Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration

19 February 2008 | Volume 148 Issue 4 | Pages 295-309

Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram.

To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. 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.

Author and Article Information

From INSERM U738, AP-HP, Hôpital Bichat-Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France; Chalmers Research Group, Children's Hospital of Eastern Ontario Research Unit, University of Ottawa, Ottawa, Ontario, Canada; University of Oxford, Oxford, United Kingdom; and Family Health International, Research Triangle Park, North Carolina.

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. They also thank Drs. Homs and Siersema (Departments of Gastroenterology and Hepatology, Erasmus MC/University Medical Centre Rotterdam, Rotterdam, the Netherlands), who helped reconstruct Figure 2.

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, isabelle.boutron{at}bch.aphp.fr.

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.

^* For contributors to the CONSORT Extension for Nonpharmacologic Treatment Interventions, see the Appendix.

Read all Rapid Responses

Time to upgrade the original CONSORT statement?

Ludovic G van Amelsvoort, et al.

Annals Online, 4 Apr 2008 [Full text]