Session 1 Flashcards
Ethical pillars of NHS
Beneficence
Non-maleficence
Autonomy
Justice
Aims of good prescribing?
Maximise effectiveness
Respect patient choice
Minimise cost
Minimise risk
Sources of prescribing error?
Types of prescibing error?
How does number of drugs affect compliance
Generally increasing number of drugs causes a reduction in compliance as it becomes more difficult for the patient to follow.
How to minimise prescibing risk?
- Recognise this is a high risk activity
- Aim to give the task the attentionand focusit deserves
- Ask for help from the team
- Check:
Medication History/Allergies
Drug/dose/route/frequency/duration
Interactions and Side effects
Correct instructions and monitoring
Local/national guidance/policies
- Shared decision making - Talk to the patient and other healthcare proffesionals to find best treament option
- Ask the patient to check the prescription and drugs dispensed
- Double check
- Consider non prescribing alternatives
Define what a clinical trial is
Any form of planned experiment which involves patients and is designed to elucidate the most appropriate method of treatment for future patients with a given medical condition
What is the purpose of a clinical trial?
“To provide reliable evidence of treatment efficacy and safety”
- Efficacy=the ability of a health care intervention to improve the health ofa defined group under specific conditions
- Safety=the ability of a health care intervention not to harma defined group under specific conditions
In order to be able to give a fair comparison of effect and safety, a clinical trial needs to be what?
- Reproducible – in experimental conditions
- Controlled – comparison of interventions
- Fair–unbiased without confounding
N.B. –clinical trials are subject to random variation differences observed in small trials (<1,000) are more prone to ‘chance’
What’s the difference between efficacy and effectiveness in clincal trials?
- Efficacy = ideal clinical conditions
- Effectiveness = real world clinical experience
- Effectiveness estimates are more realistic
What are the different phases in drug development and trials?
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Explain the disadvantages of non-randomised clinical trials and the use of historical controls
Non-randomised clinical trials involve the allocation of patients receiving a new treatment to compare with a group of patients receiving the standard treatment BUT there’s:
Allocation bias–by patient, clinician or investigator
•Confounding–known and unknown
Comparison with historical controls involves the comparison of a group of patients who had the standard treatment with a group of patients receiving a new treatment BUT for the ‘standard treatment’ group: •selection often less well defined, less rigorous •treated differently from ‘new treatment’ group •less information about potential bias/confounders •unable to control for confounders
Outline the steps involved in a randomised controlled trial (RCT)
–Definition of key study variables
–Conduct of the trial
–Comparison of outcomes
•Define:
–The disease of interest
- The patients eligible for the trial
- The patients to be excluded from the trial
–The treatments to be compared
–The outcomes to be measured
–Possible bias and confounders
Conduct of the Trial
- Identify a source of eligible patients
- Invite eligible patients to be in the trial
- Consent patients willing to be in the trial
- Allocate participants to the treatments fairly, i.e. without bias or confounding
- Follow-up participants in identical ways
- Minimise losses to follow-up
- Maximise adherence to treatments
Comparison of Outcomes
•Compare the outcomes fairly to see:
–Is there an observed difference in outcome between the treatment groups?
–Could the observed difference have arisen by chance, i.e. is it statistically significant?
–How big is the observed difference between the treatment groups, i.e. is it clinically important?
–Is the observed difference attributable to the treatments compared in the trial? i.e.was the design & conduct of trial ‘good’?
Explain the 95% Confidence Interval and the p-value
•If the null hypothesis value is consistent with the observed data, then any observeddifference from the null hypothesis may be due to chance: –null hypothesis value inside 95% CI p ≥ 0.05 nu hypothesis value outside 95% CI ⇒ p < 0.05
N.B. –the observed value is ALWAYS within the 95% Confidence Interval, in fact in the middle
Describe suitable ‘outcome measures’ for clinical trials
–Reasons for pre-defining outcomes –Primary and secondary outcomes –Types of outcomes –Features of an ideal outcome –Timing of measurements
Reasons for Pre-Defining Outcomes
•Need to define what, when and how outcomes are to be measured before start of the clinical trial:
–prevent ‘data dredging’, ‘repeated analyses’
–protocol for data collection
–agreed criteria for measurement and assessment of outcomes
Primary and Secondary Outcomes
•Primary outcome
–preferably only one primary outcome
–used in the sample size calculation
•Secondary outcomes
–other outcomes of interest
–often includes occurrence of side-effects
Types of Outcomes
- Patho-physiological, e.g.–tumour size –thyroxine level –ECG changes
- Clinically defined, e.g. –death (mortality) –disease (morbidity) –disability
- Patient-focused, e.g.–quality of life –psychological well-being –social well-being –satisfaction
Features of an Ideal Outcome
- Appropriate and Relevant–to patient, clinician, society, etc.
- Valid and Attributable–any observed effect can be reasonably linked to the treatments being compared
- Sensitive and Specific–chosen method of measurement can detect changes accurately
- Reliable and Robust–outcome measurable by different people in various settings → similar result
- Simple and Sustainable–method of measurement is easily carried out repeatedly
- Cheap and Timely–not excessively expensive to measure nor has a long lag time
Timing of Measurements
•Baseline measurement of relevant factors
–monitoring for inadvertent differences in groups
•Monitoring outcomes during the trial
–monitoring for possible effect, i.e. is one group being disadvantaged?
–monitoring for adverse effects, i.e. are individual patients being harmed?
•Final measurement of outcomes
–comparing final effect of treatments in trial