Author Affiliations: Lawson Health Research Institute, Lawson Research Institute, London, ON, Canada (Drs Teasell, MacKenzie, Flores-Sandoval, McIntyre, Barua, Mehta, and Bateman); Department of Physical Medicine and Rehabilitation, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada (Dr Teasell, MacKenzie, Mehta, and Bateman); Parkwood Institute, St. Joseph's Health Care London, London, Ontario, Canada (Drs Teasell, MacKenzie, and Bateman); Arthur Labatt School of Nursing, Western University, London, Ontario, Canada (Dr McIntyre); Division of Physical Medicine and Rehabilitation, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada (Dr Bayley); KITE Research Institute, University Health Network, Toronto, Ontario, Canada (Dr Bayley) University Health Network, Toronto Rehabilitation Institute, Toronto, Ontatio, Canada (Dr Bayley).
J Head Trauma Rehabil. 2024;39(5):329-334. doi: 10.1097/HTR.0000000000000969. Epub 2024 Sep 10.
To describe experiences and challenges when updating a living evidence-based review database of randomized controlled trials (RCTs) on mental health and behavioral disorders in moderate to severe traumatic brain injury (MSTBI).
This commentary derives from our experience developing an extensive database of RCTs on MSTBI that has been conceptualized as a living evidence-based review. Our working group focused on mental health and behavior RCTs and reflected upon their experiences and challenges using the living systematic approach. We discuss challenges associated with metrics of study quality, injury etiology and severity, time post-injury, country of origin, and variability in outcome measures.
RCTs were conducted almost solely in high income countries, with smaller sample sizes, and most conducted in the chronic phase post-TBI. Issues related to lack of transparency, unclear and incomplete reporting of injury severity, etiology, and time post-injury remain a concern and can lead to challenges associated with interpretation of results, validity, and reliability of the data. There was significant heterogeneity regarding the use of outcome measures and constructs, underscoring the need for standardization.
Lack of standardization and incomplete reporting of injury characteristics makes it difficult to compare data between RCTs of MSTBI, perform meta-analyses, and generate evidence-based clinical recommendations.
描述更新一个关于中度至重度创伤性脑损伤（MSTBI）的心理健康和行为障碍的随机对照试验（RCT）的实时循证综述数据库时的经验和挑战。
本评论源自我们开发一个广泛的关于 MSTBI 的 RCT 数据库的经验，该数据库被概念化为实时循证综述。我们的工作组专注于心理健康和行为 RCT，并使用实时系统方法反思他们的经验和挑战。我们讨论了与研究质量指标、损伤病因和严重程度、受伤后时间、起源国以及结果测量指标的变异性相关的挑战。
RCT 几乎仅在高收入国家进行，样本量较小，且大多数在 TBI 后的慢性期进行。与缺乏透明度、损伤严重程度、病因和受伤后时间的不明确和不完整报告相关的问题仍然令人关注，并可能导致对结果的解释、数据的有效性和可靠性的挑战。在使用结局测量和结构方面存在显著的异质性，强调需要标准化。
损伤特征缺乏标准化和不完整报告使得难以在 MSTBI 的 RCT 之间比较数据、进行荟萃分析以及生成基于循证的临床建议。
