Weight Loss for Patients With Gout and Concomitant Obesity: A Proof-of-Concept Randomized Trial.

OBJECTIVE: Despite scarce evidence, guidelines recommend weight loss as a management strategy for patients with gout. We investigated the effect of an intensive dietary intervention on body weight and clinical measures of gout severity in individuals with obesity and gout. METHODS: We conducted a 16-week randomized nonmasked parallel-group trial in Denmark, randomly assigning (one-to-one) individuals with obesity and gout to a low-energy diet or a control diet. The primary outcome was change in body weight. Key secondary outcomes were changes in serum urate (SU) level and visual analog scale-assessed pain and fatigue. RESULTS: Between December 1, 2018, and June 1, 2019, 61 participants were included in the intention-to-treat population and randomly assigned to the intensive diet group (n = 29) or control diet group (n = 32). Participants had a mean age of 60.3 (SD 9.9) years and mean body mass index of 35.6 (SD 5.0), and 59 (97%) were men. After 16 weeks, there was a significant difference in change in body weight between the diet and control groups (-15.4 vs -7.7 kg; difference -7.7 kg [95% confidence interval -10.7 to -4.7], P < 0.001). Despite results being potentially in favor of a low-energy diet, we could not confirm differences in SU level changes and fatigue between groups. No differences in pain and gout flares were observed between groups. No serious adverse events or deaths occurred during the trial. CONCLUSION: An intensive dietary intervention was safe and effectively lowered body weight in people with obesity and gout, but the weight loss did not directly translate into effects on SU level, fatigue, and pain.

Constructing a clinical radiographic knee osteoarthritis database using artificial intelligence tools with limited human labor: A proof of principle.

OBJECTIVE: To create a scalable and feasible retrospective consecutive knee osteoarthritis (OA) radiographic database with limited human labor using commercial and custom-built artificial intelligence (AI) tools. METHODS: We applied four AI tools, two commercially available and two custom-built tools, to analyze 6 years of clinical consecutive knee radiographs from patients aged 35-79 at the University of Copenhagen Hospital, Bispebjerg-Frederiksberg Hospital, Denmark. The tools provided Kellgren-Lawrence (KL) grades, joint space widths, patella osteophyte detection, radiographic view detection, knee joint implant detection, and radiographic marker detection. RESULTS: In total, 25,778 knee radiographs from 8575 patients were included in the database after excluding inapplicable radiographs, and 92.5% of the knees had a complete OA dataset. Using the four AI tools, we saved about 800 hours of radiologist reading time and only manually reviewed 16.0% of the images in the database. CONCLUSIONS: This study shows that clinical knee OA databases can be built using AI with limited human reading time for uniform grading and measurements. The concept is scalable temporally and across geographic regions and could help diversify further OA research by efficiently including radiographic knee OA data from different populations globally. We can prevent data dredging and overfitting OA theories on existing trite cohorts by including various gene pools and continuous expansion of new clinical cohorts. Furthermore, the suggested tools and applied approaches provide an ability to retest previous hypotheses and test new hypotheses on real-life clinical data with current disease prevalence and trends.

Reaching the Frail Elderly for the Diagnosis and Management of Atrial Fibrillation-REAFEL.

BACKGROUND: Frail elderly patients are exposed to suffering strokes if they do not receive timely anticoagulation to prevent stroke associated to atrial fibrillation (AF). Evaluation in the cardiological ambulatory can be cumbersome as it often requires repeated visits. AIM: To develop and implement CardioShare, a shared-care model where primary care leads patient management, using a compact Holter monitor device with asynchronous remote support from cardiologists. METHODS: CardioShare was developed in a feasibility phase, tested in a pragmatic cluster randomization trial (primary care clinics as clusters), and its implementation potential was evaluated with an escalation test. Mixed methods were used to evaluate the impact of this complex intervention, comprising quantitative observations, semi-structured interviews, and workshops. RESULTS: Between February 2020 and December 2021, 314 patients (30% frail) were included, of whom 75% had AF diagnosed/not found within 13 days; 80% in both groups avoided referral to cardiologists. Patients felt safe and primary care clinicians satisfied. In an escalation test, 58 primary-care doctors evaluated 93 patients over three months, with remote support from four hospitals in the Capital Region of Denmark. CONCLUSIONS: CardioShare was successfully implemented for AF evaluation in primary care.

Telemedicine Support for Primary Care Providers versus Usual Care in Patients with Heart Failure: Protocol of a Pragmatic Cluster Randomised Trial within the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) Study.

Heart failure is a prevalent condition and a frequent cause of hospital readmissions and poor quality of life. Teleconsultation support from cardiologists to primary care physicians managing patients with heart failure may improve care, but the effect on patient-relevant outcomes is unclear. We aim to evaluate whether collaboration through a novel teleconsultation platform in the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) project, tested on a previous feasibility study, can improve patient-relevant outcomes. We will conduct a parallel-group, two-arm, cluster-randomised superiority trial with a 1:1 allocation ratio, with primary care practices from Rio de Janeiro as clusters. Physicians from the intervention group practices will receive teleconsultation support from a cardiologist to assist patients discharged from hospitals after admission for heart failure. In contrast, physicians from the control group practices will perform usual care. We will include 10 patients per each of the 80 enrolled practices (n = 800). The primary outcome will be a composite of mortality and hospital admissions after six months. Secondary outcomes will be adverse events, symptoms frequency, quality of life, and primary care physicians' compliance with treatment guidelines. We hypothesise that teleconsulting support will improve patient outcomes.

Changes in physical activity during a one-year weight loss trial with liraglutide vs placebo in participants with knee osteoarthritis: Secondary analyses of a randomised controlled trial.

Objective: To assess if a change in physical activity occurred after a one-year weight loss period on either liraglutide or placebo in patients with knee osteoarthritis (OA) and overweight. Method: This is secondary analysis of a one-year weight loss trial, with participants randomised (1:1) to either liraglutide 3 â€‹mg/day or placebo. The main outcome was change in physical activity (min/day) after one year assessed by accelerometer. Physical function was assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), function subscale with 100 indicating no disability and 0 indicating extreme disability. Analyses were done on the modified intention to treat population defined as complete baseline accelerometer data. Results: A total of 135 participants were analysed (66 liraglutide; 69 placebo). Daily physical activity time did not change in either group (liraglutide: 15.8 â€‹min/day; placebo: 14.2 â€‹min/day; mean difference 1.6 â€‹min/day (95%CI -16 to 19; P â€‹= â€‹0.90)). The liraglutide group lost -4.1 â€‹kg more than placebo (95% CI -6.0 to -2.1; P â€‹< â€‹0.0001) and improved in KOOS function 3.8 points more than placebo (95% CI 0.9 to 6.7; P â€‹= â€‹0.01). Conclusion: Despite better outcomes on body weight and self-reported physical functioning liraglutide did not induce changes in physical activity over one year in individuals with knee OA.

Reaching Frail Elderly Patients to Optimize Diagnosis and Management of Atrial Fibrillation (REAFEL): A Feasibility Study of a Cross-Sectoral Shared-Care Model.

Introduction: Atrial fibrillation (AF) management in primary care often requires a referral to cardiology clinics, which can be strenuous for frail patients. We developed "cardio-share" (CS), a new cross-sector collaboration model, to ease this process. General practitioners (GPs) can use a compact Holter monitor (C3 from Cortrium) to receive remote advice from the cardiologist. Objective: To test the feasibility and acceptability of the CS model to manage suspected AF in frail elderly patients. Methods: We used a mixed methods design, including the preparation of qualitative semistructured interviews of GPs and nurses. Results: Between MAR-2019 and FEB-2020, 54 patients were consulted through the CS model, of whom 35 underwent C3 Holter monitoring. The time from referral to a final Holter report was shortened from a mean (SD) of 117 (45) days in usual care to 30 days (13) with the CS model. Furthermore, 90% of the patients did not need to attend visits at the cardiology clinic. The GPs and nurses highlighted the ease of using the C3 monitor. Their perception was that patients were confident in the GPs' collaboration with cardiologists. Conclusions: The CS model using a C3 monitor for AF is both feasible and seems acceptable to GPs. The elapsed time from referral to the Holter report performed for the diagnosis was significantly reduced.

Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial.

BACKGROUND: Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA). OBJECTIVE: To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA. METHODS: The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a pre-random assignment diet intervention (week -8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52. RESULTS: In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre-random assignment dietary intervention period (week -8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: -2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: -6.9, -1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and -0.6 points, respectively; group difference, 0.9 points; 95% CI: -3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively. CONCLUSIONS: In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre-random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.

Association Between Weight Loss and Spontaneous Changes in Physical Inactivity in Overweight/Obese Individuals With Knee Osteoarthritis: An Eight-Week Prospective Cohort Study.

OBJECTIVE: To describe spontaneous changes in time spent being physically inactive that is measured continuously by accelerometry during an 8-week weight-loss intervention in overweight/obese individuals with knee osteoarthritis (OA). METHODS: This study was designed as an observational cohort study including individuals from an OA outpatient clinic who were concomitantly overweight/obese and had symptomatic knee OA. Participants completed an 8-week dietary intervention that had been previously shown to induce substantial weight loss. The main outcome was accelerometer-based measurement of daily physical inactivity for 24 hours during the 8-week intervention period that was presented as change in the average daily time spent inactive (sitting, reclined, or sleeping) from 1 week prior to intervention to the last week of the intervention. RESULTS: A total of 124 participants completed the dietary intervention and had valid accelerometer recordings. The mean weight loss was 12.7 kg (95% confidence interval [95% CI] -13.2, -12.1; P < 0.0001) after 8 weeks, which corresponded to a decrease in body mass index of 4.3 kg/m2 (95% CI -4.5, -4.2; P < 0.0001). Significant improvements in OA symptoms (assessed by the Knee Injury and Osteoarthritis Outcome Score [KOOS]) was found across all subscales; an improvement of 12.8 points (95% CI 10.6, 15.0; P < 0.0001) was observed for pain using the KOOS. No statistically significant change occurred in the average daily time spent inactive from baseline to follow-up (mean change 8.8 minutes/day [95% CI -12.1, 29.7]; P = 0.41). CONCLUSION: Physical inactivity remains stable despite a clinically significant weight loss and improvements in knee OA symptoms. Change in inactivity does not seem to occur spontaneously, suggesting that focused efforts to reduce inactive behaviors are needed.

Relationship Between Fatigue and Inflammation, Disease Duration, and Chronic Pain in Psoriatic Arthritis: An Observational DANBIO Registry Study.

OBJECTIVE: Fatigue is one of the most significant symptoms, and an outcome of great importance, in patients with psoriatic arthritis (PsA), but associations between underlying components of fatigue experienced by patients in relation to the disease have been sparsely investigated. The objectives were to describe the degree of fatigue in patients with PsA, and to examine important components associated with fatigue. METHODS: We performed a cross-sectional survey including patients registered in the Danish nationwide registry DANBIO from December 2013 to June 2014. Principal component analysis (PCA) was used to identify factors associated with fatigue. RESULTS: A total of 1062 patients with PsA were included in the study. A PCA reduced co-variables into 3 components explaining 63% of fatigue in patients. The first component, contributing to 31% of fatigue, was composed of inflammatory factors including swollen and tender joints, physician's global assessment, elevated C-reactive protein (CRP), and high Pain Detect Questionnaire (PDQ) score. The second component, contributing to 17% of fatigue, consisted of increasing age and long disease duration. The third component, contributing to 15% of fatigue, consisted of high PDQ score, tender joint count, increasing age, and concomitant low CRP, suggestive of a chronic pain component consisting of central pain sensitization or structural joint damage. CONCLUSION: Fatigue in patients with PsA may be driven by clinical inflammatory factors, disease duration, and chronic pain in the absence of inflammation.

Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I).

OBJECTIVE: In an eHealth setting, to investigate intra- and interrater reliability and agreement of joint assessments and Disease Activity Score using C-reactive protein (DAS28-CRP) in patients with rheumatoid arthritis (RA) and test the effect of repeated joint assessment training. METHODS: Patients with DAS28-CRP ≤ 5.1 were included in a prospective cohort study (clinicaltrials.gov: NCT02317939). Intrarater reliability and agreement of patient-performed joint counts were assessed through completion of 5 joint assessments over a 2-month period. All patients received training on joint assessment at baseline; only half of the patients received repeated training. A subset of patients was included in an appraisal of interrater reliability and agreement comparing joint assessments completed by patients, healthcare professionals (HCP), and ultrasonography. Cohen's κ coefficients and intraclass correlation coefficients (ICC) were used for quantifying of reliability of joint assessments and DAS28-CRP. Agreement was assessed using Bland-Altman plots. RESULTS: Intrarater reliability was excellent with ICC of 0.87 (95% CI 0.83-0.90) and minimal detectable change of 1.13. ICC for interrater reliability ranged between 0.69 and 0.90 (good to excellent). Patients tended to rate DAS28-CRP slightly higher than HCP. In patients receiving repeated training, a mean difference in DAS28-CRP of -0.08 was observed (limits of agreements of -1.06 and 0.90). After 2 months, reliability between patients and HCP was similar between groups receiving single or repeated training. CONCLUSION: Patient-performed assessments of joints and DAS28-CRP in an eHealth home-monitoring solution were reliable and comparable with HCP. Patients can acquire the necessary skills to conduct a correct joint assessment after initial and thorough training. [clinicaltrials.gov (NCT02317939)].

Perfusion in bone marrow lesions assessed on DCE-MRI and its association with pain in knee osteoarthritis: a cross-sectional study.

OBJECTIVE: To investigate the association between pain and perfusion in bone marrow lesions with and without cysts assessed dynamic contrast-enhanced (DCE)-MRI in patients with knee osteoarthritis. SUBJECTS AND METHODS: In a cross-sectional setting, perfusion in bone marrow lesions was assessed using 3 Tesla MRI and correlated (Spearman's rank correlation) to pain using the knee injury and osteoarthritis outcome score (KOOS). Bone marrow lesions were assessed across the whole knee with DCE-MRI using heuristic variable and non-contrast-enhanced-MRI using MRI osteoarthritis knee score. RESULTS: Data were available from 107 participants. The participants had a mean age of 60.8 years, mean BMI of 34.5 kg/m2, mean KOOS-pain of 63.7 (0-100 scale), and mean bone marrow lesion sum score of 6.5 (0-45 scale). The bivariate association between KOOS-pain and the heuristic perfusion variable time to peak in bone marrow lesions containing subchondral cysts showed a statistically significant correlation (r = 0.40; p = 0.002). The perfusion variables were not correlated with KOOS-pain in bone marrow lesions without cysts. CONCLUSION: In this cross-sectional study, the rate of perfusion (TTP) in bone marrow lesions containing subchondral cysts was associated with pain in patients with knee OA. DCE-MRI has a potential to be used for separating subtypes of OA.

Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial.

INTRODUCTION: With an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA. METHODS AND ANALYSIS: 150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week -8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52. ETHICS AND DISSEMINATION: The trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: 2015-005163-16, NCT02905864, U1111-1171-4970 BASED ON PROTOCOL VERSION: V.6; 30 January 2017, 15:30 hours.

Single- vs. double-dose gadolinium contrast in delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) in knee osteoarthritis: is dose reduction possible on 3-T MRI?

BACKGROUND: Reduction in gadolinium (Gd) contrast agents is wanted due to the uncertainty of the potential side effects. PURPOSE: To investigate whether it is possible to reduce the contrast dose from conventional double dose to single dose when increasing the field strength from 1.5-T to 3-T for separating early cartilage degeneration from healthy cartilage, assessed by delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC). MATERIAL AND METHODS: Nine patients with knee osteoarthritis (OA), Kellgren-Lawrence grade (KLG) 1-4, were recruited from an ongoing weight loss cohort study. dGEMRIC was performed at 3-T using single (0.1 mmoI/kg) and double (0.2 mmoI/kg) doses of intravenous (i.v.) Gd-DTPA2-. Regions of interest (ROls) were drawn around the posterior weight-bearing femoral knee cartilage in lateral and medial compartments. In five medial compartments ROIs could not be drawn due to severe degeneration of cartilage. T1-relaxation times were compared to previously published values from 1.5-T and to non-contrast values from 3-T. RESULTS: Mean dGEMRIC T1-relaxation time in the lateral compartment was 769 ms for single dose vs. 561 ms for double dose ( P < 0.0001); and 685 ms for single dose vs. 454 ms for double dose ( P = 0.004) in the medial compartment. CONCLUSION: We found a dose-response relationship between single and double doses of Gd-DTPA2- using 3-T in knee OA patients, similar to the findings at 1.5-T. Compared to the T1-relaxation time at 3-T without contrast (1240 ms), this further separation between OA and normal cartilage indicates that "single dose" dGEMRIC could be sufficient for cartilage health assessment at 3-T.

Protocol for evaluating and implementing a pragmatic value-based healthcare management model for patients with inflammatory arthritis: a Danish population-based regional cohort and qualitative implementation study.

INTRODUCTION: The provision of healthcare for patients with inflammatory arthritis occurs in the context of somewhat conflicting targets, values and drivers. Therefore, there is a need for introducing 'value-based healthcare' defined as the value of patient relevant health outcomes in relation to costs. This term is a central part of tomorrow's healthcare sector, especially for rheumatic diseases, yet the transition is a huge challenge, as it will impact the development, delivery and assessment of healthcare. AIMS: The aim of this study is to compare medical and patient evaluated impact of the traditional settlement and financing production (DAGS) controlled healthcare setting with a value-based and patient-centred adjunctive to standard care. METHODS AND ANALYSIS: Patients with inflammatory arthritis receiving treatment in routine care at the outpatient clinics in the Capital Region of Denmark will prospectively and consecutively be enrolled in a Non-Intervention-Study framework providing a pragmatic value-based management model. A Danish reference cohort, used for comparison will be collected as part of routine clinical care. The enrolment period will be from 1 June 2018 until 31December 2023. Baseline and follow-up visits will be according to routine clinical care. Registry data will be obtained directly from patients and include personal, clinical and outcomes information. The study results will be reported in accordance with the STROBE statement. ETHICS AND DISSEMINATION: The study has been notified to the Danish Data Protection Agency and granted authorisation for the period June 2018 to January 2025 (pending). Informed consent will be obtained from all patients before enrolment in the study. The study is approved by the ethics committee, Capital Region of Denmark (H-18013158). Results of the study will be disseminated through publication in international peer-reviewed journals.

Delayed gadolinium-enhanced MRI of menisci and cartilage (dGEMRIM/dGEMRIC) in obese patients with knee osteoarthritis: Cross-sectional study of 85 obese patients with intra-articular administered gadolinium contrast.

BACKGROUND: Early cartilage changes in knee osteoarthritis (OA) can be assessed by both intravenous (i.v.) and intra-articular (i.a.) delayed gadolinium-enhanced MRI of cartilage (dGEMRIC). PURPOSE: To examine the relationship between i.a. dGEMRIC and delayed gadolinium-enhanced MRI of menisci (dGEMRIM), and to investigate if the approach can be used to assess the morphological degeneration of menisci in obese patients with knee OA. STUDY TYPE: Cross-sectional. POPULATION: Eighty-five obese patients with knee OA. FIELD STRENGTH/SEQUENCES: 1.5T. Inversion recovery sequence with four inversion times. ASSESSMENT: T1 relaxation times were calculated for posterior weight-bearing femoral cartilage and the posterior horns of the menisci. Meniscus degeneration sum score (0-2) was assessed as increased signal/no signal (1/0) and tear/no tear (1/0). STATISTICAL TESTS: T1 relaxation times were compared using Student's t-test. Comparison of cartilage and meniscus T1 relaxation times was done by regression analysis. Analysis of variance (ANOVA) was used for comparison of meniscal T1 relaxation times among the three summed morphological scores (0-2). Statistical analyses were performed with a level of significance at 0.05. RESULTS: For lateral menisci, morphology sum scores of 0, 1, and 2 were found in 13, 58, and 14 patients and for medial menisci in 2, 30, and 30 patients, respectively. Mean T1 relaxation times were 441 msec, 480 msec, and 497 msec for cartilage, lateral menisci, and medial menisci, respectively. T1 relaxation times for the menisci were similar (P = 0.53), and a weak correlation was found between dGEMRIC and dGEMRIM in the lateral compartments (R = 0.26). Comparing dGEMRIM between different morphology sum scores showed no differences (P > 0.4). DATA CONCLUSION: I.a. dGEMRIM showed no correlation between the degree of meniscal degeneration and meniscus T1 relaxation times. I.a. dGEMRIM do not seem to deliver useful information about meniscus degeneration to be suitable for clinical applications, but i.a. dGEMRIC may still be considered an alternative contrast-saving method for cartilage. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2018;48:1700-1706.

The Development of Complex Digital Health Solutions: Formative Evaluation Combining Different Methodologies.

BACKGROUND: The development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA). OBJECTIVE: The aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems. METHODS: The formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe. RESULTS: The formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics' working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other's feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a 'tipping point' during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment. CONCLUSIONS: A formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health solution, and provided constructive input and feedback enabling the consortium to control the development process.

The Parker Model: Applying a Qualitative Three-Step Approach to Optimally Utilize Input from Stakeholders When Introducing New Device Technologies in the Management of Chronic Rheumatic Diseases.

BACKGROUND AND OBJECTIVE: Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava®, an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases. METHODS: The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE). CM, a structured group process, was used to identify patients' opinions and concerns regarding the e-Device. Patients used this information in iterative PD sessions to create personal e-Device prototypes in cooperation with a designer and a healthcare professional. SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders. RESULTS: The study recruited 14 patients, two doctors, two nurses, one medical secretary, and four other public servants. Three CM workshops revealed four key considerations: technical usability, physical design, concerns, and enthusiasm. Four personalized prototypes were developed during PD sessions. SE confirmed that the identified considerations were pivotal for the implementation and adaptation of the e-Device. CONCLUSIONS: This study is the first to apply a composite, qualitative research model when introducing an e-Device for the treatment and management of rheumatic disease. Results show that input from patients and other stakeholders using the Parker Model can add value to the development and implementation of an e-Device.

Reliability and Construct Validity of the SENS Motion® Activity Measurement System as a Tool to Detect Sedentary Behaviour in Patients with Knee Osteoarthritis.

Physical inactivity is important to address, and an objective way of measuring inactivity is by accelerometry. The objective of this study was to determine the reliability and construct validity of the SENS motion system to record physical activity and inactivity in patients with knee osteoarthritis. Participants with an age > 40 years and an average weekly pain above 0 on a numeric rating scale (0 = no pain, 10 = worst pain) were included. Participants had a total of two study visits and at each visit participants completed a standardized activity. Data from 24 participants were analysed. A mean agreement of 99% (SD 3%) for sedentary behaviour and a mean agreement of 97% (SD 9%) for active behaviour were found. The agreement for "walking" was 28% (SD 18%). Mean agreement between recordings on the two visits was 96% (SD 8%) for sedentary behaviour and 99% (SD 1%) for active behaviour. The SENS motion activity measurement system can be regarded as a reliable and valid device for measuring sedentary behaviour in patients with knee OA, whereas detection of walking is not reliable and would require further work.

Point of no return for improvement of cartilage quality indicated by dGEMRIC before and after weight loss in patients with knee osteoarthritis: a cohort study.

Background It has been demonstrated that weight loss improves symptoms in obese subjects with knee osteoarthritis (KOA). A parallel change in cartilage morphology remains to be demonstrated. Purpose To demonstrate a parallel change in cartilage morphology. Material and Methods Obese patients with KOA were examined before and after weight loss over 16 weeks. Target knee joints were radiographically assessed by the Kellgren/Lawrence grading (KLG) system. Patients with KLG-1 and 2 changes in the lateral compartment were included. Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) was performed using intra-articular contrast. Results Nine patients with lateral KLG-1 and ten patients with lateral KLG-2 were studied. There were no group differences regarding the lateral compartment baseline dGEMRIC T1 values: median = 497 ms (KLG-1) and 533 ms (KLG-2) ( P = 0.12), or regarding reduction in body mass index (BMI) after 16 weeks: 12.8% versus 11.4% ( P = 0.74). In the KLG-1 group, several cases of increased dGEMRIC T1 values were seen and median value decreased significantly less than in KLG-2 group (15 ms versus 41 ms, P = 0.03) after weight loss. Conclusion Improvement of cartilage quality, assessed with dGEMRIC, after weight loss might be possible in early stage KOA (KLG-1), but not in later stage KOA (KLG-2). The results may suggest a point of no return for improvement of cartilage quality that should be tested in larger trials.

Weight loss for overweight and obese individuals with gout: a systematic review of longitudinal studies.

OBJECTIVES: Weight loss is commonly recommended for gout, but the magnitude of the effect has not been evaluated in a systematic review. The aim of this systematic review was to determine benefits and harms associated with weight loss in overweight and obese patients with gout. METHODS: We searched six databases for longitudinal studies, reporting the effect of weight loss in overweight/obese gout patients. Risk of bias was assessed using the tool Risk of Bias in Non-Randomised Studies of Interventions. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation. RESULTS: From 3991 potentially eligible studies, 10 were included (including one randomised trial). Interventions included diet with/without physical activity, bariatric surgery, diuretics, metformin or no intervention. Mean weight losses ranged from 3 kg to 34 kg. Clinical heterogeneity in study characteristics precluded meta-analysis. The effect on serum uric acid (sUA) ranged from -168 to 30 µmol/L, and 0%-60% patients achieving sUA target (<360 µmol/L). Six out of eight studies (75%) showed beneficial effects on gout attacks. Two studies indicated dose-response relationship for sUA, achieving sUA target and gout attacks. At short term, temporary increased sUA and gout attacks tended to occur after bariatric surgery. CONCLUSIONS: The available evidence is in favour of weight loss for overweight/obese gout patients, with low, moderate and low quality of evidence for effects on sUA, achieving sUA target and gout attacks, respectively. At short term, unfavourable effects may occur. Since the current evidence consists of a few studies (mostly observational) of low methodological quality, there is an urgent need to initiate rigorous prospective studies (preferably randomised controlled trials). SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42016037937.