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Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials — A meta-epidemiologic study


Stoll, Marlene; Mancini, Alexander; Hubenschmid, Lara; Dreimüller, Nadine; König, Jochem; Cuijpers, Pim; Barth, Jürgen; Lieb, Klaus (2020). Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials — A meta-epidemiologic study. Journal of Clinical Epidemiology, 128:49-56.

Abstract

Objectives: This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
Study Design and Setting: Recent psychotherapy trials on depression (2015-2018) were analyzed regarding their registration status and its relationship to discrepancies between registered and published primary outcomes and to spin (discrepancy between the nonsignificant finding in a study and an overly beneficial interpretation of the effect of the treatment).
Results: A total of 196 trials were identified, of which 78 (40%) had been registered prospectively and 56 (29%) had been registered retrospectively. In 102 (76%) of 134 registered trials, discrepancies between trial and protocol were present. Of 72 trials with a nonsignif-icant difference between treatments for the primary outcome, 68 trials (94%) showed spin. Discrepancies from protocol were less frequent in prospectively than in retrospectively registered trials (odds ratio5 0.19; 95% confidence interval [CI]: 0.07-0.52), but regarding the amount of spin, there was no difference between prospectively and retrospectively registered trials (rb=0.12; 95% CI: -0.41 to 0.19) or between registered and unregistered trials (rb=0.22, 95% CI -0.49 to 0.08).
Conclusion: Protocol discrepancies and spin have a high prevalence in psychotherapy outcome research. The results show no relation between registration and spin, but prospective registration may prevent discrepancies from protocol.

Abstract

Objectives: This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
Study Design and Setting: Recent psychotherapy trials on depression (2015-2018) were analyzed regarding their registration status and its relationship to discrepancies between registered and published primary outcomes and to spin (discrepancy between the nonsignificant finding in a study and an overly beneficial interpretation of the effect of the treatment).
Results: A total of 196 trials were identified, of which 78 (40%) had been registered prospectively and 56 (29%) had been registered retrospectively. In 102 (76%) of 134 registered trials, discrepancies between trial and protocol were present. Of 72 trials with a nonsignif-icant difference between treatments for the primary outcome, 68 trials (94%) showed spin. Discrepancies from protocol were less frequent in prospectively than in retrospectively registered trials (odds ratio5 0.19; 95% confidence interval [CI]: 0.07-0.52), but regarding the amount of spin, there was no difference between prospectively and retrospectively registered trials (rb=0.12; 95% CI: -0.41 to 0.19) or between registered and unregistered trials (rb=0.22, 95% CI -0.49 to 0.08).
Conclusion: Protocol discrepancies and spin have a high prevalence in psychotherapy outcome research. The results show no relation between registration and spin, but prospective registration may prevent discrepancies from protocol.

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Additional indexing

Item Type:Journal Article, refereed, further contribution
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Institute of Complementary Medicine
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Epidemiology
Uncontrolled Keywords:Psychotherapy; Depression; Reporting bias; Spin in research; Conflict of interest; Review
Language:English
Date:1 December 2020
Deposited On:03 Feb 2021 15:28
Last Modified:08 Feb 2021 08:06
Publisher:Elsevier
ISSN:0895-4356
OA Status:Closed
Publisher DOI:https://doi.org/10.1016/j.jclinepi.2020.08.013
PubMed ID:32828837

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