Performance and Evaluation for CT Colonography Screening

NCT02892721 | Completed DMC

• 1 other identifier: RD16/055
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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).

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Keywords

CT Colonography; Virtual colonoscopy; Colorectal cancer; Colon cancer; Training

Outcome Measures

Primary Outcomes (1)

• 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.

  One month after intervention

Secondary Outcomes (8)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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.

Training with feedback

OTHER

See intervention description

Other: Training with feedback

Interventions

Training with feedback OTHER

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.

Training with feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Radiologists who do not routinely report CT colonography scans.
• This study is limited to NHS staff and does not involve any patients.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• University College London Hospitals: collaborator

Study Sites (1)

LNW Healthcare NHS Trust

Harrow, Middlx, HA1 3UJ, United Kingdom

Location

Related Publications (10)

• Pickhardt PJ, Hassan C, Halligan S, Marmo R. Colorectal cancer: CT colonography and colonoscopy for detection--systematic review and meta-analysis. Radiology. 2011 May;259(2):393-405. doi: 10.1148/radiol.11101887. Epub 2011 Mar 17.

  PMID: 21415247 BACKGROUND

• Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003 Dec 4;349(23):2191-200. doi: 10.1056/NEJMoa031618. Epub 2003 Dec 1.

  PMID: 14657426 BACKGROUND

• Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.

  PMID: 18799557 BACKGROUND

• Atkin W, Dadswell E, Wooldrage K, Kralj-Hans I, von Wagner C, Edwards R, Yao G, Kay C, Burling D, Faiz O, Teare J, Lilford RJ, Morton D, Wardle J, Halligan S; SIGGAR investigators. Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial. Lancet. 2013 Apr 6;381(9873):1194-202. doi: 10.1016/S0140-6736(12)62186-2. Epub 2013 Feb 14.

  PMID: 23414650 BACKGROUND

• Stoop EM, de Haan MC, de Wijkerslooth TR, Bossuyt PM, van Ballegooijen M, Nio CY, van de Vijver MJ, Biermann K, Thomeer M, van Leerdam ME, Fockens P, Stoker J, Kuipers EJ, Dekker E. Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):55-64. doi: 10.1016/S1470-2045(11)70283-2. Epub 2011 Nov 15.

  PMID: 22088831 BACKGROUND

• Plumb AA, Halligan S, Taylor SA, Burling D, Nickerson C, Patnick J. CT colonography in the English Bowel Cancer Screening Programme: national survey of current practice. Clin Radiol. 2013 May;68(5):479-87. doi: 10.1016/j.crad.2012.10.018. Epub 2012 Dec 11.

  PMID: 23245277 BACKGROUND

• Plumb AA, Halligan S, Nickerson C, Bassett P, Goddard AF, Taylor SA, Patnick J, Burling D. Use of CT colonography in the English Bowel Cancer Screening Programme. Gut. 2014 Jun;63(6):964-73. doi: 10.1136/gutjnl-2013-304697. Epub 2013 Aug 16.

  PMID: 23955527 BACKGROUND

• McCoubrie P. Metrics in medical education. Ulster Med J. 2010 May;79(2):52-6.

  PMID: 21116419 BACKGROUND

• Halligan S, Altman DG, Mallett S, Taylor SA, Burling D, Roddie M, Honeyfield L, McQuillan J, Amin H, Dehmeshki J. Computed tomographic colonography: assessment of radiologist performance with and without computer-aided detection. Gastroenterology. 2006 Dec;131(6):1690-9. doi: 10.1053/j.gastro.2006.09.051. Epub 2006 Oct 1.

  PMID: 17087934 BACKGROUND

• Obaro AE, Plumb AA, Halligan S, Mallett S, Bassett P, McCoubrie P, Baldwin-Cleland R, Ugarte-Cano C, Lung P, Muckian J, Ilangovan R, Gupta A, Robinson C, Higginson A, Britton I, Greenhalgh R, Patel U, Mainta E, Gangi A, Taylor SA, Burling D. Colorectal Cancer: Performance and Evaluation for CT Colonography Screening- A Multicenter Cluster-randomized Controlled Trial. Radiology. 2022 May;303(2):361-370. doi: 10.1148/radiol.211456. Epub 2022 Feb 15.

  PMID: 35166585 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andrew Plumb, FRCR

  University College London Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: April 20, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: September 10, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)