{"title":"发表观察性研究报告,声称存在长期因果关系","authors":"Alyson Haslam , Vinay Prasad","doi":"10.1016/j.conctc.2024.101327","DOIUrl":null,"url":null,"abstract":"<div><p>To examine methodology characteristics over time and investigate research impact before and after the start of the COVID-19 era, we analyzed original articles published in <em>The New England Journal of Medicine</em> between October 26, 2017 and August 27, 2022. April 1, 2020 was used as the defining date dividing before and after the COVID-19 era. Out of 1051 original articles, 515 (49 %) were before and 536 (51 %) were after the COVID-19 era. Two independent reviewers categorized and reconciled methodology into groups: “randomized trial” (715 articles), “uncontrolled experimental study” (128), “descriptive observational study” (168), and “observational study making a causal claim” (40). We extracted subsequent citations and Altmetric data for each article to assess impact.</p><p>The median number of social media shares was 2272 (IQR: 743–7821) for observational studies making a causal conclusion, compared to 306 (IQR: 70–606) for randomized trials (p-value=<0.001). The median Altmetric score for randomized COVID-19 trials (2421, IQR: 1063–3920) was not significantly different than that of COVID-19 observational studies making a causal claim (2583, IQR: 1513–6197, p-value = 0.42), but it was significantly lower than descriptive observational COVID-19 studies (4093, IQR: 2545–6823, p-value = 0.04).</p><p>We conclude that there has been a steady increase in the number and percentage of observational studies that make causal conclusions about the efficacy of an intervention. Research concerning COVID-19, regardless of methodology, has seen a sharp rise in dissemination as measured through Altmetric's social media score and subsequent citations.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000747/pdfft?md5=1c231c420eb704b3b99ab2fa089c0f89&pid=1-s2.0-S2451865424000747-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Publication of observational studies making claims of causation over time\",\"authors\":\"Alyson Haslam , Vinay Prasad\",\"doi\":\"10.1016/j.conctc.2024.101327\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>To examine methodology characteristics over time and investigate research impact before and after the start of the COVID-19 era, we analyzed original articles published in <em>The New England Journal of Medicine</em> between October 26, 2017 and August 27, 2022. April 1, 2020 was used as the defining date dividing before and after the COVID-19 era. Out of 1051 original articles, 515 (49 %) were before and 536 (51 %) were after the COVID-19 era. Two independent reviewers categorized and reconciled methodology into groups: “randomized trial” (715 articles), “uncontrolled experimental study” (128), “descriptive observational study” (168), and “observational study making a causal claim” (40). We extracted subsequent citations and Altmetric data for each article to assess impact.</p><p>The median number of social media shares was 2272 (IQR: 743–7821) for observational studies making a causal conclusion, compared to 306 (IQR: 70–606) for randomized trials (p-value=<0.001). The median Altmetric score for randomized COVID-19 trials (2421, IQR: 1063–3920) was not significantly different than that of COVID-19 observational studies making a causal claim (2583, IQR: 1513–6197, p-value = 0.42), but it was significantly lower than descriptive observational COVID-19 studies (4093, IQR: 2545–6823, p-value = 0.04).</p><p>We conclude that there has been a steady increase in the number and percentage of observational studies that make causal conclusions about the efficacy of an intervention. Research concerning COVID-19, regardless of methodology, has seen a sharp rise in dissemination as measured through Altmetric's social media score and subsequent citations.</p></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-06-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000747/pdfft?md5=1c231c420eb704b3b99ab2fa089c0f89&pid=1-s2.0-S2451865424000747-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000747\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424000747","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Publication of observational studies making claims of causation over time
To examine methodology characteristics over time and investigate research impact before and after the start of the COVID-19 era, we analyzed original articles published in The New England Journal of Medicine between October 26, 2017 and August 27, 2022. April 1, 2020 was used as the defining date dividing before and after the COVID-19 era. Out of 1051 original articles, 515 (49 %) were before and 536 (51 %) were after the COVID-19 era. Two independent reviewers categorized and reconciled methodology into groups: “randomized trial” (715 articles), “uncontrolled experimental study” (128), “descriptive observational study” (168), and “observational study making a causal claim” (40). We extracted subsequent citations and Altmetric data for each article to assess impact.
The median number of social media shares was 2272 (IQR: 743–7821) for observational studies making a causal conclusion, compared to 306 (IQR: 70–606) for randomized trials (p-value=<0.001). The median Altmetric score for randomized COVID-19 trials (2421, IQR: 1063–3920) was not significantly different than that of COVID-19 observational studies making a causal claim (2583, IQR: 1513–6197, p-value = 0.42), but it was significantly lower than descriptive observational COVID-19 studies (4093, IQR: 2545–6823, p-value = 0.04).
We conclude that there has been a steady increase in the number and percentage of observational studies that make causal conclusions about the efficacy of an intervention. Research concerning COVID-19, regardless of methodology, has seen a sharp rise in dissemination as measured through Altmetric's social media score and subsequent citations.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.