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Performance and Evaluation for CT Colonography Screening (PERFECTS)

Primary Purpose

Colonic Neoplasms, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Training with feedback
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colonic Neoplasms focused on measuring CT Colonography, Virtual colonoscopy, Colorectal cancer, Colon cancer, Training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • LNW Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control group

Training with feedback

Arm Description

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.

See intervention description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 2, 2016
Last Updated
September 9, 2020
Sponsor
London North West Healthcare NHS Trust
Collaborators
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02892721
Brief Title
Performance and Evaluation for CT Colonography Screening
Acronym
PERFECTS
Official Title
Performance and Evaluation for CT Colonography Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust
Collaborators
University College London Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Colorectal Neoplasms
Keywords
CT Colonography, Virtual colonoscopy, Colorectal cancer, Colon cancer, Training

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Training with feedback
Arm Type
Other
Arm Description
See intervention description
Intervention Type
Other
Intervention Name(s)
Training with feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in sensitivity between arms
Description
Difference in sensitivity between intervention and control groups for detection of colorectal cancer / polyps on CT colonography at the 1 month post-intervention test.
Time Frame
One month after intervention
Secondary Outcome Measure Information:
Title
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
Title
Difference in specificity between intervention and controls at 1 month.
Time Frame
One month after intervention
Title
Difference in specificity between intervention and controls at 12 months.
Time Frame
Twelve months after intervention
Title
Difference in sensitivity between intervention and controls at 6 months.
Time Frame
Six months after intervention
Title
Difference in specificity between intervention and controls at 6 months.
Time Frame
Six months after intervention
Title
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
Title
Association between interpretation time and diagnostic performance of radiologists on all test sets.
Time Frame
12 months after intervention and after final test set.
Title
Characteristics of radiologists performing well versus those that do not.
Time Frame
After the final test set at 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Plumb, FRCR
Organizational Affiliation
University College London Hospitals
Official's Role
Study Director
Facility Information:
Facility Name
LNW Healthcare NHS Trust
City
Harrow
State/Province
Middlx
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised participant data will be included in the research analysis.
Citations:
PubMed Identifier
21415247
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
derived

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Performance and Evaluation for CT Colonography Screening

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