Reporting non-adherence in cluster randomised trials: A systematic review.
Reporting non-adherence in cluster randomised trials: A systematic review.
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报告在群集随机试验中不遵守：系统评价。
DOI：
10.1177/1740774518761666
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发表时间：
2018-06
期刊：
影响因子：
--
通讯作者：
DiazOrdaz K
中科院分区：
文献类型：
--
作者：
Agbla SC;DiazOrdaz K
随机试验中的治疗不依从是指某些受试者未按预期接受分配的治疗。对于群集随机化试验，随机化单位是一组受试者，不依从可能发生在群集或个体水平。当发生不依从时，随机化不再保证治疗接受和结局之间的关系不受混杂因素影响，并且在意向治疗分析中检测治疗效果的把握度可能会降低。因此，记录依从性和估计因果治疗效果充分的临床试验的兴趣。评估已发表的群集试验中报告不依从问题的程度，并确定目前用于解决不依从问题的方法（如有），以及这些方法中是否考虑了群集。我们系统地回顾了2011年发表的132项英文聚类试验，这些试验之前是通过PubMed检索确定的。123项聚类试验被纳入本系统评价。在56项群集试验中报告了不依从性。其中，19例报告了治疗疗效估计值：15例符合方案，4例接受治疗。没有任何研究讨论这些方法所作的假设、其可行性或结果对偏离这些假设的敏感性。本综述中包含的群集试验的发表年份（2011年）可视为本研究的局限性，但此后未发布关于群集试验不依从性报告和处理的新指南。此外，由一名审查员进行数据提取。为了缓解这一问题，第二位审查员对随机选择的15份报告进行了提取过程验证。一致性满意（93%）。尽管CONSORT声明建议扩展到随机分组试验，但治疗依从性报告不足。在提供依从性信息的试验中，依从性的定义、处理和报告方式存在显著差异。研究人员应该讨论对结果进行因果解释所需的假设，以及这些假设在他们的研究中是否科学合理。应进行敏感性分析，以研究结果对偏离这些假设的稳健性。
Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials. To assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these. We systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed. One-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Amongst these, 19 reported a treatment efficacy estimate: per protocol in 15 and as-treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. The year of publication of the cluster trials included in this review (2011) could be considered a limitation of the present study, however no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%). Despite the recommendations of the CONSORT statement extension to cluster randomised trials, treatment adherence is under-reported. Amongst the trials providing adherence information, there was substantial variation in how adherence was defined, handled and reported. Researchers should discuss the assumptions required for the results to be interpreted causally, and whether these are scientifically plausible in their studies. Sensitivity analyses to study the robustness of the results to departures from these assumptions should be performed.
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DOI：
10.1136/bmj.d5886
发表时间：
2011-09-26
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Ivers NM;Taljaard M;Dixon S;Bennett C;McRae A;Taleban J;Skea Z;Brehaut JC;Boruch RF;Eccles MP;Grimshaw JM;Weijer C;Zwarenstein M;Donner A
通讯作者：
Donner A
影响因子：
105.7
作者：
Campbell, MK;Elbourne, DR;Altman, DG
通讯作者：
Altman, DG
影响因子：
3.7
作者：
Angrist, JD;Imbens, GW;Rubin, DB
通讯作者：
Rubin, DB
DOI：
10.1093/biostatistics/1.1.69
发表时间：
2000-03-01
期刊：
Biostatistics (Oxford, England)
影响因子：
--
作者：
Hirano, K;Imbens, G W;Zhou, X H
通讯作者：
Zhou, X H
影响因子：
3.7
作者：
Beer C;Horner B;Flicker L;Scherer S;Lautenschlager NT;Bretland N;Flett P;Schaper F;Almeida OP
通讯作者：
Almeida OP