Reporting bias in randomized controlled trials of moderate to severe traumatic brain injury : a two-decade from recommendation to reality

Position du problème et objectif(s) de l’étude

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide in young adults, posing a significant public health challenge. Randomized controlled trials (RCTs) are crucial for evidence-based practice in neurocritical care for TBI. However, concerns exist regarding the methodological robustness and transparency of these trials. This study aims to systematically evaluate the methodological robustness and transparency of RCTs conducted in prehospital and intensive care unit (ICU) settings on moderate to severely adult TBI patients between August 2005 and December 2024. Our primary objective is to assess the rate of unregistered RCTs and to determine the characteristics of these studies.

Matériel et méthodes

We conducted a cross-sectional study of RCTs published between August 2005 and December 2024. All RCTs concerning therapeutic modalities, without limitation to specific interventions were included. A systematic search was performed in MEDLINE and EMBASE. We also screened reference list of RCTs in the Trauma Brain Foundation and the French guidelines. Two reviewers screened records, retrieved full-text articles, and extracted data using a standardized form. Discrepancies were resolved with a third independent reviewer involved. We assessed trial registration status, modifications in primary outcomes, citation in TBI guidelines, reuse of prospective data, and risk of bias using the Cochrane ROB2 tool.

Résultats & Discussion

In this study, 18 805 RCTs were screened, among them 231 RCTs were eligible. A total of 173 RCTs published between August 2005 and December 2024 were included in the analysis. This abstract presents preliminary data from 90 RCTs reviewers out of 173. Thirty-four RCTs, representing 37,78%, were not registered. Among the 56 (62,22%) registered RCTs, 36 (64%) were prospectively registered and 20 (36%) were retrospectively registered. Twenty RCTs were considered to have high risk of bias using the ROB2 tool of which 12 RCTs (35,29%) were not registered. Significant differences were identified between registered and unregistered RCTs regarding the journal impact factor at the year of publication, funding source, type of center, intention-to-treat analysis conducted as reported, the required sample size achieved, and the risk of bias assessed with ROB 2.

Conclusion

Based on these preliminary data, RCTs concerning moderate to severe TBI conducted in prehospital and intensive care settings demonstrate concerning levels of suboptimal transparency and methodological robustness, particularly evident in the significant proportion of unregistered trials and those exhibiting a high risk of bias. These findings underscore the urgent need for improved adherence to registration practices and rigorous methodological standards in future clinical trials within the field of TBI.

Auteurs

Myriam LAMAMRI, Antoine GALLET, Charles BERNARD, Simon AUBERT, Emmanuel WEISS - (1)Université Paris Cité-Hopital Beaujon, Assistance Publique-Hôpitaux De Paris Fr, Clichy

Orateur(s)

Antoine GALLET (Clichy)