Original Title: Descripción de la metodología de elaboración-adaptación-actualización empleada en la guía de práctica clínica sobre asma de la CAPV

Authors' objectives: Primary: draw up clinical practice guidelines (CPG) based on the evidence, used as an instrument to improve the health care of asthmatic children and adults. Secondary: evaluate the application of a guideline adaptation method in the development process of a CPG. This document includes a detailed description of the methodological aspects and will be used as the basis for drawing up the “Asthma Guide of the Basque Country”strictly speaking, focused more on the clinical contents and with a more practical format.

Authors' results and conclusions: Twenty-nine key questions were formulated. We applied the AGREE Instrument to 12 guidelines. From these, 7 were selected (SIGN; New Zealand, GINA, update of the EPR-2, Canadian, Cincinnati and Gipuzkoa), and classified as highly recommended or recommended according to the scores in domains and items. 227 Cochrane reviews relating to asthma were located, of which a pre-selection was made of those that might relate to the key questions: 30 relating to pharmacological treatment, 8 with education, 14 with non pharmacological treatment or prevention. None were found about diagnostics. Of the 29 key questions, 25 are dealt with thoroughly in the guidelines, 3 are partially dealt with and only one was not included in any of the original guidelines. A Cochrane review was found in 11 of the 29 questions (37.9%). Consistency was high in 53.6% of the questions, partial in 21.4%, poor in 7.1% and was not applicable in the rest. Updating was considered to be necessary in 75% of the questions. The grading of the evidence was firm in 46.4% of the questions and consensual in 39.3%. The formulation of the recommendation was considered to be clear and applicable for 85.7% of the questions. With regard to the strategy followed, 18 questions (62.1%) were partially drafted, 4 (13.8%) were de novo drafts and 7 (24.1%) were sufficient with the guidelines and/or Cochrane reviews. On evaluating the adaptation criteria according to sections, statistically significant differences were observed in the level of recommendation, applicability, existence of Cochrane reviews and the need for updating. The recommendations were firm in all the questions in the education section, in more than half of those in the treatment section and in a quarter of those in the prevention section, but in none of the questions relating to diagnostics (all consensual). The questions in the education section entailed problems of applicability in spite of the fact that there were Cochrane reviews and no updating was required. The strategy followed shows significant and relevant differences depending on the section to which the questions belong. In all the diagnostics questions we drafted a de novo or partially prepared response, while in the 3 questions on education, we followed a strategy of collecting the contents of guidelines together with the Cochrane reviews. Three of the 4 questions in the prevention section have required a partial drafting, and guidelines and Cochrane strategy have been followed in the other. The responses to 7 of the 13 questions in the treatment section have been partially drafted, de novo in 3 cases, and guidelines and Cochrane reviews as a single source have been used in the responses to only 3 questions. The application of our method to these questions has meant that many of the new recommendations reach a higher level than in the original guidelines. In 7 of the 9 questions in the diagnostics section, the recommendation changed to C (before it was consensual). In the prevention section, the level of recommendation was maintained except in one question that dropped from A to B; in another question, the sense of recommendation was changed. Of the 13 questions in the pharmacological treatment section, the percentage of firm questions rose from 46.2% to 100%. The questions in the education section maintain the initial level.

Authors' recommendations: The development of this guideline by means of a mixed methodology of adaptation de novo development-updating has entailed a great deal of work in the search for, evaluation and synthesis of information. Nevertheless, this has allowed us to identify the strengths and weaknesses of the guideline adaptation method as well as the steps that can be easily simplified for future adaptation work. A novel aspect of our adaptation method has been to approach this on the basis of structured clinical questions. In our work, the quality of the asthma guidelines selected was high in all the domains; this may not be applicable to other pathologies. Working with 7 guidelines simultaneously has made the development of the guideline tables excessively laborious; we believe that future adaptations should not consider more than 2 or 3 base guidelines. The Cochrane reviews play a decisive role in adapting guidelines. In our work, the adaptation in education questions has been greatly simplified, as is the case, although to a lesser extent, of the treatment questions. The fact that there were no Cochrane reviews available for diagnostics is a major limitation. Despite the availability of high-quality base guidelines, it should be pointed out that a large proportion of key questions have required partial development, and to a lesser extent, de novo development. In the pharmacological treatment questions, the main motive which led to a partial development was the need to update, as new clinical trials are being published constantly in this field, especially for the newer treatments. In the diagnostics section, the main motive was the fact that the guidelines responded to the questions in a narrative manner, without grading the evidence or due to a consensus. Although this may not be the case of other pathologies, we believe that it is customary practice in guidelines to approach the diagnosis in the form of a consensus, without basing the recommendations on adequate studies. The evaluation of the evidence from studies on diagnostics and the drawing up of recommendations based on their analysis are the subject of methodological controversy, which is still unresolved at this time. Nevertheless, this cannot justify not approaching these questions with the same methodology as other CPG questions (for example treatment or prevention). This study has shown us that it is possible to base recommendations on more strong evidence.

Authors' methods: We used a mixed adaptation-development-updating methodology. The steps taken were as follows: – Creation of a multidisciplinary development team, with representatives from scientific societies and local workgroups. They received information on the evaluation of guidelines with the AGREE instrument. – Formulation of the key questions of the Guideline, using the Patient/Problem, Intervention, Outcome and study type procedure. – Search, evaluation and selection of reference CPGs and Cochrane reviews on asthma. The CPGs found were evaluated with the AGREE instrument and a selection was made of the highest quality guidelines published as of 2002.Analysis of the clinical contents of the selected guides, focusing on the key questions. To do this we used the “Guidelines Table” for each of the key questions. – Application of guideline allocation criteria to the key questions formulated, in order to assess whether the guideline(s) and Cochrane reviews correspond adequately to each one of the questions. There were 7 criteria: question dealt with in the guidelines, existence of a Cochrane review, consistency, need for updating, recommendation level, clarity and applicability. In accordance with these criteria, the strategy to be followed with each question was selected: de novo development, partial development or adopting recommendations based on guidelines and/or Cochrane. – In the case of those questions for which we opted de novo development, the following steps were taken: search for and evaluation of evidence, formal evaluation, summary of the evidence and drafting of recommendations according to the methodology proposed by SIGN. In the case of partial development, these steps are simplified. – Descriptive analysis of the application of the guideline adaptation criteria to the questions and of the strategy followed in accordance with the section to which they belong: diagnosis/prognosis, primary/secondary prevention, pharmacological treatment, and health education. The differences were analysed by means of the chi-square test, using the SPSS programme version 12.0

Project Status: Completed

Year Published: 2005

URL for published report: https://www.euskadi.eus/contenidos/informacion/2005_osteba_publicacion/es_def/adjuntos/2005/d_05-03_adaptacion_guia_asma.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Basque Office for Health Technology Assessment, Health Department Basque Government (OSTEBA)</p>