Study On The Optimization Of Blood Heat Type Case Report Form For Threatened Abortion

Objective:Effective clinical trials cannot be separated from an objective,scientific,and rigorous case report form.This article is based on the clinical subject needs,combined with the clinical observation subject undertaken by the tutor.Taking randomized controlled trials as an example,from the characteristics of the project and the practicality of the case report form,the report form will be comprehensively and objectively improved.The purpose is to better serve clinical observation studies,provide reference and ideas for the designers of the special case report table for the clinical research of TCM on the blood heat type of threatened abortion.Methods:The composition and contents of relevant case report tables were selected,compared with the modules and fields stipulated by the Clinical Data Interchange Standards Consortium,and the shortcomings of all current case report forms were mapped out,and a large framework was made to facilitate the optimization of CRF.By collecting,sorting,analyzing and optimizing the common and individuality of all kinds of threatened abortion CRF,the relevant elements were extracted.On the premise of scientific,rigorous,concise and complete,the design points and considerations of CRF are summarized.The specific contents of CRF are preliminarily determined.Through multiple disciplines,many aspects,and multiple exchanges and certifications with the tutor group and the professors outside of it.Such as obstetrics,pediatrics,statistics,clinical research methodology,ethics,evidence-based medicine,etc.The initial CRF was developed and applied to clinical practice.After clinical practice,the CRF was obtained and evaluated for the practicability of CRF.Results:1 Complete the study on the report forms of all the Doctor and Master Theses on the threatened abortion with blood heat type.2 Determine the inclusion criteria,exclusion criteria,excluding criteria,criteria for discontinued cases,standards and causes of shedding cases,general data,grading scales for symptoms,clinical signs and symptoms,laboratory items and auxiliary examinations,and adverse events report form,summary of test completion,efficacy criteria,and follow-up details in clinical studies of blood-threatening threatened abortions.And to produce a report form of blood-threatening threatened abortion cases that conforms to traditional Chinese medicine standards,clinical practice,and comprehensive content.3 The contents of the verification of clinical trials for threatened abortion was introduced in detailed,including the accurate,scientific,rigorous,comprehensive and timeliness of baseline,safety,and efficacy indicators.Put forward the key and difficult points of verification,and its core lies in the logical relationship of exclusion,inclusion criteria,the indicator of threatened abortion outcome and the verification of pregnancy outcome.4 Provide an effective clinical observation tool for the tutor’s blood-threatening threatened abortion,and provide clinical research methods for the theory of clear and quiet the fetus headed by the Pang gynecology department in the Central Plains.Conclusion: This topic is a retrospective study of literature through the collection,analysis,and organization of key information.Concluded as follow:1 There is no uniform standard for the present report form of the case of blood-threatening threatened abortion.CRF,a blood-heat threatened abortion designed by the institute,conforms to the standard of traditional Chinese medicine.It is a better case report suitable for clinical study needs.Providing methods and tools for clinical research,it has practical value,and convenient to collect data and statistic for clinical observations.2 Not only provides reference basis for the study of the threatened abortion of multiple syndromes,but also this topic provides reference for multidisciplinary and multi-genre,so that the case report form is more practical.3 Currently,there are relatively few papers devoted to clinical research and research tools,and this topic is the first clinical paper from the department of medicine.After collecting,sorting,and optimizing the analysis,this study conducted multiple rounds,multi-disciplines,and multi-experts,and repeatedly conducted research from the perspective of clinical research methodologies to create a ground-breaking case report.4 More comprehensive,accurate,scientific and rigorous in comparison with other master’s papers and the guiding principles for clinical research on new drugs in Chinese medicine(trial).The paper introduces the composition of the case report form and analyzes the characteristics of the case report,highlighting the characteristics of TCM and humanistic care.