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A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus |
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| Authors: | Boutron Isabelle Moher David Tugwell Peter Giraudeau Bruno Poiraudeau Serge Nizard Remy Ravaud Philippe |
| Institution: | aINSERM U738, Paris, F-75018, France bDépartement d'Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 Paris Cedex 18, France cUniversité Paris VII, Faculté Xavier Bichat, Paris, F-75018 France dChalmers Research Group, Children's Hospital of Eastern Ontario Research Institute; Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada eInstitute of Population Health, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada fINSERM CIC 202, Tours, France gDépartement de Médecine Physique et de Réadaptation, Hôpital Cochin (AP-HP), Université Rene Descartes, Paris, France hService d'Orthopédie, Hôpital Lariboisière (AP-HP), Université Denis Diderot, Paris, France |
| Abstract: | BACKGROUND AND OBJECTIVE: To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatments (NPTs). STUDY DESIGN AND SETTING: The Delphi consensus method was used to select and reduce the number of items in the checklist. A total of 154 individuals were invited to participate: epidemiologists and statisticians involved in the field of methodology of RCTs (n = 55), members of the Cochrane Collaboration (n = 41), and clinicians involved in planning NPT clinical trials (n = 58). Participants ranked on a 10-point Likert scale whether an item should be included in the checklist. RESULTS: Fifty-five experts (36%) participated in the survey. They were experienced in systematic reviews (68% were involved in the Cochrane Collaboration) and in planning RCTs (76%). Three rounds of the Delphi method were conducted to achieve consensus. The final checklist contains 10 items and 5 subitems, with items related to the standardization of the intervention, care provider influence, and additional measures to minimize the potential bias from lack of blinding of participants, care providers, and outcome assessors. CONCLUSIONS: This tool can be used to critically appraise the medical literature, design NPT studies, and assess the quality of trial reports included in systematic reviews. |
| Keywords: | Randomized controlled trials Quality assurance Surgery Rehabilitation therapy Psychotherapy Education Meta-analysis |
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