{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T22:56:28Z","timestamp":1780613788260,"version":"3.54.1"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2024,11,8]],"date-time":"2024-11-08T00:00:00Z","timestamp":1731024000000},"content-version":"vor","delay-in-days":7,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100008460","name":"National Center for Complementary and Integrative Health","doi-asserted-by":"publisher","award":["U24 AT009769"],"award-info":[{"award-number":["U24 AT009769"]}],"id":[{"id":"10.13039\/100008460","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000118","name":"Office of Behavioral and Social Sciences Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000118","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Center for Complementary & Integrative Health"},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UG3\/UH3 AT009790"],"award-info":[{"award-number":["UG3\/UH3 AT009790"]}],"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":["UG3\/UH3AT009761"],"award-info":[{"award-number":["UG3\/UH3AT009761"]}],"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":["UG3\/UH3 AT009763"],"award-info":[{"award-number":["UG3\/UH3 AT009763"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Assistant Secretary of Defense for Health Affairs"},{"DOI":"10.13039\/100000005","name":"Department of Defense","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Pain Management Collaboratory\u2014Pragmatic Clinical Trials Demonstration","award":["W81XWH-18\u20132-0007"],"award-info":[{"award-number":["W81XWH-18\u20132-0007"]}]},{"name":"Pain Management Collaboratory\u2014Pragmatic Clinical Trials Demonstration","award":["W81XWH-18\u20132-0009"],"award-info":[{"award-number":["W81XWH-18\u20132-0009"]}]},{"name":"Army Medical Research Acquisition Activity"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Despite careful design of clinical trials, unforeseen disruptions can arise. The PICOTS (Patient population, Intervention, Comparator, Outcomes, Timepoints, Setting) framework was used to assess disruptions in pain management research imposed by coronavirus disease 2019 (COVID-19) within the Pain Management Collaboratory.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Rapid qualitative methods were employed to identify trial disruptions due to COVID-19 in 11 pragmatic clinical trials of nonpharmacological approaches for pain management. The PICOTS framework was applied by investigators of 4 Collaboratory trials selected to cover 4 types of trial designs (individually randomized, stepped-wedge, cluster, sequential multiple assignment randomized trial\u2014SMART). Interviews with the lead investigators of these trials were completed, and findings were presented\/discussed on video calls over a 6-month period (March-August 2021) from which themes\/lessons learned were identified and consensus reached.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Investigators indicated that patient populations remained generally stable. A major COVID-19 trial disruption was moving from in-person to virtual care affecting delivery of interventions\/comparators and outcome assessments. The resultant mixed-mode of care delivery created issues with intervention fidelity posing analytic challenges. COVID-19 also induced ongoing\/intermittent delays and other barriers to accessing primary and specialty care at some facilities, creating research capacity issues affecting delivery of experimental interventions requiring sustained, reliable participation of clinical partners. Study designs most affected by COVID-19 were stepped-wedge (intervention\/comparator changing over time), cluster (increased site variability inflating intracluster correlation), and SMART (second-stage randomizations disrupted); stratified individually-randomized trials were less vulnerable because of individual-level randomization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>PICOTS provides a framework for assessing the impact of trial disruptions in a structured manner. Given the COVID-19 experience, it is important for researchers to consider the potential impact of future trial disruptions during study planning.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/pm\/pnae078","type":"journal-article","created":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T09:52:34Z","timestamp":1722592354000},"page":"S34-S40","source":"Crossref","is-referenced-by-count":1,"title":["Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory"],"prefix":"10.1093","volume":"25","author":[{"given":"Peter","family":"Peduzzi","sequence":"first","affiliation":[{"name":"Pain Management Collaboratory Coordinating Center, Yale University , New Haven, CT,","place":["United States"]},{"name":"Department of Biostatistics and Yale Center for Analytical Sciences, Yale School of Public Health , New Haven, CT,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Brandt","sequence":"additional","affiliation":[{"name":"Pain Management Collaboratory Coordinating Center, Yale University , New Haven, CT,","place":["United States"]},{"name":"VA Connecticut Healthcare System , West Haven, CT,","place":["United States"]},{"name":"Section of Biomedical Informatics & Data Science, Yale School of Medicine , New Haven, CT,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L","family":"Dearth","sequence":"additional","affiliation":[{"name":"Research & Surveillance Section, Extremity Trauma & Amputation Center of Excellence Research Branch, Defense Health Agency , Bethesda, MD,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Dziura","sequence":"additional","affiliation":[{"name":"Pain Management Collaboratory Coordinating Center, Yale University , New Haven, CT,","place":["United States"]},{"name":"Department of Biostatistics and Yale Center for Analytical Sciences, Yale School of Public Health , New Haven, CT,","place":["United States"]},{"name":"Department of Emergency Medicine, Yale School of Medicine , New Haven, CT,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn","family":"Farrokhi","sequence":"additional","affiliation":[{"name":"Department of Physical Therapy, Chapman University , Irvine, CA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4988-9421","authenticated-orcid":false,"given":"Steven Z","family":"George","sequence":"additional","affiliation":[{"name":"Departments of Orthopedic Surgery and Population Health Sciences and Duke Clinical Research Institute, Duke University , Durham, NC,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tassos C","family":"Kyriakides","sequence":"additional","affiliation":[{"name":"Pain Management Collaboratory Coordinating Center, Yale University , New Haven, CT,","place":["United States"]},{"name":"Department of Biostatistics and Yale Center for Analytical Sciences, Yale School of Public Health , New Haven, CT,","place":["United States"]},{"name":"VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare Systems , West Haven, CT,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia R","family":"Long","sequence":"additional","affiliation":[{"name":"Palmer Center for Chiropractic Research, Palmer College of Chiropractic , Davenport, IA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward J","family":"Mascha","sequence":"additional","affiliation":[{"name":"Department of Quantitative Health Sciences, Lerner Research Institute, and Department of Anesthesiology, Integrated Hospital Institute, Cleveland Clinic , Cleveland, OH,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charity G","family":"Patterson","sequence":"additional","affiliation":[{"name":"Department of Physical Therapy, School of Health and Rehabilitation Sciences Data Center, University of Pittsburgh , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4320-990X","authenticated-orcid":false,"given":"Daniel I","family":"Rhon","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation Medicine, F. Edward Hebert School of Medicine, Uniformed Services University , Bethesda, MD,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3834-973X","authenticated-orcid":false,"given":"Robert D","family":"Kerns","sequence":"additional","affiliation":[{"name":"Pain Management Collaboratory Coordinating Center, Yale University , New Haven, CT,","place":["United States"]},{"name":"Department of Psychiatry, Yale School of Medicine , New Haven, CT,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,11,8]]},"reference":[{"issue":"3","key":"2025110905363422500_pnae078-B1","doi-asserted-by":"crossref","first-page":"878","DOI":"10.3126\/nje.v10i3.31622","article-title":"Impact of COVID-19 on clinical trials and clinical research: a systematic review","volume":"10","author":"Sathian","year":"2020","journal-title":"Nepal J Epidemiol"},{"issue":"6","key":"2025110905363422500_pnae078-B2","doi-asserted-by":"crossref","first-page":"1591","DOI":"10.1097\/j.pain.0000000000002139","article-title":"Pivoting to virtual delivery for managing chronic pain with nonpharmacological treatments\u2014Implications for pragmatic research","volume":"162","author":"Fritz","year":"2021","journal-title":"Pain"},{"issue":"12","key":"2025110905363422500_pnae078-B3","doi-asserted-by":"crossref","first-page":"2336","DOI":"10.1093\/pm\/pnz186","article-title":"NIH-DoD-VA Pain Management Collaboratory. NIH-DoD-VA Pain Management Collaboratory","volume":"20","author":"Kerns","year":"2019","journal-title":"Pain Med"},{"key":"2025110905363422500_pnae078-B4","doi-asserted-by":"crossref","first-page":"106619","DOI":"10.1016\/j.cct.2021.106619","article-title":"Assessing the impact of the covid-19 pandemic on pragmatic clinical trial participants","volume":"111","author":"Coleman","year":"2021","journal-title":"Contemp Clin Trials"},{"issue":"8","key":"2025110905363422500_pnae078-B5","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1093\/tbm\/ibad015","article-title":"Impact of the COVID-19 pandemic on nonpharmacological pain management trials in military and veteran healthcare settings: an evaluation informed by implementation science","volume":"13","author":"Midboe","year":"2023","journal-title":"Transl Behav Med"},{"issue":"5","key":"2025110905363422500_pnae078-B6","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1016\/j.jclinepi.2008.12.011","article-title":"A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers","volume":"62","author":"Thorpe","year":"2009","journal-title":"J Clin Epidemiol"},{"key":"2025110905363422500_pnae078-B7","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1016\/j.jclinepi.2017.06.001","article-title":"The PRECIS-2 tool has good interrater reliability and modest discriminant validity","volume":"88","author":"Loudon","year":"2017","journal-title":"J Clin Epidemiol"},{"key":"2025110905363422500_pnae078-B8","first-page":"2","volume-title":"Methods Guide for Medical Test Reviews.","author":"Samson","year":"2012"},{"issue":"6","key":"2025110905363422500_pnae078-B9","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1111\/wvn.12408","article-title":"The underappreciated and misunderstood PICOT question: A critical step in the EBP process","volume":"16","author":"Ford","year":"2019","journal-title":"Worldviews Evid Based Nurs"},{"issue":"1","key":"2025110905363422500_pnae078-B10","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1186\/s13063-022-06385-8","article-title":"The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory","volume":"23","author":"O'Brien","year":"2022","journal-title":"Trials"},{"issue":"10","key":"2025110905363422500_pnae078-B11","doi-asserted-by":"crossref","first-page":"e019993","DOI":"10.1136\/bmjopen-2017-019993","article-title":"Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis","volume":"8","author":"Taylor","year":"2018","journal-title":"BMJ Open"},{"issue":"suppl 2","key":"2025110905363422500_pnae078-B12","doi-asserted-by":"crossref","first-page":"S37","DOI":"10.1093\/pm\/pnaa289","article-title":"Veteran response to dosage in chiropractic therapy (VERDICT): study protocol of a pragmatic randomized trial for chronic low back pain","volume":"21","author":"Long","year":"2020","journal-title":"Pain Med"},{"issue":"24","key":"2025110905363422500_pnae078-B13","doi-asserted-by":"crossref","first-page":"3115","DOI":"10.1097\/00007632-200012150-00006","article-title":"The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire","volume":"25","author":"Roland","year":"2000","journal-title":"Spine (Phila Pa 1976)"},{"issue":"suppl 2","key":"2025110905363422500_pnae078-B14","doi-asserted-by":"crossref","first-page":"S45","DOI":"10.1093\/pm\/pnaa367","article-title":"Resolving the burden of low back pain in military service members and veterans (RESOLVE): protocol for a multisite pragmatic clinical trial","volume":"21","author":"Farrokhi","year":"2020","journal-title":"Pain Med"},{"issue":"4","key":"2025110905363422500_pnae078-B15","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1016\/j.jcm.2008.07.001","article-title":"Psychometric properties and clinical usefulness of the Oswestry Disability Index","volume":"7","author":"Vianin","year":"2008","journal-title":"J Chiropr Med"},{"issue":"8","key":"2025110905363422500_pnae078-B16","doi-asserted-by":"crossref","first-page":"1505","DOI":"10.1093\/pm\/pnw105","article-title":"Psychometric testing of the Defense and Veterans Pain Rating Scale (DVPRS): a new pain scale for military population","volume":"17","author":"Polomano","year":"2016","journal-title":"Pain Med"},{"issue":"suppl 2","key":"2025110905363422500_pnae078-B17","doi-asserted-by":"crossref","first-page":"S62","DOI":"10.1093\/pm\/pnaa348","article-title":"Improving veteran access to integrated management of back pain (aim-back): protocol for an embedded pragmatic cluster-randomized trial","volume":"21","author":"George","year":"2020","journal-title":"Pain Med"},{"issue":"5","key":"2025110905363422500_pnae078-B18","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1016\/j.jval.2019.02.004","article-title":"PROMIS\u00ae adult health profiles: efficient short-form measures of seven health domains","volume":"22","author":"Cella","year":"2019","journal-title":"Value Health"},{"issue":"suppl 2","key":"2025110905363422500_pnae078-B19","doi-asserted-by":"publisher","first-page":"S73","DOI":"10.1093\/pm\/pnaa338","article-title":"A sequential multiple-assignment randomized trial (SMART) for stepped care management of low back pain in the military health system: a trial protocol","volume":"21","author":"Fritz","year":"2020","journal-title":"Pain Med"},{"issue":"1","key":"2025110905363422500_pnae078-B20","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1186\/s12967-021-03013-y","article-title":"Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial","volume":"19","author":"Rhon","year":"2021","journal-title":"J Transl Med"},{"key":"2025110905363422500_pnae078-B21","volume-title":"Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, and Pain","author":"Garland","year":"2013"},{"issue":"2","key":"2025110905363422500_pnae078-B22","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1097\/BRS.0000000000000097","article-title":"Psychometric properties of the PROMIS physical function item bank in patients with spinal disorders","volume":"39","author":"Hung","year":"2014","journal-title":"Spine"},{"issue":"4","key":"2025110905363422500_pnae078-B23","doi-asserted-by":"crossref","first-page":"568","DOI":"10.1016\/j.jpain.2022.12.008","article-title":"Intervention fidelity in pain pragmatic trials for nonpharmacologic pain management: nuanced considerations for determining PRECIS-2 flexibility in delivery and adherence","volume":"24","author":"Kerns","year":"2022","journal-title":"J Pain"},{"issue":"11","key":"2025110905363422500_pnae078-B24","doi-asserted-by":"crossref","first-page":"1815","DOI":"10.1093\/pm\/pnac083","article-title":"Chronic pain self-management: psychologically guided core competencies for providers","volume":"23","author":"Kerns","year":"2022","journal-title":"Pain Med"},{"issue":"3","key":"2025110905363422500_pnae078-B25","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1007\/s00540-022-03042-x","article-title":"What changes occurred in patients with chronic pain in the early phase of the COVID-19 pandemic?","volume":"36","author":"Tanaka","year":"2022","journal-title":"J Anesth"},{"issue":"12 suppl 2","key":"2025110905363422500_pnae078-B26","doi-asserted-by":"crossref","first-page":"S110","DOI":"10.1093\/pm\/pnaa334","article-title":"Screening, brief intervention, and referral to treatment for pain management for Veterans seeking service-connection payments for musculoskeletal disorders: SBIRT-PM study protocol","volume":"21","author":"Martino","year":"2020","journal-title":"Pain Med"},{"issue":"CS1","key":"2025110905363422500_pnae078-B27","first-page":"1","article-title":"A SAS macro for covariate-constrained randomization of general cluster-randomized and unstratified designs","volume":"77","author":"Greene","year":"2017","journal-title":"J Stat Softw"},{"issue":"12 suppl 5","key":"2025110905363422500_pnae078-B28","doi-asserted-by":"crossref","first-page":"S5","DOI":"10.1097\/MLR.0000000000000226","article-title":"The vision and implementation of personalized, proactive, patient-driven health care for veterans","volume":"52","author":"Krejci","year":"2014","journal-title":"Med Care"},{"issue":"3","key":"2025110905363422500_pnae078-B29","doi-asserted-by":"crossref","first-page":"1","DOI":"10.15585\/mmwr.rr7103a1","article-title":"CDC clinical practice guideline for prescribing opioids for pain\u2013United States, 2022","volume":"71","author":"Dowell","year":"2022","journal-title":"MMWR Recomm Rep"},{"key":"2025110905363422500_pnae078-B30","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/19466315.2023.2257894","article-title":"Using randomization tests to address disruptions in clinical trials: a report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions","author":"Uschner","year":"2023","journal-title":"Stat Biopharm Res"},{"issue":"1","key":"2025110905363422500_pnae078-B31","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1080\/19466315.2022.2094459","article-title":"Estimands and their estimators for clinical trials impacted by the COVID-19 pandemic: a report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions","volume":"15","author":"Van Lancker","year":"2022","journal-title":"Stat Biopharm Res"}],"container-title":["Pain Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/painmedicine\/article-pdf\/25\/Supplement_1\/S34\/60543629\/pnae078.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/painmedicine\/article-pdf\/25\/Supplement_1\/S34\/60543629\/pnae078.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T10:36:41Z","timestamp":1762684601000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/painmedicine\/article\/25\/Supplement_1\/S34\/7887770"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,1]]},"references-count":31,"journal-issue":{"issue":"Supplement_1","published-online":{"date-parts":[[2024,11,8]]},"published-print":{"date-parts":[[2024,11,1]]}},"URL":"https:\/\/doi.org\/10.1093\/pm\/pnae078","relation":{},"ISSN":["1526-2375","1526-4637"],"issn-type":[{"value":"1526-2375","type":"print"},{"value":"1526-4637","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,11]]},"published":{"date-parts":[[2024,11,1]]}}}