{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:05:42Z","timestamp":1785297942714,"version":"3.55.0"},"reference-count":35,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T00:00:00Z","timestamp":1784332800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"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":["U54AG063546"],"award-info":[{"award-number":["U54AG063546"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp; Dementia"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>The National Institute on Aging\u2010funded IMbedded\u00a0Pragmatic\u00a0Alzheimer's disease and AD\u2010Related Dementias Clinical\u00a0Trials (IMPACT) Collaboratory was established to build capacity for conducting embedded pragmatic clinical trials (ePCTs) within healthcare systems for people living with dementia and their care partners. Here we present methodology and describe lessons learned from the first five years of IMPACT's Design and Statistics Core (DSC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>The DSC assembled a multidisciplinary team focused on advancing the design, analysis, and implementation of ePCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The DSC developed and disseminated methods for design and sample size of cluster randomized designs with complex correlation structures; guidance for pilot ePCTs; approaches to patient\u2013care partner ePCTs; approaches to testing health\u2010equity\u2010relevant hypotheses; and guidance for training quantitative and clinical scientists developing ePCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>Key gaps remain in applying dyadic designs and when studying heterogeneity of treatment effects, which will be major priorities for the next funding cycle.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/alz.71660","type":"journal-article","created":{"date-parts":[[2026,7,19]],"date-time":"2026-07-19T04:44:24Z","timestamp":1784436264000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The design of embedded pragmatic clinical trials: methodological developments and statistical lessons learned from the first cycle of the NIA IMPACT collaboratory"],"prefix":"10.1002","volume":"22","author":[{"given":"Thomas G","family":"Travison","sequence":"first","affiliation":[{"name":"Center for Analytic Sciences in Aging Marcus Institute for Aging Research Hebrew SeniorLife Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kendra","family":"Davis\u2010Plourde","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Yale School of Public Health  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith S.","family":"Goldfeld","sequence":"additional","affiliation":[{"name":"Division of Biostatistics Department of Population Health NYU Grossman School of Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Yale School of Public Health  New Haven Connecticut USA"},{"name":"Center for Methods in Implementation and Prevention Science Yale School of Public Health  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifan","family":"Lou","sequence":"additional","affiliation":[{"name":"School of Social Work Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan K.","family":"Monin","sequence":"additional","affiliation":[{"name":"Department of Social and Behavioral Sciences Yale School of Public Health  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Taljaard","sequence":"additional","affiliation":[{"name":"Methodological and Implementation Research Ottawa Hospital Research Institute  Ottawa Ontario Canada"},{"name":"School of Epidemiology and Public Health University of Ottawa  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Turner","sequence":"additional","affiliation":[{"name":"Center for Gerontology &amp; Healthcare Research Brown University School of Public Health  Providence Rhode Island USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana\u2010Maria","family":"Vranceanu","sequence":"additional","affiliation":[{"name":"Office of Research Careers Center for Academic Development and Enrichment Mass General Brigham Academic Medical Centers  Boston Massachusetts USA"},{"name":"Department of Psychiatry Mass General Brigham Academic Medical Centers Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7685-8175","authenticated-orcid":false,"given":"Heather G","family":"Allore","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Yale School of Public Health  New Haven Connecticut USA"},{"name":"Department of Internal Medicine Yale School of Medicine  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,18]]},"reference":[{"key":"e_1_2_5_2_1","unstructured":"NIA IMPACT Collaboratory.NIA IMPACT Collaboratory. 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