Oklahoma State University Center for Health Sciences, Department of Psychiatry and Behavioral Science, Tulsa, OK, USA.
Kansas. City University of Medicine and Biosciences, 2901 St. John's Boulevard, Joplin, MO, USA.
Drug Alcohol Depend. 2020 Mar 1;208:107824. doi: 10.1016/j.drugalcdep.2019.107824. Epub 2020 Jan 28.
BACKGROUND/PURPOSE: Properly designed randomized controlled trials (RCTs) are the gold standard in patient-centered clinical research. Incomplete intervention reporting affects the readers' ability to evaluate treatment efficacy. Previous studies show that detailed descriptions of trial interventions remains insufficient for reliable replication. Understanding reporting areas in need of improvement can improve the quality of intervention reporting.
This cross-sectional review uses the Template for Intervention Description and Replication (TIDieR) checklist to evaluate the quality of intervention reporting in RCTs. The primary outcome was to investigate the completeness of intervention reporting of RCTs reporting outcomes for patients with alcohol use disorder (AUD) published in highly ranked addiction journals. The secondary outcomes were to: 1) evaluate whether publication of the TIDieR checklist resulted in better intervention reporting practices and 2) determine whether particular trial characteristics were associated with the completeness of intervention reporting.
The final analysis included 56 records. The mean number of reported TIDieR items was 5.1 (SD = 1.47) of a possible 12. TIDieR checklist publication did not increase the average completion of the TIDieR checklist items (p = 0.76). Improved TIDieR adherence was associated with trials with double blinding, non-drug interventions, and CONSORT endorsement.
DISCUSSION/CONCLUSIONS: We found the reporting of interventions to be inadequate in our sample of AUD-related RCTs. Fundamental details were often not reported, hampering both clinical and research reproducibility. Moving forward, it may be necessary to consider additional mechanisms to either improve TIDieR uptake or to find other solutions to improve intervention reporting.
背景/目的：精心设计的随机对照试验（RCT）是患者为中心的临床研究的金标准。干预措施报告不完整会影响读者评估治疗效果的能力。先前的研究表明，试验干预措施的详细描述仍然不足以进行可靠的复制。了解需要改进的报告领域可以提高干预措施报告的质量。
本横断面回顾使用干预描述和复制工具（TIDieR）检查表来评估发表在高排名成瘾期刊上的酒精使用障碍（AUD）患者结局的 RCT 中干预措施报告的质量。主要结局是调查报告 RCT 干预措施报告的完整性，这些 RCT 报告了 AUD 患者的结局。次要结局是：1）评估 TIDieR 检查表的发表是否能改善干预措施报告实践；2）确定特定试验特征是否与干预措施报告的完整性相关。
最终分析纳入了 56 项记录。报告的 TIDieR 项目的平均数量为 12 个可能项目中的 5.1（SD=1.47）。TIDieR 检查表的发表并没有增加 TIDieR 检查表项目的平均完成率（p=0.76）。TIDieR 依从性的提高与双盲、非药物干预和 CONSORT 认可的试验相关。
讨论/结论：我们发现我们的 AUD 相关 RCT 样本中的干预措施报告不充分。重要的细节通常未报告，这既妨碍了临床也妨碍了研究的可重复性。未来可能需要考虑其他机制来提高 TIDieR 的采用率，或寻找其他解决方案来改进干预措施报告。
