Clinical Trial Participant Willingness and Influencing Factors Study of Patients with Inflammatory Bowel Disease

Objective: The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the clinical trial participation of patients with IBD. A clinical experiment guidance will be proved by this study to maximized the benefits to patients and to help the clinical trial to conduct successfully. Method: An anonymous questionnaire was designed and was administrated to the patients with IBD who were randomly delivered in the inpatient or outpatient departments. The survey result was analyzed. Result: Total 372 available questionnaires were returned. Among these patients, 26.3% patients with IBD indicated willingness to participate, 57.3% indicated a situation dependence, and 41.04% indicated unwillingness. Among the potential factors that may influence the patient’s willingness to participate the clinical, trusted physician’s recommendation, no proved drugs to use and accessing to free medication to release financial burden were statistically significant. Conclusion: The overall willingness of IBD patients to participate in drug clinical trials is not high. Among the patients who are willing to participate in clinical trials, the main reasons for their participation are that they trust doctors’ recommendation, can get free medication and examination, and can reduce the economic burden. Efficacy and safety were the main influencing factors in patients who were case-dependent and unwilling to participate in clinical trials.

The Role of Study Nurses in Clinical Trials of IBD Drugs

Objective: To explore the establishment and roles of study nurses in IBD drug clinical trials. Methods: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. Results: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. Conclusions: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.

Management of Patients with Inflammatory Bowel Disease during the Prevention of COVID-19

Objective: To explore the disease management methods and effects for patients with inflammatory bowel disease (IBD) in the special period of pandemic. Methods: Medical staffs carried out the management of patients with IBD on the inflammatory disease service platform of this center from February to May of 2020 in addition to routine clinical works. Results: None of the nearly 3000 IBD patients who are being followed up at our center were infected with COVID-19. During this period, no patients experienced drug-related serious side effects or disease recurrence that could not be treated in time due to failure to reach the medical staffs. Conclusion: The disease management methods based on IBD platform allow the patients to be properly managed during this special period.

Long-Term Efficacy Analysis of Exclusive Enteral Nutrition for the Treatment of Abdominal Abscess in Crohn’s Disease

Objective: The objective is to explore the long-term efficacy of total enteral nutrition in the treatment of abdominal abscess in Crohn’s disease. Methods: Patients treated with EEN in our hospital and whose abdominal abscess disappeared after 12 weeks of treatment were included, and the data of abscess recurrence and surgical treatment during follow-up were included. Results: A total of 44 consecutive cases meeting the criteria were included. The 1-year and 2-year recurrence rates were 22.5% and 39.9% respectively. Among the patients with recurrence, 10 patients chose EEN treatment again, and 5 patients received direct surgical treatment. Of the patients who chose to undergo EEN treatment again, 8 still eventually required surgery. The 1-year operative rate was 16.9%, and the 2-year operative rate was 35.6%. The median operative time was 33.3 (95% CI: 21.3, 45.4) months. Conclusions: The 2-year cumulative incidence of recurrence of abdominal abscess in CD patients whose abdominal abscess disappeared after EEN was 39.9%, and the 2-year cumulative surgical rate was 35.6%. The operative stomy rate decreased after EEN, and the primary anastomosis rate increased significantly.