Retracted vs non-retracted obstetrical randomized trials: Which quality criteria are most associated with retraction for untrustworthiness?

Background: Randomized control trials (RCTs) are an essential pillar of scientific knowledge and medical practice, and their integrity has important implications for reliable systemic reviews and meta-analyses. However, the number of article retractions due to falsified data and scientific misconduct has increased in recent years. In response, the scientific community has pursued the creation of quality criteria that can be utilized to promote trustworthiness.

Methods: After a quality criteria checklist was created by a team of experts, retracted and nonretracted studies were evaluated for adherence to assess the checklist's usefulness and identify potential pitfalls. Retracted studies published in obstetric literature and retracted between 1994-2024 were identified using the online Retraction Watch Database. A previously created database of non-retracted obstetric RCTs published between 2018-2020 was used for the control group.

Results: A total of 173 studies were identified, 136 non-retracted and 37 retracted. Overall, 13 of 17 (76.5 %) criteria were statistically different between retracted and non-retracted articles. A cutoff of ≤ 11 total quality criteria granted 94.9 % (95 % CI, 89.7 - 97.9) sensitivity and 78.4 % (95 % CI, 61.8 - 90.2) specificity in distinguishing non-retracted from retracted studies.

Conclusions: Retracted studies were significantly less likely to adhere to the 17-quality criteria checklist compared to non-retracted studies, providing useful insight to peer-reviewed scientific journals about what to evaluate for in an RCT manuscript prior to publication. The authors recommend that journal editors play close attention to criteria related to research ethics, data falsification, and risk of bias.