Principles & Applied Sciences (FRCA Box) Flashcards
Define “critical incident”
Any event which results in actual harm or would do so if not actively managed.
Which organisation is responsible for co-ordinating national reporting of critical incidents and disseminating info learned?
National Patient Safety Agency
What are the stages of critical incident reporting? (7)
- Notification (via Trust intranet to risk management dept)
- Investigation
- Analysis
- Conclusions
- Implementation of action
- Feedback to staff (MM meeting)
- Monitoring of actions
What info should be given to patient taking part in clinical trial?
- Study title and invitation
- Reason for trial
- Details of patient involvement
- Explanation of randomisation, risks & benfits
- Assurance of confidentiality
- Ability to refuse / withdraw
- Involvement of other parties (eg pharma company)
- Subject’s GP informed
- Researcher’s name and contact details
- Any conflict of interest (commercial, political)
Clinical Trial: Design Features (7 steps)
- Subject selection:
- Groups should be matched (age, sex, ASA)
- Inclusion / exclusion criteria defined
- Selection bias to be avoided - Sample size
- Must be appropriate to avoid Type 1 and Type 2 errors
- Power = ability to reveal a difference of a particular size; should be calculated before study commences. - Randomisation and blinding
- by computer-generated program (reduces bias) - Data collection
- Guidelines drawn up
- small number of appropriately trained collectors
- machinery / monitors tested and calibrated - Statistical evaluation
- Establish type of data and apply appropriate tests - Endpoint
- Determined either by total number studied or periodic analysis of results - Publication / Interpretation
- comprehensive account of methods
- raw data available for analysis
- statistical significance does not equal clinical significance
EBM: Grades of Evidence
I - High quality meta-analysis or systematic review of RCTs
II - RCTs
III - Experimental studies without randomisation
IV - Well designed non-experimental studies
V - Expert opinion / case reports
EBM: Recommendations
A - Consistent level I studies
B - Consistent level II/III studies
C - IV evidence or extrapolation from II/III
D - V / inconclusive or inconsistent studies
EBM: Phases of pharmacological clinical trials
Pre-clinical studies: in-vivo
Phase 0 - Human micro dosing - sub-therapeutic dose to 10-15 subjects
Phase I - Small group (20-50) healthy volunteers. Assess safety, tolerability, PK & PD.
Phase II - 200-300 patients
Phase III - Multicentre RCTs to define efficacy
Phase IV - Post marketing surveillance trials to detect rare / long-term adverse effects.
Define “systematic review” and “meta-analysis”
Systematic review - a method to confirm or refute an effect from a number of RCTs that individually may have been too small to demonstrate.
Meta-analysis: the statistical tool that aggregates this data
What is the Methodology of a systematic review and meta-analysis? (7)
- Pose a question
- Define trial inclusion criteria
- Systematic search for studies - may include abstracts and unpublished studies
- Authors may need to be contacted for raw data
- Studies are individually weighted for size (ie power) and quality
- Results displayed as Forest plot (x axis: trials, y axis: odds ratio)
- Odds ratio (95% CI) crossing 1 indicates no statistical significance.
Advantages of meta-analysis (2)
- Can produce consensus on a number of trials with contradictory findings.
- May result in higher statistical significance where none existed individually
Disadvantages of meta-analysis (6)
- Credibility damaged if included RCTs are based on different populations
- Flaws in methodology may be carried from individual studies to systematic review
- Searching may be subject to publication bias (funnel plot used to uncover this)
- Double counting may occur (same data published in multiple papers)
- Coding and decision to include study is subjective
- Potential COI (no ethical approval needed)
Consent requires (3): (AAGBI 2006)
- Patient to have capacity to understand and remember relevant info and options
- Full disclosure of relevant info
- Autonomy to make voluntary decision even if it seems irrational
Legal considerations re consent (5):
AAGBI 2006
- Performing procedure without consent may be interpreted as battery
- Inadequate counselling when obtaining consent may result in charge of negligence
- Treating Dr is responsible for ensuring patient is consented
- Significant risks should be discussed in accordance with Bolam principle
- Refusal of treatment in a competent adult is legally binding, even if it results in death
Process of consent (6):
AAGBI 2006
- May be written, verbal, implied or expressed
- Info provided: procedure, indications, risks - common and rare but serious
- Patients given opportunity to ask questions; honest answers provided
- Formal signed consent not required but recommended for invasive procedures or those with significant risk (e.g. CVP lines)
- Documentation is paramount where no formal writted consent (e.g. conversion to GA in LSCS)
- Qualified consent: where patient reuses certain aspects of treatment (e.g. Jehovah’s witness)
Define “clinical risk”
The potential of for an unwanted outcome
5 stages of clinical risk management
- Awareness - that complexity of healthcare has inherent risks
- Identification (prospective / retrospective)
- Assessment - of risk magnitude
- Management - plans / strategies to minimise risk
- Re-evaluation - continuous process of review
Sources of risk to anaesthetized patients (4)
- Actions/inactions of anaesthetist
- Actions/inactions of surgeon
- Failure/malfunction of equipment
- Organisational risks
Ways to reduce risk to patients: Anaesthetist / Surgeon related (8):
- Training:
- competency-based training
- Formal exam-based assessments
- Appropriate supervision of trainees - Simulators / training devices
- Training to deal with rare life-threatening emergencies - Continuing medical education
- Avoidance of fatigue
- EWTD for doctors’ hours - Vigilance re drug/alcohol abuse
- Anaesthetic / surgical planning
- Checklists / guidelines and protocols
- Minimum monitoring standards (AAGBI)
- Throat packs - Critical incident / SUI reporting
- All Trusts submit data to NPSA; allowing publication of ‘Patient Safety Alerts’
- Highlights areas of danger (e.g. similar plastic vials of potassium and saline)
Ways to reduce risk to patients: Theatre related (3):
- WHO surgical checklist
- 3 phased checklist
- ‘Sign in’ prior to induction to identify anaesthetic risk
- ‘Time out’ prior to incision; confirms consent, surgeons concerns, abx, DVT prophylaxis
- ‘Sign out’ before patient leaves OR; includes count of surgical instruments and concerns for recovery - Standardisation of hospital wristbands
- Marking of surgical site at same time as consenting patient before leaving ward
Ways to reduce risk to patients: Anaesthetic equipment related (3):
- Regular equipment checks - by anaesthetists, ODPs
- Protocols: course of action if equipment fails
- Development of equipment to reduce risks: pre-filled epidural mixtures; catheters with unique syringe connectors to avoid inadvertent iv administration of LA
Ways to reduce risk to patients: Organisation related:
- Endure high quality employment practice (locum procedures; reviews of individual and team performance)
- Provision of safe environment (estates, privacy)
- Well designed policies on public envolvement
- Regular audit and governance meetings
7 Pillars of Clinical Governance
P atient and public involvement I nformation and IT R isk management A udit T raining and education E ffectiveness in clinical care S taff Management
Malnutrition: definition (3)
- BMI <18.5
- Unintentional weightloss >10% in 3-6m
- BMI <20 with unintentional weightloss >5% in 3-6m
Malnutrition: risk factors (5)
- Elderly
- Alcoholism
- Chronic illness
- GIT surgery / disease
- Mental illness (incl. anorexia)
Malnutrition: implications (8)
- Decreased wound healing
- Weakness (incl respiratory muscles)
- Anaemia
- Immunological compromise
- Hypoproteinaemia
- Dehydration
- Electrolyte disturbance
- Hypothermia
Malnutrition: identifying patients (3)
NICE 2006
- Screen BMI on admission
- Consider nutritional support for those at risk
- Specialist nutrition nurse in all Trusts
Malnutrition: Aneas implications
- Take thorough history: drug/alcohol/eating habits
- FBC, UandEs, LFTs, Phos, Mg2+, Ca2+, glucose - correct abnormalities
- ECG (arrhythmia risk: long QT, AV block, ST depression)
- Careful positioning - avoid tissue / nerve damage)
- Monitor temp; avoid hypothermia
- Altered drug metabolism
- Prolonged block from NDMRs if electrolyte abN
- Increased ‘free drug’ due to decreased drug binding if low alb.
- Metabolism / clearance affected by ↑↓BMR
Alcohol intoxication:
- Annual cost to NHS
- DD (3)
- Complications (4)
(CEACCP 2009)
- £3bn
- HI, coma, drug OD
- Confusion, agitation, psychomotor impairment, inability to give informed consent
Chronic alcohol abuse: CVS effects (4)
Cardiomyopathy
Heart failure
HTN
Arrhythmias
Chronic alcohol abuse: CNS effects (3)
Wernicke-Korsakoff
Peripheral neuropathy
Autonomic dysfunction
Chronic alcohol abuse: GI effects
ALD
Pancreatitis
Gastritis
Oesoph / bowel CA
Chronic alcohol abuse: Metabolic effects
Hyperlipidaemia Obesity Hypoglycaemia Low K+ Low Mg++ High urea
Chronic alcohol abuse: Heamatological effects
Macrocytosis
Low plts
Leucopoenia
Chronic alcohol abuse: MSK effects
Myopathy
Osteoporosis
Osteomalacia
COPD is characterised by:
- Chronic bronchitis (cough with productive sputum for at least 3/12 on 2 consecutive years)
- Emphysema (permanent destructive enlargement of airspaces distal to the terminal bronchioles without obvious fibrosis)
Causes of COPD (3)
Smoking
Occupational exposure
Genetic causes
Smoking: Acute effects (3)
- Nicotine stimulation of SNS: tachycardia and HTN
- Decreased O2 delivery due to COHb
- Resulting in increased cardiac workload
Smoking: Chronic RS effects (3)
- COPD: due to increased proteases and decreased anti-proteases such as a1-antitrypsin
- Increased airway resistance and reactivity
- Increased post op respiratory complications
Smoking: Chronic CVS effects (3)
IHD
PVD
Decreased wound healing and graft success
Smoking: Chronic CNS effects
Addiction
Increased risk of aneurism rupture
Benefit of peri-op smoking cessation (4)
12-24h: decreased COHb and nicotine
48-72h: Increased sputum production
2/52: decreased sputum, increased airway reactivity (bronchoconstriction, laryngospasm)
8/52: ↓post-op RS complications
Smoking: Pre-op measures (4 headings)
- History:
- pack-years
- Ex tol, dyspnoea, cough, sputum
- ?IHD, HTN
- Meds
- Hospital / ITU admissions - Examination
- Dyspnoea, resp pattern
- Heart failure, PVD - Investigations
- Bloods: FBC - ↑WCC, polycythaemia
- ABG: hypoxia, CO2 retention
- CXR - emphysema, bullae, malignancy
- ECG: ?ischaemia/ infarct, ventricular strain
- PFTs: Predictors of post-op ventilation:
i) FEV1<1L
ii) FEV2/FVC <50%
iii) PaCO2 >7kPa - Pre-op optimisation:
- Cessation ideally 2/12 before surgery
- Physiotherapy
- Optimise meds
- Treat infections
- Consider CPEX if major surgery
Smoking: Intra-op risks and measures (5)
- RA where poss (↓ intubation / vent and ↓post-op resp complications
- ↑ coughing, laryngospasm and desaturation on induction and emergence.
- Histamine-releasing drugs (atracurium) ↑ risk of bronchospasm
- Large doses of opioids may impair resp function in CO2 retaining patients
- Spontaneous ventilation may be difficult (airway irritability)
- consider NDMR and IPPV
- pneumothorax more common with bullae, N2O
Smoking: Post-op (5)
- Extubate and recover sitting up (beware CO2 retainers and prolonged high flow O2)
- Elective HDU/ITU if severe COPD
- Adequate analgesia ↓ post-op respiratory complications
- Early physio and ambulation
- Regular bronchodilators until fully mobile
Drug abuse: anaes considerations (5)
- High index of suspicion in all patients req emergency / trauma surgery
- Alcohol abuse + complications may co-exist
- CNS depressants may complicate pt presenting with ↓GCS
- Stimulants (amph, cocaine) may cause hallucinations, psychoses, tachycardia, increased volatile/ induction requirements
- Consider chronic effects: hepatic impairment, enzyme induction, cardiomyopathy
IV drug abuse: complications (5)
- Sepsis
- Thrombophlebitis
- endocarditis
- Difficult iv access
- Difficult post-op pain control - discuss management pre-operatively (e.g. RA)
Drug abuse: Peri-op management (5)
- Early involvement of drug-dependency team
- Full infective precautions
- Consider ↑↓ requirements for analgesia / anaesthesia
- RA where possible
- Acute pain team involvement
Crack / Cocaine considerations (6)
- Adrenergic-receptor stimulant derived from Erythroxylon coca plant
- May precipitate widespread vasospasm → arrhythmias, Ao dissection, IHD, coronary a. spasm, intracerebral events, sudden death
- Inhalation may → pulm oedema and haemorrhage
- Intra-arterial injection may → limb / organ ischaemia
- Pre-op: consider stabilisation on ITU with vasodilators, anti-HTN, anti-arrhythmics
- Peri-op: invasive monitoring, avoid vasopressors if poss.
Hepatitis: Definition + causes (4)
Def: Inflammn of liver from any cause
Causes:
- Infective: viral (A,B,C,D,E), bacterial (leptospirosis), protozoal (toxoplasmosis)
- Drug-induced: idiosyncratic (MAOIs), dose-related (alcohol)
- Metabolic: Wilson’s, pregnancy
- CV: RH failure, severe HTN
Hep B: Cause
DNA virus
Vertical transmission, blood, body secretions
Hep B: Symptoms (5)
Fever GIT symptoms raised LFTs hepatomegaly jaundice
Hep B: Prevention
- Active immunisation (anti-HBs) of high risk groups
- Passive immunisation 0-7 days after exposure (Ig)
- Screening of blood for transfusion
- Universal precautions
Sequelae of carrier state Hep B and C
Hep B: hepatic failure, hepatocellular CA
Hep C: Cirrhosis (20-30y post-exposure), hepatocellular CA
HIV: 20% of all HIV patients will have anaesthetic - commonly for (4):
Lymph node biopsies
Splenectomies
Parital colectomies
CVP line insertion
HIV pathophysiology (4)
- Retroviral lentivirus
- Contains reverse transcriptase viral RNA→DNA in corporated into host genome)
- Infects + destroys CD4+ T-Lymphocytes
- Reduces host immunity
HIV stages of disease
I - Acute seroconversion (asymptomatic with high viral load)
II - Asymptomatic infection (median time to AIDS = 10y)
III - Persistant generalised lymphadenopathy
IV - Symptomatic HIV infection
HIV detection
anti-HIV IgG via ELISA
HIV RNA detection
HIV treatment
- Nucleoside reverse transcriptase inhibitors (NRTIs) e.g. Zidovudine
- Non-nucleoside reverse transcriptase inhibitors (NNRTIs) e.g. Nevirapine
- Protease inhibitors (PIs) e.g. Saquinavir
Note: poor compliance due to SEs and complicated regimes
Pre-op assessment of patient with AIDS: RS (5)
- Opportunistic infections:
- Fungal (PCP, aspergillosis, candidiasis)
- Bacterial (TB, atypical mycobacter, strep, staph)
- Viral (CMV, hepetic) - Cavitating lung disease (TB, abscess)
- Kaposi’s sarcoma, lymphoma
- ABGs, spirometry
- Consider post-op ITU
Pre-op assessment of patient with AIDS: CVS (4)
- Opportunistic infection (endocarditis, esp if IVDU)
- Myocarditis + dilated cardiomyopathy
- Arrhythmias (secondary to brainstem infection)
- ECG + echo
Pre-op assessment of patient with AIDS: GIT (3)
- D+V
- Anorexia
- Check + correct electrolytes
Pre-op assessment of patient with AIDS: CNS (5)
- Opportunistic infections: Cryptococcus, mycobacter
- Encephalitis (HSV) + meningitis
- Neoplasia
- Polyneuropathy
- HIV-related dementia
Pre-op assessment of patient with AIDS: Haem (4)
- ↓Hb, ↓plts, ↓WCC
- Additional steroids may be needed for those treated for peripheral neuropathy
- IVDUs - poor access
- Drug interactions
Pre-op assessment of patient with AIDS: Obstetrics (3)
Vertical transmission (~25%) reduced by:
- Antiretrovirals at delivery
- Elective LSCS
- Abstaining form Br feeding (risk 10-20%)
HIV: risk to anaesthetist (2)
- Needlestick injury - 0.3%
2. Mucocutaneous transmission - 0.03%
HIV transmission: risk reduction (4)
- Universal precautions
- Gloves reduce transmission by 10-100x
- Disposable equipment
- Post-exposure prophylaxis (ideally within 1-2h)
Prion disease: Pathophysiology (5)
- Small proteinaceous particles
- Cause Bovine Spongiform Encephalitis (BSE) and variant Creuzfeldt-Jakob Disease (vCJD) in humans.
- Progressive neurological symptoms + death occur within months
- Highest concentration of prion protein: brain, spinal cord, posterior eye
- Also detected post-mortem in: appendix, tonsils, spleen, GI lymph nodes
Prion disease: prevention of transmission (4)
- Prions are resistant to deactivation by most sterilisation procedures
- Currently no reliable method to sterilise equipment
- Washing may reduce prion conc exponentially: 10-20 cycles may render infections risk to negligible
- Fibre-optic endoscopes:
- Cannot be autoclaved
- Glutaraldehyde disinfection has no effect on prions
- Sodium hydroxide would need damaging concentrations
Prion Disease: Anaesthetic management of suspected CJD (4)
- High risk procedures: tonsillectomy + adenoidectomy
- High index of suspicion
i) Clinical features suggestive of CJD
ii) Recipients of hoemones derived from human pituitary glands or human dura mater grafts - Universal precautions, full aseptic techniques
- Single-use disposable instruments especially laryngoscope blades
