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Background: EQ-5D health state utilities (HSU) are commonly used in health economics to compute quality-adjusted life years (QALYs). The EQ-5D, which is country-specific, can be derived directly or by mapping from self-reported health-related quality of life (HRQoL) scales such as the PROMIS-29 profile. The PROMIS-29 from the Patient Reported Outcome Measures Information System is a comprehensive assessment of self-reported health with excellent psychometric properties. We sought to find optimal models predicting the EQ-5D-5L crosswalk from the PROMIS-29 in the United Kingdom, France, and Germany and compared the prediction performances with that of a US model.Methods: We collected EQ-5D-5L and PROMIS-29 profiles and three samples representative of the general populations in the UK (n=1,509), France (n=1,501), and Germany (n=1,502). We used stepwise regression with backward selection to find the best models to predict the EQ-5D-5L crosswalk from all seven PROMIS-29 domains. We investigated the agreement between the observed and predicted EQ-5D-5L crosswalk in all three countries using various indices for the prediction performance, including Bland-Altman plots to examine the performance along the HSU continuum.Results: The EQ-5D-5L crosswalk was best predicted in France (nRMSEFRA = 0.075, nMAEFRA = 0.052), followed by the UK (nRMSEUK = 0.076, nMAEUK = 0.053) and Germany (nRMSEGER = 0.079, nMAEGER = 0.051). The Bland-Altman plots show that the inclusion of higher-order effects reduced the overprediction of low HSU scores.Conclusions: Our models provide a valid method to predict the EQ-5D-5L crosswalk from the PROMIS-29 for the UK, France, and Germany.

International audience; Purpose: Comparability of patient-reported outcome measures over different languages is essential to allow cross-national research. We investigate the comparability of the PROMIS Profile 29, a generic health-related quality of life measure, in general population samples in the UK, France, and Germany and present general population reference values.Methods: A web-based survey was simultaneously conducted in the UK (n = 1509), France (1501), and Germany (1502). Along with the PROMIS Profile 29, we collected sociodemographic information as well as the EQ-5D. We tested measurement invariance by means of multigroup confirmatory factor analysis (CFA). Differences in the health-related quality of life between countries were modeled by linear regression analysis. We present general population reference data for the included PROMIS domains utilizing plausible value imputation and quantile regression.Results: Multigroup CFA of the PROMIS Profile 29 showed that factor means are insensitive to potential measurement bias except in one item. We observed significant differences in patient-reported health between countries, which could be partially explained by the differences in overall ratings of health. The physical function and pain interference scales showed considerable floor effects in the normal population in all countries.Conclusions: Scores derived from the PROMIS Profile 29 are largely comparable across the UK, France, and Germany. Due to the use of plausible value imputation, the presented general population reference values can be compared to data collected with other PROMIS short forms or computer-adaptive tests.

Background PROMIS-29 is a new generic standardized questionnaire measuring self-reported health status. It was developed as part of the Patient Reported Outcome Measurement Information System (PROMIS) in the United States. The objective of this study was to carry out the psychometric validation of a French-language version of PROMIS-29 and to establish general population reference values for France. Methods Quota sampling was conducted by an independent polling company (Ipsos) to obtain a general population sample (n = 1,501) representative with regards to: gender, age, occupation, region, and population density of the place of residence. Data collected included the results of the questionnaires PROMIS-29 and Short Form Health Survey (SF-36), the presence of selected chronic diseases, and socio-demographic information. Results The French PROMIS-29 demonstrated excellent factorial validity, confirming the 7-factor model of the original PROMIS-29. The use of modern measurement methods indicated that the PROMIS-29 scales satisfy the important characteristics of unidimensionality and, for five of the seven composite scales, invariance across age, educational level and gender. Gender and age specific (10-year intervals) reference values were generated for PROMIS-29 use in France. Conclusion The French version of PROMIS-29 is a valid and reliable measure of self-reported health status in the French population. The instrument's sensitivity to change needs to be evaluated before its use in longitudinal studies can be recommended.

International audience; The International Classification of Functioning, Disability and Health (ICF) published in 2001 describes the consequences of health conditions with three components of impairments in body structures or functions, activity limitations and participation restrictions. Two of the new features of the conceptual model were the possibility of feedback effects between each ICF component and the introduction of contextual factors conceptualized as moderators of the relationship between the components. The aim of this longitudinal study is to provide empirical evidence of these two kinds of effect. Structural equation modeling was used to analyze data from a French population-based cohort of 548 patients with knee osteoarthritis recruited between April 2007 and March 2009 and followed for three years. Indicators of the body structure and function, activity and participation components of the ICF were derived from self-administered standardized instruments. The measurement model revealed four separate factors for body structures impairments, body functions impairments, activity limitations and participation restrictions. The classic sequence from body impairments to participation restrictions through activity limitations was found at each assessment time. Longitudinal study of the ICF component relationships showed a feedback pathway indicating that the level of participation restrictions at baseline was predictive of activity limitations three years later. Finally, the moderating role of personal (age, sex, mental health, etc.) and environmental factors (family relationships, mobility device use, etc.) was investigated. Three contextual factors (sex, family relationships and walking stick use) were found to be moderators for the relationship between the body impairments and the activity limitations components. Mental health was found to be a mediating factor of the effect of activity limitations on participation restrictions.

Neurofibromatosis 1 (NF1), a genetic condition most commonly characterized by the presence of dermal neurofibromas and café au lait macules, has a significant impact on Quality of Life (QoL). There is a wide range of phenotypic variability, so that affected individuals may have either medically devastating or relatively mild manifestations that do not impact their daily lives. In this study, the SF-36 and Skindex questionnaires were used to quantitatively investigate the impact of severity and visibility on QoL in an American population. Participants were recruited primarily through advertisements distributed by The Children's Tumor Foundation (CTF). The majority participated by completing a mailed questionnaire in which they rated themselves using Ablon's visibility and Riccardi's severity scales, and then completed the SF-36 and Skindex questionnaires. Participants with NF1 reported a significant impact in all aspects of skin-disease-specific QoL, but the emotional aspect demonstrated the greatest effect. Participants with more visible signs of NF1 reported significantly greater overall effects on their skin-disease-specific QoL than those whose manifestations were more subtle. All domains of general health QoL were affected as well, especially in participants who reported having severe complications. Interestingly, greater visibility was not found to be associated with a significant decrease in general health QoL. These findings are consistent with those found in a French cohort, and demonstrate the utility of incorporating tools designed for use in both the general population and for patients with skin disease in examining the impact of NF1 on QoL.

To investigate in men with benign prostatic hyperplasia (BPH) treated in the general practitioner setting (1) the magnitude and durability of symptom score improvement with alfuzosin; (2) the effect on patients perceived health-related quality of life (HRQL) and sexuality, (3) adverse outcomes and treatment failure; and (4) progression to acute urinary retention and prostate surgery.A large, open outcome study was undertaken in the general practitioner setting in France, and a cohort of men with symptomatic BPH who received alfuzosin for 12 months was established. A total of 5849 patients (mean age 66.7 years) were enrolled by 1508 general practitioners in France. Men were examined at baseline and at 3 months, 6 months, and 1 year. To produce standardized outcome measures of disease-specific health status, under the conditions of routine care in the community, patients in the study completed a self-administered symptom questionnaire (score range 0 to 40) and a new, validated BPH-specific HRQL questionnaire (score range 0 to 200). Questionnaires were completed at baseline and during follow-up at 3, 6, and 12 months.Alfuzosin was effective in reducing symptoms; 98% (420) of severely and 85% (2479) of moderately symptomatic patients experienced improvement. At 3 months, the global symptom score was reduced by 9.49 +/- 0.08 (-53%), and this reduction persisted for the remainder of the study (-9.76 +/- 0.11). In contrast to the global reduction of symptom scores, there was a time-dependent improvement (+18.41 +/- 0.32 [+30%], +18.45 +/- 0.54 [+37%], and +23.42 +/- 0.57 [+43%] at 3, 6, and 12 months, respectively), in patients' perception of HRQL status. The magnitude of the improvement in HROL status was significantly more pronounced for those patients who had moderate or severe nocturia and daytime frequency at baseline than for those who had mild levels of the same symptoms. Sexuality score at baseline was significantly related to age and was significantly (P0.0001) higher in patients less than 70 years old than in older patients. Improvement in patients' perceived sexuality was significant at 12 months (P0.0001) and was correlated with age.The results of this large cohort study demonstrate the effectiveness of alfuzosin in reducing symptom severity and improving HRQL status over a 12-month period in men with BPH. It also suggests that HQRL and symptom severity are different and complementary entities. The results of the present study highlight the improvement in HRQL and patients' perceived sexuality that can be achieved in symptomatic patients with BPH receiving a 12-month course of alfuzosin therapy.

Plasma levels of dehydroepiandrosterone sulphate (DHEA-S) decrease with the progression of HIV disease. Here, we report on the efficacy and safety of the oral administration of DHEA as replacement therapy, in patients with advanced HIV disease, in a trial that was primarily aimed at assessing quality of life.The trial was randomized and double-blind. Thirty-two patients were allocated to either DHEA 50 mg per day for 4 months (n = 14) or a matching placebo (n = 18). Clinical data, virological and immunological surrogate markers of HIV infection, plasma levels of DHEA-S and the Medical Outcomes Study HIV Health Survey (MOS-HIV) quality of life scale were recorded every month.The mean age of the patients was 40 +/- 11 years. The mean CD4 cell count at baseline was 32.5 +/- 32.4 x 10(6)/l. The mean DHEA-S plasma level at baseline was 5.23 +/- 0.76 micromol/l. No side-effects related to DHEA occurred during the study. A statistically significant increase in the levels of DHEA-S was observed in the treated group throughout the study (P0.01). A significant improvement in the Mental Health and Health Distress dimension of MOS-HIV was observed in the DHEA treated group; P = 0.001 and 0.004, respectively. No change in CD4 cell counts was seen during follow-up.The administration of DHEA in patients with advanced HIV infection results in improved mental function scores as assessed by the MOS-HIV quality of life scale.

In order to develop a quality of life scale related to the state of health, specific for benign prostatic hypertrophy, a group of French specialists constructed a self-administered questionnaire, designed to complete the usual evaluations of the efficacy and safety of new medical treatments for this disease. This questionnaire was well accepted, reliable, clinically valid and sensitive to clinical changes occurring in a given patient. It includes questions concerning sexuality. An abbreviated form of the questionnaire was then developed in order to obtain a tool suitable for use in daily practice, in combination with the International Prostate Symptom Score (IPPS).

The authors made a survey in the setting of the Ste Anne hospital Emergency outpatient clinic to determine the incidence of somatic troubles in mental patients during a crisis situation. 1,000 patients were examined during a 24 day period. More than half of somatic problems had not been addressed to priori to Psychiatric consultation. More over, during those psycho-organic troubles, no precise information had been made available in half of the patient population. In 3% of cases, hospitalization could not continue in a psychiatric setting, which points to both the difficulty in assessing the medical capacity of psychiatric institutions ("secteurs") and acceptance of mental patients by the general medical hospital.