INSERM, CIC-EC CIE6, Nancy, France.
BMC Med Res Methodol. 2012 Sep 19;12:146. doi: 10.1186/1471-2288-12-146.
Although the outcomes of health promotion and prevention programmes may depend on the level of intervention, studies and trials often fail to take it into account. The objective of this work was to develop a framework within which to consider the implementation of interventions, and to propose a tool with which to measure the quantity and the quality of activities, whether planned or not, relevant to the intervention under investigation. The framework and the tool were applied to data from the diet and physical activity promotion PRALIMAP trial.
A framework allowing for calculation of an intervention dose in any health promotion programme was developed. A literature reviews revealed several relevant concepts that were considered in greater detail by a multidisciplinary working group. A method was devised with which to calculate the dose of intervention planned and that is actually received (programme-driven activities dose), as well as the amount of non-planned intervention (non-programme-driven activities dose).
Indicators cover the roles of all those involved (supervisors, anchor personnel as receivers and providers, targets), in each intervention-related groups (IRG: basic setting in which a given intervention is planned by the programme and may differ in implementation level) and for every intervention period. All indicators are described according to two domains (delivery, participation) in two declensions (quantity and quality). Application to PRALIMAP data revealed important inter- and intra-IRG variability in intervention dose.
A literature analysis shows that the terminology in this area is not yet consolidated and that research is ongoing. The present work provides a methodological framework by specifying concepts, by defining new constructs and by developing multiple information synthesis methods which must be introduced from the programme's conception. Application to PRALIMAP underlined the feasibility of measuring the implementation level. The framework and the tool can be used in any complex programme evaluation. The intervention doses obtained could be particularly useful in comparative trials.
PRALIMAP is registered at ClinicalTrials.gov under NCT00814554.
尽管健康促进和预防计划的结果可能取决于干预的程度，但研究和试验往往未能考虑到这一点。这项工作的目的是制定一个框架，考虑干预措施的实施，并提出一个工具来衡量与所研究干预措施相关的计划和非计划活动的数量和质量。该框架和工具应用于饮食和身体活动促进 PRALIMAP 试验的数据。
开发了一种计算任何健康促进计划中干预剂量的框架。文献综述揭示了几个相关概念，这些概念由一个多学科工作组进行了更详细的考虑。设计了一种方法来计算计划的干预剂量和实际接受的剂量（方案驱动活动剂量），以及非计划干预的量（非方案驱动活动剂量）。
指标涵盖了所有参与人员（主管、锚定人员作为接收者和提供者、目标）在每个干预相关组（IRG：计划给定干预的基本环境，可能在实施水平上有所不同）和每个干预期间的角色。所有指标都根据两个领域（传递、参与）和两个变项（数量和质量）进行描述。PRALIMAP 数据的应用表明，干预剂量在 IRG 之间和之内存在重要的差异。
文献分析表明，该领域的术语尚未得到巩固，研究仍在进行中。本工作提供了一个方法学框架，通过明确概念、定义新结构和开发多种信息综合方法来实现，这些方法必须从项目的构思开始引入。PRALIMAP 的应用强调了测量实施水平的可行性。该框架和工具可用于任何复杂的方案评估。获得的干预剂量在比较试验中可能特别有用。
PRALIMAP 在 ClinicalTrials.gov 注册，注册号为 NCT00814554。
