Condition category
Cancer
Date applied
26/03/2013
Date assigned
26/03/2013
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In breast cancer screening, mammograms (x-ray images) are taken of women’s breasts and examined for signs of cancer. In the NHS Breast Screening Programme each woman’s 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 women’s 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 women’s 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 women’s 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
-
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 women’s 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 measures

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

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

http://www2.warwick.ac.uk/

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

Federal/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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24411004
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27163985

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

11/05/2016: Publication reference added. 17/09/2013: the overall trial end date was changed from 30/04/2014 to 01/09/2014 and the target number of participants was changed from 36 to 44. The trial was initially submitted for ISRCTN registration on 24/10/2012. It received ethical approval on 27/06/2012 and was approved by the NIHR portfolio on 03/03/2013. Recruitment of participants started on 20/12/2012 and ISRCTN registration was finalised on 26/03/2013.