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.

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-naive 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. 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 . The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1%. 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.

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-naive 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. 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 . The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1%. 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.

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 these 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. Conclusions: 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.

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. Conclusions: 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.

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 compare 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). Conclusions: CS-OIDP attributed to malocclusion was better able than OHIP-14 to discriminate between adolescents with and without normative needs for orthodontic treatment.

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.

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 patientas 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 US, 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. Conclusions: Based on data from these focus groups, the NPSI is an acceptable instrument for assessing neuropathic pain.

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 with high monitoring in the Portuguese but not the Moroccan sample. Conclusions: 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.

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. Conclusions: 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.

Background: To validate the Argentinean Spanish version of the PedsQLTM 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 PedsQLTM 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. Results: The PedsQLTM 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 PedsQLTM 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 PedsQLTM 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. Conclusions: Results suggest that the Argentinean Spanish PedsQLTM 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 PedsQLTM 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.

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 PROM s; 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 (Cronbachas alpha >0.92, test-retest intraclass correlations >0.83); and 5) validity was supported. Conclusions: 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.

ObjectiveQoL 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.

ObjectiveSeasonal 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. Conclusions: 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.

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[greater than or equal to]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 a large proportion of patient's scores were affected by floor or ceiling effects on several subscales and the sensitivity to individual change was very low. Conclusions: 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.

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.

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.

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 evidence that the translated instrument satisfies 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. Conclusions: 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 physical functioning, social functioning, vitality and mental health to improve the reliability and discriminant validity of these scales.

Background: Mapping has been used to convert scores from condition-specific measures into a utility score, and to produce estimates of cost-effectiveness. We developed mapping models and compared the QALY gains, and 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 scores at 6, 12 and 24 months post-intervention. 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 costs, were also to estimate the actual and predicted cost per QALY gain 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 based on this model 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, 0.089, 0.126, and 0.152. The most effective intervention was estimated to be associated with a cost per QALY of GBP6,182, according to our preferred model, compared to GBP11,830 when actual data was used. Conclusion: We found that actual QALY gains, and 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 ISRCTN 93206785

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. Conclusions: 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.