Trial registration as a safeguard against outcome reporting bias and spin? A case study of randomized controlled trials of acupuncture


Autoři: Jiyoon Won aff001;  Seoyeon Kim aff001;  Inhu Bae aff003;  Hyangsook Lee aff001
Působiště autorů: Department of Korean Medical Science, Graduate School, Kyung Hee University, Dongdaemun-gu, Seoul, Republic of Korea aff001;  Acupuncture & Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University, Dongdaemun-gu, Seoul, Republic of Korea aff002;  Kyung Hee University Korean Medicine Hospital, Dongdaemun-gu, Seoul, Republic of Korea aff003
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223305

Souhrn

Background and objective

Trial registration is widely endorsed as it is considered not only to enhance transparency and quality of reporting but also to help safeguard against outcome reporting bias and probably spin, known as specific reporting that could distort the interpretation of results thus mislead readers. We planned to investigate the current registration status of recently published randomized controlled trials (RCTs) of acupuncture, outcome reporting bias in the prospectively registered trials, and the association between trial registration and presence of spin and methodological factors in acupuncture RCTs.

Methods

Acupuncture RCTs published in English in recent 5 years (January 2013 to December 2017) were searched in PubMed, Cochrane Central Register of Controlled Trials, and EMBASE. Trial registration records identified in the publications and trial registries were classified into prospectively registered, retrospectively registered, or unregistered. Primary outcomes were identified and the direction of the results was judged as statistically significant (positive) or statistically nonsignificant (negative). We compared registered and published primary outcomes to assess outcome reporting bias and assessed whether discrepancies favored statistically significant outcomes. Frequency and strategies of spin in published reports with statistically nonsignificant results for primary outcomes were then identified. We also analyzed whether the trial registration status was associated with spin and quality of methodological factors.

Results

Of the 322 included RCTs, 41.9% (n = 135) were prospectively registered. Among 64 studies that were prospectively registered and specified primary outcomes, 25 trials had the discrepancies between the registered and published primary outcomes and 60% of them (15 trials) favored the statistically significant findings. Among 169 studies that specified primary outcomes, trial registration status was not associated with the direction of results, i.e., statistically significant or not. Spin was identified in 56.4% out of 78 studies with statistically nonsignificant primary outcomes and claiming efficacy with no consideration of statistically nonsignificant primary outcomes was the most common strategy for spin. Trial registration status was not statistically different between studies with and without spin.

Conclusion

While trial registration seemed to have improved over time, primary outcomes in registered records and publications were often inconsistent, tending to favor statistically significant findings and spin was common in studies with statistically nonsignificant primary outcomes. Journal editors and researchers in this field should be alerted to still prevalent reporting bias and spin.

Klíčová slova:

Asia – Clinical trials – Database searching – Drug therapy – Randomized controlled trials – Scientific publishing – Sleep – Acupuncture


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