1 Division of Psychology, University of Stirling , Stirling, Scotland, United Kingdom .
2 Department of Anaesthesia, Critical Care and Pain Medicine, Western General Hospital, University of Edinburgh , Edinburgh, Scotland, United Kingdom .
J Neurotrauma. 2018 Sep 1;35(17):2005-2014. doi: 10.1089/neu.2018.5648. Epub 2018 Jun 7.
As part of efforts to improve study design, the use of outcome measures in randomized controlled trials (RCTs) in traumatic brain injury (TBI) is receiving increasing attention. This review aimed to assess how clinical outcome assessments (COAs) have been used and reported in RCTs in adult TBI. Systematic literature searches were conducted to identify medium to large (n ≥ 100) acute and post-acute TBI trials published since 2000. Data were extracted independently by two reviewers using a set of structured templates. Items from the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and CONSORT patient-reported outcomes (PROs) extension were used to evaluate reporting quality of COAs. Glasgow Outcome Scale/Extended (GOS/GOSE) data were extracted using a checklist developed specifically for the review. A total of 126 separate COAs were identified in 58 studies. The findings demonstrate heterogeneity in the use of TBI outcomes, limiting comparisons and meta-analyses of RCT findings. The GOS/GOSE was included in 39 studies, but implemented in a variety of ways, which may not be equivalent. Multi-dimensional outcomes were used in 30 studies, and these were relatively more common in rehabilitation settings. The use of PROs was limited, especially in acute study settings. Quality of reporting was variable, and key information concerning COAs was often omitted, making it difficult to know how precisely outcomes were assessed. Consistency across studies would be increased and future meta-analyses facilitated by (a) using common data elements (CDEs) recommendations for TBI outcomes and (b) following CONSORT guidelines when publishing RCTs.
作为提高研究设计的努力的一部分，随机对照试验（RCT）中使用结局测量在创伤性脑损伤（TBI）中受到越来越多的关注。本综述旨在评估成人 TBI 中 RCT 中临床结局评估（COA）的使用和报告情况。系统文献检索旨在识别自 2000 年以来发表的中型至大型（n≥100）急性和亚急性 TBI 试验。两名评审员使用一组结构化模板独立提取数据。从 CONSORT 2010 声明和 CONSORT 患者报告结局（PROs）扩展中提取项目，以评估 COA 的报告质量。使用专门为审查开发的清单提取格拉斯哥结局量表/扩展（GOS/GOSE）数据。在 58 项研究中确定了 126 个单独的 COA。研究结果表明 TBI 结局的使用存在异质性，限制了 RCT 结果的比较和荟萃分析。GOS/GOSE 纳入了 39 项研究，但实施方式多种多样，可能并不等同。多维结局在 30 项研究中使用，在康复环境中更为常见。PROs 的使用有限，尤其是在急性研究环境中。报告质量参差不齐，关键的 COA 信息经常被省略，使得难以确切了解结局是如何评估的。通过（a）使用 TBI 结局的通用数据元素（CDE）建议，以及（b）在发布 RCT 时遵循 CONSORT 指南，可以提高研究之间的一致性并促进未来的荟萃分析。
