背景:目前医疗事务没有标准的定义,尽管它对制药行业的重要性日益增加。医疗事务的演变需要制定一个标准化的定义来指导政策和实践，以确保患者的利益在已经发生的变化中仍然是中心，在过去,为违反道德创造了沃土。目标：本研究的目的是使用经验方法观察专家对医疗事务定义的共识，以指导该职能范围内的政策和实践。方法：总计，11名医疗事务药物医生（MAPP）完成了一项定性在线调查，以确定使用Jandhyala方法定义医疗事务的关键项目列表，以产生专家意见的共识。回答被编码和评分，并在共识回合中向参与者提交了汇总的答复。参与者以5分的李克特量表对每个项目的协议进行了评分，从强烈同意到强烈不同意。达到共识指数>50%(CI>=0.51)的指标被保留。根据先前定义的医疗事务功能对项目进行分类，以确定定义的范围。使用文献中确定的先前定义进行了比较内容分析，以确定此处生成的定义的实用性。结果：总的来说，11个MAPP生成了15个独特的项目来定义医疗事务。项目意识指数范围从0.24（“沟通/教育”）到1.00（“设计/策略”）。所有项目的aCI均大于0.5，并包括在最终定义中。可以根据先前定义的医疗事务功能对所有项目进行分类。比较内容分析表明，我们的定义在四个方面有所不同：将医疗事务指定为医学专业（及其主要目标，因此,是为了保护病人)，医药领养方面的医疗领导，现实世界证据的产生和从医疗事务中受益的不同利益相关者的规范。结论：医学事务的标准定义将医学事务的关键原则纳入医学专业，引导医学采用并为特定利益相关者提供现实证据，可以通过管理实践和政策来保护和促进患者的利益。
Background: There is currently no standard definition of medical affairs, despite its increasing importance to the pharmaceutical industry. The evolution of medical affairs necessitated the development of a standardised definition to guide policy and practice to ensure that patients\' interests remain central amid shifts that have, in the past, created fertile ground for ethical violations. Objectives: The aim of this study was to use an empirical method to observe a
consensus of expert opinion on the definition of medical affairs to guide policy and practice within this function. Methods: In total, 11 medical affairs pharmaceutical physicians (MAPPs) completed a qualitative online survey to identify a list of key items to define medical affairs using the Jandhyala method for generating a
consensus of expert opinion. Responses were coded and scored, and aggregated responses were presented to participants in a
consensus round. Participants rated their agreement with each item on a 5-point Likert scale from strongly agree to strongly disagree. Indicators that reached a
consensus index of >50% (CI > = 0.51) were retained. Items were categorised per previously defined medical affairs functions to determine the scope of the definition. A comparative content analysis using a previous definition identified in the literature was conducted to determine the utility of the definition generated here. Results: In total, 11 MAPPs generated 15 unique items to define medical affairs. Item awareness indices ranged from 0.24 (\'communication/education\') to 1.00 (\'design/strategy\'). All items had a CI of more than 0.5 and were included in the final definition. All items could be categorised per previously defined medical affairs functions. Comparative content analysis showed that our definition varied in four ways: the designation of medical affairs as a medical specialty (and its primary aim, therefore, is to protect patients), the leadership of medical affairs in medicine adoption, the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs. Conclusion: A standard definition of medical affairs that incorporates the key principles of medical affairs as a medical specialty that leads medicine adoption and generates real-world evidence for specific stakeholders may protect and further the interests of patients by governing practice and policy.
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