Papers by olivier chassany
Annales de medecine interne
Multiple Sclerosis
Background: Multiple sclerosis (MS) causes disability of varying degrees. Moreover, life long tre... more Background: Multiple sclerosis (MS) causes disability of varying degrees. Moreover, life long treatment has also an impact to patient's quality of Life (QoL). QoL assessment may provide unique informa-tion underestimated by clinical estimate like the Expanded Disability Status Scale (EDSS). There are numerous QoL questionnaires but they are complex and poorly adapted to MS. Objectives: to validate the Subjective Quality of Life Profile (SQLP) questionnaire in MS, and to evaluate the change in QoL at 10 months for patients treated with Glatiramere Acetate. Methods: QUALISEP is a prospective and multicentre French pilot study. Patients over 18 years treated with Copaxone(registered trademark) were included by neurologists and followed for 10 months in a two-visit study. At initial (Vi) and final (Vf) visit, socio-demographic and clinical items including the EDSS have been completed. Patients completed 3 questionnaires: the SQLP, the Fatigue Impact Scale (FIS) and the Hospital Anxi...
Résumé La mise au point d’un traitement médicamenteux « universel » du syndrome de l’intestin ir... more Résumé La mise au point d’un traitement médicamenteux « universel » du syndrome de l’intestin irritable se heurte à de multiples obstacles difficiles à surmonter. L’absence de mécanisme physiopathologique unique, la grande variabilité des symptômes dans le temps, les troubles psychologiques associés, l’importance de l’effet placebo, la définition des critères d’évaluation, et la durée du traitement, sont les principales difficultés rencontrées
BMC infectious diseases, 2014
Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV)... more Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients. A longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA. The average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2...
Presse médicale (Paris, France : 1983), 2008
a publication de 2 articles portant surla recherche sur les soins courants par 2auteurs qui ontla... more a publication de 2 articles portant surla recherche sur les soins courants par 2auteurs qui ontlargement contribue ´pourl’e´criture et l’adoption des textes le´gisla-tifs affe´rents [1,2] pouvait laisser entre-voir, pour les acteurs de la recherche(essentiellement acade´miques), une fa-cilitation de certains de leurs projets.Apre`s une expe ´rience de soumission dequelques projets dans ce cadre, la re´alite´est bien diffe ´rente.Pour rappel, la recherche sur le soincourant tel que de´fini par la loi est unerecherche interventionnelle visant a` e´va-luer les soins courants, lorsque tous lesactes sont pratique ´s et les produits uti-lise´s de manie`re habituelle mais que desmodalite´s particulie`res de surveillancesont pre´vues par un protocole. Ainsi laloi permet la comparaison et la randomi-sation. Sur le plan re´glementaire, pointde promoteur ne ´cessaire (mais un ges-tionnaire), point d’assurance, point desoumission du projet a` une autorite´compe´tente (DGS ou Afssaps), point deconsentement (mais le recueil d’unenon-opposition). Seule une soumissionpour avis a` un Comite´ de protectiondes personnes (CPP) est ne´cessaire. Ilest vrai, que vue sous cet angle, cetteloi paraiˆt avenante.Plusieurs facteurs viennent oberer la por-te ´e de la recherche portant sur les soinscourants.La principale limitation est que le le´gis-lateur a exclu les me´dicaments de larecherchesurlessoinscourants(l’Afssaps,les entreprises pharmaceutiques ne sontprobablement pas e´trange `res a cetteexclusion, ainsi que la Directiveeurope ´enne de 2001). Et de citer dessituations de comparaison de strate´giestherapeutiques extreˆmement courantes,avec des me´dicaments ayant l’autorisa-tion de mise sur le marche (AMM), maispour lesquels se pose la question de ladure´e optimale du traitement (non ren-seigne ´e dans le resume des caracteris-tiques du produit, RCP). C’est le cas, parexemple,d’essaisdecomparaisondedur-ee d’antibiotique dans des infectionscommunes. Ces e´tudes sur le bon usagedu medicament, qui n’evaluent pasl’efficacite intrinse`que d’une molecule,mais qui e ´valuent l’efficacite d’une strate-gie the´rapeutique courante, relevaienttypiquement de la recherche sur le soincourant.Ced’autantquecesetudessontleplus souvent mene´es par les institution-nels et non pas les industriels. C’est toutel’hypocrisie du syste `me, ou tout me´decinpeutprescrireunedureed’unantibiotique
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
Vertigo and dizziness, which are major symptoms of diseases affecting the vestibular system, dras... more Vertigo and dizziness, which are major symptoms of diseases affecting the vestibular system, drastically impair patients' health-related quality of life (QoL). Patient's perspectives are thus essential to symptom assessment. We sought to make a critical review of published questionnaires measuring vertigo or dizziness, and/or their impact on QoL. Twenty-nine articles reporting the validation or use in clinical trials of vertigo- or dizziness-specific questionnaires were identified over the 1991-2004 period, and reviewed using a methodological and a Patient-Reported Outcomes specific checklist. Questionnaires were classified into three categories according to content: QoL (or handicap), mixed (assessing both symptoms and QoL), and symptom questionnaires. Four QoL, three mixed questionnaires, two symptoms, and one Meniere's disease-specific questionnaire were identified. QoL questionnaire validation was usually not complete. The structural validity of the Dizziness Handica...
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
To explore the degree of agreement between patient- and clinician-reported outcomes (PROs and CRO... more To explore the degree of agreement between patient- and clinician-reported outcomes (PROs and CROs, respectively) in three chronic diseases. Respectively, 120, 131, and 61 French general practitioners (GPs) included 291, 307, and 90 patients with chronic venous disease (CVD), irritable bowel syndrome (IBS), and peripheral arterial occlusive disease (PAOD), in a cross-sectional survey. Patients completed a specific Health-Related Quality of Life (QoL) questionnaire (Chronic Venous Insufficiency Questionnaire [CIVIQ], Functional Digestive Disorders Quality of Life [FDDQL], and Claudication Scale [CLAU-S], respectively) and scored their pain (visual analog scale, pain-free walking distance). GPs were concomitantly asked to estimate patients' pain and QoL. Although correlated (CVD and IBS: Kw = 0.27 and Kw = 0.31, respectively; PAOD: r = 0.64, P < 0.01), pain intensity estimated by GPs was lower than as estimated by patients with CVD and IBS (e.g., 39.0 +/- 24.9 vs. 30.4 +/- 21.0...
La Revue de Médecine Interne, 1998
Nutrition & Dietetics, 2012
ABSTRACT Aim: To report changes in the quality of sleep after drinking an evening cup of either c... more ABSTRACT Aim: To report changes in the quality of sleep after drinking an evening cup of either caffeinated or decaffeinated coffee, in healthy subjects in everyday life.Methods: Sixty‐three healthy men and women, who considered themselves to be caffeine sensitive were included in a double‐blind, cross‐over trial, randomised to receive either caffeinated coffee containing 90 mg of caffeine, or, as control, a dose of decaffeinated coffee containing 4.5 mg caffeine, taken after dinner. The primary outcome measure was the degree of sleep disturbance, scored on a visual analogue scale, ranging from 0 (excellent sleep) to 100 (very disturbed sleep). Ancillary criteria were patients&#39; reported estimate of sleep latency, and how often the subjects reported waking.Results: Mean age of subjects was 30.5 ± 12 years. The quality of sleep was significantly worse with caffeinated (mean 30.8 ± 22.7) than with decaffeinated coffee (mean 19.5 ± 16.9), P = 0.001. Caffeinated coffee also significantly increased the sleep latency (mean difference 17 ± 31 minutes, P vs 0.8 episodes in the night, P = 0.006) compared with decaffeinated coffee.Conclusions: Even a single cup of caffeinated coffee consumed before bedtime in real‐life conditions causes a deterioration in the quality of sleep in caffeine‐sensitive subjects.
Thérapie, 2009
-Les personnes qui participent à une recherche biomédicale doivent recevoir une information lisib... more -Les personnes qui participent à une recherche biomédicale doivent recevoir une information lisible et intelligible afin de pouvoir donner un consentement libre et éclairé. À ce jour, on note que les promoteurs ont tendance à apporter de nombreuses informations de différentes natures n'ayant pas toujours un rapport direct et réellement informatif pour les personnes qui se prêtent à cette recherche. Ce constat a conduit à l'organisation d'une table ronde lors des rencontres de Pharmacologie Clinique et à une réflexion sur l'établissement d'une charte relative à la rédaction d'un document d'information des personnes participant à une Recherche Biomédicale ainsi que des bonnes pratiques de rédaction. Les recommandations qui ont été faites, sont basées sur les travaux des différents groupes de travail tels que ceux de la Conférence Nationale des Comités de Protection des Personnes (CNCP), des représentants des usagers, des associations de patients, ceux des promoteurs industriels et institutionnels (CPI), et issus de la littérature. La restitution de cette table ronde est structurée en 3 catégories et 14 points. 1) Le format : la conception ; les règles de la rédaction ; la mise en forme ; le sommaire et le lexique. 2) Le contenu : la page d'introduction ; la description de l'étude ; les risques et les bénéfices. 3) Les aspects réglementaires : les aspects Juridiques ; les mentions CNIL (Commission Nationale Informatique et Liberté) ; les aspects financiers ; les conflits d'intérêts et les signatures multiples et variées. Ce document doit contribuer à l'attractivité de la Recherche en France et il a été convenu de présenter la charte et ses documents après les rencontres de Pharmacologie Clinique et de les faire avaliser par l'ensemble des acteurs : DGS (Direction Générale de la Santé), Afssaps (Agence française de sécurité sanitaire des produits de santé), CNCP, CPI et Leem (Les entreprises du médicament). Une fois, cette charte validée, elle pourra être mise à disposition des Promoteurs et des CPP (Comités de Protection des Personnes) afin de rendre l'information donnée aux patients uniforme et lisible.
La Presse Médicale, 2011
Research on usual care: Assessing the qualification criteria of the current legal framework
Clinical Pharmacology & Therapeutics, 1995
We propose a noninvasive method for the measurement of orocecal transit time assessed by the sulf... more We propose a noninvasive method for the measurement of orocecal transit time assessed by the sulfapyridine appearance time in saliva after ingestion of sulfasalazine. In 12 healthy volunteers, we studied the correlation between plasma and saliva sulfapyridine appearance times and then the sulfapyridine appearance times in saliva under various experimental conditions to assess the reproducibility, the effects of meals, and the role of the formulation, and the effects of gastrointestinal kinetic drugs. The correlation between saliva and plasma sulfapyridine appearance times was strong (r = 0.84; p = 0.0004). The sulfapyridine saliva appearance time was significantly delayed by the meal. Compared with placebo, the saliva sulfapyridine appearance time was reduced by cisapride (312 +/- 128 versus 551 +/- 97 minutes; p = 0.0001) and increased by loperamide (674 +/- 267 versus 501 +/- 131 minutes; p = 0.044). We propose the salivary sample method as a validated simplification of the plasma sulfasalazine-sulfapyridine test for the measurement of orocecal transit time.
Value in Health, 2004
Objectives: Health-related quality of life (HRQL) instruments generally undergo a rigorous develo... more Objectives: Health-related quality of life (HRQL) instruments generally undergo a rigorous development and validation process. In contrast, methods for interpreting HRQL data are varied, and no comprehensive widely applicable procedure exists. Determining whether differences are statistically significant is the most common method, but this yields conclusions that may be difficult to understand in a clinical context or which may be of no practical value. Consequently, there is a need for a comprehensive interpretation strategy that gives results that are meaningful to a variety of audiences, including patients, clinicians, and decision-makers. Methods: The review of available interpretation strategies revealed that not all methods are applicable to all questionnaires, and some strategies may be difficult to implement for interpreting trial results. In addition, the issues decision-makers may have when assessing HRQL results have not really been addressed: what is measured and what is the meaning beyond statistical significance? Results: A comprehensive stepwise strategy, based on the most effective methods available, has been developed to address the key interpretation issues of decision-makers. It is structured around several steps: understanding the content of the questionnaire; evaluating the magnitude of changes and their statistical significance; determining whether results are clinically significant, e.g., whether the observed changes crossed ranges of established threshold for meaningful differences; comparing pre-and post-treatment scores distribution with norms of references; and relating score changes to other outcomes end points such as morbidity, death, compliance, resource utilization, or productivity. Conclusions: The proposed strategy should help to structure and successfully address interpretation issues and thus make HRQL results more convincing.
Thrombosis Research, 2012
Atrial fibrillation (AF), the most frequent arrhythmia, is a major independent cardiovascular (CV... more Atrial fibrillation (AF), the most frequent arrhythmia, is a major independent cardiovascular (CV) risk factor, especially in elderly patients. The interest of Ddimer (DD) measurement for predicting CV risk has been suggested in some subgroups of patients with AF but little is known about the negative prognostic value of DD measurement. The primary aim was to assess whether DD measurement and monitoring could predict the occurrence of subsequent CV events, defined as MI, stroke or transient ischemic attack and arterial embolic events. Methods and results: It was a prospective observational study including patients with AF. Overall 425 patients (mean age 77 years) were included and followed-up every 4 months for a 16-months-mean duration. During this period, 26 patients experienced an endpoint of combined CV events. Patients with DD lower than 334 ng/ml had a very low risk of suffering of CV events (1.7%). Patients who will suffer from a CV event had a higher DD value, just before the occurrence of the CV event, while patients without CV event kept stable levels. Conclusion: We identified a DD threshold defining at any time patients at low risk of CV event. In addition, patients with higher DD levels are at higher risk of CV events, even if they are receiving oral anticoagulants. Otherwise, DD measurement is relevant in elderly patients. DD measurement and monitoring are useful to assess the risk of CV events in usual care. The implications of DD measurement on the choice and the intensity of the antithrombotic treatment remain to be determined.
British Journal of Nutrition, 2013
There is a lack of recognised markers for measuring gastrointestinal (GI) well-being and digestiv... more There is a lack of recognised markers for measuring gastrointestinal (GI) well-being and digestive symptoms in the general population. The aim of the present study was to demonstrate construct validity of a global assessment tool of GI well-being. In this randomised double-blind study, 197 adult women consumed either a probiotic fermented milk or a control dairy product daily during 4 weeks. GI well-being was assessed weekly using a single question and subjects indicated whether their GI well-being remained the same, improved or worsened compared with the baseline period. Responders for GI well-being were subjects reporting improvement for at least 2 weeks of the 4 weeks of intervention. Frequency of individual digestive symptoms was assessed weekly. Health-related quality of life (HRQoL) was measured at baseline and at the end of the study. Subjects reporting improvement of their GI well-being had a significantly (P< 0·05) lower frequency of combined digestive symptoms than indi...
Public Health Nutrition, 2008
ObjectiveTo assess the perceived outcomes associated with diet/food intake in the general adult p... more ObjectiveTo assess the perceived outcomes associated with diet/food intake in the general adult population.Design and subjectsThe Food Benefits Assessment (FBA©) questionnaire was developed from subjects’ verbatim transcripts (n 18) and after comprehension tests (n 5). Normal-weight (n 130) and overweight (n 67) subjects then completed the final questionnaire twice, 7 d apart. Psychometric properties were assessed, including construct validity by principal components analysis (PCA), concurrent validity (Spearman coefficient) with the Short Form-36 scale (SF-36), known-group validity by comparing FBA dimension scores according to lifestyle and clinical variables, internal consistency reliability (Cronbach’s α) and test–retest reproducibility in stable subjects over 1 week (intraclass correlation coefficient, ICC).ResultsPCA and Multitrait analysis confirmed the final version of the FBA comprising forty-one items split into seven dimensions (vitality; digestive comfort; physical appea...
Journal of Medical Internet Research, 2014
Background: Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessm... more Background: Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients' health-related quality of life (HRQL). Objective: An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. Methods: A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients' survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. Results: Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients' survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in
Journal of acquired immune deficiency syndromes (1999), Jan 15, 2012
This study reports the psychometric validation of a new HIV/AIDS-specific health-related quality ... more This study reports the psychometric validation of a new HIV/AIDS-specific health-related quality of life (HRQL) questionnaire, the Patient Reported Outcomes Quality of Life-HIV. The instrument was developed simultaneously across Europe, North and South America, Africa, Asia, and Australia to assess multidimensional quality of life impairments in the era of highly active antiretroviral therapy.
Intensive Care Medicine, 2009
This issue of Intensive Care Medicine presents two aspects of the difficulties that face Independ... more This issue of Intensive Care Medicine presents two aspects of the difficulties that face Independent Ethics Committees (IEC) regarding their role and responsibilities, and not resolved either by the European Directive or by its translation in national laws: a negative point of view on the utility of European IECs through a survey among authors of clinical trials published in some major journals in 2007 [1], and a constructive initiative of the Vienna university IEC, on reviewing interventional studies at minimal risk through an expedited process [2].
Uploads
Papers by olivier chassany