Summary
The National Osteoporosis Guideline Group (NOGG) has revised the UK guideline for the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal ...women, and men age 50 years and older. Accredited by NICE, this guideline is relevant for all healthcare professionals involved in osteoporosis management.
Introduction
The UK National Osteoporosis Guideline Group (NOGG) first produced a guideline on the prevention and treatment of osteoporosis in 2008, with updates in 2013 and 2017. This paper presents a major update of the guideline, the scope of which is to review the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women, and men age 50 years and older.
Methods
Where available, systematic reviews, meta-analyses and randomised controlled trials were used to provide the evidence base. Conclusions and recommendations were systematically graded according to the strength of the available evidence.
Results
Review of the evidence and recommendations are provided for the diagnosis of osteoporosis, fracture-risk assessment and intervention thresholds, management of vertebral fractures, non-pharmacological and pharmacological treatments, including duration and monitoring of anti-resorptive therapy, glucocorticoid-induced osteoporosis, and models of care for fracture prevention. Recommendations are made for training; service leads and commissioners of healthcare; and for review criteria for audit and quality improvement.
Conclusion
The guideline, which has received accreditation from the National Institute of Health and Care Excellence (NICE), provides a comprehensive overview of the assessment and management of osteoporosis for all healthcare professionals involved in its management. This position paper has been endorsed by the International Osteoporosis Foundation and by the European Society for the Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.
In light of the current COVID-19 pandemic, and given the importance of diet to overall health and well-being, nutrients (macro and micro) deserve special attention.10 As a key micronutrient, vitamin ...D should be given particular focus—not as a ‘magic bullet’ to beat COVID-19, as the scientific evidence base is severely lacking at this time—but rather as part of a healthy lifestyle strategy to ensure that populations are nutritionally in the best possible place.11 Vitamin D is unique: it is a prohormone which is produced in the skin during exposure to sunlight (UVB radiation at 290–315 nm) with, usually, smaller amounts obtained from food. ...in Manchester, UK (53.5N) the nadir of seasonal vitamin D status occurs in February, with sunlight exposure once again becoming effective for vitamin D synthesis in the skin only from March onwards.13 Relatively high prevalence of low vitamin D status globally has been reported over recent decades in a wide range of population groups,14 including those in low latitude areas (despite the abundance of sunlight) and not necessarily confined to winter.15 This may be due to environmental factors, such as air pollution, as well as cultural factors that lead to skin being covered and not subject to sunlight exposure.16 Older, housebound individuals are at particularly high risk of vitamin D deficiency.17 Vitamin D status is reflected by the level of the circulating metabolite 25-hydroxyvitamin D (25OHD), which is produced by hepatic hydroxylation of vitamin D coming from either skin or the gut from oral intake.18 If the 25OHD concentration is low (as defined in the UK by a 25OHD concentration of <25 nmol/L7 and in the USA and some other countries by a 25OHD concentration of <30 nmol/L),8 9 such as observed commonly during and towards the end of the winter, this indicates that stores are depleted and vitamin D-requiring functions may be impaired. ...vitamin D, via its active metabolites, regulates more than 200 genes including those genes that are responsible for cellular proliferation, differentiation and apoptosis.19 The discovery of the expression of nuclear vitamin D receptors and vitamin D metabolic enzymes in immune cells provides a scientific rationale for the potential role of vitamin D in maintaining immune homoeostasis and in preventing the development of autoimmune processes.20 The field of vitamin D research has grown exponentially in recent years with a much improved understanding of its biological importance. Epidemiological studies in children have found a strong association between URTI and rickets.28 A large cross-sectional study of the US population reported that URTI infections were higher in those with lower vitamin D status, with the association being stronger in those with respiratory diseases such as asthma and chronic obstructive pulmonary disease.29 There is evidence that lower vitamin D status is associated with acute respiratory tract infections (ARTIs).30 In a recent systematic review and meta-analysis of individual participant data from vitamin D supplementation RCTs, vitamin D supplementation reduced the risk of ARTI, with the greatest benefit in those with vitamin D deficiency at baseline.31 However, it is important to note the limitations to this systematic review/meta-analysis;32 33 there was a high level of heterogeneity in the findings and concomitantly, the overall significant results in the meta-analysis of the 24 included trials was dependent on the inclusion of the two studies undertaken in developing countries:
IntroductionPrevention 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 analysisThe 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 disseminationEthical 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 numberresearchregistry5041.
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’s life, beliefs, and values. We developed the i mproving uptake of Fra cture P 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 ≥50 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 ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407
Exercise and physical activity can improve bone strength and the risk of falls, which may offer benefits in the prevention and management of osteoporosis. However, uncertainty about the types of ...exercise that are safe and effective instigates lack of confidence in people with osteoporosis and health professionals. Existing guidelines leave some questions unresolved. This consensus statement aimed to determine the physical activity and exercise needed to optimise bone strength, reduce fall and fracture risk, improve posture and manage vertebral fracture symptoms, while minimising potential risks in people with osteoporosis. The scope of this statement was developed following stakeholder consultation. Meta-analyses were reviewed and where evidence was lacking, individual studies or expert opinion were used to develop recommendations. A multidisciplinary expert group reviewed evidence to make recommendations, by consensus when evidence was not available. Key recommendations are that people with osteoporosis should undertake (1) resistance and impact exercise to maximise bone strength; (2) activities to improve strength and balance to reduce falls; (3) spinal extension exercise to improve posture and potentially reduce risk of falls and vertebral fractures. For safety, we recommend avoiding postures involving a high degree of spinal flexion during exercise or daily life. People with vertebral fracture or multiple low trauma fractures should usually exercise only up to an impact equivalent to brisk walking. Those at risk of falls should start with targeted strength and balance training. Vertebral fracture symptoms may benefit from exercise to reduce pain, improve mobility and quality of life, ideally with specialist advice to encourage return to normal activities. Everyone with osteoporosis may benefit from guidance on adapting postures and movements. There is little evidence that physical activity is associated with significant harm, and the benefits, in general, outweigh the risks.
Abstract Background/Aims Shared decision-making (SDM) is a joint process in which a person and healthcare professional work together to reach decisions about care. The iFraP (Improving uptake of ...Fracture Prevention drug treatments) intervention comprises computerised decision aid (DA), Fracture Liaison Service (FLS) clinician training package, and information resources to support SDM about osteoporosis medicines. This abstract details our multi-method approach to develop this intervention. Methods Intervention development was underpinned by the Medical Research Council guidelines for development of complex interventions. Four studies guided intervention prototype development, including (1) an evidence synthesis of existing osteoporosis DAs to examine quality and effectiveness; (2) a review of patient information about osteoporosis to evaluate quality and optimal language for talking about osteoporosis; (3) a Delphi consensus survey with patients, carers, and health professionals to gain consensus on intervention content, informed by an evidence review of relevant clinical guidelines and behavioural theories; (4) and focus groups and interviews with patients recently attending FLS, FLS clinicians and general practitioners (GPs) to explore current FLS practice, and barriers and facilitators to change. Expert stakeholders and public contributors informed each sub-study. Results Studies one and two informed design of the iFraP computerised DA. Evidence reviews of existing osteoporosis DAs and patient information found that they did not meet patient needs and identified poor readability, variable quality, and unbalanced and confusing content. Public contributors preferred DAs which were individualised, and together with expert stakeholders, supported the development of understandable explanations of osteoporosis and osteoporosis medicines to include in iFraP resources. Study three identified essential components of the FLS consultation which directly informed DA content. Study four identified the need for complementary iFraP information resources, training, and potential barriers to iFraP DA use. Patients expressed that they did not feel adequately prepared for their FLS consultation, leading to the development of an enhanced leaflet to accompany their FLS appointment letter. Patients, FLS clinicians, and GPs all expressed the need for a patient-friendly individualised summary of the FLS consultation, to facilitate consistent information across services and reinforce FLS messaging. This finding informed development of the iFraP Bone Health Record, an individualised, easy-read PDF print-out of the iFraP DA. FLS clinicians identified training needs relating to communicating risk, involving patients in decisions and clinical decision-making. Barriers to use included concerns that the DA would increase consultation duration, and that SDM may undermine their goal to facilitate medicine adherence. Identified barriers to use and training needs informed the content and delivery of the interactive eLearning and role play session, with consideration of theoretically-informed behaviour change techniques. Conclusion The iFraP complex intervention development work demonstrates the use of multiple methods to develop an evidence-based and theoretically-driven intervention in-preparation for testing. Disclosure L. Bullock: None. J. Fleming: None. E.M. Clark: None. S. Leyland: None. S. Thomas: Grants/research support; ST owns Prescribing Decision Support Ltd that developed the iFraP decision aid. C. Gidlow: None. T.W. O'Neill: Grants/research support; TON is supported by the NIHR Manchester Biomedical Research Centre. C.P. Iglesias-Urrutia: None. A. Hawarden: Grants/research support; AH is funded by a Versus Arthritis Clinical Research Fellowship (reference 22726). F. Manning: None. J. Protheroe: None. J. Lefroy: None. S. Ryan: None. R. Horne: None. C.D. Mallen: Grants/research support; CM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. C. Jinks: Grants/research support; CJ is part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Consultancies; ZP has received consultancy fees from UCB Pharma. Grants/research support; ZP is funded by the National Institute for Health Research (NIHR) Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy.
Abstract
Background/Aims
Fracture Liaison Services (FLSs) are recommended to deliver best practice in secondary fracture prevention. As part of the iFraP (Improving uptake of Fracture Prevention ...drug Treatments) research programme this study aimed to 1) co-design content for a ‘model FLS consultation’ and 2) gain consensus on the appropriateness of osteoporosis clinical guidelines in the context of FLSs.
Methods
Three rounds of modified Delphi survey were sent to patients with osteoporosis and/or fragility fractures, carers, and clinicians. Participants were presented with potential consultation content derived from an evidence synthesis of current guidelines, frameworks and theories of shared decision-making, communication and medicine adherence, and stakeholder consultation. Participants were asked to rate their perception of the importance of each statement on a 5-point Likert scale and elaborate using free-text boxes. In Round 2, participants were shown mean scores of importance from Round 1. Statements identified as of ‘low importance’ at the end of Rounds 1 and 2 were discussed by the study team, including patient contributors, and were removed or amended. In Round 3, participants were asked whether the statement was ‘essential’ or ‘optional’ in a time-limited FLS consultation. Percentage agreement with each statement was ranked. The threshold for ‘essential’ versus ‘optional’ was determined by the study team.
Results
391 invitations to participate were sent, with 72, 49, and 52 responders to Rounds 1, 2 and 3 respectively. Throughout Rounds 1-3 participants considered 122 statements. By Round 3, 81 statements were deemed essential, with an additional 14 optional statements. Essential statements were distilled into 18 recommendations constituting the ‘model FLS consultation’. Statements related to stages of the consultation, including: introductions; gather information; consider therapeutic options; elicit patient perceptions; establish shared decision-making preferences; share information about condition and treatment; check understanding; and signpost next steps. There was consensus that FLS clinicians should discuss the benefits and risks of oral and intravenous bisphosphonates and denosumab. Optional consultation content included a statement suggesting clinicians should observe the patient to look for signs of fractures in their spine, with free-text responses suggesting that FLS clinicians may not ‘be best qualified’ to perform physical examinations. Removed statements included those relating to the discussion of Hormone Replacement Therapy, Raloxifene and Teriparatide, with free-text statements suggesting that ‘specialists’ (e.g. Rheumatologists) should discuss these medications. Additionally, statements that described the potential consequences of fracture (e.g. ‘the clinician should explain that one in ten patients with a hip fracture will die within 12 months of fracture.’) were removed. Free-text comments described these statements as potentially ‘scary’.
Conclusion
The Delphi survey has informed iFraP intervention development by highlighting essential and optional FLS consultation content. Findings also provide insight into aspects of current osteoporosis clinical guidelines deemed appropriate in nurse/allied health professional led FLSs.
Disclosure
L. Bullock: None. C. Jinks: Grants/research support; CJ is part funded by the NIHR Applied Research Collaboration (ARC) West Midlands. F. Crawford-Manning: Grants/research support; FCM is part funded by the NIHR Clinical Research Network Scholar Programme. S. Leyland: None. J. Fleming: None. E.M. Clark: None. E. Cottrell: None. J. Edwards: Grants/research support; JE is an NIHR Academic Clinical Lecturer in Primary Care (CL-2016-10-003). Z. Paskins: Grants/research support; ZP is funded by the NIHR, Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy.
Abstract
Background/Aims
Shared decision-making (SDM) is a joint process in which a person and healthcare professional work together to reach decisions about care. The Improving uptake of Fracture ...Prevention drug treatments (iFraP) study developed a prototype theoretically-informed intervention consisting of a computerised decision aid (DA) and Fracture Liaison Service (FLS) clinician training package to improve SDM about osteoporosis medicines. This abstract focuses on the early prototype iFraP in-practice testing phase that explored perceived acceptability of iFraP by those using it, barriers to, and facilitators of, implementation of the prototype iFraP in practice, and necessary changes required ahead of a full-scale randomised controlled trial (RCT).
Methods
In-practice testing was conducted at one FLS site. Participating FLS clinicians completed the prototype iFraP clinician training package, covering enhanced communication skills (e.g SDM, risk communication and health literacy techniques). Consenting patients with a recent fragility fracture referred for an FLS consultation were eligible to participate. Three cycles of iFraP in-practice testing were completed. Each cycle included observed iFraP consultations and post-consultation patient think-aloud interviews. After each complete cycle, the FLS clinician(s) was interviewed. Data were analysed using a framework approach. The Theoretical Framework of Acceptability and Theoretical Domains Framework facilitated understanding of iFraP acceptability and barriers to, and facilitators of, implementation.
Results
Four FLS clinicians (3 nurses, 1 allied health professional) completed the iFraP clinician training and delivered 10 iFraP consultations (8 face-to-face, 2 telephone) using the iFraP DA with participating patients (n = 3 cycle 1; n = 3 cycle 2; n = 4 cycle 3). In total, the four FLS clinicians completed 7 interviews, with all 10 patients completing a post-consultation interview. Findings demonstrate that patients and clinicians perceived the prototype iFraP DA as acceptable. Clinicians suggested that the iFraP DA supported them to elicit and address patient perceptions, increase patient involvement, and provide patients with sufficient and accessible information. Patients and clinicians expressed wanting to use iFraP in future FLS appointments, with some clinicians continuing to use the DA outside of iFraP in-practice testing. Identified barriers included: some clinicians questioned both the use of iFraP DA with patients not recommended first-line drug treatment; and, expressed concern that iFraP DA could extend the consultation length. Our findings demonstrated necessary updates to meet user needs and overcome identified barriers to iFraP intervention use, including presentation and structural changes to support integration of the iFraP DA into the consultation flow. Clinicians also provided feedback to improve the training package, including the need to demonstrate the DA in use, and increased allocated time to practice using the DA.
Conclusion
The iFraP intervention was perceived as acceptable, with the potential to support SDM about osteoporosis medicines. The iFraP RCT will now test our improved iFraP intervention across 3 FLS sites in England.
Disclosure
L. Bullock: None. N. Tyler: None. M. Thompson: None. S. Ryan: Grants/research support; the General Nursing Council for England and Wales Trust. J. Lefroy: None. S. Leyland: None. J. Fleming: None. E.M. Clark: None. S. Thomas: Other; owns Prescribing Decision Support Ltd that developed the iFraP decision aid. C. Gidlow: None. C.P. Iglesias-Urrutia: None. T.W. O'Neill: Grants/research support; supported by the NIHR Manchester Biomedical Research Centre. C.D. Mallen: Grants/research support; funded by the NIHR Applied Research Collaboration West Midlands, funded by the NIHR School for Primary Care Research. C. Jinks: Grants/research support; part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Grants/research support; funded by the National Institute for Health Research (NIHR) Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy.
Abstract
Background/Aims
The iFraP study (Improving uptake of Fracture Prevention Treatments) is developing a computerised decision-support tool to support clinician decision-making, risk ...communication and informed patient decision-making in Fracture Liaison Service (FLS) consultations. To inform iFraP intervention development, this study explored 1) patient and clinician experiences of FLSs and 2) perspectives towards the new iFraP tool.
Methods
Four focus groups and supplementary interviews included 9 FLS clinicians, 7 General Practitioners (GPs), and 8 patients who recently attended an FLS consultation. Theoretically-informed thematic analysis was conducted to facilitate understanding of current FLS practice, potential intervention acceptability and possible barriers to, and facilitators of, implementation.
Results
FLS clinicians and GPs suggested that FLSs worked well to identify patients at high risk of future fracture and to recommend medication. FLS clinicians were confident in their role and felt their consultations were person-centred and addressed information needs. However, some FLS clinicians described communicating risk as difficult and gave examples of when they are uncertain whether medication should be recommended (e.g. patient with osteopenic bone mineral density). FLS clinicians had varying perceptions of their roles in discussing medications, with some not viewing this as their responsibility; whereas GPs reported that medication discussions were an important aspect of the FLS clinician role. When medication recommendations (and discussion) were delivered, the setting varied across services including face-to-face in clinic or at the patient’s home, by letter, or by telephone. On the whole, patients reflected positively on their FLS appointment. However, some patients described unmet information needs, such as risk of future fractures, potential benefits and risks of medications, and information about follow-up.Many FLS clinicians and GPs reflected upon the potential value of the tool, including the inclusion of visual images to facilitate understanding of fracture risk, and to promote consistent messages across FLSs and between primary and secondary care. Barriers to intervention implementation were also identified. Clinicians expressed concern that evidence-based Cates plots to support explanations of medication effectiveness may make patients believe medications are not ‘worthwhile’. This suggests that clinicians prioritised promotion of medication adherence over informed decision-making, highlighting that the goal of FLS clinicians and iFraP may not align. Furthermore, concern was expressed that use of a computerised tool may detract from the clinician-patient relationship.
Conclusion
These novel findings illustrate the experience of FLS consultations from three perspectives. They highlight FLS clinicians’ clinical decision-support needs and patients’ unmet need for clear information that addresses their medication concerns. Overall, the iFraP intervention was viewed as acceptable, with the potential to support clinicians’ decision-making and to facilitate informed decision-making. Differences in FLS configuration and a move to more remote consulting may mean the intervention needs to be adaptable to different settings to address barriers to implementation.
Disclosure
L. Bullock: None. C. Jinks: Grants/research support; CJ is part funded by the NIHR Applied Research Collaboration (ARC) West Midlands. A. Hawarden: Grants/research support; AH is a NIHR funded Academic Clinical Fellow. F. Crawford-Manning: Grants/research support; FCM is part funded by the NIHR Clinical Research Network Scholar Programme. S. Leyland: None. J. Fleming: None. E.M. Clark: None. E. Cottrell: None. J. Edwards: Grants/research support; JE is an NIHR Academic Clinical Lecturer in Primary Care (CL-2016-10-003). Z. Paskins: Grants/research support; ZP is funded by the NIHR, Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy.
PDF
