What are the Caldicott principles?
- Justify the purpose for use of patient identifiable information
- Only use patient identifiable information if absolutely necessary
- Only use minimum necessary for purpose
- Access should be restricted to “need to know” basis
- Everyone with access should be aware of responsibilities
- Everyone with access should understand and comply with data protection and security legislation
- The duty to share can be as important as the duty to protect patient confidentiality
Justify - Necessary - Minimum - Access - Responsibilities - Legislation - Share
What are the principles in the Data Protection Act?
- Fairly and Lawfully Processed
- Processed for limited purposes
- Adequate, relevant and not excessive
- Accurate and up to date
- Not kept for longer than necessary
- Processed in accordance with right of data subject (can access information, request change)
- Be protected (security measures)
- Not be transferred outside the European Economic Area (EEA)
What are the domains of Good Scientific Practice?
- Professional Practice
- Scientific Practice
- Clinical Practice
- Research, development and innovation
- Clinical Leadership
What does Professional Practice include (domain 1 of GSP)?
- Professional Practice: Make patient priority, work within scope, keep skills and knowledge up to date, do not discriminate
- Probity/moral principles: Inform regulatory bodies if necessary, be open and honest (duty of candour)
- Working with colleagues: Communicate effectively in multi-disciplinary team, take advice, respect skills and contributions, participate in reviews of performance
- Training and development of others: Training, supervision, support colleagues with difficulties, share information
What does Scientific Practice include (domain 2 of GSP)?
- Scientific Practice: Develop investigative strategies, undertake scientific investigations, provide clear reports, critically evaluate data and draw conclusions
- Technical Practice: Provide technical advice, take part in audits, assess new technologies, identify and manage risk, apply good health and safety practice
- Quality: Set, maintain, apply quality standards, make judgements on effectiveness of processes, participate in quality assurance programmes, maintain audit trail
What does Clinical Practice include (domain 3 of GSP)?
- Clinical Practice: Ensure consent, confidentiality, understand clinical consequence of decisions, maintain up to date knowledge, provide expert interpretation and clinical advice based on results, prioritise delivery of investigations, ensure audit is undertaken
- Investigation and reporting: Plan and conduct procedures with professional skill, ensure safety
Consent - Confidentiality - Consequence - Expert - Prioritise - Safety
What does Research, Development and Innovation include (domain 4 of GSP)?
- Critically appraise scientific literature, engage in evidence based practice, participate in audit, identify innovative approaches, participate in research
- Develop, evaluate, validate and verify new procedures, implement new procedures, evaluate research, interpret data in clinical context, present data, support healthcare team
What does Clinical Leadership include (domain 5 of GSP)?
- Maintain responsibility when delegating, respect skills of colleagues, protect patients from risk and harm, treat colleagues fairly and with respect, ensure responsibilities are covered when absent
- Ensure colleagues can raise concerns, review team performance, remedy poor performance, identify and take action to meet development needs of yourself and team
- Act as an ambassador
What are the key principles of the NHS constitution?
- Comprehensive service (available to all)
- Access is based on clinical need not ability to pay
- High standards of excellence and professionalism ensures safe and effective care
- The patient is at the heart of everything - individuals are supported to manage and promote their own health
- NHS works across organisational boundaries
- NHS provides best value for money (most effective, fair and sustainable use of resources)
- NHS is accountable to the public and must be transparent and clear
CAE-PAVA: Comprehensive, Access, Excellence, Patient-centred, Across boundaries, Value for money, Accountable to public
What are the NHS values?
- Working together for patients: Patient-centred care, speak up when things go wrong
- Respect and dignity: Equality and diversity, transparency in what can and can’t be done
- Commitment to quality of care: Encourage feedback for improvement
- Compassion
- Improving lives: Improve health and well-being, strive to excellence and professionalism
- Everyone counts: Exclude nobody, some may need more help, do not waste resources
PEQ-CIE: Patient-centered, Equality and diversity, Quality, Compassion, Improving lives, Everyone counts
What are the different types of audits and their benefits?
Internal/external audit (e.g. accreditation body)
Vertical audit: Follows one sample through all steps of processing - is good for identifying where an error has occurred
Horizontal audit: Looks at one process (many samples) - can identify if outcomes of process fall within accepted range for a variety of samples
Examination audit: Observing a technique being done - tests if a SOP is being followed - can identify training needs or improvement needs to SOP
Evaluating user feedback
Evaluating staff suggestions
Benefit of audit: allow quality improvement to take place where it will be most helpful and will improve outcomes for patients
How can you engage a colleague/patient with questioning styles?
TED: Tell me what… Explain to me… Describe to me…
5Wh’s: What, where, when, why, who, (how)…
These are open-ended questions.
Which model can be used when presented with a task/situation?
STAR: Situation: Describe the situation. Task: What you have to do. Action: What actions you did/will do. Result: What result do you expect.
How to manage a user complaint?
May be received by letter, email, phone, personal, social media, third party
Formal complaints: Resolution sought through Complaints Team (Trust) through formal investigation
Informal complaints: Redirect to Directorate General Manager, if relating to patient currently receiving treatment, then must be escalated to Complaints Team
Complainant’s personal details should remain limited to those, who need to know.
Statements from those involved are gathered.
A response is given out in writing.
Actions arising may be implementation and monitoring, audit, feedback to staff, supporting staff involved (counsellor/OWLS)
The Patient Advice and Liaison Service (PALS) offers confidential advice, support and information on health-related matters. They provide a point of contact for patients, their families and their carers
Questions to ask when reviewing literature?
- Did the study address a clearly focused issue?
- Did the authors use an appropriate method to answer their question?
- Case-control: Were the cases/controls recruited in an acceptable way? (Selection bias, were they representive? Non-responders?) RCT: Were patients randomised? Were everyone “blind” to treatment?
- Case-control/RCT: Were groups treated equally? (Measurement, recall or classification bias)
- Were groups comparable? (Genetics, environmental, socio-economic)
- Confounding factors/bias?
- Do we believe the results? (Have confidence limits been given?)
- Are the results important? (Are benefits worth the harm?)
How to react to an incident e.g. a person tripping?
- Assess the environment
- Ask what happened
- Problem solving: Suggest appropriate solutions
- Information gathering: Ask if a person is OK? Why is the wire there in the first place? What was nature of spillage? Can it be moved straight away? etc.
- Informing Health and Safety manager or relevant person
- Incident form
- Root cause analysis
- Do risk assessment
What is validation and verification?
Validation: Are we building the right product? Is the process is capable of consistently delivering the required quality? Is the method fit for purpose? Does it have the right sensitivity and specificity?
ISO 15189:2012, validation is defined as “confirmation, through the provision of objective evidence that the requirements for a specific intended use or
application have been fulfilled”
Can be pre-purchasing stage.
Verification: Are we building the product right? Is the process is in reality consistently delivering the required quality? Describing the performance of the test. ISO 15189: 2012 defines “verification as the confirmation, through provision of objective evidence that specified requirements have been fulfilled”
Any new or changed process, equipment, facilities and systems must follow the change planning procedure. Risk and impact assessment must always be carried out for any change (assess consequences)
What is the parameter to compare groups in case-control studies? Cross-sectional studies?
Case-control: Odds ratio
Cross-sectional: Risk ratio
proportion of disease in exposed/proportion of disease in unexposed
What does the p-value depend on?
- How big the difference is
- Sample size
- Variability of measurements
Small study => Large p-value even if effect is large
Large study => Small p-value even if effect is small (clinically irrelevant)
What is the difference between bias and confounding?
Bias: Disease is not associated with exposure - the finding is wrong, problem with study design (e.g. selection bias, information bias)
Confounding: Disease is associated with exposure, but something else explains the association (but confounder is not causal) - e.g. if coal miners have lung cancer, but are also more likely to be smokers
Which ways are there to deal with confounding?
Randomisation
Restriction
Analyse groups seperately
Multivariate analysis
Give 3 examples of bias
Recall bias (more likely to recall something if affected) Reporting bias (more likely to report exposure if affected) Observer bias (probes more about exposure if know affected) Use objective rather than self-reported measurements Blind interviewer
What does a p-value measure?
Probability that the observed effect happened by chance/probability that null hypothesis of no effect is true
Large p-value does not necessarily mean there is no effect - only that we can’t measure it with the sample size
Give 3 examples of selection bias
Not from representative population (case/control studies)
Non-response (poor response amongst low SE-status)
Loss to follow-up (cohort studies, if drop-out is related to exposure)
