{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T14:51:36Z","timestamp":1787755896359,"version":"build-2784847793"},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Many orthopaedic trials use any unplanned reoperation as the primary outcome, but this overlooks how patients experience those outcomes. Using a high-quality hip fracture trial, we demonstrate how the relative importance of multiple patient-important outcomes can be effectively incorporated into data analysis, providing a more comprehensive understanding of treatment impact.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This secondary analysis of the Fixation using Alternative Implants for the Treatment of Hip Fracture (FAITH) trial included 1,079 patients aged 50 years or older with a low-energy femoral neck fracture who were randomly assigned to treatment with a sliding hip screw or cancellous screws. The original trial used unplanned revision surgery as the primary outcome. Our primary analysis instead used a composite outcome of all-cause mortality at 4 months, ambulation status at 10 weeks (measured by the EuroQol-5 Dimension [EQ-5D] mobility dimension), and days at home within 4 months. We assessed outcomes hierarchically using the win ratio method, comparing each patient with every other patient in the alternative treatment group in a pairwise manner. We conducted sensitivity analyses at 6 and 12 months, and subgroup analyses to explore smoking status and fracture displacement as potential effect modifiers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of the 1,079 participants, 741 had EQ-5D data available for the primary analysis at 4 months, yielding 137,114 pairwise comparisons. A sliding hip screw was superior to cancellous screws in 65,158 (47.5%) comparisons, inferior to cancellous screws in 63,378 (46.2%) comparisons, and tied in 8,578 (6.3%), leading to a win ratio of 1.03 (95% confidence interval [CI] 0.86-1.23), but this difference was not statistically significant (p = 0.76). The sensitivity analysis results were similar at 6 and 12 months. In the subgroup analysis, a sliding hip screw was superior to cancellous screws in current smokers, with a win ratio of 1.65 (95% CI 1.02-2.65) at 6 months (p = 0.007).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This analysis approach should be considered for future orthopaedic trials as it was consistent with the FAITH primary analysis findings but yielded a more nuanced interpretation of the patients' experience and offers deeper insights into intervention effectiveness. The bounds of the 95% CI for the primary outcome were within many standard definitions of equivalence, suggesting surgeons can assume similar patient-important outcomes with either treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2106\/jbjs.oa.25.00230","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T19:00:24Z","timestamp":1764097224000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Revisiting the FAITH Trial: A Secondary Analysis Yielding Novel Insights with the Win Ratio"],"prefix":"10.2106","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3505-1396","authenticated-orcid":false,"given":"Sofia","family":"Bzovsky","sequence":"first","affiliation":[{"name":"Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0537-3474","authenticated-orcid":false,"given":"Nathan N.","family":"O'Hara","sequence":"additional","affiliation":[{"name":"R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9111-9239","authenticated-orcid":false,"given":"Gerard P.","family":"Slobogean","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics, University of California, Irvine, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1466-8063","authenticated-orcid":false,"given":"Sheila","family":"Sprague","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0460-1298","authenticated-orcid":false,"given":"Daniel E.","family":"Axelrod","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5114-6999","authenticated-orcid":false,"given":"Graeme","family":"Hoit","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2044-1477","authenticated-orcid":false,"given":"Kiara","family":"Pannozzo","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit","family":"Bhandari","sequence":"additional","affiliation":[{"name":"Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada"},{"name":"R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7036-1782","authenticated-orcid":false,"given":"Marc","family":"Swiontkowski","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6435-9069","authenticated-orcid":false,"given":"Emil","family":"Schemitsch","sequence":"additional","affiliation":[{"name":"Department of Surgery, Western University, London, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3178-2247","authenticated-orcid":false,"given":"Rudolf W.","family":"Poolman","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, Netherlands"},{"name":"Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the FAITH Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,10]]},"reference":[{"issue":"2","key":"R1-20251125","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1093\/eurheartj\/ehr352","article-title":"The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities","volume":"33","author":"Pocock","year":"2012","journal-title":"Eur Heart J"},{"issue":"46","key":"R2-20251125","doi-asserted-by":"crossref","first-page":"4391","DOI":"10.1093\/eurheartj\/ehaa665","article-title":"The win ratio approach for composite endpoints: practical guidance based on previous experience","volume":"41","author":"Redfors","year":"2020","journal-title":"Eur Heart J"},{"issue":"10078","key":"R3-20251125","doi-asserted-by":"crossref","first-page":"1519","DOI":"10.1016\/S0140-6736(17)30066-1","article-title":"Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial","volume":"389","year":"2017","journal-title":"Lancet"},{"issue":"5","key":"R4-20251125","doi-asserted-by":"crossref","first-page":"337","DOI":"10.3109\/07853890109002087","article-title":"EQ-5D: a measure of health status from the EuroQol Group","volume":"33","author":"Rabin","year":"2001","journal-title":"Ann Med"},{"issue":"1","key":"R5-20251125","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1186\/s12874-019-0885-7","article-title":"A patient-centered composite endpoint weighting technique for orthopaedic trauma research","volume":"19","author":"Udogwu","year":"2019","journal-title":"BMC Med Res Methodol"},{"issue":"6","key":"R6-20251125","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1097\/BOT.0000000000002794","article-title":"Patient preferences for operative versus nonoperative treatment of LC1 pelvis fracture: a discrete choice experiment","volume":"38","author":"Patterson","year":"2024","journal-title":"J Orthop Trauma"},{"issue":"10","key":"R7-20251125","doi-asserted-by":"crossref","first-page":"e072583","DOI":"10.1136\/bmjopen-2023-072583","article-title":"Patient preferences for physical therapy programs after a lower extremity fracture: a discrete choice experiment","volume":"13","author":"McKibben","year":"2023","journal-title":"BMJ Open"},{"key":"R8-20251125","doi-asserted-by":"crossref","first-page":"21514593241236647","DOI":"10.1177\/21514593241236647","article-title":"Fix or replace? Patient preferences for the treatment of geriatric lower extremity fractures: a discrete choice experiment","volume":"15","author":"Richards","year":"2024","journal-title":"Geriatr Orthop Surg Rehabil"},{"issue":"1","key":"R9-20251125","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1093\/biostatistics\/kxv032","article-title":"Large sample inference for a win ratio analysis of a composite outcome based on prioritized components","volume":"17","author":"Bebu","year":"2016","journal-title":"Biostatistics (Oxford, England)"},{"issue":"4","key":"R10-20251125","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1208\/s12248-012-9406-x","article-title":"Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration","volume":"14","author":"Davit","year":"2012","journal-title":"AAPS J"},{"issue":"44","key":"R11-20251125","doi-asserted-by":"crossref","first-page":"4684","DOI":"10.1093\/eurheartj\/ehae647","article-title":"The win ratio in cardiology trials: lessons learnt, new developments, and wise future use","volume":"45","author":"Pocock","year":"2024","journal-title":"Eur Heart J"},{"issue":"4","key":"R12-20251125","doi-asserted-by":"crossref","first-page":"631","DOI":"10.5811\/westjem.2018.4.38383","article-title":"Understanding the use of composite endpoints in clinical trials","volume":"19","author":"McCoy","year":"2018","journal-title":"West J Emerg Med"},{"issue":"11","key":"R13-20251125","doi-asserted-by":"crossref","first-page":"EVIDoa2300042","DOI":"10.1056\/EVIDoa2300042","article-title":"Use of win statistics to analyze outcomes in the DAPA-HF and DELIVER trials","volume":"2","author":"Kondo","year":"2023","journal-title":"NEJM Evid"},{"issue":"3","key":"R14-20251125","doi-asserted-by":"crossref","first-page":"742","DOI":"10.1093\/biomet\/asw026","article-title":"On the win-ratio statistic in clinical trials with multiple types of event","volume":"103","author":"Oakes","year":"2016","journal-title":"Biometrika"}],"container-title":["JBJS Open Access"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.2106\/JBJS.OA.25.00230","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T13:54:46Z","timestamp":1787752486000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.2106\/JBJS.OA.25.00230"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":14,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.2106\/jbjs.oa.25.00230","relation":{},"ISSN":["2472-7245"],"issn-type":[{"value":"2472-7245","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]}}}