Longer-term quality of care, effectiveness, and cost-effectiveness of implementing a model of care for osteoarthritis: A cluster-randomized controlled trial.

OBJECTIVE: To assess the quality of care, effectiveness, and cost-effectiveness over 12 months after implementing a structured model of care for hip and knee osteoarthritis (OA) in primary healthcare as compared to usual care. DESIGN: In this pragmatic cluster-randomized, controlled trial with a stepped-wedge cohort design, we recruited 40 general practitioners (GPs), 37 physiotherapists (PTs), and 393 patients with symptomatic hip or knee OA from six municipalities (clusters) in Norway. The model included the delivery of a 3-hour patient education and 8-12 weeks individually tailored exercise programs, and interactive workshops for GPs and PTs. At 12 months, the patient-reported quality of care was assessed by the OsteoArthritis Quality Indicator questionnaire (16 items, pass rate 0-100%, 100%=best). Costs were obtained from patient-reported and national register data. Cost-effectiveness at the healthcare perspective was evaluated using incremental net monetary benefit (INMB). RESULTS: Of 393 patients, 109 were recruited during the control periods (control group) and 284 were recruited during interventions periods (intervention group). At 12 months the intervention group reported statistically significant higher quality of care compared to the control group (59% vs. 40%; mean difference: 17.6 (95% confidence interval [CI] 11.1, 24.0)). Cost-effectiveness analyses showed that the model of care resulted in quality-adjusted life-years gained and cost-savings compared to usual care with mean INMB €2020 (95% CI 611, 3492) over 12 months. CONCLUSIONS: This study showed that implementing the model of care for OA in primary healthcare, improved quality of care and showed cost-effectiveness over 12 months compared to usual care. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02333656.

Adequately dosed aerobic physical activity in people with axial spondyloarthritis: associations with physical therapy.

INTRODUCTION: This study aimed to compare the engagement in moderate- and vigorous-intensity PA in axSpA patients with and without current physical therapy (PT). METHODS: In this cross-sectional study, a survey, including current PT treatment (yes/no) and PA, using the 'Short QUestionnaire to ASsess Health-enhancing PA' (SQUASH), was sent to 458 axSpA patients from three Dutch hospitals. From the SQUASH, the proportions meeting aerobic PA recommendations (≥ 150 min/week moderate-, ≥ 75 min/week vigorous-intensity PA or equivalent combination; yes/no) were calculated. To investigate the association between PT treatment and meeting the PA recommendations, odds ratios (OR) with 95% confidence intervals (95% CI) were estimated using logistic regression models, adjusting for sex, age, health status and hospital. RESULTS: The questionnaire was completed by 200 patients, of whom 68%, 50% and 82% met the moderate-, vigorous- or combined-intensity PA recommendations, respectively. Ninety-nine patients (50%) had PT treatment, and those patients were more likely to meet the moderate- (OR 2.09 [95% CI 1.09-3.99]) or combined-intensity (OR 3.35 [95% CI 1.38-8.13]) PA recommendations, but not the vigorous-intensity PA recommendation (OR 1.53 [95% CI 0.80-2.93]). Aerobic exercise was executed in 19% of individual PT programs. CONCLUSION: AxSpA patients with PT were more likely to meet the moderate- and combined-intensity PA recommendations, whereas there was no difference in meeting the vigorous-intensity PA recommendation. Irrespective of having PT treatment, recommendations for vigorous-intensity PA are met by only half of the patients. Implementation should thus focus on aerobic PA in patients without PT and on vigorous-intensity PA in PT programs.

Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial.

BACKGROUND: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. METHODS: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. RESULTS: Two hundred eighty-four intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (ORadjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. CONCLUSIONS: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02333656. Registered 7. January 2015.

Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002949.].

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

BACKGROUND: To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international recommendations. The objective of this study was to assess the effectiveness of this model in primary care. METHODS AND FINDINGS: We conducted a cluster-randomised controlled trial with stepped-wedge cohort design in 6 Norwegian municipalities (clusters) between January 2015 and October 2017. The randomised order was concealed to the clusters until the time of crossover from the control to the intervention phase. The intervention was implementation of the SAMBA model, facilitated by interactive workshops for general practitioners and physiotherapists with an update on OA treatment recommendations. Patients in the intervention group attended a physiotherapist-led OA education and individually tailored exercise programme for 8-12 weeks. The primary outcome was patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire; 0-100, 100 = optimal quality) at 6 months. Secondary outcomes included patient-reported referrals to physiotherapy, magnetic resonance imaging (MRI), and orthopaedic surgeon consultation; patients' satisfaction with care; physical activity level; and proportion of patients who were overweight or obese (body mass index ≥ 25 kg/m2). In all, 40 of 80 general practitioners (mean age [SD] 50 [12] years, 42% females) and 37 of 64 physiotherapists (mean age [SD] 42 [8] years, 65% females) participated. They identified 531 patients, of which 393 patients (mean age [SD] 64 [10] years, 71% females) with symptomatic hip or knee OA were included. Among these, 109 patients were recruited during the control periods (control group), and 284 patients were recruited during interventions periods (intervention group). The patients in the intervention group reported significantly higher quality of care (score of 60 versus 41, mean difference 18.9; 95% CI 12.7, 25.1; p < 0.001) and higher satisfaction with OA care (odds ratio [OR] 12.1; 95% CI 6.44, 22.72; p < 0.001) compared to patients in the control group. The increase in quality of care was close to, but below, the pre-specified minimal important change. In the intervention group, a higher proportion was referred to physiotherapy (OR 2.5; 95% CI 1.08, 5.73; p = 0.03), a higher proportion fulfilled physical activity recommendations (OR 9.3; 95% CI 2.87, 30.37; p < 0.001), and a lower proportion was referred to an orthopaedic surgeon (OR 0.3; 95% CI 0.08, 0.80; p = 0.02), as compared to the control group. There were no significant group differences regarding referral to MRI (OR 0.6; 95% CI 0.13, 2.38; p = 0.42) and proportion of patients who were overweight or obese (OR 1.3; 95% CI 0.70, 2.51; p = 0.34). Study limitations include the imbalance in patient group size, which may have been due to an increased attention to OA patients among the health professionals during the intervention phase, and a potential recruitment bias as the patient participants were identified by their health professionals. CONCLUSIONS: In this study, a structured model in primary care resulted in higher quality of OA care as compared to usual care. Future studies should explore ways to implement the structured model for integrated OA care on a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT02333656.

Left ventricular dysfunction assessed by speckle-tracking strain analysis in patients with systemic sclerosis: relationship to functional capacity and ventricular arrhythmias.

OBJECTIVE: Systemic sclerosis (SSc) is a connective tissue disease characterized by vascular inflammation and fibrosis. Visceral involvement, including cardiac manifestations, can lead to severe clinical complications, such as congestive heart failure, arrhythmias, and sudden death. Conventional echocardiography parameters have limited sensitivity to detect subtle myocardial dysfunction in patients with SSc. The aim of this study was to assess, using novel speckle-tracking strain analysis, the presence of myocardial dysfunction in patients with SSc, and to investigate its relationship to functional capacity and ventricular arrhythmias. METHODS: A total of 104 patients with SSc (mean ± SD age 54 ± 12 years, 77% female) were included and underwent cardiopulmonary exercise testing, 24-hour electrocardiography (EKG) Holter monitoring, and transthoracic echocardiography. For comparison, 37 matched healthy control subjects were included. RESULTS: The total patient population consisted of 51 patients with limited cutaneous SSc and 53 with diffuse cutaneous SSc. Peak VO(2) was a mean ± SD 91 ± 20% predicted, and 28 patients had abnormal findings (ventricular tachycardia or ventricular ectopics >100/day) on EKG Holter monitoring. Patients with SSc, as compared with controls, had impaired global longitudinal and circumferential strains (mean ± SD -18.2 ± 1.8% versus -21.3 ± 1.7% and -18.2 ± 2.3% versus -21.3 ± 2.1%, respectively; each P < 0.01), but there was no difference in the left ventricular ejection fraction between patients and controls (mean ± SD 63.5 ± 7.2% versus 64.6 ± 4.4%; P = 0.20). In patients with SSc, global longitudinal and circumferential strains each correlated with the peak VO(2) (r = -0.46 and r = -0.41, respectively; both P < 0.01), and multivariate analysis confirmed the independent association of each strain measure with the peak VO(2). Compared to SSc patients with normal results on EKG Holter monitoring, SSc patients with abnormal results showed impaired global longitudinal strains (-18.5 ± 1.5% versus -17.1 ± 2.1%; P < 0.01) and circumferential strains (-18.7 ± 2.0% versus -17.3 ± 2.5%; P = 0.01), and each strain measure was independently associated with abnormal Holter findings. CONCLUSION: Speckle-tracking strain analysis can detect subtle myocardial dysfunction in patients with SSc. Importantly, decreased global longitudinal and circumferential strains are associated with lower functional capacity and rhythm disturbances in patients with SSc.

Participation Restrictions among Children and Young Adults with Acquired Brain Injury in a Pediatric Outpatient Rehabilitation Cohort: The Patients' and Parents' Perspective.

Improving participation is an important aim in outpatient rehabilitation treatment. Knowledge regarding participation restrictions in children and young adults with acquired brain injury (ABI) is scarce and little is known regarding the differences in perspectives between patients and parents in the outpatient rehabilitation setting. The aims are to describe participation restrictions among children/young adults (5-24 years) with ABI and investigating differences between patients' and parents' perspectives. At admission in 10 rehabilitation centers, patients and parents were asked to complete the Child and Adolescent Scale of Participation (CASP; score 0-100; lower score = more restrictions) and injury/patient/family-related questions. CASP scores were categorized (full/somewhat-limited/limited/very-limited participation). Patient/parent-reported outcomes were compared using the Wilcoxon signed-rank test. 223 patients and 245 parents participated (209 paired-samples). Median patients' age was 14 years (IQR; 11-16), 135 were female (52%), 195 had traumatic brain injury (75%). The median CASP score reported by patients was 82.5 (IQR: 67.5-90) and by parents 91.3 (IQR: 80.0-97.5) (difference = p < 0.05). The score of 58 patients (26%) and 25 parents (10%) was classified as 'very-limited'. Twenty-six percent of children and young adults referred for rehabilitation after ABI had "very-limited" participation. Overall, parents rated their child's participation better than patients themselves. Quantifying participation restrictions after ABI and considering both perspectives is important for outpatient rehabilitation treatment.

Accuracy of AccuChek glucose measurement in intensive care patients.

OBJECTIVE: To evaluate the accuracy of the AccuChek Inform point-of-care glucose measurement device as compared with central laboratory glucose measurement. DESIGN: Prospective, observational study. SETTING: A ten-bed mixed closed format intensive care unit ina 500-bed general hospital. The unit has a computerized insulin protocol aiming for 81 to 135 mg/dL. PATIENTS: All intensive care unit patients were eligible. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Paired samples (AccuChek glucose in whole blood calibrated to give whole blood results and central laboratory glucose in serum) were taken simultaneously. In 32 critically ill patients, we obtained the following information: mean +/- standard deviation age 71.6 +/- 11.9 yrs; mean Acute Physiology and Chronic Health Evaluation II score at admission 17.8 +/- 6.7; 239 paired samples were taken from arterial catheters. Mean AccuChek whole blood glucose was 126 +/- 36 mg/dL (7.0 +/- 2.0 mmol/L); mean central laboratory serum glucose was 137 +/- 38 mg/dL (7.6 +/- 2.1 mmol/L). Mean difference was 11 mg/dL (0.61 mmol/L) (8%) (95% Confidence Interval 9-13 mg/dL, p < .001). ISO 15197 guideline requires 95% of point-of-care measurements to be within 15 mg/dL margins with reference <75 mg/dL or within 20% if reference is higher. In total, 216 (90.4%) of AccuChek measurements were within ISO 15197 margins. Because AccuChek was calibrated to give whole blood results, we calculated a correction factor of 1.086 from the two mean values to correct whole blood AccuChek into serum-like results. This is almost the same as the correction factor of 1.080 given by Roche Diagnostics. By multiplying AccuChek whole blood results with 1.086, 225 (94.1%) of results were within the ISO 15197 margins. Hematocrit did not influence AccuChek results in the 0.20 to 0.44 range. Beyond this range, there were not enough data to draw conclusions. CONCLUSIONS: In critically ill patients, the accuracy of AccuChek glucose measurement calibrated to give serum-like results with blood samples derived from arterial catheters is acceptable but falls short by about 1% of complying with the ISO 15197 guideline.

Explaining Physical Activity Maintenance After a Theory-Based Intervention Among Patients With Rheumatoid Arthritis: Process Evaluation of a Randomized Controlled Trial.

OBJECTIVE: Regular physical activity (PA) benefits patients with rheumatoid arthritis (RA), particularly when maintained over time. Research in this area has largely focused on factors associated with initiating PA, while factors contributing to PA maintenance, particularly after lifestyle interventions, have received less attention. This study examined whether higher levels of autonomous motivation, self-efficacy for PA, and greater use of self-regulation skills mediated PA initiation and maintenance 6 months after a theory-based motivational interviewing and self-regulation coaching intervention. METHODS: Seventy-eight individuals with RA were randomized to receive either a patient-education session (control group), or the patient-education session plus 1 motivational interview and 2 self-regulation coaching sessions (treatment group). Mediation analyses examined the effects of this intervention on PA initiation and maintenance through the intermediate variables autonomous motivation, self-efficacy for PA, and use of self-regulation skills. Analyses were controlled for age, sex, and previous levels of PA. RESULTS: The treatment group reported significantly higher autonomous motivation and greater use of self-regulation skills than controls at posttreatment. Increases in PA from baseline to posttreatment were not mediated by any intermediate variables. However, maintenance of PA from posttreatment to followup (6 months later) was mediated by greater autonomous motivation and use of self-regulation skills. CONCLUSION: Greater autonomous motivation and use of self-regulation skills predict maintenance of PA following a motivational interviewing and self-regulation coaching intervention. In promoting PA among patients with RA, supporting patient autonomy and teaching self-regulation skills, which focus attention on achieving PA goals, may improve long-term maintenance of PA.

Targeting motivation and self-regulation to increase physical activity among patients with rheumatoid arthritis: a randomised controlled trial.

The purpose of this study is to evaluate the effects of targeting both the motivation and action phases of behaviour change in a 5-week intervention to increase physical activity (PA) among patients with rheumatoid arthritis (RA) not meeting current PA recommendations. In a randomised controlled trial, a control group­which received a group-based patient education session led by a physical therapist­was compared to a treatment group which received the education session plus a motivational interview from a physical therapist and two self-regulation coaching sessions from a rheumatology nurse. Outcomes included leisure-time PA, days per week with at least 30 min of moderate-intensity PA, self-efficacy and autonomous motivation (cognitions which predict PA initiation and maintenance), disease activity, functional status, depressive symptoms and fatigue. Effects were assessed using mixed models repeated measures. Of the 78 patients randomised, 76 and 67 completed the post-treatment and follow-up assessments, respectively. Significant treatment effects were found for leisure-time PA (p = 0.022), active days/week (p = 0.016), self-efficacy (p = 0.008) and autonomous motivation (p = 0.001). At post-treatment and 6-months follow-up, significantly more treated patients than controls met current PA recommendations. No significant effects were found for disease activity, functional status, depressive symptoms or fatigue. Combining motivation- and action-focused intervention approaches improved PA-related cognitions and led to improved uptake and maintenance of leisure-time PA. However, further research is necessary to identify ways of helping patients with RA transition to­and maintain­more intensive forms of PA which are more likely to improve disease activity and functional status.

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

BACKGROUND: Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. METHODS/DESIGN: A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). DISCUSSION: The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02333656.

Goal-setting in multidisciplinary team care for patients with rheumatoid arthritis: an international multi-center evaluation of the contents using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVE: To make a cross-cultural comparison of the contents of rehabilitation goals of patients admitted for rehabilitation and to compare the contents with the comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis, by linking their contents to the ICF. PATIENTS: A random sample of 80 patients with rheumatoid arthritis was retrieved from rehabilitation clinics in 4 countries. METHODS: Rehabilitation goals were extracted from the medical records and linked to the ICF using standardized linking rules. RESULTS: A total of 495 rehabilitation goals were identified and linked to 952 ICF codes, resulting in 151 unique ICF codes. Two-hundred and seventy-five (29%) of the 952 ICF codes were related to "Body Functions" (b-codes), 80 (8%) to "Body Structures" (s-codes), 419 (44%) to "Activities and Participation" (d-codes) and 178 (19%) to "Environmental Factors" (e-codes). Thirty-five of the 151 unique ICF codes (23%) were not in the comprehensive ICF Core Set for RA, whereas 23 of the ICF codes in this Core Set (24%) were not in the rehabilitation goals. CONCLUSION: The goals set in a team rehabilitation setting for patients with rheumatoid arthritis are related to all ICF components, with "Activities and Participation" being the most frequently addressed. The contents of the goals are, to a considerable extent, covered by the comprehensive ICF Core Set for RA, but additional evaluation is required before the ICF Core Set is used as a rehabilitation tool in rheumatoid arthritis.

Development of a framework identifying domains and elements of importance for arthritis rehabilitation.

BACKGROUND: Rehabilitation is effective and beneficial for patients with arthritis. The lack of a common structure for describing the content of rehabilitation makes it difficult to compare, transfer and implement research evidence into clinical practice. OBJECTIVE: To develop a framework comprising domains and elements of importance when describing arthritis rehabilitation. METHODS: On the basis of a systematic literature search and review, the framework was developed through a 9-step development process, including 5 Delphi consensus rounds within the Scandinavian Team Arthritis Register - European Team Initiative for Care Research (STAR-ETIC) collaboration, a group of clinicians, researchers and patients from northern Europe. RESULTS: Based on Donabedian's healthcare model, the Inter-national Classification of Function, Disability and Health, and a rehabilitation model by D. T. Wade, 4 domains (context, structure, process and outcome) were defined. Within each domain, the most important and relevant key elements for describing rehabilitation were selected. This framework contains 1 key element under context, 9 under structure, 3 under process, and 9 under outcome. CONCLUSION: The STAR-ETIC framework can be used to describe arthritis rehabilitation, by emphasizing key elements in 4 main domains. A common framework may facilitate comparisons of rehabilitation programmes across countries and different levels of care, and may improve the implementation of rehabilitation research in clinical practice.