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PENGANTAR

PENAPISAN DAN
ADAPTASI
TEKNOLOGI
KESEHATAN
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Health Technology Assessment

Pendahuluan

Healthcare Technology Assessment (HTA)


first came to prominence in 1972 when the
United States Congressional Office of
Technology Assessment was established. Up
to that time assessments did take place in
healthcare. Many western countries have
formal HTA programs in place.

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Pendahuluan

The International Society of Technology Assessment


in Health Care (ISTAHC) was founded to promote
research, education, co-operation and exchange of
information on the clinical and social implications of
health technology

More recently ISTAHC has been dissolved but


Health Technology Assessment International (HTAI)
has been launched to continue the work of ISTAHC

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Sekilas tentang HTA

HTA memprediksi:
- pengaruh teknologi baru
- muncul & meluas
- bidang kesehatan & kedokteran

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Dampak:
Safety & efikasi
Faktor ekonomi cost effectiveness
Faktor etik, legalitas, kewajaran
Isue luas terhadap kesehatan & keuntungan
sosial

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Sekilas tentang HTA

Tujuan HTA:
mempengaruhi & mendukung pembuatan
tata cara keputusan klinik

Idealnya HTA meliputi:


- kerangka kebijakan
- hasil yang potensial dari perkiraan
- penilaian keputusan yang nyata

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Salah penafsiran Healthcare technology


- pemahaman tradisional

Ruang lingkup HTA lebih luas meliputi:


- Drugs and Pharmaceuticals
- Medical Equipment
- Information Systems
- Clinical Procedures
- Organisational and support system
Bersama untuk pelayanan medik

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Technology can be extended to include:


- a health improving nutritional product
- a health service and any other tool
- method or structure relevant to health care

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Peran HTA

To support policymaking irrespective of the


environment
Policy formulation can arise in different
settings and for different reasons

For example HTA could be used to support


product development and marketing
Health insurers could use HTA to decide
which technology they will cover.

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HTA could help government and its agencies


determine the most appropriate ways of
allocating scarce resources

Health care managers could use HTA to


decide upon which technologies are the most
appropriate to adopt or indeed determine
which technologies to decommission
(dihentikan)

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HTA can be used to educate clinicians and patients


regarding the adoption and proper use of particular
technologies

Regulatory agencies rely upon (mendasarkan) HTA


methodologies to provide important information, which will
help them to license or support health care technologies

Scope HTA is used today in all health care settings


including Prevention, Screening, Diagnosis, Treatment
and Rehabilitative care.

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1. Identification and priority


setting

The first important step is to identify the technologies


that need to be assessed, taking into consideration the
scope of HTA identified above. This may prove to be
relatively straightforward

The requirement for example may be mandatory as:


- in the case of drug regulations and licensing
- the cost of a particular technology may be very high
and consequently unavailable to all patients so choices
have to be made about who gets it

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Identification and priority setting

Sometimes technologies which are unregulated


can give rise to closer scrutiny (penelitian
cermat), as in the case of herbal remedies, for
example

ideally assessments should be done in phase


with the life cycle of a particular technology:

Future Technology
Emerging (bermunculan) Technology
New Technology
Accepted Technology
Obsolete (kuno, tak terpakai) Technology

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Isu dalam penapisan dan


adaptasi teknologi kesehatan

Inovasi
Pengembangan teknologi
Evaluasi
Penyebarluasan pemakaian
Efisiensi

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Innovation, development &


diffusion of Medical technology

Established technol
Late adopters

Obsolete
technology

Early adopters
Clinical trials
First medical use

Abandoned/
ditinggalkan
technology

Innovation Development Diffusion Evaluation


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Identification and priority setting


Life Cycle

Phase

Potential Assessments

Future Technology

Design Phase

Prospective Assessment
Access Societal Effect

Emerging Technology

Not Yet Adopted

Prospective Assessment
Assess Societal Effect
Pilot Efficacy and Safety

New Technology

Being Adopted

Economic Analysis

Accepted Technology

Widely Adopted

Assess Societal Effect


Appropriateness
Resuability

Obsolete Technology

Decommission
(ditinggalkan)

Appropriateness
Resuability

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Checklist untuk evaluasi


Criterion

Description

Burden of Disease
Epidemiological Criteria

1. Pervalence
2. Incidence
3. Mortality
4. Qualitative Description

Quality of Life

5. Generic Questionnaire
6. Diseace-specific Questionnaire
7. Utility Measurement
8. Qualitative Description

Cost of Illness

9. Direct Cost
10. Indirect Costs
11. Qualitative Description

Frequency
of Use
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12. Number of Treatments in a period and/or


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Health Technology Assessment
geographic area

Checklist untuk evaluasi


Criterion

Description

Potential Effects
Efficacy

13. Morbidity
14. Mortality
15. Generic Questionnaire
16. Disease-specific Questionnaire
17. Utility - measurement
18. Qualitive Description

Potential Costs of the


Technology
Costs
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19. Costs of Treatment


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Checklist untuk evaluasi


Criterion

Description

Uncertainty of Applying
the Technology
Controversy

20. Different Judgements in a Profession

Susceptibility of
Physicians to new
knowledge

21. Differences between Physicians

Indication Region

22. Defination (penonaktifan)

Ethical and Social


Implications

23. Initial Questions


24. Applications Questions
25. Regulation Questions

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2. Determine the Nature of the


Assessment Problem

This stage is all about coming to terms with the


exact nature of the problem and why it needs to be
investigated. In reality, researchers or indeed
anyone setting out to undertake an investigation will
want to find out in advance the parameters or scope
of the problem. Who are the target population? What
is the environment? Can the users be identified?
What are the economic perspectives which should
be taken into consideration? All of these are
important. The most important one, however, is
associated with scoping the problem.

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2.1 Health Related Quality of Life Indexes

It is also important to consider at this stage the type(s) of


analysis which will have be undertaken in order to draw
conclusions from the work
The yardstick (ukuran) by which the effectiveness, safety,
efficacy and often appropriateness of health care
technology are measured is through health outcomes.
Although the common method of expressing outcomes
might be in terms of morbidity and mortality, other
measures may also be considered.
A particular health care technology application might, for
example have a social impact or may result in either a loss
or gain from a health or societal perspective.

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2.1 Health Related Quality of Life Indexes

A more appropriate means of measuring such impacts


could be achieved by using Health Related Quality of Life
(HRQL) indexes or measures. Goodman includes the
following examples of general HRQL indexes:
Sickness Impact Profile, Nottingham Health Profile, Quality
of Well-being Scale,
Functional Independence Measure,
Short Form ( SF)-36,
Euro-Qol Descriptive System,
Katz Activities of Daily Living. Examples of disease specific
HRQL indexes include the New York Heart Association
Functional Classification, Arthritis Impact Measurement
Scales and the Visual Functioning (VF)-14 Index.

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2.2 Socio-Economic Evaluations

Cost Benefit Analysis: - The costs and


outcomes or benefits of particular technology
are expressed purely in monetary terms
Cost Effectiveness Analysis: - In this case the
costs associated with a particular technology
are measured in monetary terms while the
outcome is measured in its natural units
Cost Utility Analysis: - To overcome the
shortcomings in CEA, the value or quality of
years of life (called utility) is measured

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2.2 Socio-Economic Evaluations

Cost Minimization Analysis: - In situations where the


outcome of using particular technologies might be
the same or relatively close then netting off the
direct costs relating to the intervention may be
appropriate. This method is referred to as Cost
Minimisation Analysis.
Cost of Illness Analysis: - In certain circumstances
one might wish to determine the impact of a disease
or condition like drinking, drug abuse or smoking
solely in economic terms.

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Cost-efectiveness analysis

Comparison of the cost of different ways to


achieve a common outcome
Result: Cost per unit outcome, Units of
outcome per dollar spent
Example: Dollars per life saved

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Cost-benefit analysis

Comparison of an interventions cost and


benefit in the same units (misal Rupiah)
Result: Net benefit or cost, Ratio benefit to
costs
Example: Saving from the cost of a
prevention program

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Prophylaxis of Urinary Tract Infection


(CBA)
Cost:
Cost per year of prophylaxis $85
(trimetoprim-sulfamethoxazole)
Cost per infection
$126
Expected frequency (women with two or more
episodes in prior year)
Placebo: 3.0 infection/year
Treatment:
0.15 infection/year
Cost-benefit
Cost: $85
Benefit: (3-0.15) X ($126) = $ 359
Annals of Internal Medicine, 1981: 94:251-255
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CBA Rubella Vaccination

Benefit (millions of $)
Prevention of:
Acute rubella
Congenital rubella
Total
Cost (millions)
Net benefit (millions)
Benefit-cost ratio
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2 yr-old
children
Both
sexes

12 yr-old
females

5.7
40.3
46
6
40
7.7:1

1.4
72.2
73.6
3
70.6
24.5:1

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CBA & CEA of Lead Screening

FEP screening costs $2890 per case of


learning disability averted and $19,380 per
case of mental retardation averted
In communities where the prevalence of lead
poisoning is greater than 7%, FEP screening
also saved money
NEJM 1982, 306:1392-8

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Economic analysis

CBA/CBU enable decision maker to compare


the returns on investing resources in services
designed to treat different health problem
CEA enables decision maker to compare the
costs of different ways of tackling the same
health problem

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Example of CBA & CEA

CBA would help decision maker asses the


return on investing $500,000 additional
resources in either renal transplantation
program or cardiac surgery program
CEA would help the decision maker asses
the relative cost-effectiveness of dialysis and
of transplantation as methods of treating endstage renal failure

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3. Undertaking the Research

This stage is not difficult to understand and follows


the norms usually employed in research and
investigation. The first task is to determine if similar
research has been undertaken elsewhere. The
usual sources of secondary data are examined,
including published literature, Government Reports,
Journals, Databases and so forth. New fieldwork
should only be commissioned when it becomes
clear that secondary studies cannot provide the
necessary evidence.

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3. Undertaking the Research

The basic rules for quality research should


apply to new studies. In other words
preference should be given for prospective,
controlled, randomised, blinded studies
where the cohort is as large as possible.
What is lacking, however, in HTA Studies to
date is the shortage of real live situations
where the technology is actually in use. New
studies should seek to try and redress this
imbalance.

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4. Reviewing the Evidence

Once the body of evidence or fieldwork has been


done the next stage is to critically analyse the
results. This is called synthesis as we are trying
synthesis or determine the outcome of the
investigation.
Literature Reviews, Systemetic Reviews,
Group decision making methods, Outcome analysis,
Impact Analysis, Secondary Analysis and other
types of quantitative research may all be used or
combined depending upon the circumstances.

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4. Reviewing the Evidence

In HTA however it is preferable also to use


methodologies which are formal, structured, quantifiable
and well documented.
Both Meta Analysis and Decision Analysis are commonly
used. Meta Analysis involves the application of statistical
techniques to findings from research reports. Basically
Meta Analysis regards the findings from one study as a
single piece of data. The results or findings from multiple
studies on the same topic therefore can be merged to
yield a data set that can be analysed in a manner similar
to that obtained from individual subjects . Careful
selection and organisation of material can help reduce
bias, which is often a prominent feature of Meta Analysis

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5. Evidence Grading

It has become accepted practice that the quality of


research should be clearly benchmarked so that the
reader knows the strengths of the findings. These
benchmarks are sometimes referred to as Evidence
Grading. Two common schemes include Evidence
Grading for Practice Guidelines published by the
Agency for Healthcare Policy and Research, and
Evidence Grading for Clinical Preventative Services
published by the US Preventative Services Task
Force

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6. Dissemination

Once the evidence has been reviewed, the analysis


completed and the conclusions reached, the next
stage is to report the findings. Traditionally, medical
literature and scientific meetings have been the main
vehicles for getting the message across. However,
this mode of transport has not always been kind to
HTA.
Basically, scientific literature is geared towards
research and there is little or no interest in work
which addresses benefits realisation or social
issues.

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Another factor is the time lag before studies


are actually published and of course not
everyone keeps up to date with the literature.
Indeed, there is so much material being
circulated that it is hard to prioritise what is
really important. All these factors sometimes
mitigate against getting the kind of exposure
in the literature that good quality research in
HTA often deserves.

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6. Dissemination

There are, of course, other routes.


Special Conference, such as Consensus
Conferences, for example, could be arranged among
expert analysts to disseminate important research
findings.
Annual Meetings and Seminars arranged by
professional bodies are also another forum. In the
case of licensing requirements or in the event of a
technology, which impacts upon the entire community,
then either the appropriate regulatory bodies or the
relevant Government Agencies will usually take a
leading role in making the research findings available.

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7. Monitoring the Impact of HTA

The final stage in the HTA process is to monitor what


impact, if any the HTA research has made
Remember we said at the outset that one of the
primary goals of HTA is to influence policy makers
and ensure that resources are allocated more
effectively
We can now expand upon these goals. HTA should
also help to decommission (ditinggalkan)
technologies which are ineffective, resolve
controversies regarding competing treatments and
promote the greater usage of proven technologies.

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7. Monitoring the Impact of HTA

Another important role, which HTA should have, is to


help the consumer choose the most appropriate
healthcare technology for them. Nowadays,
consumers are bombarded with advertisements that
are presented in all sorts of shapes and forms. Chat
show programmes devote a lot of air time to health
and medical matters while the power of the web
delivers the ultimate in direct marketing and the best
or worst is yet to come! HTA can take a lead role in
putting technologies into perspective for consumers.

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The technology assessment iterative loop


Burden of illness
Efficacy

Monitoring &
reassessment

Screening & diagnosis


Synthesis &
implementation

Community Effectiveness

Efficiency
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Teknologi kesehatan yg
baru

Disambut dg antusias oleh dokter dan


pasien, dg menaruh kepercayaan besar akan
hasil gunanya.
Jarang dievaluasi sebelum pemakaiannya
scr luas
Kekecewaan muncul manakala pengalaman
klinik tidak sesuai dg yang diiklankan,
ditambah kenaikan biaya

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Dasar penilaian teknologi


kesehatan

Teknologi baru versus teknologi yang sudah


ada.
Manfaat vs risiko
Accuracy, reproducibility ?
Apakah bisa diterapkan dalam prosedur
pengobatan
Biaya.

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Dasar penilaian teknologi


kesehatan

Kalau ada apakah akan dipakai


Apakah perlu operator khusus
Pemeliharaan apakah mudah atau sulit
Kondisi lingkungan yang mendukung
Suku cadang
Biaya operasional

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Penilaian dalam penapisan


dan adaptasi teknologi
kesehatan

Penilaian hasil guna scr klinis


Penilaian ekonomik dan kualitas hidup
Adopsi daan pemakaian scr luas

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Mengapa teknologi kesehatan yg baru


banyak dipakai sebelum dilakukan
penilaian?

Pengaruh pihak ketiga penyandang dana


Ketersediaan standar evaluasi kritis dalam
program pendidikan dokter
Insentif

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Number needed to treat (NNT)

One measure of treatment effectiveness.


The number of people you would need to
treat with specific intervention for a given
period of time to prevent one additional
adverse outcome or achieve one additional
beneficial outcome.
NNT = 1/ARR

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Efikasi berbagai AINS berdasarkan nilai


NNT (Number Needed to Treat)
Diklofenak 50 mg
Naproksen 440 mg
Ketorolak 10 mg
Ibuprofen 400 mg
Morfin 10 mg IM
Parasetamol 650 mg + kodein 60 mg
Aspirin 650 mg
Parasetamol 1000 mg
Parasetamol 650 mg
Tramadol 75mg
0

Number Needed to Treat (NNT)


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Number needed to harm (NNH)

One measure of treatment harm.


The number of people you would need to
treat with specific intervention for a given
period of time to cause one additional
adverse outcome.
NNH = 1/ARI

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Pokok Bahasan

Teknologi Diagnosis
Teknologi terapi
Teknologi Pencegahan
Teknologi Bedah
Dampak adopsi teknologi
Evaluasi ekonomi teknologi kesehatan

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