{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T16:49:45Z","timestamp":1772642985060,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,12,5]],"date-time":"2017-12-05T00:00:00Z","timestamp":1512432000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006093","name":"Patient-Centered Outcomes Research Institute","doi-asserted-by":"publisher","award":["IP2PI000487\u201001"],"award-info":[{"award-number":["IP2PI000487\u201001"]}],"id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Learning Health Systems"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non\u2010investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative streamlined approaches to disclosure and consent in this context have been limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We used a deliberative engagement method to solicit the views of a multi\u2010stakeholder group regarding 3 alternative models of disclosure, consent, and authorization in CER studies: Opt\u2010In, Opt\u2010Out, and \u201cGeneral Approval\u201d. Participants considered the acceptability of these 3 models for observational and randomized CER studies of hypertension medications and for alternative treatments for spinal stenosis, all conducted in the context of a learning health care system.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010eight stakeholders participated in the all\u2010day deliberative engagement session. Following deliberation, a majority of stakeholders (67%) liked the General Approval model for the observational hypertension study, more than the number who reported liking Opt\u2010Out or Opt\u2010In (45% and 36%, respectively). Support was lower for General Approval model in the context of a randomized hypertension study, with 80% liking a traditional Opt\u2010In approach, compared with 54% liking Opt\u2010Out, and 11% liking General Approval. Similarly, for the spinal stenosis CER studies, while most stakeholders preferred a streamlined Opt\u2010Out approach for the observational design, most preferred a traditional Opt\u2010In approach for the randomized version.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This multi\u2010stakeholder group was more favorable towards streamlined models for disclosure and authorization for observational CER than randomized designs. These findings are consistent with arguments that informed consent requirements should be tailored to the context of the research design, rather than a standard \u201cone size fits all\u201d approach.<\/jats:p><\/jats:sec>","DOI":"10.1002\/lrh2.10047","type":"journal-article","created":{"date-parts":[[2017,12,6]],"date-time":"2017-12-06T02:22:47Z","timestamp":1512526967000},"source":"Crossref","is-referenced-by-count":12,"title":["Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research"],"prefix":"10.1002","volume":"2","author":[{"given":"Stephanie R.","family":"Morain","sequence":"first","affiliation":[{"name":"Center for Medical Ethics and Health Policy Baylor College of Medicine  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ellen","family":"Tambor","sequence":"additional","affiliation":[{"name":"Center for Medical Technology Policy World Trade Center Baltimore  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachael","family":"Moloney","sequence":"additional","affiliation":[{"name":"Center for Medical Technology Policy World Trade Center Baltimore  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy E.","family":"Kass","sequence":"additional","affiliation":[{"name":"Johns Hopkins Berman Institute of Bioethics  Baltimore Maryland"},{"name":"Johns Hopkins Bloomberg School of Public Health  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sean","family":"Tunis","sequence":"additional","affiliation":[{"name":"Center for Medical Technology Policy World Trade Center Baltimore  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Hallez","sequence":"additional","affiliation":[{"name":"Johns Hopkins Berman Institute of Bioethics  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth R.","family":"Faden","sequence":"additional","affiliation":[{"name":"Johns Hopkins Berman Institute of Bioethics  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,12,5]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3818"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/lrh2.10015"},{"key":"e_1_2_7_4_1","volume-title":"Final Report of the Tuskegee Syphilis Study Ad Hoc Panel","author":"U.S. Department of Health, Education, and Welfare","year":"1973"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199903113401013"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1313674"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.4164"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-014-3169-2"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2015.0906"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1312508"},{"issue":"9","key":"e_1_2_7_11_1","first-page":"895","article-title":"Ethical complexities in standard of care randomized trials: a case study of morning versus nighttime dosing of blood pressure drugs","volume":"313","author":"Kim SYH","year":"2015","journal-title":"Clin Trials"},{"issue":"1","key":"e_1_2_7_12_1","first-page":"S28","article-title":"A prescription for ethical learning","volume":"43","author":"Largent EA","year":"2013","journal-title":"Hastings Cent Rep"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1411250"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/23294515.2016.1156188"},{"issue":"5","key":"e_1_2_7_15_1","doi-asserted-by":"crossref","first-page":"356","DOI":"10.7326\/M15-0817","article-title":"Pragmatic randomized trials without standard informed consent? A national survey","volume":"163","author":"Nayak RK","year":"2015","journal-title":"Ann Intern Med"},{"issue":"9","key":"e_1_2_7_16_1","doi-asserted-by":"crossref","first-page":"725","DOI":"10.7326\/L15-5152-2","article-title":"Attitudes toward risk and informed consent for research on medical practices: a cross sectional survey","volume":"163","author":"Cho MK","year":"2015","journal-title":"Ann Intern Med"},{"key":"e_1_2_7_17_1","doi-asserted-by":"crossref","DOI":"10.1080\/23294515.2015.1117536","article-title":"Patients' views concerning research on medical practices: implications for consent","author":"Weinfurt KP","year":"2016","journal-title":"AJOB Empir Bioeth"},{"issue":"5","key":"e_1_2_7_18_1","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1177\/1740774516648907","article-title":"A comparison of institutional review board professionals' and patients' views on consent for research on medical practices","volume":"13","author":"Kraft SA","year":"2016","journal-title":"Clin Trial"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/jlme.12256"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.2217\/cer-2016-0024"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2006.08.045"},{"issue":"5","key":"e_1_2_7_22_1","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1007\/s40271-017-0238-8","article-title":"Deliberative engagement methods for patient\u2010centered outcomes research","volume":"10","author":"Morain SR","year":"2017","journal-title":"Patient"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1080\/23294515.2015.1111272"},{"issue":"2","key":"e_1_2_7_24_1","doi-asserted-by":"crossref","first-page":"123","DOI":"10.2217\/cer.15.67","article-title":"Patient and clinician support for the learning healthcare system: recommendations for enhancing value","volume":"5","author":"Maloney RM","year":"2016","journal-title":"J Comp Eff Res"},{"issue":"2","key":"e_1_2_7_25_1","first-page":"125","article-title":"Adrift in the gray zone: IRB perspectives on research in the learning health system","volume":"7","author":"Lee SJL","year":"2015","journal-title":"AJOB Empir Bioeth"}],"container-title":["Learning Health Systems"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flrh2.10047","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lrh2.10047","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T13:33:31Z","timestamp":1695562411000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lrh2.10047"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12,5]]},"references-count":24,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2018,4]]}},"alternative-id":["10.1002\/lrh2.10047"],"URL":"https:\/\/doi.org\/10.1002\/lrh2.10047","archive":["Portico"],"relation":{},"ISSN":["2379-6146","2379-6146"],"issn-type":[{"value":"2379-6146","type":"print"},{"value":"2379-6146","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12,5]]},"article-number":"e10047"}}