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