Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study
[Display omitted] •Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered trials.•Psychotherapy trial registration is not associated with less spin in the publications. This study aimed to i...
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| Veröffentlicht in: | Journal of clinical epidemiology 2020-12, Vol.128, p.49-56 |
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| creator | Stoll, Marlene Mancini, Alexander Hubenschmid, Lara Dreimüller, Nadine König, Jochem Cuijpers, Pim Barth, Jürgen Lieb, Klaus |
| description | [Display omitted]
•Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered trials.•Psychotherapy trial registration is not associated with less spin in the publications.
This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
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).
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).
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. |
| doi_str_mv | 10.1016/j.jclinepi.2020.08.013 |
| format | Article |
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•Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered trials.•Psychotherapy trial registration is not associated with less spin in the publications.
This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
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).
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).
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.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2020.08.013</identifier><identifier>PMID: 32828837</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Bias ; Clinical trials ; Confidence intervals ; Conflict of interest ; Depression ; Epidemiologic Research Design ; Epidemiology ; Humans ; Medical research ; Mental depression ; Psychotherapy ; Randomized Controlled Trials as Topic - methods ; Registration ; Reporting bias ; Review ; Spin in research</subject><ispartof>Journal of clinical epidemiology, 2020-12, Vol.128, p.49-56</ispartof><rights>2020 Elsevier Inc.</rights><rights>Copyright © 2020 Elsevier Inc. All rights reserved.</rights><rights>2020. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c450t-3a22d408ba8ce98cffb617e2df83b17750257af8f24cc50415464661d482b4fa3</citedby><cites>FETCH-LOGICAL-c450t-3a22d408ba8ce98cffb617e2df83b17750257af8f24cc50415464661d482b4fa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2462417678?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3549,27923,27924,45994,64384,64386,64388,72340</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32828837$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stoll, Marlene</creatorcontrib><creatorcontrib>Mancini, Alexander</creatorcontrib><creatorcontrib>Hubenschmid, Lara</creatorcontrib><creatorcontrib>Dreimüller, Nadine</creatorcontrib><creatorcontrib>König, Jochem</creatorcontrib><creatorcontrib>Cuijpers, Pim</creatorcontrib><creatorcontrib>Barth, Jürgen</creatorcontrib><creatorcontrib>Lieb, Klaus</creatorcontrib><title>Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>[Display omitted]
•Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered trials.•Psychotherapy trial registration is not associated with less spin in the publications.
This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
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).
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).
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.</description><subject>Bias</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Conflict of interest</subject><subject>Depression</subject><subject>Epidemiologic Research Design</subject><subject>Epidemiology</subject><subject>Humans</subject><subject>Medical research</subject><subject>Mental depression</subject><subject>Psychotherapy</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Registration</subject><subject>Reporting bias</subject><subject>Review</subject><subject>Spin in research</subject><issn>0895-4356</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkc9uFSEUh4nR2Gv1FRoSN25mBIYB7s6m_k2auNE1YeDQcjMzjMCYTFcufASf0CeRm9u6cOOKBL5z-J3zIXRBSUsJFa8P7cGOYYYltIww0hLVEto9QjuqpGr6PaOP0Y6ofd_wrhdn6FnOB0KoJLJ_is46pphSndyhn29DtgkWM9sAGfsUJ5zgJuQCCRxeUizRxjFjMzuclzDjaO2ajm8-wbcV5jJuuF6nCsQp3B2L8mZvY7mFZJYNlxTMmH__-HWJJyimqZEdTCGO8SZYnMvqtufoia8MvLg_z9HX9---XH1srj9_-HR1ed1Y3pPSdIYxx4kajLKwV9b7QVAJzHnVDVTKnrBeGq8849b2hNOeCy4EdVyxgXvTnaNXp751rBo9Fz3V6WEczQxxzZrxTighqdhX9OU_6CGuaa7pKiUYp1JIVSlxomyKOSfweklhMmnTlOijJ33QD5700ZMmSldPtfDivv06TOD-lj2IqcCbEwB1H98DJJ2roNmCCwls0S6G__3xB8vhq34</recordid><startdate>20201201</startdate><enddate>20201201</enddate><creator>Stoll, Marlene</creator><creator>Mancini, Alexander</creator><creator>Hubenschmid, Lara</creator><creator>Dreimüller, Nadine</creator><creator>König, Jochem</creator><creator>Cuijpers, Pim</creator><creator>Barth, Jürgen</creator><creator>Lieb, Klaus</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20201201</creationdate><title>Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study</title><author>Stoll, Marlene ; Mancini, Alexander ; Hubenschmid, Lara ; Dreimüller, Nadine ; König, Jochem ; Cuijpers, Pim ; Barth, Jürgen ; Lieb, Klaus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c450t-3a22d408ba8ce98cffb617e2df83b17750257af8f24cc50415464661d482b4fa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Bias</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Conflict of interest</topic><topic>Depression</topic><topic>Epidemiologic Research Design</topic><topic>Epidemiology</topic><topic>Humans</topic><topic>Medical research</topic><topic>Mental depression</topic><topic>Psychotherapy</topic><topic>Randomized Controlled Trials as Topic - 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Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stoll, Marlene</au><au>Mancini, Alexander</au><au>Hubenschmid, Lara</au><au>Dreimüller, Nadine</au><au>König, Jochem</au><au>Cuijpers, Pim</au><au>Barth, Jürgen</au><au>Lieb, Klaus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2020-12-01</date><risdate>2020</risdate><volume>128</volume><spage>49</spage><epage>56</epage><pages>49-56</pages><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>[Display omitted]
•Protocol discrepancies and spin in psychotherapy research are investigated in detail.•Discrepancies are less frequent in prospectively vs retrospectively registered trials.•Psychotherapy trial registration is not associated with less spin in the publications.
This study aimed to investigate the relationship between trial registration, trial discrepancy from registered protocol, and spin in nonpharmacological trials.
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).
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).
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><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32828837</pmid><doi>10.1016/j.jclinepi.2020.08.013</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Bias Clinical trials Confidence intervals Conflict of interest Depression Epidemiologic Research Design Epidemiology Humans Medical research Mental depression Psychotherapy Randomized Controlled Trials as Topic - methods Registration Reporting bias Review Spin in research |
| title | Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study |
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