With the gradual standardization and improvement of the real-world study system, real-world evidence, as a supplement to evidence from classical randomized controlled trials, is increasingly used to evaluate the effectiveness and safety of pharmaceuticals and medical devices. High-quality real-world evidence is not only related to the quality of real-world data, but also depends on the type of study design. Therefore, as one of the important designs for pragmatic clinical trials, the Zelen design has received much attention from investigators in recent years. This paper discussed the implementation processes, subtypes of design, advantages, limitations, statistical concerns, and appropriate application scenarios of the Zelen design, on the basis of published papers, in order to clarify its application value, and to provide references for future research.
【摘要】目的探討新型醫患溝通范式的臨床價值。方法分析新型醫患溝通范式的基本文書和臨床應用效果。結果自2002年1月2009年12月,新型醫患溝通范式應用于9800余例住院患者,無1起醫療事故發生。結論新型醫患溝通范式從形式上和內容上對患者知情權進行了充分的保障,對構建和諧醫患關系具有重大價值。【Abstract】Objective To explore the clinical value of new doctorpatient communication paradigms. Methods The primary documents and clinical application results of new doctorpatient communication paradigms were analyzed in our study. Results We applied the new doctorpatient communication paradigms to more than 9800 patients of inpatient from January 2001 to December 2009. No medical negligence was observed. Conclusion The new doctorpatient communication paradigms can ensure the patient’s right of informed consent in form and in content. Its value to construct harmony doctorpatient relationship is great.
【摘要】 目的 探討醫院產前超聲檢查中應用知情同意書的價值。 方法 對2002年1月-2010年1月經產前超聲常規篩查并分娩出生缺陷兒（均為基層醫院常規超聲篩查難以顯示或無法診斷的先天性異常）的產婦，按實行知情同意前后分為兩組：實施前的有21例（A組），實施后的有19例（B組），比較兩組出生缺陷兒產婦對產后結果的反映情況。 結果 B組產婦對產前超聲篩查理解13例，可以理解4例，難以理解2例；A組理解3例，可以理解5例，難以理解13例，兩組理解程度差異有統計學意義（Z=-3.741，P=0.000）。 結論 知情同意書是產前超聲檢查過程中孕婦對醫方理解及對孕婦負責的必要手段。 【Abstract】 Objective To explore the value of informed consent in prenatal ultrasonographic examination. Methods Between January 2002 and January 2010, the puerperants who underwent routine screening by prenatal ultrasonography in our hospital and delivered the birth of babies with defects (conventional ultrasound screening in basic-level hospitals hard to display or unable to diagnosis of congenital anomaly) were selected. The patients were divided into two groups according to whether had informed consent. The responses after the parturition (having babies with defects) of the puerperants between the two groups were compared. Results The puerperants in informed consent group had more objective understanding of prenatal ultrasonographic examination, and better acceptance level of the results of ultrasonography. Conclusion Informed consent of prenatal ultrasonography process is necessary.
Informing is an initiative behavior of medical staff in their clinical practice. Besides, informing is a key
principle of informed consent. The number of cases of infringing upon patient’s informed consent is increasing because of
the underestimate or ignorance of the obligation of informing. This paper discusses the concept, significance, content, and
procedure of informing as well as the relationship between informed consent and informing.
Through reviewing the regulations on the right of emergency treatment of hospitals, we analyzed reasons of emergency treatment of hospitals, including uninformed patients and informed patients without consent in emergency situations, as well as the risk of emergency rescue of hospitals. We put forward how to consider the judgment of emergency situations, justification of emergency treatment of hospitals, and risk attribution. We suggested improving the related legislation and regulations, developing compulsory medical insurance and a medical rescue system on emergency treatment.
In order to promote the responsible development of precision medicine in China, the current situation of precision medicine in three major fields (clinical, research and commercial) was briefly introduced, and key ethical issues or disputes in each field (including informed consent, return of incidental findings, and allocation of medical resources in the clinical field; informed consent, return of research results, and data use and sharing in the research field; genetic counseling, clinical utility of genetic testing, and use of data in the field of direct-to-consumer genetic testing) were discussed. It is necessary to actively meet these ethical challenges for the development of precision medicine in China.
ObjectiveThis study investigates the adherence to ethical principles in doctoral dissertations focused on human as the research subject, aiming to provide a foundation for enhancing ethical awareness among medical doctoral candidates. MethodsUtilizing the Chinese database of doctoral dissertations, a total of 1 733 relevant papers published in 2021 were collected. The study compared ethical considerations among double first-class universities, other high-ranking institutions, different university types, various disciplines, diverse training orientations, enrollment types, and medical doctoral dissertations from different regions. ResultsIn 2021, among Chinese medical doctoral dissertations involving human as the research subject, 73.34% mentioned ethical considerations, and 86.27% mentioned informed consent. Dissertations reporting ethical approval descriptions, approval numbers, ethical approvals, and informed consent constituted only 2.19%. Notably, 12.52% of medical doctoral dissertations failed to incorporate ethical considerations and informed consent details in their content. ConclusionThe ethical awareness of medical doctoral candidates in China and the reporting of ethical information in their dissertations require urgent enhancement and improvement.
On the basis of fundamental ethical principles and requirements, combining the practice of ethical management and according to the characteristics and requirements of the prospective cohort study of natural populations, this paper probes into the many key points of ethical design, including the use of existing data, the choice of exposures, the protection of special population subjects and the renewal of informed consent, and the selection of prospective cohort study of natural populations, to provide the beneficial reference to maximize the guarantee of the safety and rights and interests of the subjects.
