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Masking: Janet Holbrook, PHD, MPH Johns Hopkins University
Masking: Janet Holbrook, PHD, MPH Johns Hopkins University
Masking: Janet Holbrook, PHD, MPH Johns Hopkins University
Copyright 2013 Johns Hopkins University and Janet Holbrook. All Rights Reserved.
Outline
n
Masking
- Definition
- Rationale
- Advantage and disadvantage
Masking
n
n
Rationale
n
Level of Masking
n
Single
- Participant is masked
Double
- Participant and clinical investigator are masked
Triple
- Participant and clinical investigator and others are masked
Others: outcome evaluators, data analysts, data
monitoring committees, sponsors . . .
Advantages/Disadvantages
n
Advantages of masking
- Protects against performance/reporting bias
Data collection and follow-up
Outcome assessment and reporting
Other care received during the trial
Interpretation of results
Disadvantages
- May be logistically or ethically impossible
- May not reflect clinical care practices
Concomitant care
- Increases logistical complexity
- Increased cost
None
Single
Double
Triple
Data reporting
No
Yes
Yes
Yes
Data collection/follow-up
No
No
Yes
Yes
No
No/No/
Yes
Yes
Yes
Outcome assessment
No
No
Yes
Yes
Data analysis/interpretation
No
No
No
Yes
7
Is it ethical?
- Exposure to risk with placebo treatment, e.g., sham surgery,
IV infusions
- Risk increased if investigator/caregiver doesnt know
- Viable unmasking plan
Is it possible?
- Distinctive characteristic, behavioral intervention, community
interventions may make it impossible
- Can you make the treatments seem identical
Or
- Can you create a placebo for each treatment, frequently
called a dummy treatment
UnmaskingPlanned
n
10
UnmaskingUnplanned
n
11