Validity of Turkish Version of PROMIS-29 Measure

NCT ID: NCT04782219

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-20
• Study Completion Date: 2021-05-30

Brief Summary

This study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to Acıbadem Maslak Hospital Orthopedics and Traumatology Department. Demographic information (age, education level, occupation, marital status) will be obtained from the patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor, and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires.

The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. Each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20. SF-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health). The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2.

The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method. Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research.

Participants will first be asked to sign the informed consent form electronically. PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform.

The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2, a similar general health profile questionnaire.

To evaluate inter-rater test-retest reliability, both scales will be filled in by patients a second time between 7-14 days.

Conditions

Musculoskeletal Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Being over the age of 18,
• To be able to read and speak Turkish,
• To have a chronic musculoskeletal disease
• volunteering to participate in the study

Exclusion Criteria

• To have serious medical conditions or complications (such as vision or hearing impairments) that may affect the participant's ability to respond to study questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Burcu Özdemir Kocabey

MSc, PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Göksel Dikmen, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

Maslak Acıbadem Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AcibademH

Identifier Type: -

Identifier Source: org_study_id