Align module Flashcards

1
Q

What is an experimental research design

A

When the investigator specifies the intervention as part of the research design. People are observed, outcome is measured

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2
Q

What are the concepts of a RCT

A
Equipoise 
Randomization 
Placebo 
Masking (blinding) 
Bias
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3
Q

Wat is an observational study

A

Investigator does not specify intervention of research purposes. People are observed over time, outcomes are measured
Can be retrospective or prospective

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4
Q

What kind of study has more risk of bias

A

Observational

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5
Q

What types of studies are considered “controlled observational”

A
Case control (look at pts with and without condition at a certain point in time) 
Cohort (follow pt w/ or w/o disease over a certain amount of time)
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6
Q

What is considered an “uncontrolled observational study”

A

Case report

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7
Q

Why are cross sectional studies difficult to infer

A

Because we aren’t observing patients over time

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8
Q

Which study type is not good for studying multiple outcomes

A

Case-control, because it is a retrospective study

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9
Q

What are problems in research design

A

outcomes and endpoints
We want answers ASAP
short term outcomes may not predict long term benefits
short cuts lead to negative consequences

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10
Q

What are solutions in research design

A

consider future patients and get right answer for long term
Make sure RCT has adequate follow up
Make sure RCT is carried through completion

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11
Q

What are the levels of evidence (ascending)

A
  • Unsystematic clinical observation (stories of people trying to deal with healthcare issues)
  • Physiologic studies (vitals, imaging, lab values)
  • Single UNcontrolled obs study/case series (not good for finding cause/effect)
  • Single controlled obs study (still affected by bias)
  • Systematic review of controlled obs (doesn’t correct for bias in design)
  • Single randomized trial
  • Systematic review of RCT (BEST- confirms that results of singe RCT weren’t coincidence)
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12
Q

What is the primary purpose of research

A

to benefit future patients

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13
Q

What are important lessons learned for consumer advocates (ERT and CVD)

A

There was an over reliance on observational studies
Systematic review (meta) of RCT contradicted observational findings
Clinical guidelines encouraged prescription of hormones for prevention w/o conclusive evidence
Pharmaceuticals emphasized benefit over risk and underwrite med ed for physicians
Natural aging was transformed into a disease in need of treatment

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14
Q

What is an ecologic study

A

a type of observational study that can find correlations of disease in groups (not individuals) but can’t show cause
ex: public smoking

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15
Q

What is an ecologic study good for

A

generating hypothesis for future studies

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16
Q

What is a cross sectional study good for

A

finding prevalence of a condition

17
Q

What are the problems with a case-control

A

masking is not possible
BIAS
not randomized

18
Q

How can you fix the problem of selection bias associated with a cohort study

19
Q

Compare controlled usb uncontrolled study

A

Controlled: more than one group studied (comparison/control Vs. Experimental)
Uncontrolled: single group studied, no comparison made

20
Q

What is selection bias

A

not true randomization

selection of people into a group is biased

21
Q

What is attrition bias

A

exclusion of people entered into a study

one side has fewer or more participants, affecting statistical conclusion

22
Q

How do you adjust for attrition bias

A

Use intention to treat analysis

23
Q

What is performance bias

A

difference in care provided and exposure to other factors

24
Q

How can you correct for performance bias

A

Use masking/ double blind

25
What is information bias
difference in how data is collected and assessed between groups (use double blind)
26
What is a confounding variable
factor associated with intervention and outcome of a treatment
27
What is a surrogate end point
outcome measures not of direct importance, but believed to reflect outcomes
28
What is equipoise
uncertainty whether experimental intervention is better than comparison
29
What is Intention to treat analysis
All patients enrolled in the study are included in the analysis, regardless of dropping out?