Chapter 3 - Types of Studies Flashcards

1
Q

Are case control studies prospective, retrospective or both?

A

Retrospective.

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2
Q

About how many people show a placebo effect?

A

1/3

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3
Q

Why are anecdotes the weakest kind of evidence?

A

Some described effects could be due to anything, not necessarily a particular treatment. There are no controls. Most medical conditions get better anyway by themselves. Bias or expectation can influence reporting.

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4
Q

Anecdotes

A

Personal communications, the weakest type of evidence.

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5
Q

Types of bias that can be found in clinical trials

A

Failed trials aren’t published, trial details left out of publication, invalid comparisons can be made, effects can be misrepresented, and side-effects can be minimized.

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6
Q

Epidemiology

A

study of disease within populations

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7
Q

Publication bias

A

When positive results are more likely to be published than negative ones.

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8
Q

Case studies

A

Report on one patient’s symptoms, signs, diagnosis, treatment, and follow-up. Usually describes a novel or unusual occurrence.

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9
Q

What factors associated with expectation can affect the placebo response?

A

Enthusiasm of the practitioner, larger pills, capsules (vs pills), injections (vs pills), colour, believing in the treatment.

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10
Q

Limitations of case studies

A

No control, sample size of only 1.

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11
Q

Limits of observational studies

A

The weakest of the scientific studies. Subjects not randomized into different groups. Show correlation at best.

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12
Q

Placebo pain relief is in part due to…

A

Opiate-receptors, and the release of dopamine.

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13
Q

How many papers in CAM journals report negative results?

A

Only 1-5%

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14
Q

Prospective

A

looks into the future

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15
Q

What can be learned from post-marketing surveillance?

A

What the rare adverse effects and long-term adverse effects are.

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16
Q

Unique problems of testing CAMs.

A

Unethical to test a treatment against one already shown to work. Difficult to blind. Treatments may be patient specific.

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17
Q

Is it ethical for a doctor to use a placebo to diagnose if a patient’s symptoms are real?

A

No, and it’s misguided.

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18
Q

What is the placebo effect important?

A

it may be the real cause of a positive result from some studies (especially those with poor controls).

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19
Q

What features should interventional studies have?

A

Placebo controlled, randomized and double-blinded.

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20
Q

Gold standard treatment

A

most commonly used treatments

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21
Q

Placebo effect

A

The perceived or actual improvement of a medical condition after receiving a sham intervention.

22
Q

Nocebo reaction

A

A negative placebo reaction.

23
Q

3 categories of scientific medical studies

A
  1. observational studies. 2. interventional studies. 3. summaries of other studies.
24
Q

Phase III clinical trials

A

300-3000 participants. Randomized. Compares treatment to existing ‘gold standard’ treatment.

25
Q

Phase II clinical trials

A

20-300 patients who are targets of the drug. Determines how well the drug works. Continues safety assessment.

26
Q

Case series

A

Follows a group of subjects with a similar exposure and examines the outcome.

27
Q

Perks of case control studies

A

Fast an inexpensive.

28
Q

The most powerful type of evidence

A

Meta-analysis and systematic reviews.

29
Q

Safety issues with CAM

A

Sometimes they’re really dangerous. Wasting time in treating a serious condition. May interact negatively with conventional treatments. 1/2 of patients do not tell their doctors they use CAM. Waste of money.

30
Q

Retrospective

A

looks backward

31
Q

Systematic reviews

A

Collect and critically analyze multiple research studies or papers

32
Q

Phases of OM treatment testing

A

Pre-clinical (in vitro); phase I; phase II; phase III; phase IV (post marketing surveillance).

33
Q

Results of many CAM studies are confounded by…

A

Placebo effect, regression fallacy, improper initial diagnosis, treatments improperly described, lack of randomization, lack of double blinding.

34
Q

Criticisms of many CAM studies

A

Anecdotal evidence, small sample sizes, and inadequate controls.

35
Q

Case control studies compare subjects who…

A

have a condition/disease with subjects who do not have that condition/disease, but are otherwise similar.

36
Q

Efficacy

A

how well something works in a trial

37
Q

Case control studies

A

Used to identify factors that may contribute to a medical condition. Not an experiment. Typically involve large numbers of people. Often used in epidemiology.

38
Q

Meta-analysis

A

combines the results of several randomized, controlled studies and re-analyzes them using statistics, in order to increase statistical power to detect a treatment effect.

39
Q

Are case series prospective, retrospective or both?

A

Can be both prospective and retrospective.

40
Q

Limitations of case series

A

No control. Prone to selection bias, may not represent the wider population.

41
Q

Why is private funding of CAM research unlikely to be economical?

A

Most CAM treatments aren’t patentable. In many countries there is no incentive to do so

42
Q

Cochrane

A

Non-profit group that promotes evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence.

43
Q

Regression fallacy

A

The condition was going to go away on its own anyway, but the ‘treatment’ is given the recognition of ‘curing’ the disease.

44
Q

Interventional sutides

A

compare treated subjects to those who receive a control or standard treatment.

45
Q

Effectiveness

A

how well something works in the real world.

46
Q

Types of observational studies

A

Case series/reports, case-control studies, and cohort control studies.

47
Q

Weakness of case control studies

A

Can only show correlation between treatment and outcome. Not direct evidence of cause and effect.

48
Q

What is the most common stage of failure for new drugs?

A

Phase II

49
Q

In what kind of trials is the placebo effect the weakest?

A

Well done trials that are measured by a third person.

50
Q

Phase I clinical testing

A

Small groups (20-100 healthy human volunteers); inpatient (at hospital); paid for time. Tests for safety and effective dose.