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ABSTRACT
Background
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).
Methods
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 (ICC2,1) 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 (MDC95) was calculated based on the standard error of measurement (SEM95).
Results
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 (r = 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.
Conclusion
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.
Disclosure statement
No potential conflict of interest was reported by the author(s).