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. 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, email@example.com.
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.
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.
Table 1. Checklist of Items for Reporting Trials of Nonpharmacologic Treatments
Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.
An extra box per 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.
Table 2. Checklist of Items for Reporting Trials of Nonpharmacologic Treatments, with Examples
Example of modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.
This example was not reported in the article but was developed with the help of the authors (39). IQR = interquartile range; max = maximum; min = minimum.
Table 3. Clustering Effect
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Ludovic G van Amelsvoort
School for Public Health and Primary Care (Caphri)
April 4, 2008
Time to upgrade the original CONSORT statement?
A recent publication of the CONSORT group in this journal presents the extension of the well-known CONSORT statement to trials of nonpharmacological treatment.(1) The development and adoption of the original statement have indisputably led to improved quality reporting of randomized controlled trials(2). Further transparency and quality improvement may be expected with it's increased application. The extensions to the items of the original statement, presented by Boutron et al., are unquestionably important and germane and will confidently lead to increased quality in reporting.
However, we do feel that several of the items presented as extensions should actually also be included in a revised version of the original CONSORT statement as they can be as relevant for pharmacological as well as non-pharmacological trials. In particular, reporting about, and adjusting for clustering is emphasized in many items of the extension (table 2, items 3, 4C, 7, 12, 13, 15, 20 and, 21). Authors are commended for clearly defining cluster effects in table 3. Based on a review of 42 trials(3), of which 38 had some form of clustering which was largely ignored in the analysis and interpretation of results, the authors conclude that clustering effects are often not recognized and underreported in nonpharmacological trials. This conclusion is clearly overstated. A closer examination of the cited study revealed that 11 of the included trials actually involved pharmacological intervention. Moreover, it is increasingly recognized that clustering should be taken into account in individual RCTs, also in pharmacological comparisons(4). The correlation of diagnostic quality, co-interventions, outcomes and exposures among patients within centers deserves more attention with the ever-increasing flow of multicenter studies and provides often unrecognized analytic challenges, especially in cases of differential numbers of recruited patients per center. Even when there is little apparent heterogeneity across clusters, it can still have a large impact on the estimation and interpretation of the treatment effect.(5)
The authors mention that the original 2001 CONSORT statement is planned to be revised on the item of blinding (item 11). Nonetheless, we contend that the original CONSORT statement should be updated with many of the additional items mentioned in the presented extension.
Two decades ago, uniform reporting was an exception, now it has become the rule on account of the CONSORT statement and extensions are warmly welcomed. Yet, the original statement, being the backbone of the extensions, needs to be state of the art and fully up-to-date.
1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295- 309.
2. Kane RL, Wang J, Garrard J. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol. 2007;60(3):241-9.
3. Lee KJ, Thompson SG. Clustering by health professional in individually randomised trials. BMJ. 2005;330(7483):142-4.
4. Lee KJ, Thompson SG. The use of random effects models to allow for clustering in individually randomized trials. Clin Trials. 2005;2(2):163-73.
5. Localio AR, Berlin JA, Ten Have TR, Kimmel SE. Adjustments for center in multicenter studies: an overview. Ann Intern Med. 2001;135(2):112-23.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, for the CONSORT Group. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. ;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008
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Published: Ann Intern Med. 2008;148(4):295-309.
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