A checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist)
Open accessPreprint — published as 10.1186/s41073-023-00130-8 · Paper page
Abstract
Objectives: To develop a checklist to screen, for trustworthiness, papers reporting the results of randomised controlled trials (RCTs). Design: A screening tool was developed using the four-stage approach proposed by Moher et al. This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting as part of a Delphi method. The initial checklist was set-up by a core group who had been involved in the assessment of dubious RCTs for several years. We piloted this in a Delphi panel of several stakeholders, including health professionals, reviewers, journal editors, policymakers, researchers and evidence-synthesis specialists. Each member was asked to score three articles with the checklist and the the results were then discussed in two Delphi sessions. Results: The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes seven domains that are applicable to every RCT: governance, author group, plausibility of intervention usage, timeframe, drop-out rates, baseline characteristics and outcomes. Each domain contains two or three signalling questions that can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have significant concerns, then editors or reviewers should consider a more thorough investigation, including assessment of original individual participant data. Conclusions: The TRACT checklist is the first checklist developed in a formal process to detect trustworthiness issues in RCTs. It might help editors, publishers and researchers to screen for such issues in submitted or published RCTs in a transparent and replicable manner.
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Callado, G. Y., Gutfreund, M. C., Palumbo, C. M., Higgins, C., Júnior, E. A., Santana, E. F. M., & Rolnik, D. L. (2025) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.1111/aogs.70074 · Cited by 3 · see citing works
Safeguarding the integrity of scientific literature in the 21st century
Vereen, R. J., King, B., Razak, A., Mol, B. W., & Malhotra, A. (2025) · Pediatric Research · doi:10.1038/s41390-025-04647-0 · Cited by 3 · see citing works
Self-citationMcKinney, J. A., Sanchez‐Ramos, L., Duncan, J. R., Lin, L., Rhoades, C. P., Mateus, J., Dussan, L. E., Niño, G. V. R., Hansen, A., Messiah, C., et al. (2026) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2025.09.046 · Cited by 3 · see citing works
Venetis, C. A., Kiose, K. I., Apostolidou, M., Katsika, E., Bosdou, J. Κ., Lainas, G. T., & Kolibianakis, E. M. (2026) · Fertility and Sterility · doi:10.1016/j.fertnstert.2026.02.021 · Cited by 3 · see citing works
Papapanou, M., Siristatidis, C. S., Paraskevas, T., Lai, S., & Mol, B. W. (2026) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2026.112259 · Cited by 3 · see citing works
Self-citationLensen, S. F., Wilkinson, J., Steeper, M., Melo, P., Kamath, M. S., Craciunas, L., Wang, R., Jordan, V., Showell, M. G., Attinger, S. A., et al. (2026) · The Lancet Obstetrics Gynaecology & Women s Health · doi:10.1016/s3050-5038(26)00054-3 · Cited by 3 · see citing works
Self-citationMol, B. W., Flanagan, M., & Li, W. (2024) · The Lancet · doi:10.1016/s0140-6736(24)02302-x · Cited by 3 · see citing works
Self-citationHigh- vs low-dose oxytocin regimens for labor augmentation: a systematic review and meta-analysis
Logue, T. C., Zullo, F., van Biema, F., Son, M., London, L., Paranandi, S., SCISCIONE, A. C., Rizzo, G., Mascio, D. D., & Chauhan, S. P. (2025) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2025.101604 · Cited by 3 · see citing works
Betamethasone dosing interval at 12 or 24 h apart: A systematic review and meta-analysis
Said, M. R., Zullo, F., Gulersen, M., & Berghella, V. (2025) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2025.02.017 · Cited by 3 · see citing works
Bhide, P., Chan, D. Y. L., Ahlström, A., del Campo-Albendea, L., Kieslinger, D. C., Lundin, K., Hannah, P., Fauque, P., Kahraman, S., Khan, K. S., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-101761 · Cited by 3 · see citing works
Self-citationTrustworthiness assessment of published clinical trials: Literature review of domains and questions
Alfirević, Ž., & Weeks, J. (2024) · Cochrane Evidence Synthesis and Methods · doi:10.1002/cesm.12099 · Cited by 3 · see citing works
Flanagan, M., Rattan, A., Au, L. S., Patabendige, M., Whigham, C., Jans, S. M. P. J., Cofie, P., Hofmeyr, G. J., Rosseland, L. A., Weeks, A. D., et al. (2025) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.18279 · Cited by 3 · see citing works
Self-citationThe OBGYN Editors' Integrity Group (OGEIG) (2024) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.17945 · Cited by 3 · see citing works
Problematic trials are contaminating the evidence ecosystem
Liu, F., Xu, C., Doi, S. A. R., Chu, H., & Liu, H. (2025) · BMJ · doi:10.1136/bmj.r809 · Cited by 3 · see citing works
The trustworthiness of registered randomised control trials on hysteroscopy
Freeman-Spratt, G., Spratt, W., Vu, J., Bosteels, J., & Mol, B. W. (2024) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2024.12.002 · Cited by 2 · see citing works
Self-citationWattar, B. H. A., Rogozińska, E., Nicholson, L., Fisher, D. J., Bordea, E., Hutchinson-Pascal, N., Moss, N., Hunter, R. M., Khan, K. S., Jurkovic, D., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-085292 · Cited by 2 · see citing works
Kiose, K. I., Kolibianakis, E. M., Kolibianaki, E., Moysiadou, A. I., Zepiridis, L. I., & Venetis, C. A. (2025) · Minerva Obstetrics and Gynecology · doi:10.23736/s2724-606x.25.05741-0 · Cited by 2 · see citing works
Hybrid Maternity Care and Impact on Pregnancy Outcomes: A Systematic Review and Meta-Analysis
D’Alberti, E., Giancotti, A., Hod, M., Papageorghiou, A. T., & Mascio, D. D. (2026) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0000000000000988 · Cited by 2 · see citing works
Grey, A. B., Avenell, A., & Bolland, M. J. (2026) · Reproductive Biology and Endocrinology · doi:10.1186/s12958-026-01526-z · Cited by 2 · see citing works
van Haaps, A. P., Oskam, M. A., Dreyer, K., Rosielle, K., de Vries, R., Mol, B. W., van Wely, M., Kallewaard, J. W., Schreurs, A. M. F., & Mijatovic, V. (2026) · AJOG Global Reports · doi:10.1016/j.xagr.2026.100640 · Cited by 2 · see citing works
Self-citationEndometrial injury in women undergoing in vitro fertilisation (IVF)
Perera, A. K., Gan, J., Afroz, A., Armstrong, S., Raine-Fenning, N., Martins, W. P., & Lensen, S. F. (2026) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009517.pub5 · Cited by 2 · see citing works
Bosteels, J., Spratt, W., & Mol, B. W. (2025) · Journal of Ultrasound in Medicine · doi:10.1002/jum.16720 · Cited by 2 · see citing works
Self-citationFlanagan, M., Au, N., Patabendige, M., Rattan, A., Samanta, R., Sahota, D. S., Terán, E., Jain, V., Musa, A. O., Ijaiya, M. A., et al. (2025) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.18197 · Cited by 2 · see citing works
Self-citationPatabendige, M., Chan, F. L., Al-Ibraheemi, Z., Kibii, D. K., Osoti, A. O., Ayieko, P., Surapaneni, T., Ramírez, M. R., Argilagós, Á. V., Gilani, S., et al. (2026) · International Journal of Gynecology & Obstetrics · doi:10.1002/ijgo.70949 · Cited by 2 · see citing works
Self-citationAzhar, S., Akram, J., Latif, W., Ibáñez, N. C., Mumtaz, S., Rafi, A., Aftab, U., Iqtadar, S., Shahzad, M., Syed, F., et al. (2024) · Pakistan Journal of Medical Sciences · doi:10.12669/pjms.40.5.8757 · Cited by 2 · see citing works
The OBGYN Editors’ Integrity Group (OGEIG) (2024) · Gynecologic and Obstetric Investigation · doi:10.1159/000541479 · Cited by 2 · see citing works
Beebeejaun, Y., Copeland, T. P., Sarris, I., Showell, M. G., Sunkara, S. K., & Duffy, J. M. (2025) · F&S Reviews · doi:10.1016/j.xfnr.2025.100088 · Cited by 1 · see citing works
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Intraperitoneal chemotherapy for gastric cancer
Mu, M., Cai, Z., Hu, J., Liu, X., Zhang, B., Chen, Z., Hu, J.-K., & Yang, K. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015698.pub2 · Cited by 1 · see citing works
Evidence contamination: what it is and why it matters
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Self-citationKayimu, K., Berntsen, S., Fu, Y., Yuan, Y., Vomstein, K., Tian, T., Liu, F., Gao, J., Vuong, L. N., Ho, T. M., et al. (2026) · Human Reproduction · doi:10.1093/humrep/deag066 · Cited by 1 · see citing works
Self-citationAdvanced sperm selection techniques for assisted reproduction
Garg, A., Nakhla, O., Steeper, M., Afroz, A., Lepine, S. J., McDowell, S., Kroon, B., Glujovsky, D., Yazdani, A., & Lensen, S. F. (2026) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010461.pub4 · Cited by 1 · see citing works
Clinical potential of fluid-based biomarkers for recurrent implantation failure: a systematic review
Moradi, M., Santos, L. L., Zhou, W., Menkhorst, E. M., & Dimitriadis, E. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1854111 · Cited by 1 · see citing works
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Self-citationIdentifying and Addressing Problematic Studies in Allergy and Asthma Research: A Commentary
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Celebrating 30 years at Human Reproduction Update
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Self-citation
- Authors
- Mol, B. W., Lai, S., Rahim, A., Bordewijk, E. M., Wang, R., Eekelen, R. V., Gurrin, L. C., Thornton, J. G., Wely, M. V., & Li, W.
- Affiliations
- University of Aberdeen (GB)
- Monash University (AU)
- Amsterdam UMC Location University of Amsterdam (NL)
- The University of Melbourne (AU)
- University of Nottingham (GB)
- Corresponding author
- Gurrin, Lyle C
- ORCID
- Venue
- Research Integrity and Peer Review
- Publisher
- Research Square Platform LLC
- Published
- 2023-01-11
- Volume
- 8
- Issue
- 1
- Pages
- 6-6
- ISSN
- 2058-8615 (ISSN-L)
- PMC
- PMC10280869
- OpenAlex
- W4381250920
- Cited by
- 149
- References
- 24
- Citations by year
- 2026: 46 · 2025: 47 · 2024: 42 · 2023: 14
- FWCI
- 27.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Research Integrity and Peer Review (publishedVersion, cc-by)
- Research Square (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Social Sciences › Safety Research › Academic integrity and plagiarism
- Keywords
- trustworthiness assessment, randomized controlled trials, screening tool, research integrity, questionable research practices, peer review, individual patient data, dropout rates
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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