Lecture 1 Flashcards

1
Q

Experimental Research

A

Variables are subject to manipulation by the investigator. In clinical research, this involves ASSIGNMENT to treatment status

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2
Q

Observational Research

A

Investigator(s) “observe” what occurs naturally, i.e. in real-world settings. Treatment status is based on patient/system factors, not assigned.

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3
Q

Intervention Research

A

Establishes EFFICACY or EFFECTIVENESS as well as safety, of an intervention in a specific clinical population

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4
Q

Diagnosis Research

A

Validates a clinical diagnostic test against an established (and valid) “Gold standard” for that diagnosis.

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5
Q

Prognosis Research

A

Assesses demographic, behavioral and clinical characteristics that predict disease, or other outcomes of interest

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6
Q

Randomized Controlled Trials

A
  • Most rigorous EXPERIMENTAL research design
  • Useful ONLY for research on interventions
  • Subjects are randomly assigned to an intervention (or not)
  • Blinding of intervention may be applied to participants, clinicians etc.
  • Timing of data collection is PROSPECTIVE
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7
Q

Cohort Studies

A
  • Most rigorous OBSERVATIONAL research design
  • Study of “naturally” occurring groups
  • Subjects classified by exposure status and followed forward in time for outcome
  • Useful for cause of disease and prognosis, diagnosis/screening tests, interventions
  • Timing may be prospective or retrospective
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8
Q

Case-Control Studies

A
  • Outcome (disease) is rare or unusual
  • Subjects initially classified by outcome status
  • Exposures are already occurred or did not occur
  • Useful for research on etiology (cause of disease)/prognosis
  • Usually NOT for intervention or diagnosis research
  • Timing is always retro
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9
Q

Cross-Sectional Studies

A
  • Exposure and outcome measured at same time
  • Useful for study of disease burden within a community (prevalence)
  • May be used in diagnosis research (concurrent validity)
  • Utility for research on intervention, etiology, prognosis is limited
  • Timing is neither prospective or retro
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10
Q

Systematic Reviews

A
  • Examine multiple primary studies addressing a specific clinical question
  • I.E. intervention effectiveness, diagnostic test accuracy, prognostic factor
  • Included primary studies are rigorously appraised to assess credibility
  • Data from individual studies is combined to produce more powerful summary findings (meta-analysis)
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11
Q

Clinical practice guidelines, evidence syntheses, critically appraised topics

A
  • Organizations that summarize findings for a specific clinical issue
  • May include systematic reviews or appraisals or systemic reviews/primary studies
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