{"title":"[电子烟在临床研究中的预期效果和意外效果:要求(更多)透明度]。","authors":"Reiner Hanewinkel, Sabina Ulbricht","doi":"10.1055/a-2243-9399","DOIUrl":null,"url":null,"abstract":"<p><p>E-cigarettes are used in clinical trials to facilitate smoking cessation. Due to the health risks associated with the use of e-cigarettes, the results of clinical trials should be fully reported, including continued exclusive use and dual use of tobacco and e-cigarettes. Nicotine cessation outcomes should be reported as the primary endpoint as well as the analysis of tobacco cessation alone. As there is currently no robust evidence that reducing cigarette consumption provides substantial health benefits, cigarette consumption reduction should not be used as a health outcome in clinical trials. Continued nicotine dependence should be included as an \"adverse event\" in the reporting of trial results.</p>","PeriodicalId":20197,"journal":{"name":"Pneumologie","volume":" ","pages":"561-565"},"PeriodicalIF":1.2000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Intended and unintended effects of e-cigarettes in clinical studies: a plea for (more) transparency].\",\"authors\":\"Reiner Hanewinkel, Sabina Ulbricht\",\"doi\":\"10.1055/a-2243-9399\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>E-cigarettes are used in clinical trials to facilitate smoking cessation. Due to the health risks associated with the use of e-cigarettes, the results of clinical trials should be fully reported, including continued exclusive use and dual use of tobacco and e-cigarettes. Nicotine cessation outcomes should be reported as the primary endpoint as well as the analysis of tobacco cessation alone. As there is currently no robust evidence that reducing cigarette consumption provides substantial health benefits, cigarette consumption reduction should not be used as a health outcome in clinical trials. Continued nicotine dependence should be included as an \\\"adverse event\\\" in the reporting of trial results.</p>\",\"PeriodicalId\":20197,\"journal\":{\"name\":\"Pneumologie\",\"volume\":\" \",\"pages\":\"561-565\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pneumologie\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1055/a-2243-9399\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/24 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pneumologie","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1055/a-2243-9399","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/24 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
[Intended and unintended effects of e-cigarettes in clinical studies: a plea for (more) transparency].
E-cigarettes are used in clinical trials to facilitate smoking cessation. Due to the health risks associated with the use of e-cigarettes, the results of clinical trials should be fully reported, including continued exclusive use and dual use of tobacco and e-cigarettes. Nicotine cessation outcomes should be reported as the primary endpoint as well as the analysis of tobacco cessation alone. As there is currently no robust evidence that reducing cigarette consumption provides substantial health benefits, cigarette consumption reduction should not be used as a health outcome in clinical trials. Continued nicotine dependence should be included as an "adverse event" in the reporting of trial results.
期刊介绍:
Organ der Deutschen Gesellschaft für Pneumologie DGP Organ des Deutschen Zentralkomitees zur Bekämpfung der Tuberkulose DZK Organ des Bundesverbandes der Pneumologen BdP Fachärzte für Lungen- und Bronchialheilkunde, Pneumologen und Allergologen