10.00 - 10.30 Session 1:

Evelinda.Trindade@InCor.USP.br for the

• The Information Resources Group of HTAi, • the Brazilian Cochrane Centre and • the Iberoamerican Cochrane Centre

To summarise the purpose of HTA and the

key elements of HTA: effects evidence,

cost-effectiveness, local and contextual

data, patient views/interests

The key current developments in HTA e.g.

interest in rapid reviews

Purpose: Health Technology Assessment is the systematic evaluation of properties, effects or other impacts of ‘health technology’.

Object: ‘Health technology’ includes the use of devices, equipment, drugs, procedures and care programs or any method used in the health services to promote health, prevent and treat disease and improve rehabilitation and long-term care.

The HTA is applied research to contribute to a more evidence-based health policy.

The HTA is a scientific multi- and inter-disciplinary activity delivering input for priorities and decisions in the health care system.

Kristensen FB & Sigmund H (ed.) Health Technology Assessment Handbook Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health, 2007

The Health Technology Assessment (HTA) program aims to answer questions of managers, providers and users of health services on effects and cost-effectiveness of interventions.

Remember:

Effectiveness of ‘Health technology’ includes the effects of their use in the routine conditions of the healthcare services.

Efficacy of ‘Health technology’ is tested/ trialed in controlled settings & conditions, with selected patient groups, during clinically meaningful periods and usually for regulatory purposes.

Efficiency of ‘Health technology’ is the relation of their effects to their cost, usually ascertained for the health care system.

Efficacy

Effectiveness

Patient Population Homogeneous; patients with coexisting illness

often excluded

Heterogeneous; includes all patients who usually use the HT

Procedures Standardized Often variable

Testing Conditions Ideal Conditions of everyday practice

Practitioner Experts All users

Efficiency Reference Price Real Market Price

Adapted from: Institute of Medicine 1989.

Perspective & elements

Problem/Project Patients’ conditions

& Context Technology attributes

Time- dead-line Program Organization

Evidence Economic aspects.

- can overlap and complement one another

Reliability

Accuracy

Appropriatedness , consistency

(methods & results & conclusions)

Reproducibility

How much do we know now?

Key attributes of an HTA

Perspectives

– Who is asking this evaluation and Why?

1. Society’s approach: regulatory approval, safety

appraisals, public health, clinical practice guidelines,

standards, and other statements regarding the

appropriate use or other population benefits

2. Stakeholder’s interests: reimbursement listings,

investment or disinvestments

3. Or other local or particular individuals’ issues

- can overlap and complement one another

•Technology-oriented assessments are intended to determine the

characteristics or impacts of particular technologies. For example, a

government agency may want to determine the impacts of particular interventions.

•Problem-oriented assessments focus on solutions or strategies

for managing a particular problem for which alternative or

complementary technologies might be used. For example, development

of clinical practice guidelines using various technologies…

•Project-oriented assessments focus on a local placement or use

of a technology in a particular institution, program, or other

designated project. For example, a hospital decision to purchase a technology…

What is the time- dead-line for this HTA?

The decision to do or not and about which HTA format will be adopted depends on:

Available time, timeliness for the decision it intends to support & versus idle resources to do the HTA, and

How many published Evidence about this ‘HT’ is available?

What is the Problem / Project to be evaluated?

What is the Context, Question and Scope of this problem in the healthcare system and services? For

example, a “reactive” HTA is demanded upon press pressure to incorporate one more expensive «me too drug» claiming to be breakthrough.

What is its magnitude in terms of impact on disease burden and costs? For example, «cancer» diagnostic technologies.

How much Evidence is available about this problem?

Patients’ conditions

What is the incidence or prevalence of the health and social condition to be evaluated? For example, diabetes

is highly prevalent regardless of the jurisdiction and social class.

What age or particular group is most affected? For

example, congenital defects in pediatric patients or adult survivors.

What is the severity of the health effects? For example,

cancer mortality rate.

What are the patient’s perception of the health effects? For example, dialysis utilities.

How many published Evidence of this condition is available? For example, depression in pediatric populations.

e.g., if applicable, specific component parts, dimensions, connections, technology interactions & limitations.

Technology attributes

What is its intended purpose? ‘regulatory’ ap-proved indications, contra-indications or use restrictions

Technical description of this technology:

What is the published Evidence about this technology? For example, sensitivity of a digital chest X-Ray to detect

cancer metastasis.

safety aspects, performance effects, advantages or dis- regarding existing alternatives or not,

program intended use & purposes,

physical installation, reforms required,

users’ circulation, services’ logistics

potential additional interactions/ impact on other

services, new in- out- referrals related to the installation

capacity,

staff requirement & training, continued education.

Program organization to use this ‘HT’

What is the published Evidence about this program? For

example, technologies insulation for Magnetic Resonance.

What are the technology acquisition upfront costs?

What are the costs of physical installation, reforms & new

logistics required?

How much will other HT(s) & consumables required cost?

What would be the projected cost for the institutional

program? For the regional or national health care system?

What is the expected relation between costs and effects?

What degree of uncertainty applies to estimated

calculations?

Economic aspects of this ‘HT’ program

What is the published Evidence about this program? For

example, technologies insulation for Magnetic Resonance.

What is ?

The term evidence-based medicine refers to the

use of the current best knowledge evidenced from scientific and medical research, and the application of clinical experience and observation, in making decisions about the care of individual patients.

Available sources

Appropriated methods

Process & documentation

Results presentation

Secondary sources: Gathering published or

existing information, most commonly

aggregated, efficient with appropriated

methods;

Primary data: individual patient-based, clinical

controlled, experimental or observational trial (e.g.

Registries), very important for evidence in rare

conditions and long-term effects, but expensive –

beyond the scope of this workshop.

Appropriated methods

Standardized subject terms & headings

Systematic and reproducible searches

Independent process & freedom from

other interests’ conflicts

Quality ascertainment according to guidelines

Critical appraisal standard methods

Complete documentation re:

1. source specific search strategies adopted,

2. inclusion and excluded studies according to study plan,

3. uniform bibliography standard.

Evidence Tables:

Included & excluded studies justification &

bibliography

Explicit Study Quality variables synthesized

Explicit structured results summary or

standardized statistical synthesis presentation.

Hailey D. Toward transparency in Health Technology Assessment: A Checklist for HTA Reports. International Journal of Technology Assessment in Health Care. 2003;19(1):1–7.

http://www.nlm.nih.gov “Early Identification e Assessment of Emerging Health Technology”, International Journal for Technology

Assessment in Health Care (IJTAHC), Special Issue Autumn 1998,vol 14 (4): 644-651. PMID: 9885454