ABSTRACT
Objective:To investigate how medical staff recognize and understand the nursing quality evaluation in robot-assisted arthroplasty so as to provide reference and evidence for construction of a nursing quality evaluation system for robot-assisted arthroplasty.Methods:The descriptive phenomenological research method was used for this qualitative research. From May to October, 2021, 6 doctors and 9 nurses from Operating Room, Laoshan Campus, Hospital Affiliated to Qingdao University were interviewed in a semi-structured way about the nursing quality evaluation for robot-assisted arthroplasty. The data were sorted out by Nvivo12.0 qualitative analysis software, and the interview data were analyzed while the themes and topics refined according to the Colaizzi seven-step analysis of phenomenological data.Results:Three themes were extracted. ① The first theme was related to the quality evaluation of nursing structure, including 2 topics: nursing staff allocation and nursing quality management in operating room. ② The second theme was related to the quality evaluation of nursing process, including 4 topics: environment and facilities, nosocomial infection control, management of patients' operative safety, and specialized operative nursing. ③ The third theme was related to the quality evaluation of nursing outcomes, including 3 topics: satisfaction for operating room nursing, incidence of adverse events and patients' benefits.Conclusion:The themes and topics for nursing quality evaluation in robot-assisted arthroplasty extracted from the perspective of medical staff can provide reference for construction of a reasonable, scientific, efficient and comprehensive nursing quality evaluation index system.
ABSTRACT
OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.