Reducing the burden of knee osteoarthritis through community pharmacy: Protocol for a randomised controlled trial of the Knee Care for Arthritis through Pharmacy Service.

INTRODUCTION: Knee osteoarthritis (OA) negatively impacts the health outcomes and equity, social and employment participation, and socio-economic wellbeing of those affected. Little community-based support is offered to people with knee OA in Aotearoa New Zealand. Identifying Maori and non-Maori with knee OA in community pharmacy and providing co-ordinated, evidence- and community-based care may be a scalable, sustainable, equitable, effective and cost-effective approach to improve health and wellbeing. AIM: Assess whether the Knee Care for Arthritis through Pharmacy Service (KneeCAPS) intervention improves knee-related physical function and pain (co-primary outcomes). Secondary aims assess impacts on health-related quality of life, employment participation, medication use, secondary health care utilisation, and relative effectiveness for Maori. METHODS AND ANALYSIS: A pragmatic randomised controlled trial will compare the KneeCAPS intervention to the Pharmaceutical Society of New Zealand Arthritis Fact Sheet and usual care (active control) at 12 months for Maori and non-Maori who have knee OA. Participants will be recruited in community pharmacies. Knee-related physical function will be measured using the function subscale of the Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index. Knee-related pain will be measured using an 11-point numeric pain rating scale. Primary outcome analyses will be conducted on an intention-to-treat basis using linear mixed models. Parallel within-trial health economic analysis and process evaluation will also be conducted. ETHICS AND TRIAL DISSEMINATION: Ethical approval was obtained from the Central Health and Ethics Committee (2022-EXP-11725). The trial is registered with ANZCTR (ACTRN12622000469718). Findings will be submitted for publication and shared with participants.

Exploring the current and future osteoarthritis health service delivery needs in Aotearoa New Zealand.

AIM: Osteoarthritis (OA) affects the wellbeing of one in 10 people in Aotearoa New Zealand, yet current healthcare delivery for these people is fragmented, un-coordinated and inconsistent. How current and future needs should be addressed has not been systematically explored. This study aimed to describe the views of interested people from the health sector regarding current and future OA health service delivery in the public health system in Aotearoa New Zealand. METHOD: Data were collected via a co-design approach within an interprofessional workshop at the Taupuni Hao Huatau Kaikoiwi: Osteoarthritis Aotearoa New Zealand Basecamp symposium and analysed using direct qualitative content analysis. RESULTS: The results highlighted several promising current healthcare delivery initiatives. Health literacy and obesity prevention policies featured in the thematic analysis suggesting a lifespan or systemwide approach is needed. Data highlighted a need for reformed systems that enhances hauora/wellbeing, promotes physical activity, facilitates interprofessional service delivery and collaborates across care settings. CONCLUSION: Participants identified several promising healthcare delivery initiatives for people with OA in Aotearoa New Zealand. Public health policy initiatives are needed to reduce osteoarthritis risk factors. Developing future care pathways should support the diverse needs within Aotearoa New Zealand, coordinate and stratify care, value interprofessional collaboration and practice, and improve health literacy and self-management.

Are the outcomes of relative motion extension orthoses non-inferior and cost-effective compared with dynamic extension orthoses for management of zones V-VI finger extensor tendon repairs: A randomized controlled trial.

INTRODUCTION: There is no comparative evidence for relative motion extension (RME) orthosis with dynamic wrist-hand-finger-orthosis (WHFO) management of zones V-VI extensor tendon repairs. PURPOSE OF THE STUDY: To determine if RME with wrist-hand-orthosis (RME plus) is noninferior to dynamic WHFO for these zones in clinical outcomes. STUDY DESIGN: Randomized controlled non-inferiority trial. METHODS: Skilled hand therapists managed 37 participants (95% male; mean age 39 years, SD 18) with repaired zones V-VI extensor tendons randomized to RME plus (n = 19) or dynamic WHFO (n = 18). The primary outcome of percentage of total active motion (%TAM) and secondary outcomes of satisfaction, function, and quality of life were measured at week-6 and -12 postoperatively; percentage grip strength (%Grip), complication rates, and cost data at week-12. Following the intention-to-treat principle non-inferiority was assessed using linear regression analysis (5% significance) and adjusted for injury complexity factors with an analysis of costs performed. RESULTS: RME plus was noninferior for %TAM at week-6 (adjusted estimates 2.5; 95% CI -9.0 to 14.0), %TAM at week-12 (0.3; -6.8 to 7.5), therapy satisfaction at week-6 and -12, and orthosis satisfaction, QuickDASH, and %Grip at week-12. Per protocol analysis yielded 2 tendon ruptures in the RME plus orthoses and 1 in the dynamic WHFO. There were no differences in health system and societal cost, or quality-adjusted life years. DISCUSSION: RME plus orthosis wearers had greater injury complexity than those in dynamic WHFOs, with overall rupture rate for both groups comparatively more than reported by others; however, percentage %TAM was comparable. The number of participants needed was underestimated, so risk of chance findings should be considered. CONCLUSIONS: RME plus management of finger zones V-VI extensor tendon repairs is non-inferior to dynamic WHFO in %TAM, therapy and orthotic satisfaction, QuickDASH, and %Grip. Major costs associated with this injury are related to lost work time.

Education plus exercise for persistent gluteal tendinopathy improves quality of life and is cost-effective compared with corticosteroid injection and wait and see: economic evaluation of a randomised trial.

QUESTION: For patients with gluteal tendinopathy, what is the cost utility from health system and societal perspectives of three management approaches: education plus exercise, ultrasound-guided corticosteroid injection or wait and see? DESIGN: Economic evaluation alongside a three-group, parallel, randomised clinical efficacy trial. PARTICIPANTS: People aged between 35 and 70 years with image-confirmed gluteal tendinopathy were recruited via advertisements. INTERVENTIONS: Education plus exercise, consisting of 14 visits to a physiotherapist, with detailed instruction on tendinopathy management, twice weekly supervised exercise sessions, daily home exercises, a handout and a CD; corticosteroid injection, consisting of one ultrasound-guided injection and a handout on general tendon care; and 'wait and see', consisting of one visit to a physiotherapist with assurance and advice on staying active whilst respecting pain. OUTCOME MEASURES: Economic outcome measures were quality-adjusted life years (QALYs) calculated from EuroQol EQ-5D-3L using Australian population preference weights, and total economic costs obtained from participant-reported data collected over the 1-year follow-up period. Missing data (<12% per group) were imputed. Linear regression was used to estimate incremental QALYs and costs between interventions; uncertainty was assessed by calculating 90% confidence intervals, cost-effectiveness acceptability curves and confidence ellipses. RESULTS: A total of 204 individuals (82% women) were enrolled. Incremental cost-effectiveness ratio favoured education plus exercise over corticosteroid injection (AU$12,719 and $5,592 on societal and health system perspectives, respectively) and over wait and see ($29,258 and $3,444 on societal and health system perspectives, respectively). Complete case analysis and varying the direct intervention costs did not change the (imputed analysis) results, with the exception that corticosteroid injection was less cost-effective. CONCLUSION: Education plus exercise for gluteal tendinopathy improves health-related quality of life and is cost-effective compared with corticosteroid injection and wait and see for treating gluteal tendinopathy. REGISTRATION: ACTRN12612001126808.

A Guideline-Implementation Intervention to Improve the Management of Low Back Pain in Primary Care: A Difference-in-Difference-in-Differences Analysis.

BACKGROUND: Real-world adherence to clinical practice guidelines is often poor, resulting in sub-standard patient care and unnecessary healthcare costs. This study evaluates the effect of a guideline-implementation intervention for the management of low back pain (LBP) in general practice-the Fear Reduction Exercised Early (FREE) approach-on LBP-related injury insurance claims, healthcare utilisation, and costs of treatment. DESIGN: Data were extracted from comprehensive nationwide New Zealand injury insurance claims records. Data were analysed using a 'triple-difference' (difference-in-difference-in-differences) method to isolate the causal effect of FREE training on LBP claims activity, comparing the difference in general practitioner (GP) LBP claims and associated activity before and after training with their non-musculoskeletal injury claims for the same periods (assumed to be unaffected by training), relative to the same comparisons for GPs not trained in the FREE approach. RESULTS: Training GPs in the FREE approach resulted in significant reductions in the number of LBP injury claims lodged (- 19%, 95% CI -34 to -5), the use of physiotherapy (-30%, 95% CI - 42 to - 18) and imaging (- 27%, 95% CI - 46 to - 8%), and the healthcare costs (- 21%, 95% CI - 41 to - 1) of LBP injury. Changes in claims for earnings' compensation (- 10%, 95% CI - 34 to 13) were not significant. CONCLUSIONS: A brief guideline-implementation intervention following best-practice LBP management and guideline-implementation strategies achieved significant reductions, persisting over at least 6 to18 months, in healthcare utilisation consistent with improved delivery of guideline-concordant care.

Economic evaluation: a reader's guide to studies of cost-effectiveness.

BACKGROUND: Understanding what an economic evaluation is, how to interpret it, and what it means for making choices in a health delivery context is necessary to contribute to decisions about healthcare resource allocation. The aim of this paper to demystify the working parts of a health economic evaluation, and explain to clinicians and clinical researchers how to read and interpret cost-effectiveness research. MAIN BODY: This primer distils key content and constructs of economic evaluation studies, and explains health economic evaluation in plain language. We use the PICOT (participant, intervention, comparison, outcome, timeframe) clinical trial framework familiar to clinicians, clinical decision-makers, and clinical researchers, who may be unfamiliar with economics, as an aide to reading and interpreting cost-effectiveness research. We provide examples, primarily of physiotherapy interventions for osteoarthritis. CONCLUSIONS: Economic evaluation studies are essential to improve decisions about allocating resources, whether those resources be your time, the capacity of your service, or the available funding across the entire healthcare system. The PICOT framework can be used to understand and interpret cost-effectiveness research.

Prioritizing Healthcare Interventions: A Comparison of Multicriteria Decision Analysis and Cost-Effectiveness Analysis.

OBJECTIVES: To investigate the extent to which stated preferences for treatment criteria elicited using multicriteria decision analysis (MCDA) methods are consistent with the trade-offs (implicitly) applied in cost-effectiveness analysis (CEA), and the impact of any differences on the prioritization of treatments. METHODS: We used existing MCDA and CEA models developed to evaluate interventions for knee osteoarthritis in the New Zealand population. We established equivalent input parameters for each model, for the criteria "treatment effectiveness," "cost," "risk of serious harms," and "risk of mild-to-moderate harms" across a comprehensive range of (hypothetical) interventions to produce a complete ranking of interventions from each model. We evaluated the consistency of these rankings between the 2 models and investigated any systematic differences between the (implied) weight placed on each criterion in determining rankings. RESULTS: There was an overall moderate-to-strong correlation in intervention rankings between the MCDA and CEA models (Spearman correlation coefficient = 0.51). Nevertheless, there were systematic differences in the evaluation of trade-offs between intervention attributes and the resulting weights placed on each criterion. The CEA model placed lower weights on risks of harm and much greater weight on cost (at all accepted levels of willingness-to-pay per quality-adjusted life-year than did respondents to the MCDA survey. CONCLUSIONS: MCDA and CEA approaches to inform intervention prioritization may give systematically different results, even when considering the same criteria and input data. These differences should be considered when designing and interpreting such studies to inform treatment prioritization decisions.

Are manual therapy or booster sessions worthwhile in addition to exercise therapy for knee osteoarthritis: Economic evaluation and 2-year follow-up of a randomized controlled trial.

BACKGROUND: Exercise therapy is known to be an effective intervention for patients with osteoarthritis, however the evidence is limited as to whether adding manual therapy or booster sessions are cost-effective strategies to extend the duration of benefits. OBJECTIVE: To investigate the cost-effectiveness, at 2-year follow-up, of adding manual therapy and/or booster sessions to exercise therapy. DESIGN: 2-by-2 factorial randomized controlled trial. METHODS: Participants with knee osteoarthritis were randomly allocated (1:1:1:1) to: exercise therapy delivered in consecutive sessions within 9 weeks (control group), exercise therapy distributed over 1 year using booster sessions, exercise therapy plus manual therapy delivered within 9 weeks, and exercise therapy plus manual therapy with booster sessions. The primary outcome was incremental cost-effectiveness from health system and societal perspectives interpreted as incremental net monetary benefit (INMB). RESULTS: Of 75 participants, 66 (88 %) were retained at 1-year and 40 (53 %) at 2-year follow-up. All three interventions were cost-effective from both the health system and societal perspectives (INMBs, at 0.5 × GDP/capita willingness to pay (WTP) threshold: $3278 (95%CI -3244 to 9800) and $3904 (95%CI -2823 to 10,632) respectively for booster sessions; $2941 (95%CI -3686 to 9568) and $2618 (95%CI -4005 to 9241) for manual therapy; $270 (95%CI -6139 to 6679) and $404 (95%CI -6097 to 6905) for manual therapy with booster sessions). CONCLUSION: Manual therapy or booster sessions in addition to exercise therapy are cost-effective at 2-year follow-up. The evidence did not support combining both booster sessions and manual therapy in addition to exercise therapy.

Total Hip and Knee Arthroplasties Are Highly Cost-Effective Procedures: The Importance of Duration of Follow-Up.

BACKGROUND: Total hip and knee arthroplasties (THA/TKA) are clinically effective but high cost procedures. The aim of this study is to perform a cost-effectiveness analysis of THA and TKA in the New Zealand (NZ) healthcare system. METHODS: Data were collected from 713 patients undergoing THA and 520 patients undergoing TKA at our local public hospital. SF-6D utility values were obtained from participants preoperatively and 1-year postoperatively, and deaths and any revision surgeries from patient records and the New Zealand Joint Registry at minimum 8-year follow-up. A continuous-time state-transition simulation model was used to estimate costs and health gains to 15 years. Quality-adjusted life years (QALYs), treatment costs, and incremental cost-effectiveness ratios (ICERs) were calculated to determine cost effectiveness. ICERs below NZ gross domestic product (GDP; NZ$60 600) and 0.5 times GDP per capita were considered "cost effective" and "highly cost effective" respectively. RESULTS: Cumulative health gains were 2.8 QALYs (THA) and 2.3 QALYs (TKA) over 15 years. Cost effectiveness improved from ICERs of NZ$74,400 (THA) and NZ$93,000 (TKA) at 1 year to NZ$6000 (THA) and NZ$7500 (TKA) at 15 years. THA and TKA were cost effective after 2 years and highly cost effective after 3 years. QALY gains and cost effectiveness were greater in patients with worse preoperative functional status and younger age. CONCLUSION: THA and TKA are highly cost-effective procedures over longer term horizons. Although preoperative status and age were associated with cost effectiveness, both THA and TKA remained cost effective in patients with less severe preoperative scores and older ages.

Development and assessment of a verbal response scale for the Patient-Specific Functional Scale (PSFS) in a low-literacy, non-western population.

PURPOSE: The Patient-Specific Functional Scale (PSFS) is a routinely used measure of physical function with a 0-10 response scale. We aimed to develop verbal response options for the PSFS, pre-test it for use in a multilingual, low-literacy country- Nepal, and compare preference and error rates between numeric and verbal scale. We hypothesized that a verbal scale would be preferred by respondents and yield fewer errors. METHOD: We interviewed 42 individuals with musculoskeletal, neurological, and cardiopulmonary conditions to understand how people describe varying levels of physical ability. Transcripts were thematically analyzed, and through consensus, we developed two sets of verbal responses for the PSFS. Next, we pre-tested the scales on an additional 119 respondents following which participants were asked to specify their preferred scale. Error rates were analyzed retrospectively using pre-specified criteria. RESULTS: Participants described their ability in terms of the quality (95%) and the quantity of task performance (88%). Although the verbal scales were preferred over the numeric scale (50% versus 12%), there was no significant difference in error rates between numeric (34%) and verbal scales (32% and 36%). Higher error rates were associated with greater age, fewer years of education, and inexperience with numeric scales. CONCLUSION: Despite a higher preference for verbal scale, 1 out of 3 patients made errors in using the PSFS, even with an interview format. The error rates were higher among participants with low literacy. The findings raise questions about the utility of PROMs in countries with low literacy rates.

Systematic review of economic evaluations investigating education, exercise, and dietary weight management to manage hip and knee osteoarthritis: protocol.

BACKGROUND: International guidelines recommend education, exercise, and dietary weight management as core treatments to manage osteoarthritis (OA) regardless of disease severity or co-morbidity. Evidence supports the clinical effectiveness of OA management programs, but the cost-effectiveness of core treatments remains unclear. We will systematically review, synthesize, and assess the literature in economic evaluations of core treatments (education, exercise, and dietary weight management) for the management of hip and/or knee OA. METHODS: We will search the following elecftronic databases (from inception onwards): MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), National Health Services Economic Evaluation Database, and EconLit. Economic evaluations alongside randomized or nonrandomized clinical trials investigating OA education, exercise, and dietary weight management interventions will be included. Title, abstract, and full text of relevant publications will be screened independently by two reviewers. A content matter expert will resolve any conflicts between two reviewers. Key information from relevant papers will be extracted and tabulated to provide an overview of the published literature. Methodological quality will be evaluated using the Consensus on Health Economic Criteria list. A narrative synthesis without meta-analysis will be conducted. Subgroup analysis will attempt to find trends between research methods, intervention characteristics, and results. DISCUSSION: The findings of this review will evaluate the breadth and quality of economic evaluations conducted alongside clinical trials for core treatments in OA management. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020155964.

Stakeholders' preferences for osteoarthritis interventions in health services: A cross-sectional study using multi-criteria decision analysis.

Objectives: To combine cross-sectoral stakeholders' preferences over interventions for knee osteoarthritis (OA) with guideline recommendations and evidence about interventions, and to investigate if these preferences differ by stakeholder group. Design: A survey based on multi-criteria decision analysis was implemented whereby the stakeholders revealed the relative importance, represented as weights, of eight criteria for choosing or recommending knee OA interventions. Using data from an OA clinical guideline, 15 recommended interventions were rated on the criteria and ranked by their total scores, calculated by summing the corresponding weights. Associations between the weights and stakeholder groups were explored using regression analysis. Results: Participants comprised 58 consumers with OA, 5 Maori health advocates, 79 healthcare providers, 24 policy-informants and 12 OA-researchers (N = 178; 63% female, [mean age±SD] 54 ± 13 years). Mean weights on the eight criteria, in decreasing order of importance, are: recommendation: 19.0%; quality of evidence: 17.7%; effectiveness: 15.0%; duration of effect: 13.2%; risk of serious harm: 12.8%; risk of mild/moderate side-effects: 9.4%; cost: 6.6%; and accessibility: 6.3%. For first-, second- and third-line OA interventions respectively, all land-based exercise (total score = 71.7%), NSAIDs (topical) (74.2%) and total joint replacement (74.3%) were ranked first. At all care phases, the recommended core interventions of weight management and self-management education ranked between 11th and 15th (48.0%-56.0%). Regression analysis identified only small differences in weights (≤5.7%; p < 0.01) between stakeholder groups. Conclusions: Not all recommended core interventions are preferred by cross-sectoral stakeholders, which may represent a barrier to their uptake. Stakeholders' preferences do not appreciably differ by stakeholder group.

The cost-effectiveness of recommended adjunctive interventions for knee osteoarthritis: Results from a computer simulation model.

Objective: To estimate the potential lifetime health gains, healthcare costs, and cost-effectiveness of recommended adjunctive treatments for knee osteoarthritis delivered in addition to established core treatments, relative to core treatment only, from the perspective of the New Zealand (NZ) healthcare sector. Design: Recommended adjunctive knee osteoarthritis treatments were identified in clinical practice guidelines. Evidence of effectiveness was sourced from existing systematic reviews and meta-analyses. Treatment costs were calculated by applying local reference prices to estimated resource use. We used a validated computer simulation model of the impacts of knee osteoarthritis to estimate the cost-effectiveness of each adjunctive treatment at willingness-to-pay thresholds of one (primary), two, and three times per-capita GDP ($NZ52 300). Results: Data were collected on nine recommended adjunctive treatments: aquatic-based exercise, heat therapy, massage therapy, walking cane, cognitive behavioural therapy (CBT), topical non-steroidal anti-inflammatory drugs (NSAIDs), oral NSAIDs, intra-articular corticosteroids, and duloxetine. Relative to core treatments only, walking cane and heat therapy were cost-saving and provided greater QALYs; aquatic exercise and intra-articular corticosteroids were also cost-effective at all WTP thresholds. Topical NSAIDs and CBT were cost-effective only at higher WTP thresholds, while duloxetine, massage therapy, and oral NSAIDs were not cost-effective at any relevant threshold. Results were generally robust to varying modelling assumptions, although topical and oral NSAIDs and CBT became cost-effective in some scenarios. Conclusions: Delivering high-value, low-cost adjunctive interventions for knee osteoarthritis, alongside recommended core treatment, could deliver substantial health gains at low cost to the health system.

The projected burden of knee osteoarthritis in New Zealand: healthcare expenditure and total joint replacement provision.

AIM: To estimate the healthcare costs and demand for total knee replacement (TKR) associated with knee osteoarthritis in New Zealand over the period 2013-2038 and the contribution of increasing obesity rates to these costs. METHOD: We used the NZ-MOA computer simulation model of knee osteoarthritis in the New Zealand population. Osteoarthritis-related healthcare costs and TKR incidence were modelled for a 25-year horizon, for a starting cohort drawn from the 2013 New Zealand population. Population obesity projections were used to estimate the life-course of cohort obesity. Per-person projected outcomes were multiplied by national demographic population projections to obtain total population projections. RESULTS: Healthcare costs of knee osteoarthritis were projected to increase from NZ$199 million in 2013 to $370 million in 2038. Annual TKR incidence was projected to increase from 5,070 to 9,040 over the same period. Projected increases in population obesity rates (above the obesity prevalence seen in 2013) accounted for 25% and 47% of the projected increase in per-capita healthcare costs and TKR provision rates, respectively. CONCLUSION: The healthcare burden of knee OA will continue to increase for the foreseeable future. Public health measures to reduce further increases in population obesity rates would contribute to slowing this rising burden.

The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: A pragmatic cluster-randomised controlled trial.

BACKGROUND: Effective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control). METHODS AND FINDINGS: This pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI -0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices. CONCLUSIONS: Findings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP. TRIAL REGISTRATION: ACTRN12616000888460.

Implementation of a 'Joint Clinic' to resolve unmet need for orthopaedic services in patients with hip and knee osteoarthritis: a program evaluation.

BACKGROUND: Osteoarthritis is the most common form of arthritis, principally affecting the older population. Highly prevalent, disabling diseases such as osteoarthritis strain the capacity of health systems, and can result in unmet need for services. The Joint Clinic was initiated to provide secondary care consultations and access to outpatient services for people with advanced hip or knee osteoarthritis, who were referred by their general practitioner for orthopaedic consultation but not offered an orthopaedic specialist appointment. METHODS: This longitudinal programme evaluation comprised four components: a proof-of-concept evaluation; an implementation evaluation; a process evaluation; and an outcomes evaluation. Interviews and surveys of general practitioners, staff, and patients were conducted pre- and post-implementation. Interviews were transcribed, and thematic analysis was completed. In addition, Joint Clinic patient visits and outcomes were reviewed. RESULTS: One hundred and eleven primary care physicians (GPs) and 66 patients were surveyed, and 28 semi-structured interviews of hospital staff and GPs were conducted. Proof of concept was satisfied. Interim and final implementation evaluations indicated adherence to the concept model, high levels of acceptance of and confidence in the programme and its staff, and timely completion within budget. Process evaluation revealed positive impacts of the programme and positive stakeholder perceptions, with some weaknesses in communication to the outer context of primary care. The Joint Clinic saw a total of 637 patient visits during 2 years of operation. Unmet need was reduced by 90%. Patient and referring physician satisfaction was high. Hospital management confirmed that the programme will continue. CONCLUSIONS: This evaluation indicates that the Joint Clinic concept model is fit for purpose, functioned well within the organisation, and achieved its primary objective of reducing unmet need of secondary care consultation for those suffering advanced hip or knee osteoarthritis.

Associations between Health Assessment Questionnaire Disability Index and physical performance in rheumatoid arthritis and osteoarthritis.

OBJECTIVES: To investigate whether the Health Assessment Questionnaire Disability Index (HAQ-DI) reflects objective measures of physical function in people with osteoarthritis (OA) and rheumatoid arthritis (RA). METHODS: In total, 139 people, 71 with RA fulfilling the American College of Rheumatology (ACR) criteria (1987) and 68 with OA fulfilling ACR criteria for OA of the hip or knee, completed the HAQ-DI. Physical function was assessed using Timed Up and Go (TUG), 30 seconds Sit to Stand (STS), grip strength dynamometry and pedometer steps over 7 days. RESULTS: The strongest association with HAQ-DI was with the TUG (R2 of 0.671 and 0.512 in RA and OA groups, respectively). HAQ-DI and STS showed a non-linear association in both groups with R2 of 0.380 in RA and 0.359 in OA. A strong association was found between HAQ-DI and grip strength in the OA group (R2  = 0.681), whereas the RA group showed a moderate association (R2  = 0.285). There was a strong association between the HAQ-DI and pedometer measures in RA (R2  = 0.562), although this association was weak in OA (R2  = 0.156). CONCLUSION: The HAQ-DI has a strong association with the TUG in both RA and OA. There was variable association between the HAQ-DI and other physical performance measures, as well as differences between the RA and OA cohorts. In order to form a full and accurate clinical picture, health professionals should perform both subjective patient-reported outcome measures and objective physical performance measures of disability.

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. METHODS/DESIGN: This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. DISCUSSION: In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

Exercise and load modification versus corticosteroid injection versus 'wait and see' for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial.

BACKGROUND: Lateral hip pain is common, particularly in females aged 40-60 years. The pain can affect sleep and daily activities, and is frequently recalcitrant. The condition is often diagnosed as trochanteric bursitis, however radiological and surgical studies have revealed that the most common pathology is gluteus medius/minimus tendinopathy. Patients are usually offered three treatment options: (a) corticosteroid injection (CSI), (b) physiotherapy, or (c) reassurance and observation. Research on Achilles and patellar tendons has shown that load modification and exercise appears to be more effective than other treatments for managing tendinopathy, however, it is unclear whether a CSI, or a load modification and exercise-based physiotherapy approach is more effective in gluteal tendinopathy. This randomised controlled trial aims to compare the efficacy on pain and function of a load modification and exercise-based programme with a CSI and a 'wait and see' approach for gluteal tendinopathy. METHODS: Two hundred one people with gluteal tendinopathy will be randomly allocated into one of three groups: (i) CSI; (ii) physiotherapist-administered load modification and exercise intervention; and (iii) wait and see approach. The CSI therapy will consist of one ultrasound (US) guided CSI around the affected tendons and advice on tendon care. Education about load modification will be delivered in physiotherapy clinics and the exercise programme will be both home-based and supervised. The group allocated the wait and see approach will receive basic tendon care advice and reassurance in a single session by a trial physiotherapist. Outcomes will be evaluated at baseline, 4, 8, 12, 26 and 52 weeks using validated global rating of change, pain and physical function scales, psychological measures, quality of life and physical activity levels. Hip abductor muscle strength will be measured at baseline and 8 weeks. Economic evaluation will be performed to investigate the cost-effectiveness of the active interventions compared with the wait and see approach. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models and the economic evaluation will report incremental cost-utility ratios. The trial reporting will comply with CONSORT guidelines. DISCUSSION: This study will provide clinicians with directly applicable evidence of the relative efficacy of three common approaches to the management of gluteal tendinopathy. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12612001126808. Date Registered: 22/10/2012.