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Scientific Basis of Medicine > Research Methods - Encountering evidence > Flashcards

Research Methods - Encountering evidence Flashcards

1
Q

What is evidence-based medicine? (EBM)

A

• “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” (David Sackett)
• Clinical decisions should be based on best evidence
• The problem determines the nature/source of evidence needed
• Best evidence is integrative
• Evidence should be identified, integrated,
appraised and applied
• Performance should be continually evaluated

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2
Q

Clinical decisions should be based on … …

A

Best evidence - the problem determines the nature/source of evidence needed
Best evidence is integrative
Evidence should be identified, integrated, appraised and applied
Performance should be continually evaluated

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3
Q

What is research ethical approval?

A
  • Research ethics govern the standards of conduct for researchers
  • Research ethics protect the dignity, rights and welfare of human and animal research participants
  • Research ethics approval is provided by a committee (who review a research protocol, and to ensure appropriate ethical standards are being upheld)
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4
Q

Which studies require research ethical approvals?

A

Studies involving human/animal participants if - gathering novel data or information, creating knowledge that can be generalised beyond the participant sample or setting

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5
Q

Which studies require research ethical approvals?

A

Studies involving human/animal participants if:

  • gathering novel data or information
  • creating knowledge that can be generalised beyond the participant sample or setting
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6
Q

Which projects do not require ethical approvals?

A

Health improvement studies:
- service evaluations/service improvement/quality improvement (finds out something that service which can be/is used to improve that service)
- clinical audit (as per service evaluation, but evaluating service against a benchmark (e.g. national standard)
NB - NHS audits should be registered with the NHS trust in which they are being conducted

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7
Q

Which committee needs to be involved if the participants are NHS patients and/or staff / work conducted on NHS site/s?

A

NHS health research authority

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8
Q

Which committee needs to be involved if the participants are individuals (or animals/cells) recruited anywhere except the NHS site / no NHS site involved?

A

School research ethics officer (SREO) / BSMS RGEC (Research governance and ethics committee)

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9
Q

IRP project types that require ethics approval?

A
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10
Q

Epidemiological studies can be either …. Or ….

A

Descriptive: amount and distribution in populations (person, place and time)
Analytic: test hypothesis, identify and quantify risk or exposure

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11
Q

Descriptive study types include (4)…

A

Case reports, case series, ecological studies, cross sectional or prevalence survey

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12
Q

Observational study type examples (4)

A

Case control, cohort and ecological studies, cross sectional or prevalence surveys

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13
Q

Experimental study type examples:

A

Clinical trials, preventive trials, community intervention trials

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14
Q

Exposure is …

A

Risk factor for a disease/outcome e.g. obesity, socioeconomic status, gender

  • can increase or decrease risk of disease/outcome
  • those which decrease risk of disease/ (negative) outcome are protective
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15
Q

Outcome is …

A

Disease, condition or event of interest e.g. HIV/AIDS, depression, mortality relating to cardiovascular disease

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16
Q

… measures the frequency of “cases” of a disease (/condition/outcome) in a given population at a designated time (e.g. asthma) - the numerator

A

Prevalence measures the frequency of “cases” of a disease (/condition/outcome) in a given population at a designated time (e.g. asthma) - the numerator

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17
Q

Calculation of prevalence requires a suitable …

A

denominator (e.g. GP registered patients, schoolchildren) - the number of people who are ‘at risk’ of the disease

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18
Q

Prevalence

A

Number of people who have disease at given time/ number of people at risk of having disease at given time

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19
Q

Prevalence is expressed as either a …, a …. Or a … per unit of population

A

Prevalence is expressed as a percentage (e.g. 70%), a proportion of 1 (0.7 is equivalent), or a proportion per unit of population (700 of every 1000 people)

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20
Q

Why might we be interested in prevalence of asthma?

A
  • Informing clinical diagnosis e.g. the more prevalent asthma, the more likely it is that this explains why the teenager is breathless…
  • Understanding the disease/condition and its risk factors (exposures) and outcomes e.g. identifying risk factors for breathless teenagers, identifying changes over time/place
  • Informing prevention and public health interventions e.g. educating teenagers/parents/public about asthma and its causes/consequences
  • Informing service planning and commissioning e.g. ensuring enough people/resources available to treat number of breathless teenagers
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21
Q

Prevalence measures the frequency of … of a disease

A

“Cases” of a disease (/condition/outcome) in a given population at a designated time (E.g. asthma) - the numerator

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22
Q

Types of prevalence (3)

A

Point, period, Lifetime

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23
Q

Uses of different types of prevalence

A

Point and period - for better patient recall and tracking changes
Lifetime - short/fluctuating/episodic conditions

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24
Q

What is point prevalence?

A

The proportion of a population that has the characteristic at a specific point in time

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25
Q

What is period prevalence?

A

The proportion of a population that has the characteristic at any point during a given time period of interest

26
Q

What is lifetime prevalence?

A

The proportion of a population who has ever had the characteristic at some point in their lifetime

27
Q

Calculating prevalence:

A

Disease prevalence:
Prevalence of disease = (A+C)/ N
Prevalence of disease in exposed = A / (A+B)
Prevalence of disease in unexposed = C / (C+D)

28
Q

Exposure prevalence:

A

Prevalence of exposure = (A+B)/ N
Prevalence of exposure in diseased = A / (A+C)
Prevalence of exposure in non-diseased = B/ (B+D)

29
Q

Cross-sectional study design - a defined population is surveyed to measure … … …

A

Cross-sectional study design - a defined population is surveyed to measure variable/s of interest (e.g. disease/outcome (E.g. asthma), exposure (E.g. sedentary lifestyle,sex)

30
Q

In cross-sectional study, the sample is selected using …

A

Inclusion and exclusion criteria (Determined by study aims/research questions/hypotheses) - could be general population or clinic-based

31
Q

Prevalence is reported for the sample and/ or subgroups based on … status

A

Prevalence is reported for the sample and/ or subgroups based on exposure status

32
Q

Is the cross-sectional study descriptive or analytic?

A

Can be analytic or descriptive

  • Descriptive (about amount and distribution in population person, place and time)
  • Analytic (test hypotheses, identify or quantify risk or protective factors)
33
Q

Strengths and weaknesses of cross-sectional studies

A

+ Can compare prevalence in exposed and non-exposed to risk factors
Quick and inexpensive study type
Can be used to initially explore/inform a hypothesis, prior to another type of study
- Not suitable for rare diseases
- Cannot separate cause (exposure) and effect (outcome) as they are measured at the same time
- Cannot measure rate of new cases arising and any changes therein

34
Q

Sources of cross-sectional study data?

A

Secondary - collected by someone else previously for a different purpose, then used by the researches in the specific study
Primary - collected by the researches directly from main sources for the specific purpose

35
Q

Examples of secondary cross-sectional data

A

Mortality registers, hospital/medical records, census data, previous research studies

36
Q

Examples of primary cross-sectional study data?

A

Survey data

37
Q

Pros of secondary cross-sectional study data

A

Cheap, if anonymous, minimal to no ethical/governance approval needed

38
Q

Negatives of secondary cross-sectional study data

A

Limited by what data already gathered, poor accuracy and missing data

39
Q

Pros of primary cross-sectional study data

A

Control over how variable/s of interest measured

40
Q

Negatives of primary cross-sectional study data

A

More expensive and time-consuming, difficult to achieve representative sample

41
Q

Research methods =

A

Foundational skills for evidence-based medicine

42
Q

Prevalence = number of people with a condition in a defined … at a given … in time e.g. number breathless teenagers now

A

Prevalence = number of people with a condition in a defined population at a given point in time e.g. number breathless teenagers now

43
Q

Examples of prevalence: What are the types?

Current number of teenagers breathless now?
Current number of teenagers breathless July-august 2020?
Current number teenagers breathless ever in their lifetimes 2020?

A

Point – current number teenagers breathless now
Period- current number teenagers breathless July-August 2020
Lifetime- current number teenagers breathless ever in their lifetimes 2020

44
Q

Define prevalence

A

Number of people with a condition in a defined population at a given point in time

45
Q

How to calculate prevalence

A

Prevalence = number with disease at given time / number at risk of disease at given time

46
Q

What is a key study design to establish prevalence?

A

Cross-sectional study

47
Q

Advantages vs Disadvantages of a cross-sectional study

A

Advantages – cheap, quick

Disadvantages – some issues with usefulness for establishing prevalence of rare or time-limited diseases

48
Q

What does incidence measure?

A

Measures the frequency of “new onset cases” of a disease (/condition/outcome) (E.g. Covid-19) in a given population over a designated period of time (E.g. 12 months)

49
Q

what studies don’t need research ethics approval?

A

service evaluation
service improvement
quality improvement
audit

50
Q

when do studies need research ethics approval?

A

if patients or staff are involved

51
Q

point prevalence

A

The number of cases of a specific condition or disorder that can be found in a population at one given point in time.

52
Q

period prevalence

A

A measure of how many individuals were affected by the disease during a specified time period.

53
Q

lifetime prevalence

A

the proportion of people in the population who have had a disease/exposure at some point over their lifetime

54
Q

what are point and period prevalence better for?

A

better patient recall

better at tracking changes

55
Q

what is lifetime prevalence better for?

A

tracking short, fluctuating or episodic conditions

56
Q

cross-sectional study

A

A study in which a representative cross section of the population is tested or surveyed at one specific time to measure variable of interest

57
Q

Pros of Cross-Sectional Studies

A

quick
cheap
can compare prevalence in exposed and non-exposed
can initially form a hypothesis before another type of study

58
Q

Cons of Cross-Sectional Studies

A

not good for rare exposures
can’t separate cause and effect
can’t measure incidence

59
Q

descriptive study

A

a study designed to describe the amount and distribution of variables in populations

60
Q

analytic study

A

an epidemiological study aimed at testing hypotheses, can identify and quantify risk

61
Q

primary data sources

A

surveys, interviews, observation, community forums, focus groups

62
Q

secondary data sources

A

mortality registers, medical records, census data, previous studies

Scientific Basis of Medicine (35 decks)

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