing instruments for measuring mobility are inadequate for accurately assessing older people across the broad spectrum of abilities. Like other indices that monitor critical aspects of health such as blood pressure tests, a mobility test for all older acute medical patients provides essential health data. We have developed and validated an instrument that captures essential information about the mobility status of older acute medical patients. Methods Items suitable for a new mobility instrument were generated from existing scales, patient interviews and focus groups with experts. 51 items were pilot tested on older acute medical inpatients. An interval-level unidimensional mobility measure was constructed using Rasch analysis. The final item set required minimal equipment and was quick and simple to administer. The de Morton Mobility Index (DEMMI) was validated on an independent sample of older acute medical inpatients and its clinimetric properties confirmed. Results The DEMMI is a 15 item unidimensional measure of mobility. Reliability (MDC90), validity and the minimally clinically important difference (MCID) of the DEMMI were consistent across independent samples. The MDC90 and MCID were 9 and 10 points respectively (on the 100 point Rasch converted interval DEMMI scale). Conclusion The DEMMI provides clinicians and researchers with a valid interval-level method for accurately measuring and monitoring mobility levels of older acute medical patients. DEMMI validation studies are underway in other clinical settings and in the community. Given the ageing population and the importance of mobility for health and community participation, there has never been a greater need for this instrument.

Bernabe:2008

Comparison of the discriminative ability of a generic and a condition-specific OHRQoL measure in adolescents with and without normative need for orthodontic treatment
E. Bernabe and C. de Oliveira and A. Sheiham
Health and Quality of Life Outcomes  6    (2008)

Background At present, there is no evidence on whether using condition-specific Oral Health-Related Quality of Life (OHRQoL) measures provides more reliable information than generic measures for needs assessment. Therefore, the objective was to assess the discriminative ability of one generic and one condition-specific OHRQoL measure, namely, respectively, the short form of the Oral Health Impact Profile (OHIP-14) and the Condition-Specific form of the Oral Impacts on Daily Performances (CS-OIDP) attributed to malocclusion, between adolescents with and without normative need for orthodontic treatment. Methods 200 16--17-year-old adolescents were randomly selected from 957 schoolchildren attending a Sixth Form College in London, United Kingdom. The impact of their oral conditions on quality of life during the last 6 months was assessed using two OHRQoL measures; OHIP-14 and OIDP. Adolescents were also examined for normative orthodontic treatment need using the Index of Orthodontic Treatment Need (IOTN) and the Dental Aesthetic Index (DAI). Discriminative ability was assessed comparing the overall scores and prevalence of oral impacts, calculated using each OHRQoL measure, between adolescents with and without normative need. Using the prevalence of oral impacts allowed adjusting for covariates. Results There were significant differences in overall scores for CS-OIDP attributed to malocclusion between adolescents with and without normative need for orthodontic treatment when IOTN or DAI were used to define need (p = 0.029 or 0.011 respectively), and in overall scores for OHIP-14 when DAI, but not IOTN was used to define need (p = 0.029 and 0.080 respectively). For the prevalence of impacts, only the prevalence of CS-OIDP attributed to malocclusion differed significantly between adolescents with and without normative need, even after adjusting for covariates (p = 0.017 and 0.049 using IOTN and DAI to define need). Conclusion CS-OIDP attributed to malocclusion was better able than OHIP-14 to discriminate between adolescents with and without normative needs for orthodontic treatment.

McKenna:2008

Development and validation of a preference based measure derived from the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for use in cost utility analyses
S. McKenna and J. Ratcliffe and D. Meads and J. Brazier
Health and Quality of Life Outcomes  6    (2008)

Background Pulmonary Hypertension is a severe and incurable disease with poor prognosis. A suite of new disease-specific measures -- the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) -- was recently developed for use in this condition. The purpose of this study was to develop and validate a preference based measure from the CAMPHOR that could be used in cost-utility analyses. Methods Items were selected that covered major issues covered by the CAMPHOR QoL scale (activities, travelling, dependence and communication). These were used to create 36 health states that were valued by 249 people representative of the UK adult population, using the time trade-off (TTO) technique. Data from the TTO interviews were analysed using both aggregate and individual level modelling. Finally, the original CAMPHOR validation data were used to validate the new preference based model. Results The predicted health state values ranged from 0.962 to 0.136. The mean level model selected for analyzing the data had good explanatory power (0.936), did not systematically over- or underestimate the observed mean health state values and showed no evidence of auto correlation in the prediction errors. The value of less than 1 reflects a background level of ill health in state 1111, as judged by the respondents. Scores derived from the new measure had excellent test-retest reliability (0.85) and construct validity. The CAMPHOR utility score appears better able to distinguish between WHO functional classes (II and III) than the EQ-5D and SF-6D. Conclusion The tariff derived in this study can be used to classify an individual into a health state based on their responses to the CAMPHOR. The results of this study widen the evidence base for conducting economic evaluations of interventions designed to improve QoL for patients with PH.

Yost:2008

Predictors of health-related quality of life in patients with colorectal cancer
K. Yost and E. Hahn and A. Zaslavsky and J. Ayanian and D. West
Health and Quality of Life Outcomes  6    (2008)

Background Most studies that have identified variables associated with the health-related quality of life (HRQL) of patients with colorectal cancer have been cross-sectional or included patients with other diagnoses. The objectives of this study were to identify predictors of HRQL in patients with colorectal cancer and interpret the clinical importance of the results. Methods We conducted a population-based longitudinal study of patients identified through three regions of the California Cancer Registry. Surveys were completed by 568 patients approximately 9 and 19 months post-diagnosis. Three HRQL outcomes from the Functional Assessment of Cancer Therapy -- Colorectal (FACT-C) were evaluated: social/family well-being (SWB), emotional well-being (EWB) and the Trial Outcome Index (TOI), which is a colorectal cancer-specific summary measure of physical function and well-being. Sociodemographic, cancer/health, and healthcare variables were assessed in multivariable regression models. We computed the difference in predicted HRQL scores corresponding to a large difference in a predictor variable, defined as a 1 standard deviation difference for interval variables or the difference relative to the reference category for nominal variables. The effect of an explanatory variable on HRQL was considered clinically meaningful if the predicted score difference was at least as large as the minimally important difference. Results Common predictors of better TOI, SWB and EWB were better general health and factors related to better perceived quality of cancer care. Predictor variables in addition to general health and perceived quality of care were identified only for SWB. Being married/living as married was associated with better SWB, whereas being male or of Hispanic ethnicity was associated with worse SWB. Among the sociodemographic, cancer/health, and healthcare variables evaluated, only Hispanic ethnicity had a clinically meaningful effect on an HRQL outcome. Conclusion Our findings, particularly the information on the clinical importance of predictor variables, can help clinicians identify patients who may be at risk for poor future HRQL. Potentially modifiable factors were related to perceived quality of cancer care; thus, future research should evaluate whether improving these factors improves HRQL.

Ziemssen:2008

Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis
T. Ziemssen and J. Hoffmann and R. Apfel and S. Kern
Health and Quality of Life Outcomes  6    (2008)

Objectives Treatment of multiple sclerosis patients with glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of glatiramer acetate on fatigue and work absenteeism. Methods 291 treatment-naïve patients with relapsing remitting multiple sclerosis were included and treated with glatiramer acetate for twelve months. Relapse rates, disability, fatigue symptoms, days of absence from work and adverse events were monitored. Fatigue was measured with the MFIS scale and with a visual analogue scale. Results Total MFIS scores decreased by 7.6 +/- 16.4 from 34.6 to 27.0 (p < 0.001). Significant reductions were observed on all three subscales of the MFIS. Fatigue symptoms, assessed using a visual analogue scale, decreased by 1.04 +/- 2.88 cm from 4.47 cm to 3.43 cm (p < 0.001). The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1% (p < 0.001). Tolerance to treatment was rated as very good or good in 78.3% of patients. Adverse effects, most frequently local injection site reactions, were reported in 15.1% of patients. Conclusion Treatment with glatiramer acetate was associated with a significant improvement in fatigue symptoms and a marked reduction in absence from work. Treatment was well-tolerated. Such benefits are of relevance to overall patient well-being.

Castro:2008

Child-OIDP index in Brazil: cross-cultural adaptation and validation
R. Castro and M. Cortes and A. Leao and M. Portela and I. Souza and G. Tsakos and W. Marcenes and A. Sheiham
Health and Quality of Life Outcomes  6    (2008)

Background Oral health-related quality of life (OHRQoL) measures are being increasingly used to introduce dimensions excluded by normative measures. Consequently, there is a need for an index which evaluates children's OHRQoL validated for Brazilian population, useful for oral health needs assessments and for the evaluation of oral health programs, services and technologies. The aim of this study was to do a cross-cultural adaptation of the Child Oral Impacts on Daily Performances (Child-OIDP) index, and assess its reliability and validity for application among Brazilian children between the ages of eleven and fourteen. Methods For cross-cultural adaptation, a translation/back-translation method integrated with expert panel reviews was applied. A total of 342 students from four public schools took part of the study. Results Overall, 80.7% of the sample reported at least one oral impact in the last three months. Cronbach's alpha was 0.63, the weighted kappa 0.76, and the intraclass correlation coefficient (ICC) 0.79. The index had a significant association with self-reported health measurements (self-rated oral health, satisfaction with oral health, perceived dental treatment needs, self-rated general health; all p < 0.01). Conclusion It was concluded that the Child-OIDP index is a measure of oral health-related quality of life that can be applied to Brazilian children.

Joyce:2008

Identification of Symptom Domains in Ulcerative Colitis that Occur Frequently During Flares and are Responsive to Changes in Disease Activity
J. Joyce and A. Waljee and T. Khan and P. Wren and M. Dave and E. Zimmermann and S. Wang and J. Zhu and P. Higgins
Health and Quality of Life Outcomes  6    (2008)

Background Ulcerative colitis disease activity is determined by measuring symptoms and signs. Our aim was to determine which symptom domains are frequent and responsive to change in the evaluation of disease activity, which are those defined by three criteria: 1) they occur frequently during flares; 2) they improve during effective therapy for ulcerative colitis; and 3) they resolve during remission. Methods Twenty-eight symptom domains, 16 from standard indices and 12 novel domains identified by ulcerative colitis patient focus groups, were evaluated. Sixty subjects with ulcerative colitis were surveyed, rating each symptom on the three criteria with a 100 mm Visual Analogue Scale. Frequent and responsive symptoms were defined a priori as those whose median Visual Analogue Scale rating for all 3 criteria was significantly greater than 50. Results Thirteen of the 28 symptom domains were identified as both frequent in ulcerative colitis flares and responsive to changes in disease activity. Seven of these 13 symptom domains were novel symptoms derived from ulcerative colitis patient focus groups including stool mucus, tenesmus, fatigue, rapid postprandial bowel movements, and inability to differentiate liquid or gas from solid stool when rectal urgency occurs. Ten of the 16 symptom domains from standard indices were either infrequent or unresponsive to changes in disease activity. Conclusion Only some of the symptoms of ulcerative colitis that are important to patients are included in standard indices, and several symptoms currently measured are not frequent or responsive to change in ulcerative colitis patients. Development of survey measures of these symptom domains could significantly improve the assessment of disease activity in ulcerative colitis.

Montero:2008

Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10) in two qualitatively distinct samples of the Spanish population
J. Montero and M. Bravo and A. Albaladejo
Health and Quality of Life Outcomes  6    (2008)

Background Oral health-related quality of life can be assessed positively, by measuring satisfaction with mouth, or negatively, by measuring oral impact on the performance of daily activities. The study objective was to validate two complementary indicators, i.e., the OIDP (Oral Impacts on Daily Performances) and Oral Satisfaction 0-10 Scale (OSS), in two qualitatively different socio-demographic samples of the Spanish adult population, and to analyse the factors affecting both perspectives of well-being. Methods A cross-sectional study was performed, recruiting a Validation Sample from randomly selected Health Centres in Granada (Spain), representing the general population (n=253), and a Working Sample (n=561) randomly selected from active Regional Government staff, i.e., representing the more privileged end of the socio-demographic spectrum of this reference population. All participants were examined according to WHO methodology and completed an in-person interview on their oral impacts and oral satisfaction using the OIDP and OSS 0-10 respectively. The reliability and validity of the two indicators were assessed. An alternative method of describing the causes of oral impacts is presented. Results The reliability coefficient (Cronbach's alpha) of the OIDP was above the recommended 0.7 threshold in both Validation and Occupational samples (0.79 and 0.71 respectively). Test-retest analysis confirmed the external reliability of the OSS (Intraclass Correlation Coefficient, 0.89; p< 0.001) Some subjective factors (perceived need for dental treatment, complaints about mouth and intermediate impacts) were strongly associated with both indicators, supporting their construct and criterion validity. The main cause of oral impact was dental pain. Several socio-demographic, behavioural and clinical variables were identified as modulating factors. Conclusions OIDP and OSS are valid and reliable subjective measures of oral impacts and oral satisfaction, respectively, in an adult Spanish population. Exploring simultaneously these issues may provide useful insights into how satisfaction and impact on well-being are constructed.

Mazer:2008

Impact of a child with congenital anomalies on parents (ICCAP) questionnaire; a psychometric analysis
P. Mazer and S. Gischler and H. Koot and D. Tibboel and M. van Dijk and H. Duivenvoorden
Health and Quality of Life Outcomes  6    (2008)

Background The objective of this study was to validate the Impact of a Child with Congenital Anomalies on Parents (ICCAP) questionnaire. ICCAP was newly designed to assess the impact of giving birth to a child with severe anatomical congenital anomalies (CA) on parental quality of life as a result of early stress. Methods At 6 weeks and 6 months after birth, mothers and fathers of 100 children with severe CA were asked to complete the ICCAP questionnaire and the SF36. The ICCAP questionnaire measures six domains: contact with caregivers, social network, partner relationship, state of mind, child acceptance, and fears and anxiety. Reliability (i.e. internal consistency and test-retest) and validity were tested and the ICCAP was compared to the SF-36. Results Confirmatory factor analysis resulted in six a priori constructed subscales covering different psychological and social domains of parental quality of life as a result of early stress. Reliability estimates (congeneric approach) ranged from .49 to .92. Positive correlations with SF-36 scales ranging from .34 to .77 confirmed congruent validity. Correlations between ICCAP subscales and children's biographic characteristics, primary CA, and medical care as well as parental biographic and demographic variables ranged from -.23 to .58 and thus indicated known-group validity of the instrument. Over time both mothers and fathers showed changes on subscales (Cohen's d varied from .07 to .49), while the test-retest reliability estimates varied from .42 to .91. Conclusions The ICCAP is a reliable and valid instrument for clinical practice. It enables early signaling of parental quality of life as a result of early stress, and thus early intervention.

Silvemark:2008

Life satisfaction in patients with long-term non-malignant pain - relating LiSat-11 to the Multidimensional Pain Inventory (MPI)
A. Silvemark and H. Kallmen and K. Portala and C. Molander
Health and Quality of Life Outcomes  6    (2008)

Background The West-Haven Multidimensional Pain Inventory (MPI) can be used to describe behavioural and psychosocial consequences of long-term pain but little is known about how MPI items and MPI subgroups relate to goals that patients find important in rehabilitation. Life satisfaction measured by the LiSat-11 checklist can be defined as an individual's perception of the difference between his reality and his needs or wants. This difference can be considered a "goal achievement gap". This study investigates the relation of MPI to LiSat-11 with the aim to explore the possibility that LiSat-11 can be used to measure pain rehabilitation outcomes that are important from the patients' view. Methods Participators were patients (n = 294) referred to the Pain and Rehabilitation Clinic in Uppsala, Sweden. Measures used were LiSat-11, MPI and its Swedish version MPI-S. LiSat-11 domains were correlated to MPI scales. Cluster analysis was used to demonstrate MPI-S subgroups. Analysis of variance followed by post-hoc analysis was used to investigate life satisfaction in the three MPI-S subgroups. Results The strongest positive correlation were found for the LiSat-11 domains/MPI scales: psychological health/life control and contacts/social activities, and the strongest negative correlation for: psychological health/affective distress, partner relationship/punishing responses, somatic health/interference and leisure/interference. None or only little correlation was found between MPI scale pain severity and most LiSat-11 domains and satisfaction with life as a whole. Among the MPI-S subgroups, adaptive copers generally had better life satisfaction than the dysfunctional and the interpersonally distressed. Conclusion Pain severity alone is a rather poor predictor of low life satisfaction. MPI and LiSat-11 partly supplement each other as tools to describe how functional impairments relate to life satisfaction domains, which may be relevant for identifying domains which the patients find important to improve. Furthermore, differences in life satisfaction between the MPI-S subgroups may help to identify functional domains that may be of particular importance in specialised rehabilitation programs.

Sakthong:2008

A comparison of EQ-5D index scores using the UK, US, and Japan preference weights in a Thai sample with type 2 diabetes
P. Sakthong and R. Charoenvisuthiwongs and R. Shabunthom
Health and Quality of Life Outcomes  6    (2008)

Background Data are scarce on the comparison of EQ-5D index scores using the UK, US, and Japan preference weights in other populations. This study was aimed to examine the differences and agreements between these three weights, psychometric properties including test-retest reliability, convergent and known-groups validity, and the impact of differences in the EQ-5D scores on the outcome of cost-utility analysis in Thai people. Methods A convenience sample of 303 type 2 diabetic outpatients (18 years or older) from a cross-sectional study was examined. ANOVA and pos-hoc Bonferroni tests were used to determine the differences among the three EQ-5D scores. The agreements among the EQ-5D scores were assessed employing intraclass correlations coefficients (ICCs) and Bland-Altman plots. The ICCs were utilized to examine the test-retest reliability. Spearman's rho correlation coefficients were used to assess the convergent validity between the EQ-5D scores and sociodemographic & clinical data, and health status. Mann-Whitney U tests were used to test the differences in EQ-5D scores between the known groups including HbA1c level (cut point of 7%), and the presence of diabetic complications namely neuropathy, retinopathy, nephropathy and cardiovascular diseases. Seven hypothetical decision trees were created to evaluate the impact of differences in the EQ-5D scores on the incremental cost-utility ratio (ICUR). Results The US weights yielded higher scores than those of the UK and the Japan weights (p < 0.001, both), while the UK and the Japan weighted scores did not differ (p > 0.05). Both UK and US scores had more agreement with each other than with the Japan scores. Regarding psychometric properties, the Japan scheme provided better test-retest reliability, convergent and known-groups validity than both UK and US schemes. The variation in EQ-5D scores estimated from UK, US, and Japan preference weights had a marginal impact on ICUR (range: 1.23--6.32%). Conclusion Since the Japan model showed more preferable psychometric properties than the UK and the US models and the differences in these EQ-5D scores had a small impact on ICUR, we recommended that for both clinical and policy purposes the Japan scheme should be used in Thai people. However, more research needs to be done.

Innerkofler:2008

Improvement of quality of life, anxiety and depression after surgery in patients with stress urinary incontinence: results of a longitudinal short-term follow-up
P. Innerkofler and V. Guenther and P. Rehder and M. Kopp and D. Nguyen-Van-Tam and J. Giesinger and B. Holzner
Health and Quality of Life Outcomes  6    (2008)

Objective The objective of this study was to compare the effect of incontinence surgery and pelvic floor training on quality of life (QOL), anxiety and depression in patients with stress urinary incontinence (SUI). Methods In a prospective longitudinal study, females with proven SUI were asked to complete a set of standardized questionnaires (sociodemographic data sheet, FACT-G, I-QOL, HADS) before and eight weeks after treatment. The comparison groups consisted of a surgical treatment group and a conservative group that underwent supervised pelvic floor training for eight weeks. Results From the 67 female patients included in the study a number of 53 patients completed both assessment time points (mean age 57.4, mean years of SUI 7.6). The surgical treatment group consisted of 32 patients of which 21 patients received a modified Burch colposuspension and 11 patients a tension-free mid-urethral tape suspension. The 21 patients in the conservative group attended eight once-weekly supervised pelvic floor training sessions. After treatment the surgical intervention group showed a significantly higher improvement of QOL (FACT-G and I-QOL) and anxiety (HADS) than the pelvic floor training group. Conclusion For female patients with SUI surgery yielded a better outcome than pelvic floor training with regard to quality of life and anxiety.

Levy:2008

Utility values for hypoglycaemia elicited from diabetic and non-diabetic respondents in Canada and the United Kingdom
A. Levy and T. Christensen and J. Johnson
Health and Quality of Life Outcomes  6    (2008)

Objective To elicit societal and patient utilities associated with diabetic symptomatic non-severe hypoglycaemia for three health states: 1) rare (quarterly), 2) intermittent (monthly), 3) and frequent (weekly) hypoglycaemia episodes. Methods Using validated health states, time trade-off utilities were elicited from 51 Canadian respondents with diabetes, and 79 respondents in Canada and 75 respondents in the United Kingdom (UK) without diabetes. Results and discussion Each hypoglycaemic episode was associated with a reduction in utility and persons with diabetes consistently reported slightly higher utility values than respondents without diabetes. The utility for diabetes without hypoglycaemia ranged from 0.88 to 0.97, the mean utility for rare hypoglycaemic events (quarterly) ranged between 0.85 and 0.94. The utility for the intermittent state (monthly) ranged from 0.77 to 0.90 and from 0.66 to 0.0.83 for the frequent state (weekly). Differences were observed between respondents without diabetes in Canada and the UK. Using a multivariate linear OLS regression, the estimated utilities associated with a single hypoglycaemic event were -0.0033 and -0.0032 for respondents with diabetes and without diabetes, respectively. Conclusion Among respondents with and without diabetes, there was a demonstrable utility loss associated with hypoglycaemia. Considering a utility loss of 0.03 as a minimum clinically important difference for persons with diabetes, the evidence from this study indicates that as low as ten symptomatic non-severe hypoglycaemic episodes per year may be of clinical importance and that the importance increases with frequency of episodes. Integrating directly elicited utility values such as those reported here will improve the quality and applicability of economic evaluations of diabetes treatment.

Vlassov:2008

Biomedical journals and databases in Russia and Russian language in the former Soviet Union and beyond
V. Vlassov and K. Danishevskiy
Emerging Themes in Epidemiology  5    (2008)

In the 20th century, Russian biomedical science experienced a decline from the blossom of the early years to a drastic state. Through the first decades of the USSR, it was transformed to suit the ideological requirements of a totalitarian state and biased directives of communist leaders. Later, depressing economic conditions and isolation from the international research community further impeded its development. Contemporary Russia has inherited a system of medical education quite different from the west as well as counterproductive regulations for the allocation of research funding. The methodology of medical and epidemiological research in Russia is largely outdated. Epidemiology continues to focus on infectious disease and results of the best studies tend to be published in international periodicals. MEDLINE continues to be the best database to search for Russian biomedical publications, despite only a small proportion being indexed. The database of the Moscow Central Medical Library is the largest national database of medical periodicals, but does not provide abstracts and full subject heading codes, and it does not cover even the entire collection of the Library. New databases and catalogs (e.g. Panteleimon) that have appeared recently are incomplete and do not enable effective searching.

Lefebvre:2008

Enhancing access to reports of randomized trials published world-wide - the contribution of EMBASE records to the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library
C. Lefebvre and A. Eisinga and S. McDonald and N. Paul
Emerging Themes in Epidemiology  5    (2008)

Background Randomized trials are essential in assessing the effects of healthcare interventions and are a key component in systematic reviews of effectiveness. Searching for reports of randomized trials in databases is problematic due to the absence of appropriate indexing terms until the 1990s and inconsistent application of these indexing terms thereafter. Objectives The objectives of this study are to devise a search strategy for identifying reports of randomized trials in EMBASE which are not already indexed as trials in MEDLINE and to make these reports easily accessible by including them in the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, with the permission of Elsevier, the publishers of EMBASE. Methods A highly sensitive search strategy was designed for EMBASE based on free-text and thesaurus terms which occurred frequently in the titles, abstracts, EMTREE terms (or some combination of these) of reports of trials indexed in EMBASE. This search strategy was run against EMBASE from 1980 to 2005 (1974 to 2005 for four of the terms) and records retrieved by the search, which were not already indexed as randomized trials in MEDLINE, were downloaded from EMBASE, printed and read. An analysis of the language of publication was conducted for the reports of trials published in 2005 (the most recent year completed at the time of this study). Results Twenty-two search terms were used (including nine which were later rejected due to poor cumulative precision). More than a third of a million records were downloaded and scanned and approximately 80,000 reports of trials were identified which were not already indexed as randomized trials in MEDLINE. These are now easily identifiable in CENTRAL, in The Cochrane Library. Cumulative sensitivity ranged from 0.1% to 60% and cumulative precision ranged from 8% to 61%. The truncated term 'random$' identified 60% of the total number of reports of trials but only 35% of the more than 130,000 records retrieved by this term were reports of trials. The language analysis for the sample year 2005 indicated that of the 18,427 reports indexed as randomized trials in MEDLINE, 959 (5%) were in languages other than English. The EMBASE search identified an additional 658 reports in languages other than English, of which the highest number were in Chinese (320). Conclusions The results of the search to date have greatly increased access to reports of trials in EMBASE, especially in some languages other than English. The search strategy used was subjectively derived from a small 'gold standard' set of test records and was not validated in an independent test set. We intend to design an objectively-derived validated search strategy using logistic regression based on the frequency of occurrence of terms in the approximately 80,000 reports of randomized trials identified compared with the frequency of these terms across the entire EMBASE database.

Al-Shorbaji:2008

Index medicus for the Eastern Mediterranean region
N. Al-Shorbaji
Emerging Themes in Epidemiology  5    (2008)

The study provides the rationale, history and current status of the Index Medicus for the World Health Organization Eastern Mediterranean Region. The Index is unique in combining the geographic coverage of peer-reviewed health and biomedical journals (408 titles) from the 22 countries of the Region. Compiling and publishing the Index coupled with a document delivery service is an integral part of the WHO Regional Office's knowledge management and sharing programme. In this paper, bibliometric indicators are presented to demonstrate the distribution of journals, articles, languages, subjects and authors as well as availability in printed and electronic formats. Two countries in the Region (Egypt and Pakistan) contribute over 50% of the articles in the Index. About 90% of the articles are published in English. Epidemiology articles represent 8% of the entire Index. 15% of the journals in the Index are also indexed in MEDLINE, while 7% are indexed in EMBASE. Future developments of the Index will include covering more journals and adding other types of health and biomedical literature, including reports, theses, books and current research. The challenges and lessons learnt are discussed.

Baussano:2008

Does language matter? A case study of epidemiological and public health journals, databases and professional education in French, German and Italian
I. Baussano and P. Brzoska and U. Fedeli and C. Larouche and O. Razum and I. Fung
Emerging Themes in Epidemiology  5    (2008)

Epidemiology and public health are usually context-specific. Journals published in different languages and countries play a role both as sources of data and as channels through which evidence is incorporated into local public health practice. Databases in these languages facilitate access to relevant journals, and professional education in these languages facilitates the growth of native expertise in epidemiology and public health. However, as English has become the lingua franca of scientific communication in the era of globalisation, many journals published in non-English languages face the difficult dilemma of either switching to English and competing internationally, or sticking to the native tongue and having a restricted circulation among a local readership. This paper discusses the historical development of epidemiology and the current scene of epidemiological and public health journals, databases and professional education in three Western European languages: French, German and Italian, and examines the dynamics and struggles they have today.

Barreto:2008

Public health and epidemiology journals published in Brazil and other Portuguese speaking countries
M. Barreto and R. B. Barata
Emerging Themes in Epidemiology  5    (2008)

It is well known that papers written in languages other than English have a great risk of being ignored simply because these languages are not accessible to the international scientific community. The objective of this paper is to facilitate the access to the public health and epidemiology literature available in Portuguese speaking countries. It was found that it is particularly concentrated in Brazil, with some few examples in Portugal and none in other Portuguese speaking countries. This literature is predominantly written in Portuguese, but also in other languages such as English or Spanish. The paper describes the several journals, as well as the bibliographic databases that index these journals and how to access them. Most journals provide open-access with direct links in the indexing databases. The importance of this scientific production for the development of epidemiology as a scientific discipline and as a basic discipline for public health practice is discussed. To marginalize these publications has implications for a more balanced knowledge and understanding of the health problems and their determinants at a world-wide level.

Liu:2008

Harnessing the wealth of Chinese scientific literature: schistosomiasis research and control in China
Q. Liu and L. Tian and S. Xiao and Z. Qi and P. Steinmann and T. Mak and J. Utzinger and X. Zhou
Emerging Themes in Epidemiology  5    (2008)

he economy of China continues to boom and so have its biomedical research and related publishing activities. Several so-called neglected tropical diseases that are most common in the developing world are still rampant or even emerging in some parts of China. The purpose of this article is to document the significant research potential from the Chinese biomedical bibliographic databases. The research contributions from China in the epidemiology and control of schistosomiasis provide an excellent illustration. We searched two widely used databases, namely China National Knowledge Infrastructure (CNKI) and VIP Information (VIP). Employing the keyword "Schistosoma" () and covering the period 1990--2006, we obtained 10,244 hits in the CNKI database and 5,975 in VIP. We examined 10 Chinese biomedical journals that published the highest number of original research articles on schistosomiasis for issues including languages and open access. Although most of the journals are published in Chinese, English abstracts are usually available. Open access to full articles was available in China Tropical Medicine in 2005/2006 and is granted by the Chinese Journal of Parasitology and Parasitic Diseases since 2003; none of the other journals examined offered open access. We reviewed (i) the discovery and development of antischistosomal drugs, (ii) the progress made with molluscicides and (iii) environmental management for schistosomiasis control in China over the past 20 years. In conclusion, significant research is published in the Chinese literature, which is relevant for local control measures and global scientific knowledge. Open access should be encouraged and language barriers removed so the wealth of Chinese research can be more fully appreciated by the scientific community.

Fung:2008

Chinese journals: a guide for epidemiologists
I. Fung
Emerging Themes in Epidemiology  5    (2008)

Chinese journals in epidemiology, preventive medicine and public health contain much that is of potential international interest. However, few non-Chinese speakers are acquainted with this literature. This article therefore provides an overview of the contemporary scene in Chinese biomedical journal publication, Chinese bibliographic databases and Chinese journals in epidemiology, preventive medicine and public health. The challenge of switching to English as the medium of publication, the development of publishing bibliometric data from Chinese databases, the prospect of an Open Access publication model in China, the issue of language bias in literature reviews and the quality of Chinese journals are discussed. Epidemiologists are encouraged to search the Chinese bibliographic databases for Chinese journal articles.

Esch:2008

Patient satisfaction with primary care: an observational study comparing anthroposophic and conventional care
B. Esch and F. Marian and A. Busato and P. Heusser
Health and Quality of Life Outcomes  6    (2008)

Background This study is part of a cross-sectional evaluation of complementary medicine providers in primary care in Switzerland. It compares patient satisfaction with anthroposophic medicine (AM) and conventional medicine (CON). Methods We collected baseline data on structural characteristics of the physicians and their practices and health status and demographics of the patients. Four weeks later patients assessed their satisfaction with the received treatment (five items, four point rating scale) and evaluated the praxis care (validated 23-item questionnaire, five point rating scale). 1946 adult patients of 71 CON and 32 AM primary care physicians participated. Results 1. Baseline characteristics: AM patients were more likely female (75.6% vs. 59.0%, p < 0.001) and had higher education (38.6% vs. 24.7%, p < 0.001). They suffered more often from chronic illnesses (52.8% vs. 46.2%, p = 0.015) and cancer (7.4% vs. 1.1%). AM consultations lasted on average 23,3 minutes (CON: 16,8 minutes, p < 0.001). 2. Satisfaction: More AM patients expressed a general treatment satisfaction (56.1% vs. 43.4%, p < 0.001) and saw their expectations completely fulfilled at follow-up (38.7% vs. 32.6%, p < 0.001). AM patients reported significantly fewer adverse side effects (9.3% vs. 15.4%, p = 0.003), and more other positive effects from treatment (31.7% vs. 17.1%, p < 0.001). Europep: AM patients appreciated that their physicians listened to them (80.0% vs. 67.1%, p < 0.001), spent more time (76.5% vs. 61.7%, p < 0.001), had more interest in their personal situation (74.6% vs. 60.3%, p < 0.001), involved them more in decisions about their medical care (67.8% vs. 58.4%, p = 0.022), and made it easy to tell the physician about their problems (71.6% vs. 62.9%, p = 0.023). AM patients gave significantly better rating as to information and support (in 3 of 4 items p [less than or equal to] 0.044) and for thoroughness (70.4% vs. 56.5%, p < 0.001). Conclusion AM patients were significantly more satisfied and rated their physicians as valuable partners in the treatment. This suggests that subject to certain limitations, AM therapy may be beneficial in primary care. To confirm this, more detailed qualitative studies would be necessary.

Revicki:2008a

Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: Results from a randomized, controlled Phase III study
D. Revicki and A. Menter and S. Feldman and M. Kimel and N. Harnam and M. Willian
Health and Quality of Life Outcomes  6    (2008)

Objective To evaluate the impact of adalimumab on health-related quality of life (HRQOL) for patients with moderate to severe plaque psoriasis. Background Psoriasis is a chronic, inflammatory, immune-mediated disease that has a significant impact on patients' HRQOL. Adalimumab is a fully human monoclonal antibody that blocks tumor necrosis factor, a pro-inflammatory cytokine, and is effective and well-tolerated for patients with moderate to severe psoriasis. Methods Data were obtained for a secondary analysis of patients in a randomized, controlled Phase III trial evaluating the effect of adalimumab in patients with psoriasis (N = 1,205). Patients with moderate to severe psoriasis were randomized in a 2:1 ratio to adalimumab 80 mg (two 40 mg injections administered subcutaneously at baseline followed by one 40 mg injection every other week from Week 1 to Week 15) or placebo. Short Form-36 (SF-36) Health Survey scores of psoriasis patients were used to assess HRQOL and were compared with United States (US) population norms at baseline and Week 16. Results Baseline Physical Component Summary (PCS) scores for the placebo and adalimumab groups were similar to the general US population. Baseline mean Mental Component Summary (MCS) scores were significantly lower for the adalimumab and placebo groups compared with the general population (47.4, 47.7, and 50.8 points, respectively; p < 0.0001). PCS scores at Week 16 for patients receiving adalimumab had improved and were significantly greater than scores for the general US population (52.7 vs 48.9; p < 0.001). Compared with the general US population, MCS scores at Week 16 were similar for patients receiving adalimumab (51.2 vs 50.8; p = 1.000) and lower for patients receiving placebo (50.8 vs 48.7; p < 0.0001). Conclusion Psoriasis has a broad impact on patient functioning and well-being. Improvement in skin lesions and joint symptoms associated with adalimumab treatment was accompanied by improvements in HRQOL to levels that were similar to or greater than those of the general US population.

OBrien:2008

Exploring disability from the perspective of adults living with HIV/AIDS: Development of a conceptual framework
K. O'Brien and A. Bayoumi and C. Strike and N. Young and A. Davis
Health and Quality of Life Outcomes  6    (2008)

Background Since the advent of combination antiretroviral therapy, in developed countries HIV increasingly is perceived as a long-term illness. Individuals may experience health-related consequences of HIV and its associated treatments, a concept that may be termed disability. To date, a comprehensive framework for understanding the health-related consequences experienced by people living with HIV has not been developed. The purpose of this research was to develop a conceptual framework of disability from the perspective of adults living with HIV. Methods We conducted four focus groups and 15 face-to-face interviews with 38 adults living with HIV. We asked participants to describe their health-related challenges, their physical, social and psychological areas of life affected, and impact on their overall health. We analyzed data using grounded theory techniques. We also conducted two validity check focus groups with seven returning participants. Results Disability was conceptualized by participants as multi-dimensional and episodic characterized by unpredictable periods of wellness and illness. The Episodic Disability Framework consisted of three main components: a) dimensions of disability that included symptoms and impairments, difficulties carrying out day-to-day activities, challenges to social inclusion, and uncertainty that may fluctuate on a daily basis and over the course of living with HIV, b) contextual factors that included extrinsic factors (social support and stigma) and intrinsic factors (living strategies and personal attributes) that may exacerbate or alleviate disability, and c) triggers that initiate momentous or major episodes of disability such as receiving an HIV diagnosis, starting or changing medications, experiencing a serious illness, and suffering a loss of others. Conclusion The Episodic Disability Framework considers the variable nature of disability, acknowledges uncertainty as a key component, describes contextual factors that influence experiences of disability, and considers life events that may initiate a major or momentous episode. This framework presents a new way to conceptualize disability based on the experience of living with HIV.

Gentile:2008

Development and validation of a French patient-based health-related quality of life instrument in kidney transplant: the ReTransQoL
S. Gentile and E. Jouve and B. Dussol and V. Moal and Y. Berland and R. Sambuc
Health and Quality of Life Outcomes  6    (2008)

Background In the absence of a French health-related quality of life (QOL) instrument for renal transplant recipients (RTR), we developed a self-administered questionnaire: the ReTransQol (RTQ). Methods This questionnaire was developed using classical methodology in the following three phases over a two-year period: Item Generation phase, identifying all possible items having adverse impact on the QOL of RTR, Item Reduction phase, selecting the most pertinent items related to QOL, and Validation phase, analyzing the psychometric properties. All RTR involved in these phases were over 18 and were randomly selected from a transplant registry. Results Item generation was conducted through 24 interviews of RTR. The first version of RTQ (85 items) was sent to 225 randomized RTR, and 40 items were eliminated at the end of the item reduction phase. The second version of RTQ (45 items) was validated from 130 RTR, resulting in the RTQ final version. The factor analysis identified a structure of five factors: Physical Health (PH), Mental Health (MH), Medical Care (MC), Fear of losing the Graft (FG) and Treatment (TR). The psychometric properties of RTQ were satisfactory. Comparison between known groups from the literature confirmed the construct validity: patients without employment or living alone have lower QOL scores, and women have lower QOL scores than men. RTQ was more responsive than SF36 to detect changes in the QOL of RTR who were hospitalized secondary to their renal disease in the 4 weeks preceding their inclusion. Conclusion According to French public health priorities, RTQ appears to be a reliable and valid questionnaire.

Zhang:2008

Body mass index and health related quality of life in elementary school children: a pilot study
L. Zhang and P. Fos and W. Johnason and V. Kamali and R. Cox and M. Zuniga and T. Kittle
Health and Quality of Life Outcomes  6    (2008)

Background We investigated the relationship between Body Mass Index (BMI) and health-related quality of life (HRQOL) indicated by baseline health status in elementary school children. Methods Data were obtained via parents whose children enrolled in an elementary school, kindergarten to fourth grade, in southern Mississippi in spring 2004. Parents completed the SF-10 for Children™, a brief 10-item questionnaire designed to measure children's HRQOL on a voluntary basis. Results A total of 279 parents completed the questionnaires for their children. On average, physical and psychosocial summary scores, major indicators for HRQOL, were significantly higher among the elementary school children in our study relative to those from U.S. children overall (p < 0.0001 and p = 0.0007, respectively). Males tended to have better physical functioning than their female classmates, whereas females had better psychosocial health. Overall, except for third graders, the physical summary scores increased as grade level increased. The means for psychosocial score fluctuated without a clear pattern over the five grade levels. High level of BMI was significantly associated with children's physical summary scores below 50, a norm used for U.S. children (p = 0.003). Gender and grade were not significant predictors of children's physical and psychosocial scores. Discussion This study can be used as baseline information to track changes over time, in BMI and health status among the elementary school children. In addition, this study can be used to investigate relationships between BMI, health status, intellectual ability, and performance in school. Conclusion The findings suggest that programs designed to encourage children to lose weight in a healthy manner, thus reducing their BMI, could improve the physical and psychosocial health, and subsequently increase HRQOL.

Tuncay:2008

The relationship between anxiety, coping strategies and characteristics of patients with diabetes
T. Tuncay and I. Musabak and D. E. Gok and M. Kutlu
Health and Quality of Life Outcomes  6    (2008)

Background This study provided essential information, about Turkish patients with type I and type II diabetes, concerning: levels of anxiety, coping strategies used, and relationships that exist among anxiety, coping strategies, sociodemographic and medical characteristics. Methods A sample comprising 161 Turkish adults with both types of diabetes participated in the study. The trait anxiety scale, the brief COPE, sociodemographic and medical questionnaire were administered to patients with diabetes. Results The mean age was 49.01 (SD = 9.74), with a range from 20 to 60 years. The majority of the participants were female (60.9%) and type II diabetes (75.8%). 79% of the participants experienced anxiety. A clear majority of the participants reported to integrate their diabetes. Acceptance, religion, planning, positive reframing, instrumental support, emotional support, self-distraction and venting were the most frequently used coping strategies. The most frequently used problem-focused and the emotion-focused coping strategies were found to be similar in both type I and type II diabetes. However, participants with type II diabetes had relatively higher scores on the problem-focused strategies than those with type I. Participants with type I diabetes used humour, venting and self-blame more than those with type II diabetes. Other findings indicated that only a small minority responded to diabetes-related problems by denial, behavioural disengagement and substance use. Significant correlations were found among anxiety, coping strategies and sociodemographic characteristics of the participants. Moreover, Self-blame was found to be correlated significantly with both the problem-focused and emotion-focused coping strategies. Self-blame was also significantly correlated with both instrumental support and emotional support indicated that higher self-blame caused more frequent use of instrumental and emotional support by patients with diabetes. Conclusion The findings of this study indicate that care for patients with diabetes should address their physical, psychological, social and economic wellbeing and the findings point to the importance of taking individual coping strategies into account when evaluating the impact of diabetes on psychosocial wellbeing. Because of the mean of anxiety were not in normal range, for this study, health professionals need to pay attention to patient's psychological state. This is especially true for patients who are likely to use self-blame and behavioural disengagement as a coping strategy. Through psychosocial interventions, professionals need to assist patients in establishing positive self evaluations. Delineation of coping strategies might be useful for identifying patients in need of particular counselling and support.

Arbuckle:2008

Patient experiences with oily skin: The qualitative development of content for two new patient reported outcome questionnaires
R. Arbuckle and M. Atkinson and M. Clark and L. Abetz-Webb and J. Lohs and I. Kuhagen and J. Harness and Z. Draelos and D. Thiboutot and U. Blume-Peytavi and K. Copley-Merriman
Health and Quality of Life Outcomes  6    (2008)

Objective To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere.

Norman:2008

Discrimination and reliability: Equal partners?
G. Norman
Health and Quality of Life Outcomes  6    (2008)

A critique of Hankins, M article: How discriminating are discriminative instruments?" Health and Quality of Life Outcomes 2008, 6:36

Wyrwich:2008

Understanding the role of discriminative instruments in HRQoL research: can Ferguson's Delta help?
K. Wyrwich
Health and Quality of Life Outcomes  6    (2008)

A critique of Hankins, M: How discriminating are discriminative instruments?" Health and Quality of Life Outcomes 2008, 6:36

Hankins:2008a

Discrimination and reliability: Equal partners? Understanding the Role of Discriminative Instruments in HRQOL Research: Can Ferguson's Delta Help? A Response
M. Hankins
Health and Quality of Life Outcomes  6    (2008)

A response to Norman GR 'Discrimination and reliability: equal partners?' and Wyrwich KW 'Understanding the role of discriminative instruments in HRQoL research: can Ferguson's Delta help?'

Iversen:2008

Questions on causality and responsibility arising from an outbreak of Pseudomonas aeruginosa infections in Norway
B. Iversen and B. Hofmann and P. Aavitsland
Emerging Themes in Epidemiology  5    (2008)

In 2002, Norway experienced a large outbreak of Pseudomonas aeruginosa infections in hospitals with 231 confirmed cases. This fuelled intense public and professional debates on what were the causes and who were responsible. In epidemiology, other sciences, in philosophy and in law there is a long tradition of discussing the concept of causality. We use this outbreak as a case; apply various theories of causality from different disciplines to discuss the roles and responsibilities of some of the parties involved. Mackie's concept of INUS conditions, Hill's nine viewpoints to study association for claiming causation, deterministic and probabilistic ways of reasoning, all shed light on the issues of causality in this outbreak. Moreover, applying legal theories of causation (counterfactual reasoning and the "but-for" test and the NESS test) proved especially useful, but the case also illustrated the weaknesses of the various theories of causation. We conclude that many factors contributed to causing the outbreak, but that contamination of a medical device in the production facility was the major necessary condition. The reuse of the medical device in hospitals contributed primarily to the size of the outbreak. The unintended error by its producer -- and to a minor extent by the hospital practice -- was mainly due to non-application of relevant knowledge and skills, and appears to constitute professional negligence. Due to criminal procedure laws and other factors outside the discourse of causality, no one was criminally charged for the outbreak which caused much suffering and shortening the life of at least 34 people.

Nafees:2008

Health state utilities for non small cell lung cancer
B. Nafees and M. Stafford and S. Gavriel and S. Bhalla and J. Watkins
Health and Quality of Life Outcomes  6    (2008)

Background Existing reports of utility values for metastatic non-small cell lung cancer (NSCLC) vary quite widely and are not all suitable for use in submissions in the UK. The aim of this study was to elicit UK societal based utility values for different stages of NSCLC and different grade III-IV toxicities commonly associated with chemotherapy treatments. Toxicities included neutropenia, febrile neutropenia, fatigue, diarrhoea, nausea and vomiting, rash and hair loss. Methods Existing health state descriptions of metastatic breast cancer were revised to make them suitable as descriptions of metastatic NSCLC patients on second-line treatment. The existing health states were used in cognitive debrief interviews with oncologists (n = 5) and oncology specialist nurses (n = 5). Changes were made as suggested by the clinical experts. The resulting health states (n = 17) were piloted and used in a societal based valuation study (n = 100). Participants rated half of the total health states in a standard gamble interview to derive health state utility scores. Data were analysed using a mixed model analysis. Results Each health state described the symptom burden of disease and impact on different levels of functioning (physical, emotional, sexual, and social). The disutility related to each disease state and toxicity was estimated and were combined to give health state values. All disease states and toxicities were independent significant predictors of utility (p < 0.001). Stable disease with no toxicity (our base state) had a utility value of 0.653. Utility scores ranged from 0.673 (responding disease with no toxicity) to 0.473 for progressive disease. Conclusion This study reflects the value that society place on the avoidance of disease progression and severe toxicities in NSCLC.

Drageset:2008

Sense of coherence as a resource in relation to health-related quality of life among mentally intact nursing home residents - a questionnaire study
J. Drageset and H. Nygaard and G. Eide and M. Bondevik and M. Nortvedt and G. Natvig
Health and Quality of Life Outcomes  6    (2008)

Background Sense of coherence (SOC) is a strong determinant of positive health and successful coping. For older people living in the community or staying in a hospital, SOC has been shown to be associated with health-related quality of life (HRQOL). Studies focusing on this aspect among nursing home (NH) residents have been limited. This study investigated the relationship between SOC and HRQOL among older people living in NHs in Bergen, Norway. Method Based on the salutogenic theoretical framework, we used a descriptive correlation design using personal interviews. We collected data from 227 mentally intact NH residents for 14 months in 2004-2005. The residents' HRQOL and coping ability were measured using the SF-36 Health Survey and the Sense of Coherence Scale (SOC-13), respectively. We analyzed possible relationships between the SOC-13 variables and SF-36 subdimensions, controlling for age, sex, marital status, education and comorbidity, and investigated interactions between the SOC and demographic variables by using multiple regression. Results SOC scores were significantly correlated with all SF-36 subscales: the strongest with mental health (r = 0.61) and the weakest with bodily pain (r = 0.28). These did not change substantially after adjusting for the associations with demographic variables and comorbidity. SOC-13 did not interact significantly with the other covariates. Conclusion These findings suggest that more coping resources improve HRQOL. This may indicate the importance of strengthening the residents' SOC to improve the perceived HRQOL. Such knowledge may help the international community in developing nursing regimens to improve HRQOL for older people living in NHs.

Odole:2008

Validity and internal consistency of a Hausa version of the Ibadan knee/hip osteoarthritis outcome measure
A. Odole and A. Akinpelu
Health and Quality of Life Outcomes  6    (2008)

Background The Ibadan Knee/Hip Osteoarthritis Outcome Measure (IKHOAM) was developed for measuring end results of care in patients with knee or hip OA in Nigeria. The purpose of this study was to validate a Hausa translation of IKHOAM in order to promote its use among the Hausa populations of Nigeria and other West African countries. Methods Sixty-seven patients with knee OA, literate in Hausa and English, recruited consecutively from all government hospitals in Kano were assessed on both English and Hausa versions of IKHOAM. The order of assessment with the versions was randomized and separated by 24 hours. Participants also rated their pain intensity on the Visual Analogue Scale. Data was analyzed using the Spearman Rank Order correlation and Cronbach's alpha. Results The participants (17 males, 50 females) were aged 55.7 $\pm$ 13.4 years. Participants' scores on the Hausa version correlated significantly with the original version (r = 0.67, p = 0.000) and with pain intensity scores on the Visual Analogue Scale (r = -0.24, p = 0.005). The Cronbach's alpha for correlation on the different parts of the Hausa version ranged between 0.28 and 0.95. Conclusion The Hausa version of IKHOAM meets the criteria for validity and internal consistency and may be used in the Hausa speaking parts of Nigeria and other West African countries.

Sprangers:2008

Reflections on changeability versus stability of health-related quality of life: distinguishing between its environmental and genetic components
M. Sprangers and C. Schwartz
Health and Quality of Life Outcomes  6    (2008)

The field of health-related quality of life (HRQOL) could benefit from a broadening of perspectives to include recent advancements in research on adaptation, positive psychology, and genetics. These advances shed new light on the extent to which HRQOL is changeable or fixed. The objective of this paper is to integrate these insights and to discuss their implications for HRQOL research. We describe the Hedonic Treadmill theory, which asserts that positive events only temporarily affect happiness since people quickly return to hedonic neutrality. New empirical evidence suggests important revisions of this theory, providing a more optimistic picture of the possibility for change. Advances in positive psychology show that relatively simple interventions have the power to induce a sustainable increase in levels of happiness. Finally, a small but growing number of studies have found independent genetic influences in well-being, life satisfaction, perceived health, and even HRQOL. Given the increasing empirical evidence that HRQOL can be sustainably enhanced and is in part genetically determined, it may be useful to consider HRQOL as a concept that has state (environmental) and trait (genetic) components. This distinction will allow us to explore new pathways of improving theory, methods, and clinical practice. The overarching novel questions concern the extent to which HRQOL components are environmentally or genetically determined, and which factors lead to lasting improvement. This distinction begs for new research approaches, such as time-sampling techniques and interdisciplinary research investigating the genetic variants of HRQOL. Distinguishing between those aspects that are amenable to change from those that are relatively fixed and stable will help better target specific support interventions.

Huang:2008

Evaluating the reliability, validity and minimally important difference of the Taiwanese version of the diabetes quality of life (DQOL) measurement
I. Huang and J. Liu and A. Wu and M. Wu and W. Leite and C. Hwang
Health and Quality of Life Outcomes  6    (2008)

Background Few diabetes HRQOL instruments are available in Chinese language. We tested psychometric properties of a Diabetes Quality of Life (DQOL) in Chinese language for diabetes patients in Taiwan and estimated its minimally important differences (MIDs). Methods Data were collected from 337 patients treated in diabetes clinics of a Taiwan teaching hospital. Pearson's correlations among domain scores of the DQOL (satisfaction, impact, and worry), the D-39S (a diabetes-specific instrument, including domains of diabetes control, energy and mobility, social burden and anxiety and worry, and sexual functioning) and the RAND-12 (a generic instrument, including physical health composite (PHC) and mental health composite (MHC)) were estimated to determine convergent/discriminant validity. Known-groups validity was examined using 2-hour postprandial plasma glucose (2h PPG), hemoglobin A1c (HbA1c)) and presence of complications (retinopathy, neuropathy, and diabetic foot complications rather than the known groups of cardiovascular and cerebrovascular complications). We used a combined anchor- and distribution-based approach to establish MIDs. Results The DQOL scores were more strongly correlated with the physical domains of the D-39S (diabetes control and energy and mobility) and RAND-12 PHC than psychological domains of the D-39S (social burden, anxiety and worry, and sexual functioning) and RAND-12 MHC. The DQOL showed satisfactory discriminative ability for the known groups of 2h PPG and HbA1c (effect size (ES) >= 0.2) and retinopathy, neuropathy, and diabetic foot complications (ES >= 0.3), but less satisfactory for the known groups of cardiovascular and cerebrovascular complications. MIDs for the DQOL domains were 3-5 points for satisfaction, 4-5 points for impact, 6-8 points for worry, and 3-4 points for overall HRQOL. Conclusions We validated a DQOL in Chinese language for diabetes patients in Taiwan and provided MIDs to facilitate the measure of diabetes HRQOL.

Jermendy:2008

Outcomes of adding second hypoglycemic drug after metformin monotherapy failure among type 2 diabetes in Hungary
G. Jermendy and D. Erdesz and L. Nagy and D. Yin and H. Phatak and S. Karve and S. Engel and R. Balkrishnan
Health and Quality of Life Outcomes  6    (2008)

Aim: The objective of this observational study was to assess the status of glycemic control and associated patient-reported outcomes in ambulatory Hungarian patients with type 2 diabetes mellitus (T2DM) who were prescribed either a sulfonylurea (SU) or a thiazolidinedione (TZD) in addition to the prior metformin (MF) monotherapy. Methods Type 2 diabetics aged [greater than or equal to]30 years and who had added an SU or TZD to previous MF monotherapy at least 1 year prior to the visit date were identified during January 2006 to March 2007. Information was extracted from the medical record up to 6 months prior to the addition of SU or TZD to MF (baseline), and a minimum of one year after the initiation of either therapy. Results: A total of 414 patients participated in the study. About 27% of patients reported hypoglycemic episodes, with about one-third reporting episodes that resulted into interruption of activities or required medical/non-medical assistance. Patients' HRQoL was significantly associated with self-reported hypoglycemic episodes (p=0.017), and duration of diabetes (p=0.045). Conclusion Nearly 75% of patients were not at A1C goal of < 6.5% despite using two oral anti-hyperglycemic medications. Self- reports of hypoglycemia and duration of diabetes were associated with low HRQoL.

Rohde:2008

Is global quality of life reduced before fracture in patients with low-energy wrist or hip fracture: a comparison with matched controls
G. Rohde and G. Haugeberg and A. Mengshoel and T. Moum and A. Wahl
Health and Quality of Life Outcomes  6    (2008)

Background The aims of the study were (i) to examine global quality of life (GQOL) before fracture in patients with low-energy wrist or hip fracture compared with an age- and sex-matched control group, and (ii) to identify relationships between demographic variables, clinical fracture variables, and health- and global-focused quality of life (QOL) prior to fracture. Methods Patients with a low-energy fracture of the wrist (n = 181) or hip (n = 97) aged 50 years and older at a regional hospital in Norway and matched controls (n = 226) were included. The participants answered retrospectively, within two weeks after the fracture, a questionnaire on their GQOL before the fracture occurred using the Quality of Life Scale (QOLS), and health-focused QOL using the Short Form-36, physical component summary, and mental component summary scales. A broad range of clinical data including bone density was also collected. ANOVA and multiple linear regression analysis were used to analyse the data. Results Osteoporosis was identified in 59% of the hip fracture patients, 33% of the wrist fracture patients, and 16% of the controls. After adjusting GQOL scores and the three sub-dimensions for known covariates (sociodemographics, clinical fracture characteristics, and health-focused QOL), the hip patients reported significantly lower scores compared with the controls, except for the sub-dimension of personal, social, and community commitment (p = 0.096). Unadjusted and adjusted GQOL scores did not differ between the wrist fracture patients and controls. Sociodemographics (age, sex, education, marital status), clinical fracture variables (osteoporosis, falls, fracture group) and health-focused QOL explained 51.4% of the variance in the QOLS, 35.2% of the variance in relationship and marital well-being, 59.3% of the variance in health and functioning, and 24.9% of the variance of personal, social, and community commitment. Conclusion The hip fracture patients had lower GQOL before the fracture occurred than did controls, even after adjusting for known factors such as sociodemographics, clinical variables and health-focused QOL. The findings suggest that by identifying patients with low GQOL, in addition to other known risk factors for hip fracture, may raise the probability to target preventive health care activities.

Arafa:2008

Quality of life of parents of children with heart diseases
M. Arafa and S. Zaher and A. A. dowati and D. Moneeb
Health and Quality of Life Outcomes  6    (2008)

Background Quality of life of parents of chronically ill children has become increasingly important as the mortality rates associated with such illnesses have decreased and survival rates have increased. Aim: To describe the Health related quality of life (HRQOL) of parents whose children are suffering from heart diseases and to identify the most important factors that could affect it. Methods A cross sectional study was conducted in Alexandria, Egypt in the two main hospitals that treat children with heart diseases. 400 parents of children with heart diseases were recruited and a comparison group (400) of parents of children with minor illnesses were included from both hospitals. Socioeconomic and disease related data were collected, SF36 was used to collect data regarding the QOL. MANOVA was used to compare the SF-36 scores between groups and to explore the impact of different variables. Results In all SF-36 subscales, parents of children with heart diseases reported significantly poorer HRQOL, except for pain subscale. The most striking differences were for General Health, Vitality and role limitation physical. Factors that had a significant impact of HRQOL were severity of illness, type of heart disease in addition to age of child, having multiple children, financial situation and presence of comorbid condition. The mean scores for different domains were the lowest for younger age, rheumatic heart disease and female children. Conclusion QOL of parents of children with heart diseases was significantly impaired and it was influenced by several factors; mainly related to the clinical status of the child. Psychological status, social support and reassurance of the parents should be considered when making treatment decision for their children.

Wilkie:2008

Onset, persistence and recovery of person-perceived participation restriction in older adults: A 3-year follow-up study in the general population.
R. Wilkie and E. Thomas and S. Mottram and G. Peat and P. Croft
Health and Quality of Life Outcomes  6    (2008)

Background Participation restriction is defined as "problems an individual may experience in involvement in life situations" and refers to the personal and societal consequences of health conditions. There is a growing interest in participation restriction because (i) problems with work or looking after others may be more concerning to individuals than the signs and symptoms of health conditions and (ii) even when poor health persists, participation may still be maintained. The natural history of participation restriction in the general population is unknown and the aim of this report is to describe change in status of person-perceived participation restriction over three years in community-dwelling adults aged 50 years and over. Method Prospective cohort study (baseline and 3-year follow-up) using postal questionnaires mailed to a population-based sample of older adults. Responders were included in this study if they completed all items of the Keele Assessment of Participation, at both baseline and follow-up (n=3709). Onset and persistence of person-perceived participation restriction at 3-year follow-up were calculated for any and for each aspect of life in the sample as a whole, and then by age and gender. Results In the whole sample of 3709 persons, overall participation status at three years was unchanged in 69%, and changed in 31%. Of 2049 persons with no restriction at baseline, 29.2% (n=599) reported restriction in at least one aspect of life at 3-year follow-up. Of 1660 persons who had baseline restriction, 69.2% (n=1149) reported continuing restriction in at least one aspect of life after 3 years. Onset and persistence both increased with age, and were most frequently recorded for restricted mobility outside the home. Conclusion Although most older persons do not change their overall participation status during a three-year period, change does occur which implies that population approaches to improving participation can be sought. Both onset and persistence of person-perceived participation restriction are more common the older the age-group.

Ferrara:2008

Prevalence of stress, anxiety and depression in with Alzheimer caregivers
M. Ferrara and E. Langiano and T. D. Brango and E. D. Vito and L. D. Cioccio and C. Bauco
Health and Quality of Life Outcomes  6    (2008)

Background Alzheimer's disease presents a social and public health problem affecting millions of Italians. Those affected receive home care from caregivers, subjected to risk of stress. The present investigation focuses on stress, anxiety and depression in caregivers. Methods Data on 200 caregivers and their patients were collected using a specific form to assess cognitive, behavioural, functional patient (MMSE, and ADL-IAD) and caregiver stress (CBI). The relationship between stress, depression and disease has been assessed by means of a linear regression, logistic analysis which reveals the relationship between anxiety, stress and depression and cognitive problems, age, the patient's income. Results The caregivers are usually female (64%), mean age of 56.1 years, daughters (70.5%), pensioners and housewives (30%), who care for the sick at home (79%). Of these, 53% had little time for themselves, 55% observed worsening of health, 56% are tired, 51% are not getting enough sleep. Overall, 55% have problems with the patient's family and/or their own family, 57% at work. Furthermore, 29% feel they are failing to cope with the situation as they wish to move away from home. The increase in the degree of anxiety and depression is directly proportional to the severity of the illness, affecting the patient (r = 0.3 stress and depression r = 0.4 related to CBI score). The memory disorders (OR = 8.4), engine problems (OR = 2.6), perception disorders (OR = 1.9) sick of the patient with Alzheimer's disease are predictive of caregiver stress, depression is associated with the presence of other disorders, mainly behavioural (OR = 5.2), low income (OR = 3.4), patients < 65 years of age (OR = 2.9). Conclusion The quality of life of caregivers is correlated with the severity of behavioural disorders and duration of the Alzheimer's disease. The severity of the disease plays an important role in reorganization of the family environment in families caring for patients not institutionalised. It is important to promote measures to soften the impact that the patient has on the caregiver, and that, at the same time, improves the quality of life of the patient.

Whynes:2008

Correspondence between EQ-5D health state classifications and EQ VAS scores
D. Whynes
Health and Quality of Life Outcomes  6    (2008)

Background The EQ-5D health-related quality of life instrument comprises a health state classification followed by a health evaluation using a visual analogue scale (VAS). The EQ-5D has been employed frequently in economic evaluations, yet the relationship between the two parts of the instrument remains ill-understood. In this paper, we examine the correspondence between VAS scores and health state classifications for a large sample, and identify variables which contribute to determining the VAS scores independently of the health states as classified. Methods A UK trial of management of low-grade abnormalities detected on screening for cervical pre-cancer (TOMBOLA) provided EQ-5D data for over 3,000 women. Information on distress and multi-dimensional health locus of control had been collected using other instruments. A linear regression model was fitted, with VAS score as the dependent variable. Independent variables comprised EQ-5D health state classifications, distress, locus of control, and socio-demographic characteristics. Equivalent EQ-5D and distress data, collected at twelve months, were available for over 2,000 of the women, enabling us to predict changes in VAS score over time from changes in EQ-5D classification and distress. Results In addition to EQ-5D health state classification, VAS score was influenced by the subject's perceived locus of control, and by her age, educational attainment, ethnic origin and smoking behaviour. Although the EQ-5D classification includes a distress dimension, the independent measure of distress was an additional determinant of VAS score. Changes in VAS score over time were explained by changes in both EQ-5D severities and distress. Women allocated to the experimental management arm of the trial reported an increase in VAS score, independently of any changes in health state and distress. Conclusions In this sample, EQ VAS scores were predictable from the EQ-5D health state classification, although there also existed other group variables which contributed systematically and independently towards determining such scores. These variables comprised psychological disposition, socio-demographic factors such as age and education, clinically-important distress, and the clinical intervention itself.

Matza:2008

The longitudinal link between visual acuity and health-related quality of life in patients with diabetic retinopathy
L. Matza and M. Rousculp and K. Malley and K. Boye and A. Oglesby
Health and Quality of Life Outcomes  6    (2008)

Background This study characterized the degree of change in health-related quality of life (HRQL) associated with change in visual acuity among patients with diabetic retinopathy. Methods Data are from a randomized, placebo-controlled trial of ruboxistaurin for vision loss in patients with diabetic retinopathy. Visual acuity was quantified as letters on the ETDRS visual acuity chart. HRQL was assessed with the 25-Item Visual Function Questionnaire (VFQ-25) and the SF-36. Patients were categorized into groups based on visual acuity change from baseline to month 18. HRQL change of these groups was compared using general linear models. Regression analyses examined visual acuity change defined continuously. Results Patients (N = 535) were primarily Caucasian (81.9%) and male (64.1%); mean age = 59.3 years. Compared to patients whose visual acuity did not change, the group with > 10 letters vision loss had significantly greater decreases in all VFQ-25 subscales except ocular pain. SF-36 change scores did not correspond as closely to change in vision. Change in visual acuity defined continuously was significantly associated with change in all VFQ-25 scales except ocular pain (p < 0.0001). Conclusions Change in visual acuity was associated with corresponding changes in HRQL among patients with diabetic retinopathy. Previous research has often defined vision loss as a loss of at least 15 letters on the ETDRS visual acuity chart. In the current study, however, a loss of at least 10 letters was associated with substantial declines in HRQL domains such as driving, dependency, role limitations, and mental health. These findings suggest that patients who experience vision loss of at least 10 letters may be appropriate targets of future research and clinical intervention.

Sitaresmi:2008

Health-related quality of life assessment in Indonesian childhood acute lymphoblastic leukemia
M. Sitaresmi and S. Mostert and C. Gundy and S. Sutaryo and A. Veerman
Health and Quality of Life Outcomes  6    (2008)

Background Most studies on Health-related Quality of Life (HRQOL) in children with cancer were conducted in developed countries. The aims of this study were to assess the HRQOL in childhood acute lymphoblastic leukemia (ALL) patients in Indonesia and to assess the influence of demographic and medical characteristics on HRQOL. Methods After cultural linguistic validation, a cross-sectional study of HRQOL was conducted with childhood ALL patients and their guardians in various phases of treatment using the Pediatric Quality of Life InventoryTM (PedsQLTM) 4.0 Generic Core Scale and the Pediatric Quality of Life InventoryTM (PedsQLTM) 3.0 Cancer Module. Results Ninety-eight guardians and 55 patients participated. The internal consistency of both scales ranged from 0.57 to 0.92. HRQOL of Indonesian patients was comparable with those in developed countries. There were moderate to good correlations between self-reports and proxy-reports, however guardians tended to report worse HRQOL than patients. Children of the 2-5 year-group significantly had more problems in procedural anxiety, treatment anxiety and communication subscales than in older groups (p<0.05). In the non-intensive phase HRQOL was significantly better than in the intensive phase, both in patient self-reports and proxy-reports. Conclusion Younger children had more problems in procedural anxiety, treatment anxiety and communication subscales. Therefore, special care during intervention procedures is needed to promote their normal development. Psychosocial support should be provided to children and their parents to facilitate their coping with disease and its treatment.

Gutteling:2008

Logistic feasibility of health related quality of life measurement in clinical practice: results of a prospective study in a large population of chronic liver patients
J. Gutteling and J. Busschbach and R. de Man and A. Darlington
Health and Quality of Life Outcomes  6    (2008)

Background The objective of the present study was to provide a complete and detailed report of technical and logistical feasibility problems with the implementation of routine computerized HRQoL measurement at a busy outpatient department of Hepatology that can serve as a tool for future researchers interested in the procedure. Methods Practical feasibility was assessed by observing problems encountered during the development of the computer program, observing patients' ability to complete the HRQoL questionnaires, monitoring the number of times that patients completed the HRQoL questionnaires and observing logistics at the outpatient department. Patients' reasons for not completing the HRQoL questionnaires were assessed retrospectively by means of a mailed questionnaire. Physicians' attitudes towards the availability of computerized HRQoL information about their patients were assessed by means semi-structured interviews and by means of checklists administered after each consultation with s study participant. Results All physicians (n=11) and 587 patients agreed to participate in the study. Practical feasibility problems concerned complicated technical aspects of developing a user-friendly computer program and safe data transmission over the Internet, patients' lack of basic computer skills and patients' lack of compliance (completion of questionnaires on only 43% of the occasions). The main reason given for non-compliance was simply forgetting, which seemed to be related to reception employees' passive attitude towards sending patients to the computer. Physicians were generally positive about the instant computerized availability of HRQoL information. They requested the information in 92% of the consultations and found the information useful in 45% of the consultations, especially when it provided them with new information. Conclusions This study was among the first to implement the complete procedure of routine computerized HRQoL measurements in clinical practice and to subsequently describe the feasibility issues encountered. It was shown that the attitudes of physicians were generally positive. Several barriers towards successful implementation of such a procedure were encountered, and subsequently solutions were provided. Most importantly, when implementing routine computerized HRQoL measurements in clinical practice, assistance of an IT professional for the development of a tailor-made computer program, availability of questionnaires in multiple languages and the use of touch-screen computers to optimise patient participation are essential. Also, all staff of the department concerned should approve of the intervention and consider it as part of standard clinical routine if successful implementation is to be obtained.

Arvidsson:2008

Health predicting factors in a general population over an eight-year period in subjects with and without chronic musculoskeletal pain
S. Arvidsson and B. Ardvisson and B. Fridlund and S. Bergman
Health and Quality of Life Outcomes  6    (2008)

Background Many factors are proposed to be associated with health-related quality of life. Knowledge of health factors associated to development of a good health-related quality of life could be of use in clinical practice and public health work. The aim of this study was to investigate the associations between suggested health factors and health-related quality of life at baseline and in an eight-year follow up in subjects with and without chronic musculoskeletal pain in a cohort from a general population. Methods The study was designed as a longitudinal study in a Swedish general population (N=1 849) with a postal questionnaire at baseline 1995 and at follow up 2003. Subjects were divided into two groups, according to their response about chronic musculoskeletal pain at baseline. Health-related quality of life was assessed by the SF-36 together with suggested health factors. The associations between SF-36 subscales and suggested health factors were estimated by OR and 95 % CI calculated by multivariable logistic regressions, with adjustment for all health factors, age, sex and baseline SF-36 values. Results Although subjects without chronic musculoskeletal pain reported better health-related quality of life than subjects with chronic pain, similar health factors were found to be associated to higher scores in SF-36 at baseline and predicted a better outcome in the eight-year follow up. The most consistent finding was a better health outcome in the eight-year follow up for subjects that were feeling rested after sleep. Other factors that in some aspects predicted a better outcome were belonging to higher socioeconomic group, being a native Swede, having emotional support, having good sleep structure, never being or being a former smoker, and regularly drinking alcohol. Conclusions The most important health factor in subjects with and without chronic musculoskeletal pain was feeling rested after sleep, but also emotional support, sleep structure, smoking and alcoholic habits appears to be important components. These health factors could be important to address in clinical work with painful musculoskeletal disorders. Since several health factors are common in both subjects with and without pain there could be a common strategy to be formed in public health programmes.

Harding:2008

The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL)
G. Harding and K. Coyne and C. Thompson and J. Spies
Health and Quality of Life Outcomes  6    (2008)

Background A number of noninvasive alternatives to hysterectomy have become available as treatments for uterine fibroids. These alternative therapies, however, may not relieve all symptoms. Consequently, the need for patient-reported outcomes to assess symptom reduction of uterine fibroids has become increasingly important to evaluate the clinical success of patients who choose these alternative therapies. The purpose of the study was to examine the responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) with treatment of uterine fibroids. Methods The responsiveness of the UFS-QOL was assessed as a post-hoc analysis of patients treated with MRI-guided focused ultrasound thermal ablation (MRgFUS) for uterine fibroids. The UFS-QOL and SF-36 were completed at baseline and months 1, 3, and 6. Patient perceived overall treatment effect (OTE) was assessed at month 3, while satisfaction with treatment was collected at month 6. The responsiveness of the UFS-QOL was examined using effect sizes and change scores by patient-reported overall treatment effect and satisfaction. Results A total of 102 women with complete UFS-QOL data were included in the analysis; the mean age was 45 years and 79% were Caucasian. From baseline to 6 months, significant improvements were observed in UFS-QOL Symptom Severity and all Health-Related Quality of Life (HRQL) subscale scores (p < 0.0001). When examining change in general health status over the 6-month follow-up period, significant improvements were noted in all 8 SF-36 subscales. The UFS-QOL was highly responsive with subscale effect sizes ranging from 0.74 for Sexual Function to -1.9 for Symptom Severity. Improvements in UFS-QOL subscales were associated with patient perceptions of perceived benefit and treatment satisfaction. Conclusions The UFS-QOL is responsive to treatment for uterine fibroids and is a useful outcome measure for uterine-sparing uterine fibroid treatments.

Hadjimichael:2008

Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey
O. Hadjimichael and T. Vollmer and M. Oleen-Burkey
Health and Quality of Life Outcomes  6    (2008)

Background Fatigue is a common disabling symptom of multiple sclerosis (MS) and has a significantly negative impact on quality of life. Persons with MS enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) Patient Registry are invited to complete follow-up surveys every six months to update their original registration information. One of these surveys was designed to focus on the severity and impact of fatigue, and its association with other clinical parameters of MS such as physical disability. Methods In addition to the usual data collected in Registry update surveys such as demographic characteristics, MS-related medical history, disability and handicap, immunomodulatory and symptomatic therapies taken, and healthcare services used, the survey for this study included two validated self-report fatigue scales, the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) and questions about the use of symptomatic management for fatigue, both pharmacologic and non-pharmacologic treatments. This Registry update survey was mailed to all NARCOMS registrants (n= 18,595) in November 2002. Information provided by registry participants was approved for research purposes by the Yale University Institutional Review Board. Results The response rate for the survey was 49.5% (9205/18,595). Severe fatigue as measured with the FSS using the developer's recommended severity cutpoint of >=36 was reported by 6691 (74%) of evaluable respondents (n=9077). A higher prevalence of severe fatigue was observed in relapsing-worsening MS compared with relapsing-stable and primary progressive MS. A distinct pattern of fatigue was observed across the disability levels of the Patient-Determined Disease Steps (PDDS). Although there were no differences in the severity or impact of fatigue by immunomodulatory agents (IMA), respondents who recalled therapy changes in the prior six months reported different patterns of change in fatigue with lower fatigue levels reported after changing from interferon-beta to glatiramer acetate than after changing from glatiramer acetate to interferon-beta. Concomitant therapy for fatigue was used by 47.2% of the 5799 survey respondents receiving IMA. Conclusions Characterizing MS symptoms like fatigue can increase awareness about their impact on persons with MS and suggest recommendations for a care plan.

Wong:2008

Development of a Quality Assessment Tool for Systematic Reviews of Observational Studies (QATSO) of HIV prevalence in men having sex with men and associated risk behaviours
W. Wong and C. Cheung and G. Hart
Emerging Themes in Epidemiology  5    (2008)

Background Systematic reviews based on the critical appraisal of observational and analytic studies on HIV prevalence and risk factors for HIV transmission among men having sex with men are very useful for health care decisions and planning. Such appraisal is particularly difficult, however, as the quality assessment tools available for use with observational and analytic studies are poorly established. Methods We reviewed the existing quality assessment tools for systematic reviews of observational studies and developed a concise quality assessment checklist to help standardise decisions regarding the quality of studies, with careful consideration of issues such as external and internal validity. Results A pilot version of the checklist was developed based on epidemiological principles, reviews of study designs, and existing checklists for the assessment of observational studies. The Quality Assessment Tool for Systematic Reviews of Observational Studies (QATSO) Score consists of five items: External validity (1 item), reporting (2 items), bias (1 item) and confounding factors (1 item). Expert opinions were sought and it was tested on manuscripts that fulfil the inclusion criteria of a systematic review. Like all assessment scales, QATSO may over-simplify and generalise information yet it is inclusive, simple and practical to use, and allows comparability between papers. Conclusion A specific tool that allows researchers to appraise and guide study quality of observational studies is developed and can be modified for similar studies in the future.

Puhan:2008a

The minimal important difference of the Hospital Anxiety and Depression Scale in patients with chronic obstructive pulmonary disease
M. Puhan and M. Frey and S. Buechi and H. Schunemann
Health and Quality of Life Outcomes  6    (2008)

Background Interpretation of the Hospital Anxiety and Depression Scale (HADS), commonly used to assess anxiety and depression in COPD patients, is unclear. Since its minimal important difference has never been established, our aim was to determine it using several approaches. Methods 88 COPD patients with FEV1[less than or equal to]50% predicted completed the HADS and other patient-important outcome measures before and after an inpatient respiratory rehabilitation. For the anchor-based approach we determined the correlation between the HADS and the anchors that have an established minimal important difference (Chronic Respiratory Questionnaire [CRQ] and Feeling Thermometer). If correlations were [greater than or equal to]0.5 we performed linear regression analyses to predict the minimal important difference from the anchors. As distribution-based approach we used the Effect Size approach. Results Based on CRQ emotional function and mastery domain as well as on total scores, the minimal important difference was 1.41 (95% CI 1.18-1.63) and 1.57 (1.37-1.76) for the HADS anxiety score and 1.68 (1.48-1.87) and 1.60 (1.38-1.82) for the HADS total score. Correlations of the HADS depression score and CRQ domain and Feeling Thermometer scores were <0.5. Based on the Effect Size approach the MID of the HADS anxiety and depression score was 1.32 and 1.40, respectively. Conclusions The minimal important difference of the HADS is around 1.5 in COPD patients corresponding to a change from baseline of around 20%. It can be used for the planning and interpretation of trials.

Wann-Hansson:2008

Cross-diagnostic validity of the Nottingham Health Profile index of Distress (NHPD)
C. Wann-Hansson and R. Klevsgard and P. Hagell
Health and Quality of Life Outcomes  6    (2008)

Background The Nottingham Health Profile index of Distress (NHPD) has been proposed as a generic undimensional 24-item measure of illness-related distress that is embedded in the Nottingham Health Profile (NHP). Data indicate that the NHPD may have psychometric advantages to the 6-dimensional NHP profile scores. Detailed psychometric evaluations are, however, lacking. Furthermore, to support the validity of the generic property of outcome measures evidence that scores can be interpreted in the same manner in different diagnostic groups are needed. It is currently unknown if NHPD scores have the same meaning across patient populations. This study evaluated the measurement properties and cross-diagnostic validity of the NHPD as a survey instrument among people with Parkinson's disease (PD) and peripheral arterial disease (PAD). Methods Data from 215 (PD) and 258 (PAD) people were Rasch analyzed regarding model fit, reliability, differential item functioning (DIF), unidimensionality and targeting. In cases of cross-diagnostic DIF this was adjusted for and the impact of DIF on the total score and person measures was assessed. Results The NHPD was found to have good overall and individual item fit in both disorders as well as in the pooled sample, but seven items displayed cross-diagnostic DIF. Following adjustment for DIF some aspects of model fit were slightly compromised, whereas others improved somewhat. DIF did not impact total NHPD scores or resulting person measures, but the unadjusted scale displayed minor signs of multidimensionality. Reliability was >0.8 in all within- and cross-diagnostic analyses. Items tended to represent more distress (mean, 0 logits) than that experienced by the sample (mean, -1.6 logits). Conclusions This study supports the within- and cross-diagnostic validity of the NHPD as a survey tool among people with PD and PAD. We encourage others to reassess available NHP data within the NHPD framework to further evaluate the strengths and weaknesses of this simple patient-reported index of illness-related distress.

Katula:2008

Enhancing Quality of Life in Older Adults: A Comparison of Muscular Strength and Power Training
J. Katula and W. Rejeski and A. Marsh
Health and Quality of Life Outcomes  6    (2008)

Background Although progressive resistance strength training (ST) has been found to improve various measures of physical functioning in older adults, the benefit to quality of life is unclear. Additionally, recent evidence suggests that high velocity power training (PT) may be more beneficial for physical functioning than ST, but it is not known whether this type of training impacts quality of life. The purpose of this study was to compare changes in multiple measures of quality of life resulting from ST vs. PT in older adults. A no exercise group was also included as control comparison condition. Methods Forty-five older adults (M age = 74.8 years; SD = 5.7) were randomly assigned to either a) PT, b) ST, or c) control group (no exercise). Measures of self-efficacy (SE), satisfaction with physical function (SPF), and the Satisfaction with Life Scale (SWL) were assessed at baseline and following training. The resistance training conditions met 3 times per week for 12 weeks at an intensity of 70% 1 repetition maximum. Results A series of ANCOVA's comparing between group differences in change and controlling for baseline values revealed significant group differences in all three measures: SE (F(2,31) = 9.77; p < .001); SPF (F(2,32) = 3.36; p = .047); SWL (F(2,31) = 4.76; p = .016). Follow up analyses indicated that the PT group reported significantly more change in SE, SPF, and SWL than the control group whereas the ST group reported greater change than the control group only in SE. Conclusion These pilot data indicate that high velocity power training may influence multiple levels of quality of life over and above the benefits gained through traditional strength training.

Morton:2008

A systematic review of mobility instruments and their measurement properties for older acute medical patients
N. de Morton and D. Berlowitz and J. Keating
Health and Quality of Life Outcomes  6    (2008)

Background Independent mobility is a key factor in determining readiness for discharge for older patients following acute hospitalisation and has also been identified as a predictor of many important outcomes for this patient group. This review aimed to identify a physical performance instrument that is not disease specific that has the properties required to accurately measure and monitor the mobility of older medical patients in the acute hospital setting. Methods Databases initially searched were Medline, Cinahl, Embase, Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials without language restriction or limits on year of publication until July 2005. After analysis of this yield, a second step was the systematic search of Medline, Cinahl and Embase until August 2005 for evidence of the clinical utility of each potentially suitable instrument. Reports were included in this review if instruments described had face validity for measuring from bed bound to independent levels of ambulation, the items were suitable for application in an acute hospital setting and the instrument required observation (rather than self-report) of physical performance. Evidence of the clinical utility of each potentially suitable instrument was considered if data on measurement properties were reported. Results Three instruments, the Elderly Mobility Scale (EMS), Hierarchical Assessment of Balance and Mobility (HABAM) and the Physical Performance Mobility Examination (PPME) were identified as potentially relevant. Clinimetric evaluation indicated that the HABAM has the most desirable properties of these three instruments. However, the HABAM has the limitation of a ceiling effect in an older acute medical patient population and reliability and minimally clinically important difference (MCID) estimates have not been reported for the Rasch refined HABAM. These limitations support the proposal that a new mobility instrument is required for older acute medical patients. Conclusion No existing instrument has the properties required to accurately measure and monitor mobility of older acute medical patients.

Kaoulla:2008

Development and validation of a Greek language version of the Manchester Foot Pain and Disability Index
P. Kaoulla and N. Frescos and H. Menz
Health and Quality of Life Outcomes  6    (2008)

Background The Manchester Foot Pain and Disability Index (MFPDI) is a 19 item questionnaire used to assess the severity and impact of foot pain. The aim of this study was to develop a Greek-language version of the MFPDI and to assess the instrument's psychometric properties. Methods The MFPDI was translated into Greek by three bilingual content experts and two bilingual language experts, and then back-translated into English to assess for equivalence. The final Greek version was administered, along with a questionnaire consisting medical history and the Medical Outcomes Study Short Form 36 (SF-36), to 104 Greek-speaking, community-dwelling people (64 female, 40 male), aged between 64 and 90 years (mean 73.00, SD 5.26) with disabling foot pain. Results The Greek translation of the MFPDI was found to have high internal consistency (Cronbach's alpha= 0.89, and item-total correlation coefficients from 0.33 to 0.72). Principal components analysis revealed a four-factor structure representing the constructs of functional limitation, pain intensity, concern with appearance and activity restriction, which explained 60.8% of the variance, with 38.9% of the variance explained by the first construct (functional limitation). Six items demonstrated different factor loadings to the original English version. Conclusion The Greek-language version of the MFPDI appears to be a valid tool in assessing foot pain in Greek-speaking older people. The total MFPDI scores are comparable between the Greek and English version, however due to differences in the factor loadings of some items, between-language comparisons of MFPDI should be undertaken with some caution.

Tsakos:2008

Comparison of the self-administered and interviewer-administered modes of the Child-OIDP
G. Tsakos and E. Bernabe and K. O'Brien and A. Sheiham and C. de Oliveira
Health and Quality of Life Outcomes  6    (2008)

Background The mode of questionnaire administration may affect the estimates and applicability of oral health-related quality of life indicators. The aim of this study was to compare psychometrically the self-administered Child-OIDP index with the original interviewer-administered instrument. Methods This was a cross-sectional study of 144 consecutive children aged 9--16 years referred to orthodontic clinics in Bedfordshire. To compare the two administration modes of the Child-OIDP, the sample was randomly split in two groups. The two groups were analysed in terms of baseline characteristics, self-perceived measures (self-rated oral health, self-perceived need for braces, happiness with dental appearance, frequency of thinking about dental appearance), Child-OIDP performance scores and overall score and psychometric properties (criterion validity and internal reliability). Results No significant difference between the two groups was found in relation to their sociodemographic profile and self-perceived measures. The self- and interviewer-administered Child-OIDP had identical mean scores and did not differ in recording any of the eight performances (p >= 0.206). For criterion validity, the correlation coefficients of the Child-OIDP with self-perceived measures were not different between the two modes of administration (p >= 0.118). Furthermore, the Cronbach's alpha values of the two groups were similar (p = 0.466). Conclusion This study demonstrated that the self-administered Child-OIDP performed the same as the original interviewer-administered mode, while at the same time reducing administration burden. This provides support for the use of the self-administered Child-OIDP. Further studies should focus on a more comprehensive psychometric evaluation.

Kook:2008

Validation of the Korean version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) Generic Core Scales in school children and adolescents using the Rasch model
S. Kook and J. Varni
Health and Quality of Life Outcomes  6    (2008)

Background The Pediatric Quality of Life Inventory (PedsQL) is a child self-report and parent proxy-report instrument designed to assess health-related quality of life (HRQOL) in healthy and ill children and adolescents. It has been translated into over 70 international languages and proposed as a valid and reliable pediatric HRQOL measure. This study aimed to assess the psychometric properties of the Korean translation of the PedsQL 4.0 Generic Core Scales. Methods Following the guidelines for linguistic validation, the original US English scales were translated into Korean and cognitive interviews were administered. The field testing responses of 1425 school children and adolescents and 1431 parents to the Korean version of PedsQL 4.0 Generic Core Scales were analyzed utilizing confirmatory factor analysis and the Rasch model. Results Consistent with studies using the US English instrument and other translation studies, score distributions were skewed toward higher HRQOL in a predominantly healthy population. Confirmatory factor analysis supported a four-factor and a second order-factor model. The analysis using the Rasch model showed that person reliabilities are low, item reliabilities are high, and the majority of items fit the model's expectation. The Rasch rating scale diagnostics showed that PedsQL 4.0 Generic Core Scales in general have the optimal number of response categories, but category 4 (almost always a problem) is somewhat problematic for the healthy school sample. The agreements between child self-report and parent proxy-report were moderate. Conclusion The results demonstrate the feasibility, validity, item reliability, item fit, and agreement between child self-report and parent proxy-report of the Korean version of PedsQL 4.0 Generic Core Scales for school population health research in Korea. However, the utilization of the Korean version of the PedsQL 4.0 Generic Core Scales for healthy school populations needs to consider low person reliability, ceiling effects and cultural differences, and further validation studies on Korean clinical samples are required.

Higginson:2008

Caregiver assessment of patients with advanced cancer: concordance with patients, effect of burden and positivity
I. Higginson and W. Gao
Health and Quality of Life Outcomes  6    (2008)

Background Clinicians and researchers often have to rely on information from caregivers to assess patients with advanced cancer. This study aims to assess the validity (using patients' assessment as the gold standard) of caregiver reports of patient concerns and the roles of caregiver burden and positivity. Methods A total of 64 advanced cancer patient and informal caregiver dyads were recruited from regional palliative care services and interviewed. Patients' outcomes were assessed with both the patient and the caregiver version of the Palliative Outcome Scale (POS); caregiver burden and positivity were collected with the Zarit Burden interview (ZBI) and three questions on achievements and relationships. The agreement between patient- and caregiver-rated POS was measured with weighted kappa statistics. The roles of caregiver burden and positivity in POS agreement were studied with logistic regression controlling for potential confounders; adjusted odds ratios were estimated from the models. Results Agreement was substantial for pain, moderate for four items, fair for three items and slight for two items. Compared with patients self-ratings, caregivers described more problems with information given and sharing feelings and were less likely to assess the patient felt their life was worthwhile or felt good about themselves. Disagreement for three POS item ratings was significantly associated with higher caregiver burden: "feeling anxious"(OR: 4.5; 95%CI: 1.3 to 15.6), "life worthwhile"(OR: 12.4; 95%CI: 2.9 to 54.3) and "felt good" (OR: 7.7; 95%CI: 2.0 to 29.6). Caregivers with higher positivity scores were more likely to agree patients' rating of "felt good"(OR: 0.3; 95%CI: 0.1--0.9) but at increased risk of disagreeing about patient's "practical problems"(OR: 4.2; 95%CI: 1.1 to 16.6). Conclusion Caregiver burden and positivity affect their assessments, especially of psychological patient domains and whether patients assess their life as worthwhile. Awareness of this might help clinicians and researchers better interpret caregiver assessments.

Kintner:2008a

Reliability and construct validity of the Participation in Life Activities Scale for children and adolescents with asthma: an instrument evaluation study
E. Kintner and A. Sikorskii
Health and Quality of Life Outcomes  6    (2008)

Background The purpose of this study was to evaluate the reliability and construct validity of the Participation in Life Activities Scale, an instrument designed to measure older school-age child and early adolescent level of involvement in chosen pursuits. Methods A cross-sectional design was used. The convenience sample consisted of 313 school-age children and early adolescents with asthma, ages 9-15 years. The self-report summative scale of interest is a 3-indicator survey. Higher scores are reflective of higher levels of participation. Internal consistency reliability and construct validity for the entire sample and sub groups of the sample were evaluated. Results The instrument was deemed sound for the entire sample as well as sub groups based on sex, race, age, socioeconomic status, and severity of illness. Cronbach's alpha coefficient for internal consistency reliability for the entire sample was .74. Exploratory factor analysis indicated a single component solution (loadings .79-.85) accounting for 66% of the explained variance. Construct validity was established by testing the posed relationship between participation in life activities scores and severity of illness. Confirmatory factor analysis revealed a good fit between the data and specified model, chi2(10, n = 302) = 8.074, p = .62. Conclusion This instrument could be used (a) in clinical settings to diagnose restricted participation in desired activities, guide decision-making about treatment plans to increase participation, and motivate behavioral change in the management of asthma; and (b) in research settings to explore factors influencing and consequences of restricted and unrestricted participation, and as an outcome measure to evaluate the effectiveness of programs designed to foster child and early adolescent management of asthma.

Hankins:2008

How discriminating are discriminative instruments?
M. Hankins
Health and Quality of Life Outcomes  6    (2008)

The McMaster framework introduced by Kirshner & Guyatt is the dominant paradigm for the development of measures of health status and health-related quality of life (HRQL). The framework defines the functions of such instruments as evaluative, predictive or discriminative. Evaluative instruments are required to be sensitive to change (responsiveness), but there is no corresponding index of the degree to which discriminative instruments are sensitive to cross-sectional differences. This paper argues that indices of validity and reliability are not sufficient to demonstrate that a discriminative instrument performs its function of discriminating between individuals, and that the McMaster framework would be augmented by the addition of a separate index of discrimination. The coefficient proposed by Ferguson (Delta) is easily adapted to HRQL instruments and is a direct, non-parametric index of the degree to which an instrument distinguishes between individuals. While Delta should prove useful in the development and evaluation of discriminative instruments, further research is required to elucidate the relationship between the measurement properties of discrimination, reliability and responsiveness.

Kintner:2008

Development and preliminary evaluation of the Participation in Life Activities Scale for children and adolescents with asthma: an instrument development study
E. Kintner
Health and Quality of Life Outcomes  6    (2008)

Background Being able to do things other kids do is the desire of school-age children and adolescents with asthma. In a phenomenology study, adolescents identified participation in life activities as the outcome variable and primary motivator for behavioral changes in coming to accept asthma as a chronic condition. In preparation for testing an acceptance model for older school-age children and early adolescents diagnosed with asthma, the Participation in Life Activities Scale was developed. The purposes of this paper are to describe development, and report on face and content validity of the scale designed to measure one aspect of quality of life defined as level of unrestricted involvement in chosen pursuits. Methods Items generated for the instrument evolved from statements and themes extracted from qualitative interviews. Face and content validity were evaluated by eight lay reviewers and 10 expert reviewers. Rate of accurate completion was computed using a convenience, cross-section sample consisting of 313 children and adolescents with asthma, ages 9--15 years, drawn from three studies. Preliminary cross-group comparisons of scores were assessed using t-tests and analysis of variance. Results Face and content validity were determined to be highly acceptable and relevant, respectively. Completion rate across all three studies was 97%. Although cross-group comparisons revealed no significant differences in overall participation scores based on age, race or residence groupings (p > .05), significant difference were indicated between males and females (p = .02), as well as the highest and lowest socioeconomic groups (p = .002). Conclusion Assessing content validity was the first step in evaluating properties of this newly developed instrument. Once face and content validity were established, psychometric evaluation related to internal consistency reliability and construct validity using factor analysis procedures was begun. Results will be reported elsewhere.

Ulvik:2008

Associations between disease severity, coping and dimensions of health-related quality of life in patients admitted for elective coronary angiography- a cross-sectional study
B. Ulvik and O. Nygard and B. Hanestad and T. Wentzel-Larsen and A. Wahl
Health and Quality of Life Outcomes  6    (2008)

Background In patients with suspected coronary artery disease (CAD), the overall aim was to analyse the relationships between disease severity and both mental and physical dimensions of health related quality of life (HRQOL) using a modified version of the Wilson and Cleary model. Methods Using a cross-sectional design, 753 patients (74% men), mean age 62 years, referred for elective cardiac catheterisation were included. The measures included 1) physiological factors 2) symptoms (disease severity, self-reported symptoms, anxiety and depression 3) self-reported functional status, 4) coping, 5) perceived disease burden, 6) general health perception and 7) overall quality of life. To analyse relationships, we performed linear and ordinal logistic regressions. Results CAD and left ventricular ejection fraction (LVEF) were significantly associated with symptoms of angina pectoris and dyspnea. CAD was not related to symptoms of anxiety and depression, but less depression was found in patients with low LVEF. Angina pectoris and dyspnea were both associated with impaired physical function, and dyspnea was also negatively related to social function. Overall, less perceived burden and better overall QOL were observed in patients using more confronting coping strategy. Conclusion The present study demonstrated that data from cardiac patients to a large extent support the suggested model by Wilson and Cleary.

Jozefiak:2008

Quality of Life as reported by school children and their parents: a cross-sectional survey
T. Jozefiak and B. Larsson and L. Wichstrom and F. Mattejat and U. Ravens-Sieberer
Health and Quality of Life Outcomes  6    (2008)

Background Comprehensive evidence exists regarding the discrepancy between children's reports and parents' by proxy reports on emotional and behavioural problems. However, little is yet known about factors influencing the extent to which child self- and parent by proxy reports differ in respect of child Quality of Life (QoL). The aim of the study was to investigate the degree of discrepancy between child and parent by proxy reports as measured by two different QoL instruments. Methods A representative Norwegian sample of 1997 school children aged 8--16 years, and their parents were studied using the Inventory of Life Quality (ILC) and the 'Kinder Lebensqualität Fragebogen' (KINDL). Child and parent reports were compared by t-test, and correlations were calculated by Pearson product moment coefficient. Psychometric aspects were examined in regard to both translated QoL instruments (internal consistency by Cronbach's alpha and test-retest reliability by intraclass correlation coefficients). Results Parents evaluated the QoL of their children significantly more positively than did the children. Correlations between mother-child and father-child reports were significant (p < 0.01) and similar but low to moderate (r = 0.32; and r = 0.30, respectively, for the KINDL, and r = 0.30 and r = 0.26, respectively, for the ILC). Mother and father reports correlated moderately highly (r = 0.54 and r = 0.61 for the KINDL and ILC, respectively). No significant differences between correlations of mother-daughter/son and father-daughter/son pairs in regard to reported child QoL were observed on either of the two instruments. Conclusion In the present general population sample, parents reported higher child QoL than did their children. Concordance between child and parent by proxy report was low to moderate. The level of agreement between mothers and fathers in regard to their child's QoL was moderate. No significant impact of parent and child gender in regard to agreement in ratings of child QoL was found. Both the child and parent versions of the Norwegian translations of the KINDL and ILC can be used in surveys of community populations, but in regard to the self-report of 9--10 years old children, only the KINDL total QoL scale or the ILC are recommended.

Scarpelli:2008a

The Pediatric Quality of Life Inventory (PedsQL) family impact module: reliability and validity of the Brazilian version
A. Scarpelli and S. Paiva and I. Pordeus and J. Varni and C. Viegas and P. Allison
Health and Quality of Life Outcomes  6    (2008)

Revicki:2008

Characterizing the burden of premature ejaculation from a patient and partner perspective: a multi-country qualitative analysis
D. Revicki and K. Howard and J. Hanlon and S. Mannix and A. Greene and M. Rothman
Health and Quality of Life Outcomes  6    (2008)

Background Premature ejaculation (PE) is a common sexual dysfunction among men which affects men and their partners. Little qualitative data are available to characterize the impact of PE on men and their partners about ejaculatory control, sexual satisfaction, emotional distress and relationships. The objective of this study was to assess the impact of PE from the perspective of men with PE and the female partners of men with PE on their sexual experience, distress and relationships. Methods Qualitative data were collected through 14 focus groups in the US and through one-on-one interviews in the US, UK, Italy, France, Germany, and Poland. Study participants included heterosexual men with PE and female partners of males with PE. All participants were asked about how PE affects their daily life, including emotional impacts. One-on-one interviews also included obtaining feedback on the male and female versions of 4-single item measures of PE focusing on ejaculatory control, satisfaction with intercourse, interpersonal distress, and relationship difficulty. Results Participants included 172 males with PE and 67 female partners of men with PE. Lack of control over ejaculation and dissatisfaction with intercourse emerged as central themes of PE. Lack of ejaculatory control resulted in greater dissatisfaction and greater emotional distress, including feelings of inadequacy, disappointment, and anxiety. Continued PE ultimately leads to greater problems with partners and often disrupts partner relationships. Participants indicated that PE was keeping them from attaining complete intimacy in their relationships even when their partners were generally satisfied with sexual intercourse. Impacts of PE on sexual satisfaction, emotional distress and partner relationships were consistent across countries. Feedback on the single-item PE measures confirmed relevance of the item content and further confirmed major themes identified from the qualitative data. Conclusion This qualitative study provides valuable insights on the substantial psychosocial burden of PE in the US and the Europe. Lack of control over ejaculation resulted in dissatisfaction with intercourse and increased emotional distress, and wide-ranging impact for both men with PE and their partners of men with PE. Data collected in this study may help inform the content of new patient reported measures for use in PE research.

Lacasse:2008

Validation of the nausea and vomiting of pregnancy specific health related quality of life questionnaire
A. Lacasse and A. Berard
Health and Quality of Life Outcomes  6    (2008)

Deitchler:2008

Precision, time, and cost: a comparison of three sampling designs in an emergency setting
M. Deitchler and H. Deconinck and G. Bergeron
Emerging Themes in Epidemiology  5    (2008)

The conventional method to collect data on the health, nutrition, and food security status of a population affected by an emergency is a 30 × 30 cluster survey. This sampling method can be time and resource intensive and, accordingly, may not be the most appropriate one when data are needed rapidly for decision making. In this study, we compare the precision, time and cost of the 30 × 30 cluster survey with two alternative sampling designs: a 33 × 6 cluster design (33 clusters, 6 observations per cluster) and a 67 × 3 cluster design (67 clusters, 3 observations per cluster). Data for each sampling design were collected concurrently in West Darfur, Sudan in September-October 2005 in an emergency setting. Results of the study show the 30 × 30 design to provide more precise results (i.e. narrower 95% confidence intervals) than the 33 × 6 and 67 × 3 design for most child-level indicators. Exceptions are indicators of immunization and vitamin A capsule supplementation coverage which show a high intra-cluster correlation. Although the 33 × 6 and 67 × 3 designs provide wider confidence intervals than the 30 × 30 design for child anthropometric indicators, the 33 × 6 and 67 × 3 designs provide the opportunity to conduct a LQAS hypothesis test to detect whether or not a critical threshold of global acute malnutrition prevalence has been exceeded, whereas the 30 × 30 design does not. For the household-level indicators tested in this study, the 67 × 3 design provides the most precise results. However, our results show that neither the 33 × 6 nor the 67 × 3 design are appropriate for assessing indicators of mortality. In this field application, data collection for the 33 × 6 and 67 × 3 designs required substantially less time and cost than that required for the 30 × 30 design. The findings of this study suggest the 33 × 6 and 67 × 3 designs can provide useful time- and resource-saving alternatives to the 30 × 30 method of data collection in emergency settings.

Levasseur:2008

Do quality of life, participation and environment of older adults differ according to level of activity?
M. Levasseur and J. Desrosiers and D. S. Tribble
Health and Quality of Life Outcomes  6    (2008)

Background Activity limitation is one of the most frequent geriatric clinical syndromes that have significant individual and societal impacts. People living with activity limitations might have fewer opportunities to be satisfied with life or experience happiness, which can have a negative effect on their quality of life. Participation and environment are also important modifiable variables that influence community living and are targeted by health interventions. However, little is known about how quality of life, participation and environment differ according to activity level. This study examines if quality of life, participation (level and satisfaction) and perceived quality of the environment (facilitators or obstacles in the physical or social environment) of community-dwelling older adults differ according to level of activity. Methods A cross-sectional design was used with a convenience sample of 156 older adults (mean age = 73.7; 76.9% women), living at home and having good cognitive functions, recruited according to three levels of activity limitations (none, slight to moderate and moderate to severe). Quality of life was estimated with the Quality of Life Index, participation with the Assessment of Life Habits and environment with the Measure of the Quality of the Environment. Analysis of variance (ANOVA) or Welch F-ratio indicated if the main variables differed according to activity level. Results Quality of life and satisfaction with participation were greater with a higher activity level (p < 0.001). However, these differences were clinically significant only between participants without activity limitations and those with moderate to severe activity limitations. When activity level was more limited, participation level was further restricted (p < 0.001) and the physical environment was perceived as having more obstacles (p < 0.001). No differences were observed for facilitators in the physical and social environment or for obstacles in the social environment. Conclusion This study suggests that older adults' participation level and obstacles in the physical environment differ according to level of activity. Quality of life and satisfaction with participation also differ but only when activity level is sufficiently disrupted. The study suggests the importance of looking beyond activity when helping older adults live in the community.

Shaw:2008

The Reflux Disease Questionnaire: a measure for assessing treatment response in clinical trials
M. Shaw and J. Dent and T. Beebe and O. Junghard and I. Wiklund and T. Lind and F. Johnsson
Health and Quality of Life Outcomes  6    (2008)

Background Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. Methods Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. Results The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89. Conclusion The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.

Sepulveda:2008

Development and validation of an Eating Disorders Symptom Impact Scale (EDSIS) for carers of people with eating disorders
A. Sepulveda and J. Whitney and M. Hankins and J. Treasure
Health and Quality of Life Outcomes  6    (2008)

Background Family members of relatives with eating disorders experience high levels of distress due to the difficulties in their care giving role. However no measures have been developed to measure the specific impact that an individual with an eating disorder has on family life. The aim of this study was to develop a measure to assess the specific caregiving burden of both anorexia nervosa and bulimia nervosa. A secondary aim was to examine whether this measure was sensitive to change. Methods A new scale, the Eating Disorders Symptom Impact Scale (EDSIS), was generated by a panel of clinicians and researchers based upon quantitative and qualitative work with carers and reviewed by a panel of "expert carers". A cross-sectional study was conducted among carers of relatives with an eating disorder to examine the properties of the new scale. In addition, participants from an ongoing pre-and-post design study completed several self-report questionnaires to assess the sensitivity of the EDSIS to change. Results A sample of 196 carers of relatives with an eating disorder aged 25--68 compted the scale. A 24-item EDSIS scale was derived with four factors: nutrition, guilt, dysregulated behaviour and social isolation. These explained 58.4% of the variance in carer distress. Reliability was acceptable (Cronbach's alpha ranged from 0.84 to 0.90). The convergent validity of the EDSIS subscales was moderately supported by correlations with a general caregiving measure (Experience of Caregiving Inventory (ECI), r = 0.42 to 0.60), psychological distress (General Health Questionnaire (GHQ-12), r = 0.33) and perceived functioning of the relative (Children Global Assessment Scale (CGAS), r = -30). A sample of 57 primary caregivers completed pre-post intervention assessments and the overall scale (t = 2.3, p < 0.05) and guilt subscale (t = 3.4, p < 0.01) were sensitive to change following a skills training workshop. Conclusion The EDSIS instrument has good psychometric properties and may be of value to assess the impact of eating disorder symptoms on family members. It may be of value to highlight carers' needs and to monitor the effectiveness of family based interventions.

Seino:2008

Prevalence of and factors influencing posttraumatic stress disorder among mothers of children under five in Kabul, Afghanistan, after decades of armed conflicts
K. Seino and T. Takano and T. Mashal and S. Hemat and K. Nakamura
Health and Quality of Life Outcomes  6    (2008)

Background In the period following wars and other forms of armed conflict, health and quality of life of mothers is a major concern as they have the closest contact with children. The present study was performed to examine the impact of exposure to events related to armed conflicts on post traumatic stress disorder (PTSD) among women raising children, and to identify factors that alleviate the negative consequences of exposure to traumatic events. Methods A structured interview survey was conducted in Kabul Province, Afghanistan, in 2006. The subjects were the mothers of children less than 5 years old randomly selected from 1400 households in Kabul Province, Afghanistan. Symptoms of PTSD were assessed according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Exposure to traumatic events related to armed conflict, experience of hardship with regard to basic needs, resources that the subjects seek for mental health support, and socioeconomic variables were evaluated. Logistic regression analysis was performed to determine the association between PTSD symptoms and predictor variables. Results The prevalence rate of PTSD among 1172 women participated in this study was 29.8%. The most prevalent symptom was arousal (74.8%), followed by re-experiencing (54.9%) and avoidance (33.7%). The prevalence rate of PTSD symptoms among subjects who reported having experienced at least one event related to armed conflict (52.7%) was significantly higher than that among those who reported no such experiences (9.6%). Experience of food shortage was independently associated with PTSD. Seeking support for mental health was related to lower prevalence of PTSD symptoms among those who reported no direct experience of events related to armed conflict. However, no such relationship was observed with PTSD symptoms among those who reported having direct experience of events related to armed conflict. Conclusion Direct exposure to traumatic events was significantly associated with PTSD symptoms among women raising children. For those who had experienced armed conflict-related events, food security mitigated the occurrence of PTSD symptoms; however, support seeking behavior did not show a significant mitigating influence on PTSD. Means to alleviate the negative influence of exposure to armed conflicts on the quality of life of women should be developed from the viewpoint of quality of mental health support and avoidance of material hardship.

Witham:2008

Validation of an individualised quality of life measure in older day hospital patients
M. Witham and R. Fulton and L. Wilson and C. Leslie and M. McMurdo
Health and Quality of Life Outcomes  6    (2008)

Background To test the ease of use, reliability, responsiveness and construct validity of the Patient Generated Index, an individualised quality of life score, in older people attending a Medicine for Older People Day Hospital. Methods Prospective longitudinal study in patients attending a specialist Medicine for Older People Day Hospital in Scotland. The Patient Generated Index was administered at baseline, one week later, and at the end of Day Hospital attendance. Functional Limitations Profile, Hospital Anxiety and Depression Score, Barthel index and global subjective impressions of change were also collected and compared with baseline scores and change in Patient Generated Index scores. Reliability was assessed using intraclass correlation coefficients in subjects reporting no change in global quality of life; responsiveness was assessed using effect size and Guyatt coefficients in subjects reporting change in global quality of life. External validity was assessed via correlation with measures of physical function, comorbid disease and psychological state. Results 75 patients were enrolled, mean age 81 years. Mean completion time was 5.0 minutes at baseline. Reliability was moderate (intraclass correlation coefficient 0.72) but there were weak and inconsistent responses to change (effect sizes 0.02 to 0.15; Guyatt responsiveness coefficient 0.29). Patient Generated Index scores correlated with Functional Limitation Profile scores (r = 0.51, p < 0.001), baseline anxiety score (r = -0.25, P = 0.039) and baseline depression score (r = -0.37, P = 0.002) but displayed only weak, non-significant correlation with number of comorbid diseases (r = -0.22, P = 0.07), number of medications (r = -0.21, P = 0.08) and Barthel score (r = 0.09, p = 0.45). Conclusion The Patient Generated Index appears moderately reliable and easy to complete, but is poorly responsive to change, limiting its usefulness in clinical practice or research.

Attieh:2008

Voice Restoration Following Total Laryngectomy by Tracheoesophageal Prosthesis: Effect on Patients' Quality of Life
A. Attieh and J. Searl and N. Shahaltough and M. Wreikat and D. Lundy
Health and Quality of Life Outcomes  6    (2008)

Background Little has been reported about the impact of tracheoesophageal (TE) speech on individuals in the Middle East where the procedure has been gaining in popularity. After total laryngectomy, individuals in Europe and North America have rated their quality of life as being lower than non-laryngectomized individuals. The purpose of this study was to evaluate changes in quality of life and degree of voice handicap reported by laryngectomized speakers from Jordan before and after establishment of TE speech. Methods Twelve male Jordanian laryngectomees completed the University of Michigan Head & Neck Quality of Life instrument and the Voice Handicap Index pre- and post-TE puncture. Results All subjects showed significant improvements in their quality of life following successful prosthetic voice restoration. In addition, voice handicap scores were significantly reduced from pre- to post-TE puncture. Conclusion Tracheoesophageal speech significantly improved the quality of life and limited the voice handicap imposed by total laryngectomy. This method of voice restoration has been used for a number of years in other countries and now appears to be a viable alternative within Jordan.

Peeters:2008

Predictors of quality of life: A quantitative investigation of the stress-coping model in children with asthma
Y. Peeters and S. Boersma and H. Koopman
Health and Quality of Life Outcomes  6    (2008)

Background Aim of this study is to further explore predictors of health related quality of life in children with asthma using factors derived from to the extended stress-coping model. While the stress-coping model has often been used as a frame of reference in studying health related quality of life in chronic illness, few have actually tested the model in children with asthma. Method In this survey study data were obtained by means of self-report questionnaires from seventy-eight children with asthma and their parents. Based on data derived from these questionnaires the constructs of the extended stress-coping model were assessed, using regression analysis and path analysis. Results The results of both regression analysis and path analysis reveal tentative support for the proposed relationships between predictors and health related quality of life in the stress-coping model. Moreover, as indicated in the stress-coping model, HRQoL is only directly predicted by coping. Both coping strategies 'emotional reaction' (significantly) and 'avoidance' are directly related to HRQoL. Conclusion In children with asthma, the extended stress-coping model appears to be a useful theoretical framework for understanding the impact of the illness on their quality of life. Consequently, the factors suggested by this model should be taken into account when designing optimal psychosocial-care interventions.

Simon:2008

Evaluation of quality of life and description of the sociodemographic state in adolescent and young adult patients with phenylketonuria (PKU)
E. Simon and M. Schwarz and J. Roos and N. Dragano and M. Geraedts and J. Siegrist and G. Kamp and U. Wendel
Health and Quality of Life Outcomes  6    (2008)

Background Normal intellectual and personal development can be expected in early-diagnosed and treated PKU patients. Aim of the study was to analyse quality of life and social status, which are important parameters for an overall estimation of success of treatment apart from intellectual outcome in adult PKU patients. Methods 67 patients completed a questionnaire on quality of life and social status. Data was compared to the German census on an age matched control collective. Results Quality of life measured with the Profile of Quality of Life in the Chronically Ill (PLC) revealed mean values for capacity of performance in the patient group in the same range as in the control collective. The analysis of the social state of PKU patients revealed a tendency towards lower or delayed autonomy, and a low rate of forming normal adult relationships in which to have children. Schooling and professional career corresponded approximately to the control collective. Conclusion Though every chronic disorder must be regarded as restraining, it shows that PKU does not preclude healthy emotional adjustment when the disease is diagnosed early and treated well.

Yuan:2008

Some psychometric properties of the Chinese version of the Modified Dental Anxiety Scale with cross validation
S. Yuan and R. Freeman and S. Lahti and F. Lloyd-Williams and G. Humphris
Health and Quality of Life Outcomes  6    (2008)

Objective To assess the factorial structure and construct validity for the Chinese version of the Modified Dental Anxiety Scale (MDAS). Materials and methods A cross-sectional survey was conducted in March 2006 from adults in the Beijing area. The questionnaire consisted of sections to assess for participants' demographic profile and dental attendance patterns, the Chinese MDAS and the anxiety items from the Hospital Anxiety and Depression Scale (HADS). The analysis was conducted in two stages using confirmatory factor analysis and structural equation modelling. Cross validation was tested with a North West of England comparison sample. Results 783 questionnaires were successfully completed from Beijing, 468 from England. The Chinese MDAS consisted of two factors: anticipatory dental anxiety (ADA) and treatment dental anxiety (TDA). Internal consistency coefficients (tau non-equivalent) were 0.74 and 0.86 respectively. Measurement properties were virtually identical for male and female respondents. Relationships of the Chinese MDAS with gender, age and dental attendance supported predictions. Significant structural parameters between the two sub-scales (negative affectivity and autonomic anxiety) of the HADS anxiety items and the two newly identified factors of the MDAS were confirmed and duplicated in the comparison sample. Conclusion The Chinese version of the MDAS has good psychometric properties and has the ability to assess, briefly, overall dental anxiety and two correlated but distinct aspects.

Krikmann:2008

Validation of an Estonian version of the Parkinson's Disease Questionnaire (PDQ-39)
U. Krikmann and P. Taba and T. Lai and T. Asser
Health and Quality of Life Outcomes  6    (2008)

Introduction Diagnosis and management of Parkinson's disease (PD) rely heavily on evaluation of clinical symptoms and patients' subjective perception of their condition. The purpose of this study was to evaluate the validity, acceptability, and reliability of the Estonian version of the 39-question Parkinson 's disease Questionnaire (PDQ-39). Methods Study subjects were approached during their regular clinic follow-up visits. 104 patients consented to the study and 81 completed questionnaires were used for subsequent testing of psychometric characteristics, validity and reliability. Results The content validity was assessed through qualitative content analysis during the pilot study. The patients indicated that the questions were relevant to measure the quality of life of people with PD. The analysis of means showed that the ceiling and floor effects of domain results were within the limits of 15% of Summary Index and of all domains except Stigma, Social Support and Communication where the ceiling effect was 16% to 24% of the responses. Convergent validity was interpreted through correlation between disease severity and PDQ-39 domains. There was a statistically significant difference between the domain scores in patients with mild versus moderate PD in domains of Mobility, ADL, and Communication but not for Stigma, Social Support and Cognition. The reliability was good, Cronbach alpha for all domains and summary index was over 0.8 and item-test correlations between domains and summary index ranged from 0.56 to 0.83. Conclusion The psychometric characteristics of an Estonian version of the PDQ-39 were satisfactory. The results of this study were comparable to the results of previous validation studies in other cultural settings in UK, USA, Canada, Spain and Italy. The Estonian version of the PDQ-39 is an acceptable, valid and reliable instrument for quality of life measurement in PD patients.

Rapkin:2008

Beyond satisfaction: Using the Dynamics of Care assessment to better understand patients' experiences in care
B. Rapkin and E. Weiss and R. Chhabra and L. Ryniker and S. Patel and J. Carness and R. Adsuar and W. Kahalas
Health and Quality of Life Outcomes  6    (2008)

Background Patient perceptions of and satisfaction with care have become important indicators of the quality of services and the relationship of services to treatment outcomes. However, assessment of these indicators continues to be plagued by measurement problems, particularly the lack of variance in satisfaction data. In this article, we present a new approach to better capture patient perceptions of experiences in care, the Dynamics of Care (DoC) assessment. It is an in-depth approach to defining and assessing patients' perspectives at different junctures in care, including their decisions about whether and where to seek care, the barriers encountered, and the treatments and services received. Methods The purpose of this article is to describe, validate, and discuss the benefits and limitations of the DoC, which was administered as part of a longitudinal study to evaluate the New York State HIV Special Needs Plan (HIV SNP), a Medicaid managed care model for people living with HIV/AIDS. Data are from 426 study respondents across two time points. Results The results demonstrate the validity and value of the DoC. Help seeking decisions and satisfaction with care appear to be situation-specific, rather than person-specific. However, barriers to care appear to be more cross-situational for respondents, and may be associated with clients' living situations or care arrangements. Inventories in this assessment that were designed to identify potential deterrents to help seeking and difficulties encountered in care demonstrated clear principal component structures, and helped to explain satisfaction with care. The problem resolution index was found to be independent from satisfaction with care and the data were more normally distributed. DoC data were also associated with subsequent utilization and change in quality of life. Conclusions The DoC was designed to be a flexible, integrated measure to determine individuals' salient service needs, help seeking and experiences in care. One of the many strengths of the assessment is its focus on specific problems in context, thus providing a more sensitive and informative way to understand processes in care from the patient's perspective. This approach can be used to direct new programs and resources to the patients and situations that require them.

Knoester:2008

Quality of life in children three and nine months after discharge from a paediatric intensive care unit: a prospective cohort study
H. Knoester and M. Bronner and A. B. ad M Grootenhuis
Health and Quality of Life Outcomes  6    (2008)

Background Improved survival in children with critical illnesses has led to new disease patterns. As a consequence evaluation of the well being of survivors of Pediatric Intensive Care Units (PICU) has become important. Outcome assessment should therefore consist of evaluation of morbidity, functional health and Health Related Quality of Life (HRQoL). Awareness of HRQoL consequences and physical sequelae could lead to changes in support during the acute phase and thereafter. The aim of this study was to evaluate HRQoL in PICU survivors. Methods Prospective follow-up study three and nine months after discharge from a 14-bed tertiary PICU. Eighty-one of 142 eligible, previously healthy children were included from December 2002 through October 2005. HRQoL was assessed with the TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL-PF) for children aged 1 to 6 years of age, the TNO-AZL Children's Quality of Life Questionnaire Parent Form (TACQOL-PF) for children aged 6 to 12 years of age, and the TNO-AZL Children's Quality of Life Questionnaire Child Form (TACQOL-CF) for children aged 8 to 15 years of age. The studied patients were compared with age appropriate normative data using non-parametric tests and effect sizes. Results Thirty-one and 27 children, and 55 and 50 parents completed questionnaires respectively three and nine months after discharge. In 1-6 year old children parents reported more lung problems (3 and 9 months), worse liveliness (9 months) and better appetite and problem behaviour (3 months); in 6-12 year old children parents reported worse motor functioning (3 months); and 12-15 year old adolescents reported worse motor functioning (3 months). Large effect sizes indicating clinical significant differences in HRQoL with healthy control subjects were found on more domains. Conclusions In this small group of PICU survivors differences in HRQoL with the normative population exist three and nine months after discharge. Calculated effect sizes were smaller nine months after discharge. These changes suggest that HRQoL improves over time. More research is necessary but we believe that HRQoL assessment should be incorporated in follow-up programs of PICU survivors.

Jung:2008

A Korean version of the Oral Impacts on Daily Performances (OIDP) scale in elderly populations: validity, reliability and prevalence
S. Jung and J. Ryu and G. Tsakos and A. Sheiham
Health and Quality of Life Outcomes  6    (2008)

Background This study aimed to develop a Korean version of the OIDP index for elderly people and to assess the levels of sociodental impacts in an older Korean population. Methods The OIDP index for elderly people was cross-culturally adapted from English into Korean and then the derived instrument was tested for reliability and validity. The study population was elderly (65+ year-old) residents of Gangneung City, South Korea. Twenty two of the 222 senior day centres were randomly selected. Results 687 people were invited and 668 participated in the study (response rate: 97.2%). The standardized Cronbach alpha coefficient was 0.85. The OIDP related significantly with different subjective measures of oral and general health (p<0.001). 62.9% of the people had oral impacts relating to one or more performances, with eating food being the most frequently affected performance (47.6%). More than 70% of people with oral impacts had up to 3 performances affected by oral health conditions. Conclusions The Korean OIDP index showed satisfactory validity and internal consistency reliability, confirming its appropriateness for use among older Korean people. The prevalence of oral health related impacts was high. Future studies should focus on the test-retest reliability and the sensitivity to change of the Korean OIDP.

Grandy:2008

EQ-5D visual analog scale and utility index values in individuals with diabetes and at risk for diabetes: Findings from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD)
S. Grandy and K. Fox
Health and Quality of Life Outcomes  6    (2008)

Background The EQ-5D was used to compare burden experienced by respondents with diabetes to those at risk for diabetes. Methods A survey including the EQ-5D was mailed to individuals with self-reported diabetes, as well as those without diabetes but with the following risk factors (RFs): (1) abdominal obesity, (2) body mass index >28 kg/m2, (3) dyslipidemia, (4) hypertension, and (5) cardiovascular disease. Non-diabetes respondents were combined into 0-2 RFs and 3-5 RFs. Mean EQ-5D scores were compared across groups using analysis of variance. Multivariable linear regression modeling identified factors affecting respondents' EQ-5D scores. Results Complete responses were available from >75% of each cohort. Mean EQ-5D index scores were significantly lower for respondents with type 2 diabetes and 3-5 RFs (0.778 and 0.792, respectively) than 0-2 RFs (0.870, p<0.001 for each); score for type 2 diabetes was also significantly lower than 3-5 RFs (p<0.001). Similar patterns were seen for VAS. For both VAS and index scores, after adjusting for other characteristics, respondents reported decreasing EQ-5D scores as status moved from low to high risk (-6.49 for VAS score and -0.045 for index) to a diagnosis of type 2 diabetes (-9.75 for VAS and -0.054 for index; p<0.001 vs. 0-2 RFs for all). Conclusions High-risk and type 2 diabetes groups had similar EQ-5D scores, and both were substantially lower than in low-risk respondents.

Hutchings:2008

Development of a parent version of the Manchester-Minneapolis quality of life survey for use by parents and carers of UK children: MMQL-UK (PF)
H. Hutchings and P. Upton and W. Cheung and A. Maddocks and C. Eiser and J. Williams and I. Russell and S. Jackson
Health and Quality of Life Outcomes  6    (2008)

Background Although it is now widely endorsed that children should as far as possible rate their own health related quality of life (HRQL), there are situations where proxy information on child HRQL may be useful, especially where a child is too ill or young to provide their own HRQL assessment. There is limited availability of generic HRQL scales that have a parallel child and parent version and that are reliable, valid, brief, comprehensible and suitable for use in UK populations. The aims of this study were therefore to develop and validate a parent version of the anglicised Manchester-Minneapolis Quality of Life child form (MMQL-UK (CF)) and to determine the level of association between the child and parent versions of this form. Methods This study was undertaken concurrently with the anglicisation and validation of the MMQL, a measure of HRQL developed for use with children in North America. At that time, no parent version existed, so the MMQL form for children (MMQL-UK (CF)) was used as the basis for the development of the MMQL-UK parent form (PF). The sample included a control group of healthy children and their parents and five exemplar groups; children diagnosed with asthma, diabetes or inflammatory bowel disease and their parents, children in remission from cancer and their parents and children in public care and their carers. Consistency of the MMQL-UK (PF) components were assessed by calculating Cronbachas alpha. Validation of the parent questionnaire was undertaken by comparing MMQL-UK (PF) component scores with comparable components on the proxy PedsQLTM quality of life scales, comparing MMQL-UK (PF) component scores between parents of healthy and chronic disease children and by comparison of component scores from children and their parents or carers. Reproducibility and responsiveness were assessed by retesting parents by follow-up questionnaires. Results A total of 874 children (completing MMQL-UK (CF)) and 572 parents or carers (completing MMQL-UK (PF)) took part in the study. The internal consistency of all the MMQL-UK (PF) components exceeding the accepted criterion of 0.70 and the construct validity was good with moderate correlations being evident between comparable components of the MMQL-UK (PF) and the proxy PedsQLTM. Discriminant validity was demonstrated with significant differences being identified between parents of healthy children and those with chronic conditions. Intra-class correlations exceeded 0.65 for all MMQL-UK (PF) components demonstrating good reproducibility. Weak to moderate levels of responsiveness were demonstrated for all but social functioning. The MMQL-UK (PF) showed moderate parent-child correlation with the MMQL-UK (CF) for all components. The best correlations were seen for those components measuring the same construct (Pearsonas r ranged from 0.31 to 0.61, p< 0.01 for equivalent components). Conclusions The MMQL-UK (PF) showed moderate to good correlations with the MMQL-UK (CF) component scores. The MMQL-UK (PF) will be of use when comparing child and parent/carer perception of the impact of a child's condition on their HRQL or where the child is too ill or young to provide their own report.

Groot:2008

The Dutch version of the knee injury and osteoarthritis outcome score: a validation study
I. D. Groot and M. Favejee and M. Reijman and J. Verhaar and C. Terwee
Health and Quality of Life Outcomes  6    (2008)

Background The Knee Injury and Osteoarthritis Outcome Score (KOOS) was constructed in Sweden. This questionnaire has proved to be valid for several orthopedic interventions of the knee. It has been formally translated and validated in several languages, but not yet in Dutch. The purpose of the present study was to evaluate the clinimetric properties of the Dutch version of the KOOS questionnaire in knee patients with various stages of osteoarthritis (OA). Methods The Swedish version of the KOOS questionnaire was first translated into Dutch according to a standardized procedure and second tested for clinimetric quality. The study population consisted of patients with different stages of OA (mild, moderate and severe) and of patients after primary TKA, and after a revision of the TKA. All patients filled in the Dutch KOOS questionnaire, as well as the SF-36 and a Visual Analogue Scale for pain. The following analyses were performed to evaluate the clinimetric quality of the KOOS: Cronbach's alpha (internal consistency), principal component analyses (factor analysis), intraclass correlation coefficients (reliability), spearman's correlation coefficient (construct validity), and floor and ceiling effects. Results For all patients groups Cronbach's alpha was for all subscales above 0.70. The ICCs, assessed for the patient groups with mild and moderate OA and after revision of the TKA patients, were above 0.70 for all subscales. Of the predefined hypotheses 60% or more could be confirmed for the patients with mild and moderate OA and for the TKA patients for the other patient groups less than 45% could be confirmed. Ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for the subscale Sport/Recreation in the severe OA group. Floor effects were found for the subscales Sport/Recreation and Qol in the severe OA and revision TKA groups. Conclusion Based on these different clinimetric properties within the present study we conclude that the KOOS questionnaire seems to be suitable for patients with mild and moderate OA and for patients with a primary TKA. The Dutch version of the KOOS had a lower construct validity for patients with severe OA on a waiting list for TKA and patients after revision of a TKA. Further validation studies on the Dutch version of the KOOS should also include a knee specific questionnaire for assessing the construct validity.

Osteras:2008

A randomised comparison of a four- and a five-point scale version of the Norwegian Function Assessment Scale
N. Osteras and P. Gulbrandsen and A. Garratt and J. Benth and F. Dahl and B. Natvig and S. Brage
Health and Quality of Life Outcomes  6    (2008)

Background There is variation in the number of response alternatives used within health-related questionnaires. This study compared a four- and a five-point scale version of the Norwegian Function Assessment Scale (NFAS) by evaluating data quality, internal consistency and validity. Methods All inhabitants in seven birth cohorts in the Ullensaker municipality of Norway were approached by means of a postal questionnaire. The NFAS was included as part of The Ullensaker Study 2004. The instrument comprises 39 items derived from the activities/participation component in the International Classification for Functioning, Disabilities and Health (ICF). The sample was computer-randomised to either the four-point or the five-point scale version. Results Both versions of the NFAS had acceptable response rates and good data quality and internal consistency. The five-point scale version had better data quality in terms of missing data, end effects at the item and scale level, as well as higher levels of internal consistency. Construct validity was acceptable for both versions, demonstrated by correlations with instruments assessing similar aspects of health and comparisons with groups of individuals known to differ in their functioning according to existing evidence. Conclusions Data quality, internal consistency and discriminative validity suggest that the five-point scale version should be used in future applications.

Puhan:2008

Comparing a disease-specific and a generic health-related quality of life instrument in subjects with asthma from the general population
M. Puhan and J. Gaspoz and P. Bridevaux and C. Schindler and U. Ackermann-Liebrich and T. Rochat and M. Gerbase
Health and Quality of Life Outcomes  6    (2008)

Background Few epidemiologic studies have assessed health-related quality of life (HRQL) of asthma patients from a general population and it is unclear which instrument is best suitable for this purpose. We investigated the validity of the Asthma Quality of Life Questionnaire (AQLQ) and the SF-36 completed by individuals with asthma from the population-based SAPALDIA (Swiss study on air pollution and lung diseases in adults) cohort. Methods The study included 258 participants with a physician-diagnosed asthma who had completed the AQLQ and SF-36. We assessed floor and ceiling effects, internal consistency reliability and cross-sectional validity with a priori hypotheses that correlations between the specific HRQL domains (e.g. symptoms or physical functioning) and the corresponding external validation measures (respiratory symptoms, need for doctor visits, limitation in activities due to asthma and lung function) would capture similar aspects and be correlated moderately (>=0.3) to strongly (>=0.5), whereas non-corresponding domains be correlated weakly with each other (<0.3). Results The AQLQ showed pronounced ceiling effects with all median domain scores above 6 (scores varied from 1-7). For the SF-36, ceiling effects were present in 5 out of 8 domains. Cronbachas alpha was >0.7 for all AQLQ and SF-36 domains. Correlations between the AQLQ domains respiratory symptoms, activity limitation and environmental exposure, and the validation measures ranged from 0.29-0.57. Correlations between the emotional function domain and the validation measures were also in this range (0.31-0.55) and not as low as we hypothesized. For the SF-36, correlations between physical functioning and role physical, and the validation measures ranged from 0.25-0.56, whereas role emotional and mental health correlated with these measures from 0.01-0.23. Conclusion The AQLQ and the SF-36 showed fairly good internal consistency. Both instruments are limited by ceiling effects, but they appear less pronounced in the SF-36, which also shows a better discrimination between different aspects of HRQL. The SF-36 may therefore be a more valid measure of HRQL than the AQLQ when applied to individuals with asthma from the general population.

Len:1997

Retrospective Power Analysis
T. Len
Conservation Biology  11  276-280  (1997)

Stangl:1995

Assessing placebo response using bayesian hierarchical survival models
D. K. Stangl and J. B. Greenhouse
      (1995)

Rothman:1976

Causes
K. J. Rothman
American Journal of Epidemiology  104  90-95  (1976)

Buuren:2001

T+31 71 518 18 18 Response conversion: A new technology for comparing existing health information
S. van Buuren and S. Eyres and A. Tennant and M. Hopman-Rock
      (2001)

Lenth:2001

Some Practical Guidelines for Effective Sample Size Determination
R. V. Lenth
The American Statistician  55  187-193  (2001)

Kirby:2002

Determining the sample size in a clinical trial
A. Kirby and V. Gebski and A. C. Keech
MJA  177  256-257  (2002)

Garrett:1997

Use of Statistical Tests of Equivalence (Bioequivalence Tests) in Plant Pathology
K. A. Garrett
The American Phytopathological Society      (1997)

Richiardi:2007

Feasibility of recruiting a birth cohort through the Internet: the experience of the NINFEA cohort
L. Richiardi and I. Baussano and L. Vizzini and J. Douwes and N. Pearce and F. Merletti
European Journal of Epidemiology      (2007)

Richard:2007

A 5-year comparison of performance of sentinel and mandatory notification surveillance systems for measles in Switzerland
J. Richard and B. Vidondo and M. Mäusezahl
European Journal of Epidemiology      (2007)

Rochon:1999

Issues in adjusting for covariates arising postrandomization in clinical trials
J. Rochon
Drug Information Journal      (1999)

Bengtsson:2007

Development and psychometric testing of the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS)
M. Bengtsson and B. Ohlsson and K. Ulander
BMC Gastroenterology  7    (2007)

Schmidt:2005

The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study
S. Schmidt and H. Mühlan and M. Power
European Journal of Public Health  16  420-428  (2005)

Petrini:2007

From evidence based bioethics to evidence based social policies
C. Petrini
European Journal of Epidemiology      (2007)

Rzehak:2007

A prospective study on the association between hay fever among children and incidence of asthma in East Germany
P. Rzehak and Y. Schoefer and H. E. Wichmann and J. Heinrich
European Journal of Epidemiology      (2007)

Gemes:2007

Inflammation a possible link between economical stress and coronary heart disease
K. Gémes and S. Ahnve and I. Janszky
European Journal of Epidemiology      (2007)

Zatonski:2007

Rapid declines in coronary heart disease mortality in Eastern Europe are associated with increased consumption of oils rich in alpha-linolenic acid
W. Zatonski and H. Campos and W. Willett
European Journal of Epidemiology      (2007)

Ansaldi:2007

Hepatitis A incidence and hospital-based seroprevalence in Italy: a nation-wide study
F. Ansaldi and B. Bruzzone and M. C. Rota and A. Bella and M. C. degli Atti and P. Durando and R. Gasparini and G. Icardi and the Serologic Study Group
European Journal of Epidemiology      (2007)

Britton:2007

The cardioprotective effects of alcohol consumption: does cardiac autonomic function play a role?
A. Britton and M. Malik and M. Marmot
European Journal of Epidemiology      (2007)

Stolk:2007

Universal risk factors for multifactorial diseases
R. P. Stolk and J. G. M. Rosmalen and D. S. Postma and R. A. de Boer and G. navis and J. P. J. Slaets and J. Ormel and B. H. R. Wolffenbuttel
European Journal of Epidemiology      (2007)

Jaddoe:2007

The Generation R Study Biobank: a resource for epidemiological studies in children and their parents
V. W. V. Jaddoe and R. Bakker and C. M. van Duijn and A. J. van der Heijden and J. Lindemans and J. P. Mackenbach and H. A. Moll and E. A. P. Steegers and H. Tiemeier and A. G. Uitterlinden and F. C. Verhulst and A. Hofman
European Journal of Epidemiology      (2007)

Mathias:2008

Impact of chronic Immune Thrombocytopenic Purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective
S. Mathias and S. Gao and K. Miller and D. Cella and C. Snyder and R. Turner and A. Wu and J. Bussel and J. George and R. McMillan and D. K. Wysocki and J. Nichol
Health and Quality of Life Outcomes  6 13    (2008)

Background Immune thrombocytopenic purpura (ITP), a condition characterized by autoimmune-mediated platelet destruction and suboptimal platelet production, is associated with symptoms such as bruising, epistaxis, menorrhagia, mucosal bleeding from the gastrointestinal and urinary tracts and, rarely central nervous system bleeding. The aim of this research is to develop a conceptual model to describe the impact of ITP and its treatment on patientsa health-related quality of life (HRQoL). Methods A literature search and focus groups with adult ITP patients were conducted to identify areas of HRQoL affected by ITP. Published literature was reviewed to identify key HRQoL issues and existing questionnaires used to assess HRQoL. Focus group transcripts were reviewed, and common themes were extracted by grouping conceptual categories that described the impact on HRQoL. Results The literature synthesis and themes from the focus group data suggest that decreased platelet counts, disease symptoms, and treatment side effects influence multiple domains of HRQoL for ITP patients. Key areas affected by ITP and its treatments include emotional and functional health, work life, social and leisure activities, and reproductive health. Conclusions ITP affects various areas of HRQoL. This conceptual model will help inform the evaluation of therapeutic strategies for ITP.

Armstrong:2007

Geographic variation and localised clustering of congenital anomalies in Great Britain
B. G. Armstrong and H. Dolk and S. Pattenden and M. Vrijheid and M. Loane and J. Rankin and C. E. Dunn and C. Grundy and L. Abramsky and P. A. Boyd and D. Stone and D. Wellesley
Emerging Themes in Epidemiology  4    (2007)

Bostoen:2007

Methods for health surveys in difficult settings: charting progress, moving forward
K. Bostoen and O. O. Bilukha and B. Fenn and O. W. Morgan and C. C. Tam and A. ter Veen and F. Checchi
Emerging Themes in Epidemiology  4    (2007)

Spiegel:2007

Who should be undertaking population-based surveys in humanitarian emergencies?
P. B. Spiegel
Emerging Themes in Epidemiology  4    (2007)

Redelings:2007

Using Multiple Cause-of-Death Data to Investigate Associations and Causality between Conditions Listed on the Death Certificate
M. D. Redelings and M. Wise and F. Sorvillo
American Journal of Epidemiology  166  104-108  (2007)

Keppel:2007

Ten Largest Racial and Ethnic Health Disparities in the United States based on Healthy People 2010 Objectives
K. G. Keppel
American Journal of Epidemiology  166  97-103  (2007)

Macaluso:2007

Efficacy of the Male Latex Condom and of the Female Polyurethane Condom as Barriers to Semen during Intercourse: A Randomized Clinical Trial
M. Macaluso and R. Blackwell and D. J. Jamieson and A. Kulczycki and M. P. Chen and R. Akers and D. Kim and A. Duerr
American Journal of Epidemiology  166  88-96  (2007)

Robbins:2007

Differences in Prognostic Factors and Survival among White Men and Black Men with Prostate Cancer, California, 1995--2004
A. S. Robbins and D. Yin and A. Parikh-Patel
American Journal of Epidemiology  166  71-78  (2007)

Wee:2008

Comparing the SF-12 and SF-36 health status questionnaires in patients with and without obesity
C. Wee and R. Davis and M. Hamel
Health and Quality of Life Outcomes  6    (2008)

Objective To assess how well the SF-36, a well-validated generic quality of life (QOL), compares with its shorter adaptation, the SF-12, in capturing differences in QOL among patients with and without obesity. Methods We compared the correlation between the physical (PCS) and mental (MCS) component summary measures of the SF-12 and SF-36 among 356 primary care patients using Pearson coefficients (r) and conducted linear regression models to see how these summary measures differed across BMI. We used model R2 to assess qualitatively how well each measure explained the variation across BMI. Results Correlations between SF-12 and SF-36 were higher for the PCS in obese (r=0.89) compared to overweight (r=0.73) and normal weight patients (r=0.75), p<0.001, but were similar for the MCS across BMI. Compared to normal weight patients, obese patients scored 8.8 points lower on the PCS-12 and 5.7 points lower on the PCS-36 after adjustment for age, sex, and race; the model R2 was higher with PCS-12 (R2=0.22) than with PCS-36 (R2=0.16). BMI was not significantly associated with either the MCS-12 or MCS-36. Conclusion The SF-12 correlated highly with SF-36 in obese and non-obese patients and appeared to be a better measure of differences in QOL associated with BMI.

Kulich:2008

Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study
K. Kulich and A. Madisch and F. Pacini and J. Pique and J. Regula and C. V. Rensburg and L. Ujszaszy and J. Carlsson and K. Halling and I. Wiklund
Health and Quality of Life Outcomes  6    (2008)

Background Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia. Methods 853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale. Results The internal consistency reliability of the GSRS was 0.43-0.87 and of the QOLRAD 0.79-0.95. Test-retest reliability of the GSRS was 0.36-0.75 and of the QOLRAD 0.41-0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity. Conclusions The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.

Scarpelli:2008

Measurement properties of the Brazilian version of the Pediatric Quality of Life Inventory (PedsQL) cancer module scale
A. Scarpelli and S. Paiva and I. Pordeus and M. Ramos-Jorge and J. Varni and P. Allison
Health and Quality of Life Outcomes  6    (2008)

Verbunt:2008

Disability and quality of life in patients with fibromyalgia
J. Verbunt and D. Pernot and R. Smeets
Health and Quality of Life Outcomes  6    (2008)

Background Patients with fibromyalgia often feel disabled in the performance of daily activities. Psychological factors seem to play a pronounced disabling role in fibromyalgia. The objectives of the study are: Firstly, to investigate contributing factors for disability in fibromyalgia. Secondly, to study psychological distress in patients with fibromyalgia as compared to other nonspecific pain syndromes. And finally, to explore the impact of fibromyalgia on a patient's quality of life. Methods In this cross sectional study, explaining factors for disability were studied based on a regression analysis with gender, mental health, physical and social functioning as independent variables. For the assessment of disability in fibromyalgia the FIQ was used. The levels of psychological distress in patients with fibromyalgia, Complex Regional Pain Syndrome (CRPS) and chronic low back pain (CLBP) were compared based on scores on the Symptom Checklist (SCL90). Quality of life of patients with fibromyalgia was compared with scores (SF36) of both patients with fibromyalgia and other health conditions as derived from the literature. Results Disability in fibromyalgia seemed best explained by a patients mental health condition (beta=-0.360 p=0.02). The level of psychological distress was higher in patients with fibromyalgia as compared to patients with CRPS or CLBP (p<0.01). The impact of fibromyalgia on quality of life appeared to be high as compared to the impact of other health conditions. Conclusions Patients with fibromyalgia report a considerable impact on their quality of life and their perceived disability level seems influenced by their mental health condition. In comparison with patients with other pain conditions psychological distress is higher.

Li:2008

Validation of a French language version of the Early Childhood Oral Health Impact Scale (ECOHIS)
S. Li and J. Veronneau and P. Allison
Health and Quality of Life Outcomes  6    (2008)

Background An English language oral health-related negative impact scale for 0-5 year old infants (the Early Childhood Oral Health Impact Scale [ECOHIS]) has recently been developed and validated. The overall aim of our study was to validate a French version of the ECOHIS. The objectives were to investigate the scaleas: i) internal consistency; ii) test-retest reliability; iii) convergent validity; and iv) discriminant validity. Methods: Data were collected from two separate samples. Firstly, from 398 parents of children aged 12 months, recruited to a community-based intervention study, and secondly from 94 parents of 0-5 year-old children attending a hospital dental clinic. In a sub-sample of 101 of the community-based group, the scale was distributed a second time two weeks after initial evaluation. Internal consistency was evaluated through generation of Cronbachas alpha, test-retest reliability through intra-class-correlation coefficients (ICC), convergent validity through comparing scale total scores with a global evaluation of oral health and discriminant validity through investigation of differences in total scale scores between the community- and clinic-based samples. Results: Cronbachas alpha for both the child and family impact sections was 0.79, and for the whole scale was 0.82. The ICC was 0.95. Mean ECOHIS scores for parents rating their childas oral health as arelatively poora, agooda and avery gooda were 10.8, 3.4 and 2.7 respectively. In the community- and clinic-based samples, the mean ECOHIS scores were 3.7 and 4.9 respectively. Conclusions: These results suggest this French language version of the ECOHIS is valid.

Berdeaux:2008

Patient-reported benefit of ReSTORA(R) multi-focal intraocular lenses after cataract surgery: results of Principal Component Analysis on clinical trial data
G. Berdeaux and M. Viala and A. R. de Climens and B. Arnould
Health and Quality of Life Outcomes  6    (2008)

Background Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTORA(R), a new multi-focal intraocular lens (IOL) addresses this issue with an improvement in both distance and near vision, often without need for glasses. This analysis attempted to discuss the patient-reported benefit of ReSTORA(R) using a full but organised representation of data. Methods Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTORA(R) to AcrySofA(R) mono-focal IOLs. A total of 710 patients in need of bilateral cataract extraction were included in the pooled study. The TyPE, a patient questionnaire, was fully completed by 672 of them before and after each eye surgery. The TyPE, composed of 67 items measuring overall visual functioning in both conditions (with and without wearing glasses), evaluates limitations, troubles and satisfaction in distance and near vision. A principal component analysis (PCA) of the TyPE questionnaire was performed on pooled data from baseline and post-surgery observations in order to fully represent the change in the TyPE data over time. ReSTORA(R) and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTORA(R) vs. mono-focal), using paired t-tests and t-tests, respectively. Results The first factor of the PCA explained 55% of the variance and represented avisual functioning and patient satisfactiona. The second factor explained 6% of the variance and was interpreted as aindependence from glassesa. An overall difference in factorial coordinates in both factors was seen between baseline and the first eye surgery, and between the first and the second eye surgery. No difference between ReSTORA(R) and mono-focal IOL groups was observed at baseline. After surgery, ReSTORA(R) treated-patients had higher coordinates on both avisual functioning and satisfactiona and aindependence from glassesa factors. Findings observed on the factorial plan were supported by statistical comparisons of factorial coordinates. Conclusions Both mono-focal and ReSTORA(R)-implanted patients improved their visual functioning after bilateral cataract surgery. Moreover, ReSTORA(R) patients reported an additional benefit in independence from glasses as well as in visual functioning and patient satisfaction.

Tu:2008

Simpsons Paradox, Lord's Paradox, and Suppression Effects are the same phenomenon - the reversal paradox
Y. Tu and D. Gunnell and M. Gilthorpe
Emerging Themes in Epidemiology  5    (2008)

This article discusses three statistical paradoxes that pervade epidemiological research: Simpson's paradox, Lord's paradox, and suppression. These paradoxes have important implications for the interpretation of evidence from observational studies. This article uses hypothetical scenarios to illustrate how the three paradoxes are different manifestations of one phenomenon - the reversal paradox - depending on whether the outcome and explanatory variables are categorical, continuous or a combination of both; this renders the issues and remedies for any one to be similar for all three. Although the three statistical paradoxes occur in different types of variables, they share the same characteristic: the association between two variables can be reversed, diminished, or enhanced when another variable is statistically controlled for. Understanding the concepts and theory behind these paradoxes provides insights into some controversial or contradictory research findings. These paradoxes show that prior knowledge and underlying causal theory play an important role in the statistical modelling of epidemiological data, where incorrect use of statistical models might produce consistent, replicable, yet erroneous results.

Howe:2008

Issues in the construction of wealth indices for the measurement of socio-economic position in low-income countries
L. Howe and J. Hargreaves and S. Huttly
Emerging Themes in Epidemiology  5    (2008)

Background Epidemiological studies often require measures of socio-economic position (SEP). The application of principal components analysis (PCA) to data on asset-ownership is one popular approach to household SEP measurement. Proponents suggest the approach provides a rational method for weighting asset data in a single indicator, captures the most important aspect of SEP for health studies, and is based on data that are readily available and/or simple to collect. However, the use of PCA on asset data may not be the best approach to SEP measurement. There remains concern that this approach can obscure the meaning of the final index and is statistically inappropriate for use with discrete data. In addition, the choice of assets to include and the level of agreement between wealth indices and more conventional measures of SEP such as consumption expenditure remain unclear. We discuss these issues, illustrating our examples with data from the Malawi Integrated Household Survey 2004-5. Methods Wealth indices were constructed using the assets on which data are collected within Demographic and Health Surveys. Indices were constructed using five weighting methods: PCA, PCA using dichotomised versions of categorical variables, equal weights, weights equal to the inverse of the proportion of households owning the item, and Multiple Correspondence Analysis. Agreement between indices was assessed by Kappa statistics. Indices were also compared with per capita consumption expenditure. Results All indices demonstrated similarly modest agreement with consumption expenditure. Indices constructed using data coded in the same way (i.e. either categorical or binary variables) showed strong agreement with each other, whereas agreement was considerably lower between indices using data coded in different ways (i.e. an index using categorical against an index using binary variables). Conclusion This study provides further doubt on the appropriateness of considering wealth indices as proxies for consumption expenditure. The choice of data included had a greater influence on the wealth index than the method used to weight the data. Despite the limitations of PCA, alternative methods also all had disadvantages, and there appears to be little reason to advocate the alternative weighting methods explored here.

Cappelleri:2008

Development and validation of the WEll-being and Satisfaction of CAREgivers of Children with Diabetes Questionnaire (WE-CARE)
J. Cappelleri and R. Gerber and T. Quattrin and R. Deutschmann and X. Luo and R. Arbuckle and L. Abetz
Health and Quality of Life Outcomes  6    (2008)

Background This study was designed to develop a diabetes-specific questionnaire on parents' quality of life and satisfaction with their child's diabetes treatment, the WEll-being and Satisfaction of CAREgivers of Children with Diabetes Questionnaire, and to conduct psychometric validation of the WE-CARE. Methods Parents of 116 children aged 6 to 11 years were enrolled in the United States. Children had type 1 diabetes mellitus for > 1 year, had been treated with subcutaneous insulin for [greater than or equal to] 2 months, and had a recent glycosylated hemoglobin (HbA1C) measurement. Recruiting clinicians provided clinical information on the children. Over a two-week period, parents completed WE-CARE (initial 68 items) and two other questionnaires (the 36-item Short Form of the Medical Outcomes Study and the 50-item Child Health Questionnaire-Parent Form) twice. Results A literature review and one-on-one interview with caregivers and pediatricians led to the development of a draft questionnaire consisting of 68 items. Factor analysis suggested retention of 37 of the 68 initial items grouped into four multi-item scales (Psychosocial Well-being, Ease of Insulin Use, Treatment Satisfaction, and Acceptance of Insulin Administration as well as a Total Score). The four multi-item domains of WE-CARE were found to be psychometrically robust--they had negligible floor and ceiling effects, excellent internal consistency and test-retest reliability, high item-discriminant validity and good concurrent, divergent, known-group and clinical validity. Moderate interscale correlations among the four WE-CARE domains indicated that the concepts they measure are related but distinct. Conclusions These data suggest that WE-CARE provides a reliable and valid measure of parents' well-being and treatment satisfaction related to their child's diabetes. While these results show promise, additional validation of WE-CARE is warranted.

Buessing:2008

Emotional and rational disease acceptance in patients with depression and alcohol addiction
A. Buessing and P. Matthiessen and G. Mundle
Health and Quality of Life Outcomes  6    (2008)

Background The concept of a rational respectively emotional acceptance of disease is highly valued in the treatment of patients with depression or addiction. Due to the importance of this concept for the long-term course of disease, there is a strong interest to develop a tool to identify the levels and factors of acceptance. We thus intended to test an instrument designed to assess the level of positive psychological wellbeing and coping, particularly emotional disease acceptance and life satisfaction Methods In an anonymous cross-sectional survey enrolling 115 patients (51% female, 49% male; mean age 47.6 +/- 10.0 years) with depression and/or alcohol addiction, the ERDA questionnaire was tested. Results Factor analysis of the 29-item construct (Cronbach's alpha = 0.933) revealed a 4-factor solution, which explained 59.4% of variance: (1) Positive Life Construction, Contentedness and Well-Being; (2) Conscious Dealing with Illness; (3) Rejection of an Irrational Dealing with Disease; (4) Disease Acceptance. Two factors could be ascribed to a rational, and two to an emotional acceptance. All factors correlated negatively with Depression and Escape, while several aspects of Life Satisfaction" (i.e. myself, overall life, where I live, and future prospects) correlated positively. The highest factor scores were found for the rational acceptance styles (i.e. Conscious Dealing with Illness; Disease Acceptance). Emotional acceptance styles were not valued in a state of depression. Escape from illness was the strongest predictor for several acceptance aspects, while life satisfaction was the most relevant predictor for "Positive Life Construction, Contentedness and Well-Being". Conclusions The ERDA questionnaire was found to be a reliable and valid assessment of disease acceptance strategies in patients with depressive disorders and drug abuses. The results indicate the preferential use of rational acceptance styles even in depression. Disease acceptance should not be regarded as a coping style with an attitude of fatalistic resignation, but as a complex and active process of dealing with a chronic disease. One may assume that an emotional acceptance of disease will result in a therapeutic coping process associated with higher level of life satisfaction and overall quality of life.

Chachamovich:2008

Development and validation of the Brazilian version of the Attitudes to Aging Questionnaire (AAQ): an example of merging classical psychometric theory and the Rasch measurement model
E. Chachamovich and M. Fleck and C. Trentini and K. Laidlaw and Power
Health and Quality of Life Outcomes  6    (2008)

Background Aging has determined a demographic shift in the world, which is considered a major societal achievement, and a challenge. Aging is primarily a subjective experience, shaped by factors such as gender and culture. There is a lack of instruments to assess attitudes to aging adequately. In addition, there is no instrument developed or validated in developing region contexts, so that the particularities of ageing in these areas are not included in the measures available. This paper aims to develop and validate a reliable attitude to aging instrument by combining classical psychometric approach and Rasch analysis. Methods Pilot study and field trial are described in details. Statistical analysis included classic psychometric theory (EFA and CFA) and Rasch measurement model. The latter was applied to examine unidimensionality, response scale and item fit. Results Sample was composed of 424 Brazilian old adults, which was compared to an international sample (n=5238). The final instrument shows excellent psychometric performance (discriminant validity, confirmatory factor analysis and Rasch fit statistics). Rasch analysis indicated that modifications in the response scale and item deletions improved the initial solution derived from the classic approach. Conclusions The combination of classic and modern psychometric theories in a complementary way is fruitful for development and validation of instruments. The construction of a reliable Brazilian Attitudes to Aging Questionnaire is important for assessing cultural specificities of aging in a transcultural perspective and can be applied in international cross-cultural investigations running less risk of cultural bias.

Misajon:2008

Measuring the impact of health problems among adults with limited mobility in Thailand: further validation of the Perceived Impact of Problem Profile
R. Misajon and J. Pallant and L. Manderson and S. Chirawatkul
Health and Quality of Life Outcomes  6    (2008)

Background The Perceived Impact of Problem Profile (PIPP) was developed to provide a tool for measuring the impact of a health condition from the individual's perspective, using the ICF model as a framework. One of the aims of the ICF is to enable the comparison of data across countries, however, relatively little is known about the subjective experience of disability in middle and low-income countries. The aim of this study was to assess the validity of the Perceived Impact of Problem Profile (PIPP) for use among adults with a disability in Thailand using Rasch analysis. Methods A total of 210 adults with mobility impairment from the urban, rural and remote areas of northeast Thailand completed the PIPP, which contains 23 items assessing both impact and distress across five key domains (Self-care, Mobility, Participation, Relationships, and Psychological Well-being). Rasch analysis, using RUMM2020, was conducted to assess the internal validity and psychometric properties of the PIPP Impact subscales. Validation of the PIPP Impact scales was conducted by comparing scores across the different response levels of the EQ5D items. Results Rasch analysis indicated that participants did not clearly differentiate between 'impact' and 'distress,' the two aspects assessed by the PIPP. Further analyses were therefore limited to the PIPP Impact subscales. These showed adequate psychometric properties, demonstrating fit to the Rasch model and good person separation reliability. Preliminary validity testing using the EQ5D items provided support for the PIPP Impact subscales. Conclusion The results provide further support for the psychometric properties of the PIPP Impact scales and indicate that it is a suitable tool for use among adults with a locomotor disability in Thailand. Further research is needed to validate the PIPP across different cultural contexts and health conditions and to assess the usefulness of separate Impact and Distress subscales.

Goursand:2008

Cross-cultural adaptation of the Child Perceptions Questionnaire 11-14 (CPQ11-14) for the Brazilian Portuguese language
D. Goursand and S. Paiva and P. Zarzar and M. Ramos-Jorge and G. Cornacchia and I. Pordeus and P. Allison
Health and Quality of Life Outcomes  6    (2008)

Background Oral-Health-Related Quality of Life (OHRQoL) instruments are being used with increasing frequency in oral health surveys. However, these instruments are not available in all countries or all languages. The availability of cross-culturally valid, multi-lingual versions of instruments is important for epidemiological research. The Child Perceptions Questionnaire 11-14 (CPQ11-14) is an OHRQoL instrument that assesses the impact of oral conditions on the quality of life of children and adolescents. The objective of the current study was to carry out the cross-cultural adaptation of CPQ11-14 for the Brazilian Portuguese language. Methods After translation and cross-cultural adaptation, the CPQ 11-14 was tested on 160 11-to-14-year-old children who were clinically and radiographically examined for the presence or absence of dental caries. The children were receiving dental care at the Pediatric Dental and Orthodontic clinics of the Federal University of Minas Gerais, Brazil. To test the quality of the translation, 17 children answered the questionnaire. The internal consistency of the instrument was assessed by Cronbachas Alpha Coefficient and the test-retest reliability by Intraclass Correlation Coefficient (ICC). Results The mean CPQ11-14 score were 24.5 [standard deviation (SD) 18.27] in the group with caries and 12.89 [SD 10.95] in the group without caries. Median scores were 20 and 10 in the groups with and without caries, respectively (p<0.001). Significant associations were identified between caries status and all CPQ domains (p<0.05). Internal reliability was confirmed by a CronbachA's alpha coefficient of 0.86. Test-retest reliability revealed satisfactory reproducibility (ICC = 0.85). The questionnaire proved to be a valid instrument. Construct validity was satisfactory, demonstrating highly significant correlations with global indicators for the total scale and subscales. The CPQ11-14 score was able to discriminate between different oral conditions (groups without and with untreated caries). Conclusion The present study demonstrated that the CPQ11-14 is applicable to children in Brazil. It has satisfactory psychometric properties, but further research is required to evaluate these properties in a population study.

Jones:2008

The burden of multiple sclerosis: community health survey
C. Jones and S. Pohar and S. Warren and K. Turpin and K. Warren
Health and Quality of Life Outcomes  6    (2008)

Background Health-related quality of life (HRQL) in persons with multiple sclerosis (MS) who reside within the community relative to the general population is largely unknown. Data from the Canadian Community Health Survey Cycle 1.1 (CCHS 1.1) were used to compare HRQL of persons with MS and the general population. Methods A representative sample of adults (18 years or older) from the cross sectional population health survey, CCHS 1.1, was examined to compare scores on the Health Utilities Index Mark 3 (HUI3), a generic preference-based HRQL measure, of respondents with (n=302) and without (n=109,741) MS. Selected sociodemographic covariates were adjusted for in ANCOVA models. Normalized sampling weights and bootstrap variance estimates were used in the analysis. Results The mean difference in overall HUI3 scores between respondents with and without MS was 0.25 (95% CI: 0.20, 0.31); eight times greater than the clinically important difference. The largest differences in scores were seen with the ambulation (0.26; 95% CI: 0.20, 0.32) and pain attributes (0.14; 95% CI: 0.09, 0.19). Clinically important differences with dexterity and cognition were also observed. Conclusions While the proportion of the Canadian population with MS is relatively small in comparison to other diseases, the magnitude of the burden is severe relative to the general population.