Reliability and Validity of the Turkish Version of Patient-Reported Outcomes Measurement Information System-29 in Individuals With Musculoskeletal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Short Form-36 (SF-36)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Short Form-36 (SF-36)
时间窗: 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)
Patient Reported Outcome Measures Information System-29 (PROMIS-29)
时间窗: 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.
次要结局
未报告次要终点
研究者
Burcu Özdemir Kocabey
MSc, PhD(c)
Bahçeşehir University