1. The 2004 Report of the National Confidential Enquiry into Patient Outcome and Death Scoping our Practice

2. Elements of the study Deaths within 30 days of a therapeutic endoscopy Complications (incl. death) following upper GI dilation and tubal prosthesis insertion (includes denominator data) Organisational questionnaire

3. GI therapeutic endoscopy - method All deaths April 2002 - March 2003 reported to NCEPOD Sample cases identified by OPCS codes and included if death occurred within 30 days of procedure Retrospective data - questionnaires and case note extracts

4. Data overview

5. Patient assessment

6. 91% admitted as emergencies 76% had 2 or more comorbidities 74% of deaths were either a ‘definite risk’ or ‘expected’

7. Patient assessment 86% of procedures were appropriate 83% of procedures were timely 9% of procedures were either futile or too late to be of any benefit

8. Recommendation Patients must be assessed by the referring clinician and the endoscopist to justify that the procedure is in the patient’s interest. (Professional specialist associations)

9. Training and education

10. Experience 74% of procedures performed by consultants, some doing less than 20/ year 94% appropriate grade 91% appropriate experience

11. Training and education Supervision 88% - senior endoscopist in hospital 18% - direct supervision Audit 78% of procedures in hospitals that held audit meetings 26% of cases reviewed

12. Recommendations There should be national guidelines for assuring continuing competency in endoscopy. (Professional specialist associations) All endoscopy units should perform regular audit and all deaths during, or within 30 days of, therapeutic endoscopy should be reviewed. (Local hospitals; Professional specialist associations)

13. Recommendations (cont.) All those responsible for the administration of sedation should have received formal training and assessment. (Local hospitals)

14. Patient consent

15. Consent

17. Recommendation The risks and benefits of therapeutic endoscopy should be explained to the patient, and this should be documented on the consent forms as laid down in the Department of Health guidelines. (Local hospitals)

18. Consent 16% of patients studied had dementia or acute confusion

19. Recommendation The ability of those with dementia or acute confusion to provide consent should be tested and clearly documented. (Local hospitals)

20. Sedation and monitoring

22. 14% of patients received inappropriate sedation 14% of those that received sedation required a reversal agent afterwards

23. A patient with severe alcoholic liver disease, Childs-Pugh C, and bacterial peritonitis had undergone previous gastroscopies for bleeding. Bleeding continued and an endoscopist who had received training in sedation, performed what was the patient’s second gastroscopy in two days. Sedation comprised IV midazolam 5mg and further IV midazolam 2mg. Pulse oximetry was recorded as 87-91% during the whole of the procedure and flumazenil was used to reverse the effects of midazolam following it.

24. Sedation and monitoring

25. A patient was admitted with an acute inferior myocardial infarction. Four weeks later the patient suffered a large haematemesis, became hypotensive and their haemoglobin decreased by 2.5 gm/dl. A CVP line was inserted to monitor resuscitation. The next day an endoscopy was performed and adrenaline was injected into two large gastric ulcers. Pulse oximetry and automatic blood pressure were monitored, but ECG was not.

26. Sedation and monitoring

27. Recommendations Sedation and monitoring practices within endoscopy units should be audited and reviewed. (Local hospitals; Professional specialist associations) There should be national guidelines on the frequency and method of the recording of vital signs during the endoscopy. (NPSA; Professional specialist associations)

28. Recommendations (cont.) Clear protocols for the administration of sedation should be available and implemented. (Local hospitals)

29. Percutaneous endoscopic gastrostomy (PEG)

30. PEG Indication Neurological disorders of swallowing Cognitive impairment/depressed consciousness Mechanical obstruction to swallowing Long-term partial failure of intestinal function requiring supplemental intake

31. PEG Profile In 59% of cases the indication included acute neurological disease (stroke/trauma) 82% were  70 years of age 84% were ASA 3 or poorer 95% were elective/scheduled procedures

32. PEG Patient selection and timing 19% of PEG procedures were thought to be futile 40% had a co-existing diagnosis of chest infection 18% had dementia 43% died within 7 days

33. In one case where a patient was over 90 years-of-age an advisor commented: “The PEG placement was technically OK - but the timing was wrong. The patient was very ill, dehydrated and had pneumonia. They should not have had a PEG at this time and died six days later. There is no information about the last few days of life.”

34. Recommendations The decision to use a PEG feeding tube requires an in-depth assessment of the potential benefits to the individual. All patients in whom PEG feeding is proposed should be reviewed by a multidisciplinary team. (NICE) There is a need for more comprehensive national guidelines for the use of PEG feeding, including issues of patient selection. (NICE)

35. Endoscopic retrograde cholangiopancreatography (ERCP)

36. ERCP Profile 82%  70 years of age 77% were ASA 3 or poorer 87% received prophylactic antibiotics 68% were considered futile

37. ERCP Procedure 97% performed by consultants 11% of cases by endoscopist who performed < 50 ERCPs/year 92% involved the biliary tract

38. ERCP Complications In 9% of cases during the procedure 64% of patients had one or more complications in the 30 days following ERCP

39. Recommendation Patients should be reviewed by the consultant endoscopist before therapeutic ERCP to ensure that the procedure is appropriate and the patient’s condition has been optimised. (Local hospitals)

40. Oesophagogastroduodenoscopy (OGD)

41. OGD Profile 44% of sample cases 61%  70 years of age 44% bleeding varices 35% stricturing disease in oesophagus 20% ulcer disease

42. OGD Treatment sclerotherapy, coagulation, banding Complications haemorrhage, respiratory and cardiac

43. Upper GI haemorrhage

44. 86% needed emergency/urgent endoscopy In 89% of cases there was a definite or expected risk of death 94% of endoscopists were GI specialists 25% had both topical anaesthesia and intravenous sedation

45. Upper GI haemorrhage 92% of cases were appropriate and timely and in the correct location for both procedure and recovery 73% had good ‘overall’ care clinical factors organisational factors

46. An elderly patient with cirrhosis (no cause stated) and ischaemia related biventricular failure presented with a haematemesis that was not considered to be severe by the admitting clinician as the “urea is only 6.5”. The patient was tachypnoeic, tachycardic and hypotensive. Before endoscopy, the patient did not receive either supplemental oxygen or intravenous fluids - which in view of the cardiac condition should have been governed by central venous monitoring.

47. Recommendations Only experienced endoscopists should treat patients with upper GI haemorrhage. Experience will vary by grade but competence should be assessed by the supervising consultant. (Local hospitals)

48. Recommendations (cont.) Optimising the patient’s pre-endoscopy condition will reduce both morbidity and mortality. Early involvement of an anaesthetist/intensivist if necessary will assist this. (Local hospitals)

49. Pathology

50. Reporting deaths to the coroner and autopsy rates Total autopsies - 144 (8% of all deaths)

51. Autopsy rates comparison NCEPOD study 27% deaths reported 30% accepted for autopsy England & Wales national averages - all deaths 38% deaths reported 58% accepted for autopsy

52. Evaluable autopsy reports Clinical history present in 86% of cases (increase on previous NCEPOD studies) Gross description ‘satisfactory’ or better in 89% of cases (increase) Histology taken in 37% of cases (increase) Clinico-pathological summary absent or poor in 44% of cases (same)

53. ONS cause of death formulation 1a. Disease, due to 1b. Disease, due to 1c. Fundamental pathological cause of death 2. Other diseases contributing to death, but not the main cause

54. ONS Wrong structure = 13% Wrong cause of death = 34%

55. Main deficiencies in cause of death Omitting the operative procedure Lazy thinking on sequence of events Leaving out fundamental pathology (e.g. cancer) Attributing death to ‘ischaemic heart disease’ instead - convenient but probably not true

56. In an otherwise excellent report, including histology, of a patient who died of cholangiocarcinoma, and who also had documented 60-70% stenoses of the coronary arteries, the cause of death was stated to be: 1a. Myocardial insult due to anaemia following ERCP (August 2002) 1b. Ischaemic heart disease Better would be: 1a. Cholangiocarcinoma (ERCP August 2002) 2. Ischaemic heart disease

57. Recommendations The operative procedure should be included in the cause of death statement. (Undergraduate and post-graduate deans; ONS) Post-procedure deaths (i.e. those occurring during or within 24 hours of anaesthesia or sedation or those where it is known that the procedure is implicated in the death) should be reported to the coroner. (Local hospitals)

58. Recommendations (cont.) Pathologists should think more carefully about all the clinical circumstances of a death, to produce an autopsy report more useful for clinical governance and audit. (Professional specialist associations particularly the Royal College of Pathology) NCEPOD supports the reforms of the coronial and death certification systems, which will result in better scrutiny of deaths. (Home Office)

59. Additional recommendations

60. Organisational issues Hospitals should ensure that the appropriate monitoring equipment and resuscitation equipment is available in each of their endoscopy rooms and recovery areas. (Local hospitals; Primary Care Trusts) In order to produce optimal care for what is a large group of severely ill patients, hospitals should consider establishing formal on-call arrangements. (Local hospitals)

61. Upper GI dilation and tubal prosthesis insertion A national audit across all specialties of specific techniques and equipment that is used for upper GI dilation and tubal prosthesis insertion is indicated. (NPSA)

62. The future for NCEPOD

63. Changes Responsibility for the confidential enquiries passed from NICE to the NPSA -April 2005 Bulletin board

64. Studies in progress Medical admissions into intensive care - May 11th 2005 Abdominal aortic aneurysms (Oct ‘05) Emergency admissions (Oct’ 06) Coronary artery bypass grafts Sickle cell and thalassaemia

65. Studies in progress (cont.) Severely injured patients Coronial autopsies