Psychology | Social and Behavioral Sciences
Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of pub- lished trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered tri- als, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.
Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators inde- pendently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration.
Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analy- ses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjust- ment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome anal- ysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The pro- portion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709).
The quality of published outcome analysis definitions and trial registrations in JCCP is sub- optimal. Greater attention to proper trial registration and outcome analysis definition in pub- lished reports is needed.
Azar, M., Riehm, K., McKay, D., & Thombs, B.D. (2015). Transparency of outcome reporting and trial registration of randomized controlled trials published in the Journal of Consulting and Clinical Psychology. PLoS One, 10, e0142894.
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