OBJECTIVES: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields. STUDY DESIGN AND SETTING: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group. RESULTS: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan. CONCLUSION: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.

American College of Physicians 190 N Independence Mall West Philadelphia PA 19087 USA

Amsterdam UMC University of Amsterdam Epidemiology and Data Science Amsterdam Institute of Public Health Meibergdreef 9 Amsterdam the Netherlands

Center for Evidence based Policy Oregon Health and Science University 3030 South Moody Ave Suite 250 Portland OR 97201 USA

Czech National Centre for Evidence Based Healthcare and Knowledge Translation Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic

Department 1 of Internal Medicine and Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf Evidence based Oncology Faculty of Medicine and University Hospital Cologne University of Cologne Kerpener Str 15 50935 Cologne Germany

Department for Evidence based Medicine and Evaluation RTI International Danube University Dr Karl Dorrekstrasse Krems Austria 3040 East Cornwallis Rd Research Triangle Park NC USA

Department of Biomedical Sciences for Health University of Milan Milan Italy

Department of Epidemiology Lazio Regional Health Services Rome via Cristoforo Colombo 112 00147 Rome Italy

Department of Family and Community Medicine Medical Knowledge Office EBSCO Information Services University of Missouri Columbia School of Medicine 10 Estes Street Ipswich MA 01938 USA

Department of Family Medicine Department of Health Research Methods Evidence and Impact McMaster University McMaster University Medical Centre 1280 Main Street West Hamilton Ontario L8S 4K1 Canada

Department of Health Research Methods Evidence and Impact McMaster University McMaster University Medical Centre 1280 Main Street West 2C Area Hamilton Ontario L8S 4K1 Canada

Department of Health Research Methods Evidence and Impact McMaster University McMaster University Medical Centre 1280 Main Street West Hamilton Ontario L8S 4K1 Canada

Department of Health Research Methods Evidence and Impact McMaster University Rm 3V49 McMaster University Medical Centre Hamilton ON L8S 4K1 Canada; Department of Medicine Rm 3V49 McMaster University Medical Centre Hamilton ON L8S 4K1 Canada; The Research Institute of St Joe's Hamilton Rm 3V49 McMaster University Medical Centre Hamilton ON L8S 4K1 Canada

Department of Internal Medicine University of Kansas Medical Center 3901 Rainbow Blvd MS3002 Kansas City KS 66160 USA; Department of Health Research Methods Evidence and Impact McMaster University 3901 Rainbow Blvd MS3002 Kansas City KS 66160 USA

Department of Medicine State University of New York at Buffalo 100 High Street Buffalo NY USA

Department of Medicine University of Toronto C David Naylor Building 6 Queen's Park Crescent West 3rd Floor Toronto ON M5S 3H2 Canada

Department of Urology Minneapolis VA Healthcare System Urology Section University of Minnesota One Veterans Drive Minneapolis MN 55417 USA

Division of Epidemiology and Biostatistics Department of Global Health Stellenbosch University Teaching Building Faculty of Medicine and Health Sciences Francie van Zijl Drive Bellville Western Cape South Africa

Division of Infection Immunity and Respiratory Medicine School of Biological Sciences The University of Manchester Manchester Academic Health Science Centre 2nd Floor Education and Research Centre Wythenshawe Hospital Manchester University NHS Foundation Trust Southmoor Road Manchester M23 9LT UK; The North West Lung Centre Wythenshawe Hospital Manchester University NHS Foundation Trust 2nd Floor Education and Research Centre Wythenshawe Hospital Manchester University NHS Foundation Trust Southmoor Road Manchester M23 9LT UK

Hospital Moinhos de Vento Porto Alegre Brazil

Iberoamerican Cochrane Centre Sant Pau Biomedical Research Institute 08025 Barcelona Spain

Institute for Evidence in Medicine Medical Center and Faculty of Medicine University of Freiburg Breisacher Strasse 153 79110 Freiburg Germany; Cochrane Germany Cochrane Germany Foundation Breisacher Strasse 153 79110 Freiburg Germany

IRCCS Istituto delle Scienze Neurologiche di Bologna UOSI Epidemiologia e Statistica IRCCS ISNB Ospedale Bellaria Via Altura 3 40139 Bologna Italy

JBI School of Public Health University of Adelaide Level 3 55 King William Road North Adelaide 5005 Australia

MRC CSO Social and Public Health Sciences Unit University of Glasgow 200 Renfield Street Glasgow G2 3AX UK

National Institute of Environmental Health Science Durham NC USA

Public Health Agency of Canada 785 Carling Avenue Ottawa Ontario Canada

Public Health Agency of Canada Ottawa Ontario Canada

School of Epidemiology and Public Health Faculty of Medicine University of Ottawa Room 101 600 Peter Morand Crescent Ottawa Ontario K1G 5Z3 Canada

U S Environmental Protection Agency Office of Research and Development Research Triangle Park NC 27711 USA

Universidad Científica del Sur Facultad de Ciencias de la Salud Panamericana Sur km 19 Villa Lima Peru

Zobrazit více v PubMed

Schunemann H.J., Wiercioch W., Etxeandia I., Falavigna M., Santesso N., Mustafa R., et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123–E142. PubMed PMC

Qaseem A., Forland F., Macbeth F., Ollenschlager G., Phillips S., van der Wees P., et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156:525–531. PubMed

Alonso-Coello P., Oxman A.D., Moberg J., Brignardello-Petersen R., Akl E.A., Davoli M., et al. GRADE Evidence to Decision (etd) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016;353:i2089. PubMed

Moberg J., Oxman A.D., Rosenbaum S., Schünemann H.J., Guyatt G., Flottorp S., et al. The GRADE Evidence to Decision (EtD) framework for health system and public health decisions. Health Res Pol Syst. 2018;16(1):45. PubMed PMC

Neumann I., Brignardello-Petersen R., Wiercioch W., Carrasco-Labra A., Cuello C., Akl E., et al. The GRADE evidence-to-decision framework: a report of its testing and application in 15 international guideline panels. Implement Sci. 2016;11:93. PubMed PMC

Thayer K.A., Schunemann H.J. Using GRADE to respond to health questions with different levels of urgency. Environ Int. 2016;92-93:585–589. PubMed

Schunemann H.J., Hill S.R., Kakad M., Bellamy R., Uyeki T.M., Hayden F.G., et al. WHO Rapid Advice Guidelines for pharmacological management of sporadic human infection with avian influenza A (H5N1) virus. Lancet Infect Dis. 2007;7:21–31. PubMed PMC

Vernooij R.W., Sanabria A.J., Sola I., Alonso-Coello P., Martinez Garcia L. Guidance for updating clinical practice guidelines: a systematic review of methodological handbooks. Implement Sci. 2014;9:3. PubMed PMC

Garritty C.M., Norris S.L., Moher D. Developing WHO rapid advice guidelines in the setting of a public health emergency. J Clin Epidemiol. 2017;82:47–60. PubMed PMC

World Health Organization . World Health Organization; Geneva: 2003. Guidelines for WHO guidelines.

Florez I.D., Morgan R.L., Falavigna M., Kowalski S.C., Zhang Y., Etxeandia-Ikobaltzeta I., et al. Development of rapid guidelines: 2. A qualitative study with WHO guideline developers. Health Res Policy Syst. 2018;16(1):62. PubMed PMC

Kowalski S.C., Morgan R.L., Falavigna M., Florez I.D., Etxeandia-Ikobaltzeta I., Wiercioch W., et al. Development of rapid guidelines: 1. Systematic survey of current practices and methods. Health Res Policy Syst. 2018;16(1):61. PubMed PMC

Morgan R.L., Florez I., Falavigna M., Kowalski S., Akl E.A., Thayer K.A., et al. Development of rapid guidelines: 3. GIN-McMaster Guideline Development Checklist extension for rapid recommendations. Health Res Policy Syst. 2018;16(1):63. PubMed PMC

World Health Organization . World Health Organization; 2020. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected: interim guidance, 28 January 2020.https://apps.who.int/iris/handle/10665/330893 Available at.

Schünemann H.J., Wiercioch W., Brozek J., Etxeandia-Ikobaltzeta I., Mustafa R.A., Manja V., et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: grade-adolopment. J Clin Epidemiol. 2017;81:101–110. PubMed

World Health Organization . World Health Organization; 2020. Infection Prevention and Control guidance for Long-Term Care Facilities in the context of COVID-19: interim guidance, 21 March 2020.https://apps.who.int/iris/handle/10665/331508 Available at.

Bhimraj A., Morgan R.L., Shumaker A.H., Lavergne V., Baden L., Cheng V.C., et al. Infectious Diseases Society of America Guidelines on the treatment and management of patients with COVID-19. Clin Infect Dis. 2020 PubMed PMC

Sultan S., Lim J.K., Altayar O., Davitkov P., Feuerstein J.D., Siddique S.M., et al. AGA institute rapid recommendations for gastrointestinal procedures during the COVID-19 pandemic. Gastroenterology. 2020 PubMed PMC

Qaseem A., Yost J., Etxeandia-Ikobaltzeta I., Miller M.C., Abraham G.M., Obley A.J., et al. Should clinicians use chloroquine or hydroxychloroquine alone or in combination with azithromycin for the prophylaxis or treatment of COVID-19? Ann Intern Med. 2020 PubMed PMC

Cardiac involvement in a patient with coronavirus disease 2019 (COVID-19) JAMA Cardiol. 2020 PubMed PMC

Alonso-Coello P., Schünemann H.J., Moberg J., Brignardello-Petersen R., Akl E.A., Davoli M., et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016:353. PubMed

Garritty C., Gartlehner G., Kamel C., King V., Nussbaumer-Streit B., Stevens A. Interim guidance from the cochrane rapid reviews methods group. Cochrane Rapid Rev. 2020;2020 PubMed PMC

Clinical characteristics of children with coronavirus disease 2019 in Hubei, China. Curr Med Sci. 2020;24 PubMed PMC

Rapid risk assessment of acute public health events. World Health Organization; 2012. https://www.who.int/csr/resources/publications/HSE_GAR_ARO_2012_1/en/ Available at.

Petkovic J., Riddle A., Akl E.A., Khabsa J., Lytvyn L., Atwere P., et al. Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation. Syst Rev. 2020;9(1):21. PubMed PMC

Morgan R.L., Whaley P., Thayer K.A., Schunemann H.J. Identifying the PECO: a framework for formulating good questions to explore the association of environmental and other exposures with health outcomes. Environ Int. 2018;121(Pt 1):1027–1031. PubMed PMC

Guyatt G.H., Oxman A.D., Kunz R., Atkins D., Brozek J., Vist G., et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64:395–400. PubMed

Analysis of epidemiological and clinical features in older patients with Corona Virus Disease 2019 (COVID-19) out of Wuhan. Clin Infect Dis. 2020;25 PubMed PMC

Alhazzani W., Moller M.H., Arabi Y.M., Loeb M., Gong M.N., Fan E., et al. Surviving sepsis campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19) Intensive Care Med. 2020;46(5):854–887. PubMed PMC

Clinical observation and management of COVID-19 patients. Emerg. 2020;9(1):687–690. PubMed PMC

European Food Safety Authority Statement of EFSA on risks for public health due to the presence of melamine in infant milk and other milk products in China. EFSA J. 2008;6(9):807.

Darzi A., Harfouche M., Arayssi T., Alemadi S., Alnaqbi K.A., Badsha H., et al. Adaptation of the 2015 American College of Rheumatology treatment guideline for rheumatoid arthritis for the Eastern Mediterranean Region: an exemplar of the GRADE Adolopment. Health Qual Life Outcomes. 2017;15(1):183. PubMed PMC

Guyatt G.H., Oxman A.D., Kunz R., Woodcock J., Brozek J., Helfand M., et al. GRADE guidelines: 8. Rating the quality of evidence--indirectness. J Clin Epidemiol. 2011;64:1303–1310. PubMed

Brouwers M.C., Kho M.E., Browman G.P., Burgers J.S., Cluzeau F., Feder G., et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839–E842. PubMed PMC

Shea B.J., Reeves B.C., Wells G., Thuku M., Hamel C., Moran J., et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017;358:j4008. PubMed PMC

Whiting P., Savovic J., Higgins J.P., Caldwell D.M., Reeves B.C., Shea B., et al. ROBIS: a new tool to assess risk of bias in systematic reviews was developed. J Clin Epidemiol. 2016;69:225–234. PubMed PMC

Garner P., Hopewell S., Chandler J., MacLehose H., Schunemann H.J., Akl E.A., et al. When and how to update systematic reviews: consensus and checklist. BMJ. 2016;354:i3507. PubMed PMC

National Toxicology Program National Toxicology Program research project: West Virginia chemical spill. Board of Scientific Counselors December 9–10, 2014 meeting. 2014. https://ntp.niehs.nih.gov/ntp/about_ntp/bsc/2014/dec/bsc_dec2014_minutes_508.pdf Available at.

National Toxicology Program Nomination Summary for West Virginia Elk River chemical spill (N21408) 2014. https://ntp.niehs.nih.gov/getinvolved/nominate/summary/nm-n21408.html?utm_source=direct&utm_medium=prod&utm_campaign=ntpgolinks&utm_term=nm-n21408 Available at.

Schunemann H.J., Zhang Y., Oxman A.D., Expert Evidence in Guidelines G Distinguishing opinion from evidence in guidelines. BMJ. 2019;366:l4606. PubMed

Schunemann H.J., Khabsa J., Solo K., Khamis A.M., Brignardello-Petersen R., El-Harakeh A., et al. Ventilation techniques and risk for transmission of coronavirus disease, including COVID-19. Ann Intern Med. 2020 PubMed

World Health Organization . World Health Organization; 2019. Clinical management of severe acute respiratory infection when Middle East respiratory syndrome coronavirus (MERS-CoV) infection is suspected: interim guidance.https://apps.who.int/iris/handle/10665/178529 Available at.

Stockman L.J., Bellamy R., Garner P. SARS: systematic review of treatment effects. PLoS Med. 2006;3(9):e343. PubMed PMC

Akl E.A., Meerpohl J.J., Elliott J., Kahale L.A., Schünemann H.J. Living systematic reviews: 4. Living guideline recommendations. J Clin Epidemiol. 2017;91:47–53. PubMed

Schunemann H.J., Wiercioch W., Brozek J., Etxeandia-Ikobaltzeta I., Mustafa R.A., Manja V., et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: grade-adolopment. J Clin Epidemiol. 2017;81:101–110. PubMed

Djulbegovic B., Guyatt G. Evidence vs consensus in clinical practice guidelines. JAMA. 2019;322:725–726. PubMed PMC

Nisbet A.F. PHE publication; 2019. Public health protection in radiation emergencies.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/805655/Advice_for_Radiation_Emergencies_2019.pdf Available at.

Fineberg H.V. Ten weeks to crush the curve. N Engl J Med. 2020;382:e37. PubMed

Digitally-enabled, patient-centred care in rhinitis and asthma multimorbidity: The ARIA-MASK-air® approach