Assessing the usefulness of randomised trials in obstetrics and gynaecology

Hooft, Janneke van ’t; Dijk, Charlotte E. van; Axfors, Cathrine; Alfirević, Z̄arko; Oudijk, Martijn A.; Khan, Khalid S.; Mol, Ben W.; Bossuyt, Patrick M.; Ioannidis, John P. A.

doi:10.1111/1471-0528.17411

Cited by 10 publications

(1 citation statement)

References 36 publications

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“…'IUI in cervical factor 2007' [12] was the only trial classi ed as low risk, while no trial was classi ed as moderate risk. The TRACT lead developer coauthored 11 publications in the rst month of 2023 alone [13][14][15][16][17][18][19][20][21][22][23], leading us to consider the item "large number of RCTs published in a short time frame by one author/in one institute" to be ful lled in all reviewed trials. A total of 9 trials (56.25%) showed a discrepancy in reported ndings between the published abstract and the nal article [7][8][9][10][24][25][26][27][28].…”

Section: Tract Checklist Evidence Synthesismentioning

confidence: 99%

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Al-Inany

2023

Preprint

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Randomized controlled trials (RCTs) are considered the gold standard study design in clinical effectiveness research, albeit some RCTs have been found to be fraudulent post-publication. The Trustworthiness in RAndomized Controlled Trials (TRACT) checklist examines RCT integrity through an assessment covering seven domains. While the authors claim that it can identify problematic trials, it has never been validated. A critical appraisal of the checklist highlights major failures in terms of health measurement methodology, including the arbitrary nature of items chosen. We applied the checklist to 16 RCTs coauthored by the checklist developer, and identified potential violations related to retrospective registration, ethical implications, authorship, methodology, implausible timeframes, zero participants to follow-up, implausible baseline characteristics, and excessive inter-group within trial as well as inter-trial similarities. In addition, we identified inconsistencies between the trials’ registration and data in the final published manuscripts. If we uncritically assume that the checklist is valid, then a formal institutional investigation into the trial portfolio its developer is warranted; especially targeting these 16 trials objectively shown to be problematic. The checklist should be considered as neither investigative nor conclusive of potential problems with RCTs until it is further refined and validated.

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Section: Tract Checklist Evidence Synthesismentioning

confidence: 99%

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Al-Inany

2023

Preprint

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Response: Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment

Chien

2023

Intl J Gynecology & Obste

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We thank Alfirevic, 1 Bolland et al., 2 and Thornton 3 for their interest in our review article. 4 Their comments enrich the discussion concerning the integrity of randomized clinical trials (RCTs).Alfirevic 1 hits the RCT integrity testing nail right on the head-"Sweeping this issue under the carpet by hiding behind imperfect tools should no longer be an option"-and this provides further context to the points raised by Thornton. 3 For systematic reviews, a proposal for upgrading methodology to incorporate integrity assessment, and for RCTs, an international consensus statement, have recently been published. 5,6 The responsibility for trustworthiness is shared by all stakeholders involved in the RCT lifecycle from preapproval to post-publication, and transparency is their guiding principle. RCT authors should take note that, according to Alfirevic, 1 trialists shoulder the lion's share of the burden to prove integrity. His comment 1 concerning the bar for trustworthiness requires careful consideration, as both false positives (genuine RCTs that fail on testing) and false negatives (non-genuine RCTs that pass on testing) are relevant for protecting patients. No doubt this will be a key future research topic.

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The usefulness of randomized trials of lifestyle interventions for overweight, obesity, or metabolic syndrome: A systematic review

Tsirogianni,

Bouzalmate-Hajjaj,

van ’t Hooft

et al. 2024

Clinical Nutrition ESPEN

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Assessing the usefulness of randomised trials in obstetrics and gynaecology

Abstract: This article includes Author Insights, a video abstract available at: https://vimeo.com/785911255

Cited by 10 publications

References 36 publications

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Response: Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment

The usefulness of randomized trials of lifestyle interventions for overweight, obesity, or metabolic syndrome: A systematic review

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