HEALTH TECHNOLOGY 6.
Support systems – clinical
ASSESSMENTS & HEALTH POLICY
 Definition of Health Technology
Assessment
 is a multidisciplinary process that
summarizes information about the
medical, social, economic and ethical
issues related to the use of health
technology in a systematic,
transparent, unbiased, robust
manner.
 Aim: to inform the formulation of
safe, effective, health policies that
are patient
 focused and seek to achieve the best
value.
 systematic evaluation of properties,
effects or other impacts of health
technology.
 Purpose: to inform decision makers
about what is known and what is not
known about a technology, with the
goal of creating policies that gets the
right treatment to the right patient
at the right time at the right cost
 Three ways to describe health
technology
A. Physical nature
1. Drugs – aspirin, beta blockers,
antibiotics, cancer chemotherapy
2. Biologics – vaccines, blood products,
cellular and gene therapies
3. Devices, equipment and supplies –
cardiac pacemaker, magnetic
resonance imaging scanner, surgical
gloves
4. Medical and surgical procedures –
acupuncture, nutrition counseling,
psychotherapy, coronary
angiography
5. Public health programs – water
purification system, immunization
program
laboratory, blood bank, telemedicine
systems, drug formulary
7. Organizational and managerial
systems – medication adherence
program, prospective payment using
diagnosis related group
B. Purpose or Application
1. Prevention: protect against disease
by preventing it from occurring,
reducing the risk of its occurrence,
or limiting its extent or sequelae
(immunization, hospital infection
control program)
2. Screening: detect a disease,
abnormality, or associated risk
factors in asymptomatic people (pap
smear, tuberculin test, serum
cholesterol testing)
3. Diagnosis: Identify the cause and
nature or extent of disease in a
person with clinical signs or
symptoms (serological test for
typhoid, x-ray for possible broken
bone)
4. Treatment: intend to improve or
maintain health status or avoid
further deterioration (antiviral
therapy, coronary artery bypass
graft surgery)
5. Rehabilitation: restore, maintain or
improve a physically or mentally
disabled persons function and well-
being (exercise program for stroke
treatments)
6. Palliation: improve the quality of life
of patients, particularly for relief of
pain, symptoms, discomfort, and
stress of serious illness. Can be
provided at any point in illness with
treatment. (patient controlled
analgesia, medication for depression
or insomnia)
C. Stage of Diffusion
1. future: in a conceptual stage,
anticipated, or in the earliest stage of
development
2. experimental: undergoing bench or
laboratory testing using animals or
other models
3. Investigational: undergoing initial
clinical ( in humans) evaluation for a
particular condition or indication
4. Established: considered by clinicians
to be a standard approach to a
particular condition or indication
and diffused into general use.
5. Obsolete/Abandoned: superseded
by other technologies or
demonstrated to be ineffective or
harmful.
example of obsolete:
colectomy to treat epilepsy, gastric
freezing for peptic ulcer
 TARGET GROUPS OF HTA
1. Politicians and civil servants at
national or regional levels
2. Planners at county or hospital
levels
3. Administrations in hospitals or
clinical departments
4. Organizations and companies
5. Citizens in genera
 PURPOSES OF HTA
1. Advise regulatory agencies about
whether to allow the commercial
use of a drug, device, or other
regulated technology
2. Advise clinicians and patients
about the appropriate use of
health care interventions for a
particular patients clinical needs
and circumstances
3. Support decision by healthcare
technology companies about
product development and
marketing
4. Research agencies about
evidence gaps and unmet health
needs
5. Support government health
officials about undertaking
public health programs
6. Support hospitals, health care
networks, group purchasing
organizations, and other health
care organizations about
decisions regarding technology
purchase and management.
 BASIC HTA ORIENTATIONS
1. Technology oriented assessments are
intended to determine the
characteristics or impacts of
particular technologies.
2. Problem oriented assessments focus
on solutions or strategies for
managing a particular disease,
condition, or other problem for
which alternative or complementary
technologies might be used
3. Project oriented assessment focus on
a local placement or use of a
technology in a particular
institution, program, or other
designated project
 PROPERTIES AND IMPACTS
ASSESSED
1. Technical properties: include
performance characteristics and
conformity with specifications for
design, composition, manufacturing,
tolerances, reliability, ease of use,
maintenance, etc.
2. Safety: is a result of the acceptability
of risk associated with using a
technology in a given situation
3. Efficacy and/or effectiveness: refer to
how well a technology works,
accomplishes its intended purpose.
a. Efficacy – refers to the benefit of
using a technology for a particular
problem under ideal conditions
(involving patients meeting
narrowly defined criteria, or
conducted at a center of excellence).
b. Effectiveness – refers to the benefit of
using a technology for a particular
problem under general or routine
conditions (by a physician in a
community hospital for a variety of
types of patients).
4. Economic attributes or impacts:
Health technology can have or
contribute to a broad range of
macroeconomic impacts which
include impacts on: a nation’s gross
domestic product, national health
care costs, and resource allocation
across health care sectors.
a. Microeconomics – deals
with making of a single
economic variable such as
demand, supply, price,
consumer
b. Macroeconomics - deals
with the behavior and
aggregates of the entire
economy
5. Social, legal, ethical, and political
impacts: technological innovations
can challenge certain ethical,
religious, cultural, and legal norms.
(genetic testing, use of stem cells to
grow new tissues, allocation of
scarce organs for transplantation).
 MEASURING HEALTH OUTCOMES
Health outcome variables are used to
measure the safety, efficacy, and
effectiveness of health care
technologies.
Main categories of health outcomes are:
Mortality Quality of life
(death rate)
Morbidity (disease Functional status
rate)
Adverse health Patient
events (Harmful satisfaction
side effects)
 BIOMARKERS AND SURROGATE
ENDPOINTS
1. Biomarker: objectively measured
variable or trait that is used as an
indicator of a normal biological
process, a disease state, or effect of a
treatment.
a. Physiological measurement
(height, weight, blood
pressure, etc.)
b. Blood component or other
biochemical assay (RBC
count, viral load)
c. Genetic data (presence of a
specific genetic mutation)
d. Measurement from an image
(coronary artery stenosis,
cancer metastases).
2. Intermediate endpoint: is a non-
ultimate endpoint (not mortality or
morbidity) that may be associated
with disease status or progression
toward an ultimate endpoint.
 a. certain biomarkers (HbA1c in
prediabetes, tumor
progression in cancer)
b. disease symptoms (angina
frequency in heart disease,
measures of lung function in
COPD)
3. Surrogate endpoint: is a measure
(typically a biomarker) that is used
as a substitute for a clinical endpoint
of interest, such as morbidity and
mortality. They are used in clinical
trials when it is impractical to
measure the primary endpoint
during the course of the trial.
A surrogate endpoint is assumed, based
on scientific evidence, to be valid and
reliable predictor of clinical endpoint of
interest.
a. A long standing surrogate marker
for risk of stroke is hypertension
b. Negative cultures for cures of
bacterial infections and decrease
intraocular pressure for loss of
vision in glaucoma
 QUALITY OF LIFE MEASURES
Quality of life (QoL) measures, or health
related quality of life measures or indexes,
are increasingly used
along with more traditional outcome
measures to assess efficacy and
effectiveness, providing a more complete
picture of the ways in which health care
affects patients.
o physical function
o bodily pain
o social function
o sleep/rest
o cognitive function
o energy/fatigue
o anxiety/distress
o general health perception
The use of QoL Measures inTechnology
Assessment have generally been applied to
therapies for chronic conditions, for
conditions where an increase in length of
survival is unlikely, and for conditions with
negative concerns of care that may
outweigh its benefits.
 HEALTH ADJUSTED LIFE YEARS
HALYs recognizes that changes in an
individuals health status or the burden
of population health should reflect not
only the dimension of life expectancy
but a dimension of QoL or functional
status. 3 main types of HALYs:
a. Quality adjusted life years (QALYs)
b. Disability – adjusted life years
(DALYs)
c. Healthy-years equivalents (HYEs)
HALYs are not specific to a particular
disease or condition.
QALYs are usually used to represent years
of life subsequent to a health care
intervention that are
outweighed or adjusted for the quality of
life experienced by the patient during those
years.
- used to quantify the cost effectiveness
studies, for instance, a new medicine versus
the current
one.
QALY = Length of Life X Utility Value
Utility – refers to the relative preference
(value) that an individual (or society) has
for a particular state of health
In other words, the current standard of care
is taken as the baseline, and the
 QALYs gained from the new
(improved) intervention are counted
in addition.
  QALY can be calculated using the
following formula which assumes a
utility value (quality of life) between
1 = perfect health
0 = dead
QALYs – to adjust a person’s life expectancy
by the levels of health related quality of life
that the person is predicted to experience
during the remainder of life or some
interval of it.
DALYs – to measure population disease
burden; they are measure of
something lost rather than something
gained
The health-related quality of life weights
used for QALYs are intended to represent
quality of life levels experienced by
individuals (gain) in particular health
states, whereas the disability weights used
for DALYs represent levels of loss of
functioning caused by mental or physical
disability caused by disease or injury.
QALYs should be maximized and DALYs
should be minimized
 PERFORMANCE OF SCREENING AND
DIAGNOSTIC TECHNOLOGIES
Screening and Diagnostic tests: provide
information about the presence of a disease
or other health condition. As such, they
must be able to discriminate between
patients who have a particular disease or
condition and those who do not have it.
a. Screening – conducted in
asymptomatic patients
b. Diagnosis – conducted in
symptomatic patients
 Use of tests for Asymptomatic and
Symptomatic Patients
 Asymptomatic: susceptibility
(presence of a risk factor for a
disease), presence of hidden or
occult disease
 Symptomatic: diagnosis, differential
diagnosis, staging, prognosis,
prediction, surveillance, monitoring
 4 basic types of outcomes of
Screening or Diagnostic test
a. a true positive result (detects a
marker when disease is present)
b. a true negative result (does not
detect the marker when the
disease is absent)
c. a false positive result (detects a
marker when the disease is
absent)
d. a false negative result (does not
detect a marker when the disease
is present)
The two most commonly used operating
characteristics of screening and
diagnostic tests are sensitivity and
specificity
a. Sensitivity – measures the ability of
a test to detect a particular disease
when it is present
b. Specificity – measures the ability of a
test to correctly exclude that disease
or condition in a person who truly
does not have that disease or
condition
 Positive predictive value – the
probability of those patients with a
positive test result who actually
have the disease.
 Negative predictive value – the
probability of patients with a
 negative test result who actually do
not have the disease.

 Accuracy – the degree to which a

measurement represents the true
value of something. (How close a
measurement is to the true value?)
 Precision – the degree of closeness
among study results, where the
study to be repeated under similar
circumstances. (How close the
measurements are to each other)
 Validity – the extent to which the
study measures what is intended to
measure. (Are the values describing
what was supposed to be
measured?)
a. Internal: degree of confidence that
the causal relationship being tested
is trustworthy and not influenced by
other factors or variables
b. External: extent to which results
from a study can be applied
(generalized) to other situations,
groups or events.
 Relatability: a measure of how
dependably an observation is exactly
the same when repeated. (Will one
get the same value if the
measurements are repeated?

a. Lack of validity – Bias or systematic

error
b. Lack of precision – Random error