{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T04:04:31Z","timestamp":1792728271406,"version":"4.5.0"},"reference-count":46,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T00:00:00Z","timestamp":1681344000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T00:00:00Z","timestamp":1681344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["16\/73\/03"],"award-info":[{"award-number":["16\/73\/03"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults over 65\u00a0years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24\u00a0months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65\u00a0years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-reviewed journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ISRCTN76296703. Prospectively registered on 5th April 2018<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-023-07259-3","type":"journal-article","created":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T01:02:36Z","timestamp":1681347756000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical treatment for older adults with acute 3- or 4-part fractures of the proximal humerus: study protocol for a randomised controlled trial (PROFHER-2: PROximal Fracture of Humerus Evaluation by Randomisation \u2013 Trial Number 2)"],"prefix":"10.1186","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5452-8578","authenticated-orcid":false,"given":"Amar","family":"Rangan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Gwilym","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ada","family":"Keding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belen","family":"Corbacho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucksy","family":"Kottam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Arundel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Coleman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Livio","family":"DiMascio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Hewitt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamila","family":"Kassam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catriona","family":"McDaid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Mott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"O\u2019Carroll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Puvan","family":"Tharmanathan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Torgerson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,13]]},"reference":[{"key":"7259_CR1","doi-asserted-by":"publisher","first-page":"437","DOI":"10.2174\/1874325001408010437","volume":"8","author":"R Mafi","year":"2014","unstructured":"Mafi R, Khan W, Mafi P, Hindocha S. Suppl 2: M7: orthopaedic approaches to proximal humeral fractures following trauma. Open Orthop J. 2014;8:437.","journal-title":"Open Orthop J"},{"issue":"2","key":"7259_CR2","doi-asserted-by":"publisher","first-page":"121","DOI":"10.2106\/JBJS.I.01505","volume":"93","author":"JE Bell","year":"2011","unstructured":"Bell JE, Leung BC, Spratt KF, Koval KJ, Weinstein JD, Goodman DC, Tosteson AN. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. J Bone Joint Surg Am. 2011;93(2):121.","journal-title":"J Bone Joint Surg Am"},{"issue":"5","key":"7259_CR3","doi-asserted-by":"publisher","first-page":"817","DOI":"10.1359\/jbmr.2002.17.5.817","volume":"17","author":"SH Lee","year":"2002","unstructured":"Lee SH, Dargent-Molina P, Br\u00e9art G. Risk factors for fractures of the proximal humerus: results from the EPIDOS prospective study. J Bone Miner Res. 2002;17(5):817\u201325.","journal-title":"J Bone Miner Res"},{"key":"7259_CR4","doi-asserted-by":"crossref","unstructured":"Slobogean GP, Noonan VK, O\u2019Brien PJ. The reliability and validity of the Disabilities of Arm, Shoulder, and Hand, EuroQol-5D, Health Utilities Index, and Short Form-6D outcome instruments in patients with proximal humeral fractures. J Shoulder Elbow Surg. 2010;19(3):342\u20138.","DOI":"10.1016\/j.jse.2009.10.021"},{"issue":"7","key":"7259_CR5","doi-asserted-by":"publisher","first-page":"1025","DOI":"10.1016\/j.jse.2011.04.016","volume":"20","author":"P Olerud","year":"2011","unstructured":"Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(7):1025\u201333.","journal-title":"J Shoulder Elbow Surg"},{"issue":"5","key":"7259_CR6","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1007\/BF00932316","volume":"108","author":"T Lind","year":"1989","unstructured":"Lind T, Kr\u00f8ner K, Jensen J. The epidemiology of fractures of the proximal humerus. Arch Orthop Trauma Surg. 1989;108(5):285\u20137.","journal-title":"Arch Orthop Trauma Surg"},{"issue":"1","key":"7259_CR7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s11657-015-0209-4","volume":"10","author":"AP Launonen","year":"2015","unstructured":"Launonen AP, Lepola V, Saranko A, Flinkkil\u00e4 T, Laitinen M, Mattila VM. Epidemiology of proximal humerus fractures. Arch Osteoporos. 2015;10(1):1\u20135.","journal-title":"Arch Osteoporos"},{"issue":"10","key":"7259_CR8","doi-asserted-by":"publisher","first-page":"1037","DOI":"10.1001\/jama.2015.1629","volume":"313","author":"A Rangan","year":"2015","unstructured":"Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, Goodchild L, Chuang LH, Hewitt C, Torgerson D, PROFHER Trial Collaborators. Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA. 2015;313(10):1037\u201347.","journal-title":"JAMA"},{"issue":"4","key":"7259_CR9","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1302\/0301-620X.89B4.18435","volume":"89","author":"T Bufquin","year":"2007","unstructured":"Bufquin T, Hersan A, Hubert L, Massin P. Reverse shoulder arthroplasty for the treatment of three-and four-part fractures of the proximal humerus in the elderly: a prospective review of 43 cases with a short-term follow-up. J Bone Joint Surg Br. 2007;89(4):516\u201320.","journal-title":"J Bone Joint Surg Br"},{"issue":"10","key":"7259_CR10","doi-asserted-by":"publisher","first-page":"698","DOI":"10.1097\/BOT.0b013e31818afe40","volume":"22","author":"M Klein","year":"2008","unstructured":"Klein M, Juschka M, Hinkenjann B, Scherger B, Ostermann PA. Treatment of comminuted fractures of the proximal humerus in elderly patients with the Delta III reverse shoulder prosthesis. J Orthop Trauma. 2008;22(10):698\u2013704.","journal-title":"J Orthop Trauma"},{"issue":"1","key":"7259_CR11","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1097\/BOT.0000000000000229","volume":"29","author":"AK Gupta","year":"2015","unstructured":"Gupta AK, Harris JD, Erickson BJ, Abrams GD, Bruce B, McCormick F, Nicholson GP, Romeo AA. Surgical management of complex proximal humerus fractures\u2014a systematic review of 92 studies including 4500 patients. J Orthop Trauma. 2015;29(1):54\u20139.","journal-title":"J Orthop Trauma"},{"issue":"1","key":"7259_CR12","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1097\/BOT.0000000000000224","volume":"29","author":"JR Ferrel","year":"2015","unstructured":"Ferrel JR, Trinh TQ, Fischer RA. Reverse total shoulder arthroplasty versus hemiarthroplasty for proximal humeral fractures: a systematic review. J Orthop Trauma. 2015;29(1):60\u20138.","journal-title":"J Orthop Trauma"},{"issue":"12","key":"7259_CR13","doi-asserted-by":"publisher","first-page":"1737","DOI":"10.1016\/j.jse.2013.08.021","volume":"22","author":"A Mata-Fink","year":"2013","unstructured":"Mata-Fink A, Meinke M, Jones C, Kim B, Bell JE. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. J Shoulder Elbow Surg. 2013;22(12):1737\u201348.","journal-title":"J Shoulder Elbow Surg"},{"issue":"1","key":"7259_CR14","doi-asserted-by":"publisher","first-page":"42","DOI":"10.5397\/cise.2021.00066","volume":"24","author":"SC Kim","year":"2021","unstructured":"Kim SC, Kim IS, Jang MC, Yoo JC. Complications of reverse shoulder arthroplasty: a concise review. Clin Shoulder Elbow. 2021;24(1):42.","journal-title":"Clin Shoulder Elbow"},{"issue":"18","key":"7259_CR15","doi-asserted-by":"publisher","first-page":"1701","DOI":"10.2106\/JBJS.L.01115","volume":"95","author":"S Namdari","year":"2013","unstructured":"Namdari S, Horneff JG, Baldwin K. Comparison of hemiarthroplasty and reverse arthroplasty for treatment of proximal humeral fractures: a systematic review. JBJS. 2013;95(18):1701\u20138.","journal-title":"JBJS"},{"issue":"12","key":"7259_CR16","doi-asserted-by":"publisher","first-page":"2259","DOI":"10.1016\/j.jse.2019.06.024","volume":"28","author":"Y Lopiz","year":"2019","unstructured":"Lopiz Y, Alcob\u00eda-D\u00edaz B, Gal\u00e1n-Olleros M, Garc\u00eda-Fern\u00e1ndez C, Picado AL, Marco F. Reverse shoulder arthroplasty versus nonoperative treatment for 3-or 4-part proximal humeral fractures in elderly patients: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2019;28(12):2259\u201371.","journal-title":"J Shoulder Elbow Surg"},{"issue":"2","key":"7259_CR17","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1016\/j.jse.2013.10.003","volume":"23","author":"DC Acevedo","year":"2014","unstructured":"Acevedo DC, VanBeek C, Lazarus MD, Williams GR, Abboud JA. Reverse shoulder arthroplasty for proximal humeral fractures: update on indications, technique, and results. J Shoulder Elbow Surg. 2014;23(2):279\u201389.","journal-title":"J Shoulder Elbow Surg"},{"issue":"9","key":"7259_CR18","doi-asserted-by":"publisher","first-page":"1356","DOI":"10.1016\/j.jse.2013.12.034","volume":"23","author":"O Khatib","year":"2014","unstructured":"Khatib O, Onyekwelu I, Zuckerman JD. The incidence of proximal humeral fractures in New York State from 1990 through 2010 with an emphasis on operative management in patients aged 65 years or older. J Shoulder Elbow Surg. 2014;23(9):1356\u201362.","journal-title":"J Shoulder Elbow Surg"},{"key":"7259_CR19","unstructured":"The National Joint Registry 18th Annual report. https:\/\/reports.njrcentre.org.uk\/Portals\/0\/PDFdownloads\/NJR%2018th%20Annual%20Report%202021.pdf. Accessed 12 Mar 2023."},{"issue":"4","key":"7259_CR20","doi-asserted-by":"publisher","first-page":"e010412","DOI":"10.1136\/bmjopen-2015-010412","volume":"6","author":"A Rangan","year":"2016","unstructured":"Rangan A, Upadhaya S, Regan S, Toye F, Rees JL. Research priorities for shoulder surgery: results of the 2015 James Lind Alliance patient and clinician priority setting partnership. BMJ Open. 2016;6(4):e010412.","journal-title":"BMJ Open"},{"issue":"6","key":"7259_CR21","doi-asserted-by":"publisher","first-page":"1077","DOI":"10.2106\/00004623-197052060-00001","volume":"52","author":"S Charles","year":"1970","unstructured":"Charles S, Neer II. Displaced proximal humeral fractures: Part I. Classification and evaluation. JBJS. 1970;52(6):1077\u201389.","journal-title":"JBJS"},{"issue":"12","key":"7259_CR22","doi-asserted-by":"publisher","first-page":"734","DOI":"10.2519\/jospt.2007.2562","volume":"37","author":"S Boudreau","year":"2007","unstructured":"Boudreau S, Boudreau ED, Higgins LD, et al. Rehabilitation following reverse total shoulder arthroplasty. J Orthop Sports Phys Ther. 2007;37(12):734\u201343.","journal-title":"J Orthop Sports Phys Ther"},{"issue":"8","key":"7259_CR23","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1308\/003588411X13165261994193","volume":"93","author":"F Younis","year":"2011","unstructured":"Younis F, Sultan J, Dix S, Hughes PJ. The range of the Oxford Shoulder Score in the asymptomatic population: a marker for post-operative improvement. Ann R Coll Surg Engl. 2011;93(8):629\u201333.","journal-title":"Ann R Coll Surg Engl"},{"issue":"10256","key":"7259_CR24","doi-asserted-by":"publisher","first-page":"977","DOI":"10.1016\/S0140-6736(20)31965-6","volume":"396","author":"A Rangan","year":"2020","unstructured":"Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020;396(10256):977\u201389.","journal-title":"Lancet"},{"issue":"1","key":"7259_CR25","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1302\/0301-620X.99B1.BJJ-2016-0424.R1","volume":"99","author":"A Carr","year":"2017","unstructured":"Carr A, Cooper C, Campbell MK, Rees J, Moser J, Beard DJ, Fitzpatrick R, Gray A, Dawson J, Murphy J, Bruhn H. Effectiveness of open and arthroscopic rotator cuff repair (UKUFF) a randomised controlled trial. Bone Joint J. 2017;99(1):107\u201315.","journal-title":"Bone Joint J"},{"issue":"10118","key":"7259_CR26","doi-asserted-by":"publisher","first-page":"329","DOI":"10.1016\/S0140-6736(17)32457-1","volume":"391","author":"DJ Beard","year":"2018","unstructured":"Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, Shirkey BA, Donovan JL, Gwilym S, Savulescu J, Moser J. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391(10118):329\u201338.","journal-title":"Lancet"},{"key":"7259_CR27","unstructured":"EuroQOL Research Foundation. EQ-5D-5L user guide, 2019. https:\/\/euroqol.org\/publications\/user-guides\/. Accessed 12 Mar 2023."},{"issue":"1","key":"7259_CR28","doi-asserted-by":"publisher","first-page":"173","DOI":"10.1016\/j.pain.2010.04.025","volume":"150","author":"D Amtmann","year":"2010","unstructured":"Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010;150(1):173\u201382.","journal-title":"Pain"},{"key":"7259_CR29","unstructured":"Jamar hydraulic hand dynamometer, grip strength testing. https:\/\/www.performancehealth.co.uk\/jamar-hydraulic-hand-dynamometer. Accessed 12 Mar 2023."},{"issue":"1","key":"7259_CR30","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1007\/s00402-007-0549-7","volume":"129","author":"J Dawson","year":"2009","unstructured":"Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford shoulder score revisited. Arch Orthop Trauma Surg. 2009;129(1):119\u201323.","journal-title":"Arch Orthop Trauma Surg"},{"issue":"1","key":"7259_CR31","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1016\/j.jse.2007.04.019","volume":"17","author":"P Baker","year":"2008","unstructured":"Baker P, Nanda R, Goodchild L, Finn P, Rangan A. A comparison of the Constant and Oxford shoulder scores in patients with conservatively treated proximal humeral fractures. J Shoulder Elbow Surg. 2008;17(1):37\u201341.","journal-title":"J Shoulder Elbow Surg"},{"issue":"1","key":"7259_CR32","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1186\/1749-799X-8-40","volume":"8","author":"DA van Kampen","year":"2013","unstructured":"van Kampen DA, Willems W, van Beers LWAH, Castelein RM, Scholtes VAB, Terwee CB. Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs). J Orthop Surg Res. 2013;8(1):40.","journal-title":"J Orthop Surg Res"},{"key":"7259_CR33","unstructured":"Trial Forge evidence pack for using pens to increase retention. https:\/\/www.trialforge.org\/resource\/evidence-pack-retention-adding-a-pen-ret3\/#. Accessed 20 Dec 2022."},{"issue":"3","key":"7259_CR34","first-page":"MR000008","volume":"2009","author":"PJ Edwards","year":"2009","unstructured":"Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009;2009(3):MR000008.","journal-title":"Cochrane Database Syst Rev"},{"key":"7259_CR35","doi-asserted-by":"publisher","unstructured":"Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;(12):MR000032. https:\/\/doi.org\/10.1002\/14651858.MR000032.pub2.","DOI":"10.1002\/14651858.MR000032.pub2"},{"key":"7259_CR36","unstructured":"MRC Hub for Trial Methodology Research SWAT Repository. https:\/\/www.qub.ac.uk\/sites\/TheNorthernIrelandNetworkforTrialsMethodologyResearch\/FileStore\/Filetoupload,604630,en.pdf. Accessed 12 Mar 2023."},{"key":"7259_CR37","unstructured":"NHS reference costs. https:\/\/digital.nhs.uk\/data-and-information\/data-collections-and-data-sets\/data-collections\/reference-costs. Accessed 12 Mar 2023."},{"key":"7259_CR38","unstructured":"PSSRU Unit costs of health and social care. https:\/\/www.pssru.ac.uk\/project-pages\/unit-costs\/. Accessed 12 Mar 2023."},{"key":"7259_CR39","unstructured":"British National Formulary. https:\/\/bnf.nice.org.uk\/. Accessed 12 Mar 2023."},{"issue":"5","key":"7259_CR40","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1016\/j.jval.2012.02.008","volume":"15","author":"B Van Hout","year":"2012","unstructured":"Van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708\u201315.","journal-title":"Value Health"},{"key":"7259_CR41","unstructured":"National Institute for Health and Care Excellence. Position statement on use of the EQ-5D-5L value set for England, 2019. https:\/\/www.nice.org.uk\/about\/what-we-do\/our-programmes\/nice-guidance\/technology-appraisal-guidance\/eq-5d-5l. Accessed 12 Mar 2023."},{"issue":"10","key":"7259_CR42","first-page":"1","volume":"3","author":"LJ Billingham","year":"1999","unstructured":"Billingham LJ, Abrams KR, Jones DR. Methods for the analysis of quality-of-life and survival data in health technology assessment. Health Technol Assess (Winchester, England). 1999;3(10):1\u201352.","journal-title":"Health Technol Assess (Winchester, England)"},{"issue":"9","key":"7259_CR43","doi-asserted-by":"publisher","first-page":"725","DOI":"10.2165\/00019053-200826090-00002","volume":"26","author":"J Earnshaw","year":"2008","unstructured":"Earnshaw J, Lewis G. NICE guide to the methods of technology appraisal. Pharmacoeconomics. 2008;26(9):725\u20137.","journal-title":"Pharmacoeconomics"},{"issue":"2","key":"7259_CR44","doi-asserted-by":"publisher","first-page":"65","DOI":"10.2165\/00148365-200504020-00001","volume":"4","author":"A Manca","year":"2005","unstructured":"Manca A, Palmer S. Handling missing data in patient-level cost-effectiveness analysis alongside randomised clinical trials. Appl Health Econ Health Policy. 2005;4(2):65\u201375.","journal-title":"Appl Health Econ Health Policy"},{"key":"7259_CR45","unstructured":"NIHR. Effectiveness and cost-effectiveness of Reverse Shoulder Arthroplasty versus Hemiarthroplasty versus Non-surgical care for acute 3 and 4 part fractures of the proximal humerus in older adults - The PROFHER-2 Randomised Clinical Trial. https:\/\/www.fundingawards.nihr.ac.uk\/award\/16\/73\/03. Accessed 12 Mar 2023."},{"issue":"4","key":"7259_CR46","doi-asserted-by":"publisher","first-page":"e73","DOI":"10.1016\/j.jse.2013.09.012","volume":"23","author":"OA Anakwenze","year":"2014","unstructured":"Anakwenze OA, Zoller S, Ahmad CS, Levine WN. Reverse shoulder arthroplasty for acute proximal humerus fractures: a systematic review. J Shoulder Elbow Surg. 2014;23(4):e73-80.","journal-title":"J Shoulder Elbow Surg"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-023-07259-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-023-07259-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-023-07259-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T13:05:14Z","timestamp":1681391114000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-023-07259-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,13]]},"references-count":46,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["7259"],"URL":"https:\/\/doi.org\/10.1186\/s13063-023-07259-3","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-2620399\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4,13]]},"assertion":[{"value":"23 February 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 March 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 April 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval for this trial has been granted by the North East - Tyne & Wear South REC. Reference number: 18\/NE\/0125 dated 2nd May 2018 (Additional file\n                      \n                      ), and HRA \/ HCRW dated 15th May 2018 (Additional file\n                      \n                      ). Before being enrolled in the PROFHER-2 study, participants must consent to participate after the nature, scope, and possible consequences of participating in the clinical study have been explained in a form understandable to them. The Investigator will not undertake any measures specifically required only for the clinical study until valid consent has been obtained. Written informed consent will be obtained from all participants. A copy of the PROFHER-2 consent form (v1.0 12.03.18, Additional file\n                      \n                      ) is provided as a supplement.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable - no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials - Additional file\n                      \n                      .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"AR is a member of the NIHR i4i challenge awards committee and has received research and educational grants to his department from NIHR, ORUK, Horizon 2020, AOUK and DePuy J&J Ltd.CMcD is a member of the NIHR HTA and EME Editorial Board (2017 to present).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"270"}}