Changing case Order to Optimise patterns of Performance in Screening (CO-OPS) Trial
| ISRCTN | ISRCTN46603370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46603370 |
| Protocol serial number | 13796 |
| Sponsor | University of Warwick (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- 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
Plain English summary of protocol
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
Contact information
Scientific
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| S.Taylor-Phillips@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Screening |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Changing case Order to Optimise patterns of Performance in Screening (CO-OPS) randomised trial |
| Study acronym | CO-OPS |
| Study objectives | 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(s) | West Midlands Research Ethics Committee, First MREC approval date 27/06/2012, ref: 12/WM/0182 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cancer detection rate; Timepoint(s): 1 year |
| Key secondary outcome measure(s) |
1. Interval cancer rate; Timepoint(s): 3.5 years |
| Completion date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 44 |
| Key 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) |
| Key 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. |
| Date of first enrolment | 20/12/2012 |
| Date of final enrolment | 01/09/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CV4 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/05/2016 | Yes | No | |
| Protocol article | protocol | 10/01/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
