Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire

• Conditions: Primary Sjögren's Syndrome
• Interventions: Other: Survey study

• Registration Number: NCT04858464
• Lead Sponsor: Gazi University

Brief Summary

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire

Detailed Description

Primary Sjögren's Syndrome (PSS) is a chronic systemic disease characterized by lymphocytic infiltration of exocrine glands. Dryness, chronic pain, physical fatigue, glandular and extraglandular symptoms seen in PSS cause deterioration of the health-related quality of life.

The Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire has recently developed as a patient-reported condition-specific outcome measurement tool to assess the quality of life associated with PSS. The PSS-QoL questionnaire consists of 25 questions with a physical and psychosocial dimension.The physical dimension consists of a numeric rating scale (NRS, ranging from 0 to 10) for pain and physical symptoms. The question related to vaginal dryness is intended to be answered by women only. Each "yes" answer about physical symptoms-related questions adds 1 point to the score. The psychosocial dimension can be scored on a 5-point Likert scale and contains 14 question with the following possible answers: never (0), rarely (1), sometimes (2), often (3), and always (4). The PSS-QoL score ranges from 0-96 (for women) and 0-92 (excluding the question of vaginal dryness for men). After questioning the sociodemographic characteristics of the individuals, PSS-QoL, EuroQuol-5D, the EULAR Sjögren's Syndrome Disease Activity Index and EULAR Sjögren's Syndrome Patient Reported Index will be used. Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Study Start: 2021-05-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Diagnosed with primary Sjögren's syndrome

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Exclusion Criteria

• Having neurological and cognitive disorders,
• Having another rheumatological diseases

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients group	Survey study	Individuals with primary Sjögren's syndrome

Primary Outcome Measures

Name	Time	Method
Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire	10 minutes	Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire was designed to evaluate measurement of health related quality of life in patients with primary Sjögren's syndrome.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey