[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.

[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.

[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).

Recurrent genital herpes and quality of life in France.

Recurrent genital herpes is an incurable disease that may give rise to considerable psychological disturbance. This paper describes the impact of the disease on quality of life in a French population. The population study was also used to provide additional validation data for the French version of the RGHQoL (the Recurrent Genital Herpes Quality of Life) measure. The content of the RGHQoL was derived from patient interviews in the UK. The measure was then developed and tested simultaneously in several countries, including France. Statements in the measure were translated into French by a bilingual panel and then by a lay panel. Field-testing in France took place with 15 patients who judged the instrument to be relevant and easy to complete. The final version of the questionnaire was assessed for reliability and construct validity. The measure was found to have good test-retest reliability (0.94) and internal consistency (0.93) as assessed by Cronbach's alpha. The French RGHQoL was then used with 150 herpes patients obtained from a general population sample. A majority of the respondents completed all questions, indicating a high level of acceptability. Quality of life was found to be lowest in the under 25-year-olds and in those respondents who were most psychologically and sexually disturbed by their outbreaks and found it difficult to discuss the problem with their partner. It is concluded that the French version of the RGHQoL is an acceptable, reliable and valid instrument and that the measure provides valuable information about the impact of the disease.

The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation.

This article reports on the main developmental stages and on the preliminary psychometric assessment of the final French version of the SF-36. A standard forward/backward translation procedure was followed. When translating survey items, the emphasis was placed on conceptual equivalence. When translating response choices, we attempted to select a set of response choices that replicate the U.S. version. The distance between the response choices was checked using visual analogue scales (N = 30). The adaptation procedure also included formal ratings of the difficulty of the translation, of the quality of the translation, and of the equivalence between the American source version and the French target version. The face validity was checked during lay panel sessions at which the translated questionnaire was administered to subjects from the general public, hospital employees, and subjects with a low level of education. Standard psychometric techniques were used to evaluate the cultural adaptation of the SF-36, using data from a general population survey. The main objective of this analysis was to determine how well the scaling assumptions (summated rating or Likert-type scaling construction) of the SF-36 were satisfied. The results support the claim that the scaling properties of the French version of the SF-36 are adequate and that health outcomes may be reliably assessed using this version of the instrument.

COOP Charts in French: translation and preliminary data on instrument properties.

This paper describes the procedure used to translate the COOP Charts into French and provides preliminary information on the instrument's acceptability, reliability and validity. The charts were translated in several steps: seven initial translations were combined into a first pilot version, which was then tested for acceptability, clarity and alternative wordings in two convenience samples taken from the general population (n = 53). The modified version was then reviewed by a lay panel and another translator and submitted by mail to 209 congress participants to test several construct validity hypotheses through known-groups comparisons. A panel of public health professionals discussed the content validity of the charts. Finally, test-retest reliability and concurrent validity with SF-36 Health Survey scores were examined among 65 patients with end-stage renal disease. The translation process identified a wide variability in translation options for several items. The acceptability of the charts was excellent. The test-retest correlations ranged from 0.60 to 0.87. Content validity appeared to be appropriate, except for the chart on 'social support', which combines the questions of need and availability of social support. The utility of illustrations was questioned by some respondents: many claimed not to have used the illustrations in selecting their response, while others found them to be not expressive enough. Most preliminary tests of construct validity were consistent with theory. This French translation of the COOP Charts appears to be ready for more extensive testing in the intended target population of ambulatory patients.

Measuring quality of life from the point of view of HIV-positive subjects: the HIV-QL31.

Assessment of the quality of life (QoL) of human immunodeficiency virus (HIV)-infected subjects is often based on questionnaires in which the items or questions are not seen to be relevant by patients, nor by the users of the data obtained. It therefore seemed appropriate to return to the issue. The methodological and bibliographical research as well as the consultations we conducted convinced us that the elaboration of a new questionnaire was both necessary and possible. In order to do so, we adopted methodological principles based on the Sickness Impact Profile development methodology. First a bibliographical research was conducted in order to study instruments already used for HIV infection. Then, experts concerned with HIV infection and members of patients' associations were interviewed to assess how opportune the development of a new instrument could be. Following this, a methodology was established for the design and construction of the new instrument. One hundred and eighteen candidate questions were generated from an analysis of the content of 20 patients' interviews, which were subsequently submitted to 102 patients, to obtain finally a set of 31 questions from the interpretation of the results obtained from classic psychometric analysis and also from non-classic methods (item response theory and Rasch model). The concept being measured is the impact of illness being experienced by HIV-infected subjects from their own perspective. The range of health states covered by this questionnaire relates to fairly mild conditions. Rasch analysis of this set of 31 questions (HIV-QL31) shows that it corresponds to one unidimensional construct. A single score can be calculated by simple summation of dichotomous response options. This score is highly reliable (Cronbach's alpha coefficient = 0.93) and is also discriminant regarding the severity of clinical status.