(=Health Technology Assessment)
2.EBM (= Evidense Based Medicine)
3.HE (=Health Economy)
4.Different perspectives in medical decision
Equivalent danish acronym: MTV (Medicinsk Teknologi-vurdering)
HTA is the “decision support information” necessary for assessing
the value of medical technology. The decision support information comprise
data generated with different analytical perspectives: Technology(safety
and effectiveness) and Health Economy (budget impact and/or e.g. cost-effectiveness).
In the Danish HTA definition the organisational perspective and patient
perspective are also included in the definition. For references please read:
“Different perspectives in medical decision making”
Methodology: For specific national methodology guidelines,
please consult the websites of the national HTA egencies (se LINKs).
One important international methodology guidelines is the “TA101”.
EBM/Evidence Based Medicine
Short definition: EBM implies a quality rating of clinical
trials giving rise to a ranking of validity of the derived results or postulates.
Methodology: The gold standard for quality rating is described
in the “Cochrane
manual” and the resulting Evidence reports is published in the
Library”. There are however a series of “evidence reports”
using less stringent but satisfactory quality rating methods arising from
the national HTA-agencies or from professional medical societies.
A shortened Danish methodology paper is available : “Litteratursøgning
og evidensvurdering – en kort vejledning”.
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Short definition: Health Economy is a broad discipline
comprising all kinds of economic assessments and perspectives. The most
commonly used perspective used in HTA is the “society perspective”.
It is adviced to consult a textbook of health Economy to learn the precise
definitions and theory behind the different terms.
Methodology: For easy introduction the following short
articles can be read:
quality in decision Analytical modeling, York.
Economic notes-Economic Evaluation.
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Combined use of Health Economy, EBM and HTA
The history of the combined use of these principles in medical decision
making has been summarized in the short article below:
in medical decision making?
THE PARADIGM OF EVIDENCE
We define information used to support clinical decisions as decision support
information. Scientific articles have through centuries been an important
source to decision support information.
During the latest 2 decades the paradigm of evidence has gradually become
the gold standard for quality assessment of clinical scientific publications.
The driving force behind this development was an unsatisfactory and very
large variation in quality of the design of the underlying studies. Another
driving force was also a large de facto variation in the treatment of patients
having the same disease from region to region and from doctor to doctor
within the same region. (Eddy 1992) (Grimes 1993)
The aim of the paradigm of evidence (Dans et al 1998) (Haynes and Haines,
1998) is a search for the ultimate proof that new treatments are effective
and safe compared to conventional treatments.
Today “evidence” is a mantra when decisions are made to introduce
new medical technologies. The concept of medical evidence was originally
developed to assist the single clinician with the decision processes concerning
his own patients (Sackett et al.1996).
Today the application of the paradigm of evidence is more widespread than
this (The Scharr institute: http://www.shef.ac.uk/scharr/ir/netting/). This
is due to the fact that the paradigm of evidence has also become an integral
part of HTA (Health Technology assessment) (Perleth, et al, 2001).
The application of the paradigm of evidence is today applied by a broader
group of professionals. Publically financed HTA-institutions has been set
up in many western countries with the aim of providing independent decision
support information for politicians, hospital managers, medicines agencies,
administrators, medical experts, professors and clinicians.
HEALTH ECONOMY AND EVIDENCE
One of the earliest places to introduce the paradigm of evidence was the
requirement for blinded randomized controlled trials (RCT’s), before
market authorizations can be granted to new pharmceutical drugs. This praxis
is today defined and regulated in the international ICH- guidelines (ICH,
International Committee of Harmonization) with the aim of harmonizing
the rules around Registration of new pharmaceutical drugs. (Rockhold
The focus of the ICH guidelines is to assure that new drugs have a sufficient
safety and efficacy. The efficacy is assessed by running a randomized controlled
trial with an adequate control group, in order to create the strongest possible
evidence for a causal relation between the treatment and the observed efficacy.
A significant threat against strong evidence is the presence of confounders
or other sources of bias. This risk is minimized by the exclusion of patients
with confounding diseases, treatments or other factors that are potentially
able to harm a clear conclusion on the study. In this way a high internal
validity is created for the proof of efficacy.
There has been an increasing focus on the fact that narrow patient inclusion
criteria does not reflect the patients that occur in clinical practice and
this is why data from RCT’s are not ideal for Health Economic calculations
and modeling. (Revicki and Frank 1999). This is also why naturalistic
data sources are increasingly preferred in many countries for Health Economic
calculations. This is done in order to assure that such calculations of
e.g. cost effectiveness are done on realistic patient data.
(Guidelines for economic evaluation of pharmaceuticals; Canada, 1997)
(Taylor 2001) (The pharmacoeconomic Outlook to 2003).
The idealised requirement of the application of more naturalistic data in
Health Economic analysis is therefore a new challenge that goes beyond the
design of clinical trials for registration purposes.
(Powe and Griffiths, 1995)
Jørgen Folkersen MD, Dr.
Guidelines for economic evaluation of pharmaceuticals: Canada. 1997.
CCOHTA Publications, Ontario Canada.
The pharmacoeconomic Outlook to 2003. 2003. Reuters, Datamonitor PLC.
Eddy, D. M. "Medicine, money, and mathematics." Bull Am Coll.Surg.
77.6 (1992): 36-49.
Grimes, D. A. "Technology follies. The uncritical acceptance of medical
innovation." JAMA 269.23 (1993): 3030-33.
Perleth, M., E. Jakubowski, and R. Busse. "What is 'best practice'
in health care? State of the art and perspectives in improving the effectiveness
and efficiency of the European health care systems." Health Policy
56.3 (2001): 235-50.
Powe, N. R. and R. I. Griffiths. "The clinical-economic trial: promise,
problems, and challenges." Control Clin.Trials 16.6 (1995): 377-94.
Revicki, D. A. and L. Frank. "Pharmacoeconomic evaluation in the real
world. Effectiveness versus efficacy studies." Pharmacoeconomics. 15.5
Rockhold, F. W. "Industry perspectives on ICH guidelines." Stat.Med
21.19 (2002): 2949-57.
Sackett, D. L. et al. "Evidence Based Medicine: what it is and what
it isn't." BMJ 312.7023 (1996): 71-72.
Taylor, R. "Using health outcomes data to inform decision-making: government
agency perspective." Pharmacoeconomics. 19 Suppl 2 (2001): 33-38.