Ten Cate Vincent, Essers Brigitte Ab, Prins Martin H
Department of Epidemiology, Maastricht University Medical Center, Maastricht, The Netherlands.
Maastricht University CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
BMJ Open. 2017 May 10;7(5):e015231. doi: 10.1136/bmjopen-2016-015231.
Venous thromboembolism (VTE) is a condition that annually occurs in approximately 1‰ of the world's population. Patients who have already had a VTE are at elevated risk for a recurrent VTE. Recurrent events increase the risk of long-term sequelae and can be fatal. Adequate secondary prophylaxis is thus needed to prevent such events. Patients with VTE are often prone to bleeding, and pharmacological prophylaxis exacerbates bleeding risk. Expert opinions on the optimum duration of secondary prophylaxis in VTE still vary substantially. The existence of treatment guidelines has not led to uniformity of VTE secondary prophylaxis strategies, which means that physicians still adhere to individual risk calculi in determining treatment duration.
The aim of this study is to establish what factors lie at the root of this variance in VTE secondary prophylactic treatment strategies, and what risk factors are deemed of particular importance in determining the perceived risks and benefits of variable treatment durations. To do this, we created a survey based on a D-efficient and G-efficient balanced experimental vignette design. This protocol covers all aspects of how this survey was set up and how it was implemented. The analysis of the experimental data will be carried out using mixed-effects methods, which are beneficial in scenarios with high interindividual variance and correlated (eg, repeated-measures) responses. We propose the use of maximal random effects structures insofar as possible.
All data are de-identified, and any identifying characteristics of the respondents will not be reported in a final manuscript or elsewhere. A paper describing the expert interviews is currently under peer review. A manuscript that contains the analysis of the results of the experiment described in this protocol is being drafted, and will also be submitted to a peer-reviewed journal.
静脉血栓栓塞症(VTE)是一种每年在全球约千分之一人口中发生的疾病。已经发生过VTE的患者发生复发性VTE的风险升高。复发性事件会增加长期后遗症的风险,并且可能是致命的。因此,需要进行充分的二级预防以防止此类事件发生。VTE患者往往容易出血,而药物预防会加剧出血风险。关于VTE二级预防的最佳持续时间的专家意见仍然存在很大差异。治疗指南的存在并未导致VTE二级预防策略的统一,这意味着医生在确定治疗持续时间时仍坚持个人风险计算。
本研究的目的是确定VTE二级预防治疗策略存在这种差异的根本因素是什么,以及在确定不同治疗持续时间的感知风险和益处时,哪些风险因素被认为特别重要。为此,我们基于D效率和G效率平衡实验 vignette设计创建了一项调查。本方案涵盖了该调查的设置和实施的各个方面。将使用混合效应方法对实验数据进行分析,这在个体间差异大且反应相关(例如重复测量)的情况下是有益的。我们建议尽可能使用最大随机效应结构。
所有数据均经过去识别处理,最终稿件或其他地方不会报告受访者的任何识别特征。一篇描述专家访谈的论文目前正在同行评审中。一篇包含本方案中所述实验结果分析的稿件正在起草中,也将提交给同行评审期刊。