Budget impact of the Walk With Ease program for knee osteoarthritis.

Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers' funding decisions. Methods: We estimated changes in two-year healthcare costs with and without WWE. We used the Osteoarthritis Policy (OAPol) Model to estimate per-person medical expenditures. We estimated total and per-member-per-month (PMPM) costs of funding WWE for a hypothetical insurance plan with 75,000 members under two conditions: 1) all individuals aged 45+ with knee OA eligible for WWE, and 2) inactive and insufficiently active individuals aged 45+ with knee OA eligible. In sensitivity analyses, we varied WWE cost and efficacy and considered productivity costs. Results: With eligibility unrestricted by activity level, implementing WWE results in an additional $1,002,408 to the insurance plan over two years ($0.56 PMPM). With eligibility restricted to inactive and insufficiently active individuals, funding WWE results in an additional $571,931 over two years ($0.32 PMPM). In sensitivity analyses, when per-person costs of $10 to $1000 were added with 10-50% decreases in failure rate (enhanced sustainability of WWE benefits), two-year budget impact varied from $242,684 to $6,985,674 with unrestricted eligibility and from -$43,194 (cost-saving) to $4,484,122 with restricted eligibility. Conclusion: Along with the cost-effectiveness of WWE at widely accepted willingness-to-pay thresholds, these results can inform payers in deciding to fund WWE. In the absence of accepted thresholds to define affordability, these results can assist in comparing the affordability of WWE with other behavioral interventions.

Incorporating polygenic risk into the Leicester Risk Assessment score for 10-year risk prediction of type 2 diabetes.

AIMS: We evaluated whether incorporating information on ethnic background and polygenic risk enhanced the Leicester Risk Assessment (LRA) score for predicting 10-year risk of type 2 diabetes. METHODS: The sample included 202,529 UK Biobank participants aged 40-69 years. We computed the LRA score, and developed two new risk scores using training data (80% sample): LRArev, which incorporated additional information on ethnic background, and LRAprs, which incorporated polygenic risk for type 2 diabetes. We assessed discriminative and reclassification performance in a test set (20% sample). Type 2 diabetes was ascertained using primary care, hospital inpatient and death registry records. RESULTS: Over 10 years, 7,476 participants developed type 2 diabetes. The Harrell's C indexes were 0.796 (95% Confidence Interval [CI] 0.785, 0.806), 0.802 (95% CI 0.792, 0.813), and 0.829 (95% CI 0.820, 0.839) for the LRA, LRArev and LRAprs scores, respectively. The LRAprs score significantly improved the overall reclassification compared to the LRA (net reclassification index [NRI] = 0.033, 95% CI 0.015, 0.049) and LRArev (NRI = 0.040, 95% CI 0.024, 0.055) scores. CONCLUSIONS: Polygenic risk moderately improved the performance of the existing LRA score for 10-year risk prediction of type 2 diabetes.

Cost-Effectiveness of Community-Based Diet and Exercise for Patients with Knee Osteoarthritis and Obesity or Overweight.

OBJECTIVE: Obesity exacerbates pain and functional limitation in persons with knee osteoarthritis (OA). In the Weight Loss and Exercise for Communities with Arthritis in North Carolina (WE-CAN) study, a community-based diet and exercise (D + E) intervention led to an additional 6 kg weight loss and 20% greater pain relief in persons with knee OA and body mass index (BMI) >27 kg/m2 relative to a group-based health education (HE) intervention. We sought to determine the incremental cost-effectiveness of the usual care (UC), UC + HE, and UC + (D + E) programs, comparing each strategy with the "next-best" strategy ranked by increasing lifetime cost. METHODS: We used the Osteoarthritis Policy Model to project long-term clinical and economic benefits of the WE-CAN interventions. We considered three strategies: UC, UC + HE, and UC + (D + E). We derived cohort characteristics, weight, and pain reduction from the WE-CAN trial. Our outcomes included quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios (ICERs). RESULTS: In a cohort with mean age 65 years, BMI 37 kg/m2, and Western Ontario and McMaster Universities Osteoarthritis Index pain score 38 (scale 0-100, 100 = worst), UC leads to 9.36 QALYs/person, compared with 9.44 QALYs for UC + HE and 9.49 QALYS for UC + (D + E). The corresponding lifetime costs are $147,102, $148,139, and $151,478. From the societal perspective, UC + HE leads to an ICER of $12,700/QALY; adding D + E to UC leads to an ICER of $61,700/QALY. CONCLUSION: The community-based D + E program for persons with knee OA and BMI >27kg/m2 could be cost-effective for willingness-to-pay thresholds greater than $62,000/QALY. These findings suggest that incorporation of community-based D + E programs into OA care may be beneficial for public health.

A perspective on the evolution of semi-quantitative MRI assessment of osteoarthritis: Past, present and future.

OBJECTIVE: This perspective describes the evolution of semi-quantitative (SQ) magnetic resonance imaging (MRI) in characterizing structural tissue pathologies in osteoarthritis (OA) imaging research over the last 30 years. METHODS: Authors selected representative articles from a PubMed search to illustrate key steps in SQ MRI development, validation, and application. Topics include main scoring systems, reading techniques, responsiveness, reliability, technical considerations, and potential impact of artificial intelligence (AI). RESULTS: Based on original research published between 1993 and 2023, this article introduces available scoring systems, including but not limited to Whole-Organ Magnetic Resonance Imaging Score (WORMS) as the first system for whole-organ assessment of the knee and the now commonly used MRI Osteoarthritis Knee Score (MOAKS) instrument. Specific systems for distinct OA subtypes or applications have been developed as well as MRI scoring instruments for other joints such as the hip, the fingers or thumb base. SQ assessment has proven to be valid, reliable, and responsive, aiding OA investigators in understanding the natural history of the disease and helping to detect response to treatment. AI may aid phenotypic characterization in the future. SQ MRI assessment's role is increasing in eligibility and safety evaluation in knee OA clinical trials. CONCLUSIONS: Evidence supports the validity, reliability, and responsiveness of SQ MRI assessment in understanding structural aspects of disease onset and progression. SQ scoring has helped explain associations between structural tissue damage and clinical manifestations, as well as disease progression. While AI may support human readers to more efficiently perform SQ assessment in the future, its current application in clinical trials still requires validation and regulatory approval.

Lessons learnt from a nationally funded training and mentoring programme for early-mid career musculoskeletal researchers in Australia.

INTRODUCTION: Quality training and mentoring are crucial components of successful career development for early mid career researchers (EMCRs). This paper describes the overarching framework of novel ongoing national Training and Mentoring Programme Melbourne University Sydney Queensland:Impact (MUSQ:Impact) for musculoskeletal researchers, including a description of how it was set up and established, and lessons learned from its implementation. RESULTS: The MUSQ:Impact programme spans four multidisciplinary musculoskeletal research teams across three universities in Australia, comprising 40-60 EMCR members. It was established to provide EMCRs with a unique learning environment and opportunities to gain exposure to, and network with, other national musculoskeletal research teams. Specific goals are to focus on core research competencies (e.g. writing skills, managing grant budgets, public speaking and media engagement, research translation), provide career mentoring, fund development activities (e.g. conference attendance, laboratory visits, skill development courses), and share training resources (e.g. data dictionaries, project summaries). A Steering Committee of 10-12 EMCR members, co-chaired by a senior researcher and one EMCR, is responsible for overseeing MUSQ:Impact and organising regular activities, including a monthly webinar series, a mentor/mentee scheme, annual group research retreats, annual infographic competition, and funding awards. An evaluation survey found that most participants perceived each activity to be beneficial and of value to their research career and development. CONCLUSION: This paper presents the structure of national training and mentoring programme that serves as a potential template for other research teams to adapt within their own contexts.

Assessment of Pain in Osteoarthritis of the Knee.

Knee osteoarthritis (KOA) pain is a subjective and personal experience, making it challenging to characterise patients' experiences and assess their pain. In addition, there is no global standard for the assessment of pain in KOA. Therefore, this article examines the possible methods of assessing and characterising pain in patients with KOA using clinical symptoms, pain assessment tools, and imaging. We examine the current methods of assessment of pain in KOA and their application in clinical practice and clinical trials. Furthermore, we explore the possibility of creating individualised pain management plans to focus on different pain characteristics. With better evaluation and standardisation of pain assessment in these patients, it is hoped that patients would benefit from improved quality of life. At the same time, improvement in pain assessment would enable better data collection regarding symptom response in clinical trials for the treatment of osteoarthritis.

Walk with ease for knee osteoarthritis: A cost-effectiveness analysis.

Objective: The Walk With Ease (WWE) program was developed by the Arthritis Foundation to help people with arthritis learn to exercise safely and improve arthritis symptoms. We sought to establish the value of the WWE program. Methods: We used the Osteoarthritis Policy (OAPol) Model, a widely published and validated computer simulation of knee osteoarthritis (OA), to assess the cost-effectiveness of WWE in knee OA. We derived model inputs using data from a workplace wellness initiative in Montana that offered WWE to state employees. Our primary outcomes were quality-adjusted life years (QALYs) and costs over a 2-year period, which we used to calculate the incremental cost-effectiveness ratio (ICER). The base case analysis was restricted to subjects who were inactive or insufficiently active (<180 â€‹min/week of PA) at baseline. We performed scenario and probabilistic sensitivity analyses to determine the impact of uncertainty in model parameters on our results. Results: In the base case analysis, adding WWE to usual care resulted in an ICER of $47,900/QALY. When the program was offered without preselection by baseline activity level, the ICER for WWE â€‹+ â€‹usual care was estimated at $83,400/QALY. Results of the probabilistic sensitivity analysis indicated that WWE offered to inactive or insufficiently active individuals has a 52% chance of having an ICER <$50,000/QALY. Conclusion: The WWE program offers good value for inactive/insufficiently active individuals. Payers may consider including such a program to increase physical activity in individuals with knee OA.

Cost-Effectiveness of Weight-Loss Interventions Prior to Total Knee Replacement for Patients With Class III Obesity.

OBJECTIVE: Class III obesity (body mass index >40 kg/m2 ) is associated with higher complications following total knee replacement (TKR), and weight loss is recommended. We aimed to establish the cost-effectiveness of Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (LSG), and lifestyle nonsurgical weight loss (LNSWL) interventions in knee osteoarthritis patients with class III obesity considering TKR. METHODS: Using the Osteoarthritis Policy model and data from published literature to derive model inputs for RYGB, LSG, LNSWL, and TKR, we assessed the long-term clinical benefits, costs, and cost-effectiveness of weight-loss interventions for patients with class III obesity considering TKR. We assessed the following strategies with a health care sector perspective: 1) no weight loss/no TKR, 2) immediate TKR, 3) LNSWL, 4) LSG, and 5) RYGB. Each weight-loss strategy was followed by annual TKR reevaluation. Primary outcomes were cost, quality-adjusted life expectancy (QALE), and incremental cost-effectiveness ratios (ICERs), discounted at 3% per year. We conducted deterministic and probabilistic sensitivity analyses to examine the robustness of conclusions to input uncertainty. RESULTS: LSG increased QALE by 1.64 quality-adjusted life-years (QALYs) and lifetime medical costs by $17,347 compared to no intervention, leading to an ICER of $10,600/QALY. RYGB increased QALE by 0.22 and costs by $4,607 beyond LSG, resulting in an ICER of $20,500/QALY. Relative to immediate TKR, LSG and RYGB delayed and decreased TKR utilization. In the probabilistic sensitivity analysis, RYGB was cost-effective in 67% of iterations at a willingness-to-pay threshold of $50,000/QALY. CONCLUSION: For patients with class III obesity considering TKR, RYGB provides good value while immediate TKR without weight loss is not economically efficient.

Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity.

OBJECTIVE: Class III obesity (body mass index [BMI] ≥40 kg/m2 ) is associated with worse knee pain and total knee replacement (TKR) outcomes. Because bariatric surgery yields sustainable weight loss for individuals with BMI ≥40 kg/m2 , our objective was to establish the value of Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) in conjunction with usual care for knee osteoarthritis (OA) patients with BMI ≥40 kg/m2 . METHODS: We used the Osteoarthritis Policy model to assess long-term clinical benefits, costs, and cost-effectiveness of RYGB and LSG. We derived model inputs for efficacy, costs, and complications associated with these treatments from published data. Primary outcomes included quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3%/year. This analysis was conducted from a health care sector perspective. We performed sensitivity analyses to evaluate uncertainty in input parameters. RESULTS: The usual care + RYGB strategy increased the quality-adjusted life expectancy by 1.35 years and lifetime costs by $7,209, compared to usual care alone (ICER = $5,300/QALY). The usual care + LSG strategy yielded less benefit than usual care + RYGB and was dominated. Relative to usual care alone, both usual care + RYGB and usual care + LSG reduced opioid use from 13% to 4%, and increased TKR usage from 30% to 50% and 41%, respectively. For cohorts with BMI between 38 and 41 kg/m2 , usual care + LSG dominated usual care + RYGB. In the probabilistic sensitivity analysis, at a willingness-to-pay threshold of $50,000/QALY, usual care + RYGB and usual care + LSG were cost-effective in 70% and 30% of iterations, respectively. CONCLUSION: RYGB offers good value among knee OA patients with BMI ≥40 kg/m2 , while LSG may provide good value among those with BMI between 35 and 41 kg/m2 .

Automated volumetric and statistical shape assessment of cam-type morphology of the femoral head-neck region from clinical 3D magnetic resonance images.

Background: Femoroacetabular impingement (FAI) cam morphology is routinely assessed using manual measurements of two-dimensional (2D) alpha angles which are prone to high rater variability and do not provide direct three-dimensional (3D) data on these osseous formations. We present CamMorph, a fully automated 3D pipeline for segmentation, statistical shape assessment and measurement of cam volume, surface area and height from clinical magnetic resonance (MR) images of the hip in FAI patients. Methods: The novel CamMorph pipeline involves two components: (I) accurate proximal femur segmentation generated by combining the 3D U-net to identify both global (region) and local (edge) features in clinical MR images and focused shape modelling to generate a 3D anatomical model for creating patient-specific proximal femur models; (II) patient-specific anatomical information from 3D focused shape modelling to simulate 'healthy' femoral bone models with cam-affected region constraints applied to the anterosuperior femoral head-neck region to quantify cam morphology in FAI patients. The CamMorph pipeline, which generates patient-specific data within 5 min, was used to analyse multi-site clinical MR images of the hip to measure and assess cam morphology in male (n=56) and female (n=41) FAI patients. Results: There was excellent agreement between manual and CamMorph segmentations of the proximal femur as demonstrated by the mean Dice similarity index (DSI; 0.964±0.006), 95% Hausdorff distance (HD; 2.123±0.876 mm) and average surface distance (ASD; 0.539±0.189 mm) values. Compared to female FAI patients, male patients had a significantly larger median cam volume (969.22 vs. 272.97 mm3, U=240.0, P<0.001), mean surface area [657.36 vs. 306.93 mm2, t(95)=8.79, P<0.001], median maximum-height (3.66 vs. 2.15 mm, U=407.0, P<0.001) and median average-height (1.70 vs. 0.86 mm, U=380.0, P<0.001). Conclusions: The fully automated 3D CamMorph pipeline developed in the present study successfully segmented and measured cam morphology from clinical MR images of the hip in male and female patients with differing FAI severity and pathoanatomical characteristics.

Does Screening for Depressive Symptoms Help Optimize Duloxetine Use in Knee Osteoarthritis Patients With Moderate Pain? A Cost-Effectiveness Analysis.

OBJECTIVE: Duloxetine is a treatment approved by the US Food and Drug Administration for both osteoarthritis (OA) pain and depression, though uptake of duloxetine in knee OA management varies. We examined the cost-effectiveness of adding duloxetine to knee OA care in the absence or presence of depression screening. METHODS: We used the Osteoarthritis Policy Model, a validated computer microsimulation of knee OA, to examine the value of duloxetine for patients with knee OA who have moderate pain by comparing 3 strategies: 1) usual care, 2) usual care plus duloxetine for patients who screen positive for depression on the Patient Health Questionnaire 9 (PHQ-9), and 3) usual care plus universal duloxetine. Outcome measures included quality-adjusted life years (QALYs), lifetime direct medical costs, and incremental cost-effectiveness ratios (ICERs), discounted at 3% annually. Model inputs, drawn from the published literature and national databases, included annual cost of duloxetine ($721-937); average pain reduction for duloxetine (17.5 points on the Western Ontario and McMaster Universities Osteoarthritis Index pain scale [0-100]), and likelihood of depression remission with duloxetine (27.4%). We considered 2 willingness-to-pay (WTP) thresholds of $50,000/QALY and $100,000/QALY. We varied parameters related to the PHQ-9 and the cost of duloxetine, efficacy, and toxicities to address uncertainty in model inputs. RESULTS: The screening strategy led to an additional 17 QALYs per 1,000 subjects and increased costs by $289/subject (ICER = $17,000/QALY). Universal duloxetine led to an additional 31 QALYs per 1,000 subjects and $1,205 per subject (ICER = $39,300/QALY). Under the majority of sensitivity analyses, universal duloxetine was cost-effective at the $100,000/QALY threshold. CONCLUSION: The addition of duloxetine to usual care for knee OA patients with moderate pain, regardless of depressive symptoms, is cost-effective at frequently used WTP thresholds.

Societal Cost of Opioid Use in Symptomatic Knee Osteoarthritis Patients in the United States.

OBJECTIVE: Symptomatic knee osteoarthritis (SKOA) is a chronic, disabling condition, requiring long-term pain management; over 800,000 SKOA patients in the US use opioids on a prolonged basis. We aimed to characterize the societal economic burden of opioid use in this population. METHODS: We used the Osteoarthritis Policy Model, a validated computer simulation of SKOA, to estimate the opioid-related lifetime and annual cost generated by the US SKOA population. We included direct medical, lost productivity, criminal justice, and diversion costs. We modeled the SKOA cohort with a mean ± SD age of 54 ± 14 years and Western Ontario and McMaster Universities Osteoarthritis Index pain score of 29 ± 17 (0-100, 100 = worst). We estimated annual costs of strong ($1,381) and weak ($671) opioid regimens using Medicare fee schedules, Red Book, the Federal Supply Schedule, and published literature. The annual lost productivity and criminal justice costs of opioid use disorder (OUD), obtained from published literature, were $11,387 and $4,264, per-person, respectively. The 2015-2016 Medicare Current Beneficiary Survey provided OUD prevalence. We conducted sensitivity analyses to examine the robustness of our estimates to uncertainty in input parameters. RESULTS: Assuming 5.1% prevalence of prolonged strong opioid use, the total lifetime opioid-related cost generated by the US SKOA population was estimated at $14.0 billion, of which only $7.45 billion (53%) were direct medical costs. CONCLUSION: Lost productivity, diversion, and criminal justice costs comprise approximately half of opioid-related costs generated by the US SKOA population. Reducing prolonged opioid use may lead to a meaningful reduction in societal costs that can be used for other public health causes.

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

INTRODUCTION: Knee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months. METHODS AND ANALYSIS: The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat. ETHICS AND DISSEMINATION: This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

Participatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: protocol of the PATHway trial.

INTRODUCTION: Postsurgical rehabilitation is critical for optimal recovery in people undergoing orthopaedic surgery. Currently, knee and lumbar spine postsurgical care is not standardised, economically sustainable, nor based on quality evidence, contributing to substantial clinical variation, poor outcomes and increasing healthcare costs. This protocol describes the design of a randomised controlled trial aiming to evaluate the effectiveness and cost-effectiveness of a postsurgical clinical pathway augmented by disruptive technology and compared with standardised rehabilitation alone, in decreasing pain and improving function after total knee replacement (TKR) or lumbar laminectomy (with or without fusion). METHODS: An assessor-blinded, parallel group, randomised controlled trial will be conducted to recruit 204 consenting participants (102 per arm) of whom 50% are undergoing TKR and 50% lumbar surgery. The intervention group will receive a 6-month technology-enabled rehabilitation package in addition to usual postsurgical care. The package includes (1) an exercise program delivered via the Physitrack app on the iPad, (2) a health-coaching program delivered via video calls and motivational messages, (3) use of physical activity tracker with goal setting and motivational reminders (Fitbit). For those undergoing TKR, the intervention will also include knee joint range of motion self-monitoring via the Goniometer app. The control group will receive usual postsurgical care. Participants will be followed up at 3, 6 and 12 months from the enrolment date. The primary outcome is pain measured with the Numerical Rating Scale at 3 months. Secondary outcomes include pain-related disability, quality of life, computer self-efficacy, physical activity participation and sedentary behaviour. Data analysis will be blinded and by intention-to-treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life-year gained. ETHICS AND DISSEMINATION: This protocol is approved by the human research ethics committee of the University of Sydney. Dissemination will occur through lay summary, infographics, conferences and journal publications. TRIAL REGISTRATION NUMBER: ACTRN12618001448235.

Implementation of Best-Evidence Osteoarthritis Care: Perspectives on Challenges for, and Opportunities From, Low and Middle-Income Countries.

The "Joint Effort Initiative" (JEI) is an international consortium of clinicians, researchers, and consumers under the auspices of the Osteoarthritis Research Society International (OARSI). The JEI was formed with a vision to improve the implementation of coordinated programs of best evidence osteoarthritis care globally. To better understand some of the issues around osteoarthritis care in low- and middle-income countries (LMICs), the JEI invited clinician researcher representatives from South Africa, Brazil, and Nepal to discuss their perspectives on challenges and opportunities to implementing best-evidence osteoarthritis care at the OARSI World Pre-Congress Workshop. We summarize and discuss the main themes of the presentations in this paper. The challenges to implementing evidence-based osteoarthritis care identified in LMICs include health inequities, unaffordability of osteoarthritis management and the failure to recognize osteoarthritis as an important disease. Fragmented healthcare services and a lack of health professional knowledge and skills are also important factors affecting osteoarthritis care in LMICs. We discuss considerations for developing strategies to improve osteoarthritis care in LMICs. Existing opportunities may be leveraged to facilitate the implementation of best-evidence osteoarthritis care. We also discuss strategies to support the implementation, such as the provision of high-quality healthcare professional and consumer education, and systemic healthcare reforms.

PARTNER: a service delivery model to implement optimal primary care management of people with knee osteoarthritis: description of development.

OBJECTIVE: Implementation strategies, such as new models of service delivery, are needed to address evidence practice gaps. This paper describes the process of developing and operationalising a new model of service delivery to implement recommended care for people with knee osteoarthritis (OA) in a primary care setting. METHODS: Three development stages occurred concurrently and iteratively. Each stage considered the healthcare context and was informed by stakeholder input. Stage 1 involved the design of a new model of service delivery (PARTNER). Stage 2 developed a behavioural change intervention targeting general practitioners (GPs) using the behavioural change wheel framework. In stage 3, the 'Care Support Team' component of the service delivery model was operationalised. RESULTS: The focus of PARTNER is to provide patients with education, exercise and/or weight loss advice, and facilitate effective self-management through behavioural change support. Stage 1 model design: based on clinical practice guidelines, known evidence practice gaps in current care, chronic disease management frameworks, input from stakeholders and the opportunities and constraints afforded by the Australian primary care context, we developed the PARTNER service-delivery model. The key components are: (1) an effective GP consultation and (2) follow-up and ongoing care provided remotely (telephone/email/online resources) by a 'Care Support Team'. Stage 2 GP behavioural change intervention: a multimodal behavioural change intervention was developed comprising a self-audit/feedback activity, online professional development and desktop software to provide decision support, patient information resources and a referral mechanism to the 'Care Support Team'. Stage 3 operationalising the 'care support team'-staff recruited and trained in evidence-based knee OA management and behavioural change methodology. CONCLUSION: The PARTNER model is the result of a comprehensive implementation strategy development process using evidence, behavioural change theory and intervention development guidelines. Technologies for scalable delivery were harnessed and new primary evidence was generated as part of the process.Trial registration number ACTRN12617001595303 (UTN U1111-1197-4809).

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial.

BACKGROUND: Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. METHODOLOGY: Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS4) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS4 is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated. DISCUSSION: CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03809975 . Registered January 182,019.