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Validity of Turkish Version of PROMIS-29 Measure

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ClinicalTrials.gov Identifier: NCT04782219
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Burcu Özdemir Kocabey, Bahçeşehir University

Study Description
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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.


Condition or disease
Musculoskeletal Diseases

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability and Validity of the Turkish Version of Patient-Reported Outcomes Measurement Information System-29 in Individuals With Musculoskeletal Diseases
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Patient Reported Outcome Measures Information System-29 (PROMIS-29) [ Time Frame: It will be filled for the second time between 7-14 days. ]
    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.

  2. Short Form-36 (SF-36) [ Time Frame: It will be filled for the second time between 7-14 days. ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons who applied to the Acibadem Maslak Hospital Orthopedics and Traumatology department and were diagnosed with a chronic musculoskeletal disease by orthopedists will be included in the study.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782219


Contacts
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Contact: Burcu Kocabey, PhD(c) 00905334102409 fztburcuozdemir@yahoo.com
Contact: Göksel Dikmen, Assoc. Prof. 00905052021748 drgokseldikmen@gmail.com

Sponsors and Collaborators
Bahçeşehir University
Investigators
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Principal Investigator: Göksel Dikmen, Assoc. Prof. Acibadem University
More Information
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Responsible Party: Burcu Özdemir Kocabey, MSc, PhD(c), Bahçeşehir University
ClinicalTrials.gov Identifier: NCT04782219    
Other Study ID Numbers: AcibademH
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases