Health care guidelines provide a means of assessing the best available research evidence on a given health care topic and offering recommendations about use of specific interventions and management of patient care. Guidelines allow clinicians, patients, health administrators and policy-makers to be efficiently informed and stay up to date on alternative care options. The development of guidelines is a complex and multidisciplinary process, with a defining feature of involving a panel of experts in steps such as selecting health care questions, assessing the research evidence, making judgements about health benefits and harms, and, ultimately, formulating recommendations. Guideline methodology has advanced over the past decades, including establishment of specific steps and standards to ensure trustworthiness of guidelines. However, there remain critical research questions on how to best accomplish and reach these standards, including how to best engage panels in the steps. This thesis presents a body of research on the development and evaluation of new methods for decision-making and considering health outcomes in guidelines, prioritizing health care questions for guidelines, and evaluating the guideline development process. It includes three studies: 1) a methodological study on developing health outcome descriptors to define health outcomes considered in decision-making by guideline panels; 2) a methodological study and randomized controlled trial to evaluate specific criteria for panels to consider when prioritizing health care questions for guidelines and to judge the importance of health outcomes; and 3) an instrument development and validation study to create a tool for panel members to evaluate the appropriateness of the guideline development process they participate in. In these studies, we established a method and steps for creating health outcome descriptors with panels, aimed at achieving consistency in how health outcomes are considered throughout the guideline development process, from prioritization to formulating a recommendation on the basis of those outcomes. The structured approach and criteria evaluated for prioritization of healthcare questions informed panel deliberations and decisions about choosing questions for their guideline topics, and the proposed methods for outcome prioritization facilitated panels in informing what the critical and important outcomes were for decision-making. Finally, the instrument we developed facilitated members of guideline panels to provide their assessment of the guideline development process and identify strengths and weaknesses and areas for improvement. Our findings will allow organizations responsible for guideline development to apply the new methods with their panels and to evaluate their guideline processes to inform quality-improvement efforts. / Thesis / Doctor of Philosophy (PhD) / Health care guidelines, also referred to as clinical practice or public health guidelines, involve summarizing the available research evidence on a given health care topic and issuing recommendations about the best care. Guidelines allow clinicians, patients, health administrators and policy-makers to be efficiently informed and stay up to date on alternative care options, such as the best current treatments and strategies to diagnose various diseases and health conditions. Developing a guideline is a complex and multidisciplinary process that includes involving a panel of experts, typically consisting of clinicians, patients, public health professionals and other providers or consumers of health care. The panel is involved in selecting the health care questions to address (e.g. specific treatments or diagnostic strategies to evaluate), reviewing a summary of the evidence from research studies, and making judgements about benefits and harms of alternate options or strategies. The panel then formulates recommendations that give guidance on what the best options are to use for the health condition in question. The steps and approaches to develop a guideline that is considered trustworthy have been established over the past decades, including universally accepted standards. However, there remain critical research questions on how to best reach these standards, including how to best engage guideline panels in the steps. The research work presented in this thesis focuses on proposing and evaluating new methods and approaches for guidelines panels to make decisions about health outcomes, priority health care questions for guidelines, and to evaluate the guideline development process. It includes three studies: 1) a study on creating health outcome descriptors with panels to provide a commonly accepted definition of a health outcome; 2) a study to evaluate specific criteria that panels can use to prioritize health care questions, and an approach to judge the importance of health outcomes; and 3) a study to develop a survey instrument for guideline panel members to evaluate the guideline development process they participate in. In these studies, we established an approach for creating the health outcome descriptors with panels, which helped in keeping consistency with how panels understood and considered different health outcomes throughout the guideline development process. The criteria evaluated for prioritizing healthcare questions informed panel discussions and selection of questions for their guideline topics. The proposed approach for judging the importance of health outcomes helped panels to select what the critical outcomes were for making decisions about the benefits and harms of alternate options or strategies. Finally, the survey tool we created allowed members of guideline panels to provide feedback on strengths and weaknesses and areas for improvement in the process after they participated in developing a guideline. Our findings will allow organizations responsible for guideline development to apply the new methods with their panels and to evaluate their guideline processes to inform quality-improvement efforts.

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