{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T08:49:39Z","timestamp":1791967779317,"version":"4.3.4"},"update-to":[{"DOI":"10.3310\/nihropenres.13751.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000}},{"DOI":"10.3310\/nihropenres.13751.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000}}],"reference-count":43,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000},"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":["ClinicianScientistAward(CS-2018-18-ST2-010)\/NIHRAcademy"],"award-info":[{"award-number":["ClinicianScientistAward(CS-2018-18-ST2-010)\/NIHRAcademy"]}],"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":"\n Background High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person\u2019s life, beliefs, and values. The\n i<\/ns3:bold>\n mproving uptake of\n Fra<\/ns3:bold>\n cture\n P<\/ns3:bold>\n revention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. Methods We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. Discussion The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. Trial registration\n ISRCTN:<\/ns3:bold>\n 10606407, 21\/11\/2022 https:\/\/doi.org\/10.1186\/ISRCTN10606407\n <\/ns3:p>","DOI":"10.3310\/nihropenres.13751.3","type":"journal-article","created":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T05:54:05Z","timestamp":1775109245000},"page":"70","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study"],"prefix":"10.3310","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4193-1835","authenticated-orcid":false,"given":"Laurna","family":"Bullock","sequence":"first","affiliation":[{"name":"Centre for Musculoskeletal Health Research, School of Medicine Newcastle under Lyme England Keele 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Foundation Trust"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ida","family":"Bentley","sequence":"additional","affiliation":[{"name":"School of Medicine Research User Group Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine","family":"Nicholls","sequence":"additional","affiliation":[{"name":"Centre for Musculoskeletal Health Research, School of Medicine Newcastle under Lyme England Keele University"},{"name":"Keele Clinical Trials Unit Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9313-385X","authenticated-orcid":false,"given":"David","family":"Webb","sequence":"additional","affiliation":[{"name":"Keele Clinical Trials Unit Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9030-4110","authenticated-orcid":false,"given":"Jo","family":"Smith","sequence":"additional","affiliation":[{"name":"Keele Clinical Trials Unit Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Bathers","sequence":"additional","affiliation":[{"name":"Keele Clinical Trials Unit Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3992-6938","authenticated-orcid":false,"given":"Sarah","family":"Lewis","sequence":"additional","affiliation":[{"name":"Keele Clinical Trials Unit Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Horne","sequence":"additional","affiliation":[{"name":"Centre for Behavioural Medicine, UCL School of Pharmacy London England University College London"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terence W","family":"O'Neill","sequence":"additional","affiliation":[{"name":"Centre for Epidemiology Versus Arthritis Manchester England The University of Manchester"},{"name":"NIHR Manchester Biomedical Research Centre Manchester England Manchester University NHS Foundation Trust"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2677-1028","authenticated-orcid":false,"given":"Christian D","family":"Mallen","sequence":"additional","affiliation":[{"name":"Centre for Musculoskeletal Health Research, School of Medicine Newcastle under Lyme England Keele University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clare","family":"Jinks","sequence":"additional","affiliation":[{"name":"Centre for Musculoskeletal Health Research, School of Medicine Newcastle under Lyme England Keele 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reconciling lay knowledge and scientific method.","volume":"21","author":"J Frost","year":"2018","journal-title":"Health Expect."}],"container-title":["NIHR Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T08:14:11Z","timestamp":1791965651000},"score":1,"resource":{"primary":{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,2]]},"references-count":43,"URL":"https:\/\/doi.org\/10.3310\/nihropenres.13751.3","relation":{"has-version":[{"id-type":"doi","id":"10.3310\/nihropenres.13751.2","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.13751.1","asserted-by":"subject"}]},"ISSN":["2633-4402"],"issn-type":[{"value":"2633-4402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,2]]},"assertion":[{"value":"Indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14938.r33785, Peter R. Ebeling, Monash University, Clayton, Victoria, 23 Jan 2025, version 1, 1 approved","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v1#referee-response-33785","order":0,"name":"referee-response-33785","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Laurna Bullock<\/b>; \nPosted: 09 Oct 2025<\/i>; Thank you to the reviewer for their positive feedback about the iFraP mixed methods protocol.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3#referee-comment-3491","order":1,"name":"referee-comment-3491","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.15372.r37967, Zaid Al-Sawaff, Northern Technical University, Mosul, 21 Nov 2025, version 2, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v2#referee-response-37967","order":2,"name":"referee-response-37967","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Laurna Bullock<\/b>; \nPosted: 24 Feb 2026<\/i>; Thank you for providing thoughtful review of the iFraP process evaluation protocol. Below, we have outlined each of your comments, followed by a response. \nReviewer comment:<\/b> The protocol lists measures of fidelity (e.g., DST use, OPTION-5 ratings, decisional measures) but does not pre-define a priori thresholds for what constitutes \u201cacceptable fidelity\/dose\u201d or a minimally important difference on key scales (e.g., OPTION-5, Decisional Conflict Scale). \nAuthor response: <\/b>Thank you for your comment. Intervention implementation (fidelity and dose) will be explored using various methods, including: DST analytics, consultation recordings, patient self-reporting use of DST in trial surveys, case report forms and qualitative interviews. The exploratory approach means that we did not pre-define thresholds of \u201cacceptable fidelity\/dose\u201d. Instead, we will explore implementation variation, its impact on outcomes, and the role of context. The OPTION-5 and Decisional Conflict Scales are measures of shared decision-making and will not be used to make conclusions about intervention implementation. Minimally important differences are not defined for these measures. \nReviewer comment:<\/b> You plan to sample usual-care consultations, but it is not clear how contamination (i.e., spill-over of intervention elements) will be quantified and modelled. \nAuthor response: <\/b>A predefined checklist will be used to record and quantify the presence of intervention components in the intervention and usual care consultation recordings. Use of the predefined checklist will allow for numerical comparison of any possible contamination between the trial arms. \nReviewer comment:<\/b> Purposive sampling is appropriate, but target numbers by role\/site, stopping rules for data saturation, and management of cross-site heterogeneity need more precision. \nAuthor response: <\/b>Patients who received the intervention in their FLS appointment will be purposively sampled in an iterative manner to capture maximum variation in a range of characteristics: age, sex, FLS site, and decision to take medicine (yes\/no\/unsure). By sampling patients across each of the four participating FLS sites, we aim to capture \u2018cross-site heterogeneity\u2019 \u2013 this is important when considering how contextual (e.g. site-specific) factors may influence implementation, mechanisms of action, and outcomes. We did not define strict \u2018stopping rules\u2019 for data saturation \u2013 instead, interviews will continue until the research team judge that the data provided sufficient interpretive richness to address the research questions. \nReviewer comment:<\/b>  A convergence matrix is mentioned, but the rules for resolving dissonance between qualitative and quantitative strands are not specified. \nAuthor response: <\/b>It is possible that the convergence matrix will identifying dissonance between quantitative results and qualitative findings. Dissonance (or \u2018conflicting\u2019 findings) should be embraced as opportunities for deeper insight rather than errors to be resolved. If dissonance is identified during integration, it is good practice to review the data quality, reliability, and validity. If dissonance cannot be attributed to methodological limitation, additional exploration of collected data, collaboration with the multidisciplinary team, and previous literature will validate our conclusions. We have updated the manuscript to provide definitions of terms (e.g. \u2018convergence\u2019, \u2018silence\u2019) and how we will operationalise these terms to ensure validity and credibility.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3#referee-comment-3545","order":3,"name":"referee-comment-3545","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.15372.r38441, Martina Behanova, Ludwig Boltzmann Institute of Osteology At Hanusch Hospital of OEGK and AUVA Trauma Center Meidling 1st Med.Dep. Hanusch Hospital Heinrich Collin Str. 30 1140 Vienna, Austria, Vienna, 26 Dec 2025, version 2, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v2#referee-response-38441","order":4,"name":"referee-response-38441","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Laurna Bullock<\/b>; \nPosted: 24 Feb 2026<\/i>; Thank you for providing thoughtful review of the iFraP process evaluation protocol. Below, we have outlined each of your comments, followed by a response. \nReviewer comment:<\/b> The iFraP protocol is a strong, well-designed and clinically relevant study with real potential to advance shared decision-making and improve osteoporosis treatment rates. I particularly value the involvement of public contributors with osteoporosis and carers throughout development, data interpretation and dissemination, as well as the intention to examine delivery across both face-to-face and remote consultations. Even though the design is robust, I think it could be strengthened by considering a few points related to fidelity, clinician motivation, patient understanding and equity. \nAuthor response: <\/b>Thank you for your positive comments and spending the time to provide thoughtful feedback. Data collection for the iFraP randomised controlled trial and process evaluation finished in November 2024 and analysis is currently being finalised. We therefore acknowledge our limited scope to make larger changes suggested by the reviewer. Specifically, we are unable to amend the study data collection methods at this point and will therefore consider the points raised below as study limitations when we come to write the final results paper. \nReviewer comment:<\/b> Regarding fidelity, it will be documented comprehensively, but mainly in terms of whether tasks were completed rather than whether patients actually understood them. In my view, the consultation recordings are the most powerful fidelity tool in the study, yet they may be under-used as currently planned. Currently, it measures delivery, but not absorption. Adding teach-back analysis, where patients demonstrate understanding of their fracture risk or treatment rationale, would meaningfully differentiate true shared decision-making from procedural box-ticking. \nAuthor response: <\/b>Thank you for this comment. We are using a variety of methods (e.g. DST analytics, consultation recordings, patient self-reporting use of DST in trial surveys, case report forms and qualitative interviews) to gain a multi-dimensional understanding of implementation variation, its impact on mechanisms of action, outcomes, and the role of context. This means that we did not pre-define thresholds of \u201cacceptable\u201d fidelity\/dose. We agree that the audio recorded consultations focus on intervention delivery rather than patient knowledge or understanding. Patient self-reported questionnaires (including measures of decisional conflict, satisfaction with information, illness and treatment perceptions, and fracture risk perception) and semi-structured interviews aim to explore patient perceptions of shared decision-making, including their understanding or perception of information provided during the consultation (e.g.their fracture risk). \nReviewer comment:<\/b> Clinician motivation is another area that warrants deeper attention. While the protocol will capture clinician behavior through evaluation forms, quizzes, case report forms and decision support tool (DST) analytics, it does not currently assess clinician belief or readiness as a potential predictor of fidelity. Shared decision-making (SDM) depends on whether clinicians genuinely believe it is beneficial, efficient, and aligned with their professional identity, motivation may strongly influence how consistently iFraP is delivered in practice. A brief baseline and follow-up assessment of attitudinal commitment to SDM could help explain variation in delivery and better predict sustainability beyond the trial. This would complement the Normalisation Process Theory-informed interview work already planned and strengthen the link between observed behaviour and underlying drivers. \nAuthor response: <\/b>Thank you for this comment, we agree that pre-and-post assessments would have provided useful insights into clinician perceptions of delivering the intervention. Instead, training course evaluation forms and qualitative interviews completed by clinicians aim to understand perceptual (e.g. motivation, readiness) and practical (e.g. skills, resources) barriers and enablers to intervention delivery and sustainability, whilst also considering complex contextual factors. \nReviewer comment:<\/b> The intervention requires longer consultations. While this is manageable within the four participating UK FLS sites, scalability to busier or less well-resourced services \u2014 particularly where IT infrastructure or staffing is more variable \u2014 remains an important question for future implementation work. \nAuthor response: <\/b>Thank you for this comment. A previous Cochrane review [1] identified that in-consultation decision aids increased the length of consultation by 1.50 minutes compared to usual care. In this process evaluation, the length of consultations will be obtained from DST analytics (for intervention consults) and consultation audio recordings (for intervention and usual care consults). This data will facilitate understanding of whether the iFraP intervention increased the length of the consultation. Practical enablers and barriers to intervention implementation, both within and beyond the trial, will be explored with clinicians in interview.    Smith, M., Carley, M., Volk, R., Douglas, E. E., Pacheco-Brousseau, L., Finderup, J., ... & Trevena, L. (2024). Decision aids for people facing health treatment or screening decisions. \nCochrane Database of Systematic Reviews<\/i>, (1). \nReviewer comment:<\/b> Equity has been acknowledged, but with 20 participants per arm subgroup analysis is not possible, so the trial will not be able to tell whether the intervention benefits all groups to the same extent. \nAuthor response: <\/b>The iFraP randomised controlled trial aimed to recruit 380 patient participants randomised (1:1 ratio) to the intervention or usual care who will complete self-report questionnaires at baseline and follow up at 2-weeks and 3-months. This will allow for subgroup analysis to if and how patient and site characteristics lead to variation in outcomes. A small portion of participating trial patients will complete an interview (approx. n=20) to explore these variations in more detail. \nReviewer comment:<\/b> The protocol is transparent about what data will be collected but less clear on how those data will be organised, managed, and made analytically usable. Several questions remain, particularly for the qualitative component: How will qualitative data be coded, and according to which framework? How will interviews be anonymised, stored, and processed, and which software will be used? Likewise, it is not yet explained how terms within the convergence matrix\u2014\nagreement, partial agreement, silence,<\/i> and \ndissonance<\/i>\u2014will be defined operationally or resolved in practice. It would also be valuable to clarify data security procedures and outline whether data will be shared or deposited in a long-term repository, as this will influence reproducibility and secondary analysis. \nAuthor response: <\/b>The qualitative data will be analysed using the commonly used \u2018framework method\u2019. The analytical framework will be developed inductively, and then systematically applied to the dataset using NVivo data management software. An external company will complete transcription with confidentiality and data sharing agreements in place. When returned to the research team, identifiable characteristics (e.g. names, places) will be removed from the transcript and recording files stored on the secure network. Trial and process evaluation data will not be shared or deposited in a long-term repository. Release of data will be subject to a data use agreement between the Sponsor and the third party requesting the data. Further information about data storage is provided in the trial protocol paper: https:\/\/doi.org\/10.1186\/ISRCTN10606407 and the ethically approved protocol published on the ISRCTN: https:\/\/doi.org\/10.1186\/ISRCTN10606407. We have added detail to the manuscript about data management processes. The convergence matrix will display findings from each data collection method. The matrix will be used to assess agreement (consistent findings), partial agreement (some overlap or consistency between findings, but also some differences or gaps), silence (data source does not provide information relevant to a specific finding or outcome), or dissonance (conflicting or contradictory findings). Partial agreement or dissonance will be embraced as opportunities for deeper insight rather than errors to be \u2018resolved\u2019. To validate judgements of \u2018agreement\u2019 and to explain dissonance (if present), we will work collaboratively with the multidisciplinary team, including public contributors, and triangulate our findings with external evidence. We have updated the manuscript to provide definitions of terms (e.g. \u2018convergence\u2019, \u2018silence\u2019) and how we will operationalise these terms to ensure validity and credibility.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/4-70\/v3#referee-comment-3546","order":5,"name":"referee-comment-3546","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This project is funded by the National Institute for Health and Care Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)\/NIHR Academy]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care.\r\nThis funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":6,"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"}]}}