Content Validity of Sjögren’s Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjögren’s

Griffiths, Natasha; Wratten, Samantha; Flynn, Jessica; Bookman, Arthur; Ndife, Briana; Hueber, Wolfgang; Goswami, Pushpendra

doi:10.1007/s40744-022-00489-y

Cited by 7 publications

(2 citation statements)

References 31 publications

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“…Final scores are the sum of the responses, ranging 0–52. Higher scores indicate better quality of life 38 . OSDI is a 12-item questionnaire that assesses dry eye symptoms and their impact on daily activities 39 .…”

Section: Methodsmentioning

confidence: 99%

CD40 ligand antagonist dazodalibep in Sjögren’s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial

St. Clair,

Baer,

et al. 2024

Nat Med

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Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease with no approved disease-modifying therapies. Dazodalibep (DAZ), a novel nonantibody fusion protein, is a CD40 ligand antagonist that blocks costimulatory signals between T and B cells and antigen-presenting cells, and therefore may suppress the wide spectrum of cellular and humoral responses that drive autoimmunity in SjD. This study was a phase 2, randomized, double-blinded, placebo (PBO)-controlled trial of DAZ with a crossover stage in two distinct populations of participants with SjD. Population 1 had moderate-to-severe systemic disease activity and population 2 had an unacceptable symptom burden and limited systemic organ involvement. All participants had a diagnosis of SjD, with 21.6% and 10.1% having an associated connective tissue disease (rheumatoid arthritis or systemic lupus erythematosus) in populations 1 and 2, respectively. The remaining participants would be considered as having primary Sjögren’s syndrome. The primary endpoint for population 1 (n = 74) was the change from baseline in the European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index at day 169. The primary endpoint for population 2 (n = 109) was the change from baseline in the European League Against Rheumatism Sjögren’s Syndrome Patient Reported Index at day 169. The primary endpoints (least squares mean ± standard error) were achieved with statistical significance for both population 1 (DAZ, −6.3 ± 0.6; PBO, −4.1 ± 0.6; P = 0.0167) and population 2 (DAZ, −1.8 ± 0.2; PBO, −0.5 ± 0.2; P = 0.0002). DAZ was generally safe and well tolerated. Among the most frequently reported adverse events were COVID-19, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, arthralgia, constipation and urinary tract infection. In summary, DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40/CD40 ligand pathway in its pathogenesis. ClinicalTrials.gov identifier: NCT04129164.

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Section: Methodsmentioning

confidence: 99%

CD40 ligand antagonist dazodalibep in Sjögren’s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial

St. Clair,

Baer,

et al. 2024

Nat Med

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“…Functional Assessment of Chronic Illness Therapy (Fatigue) (FACIT-F): This was developed in 1997 to measure fatigue in oncology. However, it has subsequently been used to assess chronic illness, and more recently, Natasha Griffiths et al have demonstrated the content validity of this questionnaire in pSS [9].…”

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confidence: 99%

The Translation, Validation and Cultural Adaptation of Questionnaires Assessing the Quality of Life and Fatigue among Patients with Sjogren’s Syndrome for the Romanian Context

Mardale,

Opriș-Belinski,

Bojincă

et al. 2023

Clinics and Practice

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About 70% of patients with Sjogren’s syndrome suffer from fatigue, and for a large proportion of patients, it is one of the most noticeable manifestations leading to disability. To date, no study has been conducted in Romania to determine the quality of life of patients and the impact of fatigue in patients with Sjogren’s syndrome. The present work proposes the translation, cultural adaptation, and validation of two questionnaires for the Romanian context, namely the ‘Profile of Fatigue and Discomfort–Sicca Symptoms Inventory’ (PROFAD-SSI-SF) and ‘Primary Sjogren’s Syndrome—Quality of Life’ (PSS-QoL), whose purpose is to assess quality of life and fatigue in patients with Sjogren’s syndrome. These two questionnaires were administered to 52 patients with Sjogren’s syndrome diagnosed according to the 2016 ACR-EULAR criteria. Subsequently, the conceptual, semantic, and operational analyses of the data were performed with the aim of cultural adaptation. The data obtained were statistically analyzed using indices of measurement accuracy such as internal consistency. Based on statistical analyses, this pilot study shows that the Romanian versions of the PROFAD-SSI and PSS-QoL questionnaires are as reliable as their English counterparts.

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Development and validation of a nomogram for predicting fatigue in patients with primary Sjögren’s syndrome

Zhao,

Dong,

et al. 2023

Clin Rheumatol

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Content Validity of Sjögren’s Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjögren’s

Cited by 7 publications

References 31 publications

CD40 ligand antagonist dazodalibep in Sjögren’s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial

CD40 ligand antagonist dazodalibep in Sjögren’s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial

The Translation, Validation and Cultural Adaptation of Questionnaires Assessing the Quality of Life and Fatigue among Patients with Sjogren’s Syndrome for the Romanian Context

Development and validation of a nomogram for predicting fatigue in patients with primary Sjögren’s syndrome

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