Duty of Candour legislation in post-colonoscopy colorectal cancer: a prospective cohort study

Abstract

Background

This study investigated the application of Duty of Candour (DoC) legislation in the context of post-colonoscopy colorectal cancers (PCCRCs). DoC mandates transparent disclosure of notifiable safety incidents to patients in the English National Health Service, including incidences leading to severe or moderate harm. This study aimed to analyze the application of DoC in PCCRCs, improve understanding of the legislation, and identify challenges in DoC implementation.

Methods

A national audit of PCCRCs was conducted between September 2021 and May 2022. PCCRCs were identified using linked administrative datasets, and root-cause analyses were performed using structured templates. “Avoidability” and harm were categorized into specific levels, and guidance was provided on improving consistency in judgments.

Results

16% of 1724 PCCRCs resulted in major harm or death, of which 27% (75) were probably or definitely avoidable. Hospitals deemed DoC discharge necessary in only 53% of these cases. When including moderate harm, 11% of all PCCRCs would trigger DoC discharge, yet this was deemed necessary in only 45% of such cases.

Conclusions

There is inconsistent application of DoC in PCCRC cases. Challenges include determining “avoidability” and harm, particularly when diagnosis is delayed. Clearer guidance and definitions of harm are needed to improve adherence to regulations.

Publikationsverlauf

Eingereicht: 25. Februar 2024

Angenommen nach Revision: 16. Oktober 2024

Accepted Manuscript online:
16. Oktober 2024

Artikel online veröffentlicht:
27. November 2024

• References

• 1 Care Quality Commission. Regulation 20: Duty of candour. 2015 Zugriff am 02. Januar 2024 unter: https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-20-duty-candour
• 2 Dyer C. Plymouth trust is first to be fined for breaching duty of candour rules. BMJ 2020; 370: m3737
• 3 Rutter MD, Beintaris I, Valori R. et al. World Endoscopy Organization consensus statements on post-colonoscopy and post-imaging colorectal cancer. Gastroenterology 2018; 155: 909-925.e3
• 4 Burr NE, Derbyshire E, Taylor J. et al. Variation in post-colonoscopy colorectal cancer across colonoscopy providers in English National Health Service: population-based cohort study. BMJ 2019; 367: l6090
• 5 Burr N, Beaton D, Trudgill N. et al. O27 English national root-cause analysis of post-colonoscopy colorectal cancers. Gastrointest Endosc 2023; 97 (Suppl. 06) AB138-AB139
• 6 Anderson R, Burr NE, Valori R. Causes of post-colonoscopy colorectal cancers based on World Endoscopy Organization system of analysis. Gastroenterology 2020; 158: 1287-1299.e2
• 7 Kaminski MF, Wieszczy P, Rupinski M. et al. Increased rate of adenoma detection associates with reduced risk of colorectal cancer and death. Gastroenterology 2017; 153: 98-105
• 8 Corley DA, Jensen CD, Marks AR. et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med 2014; 370: 1298-1306
• 9 NHS England. Policy guidance on recording patient safety events and levels of harm. 2023 Zugriff am 02. Januar 2024 unter: https://www.england.nhs.uk/long-read/policy-guidance-on-recording-patient-safety-events-and-levels-of-harm/#definitions-harm-grading
• 10 Government of Ireland. Scoping inquiry into the CervicalCheck screening programme: supplementary report. 2019 Zugriff am 02. Januar 2024 unter: https://www.gov.ie/en/publication/9fac6c-scoping-inquiry-into-the-cervicalcheck-screening-programme-supplemen/
• 11 Kachalia A. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med 2010; 153: 213
• 12 Basu S, Marcus H, Sayal P. et al. Implementation of duty of candour within neurosurgery: a national survey and framework for improved application in clinical practice. Ann R Coll Surg Engl 2020; 102: 144-148
• 13 The Royal College of Radiologists. Professional duty of candour. Guidance for radiologists. 2022 Zugriff am 02. Januar 2024 unter: https://www.rcr.ac.uk/our-services/all-our-publications/clinical-radiology-publications/professional-duty-of-candour-guidance-for-radiologists/
• 14 Kamran U, King D, Abbasi A. et al. A root cause analysis system to establish the most plausible explanation for post-endoscopy upper gastrointestinal cancer. Endoscopy 2023; 55: 109-118
• 15 Royal College of Surgeons of England. Duty of candour. 2015 Zugriff am 19. Juli 2024 unter: https://www.rcseng.ac.uk/standards-and-research/standards-and-guidance/good-practice-guides/duty-of-candour/