{"title":"肿瘤患者医疗器械相关不良事件的模式和预测因素评估:三级医院的横断面研究","authors":"Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti","doi":"10.1080/17434440.2025.2486471","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.</p><p><strong>Methodology: </strong>An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.</p><p><strong>Results: </strong>Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).</p><p><strong>Conclusion: </strong>This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"477-487"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.\",\"authors\":\"Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti\",\"doi\":\"10.1080/17434440.2025.2486471\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.</p><p><strong>Methodology: </strong>An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.</p><p><strong>Results: </strong>Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).</p><p><strong>Conclusion: </strong>This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.</p>\",\"PeriodicalId\":94006,\"journal\":{\"name\":\"Expert review of medical devices\",\"volume\":\" \",\"pages\":\"477-487\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert review of medical devices\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/17434440.2025.2486471\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert review of medical devices","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17434440.2025.2486471","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/3 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.
Background: This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.
Methodology: An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.
Results: Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).
Conclusion: This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.