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.

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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!