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The use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs.
This is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point.
This research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021.
The study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023.
UMIN000046418
We conducted a comprehensive analysis to evaluate the benefits of negative pressure wound therapy (NPWT) versus traditional dressings in preventing surgical site infections in patients undergoing cardiac surgery. We thoroughly examined several databases, including PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP, Chinese Biomedical Literature Database (CBM) and Wanfang, from inception until July 2023. Two independent researchers were responsible for the literature screening, data extraction and quality assessment; analyses were performed using RevMan 5.4 software. Thirteen studies comprising 8495 patients were deemed relevant. A total of 2685 patients were treated with NPWT, whereas 5810 received conventional dressings. The findings revealed that NPWT was more effective in reducing surgical site infections after cardiac surgery than conventional dressings (4.88% vs. 5.87%, odds ratio [OR]: 0.50, 95% confidence intervals [CIs]: 0.40–0.63, p < 0.001). Additionally, NPWT was more effective in reducing deep wound infections (1.48% vs. 4.15%, OR: 0.36, 95% CI: 0.23–0.56, p < 0.001) and resulted in shorter hospital stays (SMD: -0.33, 95% CIs: −0.54 to −0.13, p = 0.001). However, the rate of superficial wound infections was not significantly affected by the method of wound care (3.72% vs. 5.51%, OR: 0.63, 95% CI: 0.32–1.23, p = 0.180). In conclusion, NPWT was shown to be advantageous in preventing postoperative infections and reducing hospital stay durations in patients undergoing cardiac surgery. Nonetheless, given the limitations in the number and quality of the included studies, further research is recommended to validate these findings.
FreshRSS 