Improving Health (IH) Flashcards
What is meant by the term ‘incidence’?
The number of new health-related events that occur in a defined population within a specified period of time
How may incidence be represented numerically? (3)
- Frequency count; the number of new cases
- Proportion; a percentage/decimal of the population
- Rate; a number of cases per number of person-years
What is meant by the term ‘prevalence’?
The number of individuals who have a disease as a proportion of the at risk population
Outline the two main ways of expressing prevalence? (2)
- Point prevalence; the proportion of individuals with a disease at a specific timepoint
- Period prevalence; the proportion of individuals with a disease over a certain period of time
Outline the two main ways by which prevalence may be high? (2)
- High incidence
- Long duration of the disease
The larger the relative risk (RR) the […]
The larger the relative risk (RR) the more likely the exposed group is to develop the outcome compared to the non-exposed group
The absolute risk reduction (ARR) implies that for every 100 members of the exposed group, […], compared to the number of cases of the disease in the non-exposed group
The absolute risk reduction (ARR) implies that for every 100 members of the exposed group, there will be a number of people equal to the value of the ARR more cases of the disease, compared to the number of cases of the disease in the non-exposed group
Outline the hierarchy of evidence? (8)
- Systematic review or meta-analysis of ≥ 2 randomised controlled trials (RCTs)
- Randomised controlled trial (RCT)
- Non-randomised experimental designs
- Cohort-studies
- Case-control studies
- Cross-sectional studies
- Case series/case studies
- Personal communication
Outline the features of the Bradford-Hill criterion for causal relationships? (6)
- Strength of association; the stronger the association, the greater the likelihood that that association is the result of a causal relationship
- Dose-response; the greater the exposure to the risk the greater the incidence of the outcome
- Temporality; disease risk factor (exposure) must predate the disease (outcome)
- Consistency; same association demonstrated in multiple independent repeats
- Biological plausibility; biomedical reason or explanation to account for a causal relationship
- Reversibility; reduction or withdrawal of the risk factor should reduce/withdraw the outcome
What is meant by the term ‘bias’?
A systematic error in the design, conduct or analysis of a study that results in a conclusion that is different from the truth
Outline the main types of bias? (4)
- Selection bias; regarding the choice/inclusion of participants
- Information/measurement bias; regarding the appropriateness of exposure/outcome measures
- Observer bias; regarding the observers prior knowledge about the subject’s exposure to a risk factor and how this may influence results
- Recall bias; regarding the phenomenon where the subject with the outcome is more likely to remember an exposure than a subject without the outcome
What is meant by the term ‘confounder’?
The presence of another factor that provides an explanation for the results other than the conclusion determined by the study
What is meant by the term ‘chance’?
The likelihood that the observed effect/outcome could have been observed solely as a result of coincidence
In relation to study design, what is the main factor that influences the likelihood of any conclusion reached being purely the result of chance?
Sample size; the larger the sample size, the less likely that the results are to have been determined purely by chance
Which two variables are used to express chance? (2)
- Probability values (p-values)
- Confidence intervals (CIs)
What can be inferred by a p-value of 0.001?
A p-value of 0.001 means that there is a 1 in (1 / 0.001 1000) 1000 (0.1%) chance that the observed difference is due to chance
What is meant by the term ‘confidence interval (CI)’?
The confidence interval denotes the range of values that the true size of the effect lies within, for a given degree of assurance/confidence (%)
What is meant by the term ‘standardisation’?
The technique for removing the effect of confounding variables (i.e. age) on individuals when comparing between different populations
Outline the two main ways of standardising data in an epidemiological investigation? (2)
- Direct standardisation; observed rates in the population of interest are stratified according to the confounding variable and applied to a reference population
- Indirect standardisation; rates within a reference population are stratified according to to the confounding variable and applied to the population of interest
In terms of the information that they require, what is the difference between direct and indirect standardisation? (2)
- Direct standardisation; used when the number of events within each of the confounding variable (i.e. age) groups of the population of interest is known
- Indirect standardisation; used when the number of events within each of the confounding variable (i.e. age) groups of the population of interest is not known
Which parameter is calculated as a result of indirect standardisation when looking at mortality rates?
Standardised mortality ratio (SMR)
What can the value of the standardised mortality rate (SMR) tell you about the mortality rate between two difference populations? (3)
- SMR < 1; the population of interest has a lower mortality rate than the reference population
- SMR 1; the population of interest has the same mortality rate as the reference population
- SMR > 1; the population of interest has a greater mortality rate than the reference population
Outline the components of an audit cycle? (5)
- Set and agree the gold-standard for assessment/management of the problem
- Monitor performance against those standards over a certain timeframe (retrospective or prospective)
- Identify deviations from agreed standards and reasons why they occurred
- Implement changes to correct those unwanted deviations from the standard
- Repeat the cycle to assess the effectiveness of the implemented changes
Outline the key features that make for good goal setting in the audit process? (5)
SMART;
- Specific
- Measurable
- Achievable
- Realistic
- Timely
Outline the treatment-specific considerations that need to be taken into account by healthcare funding bodies when deciding whether or not to fund a new treatment? (4)
- Safety; whether the treatment can cause adverse effects
- Efficacy; whether the treatment achieves its intended outcome
- Effectiveness; to what extent does the treatment achieve its intended outcome
- Efficiency (cost-effectiveness); the additional cost/saving associated with the new treatment compared with the additional health benefits versus that of the previous/next best treatment
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; […]
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); […]
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; […]
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; […]
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Where to find evidence when assessing whether to fund a new treatment;
- Safety; Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA)
- Efficacy; National Institute for Health and Care Excellence (NICE), Medline, Cochrane Database
- Effectiveness; Clinical Evidence, National Institute for Health and Care Excellence (NICE), Published Randomised Controlled Trials (RCTs)
- Efficiency (cost-effectiveness); National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC)
Outline the population-specific factors that need to be taken into account by healthcare funding bodies when deciding whether or not to fund a new treatment? (6)
- What is the likely demand for the healthcare resource
- Do resources exist locally to provide such healthcare resource
- What are the opportunity costs associated with offering such healthcare resource
- Do other CCGs offer the healthcare resource and if so, how effective is it
- Would a decision to fund/not fund be equitable (does the healthcare problem effect all individuals within a population equally
- How does the decision to fund accord with the views of the local population
Which piece of statutory legislation outlines the types of discrimination that are prohibited by law?
Section 149 of the Equality Act (2010)
Outline the specific types of discrimination that are prohibited by law under Section 149 of the Equality Act (2010)? (8)
- Age
- Disability
- Gender
- Pregnancy/maternity
- Race
- Religion/belief
- Sex
- Sexual orientation.
Outline the responsibilities of the NHS and other public bodies as indicated by Section 149 of the Equality Act (2010)?
Public bodies have a due regard to eliminate discrimination and advance equality of opportunity between persons who share a relevant protected characteristics and persons who do not
Is there any legal framework prohibiting discrimination based on financial state?
No; there is no statutory legislation stating that this is illegal
Outline the main components to a focussed clinical question? (4)
PICO;
- Population; which population of patients should be studied
- Intervention; which intervention, treatment or approach should be used
- Comparison; what are the alternatives to the intervention being considered
- Outcome; which outcomes should be measured and how
Outline the structure and function of an ecological study? (4)
- Observational descriptive study
- Conducted at the population level
- Assesses geographic correlation
- Generate hypotheses as to the explanatory variable that governs the observed difference
What is meant by the term ‘ecological fallacy’?
Specific problem associated with ecological studies where an apparent association between exposure and outcome is true at the population level but not necessarily true at the individual level
Which type of bias are ecological studies particularly subject to?
Aggregation bias; a type of information bias whereby aggregated data can show an effect at the population level that is the opposite to the effect seen at the individual level
Outline the structure and function of a cross-sectional trial? (3)
- Observational analytical or observational descriptive
- Single examination of a population at one point in time (snapshot)
- Looks at attitudes, behaviours, health conditions or risk factors
- Can be repeated at subsequent timepoints to measure the change in the population over time
With regards to a cross-sectional trial, what is meant by a ‘sampling frame’?
A list of all those within the target population from which inviduals can be selected to act as subjects forming a sample of that population
Outline the main subtypes of a cross-sectional study? (2)
- Descriptive; measuring only one parameter in the target population at a single timepoint
- Analytical; measuring a single exposure and a single outcome in the target population at a single timepoint
What is the main disadvantage of an analytical cross-sectional study?
Temporality; it is impossible to determine if the outcome developed before or after the exposure occurred
Outline the structure and function of a case-control study? (3)
- Analytical observational trial
- Retrospective; outcome has already occurred within a target population
- Data is collected on the exposure of individuals within that population with the outcome (cases) and those without the outcome (controls)
What is assessed when comparing between cases and controls in a case control study? (2)
- The prevalence (p) of the risk factor (exposure) of interest amongst cases and controls
- The influence of the risk factor (exposure) of interest on the outcome
How is information about the exposure gathered from the population in a case-controlled study?
By means of questionnaire
Outline the main issues associated with case-control studies? (4)
- Selection of cases; a clear definition of individuals that qualify for selection as ‘cases’ is needed
- Selection of controls; controls need to be selected from a population as similar as possible to the population from which the cases were selected
- Reverse causality; additional studies are required to prove temporality and determine if the exposure preceded the outcome or not
- Bias; in order to ascertain the exposure and outcome, bias must be minimised
Which two types of bias are particularly important in case-control studies? (2)
- Recall bias; individuals with an outcome are more likely to remember an exposure compared to those without the outcome
- Observer bias; where the observer is more likely to look for an exposure in an individual if they already know the outcome in that individual
What process needs to be carried out in case-control studies to control for any potential confounding factors?
Matching of cases and controls based on age, sex, and other relevant and potentially confounding factors
Outline the main advantages of case-control studies? (4)
- Useful for rare outcomes
- Can examine multiple exposures
- Useful for outcomes with long latency
- Quick and inexpensive
Outline the main disadvantages of case-control studies? (4)
- Rely on recall/records to determine exposure
- Difficult to identify controls
- Heavily influenced by confounders
- Information (recall and observer) bias
Outline the main advantages of cohort studies? (4)
- Ethically safe
- Subjects can be matched
- Can identify temporal relationships
- Can directly measure outcome (incidence)
Outline the main disadvantages of cohort studies? (4)
- Inefficient for rare outcomes
- Influence of hidden confounders
- Controls may be difficult to identify
- Validity affected by follow-up
Outline the main advantages of interventional studies such as randomised controlled trials (RCTs)? (3)
- Randomisation minimises effect of confounders
- Blinding eliminates information bias
- Can demonstrate causality
Outline the main disadvantages of interventional studies such as randomised controlled trials (RCTs)? (3)
- Expensive and time-consuming
- Can be unethical
- Volunteer bias
Outline the main advantages of cross-sectional studies? (2)
- Cheap and simple
- Ethically safe
Outline the main disadvantages of cross-sectional studies? (2)
- Cannot establish causality
- Recall bias
Outline the main difference between a case-control study and a cohort study? (2)
- Case-control study; the outcome of interest has already occurred, cases and controls defined by whether they have the outcome of interest or not
- Cohort study; the outcome of interest has not already occurred, cases and controls defined by whether they were exposed to the risk factor or not
Outline the main similarity and main difference between prospective and retrospective cohort studies? (2)
- Similarity; in both, the outcome of interest has not yet occurred
- Difference; in retrospective cohort studies, the exposure has already occurred whereas in prospective cohort studies, it has not
Outline the main issues associated with cohort studies? (4)
- Selection; case and control groups need to be as similar as possible apart from the exposure being investigated
- Non-participation; only a proportion of those eligible actually participate, these participants may differ from non-participants in terms of health behaviours
- Follow-up; loss to follow-up can influence conclusions, this can be related to exposure, outcome or both
- Data collection; exposure and/or outcome data must be collected as objectively as possible in order to minimise measurement bias
Outline the main advantages of ecological
studies? (2)
- Can assess geographical correlation
- Good for generating hypotheses
Outline the main disadvantages of ecological studies? (2)
- Ecological fallacy
- Aggregation bias
What is the main type of primary intervention study?
Randomised controlled trial (RCT)
Outline the key principles in the design of primary intervention trials? (4)
- Randomisation; the allocation of subjects to different treatment groups based on chance
- Blinding; the extent to which the investigators, participants and analysts are aware of which subjects are allocated to which treatment groups
- Follow-up; inclusion of clear final outcomes at the end-point of the trial for both treatment groups
- Equal treatment; identical treatment of both groups with the only exception being the experimental treatment
Outline the types of randomised controlled trial blinding? (3)
- Single blinding; participants do not know which treatment they receive
- Double blinding; participants and investigators do not know which treatment is being received
- Triple blinding; participants, investigators and analysers do not know which treatment is being received
What is the benefit of single blinding?
Eliminates the placebo effect and recall bias
What is the benefit of double blinding?
Eliminates the placebo effect, recall bias and observer bias
What is the benefit of triple blinding?
Eliminates the placebo effect, recall bias, observer bias and assessment bias
What is meant by ‘intention to treat analysis’?
Method of analysis used in randomised controlled trials (RCTs) where all individuals within the treatment group at the start of the trial are analysed together regardless of whether or not they changed treatment groups or dropped out of the trial
Outline the benefit of carrying out an intention to treat analysis?
Preserves the baseline comparability between treatment groups which guards against bias that would be introduced where changes to protocol/subject dropout would influence the outcome
Outline the definition of the number needed to treat (NNT)?
The number of individuals, on average, that need to be treated in order for the treatment to produce one additional successful outcome
Outline the definition of the number needed to harm (NNH)?
The number of individuals, on average, that need to be treated in order for the treatment to produce one additional adverse outcome
Outline the three components to consider when critically analysing research? (3)
- Results; what the conclusion of the research is
- Validity; how trustworthy the research is
- Relevance; how useful the research is
What is meant by the term ‘systematic review’?
A review of all the literature on a particular topic, which has been systematically identified, appraised and summarised giving a summary answer
Outline the features of a good systematic review? (5)
- Asking a clear and focussed question
- Clearly defined inclusion and exclusion criteria
- Reproducibility
- Appraisal of included studies
- Assessment of publication bias