Co-designing a Canadian adaptation of a lifestyle-oriented intervention aimed to improve daily functioning of individuals living with chronic pain: a multi-method study protocol of REVEAL(OT) Canada.

Background: Living with chronic pain (CP) often implies major lifestyle changes, including modifications of daily routines and work. Surprisingly, few validated and effective interventions specifically target functional outcomes in this population. Redesign your Everyday Activities and Lifestyle with Occupational Therapy [REVEAL(OT)] is a lifestyle-oriented intervention led by occupational therapists that directly targets the daily functional challenges of living with CP. The intervention was initially developed and studied as an add-on to standard treatment delivered by Danish multidisciplinary specialized pain clinics. Adapting, implementing, and evaluating REVEAL(OT) within the Canadian healthcare system will contribute to broadening the scope of treatments offered in specialized pain clinics that do not yet include occupational therapy. Objective: The proposed study aims to define and refine REVEAL(OT)/CA with partners (authors of original intervention, people with lived experience, clinicians, managers). Methods: This participatory action research will use a multi-method design and follow the ORBIT model for developing behavioral treatments for chronic diseases. A process of co-construction with partners and an advisory committee will take place in two Montreal specialized pain clinics. It consists of two related work packages (WPs). In WP1, a first series of focus groups with partners (n = 86) and workshops with the advisory committee will be conducted to co-develop the hypothetical pathway describing intervention components and their potential mechanisms of action on targeted outcomes, as well as the first version of the adapted intervention manual. WP2 will co-refine REVEAL(OT)/CA by exploring its acceptability, feasibility and mechanisms of action through intervention deliveries (at least twice in each of two specialized pain clinics; n ≥ 60 patients) and focus groups and/or individual interviews with participating patients and partners. At the end of this study, the intervention manual will be generated both in French and English. Discussion: This study will set the stage for subsequent implementation and effectiveness assessment projects and be an important step towards the deployment of interventions aiming to improve engagement in meaningful daily activities among adults living with CP. Registration: OSF Registries, osf.io/8gksa. Registered 3 August 2023, https://osf.io/8gksa.

Evaluating Osteoarthritis Management Programs: outcome domain recommendations from the OARSI Joint Effort Initiative.

OBJECTIVE: To develop sets of core and optional recommended domains for describing and evaluating Osteoarthritis Management Programs (OAMPs), with a focus on hip and knee Osteoarthritis (OA). DESIGN: We conducted a 3-round modified Delphi survey involving an international group of researchers, health professionals, health administrators and people with OA. In Round 1, participants ranked the importance of 75 outcome and descriptive domains in five categories: patient impacts, implementation outcomes, and characteristics of the OAMP and its participants and clinicians. Domains ranked as "important" or "essential" by ≥80% of participants were retained, and participants could suggest additional domains. In Round 2, participants rated their level of agreement that each domain was essential for evaluating OAMPs: 0 = strongly disagree to 10 = strongly agree. A domain was retained if ≥80% rated it ≥6. In Round 3, participants rated remaining domains using same scale as in Round 2; a domain was recommended as "core" if ≥80% of participants rated it ≥9 and as "optional" if ≥80% rated it ≥7. RESULTS: A total of 178 individuals from 26 countries participated; 85 completed all survey rounds. Only one domain, "ability to participate in daily activities", met criteria for a core domain; 25 domains met criteria for an optional recommendation: 8 Patient Impacts, 5 Implementation Outcomes, 5 Participant Characteristics, 3 OAMP Characteristics and 4 Clinician Characteristics. CONCLUSION: The ability of patients with OA to participate in daily activities should be evaluated in all OAMPs. Teams evaluating OAMPs should consider including domains from the optional recommended set, with representation from all five categories and based on stakeholder priorities in their local context.

Recommendations for the delivery of therapeutic exercise for people with knee and/or hip osteoarthritis. An international consensus study from the OARSI Rehabilitation Discussion Group.

OBJECTIVE: To develop evidence-informed recommendations to support the delivery of best practice therapeutic exercise for people with knee and/or hip osteoarthritis (OA). DESIGN: A multi-stage, evidence-informed, international multi-disciplinary consensus process that included: 1) a narrative literature review to synthesise existing evidence; 2) generation of evidence-informed proposition statements about delivery of exercise for people with knee and/or hip OA by an international multi-disciplinary expert panel, with statements refined and analysed thematically; 3) an e-Delphi survey with the expert panel to gain consensus on the most important statements; 4) a final round of statement refinement and thematic analysis to group remaining statements into domains. RESULTS: The expert panel included 318 members (academics, health care professionals and exercise providers, patient representatives) from 43 countries. Final recommendations comprised 54 specific proposition statements across 11 broad domains: 1) use an evidence-based approach; 2) consider exercise in the context of living with OA and pain; 3) undertake a comprehensive baseline assessment with follow-up; 4) set goals; 5) consider the type of exercise; 6) consider the dose of exercise; 7) modify and progress exercise; 8) individualise exercise; 9) optimise the delivery of exercise; 10) focus on exercise adherence; and 11) provide education about OA and the role of exercise. CONCLUSION: The breadth of issues identified as important by the international diverse expert panel highlights that delivering therapeutic exercise for OA is multi-dimensional and complex.

Changes in physical activity and the association between pain and physical activity - a longitudinal analysis of 17,454 patients with knee or hip osteoarthritis from the GLA:D® registry.

OBJECTIVE: Investigate change in physical activity following an 8-week education and exercise therapy program for patients with knee/hip osteoarthritis, focusing on those with low physical activity level. Furthermore, to evaluate associations between changes in pain intensity and physical activity. METHOD: Data from the Good Life with osteoArthritis in Denmark (GLA:D®) registry, at baseline, immediately after completion, and 12 months after entering the program was used. Measures of interest were UCLA activity scale (1-10) and Visual Analog Scale for pain intensity (0-100 mm). Changes in physical activity levels (low 1-4, moderate 5-6, and high 7-10) over three time points were investigated. Asymmetric fixed effects regression models were used to evaluate the association between clinically relevant change in pain (≥15 mm) and change in physical activity level from baseline to 12 months. RESULTS: 37% with low activity level at baseline (n = 4,836) and 69% of all patients (n = 17,454) reached or maintained at least a moderate physical activity level at follow-ups. Surprisingly, both an improvement (ß = 1.44, P < 0.001) and a worsening (ß = 1.18, P < 0.001) in pain intensity was associated with increased physical activity in low activity patients. For all patients a similar trend was observed (ß = 0.51, P < 0.001 and ß = 0.11, P = 0.215, respectively). CONCLUSION: In low active knee or hip OA patients, a third of patients participating in an education and exercise therapy program reached and maintained at least a moderate physical activity level for 1 year. The improvement in physical activity was not dependent on pain reduction.

Chronic opioid use before and after exercise therapy and patient education among patients with knee or hip osteoarthritis.

OBJECTIVE: To investigate changes in opioid use after supervised exercise therapy and patient education among knee or hip osteoarthritis patients with chronic opioid use. METHOD: In this cohort study, we linked data from the Good Life with osteoArthritis in Denmark register (GLA:D®; standardised treatment program for osteoarthritis; January 2013 to November 2018) with national health registries. Among 35,549 patients, 1,262 were classified as chronic opioid users based on amount and temporal distribution of dispensed opioids the year before the intervention. We investigated changes in opioid use, measured as mg oral morphine equivalents (OMEQs), from the year before the intervention to the year after using generalized estimating equations. RESULTS: We found a 10% decrease in mg OMEQs from the year before to the year after the intervention (incidence rate ratio [IRR]: 0.90, 95% confidence interval [CI]: 0.86, 0.94). Additional analyses suggested this decrease to be mainly attributable to regulatory actions targeting opioid prescribing during the study period (IRR among patients participating in the intervention before: 0.98 [95% CI: 0.89, 1.07] vs after: 0.83 [0.74, 0.93] regulatory actions). In a random general population sample of matched chronic opioid users, a similar opioid use pattern was observed over time, further supporting the impact of regulatory actions on the opioid use in the study population. CONCLUSION: Among patients with knee or hip osteoarthritis and chronic opioid use, a standardised treatment program did not change opioid use when regulatory changes in opioid prescribing were taken into account.

Knee and hip osteoarthritis are more alike than different in baseline characteristics and outcomes: a longitudinal study of 32,599 patients participating in supervised education and exercise therapy.

OBJECTIVE: Compare baseline characteristics and change in outcomes in patients with symptomatic knee or hip OA participating in patient education and exercise therapy. DESIGN: Longitudinal cohort study. Good Life with osteoArthritis in Denmark (GLA:D®) is an 8-week patient education and supervised exercise program delivered by certified clinicians. Changes in pain intensity, Knee injury/Hip disability Osteoarthritis Outcome Scores' subscale Quality of Life (K/HOOS QOL), EuroQoL 5-Dimensions 5-Level (EQ-5D) and 40 m walk test at ∼3 and 12 months were compared between knee and hip patients. RESULTS: 24,241 knee and 8,358 hip patients were included, with response rates of 75% and 60% at ∼3 and 12 months. Age, gender, symptom duration, pain medication use, pain intensity, physical function and quality of life were alike. More knee than hip patients were obese and had bilateral symptoms. At 3 months, clinically relevant improvements were seen in both knee and hip OA patients with clinically irrelevant between groups differences; 2.1 (1.5; 2.8) mm in pain intensity, -1.1 (-1.5; -0.7) point in K/HOOS QOL score, -0.010 (-0.013; -0.007) in EQ-5D index score and -0.02 (-0.02; -0.01) m/sec in walking speed. At 12 months the slight immediate differences were equalized. CONCLUSION: Patients presenting with knee and hip OA in primary care were on average more alike than different. Following treatment, clinically relevant improvements were seen in both knee and hip OA patients at 3 and 12 months. Patients with knee and hip OA should be prioritized alike for treatment with patient education and supervised exercise therapy.

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery.

BACKGROUND: Prehabilitation is a promising modality for improving patient-related outcomes after major surgery; however, very little research has been done for those who may need it the most: the elderly and the frail. This study aimed to investigate the feasibility of a short course multimodal prehabilitation prior to primary surgery in high-risk, frail patients with colorectal cancer and WHO performance status I and II. METHODS: The study was conducted as a single-center, prospective one-arm feasibility study of eight patients with colon cancer between October 4, 2018, and January 14, 2019. The intervention consisted of a physical training program tailored to the patients with both high-intensity interval training and resistance training three times a week in sessions of approximately 1 h in length, for a duration of at least 4 weeks, nutritional support with protein and vitamins, a consultation with a dietician, and medical optimization prior to surgery. Feasibility was evaluated regarding recruitment, retention, compliance and adherence, acceptability, and safety. Retention was evaluated as the number of patients that completed the intervention, with a feasibility goal of 75% completing the intervention. Compliance with the high-intensity training was evaluated as the number of sessions in which the patient achieved a minimum of 4 min > 90% of their maximum heart rate and adherence as the attended out of the offered training sessions. RESULTS: During the study period, 64 patients were screened for eligibility, and out of nine eligible patients, eight patients were included and seven completed the intervention (mean age 80, range 66-88). Compliance to the high-intensity interval training using 90% of maximum heart rate as the monitor of intensity was difficult to measure in several patients; however, adherence to the training sessions was 87%. Compliance with nutritional support was 57%. Half the patients felt somewhat overwhelmed by the multiple appointments and six out of seven reported difficulties with the dosage of protein. CONCLUSIONS: This one-arm feasibility study indicates that multimodal prehabilitation including high-intensity interval training can be performed by patients with colorectal cancer and WHO performance status I and II. TRIAL REGISTRATION: Clinicaltrials.gov : the study current feasibility study was conducted prior to the initiation of a full ongoing randomized trial registered by NCT04167436; date of registration: November 18, 2019. Retrospectively registered. No separate prospectively registration of the feasibility trial was conducted but outlined by the approved study protocol (Danish Scientific Ethical Committee SJ-607).

Cross-cultural translation and adaptation of the Danish version of the Fugl-Meyer assessment for post stroke sensorimotor function.

PURPOSE: The Fugl-Meyer assessment (FMA) is the most widely used and recommended clinical assessment scale for evaluating sensorimotor impairments in stroke patients, but an official Danish version has not been available. This study aimed to perform a standardized translation and cross-cultural adaptation (TCCA) of the FMA into Danish. METHODS: First, a comprehensive eight-step TCCA procedure including forward and backward translation and step-wise reviewing by proof-reader and bilingual physiotherapists, to ensure conceptual and semantic equivalence was applied to develop a Danish version of the FMA. Second, inter-rater reliability of the Danish FMA was assessed in 10 subacute stroke patients. Svensson's statistical method designed for rank-based paired ordinal data to identify items showing non-systematic or systematic disagreements in relative position or concentration was used to make further improvements on translation. RESULTS: A Danish FMA version was successfully made by the step-wise TCCA procedure. The clinical validation revealed satisfactory to excellent inter-tester reliability across all items (70-100%). Significant systematic disagreement either in position or concentration or both were observed in about 20% of the items. CONCLUSIONS: The Danish version of the FMA was translated and adapted allowing for a wider standardized use of the FMA in stroke rehabilitation in Denmark.Implications for rehabilitationThe Fugl-Meyer assessment (FMA) is the most used and recommended clinical assessment scale for evaluating sensorimotor impairments in stroke patients.The translated and adapted Danish version of the FMA is now available for use in research and clinical practice in Denmark.This allows for a standardized and unified description of stroke motor recovery and severity in neurorehabilitation nationwide as well as the possibility to compare and conduct trials using FMA internationally.

Clinicians' beliefs and attitudes to physical activity and exercise therapy as treatment for knee and/or hip osteoarthritis: a scoping review.

OBJECTIVE: To explore clinicians' attitudes and beliefs about physical activity and exercise therapy as treatment for individuals with knee and/or hip osteoarthritis (OA). METHOD: This was a scoping review, mapping available knowledge about the topic derived from qualitative research designs and methods. A comprehensive search of selected databases (MEDLINE, EMBASE; CINAHL; Web of Science) was conducted and data were analysed thematically. RESULTS: Twelve articles met inclusion criteria. Thematic analysis identified three interrelated main themes: 1) Understandings of OA and its trajectory and management; 2) Attitudes to activity and exercise as part of OA management; 3) Clinicians' perceived knowledge of and expertise in OA management. Findings highlight that many clinicians involved in knee/hip OA management, particularly general practitioners and physiotherapists, perceive OA to be a low priority 'wear-and-tear' disease with expected progression of symptoms, making joint replacement surgery eventually inevitable. Further, many clinicians appear to lack knowledge about and interest in physical activity and exercise therapy in the management of knee/hip OA, and seem to show uncertainty about the effectiveness and safety of physical activity and exercise therapy on joint health. CONCLUSION: Clinicians' attitudes and beliefs about physical activity and exercise therapy in OA seem to reflect an outdated narrative which describes OA as a wear-and-tear disease with inevitable disease progression to joint replacement surgery. Clinicians need to adopt a contemporary narrative, which accurately reflects current knowledge and evidence-based practice, thereby ensuring consistent utilisation of exercise therapy as first-line care as recommended in OA guidelines.

Symptoms of lumbar spinal stenosis in people with knee or hip osteoarthritis or low back pain: a cross-sectional study of 10,234 participants in primary care.

OBJECTIVE: The aims of this study were to evaluate: the proportion of people reporting symptoms associated with lumbar spinal stenosis (LSS) in primary care programs for knee or hip osteoarthritis (OA) or persistent low back pain (LBP) and; the prevalence of self-reported clinical LSS in these three cohorts, according to two sets of adapted criteria. METHOD: A cross-sectional analysis of baseline data from the Good Life with osteoArthritis in Denmark primary care programs. Self-report LSS symptom questions were administered to participants with knee OA, hip OA, and persistent LBP. The prevalence of eleven LSS symptoms and clinical LSS were calculated for each cohort. RESULTS: A total of 10,234 participants were included in the analysis. A similar proportion of participants in each cohort were female (69%), with a 6- and 7-year older mean age in the knee and hip cohorts compared to the back cohort. A greater proportion of participants with LBP reported LSS symptoms (range 11-71%) than in the hip (11-50%) and knee (8-40%) cohorts. This pattern was observed for all but one symptom. The same pattern was observed for the prevalence of clinical LSS with less than 10% of people in each cohort satisfying the clinical criteria. CONCLUSION: Self-reported LSS symptoms are commonly reported by people treated in primary care for knee or hip OA, although not as frequently as reported by those with LBP. Despite symptoms of LSS being common, only a small proportion of people were classified as having self-reported clinical LSS.

Neuromuscular Electric Stimulation in Addition to Exercise Therapy in Patients with Lower Extremity Paresis Due to Acute Ischemic Stroke. A proof-of-concept randomised controlled trial.

INTRODUCTION: Exercise therapy and neuromuscular electrical stimulation (NMES) during the initial 14 days after stroke may benefit recovery of gait. We aimed to determine whether poststroke NMES of vastus medial and tibial muscles during exercise therapy is more effective than exercise therapy alone. MATERIALS AND METHODS: In this proof-of-concept randomised trial patients with first-ever acute ischemic stroke and a leg paresis (40-85 years of age) were randomised (1:1) to 10 min of daily NMES + exercise therapy or exercise therapy alone. Primary outcome was the between-group difference in change in 6 min Walk Test (6MWT) at 90 days post stroke estimated with a mixed regression model. Secondary outcomes included 10 m Walk Test, Fugl-Meyer Motor Assessment, Guralnik Timed Standing Balance, Sit to Stand, Timed Up and Go, EQ-5D-5L, Montreal Cognitive Assessment and Becks Depression Inventory. RESULTS: 50 stroke survivors (25 in each group) with a mean age of 67 years (range 43-83) were included. An insignificant between-group difference in change of 28.3 m (95%CI -16.0 to 72.6, p = 0.23, adjusted for baseline) in 6MWT at 90-days follow-up was found, in favour of the NMES group. All secondary outcomes showed no statistically significant between-group difference. The conclusion was that adding NMES to exercise therapy had no effect on poststroke walking distance measured by the 6 MWT or any of the secondary outcomes. CONCLUSIONS: In this proof-of-concept RCT, we demonstrated that NMES in addition to exercise therapy during the first 14 days after onset of ischemic stroke did not improve walking distance or any of the secondary outcomes. Future studies with a longer trial period, stratifying patients into subgroups with comparable patterns of expected spontaneous recovery - if possible within 48 h post stroke, and greater sample size, than in this study are suggestions of how rehabilitation research could go on exploring the potential for NMES as an amplifier in stroke recovery.

Immediate outcomes following the GLA:D® program in Denmark, Canada and Australia. A longitudinal analysis including 28,370 patients with symptomatic knee or hip osteoarthritis.

OBJECTIVE: To report outcomes across three countries for patients with symptomatic knee or hip OA attending the evidence-based education and exercise therapy program Good Life with osteoArthritis from Denmark (GLA:D®). DESIGN: GLA:D® is a structured treatment program including 2-3 patient education sessions and 12 supervised exercise sessions delivered over 8 weeks by certified health care practitioners. The program was introduced in Denmark in 2013, in Canada 2015 and in Australia 2016. Absolute mean change in pain intensity, number of chair stands in 30 s, 40 m walk test time and Knee injury and Osteoarthritis Outcome Score (KOOS)/Hip dysfunction and Osteoarthritis Outcome Score (HOOS) QOL subscale scores from baseline to immediately after treatment were reported as means and 95 % CIs and proportion of responders for each country. RESULTS: Patients from the three countries improved 26-33% in mean pain intensity, 8-12% in walking speed, 18-30% in chair stand ability and 12-26% in joint-related quality of life from baseline to immediately after treatment, with no clinically relevant differences between patients with hip and knee OA. These improvements correspond with moderate to large within-group effect sizes and 43-47 % of the patients experienced clinically relevant pain reductions. CONCLUSION: About half or more of patients across the three countries were categorized as responders for pain and objective function following the implementation of GLA:D®. These findings indicate positive patient outcomes associated with GLA:D® participation across varying health care systems from implementation of guideline-based patient education and exercise therapy for knee and hip OA.

The clinical profile of people with knee osteoarthritis and a self-reported prior knee injury: A cross-sectional study of 10,973 people.

BACKGROUND: Little is known about how a prior knee injury affects the clinical profile of individuals with knee osteoarthritis (KOA) although this is potentially important to personalize care. OBJECTIVES: To compare individual and clinical characteristics of individuals with KOA with and without a self-reported prior knee injury. DESIGN: Secondary data analysis of baseline data from the Good Life with osteoArthritis in Denmark (GLA:D®) registry. METHODS: Individuals with symptomatic KOA, self-reporting a prior knee injury requiring a doctor's assessment, were compared to individuals without prior knee injury on a range of individual and clinical characteristics using multivariable logistic regression. RESULTS: The analysis included 10,973 individuals with KOA of which 54% self-reported a prior knee injury. The average age was 64 years and 73% were female. We found that being male (Odds Ratio (OR): 0.99), having longer symptom duration of knee pain (OR: 1.07), having more painful body sites (OR: 1.03), being able to do more chair rises (OR: 1.02) and being more physically active in a week (2-4 days; OR:1.33) (>4 days; OR: 1.24) were associated with self-reporting a prior knee injury whereas being older (OR: 0.99), having higher BMI (OR: 0.99) and higher quality of life (OR: 0.98) were not associated with reporting a prior knee injury. CONCLUSION: The overall pattern of our findings rather than specific characteristics indicates that individuals with KOA and a history of a self-reported knee injury have a somewhat different clinical profile than their non-injured peers.

Associations between comorbidities and immediate and one-year outcomes following supervised exercise therapy and patient education - A cohort study of 24,513 individuals with knee or hip osteoarthritis.

OBJECTIVE: To investigate if comorbidities are associated with change in health outcomes following an 8-week exercise and education program in knee and hip osteoarthritis (OA). METHODS: We included 24,513 individuals with knee or hip OA from the Good Life with osteoArthritis in Denmark (GLA:D®). GLA:D® consists of two patient education sessions and 12 supervised exercise sessions. Before the program, individuals self-reported having one or more of 11 common comorbidities. Physical function was assessed using the 40-m Fast-Paced Walk Test (FPWT, m/sec) before and immediately after the program. Pain intensity and health-related quality of life was self-reported before, immediately after, and at 12 months post-intervention using a visual analogue scale (VAS, 0-100) and the EQ-5D-5L index (-0.624 to 1.000), respectively. Associations of comorbidity combinations with change in outcomes immediately and at 12 months was estimated using mixed linear regression. RESULTS: Individuals with OA improved on average 0.12 m/s (95%CI 0.12 to 0.13) in 40-m FPWT, -12.7 mm (95%CI -13.2 to -12.2) in VAS, and 0.039 (95%CI 0.036 to 0.041) in EQ-5D-5L from before to immediately after the intervention with minor additional improvements at 12 months. Despite that individuals with comorbidities had worse baseline scores in all outcomes than individuals without comorbidities, they had similar levels of improvement immediately and 12 months after the intervention. CONCLUSION: Comorbidities are not associated with worse nor better health outcomes following an 8-week exercise and education program in individuals with OA, suggesting exercise as a viable treatment option for individuals with OA, irrespective of comorbidities.

Comorbidities and their link with individual health status: A cross-sectional analysis of 23,892 people with knee and hip osteoarthritis from primary care.

OBJECTIVES: Robust data on the impact of comorbidities on health in people with osteoarthritis (OA) are lacking, despite its potential importance for patient management. Objectives were to determine coexisting conditions in people with OA in primary care and whether more comorbidities were linked with individual health status. METHODS: A retrospective analysis of 23,892 patients with knee and hip OA was conducted to determine comorbidities present (number/clusters) and how these linked with pain intensity (0-100), widespread pain (site numbers), medication usage (paracetamol, nonsteroidal anti-inflammatory drugs, opioids), quality of life EuroQol five dimension scale (EQ-5D), and physical function (walking speed) using independent t-tests or χ 2 test. RESULTS: Sixty-two percent of people with OA treated in primary care had at least one comorbidity; hypertension (37%), heart disease (8%), and diabetes (7%) being most common. Outcome measures worsened with more comorbidities (0-4+ comorbidities); pain intensity [mean (SD)] 46(22)-57(21); number of painful sites 3.7(3.0)-6.3(5.4); quality of life 0.73(0.10)-0.63(0.15); walking speed 1.57 m/s (0.33)-1.24 m/s (0.31), while the proportion of people using pain medication increased from 0 to 2 comorbidities (58-69%; p < 0.001), with an increase in opioid use from 4.6% to 19.5% with more comorbidities (0-4+ comorbidities). CONCLUSION: Most people with knee or hip OA in primary care have at least one other long-term condition. A greater number of comorbidities is linked with worsening health, highlighting the importance of screening for comorbidities when treating patients with OA. It is important for clinicians to consider how OA treatments will interact and affect other common comorbidities.

Individualized predictions of changes in knee pain, quality of life and walking speed following patient education and exercise therapy in patients with knee osteoarthritis - a prognostic model study.

OBJECTIVE: To facilitate shared decision-making for patients with knee osteoarthritis (OA), we aimed at building clinically applicable models to predict the individual change in pain intensity (VAS scale 0-100), knee-related quality of life (QoL) (KOOS QoL score 0-100) and walking speed (m/sec) immediately following two educational and 12 supervised exercise therapy sessions. METHODS: We used data from patients with knee OA from the 'Good Life with osteoArthritis in Denmark' (GLA:D®) registry (n = 6,767). From 51 patient characteristics, we selected the best performing variables to predict the outcomes via random forest regression. We evaluated model performance via R2. Lastly, we validated and compared our models with the average improvements via the mean differences in an independent validation data set from the GLA:D® registry (n = 2,896) collected 1 year later than the data used to build the models. RESULTS: Validating our models including the best performing variables yielded R2s of 0.34 for pain intensity, 0.18 for knee-related QoL, and 0.07 for walking speed. The absolute mean differences between model predictions and the true outcomes were 14.65 mm, 10.32 points, and 0.14 m/s, respectively, and similar to the absolute mean differences of 17.64, 11.28 and 0.14 observed when we subtracted the average improvements from the true outcomes. CONCLUSION: Despite including 51 potential predictors, we were unable to predict changes in individuals' pain intensity, knee-related QoL and walking speed with clinically relevant greater precision than the respective group average outcomes. Therefore, average prediction values can be used to inform patients about expected outcomes.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial.

OBJECTIVES: To investigate the effects of lower limb strength training in addition to neuromuscular exercise and education (ST + NEMEX-EDU) compared to neuromuscular exercise and education alone (NEMEX-EDU) on self-reported physical function in patients with knee osteoarthritis (KOA). DESIGN: Patient-blinded, parallel-group randomized controlled trial (RCT). METHODS: The trial included 90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement. Both groups exercised twice weekly for 12 weeks. Additional strength training consisted of a single, fatiguing knee extension set (30-60RM) before four sets of leg-press (8-12RM). Primary outcome was the between-group difference on the subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOSADL) at 12 weeks. Secondary outcomes included KOOS symptoms, pain, function in sport and recreation, and quality of life, 40 m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events. RESULTS: There was no statistically significant between-group difference in KOOSADL at 12-weeks; adjusted mean difference -1.15 (-6.78 to 4.48). Except for the stair climb test, which demonstrated an adjusted mean difference of 1.15 (0.09-2.21) in favor of ST + NEMEX-EDU, all other outcomes showed no statistically significant between-group differences. Neither group improved leg extension power. CONCLUSION: The addition of lower-limb strength training, using a low-dose approach, to neuromuscular exercise and education carried no additional benefits on self-reported physical function or on most secondary outcomes. Both groups displayed similar improvements at 12-week follow-up. Hence, the current low-dose strength training approach provided no additional clinical value in this group of KOA patients. Trial identifier (ClinicalTrials.gov): NCT03215602.

Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care.

OBJECTIVE: To determine and compare the proportion of patients treated in a primary care setting that have knee osteoarthritis (OA) according to the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR), and the National Institute for Health and Care Excellence (NICE) clinical classification criteria. DESIGN: A cross-sectional analysis of baseline data from 13,459 patients with knee symptoms or functional limitations associated with OA participating in the Good Life with osteoArthritis in Denmark (GLA:D®) treatment program. The prevalence of knee OA according to the EULAR, ACR and NICE criteria were calculated in all participants and in the subgroup of patients with self-reported radiographic changes associated with knee OA (n = 10,651 or 79%). RESULTS: Mean age (SD) was 65.3 (9.8) years, median (IQR) duration of symptoms 12 (6-36) months and mean pain intensity (0-100; SD) 46.5 (22.1) mm. 39% fulfilled all three sets of criteria. 48%, 52% and 89% fulfilled the EULAR, ACR, and NICE criteria for having knee OA, respectively. In the subgroup with self-reported radiographic changes, the corresponding numbers were 49%, 54% and 90%. CONCLUSIONS: While the EULAR and ACR criteria only identified around half of those, with or without self-reported radiographic knee OA, that were treated because of symptoms or functional limitations associated with knee OA, the NICE criteria identified most patients. The results indicate that the NICE criteria are relevant and appropriate to identify individuals treated for knee OA in primary care.