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Background Researchers are mandated ethically to share study results with participants, and funding agencies emphasize dissemination to others with relevant lived experience. Many researchers, however, find it difficult to communicate study purposes, methods, results, and significance to patients. Our Scleroderma Patient-centered Intervention Network (SPIN) piloted “co-presentation,” which involves researchers and patient partners jointly presenting results to other patients. The SPIN Patients Alongside Investigators in Research-Sharing (SPIN-PAIRS) Trial will be conducted as part of a 90-min virtual research event for people with systemic sclerosis (SSc, scleroderma) and will compare patient and researcher partner co-presentation versus researcher-alone presentation. Primary outcomes will be event attendee ratings of presentations on (1) information completeness, (2) understandability, (3) relevance to patients, and (4) trust in findings. Secondary objectives are to (1) conduct subgroup analyses of primary outcomes by participant characteristics (gender, age, race or ethnicity, country, education level, health literacy) and (2) use qualitative interviews to better understand outcome ratings and inform co-presentation. Methods This will be a mixed-method study with (1) a two-arm parallel superiority randomized controlled trial embedded in a patient-oriented research event and (2) interviews with patient and researcher co-presenters, separately, and with trial participants. Pre-event, researchers will be selected to present via an open call for abstracts and a patient-led selection committee. To avoid presentation-related biases, pre-event, researchers will record researcher-alone presentations. They will then receive co-presentation training and develop co-presentations with patient partners, which will also be recorded. Eligible trial participants will be adults aged 18 or older who indicate they have been diagnosed with SSc by a physician. We will recruit participants via social media and email lists from our multinational SPIN Cohort and from patient organization partners to attend the event and rate presentations. Participants will be recruited to register for the event beginning in August 2025. Registered participants will be invited to confirm their registration and enroll in the trial on the day of the event. We will require at least 116 participants for ≥ 80% power but will not restrict the number of enrollees. We will randomly assign event attendees 1:1 to virtual rooms with (1) four pre-recorded patient-researcher co-presentations or (2) four pre-recorded researcher-alone presentations. The same studies will be presented in each arm with live questions and answers after each presentation in each virtual room. Attendees will rate each presentation immediately following the presentation. Participants will not be informed that they are part of a randomized trial, or that two conditions are being compared and will be blind to study comparisons and hypotheses. Presenters will not be blinded during the event. We will compare outcomes, all measured via 0–10 numerical rating scales, using linear mixed models with four observations per participant for each outcome (one observation for each presentation). Interviews will be conducted < 2 weeks post-event, and verbatim transcripts will be analyzed using an inductive-deductive thematic approach. Discussion Findings will contribute to the evidence base on effective strategies for sharing results with study participants and others with relevant lived experience. Trial registration ISRCTN12805381 ( https://www.isrctn.com/ISRCTN12805381 )

Background Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network—Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy). Methods An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current N eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models. Discussion Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience. Trial registration ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).

Background Raynaud’s phenomenon is one of the first clinical manifestations observed in systemic sclerosis (SSc). This microvasculature disorder affects mostly the digits in over 95% of SSc patients, significantly affecting their health-related quality of life (HRQoL) and incurring higher hospital admissions and other healthcare costs. Exercise is known to improve both micro- and macrovascular function – aerobic exercise and resistance training, separately or combined, have been demonstrated to lead to significant vasculo-physiological improvements in conditions that present vasculopathy. However, the effects of a combined exercise programme on microcirculation in SSc patients has yet to be investigated. Therefore, the purpose of this study is to assess the effects of high-intensity interval training (HIIT) combined with circuit resistance training on the microvascular function in the digital area of SSc patients. Methods This will be a randomised controlled, feasibility trial with two arms, wherein 30 patients with SSc in receipt of medical treatment will be randomly assigned to usual care (medical treatment) or to a 12-week supervised exercise programme. Patients in the exercise group will undertake two, 45-min sessions each week consisting of 30 min HIIT (30 s 100% peak power output/30 s passive recovery) on the arm crank ergometer and 15 min of upper body circuit resistance training. Patients will be assessed before as well as at 3 and 6 months following randomisation. Primary outcomes of the study will be recruitment and retention rate, intervention acceptability and adherence to the exercise programme. Secondary outcomes include the digital area cutaneous microvascular function (laser Doppler fluximetry combined with iontophoresis), physical fitness, functional ability, upper back transcutaneous oxygen tension, body composition and quality of life (EQ-5D-5L). Selected interviews with a subsample of patients will be undertaken to explore their experiences of having Raynaud’s phenomenon and the acceptability of the exercise intervention and study procedures. Discussion Data from this study will be used to identify the feasibility of a combined exercise programme to be implemented in SSc patients, the acceptability of the intervention and the study design, and to determine the effects of exercise on the microvasculature. Overall, this study will provide sufficient data to inform and support a full multicentre clinical trial. Trial registration ClinicalTrials.gov (NCT number): NCT03058887 , February 23, 2017.

Background Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The Scleroderma Patient-centered Intervention Network (SPIN), along with SSc patient organization partners, developed a training program for SSc patient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders’ self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress. Methods/design The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60–90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention. Discussion The SPIN-SSLED trial will test whether a training program for SSc patient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases. Trial registration ClinicalTrials.gov, NCT03965780 . Registered on 29 May 2019.

Objectives To evaluate the reliability and validity and estimate the minimally important difference (MID) for the SF-6D in patients with systemic sclerosis (SSc). Subjects We used data from two clinical studies to analyze the SF-6D in patients with SSc: Study 1 was a cross-sectional observational study (N = 107) designed to assess three direct preference measures—the rating scale, time trade-off, and standard gamble (SG) in patients with diffuse SSc and limited SSc, and Study 2 was a 12-month randomized, clinical trial (N = 168) assessing oral bovine collagen versus placebo in diffuse SSc. Methods We assessed the test-retest reliability of the SF-6D in Study 2 over a mean (SD) 4.8 (3.0)-week interval and the agreement between the SF-6D and direct preference measures in Study 1 using intraclass correlations (ICC). The MID was estimated using three different anchors—the SF-36 change in health item (patients who answered \"somewhat better\" formed the MID group), the Health Assessment Questionnaire-Disability Index (HAQDI; change of ≥0.14 and ≥0.22) and the skin score (change of ≥5.3). Results The mean (SD) SF-6D scores were 0.61 (0.12) in Study 1 and 0.64 (0.13) in Study 2. Test-retest reliability for the SF-6D was high (ICC = 0.82 [95% CI: 0.76, 0.87]). Agreement between the SF-6D and three direct preferences measures was poor to moderate (0.16—0.52). The MID estimate for the SF-6D using the change in SF-36 item -0.012 and this level of change was similar to the no change group. The mean MID estimate for the SF-6D improvement using the HAQ-DI and skin score as anchors was 0.035 (effect size of 0.27). Conclusion This is the first study to assess the SF-6D in SSc. The SF-6D is reliable and valid in patients with SSc. We provide MID estimates that can aid in calculating sample size for clinical trials involving patients with diffuse SSc.

Background Systemic sclerosis (SSc) is a rare autoimmune disease characterized by fibrosis of the skin and the involvement of multiple internal organs. Previous studies reported poorer health-related quality of life (HRQoL) in patients with SSc compared with the general population. However, very little is known about how HRQoL in SSc patients compares with that in patients with other systemic autoimmune diseases, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjogren’s syndrome (SjS). Thus, the main aim of this study was to compare HRQoL in SSc patients, patients with other rheumatic diseases, and the general population. Methods In this cross-sectional study, patients from the rheumatology clinics of Seoul National University Hospital with SSc, RA, SLE, and SjS were enrolled via a random sampling technique. HRQoL was captured by the Short Form (36) health survey (SF-36), the Short Form Six-Dimensional health index (SF-6D), and the EuroQol Five-Dimensional descriptive system (EQ-5D). Demographic characteristics and standardized disease activity for each disease were also obtained. Previously reported data from 600 healthy Koreans were used for the healthy controls. An ANCOVA test was used to compare the SF-36, SF-6D, and EQ-5D values between study subjects with adjustments for age, sex, disease duration, comorbidities, and disease activity status. Results One hundred twenty patients were included in each of the SSc, RA, SLE, and SjS cohorts. Patients with rheumatic diseases had significantly lower SF-36, SF-6D, and EQ-5D scores than healthy controls (all P  < 0.001). After statistical adjustments, SSc patients reported significantly lower mental component summary (MCS) scores than patients with RA ( P  < 0.001) or SLE ( P  = 0.001). Specifically, the mental health and general health domains were significantly lower in SSc patients than reported in RA or SLE patients ( P  < 0.001 and P  = 0.001, respectively, in both domains). In SSc patients, higher modified Rodnan skin scores (mRSS) correlated with lower MCS scores. Conclusions SSc patients report poorer HRQoL than patients with RA or SLE. The extent of skin involvement is associated with poorer HRQoL in SSc patients. Trial registration NCT03257878 . Registered 22 August 2017

To demonstrate the burden of sexual dysfunction (SD) among females with rheumatic diseases, we conducted a cross-sectional comparative study in patients with systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and Behçet’s syndrome (BS) along with suitable healthy controls (HCs). Age-matched female patients with SSc (n = 50), SLE (n = 49), and BS (n = 54), along with 52 female HCs were included in this study between April and October, 2021. Sociodemographic features were recorded, and psychometric tests, i.e., female sexual function index (FSFI), Beck depression inventory (BDI), body cathexis scale, and marital adjustment test (MAT) were performed. Scale scores were compared, and binary logistic regression was used to identify predictors for SD in the whole group. The total FSFI and body cathexis scores among the patient groups were significantly lower than those of the HCs (p < 0.001). Depression was significantly more frequent in the patient groups. MAT scores did not differ significantly between the study groups. Patients with SSc had the worst scores in each psychometric index, including MAT. Decreased body cathexis score [OR 0.974, 95% CI (0.957–0.991), p = 0.003] and low MAT score [OR 0.937, 95% CI (0.896–0.980), p = 0.005], and being diagnosed with SSc [OR 6.6, 95% CI (1.975–22.498), p = 0.002], SLE [OR 2.7, 95% CI (0.998–7.753), p = 0.050], and BS [OR 2.8, 95% CI (1.100–7.359), p = 0.031], were identified as independent predictors for SD. Body cathexis seems to be the most important independent predictor for SD, and the burden of SD appears heavier in patients with SSc, probably due to poor body image satisfaction.

AbstractObjective: This study aimed to identify a pain phenotype associated with hypervigilance in systemic sclerosis (SSc) and evaluate possible variables that influence pain hypervigilance symptoms. Methods: This cross-sectional, observational study included healthy controls (HCs) and SSc patients diagnosed with a score of 9 or higher according to the 2013 American College of Rheumatology-European League against Rheumatism classification criteria. The pain hypervigilance symptoms were evaluated using the central sensitization inventory (CSI), while disease activity was assessed using the European Scleroderma Research Group Activity Index (EScSG-AI). Patients were classified by CSI scores. Comparatives were done. Results: A total of 51 SSc patients (92.2% female, mean age [50.54 years]) and 45 HCs (88.9% female, mean age [52.62]) were included. Education and monthly income were lower for SSc than HCs (p < 0.05). The CSI score ≥40 proportion was 56.9% in SSc and 15.6% in HCs (p < 0.001). Depression-Anxiety-Stress Scale (DASS-21), Epworth Sleepiness Scale (ESS), Global Pittsburgh Sleep Quality Index (PSQI), and EuroQol Five-Dimensional Three-Level Questionnaire (EQ-5D-3L) scores were higher in SSc than HCs (p < 0.05). By using multiple linear regression analysis to determine predictors of CSI score ≥40, the effective variable was EScSG-AI. In multivariate logistic regression analysis, educational level and global PSQI scores were factors associated with CSI score ≥40 in SSc. Conclusions: CSI score was positively associated with depression, disease activity, stress, anxiety, and poor sleep quality, while it was negatively associated with education and economic status. Pain hypervigilance may affect organ involvement and functioning in SSc. Clinicians should examine its biopsychosocial components.

Summary What is this summary about? Systemic sclerosis (SSc) is a condition that affects the immune system (the body’s natural defence system) and causes the skin to harden and thicken in large patches. Research shows that 30% to 90% of people with SSc also have interstitial lung disease (ILD), a condition that causes inflammation and scarring of the lungs. When people have SSc and ILD, it is known as SSc-associated ILD or SSc-ILD. The authors of this plain language summary of publication (PLS-P) reviewed different articles to find out what the key issues were in the way doctors and patients with SSc-ILD communicate with each other. What were the results? The key messages from the studies were: Most patients felt uneasy when they were diagnosed with SSc-ILD Good communication between doctors and patients at the first visit is crucial as it sets the tone for future relationships Both doctors and patients avoid talking about how SSc-ILD symptoms may get worse (prognosis) or the subject of death. Patients should be encouraged to ask questions to address important and personal topics that would not be talked about otherwise Patients may feel intimidated by a doctor, which could interfere with communication Doctors must be able to listen and show empathy to build a relationship with patients and be aware that different communication styles may suit a patient during different stages in their journey Doctors should avoid using a lot of technical terms. Patients felt metaphors helped them understand their condition better Patients have different awareness, thoughts, and feelings about SSc-ILD than doctors. If doctors understand this, it may improve the communication between doctors and patients Ways to close the gap between the way doctors and patients communicate include patients having the opportunity to access: Self-learning and patient organizations Peer-mentoring (patients mentoring other patients) Information technology Shared decision-making, where the doctor and patient work together to come to a decision about treatment and care What do the results mean? The best way to improve the feelings patients have when they are diagnosed with SSc, including SSc-ILD, is to improve the quality of the communication between doctors and patients. The quality of the first meeting between a doctor and patient sets the tone for future checkups, especially if the doctor can listen, show empathy, and allow the patient to ask questions. Improving the patient’s knowledge about SSc-ILD, for example by using websites, reading printed materials, or taking part in peer-mentoring schemes, may also contribute to a better conversation.

This study aims to investigate the relationship between sleep hygiene and sleep quality in patients with systemic sclerosis (SSc) and to compare the sleep hygiene and sleep quality outcomes across three distinct groups: SSc patients, rheumatoid arthritis (RA) patients, and healthy controls (HC). This study employed an observational, cross-sectional, and parallel group design. SSc-related and RA-related variables, depression and anxiety were assessed. Physical function and quality of life, pain and fatigue of SSc patients were also evaluated. Sleep quality using the Pittsburg Sleep Quality Index (PSQI) and sleep hygiene using the Sleep Hygiene Index (SHI) were evaluated for all participants. Linear regression analysis was performed to show the relationship between the SHI scores and the other variables. Total PSQI and SHI scores were found to be significantly higher in SSc patients than in RA patients and HC. Fatigue, smoking, all SF-36 domains, depression and anxiety scores were associated with SHI scores in SSc patients. In the univariate logistic regression analysis, SSc patients exhibited 4.50 times higher odds (95% CI 2.165–9.353, p  < 0.001) of experiencing poor sleep than RA patients and HC. In SSc patients, for every incremental increase in SHI score, the odds of poor sleep quality were 1.15 times higher (95% CI 1.093–1.220, p  < 0.001). Sleep hygiene and sleep quality exhibit a more pronounced deterioration in SSc patients. Inadequate sleep hygiene is associated with compromised sleep quality in SSc. Therefore, improving sleep hygiene practices may be a key strategy to enhance the overall sleep quality in this population.