Second film-readers and Test threshold relaxation in Breast Screening
Research type
Research Study
Full title
Patient Outcomes from Second film-readers and Test threshold relaxation in Breast screening: Observational retrospective cohort evaluation (POSTBOx)
IRAS ID
240292
Contact name
Sian Taylor-Phillips
Contact email
Sponsor organisation
University of Warwick
Clinicaltrials.gov Identifier
NIHR No:CDF-2016-09-018, NIHR Career Development Fellowship; ODR1718_062, ODR Application; BSPRAC_0016, Breast Screening Programme Research Advisory Committee
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The aim of this research is to understand how previous changes to breast cancer screening have impacted on women’s outcomes following screening. The changes to be investigated are the addition of a second reader to independently examine the mammograms for signs of cancer, and the reduction of recall threshold which means that more women are called back for further tests.
This project involves linking data from all Breast Screening Centres based on three Crystal Reports, NHAIS (for date of death) as well as to the Cancer Registry for more detailed data on tumours and treatment. The full dataset will be fully pseudonymised and sent to the University of Warwick using an ODR approved method via their SFTS (Secure File Transfer System). The data will be saved to an encrypted folder on an IT Services managed server and will follow a System Level Security Policy for secure data storage and processing.
The research has the following objectives:
Objective 1
To measure how the addition of a second reader and change in test threshold affect numbers of cancers detected and number of women over diagnosed and therefore over treated at the final appointment.
Objective 2
To measure how change in test threshold and addition of a second reader affect numbers of interval cancers detected between appointments.
Objective 3
Populate a developed framework which summarises benefits and harms associated with increasing from 1 to 2 readers and the change in recall threshold.
Objective 4
To evaluate the cost and benefits of two changes to breast cancer screening in the NHS
-To evaluate whether one or 2 readers is optimal for screening policy and which approach is cost-effective for the NHS.
-To evaluate which recall threshold is optimal for screening policy and which threshold is cost-effective for the NHS.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0355
Date of REC Opinion
31 Aug 2018
REC opinion
Favourable Opinion