Abstract
Background Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. These can be evaluated by the measurement and analysis of related outcomes. Because of selective reporting bias and the heterogeneity of study outcomes, it is not possible to combine similar studies in a meta-analysis. Consequently, not only does the low quality of original studies fails to support evidence-based decision-making, but also the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required. Methods 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).
Highlights
Chronic pulmonary heart disease (CPHD) comprises a number of disorders that raise the pressure in the pulmonary artery and modify the structure and function of the right ventricle [1, 2]. e clinical manifestations include cough and asthma, shortness of breath, palpitation, cyanosis, and edema
We have found a number of problems when analyzing the outcomes of treatments for chronic pulmonary heart disease (CPHD): 1 clinical studies of the same condition studied different outcomes, different numbers of outcomes, and variable outcome measurement time points; such problems lead to bias in the reporting of results. 2 e choice of outcomes was arbitrary, lacking any uniformity in standards. 3 e results did not correlate with outcomes that patients care about; for example, studies rarely described outcomes such as quality of life or long-term prognosis for patients instead of describing physical and chemical testing and other similar outcomes. 4 e outcomes lacked uniformity in the standards related to traditional Chinese medicine (TCM)
Methods/Design is study aimed to develop a set of core outcome set (COS) based on a series of standards [20,21,22,23] formulated by the Core Outcome Measures in Effectiveness Trials (COMET) group for future clinical research of CPHD in TCM. e study has been registered on the COMET website, with registration number 1677 [24]
Summary
Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. ese can be evaluated by the measurement and analysis of related outcomes. Does the low quality of original studies fails to support evidence-based decision-making, and the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required. E 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. Discussion. e 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 (COSSTAD). e 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. e study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677)
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