Research Topics
| Lsabelle BoutronSummaryCountry: France Publications
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Publications
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...- Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary interventionMorgane Ethgen
Institut National de la Santé et la Recherche Médiale, INSERM U738, Paris, France
BMC Med Res Methodol 9:24. 2009..The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions... 
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...- 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... - 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...- 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 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... - 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... - 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)... - 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... - 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... - 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)... - 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.... - 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... - Half of elderly patients routinely treated for colorectal cancer receive a sub-standard treatmentThomas Aparicio
Service d Hepato Gastroenterologie, AP HP, Hopital Bichat, Universite Denis Diderot, Paris 7, UFR de Medecine, Paris, France
Crit Rev Oncol Hematol 71:249-57. 2009..Several database studies report a lack of care in elderly patients with colorectal cancer... - Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomesIsabelle Boutron
Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
JAMA 303:2058-64. 2010..Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports... - Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic reviewNizar Ahmad
Centre d Epidemiologie Clinique, Hopital Hotel Dieu, AP HP Assistance Publique des Hôpitaux de Paris, 1 Place du Parvis Notre Dame, Paris 75181, France
Trials 11:20. 2010..e., whether the results of a trial can be reasonably applied or generalized to a definable group of patients in a particular setting in routine practice, also called external validity or generalisability)... - 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.... - 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... - 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.... - 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... - 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)... - 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... - 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... - 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... - 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... - 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... - 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... - 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)... - Diagnostic accuracy of serum hepcidin for iron deficiency in critically ill patients with anemiaSigismond Lasocki
Service de Réanimation Chirugicale, département d anesthésie réanimation chirurgicale, AP HP, CHU Bichat Claude Bernard, université Paris 7 Diderot, 46, rue Henri Huchard, 75877, Paris Cedex 18, France
Intensive Care Med 36:1044-8. 2010..We conducted a prospective observational study to determine the cutoff value and diagnostic accuracy of hepcidin levels for detecting ID in critically ill anemic patients... - 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... - 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.... - [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... - 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... - Inappropriateness of randomised trials for complex phenomena: single trial is never enough evidence to base decisions onIsabelle Boutron
BMJ 330:94; author reply 95. 2005 - 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... - 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...