Study design: The Roland-Morris Disability Questionnaire (RMDQ) was translated and then adapted and validated.
Objective: Translation of the RMDQ into simplified Chinese characters (SCRMDQ), and its cross-cultural adaptation and validation in patients with low back pain with or without radicular leg pain.
Summary of background data: The RMDQ is used worldwide and versions in traditional Chinese characters are available in Hong Kong and Taiwan. But there is no version in simplified Chinese characters for use in Mainland China.
Methods: The original version of the RMDQ was translated and back-translated, and then cross-cultural adaptation of the simplified Chinese version was performed following published guidelines. The SCRMDQ was validated in 150 patients, 30 of whom finished the prefinal SCRMDQ and helped determine the final version. The remaining 120 patients were asked to complete the final SCRMDQ, simplified Chinese Oswestry Disability Index (SCODI), and visual analogue scale. Reliability was assessed with the final version using internal consistency by the Cronbach α coefficient and intraclass correlation coefficient; structural validity was evaluated by correspondence analysis. Then comparison of SCRMDQ and SCODI was performed.
Results: A total of 116 patients in the final validation study finished the questionnaires completely. Their mean age was 52.17 ± 11.95 years (range, 22-78 yr) and the mean low back pain duration was 42.04 ± 60.94 months (range, 2-480 mo). The average time taken was 4.11 ± 1.48 minutes (range, 2-9 min) on SCRMDQ and 7.37 ± 3.98 minutes (range, 3-30 min) on SCODI. The mean SCRMDQ, SCODI, and visual analogue scale scores were 14.07 ± 4.79 (range, 2-24), 23.98 ± 10.38 (range, 2-47), and 57.17 ± 20.72 (range, 0-95), respectively. In the final test, the Cronbach α for internal consistency was 0.826 and intraclass correlation coefficient was 0.947; both showed adequate acceptance. Positive and statistically significant correlations were found between SCRMDQ and SCODI (r = 0.791, P < 0.01) and visual analogue scale (r = 0.493, P < 0.01), indicating sufficient structural validation. Most patients preferred SCRMDQ to SCODI, because it was simpler to understand and easier to finish.
Conclusion: The SCRMDQ was reliable and valid as a low back pain measurement tool in patients with or without radicular leg pain in Mainland China. The further use and research with the questionnaire were recommended.