{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T14:50:47Z","timestamp":1787755847878,"version":"build-2784847793"},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/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>The Finnish Shaft of the Humerus (FISH) trial compared open reduction and internal plate fixation (ORIF) with functional bracing in adult patients with displaced, closed humeral shaft fractures. Here, we compare the results of the patients in the randomized clinical trial (RCT [the randomized cohort]) with those of the cohort of patients who were also eligible but declined randomization (the nonrandomized cohort) to investigate if patients\u2019 treatment preference was associated with the outcomes during a 2-year follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A total of 321 patients were treated at 2 university hospitals in Finland between November 2012 and January 2018. Of the 140 eligible patients, 82 were randomized to ORIF or functional bracing. Of the 58 patients declining randomization, 42 consented to participate in a nonrandomized cohort in which the patients were able to choose the treatment method. The primary outcome of this study was the Disabilities of the Arm, Shoulder and Hand (DASH) score. Patients in the randomized cohort and the nonrandomized cohort were analyzed separately in 3 groups: those who had (1) initial surgery, (2) successful functional bracing, and (3) late surgery due to failed functional bracing. We used mixed-model, repeated-measures analysis of variance to compare the treatment effect among the 3 groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>In the randomized cohort, 38 patients had an initial surgical procedure. Of the 44 patients randomized to functional bracing, 30 (68%) healed successfully and 14 (32%) underwent a late surgical procedure. In the nonrandomized cohort, 9 patients preferred an initial surgical procedure. Of the 33 patients preferring functional bracing, 26 (79%) healed successfully and 7 (21%) underwent late surgery. The DASH scores in the randomized cohort and the nonrandomized cohort were 6.8 (95% confidence interval [CI], 2.3 to 11.4) and 12.3 (95% CI, 0.3 to 24.3) for the initial surgery groups, 6.0 (95% CI, 1.0 to 11.0) and 3.4 (95% CI, 0 to 9.3) for the bracing groups, and 17.5 (95% CI, 10.5 to 24.5) and 20.5 (95% CI, 9.4 to 31.6) for the late surgery groups at 2 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The results of the randomized cohort and the nonrandomized cohort were comparable and suggest that patients\u2019 treatment preferences are not associated with the treatment outcomes of these injuries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence:<\/jats:title>\n                    <jats:p>\n                      Therapeutic\n                      <jats:underline>Level I<\/jats:underline>\n                      . See Instructions for Authors for a complete description of levels of evidence.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.2106\/jbjs.oa.24.00018","type":"journal-article","created":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T14:01:52Z","timestamp":1733148112000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Comparing Treatment Outcomes of Eligible Patients Consenting to or Declining Randomization in a Randomized Clinical Trial"],"prefix":"10.2106","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9658-8571","authenticated-orcid":false,"given":"Thomas","family":"Ibounig","sequence":"first","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"},{"name":"Department of Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8383-7479","authenticated-orcid":false,"given":"Cyrill","family":"Suter","sequence":"additional","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8267-8653","authenticated-orcid":false,"given":"Bakir O.","family":"Sumrein","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3125-0171","authenticated-orcid":false,"given":"Antti P.","family":"Launonen","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0232-0425","authenticated-orcid":false,"given":"Tomasz","family":"Czuba","sequence":"additional","affiliation":[{"name":"Lund University, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3713-956X","authenticated-orcid":false,"given":"Teppo L.N.","family":"J\u00e4rvinen","sequence":"additional","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"},{"name":"Department of Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6755-2983","authenticated-orcid":false,"given":"Simo","family":"Taimela","sequence":"additional","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"},{"name":"Department of Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2506-2115","authenticated-orcid":false,"given":"Mika","family":"Paavola","sequence":"additional","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"},{"name":"Department of Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4154-8462","authenticated-orcid":false,"given":"Lasse","family":"R\u00e4m\u00f6","sequence":"additional","affiliation":[{"name":"Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki, Helsinki, Finland"},{"name":"Department of Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"and the FISH Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,10]]},"reference":[{"issue":"18","key":"R1-20250310","doi-asserted-by":"crossref","first-page":"1792","DOI":"10.1001\/jama.2020.3182","article-title":"Effect of surgery vs functional bracing on functional outcome among patients with closed displaced humeral shaft fractures: The FISH randomized clinical trial","volume":"323","author":"R\u00e4m\u00f6","year":"2020","journal-title":"JAMA"},{"issue":"6","key":"R2-20250310","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1001\/jamasurg.2021.0906","article-title":"Outcomes with surgery vs functional bracing for patients with closed, displaced humeral shaft fractures and the need for secondary surgery: a prespecified secondary analysis of the FISH randomized clinical trial","volume":"156","author":"R\u00e4m\u00f6","year":"2021","journal-title":"JAMA Surg"},{"issue":"7","key":"R3-20250310","doi-asserted-by":"crossref","first-page":"e014076","DOI":"10.1136\/bmjopen-2016-014076","article-title":"Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort","volume":"7","author":"R\u00e4m\u00f6","year":"2017","journal-title":"BMJ Open"},{"key":"R4-20250310","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/1471-2474-4-11","article-title":"The Disabilities of the Arm, Shoulder and Hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery","volume":"4","author":"Gummesson","year":"2003","journal-title":"BMC Musculoskelet Disord"},{"issue":"2","key":"R5-20250310","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1016\/S0894-1130(01)80043-0","article-title":"Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity","volume":"14","author":"Beaton","year":"2001","journal-title":"J Hand Ther"},{"key":"R6-20250310","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1097\/00003086-198701000-00023","article-title":"A clinical method of functional assessment of the shoulder","volume":"214","author":"Constant","year":"1987","journal-title":"Clin Orthop Relat Res"},{"issue":"2","key":"R7-20250310","doi-asserted-by":"crossref","first-page":"e028777","DOI":"10.1136\/bmjopen-2018-028777","article-title":"Minimal important differences for improvement in shoulder condition patient-reported outcomes: a systematic review to inform a BMJ Rapid Recommendation","volume":"9","author":"Hao","year":"2019","journal-title":"BMJ Open"},{"issue":"5","key":"R8-20250310","doi-asserted-by":"crossref","first-page":"328","DOI":"10.3109\/07853890109002086","article-title":"The 15D instrument of health-related quality of life: properties and applications","volume":"33","author":"Sintonen","year":"2001","journal-title":"Ann Med"},{"issue":"3","key":"R9-20250310","doi-asserted-by":"crossref","first-page":"469","DOI":"10.2307\/2530610","article-title":"Obtaining confidence intervals for the risk ratio in cohort studies","volume":"34","author":"Katz","year":"1978","journal-title":"Biometrics"},{"issue":"7","key":"R10-20250310","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1001\/jamasurg.2022.1554","article-title":"Writing Group for the CODA Collaborative. Self-selection vs randomized assignment of treatment for appendicitis","volume":"157","author":"Davidson","year":"2022","journal-title":"JAMA Surg"},{"issue":"1","key":"R11-20250310","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1186\/1471-2288-11-39","article-title":"The comprehensive cohort model in a pilot trial in orthopaedic trauma","volume":"11","author":"Kearney","year":"2011","journal-title":"BMC Med Res Methodol"},{"issue":"3","key":"R12-20250310","doi-asserted-by":"crossref","first-page":"e013298","DOI":"10.1136\/bmjopen-2016-013298","article-title":"Surgery for Type B ankle fracture treatment: a Combined Randomised and Observational Study (CROSSBAT)","volume":"7","author":"Mittal","year":"2017","journal-title":"BMJ Open"},{"issue":"3","key":"R13-20250310","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1007\/s00384-010-1074-7","article-title":"Problems of randomization to open or laparoscopic sigmoidectomy for diverticular disease","volume":"26","author":"Raue","year":"2011","journal-title":"Int J Colorectal Dis"},{"issue":"8","key":"R14-20250310","doi-asserted-by":"crossref","first-page":"794","DOI":"10.1056\/NEJMoa0707136","article-title":"Surgical versus nonsurgical therapy for lumbar spinal stenosis","volume":"358","author":"Weinstein","year":"2008","journal-title":"N Engl J Med"}],"container-title":["JBJS Open Access"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.2106\/JBJS.OA.24.00018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T13:53:45Z","timestamp":1787752425000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.2106\/JBJS.OA.24.00018"}},"subtitle":["A Secondary Analysis of the FISH Trial on Humeral Shaft Fractures"],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":14,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2024]]}},"URL":"https:\/\/doi.org\/10.2106\/jbjs.oa.24.00018","relation":{},"ISSN":["2472-7245"],"issn-type":[{"value":"2472-7245","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10]]}}}