Guideline Development Process Research Articles

Assessing the process and outcome of the development of practice guidelines and recommendations: PANELVIEW instrument development.

Guideline recommendations may be affected by flaws in the process, inappropriate panel member selection or conduct, conflicts of interest and other factors. To our knowledge, no validated tool exists to evaluate guideline development from the perspective of those directly involved in the process. Our objective was to develop and validate a universal tool, the PANELVIEW instrument, to assess guideline processes, methods and outcomes from the perspective of the participating guideline panellists and group members. We performed a systematic literature search and surveys of guideline groups (identified through contacting international organizations and convenience sampling of working panels) to inform item generation. Subsequent groups of guideline methodologists and panellists reviewed items for face validity and missing items. We used surveys, interviews and expert review for item reduction and phrasing. For reliability assessment and feedback, we tested the PANELVIEW tool in 8 international guideline groups. We surveyed 62 members from 13 guideline panels, contacted 19 organizations and reviewed 20 source documents to generate items. Fifty-three additional key informants provided feedback about phrasing of the items and response options. We reduced the number of items from 95 to 34 across domains that included administration, training, conflict of interest, group dynamics, chairing, evidence synthesis, formulating recommendations and publication. The tool takes about 10 minutes to complete and showed acceptable measurement properties. The PANELVIEW instrument fills a gap by enabling guideline organizations to involve clinicians, patients and other participants in evaluating their guideline processes. The tool can inform quality improvement of existing or new guideline programs, focusing on insight into and transparency of the guideline development process, methods and outcomes.

Knowledge translation of the Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: a collaborative movement guideline knowledge translation process.

Establishing a step-by-step process that provides practitioners with a blueprint for translating movement guidelines into action stands to optimize the investment in guideline development, improve guideline promotion and uptake, and ultimately enhance population health. The purpose of this paper is to describe how the Knowledge-to-Action framework and integrated knowledge translation were operationalized to systematically inform our knowledge translation (KT) efforts for the Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older. In October 2018, the need for a KT Process, operating in tandem with the Guideline Development Process, led to the establishment of a KT team with a specific structure and terms of reference. The KT team collaboratively agreed on decision-making principles prior to selecting target audiences to focus their efforts. We undertook formative research to assess the local context and determinants of guideline dissemination and implementation efforts among target audiences. Plans for the subsequent steps and research are outlined. We highlight recommendations and lessons learned for applying the process in other settings. Novelty We outline a collaborative and systematic process and research program for the knowledge translation of movement guidelines. This paper provides an innovative and replicable blueprint to optimize future movement guideline knowledge translation efforts.

The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia.

(Reprinted with permission from The American Journal of Psychiatry 2020; 177:868-872).

UEG framework for the development of high-quality clinical guidelines.

The 48 national member societies and 17 specialist member societies which operate under the umbrella of United European Gastroenterology (UEG) increasingly develop clinical practice guidelines for both national and international implementation. The methodologies and strategies used in these guidelines vary considerably. The UEG Quality of Care Taskforce aimed to provide a framework for quality guidelines in order to assist member societies in the process of developing guidelines, and to provide a tool for readers of guidelines to critically appraise their quality. We outline the steps necessary to begin the guideline development process, how to build working groups, how to search for evidence, how to grade the quality of the evidence, how to reach consensus on statements and how to write the guideline document. We believe that using this framework will increase the potential to produce a high-quality guideline which is transparent, independent, reproducible and implementable.

Approaches of integrating the development of guidelines and quality indicators: a systematic review

BackgroundGuidelines and quality indicators (for example as part of a quality assurance scheme) aim to improve health care delivery and health outcomes. Ideally, the development of quality indicators should be grounded in evidence-based, trustworthy guideline recommendations. However, anecdotally, guidelines and quality assurance schemes are developed independently, by different groups of experts who employ different methodologies. We conducted an extension and update of a previous systematic review to identify, describe and evaluate approaches to the integrated development of guidelines and related quality indicators.MethodsOn May 24th, 2019 we searched in Medline, Embase and CINAHL and included studies if they reported a methodological approach to guideline-based quality indicator development and were published in English, French, or German.Results: Out of 16,034 identified records, we included 17 articles that described a method to integrate guideline recommendations development and quality indicator development. Added to the 13 method articles from original systematic review we included a total 30 method articles. We did not find any evaluation studies. In most approaches, guidelines were a source of evidence to inform the quality indicator development. The criteria to select recommendations (e.g. level of evidence or strength of the recommendation) and to generate, select and assess quality indicators varied widely. We found methodological approaches that linked guidelines and quality indicator development explicitly, however none of the articles reported a conceptual framework that fully integrated quality indicator development into the guideline process or where quality indicator development was part of the question formulation for developing the guideline recommendations.ConclusionsIn our systematic review we found approaches which explicitly linked guidelines with quality indicator development, nevertheless none of the articles reported a comprehensive and well-defined conceptual framework which integrated quality indicator development fully into the guideline development process.

The future of Cochrane Neonatal

The future of Cochrane Neonatal

People With Lived Experience at the Centre of Canadian Stroke Best Practice Recommendations: A Model for Guideline Developers.

Actively engaging people with lived experience (PWLE) in stroke-related clinical practice guideline development has not been effectively implemented. This pilot project evaluated the feasibility, perceived value, and effectiveness of the Community Consultation and Review Panel (CCRP), a new model to engage PWLE in the writing and review of Canadian Stroke Best Practice Recommendations. Responses to a standardized evaluation tool indicated that participants perceived the CCRP as valued, impactful, effective, and beneficial to stroke care. This project successfully demonstrated that values, experiences, and recommendations of PWLE can be effectively incorporated into guideline content and is applicable to all guideline development processes.

Identifying research questions for HIV, tuberculosis, tuberculosis-HIV, malaria, and neglected tropical diseases through the World Health Organization guideline development process: a retrospective analysis, 2008–2018

ObjectivesWorld Health Organization (WHO) guidelines for health programmes and healthcare delivery are the foundation of its technical leadership in public health and essential to decision-making globally. A key function of guideline development is to identify areas in which further evidence is needed because filling these gaps will lead to future improvements in population health. The objective of this study was to examine the knowledge gaps and research questions for addressing those gaps generated through the WHO guideline development process, with the goal of informing future strategies for improving and strengthening the guideline development process. Study designWe did a systematic, retrospective analysis of research questions identified in the published guidelines. MethodsWe analyzed guidelines published between January 1, 2008, and December 31, 2018, by the Communicable Diseases Cluster in five disease areas: tuberculosis (TB), HIV, malaria, TB-HIV, and neglected tropical diseases (NTDs). Research questions were extracted independently by two researchers. We analyzed the distribution of research questions by disease and by topic category and did a qualitative assessment of optimum practice for research question generation during the guideline development process. ResultsA total of 48 guidelines were included: 26 on HIV, 1 on malaria, 11 on TB, 5 on TB/HIV, and 5 on NTDs. Overall, 36 (75%) guidelines encompassed a total of 360 explicit research questions; the remainder did not contain specific research questions. The number of research questions that focused on TB was 49, TB/HIV was 38, HIV was 250, and NTDs was 23. The number of research questions that focused on diagnosis was 43 (11.9%) of 360, prevention was 62 (17.2%), treatment was 103 (28.6%), good practice was 12 (3.3%), service delivery was 86 (23.8%), and other areas was 54 (15%). Research questions were often not formulated in a specific or actionable way and were hard to identify in the guideline. Examples of good practice identified by the review team involved the generation of specific and narrowly defined research questions, with accompanying recommendations for appropriate study design. ConclusionsThe WHO must strengthen its approach to identifying and presenting research questions during the guideline development process. Ensuring access to research questions is a key next step in adding value to the guideline development process.

Understanding international variation in national low-risk drinking guidelines: health policy report

Abstract Background The harmful use of alcohol is associated with adverse health, social, and economic consequences. National low-risk drinking guidelines provide evidence-based advice on how to reduce the risks associated with alcohol consumption and provide a basis for other alcohol-control interventions. There is substantial variation between guidelines and no international consensus on what constitutes 'low-risk' drinking. These discrepancies may lead to misinterpretation of the guidance, and such variation may undermine public confidence in experts and be exploited by the alcohol industry. Methods This project had two main components: (i) a literature review, to identify any new evidence from January 2016 to August 2019 suggesting a recommended threshold for 'low-risk' drinking; (ii) the analysis of six examples of national guidelines. Those from the UK, Ireland, Australia, New Zealand, Canada, and USA were examined for information about the utilisation of evidence to inform guidance, as well as details of the guideline development process. Thematic analysis of the UK, Canadian and Australian guidance explored wider influences on the guidelines. Results The literature review highlighted that all alcohol consumption carries some degree of risk. Content analysis of the guidelines emphasised the substantial variation in national guidance. Differences in the use of evidence and guideline development process may have given rise to at least some of the observed variation. Thematic analysis suggested that wider influences, such as differences in societal values, may also have contributed to disparities in the guidelines. Conclusions It may be possible to standardise certain areas of the development process, such as agreeing what constitutes an 'acceptable' level of alcohol-attributable risk. Further research is required to verify whether these results are generalisable to other countries, and to determine the most appropriate statistical model for risk calculations. Key messages The factors which determine guideline development are manifold and complex. Any level of alcohol consumption carries some degree of risk.

The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia

The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia

Developing evidence-based clinical imaging guidelines of justification for radiographic examination after dental implant installation

BackgroundThis study aimed to develop evidence-based clinical imaging guidelines to assess the proper implant location following implant surgery and identify potential complications during follow-up.MethodsThe guideline development process employed an adaptation methodology in accordance with the Korean clinical imaging guidelines (K-CIG). Core (Ovid-Medline, Ovid-Embase, National Guideline Clearinghouse, and Guideline International Network) and domestic databases (KoreaMed, KMbase, and KoMGI) were searched used to retrieve guidelines, and two reviewers analyzed the retrieved articles. The articles were included in this review using well-established inclusion criteria.ResultsOur online search identified 66 articles, of which 3 were selected for the development of the guidelines. Consequently, based on these three guidelines, we formulated distinct recommendations regarding the appropriate imaging modalities that should be used following implant placement.ConclusionsConventional imaging (e.g., periapical or panoramic radiography) should be the first choice for assessing the implant following its placement and osseointegration. The metal artifacts in Cone Beam Computed Tomography (CBCT) should be considered. However, CBCT is recommended for patients with sensory abnormalities following dental implant surgery to evaluate and identify the underlying cause of implant complications and to determine the appropriate treatment.

Development and implementation of guidelines for the management of depression: a systematic review.

ObjectiveTo evaluate the development and implementation of clinical practice guidelines for the management of depression globally.MethodsWe conducted a systematic review of existing guidelines for the management of depression in adults with major depressive or bipolar disorder. For each identified guideline, we assessed compliance with measures of guideline development quality (such as transparency in guideline development processes and funding, multidisciplinary author group composition, systematic review of comparative efficacy research) and implementation (such as quality indicators). We compared guidelines from low- and middle-income countries with those from high-income countries.FindingsWe identified 82 national and 13 international clinical practice guidelines from 83 countries in 27 languages. Guideline development processes and funding sources were explicitly specified in a smaller proportion of guidelines from low- and middle-income countries (8/29; 28%) relative to high-income countries (35/58; 60%). Fewer guidelines (2/29; 7%) from low- and middle-income countries, relative to high-income countries (22/58; 38%), were authored by a multidisciplinary development group. A systematic review of comparative effectiveness was conducted in 31% (9/29) of low- and middle-income country guidelines versus 71% (41/58) of high-income country guidelines. Only 10% (3/29) of low- and middle-income country and 19% (11/58) of high-income country guidelines described plans to assess quality indicators or recommendation adherence.ConclusionGlobally, guideline implementation is inadequately planned, reported and measured. Narrowing disparities in the development and implementation of guidelines in low- and middle-income countries is a priority. Future guidelines should present strategies to implement recommendations and measure feasibility, cost–effectiveness and impact on health outcomes.

GRADE-Leitlinien zu Gerechtigkeit 4. Berücksichtigung der Gerechtigkeit im Gesundheitswesen bei der Entwicklung von GRADE-Leitlinien: von der Evidenz zur Empfehlung

ObjectivesThe aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) evidence to decision process. Study Design and SettingWe developed this guidance based on the GRADE evidence to decision frame-work, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. This is a German translation of the original paper published in English. ResultsConsidering the impact on health equity may be required, both in general guidelines and guide-lines that focus on disadvantaged populations. We suggest two approaches to incorporate equity considerations: (1) assessing the potential impact of interventions on equity and (2) incorporating equity considerations when judging or weighing each of the evidence to decision criteria. We provide guidance and include illustrative examples. ConclusionGuideline panels should consider the impact of recommendations on health equity with attention to remote and underserviced settings and disadvantaged populations. Guideline panels may wish to incorporate equity judgments across the evidence to decision framework. This is the fourth and final paper in a series about considering equity in the GRADE guideline development process. This series is coming from the GRADE equity subgroup.

Development of a Multinational Clinical Practice Guideline: A Practical Structured Procedure

Introduction: The development of a clinical guideline is a challenging process. National and international organizations have established a variety of approaches, grading systems, evaluation scales, and voting modes; however, a practical description which illustrates all steps from starting the initiative to publication and dissemination of the guideline is usually not provided. We describe a structured guideline procedure that can be adjusted to the requirements of other multinational guidelines. Methods: A group of European specialist gastroenterological societies and national societies initiated a guideline for the use of breath tests in gastroenterology. A balance between scientific evidence and clinical experience was achieved by involving European specialist societies and physicians from 18 European countries. For persons contributing to the guideline process, different levels of involvement were defined. The tasks were assigned to different groups of persons, which formed scientific institutions. Results: We describe organizational structures and institutions, the stepwise approach, and illustrate the multistep guideline development procedure in a flowchart diagram that shows workflow and assigned responsibilities and provides details for the execution of each step, including timelines. The process is split into 4 phases: foundation, preparation, voting, and publication. Discussion: This structured procedure of a gastroenterological clinical practice guideline can serve as a blueprint for future multinational guideline initiatives and may aid future attempts to standardize and harmonize guideline development processes in gastroenterology and in other medical fields. Although the described procedure is for a diagnostic guideline, it may also be appropriate for therapeutic guidelines by adjusting the acceptance criteria for recommendations.

The Veterans Administration and Department of Defense clinical practice guidelines for the diagnosis and management of sleep disorders: what does this mean for the practice of sleep medicine?

In 2017 the Veterans Administration (VA) and Department of Defense (DOD) launched development of clinical practice guidelines (CPGs) for the diagnosis and treatment of sleep disorders, with the goal of informing and improving patient care. The guideline development process followed GRADE methodology, considering studies and systematic reviews published over the 10-year period prior to guideline development. A total of 41 recommendations were made,18 related to the diagnosis and treatment of obstructive sleep apnea (OSA) and 23 regarding chronic insomnia disorder. In contrast to other published guidelines, the VA DoD CPGs provide a comprehensive approach to diagnosis and management of the two most common sleep disorders, including a discussion of the sequencing of diagnostic approaches and treatment options. Regarding OSA, strong recommendations were made for follow-up evaluation after non-diagnostic home sleep apnea tests, positive airway pressure therapy as first-line treatment, and the incorporation of supportive, educational and behavioral interventions for patients at high risk for PAP therapy non-adherence due to comorbid conditions. Strong recommendations were also made for the use of cognitive-behavioral therapy for insomnia and against the use of kava (an herbal supplement) in the treatment of chronic insomnia disorder. These guidelines, while intended to directly inform care within VA and DOD, are broadly relevant to the practice of sleep medicine. The majority of scientific evidence was based on studies of non-military, non-veteran populations. The CPG is a major milestone for the VA and DOD in recognizing the importance of evidence-based treatments for sleep disorders in military personnel and veterans.

Evidence-based nutritional guidelines: What is meant by trustworthy recommendations

The article aims to describe the characteristics of trustworthy recommendations as well as standards for trustworthy guidelines published by the Institute of Medicine and tools that can be used for quality assessment. The next section summarizes published assessments of guidelines quality using AGREE (Appraisal of Guidelines, Research and Evaluation Collaboration) Instrument and the problems raised by the National Academy of Sciences regarding nutritional guidelines development process. In this ones, similar problems are also reflected in the assessment of quality of nutritional guidelines, also using AGREE Instrument, since less than 50?% of the documents rated as high quality. The article is concluded with the description of NutriRECS protocol, as an example of strict, transparent and comprehensive approach to develop nutritional guidelines.

Development of locally relevant clinical guidelines for procedure-related neonatal analgesic practice in Kenya: a systematic review and meta-analysis

SummaryBackgroundIncreasing numbers of neonates are undergoing painful procedures in low-income and middle-income countries, with adequate analgesia seldom used. In collaboration with a multi-disciplinary team in Kenya, we aimed to establish the first evidence-based guidelines for the management of routine procedure-related neonatal pain that consider low-resource hospital settings.MethodsWe did a systematic review by searching MEDLINE, Embase, CINAHL, and CENTRAL databases for studies published from Jan 1, 1953, to March 31, 2019. We included data from randomised controlled trials using heart rate, oxygen saturation (SpO2), premature infant pain profile (PIPP) score, neonatal infant pain scale (NIPS) score, neonatal facial coding system score, and douleur aiguë du nouveau-né scale score as pain outcome measures. We excluded studies in which neonates were undergoing circumcision or were intubated, studies from which data were unextractable, or when pain was scored by non-trained individuals. We did a narrative synthesis of all studies, and meta-analysis when data were available from multiple studies comparing the same analgesics and controls and using the same outcome measures. 17 Kenyan health-care professionals formed our clinical guideline development panel, and we used the Grading of Recommendations, Assessment, Development and Evaluation framework and the panel's knowledge of the local health-care context to guide the guideline development process. This study is registered with PROSPERO, CRD42019126620.FindingsOf 2782 studies assessed for eligibility, data from 149 (5%) were analysed, with 80 (3%) of these further contributing to our meta-analysis. We found a high level of certainty for the superiority of breastfeeding over placebo or no intervention (standardised mean differences [SMDs] were −1·40 [95% CI −1·96 to −0·84] in PIPP score and −2·20 [–2·91 to −1·48] in NIPS score), and the superiority of oral sugar solutions over placebo or no intervention (SMDs were −0·38 [–0·61 to −0·16] in heart rate and 0·23 [0·04 to 0·42] in SpO2). We found a moderate level of certainty for the superiority for expressed breastmilk over placebo or no intervention (SMDs were −0·46 [95% CI −0·87 to −0·05] in heart rate and 0·48 [0·20 to 0·75] in SpO2). Therefore, the panel recommended that breastfeeding should be given as first-line analgesic treatment, initiated at least 2 min pre-procedure. Given contextual factors, for neonates who are unable to breastfeed, 1–2 mL of expressed breastmilk should be given as first-line analgesic, or 1–2 mL of oral sugar (≥10% concentration) as second-line analgesic. The panel also recommended parental presence during procedures with adjunctive provision of skin-to-skin care, or non-nutritive sucking when possible.InterpretationWe have generated Kenya's first neonatal analgesic guidelines for routine procedures, which have been adopted by the Kenyan Ministry of Health, and have shown a framework for clinical guideline development that is applicable to other low-income and middle-income health-care settings.FundingWellcome Trust Research Programme, and the Africa-Oxford Initiative.

GRADE-Leitlinien zu Gerechtigkeit 3: Berücksichtigung der Gerechtigkeit im Gesundheitswesen bei der Entwicklung von GRADE-Leitlinien: Vertrauenswürdigkeit der Evidenz beurteilen

ObjectivesThe aim of this paper is to describe a conceptual framework for how to consider health equity in the Grading Recommendations Assessment and Development Evidence (GRADE) guideline development process. Study Design and SettingConsensus-based guidance developed by the GRADE working group members and other methodologists. This is a German translation of the original paper published in English. ResultsWe developed consensus-based guidance to help address health equity when rating the certainty of synthesized evidence (i.e., quality of evidence). When health inequity is determined to be a concern by stakeholders, we propose five methods for explicitly assessing health equity: (1) include health equity as an outcome; (2) consider patient-important outcomes relevant to health equity; (3) assess differences in the relative effect size of the treatment; (4) assess differences in baseline risk and the differing impacts on absolute effects; and (5) assess indirectness of evidence to disadvantaged populations and/or settings. ConclusionThe most important priority for research on health inequity and guidelines is to identify and document examples where health equity has been considered explicitly in guidelines. Although there is a weak scientific evidence base for assessing health equity, this should not discourage the explicit consideration of how guidelines and recommendations affect the most vulnerable members of society.

Development and use of health outcome descriptors: a guideline development case study

BackgroundDuring healthcare guideline development, panel members often have implicit, different definitions of health outcomes that can lead to misunderstandings about how important these outcomes are and how to balance benefits and harms. McMaster GRADE Centre researchers developed ‘health outcome descriptors’ for standardizing descriptions of health outcomes and overcoming these problems to support the European Commission Initiative on Breast Cancer (ECIBC) Guideline Development Group (GDG). We aimed to determine which aspects of the development, content, and use of health outcome descriptors were valuable to guideline developers.MethodsWe developed 24 health outcome descriptors related to breast cancer screening and diagnosis for the European Commission Breast Guideline Development Group (GDG). Eighteen GDG members provided feedback in written format or in interviews. We then evaluated the process and conducted two health utility rating surveys.ResultsFeedback from GDG members revealed that health outcome descriptors are probably useful for developing recommendations and improving transparency of guideline methods. Time commitment, methodology training, and need for multidisciplinary expertise throughout development were considered important determinants of the process. Comparison of the two health utility surveys showed a decrease in standard deviation in the second survey across 21 (88%) of the outcomes.ConclusionsHealth outcome descriptors are feasible and should be developed prior to the outcome prioritization step in the guideline development process. Guideline developers should involve a subgroup of multidisciplinary experts in all stages of development and ensure all guideline panel members are trained in guideline methodology that includes understanding the importance of defining and understanding the outcomes of interest.

From guidelines to practice: development and implementation of disability-specific physical activity guidelines

Purpose Among people with physical disabilities, one of the most frequently-cited barriers to physical activity participation is a lack of basic information on what to do. Likewise, rehabilitation professionals often cite a lack of knowledge about what to recommend or prescribe, as their primary reason for not promoting physical activity to clients with disabilities. The development and implementation of disability-specific physical activity guidelines are important steps toward addressing informational barriers. This paper describes the reasoning behind disability-specific physical activity guidelines, the gold-standard process used to develop disability-specific guidelines for people with spinal cord injury and multiple sclerosis, and the “who, what, and how” of behavioural interventions and messaging to support people with disabilities in achieving physical activity guidelines. Materials and Methods Not Applicable. Results Not Applicable. Conclusions The needs, values and preferences of people with disabilities must be taken into consideration when undertaking a disability-specific guideline development process. Guidelines can play an important role in physical activity promotion, but behavioural and other interventions are required to address the myriad physical activity barriers faced by people with disabilities. Implications for Rehabilitation People with and without disabilities can achieve significant fitness and health benefits from activity well below the WHO’s 150 minutes/week guideline. Disability-specific physical activity guidelines can alleviate informational barriers for people who want to get active and rehabilitation professionals who want to promote physical activity. Behavioural and other interventions are needed to support people’s efforts to achieve physical activity guidelines. A physiotherapist-delivered intervention has shown promise for increasing physical activity in adults with a physical disability.