{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:53:29Z","timestamp":1781513609055,"version":"3.54.1"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["3U24AG059624\u201007S1"],"award-info":[{"award-number":["3U24AG059624\u201007S1"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["agsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J American Geriatrics Society"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Monitoring adverse events (AEs) assures patient safety in clinical trials. Studies involving seriously ill and older adults can have a high volume of AEs related to underlying courses of illness rather than study procedures. Trials not regulated by the Food and Drug Administration (FDA) can incur excessive reporting burden beyond that required for compliance or patient safety assurance. In 2021, a working group proposed an alternative approach to AE evaluation, emphasizing routine, aggregate reporting, and reserving expedited reporting of individual AEs for serious events at least possibly related to study procedures and not aligned with goals of care. Another outcome was a call to operationalize the approach for eventual implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A panel comprising 31 leaders from government agencies, professional organizations, aging and serious illness research communities, research administration, and medical ethics met five times in 2024\u20132025. The panel advised on deliverables, assessed concept acceptability, and reviewed tools; a multidisciplinary project team generated content and incorporated feedback. Research compliance experts reviewed the final decision algorithm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The resulting Decision\u2010Making for Adverse Event Reporting Toolkit Tailored to Social, Behavioral and Health Services Studies involving Seriously Ill and Older Adult Populations (DART) is a novel research tool to support researchers in AE evaluation. The decision algorithm assesses: (1) relatedness, (2) goals of care alignment, (3) seriousness, and (4) greater risk of harm. The toolkit includes a case series, frequently asked questions, and reporting form. Feedback emphasized DART applies to any study population and intervention type not regulated by the FDA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>DART provides a novel solution to AE reporting challenges faced by aging and serious illness researchers. While its design centers on seriously ill older adults, DART can likely be applied to research in any population and intervention type not regulated by the FDA. Future pilot testing will inform implementation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgs.70373","type":"journal-article","created":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T06:41:00Z","timestamp":1775803260000},"page":"1692-1697","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Operationalizing a Decision\u2010Making for Adverse Event Reporting Toolkit (\n                    <scp>DART<\/scp>\n                    ) for Aging and Serious Illness Research"],"prefix":"10.1111","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9900-2780","authenticated-orcid":false,"given":"Sara","family":"Lubetsky","sequence":"first","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Woodrell","sequence":"additional","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"},{"name":"Geriatric Research Education and Clinical Center, James J Peters VA Medical Center  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabrielle","family":"Schiller","sequence":"additional","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2010-2683","authenticated-orcid":false,"given":"Brynn","family":"Bowman","sequence":"additional","affiliation":[{"name":"Center to Advance Palliative Care, Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachael","family":"Heitner","sequence":"additional","affiliation":[{"name":"Center to Advance Palliative Care, Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Sean","family":"Morrison","sequence":"additional","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"},{"name":"Geriatric Research Education and Clinical Center, James J Peters VA Medical Center  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert L.","family":"Siu","sequence":"additional","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"},{"name":"Geriatric Research Education and Clinical Center, James J Peters VA Medical Center  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dalane","family":"Kitzman","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine: Sections on Cardiovascular Medicine and Geriatrics Wake Forest School of Medicine  Winston\u2010Salem North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abigail","family":"Baim\u2010Lance","sequence":"additional","affiliation":[{"name":"Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai  New York New York USA"},{"name":"Geriatric Research Education and Clinical Center, James J Peters VA Medical Center  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,9]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606\u2010022\u201007646\u20107"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916\u2010019\u20101369\u20107"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/resp.13678"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S340587"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000011832"},{"key":"e_1_2_11_7_1","unstructured":"United States \u201cCode of Federal Regulations \u201d Title 21 Part 312.64 Investigator Reports Vol 312.64(b) 2024 https:\/\/www.ecfr.gov\/current\/title\u201021\/section\u2010312.64."},{"key":"e_1_2_11_8_1","unstructured":"United States \u201cCode of Federal Code of Federal Regulations \u201d Title 45 Part 46.108(4)(i) Institutional Review Board (IRB) Functions and Operations 2023 https:\/\/www.ecfr.gov\/current\/title\u201045\/section\u201046.108."},{"key":"e_1_2_11_9_1","volume-title":"Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance","author":"Office for Human Research Protections","year":"2007"},{"key":"e_1_2_11_10_1","volume-title":"NIH Guide: NIH Policy for Data and Safety Monitoring","author":"National Institutes of Health","year":"1998"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.3109\/13561820.2012.698328"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11673\u2010024\u201010340\u20104"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003\u20104819\u2010140\u201010\u2010200405180\u201000009"},{"key":"e_1_2_11_14_1","volume-title":"AE\u2010SAE Process Chart (Dec 2020)","author":"National Institute on Aging","year":"2020"},{"key":"e_1_2_11_15_1","volume-title":"Adverse Event Form","author":"National Institute on Aging","year":"2019"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/15710882.2025.2541289"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004587"},{"key":"e_1_2_11_18_1","volume-title":"Accessible Environments: Toward Universal Design","author":"Mace R. 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