Experiences of systemic sclerosis patients with home monitoring of their pulmonary function: a qualitative study.

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.

Efficacy of methylprednisolone in very early systemic sclerosis: results of the "Hit hard and early'' randomized controlled trial.

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.

Effectiveness of longstanding exercise therapy compared with usual care for people with rheumatoid arthritis and severe functional limitations: a randomised controlled trial.

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).

The Extent and Nature of Functional Limitations According to the Health Assessment Questionnaire Disability Index in Patients with Rheumatoid Arthritis and Severe Functional Disability.

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.

Delivery of a quality improvement program in team-based rehabilitation for patients with rheumatic and musculoskeletal diseases: a mixed methods study.

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.

Quality in rehabilitation should be characterized by a continuous and coordinated process from goal setting to follow-up.To improve the quality, sufficient involvement of next of kin and external services is needed.Clinicians may need training to build confidence in motivational interviewing, action- and coping planning, feedback on progress, and follow-up.Leaders should organize education sessions, optimize schedules, insert standardized outcome measures, and facilitate collaboration across levels of care and services.

Prioritization of Adverse Consequences After Total Knee Arthroplasty Contributing to a Poor Response: A Best-Worst Scaling Exercise Among Total Knee Arthroplasty Patients and Knee Specialists.

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.

Functional limitations of people with rheumatoid arthritis or axial spondyloarthritis and severe functional disability: a cross-sectional descriptive study.

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.

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis.

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.

Exploration of adverse consequences of total knee arthroplasty by patients and knee specialists: a qualitative study.

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.

Diagnosing knee osteoarthritis in patients, differences between general practitioners and orthopedic surgeons: a retrospective cohort study.

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.

Day-to-day fluctuations of fatigue severity in individuals with knee osteoarthritis: an ecological momentary assessment approach.

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 [ß = -0.57 (95% CI -0.67, -0.47)], weak for pain [ß = 0.41 (95% CI 0.29, 0.53)] and negative affect [ß = 0.40 (95% CI 0.21, 0.58)], and negligible for sleep [ß = -0.13 (95% CI -0.18, -0.08)] and perceived exertion of physical activity [ß = 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.

EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis.

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.

Association of Low-Dose Colchicine With Incidence of Knee and Hip Replacements : Exploratory Analyses From a Randomized, Controlled, Double-Blind Trial.

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.

Beliefs of rheumatologists and general practitioners on urate lowering therapy: a cross-sectional study.

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.

Physical Therapy in Systemic Sclerosis: The Patient Perspective.

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.

Patient-reported outcomes to assess dyspnoea in interstitial lung disease and pulmonary hypertension: a systematic literature review of measurement properties.

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.

Effect of metformin use on clinical outcomes and serum urate in gout patients with diabetes mellitus: a retrospective cohort study.

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.

Pain descriptors and determinants of pain sensitivity in knee osteoarthritis: a community-based cross-sectional study.

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 χ2 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 ß: 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.

Measurement Properties of the Polymyalgia Rheumatica Activity Score: A Systematic Literature Review.

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.

Evidence and consensus-based recommendations for non-pharmacological treatment of fatigue, hand function loss, Raynaud's phenomenon and digital ulcers in patients with systemic sclerosis.

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.