Using Explicit Thresholds were valuable for judging Benefits and Harms in partially contextualized GRADE Guidelines.

OBJECTIVES: Guideline panels must assess the magnitude of health benefits and harms to develop sensible recommendations. However, they rarely use explicit thresholds. In this paper we report on the piloting and the use thresholds for benefits and harms. STUDY DESIGN AND SETTING: We piloted the use of thresholds in a Chilean COVID-19 living guideline. For each of the critical outcomes, we asked panelists to suggest values of the thresholds for large, moderate, small, or trivial or no effect. We collected this information through a survey and an on-line discussion. RESULTS: Twelve panelists decided on thresholds for three critical outcomes (mortality, need for mechanical ventilation and serious adverse events). For all outcomes, an absolute risk reduction was considered larger with more than 50 events, moderate with less than 50 events, small with less than 25 events, and trivial with less than 10 events. Having these a priori thresholds in place significantly impacted on the development of recommendations. CONCLUSION: Explicit thresholds were a valuable addition to the judgment of the certainty in the evidence, to decide the direction and strength of the recommendation and to evaluate the need for update. We believe this is a line of research worth perusing.

Questions and health outcomes prioritization for the development of a COVID-19 dental clinical practice guideline: A case study.

RATIONALE, AIMS AND OBJECTIVES: In the context of a pandemic, the rapid development of clinical practice guidelines (CPGs) is critical. The guideline development process includes prioritization of the guideline topic, questions and health outcomes. This case study describes the application of a new methodology to prioritize questions and rate the importance of health outcomes for a COVID-19 dental guideline. METHODS: Panel members rated the topic and the questions' overall importance, using a 9-point scale (1 = least important; 9 = most important). In addition, they rated six criteria if multiple questions received the same overall importance rating: common in practice, uncertainty in practice, variation in practice, new evidence available, cost consequences, not previously addressed. Panellists also rated the importance of each outcome, defined with health outcome descriptors, using a 9-point scale and the utility of health outcomes on a visual analogue scale. The correlation between each criterion and overall question importance was tested by Spearman correlation coefficient. RESULTS: Of seven topics, four were rated as high priority and three were rated as important, but not of high priority. Thirty-six percent of the questions (18/50) were rated as high priority to address in the guideline and 64% (32/50) were rated as an important question but not of high priority. Of the 11 outcomes, 72.7% were rated as critical for decision making. The mean utility rating was 0.57 (SD 0.32), with a minimum mean rating of 0.16 and a maximum of 0.76 (SD 0.23). CONCLUSION: This case study demonstrated that this approach provides a rigorous and transparent methodology to conduct the prioritizations of guideline topics, questions and health outcomes.

Cómo interpretar guías de práctica clínica elaboradas con metodología GRADE / Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)

The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.

[Clinical practice guidelines: qualitative study of their implementation in the Chilean health system]. / Guías de práctica clínica: estudio cualitativo sobre su implementación en el sistema de salud de Chile.

OBJECTIVE: Characterize the implementation process, barriers, and facilitators of evidence-based recommendations in the context of developing clinical practice guidelines (CPGs) generated by the Ministry of Health of Chile, in order to make proposals to optimize the process. METHODS: Qualitative "action-oriented research" study. Nineteen semi-structured interviews were conducted and nine discussion groups were organized at various levels of the Chilean public health system. The analysis was conducted using Atlas.ti® software and manually, in a content analysis framework, by categorizing and coding information according to pre-specified dimensions and with the inclusion of emerging categories where relevant. RESULTS: The main challenge mentioned with regard to implementing recommendations is the lack of an explicit and structured process. Actors in the health system recognize difficulties specific to the context in which the recommendations are followed. In this unprecedented institutional review, participants suggested a series of strategies that could be implemented to overcome these challenges, presented in a management flow chart optimized for the development and implementation of CPGs. This process has raised awareness of the importance of implementing CPGs in Chile. CONCLUSION: After characterizing the implementation process, barriers, and facilitators, a plan to implement recommendations was developed in order to guide and monitor the process. It would facilitate the implementation of strategies and the introduction of improvements to the CPG development process if key informants inside and outside of the Ministry of Health were included in the review process. Studies of this kind should be conducted with physicians and patients in order to complement the collected information.

Colour and in vitro quality attributes of walnuts from different growing conditions correlate with key precursors of primary and secondary metabolism.

Walnuts (Juglans regia L.) are well known for their flavour, nutritional and health properties. The light colour of walnuts is a quality attribute that leads to consumer preference. The aim of this study was to correlate attributes such as colour and antioxidant capacity with the precursors of primary and secondary metabolism. Two growing areas and four different colours of walnuts cv. Chandler from the central region of Chile were evaluated. Walnuts grown in the zone with Andes Mountains influence showed higher (p<0.05) sugar and unsaturated fatty acid contents, which could be attributed to lower minimum temperatures during seed filling. Extra light walnuts had higher (p<0.05) total phenolic compounds, antioxidant capacity and arbutin levels than amber walnuts. To the best of our knowledge, this is the first time that arbutin has been reported in walnuts and could provide the first insight into how enzymatic browning is prevented in the Chandler cultivar.

Guías de práctica clínica: estudio cualitativo sobre su implementación en el sistema de salud de Chile / Guias de prática clínica: estudo qualitativo sobre sua implementação no sistema de saúde do Chile

Objetivo. Caracterizar el proceso de implementación, barreras y facilitadores de recomendaciones basadas en evidencia en el contexto del desarrollo de guías prácticas clínicas (GPC) generadas por el Ministerio de Salud de Chile, a fin de brindar propuestas para la optimización del proceso. Métodos. Estudio cualitativo del tipo “investigación-acción”. Se realizaron 19 entrevistas semiestructuradas y se armaron nueve grupos de discusión a distintos niveles del sistema público de salud chileno. El análisis se realizó mediante el software Atlas ti® y en forma manual, desde un marco de análisis de contenido, mediante la categorización y codificación de la información según dimensiones preespecificadas y con la inclusión de categorías emergentes cuando fue pertinente. Resultados. El principal desafío de implementación de recomendaciones mencionado es la falta de un proceso explícito y estructurado. Los actores del sistema de salud reconocen dificultades dependientes del contexto al momento de usar las recomendaciones. En esta experiencia inédita de revisión institucional, los participantes sugirieron una serie de estrategias a poner en práctica para superar dichos desafíos, representadas en un flujograma de gestión optimizada para el desarrollo e implementación de GPC. El mismo proceso ha permitido tomar conciencia de la importancia de la implementación de GPC en Chile. Conclusión. Tras caracterizar el proceso de implementación, barreras y facilitadores se articuló un plan de implementación de recomendaciones que permitiría orientar y monitorizar dicho proceso. Hacer partícipes del proceso de revisión a informantes claves dentro y fuera del Ministerio de Salud facilitaría la implementación de estrategias y la introducción de mejoras al proceso de desarrollo de GPC. Estudios de este tipo deberían ser realizados en médicos y pacientes para complementar la información recogida.

Objetivo. Caracterizar o processo de implementação, as barreiras e os fatores facilitadores de recomendações baseadas em evidências no contexto do desenvolvimento de guias de prática clínica (GPCs) criados pelo Ministério da Saúde do Chile, a fim de fazer propostas para a otimização do processo. Métodos. Estudo qualitativo do tipo “investigação-ação”. Foram realizadas 19 entrevistas semiestruturadas e organizados nove grupos de discussão em diferentes níveis do sistema público de saúde chileno. A análise foi realizada com o software Atlas ti® e de forma manual utilizando um quadro de análise de conteúdo, mediante a categorização e codificação das informações segundo dimensões pré-especificadas e com a inclusão de categorias emergentes, quando pertinente. Resultados. O principal desafio identificado para a implementação das recomendações foi a falta de um processo explícito e estruturado. Os atores do sistema de saúde reconhecem dificuldades dependentes do contexto no momento de usar as recomendações. Nesta experiência inédita de revisão institucional, os participantes sugeriram uma série de estratégias que podem ser postas em prática para superar tais desafios, representadas em um fluxograma de gestão otimizada para o desenvolvimento e a implementação dos GPCs. O mesmo processo tem gerado conscientização sobre a importância da implementação de GPCs no Chile. Conclusão. Uma vez caracterizado o processo de implementação, as barreiras e os fatores facilitadores, articulou-se um plano de implementação de recomendações que permitirá orientar e monitorar esse processo. O envolvimento de informantes-chave dentro e fora do Ministério da Saúde no processo de revisão poderá facilitar a implementação de estratégias e a introdução de melhorias no processo de desenvolvimento de GPCs. É preciso realizar estudos deste tipo com médicos e pacientes para complementar as informações coletadas.

[Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)]. / Cómo interpretar guías de práctica clínica elaboradas con metodología GRADE.

The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.

Guías de práctica clínica: estudio cualitativo sobre su implementación en el sistema de salud de Chile / Clinical practice guidelines: qualitative study of their implementation in the Chilean health system / Guias de prática clínica: estudo qualitativo sobre sua implementação no sistema de saúde do Chile

RESUMEN Objetivo Caracterizar el proceso de implementación, barreras y facilitadores de recomendaciones basadas en evidencia en el contexto del desarrollo de guías prácticas clínicas (GPC) generadas por el Ministerio de Salud de Chile, a fin de brindar propuestas para la optimización del proceso. Métodos Estudio cualitativo del tipo “investigación-acción”. Se realizaron 19 entrevistas semiestructuradas y se armaron nueve grupos de discusión a distintos niveles del sistema público de salud chileno. El análisis se realizó mediante el software Atlas ti® y en forma manual, desde un marco de análisis de contenido, mediante la categorización y codificación de la información según dimensiones preespecificadas y con la inclusión de categorías emergentes cuando fue pertinente. Resultados El principal desafío de implementación de recomendaciones mencionado es la falta de un proceso explícito y estructurado. Los actores del sistema de salud reconocen dificultades dependientes del contexto al momento de usar las recomendaciones. En esta experiencia inédita de revisión institucional, los participantes sugirieron una serie de estrategias a poner en práctica para superar dichos desafíos, representadas en un flujograma de gestión optimizada para el desarrollo e implementación de GPC. El mismo proceso ha permitido tomar conciencia de la importancia de la implementación de GPC en Chile. Conclusión Tras caracterizar el proceso de implementación, barreras y facilitadores se articuló un plan de implementación de recomendaciones que permitiría orientar y monitorizar dicho proceso. Hacer partícipes del proceso de revisión a informantes claves dentro y fuera del Ministerio de Salud facilitaría la implementación de estrategias y la introducción de mejoras al proceso de desarrollo de GPC. Estudios de este tipo deberían ser realizados en médicos y pacientes para complementar la información recogida.

ABSTRACT Objective Characterize the implementation process, barriers, and facilitators of evidence-based recommendations in the context of developing clinical practice guidelines (CPGs) generated by the Ministry of Health of Chile, in order to make proposals to optimize the process. Methods Qualitative “action-oriented research” study. Nineteen semi-structured interviews were conducted and nine discussion groups were organized at various levels of the Chilean public health system. The analysis was conducted using Atlas.ti® software and manually, in a content analysis framework, by categorizing and coding information according to pre-specified dimensions and with the inclusion of emerging categories where relevant. Results The main challenge mentioned with regard to implementing recommendations is the lack of an explicit and structured process. Actors in the health system recognize difficulties specific to the context in which the recommendations are followed. In this unprecedented institutional review, participants suggested a series of strategies that could be implemented to overcome these challenges, presented in a management flow chart optimized for the development and implementation of CPGs. This process has raised awareness of the importance of implementing CPGs in Chile. Conclusion After characterizing the implementation process, barriers, and facilitators, a plan to implement recommendations was developed in order to guide and monitor the process. It would facilitate the implementation of strategies and the introduction of improvements to the CPG development process if key informants inside and outside of the Ministry of Health were included in the review process. Studies of this kind should be conducted with physicians and patients in order to complement the collected information.

RESUMO Objetivo Caracterizar o processo de implementação, as barreiras e os fatores facilitadores de recomendações baseadas em evidências no contexto do desenvolvimento de guias de prática clínica (GPCs) criados pelo Ministério da Saúde do Chile, a fim de fazer propostas para a otimização do processo. Métodos Estudo qualitativo do tipo “investigação-ação”. Foram realizadas 19 entrevistas semiestruturadas e organizados nove grupos de discussão em diferentes níveis do sistema público de saúde chileno. A análise foi realizada com o software Atlas ti® e de forma manual utilizando um quadro de análise de conteúdo, mediante a categorização e codificação das informações segundo dimensões pré-especificadas e com a inclusão de categorias emergentes, quando pertinente. Resultados O principal desafio identificado para a implementação das recomendações foi a falta de um processo explícito e estruturado. Os atores do sistema de saúde reconhecem dificuldades dependentes do contexto no momento de usar as recomendações. Nesta experiência inédita de revisão institucional, os participantes sugeriram uma série de estratégias que podem ser postas em prática para superar tais desafios, representadas em um fluxograma de gestão otimizada para o desenvolvimento e a implementação dos GPCs. O mesmo processo tem gerado conscientização sobre a importância da implementação de GPCs no Chile. Conclusão Uma vez caracterizado o processo de implementação, as barreiras e os fatores facilitadores, articulou-se um plano de implementação de recomendações que permitirá orientar e monitorar esse processo. O envolvimento de informantes-chave dentro e fora do Ministério da Saúde no processo de revisão poderá facilitar a implementação de estratégias e a introdução de melhorias no processo de desenvolvimento de GPCs. É preciso realizar estudos deste tipo com médicos e pacientes para complementar as informações coletadas.