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1
Q

Purpose of healthcare practice study

A

Provide better evidence
Open to scrutiny
Assimilate results into guidelines and targets

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2
Q

Steps to conducting studies

A 
Identify problem
Formulate question and address gap in evidence
Select study design
Sample/Select participants
Collect Data
Analyse variables
Disseminate
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3
Q

What is Research?

A

Generates new knowledge

Potential to be generalisable or transferable

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4
Q

What is an Audit?

A

Quality improvement process
Systematic review of care against criteria
Changes introduced subsequently
Does service reach the standard?

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5
Q

What is a service evaluation?

A

Evaluates proposed service with intention to generate information to inform decision-making authorities
What standard does the service achieve?

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6
Q

What is an audit cum service evaluation?

A

Establish extent practise is achieving as well as what factors may be associated in success/failure

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7
Q

What is NICE?

A

Independent, non governmental, funded by department of health
Provides national guidelines and advice to improve care

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8
Q

Purpose of NICE

A

Reduce variation in availability and quality of treatment
Evidence for certain treatment methods
Set Guidelines

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9
Q

What are Quality Standards?

A

Statements with measurable indicators

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10
Q

What is a PECOS?

A 
Patient/Participant
Exposure
Comparison
Outcome
Study Design
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11
Q

Methods of searching

A

Free Text
MeSH
Combination of both

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12
Q

Sources of Sampling Bias

A

Non representative sample - external

Selection influences exposure - confounding

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13
Q

Sources of Measurement Bias

A

Information bias - extent of info varies between participants
Observer bias - Influenced by prior knowledge
Recall/Presteige Bias - influenced by prior knowledge

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14
Q

Sources of analytical bias

A

Loss to follow up
Omitted variables
Attributional Bias - interpretation of causality

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15
Q

Source of Dissemination Bias

A

Publication bias - eventful results more likely to be published

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16
Q

Order the different study designs

A

1) Meta analysis
2) Randomised control Trial (Experimental)
3) Cohort Study (Observational)
4) Case-Control (Descriptive) (Observational)
5) Cross Sectional (Descriptive)

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17
Q

What is the Belmont Report?

A

Respect for persons - need to obtain informed consent

Justice where benefits outweigh the burdens

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18
Q

How to minimise harm

A

Sound science, ethics, study practise

Go through management boards for high risk

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19
Q

Best practise for voluntary participation

A

Informed consent
Reward free research
Freedom to decline/withdraw
Rights Protection

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20
Q

Examples of high risk ethical issues

A

Vulnerable participants
Sensitive Topics
Collecting body materials
Conducting harmful procedures

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21
Q

What projects do not require ethical approval?

A

Secondary research
Non human research
Audits/Service Evaluation

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22
Q

What projects need approval?

A

Non human research covered by Animal Act
Service evaluations involving vulnerable participants or sensitive topics
New intervention projects
New information gathered

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23
Q

When do you need to reapply for ethical approval?

A

Any changes to project proposal

Any deleterious effects

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24
Q

What should project proposal include?

A

Why it is necessary
what it will involve
how ethical, legal and governance issues be avoided
Should Allow:
Team to conduct project
Participants to assess whether they want to be involved
Research ethics committee to decide (LREC, NHS, REC)

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25
What is a sample?
Collection of data drawn from population
26
What is target population?
Total finite population we wish to know about from which sample is drawn
27
What needs to happen to study sample to allow conclusions to be made?
Extrapolation to target population
28
What is complete samples? Pros and cons
Entire study population PRO: No bias CONS: Expensive
29
What is unstratified random samples? Pros and cons
Every member of target population has equal chance of being sampled PROS: easy to design CONS: smaller groups may be under-represented
30
What is stratified random samples? Pros and cons
Random sample from target population within strat Every member within each strata has equal chance PROS: Representative, improves power for rare strata CONS: Population not easily divisible into strata, not known
31
What is null hypothesis?
No effect
32
What is alternative hypothesis?
An effect
33
What is p value?
Probability that result happened by chance alone | <0.05 is significant
34
When are CI significant?
When they do not include the null | Increased by increasing sample size (CI shrink)
35
How do you calculate odds ratio?
odds of outcome given exposure/odds of outcome by other null exposure CI must both be <1 or >1 to be certain effect isnt due to chance
36
What is power?
Probability of rejecting null when null is false Calculated before and after Easier to detect when - mean effect large, variation in effect is small, sample is bigger (Aim 0.8)
37
What is the odds?
Probability an event occurs divided by probability event does not occur
38
What are odds ratio?
Odds of an event for 'exposed' individuals divided by odds of event for 'unexposed' individuals
39
Interpret values of odds ratio
no effect = 0 >1 = greater risk <1 = lower risk
40
How to apply odds ratio to continuous variables?
Discretise the data
41
What variables must be collected?
Exposure, outcome, covariates | Mediators do not need to be collected
42
What are confounders?
Cause both exposure and outcome | Adjusted for
43
What are competing exposures?
Cause outcome but not related to exposure | Adjusted for if cause variation
44
What are mediators?
Caused by exposure and cause outcome | NOT adjusted for
45
Types of causal relationship
Functional (no contraceptive = pregnant mother) Empirical (from past analysis) Theoretical (teenage grandmother = teenage mother) Speculative (teenage grandfather = teenage mother)
46
What are the two types of study?
Prospective | Retrospective
47
What is a prospective study?
record variables over study period with outcome measured afterwards eg cohort PRO: less bias, less chance of confounding CONS: time and resource intensive, collect unneeded data, subject dropout, unfeasible for rare outcomes
48
What is a retrospective study?
Measure outcome and look back to measure exposure eg case control, cross sectional PROS: less time, allows oversampling of rare outcomes CONS: susceptible to bias, some variables cannot be measured directly
49
Does open ended or close ended data need codign?
Open ended
50
Name one way to get over missing data?
Proxy data
51
What is purpose of linear model?
Helps indicate if association between two variables Nuisance variables can be adjusted for/eliminated Regression used to assess variation of data Regress y axis x axis If want to add covariates then just add to the line
52
How to code regression of categorical data for weight and sex
Xi: regress weight i.sex
53
What regression used if outcome is binary?
Logistic regression | Xi: logistic complynot i.sex
54
What does coefficient give?
Correlation - 0= no change
55
What does R^2 give?
Proportion of variation explained by model
56
What does P value show?
Significance of each variable
57
What is R^2 between?
0 = bad fit 1= perfect fit More variables improve R
58
In logistic, what is Coefficient given as?
Odds ratio | 1= no change
59
Strengths of qualitative research
Understand relationships Identify why people behave in a certain way Exploring context/perspectives
60
When is it best to use a 1 to 1 interview
Sensitive topics, stigma
61
Give three data interpretations for qualitative research
Framework analysis - across and within cases Interpretive phenomological analysis - focus on interviewees sense making Grounded theory - focus on identifying shared meaning
62
How is credibility increased?
Prolonged engagement Multiple sources Not prematurely foreclosing
63
What is opportunity cost?
Value of option that is foregone | If greater than option chosen then wrong decision
64
What can affect QALYs?
Improvements to quality or quantity of life
65
What does economic evaluation involve?
Opportunity cost and efficiency Used to make sure effective Provide cost per health gain of option
66
What is Efficiency?
Maximising benefit for the resources used
67
What is technical efficiency?
Meeting an objective at lowest cost
68
What is allocative efficiency?
Producing the output that matches the demand
69
What does marginal analysis involve?
The next step - cost and benefit of taking next step | Not interested in averages
70
What is cost effective anaylsis?
Benefits measured in terms of standard clinical outcome within a condition (increase/decrease of BP/Life years gained) Quality or Quantity gained
71
What is cost utility analysis?
Both quality and quantity life gained (QALYS)
72
What is cost benefit analysis?
Considers monetary benefit of health in resource use
73
What is cost effectiveness threshold?
Maximum amount the health service will pay per unit health gained Roughly 20-30K per QALYs
74
Process of Option Appraisal
``` Define objective and constraints Identify and describe options Identify monetary costs and benefits Assess risks Identify non monetary costs and benefits Weigh up Assess balance of advantages ```
75
Function of biomedical research
Understand cause, development and effects of disease and interventions
76
Give ethical restriction to research
New knowledge can never take precedence over the rights and interests of subjects (8) Subject to ethical standards that promote respect,right and health (7)
77
What are rights in research
Right to consent or refuse - free informed consent (25) Right to confidentiality Act in best interests
78
What is the Social Value Requirements
Research may only be conducted if objective outweighs risks and burdens (16) Must potentially improve health by important knowledge Well designed
79
In the blood substitute example, why was approval given?
Saline used pre hospital is not sufficient for treatment so alternatives are allowed to be used
80
When is it permissible to carry research without consent?
Helsinki declaration 28- if the research cannot instead be performed with people capable of providing informed consent 30 - physical and mental condition that prevents giving informed consent Consent must be attained as soon as consciousness appears
81
In America, what is waived consent?
In life threatening situations, permissible when available treatments are unproven/unsatisfactory and informed consent is not feasible
82
In England, when can research be done in this scenario?
If necessary to take action for purpose of trial urgently but not able to get informed consent prior Action approved by ethics committee Consent is sort as soon as legally possible
83
Types of Consent
Expressed - written, verbal, implied Tacit - opt out, must have knowledge disseminated and know that not opting out means consent (meetings, focus groups, adverts)
84
List the things needed for informed consent
Purpose of the research Procedures involved in the research Alternatives to participation All foreseeable risks and discomforts to the subject also possible psychological, social, or economic harm, discomfort, or inconvenience. Benefits of the research to society and possibly to the individual human subject Length of time the subject is expected to participate Person to contact for answers to questions or in the event of a research-related injury or emergency Statement indicating that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the subject is otherwise entitled to receive Statement regarding the subjects’ right to confidentiality and right to withdraw from the study at any time without any consequences

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