{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T06:50:11Z","timestamp":1772693411371,"version":"3.50.1"},"update-to":[{"DOI":"10.3310\/nihropenres.13571.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000}},{"DOI":"10.3310\/nihropenres.13571.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000}}],"reference-count":39,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["CS-2018-18-ST2-010"],"award-info":[{"award-number":["CS-2018-18-ST2-010"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>\n                    Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person\u2019s life, beliefs, and values. We developed the\n                    <ns3:bold>i<\/ns3:bold>\n                    mproving uptake of\n                    <ns3:bold>Fra<\/ns3:bold>\n                    cture\n                    <ns3:bold>P<\/ns3:bold>\n                    revention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged \u226550 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new \u2018iFraP\u2019 osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration ISRCTN 10606407, 21\/11\/2022\n                    <ns3:ext-link xmlns:ns4=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" ns4:href=\"https:\/\/doi.org\/10.1186\/ISRCTN10606407\">https:\/\/doi.org\/10.1186\/ISRCTN10606407<\/ns3:ext-link>\n                  <\/ns3:p>","DOI":"10.3310\/nihropenres.13571.3","type":"journal-article","created":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T07:50:06Z","timestamp":1761033006000},"page":"14","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial 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M","family":"Clark","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8127-2061","authenticated-orcid":false,"given":"Jane","family":"Fleming","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Leyland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ida","family":"Bentley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia P","family":"Iglesias-Urrutia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9313-385X","authenticated-orcid":false,"given":"David","family":"Webb","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9030-4110","authenticated-orcid":false,"given":"Jo","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Bathers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3992-6938","authenticated-orcid":false,"given":"Sarah","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0046-3331","authenticated-orcid":false,"given":"Angela","family":"Clifford","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-7354-5368","authenticated-orcid":false,"given":"Michele","family":"Siciliano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Protheroe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Ryan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2662-1919","authenticated-orcid":false,"given":"Janet","family":"Lefroy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicky","family":"Dale","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley","family":"Hawarden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Connacher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Horne","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terence 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osteoporosis"},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"503-509","DOI":"10.1016\/j.japh.2017.05.003","article-title":"Patient-reported reasons for nonadherence to recommended osteoporosis pharmacotherapy.","volume":"57","author":"S Hall","year":"2017","journal-title":"J Am Pharm Assoc (2003)."},{"key":"ref-4","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-027049","article-title":"Real-world persistence and adherence with oral bisphosphonates for osteoporosis: a systematic review.","volume":"9","author":"F Fatoye","year":"2019","journal-title":"BMJ Open."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"691-705","DOI":"10.1111\/j.1365-2125.2012.04167.x","article-title":"A new taxonomy for describing and defining adherence to medications.","volume":"73","author":"B Vrijens","year":"2012","journal-title":"Br J Clin Pharmacol."},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"1926-1928","DOI":"10.1002\/jbmr.2301","article-title":"The osteoporosis treatment gap.","volume":"29","author":"J Kanis","year":"2014","journal-title":"J Bone Miner Res."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"2049-2054","DOI":"10.1002\/jbmr.4701","article-title":"Effective communication and the osteoporosis care gap.","volume":"37","author":"K Ralston","year":"2022","journal-title":"J Bone Miner Res."},{"key":"ref-8","article-title":"Shared decision making"},{"key":"ref-9","article-title":"Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence","year":"2009"},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"657-658","DOI":"10.1001\/jama.2017.10289","article-title":"Patient decision Aids to engage adults in treatment or screening decisions.","volume":"318","author":"D Stacey","year":"2017","journal-title":"JAMA."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"1645-1669","DOI":"10.1007\/s00198-020-05378-0","article-title":"Interventions to improve adherence to anti-osteoporosis medications: an updated systematic review.","volume":"31","author":"D Cornelissen","year":"2020","journal-title":"Osteoporos Int."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"5-6","DOI":"10.1136\/bmjebm-2021-111871","article-title":"Making care fit manifesto.","volume":"28","author":"M Kunneman","year":"2023","journal-title":"BMJ Evid Based Med."},{"key":"ref-13","doi-asserted-by":"publisher","DOI":"10.1007\/s11657-017-0340-5","article-title":"Public priorities for osteoporosis and fracture research: results from a general population survey.","volume":"12","author":"Z Paskins","year":"2017","journal-title":"Arch Osteoporos."},{"key":"ref-14","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6947-13-S2-S10","article-title":"Addressing health literacy in patient decision aids.","volume":"13 Suppl 2","author":"K McCaffery","year":"2013","journal-title":"BMC Med Inform Decis Mak."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"721-723","DOI":"10.3399\/bjgp09X472584","article-title":"Health literacy: a necessity for increasing participation in health care.","volume":"59","author":"J Protheroe","year":"2009","journal-title":"Br J Gen Pract."},{"key":"ref-16","doi-asserted-by":"publisher","first-page":"521-524","DOI":"10.1007\/s11606-020-05912-0","article-title":"Health literacy and shared decision-making: exploring the relationship to enable meaningful patient engagement in healthcare.","volume":"36","author":"D Muscat","year":"2021","journal-title":"J Gen Intern Med."},{"key":"ref-17","doi-asserted-by":"publisher","first-page":"1837-1851","DOI":"10.1007\/s00198-020-05479-w","article-title":"Quality and effectiveness of osteoporosis treatment decision aids: a systematic review and environmental scan.","volume":"31","author":"Z Paskins","year":"2020","journal-title":"Osteoporosis 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Open."},{"key":"ref-21","doi-asserted-by":"publisher","first-page":"1567-1584","DOI":"10.1007\/s00198-020-05800-7","article-title":"Evaluation of quality and readability of online patient information on osteoporosis and osteoporosis drug treatment and recommendations for improvement.","volume":"32","author":"F Crawford-Manning","year":"2021","journal-title":"Osteoporos Int."},{"key":"ref-22","doi-asserted-by":"publisher","DOI":"10.1007\/s11657-023-01361-4","article-title":"Variation in UK Fracture Liaison Service consultation conduct and content before and during the COVID pandemic: results from the iFraP-D UK survey.","volume":"19","author":"L Bullock","year":"2023","journal-title":"Arch Osteoporos."},{"key":"ref-23","doi-asserted-by":"publisher","DOI":"10.1007\/s11657-021-00913-w","article-title":"Developing a model Fracture Liaison Service consultation with patients, carers and clinicians: a Delphi survey to inform content of the iFraP complex consultation intervention.","volume":"16","author":"L Bullock","year":"2021","journal-title":"Arch Osteoporos."},{"key":"ref-24","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-10-113","article-title":"Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice.","volume":"10","author":"L Pencille","year":"2009","journal-title":"Trials."},{"key":"ref-25","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2296-7-21","article-title":"The single item literacy screener: evaluation of a brief instrument to identify limited reading ability.","volume":"7","author":"N Morris","year":"2006","journal-title":"BMC Fam Pract."},{"key":"ref-26","article-title":"User Manual - Decisional Conflict Scale.","author":"A O\u2019Connor","year":"1993"},{"key":"ref-27","doi-asserted-by":"publisher","first-page":"1-24","DOI":"10.1080\/08870449908407311","article-title":"The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication.","volume":"14","author":"R Horne","year":"1999","journal-title":"Psychol Health."},{"key":"ref-28","doi-asserted-by":"publisher","first-page":"126-133","DOI":"10.1016\/j.pec.2018.08.006","article-title":"The Patient-Professional Interaction Questionnaire (PPIQ) to assess patient centered care from the patient\u2019s perspective.","volume":"102","author":"G Casu","year":"2019","journal-title":"Patient Educ Couns."},{"key":"ref-29","doi-asserted-by":"publisher","first-page":"540-548","DOI":"10.1002\/hed.20450","article-title":"Development and preliminary validation of a new measure to assess satisfaction with information among head and neck cancer patients: the Satisfaction with Cancer Information Profile (SCIP).","volume":"28","author":"C Llewellyn","year":"2006","journal-title":"Head Neck."},{"key":"ref-30","doi-asserted-by":"publisher","first-page":"631-637","DOI":"10.1016\/j.jpsychores.2005.10.020","article-title":"The brief illness perception questionnaire.","volume":"60","author":"E Broadbent","year":"2006","journal-title":"J Psychosom Res."},{"key":"ref-31","doi-asserted-by":"publisher","first-page":"327-333","DOI":"10.1080\/09638280110093686","article-title":"Fear of falling, falls efficacy, and health outcomes in older people following hip fracture.","volume":"24","author":"K McKee","year":"2002","journal-title":"Disabil Rehabil."},{"key":"ref-32","article-title":"User manual - realistic expectations (Osteoporosis).","author":"A O\u2019Connor","year":"1995"},{"key":"ref-33","doi-asserted-by":"publisher","first-page":"135-140","DOI":"10.1136\/qhc.0100135..","article-title":"The Satisfaction with Information about Medicines Scale (SIMS): a new measurement tool for audit and research.","volume":"10","author":"R Horne","year":"2001","journal-title":"Qual Health Care."},{"key":"ref-34","doi-asserted-by":"publisher","first-page":"1281-1288","DOI":"10.1111\/bcp.14193","article-title":"The medication adherence report scale: a measurement tool for eliciting patients\u2019 reports of nonadherence.","volume":"86","author":"A Chan","year":"2020","journal-title":"Br J Clin Pharmacol."},{"key":"ref-35","doi-asserted-by":"publisher","first-page":"199-208","DOI":"10.1016\/0168-8510(90)90421-9","article-title":"EuroQol--a new facility for the measurement of health-related quality of life.","volume":"16","year":"1990","journal-title":"Health Policy."},{"key":"ref-36","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h1258","article-title":"Process evaluation of complex interventions: Medical Research Council guidance.","volume":"350","author":"G Moore","year":"2015","journal-title":"BMJ."},{"key":"ref-37","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9780511803932","article-title":"Communities of practice: learning, meaning, and identity.","author":"E Wenger","year":"1998"},{"key":"ref-38","doi-asserted-by":"publisher","first-page":"907-937","DOI":"10.1177\/0272989X20978208","article-title":"What works in implementing patient decision aids in routine clinical settings? A rapid realist review and update from the international patient decision aid standards collaboration.","volume":"41","author":"N Joseph-Williams","year":"2021","journal-title":"Med Decis Making."},{"key":"ref-39","doi-asserted-by":"publisher","DOI":"10.1093\/rap\/rkac109","article-title":"Digital exclusion as a potential cause of inequalities in access to care: a survey in people with inflammatory rheumatic diseases.","volume":"7","author":"S Hider","year":"2023","journal-title":"Rheumatol Adv Pract."}],"container-title":["NIHR Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T07:50:07Z","timestamp":1761033007000},"score":1,"resource":{"primary":{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,17]]},"references-count":39,"URL":"https:\/\/doi.org\/10.3310\/nihropenres.13571.3","relation":{"has-version":[{"id-type":"doi","id":"10.3310\/nihropenres.13571.2","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.13571.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.3310\/nihropenres.15382.r37875","asserted-by":"object"}]},"ISSN":["2633-4402"],"issn-type":[{"value":"2633-4402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,17]]},"assertion":[{"value":"Indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14731.r31771, Kathlene Camp, University of North Texas Health Science Center, Fort Worth, 18 May 2024, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v1#referee-response-31771","order":0,"name":"referee-response-31771","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Laurna Bullock<\/b>; \n<i>Posted: 27 Sep 2024<\/i>; We would like to express our thanks to the reviewer for their time to provide insightful comment on this article. Below we have included each of the reviewer\u2019s comments in turn, followed by our responses. Where needed, small revisions to the text of the article have been made, as described below.&nbsp;  \n<b>Reviewer comment:<\/b> An initial question for consideration on the design is the 3-month assessment of adherence - will this be sufficient enough to assess adherence with all OP medications?&nbsp; Will a 3-month time period be sufficient to assess discontinuation rates for non-oral OP medications or is this study suggesting only oral bisphosphonates are recommended for intervention.&nbsp; \n<b>Response:<\/b> The iFraP decision support tool, used by clinicians in Fracture Liaison Services, provides evidence-based treatment recommendations in line with clinical guidelines, including oral and non-oral drug treatment options. The clinician ultimately chooses which osteoporosis drug treatment(s) to discuss with the patient, based on their clinical judgement. The reviewer rightly highlights that the trial\u2019s follow-up period is 3 months following the patient\u2019s Fracture Liaison Service appointment. We anticipate that 3 months will be adequate to examine initiation as well as short-term persistence and discontinuation of oral osteoporosis drug treatments (taken weekly). We acknowledge that, because of the dosing regimens of non-oral drug treatment options (the time between doses are monthly, 6 monthly or yearly), the three month follow up period may not be sufficient to capture persistence and discontinuation of these drugs. Although this is a limitation, most patients who are recommended drug treatment in Fracture Liaison Services are recommended first-line oral drug treatments, administered weekly\n<sup>1<\/sup>. To acknowledge this, we have added the following sentence into the manuscript discussion: \n<i>\u201cWe do acknowledge, however, that the 3-month follow-up period of this trial may limit our understanding about long-term persistence or discontinuation of osteoporosis medicines.\u201d<\/i>  \n<b>Reviewer comment:<\/b> Further details may be warranted to describe the qualitative component.&nbsp; \n<b>Response:<\/b> Thank you for this comment. We appreciate that the information provided about the qualitative components of the mixed methods process evaluation are limited. A separate protocol will soon be published providing further details about the process evaluation.  \n<b>Reviewer comment:<\/b> Not sure the health status- Euro-QoL EQ-5D-5L is an appropriate measure for this intervention, especially with the frequent delivery over a short period to time.&nbsp; \n<b>Response: <\/b>The EQ-5D-5L will capture trial participant\u2019s self-reported Health related Quality of Life at baseline (before attending their Fracture Liaison Service appointment) and 2-weeks and 3 months after their Fracture Liaison Service appointment. Self-reported health related quality of life is an essential element of the nested within-trial cost-effectiveness study. A separate protocol details this health economic study\n<sup>2<\/sup>.  NICE (2019). Bisphosphonates for treating osteoporosis. https:\/\/www.nice.org.uk\/guidance\/ta464\/resources\/bisphosphonates-for-treating-osteoporosis-pdf-82604905556677 Siciliano M, Bathers S, Bentley I&nbsp;\n<i>et al.<\/i>&nbsp;Protocol for a trial-based economic evaluation analysis of a complex digital health intervention including a computerised decision support tool: the iFraP intervention [version 1; peer review: awaiting peer review].&nbsp;\n<i>NIHR Open Res<\/i>&nbsp;2024,&nbsp;\n<b>4<\/b>:15 (https:\/\/doi.org\/10.3310\/nihropenres.13575.1)","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3#referee-comment-3367","order":1,"name":"referee-comment-3367","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14731.r31549, Li Shean Toh, University of Nottingham, Nottingham, England, 24 May 2024, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v1#referee-response-31549","order":2,"name":"referee-response-31549","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Laurna Bullock<\/b>; \n<i>Posted: 27 Sep 2024<\/i>; We would like to express our thanks to the reviewer for reflecting on the strengths of iFraP and its opportunity to improve patient care. Below we have included each of the reviewer\u2019s comments in turn, followed by our responses. Where needed, small revisions to the text of the article have been made.&nbsp;  \n<b>Reviewer comment:<\/b> The trial is conducted within the UK NHS context, which could have provided more details if the process evaluation would address more practical issues such as workload, funding, documentation time, logistics etc noting the pressures of the NHS. \n<b>Response:<\/b> The Medical Research Council\u2019s guidance highlights the importance of considering how an intervention interacts with the context in which it is implemented. In line with this, the iFraP mixed methods process evaluation will explore how contextual factors affect the quantity and quality of intervention implementation (fidelity, dose and adaptation) and hypothesised intervention outcomes. The reviewer rightly acknowledges that relevant contextual factors may include practical issues, such as workload and resources. Further details about the mixed methods process evaluation will be published in a separate protocol.  \n<b>Reviewer comment<\/b>: The other query is the follow-up duration, the follow-up period may be insufficient to fully capture long-term adherence and outcomes. \n<b>Response:<\/b> The trial\u2019s final data collection occurs 3 months following the patient\u2019s Fracture Liaison Service appointment. We anticipate that the 3-month period will provide insight into the initiation of osteoporosis drug treatments and short-term persistence and discontinuation of oral osteoporosis drug treatments (taken weekly). These findings will build on the limited evidence base to understand the clinical effectiveness of a shared decision-making intervention on uptake of preventative medicines. We do acknowledge, however, that the 3-month follow-up period may limit our understanding about long-term persistence or discontinuation, particularly for non-oral drug treatment options (which are administered less frequently e.g. monthly, 6 monthly or yearly). To acknowledge this, we have added the following sentence into the manuscript discussion:\n<i> \u201cWe do acknowledge, however, that the 3-month follow-up period of this trial may limit our understanding about long-term persistence or discontinuation of osteoporosis medicines.\u201d<\/i>  \n<b>Reviewer comment:<\/b> It was also unclear in the recruitment whether there was consideration to ensure that deprived areas would be sought more to ensure there is a holistic view of the implementation of the services or other cultural competencies aspects. \n<b>Response:<\/b> Thank you for this helpful comment. As part of the iFraP intervention development work, we conducted a national survey of Fracture Liaison Services (FLSs)\n<sup>1<\/sup>. The survey findings captured service characteristics about potential trial sites. When selecting sites for the trial, the study team considered variation in FLS provision and the characteristics of the local population (e.g. socioeconomic status). Further information has been added to the protocol to acknowledge this:\n<i> \u201cThe selection of potential FLS sites will consider capturing variation in the FLS\u2019s service provision (informed by the iFraP national survey of FLSs<sup>22<\/sup>) and characteristics of their local population,\u201d<\/i> Recruitment materials and methods were carefully considered, with public contributors, in efforts to recruit a diverse trial sample. The public contributors recommended that the trial invite letter included a translated sentence in the five most commonly used languages of each site and additional costs acquired for translation services. In a recent survey of patients attending rheumatology services (mean age 64.5), 20% of respondents reported not having access to an internet-enabled device and 18% reported limited health literacy\n<sup>2<\/sup>. This demonstrated the need for paper surveys (in addition to online surveys) to overcome barriers to participation, despite the additional work required to operate hybrid recruitment and data collection methods. This is detailed in the protocol discussion. At a mid-point in patient recruitment, the Data Monitoring Committee (DMC) examined the characteristics of the patients recruited to the trial to determine if the sample is representative of the general population. In response to this interim review, an additional FLS site joined to trial (chosen because it served a larger proportion of underserved groups). This is detailed in Table 2, which provides an overview of protocol amendments since trial registration. This will be explored further as part of the trial results publications.  Bullock L, Abdelmagid S, Fleming J, et al. Variation in UK fracture liaison service consultation conduct and content before and during the COVID pandemic: results from the iFraP-D UK survey. \n<i>Arch Osteoporos<\/i> 2023; 19: 5. Hider S, Muller S, Gray L, et al. Digital exclusion as a potential cause of inequalities in access to care: a survey in people with inflammatory rheumatic diseases. \n<i>Rheumatol Adv Pract<\/i>; 7. Epub ahead of print 30 December 2022. DOI: 10.1093\/rap\/rkac109","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3#referee-comment-3368","order":3,"name":"referee-comment-3368","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14937.r34000, Alexander J. Rodr\u00edguez, Edith Cowan University, Joondalup, 10 Jan 2025, version 2, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v2#referee-response-34000","order":4,"name":"referee-response-34000","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Laurna Bullock<\/b>; \n<i>Posted: 09 Oct 2025<\/i>; Thank you to the reviewer for their positive feedback. We have responded to each comment below in turn:  \n<b>Reviewer comment 1:<\/b> How will the investigators overcome systematic bias in terms of patient recruitment given they are drawing on a pool of older adults referred owing to a fragility fracture. Randomisation at the patient level will just overcome imbalance between the two groups. Therefore, how will the investigators ensure their recruitment is generalisable to the osteoporosis\/fragility fracture population. What efforts are in place to ensure representation of groups most at need and perhaps would be most hesitant to commence medications? \n<b>Author response: <\/b>In the UK, as part of Fracture Liaison Service normal NHS care, adults aged \u226550 years with a recent fragility fracture are systematically identified. This means that all identified patients that require a face-to-face or remote consultation in FLS where medicine may be discussed are mailed an initial invitation pack. However, it is possible that responders to the invitation may differ to non-responders. In efforts to minimise this, data collection materials and methods were carefully considered, with public contributors, in efforts to recruit a diverse trial sample. The public contributors recommended that the trial invite letter included a translated sentence in the five most commonly used languages and additional costs acquired for translation services. We also include paper completion of trial documents (in addition to electronic) to overcome barriers to participation.  \n<b>Reviewer comment 2:<\/b> Scant details are provided on the actual tool that will be used by the patients and clinicians together. Is this tool potentially modifiable or is it a proprietary product that was leveraged for the project? \n<b>Author response: <\/b>Thank you for this comment. In the article\u2019s introduction, we describe how the study team developed the tool (and other intervention components) guided by the Medical Research Council complex intervention development and evaluation framework. We also signpost the reader to a separate protocol outlining the in-depth intervention development and feasibility testing process. The results of each development study are also published and referenced in this article. The tool will be modified in response to the trial and process evaluation results.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3#referee-comment-3492","order":5,"name":"referee-comment-3492","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14937.r33896, Samuel Hawley, University of Bristol, Bristol, England, 28 Jan 2025, version 2, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v2#referee-response-33896","order":6,"name":"referee-response-33896","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Laurna Bullock<\/b>; \n<i>Posted: 09 Oct 2025<\/i>; Thank you to the reviewer for the positive feedback. We have responded to each comment below, noting where minor changes to the manuscript have been made to address uncertainities raised.  \n<b>Reviewer comment 1:<\/b> I note patients unable to comply with study procedures will be excluded. I wondered whether there were any particular study procedures envisaged that might preclude people from taking part? I suspect the study authors have already considered alternative procedures that might mitigate against too many people being excluded on this basis, but it could be worth briefly expanding on this given that the intervention is partly looking to improve decision making for those who might otherwise lack understanding\/capacity to make informed decisions? \n<b>Author response: <\/b>Thank you for this comment.\n<b> <\/b>We designed the trial to reduce barriers to participation (e.g. by including a translated sentence in trial invite letters, acquiring costs for translation services, having paper documents for patient completion, in addition to electronic). One example where a patient would be ineligible is if they were unable to attend their face-to-face or telephone FLS appointment where the intervention is delivered.  \n<b>Reviewer comment 2:<\/b> There is mention of site eligibility including the criteria of a minimum of 2 clinicians (presumably to allow each arm of the trial to be run). If I\u2019ve understood correctly, is there also a need for a third clinician to act as a champion for the trial? If so, would it be true to say there will need to be a minimum of 3 clinicians per site? \n<b>Author response:<\/b> A minimum of two clinicians per site allows one clinician to be allocated to each trial arm. If one site only had two clinicians, the clinical champion role would be allocated to the clinician delivering the intervention to avoid contamination.  \n<b>Reviewer comment 3:<\/b> If feasible, would&nbsp;blinding of study staff conducting assignment of clinician status to \u2018intervention\u2019 or \u2018standard care\u2019 help safeguard against clinician\u2019s pre-existing preferences contributing to any contamination? \n<b>Author response: <\/b>Thank you for raising this important point. Many of the clinicians in the trial were not known to the study team at the time of allocation, thereby minimising any known \u2018preferences\u2019. Unblinded allocation to each trial arm allowed clinician characteristics to balanced e.g. considering seniority and years of experience.  \n<b>Reviewer comment 4a:<\/b> There is mention of a dental card at a couple of points, I might have missed the explanation for this but is that for all participants or just the intervention arm? Is it related to side-effects related to the jaw? \n<b>Author response: <\/b>The dentist card is one of the intervention\u2019s information resources and therefore will only be provided to patients in the intervention arm (as listed in the \u2018iFraP intervention (iFraP-i)\u2019 section). The dentist card aims to support ongoing information about osteoporosis medicines and dental health outside of FLS. The card includes personalised information about the patient\u2019s medicine start date, expected treatment duration, and who the dentist should contact if they have questions. We have added more detail about the dentist card when describing the intervention components.  \n<b>Reviewer comment 4b:<\/b> I noted a secondary outcome includes asking about concerns over common side-effects \u2013 would there be any rationale\/scope to include fear of serious side effects alongside this? There is obviously good reason to expect the intervention to improve effectiveness of initiation, but it might be helpful to get insights into patient\u2019s worries about serious side effects if these will potentially be discussed in greater detail during the baseline visit? \n<b>Author response: <\/b>At 2 week follow up, patients self-report\n<b> <\/b>specific osteoporosis values, including 5 bespoke questions about the relative perceived importance of osteoporosis medicine benefits and possible side effects and adverse events. One of the five bespoke questions asks patient participants: \u201cHow likely is it, that you would be put off taking this treatment, because of concerns about rare long-term issues with medicines such as jawbone problems\u201d. Participants respond to this question using 5-response categories from \u201cnot at all\u201d to \u201cextremely\u201d. We have made minor edits to the manuscript to make clear that the bespoke items listed are examples only.  \n<b>Reviewer comment 5:<\/b> Very minor point \u2013 but typo\/repeated words 'rather than' on page 11 toward end of bullet point starting \u201csatisfaction with the consultation and\u2026\u201d \n<b>Author response: <\/b>Thank you for bringing this to our attention, we have rectified this mistake.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-14\/v3#referee-comment-3493","order":7,"name":"referee-comment-3493","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by National Institute for Health and Care Research Clinician Scientist Award (CS-2018-18-ST2-010)\/NIHR Academy. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":8,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}