The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis.

BACKGROUND: In the last few years, a new non-pharmacological treatment, termed apheresis, has been developed to lessen the burden of ulcerative colitis (UC). Several methods can be used to establish treatment recommendations, but over the last decade an informal collaboration group of guideline developers, methodologists, and clinicians has developed a more sensible and transparent approach known as the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). GRADE has mainly been used in clinical practice guidelines and systematic reviews. The aim of the present study is to describe the use of this approach in the development of recommendations for a new health technology, and to analyse the strengths, weaknesses, opportunities, and threats found when doing so. METHODS: A systematic review of the use of apheresis for UC treatment was performed in June 2004 and updated in May 2008. Two related clinical questions were selected, the outcomes of interest defined, and the quality of the evidence assessed. Finally, the overall quality of each question was taken into account to formulate recommendations following the GRADE approach. To evaluate this experience, a SWOT (strengths, weaknesses, opportunities and threats) analysis was performed to enable a comparison with our previous experience with the SIGN (Scottish Intercollegiate Guidelines Network) method. RESULTS: Application of the GRADE approach allowed recommendations to be formulated and the method to be clarified and made more explicit and transparent. Two weak recommendations were proposed to answer to the formulated questions. Some challenges, such as the limited number of studies found for the new technology and the difficulties encountered when searching for the results for the selected outcomes, none of which are specific to GRADE, were identified. GRADE was considered to be a more time-consuming method, although it has the advantage of taking into account patient values when defining and grading the relevant outcomes, thereby avoiding any influence from literature precedents, which could be considered to be a strength of this method. CONCLUSIONS: The GRADE approach could be appropriate for making the recommendation development process for Health Technology Assessment (HTA) reports more explicit, especially with regard to new technologies.

¿Podemos simplificar la elaboración de guías de práctica clínica? Evaluación de un método de elaboración, adaptación y actualización en la guía de práctica clínica sobre asma en la Comunidad Autónoma del País Vasco / It is possible to simplify the development of clinical practice guidelines? Evaluation of method for updating, adapting and developing asthma guidelines in the Basque Country Autonomous Community

Objetivo: La elaboración de guías de práctica clínica (GPC) es un proceso costoso, que requiere mucho tiempo y profesionales con conocimientos metodológicos. La utilización de otras GPC de calidad podría facilitar el proceso. El objetivo es evaluar la aplicaciónde un método mixto de elaboración-adaptación-actualización en el desarrollo de la GPC sobre asma de la Comunidad Autónoma del País Vasco.Método: Se han seguido varias etapas: a) formulación de preguntas, búsqueda de GPC y revisiones Cochrane; b) evaluación de guías con el instrumento AGREE; c) análisis del contenido clínico mediante la“Tabla de guías”, y d) aplicación de siete criterios para evaluar si las guías y las revisiones Cochrane responden adecuadamente a cada pregunta. Según su cumplimiento, se seleccionó la estrategiaa seguir: elaboración de novo, elaboración parcial (búsqueda y evaluación abreviadas) o adopción de las recomendaciones a partir de guías y/o revisiones Cochrane.Resultados: Se formularon 29 preguntas clínicas y se seleccionaron 7 GPC. El 86,2% de las preguntas estaban abordadas en GPC y el 37,9%, con revisiones Cochrane. La consistencia fue alta en un 53,6%. Hubo necesidad de actualización en el 75%. La graduación de las recomendaciones fue fuerte en el 46,4%, y por consenso enel 39,3%. La estrategia seguida fue de elaboración parcial en el 62,1%, “de novo” en el 13,8% y adopción de guías-Cochrane en el 24,1%. Se observaron diferencias estadísticamente significativas en los criterios anteriores según el tipo de pregunta (diagnóstico,tratamiento, educación, prevención).Conclusiones: A pesar de disponer de guías de calidad, muchas preguntas han precisado elaboración parcial. No obstante, este trabajo proporciona algunas claves para futuros trabajos de elaboración o adaptación de guías

Objective: Preparing clinical practice guidelines (CPG) is an expensive process requiring a great deal of time and the participation of numerous professionals with knowledge of methodology. But the use of higher-quality CPGs could make this process easier. The aimof this work was to evaluate the application of a composite development-adaptation-updating method for the development of the asthma CPG in the Basque Country Autonomous Community.Method: A four step process was followed: a) Drawing up of clinical questions and searching for CPGs and Cochrane reviews; b) Guidelines evaluation using the AGREE tool; c) Analysis of the clinicalcontent using the “Table of Guidelines”, and d) Application of 7 criteria to evaluate whether guidelines and Cochrane reviews adequatelyresolved each question. Obtained results determined theapplied strategy: de novo development, partial development (abbreviated search and evaluation) or adoption of guidelines and/or Cochrane reviews recommendations.Results: Twenty nine questions were formulated and 7 CPGs were selected. Out of the total questions, 86.2% were covered by guidelines while 37.9% by Cochrane reviews. Consistency rate was high,up to 53.6%. Updating was required in 75%. Of the recommendations, 46.4% were strongly graded and 39.3% by consensus. The strategy followed was of partial development in 62.1%, “de novo” in 13.8% and adoption of guidelines/Cochrane reviews in 24.1%.Statistically significant differences were observed in the previous criteria according to the type of question (diagnosis, treatment, education, prevention).Conclusions: Despite the availability of high-quality guidelines, many questions required partial development. However, this study provides a number of key aspects for future guideline development/adaptationprojects

[Not Available]. / ¿Podemos simplificar la elaboración de guías de práctica clínica? Evaluación de un método de elaboración, adaptación y actualización en la guía de práctica clínica sobre asma en la Comunidad Autónoma del País Vasco.

OBJECTIVE: Preparing clinical practice guidelines (CPG) is an expensive process requiring a great deal of time and the participation of numerous professionals with knowledge of methodology. But the use of higher-quality CPGs could make this process easier. The aim of this work was to evaluate the application of a composite development-adaptation-updating method for the development of the asthma CPG in the Basque Country Autonomous Community. METHOD: A four step process was followed: a) Drawing up of clinical questions and searching for CPGs and Cochrane reviews; b) Guidelines evaluation using the AGREE tool; c) Analysis of the clinical content using the "Table of Guidelines", and d) Application of 7 criteria to evaluate whether guidelines and Cochrane reviews adequately resolved each question. Obtained results determined the applied strategy: de novo development, partial development (abbreviated search and evaluation) or adoption of guidelines and/or Cochrane reviews recommendations. RESULTS: Twenty nine questions were formulated and 7 CPGs were selected. Out of the total questions, 86.2% were covered by guidelines while 37.9% by Cochrane reviews. Consistency rate was high, up to 53.6%. Updating was required in 75%. Of the recommendations, 46.4% were strongly graded and 39.3% by consensus. The strategy followed was of partial development in 62.1%, "de novo" in 13.8% and adoption of guidelines/Cochrane reviews in 24.1%. Statistically significant differences were observed in the previous criteria according to the type of question (diagnosis, treatment, education, prevention). CONCLUSIONS: Despite the availability of high-quality guidelines, many questions required partial development. However, this study provides a number of key aspects for future guideline development/ adaptationprojects.

[Assessment of clinical practice guidelines evaluation. Scales and criteria]. / Valoración de escalas y criterios para la evaluación de Guías de Práctica Clínica.

Not only are there large number of guides, protocols and other support tools available for the clinical decision-making process in the Spanish National Health System, but there is also a major degree of variability among them, reflecting inconsistencies and low quality of those documents. This study is aimed at conducting all inventory of the Clinical Practice Guideline assessment scales and clinical analysis tools and to propose a scale or set of criteria for assessing the quality of the Clinical Practice Guidelines put out in Spain. A systematic search of critical evaluation scales was conducted. The inclusion criteria and the concordance analysis of the items by three evaluators were independently applied. The discordances were resolved by explicit consensus. Ten suggested critical assessment scales and sets of criteria from eleven institutions were identified, eight of which consist of scales and tools proposed for assessing the quality of the Clinical Practice Guidelines, the other two being proposals for assessing the implementation and inclusion of the Clinical Practice Guidelines in a register. In the comparative analysis, the criteria most often repeated on the scales analysed were related to the areas included in the AGREE Instrument. The areas considered in most of the critical assessment scales were the same as those of the AGREE Instrument. Although this tool does not take in criteria for guide implementation assessment purposes, it is considered suitable for use in the assessment prior to inclusion to the national CPG register.