The 2004 Report of the NationalConfidential Enquiry into PatientOutcome and Death

Scoping our

Practice

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

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

Data overview

Patient assessment

Patient assessment

• 91% admitted as emergencies• 76% had 2 or more comorbidities• 74% of deaths were either a

‘definite risk’ or ‘expected’

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

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)

Training and education

Training and education

Experience• 74% of procedures performed

by consultants, some doing less than 20/ year

• 94% appropriate grade • 91% appropriate experience

Training and education

Supervision• 88% - senior endoscopist in

hospital• 18% - direct supervisionAudit• 78% of procedures in hospitals that

held audit meetings• 26% of cases reviewed

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)

Recommendations (cont.)

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

Patient consent

Consent

Consent

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)

Consent

16% of patients studied had dementia or acute confusion

Recommendation

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

Sedation and monitoring

Sedation and monitoring

Sedation and monitoring

• 14% of patients received inappropriate sedation

• 14% of those that received sedation required a reversal agent afterwards

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.

Sedation and monitoring

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.

Sedation and monitoring

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)

Recommendations (cont.)

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

Percutaneous endoscopic gastrostomy (PEG)

PEG

Indication• Neurological disorders of swallowing• Cognitive impairment/depressed

consciousness• Mechanical obstruction to swallowing• Long-term partial failure of intestinal

function requiring supplemental intake

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

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

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.”

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)

Endoscopic retrograde cholangiopancreatography

(ERCP)

ERCP

Profile• 82% 70 years of age• 77% were ASA 3 or poorer• 87% received prophylactic

antibiotics• 68% were considered futile

ERCP

Procedure• 97% performed by consultants• 11% of cases by endoscopist who

performed < 50 ERCPs/year• 92% involved the biliary tract

ERCP

Complications• In 9% of cases during the

procedure• 64% of patients had one or more

complications in the 30 days following ERCP

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)

Oesophagogastroduodenoscopy (OGD)

OGD

Profile• 44% of sample cases• 61% 70 years of age• 44% bleeding varices• 35% stricturing disease in

oesophagus• 20% ulcer disease

OGD

Treatment• sclerotherapy, coagulation,

banding

Complications• haemorrhage, respiratory and

cardiac

Upper GI haemorrhage

Upper GI haemorrhage

• 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

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

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.

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)

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)

Pathology

Reporting deaths to the coroner and autopsy rates

Total autopsies - 144 (8% of all deaths)

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

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)

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

ONS

• Wrong structure = 13%• Wrong cause of death = 34%

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

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

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)

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)

Additional recommendations

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)

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)

The future for NCEPOD

Changes

• Responsibility for the confidential enquiries passed from NICE to the NPSA -April 2005

• Bulletin board

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

Studies in progress (cont.)

• Severely injured patients• Coronial autopsies