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

A

RCT’s!

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
Q

What is information bias

A

difference in how data is collected and assessed between groups
(use double blind)

26
Q

What is a confounding variable

A

factor associated with intervention and outcome of a treatment

27
Q

What is a surrogate end point

A

outcome measures not of direct importance, but believed to reflect outcomes

28
Q

What is equipoise

A

uncertainty whether experimental intervention is better than comparison

29
Q

What is Intention to treat analysis

A

All patients enrolled in the study are included in the analysis, regardless of dropping out?