Maras Gokhan, Olmez Sevim Beyza, Degerli Maras Belma, Citaker Seyit
Faculty of Health Science, Department of Physical Therapy and Rehabilitation, Amasya University, Amasya, Turkey.
Faculty of Health Science, Department of Physical Therapy and Rehabilitation, Karamanoğlu Mehmetbey University, Karaman, Turkey.
Physiother Theory Pract. 2025 Feb;41(2):309-316. doi: 10.1080/09593985.2024.2337789. Epub 2024 Apr 3.
The US National Institutes of Health (NIH) has produced a minimal data set to promote more accurate and consistent reporting of clinical trials, facilitating easier comparison of research on low back pain patients worldwide. The NIH-minimal dataset has not been previously translated into Turkish, and its features are currently unknown. This study aimed to adapt the NIH-Minimal Data Set into Turkish and investigate its validity and reliability in Turkish-speaking patients with chronic low back pain (CLBP).
In the study, 245 patients with CLBP were included. Test-retest and internal consistency analyzes were performed to evaluate the reliability of the NIH-minimal dataset. The intraclass correlation coefficient (ICC) value was used to assess test-retest analysis. Cronbach's alpha value was calculated for internal consistency. Total impact scores of the NIH-minimal dataset were compared with total scores of the Roland Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI) to assess construct validity. The minimal detectable change (MDC) was calculated based on the standard error of measurement (SEM).
The NIH-Minimal Data Set was found to have high test-retest reliability (ICC2,1 = 0.928) and high internal consistency (Cronbach α = 0.905). The NIH-minimal dataset correlated well with RMDQ and ODI ( = 0.750 and 0.810, respectively). There were no floor or ceiling effects. Also, SEM95 and MDC95 for the total score were 4.57 and 12.55, respectively.
Considering all these data, it was concluded that the Turkish version of the NIH-minimal dataset is a valid and reliable outcome measure for evaluating patients with CLBP.
美国国立卫生研究院(NIH)制定了一个最小数据集,以促进临床试验报告更加准确和一致,便于全球范围内对腰痛患者的研究进行更轻松的比较。NIH最小数据集此前未被翻译成土耳其语,其特点目前尚不清楚。本研究旨在将NIH最小数据集改编为土耳其语,并调查其在讲土耳其语的慢性腰痛(CLBP)患者中的有效性和可靠性。
本研究纳入了245例CLBP患者。进行重测和内部一致性分析以评估NIH最小数据集的可靠性。组内相关系数(ICC)值用于评估重测分析。计算Cronbach's alpha值以评估内部一致性。将NIH最小数据集的总影响得分与罗兰·莫里斯残疾问卷(RMDQ)和奥斯维斯特里残疾指数(ODI)的总得分进行比较,以评估结构效度。基于测量标准误差(SEM)计算最小可检测变化(MDC)。
发现NIH最小数据集具有较高的重测可靠性(ICC2,1 = 0.928)和较高的内部一致性(Cronbach α = 0.905)。NIH最小数据集与RMDQ和ODI相关性良好(分别为 = 0.750和0.810)。没有地板效应或天花板效应。此外,总分的SEM95和MDC95分别为4.57和12.55。
综合所有这些数据,得出结论,NIH最小数据集的土耳其语版本是评估CLBP患者有效且可靠的结局指标。