Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

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Clinical Guidelines
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Gershon AS, Lindenauer PK, Wilson KC, Rose L, Walkey AJ, Sadatsafavi M, Anstrom KJ, Au DH, Bender BG, Brookhart MA, Dweik RA, Han MK, Joo MJ, Lavergne V, Mehta AB, Miravitlles M, Mularski RA, Roche N,
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Cardiology
Pulmonology
Emergency Medicine
Speciality
Cardiology
Emergency Medicine
Pulmonology
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volume
203
ISSN
1535-4970
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{"article_title":"Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.","author":"Gershon AS, Lindenauer PK, Wilson KC, Rose L, Walkey AJ, Sadatsafavi M, Anstrom KJ, Au DH, Bender BG, Brookhart MA, Dweik RA, Han MK, Joo MJ, Lavergne V, Mehta AB, Miravitlles M, Mularski RA, Roche N, Oren E, Riekert KA, Schoenberg NC, Stukel TA, Weiss CH, Wunsch H, Africk JJ, Krishnan JA","journal_title":"American journal of respiratory and critical care medicine","issn":"1535-4970","isbn":"","publication_date":"2021 Jan 01","volume":"203","issue":"1","first_page":"14","page_count":"","accession_number":"33385220","doi":"10.1164\/rccm.202010-3943ST","publisher":"American Thoracic Society","doctype":"Journal Article","subjects":"United States; Biomedical Research standards; Clinical Decision-Making; Critical Care standards; Delivery of Health Care standards; Evidence-Based Medicine standards; Observational Studies as Topic standards; Thoracic Diseases therapy; Humans; Practice Guidelines as Topic; Societies, Medical; United States","interest_area":["Cardiology"," Pulmonology"," Emergency Medicine"],"abstract":"Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine. Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines. Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1 ) no RCTs are identified or RCTs are appraised as being of low- or very low-quality ( replacement ); 2 ) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded ( complementary ); or 3 ) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; \" sequential\" ). Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.","url":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&db=mdl&AN=33385220&authtype=shib&custid=ns346513","isPdfLink":true,"isSAML":false,"additionalInfo":{"Authored_By":"Gershon AS, Lindenauer PK, Wilson KC, Rose L, Walkey AJ, Sadatsafavi M, Anstrom KJ, Au DH, Bender BG, Brookhart MA, Dweik RA, Han MK, Joo MJ, Lavergne V, Mehta AB, Miravitlles M, Mularski RA, Roche N, Oren E, Riekert KA, Schoenberg NC, Stukel TA, Weiss CH, Wunsch H, Africk JJ, Krishnan JA","Journal_Info":"Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE","Publication_Type":"Journal Article","Published_Date":"2021-01-01","Source":"American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2021 Jan 01; Vol. 203 (1), pp. 14-23.","Languages":"English","Electronic_ISSN":"1535-4970","MeSH_Terms":"Clinical Decision-Making*, Biomedical Research\/*standards , Critical Care\/*standards , Delivery of Health Care\/*standards , Evidence-Based Medicine\/*standards , Observational Studies as Topic\/*standards , Thoracic Diseases\/*therapy, Humans ; Practice Guidelines as Topic ; Societies, Medical ; United States","Subjects":"Humans, Practice Guidelines as Topic, Societies, Medical, United States, Biomedical Research standards, Clinical Decision-Making, Critical Care standards, Delivery of Health Care standards, Evidence-Based Medicine standards, Observational Studies as Topic standards, Thoracic Diseases therapy","Title_Abbreviations":"American journal of respiratory and critical care medicine","Volume":"203"},"header":{"DbId":"mdl","DbLabel":"MEDLINE Ultimate","An":"33385220","RelevancyScore":"854","PubType":"Academic Journal","PubTypeId":"academicJournal","PreciseRelevancyScore":"854.003845214844"},"plink":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&db=mdl&AN=33385220&authtype=shib&custid=ns346513&group=main&profile=eds","upload_link":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&db=mdl&AN=33385220&authtype=shib&custid=ns346513&group=main&profile=eds"}
ISSN
1535-4970
IS_Ebsco
true
Additional Info
["Gershon AS, Lindenauer PK, Wilson KC, Rose L, Walkey AJ, Sadatsafavi M, Anstrom KJ, Au DH, Bender BG, Brookhart MA, Dweik RA, Han MK, Joo MJ, Lavergne V, Mehta AB, Miravitlles M, Mularski RA, Roche N, Oren E, Riekert KA, Schoenberg NC, Stukel TA, Weiss CH, Wunsch H, Africk JJ, Krishnan JA","Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE","Journal Article","2021-01-01","American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2021 Jan 01; Vol. 203 (1), pp. 14-23.","English","1535-4970","Clinical Decision-Making*, Biomedical Research\/*standards , Critical Care\/*standards , Delivery of Health Care\/*standards , Evidence-Based Medicine\/*standards , Observational Studies as Topic\/*standards , Thoracic Diseases\/*therapy, Humans ; Practice Guidelines as Topic ; Societies, Medical ; United States","Humans, Practice Guidelines as Topic, Societies, Medical, United States, Biomedical Research standards, Clinical Decision-Making, Critical Care standards, Delivery of Health Care standards, Evidence-Based Medicine standards, Observational Studies as Topic standards, Thoracic Diseases therapy","American journal of respiratory and critical care medicine","203"]
Description
Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine. Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines. Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1 ) no RCTs are identified or RCTs are appraised as being of low- or very low-quality ( replacement ); 2 ) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded ( complementary ); or 3 ) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; " sequential" ). Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.
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