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The spectrum of acute pancreatitis (AP) affects between 4.9 and 73.4 patients out of 100,000 worldwide annually (Tenner, Baillie, DeWitt, & Vege, 2013). AP uses the Atlanta classification system to establish a diagnosis of mild, moderate, or severe. The American College of Gastroenterology (ACG) has established comprehensive clinical practice guidelines (CPG) for the management of AP, the most recent version published in 2013 (Tenner et al., 2013). There have been similar CPGs published internationally that integrate current evidence-based research into recommendations for practice. These guidelines along with the ACG's guidelines recommend initiating a diet for mild acute pancreatitis patients due to research findings of improved patient outcomes (i.e. reduced length of hospital stay, decreased rate of infections, and reduced mortality) (Horibe et al., 2015; Lariño-Noia et al., 2014). There is an international awareness of the need for increased CPG nutrition recommendation compliance in the practice setting as many studies have found providers prefer to keep patients nil per os (NPO) and do not adhere to CPGs (Andersson, Andrén-Sandberg, Nilsson, & Andersson, 2012; Greenberg et al., 2016; Sun et al., 2013). The purpose of this doctor of nursing practice (DNP) project is to assess providers' current nutrition therapy practice and knowledge of the ACG’s CPG nutrition recommendations for mild AP patients. The researcher conducted the assessment with a hospitalist practice at Banner University Medical Center in Phoenix, Arizona. The results of the project contribute to the current body of research on national adherence to CPGs for AP and act as a needs assessment for future projects where a nutrition protocol order set may be established. The investigation of nutrition therapy for AP patients seeks to improve and standardize the care this patient population receives while in the acute care setting.

Osteoporosis is a common health problem and it is increasing in prevalence due to the increase in the aging population. The interest to treat osteoporosis has increased in recent years, due to availability of screening modalities, advances in medications that may prevent osteoporotic fractures. Many studies have showed the high medical and economic burden of the disease on the patients, their caregivers and on the health system. Clinical practice guidelines for management of osteoporosis varied nationally and internationally, and the adherence of physicians to guidelines were always reported as suboptimal, though most studies were for after fragility fracture care gap and vert few looked at the primary screening to identify patients at risk before the occurrence of fractures. This thesis is composed of two manuscripts research project assessing the development and impact of screening for osteoporosis guidelines. The first chapter is an overview of osteoporosis, definition, risk factors, diagnosis and treatment. A follow up discussion of the literature on adherence of physicians to the osteoporosis guidelines, which ends up with the rational for this thesis. The first paper is a systematic review to identify guidelines for screening for osteoporosis from 2002-2016 (Chapter 2). We assessed the quality of these guidelines using the AGREE II and IOM standards, compared between the two tools, and assessed if the quality has changed over time. We extracted recommendations in key areas with summary of the systems that were used to assign the level of evidence and strength of recommendations. We found that the quality of guidelines has varied greatly between different countries with no significant change over time. The recommendations and systems for level of evidence were variable and all this may create confusion to clinicians. In the second paper, we used an interrupted time series design to assess the effect of three clinical practice guidelines for screening for osteoporosis in Ontario on the baseline bone mineral density (BMD) testing for older adults 65 years of age and above using administrative data by ICES from 1998-2006. All three guidelines recommend baseline BMD testing for this age population. In addition, we analyzed the pattern of repeated testing in accordance with the latest guideline. We have found low rates of baseline BMD testing with a decreasing pattern of testing. The last guideline in 2010 had gradually increased the trend of BMD testing, though it was a very small change. Stratified analyses by sex showed that the decrease in the total BMD testing is due to decrease in the testing for female population while there is an increasing trend of BMD testing in male population. CPG by Osteoporosis Canada in 2010 caused an immediate reduction in the BMD testing for female, yet, over a period of time, the guideline increased the BMD testing. For male population; the 2002 CPG had immediately increased the BMD testing, while over time this trend has decreased. Despite the low baseline BMD testing by physicians, there is an over use of repeated BMD testing in the low risk population, especially the annual and the 2 yearly BMD repeats. In conclusion: This research project found a varied quality of guideline development and reporting of guidelines for osteoporosis screening, and no improvement in the quality over time (2002-2016). Several systems were used to assign the level of evidence and strength of recommendations with conflicting recommendations between different health organizations in the same country such as in Canada. Many tools are available to appraise the quality of guidelines, however, comparing between two tools (AGREE II & IOM standards) showed that they may give conflicting results for guidelines quality. There is no effect of guidelines for screening for osteoporosis on the ordering of BMD testing to screen adults 65 years and above living in Ontario between 1998- 2016. A small increase the rate of baseline BMD testing followed the release of the 2010 guideline. For male population the 2002 guideline showed an evident immediate and gradual effect over time on the rate of baseline BMD testing ordering for male population. Despite the low baseline BMD testing rates for adults 65 years and above, there is an unnecessary repeated BMD testing for low risk population in Ontario between 2011-2016 which is not in compliance to the latest guideline for screening for osteoporosis.

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.

京都大学 / 新制・課程博士 / 博士(社会健康医学) / 甲第23820号 / 社医博第120号 / 新制||社医||12(附属図書館) / 京都大学大学院医学研究科社会健康医学系専攻 / (主査)教授 中山 健夫, 教授 小杉 眞司, 教授 柳田 素子 / 学位規則第4条第1項該当 / Doctor of Public Health / Kyoto University / DFAM

This thesis explores the Rapid Recommendations process, a new responsive way of creating clinical practice guidelines. / Healthcare workers rely on clinical practice guidelines to inform their practice. However, most guidelines are not trustworthy when judged by accepted standards and they typically take several years to produce. Guideline trustworthiness is undermined by panel members who often have conflicts of interest, by including representation from only a subset of stakeholders, by failing to examine the entirety of the evidence systematically, and by rapid obsolescence. Further, they are often difficult for users to understand in limited time. Rather than updating guidance on a fixed schedule, the Rapid Recommendations approach involves continuous monitoring of the literature and produces guidelines in response to new potentially practice-changing evidence. A collaborative network of clinicians, methodologists, and patients respond by rapidly producing trustworthy evidence syntheses and guidance. We have identified efficiencies at every step of the guideline development process. The guideline panel does not include anyone with a financial conflict of interest and there are strict limits professional and intellectual conflicts. Systematic reviews are produced on the relative effects of each option, on prognosis, and on patient values and preferences with the explicit intent to inform the question at hand. The panel also considers practical issues. Rapid Recommendations are published in a concise multilayered user-friendly format headed by an interactive infographic that contains all of the necessary information for users need to make informed decisions at the point of care. The guideline is published simultaneously in print and electronically, including decision aids that can be used at the point of care and integrated into electronic medical records. In this thesis, you will find a selection of exemplary publications relevant to the Rapid Recommendations process. We show that a responsive approach to rapid and trustworthy guideline creation is possible. It represents a way forward from the current limitations that plague most current clinical practice guidelines. / Thesis / Candidate in Philosophy / Healthcare workers often decide what to do in practice based on the advice of experts through clinical practice guidelines. However, most clinical practice guidelines are not completely trustworthy. Guideline authors often have conflicts of interest, do not include patients or patient views, and are created so slowly that they rapidly fall into obsolescence. This thesis explores a new way of developing clinical practice guidelines that we call Rapid Recommendations. Instead of creating them on a fixed schedule (i.e., every few years), they are created in response to new studies that might change practice. The scope is limited, and timelines are shorter, meaning that the guidelines are published sooner. The guideline authors include all stakeholders, including patients. None of the authors have any financial interests in the topic, and other conflicts are minimized. The guidelines are published on an expedited basis and in an accessible online multilayered format with infographics. This thesis includes a selection of exemplary publications relevant to the Rapid Recommendations process.

Trustworthy clinical practice guidelines assist health care professionals in selecting the management options that optimize patient health outcomes. The development of trustworthy guidelines requires the consideration of many aspects and the involvement of multiple contributors, often working in groups. The guideline panel plays the key role in the development process as it is responsible for prioritizing topics that should be covered as part of the guideline effort, formulating questions, reviewing the evidence, developing and agreeing on the recommendations, and endorsing the final guideline document. Ensuring transparency throughout the process by appropriately organizing and documenting panel activities is an essential standard that is used to assess the credibility of a developed guideline and its resulting recommendations. The adoption of conceptual frameworks that systematically guides panel members in their decision-making process (e.g. the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks) can aid in the formulation of methodologically sound recommendations. In this dissertation, I used the example of a guideline on diagnosis and treatment of autism spectrum disorders to describe how rigorous research methods can support guideline panels in the development process from early stages to the formulation of recommendations. In another prominent guideline development effort with the American Society of Hematology, I have identified two steps in the process where panel members may benefit from further support and addressed these gaps by conceptualizing and developing novel approaches. The first approach comprises modelling baseline risk estimates for patient-important outcomes when only surrogate data is available. The second approach proposes a method to estimate decision thresholds for judgments on health benefits and harms using the GRADE EtD framework. While these approaches are tailored to address specific guideline panel needs, guideline methodologists could use the underlying concepts to find solutions to aid guideline panels in other steps of the development process. / Thesis / Doctor of Philosophy (PhD) / Clinical practice guidelines assist health care professionals in selecting management options that can best improve the health outcomes of their patients. The development of trustworthy guidelines is a complex process that requires the contribution of several entities. The guideline panel, which typically comprises different experts (clinicians, patient representatives, experts in research methodologies) plays the key role in this process as it is responsible for selecting the most important questions to address in the guideline, reviewing the evidence supporting an option, agreeing on the recommendations, and endorsing the final guideline document. To ensure that the process of developing guidelines is transparent and that the recommendations are credible, it is important that panel activities are well documented and follow rigorous methods. Structured frameworks, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) approach, have been developed to systematically guide the panel members and to minimize the error that could be introduced while making decisions. In this thesis, I describe the development of an approach and its application for comprehensive guideline development by the Italian National Health Institute, to describe rigorous guideline development and propose two novel approaches to further assist panel members in enhancing their guideline development. The first of these two enhancements to guideline development describes how to derive a modelled estimate of the risk of having certain health conditions when this data is not directly available in the medical literature. The second of the two enhancements is a method to support guideline panels in judging how substantial the desirable and undesirable effects of health interventions are. Both approaches were tailored to fit specific needs but can be adapted to inform the improvement of other steps in the guideline development process.

This study retrospectively evaluated patient records from two cardiac rehabilitation (CR) service centers located in large urban hospitals using a Process Evaluation System (PES) recently developed through a collaborative project of the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), Madison, WI, and the Center for Clinical Quality Evaluation (CCQE), Washington, DC. The major aims were to: 1) evaluate the utility of the PES as an audit instrument for assessment of adherence to the 24 quality process criteria that comprised the PES; and 2) determine whether adherence to the PES criteria resulted in different patient outcomes for those cases where intervention need was documented at patient admission. Using the data abstraction manual and audit procedures developed by AACVPR/CCQE, a trained medical technician audited 150 CR records for consecutively treated outpatients who typically received 36 sessions of treatment in either Moses H. Cone Memorial Hospital, N.C. Heart Institute, Greensboro, NC, or Carolinaà ­s Medical Center, Charlotte, NC, covering a calendar period between 1995-97. The data were pooled from both sites for analyses and included patients with one or more of the following diagnoses: MI (37%), angina (14%), coronary revascularization (76%), and other (18%). The cost of utilizing the PES was assessed by evaluating the technician time required to abstract a patient record and this was observed to improve over the course of the review period, i.e., mean abstraction time for initial versus final 20 records = 13.2 min. and 4.6 min., respectively. Experience with the PES suggested areas where instrument revision should be considered, e.g., the operational guidelines for extracting acceptable markers were not always clear enough or sufficiently flexible to allow determination of adherence of a record to the 24 quality process criteria. Adherence to the PES was determined, case by case, for each of the 24 criteria. In 129 cases (86% of the sample), complete adherence was found, i.e. 100% adherence to all 24 criteria that included indicators of key clinical steps for patient intake, treatment planning, and follow-up. The remaining 21 records (14%) showed adherence to at least 21 of the 24 criteria (87.5%). Given the uniformly high levels of adherence to the PES documented by these two program sites, the data could not resolve the question of whether patient outcome effects were different between cases of high versus low adherence to PES. Nonetheless, outcome data were examined to evaluate achievement levels in four different areas widely considered by clinicians as important to treatment success: blood cholesterol, smoking status, exercise tolerance, and body mass index (BMI). Of the study patients diagnosed with dyslipidemia 12 of 27 (44%) had levels < 200 mg/dl by exit. Seven of 14 documented smokers (50%) reported quitting at exit from treatment. Forty-nine patients of 117 (42%) who initially could only maintain treadmill walking for 10 min. at levels below 4 METs, were able to exceed this level by treatment end. Six of 104 (6%) with BMI values > 24.9 kg/m2 had a documented decrease in this indicator of overweight by treatment end. The threshold levels for outcome criteria used here to describe achievement levels in this data set are somewhat arbitrary. However, the criteria are reflective of the standards typically suggested as meaningful for effective secondary risk reduction in CR programs (Franklin et al., 1996). The PES system was developed to audit the quality of CR process in treatment centers, as standardized by a consensus panel to reflect the content of the evidenced-based CR guideline recently published by the US Agency for Health Care Policy and Research (Cardiac Rehabilitation as Secondary Prevention: #17, 1995). The findings of this study suggest that the content markers of quality process in the PES are relevant and the instrument is efficient to administer. When field tested against two urban centers in North Carolina where state statutes require program certification for CR treatment centers, these centers demonstrated uniformly high adherence to the PES and a pattern of good achievement for several patient outcome measures accepted as relevant to evaluation of treatment success for individual patients. / Master of Science

The objective of the thesis was to evaluate the quality of diabetes care in the Canadian Forces by determining the extent to which physicians adhere to recommendations outlined in the 2008 Canadian Diabetes Association (CDA) clinical practice guidelines. In addition, the effect of patient age, sex, rank and size of base on quality of care was assessed and the accuracy of a diagnosis of diabetes in an extract of the electronic medical record (EMR) was evaluated. Fourteen bases within the Canadian Forces were selected for investigation, representing roughly half of the Canadian Forces population. Cases of diabetes were ascertained based on laboratory criteria following a chart review. Twenty-one CDA guideline recommendations were considered. The Canadian Forces demonstrated greater than 75% adherence with each of 9 recommendations, 50-75% adherence with each of 7 recommendations and less than 50% adherence with each of 5 recommendations. The overall adherence with all applicable recommendations per patient was 60.3% (SE 0.66). Age, sex, rank and size of base were not important factors influencing guideline adherence. The sensitivity of a diabetes diagnosis in an extract of the EMR was 84.5%, the specificity was 99.8%, the positive predictive value was 85.1% and the negative predictive value was 99.8%. This is similar to the performance of provincial and national diabetes registries. The quality of diabetes care in the Canadian Forces compared favourably with that of the civilian population within Canada and internationally. The creation of a diabetes registry is expected to lead to further improvements in diabetes care.

The objective of the thesis was to evaluate the quality of diabetes care in the Canadian Forces by determining the extent to which physicians adhere to recommendations outlined in the 2008 Canadian Diabetes Association (CDA) clinical practice guidelines. In addition, the effect of patient age, sex, rank and size of base on quality of care was assessed and the accuracy of a diagnosis of diabetes in an extract of the electronic medical record (EMR) was evaluated. Fourteen bases within the Canadian Forces were selected for investigation, representing roughly half of the Canadian Forces population. Cases of diabetes were ascertained based on laboratory criteria following a chart review. Twenty-one CDA guideline recommendations were considered. The Canadian Forces demonstrated greater than 75% adherence with each of 9 recommendations, 50-75% adherence with each of 7 recommendations and less than 50% adherence with each of 5 recommendations. The overall adherence with all applicable recommendations per patient was 60.3% (SE 0.66). Age, sex, rank and size of base were not important factors influencing guideline adherence. The sensitivity of a diabetes diagnosis in an extract of the EMR was 84.5%, the specificity was 99.8%, the positive predictive value was 85.1% and the negative predictive value was 99.8%. This is similar to the performance of provincial and national diabetes registries. The quality of diabetes care in the Canadian Forces compared favourably with that of the civilian population within Canada and internationally. The creation of a diabetes registry is expected to lead to further improvements in diabetes care.