Predicting EQ-5D-5L crosswalk from the PROMIS-29 profile for the United Kingdom, France, and Germany.

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 = 1509), France (n = 1501), and Germany (n = 1502). 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.

The French PROMIS-29. Psychometric validation and population reference values.

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.

Prevalence and impact on quality of life of post-herpetic neuralgia in French medical centers specialized in chronic pain management: the ZOCAD study.

OBJECTIVES: (1) We had for aim to determine the rate of patients consulting for post-herpetic neuralgia (PHN) in centers specialized in the management of chronic pain, (2) to assess the burden of PHN, (3) to compare the impact of PHN between new (newly consulting for PHN) and known (already treated by pain specialists) patients. PATIENTS AND METHODS: We conducted a prospective multicenter observational study including all chronic pain outpatients consulting for 3 consecutive weeks. The impact of PHN was assessed with the ZBPI, SF12, HADS, and a non-validated disability questionnaire. RESULTS: Among the patients, 4518 consulted 54 specialized centers from January 24th to July 21st 2008: 2.6% of patients (but 10.9% of patients 70 years of age or more) reported PHN. The acute herpes zoster episode had occurred more than 13.3 months before inclusion for half of the patients. 108 of the 118 PHN patients (33 new and 75 known) completed the questionnaires. Their mean scores were 3.7 (SD, 2.6) for ZBPI and 34.4 (SD, 10.9) and 55.9 (SD, 11.4) for SF12 PCS and MCS; 38% and 42% of PHN patients had HADS anxiety and depression scores > 10. Nearly all PHN patients had received antiepileptic and analgesic drugs. Tricyclic antidepressants and lidocaine patches were more frequently administered to known than to new patients. Pain relief was more effective for known than for new patients. CONCLUSIONS: PHN is a frequent cause of visit in French medical centers specialized in chronic pain management long after the rash has disappeared, and a reason for treatment with drugs that should be prescribed cautiously in elderly patients.

[A new instrument to measure quality of life in older people: The French version of the WHOQOL-OLD]. / Un nouvel instrument destiné à mesurer la qualité de vie des personnes âgées : le WHOQOL-OLD version française.

PURPOSE: We present the validation data of the French version of a new quality of life questionnaire, specifically developed for use with older adults (>60 years old): the WHOQOL-OLD module. This questionnaire, which contains 24 items in six domains, is a complementary module of the WHOQOL-BREF quality of life questionnaire. It was internationally developed by a World Health Organization (WHO) group. METHODS: The first development and pilot studies led to a first questionnaire applied in field studies in 20 centers all over the world. They were done in 5566 subjects and allowed the validation of the final form of the WHOQOL-OLD questionnaire. For its French version, 281 subjects, with a mean age of 74 years, were recruited in three centers (Paris, Nancy and Geneva). RESULTS: The results of the psychometric properties of the questionnaire, particularly the multitrait analysis, are compatible with the assumptions underlying the construction of scores. Otherwise, scores present a sufficient accuracy to use this instrument in group comparisons. CONCLUSION: The WHOQOL-OLD questionnaire can be used in older people in health services, clinical research and epidemiologic studies.

Development of the Qualeffo-31, an osteoporosis-specific quality-of-life questionnaire.

INTRODUCTION: Vertebral deformities are a common consequence of osteoporosis and are known to decrease quality of life. The Qualeffo-41 is a quality-of-life questionnaire especially developed for measuring quality of life in patients with vertebral deformities. It consists of 41 questions arranged in five domains: pain, physical function, social function, general health perception, and mental function. The objectives of this study were: (1) to develop a shorter version of the Qualeffo-41 by removing redundant questions; and (2) to investigate the scale characteristics, reliability, and validity of this shorter version. METHODS: The study was performed using data from the Qualeffo validation study and the Multiple Outcomes of Raloxifene Evaluation (MORE) study. The analyses were performed in patients with vertebral deformities (n=579). Factor analysis on polychoric correlations and an item response theory (IRT) model, i.e., the generalized partial credit model (GPCM), were used to create a shorter version of Qualeffo-41. Using GPCM, scoring weights were computed for all items. RESULTS: Three items were removed from the data set because of too many missing values. Factor analysis identified three instead of five domains: (1) pain, (2) physical function, and (3) mental function. Five items had factor loadings <0.4 and were not included in the GPCM. After excluding several items, the domains pain (four items), physical function (18 items), and mental function (nine items) showed a good, reasonable, and excellent fit, respectively. This indicates that the mental function domain and the pain domain are more unidimensional than the physical function domain. All three domains showed a very high correlation (r > or =0.95) with the corresponding domains of the Qualeffo-41. CONCLUSIONS: Qualeffo-31 was developed, consisting of three domains with a reasonable to excellent fit to the GPCM. Although the fit to the GPCM supports the construct validity of the Qualeffo-31, validation in a new study should be performed before using it in practice.

[Pilot study and preliminary validation of the French version of a quality-of-life questionnaire specific for subjects with growth hormone deficiency]. / Etude pilote et validation préliminaire de la version française d'un questionnaire de mesure de la qualité de vie spécifique des sujets atteints de déficit en hormone de croissance.

This study forms part of a research project seeking to develop a standardized questionnaire by which clinicians can assess the impact of growth hormone (GH) deficiency and its treatment on the "perceived health" or health-related quality of life of adults. The specific aim of this study was to translate and adapt for French patients the AGHDA (Adult Growth Hormone Deficiency Assessment) a standardized health-related quality of life measure for use with GH-deficient adults, initially developed in the United Kingdom, and to collect data which could be used to assess the main psychometric characteristics of its French version the ISPA-HC (Indicateur de Santé Perceptuelle Adulte-Hormone de Croissance). The main properties analyzed are: 1/ The scale's acceptability, as determined by means of face-to-face interviews with a small number of subjects, then by an ad hoc questionnaire administered during a test-retest study; 2/ The scale's reliability, as determined by a test-retest study (with a 15-days interval between tests); 3/ The scale's concurrent validity, as expressed by comparison with scores obtained by means of a generic quality of life scale, the ISPN (the French version of the Nottingham Health Profile). The results of this first trial with the ISPA-HC are conforming to what one can expect from a good instrument. The ISPA-HC has been shown to have very good levels of reliability and internal consistency. Its scores show a close correlation with those of the ISPN (the French version of the Nottingham Health Profile). This instrument can be used to measure variations in the perceived health of subjects with growth hormone deficiency. Its responsiveness to change is to be examined in subsequent studies.

[The French version of Skindex (Skindex-France). Adaptation and assessment of psychometric properties]. / Version française du Skindex (Skindex-France). Adaptation et évaluation des propriétes psychométriques.

INTRODUCTION: The Skindex is an American tool designed to measure the impact of skin diseases on quality of life. The aim of our study was to adapt and validate this questionnaire in French in a population of patients with neurofibromatosis 1. MATERIAL AND METHODS: Translation and cultural adaptation: Translations were performed independently by two bilingual persons, then discussed. A preliminary version was obtained and confronted with 5 persons with low level of education and 6 patients with neurofibromatosis 1, before assessment in 24 neurofibromatosis 1 patients. The final version was named Skindex-France. Validation study: a test-retest study (1 month interval) was performed on 129 subjects with neurofibromatosis 1 to assess reliability and validity. RESULTS: Acceptability was good with a low rate of missing data (less than 5 p. 100). Ceiling and floor effects were less than 20 p. 100. The scores are sufficiently reliable (Cronbach alpha coefficient: emotions: 0.95, symptoms: 0.86, functioning: 0.94, and test-retest Spearman r: emotions: 0.92, symptoms: 0.84, functioning: 0.90). CONCLUSION: Skindex-France can be used to measure with precision the impact of skin diseases.

Quality-of-life impairment in neurofibromatosis type 1: a cross-sectional study of 128 cases.

BACKGROUND: Neurofibromatosis type 1 affects quality of life (QoL) through association with severe complications, impact on cosmetic features, and uncertainty of the effects of the disorder. OBJECTIVE: To evaluate the impact of the severity and visibility of neurofibromatosis type 1 on QoL. DESIGN: Monocenter, cross-sectional study. SETTING: One French academic dermatological and neurofibromatoses clinic. PATIENTS: A total of 128 adult patients with neurofibromatosis type 1. MAIN OUTCOME MEASURES: Evaluation of severity and visibility using, respectively, the Riccardi and Ablon scales. Evaluation of skin disease-specific and general QoL using, respectively, Skindex-France and SF-36 (Short Form 36 health survey) profiles controlled for sex, age, severity, and visibility. RESULTS: In a multiple regression model controlling for sex, age, and visibility, visibility remained independently associated with the alteration of 3 aspects of the skin disease-specific QoL (Skindex-France): emotions, physical symptoms, and functioning (P =.03, P =.009, and P =.002, respectively). Patients with more severe neurofibromatosis reported more effects on the following domains of their general health QoL (SF-36): physical function, bodily pain, general health perception, and vitality (P =.006, P =.03, P =.01, and P =.04, respectively). CONCLUSIONS: Neurofibromatosis type 1 has a significant impact on QoL through alteration of health and appearance. The consequences of visibility and severity from the viewpoint of patients can be evaluated using Skindex and the SF-36, respectively.

Double-blind placebo-controlled trial of oral dehydroepiandrosterone in patients with advanced HIV disease.

OBJECTIVE: 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. DESIGN: 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. RESULTS: 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 (P < 0.01). 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. CONCLUSIONS: 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.

The French version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ).

We report the results of the cross-cultural adaptation and validation into the French language of two health status instruments. The Childhood Health Assessment Questionnaire (CHAQ) is a disease specific instrument that measures functional ability in daily living activities in children with juvenile idiopathic arthritis (JIA). The Child Health Questionnaire (CHQ) is a generic health related quality of life instrument designed to capture the physical and psychosocial well-being of children independently from the underlying disease. Five hundred children were enrolled including 306 patients with JIA classified into systemic (23%), polyarticular (22%), extended oligoarticular (25%), and persistent oligoarticular (30%) subtypes, and 194 healthy children. Both instruments were reliable with intra-class correlation (ICC) coefficients for the test-retest procedure of 0.91 for the CHAQ, and 0.87 and 0.89 for the physical and psychosocial summary scores of CHQ, respectively. Agreement between parents and children evaluated for the CHAQ was high with an ICC of 0.89 for the disability index; weighted kappa coefficients for the 8 domains ranged from 0.61 to 0.72. Convergent validity was demonstrated by significant correlations with the JIA core set of variables (physician and parent global assessment, scores for active joints and joints with limited range of motion, erythrocyte sedimentation rate) for both instruments. Both CHAQ and CHQ discriminated between healthy and JIA children, but only the disease specific CHAQ questionnaire discriminated clearly between the 4 JIA subtypes. In conclusion, the French versions of the CHAQ and the CHQ are reliable, and valid health assessment questionnaires to be used in children suffering from JIA.

Characteristics of patients with herpes zoster on presentation to practitioners in France.

There have been many epidemiological studies of chickenpox but only a few of herpes zoster. We report data from an observational study, conducted in France during a 1-year period, of 9038 patients who presented with acute herpes zoster (n = 8103) or postherpetic neuralgia (PHN; n = 935) at the office practices of 4635 general practitioners or dermatologists. The incidence of herpes zoster in France was found to be similar to that in the literature: from 1.4 to 4.8 cases per 1000 population per year. The patient profiles and clinical patterns were delineated, as well as the management decisions made according to the type of treating physician. The impact of herpes zoster on quality of life was evaluated on the basis of the Medical Outcome Study Short Form 36 (MOS SF 36) scale, which is widely used for assessing quality of life in the field of health. This study provides reference data on the substantial deterioration in quality of life associated with herpes zoster and PHN.

[Critical review of measures of quality of life in schizophrenia]. / Revue critique des instruments de mesure de la qualité de vie dans la schizophrénie.

UNLABELLED: In order to provide clinicians, researchers, program evaluators and administrators with current information on the assessment of humanistic outcomes of services for schizophrenic patients, a literature review is performed in which references to quality of life (QOL) assessment were made in the context of schizophrenia. Measures are summarized according to purpose, content, psychometric properties. Fifteen QOL instruments are summarized and reflect considerable variability on the relevant criteria: 11 are developed for persons with severe and persistent mental illnesses and used among populations including a major part of schizophrenic patients; 3 are specific QOL measures for schizophrenic patients; 1 is a generic QOL instrument used among psychotic patients. Given that none of these QOL measures has been widely used or accepted as a standard, the choice of a measure must rest on the investigator's particular purpose and needs. CONCLUSION: There is a clear need for a QOL instrument that is specific for schizophrenia, given its high prevalence and chronic nature. The lack of information related to responsiveness of these scales stresses the problems of their inclusion in clinical trials. Scales that have been used in studies of schizophrenia were nearly all developed in the United States and the relevance of their content must be questioned. Rather than relying on the literature or experts to determine those needs that are important to patients with schizophrenia, the content of the instrument should be derived from qualitative interviews with patients who are at different stages of their illness. Moreover, the questionnaire should be self-administered.

[Psychometric properties of a new instrument for evaluating quality of life, the WHOQOL-26, in a population of patients with neuromuscular diseases]. / Propriétés psychométriques d'un nouvel instrument d'évaluation de la qualité de vie, le WHOQOL-26, à partir d'une population de malades neuro-musculaires.

This study describes the principal psychometric properties of the French version of the WHOQOL-26, a short version (26 questions) of the WHOQOL-100, which are World Health Organization instruments for evaluation of quality of life (QOL) which include four dimensions (physical, psychological, environmental, social relations). The use of this tool with psychiatric patients is discussed. Collection of data was performed during a national inquiry on persons with neuromuscular disorders. The population included 2,102 subjects (mean age 42.9 +/- 15 years). Ten different clinical entities were represented, which differed in the type of lesion of the motor unit, the permanence and localization of the loss of muscle strength, the progression of the respiratory deficit, the moment of its occurrence and seriousness of prognosis. This questionnaire was well-adapted to the study population (weak effect of extremes) and was well-accepted (only 5% non-responses). Compared with the long version, homogeneity is less pronounced, but remains acceptable (the item-scale correlation is superior to 0.40 for 66.7% of some items), which is the same as the reliability (Cronbach's alpha coefficient always over 0.65). The sensitivity in relation to the diagnosis is verified for all four dimensions (p = 0.05). The concurrent validity, studied using general QOL evaluation scores, satisfaction with health, and the importance of repercussions of incapacities on daily life was also globally demonstrated (p < 0.0001).

Cross-cultural adaptation of a psychometric instrument: two methods compared.

Cross-cultural adaptations of questionnaires are needed in multilingual research, but little is known about the effectiveness of specific translation methods. We compared properties of two French-language adaptations of the SF36 health survey: (a) a rapid translation developed over 3 months in Geneva in 1992 (Geneva version), based on three initial translations, one synthesis, and two pretests, and (b) a comprehensive adaptation developed by the International Quality of Life Assessment Project between 1991 and 1994 (IQOLA version), which involved back-translations, focus groups, development of equidistant response options, item difficulty and quality ratings, and multiple pretests. Wordings of 34 of 36 items differed. These two instruments were administered 1 year apart to the same sample of 946 young adults. Ceiling effects were somewhat lower for the IQOLA than for the Geneva version (means 30.4% and 35.5%), and missing scores slightly less frequent (IQOLA: mean 0.5%; Geneva: 1.2%). Floor effects (means 2.7% and 2.4%), proportions of consistent respondents (93.4% and 94.0%), and internal consistency coefficients (IQOLA: 0.78-0.89, Geneva: 0.80-0.92) were similar. Factor analysis supported the existence of two main aspects of health (physical and mental) for both versions. A majority of known-group comparisons were compatible with theory, for both versions. In conclusion, the two French-language versions of the SF36 had similar psychometric properties, despite extensive differences in the development process. This suggests that a moderately resource-intensive translation may produce adequate results. More empirical research is needed to understand what translation methods yield the best results.

Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis.

Vertebral fractures may be minor or lead to pain, decreased physical function, immobility, social isolation and depression, which together contribute to quality of life. A Working Party of the European Foundation for Osteoporosis has developed a specific questionnaire for patients with vertebral fractures. This questionnaire, QUALEFFO, includes questions in the domains pain, physical function, social function, general health perception and mental function. QUALEFFO was validated in a multicenter study in seven countries. The study was done in 159 patients aged 55-80 years with clinical osteoporosis, i.e., back pain and other complaints with at least one vertebral fracture and lumbar bone mineral density T-score <-1. Patients with a recent vertebral fracture were excluded because of unstable disease. Controls were age- and sex-matched, and did not have chronic back pain or vertebral fractures. Subjects with conditions exerting a major influence on quality of life were excluded. The QUALEFFO was administered twice within 4 weeks and compared with a generic questionnaire, the Short Form 36 of the Medical Outcomes Study (SF-36). Standard spinal radiographs were made for assessment of vertebral height. Seven questions were removed from the analysis because of low response rate, linguistic ambiguities or redundancy. The 41 remaining questions were analyzed for repeatability, internal consistency and the capacity to discriminate between patients with vertebral fractures and controls. Comparison with the SF-36 was performed within similar domains by conditional logistic regression and by receiver operating characteristic (ROC) curves. The repeatability of QUALEFFO was good (kappa statistics 0.54-0.90) and 26 of 41 questions had a kappa score >/=0.70. The internal consistency of the five domains was adequate, with Crohnbach alpha around 0.80. All except five questions discriminated significantly between patients and controls. The median scores of QUALEFFO were significantly higher in patients with vertebral fractures than in controls in all five domain (p<0. 001), which is consistent with decreased quality of life in patients with osteoporosis. Spinal radiographs were assessed using the McCloskey-Kanis algorithm. According to this, 124 patients (78%) had vertebral fractures of >/=3 SD severity, in contrast with 7 controls (4%). Significant correlations existed between scores of similar domains of QUALEFFO and the SF-36, especially for pain, physical function and mental function. All five domains within each questionnaire discriminated significantly between fracture cases and controls. The odds ratios for pain and social function were greater for QUALEFFO, while general health perception was more discriminating using the SF-36. The ROC curve analysis of QUALEFFO indicated that all five domains were significantly predictive of vertebral fractures. When comparing similar domains of the two questionnaires, QUALEFFO domains demonstrated significantly better performance for pain, physical function and social function. The QUALEFFO total score and SF-36 physical composite score showed similar performance. In conclusion, QUALEFFO is repeatable, coherent and discriminates well between patients with vertebral fractures and control subjects. The results of this study confirm the decreased quality of life in patients with vertebral fractures.