Isabelle Boutron, MD, PhD; David Moher, PhD; Douglas G. Altman, DSc; Kenneth F. Schulz, PhD, MBA; Philippe Ravaud, MD, PhD; for the CONSORT Group (*)
Acknowledgment: The authors thank Lola Fourcade, who was responsible for preparing the minutes of the CONSORT meeting, and Lucie Ronceray, who developed the Web-based interface used for the preliminary survey.
Grant Support: By the Département de la Recherche Clinique et du Développement, Assistance Publique des Hôpitaux de Paris; Département d'Epidémiologie, Biostatistique et Recherche Clinique, Hôpital Bichat-Claude Bernard; INSERM U738; and the Eli Lilly Institute. Dr. Moher is funded in part by a University of Ottawa Research Chair. Dr Altman is supported by Cancer Research UK. Dr. Schulz is supported by Family Health International.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Isabelle Boutron, MD, PhD, Département d'Epidémiologie Biostatistique et Recherche Clinique, INSERM U738, AP-HP, Hôpital Bichat-Claude Bernard, Université Paris 7 Denis Diderot, 46 rue Henri Huchard, 75018 Paris, France; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Boutron and Ravaud: Département d'Epidémiologie Biostatistique et Recherche Clinique, INSERM U738, AP-HP, Hôpital Bichat-Claude Bernard, Université Paris 7 Denis Diderot, 46 rue Henri Huchard, 75018 Paris, France.
Dr. Moher: Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Faculty of Medicine, University of Ottawa, 401 Smyth Road, Room 210, Ottawa, Ontario, Canada.
Dr. Altman: Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.
Dr. Schulz: Quantitative Sciences, Family Health International, PO Box 13950, Research Triangle Park, NC 27709.
The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports.
To develop an extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement for trials of nonpharmacologic treatments.
A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses randomized trials of nonpharmacologic treatments. To prepare for the meeting, a survey was conducted to identify the specific issues for discussion.
Consensus meeting in Paris, France.
A total of 33 experts attended the meeting. The experts were methodologists (n = 17); surgeons (n = 6); editors (n = 5); and clinicians involved in rehabilitation (n = 1), psychotherapy (n = 2), education (n = 1), and implantable devices (n = 1).
Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments. During a 3-day consensus meeting, all items were discussed and additional methodological issues related to nonpharmacologic research were identified.
The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials: item 1 (title and abstract), item 3 (participants), item 4 (interventions), item 7 (sample size), item 8 (randomization), item 11 (blinding), item 12 (statistical methods), item 13 (participant flow), item 15 (baseline data), item 20 (discussion: interpretation), and item 21 (generalizability). In addition, the meeting participants added 1 item related to implementation of the intervention.
Evidence was not always available to support the inclusion of each checklist item.
The methods and processes used to develop this extension could be used for other reporting guidelines. The use of this extension to the CONSORT Statement should improve the quality of reporting randomized, controlled trials assessing nonpharmacologic treatments.
Table 1. Results of the Survey on Revisions and Additions to the CONSORT Checklist
Table 2. Checklist of Items for Reporting Trials of Nonpharmacologic Treatments
Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.
An extra box for each intervention group relating to care providers has been added. For cluster randomized, controlled trials, authors should refer to the appropriate extension. IQR = interquartile range; max = maximum; min = minimum.
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Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008;148:W-60-W-66. doi: 10.7326/0003-4819-148-4-200802190-00008-w1
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Published: Ann Intern Med. 2008;148(4):W-60-W-66.
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