5 th National Audit Project of the Royal College of Anaesthetists and Association of Anaesthetists of Great Britain and Ireland NAP5

What is NAP5? A year long national service evaluation of patient reports of Accidental Awareness during General Anaesthesia (AAGA) in the UK…and Ireland

Background 1 Numerous studies report explicit AAGA in 1 : 600 general anaesthetics. With up to 50% of cases developing significant psychological sequelae. Few departments of anaesthesia recognise these numbers The face validity of this is questioned - where are all these cases?

Background 2 Many studies are old and precede newer drugs, reduction in use of NMBA, use of TIVA, depth of anaesthesia monitors, etc. There are no large cohorts of ‘aware patients’ from which learning has taken place (most big studies patients) National approaches to prevention and management of AAGA is poorly mapped. The psychological and medicolegal impact of AAGA is poorly mapped.

We aim…… To identify all reports of AAGA over one year and to learn as much as possible from those reports, both quantitatively and qualitatively. To look for themes and to learn from both reports of AAGA and actual AAGA events

AAGA reports and events We all recognise that not all patient reports of anaesthetic awareness do in fact relate to an event that was genuine anaesthetic awareness. While some reports genuinely describe AAGA others, however genuinely reported, relate to events such as awareness during sedation or dreaming after anaesthetic emergence. A very small number may be made up. Irrespective of this NAP5 will collect all new patient reports of AAGA for a period of one year. As part of the local investigation and data reporting processes it will be clear which were actually AAGA events.

The NAP5 challenge Consciousness is difficult to define Consciousness is invisible We do not know the neurophysiology of consciousness There is no physiological consciousness centre We do not know whether the state of consciousness is a continuum or categorical in nature We have no unitary explanation for how and when anaesthetics work We have no genuine ‘consciousness monitor’ and therefore cannot as such measure it

An AAGA report occurs when a patient 1, makes a new statement, report or complaint implying that awareness was experienced 2 while the patient expected to be therapeutically unconscious? 1 or their carer or legal representative or a healthcare worker on their behalf 2 this could range from an innocent passing comment to a member of staff, without concern on part of the patient, to a formal legal complaint or letter that is very specific in its description Definition 1: AAGA report

Note: the report must be a first report NAP5 would like to be notified of all new reports of AAGA. If the patient has previously described this report of AAGA to a healthcare worker or hospital/department the report is not eligible for NAP5 The report of AAGA must take place during the year of data collection (1 st June st May 2013), though the anaesthetic care may be provided before the data collection period.

Exclusions If there has been no mention of 'awareness‘, ‘waking’ 'consciousness' or words with a similar sense (when the patient expected to be unconscious), and no part of the statement mentions that level of awareness is an issue, the case is not relevant to NAP5. For example, if the complaint concerns only experience of pain or other distress (not during general anaesthesia e.g. in recovery) then this is not relevant to NAP5

The case requires a specific surgical or medical intervention in which 'anaesthesia care' was provided? 'anaesthesia care' is interpreted in the broadest sense, ranging from monitored anaesthesia care (i.e. where the anaesthetist is on standby for purposes of resuscitation) to sedation to general anaesthesia, given by any type of practitioner Definition 2: ‘anaesthesia care’

An AAGA event is an instance of recall of events during general anaesthesia (ie after induction, during surgery or before full emergence) whether with or without pain or distress. This includes any complaint/statement ranging from a patient mentioning they have been aware to a member of a medical team (but not being perturbed by it) to a formal written complaint to the Trust/Board made by a patient extremely unhappy with their experiences. Definition 3: AAGA event

Timing The following are included Awareness of events after induction of anaesthesia before surgery started (e.g. airway management) Awareness of intraoperative events Awareness of events after surgery but before full emergence (e.g. airway management) We therefore do include events such as awareness of intubation due to difficult intubation, syringe swaps or wrong drug order errors.

AAGA reports notified to NAP5 Confirmed AAGA events notified to NAP5 (Sizes are indicative: NAP5 will provide new information as to the relative sizes each area) AAGA reports and events AAGA events not notified to NAP5

NAP5 dates Please notify all new reports of AAGA between 1 st June st May 2013 If the report occurs outside these dates it is ineligible for NAP5 NB: the date of the anaesthetic care is not relevant and may have occurred either during the collection period or may have been many years previously.

NAP5 dates 1 st June st May 2013

Data collection period 1 st June 2012 – 31 st May 2013 We wish to capture all new reports of AAGA within this time period. This is not the same capturing all AAGA events occurring during this year. A patient may make a first report of AAGA at any time during the year and this is eligible. The anaesthetic may have been administered during or before this period. If a patient first reports AAGA after 31 st May 2013, even if the anaesthetic occurred within the data collection year this is not eligible.

No change for NAP5….

Aspects of NAP5 identical to NAP3, NAP4….. All of UK invited All UK hospitals have agreed to participate Approvals of process from appropriate regulators Reporting is totally anonymous Reporting process

Approvals 1 The process has been approved by –NRES (National Research Ethics Service: all UK) –PIAG (Patient Information Advisory Group*: England/Wales) –PAGs (Patient advisory groups: Scotland/N Ireland) ie regulatory approvals from DH ‘patient information’ and ‘ethics’ groups. no need for further local approvals (Caldicott, audit dept, R&D) We have sought approval/endorsement from all UK Chief Medical Officers

Approvals 2 HQIP (Healthcare Quality Improvement Partnership) The project has received approval from HQIP for inclusion on its directory of clinical registers and databases. (This may be important to your audit department)

Partners AAGBI and RCoA Lay representatives Royal College of Psychiatrists Association of Cardiothoracic Anaesthetists Association of Paediatric Anaesthetists Group of Anaesthetists of Training Obstetric Anaesthetists Association Society of Intravenous Anaesthesia UK Medical Defence organisations (MDU, MPS)

Changes to the NAP process for NAP5

Changes for NAP5: Breadth of search for AAGA reports Search for cases outside anaesthesia Cases reported to –Surgeons –Nurses –Psychiatrists –Psychologists –PALS –Complaints –Any others

Changes Local co-ordinators extended role Disseminate information Collect data - surveys Support local anaesthetists Monthly return on activity Aid reporting of AAGA reports to NAP5 website Recognised by College/AAGBI as suitable SPA activity

Changes for NAP5: Requirement for monthly return from every hospital indicating number of reports or absence of reports A monthly statement either A This month our sources have identified ‘N’ new reports of AAGA* B This month our sources have identified NO new reports of AAGA * Each of these cases will need to be individually notified to NAP5 for issue of a NAP5 username and password and a full report uploaded.

Changes for NAP5: Ireland Included for the first time Running in parallel

Search for cases outside anaesthesia Anaesthetic department, including acute pain services Intensive care department (if different from above) All surgical departments, including maternity department All medical departments where procedures under anaesthesia or sedation may be conducted All radiology departments where procedures under anaesthesia or sedation may be conducted Any other department which requires anaesthetic services Preoperative nursing where patients may report a previous experience

Search for cases outside anaesthesia (continued) Nursing department, including midwifery and community nursing/midwifery the department needs to be made aware that we are seeking new reports of AAGA Outpatients department where patients may first report their operative experience Trust Risk Management department Trust Complaints department Patient Advice and Liaison Services (PALS) Trust Legal Services department Trust Clinical Governance department Psychiatric and psychological services

What to do if you are notified by a patient, their representative or a healthcare worker of a report of AAGA

Notification of a report of AAGA Most reports should go through the Local Co-ordinator (LC) There is a list of LCs on the NAP5 website – Others may inform the NAP5 team – Once inclusion criteria are met a username and password will be issued to enable on-line data submission via the NAP5 web-site. Data submission is required to be Anonymous

More information: NAP5 website

More information Posters and flyers appearing soon!

Phase 1 NAP5 survey Individual permanent staff’s experiences of AAGA and strategies to prevent or manage due return by 30 th April 2012 (should be completed by now!)

Individual and department forms

What? A year long service evaluation to identify reports of AAGA in the UK Why? Important to patients and anaesthetists When? 1 st June st May 2013 Who? All new reports of AAGA, whether likely to be true AAGA events or not. Where? All NHS hospitals in the UK

Your Local Co-ordinator is XXXXXXX (please complete)

NAP5 lead Prof Jaideep Pandit, Oxford NAP5 co-ordinator Ms Madeline Humphrey, NAP5 NAP5 advisor Dr Tim Cook, Bath AAGBI contactDr William Harrop-Griffiths College contactMs Sharon Drake, RCoA

FAQs

A patient tells an anaesthetist during a pre-op assessment that they were aware during a previous anaesthetic. The patient can state the hospital, date and operation. It is important to identify if this is the first time the patient has mentioned this event to a healthcare worker (i.e. it is a new report). If it is, the case should be reported to NAP5: please report as much details as you have to your local co-ordinator who will contact the local co-ordinator of the hospital where the reported event took place. If it is not the first time the patient has disclosed this information it does not meet NAP5 entry criteria.

A patient tells an anaesthetist during a pre-op assessment that they were aware during a previous anaesthetic. The patient cannot state the hospital, date or operation. If this is the first time the patient has mentioned this event to a healthcare worker (i.e. it is a new report) this case should be reported to NAP5 but clearly all that can be reported is the patient’s reported experience. This will be made easy during the upload of data.

A recovery nurse mentions that a patient the previous week said in passing they were aware. She cannot recall the date, the patient or any details that help in identify the case. Is this reportable to NAP5? This case should be reported if the patient can be identified, and we would hope an effort would be made to do this. However if you are not able to confirm this report and identify the patient the case cannot be reported to NAP5.

Sedation A patient reports unexpected consciousness after sedation delivered by an anaesthetist or a non-anaesthetist Using our definition (slide 8 and 9-12) this is technically a report of AAGA even though it is highly unlikely to be an AAGA event. The issue here is patient expectation and understanding of their experience. If the patient expected to be unconscious and was not it therefore meets inclusion criteria. Please report the case. During the reporting process you will have the opportunity to explain these details. The reason to collect these cases is to identify what proportion of reports of AAGA arise during sedation because of a disconnect between the expectations of the patient and the care-giver.

Children and their parents Patients with diminished capacity and their carers The parent of a child or the carer of a child (or a patient with diminished capacity) raises concerns indicating that they believe that have experienced AAGA. NAP5 includes patients of all ages and all capacities. This is a report of AAGA by a ‘patient’s representative’ and therefore meets inclusion criteria.

ICU1 A patient who is ‘lightened’ for weaning recalls this as distressing. Reports of AAGA during periods of stay in ICU where patients are sedated only for purpose of lung ventilation are excluded unless they relate to a specific intervention performed whilst there.

ICU2 A case of AAGA is reported from ICU where it would be reasonable to assume the patient was intended to be anaesthetised (e.g tracheostomy, transfer) Reports of AAGA during periods of stay in ICU where patients were intended to be anaesthetised are included

On June 1 st 2012 a patient tells you about AAGA that they experienced at a previous date. The report falls within the collection period even though the event did not. It should be reported to NAP5 (provided it is the first report of the experience of AAGA).

On June 1 st 2013 a patient tells you about AAGA that they experienced a few months ago. The report falls outside the collection period even though the event fell within the period. It should not be reported to NAP5. No reports of AAGA are to be collected after 31 st May 2013.

The Trust legal department (or other dept) have received a complaint but have quarantined* the patient case notes. What shall we do? First, you can usefully explain to them that the anaesthetic department does need to examine the case anonymously in line with good clinical governance practice. Second, you may also explain the background and nature of NAP5 including its absolute security and anonymity. Third, notify the case to NAP5 and if all efforts fail when you upload the report to the NAP5 website report all information you do have and explain the circumstances that limit this. *Quarantining is done to ensure the notes are not changed, not to restrict access to clinicians for clinical needs

How to find your LC Or LCs in other hospitals Visit Click on hospital name and can LC of any hospital

NAP5 moderator Please discuss any case that you are not certain about inclusion /exclusion. The moderator will have no other roles in NAP5 and is not involved in the review of cases.

NAP5 contacts Website LC Website NAP5 team NAP5 lead College NAP advisor

More Information RCoA Bulletin March 2012 Anaesthesia News March 2012

All you need to remember is.. Any 1 st report of AAGA between 1June May 2013 Inform your LC XXXXXXXX Also can contact Nap5 co-ordinator XXXXXX (nap5 moderator) Jaideep Pandit (nap5 lead) Tim Cook (nap advisor) Send no patient details

What? A year long service evaluation to identify reports of AAGA in the UK Why? Important to patients and anaesthetists When? 1 st June st May 2013 Who? All new reports of AAGA, whether likely to be true cases of AAGA or not. Where? All NHS hospitals in the UK

Thanks for your support End