Research Topics
| Isabelle BoutronSummaryCountry: France Publications
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Publications
Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritisIsabelle Boutron
Département d Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat Claude Bernard, Assistance Publique des Hopitaux de Paris, Faculte Xavier Bichat, Universite Paris VII, Paris, France
JAMA 290:1062-70. 2003....
Reporting methods of blinding in randomized trials assessing nonpharmacological treatmentsIsabelle Boutron
INSERM, U738, Paris, France
PLoS Med 4:e61. 2007..The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment...- Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trialsIsabelle Boutron
INSERM EMI 03 57, Département d Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat Claude Bernard, Assistance Publique Hopitaux de Paris, Faculte Xavier Bichat, Universite Paris 7, France
J Clin Epidemiol 57:543-50. 2004..To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis... - Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic reviewIsabelle Boutron
INSERM U738, Paris, France
PLoS Med 3:e425. 2006.... - A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensusIsabelle Boutron
INSERM U738, Paris, France
J Clin Epidemiol 58:1233-40. 2005..To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatments (NPTs)... - A review of blinding in randomized controlled trials found results inconsistent and questionableIsabelle Boutron
INSERM, U738, Paris, France
J Clin Epidemiol 58:1220-6. 2005..To determine methods to assess the success of blinding in randomized controlled trials (RCTs)... - Knee arthroplasty: disabilities in comparison to the general population and to hip arthroplasty using a French national longitudinal surveyAgnes Dechartres
INSERM, U738, Paris, France
PLoS ONE 3:e2561. 2008..A secondary objective was to compare the level of disabilities of people with knee to people with hip arthroplasty... 
Size-adjusted left ventricular outflow tract diameter reference values: a safeguard for the evaluation of the severity of aortic stenosisMohamed Leye
AP HP, Cardiology Department, Bichat Hospital, Paris, France
J Am Soc Echocardiogr 22:445-51. 2009..Transesophageal echocardiography (TEE) is reputed to be more accurate than transthoracic echocardiography (TTE), but validation studies are rare. A safeguard for LVOTd measurements is thus desirable...- Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaborationIsabelle Boutron
INSERM U738, AP HP, Hopital Bichat Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France
Ann Intern Med 148:295-309. 2008..This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field... - Evolution of disability in adults with hip arthroplasty: a national longitudinal studyAgnes Dechartres
INSERM, U738, Universite Paris 7, UFR de Medecine, AP HP Hôpital Bichat, Département d Epidémiologie, Biostatistique et Recherche Clinique, Paris, France
Arthritis Rheum 57:364-71. 2007..To describe disability in individuals with hip arthroplasty and its evolution over 2 years compared with that in the general population, and to compare the degree of disability between subjects with recent and older hip arthroplasty... - Splint for base-of-thumb osteoarthritis: a randomized trialFrancois Rannou
Assistance Publique Hopitaux de Paris, Hopital Cochin, Paris, France
Ann Intern Med 150:661-9. 2009..Some guidelines recommend splinting for base-of-thumb osteoarthritis, despite lack of evidence of efficacy... - Reporting of radiographic methods in randomised controlled trials assessing structural outcomes in rheumatoid arthritisGabriel Baron
Département d Epidémiologie Biostatistique et Recherche Clinique, INSERM, U738, Groupe Hospitalier Bichat Claude Bernard, 46 rue Henri Huchard, 75018 Paris, France
Ann Rheum Dis 66:651-7. 2007.... - Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort studyAmélie Yavchitz
INSERM, U738, Paris, France
PLoS Med 9:e1001308. 2012..We aimed to (1) evaluate the presence of "spin" in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted... - Development and validation of a questionnaire assessing fears and beliefs of patients with knee osteoarthritis: the Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)Mathilde Benhamou
service de rééducation et réadaptation de l appareil locomoteur et des pathologies du rachis, Assistance Publique Hôpitaux de Paris Université Paris Descartes INSERM IFR 25 Handicap, Paris, France
PLoS ONE 8:e53886. 2013..We aimed to develop a questionnaire assessing fears and beliefs of patients with knee OA... - Comparison of registered and published primary outcomes in randomized controlled trialsSylvain Mathieu
INSERM, U738, Assistance Publique des Hopitaux de Paris, Hopital Bichat Claude Bernard, Département d Epidémiologie Biostatistique et Recherche Clinique, Paris, France
JAMA 302:977-84. 2009..As of 2005, the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial's findings in member journals... - Reporting of safety results in published reports of randomized controlled trialsIsabelle Pitrou
Département d Epidémiologie, Biostatistique, et Recherche Clinique, Groupe Hospitalier Bichat Claude Bernard AP HP, Universite Denis Diderot, INSERM U738, Paris, France
Arch Intern Med 169:1756-61. 2009..Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs)... - Neglected external validity in reports of randomized trials: the example of hip and knee osteoarthritisNizar Ahmad
INSERM U738, Assistance Publique Hopitaux de Paris, Hopital Bichat Claude Bernard, Universite Paris 7, Paris, France
Arthritis Rheum 61:361-9. 2009..To evaluate data reporting related to external validity from randomized controlled trials (RCTs) assessing pharmacologic and nonpharmacologic treatment for hip and knee osteoarthritis (OA)... - Geographical representativeness of published and ongoing randomized controlled trials. The example of: Tobacco consumption and HIV infectionNizar Ahmad
INSERM, U738, Paris, France
PLoS ONE 6:e16878. 2011..This study aimed to compare where research is conducted to where research is needed for 2 public health priorities: tobacco consumption and HIV infection... - Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatmentsIsabelle Boutron
INSERM U738, AP HP, Hopital Bichat Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France
Ann Intern Med 148:W60-6. 2008..The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports... - Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseasesPhilippe Ravaud
University of Paris VII, Paris, France
Nat Clin Pract Rheumatol 2:313-9. 2006.... - Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseasesGabriel Baron
INSERM U 738, Groupe Hospitalier Bichat Claude Bernard, Assistance Publique Hopitaux de Paris, Paris, France
Arthritis Rheum 52:1858-65. 2005..To evaluate the methodologic quality of and identify methodologic issues in superiority trials assessing structural outcomes in rheumatic diseases... - Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposalAgnes Dechartres
INSERM U738, Paris, France
J Clin Epidemiol 62:695-702. 2009..We aimed to assess the reporting and functioning of ACs (synonyms: clinical event committees, endpoint committees) in clinical trials... - [Rehabilitation on effort of low back pain. Functional restoration programs]Serge Poiraudeau
Service de rééducation et de réadaptation fonctionnelle de l appareil locomoteur et des pathologies du rachis, Groupe Hospitalier Cochin, Paris
Presse Med 33:413-8. 2004..Finally, results of functional restoration programs in term of return-to-work rate probably strongly depend on the social security system of the country in which such programs have been developed... - Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugsCécile Konrat
INSERM U738, Paris, France
PLoS ONE 7:e33559. 2012..We focused on trials of 4 medications--pioglitazone, rosuvastatin, risedronate, and valsartan-frequently used by elderly patients with chronic medical conditions... - Impact of single centre status on estimates of intervention effects in trials with continuous outcomes: meta-epidemiological studyAïda Bafeta
INSERM U738, Paris, France
BMJ 344:e813. 2012..To compare estimates of intervention effects between single centre and multicentre randomised controlled trials with continuous outcomes... - Methodological issues in trials assessing primary prophylaxis of venous thrombo-embolismGabriel Thabut
Département d Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat Claude Bernard, Faculte Xavier Bichat, Universite Paris VII, Cedex 18, 75877 Paris, France
Eur Heart J 27:227-36. 2006..Some of these trials have been subject to methodological criticisms. We aimed to assess the methodological issues raised by VTE trials... - Provider and center effect in multicenter randomized controlled trials of surgical specialties: an analysis on patient-level dataDavid J Biau
Departement de Biostatistique et Informatique Medicale, Hopital Saint Louis, Paris, France
Ann Surg 247:892-8. 2008..To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials... - The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic reviewIsabelle Jacquier
INSERM U738, , Groupe Hospitalier Bichat-Claude Bernard, , Paris, France
Ann Surg 244:677-83. 2006..We recommend extending the CONSORT Statement to surgical interventions... - Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary interventionMorgane Ethgen
INSERM, U738, Paris, F 75018 France
Trials 10:29. 2009..The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention... - High-sensitivity C-reactive protein in chronic low back pain with vertebral end-plate Modic signal changesFrancois Rannou
Assistance Publique Hopitaux de Paris, Universite Rene Descartes, Groupe Hospitalier Cochin, Paris, France
Arthritis Rheum 57:1311-5. 2007..To assess high-sensitivity C-reactive protein (hsCRP) level as a measure of low-grade inflammation in relation to Modic vertebral end-plate marrow signal change on magnetic resonance imaging (MRI) in patients with chronic low back pain... - Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic studyAgnes Dechartres
U738 INSERM, Paris, France
Ann Intern Med 155:39-51. 2011..A recent study suggested that results of single-center trials are frequently contradicted when similar trials are performed in multicenter settings... - Inadequate description of educational interventions in ongoing randomized controlled trialsCécile Pino
INSERM, U738, Paris, France
Trials 13:63. 2012..We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education... - ASSIST applicability scoring of surgical trials. an investigator-reported assessment toolIdriss Tourabaly
INSERM, U738, Paris, France
PLoS ONE 7:e42258. 2012..We aimed to develop a new tool for assessing and depicting the applicability of the results of surgical randomized controlled trials (RCTs) from the trial investigators' perspective... - Patients' and practitioners' views of knee osteoarthritis and its management: a qualitative interview studySophie Alami
Interlis, Universite Paris Descartes, Paris, France
PLoS ONE 6:e19634. 2011..To identify the views of patients and care providers regarding the management of knee osteoarthritis (OA) and to reveal potential obstacles to improving health care strategies... - The account for provider and center effects in multicenter interventional and surgical randomized controlled trials is in need of improvement: a reviewDavid J Biau
INSERM U717 Departement de Biostatistique et Informatique Médicale, Hôpital Saint Louis Université Paris 7, Paris, France
J Clin Epidemiol 61:435-9. 2008..To systematically review the account of center and provider effects in large surgical and interventional randomized controlled trials... - Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic reviewLeslie Pibouleau
INSERM U738, Paris, France
BMJ 339:b4538. 2009..To compare the reporting of essential applicability data from randomised controlled trials and non-randomised studies evaluating four new orthopaedic surgical procedures... - Social and personal consequences of disability in adults with hip and knee arthroplasty. A French national community based surveyIsabelle Boutron
National Institute of Statistics and Economic Studies (INSEE, Paris, France
J Rheumatol 31:759-66. 2004..1, 95% CI 1.5-2.9). CONCLUSION: This study provides a detailed description based on a national random sample of participation restrictions and environmental factors of adults with hip and knee arthroplasty... - Outcomes in registered, ongoing randomized controlled trials of patient educationCécile Pino
INSERM, U738, AP HP Assistance Publique des Hôpitaux de Paris, Hopital Hotel Dieu, Centre d Epidemiologie Clinique, Paris, France
PLoS ONE 7:e42934. 2012..e., outcomes measuring patient health status and quality of life)... - Usefulness of the right parasternal view and non-imaging continuous-wave Doppler transducer for the evaluation of the severity of aortic stenosis in the modern areaCaroline Cueff de Monchy
AP HP, Cardiology Department, Bichat Hospital, Paris, France
Eur J Echocardiogr 10:420-4. 2009..Our aim was to evaluate the additional diagnostic value of the use of NI-CWD and the right parasternal view for the evaluation of AS severity in the modern area... - Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic diseaseMorgane Ethgen
Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France
Ann Intern Med 143:20-5. 2005..CONCLUSIONS: The lack of reporting harm in trials assessing nonpharmacologic treatment in rheumatic disease is an important barrier to evaluating the benefit-harm balance of nonpharmacologic treatments...