Development of the clinical practice guideline protocol registration program and its pilot application in Korea

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BackgroundIn the case of clinical practice guideline (CPG), the need for the prospective registration of protocols has been proposed several times. However, the registration of CPG protocols is not yet active. The objective of this study was to summarize the experience of the CPG protocol registration program in Korea.MethodsThis study was performed in the following order: 1) formation of a methodological expert group; 2) CPG protocol template development; 3) CPG protocol preparation and expert review; 4) exploration of the knowledge and attitude of the guideline developers toward CPG protocol.ResultsThe final version of the CPG protocol templates consists of four parts (planning, development, finalization, and timetable). The protocols for 18 cancers were submitted by 14 medical societies. conflicts of interest (n = 14, 77.8%), guideline development group (GDG; n = 9, 50%), scope of CPG (n = 9, 50%), and key questions (n = 8, 44.4%) were the under-reported areas in the submitted protocols. The GDGs (n = 13, 72.7%) was the most misreported areas of the protocol. CPG developers generally agreed on the advantages of protocol registration but responded that it was difficult to understand the concepts in the protocol and fill them with appropriate content. The areas where CPG developers responded that they felt difficulty were were recommendation grade (n = 9, 75.0%), GDG composition (n = 7, 58.3%), and determining key questions (n = 7, 58.3%).ConclusionsThe CPG protocol registration program was planned and piloted in Korea, and it could be said that it is feasible. It is necessary to evaluate the developed CPG later and determine whether protocol registration affects the quality of CPG through indices such as transparency and clarity of CPG.

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