To investigate aspects of validity and reliability of the Swedish version of the Self-Efficacy for Managing Chronic Disease (SEMCD-Swe) scale in systemic sclerosis (SSc).
A forward-backward ...translation procedure was used. Content validity was assessed through interviews with 11 people with SSc and 10 healthcare professionals. Construct validity, internal consistency, test-retest reliability, and floor and ceiling effects were evaluated in 104 SSc patients.
The content validity of the SEMCD-Swe was interpreted as satisfactory, but some adjustments were made to increase the understanding. Confirmatory factor analysis supported a single-factor structure. Moderate to strong correlations between the SEMCD-Swe and Scleroderma Health Assessment Questionnaire; Multidimensional Assessment of Fatigue; Patient Health Questionnaire-8 (r
s
= −0.4 to −0.7), and RAND-36 subscales (r
s
= 0.5 to 0.7) were found. Weak correlations were found between SEMCD-Swe and modified Rodnan skin score; and disease severity of peripheral vascular and lung (r
s
= −0.1 to −0.2) and kidney (r
s
= 0.1) systems (Medsger severity scale). Cronbach's alpha was sufficient (0.85) and corrected item-to-total correlations were good (≥ 0.50). The intraclass correlation coefficient for the total score was sufficient (0.82). No floor or ceiling effects were found.
Support for construct validity was indicated, as the SEMCD-Swe in SSc show a single-factor structure and is more strongly associated with pain, fatigue, depressive symptoms, interferences with daily activities, disability, and quality of life than with disease severity. Our results also indicate support for content validity and reliability. However, the responsiveness of the SEMCD-Swe needs to be tested.
Summary
Background
Patient‐reported outcome measures (PROMs) aimed at assessing people with systemic sclerosis (SSc) have rarely involved the target population in the item‐ and domain‐generation ...stage of the instrument construction.
Objectives
To develop a new PROM assessing activities and participation in people with SSc.
Methods
A provisional International Classification of Functioning, Disability and Health (ICF)‐based 65‐item questionnaire previously developed from interviews of people with SSc was sent by email to all patients followed in the internal medicine department of Cochin hospital (n = 184) and enrolled in the Scleroderma Patient‐centered Intervention Network Cohort. Items were reduced according to their metric properties. Dimensional structure of the questionnaire was assessed by principal component analysis, convergent and divergent validities by Spearman's rank correlation coefficient, internal consistency by Cronbach's α, and reliability by a test–retest method using the intraclass correlation coefficient (ICC) and Bland–Altman analysis.
Results
Overall, 113 of 184 patients (61·4%) completed the provisional questionnaire. The item‐reduction process resulted in a 17‐item questionnaire, the Cochin 17‐item Scleroderma Functional scale (CSF‐17). Principal component analysis extracted two dimensions: 10 items related to mobility (CSF‐17 section A) and seven items related to general tasks (CSF‐17 section B). We observed convergent validity of the CSF‐17 total score with global activity limitation, pain, depression and aesthetic burden, and divergent validity with anxiety. Cronbach's α was 0·94 for section A and 0·95 for section B. ICC (n = 25 patients) was 0·92 for the CSF‐17 total score. Bland–Altman analysis did not reveal a systematic trend for the test–retest.
Conclusions
The CSF‐17 is a new PROM assessing activities and participation specifically in people with SSc. Its content and construct validities are very high.
What is already known about this topic?
In the earliest stages of construction patient‐reported outcomes (PROMs) for people with systemic sclerosis (SSc) rarely involve the target population.
Instruments able to capture the specific needs of people with SSc in terms of activities and participation are lacking.
What does this study add?
The Cochin 17‐item Scleroderma Functional Scale (CSF‐17) is a new PROM assessing global activities and participation specifically in people with SSc.
Patients’ perspectives were prioritized at all stages of construction.
What are the clinical implications of this work?
The CSF‐17 could be used in clinical practice and research to assess the efficacy of complex multidisciplinary interventions targeting activity limitations and participation restriction in people with SSc.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
Linked Comment: Clark and Denton. Br J Dermatol 2020; 183:610.
•There are psychometrically sound measures to assess evaluative body image.•Suitability of these body image measures vary across populations.•Some measurement properties of body image measures are ...insufficiently studied.•More evaluations are needed across populations, focusing on cross-cultural validity.•More evaluations of body image measures in clinical settings are needed.
This systematic review synthesizes and critically appraises measurement properties of influential body image measures. Eight measures that met the definition of an assessment of body image (i.e., an individual’s cognitive or affective evaluation of their body or appearance with a positive or negative valence), and scored high on systematic expert priority ranking, were included. These measures were: the Body Appreciation Scale (original BAS and BAS-2), the Body Esteem Scale for Adolescents and Adults, the Body Shape Questionnaire, the Centre for Appearance Research Valence Scale, the Drive for Muscularity Scale, two subscales of the Eating Disorders Examination Questionnaire, one subscale of the Eating Disorder Inventory 3, and two subscales of the Multidimensional Body Relations Questionnaire. Articles assessing these scales’ psychometric properties (N = 136) were evaluated for their methodological quality using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist, and a best evidence synthesis was performed. The results supported the majority of measures in terms of reliability and validity; however, suitability varied across populations, and some measurement properties were insufficiently evaluated. The measures are discussed in detail, including recommendations for their future use in research and clinical practice.
People with systemic sclerosis (SSc) are vulnerable in COVID-19 and face challenges related to shifting COVID-19 risk and protective restrictions. We evaluated mental health symptom trajectories in ...people with SSc through March 2022.
The longitudinal Scleroderma Patient-centred Intervention Network (SPIN) COVID-19 cohort was launched in April 2020 and included participants from the ongoing SPIN Cohort and external enrolees. Analyses included estimated means with 95% CIs for anxiety and depression symptoms pre-COVID-19 for ongoing SPIN Cohort participants and anxiety, depression, loneliness, and fear of COVID-19 for all participants across 28 COVID-19 assessments up to March 2022. We conducted sensitivity analyse including estimating trajectories using only responses from participants who completed >90% of items for ≥21 of 28 possible assessments ("completers") and stratified analyses for all outcomes by sex, age, country, and SSc subtype.
Anxiety symptoms increased in early 2020 but returned to pre-COVID-19 levels by mid-2020 and remained stable through March 2022. Depression symptoms did not initially change but were slightly lower by mid-2020 compared to pre-COVID-19 and were stable through March 2022. COVID-19 fear started high and decreased. Loneliness did not change across the pandemic. Results were similar for completers and for all subgroups.
People with SSc continue to face COVID-19 challenges related to ongoing risk, the opening of societies, and removal of protective restrictions. People with SSc, in aggregate, appear to be weathering the pandemic well, but health care providers should be mindful that some individuals may benefit from mental health support.
Objective
To systematically and comprehensively document the effectiveness of nonpharmacologic interventions on physical functioning and psychological well‐being in patients with systemic sclerosis ...(SSc).
Methods
Multiple electronic databases were searched for studies on the effectiveness of nonpharmacologic interventions in SSc. Randomized clinical trials (RCTs), controlled clinical trials (CCTs), and observational designs (ODs) with ≥10 participants were included. Two reviewers independently assessed methodologic quality using the Downs and Black checklist.
Results
Twenty‐three studies (9 RCTs, 4 CCTs, and 10 ODs) were included. Studies assessing comparable interventions were grouped, resulting in data for 16 different interventions. The total number of patients included per study ranged from 10 to 53. Seventeen different outcome domains were assessed, with hand function, limitations in activities, and quality of life being assessed most frequently. Three studies, all RCTs, were rated as high quality. These RCTs reported that 1) a multifaceted oral health intervention improves mouth hygiene, and additional orofacial exercises did not improve mouth opening, 2) a multidisciplinary team‐care program improves limitations in activities, mouth opening, and hand grip strength, and 3) manual lymph drainage improves hand function, limitations in activities, and quality of life.
Conclusion
The body of knowledge regarding nonpharmacologic care in SSc is very limited due to the wide variety in studied interventions and outcomes in the relatively uncommon but highly disabling disease. To structure and focus future research, an international consensus should be established to prioritize primary targets for nonpharmacologic treatment and the content of interventions and to agree on a core set of outcome measures.
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.
Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research ...designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients.
Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future.
Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing.
Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting.
Functional disability and fatigue are important consequences of systemic sclerosis (SSc), but little is known about their course over time. The aim of this study was to identify and characterise ...homogeneous subgroups with distinct 3-year trajectories of disability and fatigue, separately.
A 3-year cohort study including 215 patients with SSc was conducted. Functional disability was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). Fatigue was assessed using the SF-36 Vitality subscale. Longitudinal trajectories were identified using latent class growth analyses (LCGA). Baseline patient characteristics were compared across classes using multivariable logistic regression.
Two disability classes were identified: a 'low' group (n=133) with low baseline HAQ-DI scores (intercept=0.48) and slight, statistically non-significant deterioration over time (slope=0.01), and a 'high' group (n=82) with high baseline HAQ-DI scores (intercept=1.63) and also slight, statistically non-significant deterioration over time (slope=0.01). Patients in the high disability group were more likely to be female, have higher fatigue, more helplessness, and less emotion-focused coping. Two fatigue classes were identified: an 'average' group (n=99) with average baseline Vitality scores (intercept=53.9) and slight, statistically non-significant deterioration over time (slope=-0.23), and a 'high' fatigue group (n=116) with low baseline Vitality scores (intercept=39.8) and also slight, but non-significant deterioration over time (slope=-0.15). Patients in the high fatigue group were more likely to be female, report more impact of lung involvement, and less acceptance.
Functional disability and fatigue trajectories in SSc were relatively stable over a 3-year period, and differences in baseline scores, but not slopes, defined classes.
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