Sinai Health System, Division of General Internal Medicine, Toronto, ON, Canada.
Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
J Gen Intern Med. 2023 Nov;38(14):3107-3114. doi: 10.1007/s11606-023-08313-1. Epub 2023 Aug 2.
Results from high-profile randomized controlled trials (RCTs) are routinely reported through press release months prior to peer-reviewed publication. There are potential benefits to press releases (e.g., knowledge dissemination, ensuring regulatory compliance), but also potential drawbacks (e.g., selective reporting, positive "spin").
To characterize the practice of press release predating the publication of a drug-related RCT in a peer-reviewed journal ("preemptive press release"), including factors associated with this practice.
DESIGN, SETTING, AND PARTICIPANTS: We systematically reviewed all RCTs of medications published between 2015 and 2019 in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet. Press releases were identified using a systematic search of the grey literature (e.g., press release databases, study sponsor websites). An RCT was considered to have a preemptive press release if the press release was published at least three months (90 days) prior to the date of publication in a peer-reviewed journal.
Presence of preemptive press release, defined as a press-release at least 90 days prior to the date of publication in a peer-reviewed journal. As secondary measures for dissemination, we also assessed citation count and Altmetric score.
We identified 988 RCTs, of which 172 (17%) had a press release published at least 90 days before the date of peer-reviewed publication. Press releases were published a median of 246 days (interquartile range [IQR] 169-366 days) before publication in a peer-reviewed journal. In the multivariable logistic regression model, the strongest predictor of having a preemptive press release was funding by a pharmaceutical company (odds ratio 13, 95% CI 7, 25). Approximately 85% of RCTs with preemptive press releases had a positive primary outcome and, concordantly, 81% of the corresponding press releases had a positive headline. Multivariable regression models identified studies with a preemptive press release had a similar Altmetric score (median - 15, 95% CI - 33, 12) and higher median citation count (median 22 [95% CI 10 to 33] compared to studies without a preemptive press release.
Preemptive press releases were common, most often issued for trials funded by a pharmaceutical company, and typically preceded publication in a peer-reviewed journal by approximately eight months.
高知名度的随机对照试验（RCT）的结果通常会在同行评审发表之前通过新闻发布提前公布。新闻发布有潜在的好处（例如，知识传播，确保法规遵从性），但也有潜在的缺点（例如，选择性报告，积极的“宣传”）。
描述在同行评审期刊上发表药物相关 RCT 之前发布新闻稿的情况（“先发制人的新闻稿”），包括与这种做法相关的因素。
设计、设置和参与者：我们系统地审查了 2015 年至 2019 年期间在《新英格兰医学杂志》（NEJM）、《美国医学会杂志》（JAMA）和《柳叶刀》上发表的所有药物 RCT。使用系统搜索灰色文献（例如，新闻稿数据库、研究赞助商网站）来识别新闻稿。如果新闻稿在同行评审期刊发表日期之前至少提前三个月（90 天）发布，则认为该 RCT 具有先发制人的新闻稿。
存在先发制人的新闻稿，定义为至少提前 90 天在同行评审期刊上发表的新闻稿。作为传播的次要措施，我们还评估了引文计数和 Altmetric 分数。
我们确定了 988 项 RCT，其中 172 项（17%）发布了至少提前 90 天在同行评审出版物上发表的新闻稿。新闻稿在同行评审期刊发表日期之前中位数提前 246 天（四分位距[IQR] 169-366 天）发布。在多变量逻辑回归模型中，有先发制人新闻稿的最强预测因素是制药公司的资助（优势比 13，95%CI 7，25）。大约 85%具有先发制人新闻稿的 RCT 具有阳性主要结果，相应的 81%的新闻稿具有阳性标题。多变量回归模型确定具有先发制人新闻稿的研究具有相似的 Altmetric 分数（中位数-15，95%CI-33，12）和更高的中位数引文计数（中位数 22 [95%CI 10 至 33]与没有先发制人新闻稿的研究相比。
先发制人的新闻稿很常见，大多数是为制药公司资助的试验发布的，通常在同行评审期刊发表之前提前约八个月。
