Lexchin J, Holbrook A
Emergency Department, Toronto Hospital, Ont.
CMAJ. 1994 Jul 1;151(1):47-54.
To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ).
Analytic study.
All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ.
Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement.
Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%.
Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.
评估《加拿大医学协会杂志》(CMAJ)上药品广告参考文献的方法学质量和相关性。
分析性研究。
CMAJ第146卷中前22则不同药品广告所引用的全部114篇参考文献。
每则广告中所有参考文献的平均方法学质量评分(根据美国内科医师学会《医学期刊俱乐部》用于评估文章的6分制修改而来)和平均相关性评分(基于新的5分制)。
22家公司中有20家做出回应,提供了所要求的87篇参考文献中的78篇(90%)。平均方法学质量评分为58%(95%置信区间[CL]为51%和65%),平均相关性评分为76%(95%CL为72%和80%)。这两个平均分在统计学上低于可接受的80%评分(p<0.05),且方法学质量评分超出了预设的15%临床显著差异范围。方法学质量评分较低主要是因为引用了低质量综述文章和“其他”来源(即临床试验报告以外的来源)的参考文献。一半的广告方法学质量评分低于65%,但只有5则广告相关性评分低于65%。
尽管大多数参考文献的相关性在最低可接受范围内,但方法学质量往往不可接受。由于广告是药品营销和教育的重要组成部分,我们建议公司制定广告的书面标准,并监督广告是否符合这些标准。我们还建议药品广告咨询委员会制定更严格的广告指南,并以一致、严格的方式执行这些指南。