Table 1: Results of Quality assessment for the four studies.
Chia,
Cortes, Stickeler,
Criteria
et al
et al
et al
interest measured prior to the outcome(s) being
measured?
7. Was the timeframe sufficient so that one could
reasonably expect to see an association between exposure
Yes
Yes
Yes
and outcome if it existed?
8. For exposures that can vary in amount or level, did the
study examine different levels of the exposure as related
No
No
No
to the outcome (e.g., categories of exposure, or exposure
measured as continuous variable)?
9. Were the exposure measures (independent variables)
clearly defined, valid, reliable, and implemented
Yes
Yes
Yes
consistently across all study participants?
10. Was the exposure(s) assessed more than once over
Yes
Yes
Yes
time?
11. Were the outcome measures (dependent variables)
clearly defined, valid, reliable, and implemented
Yes
Yes
Yes
consistently across all study participants?
12. Were the outcome assessors blinded to the exposure
No
No
No
status of participants?
13. Was loss to follow-up after baseline 20% or less?
Yes
Yes
Yes
14. Were key potential confounding variables measured
and adjusted statistically for their impact on the
Yes
Yes
Yes
relationship between exposure(s) and outcome(s)?
Score
12/14
12/14
11/14
Martin,
et al
Yes
No
Yes
Yes
Yes
No
Yes
Yes
12/14
3.3. Study Designs and Characteristics
The following table summarizes the study designs of the studies mentioned above
Table 2: The summary of Experimental Designs of the four studies
Study
Cortes, et al
Patient Criteria
Treatment Plan
Cardiac Monitoring
Age Range: 26-78 (Median: 53)
Liposomal Doxorubicin:
LVEF was measured using
Illness: HER-2 Overexpressing
1 hour intravenous
echocardiography or by
Metastatic or Locally Advanced
infusion, every 3 weeks,
MUGA scan (Multi Gated
Breast Cancer
for 6 cycles
Acquisition Scan). A drop
Other Criteria: Baseline LVEF ≥
Trastuzumab: Initial
in LVEF by ≥10% resulting
50%, No history of Myocardial
loading dose of 4mg/kg
in a final LVEF <50%,
Infarction. Prior administration of
on day 1, followed by 2
LVEF <40%, or any
anthracyclines, taxanes, or
mg/kg Intravenous
absolute drop ≥20% was
trastuzumab was not permitted
Infusion over 30
considered a cardiac event.