Unit 2

practical application of knowledge.

Technology

practical application of knowledge to improve or maintain individual and population health.

Health technology

Three ways to describe health technology includes:

• Physical nature

• Purpose

• Stage

in ___: “technology” connotes?

Physical Nature

mechanical devices or instrumentation

In ___: “information technology,” such as?

Physical Nature

computers, networking, software, and other equipment and processes to manage information

Main categories of health technology include the following:

➢ Drugs

➢ Biologics

➢ Devices, equipment and supplies

➢ Medical and surgical procedures

➢ Public health programs

➢ Support systems

➢ Organizational and managerial systems

aspirin, beta-blockers, antibiotics, cancer chemotherapy

Drugs

vaccines, blood products, cellular and gene therapies

Biologics

e.g., cardiac pacemaker, magnetic resonance imaging (MRI) scanner, surgical gloves, diagnostic test kits, mosquito netting

Devices, equipment and supplies

e.g., acupuncture, nutrition counseling, psychotherapy, coronary angiography, gall bladder removal, bariatric surgery, cesarean section

Medical and surgical procedures

water purification system, immunization program, smoking prevention program

Public health programs

e.g., clinical laboratory, blood bank, electronic health recordsystem, telemedicine systems, drug formulary

Support systems

e.g., medication adherence program, prospective payment using diagnosis-related groups, alternative health care delivery configurations

Organizational and managerial systems

Technologies can also be grouped according to their health care purpose, i.e.:

➢ Prevention

➢ Screening

➢ Diagnosis

➢ Treatment

➢ Rehabilitation

➢ Palliation

protect against disease by preventing it from occurring, reducing the risk of its occurrence, or limiting its extent or sequelae (e.g., immunization, hospital infection control program, fluoridated water supply)

Prevention

detect a disease, abnormality, or associated risk factors in asymptomatic people (e.g., Pap smear, tuberculin test, screening mammography, serum cholesterol testing)

Screening

identify the cause and nature or extent of disease in a person with clinical signs or symptoms (e.g., electrocardiogram, serological test for typhoid, x-ray for possible broken bone)

Diagnosis

intended to improve or maintain health status or avoid further deterioration (e.g., antiviral therapy, coronary artery bypass graft surgery, psychotherapy)

Treatment

restore, maintain or improve a physically or mentally disabled person's function and well-being (e.g., exercise program for post-stroke patients, assistive device for severe speech impairment, incontinence aid)

Rehabilitation

improve the quality of life of patients, particularly for relief of pain, symptoms, discomfort, and stress of serious illness, as well as psychological, social, and spiritual problems. (Although often provided for progressive, incurable disease, palliation can be provided at any point in illness and with treatment, e.g., patient-controlled analgesia, medication for depression or insomnia, caregiver support.)

Palliation

Technologies may be assessed at different stages of diffusion and maturity.

Stage of Diffusion

In stage or dffusion: In general, health care technologies may be described as being:

➢ Future

➢ Experimental

➢ Investigational

➢ Established

➢ Obsolete/outmoded/abandoned

in a conceptual stage, anticipated, or in the earliest stages of development

Future

undergoing bench or laboratory testing using animals or other models

Experimental

undergoing initial clinical (i.e., in humans) evaluation for a particular condition or indication

Investigational

considered by clinicians to be a standard approach to a particular condition or indication and diffused into general use

Established

superseded by other technologies or demonstrated to be ineffective or harmful

Obsolete/outmoded/abandoned

HTA can be used in many ways to advise or inform technology-related policies and decisions. Among these are to advise or inform:

➢ Regulatory agencies

➢ Payers

➢ Clinicians and patients

➢ Health professional associations

➢ Hospitals

➢ Standards

➢ Government health department officials

➢ Lawmakers and other political leaders

➢ Health care technology companies

➢ Investors and companies

➢ Research agencies

about whether to permit the commercial use (e.g., marketing) of a drug, device or other regulated technology

Regulatory agencies

(health care authorities, health plans, drug formularies, employers, etc.) about technology coverage (whether or not to pay), ___ (assigning proper codes to enable reimbursement), and ___ (how much to pay)

Payers

coding

reimbursement

about the appropriate use of health care interventions for a particular patient’s clinical needs and circumstances

Clinicians and patients

about the role of a technology in clinical protocols or practice guidelines

Health professional associations

health care networks, group purchasing organizations, and other health care organizations about decisions regarding technology acquisition and management

Hospitals

setting organizations for health technology and health care delivery regarding the manufacture, performance, appropriate use, and other aspects of health care technologies

Standards

about undertaking public health programs (e.g., immunization, screening, and environmental protection programs)

Government health department officials

about policies concerning technological innovation, research and development, regulation, payment and delivery of health care

Lawmakers and other political leaders

about product development and marketing decisions

Health care technology companies

concerning venture capital funding, acquisitions and divestitures, and other transactions concerning health care product and service companies

Investors and companies

about evidence gaps and unmet health needs

Research agencies

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

Evidence-based Medicine

Basic HTA Orientations

Technology-oriented assessments

Problem-oriented assessments

Project-oriented assessments

intended to determine the characteristics or impacts of particular technologies.

❖ For example, a government agency may want to determine the clinical, economic, social, professional, or other impacts of cochlear implants, cervical cancer screening, PET scanners, or widespread adoption of electronic health record systems.

Technology-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.

❖ For example, clinicians and other providers concerned with the problem of diagnosis of dementia may call for HTA to inform the development of clinical practice guidelines involving some combination or sequence of clinical history, neurological examination, and diagnostic imaging using various modalities.

Problem-oriented assessments

focus on a local placement or use of a technology in a particular institution, program, or other designated project.

❖ For example, this may arise when a hospital must decide whether or not to purchase a PET scanner, considering the facilities, personnel, and other resources needed to install and operate a PET scanner; the hospital’s financial status; local market potential for PET services; competitive factors; etc.

Project-oriented assessments

HTA may involve the investigation of one or more properties, impacts, or other attributes of health technologies or applications.

Properties and Impacts Assessed

Properties and Impacts Assessed: In general, these include the following

❖Technical properties

❖Safety

❖Efficacy and/or effectiveness

❖Economic attributes or impacts

❖Social, legal, ethical and/or political impacts

include performance characteristics and conformity with specifications for design, composition, manufacturing, tolerances, reliability, ease of use, maintenance, etc.

Technical properties

a judgment of the acceptability of risk (a measure of the probability of an adverse outcome and its severity) associated with using a technology in a given situation, e.g., for a patient with a particular health problem, by a clinician with certain training, or in a specified treatment setting.

Safety

refers to the benefit of using a technology for a particular problem under ideal conditions, e.g., within the protocol of a carefully managed RCT, involving patients meeting narrowly defined criteria, or conducted at a “center of excellence.”

Efficacy

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 types of patients.

Effectiveness

Efficacy answers the question, “___” (in the ___)

effectiveness answers the question “___” (in ___).

Can it work?

best conditions

Does it work?

real-world conditions

Efficacy vs. Effectiveness for Diagnostic Tests

Economic attributes or impacts of health technologies can be

microeconomic and macroeconomic

concerns include costs, prices, charges, and payment levels associated with individual technologies. Other concerns include comparisons of resource requirements and outcomes (or benefits) of technologies for particular applications, such as cost effectiveness, cost utility, and cost benefit.

Microeconomic

Health technology can have or contribute to a broad range of ___ impacts. These include impacts on: a nation’s gross domestic product, national health care costs, and resource allocation across health care and other industrial sectors, and international trade.

macroeconomic

can also be a factor in national and global patterns of investment, innovation, competitiveness, technology transfer, and employment

macroeconomic

pertain to health technologies include the effects of intellectual property policies (e.g., for patent protection), regulation, third-party payment, and other policy changes that affect technological innovation, adoption, diffusion, and use.

macroeconomic

___ arise in HTA in the form of ___ (e.g., valuation of human life); choices about how and when to use technologies; research and the advancement of knowledge; resource allocation; and the integrity of HTA processes themselves

Ethical, legal, and social considerations

normative concepts

Methods Used for Ethical Analysis in HTA

Casuistry

Coherence analysis

Principlism

Interactive, participatory HTA approaches

Social shaping of technology

Wide reflective equilibrium

Solves morally challenging situations by comparing them with relevant and similar cases where an undisputed solution exists

Casuistry

Tests the consistency of ethical argumentation, values or theories on different levels, with an ideal goal of a logically coherent set of arguments

Coherence analysis

Approaches ethical problems by addressing basic ethical principles, rooted in society’s common morality

Principlism

Involves different stakeholders in a real discourse, to reduce bias and improve the validity and applicability of the HTA

Interactive, participatory HTA approaches

Addresses the interaction between society and technology and emphasizes how to shape technology in the best ways to benefit people

Social shaping of technology

Aims at a coherent conclusion by a process of reflective mutual adjustment among general principles and particular judgements

Wide reflective equilibrium

Recent Examples of Unintended Consequences of Health Technology