Nagavci Blin, Gáspár Zsófia, Lakatos Botond
Doctoral School of Clinical Medicine, Semmelweis University, Budapest, H-1097, Hungary.
National Institute of Hematology and Infectious Diseases, Central Hospital of Southern Pest, Budapest, H-1097, Hungary.
BMC Med Res Methodol. 2025 Apr 2;25(1):87. doi: 10.1186/s12874-025-02534-0.
The use of Expert Opinion (EO) in clinical guidelines is highly variable and lacks standardization, leading to ongoing controversy. A clear and universally accepted definition of EO is also lacking. To date, no research has systematically assessed how guideline-developing societies conceptualize and apply EO. This study aims to map methodological manuals, evaluate their rationale for EO use, examine its foundations, and synthesize a comprehensive definition.
Systematic searches for clinical guidelines were conducted in PubMed to identify guideline-developing societies, supplemented by additional searches. Systematic searches were then conducted to identify methodological manuals from these societies. Screening was performed independently by two reviewers, and data extraction was conducted using piloted forms. Findings were summarized through narrative evidence synthesis using descriptive statistics.
A total of 473 national and international societies were identified, and methodological manuals from 98 societies were mapped and analysed. These manuals included 61 handbooks, 29 journal articles, and 8 websites. EO is mentioned in 65 (66%) manuals, with substantial variation in its utilization and terminology. EO is primarily used in two contexts: (1) filling evidence gaps (72%), and (2) interpreting existing evidence (8%). In the remaining 20%, EO use is unclear. Five main foundations could be identified as a potential basis for EO (clinical experience, indirect evidence, low-quality evidence, mechanism-based reasoning, and expert evidence/witnesses). Based on these findings, a novel comprehensive definition of EO was synthesized.
EO is widely used to address evidence gaps and interpret ambiguous evidence, underscoring its importance in guideline development. However, the variability in its application and conceptualization across societies highlights the need for standardization. We propose a comprehensive EO definition as a first step towards standardization to improve consistency, transparency, and clinical decision-making.
临床指南中专家意见（EO）的使用差异很大且缺乏标准化，引发了持续的争议。目前也缺乏对专家意见的清晰且被普遍接受的定义。迄今为止，尚无研究系统评估指南制定协会如何概念化和应用专家意见。本研究旨在梳理方法学手册，评估其使用专家意见的基本原理，审视其依据，并综合出一个全面的定义。
在PubMed中对临床指南进行系统检索，以识别指南制定协会，并辅以其他检索。然后进行系统检索，以识别这些协会的方法学手册。由两名评审员独立进行筛选，并使用预先试用的表格进行数据提取。通过描述性统计的叙述性证据综合对结果进行总结。
共识别出473个国家和国际协会，并梳理和分析了98个协会的方法学手册。这些手册包括61本手册、29篇期刊文章和8个网站。65本（66%）手册中提到了专家意见，其使用和术语存在很大差异。专家意见主要用于两种情况：（1）填补证据空白（72%），以及（2）解释现有证据（8%）。在其余20%的情况下，专家意见的使用不明确。可以确定五个主要依据作为专家意见的潜在基础（临床经验、间接证据、低质量证据、基于机制的推理以及专家证据/证人）。基于这些发现，综合出了一个全新的专家意见全面定义。
专家意见被广泛用于填补证据空白和解释模糊证据，凸显了其在指南制定中的重要性。然而，各协会在其应用和概念化方面的差异突出了标准化的必要性。我们提出一个全面的专家意见定义，作为迈向标准化的第一步以提高一致性、透明度和临床决策。
