Multidisciplinary Guideline Development Group Research Articles

Practice guideline of influenza vaccination and antiviral drugs use in children(2024 editon)

Influenza is the most common acute respiratory infectious diseases among children in China. The annual seasonal influenza outbreak has a significant impact on children's health, poses a significant disease and socioeconomic burden, and arouses a wide public concern. In recent years, a number of new influenza vaccines and influenza antivirals have been approved for use in children, expanding the choices for prevention and treatment of influenza. Pediatric Infection Group, Chinese Society of Infectious Diseases of Chinese Medical Association and Infection Group, Pediatric Expert Committee of National Health Commission Capacity Building and Continuing Education, and China Clinical Practice Guidelines Alliance Methodology Committee organized a multidisciplinary guideline development group (GDG) consisting of experts in pediatrics, infectious diseases,epidemiologists,health policy,and guideline methodology proposed eight key issues concerning influenza vaccination and antiviral use from a practice perspective. Through research question construction, evidence retrieval and synthesis, evidence appraisal and evidence-to-decision discussion, recommendations and implementation suggestions were formulated. This guideline is intended to provide guidance for pediatricians at different facility levels and healthcare providers engaged in vaccination services,and institutional professionals dealing with prevention and control of infectious diseases.

Interpretation of Guidelines for Diagnosis, Management, and Prevention of Pertussis in China (2024 Edition)

Abstract The resurgence of pertussis in China has recently attracted much attention. The incidence and burden of pertussis are largely underestimated in China owing to the lack of active pertussis surveillance and insufficient laboratory diagnosis. The high prevalence of macrolide-resistant Bordetella pertussis imposes a major challenge for the management of pertussis cases. To address a series of practice issues regarding pertussis diagnosis, treatment, and prevention, especially immunization practices, a multidisciplinary guideline development group (GDG) consisting of experts in the fields of infectious diseases, pediatric critical care medicine, clinical microbiology, epidemiology, and immunization planning jointly developed the first clinical practice guidelines for pertussis in China. Utilizing the Grading of Recommendations Assessment, Development and Evaluation Evidence-to-Decision framework recommended by the World Health Organization, the GDG formulated corresponding recommendations and suggestions. Good Practice Statements were created for issues not suitable for conventional evidence rating through the presentation of evidence and expert experience. The implementation suggestions for the 12 priority clinical questions given in this paper fully considered Chinese and international experiences as well as the national situation and policy. The primary target audience of these guidelines includes clinicians, microbiology laboratory staff, public health professionals, and policymakers.

China Anti-Cancer Association Guidelines for the diagnosis, treatment, and follow-up of thymic epithelial tumors (2023).

Thymic epithelial tumors (TETs) are a relatively rare type of thoracic tumors with higher incidence in Asians. The diagnosis and treatment pattern has long been based mainly on clinical experience and expert consensus. In recent years, with an increasing number of TETs detected in physical examinations, there is an urgent need to develop the guidelines that apply to the Chinese population. Thus, we intend to develop a holistic integrative guideline for TETs. Under the leadership of the Chinese Anti-Cancer Association (CACA) Mediastinal Tumor Committee, a multidisciplinary guideline development group was established. Systemic literature review and two rounds of questionnaires regarding key clinical issues were carried out. The grading of recommendations assessment, development and evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. The CACA guideline provides recommendations for the clinical differential diagnosis of anterior mediastinal lesions, management of asymptomatic small anterior mediastinal nodules, pathological classification and staging systems of TETs, as well as principles of surgery, neoadjuvant and adjuvant therapies, systemic therapies for advanced TETs, and follow-up strategies after surgical resection. This guideline provides holistic integrative management strategies for TETs and would be a useful tool for clinicians on decision-making.

Interpretation of the UK screening and treatment of retinopathy of prematurity updated 2022 guidelines

The UK screening and treatment of retinopathy of prematurity (ROP) updated 2022 guidelines were developed by a multidisciplinary guideline development group from the Royal College of Paediatrics and Child Health and the Royal College of Ophthalmologists, following the standards of the National Institute for Health and Care Excellence. They were published on the websites of the Royal College of Paediatrics and Child Health and the Royal College of Ophthalmologists in March 2022, and formally published in Early Human Development in March 2023. The guidelines provide evidence-based recommendations for the screening and treatment of ROP. The most significant change in the 2022 updated version compared to the previous guidelines is the lowering of the gestational age screening criterion to below 31 weeks. The treatment section covers treatment indications, timing, methods, and follow-up visits of ROP. This article interprets the guidelines and compares them with ROP guidelines/consensus in China, providing a reference for domestic peers.

Guidelines for diagnosis and management and prevention of pertussis of China (2024 edition)

Pertussis re-emergence is a global public health concern. The reported incidence of pertussis in China from 2018 to 2022 was comparable to that in the late 1980s. In fact, the incidence of pertussis is still significantly underestimated in China, owing to a lack of comprehensive active pertussis surveillance, missed diagnosis of atypical pertussis cases, and the fact that many medical institutions do not perform pertussis laboratory diagnosis. Meanwhile, China is also faced with the clinical issue that Bordetella pertussis is highly resistant to first-line macrolide treatment. To better guide and standardize the clinical diagnosis, treatment, monitoring, prevention and control of pertussis cases in China, a multidisciplinary guideline development group comprised of experts in infectious diseases, epidemiology, immunization planning and guideline methodology proposed 12 clinical issues related to the diagnosis, treatment and prevention, especially vaccine immunization strategies from a practical perspective. Through research question construction, evidence retrieval and synthesis, evidence appraisal and evidence-to-decision discussion, recommendations and implementation suggestions were formulated to provide references for clinical physicians engaged in the diagnosis and management of pertussis, microbiological laboratory professionals, hospital infection control professionals, and public health professionals involved in infectious disease prevention, control and immunization planning.

An Overview of the Methodology Used to Develop Clinical Practice Guidelines for the Management of Acute and Intraoperative Spinal Cord Injury.

An overview of the methods used to develop clinical practice guidelines (CPGs). Acute spinal cord injury (SCI) and intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. To date, there are several studies that have discussed the diagnostic and management strategies for both SCI and ISCI. CPGs in SCI help to distill and translate the current evidence into actionable recommendations, standardize care across centers, optimize patient outcomes, and reduce costs and unnecessary interventions. Furthermore, they can be used by patients to assist in making decisions about certain treatments and by policy makers to inform allocation of resources. The objective of this article is to summarize the methods used to develop CPGs for the timing of surgery and hemodynamic management of acute SCI, as well as the identification and treatment of ISCI. The CPGs were developed using standards established by the Institute of Medicine (now the National Academy of Medicine), the Guideline International Network and several other organizations. Systematic reviews were conducted according to accepted methodological standards (eg, Institute of Medicine, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute) in order to summarize the current body of evidence and inform the guideline development process. Protocols for each guideline were created. A multidisciplinary guideline development group (GDG) was formed that included individuals living with SCI as well as clinicians from the broad range of specialties that encounter patients with SCI: spine or trauma surgeons, critical care physicians, rehabilitation specialists, neurologists, anesthesiologists and other healthcare professionals. Individuals living with SCI were also included in the GDG. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of the evidence for each critical outcome. The "evidence to recommendation" framework was then used to translate the evidence obtained from the systematic review to an actionable recommendation. This framework provides structure when assessing the body of evidence and considers several additional factors when rating the strength of the recommendation, including the magnitude of benefits and harms, patient preferences, resource use, health equities, acceptability and feasibility. Finally, the CPGs were appraised both internally and externally. The results of the CPGs for SCI are provided in separate articles in this focus issue. Development of these CPGs for SCI followed the methodology proposed by the Institute of Medicine the Guideline International Network and the GRADE Working Group. It is anticipated that these CPGs will assist clinicians implement the best evidence into practice and facilitate shared-decision making with patients.

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on Hemodynamic Management.

Clinical practice guideline development following the GRADE process. Hemodynamic management is one of the only available treatment options that likely improves neurologic outcomes in patients with acute traumatic spinal cord injury (SCI). Augmenting mean arterial pressure (MAP) aims to improve blood perfusion and oxygen delivery to the injured spinal cord in order to minimize secondary ischemic damage to neural tissue. The objective of this guideline was to update the 2013 AANS/CNS recommendations on the hemodynamic management of patients with acute traumatic SCI, acknowledging that much has been published in this area since its publication. Specifically, we sought to make recommendations on 1. The range of mean arterial pressure (MAP) to be maintained by identifying an upper and lower MAP limit; 2. The duration of such MAP augmentation; and 3. The choice of vasopressor. Additionally, we sought to make a recommendation on spinal cord perfusion pressure (SCPP) targets. A multidisciplinary guideline development group (GDG) was formed that included health care professionals from a wide range of clinical specialities, patient advocates, and individuals living with SCI. The GDG reviewed the 2013 AANS/CNS guidelines and voted on whether each recommendation should be endorsed or updated. A systematic review of the literature, following PRISMA standards and registered in PROSPERO, was conducted to inform the guideline development process and address the following key questions: (i) what are the effects of goal-directed interventions to optimize spinal cord perfusion on extent of neurological recovery and rates of adverse events at any time point of follow-up? and (ii) what are the effects of particular monitoring techniques, perfusion ranges, pharmacological agents, and durations of treatment on extent of neurological recovery and rates of adverse events at any time point of follow-up? The GDG combined the information from this systematic review with their clinical expertise in order to develop recommendations on a MAP target range (specifically an upper and lower limit to target), the optimal duration for MAP augmentation, and the use of vasopressors or inotropes. Using methods outlined by the GRADE working group, recommendations were formulated that considered the balance of benefits and harms, financial impact, acceptability, feasibility and patient preferences. The GDG suggested that MAP should be augmented to at least 75-80 mmHg as the "lower limit," but not actively augmented beyond an "upper limit" of 90-95mmHg in order to optimize spinal cord perfusion in acute traumatic SCI. The quality of the evidence around the "target MAP" was very low, and thus the strength of this recommendation is weak. For duration of hemodynamic management, the GDG "suggested" that MAP be augmented for a duration of 3-7days. Again, the quality of the evidence around the duration of MAP support was very low, and thus the strength of this recommendation is also weak. The GDG felt that a recommendation on the choice of vasopressor or the use of SCPP targets was not warranted, given the dearth of available evidence. We provide new recommendations for blood pressure management after acute SCI that acknowledge the limitations of the current evidence on the relationship between MAP and neurologic recovery. It was felt that the low quality of existing evidence and uncertainty around the relationship between MAP and neurologic recovery justified a greater range of MAP to target, and for a broader range of days post-injury than recommended in previous guidelines. While important knowledge gaps still remain regarding hemodynamic management, these recommendations represent current perspectives on the role of MAP augmentation for acute SCI.

Context matters: using an Evidence to Decision (EtD) framework to develop and encourage uptake of opioid deprescribing guideline recommendations at the point-of-care

ObjectivesTo describe the development and use of an Evidence to Decision (EtD) framework when formulating recommendations for the Evidence-Based Clinical Practice Guideline for Deprescribing Opioid Analgesics. Study Design and SettingEvidence was derived from an overview of systematic reviews and qualitative studies conducted with healthcare professionals and people who take opioids for pain. A multidisciplinary guideline development group conducted extensive EtD framework review and iterative refinement to ensure that guideline recommendations captured contextual factors relevant to the guideline target setting and audience. ResultsThe guideline development group considered and accounted for the complexities of opioid deprescribing at the individual and health system level, shaping recommendations and practice points to facilitate point-of-care use. Stakeholders exhibited diverse preferences, beliefs, and values. This variability, low certainty of evidence, and system-level policies and funding models impacted the strength of the generated recommendations, resulting in the formulation of four ‘conditional’ recommendations. ConclusionThe context within which evidence-based recommendations are considered, as well as the political and health system environment, can contribute to the success of recommendation implementation. Use of an EtD framework allowed for the development of implementable recommendations relevant at the point-of-care through consideration of limitations of the evidence and relevant contextual factors.

Guidelines for the diagnosis, treatment, prevention and control of infections caused by carbapenem-resistant gram-negative bacilli.

The dissemination of carbapenem-resistant Gram-negative bacilli (CRGNB) is a global public health issue. CRGNB isolates are usually extensively drug-resistant or pandrug-resistant, resulting in limited antimicrobial treatment options and high mortality. A multidisciplinary guideline development group covering clinical infectious diseases, clinical microbiology, clinical pharmacology, infection control, and guideline methodology experts jointly developed the present clinical practice guidelines based on best available scientific evidence to address the clinical issues regarding laboratory testing, antimicrobial therapy, and prevention of CRGNB infections. This guideline focuses on carbapenem-resistant Enterobacteriales (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Sixteen clinical questions were proposed from the perspective of current clinical practice and translated into research questions using PICO (population, intervention, comparator, and outcomes) format to collect and synthesize relevant evidence to inform corresponding recommendations. The grading of recommendations, assessment, development and evaluation (GRADE) approach was used to evaluate the quality of evidence, benefit and risk profile of corresponding interventions and formulate recommendations or suggestions. Evidence extracted from systematic reviews and randomized controlled trials (RCTs) was considered preferentially for treatment-related clinical questions. Observational studies, non-controlled studies, and expert opinions were considered as supplementary evidence in the absence of RCTs. The strength of recommendations was classified as strong or conditional (weak). The evidence informing recommendations derives from studies worldwide, while the implementation suggestions combined the Chinese experience. The target audience of this guideline is clinician and related professionals involved in management of infectious diseases.

2018 Chinese Guidelines for the Diagnosis and Treatment of Rheumatoid Arthritis.

A multidisciplinary guideline development group was established to formulate this evidence-based diagnosis and treatment guidelines for rheumatoid arthritis (RA) in China. The grading of recommendations, assessment, development, and evaluation (GRADE) system was used to rate the quality of the evidence and the strength of recommendations, which were derived from research articles and guided by the analysis of the benefits and harms as well as patients' values and preferences. A total of 10 recommendations for the diagnosis and treatment of RA were developed. This new guideline covered the classification criteria, disease activity assessment and monitoring, and the role of disease modifying antirheumatic drugs (DMARDs), biologics, small molecule synthetic targeting drugs, and glucocorticoids in the treat-to-target approach of RA. This guideline is intended to serve as a tool for clinicians and patients to implement decision-making strategies and improve the practices of RA management in China.

China guideline for the screening, early detection and early treatment of colorectal cancer (2020, Beijing)

Colorectal cancer (CRC) is a major malignancy threatening the health of people in China, which also leads to heavy social burden. A large number of researches and practices have demonstrated that screening and early detection are effective in reducing the mortality of CRC. It is therefore imperative to design guidelines for the screening, early detection and early treatment of CRC that are in line with national conditions of China based on international guideline development standard. In 2020, under the leadership of the National Cancer Center of China, a multidisciplinary guideline development group was established. The development of the guideline followed the principles and methods recommended by the World Health Organization. The guideline provides detailed recommendations for thirteen key clinical questions to which the professionals who are involved in screening, early detection and early treatment of colorectal cancer paid close attention. The guideline is intended to serve as a tool for professionals providing best decision-making on screening, early detection and early treatment of CRC and to enhance the effectiveness of CRC prevention and control in China.

Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS®) Society recommendations

BackgroundEnhanced Recovery After Surgery (ERAS) evidence-based protocols for perioperative care have led to improvements in outcomes in numerous surgical areas, through multimodal optimization of patient pathway, reduction of complications, improved patient experience and reduction in the length of stay. ERAS represent a relatively new paradigm in spine surgery. PurposeThis multidisciplinary consensus review summarizes the literature and proposes recommendations for the perioperative care of patients undergoing lumbar fusion surgery with an ERAS program. Study DesignThis is a review article. MethodsUnder the impetus of the ERAS® society, a multidisciplinary guideline development group was constituted by bringing together international experts involved in the practice of ERAS and spine surgery. This group identified 22 ERAS items for lumbar fusion. A systematic search in the English language was performed in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Systematic reviews, randomized controlled trials, and cohort studies were included, and the evidence was graded according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. Consensus recommendation was reached by the group after a critical appraisal of the literature. ResultsTwo hundred fifty-six articles were included to develop the consensus statements for 22 ERAS items; one ERAS item (prehabilitation) was excluded from the final summary due to very poor quality and conflicting evidence in lumbar spinal fusion. From these remaining 21 ERAS items, 28 recommendations were included. All recommendations on ERAS protocol items are based on the best available evidence. These included nine preoperative, eleven intraoperative, and six postoperative recommendations. They span topics from preoperative patient education and nutritional evaluation, intraoperative anesthetic and surgical techniques, and postoperative multimodal analgesic strategies. The level of evidence for the use of each recommendation is presented. ConclusionBased on the best evidence available for each ERAS item within the multidisciplinary perioperative care pathways, the ERAS® Society presents this comprehensive consensus review for perioperative care in lumbar fusion.

2020 Chinese Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus.

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that represents a prodigious challenge of diagnosis and treatment. In 2019, under the leadership of the Chinese Rheumatology Association, a multidisciplinary guideline development group was established to develop an evidence-based diagnosis and treatment guideline for patients with SLE in PR China. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to evaluate the quality of evidence and the strength of recommendations. The guideline was reported following the Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist. In this guideline, we provided recommendations for SLE classification criteria, disease activity monitoring and assessment, medication administration and considerations for SLE patients with organs and systems involved, and management of special populations such as SLE patients in the setting of pregnancy. This guideline serves as an evidence-based tool for Chinese clinicians to diagnose and treat patients with SLE.

2019 Chinese Clinical Practice Guidelines for the Prevention of Mother-to-child Transmission of Hepatitis B Virus.

To develop the evidence-based guidelines for managing mother-to-child transmission of hepatitis B virus in China, a multidisciplinary guideline development group was established. Clinical questions were identified from two rounds of surveys on the concerns of first-line clinicians. We conducted a comprehensive search and review of the literature. A grading of recommendations’ assessment, development, and evaluation system was adopted to rate the quality of evidence and the strength of recommendations. Recommendations were formulated based on the evidence, overall balance of benefits and harms (at individual and population levels), patient/health worker values and preferences, resources available, cost-effectiveness, and feasibility. Eventually, recommendations related to 13 main clinical concerns were developed, covering diagnostic criteria, treatment indications, antiviral therapy choice, timing to initiate and discontinue treatment, immunoprophylaxis strategy at birth, and how to deal with special situations, such as unintended pregnancy, assisted reproduction, and breastfeeding. The guidelines are intended to serve as guidance for clinicians and patients, to optimize the management of majority of pregnant women who are positive for hepatitis B surface antigen. Guideline registration: International Practice Guide Registration Platform (IPGRP-2018CN040).

Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: Lifestyle management.

Lifestyle is fundamental in chronic disease prevention and management, and it has been recommended as a first-line treatment in the Australian polycystic ovary syndrome (PCOS) guideline 2011. The first international evidence-based guideline on PCOS was developed in 2018, which expanded the scope and evidence in the Australian guideline. This paper summarizes the lifestyle recommendations and evidence summaries from the guideline. International multidisciplinary guideline development groups delivered the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2018. The process followed the Appraisal of Guidelines for Research and Evaluation II and The Grading of Recommendations, Assessment, Development and Evaluation framework. Extensive communication and meetings addressed six prioritized clinical questions through five reviews. Evidence-based recommendations were formulated before consensus voting within the panel. Evidence shows the benefits of multicomponent lifestyle intervention, efficacy of exercise and weight gain prevention with no specific diet recommended. Lifestyle management is the first-line management in the intervention hierarchy in PCOS. Multicomponent lifestyle intervention including diet, exercise and behavioural strategies is central to PCOS management with a focus on weight and healthy lifestyle behaviours. The translation programme optimizes reach and dissemination for health professionals and consumers.

2020 Chinese guidelines for the diagnosis and treatment of systemic lupus erythematosus

Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. In 2019, under the leadership of the Chinese Rheumatology Association, a multidisciplinary guideline development group was established. The objective was to develop an evidence-based diagnosis and treatment guideline for SLE in China based on emerging new evidence. The guideline was registered at International Practice Guidelines Registry Platform (IPGRP-2019CN022). The grading of recommendations assessment, development and evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations, and the RIGHT (Reporting Items for Practice Guidelines in Healthcare) checklist was followed to report the guideline. The guideline provides recommendations for the SLE classification criteria, disease activity monitoring and assessing, medication principles and considerations organ and system involvement and management of patients during pregnancy. This guideline is intended to serve as a tool for Chinese clinicians for the best decisions-making on diagnosis and treatment of SLE.

Recommendations from the ERAS® Society for standards for the development of enhanced recovery after surgery guidelines.

BackgroundERAS® Society guidelines are holistic, multidisciplinary tools designed to improve outcomes after surgery. The enhanced recovery after surgery (ERAS) approach was initially developed for colorectal surgery and has been implemented successfully across a large number of settings, resulting in improved patient outcomes. As the ERAS approach is increasingly being adopted worldwide and new guidelines are being generated for new populations, there is a need to define an ERAS® Society guideline and the methodology that should be followed in its development.MethodsThe ERAS® Society recommended approach for developing new guidelines is based on the creation of multidisciplinary guideline development groups responsible for defining topics, planning the literature search, and assessing the quality of the evidence.ResultsClear definitions for the elements of an ERAS guideline involve multimodal and multidisciplinary approaches impacting on multiple patient outcomes. Recommended methodology for guideline development follows a rigorous approach with systematic identification and evaluation of evidence, and consensus‐based development of recommendations. Guidelines should then be evaluated and reviewed regularly to ensure that the best and most up‐to‐date evidence is used consistently to support surgical patients.ConclusionThere is a need for a standardized, evidence‐informed approach to both the development of new ERAS® Society guidelines, and the adaptation and revision of existing guidelines.

Development and Implementation of Clinical Practice Guidelines: An Update and Synthesis of the Literature With a Focus in Application to Spinal Conditions.

Study Design:Review.Objectives:The objectives of this review are to (a) summarize the role of clinical practice guidelines (CPGs), (b) outline the methodology involved in formulating CPGs, (c) provide an illustration of these principles using a CPG developed for degenerative cervical myelopathy, and (d) highlight the importance of knowledge translation.Methods:A review of the literature was conducted to summarize current standards in CPG development and implementation.Results:CPGs are systematically developed statements intended to affect decisions made by health care providers, policy makers, and patients. The main objectives of CPGs are to synthesize and translate evidence into recommendations, optimize patient outcomes, standardize care, and facilitate shared decision making among physicians, patients, and their caregivers. The main steps involved in the development of CPGs include defining the clinical problem, assembling a multidisciplinary guideline development group and systematic review team, conducting a systematic review of the literature, translating the evidence to recommendations, critically appraising the CPG and updating the document when new studies arise. The final step in developing a CPG is to implement it into clinical practice; this step requires an assessment of the barriers to implementation and the formulation of effective dissemination strategies.Conclusion:CPGs are an important component in the teaching and practice of medicine and are available for a wide spectrum of diseases. CPGs, however, can only be used to influence clinical practice if the recommendations are informed by a systematic review of the literature and developed using rigorous methodology. The opportunity to transform clinical management of spinal conditions is an attractive outcome of the application of high-quality CPGs.

Clinical Guideline Highlights for the Hospitalist: The Use of Intravenous Fluids in the Hospitalized Adult.

Intravenous Fluid Therapy in Adults in Hospital RELEASE DATE: December, 2013 PRIOR VERSION: Not Applicable DEVELOPER: Multidisciplinary Guideline Development Group within the United Kingdom's National Clinical Guideline Centre FUNDING SOURCE: National Institute for Health and Care Excellence TARGET POPULATION: Hospitalized adult patients.

Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility.

STUDY QUESTIONWhat is the recommended assessment and management of infertile women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertize and consumer preference?SUMMARY ANSWERInternational evidence-based guidelines, including 44 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of infertile women with PCOS.WHAT IS KNOWN ALREADYPrevious guidelines on PCOS lacked rigorous evidence-based processes, failed to engage consumer and multidisciplinary perspectives or were outdated. The assessment and management of infertile women with PCOS are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.PARTICIPANTS/MATERIALS, SETTING, METHODSGovernance included a six continent international advisory and a project board, a multidisciplinary international guideline development group (GDG), consumer and translation committees. Extensive health professional and consumer engagement informed the guideline scope and priorities. The engaged international society-nominated panel included endocrinology, gynaecology, reproductive endocrinology, obstetrics, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Extensive online communication and two face-to-face meetings over 15 months addressed 19 prioritized clinical questions involving nine evidence-based reviews and 10 narrative reviews. Evidence-based recommendations (EBRs) were formulated prior to consensus voting within the guideline panel.STUDY DESIGN, SIZE, DURATIONInternational evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. A (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, desirable and undesirable consequences, feasibility, acceptability, cost, implementation and ultimately recommendation strength. The guideline was peer-reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE II criteria and underwent methodological review. This guideline was approved by all members of the GDG and has been approved by the NHMRC. MAIN RESULTS AND THE ROLE OF CHANCEThe quality of evidence (QOE) for the EBRs in the assessment and management of infertility in PCOS included very low (n = 1), low (n = 9) and moderate (n = 4) quality with no EBRs based on high-quality evidence. The guideline provides 14 EBRs, 10 clinical consensus recommendations (CCRs) and 20 clinical practice points on the assessment and management of infertility in PCOS. Key changes in this guideline include emphasizing evidence-based fertility therapy, including cheaper and safer fertility management.LIMITATIONS, REASONS FOR CAUTIONOverall evidence is generally of low to moderate quality, requiring significantly greater research in this neglected, yet common condition. Regional health systems vary and a process for adaptation of this guideline is provided.WIDER IMPLICATIONS OF THE FINDINGSThe international guideline for the assessment and management of infertility in PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.STUDY FUNDING/COMPETING INTEREST(S)The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine (ASRM). GDG members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Norman has declared a minor shareholder interest in the IVF unit Fertility SA, travel support from Merck and grants from Ferring. Prof. Norman also has scientific advisory board duties for Ferring. The remaining authors have no conflicts of interest to declare.This article was not externally peer-reviewed by Human Reproduction Open.