The FSS-Swe supports construct validity, is feasible, has no important ceiling or floor effects, has satisfactory internal consistency, substantial test-retest reliability, and satisfactory content validity in the SLE patients studied. However, its sensitivity to change needs to be tested.

ObjectiveTo describe the experiences of people with systemic sclerosis (SSc) in different European countries of functioning and health and to link these experiences to the WHO International Classification of Functioning, Disability and Health (ICF) to develop a common understanding from a bio-psycho-social perspective.MethodA qualitative multicentre study with focus-group interviews was performed in four European countries: Austria, Romania, Sweden and Switzerland. The qualitative data analysis followed a modified form of ‘meaning condensation’ and the concepts that emerged in the analysis were linked to the ICF.Results63 people with SSc participated in 13 focus groups. In total, 86 concepts were identified. 32 (37%) of these were linked to the ICF component body functions and structures, 21 (24%) to activities and participation, 26 (30%) to environmental factors, 6 (7%) to personal factors and 1 (1%) to the health condition itself. 19 concepts (22%) were identified in all four countries and included impaired hand function, household activities, paid work, drugs, climate and coldness, support from others and experiences with healthcare institutions, non-pharmacological treatment, social security and benefits.ConclusionConcepts identified in all four countries could be used for guiding clinical assessment, as well as interdisciplinary team care and rheumatological rehabilitation for patients with SSc. For a full understanding of the aspects of the disease that were most relevant to people with SSc, people with SSc from multiple countries needed to be involved.

While we expected to find a mainly negative impact, positive aspects were also described. Our findings were complex and showed that patients with established SLE can experience both uncertainty and opportunities. This highlights the importance for healthcare professionals of gaining a better understanding of patients' uncertainty, to enable them to support patients, allowing them to focus on health and opportunities. Measurement instruments that capture different aspects of uncertainty and opportunities needs to be developed.

BackgroundPersonal factors (PFs) are internal factors that determine functioning and the individuals’ experience of disability. Their coverage by patient-reported outcome measures (PROMs) has not been examined in rheumatoid arthritis (RA) so far. The aims of this study were to identify PFs important in the life stories of people with RA and to determine their coverage by PROMs used in RA.MethodsThe qualitative data of people with RA was explored to identify PFs. Additionally a systematic literature search was conducted to find PROMs used in RA. PROMs items were linked to the components, domains and categories of the International Classification of Functioning, Disability and Health (ICF) to determine the coverage of important PFs by PROMs.ResultsTwelve PFs were found to be important in the life stories of people with RA. The PFs coping and reflecting about one’s life in an optimistic way were covered most frequently, each by 14 of the 42 explored PROMs, while job satisfaction was not covered at all. The London Coping with Rheumatoid Arthritis Questionnaire, General Self-Efficacy Scale, Arthritis Self-Efficacy Scale, Rheumatoid Arthritis Self-Efficacy Questionnaire and Revised Ways of Coping Inventory covered most PFs. Nineteen PROMs did not cover any of the PFs.ConclusionSeveral PFs were identified as important in the life stories of people with RA, but only 55% of the PROMS covered some of these PFs. When evaluating PFs important to people with RA, health professionals should be alert on which PROMs can be used to assess which PFs.

Background Depressive symptoms are common in rheumatic diseases and influence patients’ quality of life. The Patient Health Questionnaire-9 (PHQ-9), which assesses symptoms of depression, is valid in English in patients with systemic sclerosis (SSc). However, the measurement properties of the PHQ-8 (short version of the PHQ-9) have not been evaluated in Swedish patients with SSc. Objective To investigate different aspects of validity and reliability of the PHQ-8 in Swedish (PHQ-8 Swe) for individuals with SSc. Methods A total of 101 patients with SSc participated. Content validity was evaluated via interviews of 11 patients and 10 health professionals. Construct validity, internal consistency test–retest reliability, and floor/ceiling effects were evaluated in 90 patients. Results Content validity was satisfactory, but some linguistic adjustments were made. Confirmatory factor analysis supported a better fit for a two-factor structure. Moderate-to-strong correlations were found between the PHQ-8 Swe and scleroderma HAQ including VAS ( r s = 0.4–0.7); Multidimensional Assessment of Fatigue ( r s = 0.7); RAND-36 subscales ( r s = − 0.5 to − 0.8); and lung disease severity (Medsger scores) ( r s = 0.4). There were weak correlations ( r s = <0.4) between the PHQ-8 Swe and modified Rodnan skin score; and vascular, heart, and kidney disease severity. Cronbach’s alpha was 0.85, corrected item-to-total correlations were >0.40, and the ICC for the total score was 0.83. No floor/ceiling effects were found. Conclusion The PHQ-8 Swe has satisfactory content validity and sufficient reliability in patients with in majority limited SSc. It is more strongly associated with self-reported disability, pain, disease interferences with daily activities, fatigue, and quality of life than with disease severity, except for a moderate association with lung severity.

ObjectiveTo 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). Method: 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. Results: 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. Conclusion: 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. Systemic sclerosis (SSc) is a rare autoimmune inflammatory disease characterized by vasculopathy and fibrosis in skin and internal organs. The disease is commonly divided into two subtypes with regard to the extent of skin involvement: limited cutaneous (lcSSc) or diffuse cutaneous systemic sclerosis (dcSSc) (1). The clinical course can vary from limited skin thickening to severe organ damage and high mortality (2). Common disease manifestations are Raynaud's phenomenon, digital ulcers (1), joint involvement, and reduced hand function (3). Pain, fatigue (4), gastro-oesophageal reflux, exertional breathlessness (1), and proximal muscle weakness (5) are also common. Depressive symptoms, emotional distress, and concerns about appearance due to skin changes have also been described (4, 6). Thus, people with SSc may face a diversity of disease manifestations, with limitations in their daily lives (7, 8) and reduced health-related quality of life (HRQoL) (9).Self-efficacy, which is the belief in one's capabilities to produce given achievements (10), is an essential factor for self-management of chronic diseases, behaviours, and behavioural changes (11). Among people with SSc, a relatively

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.

Objective: To identify a spectrum of perspectives on functioning and health of patients with primary Sjögren's syndrome (pSS) from the five European countries in order to reveal commonalities and insights in their experiences.Methods: A multicenter focus group study on the patients with pSS about their perspectives of functioning and health was performed. Focus groups were chaired by trained moderators based on an interview guide, audiotaped, and transcribed. After conducting a meaning condensation analysis of each focus group, we subsequently combined the extracted concepts from each country and mapped them to the International Classification of Functioning, Disability and Health (ICF).Results: Fifty-one patients with pSS participated in 12 focus groups. We identified a total of 82 concepts meaningful to people with pSS. Of these, 55 (67%) were mentioned by the patients with pSS in at least four of five countries and 36 (44%) emerged in all the five countries. Most concepts were assigned to the ICF components activities and participation (n = 25, 30%), followed by 22 concepts (27%) that were considered to be not definable or not covered by the ICF; 15 concepts (18%) linked to body structures and functions. Participants reported several limitations in the daily life due to a mismatch between the capabilities of the person, the demands of the environment and the requirements of the activities.Conclusion: Concepts that emerged in all the five non-English speaking countries may be used to guide the development and adaption of the patient-reported outcome measures and to enhance the provision of treatment options based on the aspects meaningful to patients with pSS in clinical routine.