The National Endoscopy Database (NED) Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) randomized controlled trial design

Abstract

Background and study aims Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates. The United Kingdom’s National Endoscopy Database (NED) automatically captures patient level data in real time and provides endoscopy key performance indicators (KPI) at a national, endoscopy center, and individual level. Using an electronic behavior change intervention, the primary objective of this study is to assess if automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI) improves polyp detection performance.

Methods This multicenter, prospective, cluster-randomized controlled trial is randomizing NHS endoscopy centres to either intervention or control. The intervention is targeted at independent colonoscopists and each center’s endoscopy lead. The intervention reports are evidence-based from endoscopist qualitative interviews and informed by psychological theories of behavior. NED automatically creates monthly reports providing an opadKPI, using mean number of polyps, and an action plan. The primary outcome is opadKPI comparing endoscopists in intervention and control centers at 9 months. Secondary outcomes include other KPI and proximal detection measures at 9 and 12 months. A nested histological validation study will correlate opadKPI to adenoma detection rate at the center level. A cost-effectiveness and budget impact analysis will be undertaken.

Conclusion If the intervention is efficacious and cost-effective, we will showcase the potential of this learning health system, which can be implemented at local and national levels to improve colonoscopy quality, and demonstrate that an automated system that collects, analyses, and disseminates real-time clinical data can deliver evidence- and theory-informed feedback.

Publikationsverlauf

Eingereicht: 16. März 2020

Angenommen: 24. Juni 2020

Artikel online veröffentlicht:
21. Oktober 2020

• References

• 1 Cancer Research UK. Bowel cancer incidence statistics. Cancer Res UK; 2016 https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer/incidence#ref-4
• 2 International Agency for Research on Cancer. Colorectal cancer. 2018 876. 1-2 http://gco.iarc.fr/today
• 3 Snover DC. Update on the serrated pathway to colorectal carcinoma. Hum Pathol 2011; 42: 1-10
• 4 East JE, Atkin WS, Bateman AC. et al. British Society of Gastroenterology position statement on serrated polyps in the colon and rectum. Gut 2017; 66: 1181-1196
• 5 Corley D, Jensen CD, Marks AR. et al. ADR and risk of colorectal cancer and death. N Engl J Med 2014; 370: 2541
• 6 Baxter NN, Sutradhar R, Forbes SS. et al. Analysis of administrative data finds endoscopist quality measures associated with postcolonoscopy colorectal cancer. Gastroenterology 2011; 140: 65-72
• 7 Kaminski MF, Regula J, Kraszewska E. et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-1803
• 8 Barclay RL, Vicari JJ, Doughty AS. et al. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med 2006; 355: 2533-2541
• 9 pohl h, srivastava a, bensen sp. et al. incomplete polyp resection during colonoscopy – Results of the Complete Adenoma Resection (CARE) Study. Gastroenterology 2013; 144: 74-80.e1
• 10 Rees CJ, Thomas Gibson S. et al. UK key performance indicators and quality assurance standards for colonoscopy. Gut 2016; 65: 1923-1929
• 11 Lee TJW, Siau K, Esmaily S. et al. Development of a national automated endoscopy database: The United Kingdom National Endoscopy Database (NED). United Eur Gastroenterol J 2019; 7: 798-806
• 12 Ivers N, Jamtvedt G, Flottorp S. et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012; DOI: 10.1002/14651858.CD000259.pub3.
• 13 Tinmouth J, Patel J, Hilsden RJ. et al. Audit and feedback interventions to improve endoscopist performance: Principles and effectiveness. Best Pract Res Clin Gastroenterol 2016; 30: 473-485
• 14 Gurudu SR, Boroff ES, Crowell MD. et al. Impact of feedback on ADRs: Outcomes of quality improvement program. J Gastroenterol Hepatol 2018; 33: 645-649
• 15 Colquhoun H, Michie S, Sales A. et al. Reporting and design elements of audit and feedback interventions: A secondary review. BMJ Qual Saf 2017; 26: 54-60
• 16 Tuti T, Nzinga J, Njoroge M. et al. A systematic review of electronic audit and feedback: intervention effectiveness and use of behavior change theory. Implement Sci 2017; 12: 61
• 17 Liem B, Gupta N. Adenoma detection rate: The perfect colonoscopy quality measure or is there more?. Transl Gastroenterol Hepatol 2018; 3: 19
• 18 Denis B, Sauleau EA, Gendre I. et al. The mean number of adenomas per procedure should become the gold standard to measure the neoplasia yield of colonoscopy: A population-based cohort study. Dig Liver Dis 2014; 46: 176-181
• 19 Lee T, Rees C, Blanks R. et al. Colonoscopic factors associated with adenoma detection in a national colorectal cancer screening program. Endoscopy 2014; 46: 203-211
• 20 Bretagne J-F, Hamonic S, Piette C. et al. Interendoscopist variability in proximal colon polyp detection is twice higher for serrated polyps than adenomas. World J Gastroenterol 2016; 22: 8549-8557
• 21 Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process 1991; 50: 179-211
• 22 Kluger AN, Denisi A. Effects of feedback intervention on performance: A historical review, a meta-analysis, and a preliminary feedback intervention theory. Psychol Bull 1996; 119: 254-284 DOI: 10.1037//0033-2909.119.2.254.
• 23 Craig P, Dieppe P, Macintyre S. et al. Developing and evaluating complex interventions: New guidance. 2008 www.mrc.ac.uk/complexinterventionsguidance
• 24 Michie S, Richardson M, Johnston M. et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: Building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013; 46: 81-95
• 25 Dolan P, Hallsworth M, Halpern D. et al. Influencing behaviour: The mindspace way. J Econ Psychol 2012; 33: 264-277
• 26 Ivers N. effects on professional practice and healthcare outcomes (Review) Audit and feedback: effects on professional practice and healthcare outcomes (Review). Cochrane Database of Systematic Reviews Audit and feedback; 2012
• 27 Royal College of Physicians JAG on GE (JAG). A framework for managing underperformance and supporting endoscopists – a JAG perspective. 2019 https://www.thejag.org.uk/CMS/UploadedDocuments/Scheme/Scheme5/STG190917%20-%20guidance%20-%20UK%20underperformance%20for%20JAG%20v2.0.pdf
• 28 Sint Nicolaas J, De Jonge V, De Man RA. et al. The Global Rating Scale in clinical practice: A comprehensive quality assurance programme for endoscopy departments. Dig Liver Dis 2012; 44: 919-924
• 29 Denis B, Sauleau EA, Gendre I. et al. The mean number of adenomas per procedure should become the gold standard to measure the neoplasia yield of colonoscopy: A population-based cohort study. Dig Liver Dis 2014; 46: 176-181
• 30 Moore GF, Audrey S, Barker M. et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015; 350: h1258
• 31 JAG accreditation criteria and evidence requirements Version for UK services. 2019 www.thejag.org.uk
• 32 Eccles M, Grimshaw J, Campbell M. et al. Research designs for studies evaluating the effectiveness of change an improvement strategies. Qual Saf Heal Care 2003; 12: 47-52