Details

Autor(en) / Beteiligte

• Cybulski, Lukasz
• Mayo-Wilson, Evan
• Grant, Sean
• Davila, Joanne
• Nezu, Arthur M

Titel

Improving Transparency and Reproducibility Through Registration: The Status of Intervention Trials Published in Clinical Psychology Journals

Ist Teil von

• Journal of consulting and clinical psychology, 2016-09, Vol.84 (9), p.753-767

Ort / Verlag

United States: American Psychological Association

Erscheinungsjahr

2016

Link zum Volltext

Quelle

Applied Social Sciences Index & Abstracts (ASSIA)

Beschreibungen/Notizen

• Objective: Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. Method: We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. Results: We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Conclusions: Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. What is the public health significance of this article? This study shows that most trials of psychological interventions in clinical psychology journals are not registered in advance, and most registered trials do not define their outcomes completely. The widespread failure to define research hypotheses in advance threatens the validity of trials and meta-analyses, and this has negative impacts on clinical care. Journals should require prospective and complete registration of trials to fulfill ethical obligations to research participants, improve transparency and reproducibility, and reduce publication and outcome reporting bias. All trial reports should state their registration status in the abstract and, if applicable, include their registration number.