Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.
The Centre for Health, Activity and Rehabilitation Research, University of Otago, Dunedin 9016, New Zealand.
J Sport Health Sci. 2024 Jul;13(4):537-547. doi: 10.1016/j.jshs.2023.08.003. Epub 2023 Aug 22.
The study aimed to examine the reporting completeness of randomized controlled trials (RCTs) of non-pharmacological interventions following concussion.
We searched MEDLINE, Embase, PsycInfo, CINAHL, and Web of Science up to May 2022. Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication (TIDieR), Consensus on Exercise Reporting Template (CERT), and international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) checklists. Additional information was sought my study authors where reporting was incomplete. Risk of bias (ROB) was assessed with the Cochrane ROB-2 Tool. RCTs examining non-pharmacological interventions following concussion.
We included 89 RCTs (n = 53 high ROB) examining 11 different interventions for concussion: sub-symptom threshold aerobic exercise, cervicovestibular therapy, physical/cognitive rest, vision therapy, education, psychotherapy, hyperbaric oxygen therapy, transcranial magnetic stimulation, blue light therapy, osteopathic manipulation, and head/neck cooling. Median scores were: TIDieR 9/12 (75%; interquartile range (IQR) = 5; range: 5-12), CERT 17/19 (89%; IQR = 2; range: 10-19), and i-CONTENT 6/7 (86%; IQR = 1; range: 5-7). Percentage of studies completely reporting all items was TIDieR 35% (31/89), CERT 24% (5/21), and i-CONTENT 10% (2/21). Studies were more completely reported after publication of TIDieR (t = 2.08; p = 0.04) and CERT (t = 2.72; p = 0.01). Reporting completeness was not strongly associated with journal impact factor (TIDieR: r = 0.27; p = 0.01; CERT: r = -0.44; p = 0.06; i-CONTENT: r = -0.17; p = 0.48) or ROB (TIDieR: r = 0.11; p = 0.31; CERT: r = 0.04; p = 0.86; i-CONTENT: r = 0.12; p = 0.60).
RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness, but are often missing key components, particularly modifications, motivational strategies, and qualified supervisor. Reporting completeness improved after TIDieR and CERT publication, but publication in highly cited journals and low ROB do not guarantee reporting completeness.
本研究旨在评估脑震荡后非药物干预的随机对照试验（RCT）的报告完整性。
我们检索了 MEDLINE、Embase、PsycInfo、CINAHL 和 Web of Science，截至 2022 年 5 月。两名评审员独立筛选研究，并使用干预描述和复制模板（TIDieR）、运动报告模板共识（CERT）和国际治疗运动和训练共识（i-CONTENT）清单评估报告完整性。对报告不完整的研究，我们向研究作者寻求了更多信息。使用 Cochrane ROB-2 工具评估偏倚风险（ROB）。RCT 研究了脑震荡后的非药物干预。
我们纳入了 89 项 RCT（n=53 项高 ROB），研究了 11 种不同的脑震荡干预措施：亚症状阈有氧运动、颈前庭治疗、身体/认知休息、视觉治疗、教育、心理治疗、高压氧治疗、经颅磁刺激、蓝光治疗、整骨治疗和头/颈部冷却。中位数评分如下：TIDieR 9/12（75%；四分位距（IQR）=5；范围：5-12）、CERT 17/19（89%；IQR=2；范围：10-19）和 i-CONTENT 6/7（86%；IQR=1；范围：5-7）。完全报告所有项目的研究百分比为 TIDieR 35%（31/89）、CERT 24%（5/21）和 i-CONTENT 10%（2/21）。在 TIDieR（t=2.08；p=0.04）和 CERT（t=2.72；p=0.01）发表后，报告的完整性得到了更好的体现。报告的完整性与期刊影响因子（TIDieR：r=0.27；p=0.01；CERT：r=-0.44；p=0.06；i-CONTENT：r=-0.17；p=0.48）或 ROB（TIDieR：r=0.11；p=0.31；CERT：r=0.04；p=0.86；i-CONTENT：r=0.12；p=0.60）之间的相关性不强。
脑震荡后非药物干预的 RCT 报告完整性表现为中等至良好，但经常缺少关键内容，特别是修改、动机策略和合格的监督者。在 TIDieR 和 CERT 发表后，报告的完整性有所提高，但发表在高引用期刊和低 ROB 并不能保证报告的完整性。
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