Modifications of the American College of Rheumatology 2010 Preliminary Diagnostic Criteria for Fibromyalgia Syndrome and Measurement of Symptom Severity as a Screening Tool for its Diagnosis [ACR 2010 FMS-STD]: Lessons Learned from the Process of Translation and Validation into a Thai Version

Abstract

Objectives: The aim of this study is to develop a screening tool for the diagnosis of fibromyalgia syndrome [FMS, ACR 2010 FM-STD] based on the American College of Rheumatology preliminary diagnostic criteria for FMS and measurement of symptom severity [ACR 2010 FMS-STD criteria] into Thai.

Methods: Translation and validation processes were done following the key steps in the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes. This was followed by testing the specificity and sensitivity of the tool.

Results: Two modified items were suggested in the cognitive debriefing process: (1) the inclusion of an anatomical figure for widespread pain assessment and (2) the terms and definitions of cognitive and somatic symptoms. Forward reconciliation, backward translation and cognitive debriefing were repeated for the modified version. Two tables of contents, widespread pain index with illustration, and symptom severity scale, together with a block of three conditions criteria met were designed and presented as a screening tool for the diagnosis of FMS [ACR 2010 FMS-STD]. Applying this screening tool in 41 non-FMS patients and 40 FMS patients [confirmed by the ACR 1990 criteria for the classification of FMS] showed that this diagnostic tool has high sensitivity [85.37%] and specificity [87.50%] for the assessment of FMS.

Conclusions: The modified items had no impact on changing the clinical meaning. Our findings showed that this tool is a practical instrument for use in clinical settings for the preliminary diagnosis of FMS.

• ACR 2010 criteria
• diagnosis
• fibromyalgia
• patient-reported outcome
• screening tool

Acknowledgements

Dr. Prateepavanich, Dr. Aromdee, Dr. Chaudhaksetrin, Dr. Laurujisawat and Dr. Poungvarin are employees of Government University Hospitals. Dr. Leartakulpanitch and Ms. Petcharapiruch are former employee and employee of Pfizer (Thailand) LTD, respectively. Besides, the authors would like to thank Dr. Nattha Saisaveoy, a psychiatrist from the Department of Psychiatry, Faculty of Medicine Siriraj Hospital for her contribution in this study.