| Premature ventricular beats are the most common clinical arrhythmia.Premature ventricular beats occur in a wide range of people,including normal people and patients with various heart diseases.The clinical manifestations of patients with premature ventricular beats vary greatly.Most patients with mild symptoms have no symptoms,and severe patients have malignant arrhythmia or even syncope,and their clinical prognosis is also different.Therefore,objective evaluation of the efficacy of premature ventricular beats is crucial.In recent years,traditional Chinese medicine has played a certain advantage in the treatment of premature ventricular beats.There are problems such as irregular expression of evaluation indicators in clinical research on early premature ventricular beats.This study is supported by the National Key Research and Development Program project to develop a core set of indicators for the treatment of premature ventricular beats in traditional Chinese medicine,which will provide evidence for clinical decision making in traditional Chinese medicine.1.Formation of item pool in clinical research of traditional Chinese medicine on ventricular premature beatsObjective: To analyze the outcome indicators used in the published randomized controlled trials of traditional Chinese medicine for the treatment of premature ventricular beats,and to provide data support for the formation of the entry pool for the treatment of premature ventricular beats with traditional Chinese medicine.Methods: Computer searched 8 databases including CNKI,Wan Fang Data,VIP,Pub Med,Sino Med,Embase,Web of Science and Cochrane Library.Randomized controlled trials on the treatment of premature ventricular beats with traditional Chinese medicine from the establishment of the database to August 2021 were collected.Computer searched Chinese Clinical Trials Registry Database and American Clinical Trials Registry Database.Taking premature ventricular beats as the theme,other conditions are not limited to search to obtain relevant indicators.Additional outcome indicators were supplemented through the questionnaire survey of clinicians and patients.The literature screening and data extraction were carried out by two researchers,and in case of disagreements,they were resolved through consultation by a third person.By sorting,summarizing and merging the outcome indicators,the initial item list of the outcome indicators of premature ventricular beat was formed.Results: The literature search included 419 randomized controlled trials,5 clinical study registry protocols obtained from 2 clinical trial registration databases,and questionnaires participated by 90 clinicians and 10 patients with premature ventricular beats from 39 hospitals across the country.Finally,a total of 2017 efficacy evaluation indicators were obtained.After normalization,102 evaluation indicators were obtained.Including traditional Chinese medicine indicators,physical and chemical testing,symptoms and signs,safety events,quality of life,economic evaluation,long-term prognosis,and other indicators in 8 categories.The top 5evaluation indexes are clinical efficacy,24 h ventricular premature beat attack times,adverse reactions,Traditional Chinese Medicine sympotom score and Traditional Chinese Medicine syndrome curative effect.2.Construction of core index set of traditional Chinese medicine clinical research on premature ventricular beatsObjective: At present,the recognition degree of TCM clinical efficacy evaluation index for premature ventricular beat is low.Two rounds of Delphi questionnaire were used to screen out important indicators.Consensus on important indicators through expert consensus meetings.To construct a core index set for the treatment of premature ventricular beats with traditional Chinese medicine,to provide a reference for clinical research related to traditional Chinese medicine.Methods: First,a working group is established to conduct research registration.Secondly,experts from various stakeholder groups were invited to participate in two rounds of Delphi questionnaires.After each round of Delphi survey,the working group held a meeting to discuss the indicators collected in this round and reach a preliminary consensus on the indicators involved in the questionnaire.Finally,at least 70% of the indicators deemed important by the experts(score 7-9)are considered as reaching consensus through the consensus meeting.Enter the candidate list of the core index set for the treatment of premature ventricular beats with traditional Chinese medicine.Results: Through the first round of Delphi questionnaire,there are 32 indicators agreed by all stakeholder groups.In the second round of Delphi questionnaire,there are 18 indicators that have reached consensus in at least one stakeholder group.In the end,there are 4 indicators for the consensus meeting to reach consensus.Including:1 physical and chemical test indicators(24h dynamic electrocardiogram evaluation),1 Traditional Chinese medicine index(Traditional Chinese medicine symptom score),1 safety event index(adverse reaction),and 1quality of life measurement tool(SF-36 quality of life rating scale).Conclusion: Through literature search and Delphi expert consensus,referring to the relevant technical specifications of the core index set,combined with the characteristics of traditional Chinese medicine,the first core index set of traditional Chinese medicine for the treatment of ventricular premature beats was developed,which also provides valuable experience for the development of the core index set of traditional Chinese medicine in the future.Combined with the transformation of traditional Chinese medicine clinical evidence of ventricular premature beat,it provides reference for traditional Chinese medicine treatment of ventricular premature beat. |
PDF Full Text Request