Objective
TCM treatment of tumor has certain therapeutic advantages, and the expression of the advantages needs to be based on the measurement and data analysis of the recognized therapeutic outcomes.Aiming at the problem of many evaluation indexes of clinical efficacy of TCM treatment of lung cancer and low recognition degree, the research on core outcome set was carried out to construct the core outcome set of clinical trials of TCM treatment of lung cancer, and to provide reference for the development of related clinical studies and evidence-transformation studies.
Methods
This research refers to the technical specification for the development of core outcome set published by COMET Collaboration and China Core Outcome Set Research Center, and carries out the research on the construction of outcome pool and outcome consensus. In study 1,form the entry pool of lung cancer clinical efficacy evaluation outcome. In the first study, eight databases, including PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfong, VIP, and Sinomed, were searched and sampled to analyze the randomized controlled clinical trials in the treatment of lung cancer with Chinese medicine.
The databases of the Chinese Clinical Trials Registry (ChiCTR) and the U.S. Clinical
Trials.gov were searched.With lung cancer as the theme and traditional Chinese medicine as the intervention measures, the whole database was searched for relevant clinical research programs to obtain potential outcomes.
Additional outcome measures were obtained through patient and clinician questionnaires.
The clinical efficacy evaluation outcome obtained from clinical literature, registration
scheme and questionnaire survey were integrated, and the outcome were normalized to form the entry pool of lung cancer clinical efficacy evaluation outcome.
In study 2, Delphi questionnaire was used to reach a preliminary consensus on the included outcomes, and consensus was reached on the core outcome set through consensus meeting.
Results
We analyzed 654 clinical trial literatures, 66 clinical study protocols obtained from 2
registries, 64 physicians and 8 patients.A total of 2797 efficacy evaluation outcomes were obtained, and 196 outcomes were obtained after collation and standardized treatment. The number of a single research outcome is at least 1 and at most 15.The top 10 outcomes in terms of frequency of use were: solid tumor clinical efficacy, adverse reactions, quality of life, immune function, serum tumor marker level, TCM syndrome score, clinical symptom improvement, overall survival, progression-free survival, and body weight change.
In the first round of the Delphi survey, experts agreed on 24 outcomes;In the second Delphi survey, all the experts agreed on 17 ioutcomes.In the core of the consensus conference final outcomes including the lifetime/survival rates, quality of life, solid tumor clinical curative effect evaluation, adverse reactions, clinical symptoms improvement, a total of five kinds of core end outcome, after discussion, the panel considers that in the core outcome reached a consensus, can will have been agreed in the Delphi survey of secondary outcomes and the relevant measurement tools as a further discussion,Subscales of survival (progression-free survival, overall survival, and median survival) were included. Quality of life measurements included the European Organization for Cancer Research and Treatment Life Treatment Core Scale (EORTC-QLQ-C30), KPS score, QOL score for cancer patients, and lung cancer specific subscale (EORTC QLQ-LC13).Solid tumor clinical efficacy evaluation of sub outcomes (complete remission (CR), partial response (PR), stable lesions (SD), disease progression (PD), distant metastasis, disease control rates (DCR), the objective response rate (ORR) and measurement tools (WHO, RECIST), survival rate of sub outcomes (1 year survival rate, 3 year survival rate, the 5-year survival rate), adverse reactions of son outcome (bone marrow suppression of adverse reaction, radioactive lung injury).The improvement of clinical symptoms, its sub-outcomes (pain, dyspnea, TCM syndromes/symptoms) and measurement tools (pain NRS score, TCM syndrome score).
Conclusion
This study formed the core outcome set of TCM treatment of lung cancer, including 5 categories of outcomes and the corresponding recognized evaluation tools, in line with international standards and taking into account the characteristics of TCM, and has a guiding role in improving the design of TCM clinical research for non-small cell lung cancer and the transformation and application of evidence.Due to the lack of recognized standards for the evaluation of TCM syndromes, it is necessary to strengthen the development and research of characteristic outcomes for the evaluation of TCM syndromes.
Key words : Core Outcome Set; Traditional Chinese medicine; Lung cancer; Randomized controlled clinical trials; Delphi; Consensus conference
Medicine for Lung Cancer(COS-TCM-LC)[D]. Tianjin University of Traditional Chinese Medicine, 2021. And the cite in Chinese is: ??. ??????????????[D]. ???????, 2021.
Principal investigator:
Junhua Zhang,Mingyan Zhang,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China
Other contributors: Hui ZI CHUA,Kai Li,Bohan Niu,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China
Disease Category: Cancer, Lungs & airways
Disease Name: Lung cancer
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- Interview
- Systematic review
(1)Systematic literature review
(2) Qualitative semi-structured interview
(3)Two rounds Delphi Survey
(4) Consensus conference