Improving uptake of Fracture Prevention drug treatments: a protocol for Development of a consultation intervention (iFraP-D).

Funder: Wellcome TrustINTRODUCTION: Prevention of fragility fractures, a source of significant economic and personal burden, is hindered by poor uptake of fracture prevention medicines. Enhancing communication of scientific evidence and elicitation of patient medication-related beliefs has the potential to increase patient commitment to treatment. The Improving uptake of Fracture Prevention drug treatments (iFraP) programme aims to develop and evaluate a theoretically informed, complex intervention consisting of a computerised web-based decision support tool, training package and information resources, to facilitate informed decision-making about fracture prevention treatment, with a long-term aim of improving informed treatment adherence. This protocol focuses on the iFraP Development (iFraP-D) work. METHODS AND ANALYSIS: The approach to iFraP-D is informed by the Medical Research Council complex intervention development and evaluation framework and the three-step implementation of change model. The context for the study is UK fracture liaison services (FLS), which enact secondary fracture prevention. An evidence synthesis of clinical guidelines and Delphi exercise will be conducted to identify content for the intervention. Focus groups with patients, FLS clinicians and general practitioners and a usual care survey will facilitate understanding of current practice, and investigate barriers and facilitators to change. Design of the iFraP intervention will be informed by decision aid development standards and theories of implementation, behaviour change, acceptability and medicines adherence. The principles of co-design will underpin all elements of the study through a dedicated iFraP community of practice including key stakeholders and patient advisory groups. In-practice testing of the prototype intervention will inform revisions ready for further testing in a subsequent pilot and feasibility randomised trial. ETHICS AND DISSEMINATION: Ethical approval was obtained from North West-Greater Manchester West Research Ethics Committee (19/NW/0559). Dissemination and knowledge mobilisation will be facilitated through national bodies and networks, publications and presentations. TRIAL REGISTRATION NUMBER: researchregistry5041

Acceptability of bisphosphonates among patients, clinicians and managers: a systematic review and framework synthesis.

OBJECTIVE: To explore the acceptability of different bisphosphonate regimens for the treatment of osteoporosis among patients, clinicians and managers, payers and academics.DESIGN: A systematic review of primary qualitative studies. Seven databases were searched from inception to July 2019. Screening, data extraction and quality assessment of full-articles selected for inclusion were performed independently by two authors. A framework synthesis was applied to extracted data based on the Theoretical Framework of Acceptability (TFA). The TFA includes seven domains relating to sense-making, emotions, opportunity costs, burden, perceived effectiveness, ethicality and self-efficacy. Confidence in synthesis findings was assessed.SETTING: Any developed country healthcare settingPARTICIPANTS: Patients, healthcare professionals, managers, payers and academics.INTERVENTION: Experiences and views of oral and intravenous bisphosphonates.RESULTS: Twenty-five studies were included, mostly describing perceptions of oral bisphosphonates. We identified, with high confidence, how patients and HCPs make sense (coherence) of bisphosphonates by balancing perceptions of need against concerns, how uncertainty prevails about bisphosphonate perceived effectiveness and a number of individual and service factors that have potential to increase self-efficacy in recommending and adhering to bisphosphonates. We identified, with moderate confidence, that bisphosphonate taking induces concern, but has the potential to engender reassurance, and that both side effects and special instructions for taking oral bisphosphonates can result in treatment burden. Finally, we identified with low confidence that multi-morbidity plays a role in people’s perception of bisphosphonate acceptability.CONCLUSION: By using the lens of acceptability, our findings demonstrate with high confidence that a theoretically informed, whole-system approach is necessary to both understand and improve adherence. Clinicians and patients need supporting to understand the need for bisphosphonates, and clinicians need to clarify to patients what constitutes bisphosphonate treatment success. Further research is needed to explore perspectives of male patients and those with multi-morbidity receiving bisphosphonates, and patients receiving intravenous treatment

Developing a model Fracture Liaison Service consultation with patients, carers and clinicians: a Delphi survey to inform content of the iFraP complex consultation intervention

Summary Fracture Liaison Services are recommended to deliver best practice in secondary fracture prevention. This modified Delphi survey, as part of the iFraP (Improving uptake of Fracture Prevention drug Treatments) study, provides consensus regarding tasks for clinicians in a model Fracture Liaison Service consultation. Purpose The clinical consultation is of pivotal importance in addressing barriers to treatment adherence. The aim of this study was to agree to the content of the ‘model Fracture Liaison Service (FLS) consultation’ within the iFraP (Improving uptake of Fracture Prevention drug Treatments) study. Methods A Delphi survey was co-designed with patients and clinical stakeholders using an evidence synthesis of current guidelines and content from frameworks and theories of shared decision-making, communication and medicine adherence. Patients with osteoporosis and/or fragility fractures, their carers, FLS clinicians and osteoporosis specialists were sent three rounds of the Delphi survey. Participants were presented with potential consultation content and asked to rate their perception of the importance of each statement on a 5-point Likert scale and to suggest new statements (Round 1). Lowest rated statements were removed or amended after Rounds 1 and 2. In Round 3, participants were asked whether each statement was ‘essential’ and percentage agreement calculated; the study team subsequently determined the threshold for essential content. Results Seventy-two, 49 and 52 patients, carers and clinicians responded to Rounds 1, 2 and 3 respectively. One hundred twenty-two statements were considered. By Round 3, consensus was reached, with 81 statements deemed essential within FLS consultations, relating to greeting/introductions; gathering information; considering therapeutic options; eliciting patient perceptions; establishing shared decision-making preferences; sharing information about osteoporosis and treatments; checking understanding/summarising; and signposting next steps. Conclusions This Delphi consensus exercise has summarised for the first time patient/carer and clinician consensus regarding clearly defined tasks for clinicians in a model FLS consultation

Improving uptake of Fracture Prevention drug treatments: a protocol for Development of a consultation intervention (iFraP-D)

Introduction Prevention of fragility fractures, a source of significant economic and personal burden, is hindered by poor uptake of fracture prevention medicines. Enhancing communication of scientific evidence and elicitation of patient medication-related beliefs has the potential to increase patient commitment to treatment. The Improving uptake of Fracture Prevention drug treatments (iFraP) programme aims to develop and evaluate a theoretically informed, complex intervention consisting of a computerised web-based decision support tool, training package and information resources, to facilitate informed decision-making about fracture prevention treatment, with a long-term aim of improving informed treatment adherence. This protocol focuses on the iFraP Development (iFraP-D) work. Methods and analysis The approach to iFraP-D is informed by the Medical Research Council complex intervention development and evaluation framework and the three-step implementation of change model. The context for the study is UK fracture liaison services (FLS), which enact secondary fracture prevention. An evidence synthesis of clinical guidelines and Delphi exercise will be conducted to identify content for the intervention. Focus groups with patients, FLS clinicians and general practitioners and a usual care survey will facilitate understanding of current practice, and investigate barriers and facilitators to change. Design of the iFraP intervention will be informed by decision aid development standards and theories of implementation, behaviour change, acceptability and medicines adherence. The principles of co-design will underpin all elements of the study through a dedicated iFraP community of practice including key stakeholders and patient advisory groups. In-practice testing of the prototype intervention will inform revisions ready for further testing in a subsequent pilot and feasibility randomised trial

Multiphoton imaging and Raman spectroscopy of the bovine vertebral endplate

The interface between the intervertebral disc and the vertebral body is important to the discs’ biomechanics and physiology, and is widely implicated in its pathology. This study aimed to explore biochemically and structurally the bony endplate, cartilage endplate and intervertebral disc, below the nucleus and below the annulus in healthy bovine tails. Multiphoton imaging and spontaneous Raman spectroscopy were employed. Raman spectroscopy provided relative quantification of mineral and matrix components across the vertebral endplate and its adjacent areas with microscopic spatial resolution. Microscopy utilising second-harmonic generation (SHG) and two-photon fluorescence (TPF) allowed for the structural identification of distinct endplate regions. The cartilage endplate was revealed as structurally distinct from both the bone and disc, supporting its biomechanical function as a transition zone between the soft and hard tissue components. The collagen fibres were continuous across the tidemark which defines the interface between the mineralised and non-mineralised regions of the endplate. Raman spectroscopy revealed gradients in phosphate and carbonate content through the depth of the endplate and also differences beneath the nucleus and annulus consistent with a higher rate of remodelling under the annulus

Developing a model Fracture Liaison Service consultation with patients, carers and clinicians: a Delphi survey to inform content of the iFraP complex consultation intervention.

UNLABELLED: Fracture Liaison Services are recommended to deliver best practice in secondary fracture prevention. This modified Delphi survey, as part of the iFraP (Improving uptake of Fracture Prevention drug Treatments) study, provides consensus regarding tasks for clinicians in a model Fracture Liaison Service consultation. PURPOSE: The clinical consultation is of pivotal importance in addressing barriers to treatment adherence. The aim of this study was to agree to the content of the 'model Fracture Liaison Service (FLS) consultation' within the iFraP (Improving uptake of Fracture Prevention drug Treatments) study. METHODS: A Delphi survey was co-designed with patients and clinical stakeholders using an evidence synthesis of current guidelines and content from frameworks and theories of shared decision-making, communication and medicine adherence. Patients with osteoporosis and/or fragility fractures, their carers, FLS clinicians and osteoporosis specialists were sent three rounds of the Delphi survey. Participants were presented with potential consultation content and asked to rate their perception of the importance of each statement on a 5-point Likert scale and to suggest new statements (Round 1). Lowest rated statements were removed or amended after Rounds 1 and 2. In Round 3, participants were asked whether each statement was 'essential' and percentage agreement calculated; the study team subsequently determined the threshold for essential content. RESULTS: Seventy-two, 49 and 52 patients, carers and clinicians responded to Rounds 1, 2 and 3 respectively. One hundred twenty-two statements were considered. By Round 3, consensus was reached, with 81 statements deemed essential within FLS consultations, relating to greeting/introductions; gathering information; considering therapeutic options; eliciting patient perceptions; establishing shared decision-making preferences; sharing information about osteoporosis and treatments; checking understanding/summarising; and signposting next steps. CONCLUSIONS: This Delphi consensus exercise has summarised for the first time patient/carer and clinician consensus regarding clearly defined tasks for clinicians in a model FLS consultation