Guideline Development Methods Research Articles

The guideline for the treatment and prevention of lower respiratory tract infections caused by human respiratory syncytial virus (2024 edition)

Human respiratory syncytial virus (RSV) is a major pathogen causing lower respiratory tract infections in humans. It is particularly a common cause of hospitalization among high-risk groups such as infants, tots, and the old people, imposing a heavy burden on families and society. The standardized treatment and prevention of this disease are increasingly emphasized by healthcare professionals. However, there are currently no standardized guidelines in China for lower respiratory tract infections caused by RSV. Therefore, our group for this guideline has developed the "Guidelines for the treatment and prevention of lower respiratory tract infections caused by human respiratory syncytial virus (2024 edition)" based on the latest evidence-based medical evidence and guideline development methods. The aim is to provide guidance to relevant healthcare professionals and improve prevention and treatment levels.

The quality of guidelines on the pancreatic perioperative enhanced recovery after surgery: a systematic quality appraisal using AGREE II instrument.

To evaluate the quality of guidelines on the pancreatic perioperative enhanced recovery after surgery both domestically and internationally, providing reference and reference for clinical practice. Systemically retrieved in the guideline websites, professional association websites and databases, such as up to date, BMJ Best Practice, PubMed, Embase, The Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wan Fang Data, China Science and Technology Journal Database(VIP), China Biology Medicine disc (CBMdisc), Medlive, Guidelines International Network(GIN), National Guideline Clearinghouse(NGC), National Institute for Health and Care Excellence(NICE), Registered Nurses Association of Ontario(RNAO), Scottish Intercollegiate Guidelines Network(SIGN), Joanna Briggs Institute Library(JBI), including guidelines and expert consensus on enhanced postsurgical recovery in pancreatic surgery published as of December 20, 2023. The Appraisal of Guidelines for Research and Evaluation II(AGREE II) tool was applied to evaluate the quality of the guidelines by four assessors. This study included seven guidelines, all of which were rated as Grade B in terms of quality, with ICC coefficients ranging from 0.752 to 0.884, indicating a high level of consistency. When formulating guidelines in the future, it is recommended to use AGREE II as a reference, emphasizing the standardization of the guideline development process and methods, fully considering patients' values and preferences, focusing on the applicability of the guidelines, and striving to create high-quality evidence-based recommendations.

Economic Analysis of Cochlear Implants in Adults With Bilateral Severe-to-Profound Hearing Loss. A Systematic Review of the Literature.

To determine the cost-effectiveness or cost-utility of cochlear implants (CI) in adults with severe to profound bilateral hearing loss. PubMed (Medline), The Cochrane Library, Embase via Elsevier, EBSCOhost CINAHL, and Scopus. The study included adult participants with severe to profound bilateral neurosensory hearing loss. The analysis encompassed quality of life improvements, costs, cost-effectiveness, cost-utility, cost-benefit, quality-adjusted life year (QALY), incremental cost-effectiveness ratio (ICER), and incremental cost-utility ratio (ICUR). Systematic reviews, meta-analyses, case series, and prospective or retrospective cohort studies published in English between 2010 and 2023 were retrieved. Exclusion criteria included incomplete studies, abstracts, clinical cases, editorials, letters, studies involving pediatric populations, single-side deafness, methodology research, noneconomic aspects of CI, mixed child and adult data, and studies published before 2010. The risk of bias was assessed following the criteria outlined in Appendix I of the economic evaluation's quality assessment as per the NICE Guideline Development Method. Ten articles met the criteria and were included in the qualitative synthesis. One study conducted a prospective cost-utility analyses, one carried out a cost-benefit analyses, one was a randomized controlled clinical trial focusing on cost-utility, and another was a clinical trial addressing cost-effectiveness. Six studies employed Markov models, and one study utilized uniquely the Monte Carlo method. None quantified the economic impact of improved hearing on cognitive function. The heterogeneity of sources impacted data quality. Unilateral and sequential bilateral CI appeared to be cost-effective when compared with bilateral hearing aids or nontechnological support. When properly indicated, simultaneous bilateral CIs are cost-effective compared to no interventions and to unilateral cochlear implantation through differential discounting or variations from the base cases, especially with a life expectancy of 5-10 years or longer.

Postpartumzorg in de eerste lijn: samenvatting van een multidisciplinaire richtlijn (deel 1)

Postpartum care in primary care: summary of a multidisciplinary guideline The lying time at the maternity ward for a healthy woman giving birth to a healthy baby is now on average less than 3 days. Therefore, primary care providers have a greater responsibility in the follow-up of the mother and newborn during the postpartum period. This article is a summary of the first part of the multidisciplinary guideline Postpartum care in primary care developed by the national Working Group Development of Primary Care Guidelines (WOREL) according to the internationally recognised methods of guideline development. The guideline formulates recommendations for quality postpartum care in collaboration with all involved healthcare providers with the aim of recognising and addressing complications in the newborn and mother in a timely manner. It is important that healthcare providers know what is normal, which red flags they should not miss, have basic knowledge about conditions and situations, and timely refer the patient to primary or secondary care. The article describes what attitude to adopt in case of life-threatening and serious complications in the maternity woman (postpartum haemorrhage, pre-eclampsia, venous thromboembolism and endometritis) and the newborn (jaundice, neonatal sepsis, congenital heart defect, dehydration, nutritional difficulties and metabolic disorders), as well as in case of less severe complications or complaints in the maternity woman (perineal pain, headache, constipation, haemorrhoids, urinary incontinence, fatigue and back pain) and the baby (gastro-oesophageal reflux, thrush, nappy dermatitis, intestinal cramps, conjunctivitis, cord infections and fever). Finally, specific situations in both the mother (prevention of antibody formation, rubella vaccination, thyroid disorders and gestational diabetes) and the newborn (cord care, prevention of sudden death, vitamin K and vitamin D substitution, and child abuse) are highlighted.

Is it possible to make ‘living’ guidelines? An evaluation of the Australian Living Stroke Guidelines

BackgroundKeeping best practice guidelines up-to-date with rapidly emerging research evidence is challenging. ‘Living guidelines’ approaches enable continual incorporation of new research, assisting healthcare professionals to apply the latest evidence to their clinical practice. However, information about how living guidelines are developed, maintained and applied is limited. The Stroke Foundation in Australia was one of the first organisations to apply living guideline development methods for their Living Stroke Guidelines (LSGs), presenting a unique opportunity to evaluate the process and impact of this novel approach.MethodsA mixed-methods study was conducted to understand the experience of LSGs developers and end-users. We used thematic analysis of one-on-one semi-structured interview and online survey data to determine the feasibility, acceptability, and facilitators and barriers of the LSGs. Website analytics data were also reviewed to understand usage.ResultsOverall, the living guidelines approach was both feasible and acceptable to developers and users. Facilitators to use included collaboration with multidisciplinary clinicians and stroke survivors or carers. Increased workload for developers, workload unpredictability, and limited information sharing, and interoperability of technological platforms were identified as barriers. Users indicated increased trust in the LSGs (69%), likelihood of following the LSGs (66%), and frequency of access (58%), compared with previous static versions. Web analytics data showed individual access by 16,517 users in 2016 rising to 53,154 users in 2020, a threefold increase. There was also a fourfold increase in unique LSG pageviews from 2016 to 2020.ConclusionsThis study, the first evaluation of living guidelines, demonstrates that this approach to stroke guideline development is feasible and acceptable, that these approaches may add value to developers and users, and may increase guideline use. Future evaluations should be embedded along with guideline implementation to capture data prospectively.

A systematic review of nutritional guidelines for preterm infants

The estimated global preterm birth rate in 20201 was more than 10% of livebirths or 13.4 million infants. Nutrition in the neonatal period is a key factor to optimise growth, neurodevelopment, and later metabolic disease risk2. There is no consensus on optimal nutrition for preterm infants, leading to substantial practice variation3. We aimed to assess the quality of nutritional guidelines for preterm infants, the consistency of recommendations, and the gaps in these recommendations. This review is reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 checklist. The study protocol was registered with PROSPERO (CRD42022327248). We searched six databases and 44 websites for nutritional guidelines for preterm infants before first hospital discharge, which were endorsed, prepared, or authorised by a regional, national, or international body, written in English, and published between 2012-2023. Two reviewers independently screened articles and extracted relevant data including nutritional recommendations (ranges or descriptions), the quality of recommendations (certainty of evidence and strength of recommendation), and gaps in recommendations, defined as those identified by the guidelines or when recommendations were based on very low certainty evidence. Disagreements were resolved by discussion or a third reviewer. Four reviewers appraised the included guidelines using AGREE II. We identified 7051 records, 27 guidelines were included in the review, 26% of which were of high quality. Most guidelines lacked stakeholder involvement and rigour of development. Twelve guidelines had recommendations for macronutrient intake, 18 for micronutrient intake, 12 for feeding, eight for fortification, and 14 for monitoring of nutritional adequacy. Only two guidelines provided recommendations for all five of these aspects. We found considerable variation in recommendations, many of which lacked details of certainty of evidence and strength of recommendation. Recommendations for feeding types and breastmilk fortification were consistent among high quality guidelines, but recommendations varied for intakes of almost all nutrients and monitoring of nutritional adequacy. Different guidelines gave different certainty of evidence for the same recommendations. Most gaps in recommendations were due to a very low certainty of evidence. Future development of nutritional guidelines for preterm infants should follow the standard guideline development method and ensure rigorous process including stakeholders’ involvement to improve the reporting of strength of recommendation, certainty of evidence, and gaps in recommendation. Evidence is needed to support recommendations about macro and micronutrient intakes, breastmilk fortification, and markers on adequacy of intake of different nutrients.

Using Online Videos as the Basis for Developing Design Guidelines: A Case Study of AR-Based Assembly Instructions

Design guidelines serve as an important conceptual tool to guide designers of interactive applications with well-established principles and heuristics. Consulting domain experts is a common way to develop guidelines. However, experts are often not easily accessible, and their time can be expensive. This problem poses challenges in developing comprehensive and practical guidelines. We propose a new guideline development method that uses online public videos as the basis for capturing diverse patterns of design goals and interaction primitives. In a case study focusing on AR-based assembly instructions, we apply our novel Identify-Rationalize pipeline, which distills design patterns from videos featuring AR-based assembly instructions (N=146) into a set of guidelines that cover a wide range of design considerations. The evaluation conducted with 16 AR designers indicated that the pipeline is useful for generating comprehensive guidelines. We conclude by discussing the transferability and practicality of our method.

EHS Rapid Guideline: Evidence-Informed European Recommendations on Parastomal Hernia Prevention-With ESCP and EAES Participation.

Background: Growing evidence on the use of mesh as a prophylactic measure to prevent parastomal hernia and advances in guideline development methods prompted an update of a previous guideline on parastomal hernia prevention. Objective: To develop evidence-based, trustworthy recommendations, informed by an interdisciplinary panel of stakeholders. Methods: We updated a previous systematic review on the use of a prophylactic mesh for end colostomy, and we synthesized evidence using pairwise meta-analysis. A European panel of surgeons, stoma care nurses, and patients developed an evidence-to-decision framework in line with GRADE and Guidelines International Network standards, moderated by a certified guideline methodologist. The framework considered benefits and harms, the certainty of the evidence, patients' preferences and values, cost and resources considerations, acceptability, equity and feasibility. Results: The certainty of the evidence was moderate for parastomal hernia and low for major morbidity, surgery for parastomal hernia, and quality of life. There was unanimous consensus among panel members for a conditional recommendation for the use of a prophylactic mesh in patients with an end colostomy and fair life expectancy, and a strong recommendation for the use of a prophylactic mesh in patients at high risk to develop a parastomal hernia. Conclusion: This rapid guideline provides evidence-informed, interdisciplinary recommendations on the use of prophylactic mesh in patients with an end colostomy. Further, it identifies research gaps, and discusses implications for stakeholders, including overcoming barriers to implementation and specific considerations regarding validity.

Aanbevelingen voor de behandeling van urgente aandoeningen in de eerste lijn: acuut cardiogeen longoedeem, acuut coronair syndroom en hypoglykemie met verminderd bewustzijn

Recommendations for the treatment of emergencies in primary care: acute cardiogenic pulmonary oedema, acute coronary syndrome and acute hypoglycaemia with reduced consciousness General practitioners are frequently confronted with urgent medical situations both during and outside office hours, requiring a quick and accurate response. This article presents a summary of the recommendations for the treatment of emergencies (part 2), specifically addressing the management of acute cardiogenic pulmonary oedema, acute coronary syndrome (ACS) and acute hypoglycaemia with reduced consciousness. These recommendations are an update of the 2008 guidelines of Domus Medica and were developed by the national Working Group for the Development of Guidelines in Primary Care (WOREL) according to internationally recognized methods for guideline development. The focus of the recommendations is the pharmacological management by the general practitioner. If necessary, diagnostics are briefly discussed. The aim is to inform general practitioners about the recommended content of the emergency kit, as well as the recommended dosages and administration routes for the most common indications. For the 3 topics discussed, an emergency intervention is generally indicated. In the meantime, the general practitioner can already administer medication. For acute cardiogenic pulmonary oedema, the use of intravenous diuretics and oxygen is necessary. Opiates are not routinely administered. Nitrates can be considered when blood pressure is elevated. For the treatment of ACS, acetylsalicylic acid should be administered. Oxygen is recommended only if there are signs of respiratory distress or hypoxemia. Morphine is indicated if analgesia is required. In cases of acute hypoglycaemia with decreased consciousness, intravenous glucose is the first choice. Referral is not always necessary when the patient recovers consciousness after adequate management. This decision should be based on clinical judgment. Via https://www.ebp-guidelines.be/home the English guideline is available.

Aanbevelingen voor de behandeling van urgente aandoeningen in de eerste lijn: convulsies, anafylaxie en agitatie in urgente situaties

Recommendations for the treatment of emergencies in primary care: seizures, anaphylaxis and agitation General practitioners are frequently confronted with urgent medical situations both during and outside office hours, requiring a quick and accurate response. This article presents a summary of the recommendations for the treatment of emergencies (part 1), specifically addressing the management of seizures, anaphylaxis and agitation. These recommendations are an update of the 2008 guidelines of Domus Medica and were developed by the national Working Group for the Development of Guidelines in Primary Care (WOREL) according to internationally recognized methods for guideline development. The focus of the recommendations is the pharmacological management by the general practitioner. If necessary, diagnostics are briefly discussed. The aim is to inform general practitioners about the recommended content of the emergency kit, as well as the recommended dosages and administration routes for the most common indications. For the treatment of prolonged seizures, benzodiazepines should be administered, with intramuscular midazolam as first choice. In the case of anaphylaxis, immediate intramuscular administration of adrenaline and, if available, high-flow oxygen is recommended. If the response is inadequate, short-acting β2-agonists should be administered via inhalation. For agitation likely due to psychosis, an oral antipsychotic or benzodiazepine should be considered. If there are no suspicions or signs of a psychosis, only benzodiazepines are recommended. Oral administration is preferred when the patient presents with agitation, unless in case of severe agitation with a risk to oneself or others. Then, intramuscular administration is preferred. Via https://www.ebp-guidelines.be/home the full guideline in English can be consulted.

Challenges and current approaches in the development of psychiatric living guidelines in Germany

Outdated guidelines can cause inadequate care. To counter this problem adynamic updating process for guidelines is being internationally discussed (living guidelines). This process has specific challenges. The rhythm of updating has to be determined and apriori criteria have to be defined, which indicate that asubstantial change of the medical practice is needed in order to then update individual recommendations. Digital tools have to be identified that can support a dynamic updating. Their (further) development has to be oriented to the specific requirements and needs of the trialogically composed guideline development teams. Recommendations have to be examined from the user perspective. The current guideline development methods that are still divergent, have to be harmonized and specific needs with respect to the cross-linking of guidelines have to be taken into account. The German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) supports and accompanies scientific projects dealing with the challenges of the dynamics of guideline development. From the first results of "Guide2Guide", aproject funded by the Innovation Fund, it can be summarized that the development of living guidelines is acomplex dynamic process that has only just started internationally and in Germany. It demands aspecial engagement of the guideline developers including representatives of patients and relatives, to responsibly work long term and flexibly. Digital tools can be useful in various process steps but at present they still have to be meaningfully linked into the process. Central elements of the development of S3 guidelines will continue to require substantial working time of the experts in the trialogue. In order for living guidelines to be actually used dissemination and implementation have to be integrated into the dynamic process.

Developing TCM clinical practice guidelines: A comparison between traditional Chinese medicine and western medicine

Clinical practice guidelines in Traditional Chinese Medicine (CPG-TCM) is the recommendation that aims to provide the best service to users by identifying and summarizing the rules of prevention, diagnosis, treatment, rehabilitation, and regression of diseases based on systematic reviews of evidence and balancing the advantages and disadvantages of different interventions for clinical questions of Traditional Chinese Medicine. Over the past 30 years, the concept and methods of evidence-based medicine have had a significant impact on the development of clinical practice guidelines in Western Medicine (CPG-WM), and their standardized guideline development methods are being adapted and used in the development of CPG-TCM. However, the quality of CPG-TCM is far from CPG-WM, and the methodological system for developing CPG-TCM is not yet fully established. Therefore, this study aims to explore the methodological differences between CPG-TCM and CPG-WM and to inform the development of high-quality CPGTCM.

Guidelines for diagnosis and treatment of chronic gastritis in China (2022, Shanghai).

Chronic gastritis is a commonly seen disease; clinicians have always attached to the importance of understanding its etiology and clinical manifestations, standardizing its diagnosis and treatment, and preventing its progression to cancers. Based on the consensus opinions on the diagnosis and treatment of chronic gastritis in the past three editions, and referring to the international consensuses and guidelines on the management of precancerous lesions of gastric mucosa, it is of clinical value and feasibility to formulate the guidelines for the diagnosis and treatment of chronic gastritis in line with China's national conditions. This guideline was initiated by the Chinese Society of Gastroenterology, with major members of the Cancer Collaboration Group of Chinese Society of Gastroenterology serving as the convenors and authors. Based on the internationally accepted principles and methods of guideline development and the extensive collection of opinions from gastroenterologists and physicians, 53 evidence-based recommendations are given for nine major clinical problems related to chronic gastritis, aiming to improve the diagnosis, treatment, and management of chronic gastritis.

Using co-creation methods for research integrity guideline development – how, what, why and when?

ABSTRACT Existing research integrity (RI) guideline development methods are limited in including various perspectives. While co-creation methods could help to address this, there is little information available to researchers and practitioners on how, why and when to use co-creation for developing RI guidelines, nor what the outcomes of co-creation methods are. In this paper, we aim to address this gap. First, we discuss how co-creation methods can be used for RI guideline development, based on our experience of developing RI guidelines. We elaborate on steps including preparation of the aims and design; participant sensitization; organizing and facilitating workshops; and analyzing data and translating them into guidelines. Secondly, we present the resulting RI guidelines, to show what the outcome of co-creation methods are. Thirdly, we reflect on why and when researchers might want to use co-creation methods for developing RI guidelines. We discuss that stakeholder engagement and inclusion of diverse perspectives are key strengths of co-creation methods. We also reflect that co-creation methods have the potential to make guidelines implementable if followed by additional steps such as revision working groups. We conclude that co-creation methods are a valuable approach to creating new RI guidelines when used together with additional methods.

Protocol for the development of a clinical practice guideline for discharge planning of stroke patients.

BackgroundA standardized discharge plan is important to continuous medical care and discharge management of stroke patients. Currently, there is a lack of high-quality, evidence-based discharge planning guidelines for stroke patients. Most existing discharge planning guidelines have been developed for other diseases and stroke-related guidelines focus more on prevention, treatment, and rehabilitation and less on discharge planning. Therefore, they do not provide a systematic and comprehensive answer to the key issues of discharge planning for stroke patients. To improve the level of recovery and quality of life of stroke patients, to better guide clinical caregivers in developing and implementing discharge plans, the Evidence-based Nursing Center of West China Hospital, Sichuan University and the World Health Organization (WHO) Collaborating Centre for Guideline Implementation and Knowledge Translation have jointly initiated the development of the clinical practice guideline for discharge planning of patients with stroke.MethodsThe guideline development process is designed to follow the WHO handbook for guideline development and Guidelines 2.0. Evidence grading and guideline recommendations are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). The key steps in developing the guideline include: (I) establishing the guideline working groups; (II) selecting the priority clinical questions; (III) evidence retrieval and evaluation; (IV) grading the quality of evidence; (V) forming recommendations; and (VI) external review.DiscussionThis guideline will follow the clinical characteristics and management priorities of stroke and will be developed by a multidisciplinary guideline development team, in strict accordance with the core principles and methods of guideline development. This guideline will provide an evidence-based reference for standardized discharge screening, assessment, discharge procedures, and outpatient follow up, so as to improve the quality of discharge services and standardize the discharge management of stroke patients, and ultimately improve their post-discharge rehabilitation and quality of life.Trial RegistrationThe guideline was registered at the Practice guidelines REgistration for transPAREncy. The registration No. is IPGRP-2022CN331.

Development, implementation and validation of resource-stratified guidelines in low-income and middle-income countries: a scoping review protocol

IntroductionNearly every field of medicine has some form of clinical practice guidelines. However, only within the past 5–10 years has the medical community acknowledged the need for well-developed guidelines tailored...

2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association.

2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association.

An evaluation of the COVID-19 recommendation map identified diverging clinical and public health guidance

ObjectivesTo describe divergence between actionable statements issued by coronavirus disease 2019 (COVID-19) guideline developers cataloged on the “COVID-19 Recommendations and Gateway to Contextualization” platform. Study Design and SettingWe defined divergence as at least two comparable actionable statements with different explicit judgments of strength, direction, or subgroup consideration of the population or intervention. We applied a content analysis to compare guideline development methods for a sample of diverging statements and to evaluate factors associated with divergence. ResultsOf the 138 guidelines evaluated, 85 (62%) contained at least one statement that diverged from another guideline. We identified 223 diverging statements in these 85 guidelines. We grouped statements into 66 clusters. Each cluster addressed the same population, intervention, and comparator group or just similar interventions. Clinical practice statements were more likely to diverge in an explicit judgment of strength or direction compared to public health statements. Statements were more likely to diverge in strength than direction. The date of publication, used evidence, interpretation of evidence, and contextualization considerations were associated with divergence. ConclusionMore than half of the assessed guidelines issued at least one diverging statement. This study helps in understanding the types of differences between guidelines issuing comparable statements and factors associated with their divergence.

Japanese Orthopaedic Association (JOA) clinical practice guidelines on the management of soft tissue tumors 2020 - Secondary publication

BackgroundThese clinical practice guidelines are intended to provide recommendations based on the best evidence obtained to date on key issues in clinical practice to improve the prognosis, diagnostic and therapeutic processes for patients with soft tissue tumors. MethodsThe Guidelines Development Committee and Systematic Review Committee were composed of a multidisciplinary team of specialists who play an important role in soft tissue tumor care. Clinical questions (CQs) were determined by choosing key decision-making points based on Algorithms for the diagnosis and treatment of soft tissue tumors. The guidelines were developed according to the “Medical Information Network Distribution Service (Minds) Handbook for Clinical Practice Guideline Development 2014” and “Minds Manual for Clinical Practice Guideline Development 2017.” Recommendation strength was rated on two levels and the strength of evidence was rated on four levels. The recommendations were decided based on agreement by 70% or more voters. ResultsTwenty-two CQs were chosen by the Guidelines Development Committee. The Systematic Review Committee reviewed the evidence concerning each CQ, a clinical value judgment was added by experts, and the text of each recommendation was determined. ConclusionWe established 22 CQs and recommendations for key decision-making points in the diagnosis and treatment of soft tissue tumors according to the Minds Clinical Practice Guideline development methods. We hope that these guidelines will assist the decision-making of all medical staff engaged in the treatment and diagnosis of soft tissue tumors, and eventually lead to improved soft tissue tumor care in the country.

Brazilian guidelines for the treatment of outpatients with suspected or confirmed COVID-19. A joint guideline of the Brazilian Association of Emergency Medicine (ABRAMEDE), Brazilian Medical Association (AMB), Brazilian Society of Angiology and Vascular Surgery (SBACV), Brazilian Society of Geriatrics and Gerontology (SBGG), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Family and Community Medicine (SBFMC), and Brazilian Thoracic Society

BackgroundSeveral therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil.MethodsA panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method.ResultsTen technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation.ConclusionTo date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments.