1.Committee Activity to Utilize DiNQL Data for Nursing Management
Shinya ISHIDA ; Hitomi KATADA ; Shinobu MIYAHARA ; Shitomi HASEGAWA
Journal of the Japanese Association of Rural Medicine 2019;67(5):614-
Five years have passed since the Japan Nursing Association started the Diagnostic Service for Improving Labor and Nursing Quality (DiNQL). We have participated in DiNQL data input support analysis activities since 2013, and the DiNQL Promotion Committee was launched in 2015. Here, we report on the activities of the DiNQL Promotion Committee and evaluate the results of these activities. The DiNQL Promotion Committee's four main activities involve being in charge of the floor at meetings, clarifying the input method aimed at shortening data collection time, supporting analysis of the DiNQL data input, and holding workshops for analysis and utilization. A self-administered questionnaire was administered to 43 ward nursing managers (including section chiefs and managers) to evaluate these committee activities. Both section chiefs and clerical staff responded that DiNQL data input time was shortened by more than 90%. Section chiefs comprised 64% and managers 79% of those who responded that DiNQL data could be utilized for determining annual departmental goals. In total, 71% of managers and 50% of section chiefs responded that DiNQL data is useful for nursing management. Based on these results, we confirmed that setting up the DiNQL Promotion Committee and its activities has led to nursing management support.
2.Expert consensus on day-case laparoscopic cholecystectomy
MINIMALLY INVASIVE SURGERY COMMITTEE OF THE CHINESE RESEARCH HOSPITAL ASSOCIATION
Journal of Clinical Hepatology 2023;39(11):2550-2557
The concept of day-case surgery was first proposed by British surgeon Nicoll, referring to the surgery or procedure in which a patient completes admission and discharge within one day (24 h). In recent years, China has gradually implemented the day-case mode of laparoscopic cholecystectomy. Day-case laparoscopic cholecystectomy could significantly shorten hospital stay, reduce hospital infections, accelerate patient recovery, improve the efficiency of medical resource utilization, and reduce medical costs. In order to provide reference for exploring and developing standardized day-case laparoscopic cholecystectomy and promote the standardized application and promotion of day-case laparoscopic cholecystectomy, the Minimally Invasive Surgery Committee of the Chinese Research Hospital Association organized experts from surgery, anesthesia, and nursing to develop this expert consensus.
3.CHINA PH ARMACY Volume 33,Number 8,April 30,2022 Semimonthly Table of Contents Expert consensus on prescription review rules of proton pump inhibitors
China Pharmacy 2022;33(8):897-910
In order to further s tandardize the clinical application of proton pump inhibitors and provide reference for prescription suitability review ,under the guidance of Guiding Principles for Clinical Use of Proton Pump Inhibitor which was promulgated by the General Office of National Health Commission of the People ’s Republic of China ,Pharmaceutical Admini- stration Committee of Chongqing Hospital Association initiates “the formulation Project on Prescription Review Rules for Proton Pump Inhibitors ”. The First Affiliated Hospital of the Army Medical University takes the lead and cooperates with clinical experts , pharmaceutical experts and evidence-based experts from many domestic medical institutions to discuss the indications ,usage and dosage,medication for special groups and drug interactions of proton pump inhibitors ,and finally forms this consensus. The main contents of the consensus include the basic prescription review rules of omeprazole ,esmeprazole,pantoprazole,rabeprazole, lansoprazole and iprazole (including injection and oral preparations ,calculated by common name ),and 12 prescription review recommendations for some clinical applications not covered on the basic prescription review rules ,in order to provide reference for medical institutions at all levels.
4.Characteristic Analysis and Ethical Review Strategy of Medical Device Expanded Clinical Trials
Xinqing ZHAO ; Mengjie YANG ; Sijie WANG ; Wenli QIAO ; Xuening LI
Chinese Medical Ethics 2023;36(1):17-21
Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.
5.Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent
Wenli QIAO ; Sijie WANG ; Xinqing ZHAO ; Xuening LI ; Mengjie YANG
Chinese Medical Ethics 2022;35(2):175-179
Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.
6.Discussion on the practice of ethical review in organ transplantation under refined management
Fang HUANG ; Xinfeng PAN ; Hui ZENG ; Qing HE ; Yong XU ; Lanlan WEI
Chinese Medical Ethics 2025;38(4):441-447
The development of organ transplantation has brought new hope to many patients with organ failure and their families, but it has also raised numerous ethical issues. How to balance the rights and interests between organ donors and recipients, as well as ensure the fairness and transparency of the transplantation process has become an urgent problem to be solved. Based on the latest Regulations on Organ Donation and Transplantation and the Working Rules of the Ethics Committee for Human Organ Transplantation, the current difficulties and challenges in organ transplantation ethics were deeply analyzed. Taking the ethical review practice of Shenzhen Third People’s Hospital as an example, this paper explored issues such as full informed consent of both donors and recipients, risk assessment of marginal donors, and the review of relationships between donors and recipients. It also explored and constructed a set of complete ethical review models for organ transplantation through refined management. This model improved the efficiency and quality of ethical review as well as enriched the related knowledge system. It is expected that the implementation of this model can provide a reference for promoting effective ethical review nationwide, advancing the improvement and development of ethical review work in organ transplantation. Meanwhile, more medical ethics experts and practitioners are called upon to focus on and engage in the research and practice of ethical review in organ transplantation, jointly promoting progress in this field.
7.Guidelines for application of computer-assisted indocyanine green molecular fluorescence imaging in diagnosis and surgical navigation of liver tumors (2019).
Medical Association Of Chinese Medical Association DIGITAL ; Intelligent Surgery Professional Committee Of Chinese Research Hospital DIGITAL ; Cancer Professional Committee Of Chinese Medical Doctor Association LIVER ; Precise Medicine Professional Committee CLINICAL ; Imaging And Equipment Professional Committee Of China Graphics Society MEDICAL ; Imaging Professional Committee Of China Biophysical Society MOLECULAR
Journal of Southern Medical University 2019;39(10):1127-1140
Computer-assisted combined indocyanine green (ICG) molecular fluorescence imaging technology can be used for preoperative planning and intraoperative detection from three-dimensional (3D) morphological anatomy and level of cellular function to guide the anatomical, functional and radical hepatectomy of liver tumor. This technology has received wide acceptance and has shown important diagnostic and therapeutic value. This guideline is intended to standardize the application of computer-assisted combined ICG molecular fluorescence imaging for accurate diagnosis and treatment of liver tumors in the following aspects: (1) the workflow of 3D visualization technology; (2) the mechanism and application flow of ICG molecular fluorescence imaging; (3) clinical application of 3D visualization technology and virtual reality technology; and (4) clinical application of ICG molecular fluorescence imaging. ICG molecular fluorescence imaging can help to define tumor boundary, determine hepatic segment and hepatic lobectomy tangent at the molecular and cellular level, and detect small lesions or metastases. According to the fluorescence signal characteristics of liver tumors and combined with rapid frozen pathological examination during operation, the differentiation degree of liver space-occupying lesions (such as primary liver cancer) can be preliminarily determined, and residual tumors and biliary leakage on the hepatic section can be detected after hepatectomy. Computer-assisted ICG molecular fluorescence imaging in the diagnosis and surgical navigation of liver tumors provides a new approach to digital diagnosis and treatment of liver tumors. With its development in clinical practice and the technological innovation, this technology will be further improved to allow more accurate diagnosis and treatment of liver tumors.
9.CHINA PH ARMACY Volume 33,Number 15,August 15,2022 Semimonthly Table of Contents Expert consensus on the comprehensive clinical evaluation of lipid-lowering drugs under the centralized drug volume-based procurement policy in Shandong Province
China Pharmacy 2022;33(15):1793-1798
Comprehensive clinical evaluation of drugs is an important technical tool to promote the return of drugs to clinical value. Under the background of normalization and institutionalization of centralized drug volume-based procurement ,it is very crucial to actively organize and carry out comprehensive clinical evaluation of drugs. As of March 2022,there are 5 lipid-lowing drugs that have been included in the centralized drug volume-based procurement of the state and Shandong Province. In order to actively promote the medical institutions to develop the comprehensive clinical evaluation of lipid-lowing drugs standardly ,led by the Shandong Provincial Hospital Affiliated to Shandong First Medical University ,supported by Shandong Hospital Association ,and 19 third grade class A hospitals in Shandong Province jointly participated ,Using Delphi method ,through three rounds of expert opinion investigation and extensive discussion ,Expert Consensus on the Comprehensive Clinical Evaluation of Lipid-lowering Drugs under the Centralized Drug Volume-based Procurement Policy in Shandong Province was developed. The expert consensus adopted the percentage system for quantitative evaluation. The comprehensive clinical evaluation on 15 lipid-lowing drugs involved in centralized drug volume-based procurement in Shandong Province was implemented from eight dimensions including pharmaceutical characteristics ,effectiveness,safety,economy,suitability,accessibility,innovation and other attributes ,and different recommendation levels were formed according to the scores. The development of this consensus will help medical institutions to reasonably allocate and use lipid-lowering drugs in the context of centralized drug volume-based procurement ,so as to better satisfy the national policy needs and continuously improve the quality of pharmaceutical services.
10.Exploration and Reflection on Informatization Construction in Optimizing the Ethical Review Process
Chinese Medical Ethics 2023;36(3):255-262
Currently, the number of clinical research projects continues to grow. Both sponsors and researchers hope to accelerate medical ethical review efficiency, and the regulatory agencies strengthen the control over the ethical review quality. The ethics committee (EC) offices of medical institutions are relatively insufficient in terms of human resource allocation and archiving space. Combined with the development goals of the EC and the requirements of the homogeneity construction of ethical review, it was urgent to optimize the ethics review process and accelerate the efficiency of ethics review through informatization construction. Through informatization construction, the process management of ethical review could be strengthened, the work steps could be simplified, the ethical review level could be improved, and the supervision ability and efficacy of EC on clinical research could be strengthened, which may provide continuous quality improvement strategies and specific optimization measures for the operation and management of the EC, so as to effectively protect the safety, the rights and interests of subjects.