{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T02:11:58Z","timestamp":1793412718767,"version":"4.5.0"},"reference-count":50,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T00:00:00Z","timestamp":1647302400000},"content-version":"unspecified","delay-in-days":14,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Soci\u00e9t\u00e9 francaise de rhumatologie"},{"name":"Fondation France Rhumatisme"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2022,1,26]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0\u2013100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65\u2009min at baseline and 44\u2009min at 3 months). The primary outcome was met: the BioSecure score was 81.2\u00b113.1\u2009and 75.6\u00b113.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Educating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues.<\/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=\"NCT02855320\">NCT02855320<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2021-001828","type":"journal-article","created":{"date-parts":[[2022,3,16]],"date-time":"2022-03-16T12:12:56Z","timestamp":1647432776000},"page":"e001828","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct02855320","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9872-4298","authenticated-orcid":false,"given":"Catherine","family":"Beauvais","sequence":"first","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire Saint Antoine,Sorbonne Universit\u00e9, APHP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7oise","family":"Fayet","sequence":"additional","affiliation":[{"name":"Rheumatology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Rousseau","sequence":"additional","affiliation":[{"name":"Service de Pharmacologie Clinique et Plateforme de Recherche Clinique de l\u2019Est Parisien, Centre Hospitalier Universitaire Saint Antoine, Sorbonne Universit\u00e9, APHP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christelle","family":"Sordet","sequence":"additional","affiliation":[{"name":"Rheumatology Department, H\u00f4pitaux Universitaires de Strasbourg, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Pouplin","sequence":"additional","affiliation":[{"name":"Service de Rhumatologie, Centre Hospitalier Universitaire de Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Maugars","sequence":"additional","affiliation":[{"name":"Rheumatology, Centre Hospitalier Universitaire de Nantes H\u00f4pital Saint Jacques, Nantes, France"},{"name":"Medical Faculty, Universite de Nantes Pole Sante, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rose Marie","family":"Poilverd","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire Saint Antoine, Sorbonne Universit\u00e9, APHP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carine","family":"Savel","sequence":"additional","affiliation":[{"name":"Rheumatology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00e9ronique","family":"S\u00e9gard","sequence":"additional","affiliation":[{"name":"Rheumatology Department, H\u00f4pitaux Universitaires de Strasbourg, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9atrice","family":"Godon","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire de Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"L\u2019amour","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire Piti\u00e9 Salp\u00e9tri\u00e8re, Sorbonne Universit\u00e9, APHP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleth","family":"Perdriger","sequence":"additional","affiliation":[{"name":"Rhumatologie, Centre Hospitalier Universitaire de Rennes, Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabienne","family":"Brin","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire de Nantes, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Peyrard","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabienne","family":"Chalier","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier R\u00e9gional Universitaire de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9atrice","family":"Pallot-Prades","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Tuffet","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Centre Hospitalier Universitaire Saint Antoine, Sorbonne Universit\u00e9, APHP, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Griffoul","sequence":"additional","affiliation":[{"name":"Rheumatology, Centre Hospitalier Regional Universitaire de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4528-310X","authenticated-orcid":false,"given":"Laure","family":"Gossec","sequence":"additional","affiliation":[{"name":"INSERM, Institut Pierre Louis d'Epid\u00e9miologie et de Sant\u00e9 Publique, INSERM, Sorbonne Universite, Paris, France"},{"name":"APHP, Rheumatology Department, Hopital Universitaire Pitie Salpetriere, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,3,16]]},"reference":[{"key":"2025090313215058000_8.1.e001828.1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210715"},{"key":"2025090313215058000_8.1.e001828.2","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.jbspin.2018.10.002","article-title":"Update of French Society for rheumatology recommendations for managing rheumatoid arthritis","volume":"86","author":"Daien","year":"2019","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.3","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210770"},{"key":"2025090313215058000_8.1.e001828.4","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1016\/j.jbspin.2018.01.006","article-title":"2018 update of French Society for rheumatology (SFR) recommendations about the everyday management of patients with spondyloarthritis","volume":"85","author":"Wendling","year":"2018","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.5","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1016\/S0140-6736(14)61704-9","article-title":"Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis","volume":"386","author":"Singh","year":"2015","journal-title":"The Lancet"},{"key":"2025090313215058000_8.1.e001828.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2014.06.012"},{"key":"2025090313215058000_8.1.e001828.7","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-216653"},{"key":"2025090313215058000_8.1.e001828.8","article-title":"bTNF-alpha inhibitors for ankylosing spondylitis","volume":"4","author":"Maxwell","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"2025090313215058000_8.1.e001828.9","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2016-000396"},{"key":"2025090313215058000_8.1.e001828.10","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.128637"},{"key":"2025090313215058000_8.1.e001828.11","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.1692"},{"key":"2025090313215058000_8.1.e001828.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2012.06.008"},{"key":"2025090313215058000_8.1.e001828.13","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215882"},{"key":"2025090313215058000_8.1.e001828.14","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1080\/03009742.2016.1242774","article-title":"Factors associated with influenza and pneumococcal vaccine uptake among rheumatoid arthritis patients in Denmark invited to participate in a pneumococcal vaccine trial (Immunovax_RA)","volume":"46","author":"Nguyen","year":"2017","journal-title":"Scand J Rheumatol"},{"key":"2025090313215058000_8.1.e001828.15","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/j.jbspin.2015.11.005","article-title":"Influenza and pneumococcal vaccine coverage in 584 patients taking biological therapy for chronic inflammatory joint: a retrospective study","volume":"83","author":"Brocq","year":"2016","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.16","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1016\/S1297-319X(10)70001-4","article-title":"Tocilizumab: therapy and safety management","volume":"77 Suppl 1","author":"Pham","year":"2010","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.17","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/S1297-319X(11)70001-X","article-title":"Tnf alpha antagonist therapy and safety monitoring","volume":"78 Suppl 1","author":"Pham","year":"2011","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.18","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/S1297-319X(12)70011-8","article-title":"Abatacept therapy and safety management","volume":"79 Suppl 1","author":"Pham","year":"2012","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.19","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208840"},{"key":"2025090313215058000_8.1.e001828.20","unstructured":"World Health Organization . Therapeutic patient education. continuing education programmes for health care providers in the field of prevention of chronic diseases. World Health organization 1998.. Available: http:\/\/www.euro.who.int\/__data\/assets\/pdf_file\/0007\/145294\/E63674.pdf [Accessed 9 Apr 2021]."},{"key":"2025090313215058000_8.1.e001828.21","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-206807"},{"key":"2025090313215058000_8.1.e001828.22","unstructured":"Structuration d\u2019un programme d\u2019\u00e9ducation th\u00e9rapeutique du patient dans le champ des maladies chroniques [Therapeutic patient education (TPE) Definition, goals, and organization]. Recommandations Haute Autorit\u00e9 de Sant\u00e9 2007. Available: http\/\/www.has.fr [Accessed 9 Apr 2021]."},{"key":"2025090313215058000_8.1.e001828.23","doi-asserted-by":"publisher","DOI":"10.1001\/jama.288.19.2469"},{"key":"2025090313215058000_8.1.e001828.24","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1016\/j.jbspin.2012.11.009","article-title":"Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French rheumatology Society therapeutic education section","volume":"80","author":"Gossec","year":"2013","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.25","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215458"},{"key":"2025090313215058000_8.1.e001828.26","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204733"},{"key":"2025090313215058000_8.1.e001828.27","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1016\/j.semarthrit.2020.05.012","article-title":"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: the results of the COMEDSPA prospective, controlled, one year randomized trial","volume":"50","author":"Molto","year":"2020","journal-title":"Semin Arthritis Rheum"},{"key":"2025090313215058000_8.1.e001828.28","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"2025090313215058000_8.1.e001828.29","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.108233"},{"key":"2025090313215058000_8.1.e001828.30","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.133645"},{"key":"2025090313215058000_8.1.e001828.31","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.jbspin.2015.08.005","article-title":"Efficiency of an education program on the safety knowledge and skills of patients with rheumatoid arthritis treated by biologics","volume":"83","author":"Piperno","year":"2016","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.32","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"2025090313215058000_8.1.e001828.33","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.094870"},{"key":"2025090313215058000_8.1.e001828.34","first-page":"2286","article-title":"A new approach to defining disease status in ankylosing spondylitis: the Bath ankylosing spondylitis disease activity index","volume":"21","author":"Garrett","year":"1994","journal-title":"J Rheumatol"},{"key":"2025090313215058000_8.1.e001828.35","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.142901"},{"key":"2025090313215058000_8.1.e001828.36","first-page":"462","article-title":"The measurement of helplessness in rheumatoid arthritis. the development of the arthritis helplessness index","volume":"12","author":"Nicassio","year":"1985","journal-title":"J Rheumatol"},{"key":"2025090313215058000_8.1.e001828.37","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh587"},{"key":"2025090313215058000_8.1.e001828.38","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/j.jbspin.2016.02.026","article-title":"Factors associated with knowledge and safety skills of arthritis patients receiving biologics: a survey of 677 patients","volume":"84","author":"Rat","year":"2017","journal-title":"Joint Bone Spine"},{"key":"2025090313215058000_8.1.e001828.39","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209233"},{"key":"2025090313215058000_8.1.e001828.40","doi-asserted-by":"crossref","first-page":"1537","DOI":"10.1007\/s10067-019-04430-7","article-title":"Interventions to improve vaccine acceptance among rheumatoid arthritis patients: a systematic review","volume":"38","author":"Gosselin Boucher","year":"2019","journal-title":"Clin Rheumatol"},{"key":"2025090313215058000_8.1.e001828.41","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1080\/1744666X.2018.1429919","article-title":"How can primary care physicians enhance the early diagnosis of rheumatic diseases?","volume":"14","author":"Mallen","year":"2018","journal-title":"Expert Rev Clin Immunol"},{"key":"2025090313215058000_8.1.e001828.42","doi-asserted-by":"crossref","first-page":"1144","DOI":"10.1016\/j.vaccine.2019.11.018","article-title":"Vaccine hesitancy and self-vaccination behaviors among nurses in southeastern France","volume":"38","author":"Wilson","year":"2020","journal-title":"Vaccine"},{"key":"2025090313215058000_8.1.e001828.43","doi-asserted-by":"crossref","DOI":"10.1080\/17482631.2020.1757336","article-title":"Vaccine hesitancy among general practitioners in southern France and their reluctant trust in the health authorities","volume":"15","author":"Wilson","year":"2020","journal-title":"Int J Qual Stud Health Well-being"},{"key":"2025090313215058000_8.1.e001828.44","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keu531"},{"key":"2025090313215058000_8.1.e001828.45","doi-asserted-by":"crossref","first-page":"888","DOI":"10.1093\/rheumatology\/keaa480","article-title":"Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA)","volume":"60","author":"Molto","year":"2021","journal-title":"Rheumatology"},{"key":"2025090313215058000_8.1.e001828.46","first-page":"786","article-title":"Psychometric properties of sleep and coping numeric rating scales in rheumatoid arthritis: a subanalysis of an etanercept trial","volume":"35","author":"Avila-Ribeiro","year":"2017","journal-title":"Clin Exp Rheumatol"},{"key":"2025090313215058000_8.1.e001828.47","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202810"},{"key":"2025090313215058000_8.1.e001828.48","doi-asserted-by":"crossref","unstructured":"Frantzen L , Or\u00e9fice D , Sparsa L . Impact of therapeutic patient education on knowledge and safety skills of arthritis patients receiving intravenous biologics for their rheumatism. Educ Ther Patient 2017;9.","DOI":"10.1051\/tpe\/2017011"},{"key":"2025090313215058000_8.1.e001828.49","doi-asserted-by":"crossref","DOI":"10.55563\/clinexprheumatol\/pzc5lo","article-title":"Impact of a pharmacist-led programme on biologics knowledge and adherence in patients with spondyloarthritis","volume":"39","author":"Gutermann","year":"2021","journal-title":"Clin Exp Rheumatol"},{"key":"2025090313215058000_8.1.e001828.50","doi-asserted-by":"publisher","DOI":"10.1002\/acr.22085"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2021-001828","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:22:02Z","timestamp":1756930922000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2021-001828"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":50,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,3,16]]},"published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1136\/rmdopen-2021-001828"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2021-001828","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3]]}}}