This chapter begins with excerpts from the first two chapters of a book put together by the National Institutes of Health (NIH) called “Health Technology Assessment: 101.”  As technological innovations have proliferated, it has become increasingly important that these innovations are used, implemented, or diffused only in ways that lead to better health outcomes.  Accordingly, health technology assessment (HTA) strives to achieve the goal of effective use of technology.  NIH defines HTA as follows:

the systematic evaluation of properties, effects, and/or impacts of health care technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. Its main purpose is to inform technology-related policy making in health care. HTA is conducted by interdisciplinary groups using explicit analytical frameworks drawing from a variety of methods.

The full Health Technology Assessment: 101 handbook is intended for a professional audience of medical researchers, clinicians, health administrators, and policymakers.  However, the excerpts provided below will provide you with a good general overview of the range of technological innovations related to healthcare delivery, the implications of technology diffusion, and why it is important to carefully evaluate the impact of a certain technology.

Finally, we will conclude by watching a TED Talk by Dr. Atul Gawande that touches on the implications of technology and care coordination.

Excerpts from HTA 101 Chapter 1: “Introduction to Health Technology Assessment” 

Technological innovation has yielded truly remarkable advances in health care during the last five decades.  In recent years, breakthroughs in a variety of areas have helped to improve health care delivery and patient outcomes, including antivirals, anti-clotting drugs, anti-diabetic drugs, anti-hypertensive drugs, anti-rheumatic drugs, vaccines, pharmacogenomics and targeted cancer therapies, cardiac rhythm management, diagnostic imaging, minimally invasive surgery, joint replacement, pain management, infection control, and health information technology.

The proliferation of health care technology and its expanding uses have contributed to burgeoning health care costs, and the former has been cited as “culprit” for the latter.  However, this relationship is variable, complex, and evolving (Cutler 2001; Cutler 2011; Goyen 2009; Medicare Payment Advisory Commission 2001; Newhouse 1992; Smith 2000).  In the US, the Congressional Budget Office concluded that “roughly half of the increase in health care spending during the past several decades was associated with the expanded capabilities of medicine brought about by technological advances” (US Congressional Budget Office 2008).

Few patients or clinicians are willing to forego access to state-of-the-art health care technology.  In the wealthier countries and those with growing economies, adoption and use of technology has been stimulated by patient and physician incentives to seek any potential health benefit with limited regard to cost, and by third-party payment, provider competition, effective marketing of technologies, and consumer awareness.  Box I-1 shows some of the factors that influence demand for health technology.

In this era of increasing cost pressures, restructuring of health care delivery and payment, and heightened consumer demand—yet continued inadequate access to care for many millions of people—technology remains the substance of health care.  Culprit or not, technology can be managed in ways that improve patient access and health outcomes, while continuing to encourage useful innovation.  The development, adoption, and diffusion of technology are increasingly influenced by a widening group of policymakers in the health care sector.  Health product makers, regulators, clinicians, patients, hospital managers, payers, government leaders, and others increasingly demand well-founded information to support decisions about whether or how to develop technology, to allow it on the market, to acquire it, to use it, to pay for its use, to ensure its appropriate use, and more.  The growth and development of health technology assessment (HTA) in government and the private sector reflect this demand.

HTA methods are evolving and their applications are increasingly diverse.  This document introduces fundamental aspects and issues of a dynamic field of inquiry.  Broader participation of people with multiple disciplines and different roles in health care is enriching the field.  The heightened demand for HTA, in particular from the for-profit and not-for-profit private sectors as well as from government agencies, is pushing the field to evolve more systematic and transparent assessment processes and reporting to diverse users.  The body of knowledge about HTA cannot be found in one place and is not static.  Practitioners and users of HTA should not only monitor changes in the field, but have considerable opportunities to contribute to its development.

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Excerpts From HTA 101: Chapter 2 “Fundamental Concepts”

A. Health Technology

Technology is the practical application of knowledge.  Health technology is the practical application of knowledge to improve or maintain individual and population health.  Three ways to describe health technology include its physical nature, its purpose, and its stage of diffusion.

1. Physical Nature

For many people, the term “technology” connotes mechanical devices or instrumentation; to others, it is a short form of “information technology,” such as computers, networking, software, and other equipment and processes to manage information.  However, the practical application of knowledge in health care is quite broad.  Main categories of health technology include the following.

• Drugs:  e.g., aspirin, beta-blockers, antibiotics, cancer chemotherapy
• Biologics:  e.g., vaccines, blood products, cellular and gene therapies
• Devices, equipment and supplies:  e.g., cardiac pacemaker, magnetic resonance imaging (MRI) scanner, surgical gloves, diagnostic test kits, mosquito netting
• Medical and surgical procedures:  e.g., acupuncture, nutrition counseling, psychotherapy, coronary angiography, gall bladder removal, bariatric surgery, cesarean section
• Public health programs: e.g., water purification system, immunization program, smoking prevention program
• Support systems:  e.g., clinical laboratory, blood bank, electronic health record system, telemedicine systems, drug formulary,
• Organizational and managerial systems:  e.g., medication adherence program, prospective payment using diagnosis-related groups, alternative health care delivery configurations

Certainly, these categories are interdependent; for example, vaccines are biologics that are used in immunization programs, and screening tests for pathogens in donated blood are used by blood banks.

2. Purpose or Application

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

• Prevention:  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)
• Screening:  detect a disease, abnormality, or associated risk factors in asymptomatic people (e.g., Pap smear, tuberculin test, screening mammography, serum cholesterol testing)
• Diagnosis:  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)
• Treatment:  intended to improve or maintain health status or avoid further deterioration (e.g., antiviral therapy, coronary artery bypass graft surgery, psychotherapy)
• Rehabilitation:  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)
• Palliation:  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.)

Not all technologies fall neatly into single categories.  Many tests and other technologies used for diagnosis also are used for screening.  (The probability that a patient who has a positive test result for a particular disease or condition truly has that disease or condition is greatly affected by whether the test was used for screening asymptomatic patients or diagnosing symptomatic patients.  See discussion of “predictive value positive,” below.)  Some technologies are used for diagnosis as well as treatment, e.g., coronary angiography to diagnose heart disease and to guide percutaneous coronary interventions.  Implantable cardioverter defibrillators detect potentially life-threatening heart arrhythmias and deliver electrical pulses to restore normal heart rhythm.  Electronic health record systems can support all of these technological purposes or applications.

Certain “hybrid” or “combination” technologies combine characteristics of drugs, devices or other major categories of technology (Goodman 1993; Lewin Group 2001; Lauritsen 2009).  Among the many examples of these are:  photodynamic therapy, in which drugs are laser-activated (e.g., for targeted destruction of cancer cells); local drug delivery technologies (e.g., antibiotic bone cement, drug patches, drug inhalers, implantable drug pumps, and drug-eluting coronary artery stents); spermicidal condoms; and bioartificial organs that combine natural tissues and artificial components.  Examples of hybrid technologies that have complicated regulatory approval and coverage decisions are positron-emission tomography (PET, used with radiopharmaceuticals) (Coleman 1992), metered-dose inhalers (Massa 2002), and certain targeted drugs that are developed in combination with pharmacogenomic tests that are predictive of patient response to those therapies.  These pharmacogenomic test-drug combinations may require clinical trials demonstrating the clinical utility of the tests as well as the safety and efficacy of the accompanying drug (US Food and Drug Administration 2007; Hudson 2011).

3. Stage of Diffusion

Technologies may be assessed at different stages of diffusion and maturity.  In general, health care technologies may be described as being:

• Future:  in a conceptual stage, anticipated, or in the earliest stages of development
• Experimental:  undergoing bench or laboratory testing using animals or other models
• Investigational:  undergoing initial clinical (i.e., in humans) evaluation for a particular condition or indication
• Established:  considered by clinicians to be a standard approach to a particular condition or indication and diffused into general use
• Obsolete/outmoded/abandoned:  superseded by other technologies or demonstrated to be ineffective or harmful

Often, these stages are not clearly delineated, and technologies do not necessarily mature through them in a linear fashion.  A technology may be investigational for certain indications, established for others, and outmoded or abandoned for still others, such as autologous bone marrow transplantation with high-dose chemotherapy for certain types of cancers (Rettig 2007).  Many technologies undergo multiple incremental innovations after their initial acceptance into general practice (Gelijns 1994; Reiser 1994).  A technology that was once considered obsolete may return to established use for a better-defined or entirely different clinical purpose.  A prominent example is thalidomide, whose use as a sedative during pregnancy was halted 50 years ago when it was found to induce severe fetal malformation, but which is now used to treat such conditions as leprosy, advanced multiple myeloma, chronic graft vs. host disease, and certain complications of HIV infection (Breitkreutz 2008; Zhou 2013).

B. Health Technology Assessment

Health technology assessment (HTA) is the systematic evaluation of properties, effects or other impacts of health technology.  The main purpose of HTA is to inform policymaking for technology in health care, where policymaking is used in the broad sense to include decisions made at, e.g., the individual or patient level, the level of the health care provider or institution, or at the regional, national and international levels.  HTA may address the direct and intended consequences of technologies as well as their indirect and unintended consequences.  HTA is conducted by interdisciplinary groups using explicit analytical frameworks, drawing from a variety of methods.

1. Purposes of HTA

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 about whether to permit the commercial use (e.g., marketing) of a drug, device or other regulated technology
• Payers (health care authorities, health plans, drug formularies, employers, etc.) about technology coverage (whether or not to pay), coding (assigning proper codes to enable reimbursement), and reimbursement (how much to pay)
• Clinicians and patients about the appropriate use of health care interventions for a particular patient’s clinical needs and circumstances
• Health professional associations about the role of a technology in clinical protocols or practice guidelines
• Hospitals, health care networks, group purchasing organizations, and other health care organizations about decisions regarding technology acquisition and management
• Standards-setting organizations for health technology and health care delivery regarding the manufacture, performance, appropriate use, and other aspects of health care technologies
• Government health department officials about undertaking public health programs (e.g., immunization, screening, and environmental protection programs)
• Lawmakers and other political leaders about policies concerning technological innovation, research and development, regulation, payment and delivery of health care
• Health care technology companies about product development and marketing decisions
• Investors and companies concerning venture capital funding, acquisitions and divestitures, and other transactions concerning health care product and service companies
• Research agencies about evidence gaps and unmet health needs

Many of the types of organizations noted above, including government and commercial payers, hospital networks, health professional organizations, and others, have their own HTA units or functions.  Many HTA agencies are affiliated with national or regional governments or consortia of multiple organizations. Further, there are independent not-for-profit and for-profit HTA organizations.

HTA contributes in many ways to the knowledge base for improving the quality of health care, especially to support development and updating of a wide spectrum of standards, guidelines, and other health care policies.  For example, in the US, the Joint Commission (formerly JCAHO) and the National Committee for Quality Assurance (NCQA) set standards for measuring quality of care and services of hospitals, managed care organizations, long-term care facilities, hospices, ambulatory care centers, and other health care institutions.  The National Quality Forum (NQF) endorses national evidence-based consensus standards for measuring and reporting across a broad range of health care interventions.

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2. Basic HTA Orientations

The impetus for an HTA is not necessarily a particular technology.  Three basic orientations to HTA are as follows.

• Technology-oriented assessments are 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.
• 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. 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.
• Project-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.

These basic assessment orientations can overlap and complement one another.  Certainly, all three types could draw on a common body of scientific evidence and other information.  A technology-oriented assessment may address the range of problems for which the technology might be used and how appropriate the technology might be for different types of local settings (e.g., inpatient versus outpatient).  A problem-oriented assessment may compare the effectiveness, safety, and other impacts of alternative technologies for a given problem, e.g., alternative treatments for atrial fibrillation (e.g., drug therapy, surgery, or catheter ablation), and may draw on technology-oriented assessments of one or more of those alternatives as well as any direct (“head-to-head”) comparisons of them.  A project-oriented assessment would consider the range of impacts of a technology or its alternatives in a given setting, as well as the role or usefulness of that technology for various problems.  Although the information used in a project-oriented assessment by a particular hospital may include findings of pertinent technology- and problem-oriented assessments, local data collection and analysis may be required to determine what is appropriate for that hospital.  Thus, many HTAs will blend aspects of all three basic orientations.

C. Properties and Impacts Assessed

What does HTA assess?  HTA may involve the investigation of one or more properties, impacts, or other attributes of health technologies or applications.  In general, these include the following.

• Technical properties
• Safety
• Efficacy and/or effectiveness
• Economic attributes or impacts
• Social, legal, ethical and/or political impacts

The properties, impacts, and other attributes assessed in HTA pertain across the range of types of technology.  Thus, for example, just as drugs, devices, and surgical procedures can be assessed for safety, effectiveness, and cost effectiveness, so can hospital infection control programs, computer-based drug-utilization review systems, and rural telemedicine networks.

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Whether in health care or other sectors, technological innovation can challenge certain ethical, religious, cultural, and legal norms.  Current examples include genetic testing, use of stem cells to grow new tissues, allocation of scarce organs for transplantation, and life-support systems for critically ill patients.  For example, the slowly increasing supply of donated kidneys, livers, hearts, lungs, and other solid organs for transplantation continues to fall behind the expanding need for them, raising ethical, social, and political concerns about allocation of scarce, life-saving resources (Huesch 2012; Yoshida 1998).  In dialysis and transplantation for patients with end-stage renal disease, ethical concerns arise from patient selection criteria, termination of treatment, and managing non-compliant and other problem patients (Moss 2011; Rettig 1991).  Even so, these concerns continue to prompt innovations to overcome organ shortages (Lechler 2005), such as techniques for improving transplantation success rates with organs from marginal donors, organs from living donors, paired and longer chain donation, xenotransplantation (e.g., from pigs), stem cells to regenerate damaged tissues, and the longer-range goal of whole-organ tissue engineering (Soto-Gutierrez 2012).

Technologies that can diminish or strengthen patient dignity or autonomy include, e.g., end-of-life care, cancer chemotherapy, feeding devices, and assistive equipment for moving immobilized patients.  Greater involvement of patients, citizens, and other stakeholders in health care decisions, technology design and development, and the HTA process itself is helping to address some concerns about the relationships between patients and health technology.  Ethical questions also have led to improvements in informed consent procedures for patients involved in clinical trials.

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The terms “appropriate” and “necessary” often are used to describe whether or not a technology should be used in particular circumstances.  These are judgments that typically reflect considerations of one or more of the properties and impacts described above.  For example, the appropriateness of a diagnostic test may depend on its safety and effectiveness compared to alternative available interventions for particular patient indications, clinical settings, and resource constraints, perhaps as summarized in an evidence-based clinical practice guideline.  A technology may be considered necessary if it is likely to be effective and acceptably safe for particular patient indications, and if withholding it would be deleterious to the patient’s health (Hilborne 1991; Kahan 1994; Singer 2001).

As described in chapter I, HTA inquires about the unintended consequences of health technologies as well as intended ones, which may involve some or all of the types of impacts assessed.  Some unintended consequences include, or lead to, unanticipated uses of technologies.  Box II-3 lists some recent examples.

1. 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 (death rate)
• Morbidity (disease rate)
• Adverse health events (e.g., harmful side effects)
• Quality of life
• Functional status
• Patient satisfaction

For example, for a cancer treatment, the main outcome of interest may be five-year survival rate; for treatments of coronary artery disease, the main endpoints may be incidence of fatal and nonfatal acute myocardial infarction (heart attack) and recurrence of angina pectoris (chest pain due to poor oxygen supply to the heart).  Although mortality, morbidity, and adverse events are usually the outcomes of greatest interest, the other types of outcomes are often important as well to patients and others.  Many technologies affect patients, family members, providers, employers, and other interested parties in other important ways; this is particularly true for many chronic diseases.  As such, there is increasing emphasis on quality of life, functional status, patient satisfaction, and related types of patient outcomes.

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