A multicenter prospective survey on informed consent for gastrointestinal endoscopy in China.
OBJECTIVE
Data on informed consent procedures in endoscopy centers in China are lacking. The aim of this study was to record the current status of informed consent procedures in four tertiary endoscopy centers in China.


METHODS
All patients underwent upper gastrointestinal endoscopic examinations in four tertiary endoscopy centers in China from August 2006 to October 2006. Data on patients' age, gender, education level, type of endoscopic procedures, complication rates, and satisfaction were recorded prospectively.


RESULTS
Totally, 1,303 patients were included (mean age 47.7 years, 50.2% males, 88.3% outpatients, 13.1% with university education) and underwent 1,308 endoscopic procedures. Of these patients, 994 were informed prior to the endoscopic procedures; the remaining patients were not asked for their oral or written informed consent before the procedure. No serious complications occurred, but 9 patients were not satisfied with the procedures and 5 patients refused to complete the endoscopic examination.


CONCLUSIONS
Gastrointestinal endoscopic examinations, especially diagnostic gastroscopy, are safe, carrying minimal patient risk, but the current practice of informed consent procedures in China is suboptimal. More efforts should be made to improve the standards of informed consent for endoscopic procedures in China.
Bai
Yu
Y
Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
Gao
Jun
J
Yang
Yuanping
Y
Long
Feiwu
F
Jin
Hai
H
Li
Changqing
C
Zou
Duo-Wu
DW
Li
Zhao-Shen
ZS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D016099:Endoscopy, Gastrointestinal / Q000941:ethics*; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology / Q000592:standards*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011446:Prospective Studies