A systematic review of trial registration and selective outcome reporting in psychotherapy randomized controlled trials

Bradley, Hayley A.; Rucklidge, Julia J.; Mulder, Roger

doi:10.1111/acps.12647

Cited by 86 publications

(39 citation statements)

References 40 publications

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“…Thus, our findings in the addiction clinical trial literature fitted within the broader context . In addition to our previous studies, several others suggest that selective reporting of outcomes and analyses is common in clinical trials. Beyond selective outcome reporting, our study shows that a significant proportion of RCTs in our sample were registered after patient enrollment ended or were not registered at all.…”

Section: Discussionsupporting

confidence: 77%

“…after randomization and administration of the intervention), and approximately one in three registered trials had a major discrepancy between registration and publication. A lack of trial registration or incomplete description of outcomes in a trial registration should warrant concern given the rate of selective reporting found in our study and in previous studies . Overall, the implications of our findings center on a lack of transparency because many RCTs were not registered at all, only one RCT had a documented change to its outcomes in the published report, and a significant portion of RCTs had identifiable major discrepancies.…”

Section: Discussionmentioning

confidence: 56%

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Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials

et al. 2020

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Background and Aims Selective outcome reporting occurs when trialists pre-specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting. Design We conducted a cross-sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance.Setting Single-center, medical research institution. Participants Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome. Measurement We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P-value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes. Findings In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed. Conclusions There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 56%

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials

et al. 2020

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“…Even without allegiance, common problems in science are likely to apply to psychotherapy researchers; such as, the problems with outcome switching and selective reporting of studies that are not prospectively registered, enabling investigators to act as if a secondary outcome was the primary. Bradley, Rucklidge, & Mulder (2017) reviewed trials published between 2010 and 2014 in the five journals with the highest journal impact factor. Out of 112 trials, about 12% were prospectively and correctly registered.…”

Section: Allegiancementioning

confidence: 99%

Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial.

Magnusson¹,

Nilsson²,

Andersson³

et al. 2019

Journal of Consulting and Clinical Psychology

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Over the last couple of decades evidence-based psychotherapies have flourished, and there are now therapies that are well-established for a wide range of problems. At the same time the mental-health burden is still enormous, and challenges to the dissemination of treatments are substantial. Despite the considerable gains in knowledge that have been made, many issues remain unsolved, and there are many reasons to be skeptical of the current quality of the evidence.

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“…For psychotherapy RCTs, the results were even worse. Only 24.1% were registered and 4.5% free from selective outcome reporting,8 underscoring the fact that bias is not an issue just confined to pharmaceutical industry trials.…”

Section: ‘It-work-somewhere’mentioning

confidence: 99%

The limitations of using randomised controlled trials as a basis for developing treatment guidelines

Mulder

Singh

Hamilton³

et al. 2017

Evid Based Mental Health

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Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality.

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A systematic review of trial registration and selective outcome reporting in psychotherapy randomized controlled trials

Abstract: The proportion of psychotherapy randomized controlled trials correctly registered and transparently reported is poor. Psychologists should consider the impact these results have on public confidence in reported outcomes.

Cited by 86 publications

References 40 publications

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials

Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial.

The limitations of using randomised controlled trials as a basis for developing treatment guidelines

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