Treatment of Chronic Pulmonary Heart Disease with Traditional Chinese Medicine: A Protocol for the Development of a Core Outcome Set (COS-TCM-CPHD).

The development is conducted in five steps: (1) a library of outcomes through systematic review, the retrieval of libraries from two clinical trials registries, and semistructured interviews is established; (2) following data extraction and analysis of the library of outcomes, each outcome can be classified into seven outcome domains, including TCM disease, symptoms/signs, physical and chemical testing, quality of life, long-term prognosis, economic evaluation, and adverse events to form a preliminary list of outcomes; (3) stakeholder groups for participation are selected; (4) stakeholder groups are invited to participate in two rounds of Delphi surveys to score outcomes and provide additional outcomes; (5) a consensus meeting is organized to produce the final COS-TCM-CPHD. Discussion. The protocol is consistent with the guidelines defined by the Core Outcome Set-STAndardised Protocol (COS-STAP) statement and formulated with reference to Core Outcome Set-STAndards for development (COS-STAD). The COS-TCM-CPHD will improve the consistency of study reports and reduce publication bias, thereby improving the quality of TCM clinical trials and decision-making for evidence-based medicine. The study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677).