Health Services and Performance Research (HESPER EA 7425), University Claude Bernard Lyon 1, Lyon, France.
Pharmaceutical Care Research Group, University of Basel, Basel, Switzerland.
Br J Clin Pharmacol. 2021 Jun;87(6):2521-2533. doi: 10.1111/bcp.14659. Epub 2020 Dec 30.
Managing adherence to medications is a priority for health systems worldwide. Adherence research is accumulating, yet the quality of the evidence is reduced by various methodological limitations. In particular, the heterogeneity and low accuracy of adherence measures have been highlighted in many literature reviews. Recent consensus-based guidelines advise on best practices in defining adherence (ABC) and reporting of empirical studies (EMERGE). While these guidelines highlight the importance of operational definitions in adherence measurement, such definitions are rarely included in study reports. To support researchers in their measurement decisions, we developed a structured approach to formulate operational definitions of adherence.
A group of adherence and research methodology experts used theoretical, methodological and practical considerations to examine the process of applying adherence definitions to various research settings, questions and data sources. Consensus was reached through iterative review of discussion summaries and framework versions.
We introduce TEOS, a four-component framework to guide the operationalization of adherence concepts: (1) describe treatment as four simultaneous interdependent timelines (recommended and actual use, conditional on prescribing and dispensing); (2) locate four key events along these timelines to delimit the three ABC phases (first and last recommended use, first and last actual use); (3) revisit study objectives and design to fine-tune research questions and assess measurement validity and reliability needs, and (4) select data sources (e.g., electronic monitoring, self-report, electronic healthcare databases) that best address measurement needs.
Using the TEOS framework when designing research and reporting explicitly on these components can improve measurement quality.
管理药物依从性是全球卫生系统的首要任务。依从性研究正在不断积累，但由于各种方法学限制，证据质量降低。特别是，许多文献综述强调了依从性测量的异质性和低准确性。最近基于共识的指南就依从性定义（ABC）和实证研究报告（EMERGE）提出了最佳实践建议。虽然这些指南强调了在依从性测量中使用操作性定义的重要性，但这些定义很少包含在研究报告中。为了支持研究人员的测量决策，我们制定了一种结构化方法来制定依从性的操作性定义。
一组依从性和研究方法专家使用理论、方法和实践考虑因素来研究将依从性定义应用于各种研究环境、问题和数据源的过程。通过反复审查讨论摘要和框架版本达成了共识。
我们引入了 TEOS，这是一个由四个部分组成的框架，用于指导依从性概念的操作性定义：（1）将治疗描述为四个同时存在的相互依存的时间线（推荐和实际使用，取决于处方和配药）；（2）在这些时间线上找到四个关键事件来划定 ABC 三个阶段（首次和最后一次推荐使用，首次和最后一次实际使用）；（3）重新审视研究目标和设计，以调整研究问题并评估测量的有效性和可靠性需求，并（4）选择最能满足测量需求的数据来源（例如，电子监测、自我报告、电子医疗保健数据库）。
在设计研究和报告时使用 TEOS 框架，并明确报告这些组成部分，可以提高测量质量。
