| Title: |
Assessing the feasibility and impact of clinical trial trustworthiness checks via an application to Cochrane Reviews: Stage 2 of the INSPECT-SR project |
| Authors: |
Wilkinson, J; Heal, C; Antoniou, GA; Flemyng, E; Ahnström, L; Alteri, A; Avenell, A; Barker, TH; Borg, DN; Brown, NJL; Buhmann, R; Calvache, JA; Carlsson, R; Carter, LA; Cashin, AG; Cotterill, S; Färnqvist, K; Ferraro, MC; Grohmann, S; Gurrin, LC; Hayden, JA; Hunter, KE; Hyltse, N; Jung, L; Krishan, A; Laporte, S; Lasserson, TJ; Laursen, DRT; Lensen, S; Li, W; Li, T; Liu, J; Locher, C; Lu, Z; Lundh, A; Marsden, A; Meyerowitz-Katz, G; Mol, BW; Munn, Z; Naudet, F; Nunan, D; O'Connell, NE; Olsson, N; Parker, L; Patetsini, E; Redman, B; Rhodes, S; Richardson, R; Ringsten, M; Rogozińska, E; Seidler, AL; Sheldrick, K; Stocking, K; Sydenham, E; Thomas, H; Tsokani, S; Vinatier, C; Vorland, CJ; Wang, R; Al Wattar, BH; Weber, F; Weibel, S; van Wely, M; Xu, C; Bero, L; Kirkham, JJ |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2025 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
BACKGROUND AND OBJECTIVES: The aim of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is to develop a tool to identify problematic RCTs in systematic reviews. In stage 1 of the project, a list of potential trustworthiness checks was created. The checks on this list must be evaluated to determine which should be included in the INSPECT-SR tool. METHODS: We attempted to apply 72 trustworthiness checks to randomized controlled trials (RCTs) in 50 Cochrane reviews. For each, we recorded whether the check was passed, failed, or possibly failed or whether it was not feasible to complete the check. Following application of the checks, we recorded whether we had concerns about the authenticity of each RCT. We repeated each meta-analysis after removing RCTs flagged by each check and again after removing RCTs where we had concerns about authenticity to estimate the impact of trustworthiness assessment. Trustworthiness assessments were compared to Risk of Bias and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments in the reviews. RESULTS: Ninety-five RCTs were assessed. Following application of the checks, assessors had some or serious concerns about the authenticity of 25% and 6% of the RCTs, respectively. Removing RCTs with either some or serious concerns resulted in 22% of meta-analyses having no remaining RCTs. However, many checks proved difficult to understand or implement, which may have led to unwarranted skepticism in some instances. Furthermore, we restricted assessment to meta-analyses with no more than five RCTs (54% contained only 1 RCT), which will distort the impact on results. No relationship was identified between trustworthiness assessment and Risk of Bias or GRADE. CONCLUSION: This study supports the case for routine trustworthiness assessment in systematic reviews, as problematic studies do not appear to be flagged by Risk of Bias assessment. The study produced evidence on the feasibility and impact of trustworthiness checks. ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0895-4356 |
| Relation: |
https://hdl.handle.net/11343/365028 |
| Availability: |
https://hdl.handle.net/11343/365028 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 ; CC BY |
| Accession Number: |
edsbas.214F3BCE |
| Database: |
BASE |