Guideline Development Process Research Articles

Efficiency, Economy and Excellence: Experimental Exploration of Evidence-based Guideline Development in Resource-Constrained Settings.

Development of clinical practice guidelines is a scientific process based on a thorough review and appraisal of the global evidence, but factoring in local contextually relevant issues. It is highly resource intensive, demanding considerable time, human skills, and finances- making it challenging in resource-constrained settings. This article summarizes a unique attempt to develop evidence-based guidelines in such settings. This was made possible by mentoring and monitoring a group of committed healthcare professionals with limited prior expertise in evidence-based guideline development. The various steps included an online training workshop to build knowledge and skills. This was followed by a systematic process of identifying topics requiring evidence-based guidelines. Thereafter, the topics were prioritized through a Delphi process. Formal clinical questions were framed using the PICOTS (Patient/ Population, Intervention/ Exposure, Comparison, Outcome, Time-frame, Setting) format. The guideline development process was made time and resource efficient by starting with a formal search for existing guidelines whose recommendations could be adopted, adapted, or adoloped to the local setting. If such guidelines were unavailable, high quality secondary evidence (systemic reviews) was accessed to find answers to the clinical questions. If unavailable, de novo systematic reviews of primary research studies were undertaken. The evidence base was critically appraised and graded. Formal evidence-to-decision formats were used to enable translation of the evidence to recommendations implementable in the local setting. The entire guideline development process was completed with zero financial allocation. This model focusing on efficiency, economy, and excellence, can be emulated in diverse resource-constrained settings.

Using AGREE II reporting checklist to evaluate the quality of Tuina clinical practice guidelines.

The objective of this study is to evaluate the methodological quality of Tuina clinical practice guidelines (CPGs). Computer searches of China National Knowledge Infrastructure (CNKI), Chinese Technical Periodicals (VIP), Wanfang Data Knowledge Service Platform, PubMed, Cochrane Library, Embase, and other databases were conducted to search for published guidelines on Tuina, with a search time frame from database creation to March 2021. Four evaluators independently used the Appraisal of Guidelines for Research and Evaluation II instrument to evaluate the quality of the included guidelines. A total of eight guidelines related to Tuina were included in this study. The quality of reporting was low in all included guidelines. The highest quality report had a total score of 404 and was rated as "highly recommended." The worst guideline had a final score of 241 and was rated as "not recommended." Overall, 25% of the included guidelines were recommended for clinical use, 37.5% were recommended after revision, and 37.5% were not recommended. The number of existing Tuina clinical practice guidelines is limited. The methodological quality is low, far from the internationally accepted clinical practice guideline development and reporting norms. In the future, reporting specifications of guidelines and the methodology of guideline development, including the rigor of the guideline development process, the clarity, application, and independence of reporting, should be emphasized in the development of the Tuina guidelines. These initiatives could improve the quality and applicability of clinical practice guidelines to guide and standardize the clinical practice of Tuina.

THE GENIUS BEHIND GUIDELINES

Medical guidelines are documents containing recommendations which can be used in clinical practice. They are intended to help physicians make informed decisions on diagnostic or treatment dilemmas and help achieve the best outcomes for patients. Medical guidelines are not made overnight. Members of the guidelines development committee, composed of a multidisciplinary panel of experts from key groups, are carefully chosen to produce a high qualityscientificdocument. Thisisachievedthrough atransparent,evidence-baseddecision-makingprocess that is labor intensive and rigorous. This ensures that guidelines are sound, credible and at par with international standards. The process starts by defining the topic and scope for guideline development. Key issues and questions regarding the topic are drafted. Review of questions, literature search, evidence reviews, and committee discussions are done. Available medical evidence are summarized, and grading of evidence is made, until a draft recommendation is developed. Draft guidelines are then reviewed by stakeholders until a final guideline is produced and published. In this special issue, we bring you outputs from this guideline development process - four relevant documents on COVID-19, Pediatric Community Acquired Pneumonia (in collaboration with the Philippine Academy of Pediatric Pulmonologists), Leptospirosis, and Pediatric Immunization (prepared by the National Institutes of Health-Institute of Clinical Epidemiology and funded by the Department of Health ). The guideline development process is imperfect. Some shortcomings include paucity of evidence on certain questions, presence of potential conflicts of interest among members of the committee, limitations in funding, and even time. The major advantage is access to a summarized wealth of evidence on a specific topic to enhance physician expertise, improve healthcare quality, and reduce healthcare cost. Guidelines can also influence health policies so that underrecognized health concerns and services can be made available to the majority. Guidelines should be used with the best interest of the individual patient in mind. They help to improve patient care quality. The complex medical decision making process done by the physician however, should not be limited by simplistic algorithms suggested by guidelines.

PHILIPPINE GUIDELINES ON PERIODIC HEALTH EXAMINATION: PEDIATRIC IMMUNIZATION

This Clinical Practice Guideline for the Periodic Health Examination (Pediatric Immunization) is an output from the joint undertaking of the Department of Health and National Institutes of Health-Institute of Clinical Epidemiology. This clinical practice guideline is a systematic synthesis of scientific evidence on immunization for the prevention of human papilloma virus (HPV) infection, influenza, typhoid fever, Japanese encephalitis, poliomyelitis, meningococcal infection, and Hepatitis A in the pediatric population. The CPG provides nine (9) recommendations on prioritized questions regarding the relevant vaccines for preventing these seven (7) diseases. Recommendations are based on the appraisal of the best available evidence on each of the eight identified clinical questions. The CPG is intended to be used by general practitioners and specialists in the primary care setting, policy makers, employers and administrators, allied health practitioners and even patients. The guideline development process followed the widely accepted Grading of Recommendations, Assessment, Development, and Evaluation or the GRADE approach including GRADE Adolopment, a systematic process of adapting evidence summaries and the GRADE Evidence to Decision (EtD) framework. , It includes 1) identification of critical questions and critical outcomes, 2) retrieval of current evidence, 3) assessment and synthesis of the evidence base for these critical questions, 4) formulation of draft recommendations, 5) convening of a multi­sectoral stakeholder panel to discuss values and preferences and assess the strength of the recommendations, and 6) planning for dissemination, implementation, impact evaluation and updating. The recommendations in this CPG shall hold and will be updated after 3 years or when new evidence arise.

Rapid development of an evidence- and consensus-based guideline for controlling transmission of SARS-CoV-2 in schools during a public health emergency - A process evaluation.

Different measures to prevent and control the spread of SARS-CoV-2 have been implemented in German schools. Decisions regarding such measures should be informed by evidence regarding their effectiveness, and their unintended consequences for health and society. A multi-stakeholder panel was convened to develop an evidence- and consensus-based guideline for school measures, using the novel WHO-INTEGRATE framework. Developing a guideline to inform decision-making outside of the clinical realm during a public health emergency was unprecedented in Germany. This study aims to identify lessons learnt for similar endeavours by addressing the following research question: What were the strengths and weaknesses of the guideline development process as perceived by the different groups involved? Fifteen semi-structured interviews were conducted virtually. We recruited participants aiming to include the perspectives of all groups contributing to the guideline development, including both panel members (scientists, practitioners, school family and observers) and the guideline secretariat. For analysis, we carried out deductive-inductive thematic qualitative text analysis according to Kuckartz, structuring findings using a category system. Due to time pressure, the guideline secretariat was heavily involved not only in synthesising the evidence but also in developing and drafting recommendations. Participants critically reflected on certain methods-related decisions, including the development of draft recommendations and application of the WHO-INTEGRATE framework by scientists only. The full potential of the framework might not have been harnessed. Participants' understanding of relevant and valid evidence varied, and the available evidence base was limited. Participants represented different types of expertise, notably expertise informed by scientific evidence and expertise grounded in lived experience, influencing their involvement in the guideline development process and discussions during meetings. Developing an evidence- and consensus-based public health guideline in only three months was challenging, notably because of the involvement of a broad range of stakeholders and the use of a novel Evidence-to-Decision framework, both unprecedented in Germany. Learning from this process with a view to "institutionalising" the development of public health guidelines and refining methods can contribute to more evidence-informed public health decision-making in Germany and beyond, in general and during a public health emergency.

Surviving Sepsis Campaign.

Surviving Sepsis Campaign.

Exploring possibilities for child participation in guideline development: The need for a fundamental reconsideration and reconfiguration of the system

AbstractWhile the right of children to be involved in decisions that concern them has been widely recognised, they are currently barely involved in guideline development in healthcare. This paper aims to explore what a future guideline development system in which children are meaningfully involved might look like and to reflect on the transition required to achieve this. We used a systems innovation perspective, exploring child participation within its systemic context and complexity. To this end, we conducted 24 interviews with various actors, about their ideas on and experiences with child participation in guideline development in the Dutch system (between August 2018 and September 2020), complemented with a scoping review. The current system is characterised by a high‐speed, rigid process that relies heavily on scientific evidence. Children are usually not included or taken seriously. The contours of a system in which children are meaningfully involved would differ markedly: children would be considered capable and taken seriously, and the guideline development process would be flexible, with time for interaction with children and discussion about the implications of their perspectives. We encountered few examples of child participation in guideline development worldwide, and believe our results are indicative of the situation in other Western countries. We propose the following actions: (1) Development of a discussion arena to create a joint vision on the aim of guideline development and subsequently the role of child participation therein. (2) Set up of transition experiments unbound by the current constellation, conducted by front‐runners who are open to children's perspectives. These are essential to clarify pathways towards a future in which the voices of children are meaningfully integrated. It remains to be seen, however, whether there are sufficient actors who feel the necessary urgency for change.

Joint 2022 European Society of Thoracic Surgeons and The American Association for Thoracic Surgery guidelines for the prevention of cancer-associated venous thromboembolism in thoracic surgery.

Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, is a potentially fatal but preventable postoperative complication. Thoracic oncology patients undergoing surgical resection, often after multimodality induction therapy, represent among the highest risk groups for postoperative VTE. Currently there are no VTE prophylaxis guidelines specific to these thoracic surgery patients. Evidenced-based recommendations will help clinicians manage and mitigate risk of VTE in the postoperative period and inform best practice. These joint evidence-based guidelines from The American Association for Thoracic Surgery and the European Society of Thoracic Surgeons aim to inform clinicians and patients in decisions about prophylaxis to prevent VTE in patients undergoing surgical resection for lung or esophageal cancer. The American Association for Thoracic Surgery and the European Society of Thoracic Surgeons formed a multidisciplinary guideline panel that included broad membership to minimize potential bias when formulating recommendations. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used, including GRADE Evidence-to-Decision frameworks, which were subject to public comment. The panel agreed on 24 recommendations focused on pharmacological and mechanical methods for prophylaxis in patients undergoing lobectomy and segmentectomy, pneumonectomy, and esophagectomy, as well as extended resections for lung cancer. The certainty of the supporting evidence for the majority of recommendations was judged as low or very low, largely due to a lack of direct evidence for thoracic surgery. The panel made conditional recommendations for use of parenteral anticoagulation for VTE prevention, in combination with mechanical methods, over no prophylaxis for cancer patients undergoing anatomic lung resection or esophagectomy. Other key recommendations include: conditional recommendations for using parenteral anticoagulants over direct oral anticoagulants, with use of direct oral anticoagulants suggested only in the context of clinical trials; conditional recommendation for using extended prophylaxis for 28 to 35days over in-hospital prophylaxis only for patients at moderate or high risk of thrombosis; and conditional recommendations for VTE screening in patients undergoing pneumonectomy and esophagectomy. Future research priorities include the role of preoperative thromboprophylaxis and the role of risk stratification to guide use of extended prophylaxis.

Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)

(1) Background: Topical non-steroidal anti-inflammatory drugs (NSAIDs) are one of the primary drugs for treating musculoskeletal pain. However, there are currently no evidence-based recommendations about drug selection, drug administration, drug interactions, and use in special populations or other pharmacology-related content of such medications. To this end, the Chinese Pharmaceutical Association Hospital Pharmacy Professional Committee developed multidisciplinary guidelines on using topical NSAIDs to treat musculoskeletal pain. (2) Methods: The guidelines development process followed the World Health Organization guideline development handbook, the GRADE methodology, and the statement of Reporting Items for Practice Guidelines in Healthcare. The guideline panel used the Delphi method to identify six clinical questions to be addressed in the guidelines. An independent systematic review team conducted a systematic search and integration of evidence. (3) Results: Based on the balance between the benefits and harms of an intervention, the quality of the evidence, patient preferences and values, and resource utilization, the guideline panel developed 11 recommendations and nine expert consensuses on using topical NSAIDs to treat acute and chronic musculoskeletal pain. (4) Conclusions: Based on the effectiveness and overall safety of topical NSAIDs, we recommend patients with musculoskeletal pain use topical NSAIDs and suggest high-risk patients use topical NSAIDs, such as those with other diseases or receiving other concurrent treatments. The evidenced-based guidelines on topical NSAIDs for musculoskeletal pain incorporated a pharmacist perspective. The guidelines have the potential to facilitate the rational use of topical NSAIDs. The guideline panel will monitor the relevant evidence and update the recommendations accordingly.

Representation of evidence-based clinical practice guideline recommendations on FHIR

BackgroundVarious formalisms have been developed to represent clinical practice guideline recommendations in a computer-interpretable way. However, none of the existing formalisms leverage the structured and computable information that emerge from the evidence-based guideline development process. Thus, we here propose a FHIR-based format that uses computer-interpretable representations of the knowledge artifacts that emerge during the process of evidence-based guideline development to directly serve as the basis of evidence-based recommendations. MethodsWe identified the information required to represent evidence-based clinical practice guideline recommendations and reviewed the knowledge artifacts emerging during the evidence-based guideline development process. We then conducted a consensus-based design process with domain experts to develop an information model for guideline recommendation representation that is structurally aligned to the evidence-based guideline recommendation development process and a corresponding representation based on FHIR resources developed for evidence-based medicine (EBMonFHIR). The resulting recommendations were modelled and represented in conformance with the FHIR Clinical Guidelines (CPG-on-FHIR) implementation guide. ResultsThe information model of evidence-based clinical guideline recommendations and its EBMonFHIR-/CPG-on-FHIR-based representation contain the clinical contents of individual guideline recommendations, a set of metadata for the recommendations, the ratings for the recommendations (e.g., strength of recommendation, certainty of overall evidence), the ratings of certainty of evidence for individual outcomes (e.g., risk of bias) and links to the underlying evidence (systematic reviews based on primary studies). We created profiles and an implementation guide for all FHIR resources required to represent the knowledge artifacts generated during evidence-based guideline development and their re-use as the basis for recommendations and used the profiles to implement an exemplary clinical guideline recommendation. ConclusionsThe FHIR implementation guide presented here can be used to directly link the evidence assessment process of evidence-based guideline recommendation development, i.e. systematic reviews and evidence grading, and the underlying evidence from primary studies to the resulting guideline recommendations. This not only allows the evidence on which recommendations are based on to be evaluated transparently and critically, but also enables guideline developers to leverage computable evidence in a more direct way to facilitate the generation of computer-interpretable guideline recommendations.

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

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

How guideline development has informed clinical research for organic acidurias (et vice versa).

Organic acidurias, such as glutaric aciduria type 1 (GA1), methylmalonic (MMA), and propionic aciduria (PA) are a prominent group of inherited metabolic diseases involving accumulation of eponymous metabolites causing endogenous intoxication. For all three conditions, guidelines for diagnosis and management have been developed and revised over the last years, resulting in three revisions for GA1 and one revision for MMA/PA. The process of clinical guideline development in rare metabolic disorders is challenged by the scarcity and limited quality of evidence available. The body of literature is often fragmentary and where information is present, it is usually derived from small sample sizes. Therefore, the development of guidelines for GA1 and MMA/PA was initially confronted with a poor evidence foundation that hindered formulation of concrete recommendations in certain contexts, triggering specific research projects and initiation of longitudinal, prospective observational studies using patient registries. Reversely, these observational studies contributed to evaluate the value of newborn screening, phenotypic diversities, and treatment effects, thus significantly improving the quality of evidence and directly influencing formulation and evidence levels of guideline recommendations. Here, we present insights into interactions between guideline development and (pre)clinical research for GA1 and MMA/PA, and demonstrate how guidelines gradually improved from revision to revision. We describe how clinical studies help to unravel the relative impact of therapeutic interventions on outcome and conclude that despite new and better quality of research data over the last decades, significant shortcomings of evidence regarding prognosis and treatment remain. It appears that development of clinical guidelines can directly help to guide research, and vice versa.

Approaches to clinical guideline development in healthcare: a scoping review and document analysis

BackgroundOver the past decade, an industry has emerged around Clinical Practice Guideline (CPG) development in healthcare, which has increased pressure on guideline-producing organisations to develop CPGs at an accelerated rate. These are intended to improve the quality of care provided to patients while containing healthcare costs and reducing variability in clinical practice. However, this has inadvertently led to discrepancies in CPG recommendations between health organisations, also challenging healthcare providers who rely on these for decision-making and to inform clinical care. From a global perspective, although some countries have initiated national protocols regarding developing, appraising and implementing high-quality CPGs, there remains no standardised approach to any aspect of CPG production.MethodsA scoping review of the literature and document analysis were conducted according to Joanna Brigg’s Institute methodology for scoping reviews. This comprised two qualitative methods: a comprehensive review of the literature (using CINAHL, Scopus and PubMeD) and a document analysis of all national and international guideline development processes (manual search of health-related websites, national/international organisational health policies and documents).ResultsA set of clear principles and processes were identified as crucial to CPG development, informing the planning, implementation and dissemination of recommendations. Fundamentally, two common goals were reported: to improve the quality and consistency of clinical practice (patient care) and to reduce the duplication or ratification of low-grade CPGs.ConclusionsConsultation and communication between CPG working parties, including a wide range of representatives (including professional organisations, regional and local offices, and relevant national bodies) is essential. Further research is required to establish the feasibility of standardising the approach and disseminating the recommendations.

Chemotherapy and Targeted Therapy for Endocrine-Pretreated or Hormone Receptor-Negative Metastatic Breast Cancer: ASCO Guideline Rapid Recommendation Update.

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.

Methods for living guidelines: early guidance based on practical experience. Paper 5: decisions on methods for evidence synthesis and recommendation development for living guidelines

ObjectivesProducing living guidelines requires making important decisions about methods for evidence identification, appraisal, and integration to allow the living mode to function. Clarifying what these decisions are and the trade-offs between options is necessary. This article provides living guideline developers with a framework to enable them to choose the most suitable model for their living guideline topic, question, or context. Study Design and SettingWe developed this guidance through an iterative process informed by interviews, feedback, and a consensus process with an international group of living guideline developers. ResultsSeveral key decisions need to be made both before commencing and throughout the continual process of living guideline development and maintenance. These include deciding what approach is taken to the systematic review process; decisions about methods to be applied for the evidence appraisal process, including the use of unpublished data; and selection of “triggers” to incorporate new studies into living guideline recommendations. In each case, there are multiple options and trade-offs. ConclusionWe identify trade-offs and important decisions to be considered throughout the living guideline development process. The most appropriate, and most sustainable, mode of development and updating will be dependent on the choices made in each of these areas.

An Executive Summary of The Philippine Interim Clinical Practice Guidelines for the Diagnosis and Management of Well Differentiated Thyroid Cancer 2021.

Thyroid cancer is the most common endocrine cancer in the Philippines affecting primarily women in the reproductive age group. Considering the burden of thyroid cancer in the country, the Department of Health (DOH) called for the development of a national clinical practice guideline that would address patient needs, and aid physicians in clinical decision-making while considering therapeutic cost and availability in the local setting. The 2021 guidelines are aimed at providing optimal care to Filipino patients by assisting clinicians in the evaluation of thyroid nodules and management of well differentiated thyroid cancer. A steering committee convened to formulate clinical questions pertaining to the screening and evaluation of thyroid nodules, surgical and post operative management of thyroid cancer, and palliative care for unresectable disease. A technical working group reviewed existing clinical guidelines, retrieved through a systematic literature search, synthesized clinical evidence, and drafted recommendations based on the ADAPTE process of clinical practice guideline development. The consensus panel reviewed evidence summaries and voted on recommendations for the final statements of the clinical practice guidelines. The guidelines consist of clinical questions and recommendations grouped into six key areas of management of well differentiated thyroid cancer: screening, diagnosis, surgical treatment, post operative management, surveillance, and palliative care. The 2021 guidelines for well differentiated cancer could direct physicians in clinical decision making, and create better outcomes for Filipino patients afflicted with the disease. However, patient management should still be governed by sound clinical judgement and open physician-patient communication.

2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment.

Helicobacter pylori ( H. pylori ) infection is an infectious disease with a prevalence rate of up to 50% worldwide. It can cause indigestion, gastritis, peptic ulcer, and gastric cancer. H. pylori eradication treatment can effectively control disease progression and reduce the risk of the above conditions. However, the escalating trend of antibiotic resistance presents a global challenge for H. pylori eradication. We aim to provide guidance on pharmacological treatment of H. pylori infection. This clinical practice guideline is developed following the World Health Organization's recommended process, adopting Grading of Recommendations Assessment, Development and Evaluation in assessing evidence quality, and utilizing Evidence to Decision framework to formulate clinical recommendations, minimizing bias and increasing transparency of the clinical practice guideline development process. We used the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement and The Appraisal of Guidelines for Research and Evaluation II (AGREE II) as reporting and conduct guides to ensure the guideline's completeness and transparency. Though decreasing in developed countries, the prevalence of H. pylori remains high in developing countries, causing a major public health burden. This clinical practice guideline contains 12 recommendations concerning pharmacological treatment for H. pylori eradication. Among them, it is worth highlighting that bismuth preparations are inexpensive, safe, and effective, consequently making bismuth quadruple therapy a preferred choice for initial and rescue treatment. In empirical treatment, high-dose dual therapy is equally effective compared with bismuth quadruple therapy. The 12 recommendations in this clinical practice guideline are formed with consideration for stakeholders' values and preferences, resource use, feasibility, and acceptability. Recommendations are generalizable to resource limited settings with similar antibiotic resistance pattern as China, and lower middle-income countries facing comparable sociological and technical challenges. Guidelines International Network (GIN) website, https://guidelines.ebmportal.com/node/69996 .

Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines.

Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry. Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards. Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839-$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455-$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945-0.987], P=0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011-1.025], P<0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards. There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.

Overview of clinical practice guideline development, application to pharmacy practice, and roles for pharmacists

AbstractAll health care professionals have a responsibility to integrate current evidence‐based medicine into their clinical practice to ensure the best possible patient care. Clinical practice guidelines (CPGs) play a major role in helping clinicians identify when and how to implement evidence into routine clinical practice to improve patient outcomes. The primary intent of CPGs is to benefit patients by improving the quality of care; however, CPGs also improve efficiency and effectiveness within the health care system. The process used to develop CPGs is important to ensure the recommendations are trustworthy, based on the highest‐quality evidence, and free of significant conflicts of interest. The National Academy of Medicine (NAM) published guidance on best practices for developing CPGs in 1990 and again in 2011. Additional guidance is provided by various reporting checklists for CPGs, such as the Appraisal of Guidelines for Research &amp; Evaluation (AGREE) II and Reporting Items for Practice Guidelines in Healthcare (RIGHT) instruments. However, analyses of published CPGs show inconsistent application of these best practices. This paper discusses the benefits of CPGs, reviews the guideline development process, discusses limitations in this process and in applying CPGs to patient care, identifies opportunities for improvement, provides considerations for educating learners and other health care professionals about CPGs, and examines the role of pharmacists in CPG development, dissemination, and implementation.

Joint 2022 European Society of Thoracic Surgeons and The American Association for Thoracic Surgery guidelines for the prevention of cancer-associated venous thromboembolism in thoracic surgery

Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, is a potentially fatal but preventable postoperative complication. Thoracic oncology patients undergoing surgical resection, often after multimodality induction therapy, represent among the highest risk groups for postoperative VTE. Currently there are no VTE prophylaxis guidelines specific to these thoracic surgery patients. Evidenced-based recommendations will help clinicians manage and mitigate risk of VTE in the postoperative period and inform best practice. These joint evidence-based guidelines from The American Association for Thoracic Surgery and the European Society of Thoracic Surgeons aim to inform clinicians and patients in decisions about prophylaxis to prevent VTE in patients undergoing surgical resection for lung or esophageal cancer. The American Association for Thoracic Surgery and the European Society of Thoracic Surgeons formed a multidisciplinary guideline panel that included broad membership to minimize potential bias when formulating recommendations. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used, including GRADE Evidence-to-Decision frameworks, which were subject to public comment. The panel agreed on 24 recommendations focused on pharmacological and mechanical methods for prophylaxis in patients undergoing lobectomy and segmentectomy, pneumonectomy, and esophagectomy, as well as extended resections for lung cancer. The certainty of the supporting evidence for the majority of recommendations was judged as low or very low, largely due to a lack of direct evidence for thoracic surgery. The panel made conditional recommendations for use of parenteral anticoagulation for VTE prevention, in combination with mechanical methods, over no prophylaxis for cancer patients undergoing anatomic lung resection or esophagectomy. Other key recommendations include: conditional recommendations for using parenteral anticoagulants over direct oral anticoagulants, with use of direct oral anticoagulants suggested only in the context of clinical trials; conditional recommendation for using extended prophylaxis for 28 to 35days over in-hospital prophylaxis only for patients at moderate or high risk of thrombosis; and conditional recommendations for VTE screening in patients undergoing pneumonectomy and esophagectomy. Future research priorities include the role of preoperative thromboprophylaxis and the role of risk stratification to guide use of extended prophylaxis. (J Thorac Cardiovasc Surg 2022;▪:1-31).