{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T06:17:50Z","timestamp":1778221070656,"version":"3.51.4"},"reference-count":35,"publisher":"MJS Publishing, Medical Journals Sweden AB","license":[{"start":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T00:00:00Z","timestamp":1778198400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["ActaO"],"abstract":"<jats:p>Background and purpose:\u00a0Knowledge of psychological factors\u2019 influence on patients\u2019 decisions to participate in randomized controlled trials (RCTs) is scarce. We aimed to compare levels of psychological factors in patients with knee osteoarthritis (OA) eligible for total knee arthroplasty in those who agree to participate in an RCT with those who declined.Methods:\u00a0We compared anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain-related fear of movement (Fear-Avoidance Belief Questionnaire [FABQ]), catastrophizing (Pain Catastrophizing Scale [PCS]), knee symptoms (Knee Osteoarthritis and Outcome Scale [KOOS]), and knee awareness (Forgotten Joint Score [FJS]), in patients in the Multidisciplinary Intervention in Total Knee Arthroplasty (MultiKnee) trial (n = 280) and in patients who declined (n = 373). Simple and multiple logistic regression models explored associations between psychological factors and patients\u2019 willingness to participate.Results:\u00a0Patients declining participation had more fear avoidance (FABQ 1.6 points higher, 95% confidence interval [CI] 0.6\u20132.6), more knee awareness (FJS 4.0 points lower, CI 1.9\u20136.1), and worse KOOS scores (ranging from 3.4, CI 0.6\u20136.1 to 5.6 points, CI 3.1\u20138.2). In simple regression analysis, each 1-point increase in FABQ-Physical activity score was associated with a 3.9% decrease in odds of participating (OR 0.96, CI 0.94\u20130.99), and in adjusted analyses, a 3.0% decrease in odds (OR 0.97, CI 0.94\u20131.0). When considering a clinically meaningful difference of 4 points, this corresponds to a 14.7% reduction in crude odds and a 11.5% reduction in adjusted odds of study participation. Each 1-point increase in HADS Anxiety score was associated with a 5.4% increase in odds of participating (OR 1.05, CI 1.00\u20131.11). HADS Depression and PCS were not associated with RCT participation.Conclusion:\u00a0Patients with higher fear avoidance of physical activity were less willing to participate in the RCT, while patients with higher anxiety were more willing. These findings may weaken the generalizability of the findings from the RCT.<\/jats:p>","DOI":"10.2340\/17453674.2026.45869","type":"journal-article","created":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T06:05:04Z","timestamp":1778220304000},"source":"Crossref","is-referenced-by-count":0,"title":["Psychological factors associated with trial participation among patients eligible for total knee arthroplasty with a non-surgical treatment arm: a comparative cross-sectional study"],"prefix":"10.2340","volume":"97","author":[{"given":"Nina Jullum","family":"Kise","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siri","family":"Eliassen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caryl L","family":"Gay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7144-5096","authenticated-orcid":false,"given":"Anners","family":"Lerdal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2074-2071","authenticated-orcid":false,"given":"Maren Falch","family":"Lindberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tor Kjetil","family":"Nerhus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Turid","family":"Rognsv\u00e5g","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arild","family":"Aamodt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stig","family":"Heir","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1183","published-online":{"date-parts":[[2026,5,8]]},"reference":[{"key":"154632","doi-asserted-by":"crossref","unstructured":"Steers W, Richter H, Nyberg L, Kusek J, Kraus S, Dandreo K, et al. Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network. Neurourol Urodyn 2009; 28: 170-6. doi: 10.1002\/nau.20653.","DOI":"10.1002\/nau.20653"},{"key":"154633","doi-asserted-by":"crossref","unstructured":"Dickson S, Logan J, Hagen S, Stark D, Glazener C, McDonald A M, et al. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings. Trials 2013; 14: 389. doi: 10.1186\/1745-6215-14-389.","DOI":"10.1186\/1745-6215-14-389"},{"key":"154634","doi-asserted-by":"crossref","unstructured":"Bannuru R R, Osani M C, Vaysbrot E E, Arden N K, Bennell K, Bierma-Zeinstra SM A, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage 2019; 27: 1578-89. doi: 10.1016\/j.joca.2019.06.011.","DOI":"10.1016\/j.joca.2019.06.011"},{"key":"154635","doi-asserted-by":"crossref","unstructured":"Edwards R R, Bingham C O 3rd, Bathon J, Haythornthwaite J A. Catastrophizing and pain in arthritis, fibromyalgia, and other rheumatic diseases. Arthritis Rheum 2006; 55: 325-32. doi: 10.1002\/art.21865.","DOI":"10.1002\/art.21865"},{"key":"154636","doi-asserted-by":"crossref","unstructured":"Nerhus T K, Heir S, Svege I, Skramm I, Jervidalo T, Madsen J E, et al. Time-dependent improvement in functional outcome following Oxford medial unicompartmental knee arthroplasty: a prospective longitudinal multicenter study involving 96 patients. Acta Orthop 2012; 83: 46-52. doi: 10.3109\/17453674.2011.652890.","DOI":"10.3109\/17453674.2011.652890"},{"key":"154637","doi-asserted-by":"crossref","unstructured":"Wood T J, Gazendam A M, Kabali C B. Postoperative outcomes following total hip and knee arthroplasty in patients with pain catastrophizing, anxiety, or depression. J Arthroplasty 2021; 36: 1908-14. doi: 10.1016\/j.arth.2021.02.018.","DOI":"10.1016\/j.arth.2021.02.018"},{"key":"154638","doi-asserted-by":"crossref","unstructured":"Birch S, Stilling M, Mechlenburg I, Hansen T B. No effect of cognitive behavioral patient education for patients with pain catastrophizing before total knee arthroplasty: a randomized controlled trial. Acta Orthop 2020; 91: 98-103. doi: 10.1080\/17453674.2019.1694312.","DOI":"10.1080\/17453674.2019.1694312"},{"key":"154639","doi-asserted-by":"crossref","unstructured":"Olsen U, Lindberg M F, Rose C, Denison E, Gay C, Aamodt A, et al. Factors correlated with pain after total knee arthroplasty: a systematic review and meta-analysis. PLoS One 2023; 18: e0283446. doi: 10.1371\/journal.pone.0283446.","DOI":"10.1371\/journal.pone.0283446"},{"key":"154640","doi-asserted-by":"crossref","unstructured":"Leeuw M, Goossens M E, Linton S J, Crombez G, Boersma K, Vlaeyen J W. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med 2007; 30: 77-94. doi: 10.1007\/s10865-006-9085-0.","DOI":"10.1007\/s10865-006-9085-0"},{"key":"154641","doi-asserted-by":"crossref","unstructured":"Kise N J, Eliassen S, Furnes O, Gay C, Heir S, Lerdal A, et al. Fear avoidance and catastrophizing are associated with both knee awareness and quality of life in knee osteoarthritis patients: a secondary report of a cross-sectional study. Acta Orthop 2025; 96: 920-6. doi: 10.2340\/17453674.2025.45070.","DOI":"10.2340\/17453674.2025.45070"},{"key":"154642","doi-asserted-by":"crossref","unstructured":"von Elm E, Altman D G, Egger M, Pocock S J, G\u00f8tzsche P C, Vandenbroucke J P. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007; 335: 806-8. doi: 10.1136\/bmj.39335.541782.AD.","DOI":"10.1136\/bmj.39335.541782.AD"},{"key":"154643","doi-asserted-by":"crossref","unstructured":"Kellgren J H, Lawrence J S. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957; 16: 494-502. doi: 10.1136\/ard.16.4.494.","DOI":"10.1136\/ard.16.4.494"},{"key":"154644","doi-asserted-by":"crossref","unstructured":"Lindberg M F, Aamodt A, Badawy M, Bergvad I B, Borchgrevink P, Furnes O, et al. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis: study protocol for the MultiKnee trial. BMC Musculoskelet Disord 2021; 22: 1054. doi: 10.1186\/s12891-021-04924-z.","DOI":"10.1186\/s12891-021-04924-z"},{"key":"154645","unstructured":"USIT Tsg-Id. Service for Sensitive Data (TSD) University of Oslo. Available from: https:\/\/www.uio.no\/english\/services\/it\/research\/sensitive-data\/index.html"},{"key":"154646","doi-asserted-by":"crossref","unstructured":"Sullivan M J L, Bishop S R, Pivik J. The Pain Catastrophizing Scale: development and validation. Psychol Assess 1995; 7: 524-32. doi: 10.1037\/1040-3590.7.4.524.","DOI":"10.1037\/1040-3590.7.4.524"},{"key":"154647","doi-asserted-by":"crossref","unstructured":"Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord 2012; 13: 111. doi: 10.1186\/1471-2474-13-111.","DOI":"10.1186\/1471-2474-13-111"},{"key":"154648","doi-asserted-by":"crossref","unstructured":"Grotle M, Brox J I, Vollestad N K. Reliability, validity and responsiveness of the fear-avoidance beliefs questionnaire: methodological aspects of the Norwegian version. J Rehab Med 2006; 38: 346-53. doi: 10.1080\/16501970600722403.","DOI":"10.1080\/16501970600722403"},{"key":"154649","doi-asserted-by":"crossref","unstructured":"Waddell G, Newton M, Henderson I, Somerville D, Main C J. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993; 52: 157-68. doi: 10.1016\/0304-3959(93)90127-b.","DOI":"10.1016\/0304-3959(93)90127-B"},{"key":"154650","doi-asserted-by":"crossref","unstructured":"Zigmond A S, Snaith R P. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983; 67: 361-70. doi: 10.1111\/j.1600-0447.1983.tb09716.x.","DOI":"10.1111\/j.1600-0447.1983.tb09716.x"},{"key":"154651","doi-asserted-by":"crossref","unstructured":"Monticone M, Frigau L, Vernon H, Rocca B, Giordano A, Simone Vullo S, et al. Reliability, responsiveness and minimal clinically important difference of the two Fear Avoidance and Beliefs Questionnaire scales in Italian subjects with chronic low back pain undergoing multidisciplinary rehabilitation. Eur J Phys Rehabil Med 2020; 56: 600-6. doi: 10.23736\/s1973-9087.20.06158-4.","DOI":"10.23736\/S1973-9087.20.06158-4"},{"key":"154652","doi-asserted-by":"crossref","unstructured":"Bjelland I, Dahl A A, Haug T T, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. J Psychosom Res 2002; 52: 69-77. doi: 10.1016\/s0022-3999(01)00296-3.","DOI":"10.1016\/S0022-3999(01)00296-3"},{"key":"154653","doi-asserted-by":"crossref","unstructured":"Roos H, Lauren M, Adalberth T, Roos E M, Jonsson K, Lohmander L S. Knee osteoarthritis after meniscectomy: prevalence of radiographic changes after twenty-one years, compared with matched controls. Arthritis Rheum 1998; 41: 687-93. doi: 10.1002\/1529-0131(199804)41:4<687::aid-art16>3.0.co;2-2.","DOI":"10.1002\/1529-0131(199804)41:4<687::AID-ART16>3.0.CO;2-2"},{"key":"154654","doi-asserted-by":"crossref","unstructured":"Roos E M, Lohmander L S. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 2003; 1: 64. doi: 10.1186\/1477-7525-1-64.","DOI":"10.1186\/1477-7525-1-64"},{"key":"154655","doi-asserted-by":"crossref","unstructured":"Collins N J, Prinsen C A, Christensen R, Bartels E M, Terwee C B, Roos E M. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage 2016; 24: 1317-29. doi: 10.1016\/j.joca.2016.03.010.","DOI":"10.1016\/j.joca.2016.03.010"},{"key":"154656","doi-asserted-by":"crossref","unstructured":"Behrend H, Giesinger K, Giesinger J M, Kuster M S. The \u201cforgotten joint\u201d as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty 2012; 27: 430-436.e431. doi: 10.1016\/j.arth.2011.06.035.","DOI":"10.1016\/j.arth.2011.06.035"},{"key":"154657","doi-asserted-by":"crossref","unstructured":"Roos E M, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS): validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes 2003; 1: 17. doi: 10.1186\/1477-7525-1-17.","DOI":"10.1186\/1477-7525-1-17"},{"key":"154658","doi-asserted-by":"crossref","unstructured":"Behrend H, Giesinger K, Giesinger J M, Kuster M S. The \u201cforgotten joint\u201d as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty 2012; 27: 430-436.e431. doi: https:\/\/doi.org\/10.1016\/j.arth.2011.06.035.","DOI":"10.1016\/j.arth.2011.06.035"},{"key":"154659","doi-asserted-by":"crossref","unstructured":"Adriani M, Malahias M A, Gu A, Kahlenberg C A, Ast M P, Sculco P K. Determining the validity, reliability, and utility of the forgotten joint score: a systematic review. J Arthroplasty 2020; 35: 1137-44. doi: 10.1016\/j.arth.2019.10.058.","DOI":"10.1016\/j.arth.2019.10.058"},{"key":"154660","doi-asserted-by":"crossref","unstructured":"Cohen J. A power primer. Psychol Bull 1992; 112: 155-9. doi: 10.1037\/\/0033-2909.112.1.155.","DOI":"10.1037\/0033-2909.112.1.155"},{"key":"154661","doi-asserted-by":"crossref","unstructured":"Sekhon M, Cartwright M, Lawes-Wickwar S, McBain H, Ezra D, Newman S, et al. Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study. Contemp Clin Trials Commun 2021; 21: 100698. doi: 10.1016\/j.conctc.2021.100698.","DOI":"10.1016\/j.conctc.2021.100698"},{"key":"154662","doi-asserted-by":"crossref","unstructured":"Naidoo N, Nguyen V T, Ravaud P, Young B, Amiel P, Schant\u00e9 D, et al. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med 2020; 18: 6. doi: 10.1186\/s12916-019-1476-5.","DOI":"10.1186\/s12916-019-1476-5"},{"key":"154663","doi-asserted-by":"crossref","unstructured":"Englund M, Roos E M, Lohmander L S. Impact of type of meniscal tear on radiographic and symptomatic knee osteoarthritis: a sixteen-year followup of meniscectomy with matched controls. Arthritis Rheum 2003; 48: 2178-2187. doi: 10.1002\/art.11088.","DOI":"10.1002\/art.11088"},{"key":"154664","doi-asserted-by":"crossref","unstructured":"Kise N J, Risberg M A, Stensrud S, Ranstam J, Engebretsen L, Roos E M. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. BMJ 2016; 354: i3740. doi: 10.1136\/bmj.i3740.","DOI":"10.1136\/bmj.i3740"},{"key":"154665","doi-asserted-by":"crossref","unstructured":"Hare K B, Lohmander L S, Roos E M. The challenge of recruiting patients into a placebo-controlled surgical trial. Trials 2014; 15: 167. doi: 10.1186\/1745-6215-15-167.","DOI":"10.1186\/1745-6215-15-167"},{"key":"154666","doi-asserted-by":"crossref","unstructured":"Lin H M, Hsieh P S, Chen N C, Tsai C H, Kuo W F, Lee Y L, et al. Impact of cognitive behavior therapy on osteoarthritis-associated pain, insomnia, depression, fatigue, and physical function in patients with knee\/hip osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne) 2022; 9: 1083095. doi: 10.3389\/fmed.2022.1083095.","DOI":"10.3389\/fmed.2022.1083095"}],"container-title":["Acta Orthopaedica"],"original-title":[],"link":[{"URL":"https:\/\/actaorthop.org\/actao\/article\/download\/45869\/53756","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/actaorthop.org\/actao\/article\/download\/45869\/53775","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/actaorthop.org\/actao\/article\/download\/45869\/53776","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/actaorthop.org\/actao\/article\/download\/45869\/53756","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T06:05:34Z","timestamp":1778220334000},"score":1,"resource":{"primary":{"URL":"https:\/\/actaorthop.org\/actao\/article\/view\/45869"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,8]]},"references-count":35,"URL":"https:\/\/doi.org\/10.2340\/17453674.2026.45869","relation":{},"ISSN":["1745-3682","1745-3674"],"issn-type":[{"value":"1745-3682","type":"electronic"},{"value":"1745-3674","type":"print"}],"subject":[],"published":{"date-parts":[[2026,5,8]]}}}