NUR 355 EXAM 3 (CUMULATIVE) STUDY GUIDE WITH
COMPLETE SOLUTION!!
SEE ALL LABS
-ALL EXAM 1 AND 2 CARDS
(PPT:Efficacy of Preventive and Therapeutic Measures: Randomized Clinical
Trials) Importance
answers: >To modify the natural history of a disease so as to prevent or delay
death or disability and to improve the health of the patient or the population
>Select the best available preventive or therapeutic measure to achieve the above
goal (notes: drugs can be both primary and tert ex: aspirin treats condits but also
prevents heart attacks)
>Carry out studies to determine the value of these measures
Randomized Trials
answers: ideal design for evaluating both the EFFECTIVENESS and the SIDE
EFFECTS of new forms of intervention
Design of a Randomized Trial (see chart in ppt or notes/know)
answers: Line 1 Box 1: Defined Population->
Line 2 (box 2 & 3): New Treatment (vs) Current Treatment
Line 3 (box 4-7): Improved, Not Improved, Improved, Not Improved
note: current Tx is called the gold standard
Selection of Subjects
, answers: >Great effort is made to determine who is and who is NOT included in
the study - in writing
>Inclusion criteria
>Exclusion criteria
>No element of subjective decision making on the part of the PI
>Dealing with relatively large populations
Allocation of Subjects to Treatment Group
answers: -Studies without comparison
-Studies with comparison
WITHOUT Comparison
answers: >Case Study (a.k.a. case series)
>No comparison is made with an untreated group or with a group that is receiving
some other treatment
>Why is comparison important in randomized trials? bc want to be able to derive a
causal inference regarding the relationship of a Tx and subsequent outcome
-notes: causal inf=causal realt or cause-effect relat
With a Comparison Group
answers: -Historical Controls
>A comparison group from the past
>Go back to the records of patients with the same disease who were treated before
the new therapy became available
>Problems: different system for data collection and management; records for
clinical purposes NOT records----makes hard to get good, accurate data
, Randomization
answers: >Best approach in the design of a clinical trial
>Tossing a coin to decide the assignment of a patient to a study group
>Critical element of randomization is the unpredictability of the next assignment:
random number tables or computer
-notes: good bc helps make groups more equal and theres no way to predict who
gets into what group
Data Collection on Subjects
answers: >Treatment (txt) - Assigned and Received
>Need to know which group patient is assigned
>Need to know which therapy each pt. received
>Treatment
>Outcome
>Prognostic Profile
>Masking (Blinding)
Outcome
answers: >Need for comparable measurements
>Outcomes include improvements (desired effect) and any side effects that may
appear
>Need for explicitly stated criteria for all outcomes to be measured in a study
>Measured comparably in all groups
Prognostic Profile at Entry
COMPLETE SOLUTION!!
SEE ALL LABS
-ALL EXAM 1 AND 2 CARDS
(PPT:Efficacy of Preventive and Therapeutic Measures: Randomized Clinical
Trials) Importance
answers: >To modify the natural history of a disease so as to prevent or delay
death or disability and to improve the health of the patient or the population
>Select the best available preventive or therapeutic measure to achieve the above
goal (notes: drugs can be both primary and tert ex: aspirin treats condits but also
prevents heart attacks)
>Carry out studies to determine the value of these measures
Randomized Trials
answers: ideal design for evaluating both the EFFECTIVENESS and the SIDE
EFFECTS of new forms of intervention
Design of a Randomized Trial (see chart in ppt or notes/know)
answers: Line 1 Box 1: Defined Population->
Line 2 (box 2 & 3): New Treatment (vs) Current Treatment
Line 3 (box 4-7): Improved, Not Improved, Improved, Not Improved
note: current Tx is called the gold standard
Selection of Subjects
, answers: >Great effort is made to determine who is and who is NOT included in
the study - in writing
>Inclusion criteria
>Exclusion criteria
>No element of subjective decision making on the part of the PI
>Dealing with relatively large populations
Allocation of Subjects to Treatment Group
answers: -Studies without comparison
-Studies with comparison
WITHOUT Comparison
answers: >Case Study (a.k.a. case series)
>No comparison is made with an untreated group or with a group that is receiving
some other treatment
>Why is comparison important in randomized trials? bc want to be able to derive a
causal inference regarding the relationship of a Tx and subsequent outcome
-notes: causal inf=causal realt or cause-effect relat
With a Comparison Group
answers: -Historical Controls
>A comparison group from the past
>Go back to the records of patients with the same disease who were treated before
the new therapy became available
>Problems: different system for data collection and management; records for
clinical purposes NOT records----makes hard to get good, accurate data
, Randomization
answers: >Best approach in the design of a clinical trial
>Tossing a coin to decide the assignment of a patient to a study group
>Critical element of randomization is the unpredictability of the next assignment:
random number tables or computer
-notes: good bc helps make groups more equal and theres no way to predict who
gets into what group
Data Collection on Subjects
answers: >Treatment (txt) - Assigned and Received
>Need to know which group patient is assigned
>Need to know which therapy each pt. received
>Treatment
>Outcome
>Prognostic Profile
>Masking (Blinding)
Outcome
answers: >Need for comparable measurements
>Outcomes include improvements (desired effect) and any side effects that may
appear
>Need for explicitly stated criteria for all outcomes to be measured in a study
>Measured comparably in all groups
Prognostic Profile at Entry
