{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T08:57:32Z","timestamp":1775465852148,"version":"3.50.1"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"5","funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1U54AT007748-01"],"award-info":[{"award-number":["1U54AT007748-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007769-01"],"award-info":[{"award-number":["1UH2AT007769-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007782-01"],"award-info":[{"award-number":["1UH2AT007782-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007755-01"],"award-info":[{"award-number":["1UH2AT007755-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007788-01"],"award-info":[{"award-number":["1UH2AT007788-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007766-01"],"award-info":[{"award-number":["1UH2AT007766-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2 AT007784-01"],"award-info":[{"award-number":["1UH2 AT007784-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1UH2AT007797-01"],"award-info":[{"award-number":["1UH2AT007797-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research.<\/jats:p>","DOI":"10.1093\/jamia\/ocx016","type":"journal-article","created":{"date-parts":[[2017,2,15]],"date-time":"2017-02-15T08:56:51Z","timestamp":1487149011000},"page":"996-1001","source":"Crossref","is-referenced-by-count":35,"title":["Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory"],"prefix":"10.1093","volume":"24","author":[{"given":"Rachel L","family":"Richesson","sequence":"first","affiliation":[{"name":"Division of Clinical Systems and Analytics, Duke University School of Nursing, Durham, NC, USA"},{"name":"Duke Center for Health Informatics, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beverly B","family":"Green","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reesa","family":"Laws","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Center for Health Research, Portland, OR, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon","family":"Puro","sequence":"additional","affiliation":[{"name":"OCHIN Inc, Portland, OR, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael G","family":"Kahn","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Colorado, Denver, CO, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan","family":"Bauck","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Center for Health Research, Portland, OR, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Smerek","sequence":"additional","affiliation":[{"name":"Clinical Research Informatics, Duke Clinical Research Institute, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik G","family":"Van Eaton","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Washington, Seattle, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meredith","family":"Zozus","sequence":"additional","affiliation":[{"name":"University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W","family":"Ed Hammond","sequence":"additional","affiliation":[{"name":"Duke Center for Health Informatics, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kari A","family":"Stephens","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Greg E","family":"Simon","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2017,3,14]]},"reference":[{"key":"2020110612370874600_ocx016-B1","doi-asserted-by":"crossref","first-page":"217","DOI":"10.31887\/DCNS.2011.13.2\/npatsopoulos","article-title":"A pragmatic view on pragmatic trials","volume":"13","author":"Patsopoulos","year":"2011","journal-title":"Dialogues Clin Neurosci."},{"key":"2020110612370874600_ocx016-B2","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1001\/jama.290.12.1624","article-title":"Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy","volume":"290","author":"Tunis","year":"2003","journal-title":"JAMA."},{"key":"2020110612370874600_ocx016-B3","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1016\/0021-9681(67)90041-0","article-title":"Explanatory and pragmatic attitudes in therapeutical trials","volume":"20","author":"Schwartz","year":"1967","journal-title":"J Chronic Dis."},{"key":"2020110612370874600_ocx016-B4","doi-asserted-by":"crossref","first-page":"1351","DOI":"10.1001\/jama.2013.393","article-title":"The inevitable application of big data to health care","volume":"309","author":"Murdoch","year":"2013","journal-title":"JAMA."},{"key":"2020110612370874600_ocx016-B5","doi-asserted-by":"crossref","first-page":"2293","DOI":"10.1056\/NEJMsb1609216","article-title":"Real-World Evidence \u2014 What Is It and What Can It Tell Us?","volume":"375","author":"Sherman","year":"2016","journal-title":"N Engl J Med."},{"key":"2020110612370874600_ocx016-B6","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1177\/1740774515571140","article-title":"Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems","volume":"12","author":"Anderson","year":"2015","journal-title":"Clin Trials."},{"key":"2020110612370874600_ocx016-B7","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1177\/1740774515598334","article-title":"Exploring the ethical and regulatory issues in pragmatic clinical trials","volume":"12","author":"Califf","year":"2015","journal-title":"Clin Trials."},{"key":"2020110612370874600_ocx016-B8","doi-asserted-by":"crossref","first-page":"g6826","DOI":"10.1136\/bmj.g6826","article-title":"A guide to research partnerships for pragmatic clinical trials","volume":"349","author":"Johnson","year":"2014","journal-title":"BMJ."},{"key":"2020110612370874600_ocx016-B9","unstructured":"NIH Health Care Systems Research Collaboratory. Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects. January 19, 2016. https:\/\/www.nihcollaboratory.org\/Products\/Lessons%20Learned%20from%20the%20NIH%20Collaboratory%20Demonstration%20Projects_V1.0.pdf. Accessed September 20, 2016."},{"key":"2020110612370874600_ocx016-B10","doi-asserted-by":"crossref","first-page":"504","DOI":"10.1177\/1740774516646578","article-title":"Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core","volume":"13","author":"Cook","year":"2016","journal-title":"Clin Trials."},{"key":"2020110612370874600_ocx016-B11","article-title":"Designing multicenter cluster randomized trials: an introductory toolkit","author":"Pladevall","journal-title":"NIH Health Care Systems Research Collaboratory"},{"key":"2020110612370874600_ocx016-B12","article-title":"Assessing Data Quality for Healthcare Systems Data Used in Clinical Research (Version 1.0)","author":"Zozus","journal-title":"An NIH Health Care Systems Research Collaboratory White Paper."},{"key":"2020110612370874600_ocx016-B13","unstructured":"NIH Health Care Systems Research Collaboratory. Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. https:\/\/sites.duke.edu\/rethinkingclinicaltrials\/. Accessed September 20, 2016."},{"key":"2020110612370874600_ocx016-B14","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1136\/amiajnl-2014-002747","article-title":"Launching PCORnet, a national patient-centered clinical research network","volume":"21","author":"Fleurence","year":"2014","journal-title":"J Am Med Inform Assoc."},{"key":"2020110612370874600_ocx016-B15","unstructured":"National Institutes of Health.\nNIH Health Care Systems Research Collaboratory Demonstration Project. Pain Program for Active Coping and Training (PPACT). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/PPACT.aspx. Accessed September 20, 2016."},{"key":"2020110612370874600_ocx016-B16","unstructured":"National Institutes of Health.\nNIH Health Care Systems Research Collaboratory Demonstration Project. Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/STOP%20CRC.aspx. Accessed October 9, 2015."},{"key":"2020110612370874600_ocx016-B17","unstructured":"National Institutes of Health. NIH Health Care Systems Research Collaboratory Demonstration Project.Suicide Prevention Outreach Trial (SPOT).https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/SPOT.aspx. Accessed October 9, 2015."},{"key":"2020110612370874600_ocx016-B18","unstructured":"National Institutes of Health.\nNIH Health Care Systems Research Collaboratory Demonstration Project. Time to Reduce Mortality in End-Stage Renal Disease (TiME). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/TiME.aspx. Accessed October 9, 2015."},{"key":"2020110612370874600_ocx016-B19","unstructured":"National Institutes of Health.\nNIH Health Care Systems Research Collaboratory Demonstration Project. Pragmatic Trial of Video Education in Nursing Homes (PROVEN). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/PROVEN.aspx. Accessed October 9, 2015."},{"key":"2020110612370874600_ocx016-B20","unstructured":"National Institutes of Health. NIH Health Care Systems Research Collaboratory Demonstration Project. Lumbar Image Reporting with Epidemiology (LIRE). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/LIRE.aspx. Accessed October 9, 2015."},{"key":"2020110612370874600_ocx016-B21","unstructured":"National Institutes of Health. NIH Collaboratory. An Interview with Dr. Jerry Jarvik. 2015. https:\/\/www.nihcollaboratory.org\/Pages\/Jarvik%20LIRE%20Interview%207-21-15.pdf. Accessed October 20, 2015."},{"key":"2020110612370874600_ocx016-B22","unstructured":"National Institutes of Health. NIH Health Care Systems Research Collaboratory Demonstration Project. Active Bathing to Eliminate (ABATE) Infection trial. https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/ABATE.aspx. Accessed February 2, 2015."},{"key":"2020110612370874600_ocx016-B23","unstructured":"National Institutes of Health. NIH Health Care Systems Research Collaboratory Demonstration Project. Improving Chronic Disease Management with Pieces (ICD-Pieces). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/ICD-Pieces.aspx. Accessed February 4, 2015."},{"key":"2020110612370874600_ocx016-B24","doi-asserted-by":"crossref","unstructured":"National Institutes of Health. NIH Health Care Systems Research Collaboratory Demonstration Project. Trauma Survivors Outcomes and Support (TSOS). https:\/\/www.nihcollaboratory.org\/demonstration-projects\/Pages\/TSOS.aspx. Accessed January 19, 2016.","DOI":"10.1016\/j.jval.2016.03.1943"},{"key":"2020110612370874600_ocx016-B25","doi-asserted-by":"crossref","first-page":"e226","DOI":"10.1136\/amiajnl-2013-001926","article-title":"Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory","volume":"20","author":"Richesson","year":"2013","journal-title":"J Am Med Inform Assoc."},{"key":"2020110612370874600_ocx016-B26","unstructured":"NIH Health Care Systems Research Collaboratory. Phenotypes, Data Standards, and Data Quality Core Group Webpage. https:\/\/www.nihcollaboratory.org\/cores\/Pages\/phenotypes.aspx. Accessed October 27, 2016."},{"key":"2020110612370874600_ocx016-B27","article-title":"Using EHR Data to Automate Colorectal Cancer Screening at Community Health Centers: Opportunities and Barriers","author":"Puro","journal-title":"North American Primary Care Research Group 2014 Annual Meeting."},{"key":"2020110612370874600_ocx016-B28","first-page":"1025","article-title":"Preparing electronic clinical data for quality improvement and comparative effectiveness research: The SCOAP CERTAIN Automation and Validation Project","volume":"1","author":"Devine","year":"2013","journal-title":"EGEMS (Wash DC)."},{"key":"2020110612370874600_ocx016-B29","first-page":"1018","article-title":"Recommendations for the use of operational electronic health record data in comparative effectiveness research","volume":"1","author":"Hersh","year":"2013","journal-title":"EGEMS (Wash DC)."},{"key":"2020110612370874600_ocx016-B30","first-page":"215","article-title":"Clinical research informatics and electronic health record data","volume":"9","author":"Richesson","year":"2014","journal-title":"Yearb Med Inform."},{"issue":"6","key":"2020110612370874600_ocx016-B31","doi-asserted-by":"crossref","first-page":"639","DOI":"10.1093\/fampra\/cmw065","article-title":"The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics","volume":"33","author":"Petrik","year":"2016","journal-title":"Fam Pract."},{"key":"2020110612370874600_ocx016-B32","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1136\/amiajnl-2012-001194","article-title":"Informatics and operations: let\u2019s get integrated","volume":"20","author":"Marsolo","year":"2013","journal-title":"J Am Med Inform Assoc."},{"key":"2020110612370874600_ocx016-B33","first-page":"1069","article-title":"Achieving and sustaining automated health data linkages for learning systems: barriers and solutions","volume":"2","author":"Van Eaton","year":"2014","journal-title":"EGEMS (Wash DC)."},{"key":"2020110612370874600_ocx016-B34","unstructured":"Retrieve Form for Data Capture. Integrating the Healthcare Enterprise Wiki page. http:\/\/wiki.ihe.net\/index.php\/Retrieve_Form_for_Data_Capture. Accessed October 27, 2016."},{"key":"2020110612370874600_ocx016-B35","first-page":"1232","article-title":"A Framework to Support the Sharing and Reuse of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications","volume":"4","author":"Richesson","year":"2016","journal-title":"EGEMS (Wash DC)."},{"key":"2020110612370874600_ocx016-B36","doi-asserted-by":"crossref","first-page":"S49","DOI":"10.1097\/MLR.0b013e318259c02b","article-title":"A survey of informatics platforms that enable distributed comparative effectiveness research using multi-institutional heterogeneous clinical data","volume":"50","author":"Sittig","year":"2012","journal-title":"Med Care."},{"key":"2020110612370874600_ocx016-B37","unstructured":"HL7. FHIR Overview. https:\/\/www.hl7.org\/fhir\/overview.html. Accessed September 20, 2016."},{"key":"2020110612370874600_ocx016-B38","unstructured":"SMART HealthIT. Something New and Powerful: SMART on FHIR\u00ae. http:\/\/smarthealthit.org\/smart-on-fhir\/. Accessed September 20, 2016."}],"container-title":["Journal of the American Medical Informatics Association"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jamia\/article-pdf\/24\/5\/996\/34148499\/ocx016.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/jamia\/article-pdf\/24\/5\/996\/34148499\/ocx016.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,11,6]],"date-time":"2020-11-06T17:47:19Z","timestamp":1604684839000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jamia\/article\/24\/5\/996\/3069877"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3,14]]},"references-count":38,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2017,3,14]]},"published-print":{"date-parts":[[2017,9,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jamia\/ocx016","relation":{},"ISSN":["1067-5027","1527-974X"],"issn-type":[{"value":"1067-5027","type":"print"},{"value":"1527-974X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2017,9]]},"published":{"date-parts":[[2017,3,14]]}}}