TY - JOUR
T1 - Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials
T2 - A meta-epidemiologic study
AU - Stoll, Marlene
AU - Mancini, Alexander
AU - Hubenschmid, Lara
AU - Dreimüller, Nadine
AU - König, Jochem
AU - Cuijpers, Pim
AU - Barth, Jürgen
AU - Lieb, Klaus
PY - 2020/12
Y1 - 2020/12
N2 - 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 nonsignificant 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 ratio= 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.
AB - 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 nonsignificant 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 ratio= 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.
KW - Conflict of interest
KW - Depression
KW - Psychotherapy
KW - Reporting bias
KW - Review
KW - Spin in research
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U2 - 10.1016/j.jclinepi.2020.08.013
DO - 10.1016/j.jclinepi.2020.08.013
M3 - Article
C2 - 32828837
AN - SCOPUS:85090572536
SN - 0895-4356
VL - 128
SP - 49
EP - 56
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -
