MAST Safety (Domain 2) Clinical Effectiveness (Domain 3)
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Transcript of MAST Safety (Domain 2) Clinical Effectiveness (Domain 3)
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
Generic 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,
HRQol-questionnaires
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
50% of studies: non randomization, no control group
8 % of studies: non randomized with control group
Paré et al.
Paré et al
Paré et al.
Paré et al
Paré et al.
Paré et al
Paré et al
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 groupRetrospective study with non randomized control group
Cohort studyCase control studyDescriptive 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!