Principles & Applied Sciences (FRCA Box) Flashcards
(70 cards)
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