Series Of Studies On The Informed Consents Before Endoscopy&A Randomized Controlled Study About Improving Compliance With Colorectal Cancer Screening

Part 1:Investigation and study on the status of informed consent in the diagnosis and treatment of digestive endoscopy in ChinaBackground:Endoscopy technology has developed significantly in the past 20 years.With the increase in the number of endoscopic treatments and the increase in operational complexity,the risks of diagnosis and treatment are also increasing.Now,the research on informed consent of digestive endoscopy in China are still insufficient,and there is still a lack of guidelines on informed consent of digestive endoscopy with national conditions.Objective:We aimed to investigate and analyze the current status of informed consent before digestive endoscopy in China.We also aimed to evaluate the patients' understanding and readability of informed consent documents,and the patients' awareness of risks,which can give the suggestion to improve our endoscopic work.Research method:Our subject adopted single center cross-sectional survey.From May 1,2017 to March 30,2018,patients admitted to Endoscopy Center of Shanghai NO.8 People's Hospital were investigated on their preoperative informed consent.Self-made questionnaire was used to survey the people who met the standard.Data were collected mainly including gender,age,education level,patient origin,type of operation,preoperative conversation,length of conversation,informed consent,understanding of operational risks,and understanding of alternatives,etc.Results:569 cases were finally included in the investigation.The average age was 56.0 years old.50.3%had received mid-high school education and 31.1%had received university education.The outpatients accounted for 49.9%and wards for 46.9%.Endoscopic examination was performed in 312 patients,accounting for 54.8%.Endoscopy treated 257 patients,accounting for 45.2%.93.5%of patients were told about the possibility of complications and only 6.2%were seriously underinformed about death.A multi-factor analysis of the influencing factors of postoperative complications found that the probability of perforation,infection and missed diagnosis was higher in men than in women.Women report higher rates of failure.The younger group reported a higher risk of bleeding.Less educated patients are more concerned about bleeding and infection.Patients with the first endoscopy were more worried about perforation and failure,while the more endoscopic diagnosis and treatment,the better the awareness of infection and missed diagnosis was.The probability of bleeding and failure was higher in the treatment group than in the examination group.And the examination group of patients are more concerned about the possibility of missed diagnosis.Conclusions:We found that the signing rate for endoscopic informed consent was higher than before.However,due to the influence of traditional ideas,the risk of death caused by endoscopy was not well understood.There was also insufficient information about alternatives.Explaining the purpose,process and risk of endoscopic operation through other in formed consent assisted means may help to improve the effect of informed consent.Part 2:Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography:A randomized trialObjective:We conducted a randomized trial aiming at improving patients' informed consent for undergoing endoscopic retrograde cholangiopancreatography(ERCP)in clinical care by comparing the efficacy of an additional educational video to written informed consent with that of written informed consent alone.Methods:This was a single-center,randomized controlled trial.Consecutive patients undergoing ERCP were randomized to a video education or a control group.An edu-cational video detailing ERCP procedure plus standard written informed consent was administered to the video education group,while the control group reviewed stan-dard written informed consent only.The primary outcome was the patients' percep-tion of the risk or possibility of ERCP complications,Their perception of the benefits of ERCP,alternative treatments and overall satisfaction with the process of informed consent were also compared.Results:In total 205 patients were included in the study(104 in the control group and 101 in the video education group).Patients' comprehension of ERCP-related complications in the video education group was significantly increased(p<0.001),and these patients were more likely to correctly identify the incidence of such com-plications.Significantly more patients in the video education group were very satis-fied with informed consent process(87.1%vs 76.0%,p=0.040)and fewer patients needed additional explanations(31.7%vs 47.1%,p=0.024).Conclusions:A supplementary educational video could greatly improve patient's under-standing of ERCP procedure,in particular,its potential risks and complications,as well as their overall-satisfaction with the process of informed consent(ClinicalTrials.gov no.NCT02810379).Part 3:A randomized controlled study to improve compliance of colorectal cancer screeningBackground:Colorectal cancer(CRC)is one of the most common malignancies of the digestive system all over the world.There is a strong potential in primary,secondary and tertiary prevention.A number of foreign intervention studies have found that strengthening colorectal cancer health education can improve CRC knowledge and awareness,so as to improve screening compliance.However,there is still a lack of similar research on intervention in China.Research objectives:We aimed to understand effective intervention strategies through educational interventions and studies on natural screening populations,and provide an important reference for improving CRC compliance in screening populations in China.Methods:From January 1,2019 to March 30,once a person who aged 40-75 years old who was seen a doctor in the Eighth People's Hospital of Shanghai,he or she will be recommended to complete the colonoscopy exam or fecal occult blood test,but he or she refused,then he or she would get a questionnaire.Then the control group got the physicians'oral education,and the intervention group got the physicians' oral education+brochures.Three months follow-up,colonoscopy or fecal occult blood test will be investigated their understanding on the knowledge of CRC,and the willing for colorectal cancer screening during the next six months.Results:Both oral education+brochure and oral education intervention by physicians improved the update of CRC knowledge,and significantly increased the activity and willingness of CRC screening,among which oral education+pamphlet group was superior to the oral education group by physicians only.Conclusion:After this study,we found that the completion rate of CRC screening could be significantly improved by strengthen education.The intervention of oral education by physicians combined with CRC booklets improved the updating of CRC screening knowledge.And at the same time,the willingness of CRC screening increased,too.