Primary Care and Population Health, UCL, London, UK
Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
BMJ Open. 2022 Aug 17;12(8):e056532. doi: 10.1136/bmjopen-2021-056532.
The minimum clinically effective dose, and whether this is received in randomised controlled trials (RCTs) of complex self-management interventions in long-term conditions (LTCs), can be unclear. The Template for Intervention Description and Replication (TIDieR) checklist states that dose should be clearly reported to ensure validity and reliable implementation.
To identify whether the expected minimum clinically effective dose, and the dose participants received is reported within research articles and if reporting has improved since the TIDieR checklist was published.
Four databases were systematically searched (MEDLINE, PsycINFO, AMED and CINAHL) to identify published reports between 2008 and 2022 for RCTs investigating complex self-management interventions in LTCs. Data on reporting of dose were extracted and synthesised from the eligible articles.
94 articles covering various LTCs including diabetes, stroke and arthritis were included. Most complex interventions involved behaviour change combined with education and/or exercise. The maximum dose was usually reported (n=90; 97.8%), but the expected minimum clinically effective dose and the dose received were reported in only 28 (30.4%) and 62 (67.4%) articles, respectively. Reporting of the expected minimum clinically effective dose and the dose participants received did not improve following the publication of the TIDieR checklist in 2014.
Interpreting results and implementing effective complex self-management interventions is difficult when researchers' reporting of dose is not in line with guidelines. If trial findings indicate benefit from the intervention, clear reporting of dose ensures reliable implementation to standard care. If the results are non-significant, detailed reporting enables better interpretation of results, that is, differentiating between poor implementation and lack of effectiveness. This ensures quality of interventions and validity and generalisability of trial findings. Therefore, wider adoption of reporting the TIDieR checklist dose aspects is strongly recommended. Alternatively, customised guidelines for reporting dose in complex self-management interventions could be developed.
CRD42020180988.
最小临床有效剂量以及复杂自我管理干预的随机对照试验（RCT）中是否达到该剂量并不明确。干预措施描述与复制模板（TIDieR）清单指出，为确保有效性和可靠实施，应明确报告剂量。
确定研究报告中是否报告了预期的最小临床有效剂量和参与者接受的剂量，以及自 TIDieR 清单发布以来报告情况是否有所改善。
系统检索了 4 个数据库（MEDLINE、PsycINFO、AMED 和 CINAHL），以确定 2008 年至 2022 年期间发表的 RCT 研究复杂自我管理干预的报告。从合格文章中提取并综合了剂量报告的数据。
共纳入 94 篇涉及各种慢性病的文章，包括糖尿病、中风和关节炎。大多数复杂干预措施涉及行为改变与教育和/或运动相结合。最大剂量通常会被报告（n=90；97.8%），但只有 28 篇（30.4%）和 62 篇（67.4%）文章报告了预期的最小临床有效剂量和参与者接受的剂量。自 2014 年 TIDieR 清单发布以来，剂量报告的预期最小临床有效剂量和参与者接受的剂量并未改善。
如果研究人员的剂量报告不符合指南，那么解释研究结果和实施有效的复杂自我管理干预就会变得困难。如果试验结果表明干预措施有效，明确报告剂量可确保可靠地实施到标准护理中。如果结果无统计学意义，则详细报告剂量可更好地解释结果，即区分实施不良和缺乏有效性。这确保了干预措施的质量以及试验结果的有效性和普遍性。因此，强烈建议更广泛地采用报告 TIDieR 清单剂量方面的内容。或者，可以为复杂自我管理干预制定专门的剂量报告指南。
PROSPERO 注册号：CRD42020180988。
