Kastner Monika, Menon Anita, Straus Sharon E, Laupacis Andreas
Li Ka Shing Knowledge Institute (LKSKI) of St, Michael's Hospital, Toronto, ON, Canada.
BMC Res Notes. 2013 Oct 14;6:414. doi: 10.1186/1756-0500-6-414.
To identify published letters to the editor (LTE) written in response to randomized controlled trials (RCTs), determine the topics addressed in the letters, and to examine if these topics were affected by the characteristics and results of the RCTs.
Comparative cross-sectional study of a representative sample of RCTs from a set of high-impact medical journals (BMJ, Lancet, NEJM, JAMA, and Annals of Internal Medicine). RCTs and their published LTE were searched from these 5 journals in 2007. Data were collected on RCTs and their characteristics (author affiliation, funding source, intervention, and effect on the primary outcome) and the topics addressed in published LTE related to these RCTs. Analysis included chi-square and regression analysis (RCT characteristics) and thematic analysis (LTE topics).
Of 334 identified RCTs, 175 trials had at least one LTE. Of these, 381 published LTE were identified. Most RCTs, tested drug interventions (68%), were funded by government (54%) or industry (33%), and described an intervention that had a positive impact on the primary outcome (62%). RCT authors were primarily affiliated with an academic centre (78%). Ninety percent of the 623 LTE topics concerned methodological issues regarding the analysis, intervention, and population in the RCT. There was a significant association between funding source and impact on outcomes (p = 0.002) or type of intervention tested (p = 0.001) in these trials. Clinical and "Other" LTE topics were more likely to be published in response to a government funded RCT (p = 0.005 and p = 0.033, respectively); no other comparisons were significant.
This study showed that most LTE are about methodological topics, but found little evidence to support that these topics are affected by the characteristics or results of the RCTs. The lack of association may be explained by editorial censorship as a small proportion of LTE that are submitted are actually published.
识别针对随机对照试验(RCT)撰写的已发表的读者来信(LTE),确定信件中涉及的主题,并研究这些主题是否受到RCT的特征和结果的影响。
对一组高影响力医学期刊(《英国医学杂志》《柳叶刀》《新英格兰医学杂志》《美国医学会杂志》和《内科学年鉴》)中具有代表性的RCT样本进行比较横断面研究。2007年在这5种期刊中检索RCT及其发表的LTE。收集RCT及其特征(作者单位、资金来源、干预措施以及对主要结局的影响)的数据,以及与这些RCT相关的已发表LTE中涉及的主题。分析包括卡方检验和回归分析(RCT特征)以及主题分析(LTE主题)。
在334项已识别的RCT中,175项试验至少有一封LTE。其中,识别出381封已发表的LTE。大多数RCT测试药物干预措施(68%),由政府(54%)或行业(33%)资助,并描述了对主要结局有积极影响的干预措施(62%)。RCT作者主要隶属于学术中心(78%)。623个LTE主题中有90%涉及RCT分析、干预措施和研究人群的方法学问题。在这些试验中,资金来源与对结局的影响(p = 0.002)或所测试干预措施的类型(p = 0.001)之间存在显著关联。临床和“其他”LTE主题更有可能是针对政府资助的RCT发表的(分别为p = 0.005和p = 0.033);其他比较均无显著性。
本研究表明,大多数LTE是关于方法学主题的,但几乎没有证据支持这些主题受到RCT的特征或结果影响。缺乏关联可能是由于编辑审查,因为提交的LTE中只有一小部分实际发表。