Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

ABSTRACT:

Introduction

Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled).

Objective

This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.

Methods and analysis

We have identified three distinct type

SUBMITTER: Blencowe NS 

PROVIDER: S-EPMC6429900 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature