Co-designing municipal multimorbidity rehabilitation leveraging health literacy and social networks: Protocol for the CURIA study.

Background: Managing multimorbidity poses significant challenges for individuals, their families, and society due to issues with health information comprehension, communication with healthcare providers, and navigating the healthcare system. These challenges emphasise the critical need to prioritize individual and organisational health literacy. Multimorbidity is associated with a lack of social support for health; however, social networks and community dynamics can enhance health literacy. The "Co-designing municipal rehabilitation" (CURIA) project targets enhancing individual and organisational health literacy, and social networks for individuals with multimorbidity, with the overall aim of addressing health inequity through a collaborative local co-design process involving stakeholders. Methods: The CURIA study employs a mixed-method approach that initially explores the health literacy experiences of individuals with multimorbidity participating in rehabilitation programs in selected Danish municipalities and the practices of professionals overseeing these programs. The subsequent co-design process will comprise individuals with multimorbidity, their relatives, municipalities, general practitioners, civil society, and knowledge institutions working together. This iterative and collaborative process involves tailoring and aligning health literacy needs with responsiveness within the context of local healthcare systems and developing supportive social networks. Discussion: Given the increasing burden of multimorbidity, there is an urgent need to develop evidence-based practice for multimorbidity rehabilitation practices, developed in collaboration with municipalities and civil society. Emphasising self-care support for individuals, managing complex rehabilitation needs, and involving individuals in intervention prioritisation and customisation are crucial aspects addressed by CURIA to enhance health literacy and align municipal rehabilitation with identified needs.

Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

BACKGROUND: Multimodal prehabilitation is a promising adjunct to the current surgical treatment pathway for colorectal cancer patients to further improve postoperative outcomes, especially for high-risk patients with low functional capacity. The aim of the present study was to test the effect of prehabilitation on immediate postoperative recovery. METHOD: The study was designed as a RCT with two arms (intervention and control). The intervention consisted of 4 weeks of multimodal prehabilitation, with supervised physical training, nutritional support and medical optimization. The control group received standard of care. A total of 40 patients with colorectal cancer (WHO performance status I or II) undergoing elective surgery with curative intent were included. The primary outcome was postoperative recovery within the first 3 postoperative days, measured by Quality of Recovery-15, a validated questionnaire with a scoring range between 0 and 150 and a minimal clinically relevant difference of 8. RESULTS: In total, 36 patients were analysed with 16 in the intervention group and 20 in the control group. The mean age of the included patients was 79 years. The overall treatment effect associated with the intervention was a 21.9 (95% c.i. 4.5-39.3) higher quality of recovery-15 score during the first 3 postoperative days compared to control, well above the minimal clinically relevant difference. CONCLUSION: Four weeks of multimodal prehabilitation prior to elective curative intended colorectal cancer surgery in patients with WHO performance status I or II was associated with a clinically relevant improvement in postoperative recovery.Registration number: NCT04167436 (http://www.clinicaltrials.gov).

Physical activity and exercise therapy for people with multimorbidity.

Physical activity and exercise therapy appear safe and beneficial for people with multimorbidity and should therefore be considered in the prevention and management of multimorbidity, as argued in this review. General practitioners and specialists should refer people with multimorbidity to supervised exercise therapy (2-3 times/week for 8-12 weeks, strengthening or aerobic exercise or a combination), while encouraging and educating patients to improve physical activity to improve overall health by e.g., integrating physical activity in everyday-life practices such as gardening, transportation, and house chores.

The influence of comorbidities on outcomes for older people with back pain: BACE-D cohort study.

BACKGROUND: Comorbidities are common in older people with back pain but little is known about the influence of comorbidities on outcomes. OBJECTIVES: To explore the influence of the most prevalent comorbidities, and the number of comorbidities, on short (at 3 months) and long-term (at 12 months) outcomes of back pain in older people. METHODS: We analyzed data from the 'Back Complaints in the Elders' Dutch study cohort (BACE-D) and included participants aged >55 years. We used the modified Self-Administered Comorbidities Questionnaire (SCQ), the Numeric Rating Scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ) to assess the number of comorbidities, pain intensity and back-related physical functioning, respectively. We conducted separate linear regression models to analyze the association between comorbidities and outcomes including potential confounders of age, sex, body mass index, smoking and alcoholic drinking status, back pain history, and baseline NRS and RMDQ scores. RESULTS: Our study included 669 participants with a mean age of 66.5 (SD 7.7) years of whom 394 were female. More comorbidities were positively associated with higher pain intensity (3-month regression coefficient (ß) =0.27, 95% CI 0.14-0.39; 12-month ß = 0.31, 95% CI 0.17-0.45) and worse physical functioning (3-month ß = 0.54, 95% CI 0.31-0.77; 12-month ß = 0.64, 95% CI 0.37-0.92). Four of the 5 commonest comorbidities were musculoskeletal problems. Older participants with musculoskeletal comorbidities had higher pain intensity (3-month ß = 0.89 95% CI 0.41-1.37; 12-month ß = 1.17, 95% CI 0.65-1.69), and worse physical functioning (3-month ß = 1.61, 95% CI 0.71-2.52; 12-month ß = 1.85, 95% CI 0.82-2.89, P-value < 0.001) compared to participants without musculoskeletal comorbidities. CONCLUSIONS: More comorbidities are associated with worse back pain outcomes in older adults. Participants with musculoskeletal comorbidities had worse back pain outcomes than those without.

Cross-cultural translation and adaptation of the Danish version of the brief version of the 10-item Big Five Inventory.

BACKGROUND: Personality traits are associated with pain-related beliefs and coping strategies, and different chronic conditions are linked through specific personality profiles. This highlights the importance of having valid and reliable measures of personality traits for use in clinical and research settings when assessing patients in chronic pain. PURPOSE: To translate and cross-culturally adapt the 10-item Big Five Inventory (BFI-10) into Danish. METHODS: A bilingual expert panel (N = 4) and a panel of laymen (N = 8) translated and culturally adapted the questionnaire into Danish. Face validity was evaluated in a group of persons suffering from recurring or ongoing painful conditions (N = 9). Data were collected to evaluate the internal consistency, test-retest reliability and factor structure (N = 96). RESULTS: Some of the participants in the lay panel considered the questionnaire too short, considering its aim of assessing personality. Acceptable internal consistency was found for two out of five subscales (0.78 for both Extraversion and Neuroticism), while the internal consistency was non-acceptable for the remaining subscales (0.17-0.45). Test-retest reliability was acceptable for three subscales (0.80 for Neuroticism, 0.84 for Conscientiousness, and 0.85 for Extraversion). Assumptions for determining the factor structure were not met and therefore was this analysis omitted. DISCUSSION: Although face valid, only two out of five subscales had acceptable internal consistency and only three subscales had acceptable test-retest reliability. These findings indicate that interpreting findings regarding personality using the Danish BFI-10 should be done with caution.

NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial.

INTRODUCTION AND AIM: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer. METHODS AND ANALYSIS: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests. ETHICS AND DISSEMINATION: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05053997.

Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial.

INTRODUCTION: To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme. METHODS AND ANALYSIS: In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up. ETHICS AND DISSEMINATION: Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public. TRIAL REGISTRATION NUMBER: NCT05011994.

Dropout during a 12-week transitional exercise-based cardiac rehabilitation programme: a mixed-methods prospective cohort study.

AIMS: Investigate the dropout rate during a 12-week transitional exercise-based cardiac rehabilitation (exCR) programme focusing on a halfway transition phase between hospital and the municipality-based cardiac rehabilitation. Secondly, investigate patient characteristics associated with dropout at the transition. METHODS AND RESULTS: Patients with coronary heart disease, heart failure, or heart valve surgery referred to exCR were included in a prospective cohort study conducted between 1 March 2018 and 28 February 2019 at Zealand University Hospital. Exercise-based cardiac rehabilitation was initiated at the hospital with a halfway transitional to local healthcare centres in the municipalities. Dropouts were identified every third week through telephone interviews. A Kaplan-Meier time-to-event analysis was used to investigate time to dropout, while multiple logistic regression assessed associations between patient characteristics and dropout at the transition. Of 560 patients eligible for exCR, 279 participated in the study. Fourteen patients were lost to follow-up and 103 dropped out, resulting in a dropout rate of 39% [95% confidence interval (CI) 33-45%]. Of the 103 dropouts, 72 patients (70%) dropped out at the transition. In the adjusted analysis, patients attached to the labour market were associated with dropout at the transition [odds ratio (OR) = 6.31 (95% CI 2.04-19.54)]. Furthermore, odds of dropping out at transition were reduced for each extra exercise session attended [OR = 0.79 (95% CI 0.66-0.94)]. CONCLUSION: The transition phase constitutes a critical dropout period in exCR, in which increased attention on patient adherence is needed. In clinical practice, communication and strategies addressing patient retention across settings could be essential to prevent dropout in transitional exCR.

Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial.

ABSTRACT: Holm, PM, Kemnitz, J, Bandholm, T, Wernbom, M, Schrøder, HM, and Skou, ST. Muscle function tests as supportive outcome measures for performance-based and self-reported physical function in patients with knee osteoarthritis: Exploratory analysis of baseline data from a randomized trial. J Strength Cond Res 36(9): 2635-2642, 2022-Uncertainty on the role of muscle function in relation to physical function in knee osteoarthritis (KOA) persists. This study aimed to assess the associations between muscle function and performance-based and self-reported physical function in patients with KOA. Physical function in 80 subjects with symptomatic and radiographic KOA was assessed using 40-m fast-paced walk, 30-second chair stand, 9-step stair climb tests, and the subscale activities of daily living from the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL). Measurements of muscle function included leg extension (LE) power, knee extension (KE) torque, and estimated leg press one repetition maximum (LP RM). Associations were investigated using multivariable hierarchical linear regressions adjusted for age, sex, body mass index, self-reported physical activity, and thigh muscle lean area. Leg extension power was significantly associated with 40-m walk, stair climb, and 30-second chair stand, explaining 18, 8, and 3% of additional variance, respectively. Knee extension torque explained 13, 7, 17, and 7% of additional variance in the 40-m walk, stair climb, 30-second chair stand, and KOOS-ADL, respectively. Leg press one repetition maximum explained 11% of additional variance in the 30-second chair stand. In conclusion, LE power was the best explanatory variable for performance on the 40-m walk and stair climb tests, whereas KE torque best explained chair stand performance. Only KE torque was associated with KOOS-ADL. Our results highlight the importance of selecting supportive muscle function tests based on the specific physical function and suggest that other factors may be more important for certain physical function outcomes. Level of significance p < 0.05. Trial identifier: NCT03215602.

Complex Lifestyle and Psychological Intervention in Knee Osteoarthritis: Scoping Review of Randomized Controlled Trials.

Knee osteoarthritis (OA) causes pain, disability and poor quality of life in the elderly. The primary aim was to identify and map out the current evidence for randomised controlled trials (RCTs) on complex lifestyle and psychosocial interventions for knee OA. The secondary aim was to outline different components of complex lifestyle and psychosocial interventions. Our scoping review searched five databases from 2000 to 2021 where complex lifestyle or psychosocial interventions for patients with knee OA were compared to other interventions. Screening and data extraction were performed by two review authors independently and discrepancies resolved through consensus and in parallel with a third reviewer. A total of 38 articles were selected: 9 studied the effectiveness of psychological interventions; 11 were on self-management and lifestyle interventions; 18 looked at multifaceted interventions. This review highlights the substantial variation in knee OA interventions and the overall lack of quality in the current literature. Potential areas of future research, including identifying prognostic social factors, stratified care models, transdisciplinary care delivery and technology augmented interventions, have been identified. Further high-quality RCTs utilizing process evaluations and economic evaluation in accordance with the MRC guidelines are critical for the development of evidence-based knee OA programs globally.

Soft-collar use in rehabilitation of whiplash-associated disorders - A systematic review and meta-analysis.

BACKGROUND: Active rehabilitation of Whiplash Associated Disorders (WAD) is favoured over passive modalities such as soft-collars. However, the effectiveness of soft-collar use remains unclear. OBJECTIVE: To investigate the effectiveness of soft-collar use on pain and disability in WAD. DESIGN: Systematic review. METHOD: Databases (AMED, CINAHL Complete, Cochrane Library, Embase, Medline, PEDro, PsycINFO, PubMed, SPORTDiscus) were searched for guidelines, reviews and RCTs on soft-collar use as part of WAD treatment. Reference lists of reviews and guidelines were screened for additional RCTs. Study quality was rated using the PEDro-scale and overall quality of evidence with GRADE. RESULTS: Four RCTs (n = 409) of fair-good quality (PEDro-scores) were included with three using a soft collar in addition to other conservative treatment while one study compared soft-collar use to act-as-usual. All studies found that an active or act-as-usual approach was more effective in reducing pain intensity compared to soft-collar use, confirmed by meta-analysis (two RCTs with data: SMD of -0.80 (-1.20, -0.41)). No studies reported disability outcomes while contrasting results were found between groups regarding total cervical range of motion (two RCTs with data: SMD of 0.16 (-0.21, 0.54)) or rotation (two RCTs with data: SMD of 0.54 (-0.19, 1.27)). Overall quality of the evidence was low to very low. CONCLUSION: All four RCTs favoured an active approach/act-as-usual over soft-collar treatment. However, due to methodological concerns and low certainty of evidence, future studies investigating soft collar use in combination with an active rehabilitation strategy for acute/subacute WAD are needed.

Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study.

INTRODUCTION: Knee osteoarthritis (OA) is associated with chronic knee pain and functional disability that negatively affect the ability to carry out normal daily activities. Patients are offered a large variety of non-surgical treatments, often not in accordance with clinical guidelines. This observational study will provide a comprehensive overview of treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon, including timing and order of treatment modalities, predictors of treatment outcomes, cost-effectiveness of treatment pathways and patients' views on different treatment pathways. METHODS AND ANALYSIS: Patients with primary referrals to an orthopaedic surgeon due to knee OA are consecutively invited to participate and fill out a questionnaire prior to their consultation with an orthopaedic surgeon. Follow-up questionnaires will be obtained at 6 and 24 months after inclusion. Based on a prospective cohort study design, including questionnaires and register data, we will (1) describe treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon; (2) describe the characteristics of patients choosing different treatment pathways; (3) develop predictive models for patient-self-determined classifications of good and poor treatment outcomes; (4) evaluate the cost-effectiveness of treatment pathways that live up to clinical guidelines versus pathways that do not; based on a qualitative study design using semistructured individual interviews, we will (5) describe the patients' perspectives on treatment pathways for knee OA. ETHICS AND DISSEMINATION: The study is approved by the Danish regional ethical committee (journal number H-17017295) and the Danish Data Protection Agency (journal number AHH-2017-072). Data will be anonymised and handled in line with the General Data Protection Regulation and the Danish Data Protection Act. The study results will be submitted to international open-access peer-reviewed journals and disseminated at conferences. TRIAL REGISTRATION NUMBER: NCT03746184, pre-results.

The Danish Diabetes Musculoskeletal Cohort: Non-Responder Analysis of an Electronic Survey Using Registry Data.

PURPOSE: To conduct a non-responder analysis on a musculoskeletal (MSK) electronic questionnaire. METHODS: Individuals aged 18 years and older, diagnosed with diabetes mellitus (DM), and attended an ambulatory DM clinic formed the sample frame. They were invited to complete an electronic musculoskeletal (MSK) conditions and symptoms questionnaire booklet using a secured electronic email system. Individuals whose secured email box was not active at the time were discarded. Using the Central Person Registry number, a unique number assigned to all Danish residents, we linked the sample frame to different registries to learn more about non-responders. Non-responders were either individuals who did not respond to a single question and those who responded "No" to the first question about willing to participate. We calculated descriptive statistics for each characteristic. Univariate logistic regression models were conducted to determine the relationship between each characteristic and non-responder status. RESULTS: The response rate was 36% (n = 3812). Individuals with type 2 DM (OR 2.0 (95% CI 1.8-2.2)), secondary DM (1.9 (1.3-2.8)) or unspecified DM (2.1 (1.8-2.4)) were more likely to be non-responders than individuals with Type 1 DM. Also, individuals aged 70-79 (1.3 (1.1-1.6)) and 80 years and older (5.9 (4.5-7.7)) were more likely to be non-responders than 18-29 years old individuals. However, individuals aged 40-49 (1.5 (1.2-1.8)), 50-59 (1.5 (1.3-1.8)) or 60-69 (1.4 (1.1-1.6)) were more likely to be responders than 18-29 years old individuals. Individuals with Charlson Comorbidity Index (CCI) of 1 (2.0 (1.3.2.9) or CCI of 2 (1.7 (1.1-2.5) were more likely to be responders than individuals with a CCI of 0. Lastly, individuals who were currently outside of the workforce (1.6 (2.4-2.9) or had unknown/missing socioeconomic status (3.9 (2.8-5.3) were more likely to be non-responders than individuals who were working. CONCLUSION: Although we did find a non-response bias, this cohort will be an important source to determine the prevalence and consequences of MSK conditions in a secondary care DM population.

Impact of educational level and employment status on short-term and long-term pain relief from supervised exercise therapy and education: an observational study of 22 588 patients with knee and hip osteoarthritis.

OBJECTIVES: To investigate the impact of educational level and employment status on change in pain intensity after treatment among patients with knee and hip osteoarthritis (OA). DESIGN: A prospective cohort study. SETTING AND PARTICIPANTS: We analysed 22 588 patients participating in the Good Life with osteoArthritis in Denmark (GLA:D). GLA:D consists of two patient education sessions and 12 supervised exercise sessions. PRIMARY OUTCOME: Baseline educational level and employment status were used as exposures. We investigated the impact of both exposures separately on mean change in pain intensity (visual analogue scale 0-100 mm) from baseline to immediately after treatment (approximately 3 months) and at 12 months, using linear mixed models. RESULTS: On average, all patients improved in pain intensity. The average improvement in pain did not differ by educational level, except for one group. Patients with long-term education had less improvement after treatment (2.0 mm, 95% CI 0.8 to 3.1) and at 12 months (2.0 mm, 95% CI 0.6 to 3.4) compared with primary school only (reference). According to employment status, patients on sick leave had the greatest improvement in pain after treatment (-3.4, 95% CI -4.9 to -1.9) and at 12 months (-4.5, 95% CI -6.4 to -2.6) compared with retired patients (reference). CONCLUSIONS: On average, all patients reported improvement in pain at short-term and long-term follow-up. Change in pain intensity did not substantially differ by educational level or employment status, as the absolute differences were small and most likely not clinically important.

Intrarater Reliability and Agreement of Recommended Performance-Based Tests and Common Muscle Function Tests in Knee Osteoarthritis.

BACKGROUND AND PURPOSE: Some uncertainty persists regarding the reproducibility of the recommended core set of performance-based tests, as well as common muscle function tests, when applied in individuals with knee osteoarthritis (KOA). The purpose of this study was to investigate the intrarater reliability and agreement of the recommended core set of performance-based tests and common muscle function tests in KOA. METHODS: Participants (N=40) with radiographic and/or symptomatic KOA were evaluated twice with a 3-day interval between test sessions using the following tests: Leg extensor (LE) maximal muscle power measured in a Nottingham Power Rig; knee extensor (KE) peak isometric strength measured with a handheld dynamometer; 40-m walk test; 30-second chair-stand test; and 9-step stair climb test. Reliability was assessed using a 2-way, mixed-effects, single-measures model (3,1), absolute agreement-type intraclass correlation coefficient (ICC). Agreement was assessed using 95% limits of agreement (LOA) and LOA relative to the mean score from test and retest (LOA-%). RESULTS: Reliability for all tests was very high (ICC ≥ 0.97). LOA (LOA-%) was ±32.3 watt (W) (±22%) for LE power; ±22.7 N·m (±24%) for KE strength; ±0.2 m/s (±10%) for 40-m walk test; ±2.4 repetitions (±14%) for 30-second chair-stand test; and ±2 second (±20%) for stair climb test. A potential participant learning effect was found for all 3 performance-based tests, indicated by the significantly better scores at retest. DISCUSSION: The very high reliability found for the performance-based tests supports findings from previous studies and confirms discriminate reliability of these tests on a group level. Also, very high reliability estimates were demonstrated for both muscle function tests. This study also provided estimates of agreement for both performance-based and muscle function tests, which are important to consider when using these tests on an individual level in clinical practice. CONCLUSION: When using these tests to monitor changes over time in the clinic, depending on the test, improvements of less than 10% to 24% could be a result of measurement error alone and therefore may not be considered an actual improvement after treatment.

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.

Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach.

BACKGROUND: Osteoarthritis is a leading cause of global disability resulting in significant morbidity and cost to the healthcare system. Current guidelines recommend lifestyle changes such exercises and weight loss as first line treatment prior to surgical consideration. Our current model of care is inefficient with suboptimal allied health intervention for effective behaviour changes. A 12-week community based, individualized, multidisciplinary new model of care for knee osteoarthritis was developed in light of current deficiencies. METHODS: The primary aim of this study was to determine the feasibility of a full randomized controlled trial evaluating this new model of care using pre-defined progression criteria. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot exploratory, parallel arm, single blinded randomized trial design using a mixed method approach was utilized. Progression criteria for a full trial including key domains of patient recruitment and retention, outcome measure acceptability and improvement, adverse events were developed. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and 12-weeks. Secondary outcomes included quality of life, functional and psychological assessments. Semi-structured interviews were conducted with the patients at 12-weeks. RESULTS: 20 patients (3 males, 17 females) were randomized (10 intervention, 10 control). Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks. Semi-structured interviews revealed several themes pertaining to feasibility and intervention optimization. 5 out of the 6 progression criteria's domains were met (recruitment criteria not met). CONCLUSION: This pilot has demonstrated the feasibility of a full randomized control trial investigating the potential effectiveness of the new proposed model of care for knee osteoarthritis using pre-defined progression criteria and process evaluation. Results from the qualitative study were used to modify and improve the intervention content, delivery model and study design for a large effectiveness-implementation hybrid randomized control trial that is currently underway. TRIAL REGISTRATION: Retrospectively registered on 18 January 2019 at http://clinicaltrial.gov ID: NCT03809975 .

Photo-Based Range-of-Motion Measurement: Reliability and Concurrent Validity in Children With Cerebral Palsy.

PURPOSE: To investigate intrarater and interrater reliability, agreement, and concurrent validity of a smartphone photography-based application compared with a universal goniometer in children with cerebral palsy. METHODS: Range of motion of hip abduction, popliteal angle, and ankle dorsiflexion was measured with a universal goniometer and a photography-based application in children with cerebral palsy, Gross Motor Function Classification System levels I to V.A 2-way random-effects intraclass correlation coefficients and Bland-Altman plots, standard error of measurement, and smallest detectable change were used for analyses. RESULTS: The application had good to excellent reliability and concurrent validity compared with a universal goniometer, while the large measurement error of both methods suggests that changes of 10° to 23° are needed to be certain that changes over time are not results of measurement error. CONCLUSIONS: A photography-based goniometer can be a reliable and valid tool when measuring range of motion in children with cerebral palsy.

Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark.

OBJECTIVE: To assess the 24-month cost-effectiveness of total knee replacement (TKR) plus non-surgical treatment compared with non-surgical treatment with the option of later TKR if needed. METHODS: 100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care were randomised to TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone. Including quality-adjusted life years (QALYs) data from baseline, 3, 6, 12 and 24 months, effectiveness was measured as change at 24 months. Healthcare costs and transfer payments were derived from national registries. Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs) were calculated. A probabilistic sensitivity analysis was conducted and the probability of cost-effectiveness was estimated at the 22 665 Euros/QALY threshold defined by the National Institute for Health and Care Excellence. RESULTS: TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056). While cost-effective in the unadjusted scenario (ICER of 18 497 Euros/QALY), TKR plus non-surgical treatment was not cost-effective compared with non-surgical treatment with the option of later TKR if needed in the adjusted (age, sex and baseline values), base-case scenario (ICER of 32 611 Euros/QALY) with a probability of cost-effectiveness of 23.2%. Including deaths, TKR plus non-surgical treatment was still not cost-effective (ICERs of 46 277 to 64 208 Euros/QALY). CONCLUSIONS: From a 24-month perspective, TKR plus non-surgical treatment does not appear to be cost-effective compared with non-surgical treatment with the option of later TKR if needed in patients with moderate-to-severe knee osteoarthritis and moderate intensity pain in secondary care in Denmark. Results were sensitive to changes, highlighting the need for further confirmatory research also assessing the long-term cost-effectiveness of TKR. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT01410409).