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Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort (http://www.spinsclero.com/en/cohort) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.govNCT04246528. Registered on 27 January 2020

PurposePhysical and occupational therapy interventions are increasingly delivered through videoconferencing to overcome barriers related to face-to-face delivery. The objective of this scoping review was to identify barriers and facilitators of using synchronous telerehabilitation to deliver these interventions for musculoskeletal disorders.Materials and MethodsMEDLINE, EMBASE, PsycInfo, CINAHL, Cochrane Library, and ProQuest Dissertations and Theses databases were searched in May 2020. Qualitative and quantitative studies in any language that described barriers and facilitators of using synchronous videoconferencing for physical or occupational interventions or assessments for individuals with musculoskeletal diseases were eligible.ResultsTwenty-three publications were included that reported 59 facilitators and 41 barriers to using telerehabilitation. All included studies (100%) reported on facilitators, and 20 (87%) studies also reported on barriers. Most commonly reported facilitators included convenience and accessibility of services, audio and visual quality, and financial and time savings. Most commonly reported barriers included technological issues, privacy concerns, impersonal connection, and difficulty establishing rapport between patients and healthcare professionals.ConclusionsFactors including quality and user-friendliness may facilitate the delivery of physical or occupational therapy interventions or assessments for musculoskeletal diseases using telerehabilitation. Strategies to address key barriers should be considered when developing and implementing such interventions or assessments.Implications for rehabilitationVideoconferencing with a healthcare professional can be an effective way to deliver patient-centered physical or occupational therapy telerehabilitation interventions.Strategies to combat barriers to using telerehabilitation may include using a stable, high-quality videoconferencing platform, enhancing self-efficacy to using videoconferencing amongst patients and health care providers, and addressing concerns related to privacy.During the current COVID-19 pandemic, the present study provides insight into the successful development and delivery of physical or occupational telerehabilitation interventions for at-risk populations.

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.

Purpose Informal caregivers provide ongoing assistance to a loved one with a health condition. No studies have compared caregiving intensity and perception of burden across chronic medical conditions. Materials and methods Databases were searched from inception through 11 September 2020 to identify studies that included the Level of Care Index or the Zarit Burden Inventory (ZBI) among caregivers for people with chronic diseases. Pooled mean ZBI scores and 95% confidence intervals by medical condition were calculated using a random effects model and heterogeneity with I2. Results Ninety-seven included articles reported on 98 unique samples across 21 chronic diseases. No study used the Level of Care Index. Among 12 disease groups with more than one study, heterogeneity was too high (I2 range: 0-99.6%, ≥76.5% in 11 groups) to confidently estimate burden. The percent of studies rated high risk of bias ranged from 0% to 98%, but all external validity items were rated as high-risk in >50% of studies. Conclusions Findings highlight the need for studies on caregiver burden to improve sampling techniques; better report sampling procedures and caregiver and care recipient characteristics; and develop a standard set of outcomes, including a measure of caregiving intensity. Systematic Review Registration: CRD42017080962IMPLICATIONS FOR REHABILITATIONThe amount of burden reported by caregivers to loved ones is associated with reduced physical and mental health.We found considerable heterogeneity in perceived burden reported by informal caregivers across different studies within disease groups, which is likely related to methodological issues, including sampling techniques.Health care providers who use research on caregiver burden should assess how representative study samples may be and exercise caution in drawing conclusions.

Background Peer-led support groups play an important role in supporting people with chronic diseases. They may be particularly important for people with rare diseases who typically do not have access to professional support options that focus on their disease-specific needs. Many peer-led support groups in rare diseases, however, are not sustained, and many patients do not have access to support groups. Training and education for peer support group leaders could address barriers to initiating and sustaining groups, but there is little evidence on the effectiveness of support group leader training programs. A previous systematic review evaluated the effects of training programs for peer leaders of support groups for people with medical illness on leader and support group outcomes, but it identified only one randomized controlled trial (RCT) that compared high- and low-resource training programs for cancer support group leaders. The trial did not find evidence that the high-resource program was more effective, but was limited by a small sample size and serious methodological limitations. To meet the needs of people living with the rare autoimmune connective tissue disease scleroderma, the Scleroderma Patient-centered Intervention Network has partnered with patient organizations to develop the Scleroderma Support group Leader EDucation Program, and a full-scale RCT to test the effectiveness of the program is planned. To verify the need for such a trial, we updated the previous systematic review. Updated evidence Review methods for the update were unchanged from the initial review. The updated database search yielded 1504 unique citations in addition to the 9757 assessed for eligibility in the previous review. All additional citations identified in the updated search were excluded at the title and abstract review stage. Conclusions Our systematic review update found that there is presently insufficient evidence on the effectiveness of training and support programs for peer leaders of disease-based support groups, highlighting the need for well-designed and rigorously conducted RCTs to examine the effects of training for peer leaders of support groups, especially in a rare disease context. The Scleroderma Patient-centered Intervention Network’s trial of the Scleroderma Support group Leader EDucation Program will serve as such a trial. Systematic review registration PROSPERO CRD42018096369 Electronic supplementary material The online version of this article (10.1186/s13643-019-0981-0) contains supplementary material, which is available to authorized users.

Key Points Question Is a community-designed and implemented peer-to-peer (P2P) support program associated with changes in measures of health and well-being, such as depressive or anxiety symptoms, vs standard community services (SCS)? Findings In this cohort study of 448 older adults, the P2P group had a significant increase in anxiety symptoms compared with the SCS group. The P2P group had improvements in mental and physical health over the year, but these did not differ significantly from the SCS group. Meaning In this study, the results were mixed and did not show that receiving P2P support was associated with improvements in or a slower decline of health and well-being compared with the SCS group., This cohort study compares health status, quality of life, and depressive and anxiety symptoms between older adults receiving peer-to-peer support vs those receiving standard community services., Importance Literature on peer-to-peer (P2P) programs suggests they improve health and well-being of older adults. Analysis from a previous study showed P2P to be associated with higher rates of hospitalization and no significant differences in rates of emergency department or urgent care visits; however, it is not known whether measures of health and well-being varied by group over time. Objective To compare the association between receiving P2P support and secondary outcomes (ie, health status, quality of life, and depressive and anxiety symptoms) with receiving standard community services (SCS) over time. Design, Setting, and Participants This cohort study was conducted among a volunteer sample of older adults (≥65 years) who were new to P2P or were already receiving P2P and a corresponding control group. Participants were matched between groups on age, sex, and race/ethnicity. The study was conducted from March 2015 to December 2017 at 3 community-based organizations that delivered P2P in California, Florida, and New York. Data analysis was performed from October 2018 through May 2020. Exposures P2P support, provided by trained older adult volunteers. Main Outcomes and Measures Mental and physical components of the health status and quality of life measure and depressive and anxiety symptoms were collected over 12 months. The hypothesis was that older adults receiving P2P support would maintain higher health status and quality of life than the SCS group. Results A total of 503 participants were screened, 456 participants were enrolled and had baseline data, and 8 participants only had baseline information with no follow-up data, leaving 448 participants (231 [52%] in the SCS group; 217 [48%] in the P2P group; 363 [81%] women; mean [SD] age, 80 [9] years). The P2P group had improvements in mental health (change at 12 months, 1.1 points; 95% CI, −0.8 to 3.0 points) and physical health (change at 12 months, 1.0 points; 95% CI, −0.7 to 2.8 points). However, the difference of differences between the 2 groups did not differ significantly from baseline to 12 months (mental health: 0.2 points; 95% CI −2.3 to 2.7 points; physical health: 1.7 points; 95% CI, −0.6 to 3.9 points). The P2P and SCS groups had a statistically significant difference of differences in anxiety symptoms of 0.36 points (95% CI, 0.04 to 0.61 points). There were no significant differences in depressive symptoms or mental and physical components of the health status and quality of life. Conclusions and Relevance These findings suggest that receiving P2P support did not slow the decline of health and well-being in older adults compared with those who received SCS. Baseline imbalance in key characteristics, even after adjusting for the imbalance using the propensity score method, may explain the results. Randomized trials are needed.

IntroductionSystemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease with a high level of burden, a significant impact on the ability to carry out daily activities, and a considerable negative impact on health-related quality of life. Non-pharmacological interventions could be provided to potentially improve mental and physical health outcomes. However, the effectiveness of non-pharmacological interventions on health and well-being among individuals with SSc has not been well established. The proposed living systematic review aims to identify and evaluate randomised controlled trial (RCT) evidence on the effectiveness of non-pharmacological and non-surgical interventions on mental and physical health outcomes and on the delivery of such services in SSc.Methods and analysisEligible studies will be RCTs that examine non-pharmacological and non-surgical interventions aimed at improving health outcomes among individuals with SSc or the delivery of services intended to improve healthcare or support of people with SSc (eg, support groups). All RCTs included in a previous systematic review that sought studies published between 1990 and March 2014 will be evaluated for inclusion. Additional trials will be sought from January 2014 onwards using a similar, augmented search strategy developed by a health sciences librarian. We will search the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library and Web of Science databases and will not restrict by language. Two independent reviewers will determine the eligibility of identified RCTs and will extract data using a prespecified standardised form in DistillerSR. Meta-analyses will be considered if ≥2 eligible RCTs report similar non-pharmacological interventions and comparable health outcomes. We will conduct a qualitative synthesis for interventions that cannot be synthesised via meta-analysis.Ethics and disseminationWe will post initial and ongoing results via a website, publish results periodically via peer-reviewed journal publication, and present results at patient-oriented events.PROSPERO registration numberCRD42020219914.

Contains fulltext : 219490.pdf (Publisher’s version ) (Open Access) Purpose: Many people with scleroderma rely on peer-led support groups as a coping resource. Reasons for not attending support groups in scleroderma have been investigated only in North American participants. This study assesses reasons for nonattendance in European countries and compares results with previously published North American findings. Materials and Methods: The same 21-item survey as used in the North American sample assessed possible reasons for not attending scleroderma support groups. Proportions of items rated Important or Very Important were compared between samples. Results: Consistent with the North American survey findings (N = 242), the two items most commonly rated as (Very) Important reasons for nonattendance among 228 European participants were (1) already having enough support (57%), and (2) not knowing of any local scleroderma support groups (58%). Compared to North American non-attenders, European patients were significantly more likely to rate not knowing enough about what happens at support groups (46% vs 19%), not having reliable ways to get to meetings (35% vs 17%), and being uncomfortable sharing experiences with a group (22% vs 11%) as (Very) Important reasons for nonattendance. Conclusions: Improving access to European support groups, providing education about support groups and group leader training may encourage participation. 8 p.

Summary Background Pain is an important and detrimental feature of systemic sclerosis but is often overlooked or deprioritised in research and clinical care. Raynaud's phenomenon, arthritis, and cutaneous ulcers are among the commonly reported disease manifestations of systemic sclerosis that could be associated with pain. We aimed to assess levels of pain intensity and interference and to evaluate disease factors associated with pain intensity and interference. Methods In this multicentre cross-sectional study, participants from the Scleroderma Patient-centered Intervention Network cohort who completed pain intensity and interference measures (Patient Reported Outcomes Information System-29 profile, version 2·0) as part of baseline assessments were included. Patients were recruited from 46 centres in Australia, Canada, France, Mexico, Spain, the UK, and the USA between April 15, 2014, and Jan 7, 2020. Eligible patients included those aged 18 years or older who met the criteria for systemic sclerosis devised by the American College of Rheumatology and the European League Against Rheumatism. Associations of pain intensity and pain interference with systemic sclerosis-related variables and overlap syndromes, controlling for sociodemographic variables, were assessed with multiple linear regression. Continuous independent variables were standardised. Findings Among 2157 participants with systemic sclerosis (268 [12%] males and 1889 [88%] females), 1870 (87%) reported mild, moderate, or severe pain (defined as ≥1 on a 0 to 10 scale), and 815 (38%) reported moderate or severe pain (defined as ≥5). Moreover, 757 (35%) participants reported moderate or severe pain interference. Greater pain intensity was independently associated with female sex (0·58 points [95% CI 0·26–0·90]), non-White race or ethnicity (0·50 points [0·21–0·79]), fewer years in formal education (0·30 points per SD [0·19–0·41]), country (reference: USA; Canada: 0·29 points [0·01–0·57] and UK: 0·58 points [0·21–0·95]), greater body-mass index (0·35 points per SD [0·24–0·45]); joint contractures (0·67 points [0·39–0·94]), digital ulcers (0·33 points [0·10–0·55]), gastrointestinal involvement (0·66 points [0·33–0·98]), skin involvement (measured using modified Rodnan skin score; 0·22 points per SD [0·10–0·35]), rheumatoid arthritis (0·96 points [0·50–1·43]), and Sjogren's syndrome (0·42 points [0·01–0·83]). Pain interference results were similar. Interpretation Pain is common among people with systemic sclerosis. Controlling for sociodemographic variables, greater pain was associated with multiple systemic sclerosis-related manifestations, including joint contractures, digital ulcers, gastrointestinal involvement, skin involvement, and the presence of overlap syndromes. Health-care providers should work with patients to address pain, including identifying and addressing systemic sclerosis manifestations associated with their pain, and supporting behavioural approaches to minimise impact on function and quality of life. Funding Canadian Institutes of Health Research, Arthritis Society, The Lady Davis Institute for Medical Research of the Jewish General Hospital, Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclerodermie Quebec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

Introduction No studies have examined factors associated with fear in any group of people vulnerable during COVID-19 due to pre-existing medical conditions. Objective To investigate factors associated with fear of consequences of COVID-19 among people living with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including country. Methods Pre-COVID-19 data from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort were linked to COVID-19 data collected in April 2020. Multivariable linear regression was used to assess factors associated with continuous scores of the 10-item COVID-19 Fears Questionnaire for Chronic Medical Conditions, controlling for pre-COVID-19 anxiety symptoms. Results Compared to France (N = 156), COVID-19 Fear scores among participants from the United Kingdom (N = 50) were 0.12 SD (95% CI 0.03 to 0.21) higher; scores for Canada (N = 97) and the United States (N = 128) were higher, but not statistically significant. Greater interference of breathing problems was associated with higher fears due to COVID-19 (Standardized regression coefficient = 0.12, 95% CI 0.01 to 0.23). Participants with higher financial resources adequacy scores had lower COVID-19 Fear scores (Standardized coefficient = −0.18, 95% CI −0.28 to −0.09). Conclusions Fears due to COVID-19 were associated with clinical and functional vulnerabilities in this chronically ill population. This suggests that interventions may benefit from addressing specific clinical issues that apply to specific populations. Financial resources, health policies and political influences may also be important. The needs of people living with chronic illness during a pandemic may differ depending on the social and political context in which they live., Highlights • People with chronic diseases may experience high levels of fear due to COVID-19. • We examined factors associated with fears due to COVID-19 in an at-risk population. • We used the validated COVID-19 Fears Questionnaire for Chronic Medical Conditions. • Fears due to COVID-19 among people with SSc differed substantially by country. • Interference of breathing problems and financial adequacy were related to fears.

Little is known about the benefits, and barriers and facilitators to providing psychosocial support to caregivers to a loved one with a rare disease. The aim of our scoping review was to map evidence on (1) perceived benefits and (2) barriers and facilitators of establishing and maintaining services. The CINAHL and PubMed databases were searched in December 2018. Qualitative and quantitative studies in any language that described perceived or tested benefits of participating in psychosocial interventions for caregivers, or the barriers and facilitators of providing these interventions, were eligible. Thirty-four studies were included. Interventions were behavioural or psychological, supportive, educational, or multicomponent. All included studies reported on the benefits of participating in psychosocial interventions; 14 (41%) studies also reported on facilitators and 19 (56%) reported on barriers. Benefits that were most commonly found included statistically significant improvements in emotional states (e.g. stress) and caregiver burden and narrative reports of intervention helpfulness. Statistically significant improvements in mental health outcomes (e.g. depression symptoms) were rarely detected. Four themes for facilitators were identified, including intervention characteristics, intervention delivery characteristics, provision of necessary resources, and support provided outside of the intervention. Four barrier themes were also identified: misalignment of intervention to caregiver needs, inability to make time for intervention, practical barriers, emotional barriers. Psychosocial interventions for caregivers to a loved one with a rare disease may be helpful in reducing stress, burden, and feelings of isolation among caregivers. Future research should design interventions for caregivers that take into account facilitators and barriers to establishing and maintaining such interventions.

PURPOSE: To evaluate the importance of different challenges experienced by informal caregivers to persons with systemic sclerosis (SSc) and identify priorities for support services that could be developed.MATERIALS AND METHODS: Caregivers of people with SSc from three continents completed an online questionnaire to rate the importance of possible caregiver challenges and likelihood of using different forms of support services. Importance of challenges and likelihood of using support services were rated from 1 (not important; not likely to use) to 4 (very important; very likely to use).RESULTS: Two hundred and two informal caregivers completed the survey (79 women, 123 men). Mean age was 58 years (standard deviation = 13). The most important challenges were related to supporting the care recipient with emotional difficulties and physical discomfort. Caregivers indicated that they would be more likely to use support services that involved online or hard-copy information resources, including those provided soon after diagnosis, compared to support that involved interacting with others.CONCLUSIONS: Supporting the care recipient in managing emotional difficulties and physical discomfort were important challenges among caregivers. Interventions delivered through hardcopy or online resources, including those delivered soon after the care recipient's diagnosis, were rated as being most likely to be used by caregivers. Implications for rehabilitation Many caregivers for individuals with systemic sclerosis report struggling to support their care recipient with emotional difficulties and physical discomfort. Rehabilitation professionals can aid in the development of support services that caregivers have identified as being likely to use and can refer caregivers to resources that they have identified as being helpful, such as educational information about the disease. The development of support services should focus on aspects of caring that caregivers found most challenging and be delivered in a format that considers caregiver preferences.

Item does not contain fulltext Involving patients and health care professionals in research has been shown to be a useful strategy to generate program development ideas and establish research priorities. Online surveys can be used to identify patient research priorities. The Scleroderma Patient-centered Intervention Network is an international collaboration dedicated to researching problems important to people with scleroderma and developing, testing, and disseminating educational, self-management, rehabilitation, and psychological tools to support coping within the disease. The objectives of the Scleroderma Patient-centered Intervention Network Scleroderma Research Topics Survey were to (1) obtain input on online programs that Scleroderma Patient-centered Intervention Network could develop, (2) identify research topics important to members of the scleroderma community that could be addressed via the Scleroderma Patient-centered Intervention Network Cohort, and (3) identify potentially understudied groups. Eligible survey respondents included individuals with scleroderma and their caregivers, health care professionals, and patient organization representatives. Responses were evaluated separately for online programs, possible research questions, and understudied groups. In each category, thematic analysis was used to group responses into themes. A total of 125 participants (100 patients, 24 health care professionals, and 1 caregiver) completed the survey, and responses from patients and health care professionals were reported. For online programs, frequent recommendations included Interactive Platforms to facilitate communication between patients, as well as interventions targeting physical activity, and emotions and stress. Common responses for possible research questions were related to calcinosis, accessing health care, and quality of life. The most common suggestions for understudied groups were young patients, minority patients, and patients with calcinosis. Research topic suggestions provided in the survey will inform Scleroderma Patient-centered Intervention Network priorities and can be considered by other researchers. 8 p.

Objective Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. Methods The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. Ethics and dissemination The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak., Highlights • No RCTs have tested mental health interventions in contagious disease outbreaks. • People with scleroderma face fear and isolation during COVID-19. • SPIN-CHAT is designed to improve mental health in SSc patients during COVID-19. • SPIN-CHAT provides 12 group sessions over 4 weeks. • The SPIN-CHAT trial will randomize 162 participants to intervention or waitlist.

Objective Fear associated with medical vulnerability should be considered when assessing mental health among individuals with chronic medical conditions during the COVID-19 pandemic. The objective was to develop and validate the COVID-19 Fears Questionnaire for Chronic Medical Conditions. Methods Fifteen initial items were generated based on suggestions from 121 people with the chronic autoimmune disease systemic sclerosis (SSc; scleroderma). Patients in a COVID-19 SSc cohort completed items between April 9 and 27, 2020. Exploratory factor analysis (EFA) and item analysis were used to select items for inclusion. Cronbach's alpha and Pearson correlations were used to evaluate internal consistency reliability and convergent validity. Factor structure was confirmed with confirmatory factor analysis (CFA) in follow-up data collection two weeks later. Results 787 participants completed baseline measures; 563 of them completed the follow-up assessment. Ten of 15 initial items were included in the final questionnaire. EFA suggested that a single dimension explained the data reasonably well. There were no indications of floor or ceiling effects. Cronbach's alpha was 0.91. Correlations between the COVID-19 Fears Questionnaire and measures of anxiety (r = 0.53), depressive symptoms (r = 0.44), and perceived stress (r = 0.50) supported construct validity. CFA supported the single-factor structure (χ2(35) = 311.2, p, Highlights • People with chronic diseases are at risk if infected with the COVID-19 virus. • The COVID-19 Fears Questionnaire assesses fear among people with medical conditions. • 121 people with scleroderma from 10 countries provided item suggestions. • Validity was supported in a sample of 787 scleroderma patients. • The questionnaire is available for use in studies during the COVID-19 crisis.

ObjectiveTo (1) investigate the extent to which recently published meta-analyses report trial funding, author–industry financial ties and author–industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010.DesignReview of consecutive sample of recently published meta-analyses.Data sourcesMEDLINE database via PubMed searched on 19 October 2018.Eligibility criteria for selecting articlesWe selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs.Results90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author–industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author–industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%).ConclusionsReporting of trial funding sources, trial author–industry financial ties and trial author–industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.