In late 2012/early 2013, the International Society of Physiotherapy Journal Editors (http://www.wcpt.org/ispje), together with editors from 12 physiotherapy journals, published a joint editorial to implement the policy of mandatory prospective clinical trial registration. This editorial was subsequently co-published by other physiotherapy journals, including the European Journal of Physiotherapy (Citation1), for which prospective clinical trial registration became compulsory on 1 January 2015 for all clinical trials that commenced participant recruitment after 31 December 2014.
As described in that editorial, prospective clinical trial registration is important in facilitating transparency in research reporting, to tackle problems such as selective reporting of trial outcomes or publication bias. The joint promotion of mandatory prospective clinical trial registration marks a milestone for physiotherapy journals; however, promoting research transparency is not restricted to physiotherapy. The establishment of the AllTrials campaign in January 2013 (http://www.alltrials.net/), which calls for all trials to be registered and all results to be reported, is an example of the importance that the wider international community places on research transparency.
In addition to prospective trial registration, there are guidelines to facilitate better reporting of clinical trials and aid research transparency. These guidelines provide a framework not only to researchers when reporting research, but also to clinicians when reading and implementing research findings. Readers of this journal will not be unfamiliar with the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/), including the CONSORT checklist and flowchart that sets out the minimum requirements when reporting results of a clinical trial. CONSORT 2010 is the current guideline (Citation2) and several extensions of the CONSORT statement are also available to cover particular trial designs or interventions. The “pragmatic trials” (Citation3) and “non-pharmacologic treatment interventions” (Citation4) extensions may be of particular relevance to physiotherapy trials.
More recently, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement (Citation5) and Template for Intervention Description and Replication (TIDieR) checklist (Citation6) have also been developed. SPIRIT 2013 provides the minimum set of requirements that should be included in a trial protocol, while the TIDieR checklist is designed for better reporting of complex interventions, such as many physiotherapy interventions, so that sufficient information is reported to allow the replication of these interventions in clinical practice or in future research. The TIDieR checklist can be used in conjunction with the CONSORT statement.
Research is an important element to advance the practice of physiotherapy. However, we need transparency in reporting so that all available evidence is adequately reported in order to inform practice. Of course, a clinical trial is not the only research design relevant to physiotherapy. Readers interested in reporting guidelines on other designs (e.g. systematic reviews, observational studies) can refer to the Equator Network (http://www.equator-network.org/).
References
- Soderlund A. Editorial. Eur J Physiother. 2013;15:42–5.
- Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332
- Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.
- Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.
- Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.
- Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.