PERFECTS: Performance and Evaluation for CT Colonography Screening

Sponsor

London North West Healthcare NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02892721

Collaborator

University College London Hospitals (Other)

139

Enrollment

Location

Arms

35.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms Colorectal Neoplasms	Other: Training with feedback	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Performance and Evaluation for CT Colonography Screening

Actual Study Start Date :

Apr 20, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Difference in sensitivity between arms [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.

Secondary Outcome Measures

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). [Twelve months after intervention]
Difference in specificity between intervention and controls at 1 month. [One month after intervention]
Difference in specificity between intervention and controls at 12 months. [Twelve months after intervention]
Difference in sensitivity between intervention and controls at 6 months. [Six months after intervention]
Difference in specificity between intervention and controls at 6 months. [Six months after intervention]
Difference in raw score between the control and intervention arms on the knowledge questions as compared to true answers. [1 month after intervention]
Association between interpretation time and diagnostic performance of radiologists on all test sets. [12 months after intervention and after final test set.]
Characteristics of radiologists performing well versus those that do not. [After the final test set at 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.