Use of Routine Databases in the Design and Analysis of Surgical Trials

Linda Sharples

London School of Hygiene and Tropical Medicine

Thursday 5th October 2017

14:00:00

Aula Consiglio VII Piano - Edificio 14, Dipartimento di Matematica POLITECNICO DI MILANO

A number of features of surgical interventions make their evaluation in randomised trials more difficult. For example, new procedures may be technically difficult to deliver so that surgical performance takes time to stabilise and outcomes may vary over time and between different surgeons. Moreover, there is a lack of trials culture among surgeons, so that efficient designs that are acceptable to the community are required. This talk will review some of the practical and technical issues involved in evaluations of surgical interventions, focusing on our work on the use of routine databases to explore learning curves, clustering between surgeons and the multiple component nature of the interventions. Some implications for design and analysis will be discussed and the limitations will be illustrated through the AMAZE trial in cardiac surgery patients who have a history of atrial fibrillation (irregular heart rhythm). Contact: francesca.ieva@polimi.it

L. Sharples is Professor of Medical Statistics at London School of Hygiene and Tropical Medicine, Honorary Professor of Statistics at Leeds Institute of Clinical Trials Research, and Visiting Researcher at MRC Biostatistics Unit, University of Cambridge. First class degree in Maths, PhD in Bayesian Statistics for hierarchical models, 30 years experience working in medical statistics, with 15 years as a MRC programme leader, developing statistical methodology for health technology assessment and applications to cardiac and thoracic diseases.