Understanding the landscape and promoting the use of guides for real-world study: a scoping review

To provide an overview of the existing guides for real-world study (RWS).

Scoping review: a systematic and snowball search of PubMed, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wan Fang, and nine other official websites was conducted to identify guides for RWS published between January 1, 1990, and December 31, 2023. Two reviewers independently screened and extracted the data using a predefined form. Descriptive, quantitative, and qualitative summaries were also obtained.

A total of 61 guides from PubMed (26, 42.6%), CNKI (9, 14.8%), and other websites (26, 42.6%) were included. Of these, 20 guides (32.8%) were developed through international collaboration, and 49 (80.3%) were published after 2016. Fifty-three (86.9%), 6 (9.8%), and 4 (6.6%) were methodological guides, reporting guidelines, and evaluation tools, respectively. These guides addressed observational studies (24, 39.3%), interventional studies (5, 8.2%), or both (22, 36.1%) that covered design (46, 75.4%), conduct (24, 39.3%), analysis (15, 24.6%), reporting (13, 21.3%), and evaluation (3, 4.9%). Only ten guides (16.4%) used both evidence-based and consensus-driven methods in their development.

Existing RWS guides vary significantly in purpose, format, and content and are often tailored to specific contexts. However, improved guide development methods remain to be established. Researchers should carefully assess the scope, classification, and applicability of these guides, particularly at the beginning of the study, to ensure that they meet the needs of their specific research objectives.