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.
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.
【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.
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.
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
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.
藥物上市前須經過人體試驗，參與藥物臨床試驗的受試者將承擔不同程度的風險，我國GCP明確規定要充分保障受試者的權益，倫理委員會和知情同意書是保障受試者權益的主要措施，但在實際中仍存在不少問題。為此，如何切實保障受試者的權益，是臨床試驗所要解決的一個重要問題。