Health technology and EBM_508a3961-ad5a-486e-9048-5e481803a165.pdf

Health technology

1. HEALTHCARE TECHNOLOGY
ASSESSMENT AND EVIDENCE
BASED MEDICINE
Prof. Dr. Janko Jankovic

2. Technology is the application of scientific or
other organized knowledge – including any tool,
technique, product, process, method,
organization or system – to practical tasks.

Healthcare technology is defined as prevention and
rehabilitation, vaccines, pharmaceuticals and
devices, medical and surgical procedures, and the
systems within which health is protected and
maintained.

Source: The International Network of Agencies for Health
Technology Assessment
Definition

3. Classification - Physical nature
Drugs
Devices, equipment,
and supplies
Medical and surgical
procedures
Public health programs
Support systems
Organizational and
managerial systems

4. Purpose
prevention
screening
diagnosis
treatment
rehabilitation
palliation
Stage of diffusion
future
experimental
investigational
established
obsolete/outmoded/
abandoned

5. Health technology assessment
(HTA) definition
HTA is a field of scientific research to inform policy and
clinical decision making around the introduction and
diffusion of health technologies…. HTA is a
multidisciplinary field that addresses the health impacts of
technology, considering its specific healthcare context as
well as available alternatives. Contextual factors addressed
by HTA include economic, organizational, social, and
ethical impacts. The scope and methods of HTA may be
adapted to respond to the policy needs of a particular health
system (Health Technology Assessment International 2013)

6. Health technology assessment
definition
HTA is a multidisciplinary process that summarises
information about the medical, social, economic and
ethical issues related to the use of a health technology in a
systematic, transparent, unbiased, robust manner. Its aim is
to inform the formulation of safe, effective, health policies
that are patient focused and seek to achieve best value.
Despite its policy goals, HTA must always be firmly
rooted in research and the scientific method (European
network for Health Technology Assessment 2013).

7. Purposes of HCTA to advise:
Regulatory agency
Health care payers and providers
Clinicians, providers and patients
Health professional organizations
Managers of hospitals, and other health care organizations
Government health officials
Lawmakers
Healthcare technology companies
Research agencies

8. Basic HCTA orientations
Technology-oriented
assessment
Problem-oriented
assessment
Project-oriented
assessment

9. Stages of health assessment technology
Identification (purpose, characteristics, population,
indication, choice of database and indicators)
Evaluation (outcome measures, evidence pyramid)
Synthesis (based on the results of a systematic
evaluation and survey data, report and
recommendations are formulated)
Dissemination and Monitoring (policy
development and decision making)

10. Health Technology Assessment
Direct (planned, expected) effects
Indirect (unplanned, adverse) effects
It is important to get answers to the
following questions: Whether the technology
is useful? Safe? To whom it is intended? At
what price? How it compares to alternative
technologies?

11. Development of new technologies
Preclinical phase

 "in vitro" - laboratory tests (on tissues, organs,
cells etc.)

 "in vivo" - testing on experimental animals,
international regulatory framework on these issues,
such as Directive 2010/63 /EU on the protection of
animals that are used for scientific purposes

 "in silica" - simulation of natural processes using
computer modeling software

12. Development of new technologies
Clinical phase (testing on humans)
Clinical trials of drugs and medical devices usually go through
four stages:

 Phase I, in which new drugs are tested for the first time, on a
smaller group of people
 Phase II which follows when safety has been confirmed in the
previous phase of investigational drug or medical device, but it is
necessary to monitor the bigger group of respondents
 Phase III multicenter studies
 Phase IV are carried out in individual countries after placing the
drug or medical device on the market, when there is a need for
further testing on broad populations over a longer time frame

13. What is assessed in HCTA?
Technical properties
Clinical safety
Efficacy and/or
effectiveness
Economic attributes
or impacts
Social, legal, ethical
and/or political
impacts

14. What is assessed in HCTA?
Technical properties
Include performance
characteristics and
conformity with
specifications for
design, composition,
manufacturing,
tolerances, reliability,
ease of use etc.
Clinical safety
Judgment of acceptability of
risk associated with using
technology in a given
situation e.g. patient with
particular problem, by a
clinician with certain training
and/or in a specified
treatment setting.

15. What is assessed in HCTA?
Efficacy
refers to the benefit of
using a technology for a
particular problem under
ideal conditions
(randomized controlled
trial)
Effectiveness
refers to the benefit of
using a technology for a
particular problem
under general or routine
conditions, e.g. by a
physician in a
community hospital for
a variety of patients.

16. Ethical, legal and social impact
Allocation of scarce resources
Equity in health
Human dignity

17. What is assessed in HCTA?
Economic attributes or impacts

microeconomic concerns include costs,
prices, charges and payment levels
associated with individual technologies
(cost effectiveness, cost utility, cost
benefit analysis)

Macroeconomic impacts

18. What counts as an
“economic” evaluation?
COSTS (INPUTS) AND CONSEQUENCES
(OUTPUTS) EXAMINED?


COMPARISON
OF TWO OR
MORE
ALTERNATIVES?
No Yes
No Outcome
description
Cost
description
Cost-outcome
description
Yes Efficacy or
effectiveness
evaluation
Cost
analysis
Full economic
evaluation
Often confusion
with economic
evaluation
Source: Drummond et al 2005
Clinical studies or
trials

19. Type of economic evaluation
Nominator Denominator
Cost-minimization $ -
Cost-effectiveness $ Process or health
outcome in natural
unit e.g. mmHg
Cost-utility $ Outcome in a
common unit e.g.
QALY, DALY
Cost-benefit $ $

20. Key steps of HTA
Define the question to be addressed

The type of question (effectiveness? Cost-
effectiveness?)
The precise technology under evaluation
The comparator
The disease and client group for which it is being
assessed
The outcome measure of interest

21. Key steps of HTA (cont)
Search for background information
Decision tree
Health
state
improved
Health state
No better
Adults
with
growth
hormone
deficiency

22. Key steps of HTA (cont)
Find the evidence
Sort and appraise the evidence
Search for cost information
Extract the data
Perform an economic evaluation
Consider the wider ethical, social and legal
implications
Write the report

23. HCTA and Underused Technologies
Reasons
Inadequate information dissemination
Limited coverage and reimbursement

24. Development of the idea of ​​the
importance of HTA
Archibald Cochrane - Cochrane Collaboration
(Established in 1993 as is an international non-profit network of people
helping healthcare providers, policy makers, patients, their advocates and
carers, make well-informed decisions about human health care by preparing,
updating and promoting the accessibility of Cochrane Reviews. Limitations
limited to English, only addresses questions amenable to randomized trials,
most of medicine has not been studied enough to allow for conclusions, pay
per year or abstracts only)
Еvidence-based medicine
Еvidence-based health care

25. Cochrane Library
www.cochranelibrary.com/

26. The explicit, conscientious, and judicious use of the
current best evidence in making decisions about the care
of individual patients. The integration of best research
evidence with clinical expertise and patient values
(Sackett, 1996)

Еvidence-based health care extending these principles
to the entire health care system, i.e. all professionals
involved in providing healthcare with customers of
health services (insurance) and managers in the
healthcare system.
Evidence-based medicine (EBM)

27. Evidence based medicine
A new paradigm in medicine that emphasizes the
importance of relevant evidence from research, no
longer considering it sufficient to make decisions
based only on intuition and experience from
practice.
The main characteristic of EBM is paradigm shift,
i.e. changing the way doctors learn and apply
what they have learned in clinical practice.

28. What do
you see?

29. A young girl

30. An old
woman

31. Paradigm shift
The experience of
seeing the image in
a different way

32. Components of EBM decision
Patient
wishes,
values and
rights
Clinical
expertise
Research
evidence

33. Stay up to date with new developments
Save time
Save as many human lives as possible
Supplement their clinical judgment, which
they use in making decisions about how to
treat each individual patient

The purpose of the EBM for
healthcare professionals is to:

34. 1.Formulations of an answerable clinical
questions
2.Search for the best evidence (literature)
3.Critically appraise the evidence (validity and
clinically aplicable)
4.Decision making – Integration of results into
clinical decision
5.Evaluation

Steps in EBM

35. Clinical question
Is carotid endarterectomy effective in a person with
moderate carotid stenosis?

Patient: 65-year-old man with moderate carotid
stenosis

Intervention: carotid endarterectomy

Comparative intervention: medical therapy

Outcome: stroke

36. Levels of evidence in research

37. Source for EBM data
American College of Physicians

38. Good practice guidelines
Sistematically
developed guidelines
which help physicians
and patients in making
decisions about proper
health care in specific
clinical situation.

Shekelle et al, 1999

39. Evidence-based public health
Development, implementation, and evaluation
of effective programs and policies in public
health through the application of principles of
scientific decision-making, including the
systematic use of data and information systems
and appropriate behavioral theories and models
for program planning.
Brownson, 1999

40. Key differences between evidence-based
medicine and public health

41. Decision making in public health

SCIENTIFIC
EVIDENCE
NEEDS AND
VALUES OF
THE
POPULATION
RESOURCES

42. Problem definition
Literature review Problem
quantification
Program or policy
development
Plan development for
implementation
Program or policy
evaluation
Evidence-based decision
making in public health

43. Thank you for your
attention!