Validity of Turkish Version of PROMIS-29 Measure

Musculoskeletal Diseases Clinical Trial

Official title:

Reliability and Validity of the Turkish Version of Patient-Reported Outcomes Measurement Information System-29 in Individuals With Musculoskeletal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782219
• Other study ID #: AcibademH
• Status: Completed
• Start date: March 20, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2023
• Source: Bahçesehir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Locations

Country	Name	City	State
Turkey	Maslak Acibadem Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcome Measures Information System-29 (PROMIS-29)	The PROMIS 29 questionnaire contains 4 questions from each of seven PROMIS contents (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.	It will be filled for the second time between 7-14 days.
Primary	Short Form-36 (SF-36)	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)	It will be filled for the second time between 7-14 days.