Isabelle Boutron

Summary

Country: France

Publications

  1. ncbi request reprint Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis
    Isabelle 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
  2. pmc Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
    Isabelle Boutron
    INSERM, U738, Paris, France
    PLoS Med 4:e61. 2007
  3. ncbi request reprint A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus
    Isabelle Boutron
    INSERM U738, Paris, France
    J Clin Epidemiol 58:1233-40. 2005
  4. ncbi request reprint A review of blinding in randomized controlled trials found results inconsistent and questionable
    Isabelle Boutron
    INSERM, U738, Paris, France
    J Clin Epidemiol 58:1220-6. 2005
  5. pmc Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review
    Isabelle Boutron
    INSERM U738, Paris, France
    PLoS Med 3:e425. 2006
  6. ncbi request reprint Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
    Isabelle 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
  7. pmc Knee arthroplasty: disabilities in comparison to the general population and to hip arthroplasty using a French national longitudinal survey
    Agnes Dechartres
    INSERM, U738, Paris, France
    PLoS ONE 3:e2561. 2008
  8. doi request reprint Size-adjusted left ventricular outflow tract diameter reference values: a safeguard for the evaluation of the severity of aortic stenosis
    Mohamed Leye
    AP HP, Cardiology Department, Bichat Hospital, Paris, France
    J Am Soc Echocardiogr 22:445-51. 2009
  9. ncbi request reprint Evolution of disability in adults with hip arthroplasty: a national longitudinal study
    Agnes 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
  10. ncbi request reprint Splint for base-of-thumb osteoarthritis: a randomized trial
    Francois Rannou
    Assistance Publique Hopitaux de Paris, Hopital Cochin, Paris, France
    Ann Intern Med 150:661-9. 2009

Collaborators

Detail Information

Publications47

  1. ncbi request reprint Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis
    Isabelle 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
    ....
  2. pmc Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
    Isabelle 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...
  3. ncbi request reprint A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus
    Isabelle 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)...
  4. ncbi request reprint A review of blinding in randomized controlled trials found results inconsistent and questionable
    Isabelle 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)...
  5. pmc Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review
    Isabelle Boutron
    INSERM U738, Paris, France
    PLoS Med 3:e425. 2006
    ....
  6. ncbi request reprint Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
    Isabelle 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...
  7. pmc Knee arthroplasty: disabilities in comparison to the general population and to hip arthroplasty using a French national longitudinal survey
    Agnes 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...
  8. doi request reprint Size-adjusted left ventricular outflow tract diameter reference values: a safeguard for the evaluation of the severity of aortic stenosis
    Mohamed 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...
  9. ncbi request reprint Evolution of disability in adults with hip arthroplasty: a national longitudinal study
    Agnes 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...
  10. ncbi request reprint Splint for base-of-thumb osteoarthritis: a randomized trial
    Francois 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...
  11. ncbi request reprint Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration
    Isabelle 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...
  12. pmc Reporting of radiographic methods in randomised controlled trials assessing structural outcomes in rheumatoid arthritis
    Gabriel 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
    ....
  13. pmc Comparison of treatment effect estimates for pharmacological randomized controlled trials enrolling older adults only and those including adults: a meta-epidemiological study
    Valerie Seegers
    Assistance Publique Hopitaux de Paris, Hopital Hotel Dieu, Paris, France
    PLoS ONE 8:e63677. 2013
    ..Older adults are underrepresented in clinical research. To assess therapeutic efficacy in older patients, some randomized controlled trials (RCTs) include older adults only...
  14. pmc Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study
    Amélie 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...
  15. pmc 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...
  16. doi request reprint Comparison of registered and published primary outcomes in randomized controlled trials
    Sylvain 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...
  17. doi request reprint Reporting of safety results in published reports of randomized controlled trials
    Isabelle 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)...
  18. pmc Neglected external validity in reports of randomized trials: the example of hip and knee osteoarthritis
    Nizar 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)...
  19. pmc Inadequate description of educational interventions in ongoing randomized controlled trials
    Cécile 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...
  20. pmc Geographical representativeness of published and ongoing randomized controlled trials. The example of: Tobacco consumption and HIV infection
    Nizar 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...
  21. ncbi request reprint Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments
    Isabelle 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...
  22. doi request reprint Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal
    Agnes 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...
  23. ncbi request reprint Violation of the intent-to-treat principle and rate of missing data in superiority trials assessing structural outcomes in rheumatic diseases
    Gabriel 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...
  24. ncbi request reprint Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases
    Philippe Ravaud
    University of Paris VII, Paris, France
    Nat Clin Pract Rheumatol 2:313-9. 2006
    ....
  25. ncbi request reprint [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...
  26. pmc Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals
    Carolina Riveros
    INSERM U738, Paris, France Université Paris Descartes Sorbonne Paris Cité, Paris, France Centre d épidémiologie clinique, Hopital Hotel Dieu, Assistance Publique Hopitaux de Paris, Paris, France
    PLoS Med 10:e1001566; discussion e1001566. 2013
    ..gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals...
  27. pmc Reporting of analyses from randomized controlled trials with multiple arms: a systematic review
    Gabriel Baron
    INSERM, U738 Paris, France
    BMC Med 11:84. 2013
    ..We conducted a systematic review to assess the reporting of analyses in reports of randomized controlled trials (RCTs) with multiple arms...
  28. pmc ASSIST applicability scoring of surgical trials. an investigator-reported assessment tool
    Idriss 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...
  29. pmc Influence of trial sample size on treatment effect estimates: meta-epidemiological study
    Agnes Dechartres
    INSERM, U738, Paris, France
    BMJ 346:f2304. 2013
    ..To assess the influence of trial sample size on treatment effect estimates within meta-analyses...
  30. pmc Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugs
    Cécile 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...
  31. pmc Impact of single centre status on estimates of intervention effects in trials with continuous outcomes: meta-epidemiological study
    Aïda 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...
  32. ncbi request reprint High-sensitivity C-reactive protein in chronic low back pain with vertebral end-plate Modic signal changes
    Francois 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...
  33. doi request reprint Provider and center effect in multicenter randomized controlled trials of surgical specialties: an analysis on patient-level data
    David 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...
  34. ncbi request reprint Methodological issues in trials assessing primary prophylaxis of venous thrombo-embolism
    Gabriel 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...
  35. pmc The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review
    Isabelle Jacquier
    INSERM U738, Paris France corrected Assistance Publique Hôpitaux de Paris APHP, Groupe Hospitalier Bichat Claude Bernard, Département d Epidémiologie Biostatistique et Recherche Clinique, Paris, France
    Ann Surg 244:677-83. 2006
    ..To assess the reporting of surgical interventions, care providers, and number of centers in randomized clinical trials...
  36. doi request reprint Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study
    Agnes 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...
  37. pmc Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention
    Morgane 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...
  38. pmc Performance of rapid diagnostic tests for imported malaria in clinical practice: results of a national multicenter study
    Sandrine Houze
    AP HP Assistance Publique des Hôpitaux de Paris, Hopital Bichat, Laboratoire de Parasitologie Centre National de Référence du Paludisme, Paris, France Université Paris Descartes, UMR 216, Paris, France Institut de Recherche pour le Développement, UMR 216, Paris, France
    PLoS ONE 8:e75486. 2013
    ..falciparum malaria. However, as malaria may be misdiagnosed with RDTs, all negative results must be confirmed by the reference diagnostic method when clinical, biological or other factors are highly suggestive of malaria. ..
  39. doi request reprint An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial
    Ariel Cohen
    Service de cardiologie, Hopital Saint Antoine, Assistance Publique des Hopitaux de Paris, Universite Pierre et Marie Curie, Paris, France
    JAMA Intern Med 174:40-8. 2014
    ..Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve...
  40. ncbi request reprint Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
    Asbjørn Hróbjartsson
    Nordic Cochrane Centre, Rigshospitalet Department 7811, Copenhagen, Denmark, Department of Orthopaedic Surgery, Herlev University Hospital, Copenhagen, Denmark, Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark and French Cochrane Centre, Assistance Publique Hotel Dieu, Universite Paris Descartes, Paris, France
    Int J Epidemiol 43:937-48. 2014
    ..We wanted to evaluate the impact of nonblinded outcome assessors on estimated treatment effects in time-to-event trials...
  41. ncbi request reprint Social and personal consequences of disability in adults with hip and knee arthroplasty. A French national community based survey
    Isabelle Boutron
    National Institute of Statistics and Economic Studies INSEE, Paris, France
    J Rheumatol 31:759-66. 2004
    ..To describe and compare participation restrictions and environmental factors of persons with and without hip or knee arthroplasty in a national community based survey: the Handicap, Disability, Dependence Survey...
  42. doi request reprint The account for provider and center effects in multicenter interventional and surgical randomized controlled trials is in need of improvement: a review
    David 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...
  43. pmc Patients' and practitioners' views of knee osteoarthritis and its management: a qualitative interview study
    Sophie 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...
  44. pmc Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review
    Leslie 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...
  45. pmc Outcomes in registered, ongoing randomized controlled trials of patient education
    Cécile 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)...
  46. doi request reprint 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 area
    Caroline 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...
  47. ncbi request reprint Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease
    Morgane Ethgen
    Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France
    Ann Intern Med 143:20-5. 2005
    ..Reports of clinical trials usually emphasize benefits and give less attention to harms...