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Objectives: To evaluate (1) the association between nailfold capillaroscopy pattern and 5-year risk for incident interstitial lung disease and (2) the association between transition in nailfold capillaroscopy pattern and risk of incident interstitial lung disease., Methods: Data of adult patients from the EUSTAR database fulfilling the ACR-EULAR criteria with a disease duration ⩽5 years, having a scleroderma pattern at nailfold capillaroscopy with high-resolution computed tomography confirmed absence of interstitial lung disease (i.e. baseline) was used. Interstitial lung disease-free survival was assessed for up to 5 years of follow-up with a Cox proportional hazards model stratified on nailfold capillaroscopy pattern at baseline. The association of annual transition in nailfold capillaroscopy pattern on the risk to develop interstitial lung disease was assessed with a mixed logistic regression analysis., Results: Out of 771 eligible patients, 283 (37%) had an early pattern, 377 (49%) had an active pattern, and 111 (14%) had a late pattern. The Cox proportional hazard model including the identified confounders did not show an association between severity of nailfold capillaroscopy pattern at baseline and increased risk for interstitial lung disease during 5-year follow-up (hazard ratio (95 confidence interval; p value): 1.09 (0.86-1.39; 0.47)). The mixed logistic regression analysis revealed an increased annual risk for incident interstitial lung disease with increasing severity of capillaroscopic pattern (odds ratio (95% confidence interval); p value 3.76 (1.99-7.11; <0.01))., Conclusion: Our study shows that worsening of nailfold capillaroscopy has a strong association with an increased annual risk to develop interstitial lung disease. Of note, a worse scleroderma pattern at nailfold capillaroscopy is not associated with the long-term risk to develop interstitial lung disease., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.V.: none declared. J.K.B.: received consulting fees from Abbvie, Janssen and Boehringer Ingelheim, and received research grants from Roche, Galapagos Janssen, NVLE and ReumaNederland; all payments were made to her institution. J.H.: speakers bureau and consulting fees from ABBVIE,Astra-Zeneca, Boehringer Ingelheim, BMS, GSK, Janssen Pharmaceutical, Novartis, Roche, Pfizer and UCB. L.C.: none for this manuscript. L.D.: none for this manuscript. G.R.: none declared. Y.A.: received consulting fees from Boehringer Ingelheim, Janssen Pharmaceutical Companies, Astra-Zeneca, Topadur, Abbvie, Galderma, Medsenic, Prometheus regarding the management of systemic sclerosis. R.F.: none declared. J.J.A-S.: none for this manuscript. B.M.: grants from Novartis, consulting fees from Novartis, Boehringer Ingelheim, Jannsen-Cilag, GSK; speaker fees from Boehringer Ingelheim, GSK, Novartis, Otsuka, MSD; congress support from Medtalk, Pfizer, Roche, Actelion, Mepha, and MSD; and patent mir-29 for the treatment of systemic sclerosis (US8247389, EP2331143). G.C.: none for this manuscript. J.S.: received research grants from Boehringer Ingelheim and ReumaNederland; all payments were made to her institution. T.M.: none for this manuscript. M.E.T.: received consultancy and speaker fees from Boehringer Ingelheim, Pfizer, Galapagos, MSD and Lilly. C.H.M.E.: none declared. M.C.V.: received research grants from Boehringer Ingelheim, Ferrer and Galapagos; received consulting fees from Boehringer Ingelheim and Janssen Pharmaceutical Companies of Johnson & Johnson; received speaker fees from Boehringer Ingelheim, GSK, Janssen Pharmaceutical Companies of Johnson & Johnson, MSD, and Novartis; and is treasurer of EUSTAR and steering committee member of the ERN ReCONNET., (© The Author(s) 2025.)

Introduction: Despite recommendations, non-surgical treatment modalities in knee and/or hip osteoarthritis (KHOA) are underused. An information campaign was developed targeting patients with early stage KHOA and healthcare professionals (HCPs) to optimise timing of referral to secondary care. This protocol describes the development and design of this information campaign and a randomised controlled trial (RCT) on its effectiveness in impacting healthcare utilisation., Methods and Analysis: The behaviour change wheel was used as a theoretical framework for the campaign design. After an inventory of the literature, a selection was made of factors influencing healthcare use. Effectiveness will be evaluated with a cluster RCT. The study aims to recruit 300 patients in 24 general practices, randomly allocated to intervention or usual care (ratio 1:1). General practitioners and affiliated HCPs are invited to participate in the trial and recruit patients. Patients are eligible to participate if they are Dutch speaking, aged 50-75 years, registered with KHOA at the general practice, without joint replacement nor having considerable walking impairment. The main end point is the difference in rate of referral to hospital care as reported by patients over a period of 18 months. Secondary parameters include quality of care, beliefs about KHOA treatment modalities, physical activity, self-management behaviour and referral rates to secondary care. Patients receive online questionnaires at baseline, 6, 12 and 18 months. Online questionnaires are sent to HCPs at baseline and after 12 months to assess (changes in) beliefs about KHOA treatment modalities., Ethics and Dissemination: All methods are carried out in accordance with relevant guidelines and regulations and ethical approval was waived by the Dutch medical research ethical committee of Arnhem-Nijmegen (file number 2020-7246). Trial results will be communicated to participants and patient representatives via news letters, the public via the Sint Maartenskliniek website and journals of patient organisations and HCPs via congresses and international scientific journals., Trial Registration Number: NL9140., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: OA is a very heterogeneous disease. Here, we aimed to differentiate OA patients based on their serum-induced cell-integrated signalling patterns., Design: In order to monitor the activity of different cellular homeostasis-regulating pathways in response to patient serum, we analysed the response of human OA serum samples to sixteen cell-based transcription factor luciferase reporter assays. In this study we compared serum samples from 55 patients with knee OA, 56 patients with hand OA and 42 healthy controls., Results: Differential serum-induced pathway activity was observed between samples from healthy controls, knee OA and hand OA patients: Serum of hand OA patients induced high MAPK-related AP1 activity whereas serum of knee OA patients induced more SRE, ISRE and SOX9 activity, which is related to ELK1-SRF, STAT1-STAT2 and SOX9 activity respectively. Principal component analysis revealed that these differences differentiate hand OA from knee OA. Both hand and knee OA clustered clearly in 2 different endotypes each, but no principle component could be identified of these subtypes within either the hand OA or the knee OA sample group., Conclusion: This study demonstrates that serum from hand OA and knee OA patients evokes diverse cellular signalling patterns that differentiates hand OA, knee OA and healthy controls. This underlines that the pathomolecular mechanisms of OA are likely significantly different between hand and knee OA, a finding that could lead to new insight into the pathobiology of OA endotypes and joint-specific therapies., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: In patients with systemic sclerosis, interstitial lung disease (ILD) is the leading cause of mortality. Early detection of progressive ILD associated with systemic sclerosis is warranted for timely adjustment of management strategies and improved prognosis. We aimed to investigate the validity of home spirometry to detect a decline in pulmonary function in patients with systemic sclerosis-associated ILD., Methods: DecreaSSc was a prospective, observational study done in two tertiary referral centres in the Netherlands. Eligible patients were aged 18 years or older, fulfilled the American College of Rheumatology-European Alliance of Associations for Rheumatology criteria for systemic sclerosis, had a disease duration from first non-Raynaud phenomenon symptom of 5 years or less, had high-resolution CT-confirmed diagnosis of ILD, and had a maximum immunosuppressive treatment duration of 8 weeks at baseline. Patients took weekly home spirometry measurements using a handheld spirometer for 1 year. At baseline and at semi-annual study visits, patients pulmonary function testing was done in the hospital and patients completed questionnaires on patient-reported outcome measurements. The primary outcome was the κ agreement between home and hospital measurements after 1 year to detect a decline in force vital capacity (FVC) of 5% or more, estimated using separate linear regression analyses for home-based and hospital-based FVC% predicted in individual patients. The sensitivity and specificity of home spirometry to detect an absolute decline in FVC% predicted of 5% or more was assessed using the hospital pulmonary function test as the gold standard. The longitudinal correlation between hospital and home measurements was assessed with regression analysis, whereas the cross-sectional correlation was assessed with the intraclass coefficient. People with lived experience were involved at several stages of the study., Findings: Between Jan 26, 2021, and Feb 27, 2023, 43 patients were enrolled, 35 of whom completed 6 months of follow-up and 31 of whom completed 12 months of follow-up. The last follow-up visit took place on March 28, 2024. 20 (57%) of patients were women and 15 (43%) were men; 32 (91%) were White. Mean age was 57·7 years (SD 10·7). The agreement between hospital and home measurements had a κ value of 0·40 (95% CI 0·01-0·79). The sensitivity of home spirometry to detect a decline in FVC% predicted of 5% or more was 60% (95% CI 44-76) and specificity was 87% (75-98). Regression analysis showed that the course of pulmonary function was not different between hospital and home assessment as the interaction term was not significant (-0·0003 [95% CI -0·0006 to 0·000008]; p=0·057) with a longitudinal correlation of 0·55 (95% CI 0·26-0·74; p=0·0070). The intraclass coefficient between both measurements was 0·85 (95% CI 0·73-0·92; p<0·0001) at baseline, 0·84 (0·71-0·92; p<0·0001) at 6 months, and 0·72 (0·50-0·86; p<0·0001) at 12 months., Interpretation: Home spirometry has the potential to detect a decline in pulmonary function in patients with systemic sclerosis-associated ILD earlier when used in addition to regular health care management. Future research could reveal whether home spirometry can contribute to improved outcomes of patients with systemic sclerosis-associated ILD., Funding: Galapagos and Boehringer Ingelheim., Competing Interests: Declaration of interests CCM declares grants and consultancy fees from Boehringer Ingelheim, AstraZeneca, and Daiichi Sankyo, outside of the submitted work, paid to the institution. JKdV-B received consulting fees from AbbVie, Janssen, and Boehringer Ingelheim, and received research grants from Roche, Galapagos Janssen, National Association for People with Lupus, APA, Scleroderma, and MCTD, and ReumaNederland; all payments were made to her institution. MSW-L received consulting or speakers fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Galapagos, Galecto, Hoffmann-La Roche, Horizon Therapeutics, Kinevant Sciences, Molecure, NeRRe, Novartis, PureTech, Thyron, Trevi, and Vicore; and grants from The Dutch Pulmonary Fibrosis Patients Association, The Dutch Lung Foundation, The Netherlands Organisation for Health Research and Development, The Thorax Foundation, Sarcoidosis.nl, AstraZeneca/DaiichiSankyo, Boehringer Ingelheim, and Hoffmann-La Roche; all fees and grants were paid to her institution. MCV received consulting fees or speakers fees from Boehringer Ingelheim, GSK, Janssen, MSD, Novartis, Boehringer Ingelheim, and Janssen; and unrestricted research grants from Boehringer Ingelheim, Ferrer, and Galapagos; all fees and grants were paid to her institution. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Objectives: To explore patient characteristics associated with response to intramuscular methylprednisolone (MP) therapy in hand OA., Methods: We performed an exploratory monocentric retrospective study. Patients with a clinical diagnosis of hand OA who visited our outpatient clinic between July 2016 and June 2021 and received at least once an intramuscular MP injection were included. Clinical data, including laboratory and radiologic results, were retrieved from electronic patient records (EPRs). Patients' reported response to MP and its duration in the first 6 months after injection was based on free text from the EPRs. Response was categorized into three groups: no response or worsening of symptoms, modest response and good response. Duration of response was categorized as short-term (<2 weeks) or long-term (≥2 weeks). Multivariable logistic regression models were performed to determine factors associated with good response to therapy with MP., Results: Data from 262 hand OA patients (76% female) were analysed. A good response was experienced by 150 patients (57.2%). Among those with modest-good response, the perceived response of 162 patients (80.6%) lasted ≥2 weeks. Univariate regression analysis indicated that the level of CRP was associated with good response [odds ratio 1.08 (95% CI 1.00, 1.17)]. However, multivariate regression analysis showed no statistically significant associations., Conclusion: In this retrospective study, more than half of hand OA patients displayed good response to intramuscular MP administration. The possible relation between the presence of low-grade inflammation and the response to this therapy warrants further investigation., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Introduction: This study aimed to rank definitions for measuring poor response one year after TKA, after assessing the face validity and feasibility of existing or newly proposed definitions., Materials and Methods: An international, three-round, online modified Delphi study was conducted with sixty-nine panelists from twenty-three countries. Definitions were derived from a literature review or were newly proposed by an expert group. Panelists rated the face validity and feasibility of definitions, and could propose additional new definitions in round 1. Panelists reconsidered their rating of existing definitions, and rated newly suggested definitions (round 2). Definitions with a median score for face validity < 6.5 were removed from the list, and panelists distributed 100 points among the remaining definitions for ranking (round 3)., Results: Fifty-one panelists completed all three rounds (response rate 74%), and the prioritized list of definitions in round 3 comprised seventeen definitions. The single-item definition of (dis)satisfaction with the outcome of TKA obtained the highest scores for face validity and feasibility (7.5, and 8.5 respectively), and the definition "No improvement in pain OR daily knee functioning compared to pre-operative status" was the highest prioritized. In general, definitions reflecting change from the perception of patients were higher ranked than definitions requiring both preoperative and postoperative assessment of validated questionnaires., Conclusions: This study identified seventeen potential definitions of poor response to TKA, offering valuable options for integration into quality assessment investigations. Remarkably, all identified definitions were patient-centered and none were clinician-centered. Single-item questions, capturing change from the patient's viewpoint, appear to be the most practicable format to assess response., Competing Interests: Declarations. Competing interests: The authors have no competing interests to declare that are relevant to the content of this article., (© 2024. The Author(s).)

Objective: Long-term gout management is based on reducing serum urate by using urate-lowering therapy (ULT). A lifelong treat-to-target approach is advocated, although a ULT (taper to) stop attempt can be considered (treat-to-avoid symptoms approach) during remission. Exploring the beliefs of patients with gout on long-term ULT strategies during remission is important for optimizing gout management. We aimed to identify factors that influence the decision for continuation or discontinuation of ULT and to determine their relative importance according to patients with gout in remission., Methods: A mixed-methods design was used. First, semistructured interviews (substudy 1) were conducted to identify barriers and facilitators for the (dis)continuation of ULT using inductive thematic analysis. Afterwards, these barriers/facilitators were summarized into neutrally phrased items and used in a maximum difference scaling study (substudy 2) to determine their relative importance using the rescaled probability score., Results: Substudies 1 and 2 included 18 and 156 patients, respectively. Substudy 1 yielded 22 items within 10 overarching themes. Substudy 2 revealed that the perceived risk of joint damage and gout flares and that ULT use gives some assurance were the most important items. The costs, ease of receiving ULT, and its practical use were the least important items., Conclusion: These results can aid shared decision-making and provide input for what is important to discuss with patients with gout in remission when they consider ULT discontinuation. The emphasis should be on the risk of having gout flares and joint damage, not so much on facilitating how easily medication is received., (© 2024 The Author(s). Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Degenerative joint disease osteoarthritis (OA) is characterized by the degeneration of cartilage, synovial inflammation and low-grade systemic inflammation in association with microbial dysbiosis and intestinal barrier defects. Butyrate is known for its anti-inflammatory and barrier protective effects and might benefit OA patients. In a double-blind placebo-controlled randomized trial, the effects of four to five weeks of oral treatment with sustained-release (SR) butyrate tablets (600 mg/day) on systemic inflammation and immune function were studied in hand OA patients. Serum markers for systemic inflammation and lipopolysaccharide (LPS) leakage were measured and ex vivo stimulation of whole blood or peripheral blood mononuclear cells (PBMCs) was performed at baseline and after treatment. Butyrate treatment did not affect the serum markers nor the cytokine release of ex vivo LPS-stimulated whole blood or PBMCs nor the phenotype of restimulated monocytes. By contrast, butyrate treatment reduced the percentage of activated T helper (Th) cells and the Th17/Treg ratio in αCD3/CD28-activated PBMCs, though cytokine release upon stimulation remained unaffected. Nevertheless, the percentage of CD4+IL9+ cells was reduced by butyrate as compared to the placebo. In both groups, the frequency of Th1, Treg, Th17, activated Th17, CD4+IFNγ+ and CD4+TNFα+ cells was reduced. This study shows a proof of principle of some immunomodulatory effects using a SR butyrate treatment in hand OA patients. The inflammatory phenotype of Th cells was reduced, as indicated by a reduced percentage of Th9 cells, activated Th cells and improved Th17/Treg balance in ex vivo αCD3/CD28-activated PBMCs. Future studies are warranted to further optimize the butyrate dose regime to ameliorate inflammation in OA patients.

Objectives: To explore the within-person fluctuations of fatigue in systemic sclerosis and its association with negative affect, positive affect, pain, perceived exertion of physical activity and quality of sleep., Methods: We performed an ecological momentary assessment study in adult patients with a clinical diagnosis of systemic sclerosis. During 14 days, patients completed daily assessments of fatigue severity, negative affect, positive affect, pain, quality of sleep and perceived exertion of physical activity at four fixed time points. The day-to-day fluctuations in fatigue were quantified by the intra-individual variance and probability of acute change, capturing the magnitude and frequency of clinical relevant within-person day-to-day fluctuations, respectively. Using multilevel models, the within-person association between fatigue and the daily assessments were analysed., Results: Fifty-seven patients with systemic sclerosis participated. The mean (standard deviation) intra-individual variance was 1.08 (0.42) and the probability of acute change was mean (standard deviation) 0.40 (0.14), ranging from 0.08 to 0.77. For fatigue, a within-person variation of 51% was observed. Multilevel analyses showed that higher average levels and daily increases in negative affect, pain and perceived exertion of physical activity were associated with more fatigue, while the opposite was observed for positive affect and quality of sleep. Positive affect demonstrated the strongest association with fatigue fluctuations., Conclusion: This is the first quantitative study showing that fatigue in systemic sclerosis is characterized by a dynamic course and that approximately half of the day-to-day fluctuations within persons are clinically meaningful. Furthermore, our results indicate that integrating activities with positive impact on mood into fatigue treatment strategies might reduce the frequency of fatigue fluctuations., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.C.V. received honorary as speaker from Boehringer Ingelheim, Bristol-Myers Squibb, GSK, Janssen, MSD, Novartis and Roche, as consultant from Boehringer Ingelheim and Janssen, Grant/research and received support from Research grants from Boehringer Ingelheim, Janssen, Ferrer and Galapagos, none on the subject of this study. J.E.V. received honorary as speaker from Eli Lilly, but this is not pertaining to this study. The remaining authors have declared no conflicts of interest., (© The Author(s) 2024.)

Background: Variations in defining poor response to total knee arthroplasty (TKA) impede comparisons of response after TKA over time and across hospitals. This study aimed to compare the prevalence, overlap, and discriminative accuracy of 15 definitions of poor response after TKA using 2 databases., Methods: Data of patients one year after primary TKA from the Dutch Arthroplasty Register (n = 12,275) and the Osteoarthritis Initiative database (n = 204) were used to examine the prevalence, overlap (estimated by Cohen's kappa), and discriminative accuracy (sensitivity, specificity, positive predictive value, negative predictive value, and Youden index) of 15 different definitions of poor response after TKA. In the absence of a gold standard for measuring poor response to TKA, the numeric rating scale satisfaction (≤ 6 'poor responder') and the global assessment of knee impact (dichotomized: ≥ 4 'poor responder') were used as anchors for assessing discriminative accuracy for the Dutch Arthroplasty Register and Osteoarthritis Initiative dataset, respectively. These anchors were chosen based on a prior qualitative study that identified (dis)satisfaction as a central theme of poor responses to TKA by patients and knee specialists., Results: The median (25th to 75th percentile) prevalence of poor responders in the examined definitions was 18.5% (14.0 to 25.5%), and the median Cohen's kappa for the overlap between pairs of definitions was 0.41 (0.32 to 0.59). Median (25th to 75th percentile) sensitivity was 0.45 (0.39 to 0.54), specificity was 0.86 (0.82 to 0.94), positive predictive value was 0.45 (0.34 to 0.62), negative predictive value was 0.89 (0.87 to 0.89), and the Youden index was 0.36 (0.20 to 0.43)., Conclusions: This study found a lack of overlap between different definitions of poor response to TKA. None of the examined definitions adequately classified poor responders to TKA. In contrast, the absence of a poor response could be classified with confidence., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the effectiveness of long-term, personalized, supervised exercise therapy on functional ability compared with usual care in people with axial spondyloarthritis (axSpA) and severe functional limitations., Methods: Participants were randomly 1:1 assigned to the intervention(maximal 64 sessions, with 14 additional optional sessions of supervised active exercise therapy(e.g. aerobic and muscle strengthening) with individualized goal-setting, education and self-management regarding physical activity) or usual care(care determined by clinician(s) and participants themselves). Primary end point was the change in the Patient-Specific Complaints activity ranked 1 (PSC1 (0-10)) at 52 weeks. Secondary endpoints were the PSC activities ranked 2 and 3, the Bath Ankylosing Spondylitis Functional Index, 6-min walk test, Patient Reported Outcome Measurement Information System-Physical Function-10 and the Short Form-36 Physical and Mental Component Summary Score (SF-36 PCS and MCS). Statistical comparisons comprised independent student t-tests and linear mixed models, based on intention-to-treat., Results: 214 participants(49% female, age 52 (SD 12) years), were randomized to the intervention (n = 110) or usual care (N = 104) group. In the intervention group 93% started treatment, using on average 40.5 sessions (SD 15.1). At 52 weeks, the difference in change in PSC1 between groups favored the intervention group (mean difference [95% CI]; -1.8 [-2.4 to -1.2]). additionally, all secondary outcomes, except the SF-36 MSC, showed significantly greater improvements in the intervention group with effect sizes ranging from 0.4-0.7., Conclusion: Long-term, supervised exercise therapy proved more effective than usual care in improving functional disability and physical quality of life in people with axSpA and severe functional limitations., Clinical Trial Register Number: Netherlands Trial Register NL8238, included in the International Clinical Trial Registry Platform (ICTRP) (https://trialsearch.who.int/Trial2.aspx?TrialID=NL8238)., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: Inflammation is thought to play an important role in hand osteoarthritis (HOA), which is associated with pain and increased limitation of hand function., Objectives: To explore the acceptability of therapy with intramuscular methylprednisolone in HOA among health-care providers (HCPs) and HOA patients. Additionally, the response to a single methylprednisolone injection was investigated., Design: We adopted a mixed-methods design., Methods: In a qualitative study, we asked HCPs and patients for their acceptability of intramuscular methylprednisolone. A prospective observational study was performed afterward in HOA patients who received a single 120-mg intramuscular methylprednisolone injection as part of off-label administration. Average pain, functional impairment, and occurrence of adverse events were assessed at baseline and at 4, 8, and 12 weeks after the injection., Results: Fourteen HCPs and 15 patients participated in the first part of the study. They considered intramuscular methylprednisolone potentially effective, yet expressed concerns about the risk for long-term adverse events. Among the 22 HOA patients who received intramuscular methylprednisolone, 13 patients reported 44 adverse events, with half of them occurring within the first 4 weeks after injection and being classified as nonserious. Mean hand pain decreased the most 4 weeks after injection and this effect persisted till week 12, though less pronounced. Similar results were seen with HOA-related functional impairment, which improved the most at week 4 and to a lesser extent at week 12., Conclusion: We found a good acceptability of intramuscular methylprednisolone treatment among HCPs and HOA patients, as well as a potential to reduce pain and improve hand function with a good safety profile for as long as 12 weeks after a single administration., Competing Interests: The authors declare that there is no conflict of interest., (© The Author(s), 2024.)

Objective: To develop evidence-based recommendations for the non-pharmacological management of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc)., Methods: A task force comprising 7 rheumatologists, 15 other healthcare professionals and 3 patients was established. Following a systematic literature review performed to inform the recommendations, statements were formulated, discussed during online meetings and graded based on risk of bias assessment, level of evidence (LoE) and strength of recommendation (SoR; scale A-D, A comprising consistent LoE 1 studies, D comprising LoE 4 or inconsistent studies), following the European Alliance of Associations for Rheumatology standard operating procedure. Level of agreement (LoA; scale 0-10, 0 denoting complete disagreement, 10 denoting complete agreement) was determined for each statement through online voting., Results: Four overarching principles and 12 recommendations were developed. These concerned common and disease-specific aspects of non-pharmacological management. SoR ranged from A to D. The mean LoA with the overarching principles and recommendations ranged from 8.4 to 9.7. Briefly, non-pharmacological management of SLE and SSc should be tailored, person-centred and participatory. It is not intended to preclude but rather complement pharmacotherapy. Patients should be offered education and support for physical exercise, smoking cessation and avoidance of cold exposure. Photoprotection and psychosocial interventions are important for SLE patients, while mouth and hand exercises are important in SSc., Conclusions: The recommendations will guide healthcare professionals and patients towards a holistic and personalised management of SLE and SSc. Research and educational agendas were developed to address needs towards a higher evidence level, enhancement of clinician-patient communication and improved outcomes., Competing Interests: Competing interests: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, Elli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Otsuka, and Roche. LA has received research funding and/or consultancies from Alexion, Alpine, Amgen, AstraZeneca, Abbvie, Biogen, BMS, Boehringer-Ingelheim, GlaxoSmithKline, Janssen-Cilag, Kezar, Elli Lilly and Company, Medac, Novartis, Pfizer, Roche-Chugaï, Sêmeia, and Union Chimique Belge (UCB). OD has/had consultancy relationship with and/or has received research funding from and/or has served as a speaker for 4P-Pharma, Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, 4P Science, Galapagos, Glenmark, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus, Redxpharma, Roivant, Sanofi, and Topadur. AK has/had consultancy relationship with and/or has received research funding from Boehringer Ingelheim, Pfizer, Swiss Nursing Science Foundation, Swiss League Against Rheumatism, and University of Basel. MN reports research grants from BMS, Vifor Pharma and Sanofi paid to his institution, speaking fees from CCIS The Conference Company and Eli Lilly, all outside the submitted work. JEV reports speaker fees from Eli Lilly, and Galapagos. RW has received honoraria from Galapagos, Celltrion, Gilead Sciences, and Union Chimique Belge (UCB). The other authors declare that they have no conflicts of interest., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To investigate how a quality improvement program (BRIDGE), designed to promote coordination and continuity in rehabilitation services, was delivered and perceived by providers in routine practice for patients with rheumatic and musculoskeletal diseases., Methods: A convergent mixed methods approach was nested within a stepped-wedge, randomized controlled trial. The intervention program was developed to bridge gaps between secondary and primary healthcare, comprising the following elements: motivational interviewing; patient-specific goal setting; written rehabilitation-plans; personalized feedback on progress; and tailored follow-up. Data from health professionals who delivered the program were collected and analyzed separately, using two questionnaires and three focus groups. Results were integrated during the overall interpretation and discussion., Results: The program delivery depended on the providers' skills and competence, as well as on contextual factors in their teams and institutions. Suggested possibilities for improvements included follow-up with sufficient support from next of kin and external services, and the practicing of action and coping plans, standardized outcome measures, and feedback on progress., Conclusions: Leaders and clinicians should discuss efforts to ensure confident and qualified rehabilitation delivery at the levels of individual providers, teams, and institutions, and pay equal attention to each component in the process from admission to follow-up.

Objective: We hypothesized that glucocorticoids would induce remission in very early Systemic Sclerosis patients by inhibition of inflammation driving the disease. We examined the efficacy and safety of methylprednisolone in very early Systemic Sclerosis., Methods: In this trial adults with puffy fingers for less than three years, specific auto-antibodies and meeting the Very Early Diagnosis of Systemic Sclerosis criteria were randomly assigned (2:1) to methylprednisolone 1000 mg intravenously or placebo for 3 consecutive days 3 times with monthly intervals. The primary end point was nailfold capillary density at week 12. Capillary density at 52 weeks, number of megacapillaries, and patient-reported outcomes were secondary outcomes. In addition, we assessed disease progression and lung function decline over 52 weeks. We used linear regression analyses adjusted for baseline values and stratification variables to estimate differences between groups., Results: Between February 2017 and February 2021, 87 patients were screened, of whom 30 (70% female, median (IQR) age 52·9 (40·8-60·8) years, median (IQR) disease duration 11.4 (4.6-18.6) months) were randomly assigned to methylprednisolone (n = 21) or placebo (n = 9). We found no difference in nailfold capillary density at 12 weeks: -0.5 (95% CI 1.1, 0.2) nor in any of the secondary outcomes. Eleven (37%) patients showed disease progression during 1 year follow up, 7 (23%) patients had a relevant pulmonary function decline. No serious adverse events were reported., Conclusions: No clinically relevant effect of short-term methylprednisolone in patients with very early Systemic Sclerosis was observed. A substantial proportion of patients showed disease progression., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: To compare the effectiveness of longstanding (>52 weeks), supervised exercise therapy with usual care in adults with rheumatoid arthritis (RA) and severe functional limitations., Methods: Participants were randomised 1:1 to the intervention (individualised goal-setting, active exercises, education and self-management regarding physical activity) or usual care. Primary endpoint was the change in the Patient-Specific Complaints activity ranked 1 (PSC1, 0-10) at 52 weeks. Secondary endpoints included the PSC activities ranked 2 and 3 (PSC2, PSC3), Health Assessment Questionnaire-Disability Index (HAQ-DI), Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL), 6-minute walk test (6MWT), Patient Reported Outcome Measurement Information System Physical Function-10 (PROMIS PF-10) and the Short Form-36 Physical and Mental Component Summary Scales (SF-36 PCS and MCS). (Serious) Adverse events (AEs) were recorded. Measurements were done by blinded assessors. Analyses at 52 weeks were based on the intention-to-treat principle., Results: In total, 217 people (90% female, age 58.8 (SD 12.9) years) were randomised (n=104 intervention, n=98 usual care available for analyses). At 52 weeks, the improvement of the PSC1 was significantly larger in the intervention group (mean difference (95% CI) -1.7 (-2.4, -1.0)). Except for the SF-36 MCS, all secondary outcomes showed significantly greater improvements favouring the intervention (PSC2 -1.8 (-2.4, -1.1), PSC3 -1.7 (-2.4, -1.0), PROMIS PF-10 +3.09 (1.80, 4.38), HAQ-DI -0.17 (-0.29, -0.06), RAQoL -2.03 (-3.39, -0.69), SF-36 PCS +3.83 (1.49, 6.17) and 6MWT +56 (38, 75) m). One mild, transient AE occurred in the intervention group., Conclusion: Longstanding, supervised exercise therapy was more effective than usual care in people with RA and severe functional limitations., Trial Registration Number: Netherlands Trial Register (NL8235), included in the International Clinical Trial Registry Platform (https://trialsearch.who.int/Trial2.aspx?TrialID=NL8235)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the experiences, perceived benefits and disadvantages of home monitoring of pulmonary function in SSc patients with interstitial lung disease (ILD)., Methods: Semistructured interviews were conducted among SSc-ILD patients who used the home monitoring application of pulmonary function for at least 3 months. In our program, patients are instructed to perform home spirometry weekly at fixed time points using a mobile application with results being directly visible for patients and physicians. Audiotapes of the interviews were transcribed verbatim and analysed using inductive thematic analysis after performing a member check., Results: A total of 13 patients were interviewed, with a median age of 58 years (range 36-75) and a median experience with home monitoring of 12 months (range 3-12). We identified four major themes, including routine of telemonitoring, impact of telemonitoring, trust in telemonitoring and implementation in regular healthcare. Overall, patients found performing home spirometry to be feasible. Major perceived benefits of performing home spirometry are an increase in patient empowerment, better understanding of the disease course and a reduction in hospital visits, whereas identified disadvantages are an emotional burden of telemonitoring, heightened awareness of illness, doubts about its validity and the need for digital competencies. All patients expressed their willingness to continue, although some patients emphasized the need for face-to-face visits., Conclusion: Telemonitoring of pulmonary function is accepted by SSc-ILD patients with the perceived benefits outweighing the disadvantages. Adopting a patient-centred strategy that considers individual factors and addresses concerns proactively is warranted to successfully implement home spirometry., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: Total knee arthroplasty (TKA) can have a number of adverse consequences for patients that might contribute to a poor outcome. This study aimed to prioritize these consequences, from the perspective of patients and knee specialists., Methods: There were 95 TKA patients and 63 knee specialists who prioritized a set of 29 adverse consequences, based on a previous qualitative study, using a Maximum Difference Scaling method. A hierarchical Bayesian analysis was used to calculate relative importance scores. Differences and agreements between patients versus knee specialists and satisfied versus dissatisfied patients were analyzed using Mann-Whitney-U tests and Kendall's coefficients of concordance., Results: There were 4 out of 5 items in the top-5 of both patients and knee specialists that were similar, however, the ranking was different. The highest-ranked consequence for patients was: "Inability to do normal activities such as walking, cycling, swimming and heavy household chores", while knee specialists ranked: "No improvement in pain during the day" as the highest. "No improvement in walking" was in the patients' top-5, but was not ranked in the top-5 of knee specialists. For satisfied and dissatisfied patients, the top-5 of consequences was similar., Conclusion: Comparable perspectives were found for patients versus knee specialists and satisfied versus dissatisfied patients on the importance of adverse consequences after TKA. However, when looking in more detail, differences in ranking of specific subitems suggest that patients place slightly more importance on the inability to perform valued activities, while knee specialists prioritize lack of pain relief to a higher degree., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: For a subgroup of people with rheumatoid arthritis (RA) and severe disability, insight into their limitations is crucial for adequate treatment., Aim: To describe the extent and nature of functional limitations in people with RA and severe disability and to explore the associations of the extent of the functional limitations with patient characteristics, disease characteristics, and outcome measures., Methods: Baseline data of 215 participants in an RCT on the (cost-)effectiveness of longstanding physiotherapy were used. Functional limitations were assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI). The total HAQ-DI including eight domain scores were calculated. Associations between high HAQ-DI scores (≥2, yes/no) and other variables were examined using the Student's t -test or Chi-squared test where appropriate., Results: The participants (90% women, age 58.8 ± 12.8 years) had a mean HAQ-DI score of 1.7 ± 0.5. The majority (56%) showed a moderate-to-severe disability in all domains. Higher HAQ-DI scores seemed to be associated with advanced age, longer disease duration, unemployment, joint replacements, and outcomes for daily functioning and physical quality of life, but not with measures of disease activity., Conclusions: Our findings indicate that a comprehensive assessment of all areas of daily activities in this subgroup is necessary in order to provide appropriate (non-)pharmacological care.

The objective of the study is to describe the nature of functional limitations in activities and participation in people with Rheumatoid Arthritis (RA) or axial SpondyloArthritis (axSpA) with severe functional disability. Baseline data from people with RA (n = 206) or axSpA (n = 155) and severe functional disability participating in an exercise trial were used. Their three most limited activities were derived from the Patient Specific Complaint (PSC) instrument and linked to the International Classification of Functioning and Health (ICF). The frequencies of ICF categories were calculated and compared with Activities and Participation items of the ICF Core Sets for RA (32 second-level categories) and Ankylosing Spondylitis (AS) (24 second-level categories). In total 618 and 465 PSC activities were linked to 909 (72 unique in total; 25 unique second-level) and 759 (57 unique in total; 23 unique second-level) ICF categories in RA and axSpA. Taking into account all three prioritized activities, the five most frequent limited activities concerned the ICF chapter "Mobility", and included "Walking" (RA and axSpA 2 categories), "Changing basic body position" (RA and axSpA 1 category), "Stair climbing"(RA) and "Grasping" (RA),"Lifting" (axSpA) and "Maintaining a standing position" (axSpA). In RA, 21/32 (66%) and in axSpA 14/24 (58%) unique second-level categories identified in the prioritized activities are present in the Comprehensive Core Sets. Most limitations of people with RA or axSpA and severe functional disability were seen in the ICF chapter "Mobility". Most of the identified ICF categories were covered by the corresponding items of the ICF RA and AS Core Sets., (© 2023. The Author(s).)

To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objectives: A successful outcome according to the knee specialist is not a guarantee for treatment success as perceived by patients. In this study, we aimed to explore outcome expectations and experiences of patients with OA before and after total knee arthroplasty (TKA) surgery and knee specialists that might contribute to the negative appraisal of its effect, and differences in views between patients and knee specialists., Methods: Semi-structured interviews were held in Belgium and the Netherlands. Twenty-five patients (2 without indications for TKA, 11 on the waiting list for TKA and 12 postoperative TKA) and 15 knee specialists (9 orthopaedic surgeons, 1 physician assistant, 1 nurse practitioner and 4 physiotherapists) were interviewed. Conversations were audio recorded, transcribed verbatim, and analysed using thematic analysis following the grounded theory approach. Separate analyses were conducted for patients and knee specialists., Results: Patients were focused on the arduous process of getting used to the prosthesis, lingering pain, awareness of the artificial knee and limitations they experience during valued and daily activities, whereas knee specialists put emphasis on surgical failure, unexplained pain, limited walking ability and impairments that limit the physical functioning of patients., Conclusion: This study provides a comprehensive overview of potential adverse consequences from the perspective of both patients and knee specialists. Improving patients' awareness and expectations of adaptation to the knee prosthesis needs to be considered., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: Pulmonary hypertension is one of the leading causes of death in systemic sclerosis. Early detection and treatment of pulmonary hypertension in systemic sclerosis is crucial. Nailfold capillaroscopy microscopy, vascular autoantibodies AT1R and ETAR, and several candidate-biomarkers have the potential to serve as noninvasive tools to identify systemic sclerosis patients at risk for developing pulmonary hypertension. Here, we explore the classifying potential of nailfold capillaroscopy microscopy characteristics and serum levels of selected candidate-biomarkers in a sample of systemic sclerosis patients with and without different forms of pulmonary hypertension., Methods: A total of 81 consecutive systemic sclerosis patients were included, 40 with systemic sclerosis pulmonary hypertension and 41 with no pulmonary hypertension. In each group, quantitative and qualitative nailfold capillaroscopy microscopy characteristics, vascular autoantibodies AT1R and ETAR, and serum levels of 24 soluble serum factors were determined. For evaluation of the nailfold capillaroscopy microscopy characteristics, linear regression analysis accounting for age, sex, and diffusing capacity of the lungs for carbon monoxide percentage predicted was used. Autoantibodies and soluble serum factor levels were compared using two-sample t test with equal variances., Results: No statistically significant differences were observed in quantitative or qualitative nailfold capillaroscopy microscopy characteristics, or vascular autoantibody ETAR and AT1R titer between systemic sclerosis-pulmonary hypertension and systemic sclerosis-no pulmonary hypertension. In contrast, several serum levels of soluble factors differed between groups: Endostatin, sVCAM, and VEGFD were increased, and CXCL4, sVEGFR2, and PDGF-AB/BB were decreased in systemic sclerosis-pulmonary hypertension. Random forest classification identified Endostatin and CXCL4 as the most predictive classifiers to distinguish systemic sclerosispulmonary hypertension from systemic sclerosis-no pulmonary hypertension., Conclusion: This study shows the potential for several soluble serum factors to distinguish systemic sclerosis-pulmonary hypertension from systemic sclerosis-no pulmonary hypertension. We found no classifying potential for qualitative or quantitative nailfold capillaroscopy microscopy characteristics, or vascular autoantibodies., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.P.J.van.D. reports Grants or contracts from Janssen Pharmaceutical Company in the past 36 months, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen Pharmaceutical Company and Bayer. M.C.V. reports Research grants from Boehringer Ingelheim, Janssen, Ferrer and Galapagos in the past 36 months, Consulting fees from Boehringer Ingelheim and Janssen, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer Ingelheim, Bristol-Myers Squibb, GSK, Janssen, MSD, Novartis and Roche, Participation on a Data Safety Monitoring Board or Advisory Board from Corbus pharmaceuticals, Leadership or fiduciary role in other board, society, committee or advocacy group at the Eustar extended board (unpaid). For the other authors competing interests are not applicable. The Editor/Editorial Board Member of JSRD is an author of this paper; therefore, the peer-review process was managed by alternative members of the Board and the submitting Editor/Board member had no involvement in the decision-making process., (© The Author(s) 2023.)

Background: knee complaints are one of the most common reasons to consult the general practitioners in the Netherlands and contribute to the increasing burden on general practitioners. A proportion of patients that are referred to orthopedic outpatient clinics are potentially referred unnecessarily. We believe osteoarthritis is not always considered by general practitioners as the cause of atraumatic knee complaints. This may impede early recognition and timely care of osteoarthritis complaints and lead to unnecessary referrals., Methods: the aim of this study was to compare the frequency of (differential) diagnosis of osteoarthritis mentioned in referral letters of general practitioners with the frequency of osteoarthritis mentioned as orthopedic diagnosis at the outpatient clinic. Therefore we conducted a retrospective cohort study based on data collected from referral letters and the corresponding outpatient clinic reports of patients with atraumatic knee complaints of 45 years or older referred to a regional hospital in Nijmegen, The Netherlands in the period from 1-6-2019 until 1-01-2020., Results: a total of 292 referral letters were included. In the younger aged patients (45-54 years) osteoarthritis was mentioned less frequent and meniscal lesions were mentioned more frequent in referral letters when compared to diagnoses made at the outpatient clinic. Differences in differential diagnosis of osteoarthritis as well as meniscal lesions between orthopedic surgeon and general practitioners were found (both p < 0.001, McNemar). Matching diagnoses were present in 58.2% when all referral letters were analyzed (n = 292) and 75.2% when only referrals containing a differential diagnosis were analyzed (n = 226). Matching diagnoses were present in 31.6% in the younger age categories (45-54 years). A linear trend showing fewer matching diagnoses in younger patient categories was observed (p < 0.001)., Conclusions: Osteoarthritis was less frequently mentioned in general practitioner referral letters among the differential diagnosis then it was diagnosed at the outpatient clinic, especially in younger patients (45-54 years). Also matching diagnoses in younger patients were evidently lower than in older patients, partly explained by underdiagnosing of osteoarthritis in younger patients in this cohort. Better recognition of osteoarthritis in younger patients and changing the diagnostic approach of general practitioners might improve efficacy in knee care. Future research should focus on the effectiveness of musculoskeletal triage, the need for multidisciplinary educational programs for patients and promotion of conservative treatment modalities among general practitioners., (© 2023. The Author(s).)

Objective: The variable course of fatigue adds to the disease burden of patients with OA yet it has been poorly understood. This study aimed to describe within-person fluctuations of fatigue severity and explore its associations with pain, positive affect, negative affect, sleep, and perceived exertion of physical activity., Methods: Individuals with chronic knee pain or a clinical diagnosis of knee OA ≥40 years of age completed daily assessments about fatigue, pain, positive affect, negative affect, sleep, perceived exertion of physical activity (numeric rating scale 0-10), and overwhelming fatigue (yes/no) on a smartphone over 14 days. Within-person fluctuations of fatigue severity were described by the probability of acute changes (PACs) and s.d.s. Associations with pain, positive affect, negative affect, sleep, and perceived exertion of physical activity were explored using multilevel models., Results: Forty-nine individuals were included (mean age 63.4 years; 82% female). PACs and s.d.s of within-person daily fatigue fluctuations ranged from 0.00 to 0.80 and 0.35 to 2.95, respectively. Within-person associations of fatigue severity were moderate for positive affect [β = -0.57 (95% CI -0.67, -0.47)], weak for pain [β = 0.41 (95% CI 0.29, 0.53)] and negative affect [β = 0.40 (95% CI 0.21, 0.58)], and negligible for sleep [β = -0.13 (95% CI -0.18, -0.08)] and perceived exertion of physical activity [β = 0.18 (95% CI 0.09, 0.26)]., Conclusion: Some individuals showed almost stable day-to-day levels of fatigue severity, whereas others experienced a substantial number of clinically relevant fluctuations. To reduce the burden of daily fatigue fluctuations, our results suggest that pain, positive and negative affect rather than sleep and perceived exertion of physical activity should be considered as potential targets., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: Osteoarthritis is a major contributor to pain and disability worldwide. Given that inflammation plays an important role in the development of osteoarthritis, anti-inflammatory drugs may slow disease progression., Objective: To examine whether colchicine, 0.5 mg daily, reduces incident total knee replacements (TKRs) and total hip replacements (THRs)., Design: Exploratory analysis of the LoDoCo2 (Low-Dose Colchicine 2) randomized, controlled, double-blind trial. (Australian New Zealand Clinical Trials Registry: ACTRN12614000093684)., Setting: 43 centers in Australia and the Netherlands., Patients: 5522 patients with chronic coronary artery disease., Intervention: Colchicine, 0.5 mg, or placebo once daily., Measurements: The primary outcome was time to first TKR or THR since randomization. All analyses were performed on an intention-to-treat basis., Results: A total of 2762 patients received colchicine and 2760 received placebo during a median follow-up of 28.6 months. During the trial, TKR or THR was performed in 68 patients (2.5%) in the colchicine group and 97 (3.5%) in the placebo group (incidence rate, 0.90 vs. 1.30 per 100 person-years; incidence rate difference, -0.40 [95% CI, -0.74 to -0.06] per 100 person-years; hazard ratio, 0.69 [CI, 0.51 to 0.95]). In sensitivity analyses, similar results were obtained when patients with gout at baseline were excluded and when joint replacements that occurred in the first 3 and 6 months of follow-up were omitted., Limitation: LoDoCo2 was not designed to investigate the effect of colchicine in osteoarthritis of the knee or hip and did not collect information specifically on osteoarthritis., Conclusion: In this exploratory analysis of the LoDoCo2 trial, use of colchicine, 0.5 mg daily, was associated with a lower incidence of TKR and THR. Further investigation of colchicine therapy to slow disease progression in osteoarthritis is warranted., Primary Funding Source: None., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-0289.

Objective: To describe beliefs of physicians and patients in primary and secondary care about urate-lowering therapy (ULT), to examine differences in physicians' medication beliefs and to examine the association of physicians' medication beliefs with the prescribed dosage of ULT, gout outcomes and patients' medication beliefs., Methods: We conducted a cross-sectional study among rheumatologists and general practitioners (GPs) and their patients using ULT in The Netherlands. All participants filled out the Beliefs About Medication Questionnaire (BMQ). Demographics of physicians were collected through questionnaires. Patient and disease characteristics were collected through questionnaires and electronic medical records. Differences between rheumatologists and GPs in the BMQ subscales Necessity and Concern and the necessity-concern difference (NCD) score were analysed by two-sample t -tests. Multilevel analyses were performed to examine the association of physicians' BMQ scores with the prescribed dosage of ULT, gout outcomes (number of gout flares, serum urate) and patients' BMQ scores., Results: A total of 28 rheumatologists, 443 rheumatology patients, 45 GPs and 294 GP patients were included. The mean NCD scores were 7.1 (s.d. 3.6), 4.0 (s.d. 4.0), and 4.2 (s.d. 5.0) for rheumatologists, GPs and patients, respectively. Rheumatologists scored higher on necessity beliefs [mean difference 1.4 (95% CI 0.0, 2.8)] and lower on concern beliefs [mean difference -1.7 (95% CI -2.7, -0.7)] compared with GPs. No associations between physicians' beliefs and prescribed dosage of ULT, gout outcomes or patients' beliefs were found., Conclusion: Rheumatologists had higher necessity and lower ULT concern beliefs compared with GPs and patients. Physicians' beliefs were not related to prescribed ULT dosage and patient outcomes. The role of physicians' beliefs in gout management in patients using ULT seems limited. Future qualitative research can provide more insights into physicians' views of gout management., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: This study aimed to develop recommendations for communication and postgraduate education regarding primary care physical therapy for systemic sclerosis (SSc) patients., Methods: A virtual Nominal Group Technique was used with tasks forces for communication (n = 18) and education (n = 21). Both included rheumatologists, physical therapists (PTs) in primary, secondary or tertiary care, rheumatology nurses, advanced nurse practictioners and patient representatives. Three online meetings were organised for each task force to discuss (1) current bottlenecks; (2) potential solutions; and (3) the resulting draft recommendations. After the final adjustments, participants rated their level of agreement with each recommendation on a scale from 0 (not at all agree) to 100 (totally agree), using an online questionnaire., Results: 19 and 34 recommendations were formulated for communication and education, respectively. For communication the main recommendations concerned the provision of an overview of primary care physical therapists with expertise in rheumatic and musculoskeletal diseases to patients and rheumatologists, the inclusion of the indication by the rheumatologist in the referral to the physical therapist and low-threshold communication with the rheumatologist in case of questions or concerns of the physical therapist. For postgraduate education three types of "on demand" educational offerings were recommended with varying levels of content and duration, to match the competencies and preferences of individual primary care physical therapists., Conclusion: Using a systematic qualitative approach, two multi-stakeholder task forces developed practical recommendations for primary care physical therapists' communication with hospital-based care providers and postgraduate education regarding the treatment of SSc patients., (© 2022 The Authors. Musculoskeletal Care published by John Wiley & Sons Ltd.)

Objective: To assess the use, satisfaction, needs, and preferences regarding physical therapy (PT) in patients with systemic sclerosis (SSc)., Methods: A total of 405 SSc patients, treated in the Leiden University Medical Center multidisciplinary care program and fulfilling American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2013 SSc criteria, received a questionnaire containing 37 questions on use and satisfaction regarding PT over a 2-year period, and their needs and preferences for future PT., Results: A total of 204 SSc patients (median age 63 years, 81% female) completed the questionnaire. One hundred twenty-eight patients (63%) had used or were using PT in a primary care setting. For 39% of patients not using PT, lack of referral or lack of knowledge was the reason for not using it. The most frequently reported active treatments were muscle-strengthening (n = 92 [72%]), range of motion (n = 77 [60%]), and aerobic exercises (n = 72 [56%]). Specific SSc hand- and mouth-opening exercises were reported by 20 (15%) and 7 (6%) patients, respectively. Manual treatment (massage or passive mobilization) was reported by 83 patients (65%). The mean ± SD satisfaction score (range 0-10) was 8.2 ± 1.6. Regarding patients' needs, 96 patients (47%) of the total group wanted to receive more information concerning PT, and 128 (63%) wanted to continue, start, or restart PT in the near future, with 56 of the 128 patients (44%) favoring individual treatment on a continuous basis., Conclusion: We observed a significant variation in the use and content of PT for SSc patients in a primary care setting. Our results suggest potential underuse of PT care, in particular for hand and oral dysfunction, and underpin the need for initiatives to improve the quality and accessibility of PT care for SSc patients., (© 2021 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: This COnsensus-based Standards for the selection of health measurement INstruments (COSMIN)-based systematic review aims to identify and summarise the quality of measurement properties of dyspnoea-specific patient-reported outcome measures (PROMs) for patients with interstitial lung disease (ILD), pulmonary hypertension (PH) or connective tissue diseases (CTDs)., Methods and Results: Relevant articles in PubMed and Embase were screened. Based on COSMIN analysis and the Grading of Recommendations, Assessment, Development and Evaluation approach, overall rating and level of evidence were assessed to formulate recommendations. We identified 26 publications on 10 PROMs. For patients with ILD, including CTD-associated ILD, nine PROMs were evaluated, of which the Dyspnea-12 (D12), EXACT-Respiratory Symptoms Idiopathic Pulmonary Fibrosis Breathlessness subscale (ERS-IPF-B), King's Brief Interstitial Lung Disease Health Status Questionnaire breathlessness and activities subscale (KBILD-B) and the University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) had high-quality evidence for sufficient internal consistency, without high-quality evidence of insufficient measurement properties. We reached this same conclusion regarding the D12 for use in patients with PH, including CTD-associated PH. Most PROMs in this systematic review have moderate- or low-quality evidence on construct validity and responsiveness., Conclusion: Four dyspnoea-specific PROMs, D12, ERS-IPF-B, KBILD-B and UCSD-SOBQ, can be recommended for use in patients with ILD, including CTD-associated ILD. Of these four, the D12, despite the limited evidence and the lack of evidence on several important domains, is also suitable for use in patients with PH, including CTD-associated PH., Competing Interests: Conflict of interest: The authors have no conflicts of interest to report., (Copyright ©The authors 2022.)

Background: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations., Methods: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization., Results: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI - 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI - 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes., Conclusion: The offer to use the SPIN-HAND Program did not improve hand function. Low offer uptake, program access, and minimal usage among those who accessed the program limited our ability to determine if using the program would improve function. To improve engagement, the program could be tested in a group format or as a resource to support care provided by a physical or occupational therapist., Trial Registration: NCT03419208 . Registered on February 1, 2018., (© 2022. The Author(s).)

Purpose: The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program., Materials and Methods: The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews., Results: Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N  = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal., Conclusions: Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance., Competing Interests: Luc Mouthon reported personal fees from Actelion/Johnson & Johnson, grants from LFB, non-financial support from Octapharma, and non-financial support from Grifols, all outside the submitted work. All other authors declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years. All authors declare no other relationships or activities that could appear to have influenced the submitted work., (©2022 Kwakkenbos et al.)

Objective: To perform a COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic literature review of measurement properties of the Polymyalgia Rheumatica Activity Score (PMR-AS)., Methods: PubMed, EMBASE, and CINAHL were broadly searched. English full-text articles, with (quantitative) data on ≥ 5 patients with PMR using the PMR-AS were selected. Seven hypotheses for construct validity and 3 for responsiveness, concerning associations with erythrocyte sedimentation rate, physical function, quality of life, clinical disease states, ultrasound, and treatment response, were formulated. We assessed the structural validity, internal consistency, reliability, and measurement error, or the hypotheses on construct validity or responsiveness of the PMR-AS based on COSMIN criteria., Results: Out of the identified 26 articles that used the PMR-AS, we were able to use 12 articles. Structural validity, internal consistency, construct validity, and responsiveness were assessed in 1, 2, 8, and 3 articles, respectively. Insufficient evidence was found to confirm structural validity and internal consistency. No data were found on reliability or measurement error. Although 60% and 67% of hypotheses tested for construct validity and responsiveness, respectively, were confirmed, there was insufficient evidence to meet criteria for good measurement properties., Conclusion: While there is some promising evidence for construct validity and responsiveness of the PMR-AS, it is lacking for other properties and, overall, falls short of criteria for good measurement properties. Therefore, further research is needed to assess its role in clinical research and care., (Copyright © 2022 by the Journal of Rheumatology.)

Objective: To evaluate the cost-utility and cost-effectiveness of the dr. Bart app compared to usual care in people with osteoarthritis (OA) of the knees and hips, applying a health care payer perspective., Methods: This economic evaluation was conducted alongside a 6-month randomized controlled trial that included 427 participants. The dr. Bart app is a stand-alone eHealth application that invites users to select pre-formulated goals (i.e., "tiny habits") and triggers for a healthier lifestyle. Self-reported outcome measures were health care costs, quality-adjusted life years (QALYs) according to the EuroQol 5-dimension 3-level (EQ-5D-3L) descriptive system, the EuroQol visual analog scale (QALY VAS), patient activation measure 13 (PAM-13), and 5 subscales of the Knee Injury and Osteoarthritis Outcome Score/Hip Disability and Osteoarthritis Outcome Score. Missing data were multiply imputed, and bootstrapping was used to estimate statistical uncertainty., Results: The mean ± SD age of the study participants was 62.1 ± 7.3 years, and the majority of participants were female (72%). Health care costs were lower in the intervention group compared to the group who received usual care (€-22 [95% confidence interval €-36, -3]). For QALY and QALY VAS, the probability of the dr. Bart app being cost-effective compared to usual care was 0.71 and 0.67, respectively, at a willingness-to-pay (WTP) of €10,000 and 0.64 and 0.56, respectively, at a WTP of €80.000. For self-management behavior, symptoms, pain, and activities of daily living, the probability that the dr. Bart app was cost-effective was >0.82, and the probability that the dr. Bart app was cost-effective in the areas of activities and quality of life was <0.40, regardless of WTP thresholds., Conclusion: This economic evaluation showed that costs were lower for the dr. Bart app group compared to the group who received usual care. Given the noninvasive nature of the intervention and the moderate probability of it being cost-effective for the majority of outcomes, the dr. Bart app has the potential to serve as a tool to provide education and goal setting in OA and its treatment options., (© 2021 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: Gout and diabetes mellitus type 2 (DM) frequently co-exist. The pharmacological effects of metformin may include anti-inflammatory and urate lowering effects. The objective of this study was to test these effects in patients with gout starting uric acid lowering treatment (ULT) in secondary care., Methods: Retrospective cohort study including patients with gout and DM starting ULT. Differences in the incidence density of gout flares, proportion of patients reaching target sUA in the first six months after starting ULT, and difference in mean allopurinol dose at sUA target were compared between users of metformin and users of other or no anti-diabetic drugs (control group). Correction for confounding was applied., Results: A total of 307 patients were included, of whom 160 (52.1%) used metformin. The incidence of flares was 1.61 and 1.70 in the first six months for respectively the metformin group and control group. The incidence rate ratio for gout flares was not significant (0.95, 95% CI 0.78 to 1.14). At six months, 62.8% and 54.9% reached target sUA in the metformin and control group respectively, corrected odds ratio of 1.09 (95% CI 0.66 to 1.80). There was no difference in mean allopurinol dose at sUA target 266 mg for metformin users and 236 mg for the control group, difference 30 mg (95% CI - 4.7 to 65.5)., Conclusions: In conclusion we could not confirm a clinically relevant anti-inflammatory or urate lowering effect of metformin in patients starting ULT treatment and receiving usual care flare prophylaxis., (© 2022. The Author(s).)

Objectives: To investigate the reliability and validity of fluorine-18 fluorodeoxyglucose (18F-FDG) PET-CT scanning (FDG-PET) in RA patients with low disease activity tapering TNF inhibitors (TNFis) and its predictive value for successful tapering or discontinuation., Methods: Patients in the tapering arm of the Dose REduction Strategies of Subcutaneous TNFi study, a randomized controlled trial of TNFi tapering in RA, underwent FDG-PET before tapering (baseline) and after maximal tapering. A total of 48 joints per scan were scored both visually [FDG-avid joint (FAJ), yes/no] and quantitatively [maximal and mean standardized uptake values (SUVmax and SUVmean)]. Interobserver agreement was calculated in 10 patients at baseline. Quantitative and visual FDG-PET scores were investigated for (multilevel) association with clinical parameters both on a joint and patient level and for the predictive value at baseline and the change between baseline and maximal tapering (Δ) for successful tapering and discontinuation at 18 months., Results: A total of 79 patients underwent FDG-PET. For performance of identification of FAJs on PET, Cohen's κ was 0.49 (range 0.35-0.63). For SUVmax and SUVmean, intraclass correlation coefficients were 0.80 (range 0.77-0.83) and 0.96 (0.9-1.0), respectively. On a joint level, swelling was significantly associated with SUVmax and SUVmean [B coefficients 1.0 (95% CI 0.73, 1.35) and 0.2 (0.08, 0.32), respectively]. On a patient level, only correlation with acute phase reactants was found. FDG-PET scores were not predictive of successful tapering or discontinuation., Conclusions: Quantitative FDG-PET arthritis scoring in RA patients with low disease activity is reliable and has some construct validity. However, no predictive values were found for FDG-PET parameters for successful tapering and/or discontinuation of TNFi., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: SSc is a complex CTD affecting mental and physical health. Fatigue, hand function loss, and RP are the most prevalent disease-specific symptoms of systemic sclerosis. This study aimed to develop consensus and evidence-based recommendations for non-pharmacological treatment of these symptoms., Methods: A multidisciplinary task force was installed comprising 20 Dutch experts. After agreeing on the method for formulating the recommendations, clinically relevant questions about patient education and treatments were inventoried. During a face-to-face task force meeting, draft recommendations were generated through a systematically structured discussion, following the nominal group technique. To support the recommendations, an extensive literature search was conducted in MEDLINE and six other databases until September 2020, and 20 key systematic reviews, randomized controlled trials, and published recommendations were selected. Moreover, 13 Dutch medical specialists were consulted on non-pharmacological advice regarding RP and digital ulcers. For each recommendation, the level of evidence and the level of agreement was determined., Results: Forty-one evidence and consensus-based recommendations were developed, and 34, concerning treatments and patient education of fatigue, hand function loss, and RP/digital ulcers-related problems, were approved by the task force., Conclusions: These 34 recommendations provide guidance on non-pharmacological treatment of three of the most frequently described symptoms in patients with systemic sclerosis. The proposed recommendations can guide referrals to health professionals, inform the content of non-pharmacological interventions, and can be used in the development of national and international postgraduate educational offerings., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: The aim was to explore pain characteristics in individuals with knee OA (KOA), to compare pain sensitivity across individuals with KOA, individuals with chronic back pain (CBP) and pain-free individuals (NP) and to examine the relationship between clinical characteristics and pain sensitivity and between pain characteristics and pain sensitivity in KOA., Methods: We carried out a cross-sectional, community-based online survey. Two data sets were combined, consisting of Dutch individuals ≥40 years of age, who were experiencing chronic knee pain (KOA, n  = 445), chronic back pain (CBP, n  = 504) or no pain (NP, n  = 256). Demographic and clinical characteristics, global health, physical activity/exercise and pain characteristics, including intensity, spreading, duration, quality (short-form McGill pain questionnaire) and sensitivity (pain sensitivity questionnaire), were assessed. Differences between (sub)groups were examined using analyses of variance or χ 2 tests. Regression analyses were performed to examine determinants of pain sensitivity in the KOA group., Results: The quality of pain was most commonly described as aching, tender and tiring-exhausting. Overall, the KOA group had higher levels of pain sensitivity compared with the NP group, but lower levels than the CBP group. Univariately, pain intensity, its variability and spreading, global health, exercise and having co-morbidities were weakly related to pain sensitivity (standardized β: 0.12-0.27). Symptom duration was not related to pain sensitivity. Older age, higher levels of continuous pain, lower levels of global health, and exercise contributed uniquely, albeit modestly, to pain sensitivity ( P  <   0.05)., Conclusion: Continuous pain, such as aching and tenderness, in combination with decreased physical activity might be indicative for a subgroup of individuals at risk for pain sensitivity and, ultimately, poor treatment outcomes., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Aims: Little is known about usual care by physicians and pharmacy teams to support adherence to statins and whether the extent of this care is associated with adherence to statins. Objective of the study was to examine the relationship between the extent of adherence supporting activities of healthcare practitioners (HCPs) and patients' adherence to statins., Methods: Cross-sectional study in 48 pharmacies and affiliated physicians' practices, between September 3, 2014 and March 20, 2015. Patients visiting the pharmacy with a statin prescription from participating prescribers were invited to participate. Usual care to support adherence was assessed among HCPs with the Quality of Standard Care questionnaire about usual care activities to support adherence. Adherence to statins was assessed among patients with the MARS-5 questionnaire. The association between the extent of HCPs' adherence supporting activities and patients' adherence was examined by means of multilevel regression analysis., Results: 1,504 patients and 692 HCPs (209 physicians, 118 pharmacists and 365 pharmacy technicians) participated. No association was found between the extent of physicians' adherence supporting activities and patients' adherence to statins. The extent of adherence supporting activities by pharmacy teams in usual care was negatively associated with patients' adherence to statins (B coefficient -0.057 (95%CI: -0.112- -0.002)., Conclusions: This study suggests that there is no positive relationship between the extent of HCPs' adherence supporting activities in usual care and patients' adherence to statins. Other methods than questionnaires (e.g. electronic monitors (to assess adherence) and observations (to assess usual care) should be applied to confirm the results of this study., Competing Interests: There are no conflicts of interest for this manuscript. Although L. van Dijk has received grants for research not related to this study from TEVA and AstraZeneca, this does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objectives: Research on effectiveness and cost-effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost-effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning., Methods: In two separate, parallel randomized controlled trials the effectiveness and cost-effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument at 52 weeks. For cost-effectiveness analyses, the EuroQol (EQ-5D-5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost-utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow-up assessments are done at 104, 156, and 208 weeks., Conclusion: The results of these studies will provide insights in the effectiveness and cost-effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations., (© 2021 The Authors. Physiotherapy Research International published by John Wiley & Sons Ltd.)

There is convincing evidence to suggest that exercise interventions can significantly improve disease-related outcomes as well as comorbidities in rheumatic and musculoskeletal diseases (RMDs). All exercise interventions should be appropriately defined by their dose, which comprises of two components: a) the FITT (frequency, intensity, time and type) and b) the training (ie, specificity, overload, progression, initial values, reversibility, and diminishing returns) principles. In the published RMD literature, exercise dosage is often misreported, which in "pharmaceutical treatment terms", this would be the equivalent of receiving the wrong medication dosage. Lack of appropriately reporting exercise dosage in RMDs, therefore, results in limited clarity on the effects of exercise interventions on different outcomes while it also hinders reproducibility, generalisability and accuracy of research findings. Based on the collective but limited current knowledge, the main purpose of the present Position Statement is to provide specific guidance for RMD researchers to help improve the reporting of exercise dosage and help advance research into this important field of investigation. We also propose the use of the IMPACT-RMD toolkit, a tool that can be used in the design and reporting phase of every trial., (© 2021 The Mediterranean Journal of Rheumatology (MJR).)

Objective: When appraising the quality of randomised clinical trial (RCTs) on the merits of exercise therapy, we typically limit our assessment to the quality of the methods. However, heterogeneity across studies can also be caused by differences in the quality of the exercise interventions (ie, 'the potential effectiveness of a specific intervention given the potential target group of patients')-a challenging concept to assess. We propose an internationally developed, consensus-based tool that aims to assess the quality of exercise therapy programmes studied in RCTs: the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool., Methods: Forty-nine experts (from 12 different countries) in the field of physical and exercise therapy participated in a four-stage Delphi approach to develop the i-CONTENT tool: (1) item generation (Delphi round 1), (2) item selection (Delphi rounds 2 and 3), (3) item specification (focus group discussion) and (4) tool development and refinement (working group discussion and piloting)., Results: Out of the 61 items generated in the first Delphi round, consensus was reached on 17 items, resulting in seven final items that form the i-CONTENT tool: (1) patient selection; (2) qualified supervisor; (3) type and timing of outcome assessment; (4) dosage parameters (frequency, intensity, time); (5) type of exercise; (6) safety of the exercise programme and (7) adherence to the exercise programme., Conclusion: The i-CONTENT-tool is a step towards transparent assessment of the quality of exercise therapy programmes studied in RCTs, and ultimately, towards the development of future, higher quality, exercise interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The objective is to describe the spectrum of the health professional (HP) treatment approach for systemic sclerosis (SSc) from the perspective of Dutch HPs, including alignment of treatment goals set by HPs with self-reported referral reasons, coverage of patient-reported unmet care needs, and quality of communication between HPs and rheumatologists. Dutch HPs were invited through their patients with SSc to complete an anonymous online survey. The survey covered referral reasons, treatment goals, and interventions of the last patient treated, as well as the perceived quality of communication between HPs and rheumatologists. Referral reasons and treatment targets were linked to the International Classification of Functioning, Disability and Health following the refined ICF Linking Rules. Seventy-nine HPs from 8 professions (including 58 physiotherapists, 73%) completed the survey. One hundred and thirty-three different referral reasons were reported, yielding 58 different ICF codes, with 41 (70.7%) being linked to the ICF domain "body structures and functions." The reported interventions focused on body functions/structures (27.9%), training of daily activities (25.6%), education and advice (26.3%), and psychosocial interventions (20.2%). The quality of communication between HPs and rheumatologists was perceived as low. Our findings revealed numerous treatment options offered by Dutch HPs addressing the unmet care needs of patients with SSc. There is an overlap in the content of the various HP disciplines, and HP treatment goals are not sufficiently aligned with referrals of rheumatologists. HP treatment offer seemed inefficiently organized, possibly precluding rheumatologists from making targeted referrals. Communication between rheumatologists and HPs should be improved.

Objective: Non-pharmacological interventions support patients with connective tissue diseases to better cope with and self-manage their diseases. This study aimed to map existing evidence on non-pharmacological interventions in patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and mixed connective tissue diseases regarding content, feasibility and potential suitability in an e-health setting., Methods: A literature search was performed in eight different databases in July 2020. The intervention's content was extracted using the 'Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide'. A Sankey diagram and descriptive statistics were used to analyse the data and illustrate the relationships between the interventions., Results: Of 8198 identified records, 119 papers were eligible. One hundred and four of them (87.4%) were conducted between 2000 and 2020, mainly in the USA (SLE n=24 (21.2%), SSc n=16 (14.2%)), Brazil (SLE n=8 (7.1%), SSc n=5 (4.4%)) and Italy (SLE n=0 (0%), SSc n=12 (10.6%)). Fifty-two studies (SLE n=24 (21.2%), SSc n=28 (24.8%)) used multicomponent interventions. The single interventions were physical exercises (SLE n=16 (14.2%), SSc n=17 (15.0%)), coaching/counselling (SLE n=11 (18.0%), SSc n=0 (0%)) and education (SLE n=2 (1.8%), SSc n=3 (2.7%)). Primary outcomes focused on physical function (SLE n=1 (0.9%), SSc n=15 (13.3%)), mouth opening in SSc (n=4 (5.9%)) and physical capacity (SLE n=2 (1.8%), SSc n=1 (0.9%)). No interventions for mixed connective tissue disease were found., Conclusion: There was a great variety in the intervention's content due to differences in body structure, activity limitations and participation restrictions in SLE and SSc. These results highlight the need for personalised, multicomponent, non-pharmacological interventions, which could be delivered as e-health interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Non-adherence to medication (range 30-107%) is a major issue in patients with rheumatoid arthritis (RA). Previous research has shown that electronic monitoring feedback (EMF) might be an effective strategy to improve medication adherence in chronic conditions. Therefore, this study investigated the effectiveness of electronic monitoring feedback in patients with early RA to improve medication adherence and clinical outcomes compared to usual care., Methods: An open-label randomized clinical trial was performed to compare EMF with standard care during a 12-month follow-up period on two sites of the Sint Maartenskliniek (Nijmegen and Boxmeer) in the Netherlands. Patients were eligible if they: (1) had a (working) diagnosis of early RA, (2) were currently using methotrexate, (3) were aged ≥18 years, and (4) had a life expectancy of ≥12 months. Primary outcome was the difference in proportion of non-adherent patients measured with the Compliance Questionnaire on Rheumatology after 12 months. Secondary outcomes were beliefs about medicines, medication adherence measured with the MMAS-8 ® , patients' health status, prescription of biologic DMARDs, and disease activity after 12 months., Results: Of the 367 initially-invited patients, 93 patients with early RA agreed to participate in this study. No significant difference was found in the proportion of non-adherent patients between the intervention arm and the usual care arm after 12 months follow-up (60.0% and 61.3%, p=0.93, respectively). Patients in the intervention arm tended to discontinue methotrexate earlier than patients in the usual care arm (median time in weeks: 15.7 (9.1-33.6) and 21.9 (19-28.4), respectively, p=0.31), whereas patients in the usual care arm tended to initiate biologic DMARDs earlier than those in the intervention arm (median time in weeks: 11.9 (5.7-22) and 17 (9.9-40.9), respectively, p=0.55)., Conclusion: This study illustrates the challenge of targeting non-adherence with EMF in patients with early RA and shares important lessons learned about designing adherence intervention trials with respect to study attrition, accounting for drug survival, intervention fidelity, intervention uptake, and technical aspects., Competing Interests: Dr Milou van Heuckelum reports receipt of grants from the Dutch Arthritis Foundation during the conduct of the study and grants from the Dutch Arthritis Foundation outside the submitted work. The authors reported no other potential conflicts of interest in this work., (© 2021 van Heuckelum et al.)

Background: Self-management is of paramount importance in the non-surgical treatment of knee/hip osteoarthritis (OA). Modern technologies offer the possibility of 24/7 self-management support. We developed an e-self-management application (dr. Bart app) for people with knee/hip OA. The aim of this study was to document the use and usability of the dr. Bart app and its relation with health care utilisation and clinical outcomes in people with knee/hip OA., Methods: For this study we used backend data for the first 26 weeks of use by the intervention group (N = 214) of an RCT examining the effectiveness of the dr. Bart app. A central element of the dr. Bart app is that it proposes a selection of 72 preformulated goals for health behaviours based on the 'tiny habits method' (e.g. after lunch I rise 12 times from my chair to train my leg muscles). The usability of the app was measured using the System Usability Scale questionnaire (SUS), on a scale of 0-100. To assess the association between the intensity of use of the app and health care utilisation (i.e., consultations in primary or secondary health care) and clinical outcomes (i.e., self-management behaviour, physical activity, health-related quality of life, illness perceptions, symptoms, pain, activities of daily living) we calculated Spearman rank correlation coefficients., Results: Of the 214 participants, 171 (80%) logged in at least once with 151 (71%) choosing at least one goal and 114 (53%) completing at least one goal during the 26 weeks. Of those who chose at least one goal, 56 participants (37%) continued to log in for up to 26 weeks, 12 (8%) continued to select new goals from the offered goals and 37 (25%) continued to complete goals. Preformulated goals in the themes of physical activity (e.g., performing an exercise from the exercises library in the app) and nutrition (e.g., 'eat two pieces of fruit today') were found to be most popular with users. The mean usability scores (standard deviation) at the three and six month follow-ups were 65.9 (16.9) and 64.5 (17.5), respectively. The vast majority of associations between the intensity of use of the dr. Bart app and target outcomes were weak at ρ < (-) 0.25., Conclusions: More than one-third of people with knee/hip OA who started using the app, continued to use it up to 26 weeks, though usability could be improved. Patients appear to have preferences for goals related to physical activity and nutrition, rather than for goals related to vitality and education. We found weak/no associations between the intensity of use of the dr. Bart app and health care utilisation and clinical outcomes., Trial Registration: (21 September 2017): Dutch Trial Register (Trial Number NTR6693/NL6505 ).

Objective: It is generally unknown how the attitudes and beliefs of health care professionals (HCPs) might affect the attitudes, beliefs, and medication-taking behavior of patients with rheumatoid arthritis (RA). This study aims 1) to examine the attitudes, health-related associations (both implicit and explicit), and beliefs of HCPs about conventional disease-modifying antirheumatic drugs, and 2) to assess whether these attitudes, health-related associations, and beliefs of HCPs are associated with those of their patients, with their patients' medication-taking behavior, and disease activity., Methods: HCPs were recruited from 2 centers that specialized in rheumatology across The Netherlands, and patient recruitment followed. In this observational study, implicit outcomes were measured with single-category implicit association tests, whereas explicit outcomes were measured with a bipolar evaluative adjective scale and the Beliefs About Medicines Questionnaire-Specific. Spearman's rank correlations were used to describe correlations between implicit and explicit measures of the attitudes of HCPs. Multilevel, mixed-effects linear models were used to examine the association of HCP-related characteristics, including the implicit and explicit outcomes of HCPs, with those of their patients, their medication-taking behaviors, and disease activity., Results: Of the 1,659 initially invited patients, 254 patients with RA (mean age 62.8 years, mean disease duration 11.8 years, and 68.1% of the patients were female) who were treated by 26 different HCPs agreed to participate in this study. The characteristics, attitudes, health-related associations, and beliefs about medicines of HCPs were not significantly associated with those of their patients, nor with their medication-taking behaviors or disease activity scores., Conclusion: This study demonstrated that the attitudes, health-related associations (as measured both implicitly and explicitly), and beliefs of HCPs were not significantly associated with the attitudes, beliefs, medication-taking behavior, and disease activity of patients with RA., (© 2020, American College of Rheumatology.)

Aims: Adherence to statins ranges from 32% to 79%. Patients' beliefs about medication are associated with adherence. There is lack of insight into the possible association between beliefs of healthcare practitioners (HCPs) about statins and patients' beliefs and adherence. This study aims to examine whether HCPs' beliefs about statins are associated with patients' beliefs and adherence about/to statins., Methods: Cross-sectional study in 48 pharmacies and affiliated physicians' practices between 3 September 2014 and 20 March 2015. HCPs' (prescribers and pharmacy staff) and patients' beliefs about statins were assessed with the Beliefs about Medicine Questionnaire (BMQ) specific. Adherence to statins was assessed with the MARS-5 questionnaire. Multilevel regression analysis was performed to assess the association between HCPs' beliefs and patients' beliefs and adherence., Results: 1504 patients (mean age 66.8 [s.d. ± 9.9] years, 46.5% female) and 734 HCPs (209 physicians, 118 pharmacists and 366 pharmacy technicians) participated in this study. Patients have higher BMQ necessity (16.9 [s.d. ± 4.3]) and BMQ concern (12.3 [s.d. ± 3.9]) scores than HCPs (15.0 [s.d. ± 3.0] and 11.5 [s.d. ± 2.9], P < 0.001). No associations were found between any of the HCPs' BMQ and patients' BMQ scores and adherence to statins. Patients' BMQ necessity, concern and necessity-concerns (NC)-differential scores were associated with patients' adherence (MARS-5) scores. B (95% CI) coefficients were 0.057 (0.035-0.079), -0.040 (-0.064 to -0.016) and.061 (0.043-0.079)., Conclusions: Patients have stronger beliefs about medication compared to HCPs. No associations were found between HCPs' BMQ scores on the one hand and patients' BMQ scores and adherence to statins on the other hand., (© 2020 The British Pharmacological Society.)

Introduction: Systemic sclerosis starts with an early phase characterized by Raynaud's phenomenon, puffy fingers/hands, autoantibodies, and a scleroderma nailfold microscopic pattern. Alterations in the nailfold microscopic pattern are not evident in all early SSc patients. Photoacoustics (PA) and high-frequency ultrasound (HFUS) could fulfill this need. The former can measure oxygen saturation while the latter can measure skin thickening. We hypothesize that photoacoustics and high-frequency ultrasound can distinguish (early) SSc patients from individuals with primary Raynaud's phenomenon (PRP) by measuring oxygenation of the fingertip and skin thickening., Methods: We compared measurements of oxygenation and skin thickness of the third finger between (early) SSc patients and PRP individuals and healthy controls. The spearman rank correlation was used to analyze an association between capillary density and oxygen saturation of the fingers., Results: Thirty-one adult subjects participated in this study: twelve patients with SSc, 5 patients with early SSc, 5 volunteers with PR, and 9 healthy controls. We found a significant difference in oxygen saturation between (early) SSc patients (80.8% ± 8.1 and 77.9% ± 10.5) and individuals with PRP (93.9% ± 1.1). Measurements of skin thickening showed a significant difference in (early) SSc patients compared to individuals with PRP (0.48 ± 0.06 mm and 0.51 ± 0.16 mm vs. 0.27 ± 0.01 mm). There was no significant difference between healthy and PRP individuals in oxygenation or skin thickening., Conclusion: Photoacoustic and high-frequency ultrasound could help to distinguish between (early) SSc, PRP, and healthy individuals in both oxygenation and skin thickening.