Identifying and critiquing different approaches to developing complex interventions (INDEX study)

背景人们越来越认识到仔细开发和评估复杂干预措施的重要性，争论在于关注这些任务将增加干预措施在试验中有效的机会，并在真实的世界中被广泛采用。如果昂贵的试验表明这些干预措施存在缺陷，或者有效的干预措施在真实的世界中影响有限，那么糟糕的干预措施开发可能会导致纳税人的钱浪费。MRC框架为制定干预措施提供了非常广泛的指导（克雷格，2008年）。此外，研究人员还记录了各种干预方法，如基于理论，基于人，基于范式和基于证据。他们还介绍了如何在制定干预措施时使用一系列方法，例如定性方法、可用性测试、证据综合、因果建模和共识方法。然而，没有概述的方法提供给研究人员的范围，哪种方法或方法的组合可能是最有用的，在什么情况下，以及如何MRC框架已经运作。干预发展的指导，可以帮助研究人员和研究资助者作出明智的决定，如何制定干预措施，也帮助经验不足的研究人员建立在良好的实践研究人员谁有此expertise.ObjectivesThe的目的是产生指导研究人员如何开发复杂的干预措施，以改善健康或医疗保健结果。目标是：1.确定并描述采取的不同方法来干预发展，其使用的理由，以及对干预的未来效用的任何影响。比较和对比不同的干预措施制定方法及其数据收集和分析方法，考虑总体和不同背景下的优势和局限性。3.从经验丰富的研究人员和更广泛的知识产权持有者的角度了解干预发展的历史和挑战。衡量利益相关者对干预措施制定的关键方面的共识，并探讨缺乏共识的原因。提供指导研究人员良好的做法，从不同的approaches.Methods的例子设计是一个连续的混合方法研究3个阶段。第一阶段：对已发表的期刊文章、书籍章节、书籍和报告进行方法学审查，这些文章和报告描述和批评了卫生、教育和社会研究中干预发展的不同方法。同时，我们将对初级研究进行系统的绘图审查，以确定2006-2015年卫生研究中采取的不同干预措施的例子。从这两个审查中，我们还将确定在所有方法中使用的数据收集，分析和决策方法的范围，并详细说明每种方法的优势，局限性和挑战。第二阶段：与20-25名研究人员和更广泛的利益相关者进行定性访谈研究，包括资助小组成员，患者和公众代表，以及地方和国家政策制定者，以了解干预发展的挑战。这将在第二阶段开始，并在第三阶段继续。从第一阶段和早期的访谈中，我们将构建一个初步的方法类型学。对于每种类型，我们将确定选择它的理由，优势和限制，最佳使用的上下文，并显示详细的示例。然后，我们将举行一个利益相关者研讨会（n=20），讨论初步的类型学，进一步访谈的抽样策略，以及我们后来的共识小组的初步项目。第三阶段：协商一致小组确定干预措施发展的核心方面。在30名专家参加的电子德尔菲会议之后，将举行有30-35名不同利益攸关方参加的共识执行讲习班。

BackgroundThere is increasing recognition of the importance of carefully developing and evaluating complex interventions, the argument being that attention to these tasks will increase the chance of interventions being effective within trials, and being adopted widely in the real world. Poor intervention development may lead to wasted tax payers' money if expensive trials show that these interventions are flawed, or that effective interventions have limited impact in the real world. The MRC framework provides very broad guidance for intervention development (Craig 2008). In addition, researchers have documented a variety of approaches to intervention development such as theory-based, person-based, paradigm-based, and evidence-based. They have also described how to use a range of methods within intervention development e.g. qualitative methods, usability testing, evidence synthesis, causal modelling and consensus methods. However, there is no overview of the range of approaches available to researchers, which approach or combination of approaches may be most useful in what circumstances, and how the MRC framework has been operationalised. Guidance on intervention development may help researchers and research funders to make informed decisions about how to develop interventions and also help less experienced researchers build on the good practice of researchers who have this expertise.ObjectivesThe aim is to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives are to:1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions.2. Compare and contrast different intervention development approaches, and their methods of data collection and analysis, considering strengths and limitations overall and for different contexts. 3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders.4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus.5. Offer guidance to researchers on good practice, with examples from different approaches.Methods The design is a sequential mixed methods study in 3 phases. Phase 1: A methodological review of published journal articles, book chapters, books and reports which describe and critique different approaches to intervention development in health, education and social research. Concurrently we will undertake a systematic mapping review of primary research to identify examples of different approaches to intervention development undertaken in health research 2006-2015. From these two reviews we will also identify the range of data collection, analysis and decision making methods used across all approaches and detail strengths, limitations and challenges of each.Phase 2: A qualitative interview study with 20-25 researchers and wider stakeholders including funding panel members, patient and public representatives, and local and national policy makers to understand the challenges of intervention development. This will start in phase 2 and continue in Phase 3. From phase 1 and early interviews we will construct a preliminary typology of approaches. For each type we will identify the rationale for selecting it, strengths and limitations, contexts best used for, and display detailed examples. We will then hold a stakeholder workshop (n=20) to discuss the preliminary typology, sampling strategy for further interviews, and preliminary items for our later consensus group. Phase 3: Consensus group to identify core aspects of intervention development. An E-Delphi of 30 experts will be followed by a consensus implementation workshop with 30-35 different stakeholders.