Di Girolamo N, Giuffrida M A, Winter A L, Meursinge Reynders R
EBMVet, Via Sigismondo Trecchi, 20, Cremona CR 26100, Italy.
University of California Davis, Surgical & Radiological Sciences, Davis, California, USA.
Vet Rec. 2017 Aug 19;181(8):195. doi: 10.1136/vr.104035. Epub 2017 May 9.
To evaluate randomisation mechanisms in the veterinary literature, all trials defined as 'randomised' were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if the random sequence generation was actually non-random, and (2) whether method (CONSORT item 8A) and (3) type of randomisation (CONSORT item 8B) were reported. Trialists were contacted via email to establish (1) willingness to respond to questions on randomisation procedures, (2) whether reporting of randomisation improved following a suggestion to use the CONSORT 2010 guideline. Seven per cent ((95 per cent CI 2 to 12 per cent); 8/114) of the trials defined as 'randomised' explicitly used methods that are considered non-random. Almost half of the trials (49 per cent (40 to 59 per cent); 52/106) did not report any mechanism of randomisation. Only 13 trials (12.3 per cent (6 to 19 per cent); 13/106) reported both items. 39 of 114 (34.2 per cent) trialists contacted were willing to respond to further questions on randomisation mechanisms; 4 (3.5 per cent) trialists were unwilling and 71 (62.3 per cent) trialists did not respond. Email correspondence resulted in a mean clarification of 0.7 items (95 per cent CI 0.4 to 1.0) for the 15 trials for trialists that replied. Improved adherence to CONSORT guidelines and trialists communication is imperative to increase the quality of published evidence in veterinary medicine and to reduce research waste.
为评估兽医文献中的随机化机制,从2013年的五份主要兽医期刊中提取了所有定义为“随机化”的试验。三名盲法研究者评估了:(1)随机序列生成是否实际上是非随机的;(2)方法(CONSORT条目8A)是否被报告;(3)随机化类型(CONSORT条目8B)是否被报告。通过电子邮件联系试验者,以确定:(1)他们是否愿意回答有关随机化程序的问题;(2)在建议使用CONSORT 2010指南后,随机化报告是否有所改进。定义为“随机化”的试验中有7%(95%CI为2%至12%;8/114)明确使用了被认为是非随机的方法。几乎一半的试验(49%(40%至59%);52/106)未报告任何随机化机制。只有13项试验(12.3%(6%至19%);13/106)报告了这两项内容。在联系的114名试验者中,39名(34.2%)愿意回答有关随机化机制的进一步问题;4名(3.5%)试验者不愿意回答,71名(62.3%)试验者未回复。对于回复的试验者所涉及的15项试验,电子邮件通信平均使0.7项(95%CI为0.4至1.0)得到了澄清。必须提高对CONSORT指南的遵守程度以及与试验者的沟通,以提高兽医学发表证据的质量并减少研究浪费。