Null Seeking Trials: Research Method for Surgery and Social Science

by Patrick Mitchell

The null seeking trial is a research technique that was developed in response both to the difficulties of designing, setting up and running randomized trials in surgery and equally to the dilemmas facing surgeons and patients when considering participation in such trials. The specific trials that prompted its development were the above mentionsed SUDEN trial (SUrgical DEcompression for Neuroprotection) and the Surgical Trials of IntraCerebral Haemorrhage (STICH). STICH is a research programme run from Newcastle upon Tyne in England which I joined in 2002 when the first trial was recruiting. The STICH trials are randomized trials comparing surgical removal of brain haemorrhages with nonsurgical treatment. The null seeking trial is still under development. To date no real null seeking trial has been conducted. Various simulations have been run aimed at assessing the method's feasibility but it has not yet been applied. This is because the objective and methods are unfamiliar to most researchers and the kind of research projects that null seeking trials are aimed at are large and expensive collaborative efforts spanning several years. The purpose of this book is to provide the necessary background information for the design and conduct of a null seeking trial. This involves a certain amount of mathematics. Some prior knowledge of statistical and mathematical methods is assumed, at a level appropriate to the general scientific reader. The mathematical techniques used here are primarily those of regression and in particular non-parametric regression. A brief introduction to this subject is included. The null seeking method can be applied to a wide variety of research questions in different disciplines. This book concentrates on its application to the field of surgery. This is simply because it was developed by surgeons in order to solve problems encountered when applying randomized methodology to surgery. I make brief mention of the kind of research question that could be addressed in non-surgical disciplines. Most of the examples cited are from neurosurgery because that it is the subspecialist areas in which the methods were developed.

126 pages, Paperback

First published October 12, 2009