Changing case Order to Optimise patterns of Performance in Screening (CO-OPS) Trial

ISRCTN ISRCTN46603370
DOI https://doi.org/10.1186/ISRCTN46603370
Secondary identifying numbers 13796
Submission date
26/03/2013
Registration date
26/03/2013
Last edited
11/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Sian Taylor-Phillips
Scientific

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email S.Taylor-Phillips@warwick.ac.uk

Study information

Study designRandomised; Interventional; Design type: Screening
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleChanging case Order to Optimise patterns of Performance in Screening (CO-OPS) randomised trial
Study acronymCO-OPS
Study objectivesWe 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(s)West Midlands Research Ethics Committee, First MREC approval date 27/06/2012, ref: 12/WM/0182
Health condition(s) or problem(s) studiedTopic: National Cancer Research Network; Disease: Breast cancer
InterventionChanging 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 typeOther
Primary outcome measureCancer detection rate; Timepoint(s): 1 year
Secondary outcome measures1. 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 study start date20/12/2012
Completion date01/09/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsPlanned Sample Size: 44; UK Sample Size: 44
Key inclusion criteriaThe 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)
Key exclusion criteriaExclusion 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.
Date of first enrolment20/12/2012
Date of final enrolment01/09/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

University House
Kirby Corner Road
Coventry
CV4 8DS
England
United Kingdom

Website http://www2.warwick.ac.uk/
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 10/01/2014 Yes No
Results article results 10/05/2016 Yes No

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.