With every year more people are living for longer with and beyond cancer. This presents a societal challenge as we look to deliver care that maximises the quality of life with and beyond cancer. Many of the growing cohort of cancer survivors report significant unmet whilst there is incomplete understanding of long term service needs, consequences of treatment, and appropriateness of aftercare services.

This project is funded by Macmillan Cancer Support to develop a clearer picture of what happens to people leaving with and beyond cancer and the costs involved.  We will study non-identifiable data that is securely linked from GP, community and hospital records. The linkage enables a better view of patient’s health before the cancer diagnosis, the impact of cancer treatment of subsequent health and wellbeing, and the associated costs.  In addition, we will collect patient reported outcomes through the use of PROMS.

The aim is to allow patients, through such research, to benefit from the information within routinely collected data. Patient involvement is therefore central to guiding the success of the project, which has patient representation on the investigator team. The project has sought views from patient groups including the Cancer Research UK Leeds Centre’s Public and Patient Involvement in Research Group that advised:

“We all think that the ethical considerations have been dealt with very properly and that this is a good use of existing data.”

 

Project Approvals

The first stage of the project links and analyses non-identifiable data from GP, community and hospital records. This stage has been successfully reviewed by the NHS Research Ethics Council and approved by the NHS Health Research Authority Approvals (IRAS project ID 188345 REC reference 16/NE/0155). This was informed by local review by the data sources and the IRC Information Security Management System.

 

Data Flow

The non-identifiable data for the first stage of the project comes from two electronic health data sources:

– Patient hospital records and financial data held at the Leeds Teaching Hospitals NHS Trust to support patient care. This is significantly more detailed than national registry data.

GP and community records data that is opted in to ResearchOne, a non-identifiable research database held by The Phoenix Partnership (TPP). TPP maintain electronic health records for over 5,000 UK healthcare organisations.

The data is encrypted and transferred to the Integrated Research Campus (IRC) – a secure research environment within the MRC Medical Bioinformatics Centre at the Leeds Institute of Data Analytics at University of Leeds. A third discrete organisation, the IRC Data Services Team, will link the data using digests (rather than identifiers) created using a process called OpenPseudonymiser. Data will remain securely in the IRC with approved access by the research team.

The data flow protocol (IRAS project ID 188345 REC reference 16/NE/0155) may be adapted for use by other projects.

Project Data Flow Protocol

Data Flow Diagram

The IRC Information Security Management System supports the project’s data handling approach.

 

Project Team

The project, funded by Macmillan Cancer Support, is a multidisciplinary partnership including clinicians, health economists, data scientists, biostatisticians and – centrally – patients.

Team List

Geoff Hall – Principle Investigator, Senior Lecturer in Medical Oncology, University of Leeds

Adam Glaser – Principle Investigator, Professor of Paediatric Oncology, University of Leeds

Barbara Woroncow – Patient and Public Involvement Co-investigator

David Wilkinson – Deputy Patient and Public Involvement Co-investigator

Chris Bates – Head of Informatics and Analytics, TPP

Paul Baxter – Associate Professor in Biostatistics, University of Leeds

Mike Bennett – St Gemma’s Professor of Palliative Medicine, University of Leeds

Chris Bojke – Chair in Health Economics, University of Leeds

Samantha Crossfield – Research Fellow and Data Analyst, University of Leeds

Jon Fistein – Clinical Research Fellow, University of Leeds

Thomas Fleming – Data Services Manager, University of Leeds

Peter Hall – Senior Clinical Lecturer, University of Edinburgh

Jenny Hewison – Professor of the Psychology of Healthcare, University of Leeds

Claire Hulme – Professor of Health Economics, University of Leeds

Una Macleod – Professor of Primary Care Medicine, Hull York Medical School

Adam Martin – Research Fellow in Health Economics, University of Leeds

John Parry – Clinical Director, TPP

Chris Smith – Senior Research Fellow and Data Scientist, University of Leeds

Galina Velikova – Professor of Psychosocial and Medical Oncology, University of Leeds

Penny Wright – Associate Professor in Psychosocial Cancer, University of Leeds