{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T03:50:52Z","timestamp":1789617052659,"version":"build-2803163510"},"reference-count":47,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2022,2,18]],"date-time":"2022-02-18T00:00:00Z","timestamp":1645142400000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","award":["R21HS027037"],"award-info":[{"award-number":["R21HS027037"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013709","name":"Dell Medical School at the University of Texas at Austin","doi-asserted-by":"crossref","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/100013709","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,1,20]]},"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Osteoarthritis (OA) is a major clinical and public health concern. The primary surgical treatment of knee OA is total knee replacement (TKR), a procedure that aims to alleviate pain and restore physical function. TKR is expensive, however, and based on professional guidelines, inappropriately performed in up to a third of patients. Patient-reported outcome measures (PROMs) help evaluate treatment options by quantifying health outcomes that matter to patients and can thus inform shared decision-making (SDM) between patients and health professionals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a US-based 2-year, two-site hybrid type 1 study to assess clinical effectiveness and implementation of a machine learning-based patient decision aid (PDA) integrating patient-reported outcomes and clinical variables to support SDM for patients with knee OA considering TKR. Substudy 1: At one study site, a randomised controlled trial is evaluating the clinical effectiveness of the PDA and SDM process on decision quality as measured after the baseline consultation and treatment choice measured 3 and 6 months after the baseline visit among 200 patients with knee OA. Substudy 2: At a second study site, a qualitative assessment using principles of behaviour design and intervention mapping is evaluating the feasibility and acceptability of the PROMs, PDA and SDM process by interviewing seven health professionals and 25 patients before and 25 patients after PDA implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval has been obtained from The University of Texas at Austin Institutional Review Board (protocol number: 2018-11-0042). Informed consent will be obtained from all participants. Study results will be disseminated through conference presentations, publications and professional societies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04805554\">NCT04805554<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-055933","type":"journal-article","created":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T12:28:57Z","timestamp":1645446537000},"page":"e055933","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04805554","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Eugenia","family":"Lin","sequence":"first","affiliation":[{"name":"Surgery and Perioperative Care, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6485-8207","authenticated-orcid":false,"given":"Lauren M","family":"Uhler","sequence":"additional","affiliation":[{"name":"Surgery and Perioperative Care, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin P","family":"Finley","sequence":"additional","affiliation":[{"name":"Research Service, South Texas Veterans Health Care System, San Antonio, Texas, USA"},{"name":"Center for Research to Advance Community Health, Joe R. and Teresa Lozano Long School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"},{"name":"Division of General and Hospital Medicine, Department of Medicine, Joe R. and Teresa Lozano Long School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prakash","family":"Jayakumar","sequence":"additional","affiliation":[{"name":"Surgery and Perioperative Care, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul J","family":"Rathouz","sequence":"additional","affiliation":[{"name":"Population Health, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J","family":"Bozic","sequence":"additional","affiliation":[{"name":"Surgery and Perioperative Care, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Tsevat","sequence":"additional","affiliation":[{"name":"Center for Research to Advance Community Health, Joe R. and Teresa Lozano Long School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"},{"name":"Division of General and Hospital Medicine, Department of Medicine, Joe R. and Teresa Lozano Long School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"},{"name":"Population Health, The University of Texas at Austin Dell Medical School, Austin, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,2,21]]},"reference":[{"key":"2025121223554007000_12.2.e055933.1","unstructured":"Centers for Disease Control and Prevention . A national public health agenda for osteoarthritis 2020 update, 2020. Available: https:\/\/www.cdc.gov\/arthritis\/docs\/oaagenda2020.pdf"},{"key":"2025121223554007000_12.2.e055933.2","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1002\/acr.22412","article-title":"Lifetime medical costs of knee osteoarthritis management in the United States: impact of extending indications for total knee arthroplasty","volume":"67","author":"Losina","year":"2015","journal-title":"Arthritis Care Res"},{"key":"2025121223554007000_12.2.e055933.3","doi-asserted-by":"publisher","DOI":"10.2106\/JBJS.N.01141"},{"key":"2025121223554007000_12.2.e055933.4","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2017.1358"},{"key":"2025121223554007000_12.2.e055933.5","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1001\/jamainternmed.2016.8263","article-title":"Cost of joint replacement using bundled payment models","volume":"177","author":"Navathe","year":"2017","journal-title":"JAMA Intern Med"},{"key":"2025121223554007000_12.2.e055933.6","doi-asserted-by":"crossref","first-page":"252","DOI":"10.1056\/NEJMsa1809010","article-title":"Two-Year evaluation of mandatory bundled payments for joint replacement","volume":"380","author":"Barnett","year":"2019","journal-title":"N Engl J Med"},{"key":"2025121223554007000_12.2.e055933.7","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1001\/jama.2018.18162","article-title":"Potential unintended effects of Medicare's bundled payments for care improvement Program-Reply","volume":"321","author":"Navathe","year":"2019","journal-title":"JAMA"},{"key":"2025121223554007000_12.2.e055933.8","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.12345"},{"key":"2025121223554007000_12.2.e055933.9","doi-asserted-by":"crossref","first-page":"2134","DOI":"10.1002\/art.38685","article-title":"Use of a validated algorithm to judge the appropriateness of total knee arthroplasty in the United States: a multicenter longitudinal cohort study","volume":"66","author":"Riddle","year":"2014","journal-title":"Arthritis Rheumatol"},{"key":"2025121223554007000_12.2.e055933.10","unstructured":"American Academy of Orthopaedic Surgeons . Quality Programs & Guidelines (CPGS): American Academy of Orthopaedic Surgeons. Available: https:\/\/www.aaos.org\/auc\/?ssopc=1#"},{"key":"2025121223554007000_12.2.e055933.11","unstructured":"Center for Drug Evaluation and Research . Patient-Reported Outcome Measures: Use in Medical Product Development [Internet]. U.S. Food and Drug Administration, 2009. Available: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims"},{"key":"2025121223554007000_12.2.e055933.12","unstructured":"Barry MJ , Edgman-Levitan S , Sepucha K . Shared decision-making: staying focused on the ultimate goal, 2018. Available: https:\/\/catalyst.nejm.org\/shared-decision-making-patient-decision-aids\/"},{"key":"2025121223554007000_12.2.e055933.13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f4147"},{"key":"2025121223554007000_12.2.e055933.14","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1001\/jama.2018.6617","article-title":"Mandatory Shared Decision Making by the Centers for Medicare & Medicaid Services for Cardiovascular Procedures and Other Tests","volume":"320","author":"Merchant","year":"2018","journal-title":"JAMA"},{"key":"2025121223554007000_12.2.e055933.15","unstructured":"Comprehensive Care for Joint Replacement Model [Internet]. Baltimore, MD: Center for Medicare and Medicaid Services, 2021. Available: https:\/\/innovation.cms.gov\/innovation-models\/cjr"},{"key":"2025121223554007000_12.2.e055933.16","first-page":"273","article-title":"Implementing patient-reported outcome measures in your practice: pearls and pitfalls","volume":"46","author":"Brook","year":"2017","journal-title":"Am J Orthop"},{"key":"2025121223554007000_12.2.e055933.17","doi-asserted-by":"publisher","DOI":"10.1097\/JAC.0000000000000052"},{"key":"2025121223554007000_12.2.e055933.18","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocv085"},{"key":"2025121223554007000_12.2.e055933.19","doi-asserted-by":"crossref","unstructured":"L\u00e9gar\u00e9 F , Adekpedjou R , Stacey D , et al . Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev 2018;2018.doi:10.1002\/14651858.CD006732.pub4","DOI":"10.1002\/14651858.CD006732.pub4"},{"key":"2025121223554007000_12.2.e055933.20","doi-asserted-by":"crossref","unstructured":"Stacey D , L\u00e9gar\u00e9 F , Lewis K , et al . Decision AIDS for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2017;2017.doi:10.1002\/14651858.CD001431.pub5","DOI":"10.1002\/14651858.CD001431.pub5"},{"key":"2025121223554007000_12.2.e055933.21","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j4891"},{"key":"2025121223554007000_12.2.e055933.22","doi-asserted-by":"crossref","first-page":"17","DOI":"10.5334\/egems.227","article-title":"Framework to guide the collection and use of patient-reported outcome measures in the learning healthcare system","volume":"5","author":"Franklin","year":"2017","journal-title":"EGEMS"},{"key":"2025121223554007000_12.2.e055933.23","unstructured":"Development and Evaluation of Patient-Reported Outcome Score Visualization to Improve Their Utilization (PROVIZ) [Internet]. New York, NY: AHRQ Digital Healthcare Research: Informing Improvement in Care Quality, Safety, and Efficiency. Available: https:\/\/digital.ahrq.gov\/ahrq-funded-projects\/development-and-evaluation-patient-reported-outcome-score-visualization-improve"},{"key":"2025121223554007000_12.2.e055933.24","unstructured":"Rheumatology Informatics System for Effectiveness Patient-Reported Outcome (RISE PRO) Dissemination Project (California) [Internet]. San Francisco, CA: AHRQ Digital Healthcare Research: Informing Improvement in Care Quality, Safety, and Efficiency. Available: https:\/\/digital.ahrq.gov\/ahrq-funded-projects\/rheumatology-informatics-system-effectiveness-patient-reported-outcome-rise-pro"},{"key":"2025121223554007000_12.2.e055933.25","unstructured":"Optimizing the Value of Patient-Reported Outcome Measures in Improving Care Delivery through Health Information Technology (Minnesota) [Internet]. Minneapolis, MN: AHRQ Digital Healthcare Research: Informing Improvement in Care Quality, Safety, and Efficiency. Available: https:\/\/digital.ahrq.gov\/ahrq-funded-projects\/optimizing-value-patient-reported-outcome-measures-improving-care-delivery"},{"key":"2025121223554007000_12.2.e055933.26","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3182408812"},{"key":"2025121223554007000_12.2.e055933.27","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2020.37107","article-title":"Comparison of an artificial Intelligence-Enabled patient decision aid vs educational material on decision quality, shared decision-making, patient experience, and functional outcomes in adults with knee osteoarthritis: a randomized clinical trial","volume":"4","author":"Jayakumar","year":"2021","journal-title":"JAMA Netw Open"},{"key":"2025121223554007000_12.2.e055933.28","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-010-0314-z"},{"key":"2025121223554007000_12.2.e055933.29","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1186\/s13012-016-0418-2","article-title":"Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS)","volume":"11","author":"Hurley","year":"2016","journal-title":"Implement Sci"},{"key":"2025121223554007000_12.2.e055933.30","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-009-9496-9"},{"key":"2025121223554007000_12.2.e055933.31","doi-asserted-by":"publisher","DOI":"10.1007\/s11999-016-4719-1"},{"key":"2025121223554007000_12.2.e055933.32","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2474-12-149"},{"key":"2025121223554007000_12.2.e055933.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2013.05.009"},{"key":"2025121223554007000_12.2.e055933.34","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2010.12.012"},{"key":"2025121223554007000_12.2.e055933.35","doi-asserted-by":"publisher","DOI":"10.1177\/0272989X9501500105"},{"key":"2025121223554007000_12.2.e055933.36","doi-asserted-by":"publisher","DOI":"10.1177\/0272989X03256005"},{"key":"2025121223554007000_12.2.e055933.37","doi-asserted-by":"crossref","unstructured":"Fogg B . A behavior model for persuasive design. Proceedings of the 4th International Conference on Persuasive Technology - Persuasive \u201909, Claremont, California: ACM Press, 2009:1.","DOI":"10.1145\/1541948.1541999"},{"key":"2025121223554007000_12.2.e055933.38","doi-asserted-by":"crossref","DOI":"10.1186\/s12874-018-0610-y","article-title":"Periodic reflections: a method of guided discussions for documenting implementation phenomena","volume":"18","author":"Finley","year":"2018","journal-title":"BMC Med Res Methodol"},{"key":"2025121223554007000_12.2.e055933.39","doi-asserted-by":"crossref","unstructured":"Fitzmaurice GM , Laird NM , Ware JH . Applied longitudinal analysis. 2nd ed. Hoboken, N.J: Wiley, 2011: 701.","DOI":"10.1002\/9781119513469"},{"key":"2025121223554007000_12.2.e055933.40","doi-asserted-by":"crossref","first-page":"3035","DOI":"10.1002\/sim.1241","article-title":"Performance of weighted estimating equations for longitudinal binary data with Drop-outs missing at random: weighted estimating equations for Drop-outs","volume":"21","author":"Preisser","year":"2002","journal-title":"Statist Med"},{"key":"2025121223554007000_12.2.e055933.41","doi-asserted-by":"publisher","DOI":"10.1177\/1049732315617444"},{"key":"2025121223554007000_12.2.e055933.42","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/s13012-019-0853-y","article-title":"Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans health administration","volume":"14","author":"Gale","year":"2019","journal-title":"Implement Sci"},{"key":"2025121223554007000_12.2.e055933.43","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1093\/jamia\/ocx075","article-title":"Implementing prescription drug monitoring and other clinical decision support for opioid risk mitigation in a military health care setting: a qualitative feasibility study","volume":"25","author":"Finley","year":"2018","journal-title":"J Am Med Inform Assoc"},{"key":"2025121223554007000_12.2.e055933.44","doi-asserted-by":"publisher","DOI":"10.1097\/01.MLR.0000093487.78664.3C"},{"key":"2025121223554007000_12.2.e055933.45","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.2001.016009606.x"},{"key":"2025121223554007000_12.2.e055933.46","doi-asserted-by":"crossref","DOI":"10.1136\/ebm.12.5.149","article-title":"The 2-item generalized anxiety disorder scale had high sensitivity and specificity for detecting GAD in primary care","volume":"12","author":"Skapinakis","year":"2007","journal-title":"Evid Based Med"},{"key":"2025121223554007000_12.2.e055933.47","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.10.1092"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-055933","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T07:55:53Z","timestamp":1765612553000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-055933"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2]]},"references-count":47,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2022,2,21]]},"published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1136\/bmjopen-2021-055933"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-055933","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2]]}}}