Minimising paper: electronic data capture methods in the 3c study

Richard Haynes

doi:10.1186/1745-6215-14-s1-p60

Abstract

Methods In order to recruit at least 800 patients with minimum disruption to their clinical care a bespoke web-based case report form was developed which allows direct data entry by clinicians during routine clinic visits. Access to the web-based system is secure and randomization was conducted online after collection of a small number of data items to allow minimization. Data are verified at entry to avoid missing or impossible data which reduces the requirement for subsequent checks. In addition to data collected during study visits and annual postal questionnaires, all participants are flagged with national registries which capture all data of interest. The UK Transplant registry provides data to verify baseline characteristics and transplant survival; the UK Renal Registry provides transplant function information; the NHS Information Centre provides cancer and causespecific mortality data and Hospital Episode Statistics provides information on hospitalisations. Such follow-up provides unbiased, comprehensive follow-up information at very low-cost for the lifetime of the participants which allows the 3C Study to provide uniquely reliable information.

Highlights

Minimising paper: electronic data capture methods in the 3c study
Similar methods would be applicable to other clinical areas
Data are verified at entry to avoid missing or impossible data which reduces the requirement for subsequent checks

Summary

Introduction

Minimising paper: electronic data capture methods in the 3c study From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. Objective To establish a cost-effective randomized controlled trial investigating two strategies to improve the long-term function and survival of kidney transplants: The 3C Study (Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy)

Results

Conclusion