The Michael Mason Prize: Development and feasibility testing of a complex intervention to improve adherence to fracture prevention medicine using a person-centred approach

The Michael Mason Prize: Development and feasibility testing of a complex intervention to improve adherence to fracture prevention medicine using a person-centred approach | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var 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Simon Thomas , View ORCID Profile Christopher Gidlow , Ida Bentley , View ORCID Profile Ashley Hawarden , Nicola Peel , View ORCID Profile Celia L Gregson , View ORCID Profile Stuart H Ralston , View ORCID Profile Joanne Protheroe , Janet Lefroy , View ORCID Profile Terence W O’Neill , View ORCID Profile Christian Mallen , View ORCID Profile Clare Jinks , View ORCID Profile Zoe Paskins doi: https://doi.org/10.1101/2025.03.21.25324401 Laurna Bullock 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Laurna Bullock Natasha Tyler 2 NIHR School for Primary Care Research, Faculty of Biology , Medicine and Health, University of Manchester Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Natasha Tyler Emma M Clark 3 Bristol Medical School, Faculty of Health Sciences, University of Bristol , Bristol, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Emma M Clark Simon Thomas 4 Prescribing Decision Support Ltd , Cheshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site Christopher Gidlow 5 Keele Impact Accelerator Unit, School of Medicine, Keele University , Staffordshire, UK 6 Midlands Partnership University NHS Foundation Trust , Stoke-on-Trent, Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Christopher Gidlow Ida Bentley 7 Keele Research User Group, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site Ashley Hawarden 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK 8 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust , Stoke-on-Trent, Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Ashley Hawarden Nicola Peel 9 Sheffield Teaching Hospitals NHS Trust , Sheffield, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site Celia L Gregson 10 Musculoskeletal Research Unit, Bristol Medical School, University of Bristol , Bristol, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Celia L Gregson Stuart H Ralston 11 Centre for Genetic and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital , Edinburgh, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Stuart H Ralston Joanne Protheroe 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Joanne Protheroe Janet Lefroy 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site Terence W O’Neill 12 Centre for Epidemiology Versus Arthritis, University of Manchester , Manchester, UK 13 NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre , Manchester, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Terence W O’Neill Christian Mallen 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Christian Mallen Clare Jinks 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Clare Jinks Zoe Paskins 1 Centre for Musculoskeletal Health Research, School of Medicine, Keele University , Staffordshire, UK 8 Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust , Stoke-on-Trent, Staffordshire, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Zoe Paskins For correspondence: z.paskins{at}keele.ac.uk Abstract Full Text Info/History Metrics Supplementary material Data/Code Preview PDF Abstract Objectives The i mproving uptake of Fra cture P revention treatments (iFraP) intervention consists of an osteoporosis decision support tool (DST), clinician skills training, and information resources, to improve shared decision-making (SDM) about, and uptake of, osteoporosis medicines in Fracture Liaison Services (FLS). This paper details the development and feasibility of the prototype intervention. Methods Intervention development was underpinned by (1) theories of SDM, medicines adherence, and behaviour change; (2) integrated findings from six discrete development studies; and (3) extensive public contributor, patient, and clinician contribution to identify key ‘needs’ for the intervention to address and the intervention’s content, functionality and scope. Feasibility testing was conducted at one FLS. Intervention consultations were observed and audio recorded, and interviews completed with FLS clinicians and patients to explore perceived acceptability and feasibility. Results Intervention development identified patient and clinician unmet needs for personalised and evidence-based information about osteoporosis, its consequences, and its treatment within and after FLS consultations, to facilitate clinical and SDM about medicines. The prototype intervention was designed to meet identified needs and overcome barriers to use. Clinicians delivered the prototype iFraP intervention in 10 consultations with consenting patients. Findings demonstrated that the intervention was acceptable and feasible to deliver, with potential to improve patient outcomes. The intervention was refined to support implementation. Conclusion The multi-facilitated approach to intervention development and testing ensured that the iFraP intervention was acceptable and feasible for use in UK FLS to support SDM about osteoporosis medicines. The iFraP trial will evaluate implementation, and cost and clinical effectiveness. Key messages Verbal and written communications concerning osteoporosis are currently confusing, technical and impede decision-making and medicine uptake Key barriers to implementing shared decision-making and decision aids include clinician goals, professional roles and contextual factors A decision tool with clinician training and information resources was co-designed, acceptable, and addressed identified needs and barriers Introduction Osteoporosis is a common condition of weak bones characterised by a reduction in bone strength which increases propensity to fragility fracture. There are over 500,000 fragility fractures each year in the UK, costing the NHS £4.7 billion annually[ 1 ] and fragility fractures are the fourth leading cause of disability among non-communicable diseases in Europe[ 1 ]. For people with increased fracture risk, evidence-based osteoporosis medicines (anti-resorptive and anabolic treatments) are recommended for the treatment of osteoporosis by the National Institute for Health and Care Excellence (NICE)[ 2 ]. Among those who are recommended osteoporosis medicines by specialist Fracture Liaison Services (FLS), only 12% of people are reported as taking them 1-year post-fracture[ 3 ]. Shared decision-making (SDM) has the potential to support osteoporosis medicine adherence[ 4 , 5 ], by ensuring the treatment is a good ‘fit’ for the patient[ 6 ]. NICE recommend all clinicians support SDM, as a key component of person-centred, personalised care, and use good quality decision support tools (DSTs) where available[ 7 , 8 ]. Across a range of conditions, DSTs have been shown to increase patient knowledge and participation in decision-making, reduce decisional conflict, and improve the accuracy of risk perception[ 4 ]. The i mproving uptake of Fra cture P revention treatments (iFraP) intervention was conceptualised in response to a patient priority setting exercise calling for increased accessible information from health professionals about the safety and benefit of osteoporosis medicines[ 9 ]. The iFraP intervention principally consists of a DST and enhanced clinical skills training, aiming to improve SDM about, and uptake of, osteoporosis medicines. This paper describes the development and feasibility of the prototype intervention. Methods Overview and intervention development approach The Medical Research Council’s (MRC) guidance for developing and evaluating complex interventions was used as an overarching framework[ 10 ]. We drew on the three-step implementation of change model[ 11 ], which asks three pragmatic questions about the intervention and how it interacts with contextual factors (defined as: “any feature of the circumstances in which an intervention is conceived, developed, implemented and evaluated”[ 10 ]) and future implementation: 1) where do we want to be? 2) where are we now? and 3) how do we get there? To answer these questions, we used an evidence and theory-based intervention development approach, working in partnership with public contributors and stakeholders[ 12 ]. An overview of the development process is shown in Figure 1 , which was dynamic, flexible and iterative. The protocol for the iFraP development work and the findings of each development study are described in detail elsewhere[ 13 – 18 ]. This paper highlights how each study influenced intervention development (reported in accordance with the GUIDED guidelines[ 19 ]), and the feasibility findings. Download figure Open in new tab Figure 1: Overview of iFraP development process and methods 1 1 ESRM Extended Self Regulatory Model; SDM Shared Decision Making, FLS Fracture Liaison Service, PPIE Patient and Public Involvement and Engagement; GP General Praactitioner Target population and intervention context The iFraP intervention was developed to be used by UK FLS clinicians and patients. FLS (or sometimes called ‘Fracture Prevention Services’) are usually allied to either rheumatology, endocrinology or geriatric medicine specialties. In this paper, FLS ‘clinicians’ include nurses and allied health professionals who enact secondary fracture prevention by systematically identifying adults aged ≥50 years with fragility fractures, conducting bone health assessments and providing treatment recommendations[ 20 ]. The iFraP team and co-design approach The iFraP intervention development and feasibility testing research team included expertise from clinical practice, applied health research, and the third sector. The team had specialised knowledge and experience in developing and testing complex interventions, software development, behaviour change, health literacy, medicines adherence and communication skills. A Community of Practice (CoP) brought together stakeholders with a common concern or interest with the aim of improving and learning to do better through regular group interaction[ 21 ]. CoP members included FLS clinicians, General Practitioners (GPs), osteoporosis specialists, commissioning representatives, public contributors (people with lived experience of osteoporosis and/or family members), representatives from the Royal Osteoporosis Society (ROS) and Health Literacy UK. Six CoP meetings supported decision-making and codesign of intervention content and structure. Public contributors also attended regular Patient and Public Involvement (PPI) meetings as well as study team meetings, steering group meetings, and analysis discussions. An public contribution ‘impact log’ demonstrates enhanced accessibility and inclusivity of the intervention and the research design (see Supplementary Table S1). Step 1: “Where do we want to be?” Make a concrete proposal for change, and develop the content and format of the consultation intervention Programme theory and underpinning theoretical framework The intervention programme theory (or ‘logic model’) details the iFraP intervention resources, hypothesised mechanisms and outcomes, and contextual factors and was refined iteratively throughout intervention development (see Supplementary Figure S1). The Extended Self-Regulatory Model[ 22 ], incorporating Leventhal’s Common-Sense Model (CSM) of Illness[ 23 ] and the Perceptions and Practicalities Approach (PaPA)[ 22 ], provided a theoretical foundation for the iFraP intervention by explaining how a person’s beliefs about osteoporosis and treatments are linked to their decision and behaviour to adhere to medicine. Leventhal’s CSM of Illness outlines beliefs that help people to ‘make sense’ of their illness. For example, it’s common for people to not understand their bone health (illness coherence) and have low perceptions about how controllable osteoporosis is (illness controllability)[ 24 ]. The PaPA (which incorporates the Necessity Concerns Framework[ 25 ]) informs the UK’s NICE guidance on medicines adherence[ 26 ], postulating that when patients make decisions about taking a prescribed medicine, they weigh up their perceived need for the medicine (necessity beliefs) against concerns about the medicine (concern beliefs), and practicalities of taking the medicine. To inform our approach to SDM, we used the Ottawa Decision Support Framework[ 27 ], a model for designing decision aids, and the SPIKES protocol[ 28 ] which is commonly used to teach person-centred communication skills. Core shared features of both frameworks include the focus on eliciting and addressing the patient’s illness and medicine perceptions (described above), building on the patient’s existing knowledge, and establishing SDM preferences. Few SDM interventions address the needs of adults with lower health literacy[ 29 ]. Our approach incorporated evidence-based health literacy techniques to: ensure that information shared was understandable (e.g. principles of universal precautions for health literacy, Chunk and Check[ 30 ]) improve accessible risk communication, including the use of simple frequencies, absolute rather than relative risks, and positive and negative framing[ 31 ] check patient understanding using techniques such as TeachBack[ 32 ]) iFraP intervention development studies Three intervention development studies guided the content and format of the iFraP consultation intervention. Each study’s methods are briefly described below, with further detail reported in their respective publications. Evidence synthesis of existing osteoporosis decision aids[ 15 ] A core element of complex intervention research is identifying existing interventions[ 10 ]. We conducted a systematic review and environmental scan to identify existing osteoporosis decision aids and assess their quality and efficacy and we discussed results with public contributors. Evaluating existing patient information about osteoporosis[ 13 ] We purposively sampled online UK patient information resources about osteoporosis. We examined their quality, including readability. We extracted frequently used phrases and descriptors about osteoporosis and osteoporosis medicines and worked with the CoP to review this terminology and identify optimum understandable and accurate language to use in the intervention. Delphi e-survey gaining consensus on intervention content[ 17 ] A modified Delphi survey provided structure and content for the iFraP intervention by determining consensus on tasks for UK practicing clinicians in a model FLS consultation. Statements were generated by reviewing UK clinical guidelines for the assessment and management of osteoporosis/fragility fractures; the conduct of the consultation to enhance patient experience; and medicine adherence. Additional statements were incorporated from theories and frameworks of SDM, iFraP development studies, and CoP and public contributor discussions. Step 2: “Where are we now?” Understand the current clinical context including barriers and enablers to behaviour change Four intervention development studies were conducted to understand UK FLS and barriers and enablers to using a DST and implementing SDM in osteoporosis consultations. Each study’s methods are briefly described below. Qualitative study with patients and clinicians[ 16 ] To understand current FLS practice and determine barriers and enablers to using a DST to facilitate SDM conversations in FLS consultations, we conducted focus groups and semi-structured interviews with patients who had consulted in FLS, FLS clinicians, and GPs. Data collection was facilitated by stimulus material in the form of images of existing osteoporosis DSTs and Cates plots (presenting fracture risk in simple frequencies). Inductive framework analysis[ 33 ] was mapped onto the Theoretical Domains Framework (TDF) domains[ 34 ] to help understand barriers and enablers to using a DST and improving SDM about osteoporosis medicines. To consider and optimise iFraP intervention acceptability, we also used the Theoretical Framework of Acceptability (TFA) as an overarching framework[ 35 ]. Video-recorded osteoporosis consultations[ 36 ] We supplemented our development work with an observational study (secondary analysis) of video-recorded consultations to explore how beliefs about osteoporosis and osteoporosis medicines are elicited and addressed by GPs, using a bespoke coding tool. Exploring how COVID impacted the clinical context: E-survey of FLS usual care[ 14 ] and secondary analysis of qualitative data[ 37 ] The iFraP DST was originally conceptualised for use in face-to-face appointments. The COVID pandemic accelerated the widespread adoption of remote consultations[ 38 ]. In response to this changing clinical context, we conducted two additional studies not initially part of the development protocol: A usual care e-survey of UK FLS practice to quantify the extent of remote consulting and reassess how the iFraP intervention would function and interact with the changing FLS context[ 14 ]. A secondary analysis of focus group and interview data[ 16 ] to explore the acceptability of, and preferences for, remote consulting, using the TFA as a deductive framework[ 37 ]. Step 3: “How do we get there” - Develop a strategy to change behaviours, by designing and refining the prototype into a draft intervention and feasibility testing Integration of findings Findings of the development studies were summarised using joint displays which were interrogated to identify meta-inferences (see Table 1 ). View this table: View inline View popup Table 1. Joint display of key findings from iFraP development studies The qualitative findings[ 16 ] were used to identify a series of intervention design implication statements and questions, which were discussed within the team and the CoP. An integration framework was developed, which brought together the underpinning theories and frameworks, the evidence gathered, universal precautions for health literacy, and public contributor and CoP discussions. This outlined the stages of the consultation and how either the DST or training would meet the needs identified. Intervention design – DST We employed an ‘informed’ design mode to make decisions about the prototype iFraP intervention design[ 39 ]. This means that we used CoP and public contributor input, alongside theory and evidence, as a conceptual framework to draft a storyboard outlining the DST’s key functions, structure, content, visuals and navigation (see Supplementary Figure S2). Clinical drug recommendations and the benefits and risks of each osteoporosis medicine were underpinned by the best available scientific evidence and national clinical guidelines[ 40 , 41 ]. Clinical members of the iFraP team worked alongside expert advisors, including the chairs of the clinical guideline groups to develop the DST algorithm, in collaboration with the DST developer. Before formal feasibility testing, the prototype DST underwent iterative internal testing cycles to identify bugs and review written and visual tool content. Clinicians ‘tested’ the tool’s algorithm using simulated patients. Clinicians and public contributors reviewed and provided feedback on usability, written and visual content. Intervention design – clinician skills training The iFraP Enhanced Consultation Skills Training Course was developed, integrating SDM theory and evidence alongside evidence-based behaviour change techniques (BCTs) to increase use of SDM consultation skills and the DST. The barriers and enablers to behaviour change were identified using the TDF, in the qualitative intervention development study[ 16 ]. The TDF domains map to the Behaviour Change Wheel (BCW); the COM-B model of behaviour change which proposes three components for a given behaviour (‘B’) to occur: capacity (C), opportunity (O), and motivation (M)[ 42 ]. Understanding if the barriers to behaviour change are underpinned by ‘capacity’, ‘opportunity’ or ‘motivation’ guides the selection and incorporation of evidence-based strategies to facilitate behaviour change (known as ‘intervention functions’) and specific behaviour change techniques (BCTs), and the mode of delivery[ 42 ]. The APEASE criteria[ 42 ] helped the training development team (ZP,LB,JF,SR,JP) decide which of the appropriate BCTs should be integrated into the enhanced Consultation Skills Training Course, considering the affordability, practicability, (cost)effectiveness, acceptability, safety, and equity of the technique, in collaboration with the study team. Intervention feasibility testing and refinement Real-world testing of the prototype intervention was completed at one FLS site. Consenting FLS clinicians completed the Consultation Skills Training Course and completed three cycles of prototype testing with consenting FLS patients. Consultations were observed by a researcher and audio-recorded to explore intervention fidelity, using a pre-defined fidelity checklist. Interviews were completed with each patient immediately after their consultation. After each cycle of testing, the FLS clinician(s) delivering the consultation was interviewed. Interviews were informed by topic guides, consultation observations and fidelity checklist findings. Interviews were transcribed, and data were inductively coded, using a framework approach[ 33 ] by three qualitative researchers (LB,NT,MT), and then mapped to the TFA domains. Findings were discussed with the CoP to identify any required intervention refinements. More details of the feasibility testing procedures and methods are detailed in Supplementary Data S1. Documenting the intervention The intervention manual is integrated, in an interactive format, as part of the enhanced Consultation Skills Training Course with content detailing: intervention components and underpinning concepts what the intervention is hoping to achieve and why how the intervention was developed how to use the DST and integrate its use to suit patient needs and various clinical scenarios. Results Integration of key findings and intervention design A summary of the meta-inferences or key findings from the development studies are shown in the joint display ( Table 1 ). In brief, these meta-inferences demonstrate key ‘needs’ for the intervention to address: Patients need an understanding of osteoporosis and/or its consequences, as important perceptual facilitators of adherence Patients need information about osteoporosis and its treatment that is easily understandable Patients need to have shared and informed decision-making conversations about osteoporosis medicines within consultations Discussions about osteoporosis need to be personalised and person-centred Patients need support with decision-making after the (remote) consultation, with consistent information across healthcare and other settings FLS clinicians need support overcoming barriers to implementing SDM and use of DSTs FLS clinicians need support with clinical decision-making From the findings, key decisions were made relating to the scope and functionality of the intervention. A series of possible options for how the web-based DST could be used flexibly in telephone consults was considered by CoP and public contributors. Public contributors rejected the option to simultaneously view the DST with the clinician whist on the telephone, due to perceived cognitive burden. Instead, they agreed that the DST should be used by the clinician to guide the consultation and the patient receives a printout (personal ‘Bone Health Record’) after the consultation. Supporting information resources were important to address information needs after the consultation and consistency of messaging across healthcare providers and in other settings. Information resources include the DST printout (personal ‘Bone Health Record’) and a dentist card to explain osteoporosis medicines to dental care providers. Training modules identified related to SDM, health literacy and risk communication skills, but also a module outlining clear unambiguous language to talk about osteoporosis. Components of the prototype intervention are described in Table 2 . Table 3 details the relative roles of the DST and the training at different stages of the consultation, mapped to the underpinning theories and frameworks. Table 4 outlines the process of mapping the qualitative findings to the COM-B framework to identify suitable BCTs to include in the iFraP training course, addressing the identified barriers. View this table: View inline View popup Table 2: Final prototype iFraP intervention described using the TIDieR guidance View this table: View inline View popup Table 3: Consultation framework outlining role of DST and training, aligned to theories and frameworks View this table: View inline View popup Table 4: Use of the COM-B model to identify behaviour change techniques, mapped to the Theoretical Domains Framework domain Intervention feasibility testing and refinement Four clinicians working at Midlands Partnership University NHS Foundation Trust’s FLS in England completed the Enhanced Consultation Skills Training Course. FLS clinicians delivered iFraP consultations with 10 consenting FLS patients with a recent fragility fracture across three iterative testing cycles (n=3 cycle 1; n=3 cycle 2; n=4 cycle 3). Further details about participants are provided in Supplementary Data S1. Overall, patients and FLS clinicians found the prototype iFraP intervention to be acceptable and feasible for use in FLS consultations. This was particularly evident through FLS clinicians’ and patients’ expressed wishes for iFraP to be used in future FLS appointments. iFraP was perceived as effective to achieve SDM by eliciting and addressing patient beliefs about osteoporosis and medicines, increasing patient involvement, and providing patients with sufficient and accessible information. However, FLS clinicians perceived that relaying information about the effectiveness of medicines and chance of side effects included in the DST may be a threat to adherence. FLS clinicians identified work (burden) required to implement iFraP, suggesting implementation could extend the consultation length. Increased allocated time to practice using the DST and opportunities to observe the DST ‘in-action’ were valued as ways to increase confidence and reduce overly structured delivery of the DST. Quotes, mapped to each TFA domain, as well as example updates made to the iFraP intervention, are presented in Table 5 . View this table: View inline View popup Table 5. Intervention feasibility testing findings, mapped the Theoretical Framework of Acceptability (TFA) domains Discussion The iFraP intervention was developed through a rigorous, iterative and systematic approach, integrating existing evidence, frameworks and theories with primary data collection. Regular collaboration with stakeholders, expert advisors and public contributors ensured that intervention development centred on those who will deliver, use and benefit from it. Overall, the prototype iFraP intervention was perceived as acceptable and feasible to deliver in FLS, with potential to support SDM conversations about osteoporosis and related medicines. Medicine adherence is optimised if a person believes it is necessary, relevant, safe, and practicable[ 43 ]. Concerns about side effects have been blamed for poor uptake of osteoporosis medicines, but together these studies show that patients are often unclear about the ‘need’ for osteoporosis medicines, particularly because osteoporosis itself is asymptomatic and misunderstood[ 24 ], contributing to difficulties making decisions about medicines[ 16 ]. Decision aids and DSTs have often been described as ‘requiring minimal training for use’. Consequently, few evaluations of DSTs have provided users with training to support implementation. In this development work, we identified the importance of complementary clinical and SDM training to overcome evidenced barriers to DST use[ 44 , 45 ]. At present, evidence demonstrating the potential for DSTs to improve medicine adherence outcomes is limited[ 4 ]. The feasibility study showed promise that the DST could support patient decision-making and uptake of medicines, underpinned by well-evidenced theories of medicine adherence[ 25 , 43 ]. Finally, our evidence synthesis of existing osteoporosis DSTs indicated that they were not ‘fit for purpose’ and rarely involved public contributors in their development[ 15 ]. The iFraP study integrated extensive public contribution throughout all aspects of development and testing, ensuring that it was understandable, relevant, and addressed their needs. A key principle of intervention development is adapting to changing contextual factors to maximise intervention implementation in the real-world[ 12 ]. The iFraP study began in 2019, meaning that, intervention development required a flexible approach to continually assess and address uncertainties arising from a shifting context e.g. the move to remote consulting during and after the COVID pandemic, publication of NICE SDM guidelines[ 8 ], and introduction of new osteoporosis medicines into UK clinical practice[ 46 ]. In line with the MRC intervention development and testing guidance[ 10 ], we have sequentially separated ‘development’ and ‘feasibility testing’ in two distinct stages. However, the iterative and cyclical nature of development and feasibility testing allowed for continued refinement of the intervention to optimise relevance, acceptability and implementation. Limitations Contextual understanding is essential when developing a complex intervention. The iFraP intervention was designed for use in UK FLS. Feasibility testing however was only conducted at one secondary care FLS site in England. Involvement of CoP stakeholders and expert clinical advisors increased the relevance of the intervention for use in Scotland (who follow the Scottish Intercollegiate Guidelines Network (SIGN) recommendations rather than the National Osteoporosis Guideline Group (NOGG) guidelines) and non-FLS care settings. However, we cannot assume transferability of the DST to FLS operating outside of the UK (where treatment guidelines may differ) or different practice settings (such as primary care). Further consideration would be required to determine how the intervention requires adaptation for use in non-FLS and non-UK contexts, and we have begun this process to adapt the resources for primary care use. Four of the nine FLS clinicians who participated in the focus group study[ 16 ] also participated in the feasibility testing. This approach may have limited our understanding of varied FLS models of care and how the intervention might require adaptation to be implemented. Impact and Future Research The iFraP development studies have already achieved impact. Our recommendations to improve the readability and quality of patient information about osteoporosis[ 13 ] led to national providers updating their information. Additionally, iFraP outputs are being incorporated into the ROS FLS implementation toolkit and findings have influenced updates to ROS Clinical Standards for FLS. Our development work demonstrated while bone density scans are an essential component of FLS, where appropriate[ 17 ], information about bone density scans is often confusing and inconsistent[ 13 ]. These findings led to a successful funding application to explore how to optimise patient and clinician understanding of bone density scans and results[ 47 ]. The iFraP intervention will be tested in a pragmatic, parallel-group, individual RCT in four FLS sites in England (trial registration, ISRCTN55504164 )[ 48 ], with nested mixed-methods process[ 49 ] and economic evaluations[ 50 ] to further test whether the intervention is effective, cost-effective, acceptable and implementable. Conclusion We developed the iFraP intervention underpinned by evidence, theory, and extensive public contributor, patient, and clinician contribution. Feasibility testing demonstrated that the intervention was acceptable and feasible to use in UK FLS, with potential to improve patient outcomes. The iFraP RCT and nested economic and process evaluations will further evaluate implementation and effectiveness. Data Availability All data produced in the present study are available upon reasonable request to the authors Ethics approval Ethical permission for the iFraP development and feasibility studies was given by North West-Greater Manchester West Research Ethics Committee (reference number: 19/NW/0559). Funding (specific to this study) The iFraP intervention development and feasibility work was funded by the National Institute for Health and Care Research (CS-2018-18-ST2-010)/NIHR Academy], the Royal Osteoporosis Society, and Haywood Foundation. This study presents independent research funded by the NIHR. The views expressed are those of the author(s) and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care. Conflict of interest statement Keele University has received sponsorship from UCB Pharma. ZP has received consultancy for non-promotional activity from UCB Pharma. CDM is funded by grants from the NIHR and is Director of the NIHR School for Primary Care Research. SHR reports research funding to his institution from the Royal Osteoporosis Society, the Kennedy Trust, Kyowa Kirin, and UCB, outside the submitted work and unrestricted educational grants from Pfizer, Abbvie, Kyowa Kirin, Alexion, Amgen, Cellgene, Bristol Myers Squibb, Janssen-Cilag, Novartis, Eli Lilly, Thornton & Ross, Sanofi Genzyme, Sandoz and Roche, outside the submitted work. EMC is a Trustee of the Royal Osteoporosis Society Acknowledgements We would like to thank those that supported development of the iFraP intervention, including Dr Maddy Thompson, Dr Jane Fleming, Sarah Leyland, Professor Robert Horne, Professor Cynthia Paola Iglesias Urrutia, and Professor Sarah Ryan. We would also like to acknowledge the important contributions of the Keele Osteoporosis Research User Group, the NIHR Clinician Scientist Award Steering Committee, the members of the study Keele Osteoporosis Community of Practice, and the participants themselves. References 1. ↵ Borgström F , Karlsson L , Ortsäter G , Norton N , Halbout P , Cooper C , et al. Fragility fractures in Europe: burden, management and opportunities . Arch Osteoporos [Internet ] 2020 [cited 2021 Jun 23]; 15 : 59 . Available from: https://link.springer.com/10.1007/s11657-020-0706-y OpenUrl 2. ↵ National Institute for Health and Care Excellence . Osteoporosis Products [Internet] . 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Share The Michael Mason Prize: Development and feasibility testing of a complex intervention to improve adherence to fracture prevention medicine using a person-centred approach Laurna Bullock , Natasha Tyler , Emma M Clark , Simon Thomas , Christopher Gidlow , Ida Bentley , Ashley Hawarden , Nicola Peel , Celia L Gregson , Stuart H Ralston , Joanne Protheroe , Janet Lefroy , Terence W O’Neill , Christian Mallen , Clare Jinks , Zoe Paskins medRxiv 2025.03.21.25324401; doi: https://doi.org/10.1101/2025.03.21.25324401 Share This Article: Copy Citation Tools The Michael Mason Prize: Development and feasibility testing of a complex intervention to improve adherence to fracture prevention medicine using a person-centred approach Laurna Bullock , Natasha Tyler , Emma M Clark , Simon Thomas , Christopher Gidlow , Ida Bentley , Ashley Hawarden , Nicola Peel , Celia L Gregson , Stuart H Ralston , Joanne Protheroe , Janet Lefroy , Terence W O’Neill , Christian Mallen , Clare Jinks , Zoe Paskins medRxiv 2025.03.21.25324401; doi: https://doi.org/10.1101/2025.03.21.25324401 Citation Manager Formats BibTeX Bookends EasyBib EndNote (tagged) EndNote 8 (xml) Medlars Mendeley Papers RefWorks Tagged Ref Manager RIS Zotero Tweet Widget Facebook Like Google Plus One Subject Area Rheumatology Subject Areas All Articles Addiction Medicine (568) Allergy and Immunology (863) Anesthesia (299) Cardiovascular Medicine (4427) Dentistry and Oral Medicine (444) Dermatology (382) Emergency Medicine (608) Endocrinology (including Diabetes Mellitus and Metabolic Disease) (1508) Epidemiology (15224) Forensic Medicine (30) Gastroenterology (1124) Genetic and Genomic Medicine (6590) Geriatric Medicine (667) Health Economics (997) Health Informatics (4529) Health Policy (1368) Health Systems and Quality Improvement (1612) Hematology (540) HIV/AIDS (1264) Infectious Diseases (except HIV/AIDS) (15910) Intensive Care and Critical Care Medicine (1103) Medical Education (623) Medical Ethics (145) Nephrology (667) Neurology (6590) Nursing (346) Nutrition (998) Obstetrics and Gynecology (1143) Occupational and Environmental Health (956) Oncology (3331) Ophthalmology (971) Orthopedics (369) Otolaryngology (420) Pain Medicine (436) Palliative Medicine (129) Pathology (663) Pediatrics (1691) Pharmacology and Therapeutics (691) Primary Care Research (710) Psychiatry and Clinical Psychology (5441) Public and Global Health (9222) Radiology and Imaging (2196) Rehabilitation Medicine and Physical Therapy (1370) Respiratory Medicine (1196) Rheumatology (593) Sexual and Reproductive Health (711) Sports Medicine (529) Surgery (712) Toxicology (99) Transplantation (289) Urology (265) (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'a00080f5ca273fe2',t:'MTc3OTUwMjAxMQ=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();