Trials And Evidence Flashcards

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1
Q

What is single blinding?

A

Where the study participant does not know whether they are in the placebo or trial group

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2
Q

What is double blinding?

A

Where the study participants and investigator does not know about study participants allocation either trial or control group

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3
Q

What is triple blinding?

A

Where the study participants, investigator and statician do not know about the study participants allocation to either control or trial group

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4
Q

What is intention to treat analysis?

A

All the patients who were enrolled and randomly allocated to treatment are included in the analysis of a study even if some patients dropped out of the study

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5
Q

What is meta-analysis?

A

A statistical procedure for combining data from multiple studies

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6
Q

What is a case series?

A

A study that samples patients with specific outcome or specific exposure

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7
Q

What is a randomised control trial?

A

A trial where subjects are allocated randomly into an intervention or control group

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8
Q

What is a cohort study?

A

A study where one or more samples (cohorts) are followed prospectively and subsequent evaluations sign respect go disease or outcome are conducted to determine which initial participants exposure characteristics are associated with the disease or outcome

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9
Q

What is a case control study?

A

An observational study where two existing groups differing in some outcome are identified and compared on the basis of some supposed causal attribite

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10
Q

What is a cross sectional study?

A

A type of observational study that analyses data from a population at a specific point in time

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11
Q

What is internal validity?

A

Experimental design is structured and encompasses all of the steps of the scientific research method

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12
Q

What is external validity?

A

The process of examining the results and questioning whether there are any other possible causal relationships

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13
Q

What is selection bias?

A

Systematic differences in the comparison groups attributable to incomplete randomisation

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14
Q

What is performance bias?

A

Systematic differences in the care provided, apart from the intervention being evaluated

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15
Q

What is exclusion bias?

A

Systematic differences in withdrawals from the trial

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16
Q

What is detection bias?

A

Systematic differences in outcome assessment

17
Q

What is p value?

A

The probability that an outcome would have arisen by chance

18
Q

What is number needed to treat?

A

The average number of patients who need to receive treatment or other intervention for one of them to get the positive outcome in the time specified

19
Q

The higher the number needed to treat the less effective the treatment. T/F?

A

True

20
Q

What is the order of different types of studies in the hierarchy of evidence from weakest to strongest?

A
Case series
Cross sectional study
Case control studies
Cohort study
Randomised control trial
Meta analysis
Systematic review
21
Q

What is the aim of qualitative research?

A

To understand what it is like for the patient to live with a condition
To understand how patients feel and what they think about their care and treatment

22
Q

Describe the use of observational studies

A

Used to collect information about patients without trying to influence their exposure to a treatment or intervention that may prevent disease
Used when experimentation intervention is unethical to implement or when it is not appropriate to generalise

23
Q

What is the protocol for setting up a randomised control trial?

A
Research question formulated
Selection criteria made
Eligibility criteria made
Estimate sample size
Randomise patients
Intervention carrried out
Robust statistical analysis
Monitoring and management of clinical tiral
24
Q

How do patients act as their own control in cross over trials?

A

In these trials patients eventually get all of the different treatments, they just receive them in different orders in order to maintain blinding and to prevent bias

25
Q

What does monitoring snd management of clinical trials involve?

A

Quality assurance and participant management
Data monitoring, evaluation and reporting
Trial committees
Regular follow up

26
Q

What is the placebo effect?

A

A beneficial effect produced by a placebo drug or treatment which cannot be attributed to the properties of the placebo itself where the patient perceives an improvement in symptoms from the psychological effect of receiving treatment

27
Q

What is a confidence interval?

A

A range of values that has a specified probability of containing the true population parameter being investigated

28
Q

What is number needed to harm?

A

A measure of the chance of experiencing a specified harm in a specified time because of the treatment or other intervention

29
Q

What is the difference between superiority, equivalence and non inferiority trials?

A

Superiority trials aims to show that a new intervention is better than the comparison
Equivalence trials aim to show that two interventions have the same clinical benefit
An non inferiority trial aims to show that the effect of a new treatment cannot be said to be significantly weaker than that of a current treatment

30
Q

What are some of the disadvantages of a randomised control trial?

A

Costly and time consuming
Participants may not be a representative sample of the population
Recruitment may be difficult and small RCTs may lead to false conclusions
Administrative complexity of trial

31
Q

What is a positive control?

A

A sample that should definitely give a positive result and so can test experimental design

32
Q

What is a negative control?

A

A sample that should definitely not give a positive result and so can be used to test experimental design