Division of Geriatrics, Centre hospitalier de l'Université de Montréal, 1000, Saint-Denis, Montreal, Quebec, H2X0C1, Canada.
Centre de recherche du Centre hospitalier de l'Université de Montréal, Montreal, Canada.
BMC Med Res Methodol. 2021 Nov 14;21(1):248. doi: 10.1186/s12874-021-01445-0.
Not all research findings are translated to clinical practice. Reasons for lack of applicability are varied, and multiple frameworks and criteria exist to appraise the general applicability of epidemiological and clinical research. In this two-part study, we identify, map, and synthesize frameworks and criteria; we develop a framework to assist clinicians to appraise applicability specifically from a clinical perspective.
We conducted a literature search in PubMed and Embase to identify frameworks appraising applicability of study results. Conceptual thematic analysis was used to synthesize frameworks and criteria. We carried out a framework development process integrating contemporary debates in epidemiology, findings from the literature search and synthesis, iterative pilot-testing, and brainstorming and consensus discussions to propose a concise framework to appraise clinical applicability.
Of the 4622 references retrieved, we identified 26 unique frameworks featuring 21 criteria. Frameworks and criteria varied by scope and level of aggregation of the evidence appraised, target user, and specific area of applicability (internal validity, clinical applicability, external validity, and system applicability). Our proposed Framework Appraising the Clinical Applicability of Studies (FrACAS) classifies studies in three domains (research, practice informing, and practice changing) by examining six criteria sequentially: Validity, Indication-informativeness, Clinical relevance, Originality, Risk-benefit comprehensiveness, and Transposability (VICORT checklist).
Existing frameworks to applicability vary by scope, target user, and area of applicability. We introduce FrACAS to specifically assess applicability from a clinical perspective. Our framework can be used as a tool for the design, appraisal, and interpretation of epidemiological and clinical studies.
并非所有研究结果都转化为临床实践。缺乏适用性的原因多种多样，并且存在多种框架和标准来评估流行病学和临床研究的一般适用性。在这项两部分的研究中，我们确定、映射和综合了框架和标准；我们开发了一个框架，以协助临床医生从临床角度专门评估适用性。
我们在 PubMed 和 Embase 中进行了文献检索，以确定评估研究结果适用性的框架。我们使用概念性主题分析来综合框架和标准。我们进行了一个框架开发过程，整合了流行病学中的当代辩论、文献检索和综合的结果、迭代试点测试、头脑风暴和共识讨论，以提出一个简洁的框架来评估临床适用性。
在检索到的 4622 篇参考文献中，我们确定了 26 个具有 21 个标准的独特框架。框架和标准因评估证据的范围和聚合程度、目标用户以及适用性的特定领域（内部有效性、临床适用性、外部有效性和系统适用性）而异。我们提出的研究临床适用性评估框架 (FrACAS) 通过依次检查六个标准将研究分为三个领域（研究、实践信息和实践改变）：有效性、指示信息性、临床相关性、创新性、风险效益全面性和可转移性（VICORT 检查表）。
现有的适用性框架在范围、目标用户和适用性领域上存在差异。我们引入 FrACAS 来专门从临床角度评估适用性。我们的框架可以用作评估和解释流行病学和临床研究的工具。
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