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Determinants of treatment duration in the prevention of recurrent venous thromboembolism: a protocol for a balanced vignette experiment
  1. Vincent Ten Cate1,2,
  2. Brigitte AB Essers3,
  3. Martin H Prins1
  1. 1 Department of Epidemiology, Maastricht University Medical Center, Maastricht, The Netherlands
  2. 2 Maastricht University CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
  3. 3 Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands
  1. Correspondence to Mr Vincent Ten Cate; vincent.ten.cate{at}mumc.nl

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

  • Venous Thromboembolism
  • Secondary Prophylaxis
  • Duration of Treatment
  • Surveys and Questionnaires

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Acknowledgements We extend our gratitude to the thirteen interviewees whose input helped us select risk factors and outcome variables for our vignette experiment. Our thanks also go out to Maastricht University Medical Center’s thrombosis department, Dr Avi Leader of Israel and Dr Michael Nagler of Switzerland for their valuable comments and evaluation of our pilot survey. We further thank Petro van Bergen for his help in recruiting survey participants, the ISTH and the APSTH  for featuring this experiment in their newsletters (October 2016; January 2017). We thank the youth community of the ESC for featuring a call for participation on their youth community’s LinkedIn page. We are grateful to D David McAneny of Boston University, Dr Charles Mahan of the University of New Mexico and Dr José A. López-López of the University of Bristol, whose comments have inspired substantial revision of this manuscript. Lastly, we are indebted to all survey participants for contributing to our research.

  • Contributors VTC and MHP designed the protocol. VTC wrote the protocol. BABE provided helpful input throughout.

  • Competing interests VTC and BABE declare no competing interests. MHP has received research support and honoraria, and participated in advisory boards for Bayer HealthCare, Sanofi-Aventis, Boehringer Ingelheim, GlaxoSmithKline, Daiichi Sankyo, LeoPharma, ThromboGenics, and Pfizer.

  • Provenance and peer review Not commissioned; externally peer reviewed.