Exploring the potential extended role of community pharmacy in the management of osteoarthritis: A multi-methods study with pharmacy staff and other healthcare professionals.

INTRODUCTION: Osteoarthritis is the commonest form of chronic joint pain, which patients often self-manage before seeking healthcare advice. Patients frequently seek advice from community pharmacies, and a recent policy has recommended integrating community pharmacies into long-term condition pathways. This study explored community pharmacy teams' (CPs) and other healthcare professionals' (HCPs) views on community pharmacies providing an extended role for osteoarthritis management, identifying potential barriers and facilitators to this. METHODS: A multi-methods study comprising surveys of CPs and other HCPs, followed by qualitative interviews. Descriptive statistics were used in an exploratory analysis of the survey data. Qualitative data were analysed using reflexive thematic analysis and the identified barriers and facilitators were mapped to the Theoretical Domains Framework. RESULT: CPs and other HCPs in the surveys and interviews reported that an extended role for osteoarthritis management could include: a subjective assessment, explaining the joint problem and its treatment, medication management and support for self-care. There was less consensus on diagnosing the problem as OA and completing an objective assessment. A key facilitator was training to deliver the role, whilst barriers were high workload and lack of access to General Practitioner medical records. DISCUSSION: Acceptable elements of an extended community pharmacy role for osteoarthritis centre around the provision of information, advice on medication and supported self-management. CONCLUSION: CPs are well placed to contribute towards evidenced-based osteoarthritis management. Feasibility testing of delivering the extended role is needed and future implementation requires training for CPs and raising public awareness of the extended role.

Co-development and testing of an extended community pharmacy model of service delivery for managing osteoarthritis: protocol for a sequential, multi-methods study (PharmOA).

BACKGROUND: Osteoarthritis is a common, painful and disabling long-term condition. Delivery of high-quality guideline-informed osteoarthritis care that successfully promotes and maintains supported self-management is imperative. However, osteoarthritis care remains inconsistent, including under use of core non-pharmacological approaches of education, exercise and weight loss. Community pharmacies are an accessible healthcare provider. United Kingdom government initiatives are promoting their involvement in a range of long-term conditions, including musculoskeletal conditions. It is not known what an enhanced community pharmacy role for osteoarthritis care should include, what support is needed to deliver such a role, and whether it would be feasible and acceptable to community pharmacy teams. In this (PharmOA) study, we aim to address these gaps, and co-design and test an evidence-based extended community pharmacy model of service delivery for managing osteoarthritis. METHODS: Informed by the Theoretical Domains Framework, Normalisation Process Theory, and the Medical Research Council (MRC) framework for developing complex interventions, we will undertake a multi-methods study involving five phases: 1. Systematic review to summarise currently available evidence on community pharmacy roles in supporting adults with osteoarthritis and other chronic (non-cancer) pain. 2. Cross-sectional surveys and one-to-one qualitative interviews with patients, healthcare professionals and pharmacy staff to explore experiences of current, and potential extended community pharmacy roles, in delivering osteoarthritis care. 3. Stakeholder co-design to: a) agree on the extended role of community pharmacies in osteoarthritis care; b) develop a model of osteoarthritis care within which the extended roles could be delivered (PharmOA model of service delivery); and c) refine existing tools to support community pharmacies to deliver extended osteoarthritis care roles (PharmOA tools). 4. Feasibility study to explore the acceptability and feasibility of the PharmOA model of service delivery and PharmOA tools to community pharmacy teams. 5. Final stakeholder workshop to: a) finalise the PharmOA model of service delivery and PharmOA tools, and b) if applicable, prioritise recommendations for its wider future implementation. DISCUSSION: This novel study paves the way to improving access to and availability of high-quality guideline-informed, consistent care for people with osteoarthritis from within community pharmacies.

Bone health assessment in adults with fragility fracture risk factors between 2002-2014: a retrospective cohort study.

BACKGROUND: Lifetime risk of fragility fractures is 50% in post-menopausal women and 20% in men aged >50 years. Identifying people at high risk facilitates early intervention and reduction of biopsychosocial morbidity associated with these fractures. AIM: To explore if bone health assessment (BHA) rates differ between women and men aged ≥50 years with fragility fracture risk factors. DESIGN & SETTING: A primary care-based cohort study in North Staffordshire, UK. METHOD: Patients were identified from the Consultations in Primary Care Archive (CiPCA) database between 2002 and 2014 with one or more fragility fracture risk factors (previous fractures, falls, and prolonged steroid use). Evaluation of BHA within 12 months of presentation of the first risk factor was carried out by searching for codes for fracture risk assessment tools (FRAX and QFracture), bone density measurement, specialist service referral, or if bone-protection medication was started. RESULTS: A total of 15 581 patients with risk factors were identified; men represented 40.4% of the cohort. The study found 1172 (7.5%) had BHA performed within 1 year of presentation, and 8.9% of women and 5.5% of men had BHAs, which was found with strong statistical evidence (χ2 = 59.88, P = 1 × 10-14). This relationship prevailed after adjusting for other covariates, such as comorbidity and number of consultations, with an odds ratio of 1.25 (95% confidence interval [CI] = 1.08 to 1.43). CONCLUSION: This study has shown that rates of BHA were generally low and even lower in men compared with women. Primary care clinicians should be alert to fragility fracture risk factors in both men and women to enable early assessment and intervention.

The acceptability and feasibility of conducting a randomised controlled trial to test the effectiveness of a walking intervention for older people with persistent musculoskeletal pain in primary care: A mixed methods evaluation of the iPOPP pilot trial.

INTRODUCTION: Persistent musculoskeletal (MSK) pain is associated with physical inactivity in older people. While walking is an acceptable form of physical activity, the effectiveness of walking interventions in this population has yet to be established. OBJECTIVES: To assess the acceptability and feasibility of conducting a randomised controlled trial (RCT) to test the effectiveness of a healthcare assistant-led walking intervention for older people with persistent MSK pain (iPOPP) in primary care. METHODS: A mixed method, three arm pilot RCT was conducted in four general practices and recruited patients aged ≥65 years with persistent MSK pain. Participants were randomised in a 1:1:1 ratio to: (i) usual care, (ii) usual care plus a pedometer intervention, or (iii) usual care plus the iPOPP walking intervention. Descriptive statistics were used in an exploratory analysis of the quantitative data. Qualitative data were analysed using thematic analysis. A triangulation protocol was used to integrate the analyses from the mixed methods. RESULTS: All pre-specified success criteria were achieved in terms of feasibility (recruitment, follow-up and iPOPP intervention adherence) and acceptability. Triangulation of the data identified the need, in the future, to make the iPOPP training (for intervention deliverers) more patient-centred to better support already active patients and the use of individualised goal setting and improve accelerometry data collection processes to increase the amount of valid data. CONCLUSIONS: This pilot trial suggests that the iPOPP intervention and a future full-scale RCT are both acceptable and feasible. The use of a triangulation protocol enabled more robust conclusions about acceptability and feasibility to be drawn.

Improving the Effectiveness of Exercise Therapy for Adults With Knee Osteoarthritis: A Pragmatic Randomized Controlled Trial (BEEP Trial).

Objective: To investigate whether knee osteoarthritis (OA) related pain and function can be improved by offering enhanced physical therapist-led exercise interventions. Design: Three-arm prospectively designed pragmatic randomized controlled trial. Setting: General practices and National Health Service physical therapy services in England. Participants: 514 adults (252 men, 262 women) aged ≥45 years with a clinical diagnosis of knee osteoarthritis (N=514). Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at baseline were 8.4 for pain and 28.1 for function. Interventions: Participants were individually randomized (1:1:1 allocation) to usual physical therapy care (UC control: up to 4 sessions of advice and exercise over 12 weeks), individually tailored exercise (ITE: individualized, supervised, and progressed lower limb exercises, 6-8 sessions over 12 weeks), or targeted exercise adherence (TEA: transitioning from lower limb exercise to general physical activity, 8-10 contacts over 6 months). Main Outcome Measures: Primary outcomes were pain and physical function measured by the WOMAC at 6 months. Secondary outcomes were measured at 3, 6, 9, 18, and 36 months. Results: Participants receiving UC, ITE, and TEA all experienced moderate improvement in pain and function. There were no significant differences between groups at 6 months (adjusted mean differences (95% confidence intervals): pain UC vs ITE, -0.3 (-1.0 to 0.4), UC vs TEA, -0.3 (-1.0 to 0.4); function UC vs ITE, 0.5 (-1.9 to 2.9), UC vs TEA, -0.9 (-3.3 to 1.5)), or any other time-point. Conclusions: Patients receiving UC experienced moderate improvement in pain and function; however, ITE and TEA did not lead to superior outcomes. Other strategies for patients with knee osteoarthritis to enhance the benefits of exercise-based physical therapy are needed.

Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial.

Background: Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. Ulipristal acetate is prescribed to treat symptoms associated with uterine fibroids. We compared the effectiveness of ulipristal acetate and the levonorgestrel-releasing intrauterine system at reducing the burden of heavy menstrual bleeding, irrespective of the presence of fibroids. Methods: This randomised, open-label, parallel group phase III trial enrolled women over 18 years with heavy menstrual bleeding from 10 UK hospitals. Participants were centrally randomised, in a 1:1 ratio, to either three, 12-week treatment cycles of 5 mg ulipristal acetate daily, separated by 4-week treatment-free intervals, or a levonorgestrel-releasing intrauterine system. The primary outcome, analysed by intention-to-treat, was quality of life measured by the Menorrhagia Multi-Attribute Scale at 12 months. Secondary outcomes included menstrual bleeding and liver function. The trial is registered with ISRCTN, 20426843. Findings: Between June 5th, 2015 and February 26th, 2020, 236 women were randomised, either side of a recruitment suspension due to concerns of ulipristal acetate hepatoxicity. Subsequent withdrawal of ulipristal acetate led to early cessation of recruitment but the trial continued in follow-up. The primary outcome substantially improved in both groups, and was 89, (interquartile range [IQR] 65 to 100, n = 53) and 94, (IQR 70 to 100, n = 50; adjusted odds ratio 0.55, 95% confidence interval [CI] 0.26-1.17; p = 0.12) in the ulipristal and levonorgestrel-releasing intrauterine system groups. Rates of amenorrhoea at 12 months were higher in those allocated ulipristal acetate compared to levonorgestrel-releasing intrauterine system (64% versus 25%, adjusted odds ratio 7.12, 95% CI 2.29-22.2). Other outcomes were similar between the two groups and there were no cases of endometrial malignancy or hepatotoxicity due to ulipristal acetate use. Interpretation: Our findings suggested that both treatments improved quality of life. Ulipristal was more effective at inducing amenorrhoea. Ulipristal has been demonstrated to be an effective medical therapeutic option but currently its use has restrictions and requires liver function monitoring. Funding: UK Medical Research Council and National Institute of Health Research EME Programme (12/206/52).

Factors associated with change in health-related quality of life in people with gout: a 3-year prospective cohort study in primary care.

OBJECTIVE: To describe factors associated with change in health-related quality of life (HRQOL) in people living with gout in primary care. METHODS: In a UK prospective cohort study, adults with a diagnosis of gout registered with 20 general practices completed the Gout Impact Scale (GIS; scale 0-100), 36-item Short Form Physical Function subscale (PF-10; 0-100) and HAQ Disability Index (HAQ-DI; 0-3) via postal questionnaires at baseline and 6, 12, 24 and 36 months. Linear mixed modelling was used to investigate factors associated with changes in HRQOL over 3 years. RESULTS: A total of 1184 participants responded at baseline (adjusted response 65.6%); 990 (83.6%) were male, with a mean age of 65.6 years (s.d. 12.5). A total of 818, 721, 696 and 605 responded at 6, 12, 24 and 36 months, respectively. Factors associated with worse disease-specific and generic HRQOL over 3 years were flare frequency (five or more flares; GIS subscales, PF-10), oligo/polyarticular flares (GIS subscales, PF-10, HAQ-DI), worse pain (GIS subscales, PF-10, HAQ-DI), body pain (GIS subscales, PF-10, HAQ-DI) and more severe depression (GIS subscales, PF-10, HAQ-DI) (P ≤ 0.05). More severe anxiety was associated with worse disease-specific HRQOL only (GIS subscales). Older age (PF-10), being female (PF-10, HAQ-DI) and BMI (HAQ-DI) were associated with worse generic HRQOL (P ≤ 0.05). CONCLUSION: Gout-specific, comorbid and sociodemographic factors were associated with change in HRQOL over a 3-year period, highlighting people at risk of worse outcomes who could be targeted for interventions.

Subgroup effects of non-surgical and non-pharmacological treatment of patients with hand osteoarthritis: a protocol for an individual patient data meta-analysis.

INTRODUCTION: Hand osteoarthritis (OA) is a common joint disorder in the adult population. No cure for hand OA is known yet, but treatment aims to reduce symptoms. Non-surgical and non-pharmacological therapy interventions can include splinting, patient education, and strengthening and range of movement exercises. However, it is still unclear which treatment is most beneficial for which patient. This study aims to identify subgroups of patients with hand OA that benefit most from the different non-surgical and non-pharmacological treatments. METHODS AND ANALYSIS: We will conduct an individual patient data (IPD) meta-analysis by extracting IPD of eligible published randomised controlled trials (RCTs). A systematic literature search through Embase, Medline and Cochrane was performed on 8 February 2021. The primary outcome will be hand pain, and our secondary outcomes are objective and subjective hand physical functions. Subgroups include age, sex, body mass index, hypermobility and other comorbidities, pain medication, occupation, baseline pain, erosive OA, type and the number of hand joints involved, radiological severity of OA, and duration of symptoms. IPD of RCTs with homogeneous treatment interventions will be pooled and analysed using a two-stage approach to evaluate treatment effect on different subgroups. ETHICS AND DISSEMINATION: No new data will be collected, so research ethical or governance approval is exempt. Findings will be disseminated via national and international conferences, publications in peer-reviewed journals, and summaries posted on websites accessed by the public and clinicians.

Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial.

BACKGROUND: Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinicians. OBJECTIVES: To test the feasibility of a randomized controlled trial (RCT) of an intervention integrating case-finding and management for osteoarthritis, anxiety, and depression within LTC reviews. METHODS: A pilot stepped-wedge RCT across 4 general practices recruited patients aged ≥45 years attending routine LTC reviews. General practice nurses provided usual LTC reviews (control period), then, following training, delivered the ENHANCE LTC review (intervention period). Questionnaires, an ENHANCE EMIS-embedded template and consultation audio-recordings, were used in the evaluation. RESULTS: General practice recruitment and training attendance reached prespecified success criteria. Three hundred and eighteen of 466 (68%) of patients invited responded; however, more patients were recruited during the control period (206 control, 112 intervention). Eighty-two percent and 78% returned their 6-week and 6-month questionnaires, respectively. Integration of the ENHANCE LTC review into routine LTC reviews varied. Case-finding questions were generally used as intended for joint pain, but to a lesser extent for anxiety and depression. Initial management through referrals and signposting were lacking, and advice was more frequently provided for joint pain. The stepped-wedge design meant timing of the training was challenging and yielded differential recruitment. CONCLUSION: This pilot trial suggests that it is feasible to deliver a fully powered trial in primary care. Areas to optimize include improving the training and reconsidering the stepped-wedge design and the approach to recruitment by targeting those with greatest need. TRIAL REGISTRATION: ISRCTN registry (ISRCTN: 12154418). Date registered: 6 August 15. Date first participant was enrolled: 13 July 2015. https://www.isrctn.com/ISRCTN12154418?q=depression%20schizophrenia&filters=conditionCategory:Not%20Applicable&sort=&offset=5&totalResults=9&page=1&pageSize=20&searchType=basic-search.

Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.

BACKGROUND: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS: A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION: North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN28555470.

Latent Class Growth Analysis of Gout Flare Trajectories: A Three-Year Prospective Cohort Study in Primary Care.

OBJECTIVE: To investigate the existence of distinct classes of gout flare trajectories and compare their gout-specific, comorbid, and sociodemographic characteristics. METHODS: In a prospective cohort study, adults with gout who were registered with 20 general practices self-reported the number of gout flares experienced at baseline and after 6, 12, 24, and 36 months via postal questionnaires. Latent class growth analysis (LCGA) was used to identify distinct gout flare trajectory classes. Statistical criteria and clinical interpretability were used to decide the optimal number of classes. Baseline comorbidities, medications, and sociodemographic and gout-specific characteristics of members of each class were described. RESULTS: A total of 1,164 participants (mean ± SD age 65.6 ± 12.5 years; 972 [84%] male) were included. Six latent gout flare trajectory classes were identified: "frequent and persistent" (n = 95), "gradually worsening" (n = 276), "frequent then improving" (n = 14), "moderately frequent" (n = 287), "moderately frequent then improving" (n = 143), and "infrequent" (n = 349). The "frequent and persistent" trajectory had the most class members classified as obese and, along with the "gradually worsening" class, the highest proportion who were socioeconomically deprived. The "frequent and persistent," "gradually worsening," and "frequent then improving" classes had the highest proportions of class members with an estimated glomerular filtration rate <60 ml/minute/1.73 m2 . The "infrequent" gout flare class was associated with more frequent allopurinol use and lower urate levels. CONCLUSION: Six distinct gout flare trajectories were identified. Infrequent flares were associated with allopurinol use and lower serum urate levels, supporting the use of urate-lowering therapy to reduce flare frequency. The characteristics of flare trajectory classes could help to target interventions and improve patient care.

Relative prevalence and distribution of knee, hand and foot symptomatic osteoarthritis subtypes in an English population.

In this brief report, we used data from a series of three related cohorts on pain and osteoarthritis (OA) of the knee, hand and foot, which were conducted in North Staffordshire, England. We used a common approach for sampling, data collection and coding, to estimate the relative prevalence of 10 different symptomatic radiographic OA subtypes in the knee, hand and foot and to compare their association with age, sex, socioeconomic position and body mass index. Overall, symptomatic hand OA was more common than knee or foot OA (22.4% vs 17.4% vs 16.5%), due mainly to the high prevalence of nodal interphalangeal joint OA among women. The first carpometacarpal joint OA was the most frequent subtype, with patellofemoral, tibiofemoral, (nodal) interphalangeal and midfoot OA also common. Of the risk factors examined, the greatest differences between subtypes appeared to be their associations with sex and obesity: sex differences were noticeably greater for all forms of hand OA except non-nodal interphalangeal joint OA, while obesity appeared most strongly associated with forms of knee OA. The prevalence of all subtypes was higher among older ages, and among those with lower educational attainment.

Short-Term Recovery Trajectories of Acute Flares in Knee Pain: A UK-Netherlands Multicenter Prospective Cohort Analysis.

OBJECTIVE: To identify distinct recovery trajectories of acute flares of knee pain and associated participant characteristics. METHODS: Data were from the FLARE randomized controlled trial, a multicenter trial in 27 primary care centers in the UK and Netherlands of 3 regimes of oral nonsteroidal antiinflammatory therapy for acute flares of knee pain. Individuals with a history of inflammatory/crystal arthritis, fibromyalgia, and chronic pain syndrome were excluded. Latent class growth analysis was applied to measures of pain intensity repeated over 5 days to identify distinct recovery trajectories. The concurrent courses of interference with activity, stiffness, and swelling for each trajectory group were modelled using generalized estimating equations. Participant age, sex, obesity, and osteoarthritis diagnosis were described for each trajectory group. RESULTS: A total of 449 participants were included (median age 55 years, 41% female, 35% obese, and 42% diagnosed with osteoarthritis). A 6-group cubic model was deemed optimal, with trajectories distinguished by rate of pain reduction and absolute level at final measurement. At the extremes were rapid and near-complete resolution (n = 41, 9%) and persistent, high pain (n = 25, 6%), but most participants showed a reduction and plateau in pain severity within 3-5 days. Within each pain trajectory group, interference with activity, stiffness, and swelling followed the same course as pain. Baseline characteristics did not differ substantially between trajectory groups. CONCLUSION: Even under a well-adhered to regime of oral nonsteroidal antiinflammatory medication, recovery following acute flares of knee pain is heterogeneous. Our observations that favorable trajectories are apparent within 3-5 days can help to inform treatment decision-making in the patient-health care professional consultation.

Longitudinal validity of using digital hand photographs for assessing hand osteoarthritis progression over 7 years in community-dwelling older adults with hand pain.

BACKGROUND: To determine the longitudinal construct validity of assessing hand OA progression on digital photographs over 7 years compared with progression determined from radiographs, clinical features and change in symptoms. METHODS: Participants were community-dwelling older adults (≥50 years) in North Staffordshire, UK. Standardized digital hand photographs were taken at baseline and 7 years, and hand joints graded for OA severity using an established photographic atlas. Radiographic hand OA was assessed using the Kellgren and Lawrence grading system. Hand examination determined the presence of nodes, bony enlargement and deformity. Symptoms were reported in self-complete questionnaires. Radiographic and clinical progression and change in symptoms were compared to photographic progression. Differences were examined using analysis of covariance and Chi-Square tests. RESULTS: Of 253 individuals (61% women, mean age 63 years) the proportion with photographic progression at the joint and joint group-level was higher in individuals with radiographic or clinical progression compared to those without, although differences were not statistically significant. At the person-level, those with moderate photographic progression over 7 years had significantly higher summed radiographic and clinical scores (adjusted for baseline scores) compared to those with no or mild photographic progression. Similar findings were observed for change in symptoms, although differences were small and not statistically significant. CONCLUSION: Assessing hand OA on photographs shows modest longitudinal construct validity over 7 years compared with change in radiographic and clinical hand OA at the person-level. Using photographs to assess overall long-term change in a person with hand OA may be a reasonable alternative when hand examinations and radiographs are not feasible.

Can support workers from AgeUK deliver an intervention to support older people with anxiety and depression? A qualitative evaluation.

BACKGROUND: Anxiety and depression often co-exist. These disorders are under-diagnosed and under-treated, specifically among older people, and lead to increased use of health and social care services and raised mortality. Older people report a reluctance to present to their GP with depression or anxiety symptoms due to perceived stigma about mental health problems, lack of acceptable treatments and the prioritising of physical health problems. Third sector organisations, who work closely with older people in the community, are well-placed to provide additional support. We developed a brief intervention based on principles of Behavioural Activation, with encouragement to participate in a group activity, for delivery by Support Workers from AgeUK. The aim of the study was to examine whether this brief intervention could be delivered to older people with anxiety and/or depression, with sufficient fidelity, and whether this approach was acceptable to patients, GPs and AgeUK Support Workers. METHODS: Semi-structured interviews with older people with self-reported anxiety and/or depression (who received the intervention), Support Workers and GPs to assess acceptability of the intervention and impact on routine care. A constant comparative approach was used to analyse the data. Intervention sessions between Support Workers and older people were digitally recorded and reviewed by the research team to assess fidelity. RESULTS: The Support Workers delivered the intervention with fidelity; access to the training maual and ongoing supervision were important. Older people found the intervention acceptable and valued the one-to-one support they received; group activities suggested by Support Workers were not valued by all. GPs recognised the need for additional support for vulnerable older people, but acknowledged they could not provide this support. Participation in the study did not impact on GP routine care, other than responding to the calls from the study team about risk of self-harm. CONCLUSIONS: Support Workers within AgeUK, can be recruited and trained to deliver an intervention, based on the principles of Behavioural Activation, to older people with anxiety and/or depression. The training and supervision model used in the study was acceptable to Support Workers, and the intervention was acceptable to older people and GPs. This model has the potential to contribute to improving the support and care of older people in primary care with anxiety and depression. Further testing is required in a full trial. TRIAL REGISTRATION: Trial registration number ISRCTN16318986 . Registered 10/11/2016.

Cost-utility analysis of interventions to improve effectiveness of exercise therapy for adults with knee osteoarthritis: the BEEP trial.

OBJECTIVES: Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. METHODS: A trial-based cost-utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. RESULTS: The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £-62.10 to £562.60; TEA-UC: £141.80, 95% CI: £-135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: -0.015, 95% CI: -0.057 to 0.026; TEA-UC: -0.003, 95% CI: -0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability <40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups. CONCLUSION: This is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 93634563. TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at http://www.biomedcentral.com/1471-2474/15/254 doi: 10.1186/1471-2474-15-254.

Self-management of musculoskeletal hand pain and hand problems in community-dwelling adults aged 50 years and older: results from a cross-sectional study in a UK population.

BACKGROUND: Musculoskeletal pain is common in adults, with the hand being frequently affected. Healthcare services have the potential to be of benefit to adults with hand pain and problems, through promotion and facilitation of self-management. METHODS: This paper explores existing self-management in a UK population of community-dwelling adults aged 50 years and over using data from surveys and a nested clinical cohort study. Self-management of hand problems was considered in three ways: self-directed treatment approaches used, adaptation behaviours adopted and choice to consult with a healthcare professional. RESULTS: The treatment approaches most commonly used were 'exercise/movement' (n = 151, 69 %) and 'resting' the hands (n = 139, 69 %). The use of adaptation behaviour was widespread: 217 (99 %) people reported using one or more adaptation behaviours. Under half of survey respondents who reported hand pain (n = 783, 43 %) had consulted a healthcare professional about their problem during the last year: the lowest rate of consultation was for occupational therapy (n = 60, 3 %). CONCLUSIONS: Self-directed treatment and adaptation behaviours were widespread in adults aged 50 years and over with hand problems, but consultation with a healthcare professional was low.

Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial.

BACKGROUND: Long-term conditions (LTCs) are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. OBJECTIVE: To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. DESIGN: The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENAHNCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes) will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. DISCUSSION: Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418.

Joint protection and hand exercises for hand osteoarthritis: an economic evaluation comparing methods for the analysis of factorial trials.

OBJECTIVES: Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. METHODS: A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. RESULTS: Mean costs (QALYs) were £58.46 (s.d. 0.662) for leaflet and advice, £92.12 (s.d. 0.659) for joint protection, £64.51 (s.d. 0.681) for hand exercises and £112.38 (s.d. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. CONCLUSION: This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option.

Erosive osteoarthritis: a more severe form of radiographic hand osteoarthritis rather than a distinct entity?

OBJECTIVES: To determine whether erosive osteoarthritis shares the same pattern of joint involvement and risk profile as increasing grades of non-erosive hand osteoarthritis. METHODS: Participants were from two population-based cohorts, aged ≥50 years, reporting hand symptoms in the previous month. Interphalangeal joints were assessed for erosive osteoarthritis (Verbruggen-Veys erosive or remodelled phase) and radiographic osteoarthritis (sliding cut-offs of K&L≥2, K&L≥3 and K&L=4). At the joint level, similarities in the frequency and pattern of erosive and non-erosive osteoarthritis were assessed by Spearman's rank correlation coefficients and generalised estimating equations. At the person level, individuals with erosive osteoarthritis were compared to those with non-erosive osteoarthritis using logistic regression, adjusted for age and gender (aOR), for the following exposures: family history, previous injury, overuse and metabolic factors (BMI, dyslipidaemia, hypertension, diabetes). RESULTS: In 1076 symptomatic participants the ranked frequency of involvement for erosive joints was comparable to joints with K&L≥3 and K&L=4 (r>0.95). Patterns of joint involvement in erosive osteoarthritis were strongest for symmetry (aOR=6.5; 95% CI 3.0 to 14.1), followed by row (2.0; 0.8 to 5.0) and ray (0.3; 0.0 to 2.5), which was similar to joints with K&L≥3 and K&L=4. Individuals with erosive osteoarthritis (n=80) had an increased risk of metabolic syndrome (2.7; 1.0 to 7.1), notably dyslipidaemia (4.7; 2.1 to 10.6) compared with non-erosive osteoarthritis classed K&L≥3 (n=193). CONCLUSIONS: The similar frequency of radiographic joint involvement and patterning in erosive osteoarthritis and more severe non-erosive osteoarthritis is consistent with prevalent erosive osteoarthritis being a severe form of hand osteoarthritis rather than a distinct entity. Metabolic exposures, dyslipidaemia in particular, may be implicated in erosive osteoarthritis.