Statistical primer: an introduction into the principles of Bayesian statistical analyses in clinical trials

European Journal of Cardio-Thoracic Surgery, vol. 67

Abstract

Trials in cardiac surgery are often hampered at the design level by small sample sizes and ethical considerations. The conventional analytical approach, combining frequentist statistics with null hypothesis significance testing, has known limitations and its associated P-values are often misinterpreted, leading to dichotomous conclusions of trial results. The Bayesian statistical framework may overcome these limitations through probabilistic reasoning and is subsequently introduced in this Primer. The Bayesian framework combines prior beliefs and currently obtained data (the likelihood), resulting in updated beliefs, also known as posterior distributions. These distributions subsequently facilitate probabilistic interpretations. Several previous cardiac surgery trials have been performed under a Bayesian framework and this Primer enhances the understanding of their basic concepts by linking results to graphical presentations. Furthermore, contemporary trials that were initially analysed under a frequentist framework, are re-analysed within a Bayesian framework to demonstrate several interpretative advantages.

Authors 6

1. Samuel Heuts corresponding

   Maastricht University Medical Centre · Maastricht University

   Affiliation as printed

   Cardiovascular Research Institute Maastricht (CARIM), Maastricht University , Maastricht,

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+) , Maastricht,

   Cardiovascular Research Institute Maastricht (CARIM) , , Maastricht, the

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+), Maastricht, the

   Maastricht University , , Maastricht, the

2. Michal J. Kawczynski

   Maastricht University Medical Centre · Maastricht University

   Affiliation as printed

   Cardiovascular Research Institute Maastricht (CARIM), Maastricht University , Maastricht,

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+) , Maastricht,

   Cardiovascular Research Institute Maastricht (CARIM) , , Maastricht, the

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+), Maastricht, the

   Maastricht University , , Maastricht, the

3. Bart J.J. Velders Aachen Department of Cardiothoracic Surgery

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Cardiothoracic Surgery, Leiden University Medical Centre , Leiden,

   Leiden University Medical Centre Department of Cardiothoracic Surgery, , Leiden, the

4. James M. Brophy

   McGill University Health Centre

   Affiliation as printed

   McGill University Health Centre, Centre for Health Outcome Research (CORE) , Montreal, QC,

   McGill University Health Centre, Centre for Health Outcome Research (CORE) , Montreal, Quebec,

5. Graeme L. Hickey

   Medtronic (United States)

   Affiliation as printed

   Structural Heart and Aortic, Medtronic , Minneapolis, MN,

   Structural Heart and Aortic , Medtronic, Minneapolis, MN,

6. Mariusz Kowalewski

   Maastricht University Medical Centre · Ministry of Interior and Administration · National Medical Institute of the Ministry of Interior and Administration

   Affiliation as printed

   Department of Cardiac Surgery and Transplantology, National Medical Institute of the Ministry of Interior and Administration , Warsaw,

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+) , Maastricht,

   Department of Cardiothoracic Surgery, Maastricht University Medical Centre (MUMC+), Maastricht, the

   National Medical Institute Department of Cardiac Surgery and Transplantology, of the Ministry of Interior and Administration, Warsaw,