Further Refinement is Required for Patient-Reported Outcome Scales for Respiratory Diseases Based on Traditional Chinese Medicine Theory for Applicability.

OBJECTIVE

To summarize the contents and assess the methodological quality and measurement properties of the patient-reported outcome (PRO) scales featured with Traditional Chinese Medicine (TCM) for respiratory diseases based on the guideline of COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN).

METHODS

PubMed, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, and China Biology Medicine (CBM) were searched for studies on PRO scales featured with TCM for respiratory diseases from their inception until December 2022. The characteristics of the PRO scales were qualitatively summarized. Following the COSMIN guideline, the risk of bias was assessed according to the checklist, and different measurement properties (content validity, structural validity, internal consistency, reliability, criterion validity, and responsiveness) were evaluated. Finally, the evidence's overall quality was assessed, and the recommendation was formulated using the modified GRADE approach.

RESULTS

A total of 13 scales were included, with 6 for chronic obstructive pulmonary disease (COPD), 3 for lung cancer, 2 for idiopathic pulmonary fibrosis (IPF), 1 for community-acquired pneumonia (CAP), and 1 for bronchiectasis. All 13 scales are disease-specific scales and were developed based on Chinese cultural background to measure the efficacy of TCM. The study did not provide information on measurement error, cross-cultural validity, and hypothesis testing for the construct validity of these measures. No scale was rated as sufficient in content validity and responsiveness. Two scales showed sufficient structural validity, while 11 scales exhibited sufficient internal consistency. Three scales demonstrated sufficient reliability, and 7 scales showed sufficient criterion validity. All 13 scales have a recommendation level of B.

CONCLUSION

The 13 scales could reflect the clinical efficacy of TCM and are suitable for the Chinese population. Nevertheless, the validation of these scales was not comprehensive enough, and the methodological quality of their studies needs to be further strengthened.