Performance and Evaluation for CT Colonography Screening (PERFECTS)

September 9, 2020 updated by: London North West Healthcare NHS Trust

Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20 individuals, half of whom will die from the disease. Late presentation of CRC has a poor prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate and early diagnosis of CRC is therefore crucial. In most patients this is achieved via colonoscopy, a camera test which is widely available and allows tissue samples to be taken of any abnormalities seen during the procedure. However, a non-invasive alternative is Computed Tomography Colonography (CTC) which uses X-rays to produce images of the large bowel which are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis of CRC (comparable to colonoscopy) and the cancer precursor - adenomatous polyps.

Unlike colonoscopy, however, there is no accreditation process for CTC and there is no infrastructure to ensure that all reporting Radiologists are able to do so adequately and, as a result, there is a wide range of diagnostic accuracy. There are no universally-accepted standards to monitor quality or assess diagnostic performance, partly because we do not know what the quality markers are and there is currently no system to quantify them. Overall, this contributes to low cancer detection rates, missed cancers and inequity for patients across the National Health Service (NHS).

This study aims to assess the impact of a structured training programme with assessment and feedback on NHS radiologist performance. If the impact is positive and results in significantly improved performance, then such a scheme could be adopted into an accreditation programme for CTC in the English Bowel Cancer Screening Programme (BCSP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CT Colonography is a test which can can detect early cancer accurately, however, unlike colonoscopy (or mammography in breast cancer screening) there is currently no formalised program to help ensure Radiologists interpret CTC accurately. Colonoscopists are highly regulated, must be accredited and have ongoing quality assurance metrics, based on evidence linking these to clinical outcomes. Conversely, for CTC in the United Kingdom, there is no accreditation process, little regulatory oversight and no universally-accepted metrics to monitor quality or diagnostic performance.

Radiologists who interpret CTC images are often inexperienced; one-third have interpreted <300 cases in total and 20% report <100 cases per annum (the minimum recommendation). Futhermore, in clinical practice across the NHS Bowel Cancer Screening Programme (NHS BCSP) CTC may have up to a 50% lower cancer and polyp detection rate than colonoscopy. Missed abnormalities at CTC are likely to underpin this difference, as centres with highly experienced radiologists (>1000 cases) using 3-dimensional interpretation have significantly higher detection rates.

There is a Quality Assurance (QA) framework for the NHS BCSP (with an overseeing QA Committee for Radiology) but recommendations are largely based on opinion rather than evidence and any radiologist can report CTC, without accreditation; a fact which our patient representatives find extremely disappointing.

Prior to wide-scale implementation of a possible accreditation programme and to justify both financial and human resource, Public Health England and the British Society of Gastrointestinal and Abdominal Radiologists have mandated that such a program is scientifically proven to improve Radiologist performance. Consequently, this project will investigate training and assessment methods to improve diagnostic accuracy and elucidate the factors associated with higher Radiologist sensitivity.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlx
      • Harrow, Middlx, United Kingdom, HA1 3UJ
        • LNW Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • National Health Service (NHS) Consultant Radiologists or final year Registrars or Fellows in the England or Wales who currently routinely report CT colonography scans.

Exclusion Criteria:

  • Radiologists who do not routinely report CT colonography scans.

This study is limited to NHS staff and does not involve any patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will not receive the one-day training course or access to the online educational module. Test sets will be administered in the same manner as for the intervention group, but the control group will not receive any feedback on performance during the 12 month assessment phase. Feedback on test performance will only be provided after the 12 month period has ended.
Other: Training with feedback
See intervention description
Other: Training with feedback

One-day workshop of face to face training, comprising a mixture of theory and real-world CTC cases. Radiologists will complete four interpretation assessments lasting 2 to 3 hours: one set of 10 CTC cases immediately prior to training and a further test set of 10 immediately after, with tests repeated at 6 and 12 months (using different CTC cases for each set). Radiologists will be asked to identify colorectal cancer and polyps on the scans and complete an online answer form, including questions regarding diagnostic confidence, site of abnormality and management.

The intervention group will receive online, confidential, individualised feedback after each test, which will include a case by case breakdown of their performance with explanatory answers and learning points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in sensitivity between arms
Time Frame: One month after intervention
Difference in sensitivity between intervention and control groups for detection of colorectal cancer / polyps on CT colonography at the 1 month post-intervention test.
One month after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in sensitivity between intervention and controls for colorectal cancer/ polyps at the 12 month post-training test set (i.e. to test longer-term durability of one-off training supplemented by individualized feedback).
Time Frame: Twelve months after intervention
Twelve months after intervention
Difference in specificity between intervention and controls at 1 month.
Time Frame: One month after intervention
One month after intervention
Difference in specificity between intervention and controls at 12 months.
Time Frame: Twelve months after intervention
Twelve months after intervention
Difference in sensitivity between intervention and controls at 6 months.
Time Frame: Six months after intervention
Six months after intervention
Difference in specificity between intervention and controls at 6 months.
Time Frame: Six months after intervention
Six months after intervention
Difference in raw score between the control and intervention arms on the knowledge questions as compared to true answers.
Time Frame: 1 month after intervention
1 month after intervention
Association between interpretation time and diagnostic performance of radiologists on all test sets.
Time Frame: 12 months after intervention and after final test set.
12 months after intervention and after final test set.
Characteristics of radiologists performing well versus those that do not.
Time Frame: After the final test set at 12 months
After the final test set at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Collaborators

University College London Hospitals

Investigators

  • Study Director: Andrew Plumb, FRCR, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD16/055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised participant data will be included in the research analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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