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302 Scientific basis of medicine > Research methods > Flashcards

Research methods Flashcards

1
Q

Briefly describe the Tuskegee Syphilis study in 1932-1972

A

Looked at effects of syphilis on untreated African-American men
Participants didn’t know they were in a study, most didn’t know they had syphilis
No consent given
Treatment was withheld even when penicillin was available.

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2
Q

When was the Nuremberg code made?

A

1947

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3
Q

What are the 10 points of the Nuremberg code?

A

1) Voluntary, well-informed consent of human subject
2) Experiment should aim at positive results for society that can’t be obtained any other way
3) Should be based on previous knowledge that justifies the experiment
4) Experiment should be set up in a way which avoids unnecessary physical or mental suffering or injuries
5) Shouldn’t be conducted when there is any reason that it implies a risk of death or disabling injury
6) Risks should be in proportion to & not exceed the expected humanitarian benefit
7) Preparation and facilities must be provided to protect subjects against risk
8) Staff conducting experiments must be fully trained and scientifically qualified
9) Human subjects must be free to immediately quit the experiment at any point
10) Staff must stop the experiment at any point when they observe that continuation would be harmful

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4
Q

Describe the Willowbrook hepatitis experiments

A

Experiments on children living in residential care with mental health problems or learning disabilities.
Intentionally infected children with hepatitis and observed progression

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5
Q

When was the declaration of Helsinki made?

A

1964

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6
Q

What is the Helskini declaration?

A

Ethical principles for research involving human participants

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7
Q

What are the basic principles of the declaration of Helsinki?

A

Respect for the individual, their right to self determination and the right to make informed decisions
Participant’s welfare must take precedence over interests of science and society
Ethical considerations must take precedence over laws and regulations

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8
Q

What studies require ethical approval?

A

Studies involving human / animal participants
Gathering novel data or information
Creating knowledge that can be generalised beyond the patient sample or setting

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9
Q

What projects don’t require ethical approval?

A

Service evaluations

Clinical audits

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10
Q

What ethics committee do you need to apply for if using NHS staff, patients or site?

A

NHS health research authority

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11
Q

What points need to be included for ethical approval?

A 
Scientific rational
Rigorous methodology
Informed consent
Vulnerability of participant groups
Data protection, confidentiality and records management 
Research safety and wellbeing
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12
Q

What information must be included in the rigorous methodology for ethical approval?

A

Adherence to established methodology
Methods must be appropriate for producing new knowledge
Methods must be appropriate and feasible for proposed setting and sample
Study materials or equipment should be valid and reliable
Show skills for robust data management and analysis within the team

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13
Q

What methods are there for participant recruitment>

A

Face to face in clinic
Posters
Social media

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14
Q

What participant groups are considered vulnerable?

A 
Children
Patients with dementia
Patients with learning difficulties
People with mental health problems
People in care facilities
Over-researched populations
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15
Q

What is the definition of research?

A

Study which is trying to generate new knowledge about patients or conditions or healthcare services that will be generally true across a wider population than it is actually studying.

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16
Q

What is the definition of a service evaluation?

A

Evaluate or assess some part of a local healthcare service. Aims to improve service based on evidence collected.
Results from this project will only feed back into this particular service

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17
Q

What is a clinical audit?

A

Quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and implementation of change.

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18
Q

What are the 5 stages of the audit cycle?

A 
Identify
Method
Analyse
Change 
Monitor
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19
Q

What does the identify stage in the audit cycle include?

A 
Guidelines
Evidence
Patient and public involvement
Process design
Agree standards
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20
Q

What methods can be used for data collection of service evaluations or audits?

A 
Patient notes / record review
Survey of staff - paper / online
Survey of patients - paper / online
Telephone interview
Face to face interview
Focus groups
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21
Q

What are the problems with using patients notes to gather research data?

A

Limited type of information available

Need to ensure there are no patient identifies

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22
Q

What points need to be considered when creating a questionnaire?

A 
What do we want to achieve?
What information do we need to know to help this?
Who should we ask and how should we ask them?
Types of questions
Choosing categories
 - standardised
 - analyse by age or scale
 - demographic factors
Question writing
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23
Q

What is the format of questionnaire questions determined by?

A

What we want to know
What types of data we want to generate
What types of analysis we want to do

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24
Q

What are the 3 types of questions for a questionnaire?

A

Closed questions with yes / no or categorical answer
Closed statements answered on a scale
Open-ended questions

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25
Q

What are Likert scales?

A

Respondents specify level of agreement or disagreement on a symmetric scale for a series of statements

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26
Q

What can Likert scales be used for?

A 
Knowledge
Beliefs
Attitudes
Symptoms
Traits
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27
Q

What assumptions do Likert scales assume?

A

Bipolar scaling method

Assumes distance between each response is equal

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28
Q

What should be considered when writing questions for Likert scales?

A

Is the question / statement loaded with social desirability?
Does the question require knowledge or information the respondent might not have?
Is the statement based on 2 premises?

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29
Q

Why do likert scales require many items?

A

Unlikely to identify a single item which represents the whole issue being measured
Reduces error of random responses or misunderstandings
Can design questionnaires to reduce skew

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30
Q

How are Likert scales analysed?

A

Add up scores across similar questions to make a scale (total score)
Report mean total score and standard deviation

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31
Q

What is a RCT?

A

Study in which participants are allocated randomly between an intervention e.g. treatment and a control group e.g. no treatment or standard treatment

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32
Q

Why are RCTs conducted?

A

Safety
- ascertain safe dose
- demonstrate safety and tolerability of new compound
- monitor adverse events profile
Efficacy / effectiveness
- demonstrate efficacy of new drug
- show the treatment T is superior or equivalent to treatment X
- demonstrate effectiveness and cost effectiveness

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33
Q

What is a confounder?

A

Variable that influences both the dependent variable and independent variable causing a spurious association

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34
Q

What does equipoise provide?

A

Ethical basis for medical research that involves assigning patients to the different treatment arms of a clinical trial

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35
Q

What is internal validity in an RCT?

A

Is the independent variable causing the dependent variable in the study?

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36
Q

What is external validity in an RCT?

A

To what extent can these findings be generalised to other people, situations and times

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37
Q

What is bias?

A

Any departure of results from the truth

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38
Q

How does bias occur in an RCT?

A

When systematic error is introduced into sampling
Testing by selecting
Encouraging one outcome or answer over others

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39
Q

What is the definition of bias in statistics?

A

A tendency of an estimate to deviate in one direction from a true value

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40
Q

What is selection bias in an RCT?

A

Systematic differences between baseline characteristics of groups that are compared
Study sample doesn’t represent target population

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41
Q

What is performance bias in an RCT?

A

Systematic differences between groups in the care that is provided or in exposure to factors other than the interventions of interest

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42
Q

What is attrition bias?

A

Systematic differences between groups in withdrawals from a study

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43
Q

What is observer / detection bias?

A

Systematic differences between groups in how outcomes are determined
Outcome measures don’t adequately capture outcome of interest.

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44
Q

What types of trials can be blinded?

A

Drug trials
Surgery vs non surgical
Psychological interventions

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45
Q

What is a single blinded RCT?

A

Patients are blinded

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46
Q

What is a double blinded RCT?

A

Blinding of patients and treating physicians

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47
Q

What is a triple blinded RCT?

A

Blinding of patients, treating physicians and study investigators

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48
Q

What is a P-value?

A

Probability that the difference observed could have occurred by chance if the groups compared were really alike

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49
Q

What type of study causes a high p-value?

A

Few observations with high variability

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50
Q

What type of study causes a low p-value?

A

Many observations with low variability

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51
Q

What is the clinically important effect?

A

Smallest difference in outcome between treatment groups that would demonstrate a clear advantage of 1 treatment over another in terms of chosen outcome measures

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52
Q

Why is it important to calculate sample size?

A

Too few participants - if you get a null hypothesis you don’t know if you have evidence of no effect or no evidence of an effect
Too many participants is unethical and expensive

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53
Q

What are parametric tests?

A

Make assumptions about the data, particularly that its normally distributed

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54
Q

Describe a right skew

A

Skewed part is to the right
Most cases are to the left
There is more count in the tail than expected in a normal distribution
Positive skew

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55
Q

Describe a left skew

A

Skewed part is to the left
Most cases are to the right
There is more count in the tail than expected in a normal distribution
Negative skew

56
Q

What are the problems with a skewed distribution?

A

Mean is different from the median

The mean is highly influenced by the tail of the distribution

57
Q

When is a T-test done?

A

Does one group have higher scores than another?

58
Q

When is a chi-squared test done?

A

Does one group have a higher proportion of an outcome than another? (categorical)

59
Q

What assumptions have to be made to carry out a T-test for an RCT?

A

Randomly sampled
Independent observations
Variances for each group are equal
Sample is large enough

60
Q

When do you do an ANOVA test instead of a T-test?

A

If there are more than 2 groups

61
Q

What are non-parametric tests?

A

Distribution free tests

Fewer assumptions but less power

62
Q

What statistical tests are used for non-parametric tests?

A

Mann-Whitney U replace T-test
Kuskal Wallis replaces ANOVA
Spearmans Rho replaces correlation

63
Q

When is the Mann-Whitney U / Wilcoxon rank sum test used?

A

To compare non-normally distributed continuous variables between groups if randomly sampled and independent observations

64
Q

What are examples of qualitative data?

A 
Patient voice in interviews
Policy documents
Historical records
Open answers on questionnaires
Viewpoints of clinician
Media reports
65
Q

What is qualitative research?

A

Multi-method in focus, involving an interpretive naturalistic approach to its subject matter. Qualitative researches study things in their natural settings, attempting to make sense of or interpret phenomena in terms of the meanings people bring to them

66
Q

What are the benefits of qualitative research?

A 
Depth and detail
Openness in possible responses
Avoid pre-judgements
No need for restrictive hypothesis
Good if we lack understanding of a concept and need more info
67
Q

What are the limitations of qualitative research?

A

Results are highly subject
Not usually generalisable
Cant compare groups
Transcription and analysis can be time consuming
Rich data is hard to analyse on scale so need fewer participants
Complexities in data can be difficult to present

68
Q

Describe the differences between qualitative and quantitative

A

Qualitative’s social theory is action whereas quantitative is structure
Qualitative methods involve observation and interview. Quantitative involve experimental survey.
Qualitative reasoning is inductive but quantitative is deductive
Qualitative questions are what is X? Quantitative is how many X’s?
Sampling method is theoretical for qualitative and statistical for quantitative

69
Q

What are the reasons to use qualitative research?

A 
Takes an interpretative, naturalistic approach to its subject matter
Sets a patient-centred agenda
Challenges received wisdom
Theory can emerge from the data
Can inform quantitative studies
70
Q

What methods can be used for qualitative research?

A

Observation
Textual analysis / analysis of documents
Focus groups
Interviews

71
Q

What is the purpose of textual analysis for qualitative research?

A

Understanding how language is used
Understanding how stories or public opinion develop over time
Looking for biases or deviations from the truth
Understanding patients’ lived experience and how they make meaning from it

72
Q

Describe a focus group

A

Typically 8-10 participants
Group discussion about specified topics
Often a series of focus groups is conducted
Led by moderator / facilitator
Tape-recorded and transcribed
Revelations of views can spark off other participants to reveal broader insights than are possible from individual interviews

73
Q

What are the 3 ways of structuring an interview?

A

Structured
Semi-structured
Unstructured / in depth

74
Q

What does the recruitment sample depend on for qualitative research?

A

Purpose of the research
Resources available
Time available
Access to population

75
Q

What are the different types of sampling for qualitative research?

A

Extreme / deviant case
Homogenous
Typical case
Snowball

76
Q

What are the ways to evaluate validity of qualitative research?

A

Triangulation
Respondent validation
Further interviews or focus groups
Subsequent analysis / independent assessment

77
Q

What are the 6 steps for planning and carrying out a qualitative study?

A

1) Formulate research Q
2) Choose method
3) Select and recruit sample
4) Design interview schedule and data collection
5) Interpretation of data
6) Validity checks

78
Q

What is prevalence?

A

Frequency of cases in a given population at a designated time

79
Q

What are cross-sectional studies?

A

Survey or test individuals in a population individually to determine prevalence of disease
Can also measure exposure

80
Q

What is point prevalence?

A

Prevalence at a moment of time

81
Q

What is period prevalence used for?

A

Measure things that fluctuate e.g. hay fever symptoms

82
Q

What are the strengths of cross-sectional studies?

A

Measure prevalence and thus disease burden in whole population and subpopulations
Compare prevalence in exposed and non exposed to risk factors
Quick and inexpensive
Can be used to initially explore a hypothesis prior to another type of study

83
Q

What are the weaknesses of cross-sectional studies?

A

Not suitable for rare diseases
Not suitable for diseases of short duration
Can’t separate cause and effect as they are measured at same time
Can’t measure rate of new changes arising and any changes therein.

84
Q

What are cohort studies?

A

Group of people is followed through the and the onset of a disease / health event is measured

85
Q

What is incidence?

A

Number of instances of disease / illness onset in a given period in a defined population

86
Q

What are the strengths of cohort studies?

A

Can calculate incidence and relative risk
Can offer some evidence of cause-effect relationship
Can identify more than 1 disease related to single exposure
Good when exposure is rare
Minimises selection and information bias

87
Q

What are the weaknesses of cohort studies?

A 
Potential for losses to follow up
Often requires larger sample
Less suitable for rare diseases
Expensive
If retrospective, data availability and quality may be poor
88
Q

How is relative risk calculated?

A

Incidence of disease among exposed divided by indigence of disease among non-exposed

89
Q

What does a RR of less than 1.0 mean?

A

Risk in exposed group is less than risk in non-exposed group

Exposure may be protective against disease

90
Q

What does a RR of equal 1.0 mean?

A

Risk in exposed group = risk in non-exposed group

Exposure isn’t associated with disease

91
Q

What does a RR of more than 1.0 mean?

A

Risk in exposed group is higher than risk in non-exposed group
Exposure may be a risk factor for the disease

92
Q

What does a RR of 1.5 mean?

A

Risk of outcome is 50% higher in exposed than unexposed group

93
Q

What does a RR of 0.8 mean?

A

Risk of outcome is 20% lower in exposed than unexposed group

94
Q

What are case control studies?

A

Groups who differ at outset on disease status

2 groups of participants - 1 with condition (cases), 1 without condition (controls)

95
Q

What are the strengths of case-control studies?

A

Can offer some evidence of cause-effect relationship
Can identify multiple exposures
Good when disease / outcome is rare
Minimises selection and information bias
Retrospective -cheaper and often shorter duration

96
Q

What are the weaknesses of case-control studies?

A

Can’t calculate prevalence or incidence
Less suitable for rare exposures
Can be hard to ensure exposure occurred before onset
Retrospective data availability and quality may be poor
Suitable control group may be difficult to find

97
Q

How is risk calculated?

A

Outcome of interest divided by total number of all possible outcomes

98
Q

How is the odds calculated?

A

Outcome of interest divided by outcome not of interest

99
Q

How is an odds ratio calculated?

A

Odds in exposed divided by odds in unexposed

100
Q

What is relative risk?

A

Incidence of disease in exposed divided by incidence of disease in unexposed
Calculated using total population at risk of developing disease

101
Q

What is RR and OR not the same?

A

Odds ratio will always overestimate RR

102
Q

What are confidence intervals?

A

Describe the range of values with a given probability e.g. 95% that the true value of a variable is contained within that range

103
Q

What is sensitivity?

A

Proportion of people who have the disease who correctly test positive

104
Q

What is specificity?

A

Proportion of people without the disease who correctly test negative

105
Q

What is a positive predictive value?

A

Likelihood patient with positive test actually has the disease

106
Q

What is a negative predictive value?

A

Likelihood patient with negative test result doesn’t have the disease

107
Q

What happens to PPV and NPV as prevalence increases?

A

PPV increases

NPV decreases

108
Q

What happens to predictive values as a disease becomes more common?

A

There will be less false positives for every true positive
There will be more false negatives for every true positive
Due to underlying frequency of disease increasing in the given population

109
Q

What are the types of scientific report?

A 
Journal article
Conference abstract
Conference proceeding
Monograph or book
Database or dataset
Algorithm or code
110
Q

What is a good scientific question?

A 
Clearly state
Answerable
Maps onto at least 1 study design
Important
Not already answered
111
Q

What should the title of a scientific research question include?

A

State in brief the study design, population and question addressed

112
Q

What should an abstract include?

A 
Background
Aim of study
Methods
Results
Conclusion
113
Q

What does IMRaD stand for?

A

Introduction
Methods
Results
Discussion

114
Q

What should be included in the introduction section of a scientific report?

A

Why this research is important or necessary
1) Describe problem or situation that motivates research
2) Describe current state of research in field
3) Reveal a gap or problem in the field
4) Explain how the present research is a solution to that problem
Present any hypothesis at end

115
Q

What should be included in the methods section of a scientific report?

A

Study design - population, sample, methods, procedure, equipment, analyses
Ethics statements

116
Q

What should be included in the results section of a scientific report?

A

Description of study sample, response rate and participant characteristics
Presentation of findings
Tables and figures
Adjusted comparisons

117
Q

What should be included in the discussion section of a scientific report?

A 
Summary of findings
Reflect on meaning of data 
Connect findings to previous research
Strengths of study
Specific limitations
Suggest additional research
Clinical and/or research and/or policy implications of study
118
Q

What are some guidelines for method reporting?

A 
STROBE
CONSORT
COREQ
SQUIRE
PRISMA
119
Q

How should you describe the population in a scientific report?

A

Target population

Study population

120
Q

What is a type I error?

A

Study finds an association between A and B where none really exists so null hypothesis is wrongly rejected

121
Q

What is a type II error?

A

Study finds no association between A and B when there really is one so the null hypothesis is wrongly accepted

122
Q

Why does selection bias occur?

A

Recruitment from a setting which doesn’t represent target population
Those who agree to take part differ from those who don’t
Those who drop out differ to those who stay in

123
Q

Why is it important to report studies in a standardised way?

A

Failure to understand quality of medical evidence is an ethical issue
May fail to introduce an effective treatment
May disrupt delivery of a treatment that works
May create a market for ineffective or dangerous therapies

124
Q

Describe the hierarchy of evidence from bottom up

A 
Case reports / opinion papers and letters
Animal trials
Cross sectional studies
Case control studies
Cohort studies
RCT
Meta-analysis and systematic reviews
125
Q

What is a review?

A

Generic term for any attempt to synthesise the results & conclusions of 2 or more publications on a given topic

126
Q

What are the types of review?

A

Traditional literature reviews / narrative reviews

Systematic reviews / meta analysis

127
Q

Describe narrative reviews

A

Usually based on narrative or commentary & are produced by a ‘content expert’
Unsystematic approaches to collecting & summarising evidence can lead to bias
- Bias arising from studies included in review
- Bias arising from studies not included in review
- Bias arising from way review is done

128
Q

What is a systematic review?

A

Summary of medical literature that uses explicit & reproducible methods to systematically search, critically appraise & synthesise on a specific issue.
Synthesises the results of multiple primary studies related to each other by using strategies that reduce bias & random errors

129
Q

What is the aim of systematic reviews?

A

Systematic eg in its identification of literature
Explicit eg in its statement of objectives, materials & methods
Reproducible eg in its methodology & conclusions

130
Q

What are the key elements of a systematic review?

A

Well formulated question
Comprehensive database search
Unbiased selection & abstraction process
Critical appraisal of selected studies
Synthesis of data & interpretation of results (evidence synthesis)

131
Q

What is PICO-ST?

A 
Population
Intervention
Comparison
Outcomes
Setting
Timing
132
Q

What is SPIDER?

A 
Sample
Phenomenon of Interest
Design
Evaluation
Research type
133
Q

What are the limitations of systematic reviews?

A

May be no trials / evidence
If you apply all your criteria effectively & get <5 studies, this is fine
Trials may be of poor quality
Results may still be inconclusive
Practice doesn’t change just because you have evidence of effect / effectiveness

134
Q

What is a meta analysis?

A

Statistical combination of ≥2 studies to produce single estimate of effect of the health care intervention under consideration

135
Q

What is a meta-synthesis?

A

Group of methods used to synthesise qualitative (or mixed) data to produce summary result / re-analysis of previous studies / study findings

136
Q

What are the strengths of meta-analysis?

A

Statistically pools results from a range of trials
Effect of an intervention is seen over a bigger sample size than possible in a single trial
Results of each study are weighted for sample size
Results from a range of settings can be compared
Can evaluate homogeneity of results ie variability of effect sizes
Can explore variability ie test moderators of effect size (eg study quality)

137
Q

What are the weaknesses of meta-analysis?

A

Heterogeneity – studies which measure things differently are difficult to combine or combination becomes meaningless
Publication bias
Requires lot of effort & subject-area expertise
Mechanics of statistics may obscure theory

302 Scientific basis of medicine (28 decks)

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