Plain English Summary
Background and study aims
In breast cancer screening, mammograms (x-ray images) are taken of womens breasts and examined for signs of cancer. In the NHS Breast Screening Programme each womans mammograms are examined separately by two radiologists, who each indicate if there should be recall for further tests. This is a highly skilled but repetitive activity where radiologists examine batches of 30-50 womens mammograms in each session. A decrease of performance has been observed over time in similar repetitive visual tasks, such as searching a radar screen for enemy aircraft. The current practice is for both radiologists to examine each batch of mammograms in the same order as one another, so their performance decrease would occur when looking at the same womens mammograms. We plan to run an experiment to test whether the two radiologists examining batches in a different order to one another increases the number of cancers detected. The idea is to make sure that optimal performance for the first and second radiologist happen when examining different womens mammograms, to improve overall cancer detection rates.
Who can participate?
Breast screening centres in England (UK).
What does the study involve?
In the intervention group, batches of mammograms will be presented to the two radiologists in the opposite order (one in appointment order and one in reverse appointment order). In the control group, the two radiologists will be presented with the mammograms in the same order. The main outcome will be whether there are more cancers detected in the intervention group than the control group.
What are the possible benefits and risks of participating?
The potential benefits are if the intervention is successful then it will result in fewer cancers being missed in the NHS breast screening programme. Participating centres will be sent a summary of results. The potential risk is that if successful the intervention will result in a larger number of disagreements and so a larger number of cases requiring arbitration review.
Where is the study run from?
University of Warwick (UK).
When is the study starting and how long is it expected to run for?
The study started in December 2012 and will run until September 2014.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Sian Taylor-Phillips
S.Taylor-Phillips@warwick.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sian Taylor-Phillips
ORCID ID
Contact details
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
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S.Taylor-Phillips@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13796
Study information
Scientific title
Changing case Order to Optimise patterns of Performance in Screening (CO-OPS) randomised trial
Acronym
CO-OPS
Study hypothesis
We plan to run an experiment to test whether having two radiologists examine batches of mammograms in a different order to one another increases the number of cancers detected. The idea is to make sure that optimal performance for the first and second radiologist happen when examining different womens mammograms, to improve overall cancer detection rates.
Ethics approval
West Midlands Research Ethics Committee, First MREC approval date 27/06/2012, ref: 12/WM/0182
Study design
Randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Disease: Breast cancer
Intervention
Changing case order: Presenting batches of mammograms in the opposite order to the two readers (one in appointment order and one in reverse appointment order)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Cancer detection rate; Timepoint(s): 1 year
Secondary outcome measures
1. Interval cancer rate; Timepoint(s): 3.5 years
2. Rate of disagreements between readers; Timepoint(s): 1 year
3. Recall rate; Timepoint(s): 1 year
Overall trial start date
20/12/2012
Overall trial end date
01/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The intervention is a change to breast screening centre systems. So recruitment is at the breast screening centre level. Inclusion criteria are that they are an NHS breast screening centre in England with at least one set of digital mammogrephy equipment used for screening. (The software intervention only works on digital equipment)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 44; UK Sample Size: 44
Participant exclusion criteria
Exclusion criteria are centres who are outside of England, who are not part of the NHS breast screening programme, or do not have any digital mammography equipment.
Recruitment start date
20/12/2012
Recruitment end date
01/09/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
University House
Kirby Corner Road
Coventry
CV4 8DS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24411004
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27163985
Publication citations
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Protocol
Taylor-Phillips S, Wallis MG, Parsons H, Dunn J, Stallard N, Campbell H, Sellars S, Szczepura A, Gates S, Clarke A, Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial., Trials, 2014, 15, 17, doi: 10.1186/1745-6215-15-17.
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Results
Taylor-Phillips S, Wallis MG, Jenkinson D, Adekanmbi V, Parsons H, Dunn J, Stallard N, Szczepura A, Gates S, Kearins O, Duncan A, Hudson S, Clarke A, Effect of Using the Same vs Different Order for Second Readings of Screening Mammograms on Rates of Breast Cancer Detection: A Randomized Clinical Trial, JAMA, 2016 , 315, 18, 1956-1965, doi: 10.1001/jama.2016.5257.