Validation of the 2011 and 2016 American college of rheumatology diagnostic criteria for fibromyalgia in a Chinese population.

PURPOSE: To provide a foundation for clinical diagnosis, epidemiological investigation and intervention trials, we examined the reliability and validity of the American College of Rheumatology (ACR) 2011 and 2016 survey diagnostic criteria among Chinese patients based on the fibromyalgia severity (FS) scale. METHODS: In this study, 200 fibromyalgia patients diagnosed according to the 1990 criteria (1990c) were matched with rheumatoid arthritis (RA) patients based on age and gender. The FS scale score and its subscales were examined to determine their correlations with the revised fibromyalgia impact questionnaire (FIQR). Receiver operator characteristic (ROC) analysis was performed, and test-retest reliability, internal consistency, and construct validity were examined. RESULTS: The area under the curve (AUC) for the ACR 2011c and 2016c was 0.870 and 0.845, respectively, and the sensitivity and specificity were 78.0% and 96.0% for the 2011c and 70.5% and 98.5% for the 2016c, respectively. The FS scale and its subscales were confirmed to exhibit good internal consistency, and they were significantly correlated with the FIQR, thereby indicating adequate construct validity. Using a lower cutoff value 11 points for the FS scale score based on the generalized pain requirement might be a more effective approach in the Chinese population; this approach yielded an AUC of 0.923 and a sensitivity of 87.0% and specificity of 97.5%. CONCLUSION: The 2011c and 2016c are reliable instruments for diagnosing fibromyalgia patients in China. The FS scale could be a valid tool to assist in fibromyalgia diagnosis, and a cutoff value 11 points is more suitable in Chinese patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03381131.

The Chinese version of the ACR 2011c and 2016c are valid tools for fibromyalgia diagnosis; and a cutoff value 11 points for FS might be more suitable to assist in fibromyalgia diagnosis in Chinese population. The Chinese 2011c and 2016c for fibromyalgia diagnosis can be found as an appendix to this article.

A Chinese version of the revised Fibromyalgia Impact Questionnaire: A validation study.

OBJECTIVE: The revised Fibromyalgia Impact Questionnaire (FIQR) was developed to measure the quality of life of patients with fibromyalgia in randomized controlled trials and routine care. The purpose of this study was to translate and adapt the FIQR from English to Chinese, and to examine the validity and reliability of the Chinese version of the FIQR (CFIQR). METHODS: Following the translation of the FIQR, fibromyalgia patients from 6 centers were recruited and completed the CFIQR, the validated Chinese version of the Medical Outcome Study Short Form 36 Health Survey (SF-36) and the Beck Depression Inventory (BDI). In this study, Cronbach's alpha coefficient, test-retest reliability and item total correlation were used for evaluating external and internal reliability; and criterion and structural validity were evaluated. RESULTS: A total of 200 fibromyalgia patients completed the study. The internal consistency was excellent (Cronbach's alpha .90, .88, .88 and .93 for function, overall impact, symptoms scales and total score, respectively; item-total correlations from .25 to .83.) Test-retest reliability levels of the CFIQR total and subscale scores were strong correlation (intraclass correlation coefficient >0.75). Furthermore, there were significant correlations between the 3 subscale and the total score of the CFIQR and the SF-36, as well as the CFIQR and the BDI, by criterion validity (P < .01). Confirmatory factor analysis gave an acceptable value for structural validity according to the 3-factor structures of function, overall impact and symptoms. CONCLUSIONS: The CFIQR is a valid and reliable instrument for both clinical practice and research purposes with Chinese speakers globally. [ClinicalTrials.gov: NCT03381131].