Randomized feasibility trial of the Scleroderma patient-centered intervention network hand exercise program (SPIN-HAND): Study protocol

BACKGOUND: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. DESIGN AND METHODS: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. DISCUSSION: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. TRIAL REGISTRATION: ClinicalTrials.gov IDENTIFIER: NCT03092024

Створення фільтру за допомогою гравірування S-резонаторів до хвилеводу, інтегрованого у підкладку

У роботі запропоновано смуговий фільтр у гіперчастотному діапазоні за рахунок поєднання двох планарних технологій. Перша технологія – це хвилевод, інтегрований у підкладку (SIW), а друга – метаматеріали. Щодо метаматеріалів, існує декілька їх форм, але в роботі нас цікавить S-подібний резонатор. Дослідження проводиться для вилучення еквівалентної схеми з додаванням різного числа резонаторів, що означає різний порядок фільтрів. Створені структури моделюються в різних програмах, таких як ADS, HFSS та CST для підтвердження результатів, які ідеально підходять для двох вибраних діапазонів частот [8,7; 13,4] ГГц та [9,5; 15] ГГц.In this paper, a bandpass filter in the hyperfrequency has been proposed by combining two planar technologies. The first is the substrate integrated waveguide (SIW) and the second is the metamaterials. For the latter, there are several forms, but in this work, we are interested in the S-shaped resonator. A study is done to extract the equivalent circuit of different numbers of resonators add, which means different orders of the filters. The structures designed are simulated in various programs such as ADS, HFSS and CST for the validation of the results, which are perfect for the two selected frequency bands [8.7, 13.4] GHz and [9.5, 15] GHz

Validation of the Social Appearance Anxiety Scale in Patients With Systemic Sclerosis: A Scleroderma Patient-Centered Intervention Network Cohort Study

OBJECTIVE: Systemic sclerosis (SSc) is an autoimmune disease that can cause disfiguring changes in appearance. This study examined the structural validity, internal consistency reliability, convergent validity, and measurement equivalence of the Social Appearance Anxiety Scale (SAAS) across SSc disease subtypes. METHODS: Patients enrolled in the Scleroderma Patient-centered Intervention Network Cohort completed the SAAS and measures of appearance-related concerns and psychological distress. Confirmatory factor analysis (CFA) was used to examine the structural validity of the SAAS. Multiple-group CFA was used to determine whether SAAS scores can be compared across patients with limited and diffuse disease subtypes. Cronbach's alpha was used to examine internal consistency reliability. Correlations of SAAS scores with measures of body image dissatisfaction, fear of negative evaluation, social anxiety, and depression were used to examine convergent validity. SAAS scores were hypothesized to be positively associated with all convergent validity measures, with correlations significant and moderate to large in size. RESULTS: A total of 938 patients with SSc were included. CFA supported a 1-factor structure (Comparative Fit Index 0.92, Standardized Root Mean Residual 0.04, and Root Mean Square Error of Approximation 0.08), and multiple-group CFA indicated that the scalar invariance model best fit the data. Internal consistency reliability was good in the total sample (α = 0.96) and in disease subgroups. Overall, evidence of convergent validity was found with measures of body image dissatisfaction, fear of negative evaluation, social anxiety, and depression. CONCLUSION: The SAAS can be reliably and validly used to assess fear of appearance evaluation in patients with SSc, and SAAS scores can be meaningfully compared across disease subtypes

Shortening patient-reported outcome measures through optimal test assembly: application to the Social Appearance Anxiety Scale in the Scleroderma Patient-centered Intervention Network Cohort

OBJECTIVES: The Social Appearance Anxiety Scale (SAAS) is a 16-item measure that assesses social anxiety in situations where appearance is evaluated. The objective was to use optimal test assembly (OTA) methods to develop and validate a short-form SAAS based on objective and reproducible criteria. DESIGN: This study was a cross-sectional analysis of baseline data from adults enrolled in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort. SETTING: Adults in the SPIN Cohort in the present study were enrolled at 28 centres in Canada, the USA and the UK. PARTICIPANTS: The SAAS was administered to 926 adults with scleroderma. PRIMARY AND SECONDARY MEASURES: The SAAS, Brief Fear of Negative Evaluation II (BFNE II), Brief Satisfaction with Appearance Scale (Brief-SWAP), Patient Health Questionnaire-8 (PHQ8) and Social Interaction Anxiety Scale-6 (SIAS-6) were collected, as well as demographic characteristics. RESULTS: OTA methods identified a maximally informative shortened version for each possible form length between 1 and 15 items. The final shortened version was selected based on prespecified criteria for reliability, concurrent validity and statistically equivalent convergent validity with the BFNE II scale. A five-item short version was selected (SAAS-5). The SAAS-5 had a Cronbach's α of 0.95 and had high concurrent validity with the full-length form (r=0.97). The correlation of the SAAS-5 with the BFNE II was 0.66, which was statistically equivalent to that of the full-length form. Furthermore, the correlation of the SAAS-5 with the two subscales of the Brief-SWAP, and the SIAS-6, were statistically equivalent to that of the full-length form. CONCLUSIONS: OTA was an efficient method for shortening the full-length SAAS to create the SAAS-5