MAST
Safety (Domain 2)
Clinical Effectiveness (Domain 3)
Reinhard Prior, HIM, Berlin May 5, 2010
Basic principles of MAST
Strong consideration of the existing literature
when implementing a new trial
Use of validated, and generally accepted
outcomes
‘Holistic approach’ considering several
domains (not only clinical effectiveness)
Effectiveness
”The ability to produce a desired
result under real life conditions”
“Pragmatic trial”
Efficacy
”The ability to produce a desired
result under strictly controlled
conditions”
“Explanatory trial”
Which are the ‘desired results’ from a clinical point
of view?
Generic outcomes
(Not disease-specific)
All-cause mortality
All-cause morbidity
eneric Health related Qol instruments (SF-36/12, EQ-5D
Health care service utilisation
•Number of hospitalisations
•Number of hospital bed days
•Number of visits to emergency rooms
•Number of visits by specialists
•Number of visits by GPs
•Number of visits by nurses
Disease-specific
outcomes
(not disease-specific)
Scores,
Questionnaires,
HRQolquestionnaires
Depression
scales
Objective measurements
Hb A1c, cholesterol
FEV1
NYHA-class, LVEF
Requirements for primary outcomes
• Must be suitable to statistical analysis
• Must be easy to collect
• When a score, must be available and validated
in all local languages
What has already been done?
Literature overview
Paré et al.
50% of studies: non randomization, no control group
8 % of studies: non randomized with control group
Paré et al
Paré et al.
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Paré et al
How can Renewing
Health do it better?
Careful design considering the
missing evidence and missing
aspects (not just replication of
previous research)
Large scale
MAST
Patient / population ?
Intervention ?
Comparator ?
Outcomes ?
Levels of evidence:
RCT with large sample size
RCT with small sample size
Prospective study with non randomized control group
Retrospective study with non randomized control group
Cohort study
Case control study
Descriptive studies
Case reports
Randomized controlled trial
Quasi experimental methods (‘matched comparison’)
MAST
A basis to facilitate an integrated evaluation of those
domains that have not been addressed or have been
insufficiently adressed by previous research.
Thank you!