Envisioning clinical trials as complex interventions.
Envisioning clinical trials as complex interventions.
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作者：
临床试验是现代医疗保健和基础设施的关键组成部分。试验通过科学进步造福社会，通过参与试验造福个体患者。事实上，每年花费数十亿美元来支持这些福利。尽管投入巨大，但临床试验往往无法实现其主要目标，试验入组率仍然很低。先前改善试验实施和招募的努力取得的成功有限，这可能是由于过度简化了试验的复杂性和多层次性。出于这些原因，作者建议将实施科学应用于临床试验。在这篇评论中，作者认为临床试验是复杂的、多层次的循证干预措施，具有显著的社会和个人效益，但在实施中存在持续的差距。介绍了实施科学概念在临床试验背景下的应用，作为建立通用词汇和建立应用实施科学和实践以改善临床试验行为的平台的手段。将实施科学应用于临床试验环境可以增强改进工作，并为整个临床试验企业的所有患者和试验利益相关者提供更好，更有效的循证护理。临床试验具有显著的社会和个体患者益处，但昂贵且经常无法达到其终点。通过将试验视为实施中存在持续差距的复杂干预措施，可以采用实施科学方法来改善试验实施，改善患者护理并节省利益相关者资源。
Clinical trials are critical components of modern health care and infrastructure. Trials benefit society through scientific advancement and individual patients through trial participation. In fact, billions of dollars are spent annually in support of these benefits. Despite the massive investments, clinical trials often fail to accomplish their primary aims and trial enrollment rates remain low. Prior efforts to improve trial conduct and enrollment have had limited success, perhaps due to oversimplification of the complex, multilevel nature of trials. For these reasons, the authors propose applying implementation science to the clinical trials context. In this commentary, the authors posit clinical trials as complex, multilevel evidence‐based interventions with significant societal and individual benefits yet with persistent gaps in implementation. An application of implementation science concepts to the clinical trials context as means to build common vocabulary and establish a platform for applying implementation science and practice to improve clinical trial conduct is introduced. Applying implementation science to the clinical trials context can augment improvement efforts and build capacity for better and more efficient evidence‐based care for all patients and trial stakeholders throughout the clinical trials enterprise. Clinical trials have significant societal and individual patient benefits, yet are expensive and frequently fail to reach their endpoints. By considering trials as complex interventions with persistent gaps in implementation, an implementation science approach to improve trial conduct, improve patient care, and save stakeholder resources can be adapted.
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影响因子：
2.7
作者：
Alexander, John H.;Corrigan-Curay, Jacqueline;McClellan, Mark
通讯作者：
McClellan, Mark
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
DOI：
10.1136/bmj.n2061
发表时间：
2021-09-30
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Skivington K;Matthews L;Simpson SA;Craig P;Baird J;Blazeby JM;Boyd KA;Craig N;French DP;McIntosh E;Petticrew M;Rycroft-Malone J;White M;Moore L
通讯作者：
Moore L
DOI：
10.1016/j.urolonc.2020.10.070
发表时间：
2021-03
期刊：
Urologic oncology
影响因子：
--
作者：
Stensland KD;DePorto K;Ryan J;Kaffenberger S;Reinstatler LS;Galsky M;Canes D;Skolarus TA;Moinzadeh A
通讯作者：
Moinzadeh A
DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J