Background: Several proposals for adapting clinical guidelines have appeared in developed countries (Adapte, Osteba groups and others). In Latin America, each country has designed its own methodology for adaptation. In Peru, the initiative came from the Ministry of Health, but the preparation of the guidelines was entrusted to each health center for its local application. This resulted in documents of questionable quality. To avoid unnecessary duplication of efforts and to obtain a methodological quality product of national interest, another clinical guideline preparation strategy must be designed.
Objectives: The aim of this work is to present a coherent methodology for adapting clinical guidelines, based on evidence, of a practical and economic nature and that can be applied regionally or nationally in a developing country.
Methods: This proposal is based on the review of the different methodological schools for de novo guidelines preparation, of the different methods for adapting clinical guidelines based on evidence, and the evaluation of Peru's and Latin America's adaptation processes.
Results: The preparation phases for adapting guidelines include: Selection of topics, establishment of committees (writing, technical and review), adaptation methodology, training and implementation of the clinical guidelines. The proposed methodology of the national clinical guidelines include: 1) Planning: 2) Formulation of key questions, 3) Search for evidence: previous clinical guidelines and systematic reviews in Cochrane (or any systematic review based on PICO question), evidence subsequent to the preparation date of the guideline to be adapted (systematic review, consensus of experts, relevant mega trials) and national literature; 3) Evaluation of the methodological quality of the guidelines to be considered for adaptation using the AGREE grading tool; 4) Adaptation includes an analysis of the response to the evidence found to the formulated key questions, contrast of recommendations with local experience and evidence, consideration of socio-cultural characteristics and economic limitations, cost/effectiveness analysis or estimate of the recommendations, comments on CG recommendations. Based on the above, issuance of new recommendations, if pertinent, review if the recommendation grading is adequate based on the evidence used, and pursuant to the grading of the original guideline; 5) Classification of interventions (effective, uncertain, not effective or harmful); 6) Validation: for internal and external reviewers; 7) Publication; and 8) Updating: by restricted literature search.
Discussion: The strategy to be followed regarding adapting, modifying or preparing recommendations for each key question is based on the Osteba methodology group, using previous guidelines as the basis with the corresponding systematic reviews. Each member of a committee must be trained regarding the concept, design and adaptation of clinical guidelines, basic concepts of evidence, search for evidence, use of the AGREE tool, design of cost/effectiveness analysis and economic balance sheet. According to prior local experience, this process requires 250 hours per person for the members of the technical committee. Preparation of the adapted guideline should not take more than 6 months.
Conclusions: Adapted clinical guidelines (using a coherent and practical methodology) are an accessible alternative, particularly suitable for developing countries if the objective is national application of the guideline.