Article Text

Download PDFPDF
Establishment of a validated central reading system for ileocolonoscopy in an academic setting
  1. Tim Raine1,
  2. Holly Pavey2,
  3. Wendi Qian2,
  4. Gordon W Moran3,
  5. Sreedhar Subramanian1,
  6. Lizzie Swaby4,
  7. Simon PL Travis5,
  8. Shahida Din6,
  9. Peter M Irving7,8,
  10. James O Lindsay9,
  11. Miles Parkes1,10,
  12. Nicholas A Kennedy11
  1. 1Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  2. 2Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, UK
  3. 3NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK
  4. 4Clinical Trials Research Unit, ScHARR, The University of Sheffield, Sheffield, Sheffield, UK
  5. 5Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  6. 6Edinburgh IBD Unit, Western General Hospital, NHS Lothian, Edinburgh, UK
  7. 7IBD Unit, Guy's and St Thomas' Hospital NHS Trust, London, UK
  8. 8School of Immunology & Microbial Sciences, King's College London, London, London, UK
  9. 9Centre for Immunobiology, Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London, London, UK
  10. 10Department of Medicine, University of Cambridge, Cambridge, UK
  11. 11Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, Devon, UK
  1. Correspondence to Dr Tim Raine, Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK; tim.raine{at}addenbrookes.nhs.uk

Statistics from Altmetric.com

Background

Therapeutic interventions in IBD should alleviate patient symptoms and modify long-term disease outcomes. This second target is hard to demonstrate within the context of typical observational or interventional studies due to problems of sample size and duration of follow-up. Instead, there has been considerable focus on the assessment of mucosal inflammation using validated scoring systems in both Crohn’s disease (CD)1 2 and UC.3 4 Achievement of endoscopic healing correlates with avoidance of long-term disease complications in both CD and UC,5 6 and is an established therapeutic target in addition to the achievement of clinical remission.7

For these reasons, data on endoscopic outcomes are now required by regulatory agencies for any registration trial.8 In addition, endoscopic outcome data may be used in earlier phase trials to guide decisions about further asset development, adding biological context to clinical data.9 Interventions which lead to improvements in symptom scores may not demonstrate improvements in endoscopic outcomes and this additional information may inform or limit placement in treatment paradigms.10 11 Furthermore, the use of endoscopic activity as an inclusion criterion for clinical trials can reduce the high placebo response rates previously reported in trials reliant purely on clinical inclusion criteria, which may mask efficacy signals.12

Key barriers to use of endoscopy in clinical trials include patient acceptability.13 Additionally, there is a need for blinded central reading of all trial endoscopies to ensure standardisation and avoid inadvertent introduction of investigator bias: local endoscopy reads are typically less reliable than blinded central reading by a recognised expert reader.14 Reliance on local readers may even lead to critical errors in trial interpretation.15 Furthermore, use of central readers alone does not completely mitigate against errors of endoscopy reading that may lead to false conclusions about novel interventions,16 …

View Full Text

Footnotes

  • Contributors Study conception and design was done by TR, HP, WQ, JL, MP and NAK. Study was conducted by TR, HP, ES, JL, MP and NAK. Data generation was done by GWM, SS, SPLT, SD, PMI, JL, MP and NAK. Analysis and reporting was performed by TR, HP, JL, MP and NAK. All authors were involved in manuscript writing and gave approval of the final version.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.