RESUMEN
Objective: To validate a patient-reported outcome (PRO) measure for patients with tension-type headache (TTH). Methods: Literature analysis, interview, and group discussion were performed to develop an initial TTH-PRO. Thereafter, the initial scale was pre-evaluation in a small range of patients with TTH, and the expert panel made necessary adjustments based on the content feedback. The clinical test was carried out by using the adjusted initial scale. Based on the test results, the items were screened by the method of classical test theory to form the final scale, and the performance evaluation indicators such as validity, reliability, and responsiveness of the final scale were tested. Results: The final formed TTH-PRO scale contained three domains, six dimensions, and 30 items. The split-half reliability, Cronbach's α coefficients, and construct validity of the scale were acceptable, as was feasibility. The responsiveness in the physiological domain was fair, but the overall responsiveness still needed further clinical validation. Conclusions:The TTH-PRO scale has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing evaluation indicators of TTH, emphasizing the patient's experience. Further studies are needed to optimize its items and to verify its clinical applicability for population in more regions and countries.
RESUMEN
OBJECTIVES: Because current evidence regarding the effectiveness of acupuncture for a tension-type headache (TTH) is controversial, we evaluated the reliability of the methodological quality and outcome measures of systematic reviews/meta-analyses (SRs/MAs) on acupuncture for TTH. METHODS: We conducted a comprehensive literature search for SRs/MAs in major databases from the database's inception to September 2019. The Methodological Quality of Systematic Reviews 2 (AMSTAR-2) and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) assessments were used to assess the methodological quality of the included reviews and the quality of evidence, respectively. RESULTS: Eight reviews were included in the analysis. The AMSTAR-2 assessment results showed that the methodological quality of all included reviews was critically low. Thirty-six outcome measures were included in these reviews. The GRADE results showed that 25 (25/36, 69.4%) outcomes provided low- or very low-quality evidence, four (4/36, 11.1%) provided moderate-quality evidence, and seven (7/36, 19.4%) provided high-quality evidence. Descriptive analysis results showed that acupuncture treatment for TTH reduced headache frequency and severity. CONCLUSIONS: Acupuncture appears to be an effective treatment modality for TTH, but the credibility of the results is limited owing to the generally low methodological quality and evidence quality in the included SRs/MAs.