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1 practical application of knowledge 2 Application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem, and to improve quality of life

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1 Technology 2 Health Technology

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1 Technology 2 Health Technology

Three ways to describe health technology include its:

1 physical nature 2 purpose 3 stage of diffusion

PHYSICAL NATURE refers to category that being offered or used by the subjecs. these categories are interdependent/related/connected Main categories involve:

● Drugs ● Biologics ● devices/equipments/supplies ● medical and surgical procedures ● public health programs ● support system ● organizational and managerial systems

Purpose of application (Health Technology)

1 Prevention 2 Screening 3 Diagnosis 4 Treatment 5 Rehabilitation 6 Palliation PSD TRP

1 protect against disease by preventing it from occurring, reducing the risk of its occurrence, or limiting its extentor sequelae (e.g., immunization, hospital infection control program, fluoridated water supply) 2 detect a disease, abnormality, or associated risk factors in asymptomatic people (e.g., Pap smear, tuberculin test,screening mammography, serum cholesterol testing)

1 Prevention 2 Screening

1 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) 2 intended to improve or maintain health status or avoid further deterioration (e.g., antiviral therapy, coronary artery bypass graft surgery, psychotherapy)

1 Diagnosis 2 Treatment

1 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) 2 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. provided for progressive, incurable disease

1 Rehabilitation 2 Palliation

STAGE OF DIFFUSION: Technologies may be assessed at different stages of diffusion and maturity. In general, health care technologies may be DESCRIBED AS BEING:

1 Future 2 Experimental 3 Investigational 4 Established 5 Obsolete/outmoded/abandoned FE IE O

1 in a conceptual stage/planning stage, anticipated, or in the earliest stages of development 2 undergoing bench or laboratory testing using animals or other models

1 Future 2 Experimental

1 undergoing INITIAL CLINICAL (i.e., in humans) EVALUATION for a particular condition or indication 2 considered by clinicians to be a STANDARD APPROACH to a particular condition or indication and diffused into general use

1 Investigational 2 Established

Superseded by other technologies or demonstrated to be ineffective or harmful

Obsolete/outmoded/abandoned

FACTORS that REINFORCE THE MARKET for Health Technology

● Strong or growing economies ● Aging populations ● Advances in science and engineering ● Provider competition to offer state-of-the-art technology ● Increasing prevalence of chronic diseases ● Emerging pathogens and other disease threats ● Intellectual property, especially patent protection ● Third-party payment, fee-for-service payment ● Financial incentives of technology companies, clinicians, hospitals, and others ● Public demand driven by direct-to-consumer advertising, mass media reports, social media, and consumer awareness and advocacy ● Off-label use of drugs, biologics, and devices ● “Cascade” effects of unnecessary tests, unexpected results, or patient or physician anxiety ● Clinician specialty training at academic medical centers ● Malpractice avoidance

Health Technology Assessment

● Medicines ● Medical device ● Vaccines ● Procedures and systems MM VP

Refers to the the SYSTEMATIC EVALUATION of properties, effects, and/or impacts of health-related technology which utilizes a multidisciplinary process to evaluate the clinical, economic, organizational social, and ethical issues of a health intervention or health technology - WHO application of organized knowledge and skills to solve a health problem and improve quality of life. main purpose is to inform policymaking for technology in health care may address the direct, intended, indirect, & unintended consequences of technologies conducted by interdisciplinary groups using explicit analytical frameworks

Health technology assessment (HTA)

Purpose of Health Technology Assessment (HTA)

1 Regulatory agencies about whether to permit the commercial use (e.g., marketing) of a drug 2 Payers about technology coverage and reimbursement 3 Clinicians and patients about the appropriate use of health care interventions 4 Health professional associations about the role of a technology 5 health care organizations about decisions regarding technology acquisition and management

3 Basic orientation of HTA

1 Technology-oriented assessments 2 Problem-oriented assessments 3 Project-oriented assessments TPP

Are intended to determine the characteristics or impacts of particular technologies. ex. a government agency may want to determine the clinical, economic, social, professional, or other impacts of cochlear implants, cervical cancer screening

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.

Problem-oriented assessments

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

Project-oriented assessments

HTA Properties and Impacts Assessed

1 Technical properties 2 Safety 3 Efficacy & Effectiveness 4 Economic attributes or impacts 5 Ethical, legal, and social considerations TEEES

Measuring Health Outcomes:

1 Biomarkers, intermediate endpoints and surrogate endpoints 2 Quality of Life Measures

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

Technical properties

Measuring Health Outcomes:

1 Biomarkers, intermediate endpoints and surrogate endpoints 2 Quality of Life Measures

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

Safety

Refer to how well a technology works, i.e., accomplishes its intended purpose, usually based on changes in one or more specified health outcomes or “endpoints”

Efficacy & Effectiveness

1 refers to the benefit of using a technology for a particular problem under IDEAL CONDITIONS 2 refers to the benefit of using a technology for a particular problem under GENERAL OR ROUTINE CONDITIONS,

1 Efficacy 2 Effectiveness

Can be microeconomic and macroeconomic.

Economic attributes or impacts

1 concerns include costs, prices, charges, and payment levels associated with individual technologies. Other issues: comparisons of resource requirements and outcomes (cost effectiveness, cost utility, and cost benefit) 2 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. Other issues: effects of intellectual property policies, regulation, third-party payment, other policy changes affecting technological innovation, adoption, diffusion, and use.

1 Microeconomic 2 Macroeconomic

Arise in HTA in the form of NORMATIVE CONCEPTS; choices about how and when to use technologies; research and the advancement of knowledge; resource allocation; and the integrity of HTA processes themselves ex. genetic testing, stem cells, scarce organs allocation

Ethical, legal, and social considerations

Measuring Health Outcomes

•Mortality •Morbidity •Adverse health events •Quality of life •Functional status •Patient satisfaction

Main categories of health outcomes are:

Mortality – death rate Morbidity – disease rate

Measuring Health Outcomes:

1 Biomarkers, intermediate endpoints and surrogate endpoints 2 Quality of Life Measures

An OBJECTIVELY MEASURED VARIABLE or trait that is used as an INDICATOR of a normal biological process, a disease state, or effect of a treatment.

Biomarker (Biological marker)

1 NON-ULTIMATE ENDPOINT (e.g., not mortality or morbidity) that may be associated with disease status or progression toward an ultimate endpoint such as mortality or morbidity. They include certain biomarkers or disease symptoms. 2 a measure (typically a biomarker) that is used as a SUBSTITUTE for a CLINICAL ENDPOINT of interest, such as morbidity and mortality.

1 Intermediate endpoint 2 Surrogate endpoint

Measures or indexes, provides a more complete picture of the ways in which health care affects patients. measures capture such dimensions (or domains) as: physical function, social function, cognitive function, anxiety/distress, bodily pain, sleep/rest, energy/fatigue and general health perception. These measures may be GENERIC or DISEASE-SPECIFIC.

Quality of life (QoL) “health-related quality of life”

Genetic measures used:

● CAHPS (Consumer Assessment of Healthcare Providers and Systems) ● EuroQol (EQ-5D) ● Health Utilities Index ● Nottingham Health Profile ● Quality of Well-Being Scale ● Short Form (12) Health Survey (SF-12) ● Short Form (36) Health Survey (SF-36) ● Sickness Impact Profile

Health-Adjusted Life Years

1 Quality-adjusted life years (QALYs) 2 Disability-adjusted life years (DALYs) 3 Healthy-years equivalents (HYEs)

A unit of health care outcome that combines gains (or losses) in LENGTH OF LIFE w/ QUALITY OF LIFE. represent years of life subsequent to a health care intervention that are weighted or adjusted for the quality of life experienced by the patient during those years used primarily 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. purpose are to comparing the relative impact on personal and population health of specific diseases or conditions, comparing the relative impact on personal and population health of specific technologies

Quality-adjusted life years (QALYs) QALY = length of life X Quality weight

Are primarily used to measure population disease burden; they are a measure of something ‘lost’ rather than something ‘gained.’ represent levels of loss of functioning caused by mental or physical disability caused by disease or injury burden of disability in calculating __ depends on one’s age.

Disability-adjusted life years (DALYs) DALY = years lived with disability + years of life lost

Is a measure of outcome of health care programs that combines two outcomes of interest: quality of life and quantity of life.

Healthy-years equivalents (HYEs)

Provide information about the presence of a disease or other health condition. It able to discriminate between patients who have a particular disease or condition and those who do not have it.

Screening and diagnostic tests

1 conducted in asymptomatic patients 2 conducted in symptomatic patients.

1 Screening 2 Diagnosis

A screening or diagnostic test can have four basic types of outcomes.

1 True Positive test 2 True Negative test 3 False Positive test 4 False Negative test

1 result is one that detects a marker when the disease is present. 2 result is one that does not detect the marker when the disease is absent 3 result is one that detects a marker when the disease is absent 4 result is one that does not detect a marker when the disease is present.

1 true positive test 2 true negative test 3 false positive test 4 false negative test

The effectiveness of a diagnostic (or screening) technology can be determined along a chain of inquiry that leads from technical capacity of a technology to changes in patient health outcomes to cost effectiveness (where relevant to decision makers), as follows

1 Technical capacity 2 Diagnostic accuracy 3 Diagnostic impact 4 Therapeutic impact 5 Patient outcome 6 Cost effectiveness

1 Does the technology perform reliably and deliver accurate information? 2 Does the technology contribute to making an accurate diagnosis?

1 Technical capacity. 2 Diagnostic accuracy

1 Do the diagnostic results influence use of other diagnostic technologies, e.g., does it replace other diagnostic technologies? 2 Do the diagnostic findings influence the selection and delivery of treatment?

1 Diagnostic impact 2 Therapeutic impact

1 Does use of the diagnostic technology contribute to improved health of the patient? 2 Does use of the diagnostic technology improve the cost effectiveness of health care compared to alternative interventions?

1 Patient outcome 2 Cost effectiveness

Expertise for Conducting HTA

Health professionals, Managers of hospital, clinics, nursing homes, etc, Pharmacists, Laboratory technicians, Biomedical and clinical engineers, Patients and community representatives, Epidemiologists, Biostatisticians, Economists, Social scientists, Decision scientists, Ethicists, Lawyers, Computer scienticts/programmer, Librarians/information specialists

Basic HTA Framework/steps in HTA process

1. Identify assessment topics 2.Specify the assessment problem or questions 3. Determine organizational locus or responsibility for assessment 4. Retrieve available relevant evidence 5. Generate or collect new evidence (as appropriate) 6. Appraise/interpret quality of the evidence 7. Integrate/synthesize evidence 8. Formulate findings and recommendations 9. Disseminate findings and recommendations 10. Monitor impact

Health technology Council:

1 Core committee 2) 7 Subcommittees

HTA contributes to the achievement of UHC by:

•Increasing transparency, accountability, and equity •Institutionalizing priority setting mechanism on health technology coverage •Improving efficiency in allocation of resources •Negotiating better prices of health technologies

1 In the implementation of UHC law, HTAC should prioritize the review of existing health technologies within __ (years?) upon their creation (from October 2019 to October 2021) 1 In parallel, they will also accommodate the assessment of new health technologies which are proposed by the __

1 two years 2 DOH and PhilHealth.

Steps in HTA process:

1. Topic nomination 2. Topic Prioritization 3. Scoping and Protocol Development 4. Assessment 5. Evidence appraisal 6. Recommendation 7. Resolution 8. Decision 9. Dissemination

FOR THE FIRST TWO YEARS of the HTA PROCESS IMPLEMENTATION; (from October 2019 to October 2021), the HTAC shall accept topic nominations from DOH and PhilHealth for the priority assessments in accordance with the UHC Law

Nomination

Public health emergencies: (i) bioterrorism; (ii) appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; (iii) a natural disaster; (iv) a chemical attack or accidental release; (v) a nuclear attack or accident; or (vi) an attack or accidental release of radioactive materials

Prioritization

Can be performed by either the internal assessment team (i.e., HTA unit) or an external assessment team that is a part of the HTA research network that will be created by the DOH and DOST (Department of Science and Technology).

Assessment

(Prior to submitting topic nomination) HTAC will only consider the use of these health technologies within the approved marketing authorization of the product in the Philippines as certified by the FDA

Drugs and vaccines

If exempted from the current FDA process of granting marketing authorization, the technology sponsor shall submit a Certificate of Free Sale (CFS) issued by the regulatory authority from the source country or other stringent regulatory authority, which shall be validated by the Philippine FDA

Medical devices

Criteria in making Recommendation:

•Responsiveness to disease magnitude, severity, and equity •Safety and effectiveness •Household financial impact •Cost-effectiveness •Affordability and viability

2 main types of HTA Methods

1 Primary data method 2 Secondary data method or integrative methods OR synthesize methods

A retrospective observational study designed to determine the related relationship between a particular outcome of interest and also a potential cause. In here the investigator identify a group of patients with a specified outcomes and a group of patients without a specified outcome which is our cautious

Case control study

1 involves the collection of original data such as in methods of clinical trials or observational studies 2 involves combining data or information from existing sources including from the primary data

1 Primary Data methods 2 Secondary methods or integrative method or synthesize methods

Involves combining data or information from existing sources including from the primary data

Secondary methods or integrative method or synthesize methods

It involves one or both of the primary data methods and secondary methods, this is the combination.

Economic analysis methods

Primary Data Studies: Diverse Attributes

1 Comparative vs. non-comparative 2 Separate control group (external factor) vs. no separate control group (internal) 3 Participants defined by a health outcome vs. by having been exposed to, or received or been assigned, an intervention 4 Prospective vs retrospective 5 Interventional vs. observational 6 Experimental vs. non-experimental 7 Random assignment vs. non-random assignment of px to treatment and control groups

1 (mostly this is an external factor) 2 (internal)

1 Separate control group 2 no separate control group

1 (aka study population)

1 Participants defined by a health outcome

1 (it watches for outcomes; this study usually involves taking a cohort of subjects and watching them for a long period) 2 (looks backwards and examines exposure to suspected risk or protection factors in relation to an outcome that is established at the start of the study)

1 Prospective 2 retrospective

1 (this involves a participant and you have given them 2 separate intervention) 2 (purely observation or everyone received treatment and you just have to observe each one of them)

1 Interventional 2 observational

A group is chosen sometimes as a random sample from a certain larger population and then the exposures of people in the group to an intervention and outcomes of interest are determined. So, this study, is design or used to assess the accuracy of diagnostic test

Interventional cross-sectional observational study

Studies which may be better for reflecting the real-world practice; have main attributes including comparison of clinically relevant alternative interventions or a diverse population of study participants and then participants recruited from the heterogenous practice settings and lastly, data collection from a broad range of health outcomes

Pragmatic clinical trials

Case control study

Used to determine on what type of study you can use for a typical assessment of health technology

Algorithms for identifying study designs

The following will describe concepts that affects the quality of primary data studies particularly their ability to yield unbiased and precise estimate of treatment effects and other findings

1 Prospective, rather than retrospective design 2 • Experimental rather than observational 3 Controlled, rather than uncontrolled 4 Contemporaneous control groups 5 Internal control groups rather than external ones 6 Allocation concealment 7 Randomized assignment of patients 8 Blinding of patients 9 Large enough sample size to detect true treatment effects 10 Minimal patient drop-outs or loss

(it exists when the results of an intervention group and a controlled group are compared over the same time period)

Contemporaneous control groups

(you are having a controlled group within the premise or managing controlled groups within study)

Internal control groups

(usually it is a practice of keeping researchers and participants unaware of the sequence with the goal of preventing the researchers from influencing the group assignments of the study participants)

Allocation concealment

(means they are not aware who is assigned with an intervention or treatment)

Blinding of patients

Are designed to maximize the internal validity and are generally regarded as the control or the gold standard for demonstrating the causal impact of technology on health care and also outcome

RCT or the Randomized Controlled Trials

The extent to which the result of the study conducted under a particular circumstance can be generalized to other patients or population.

External Validity

Means how well a study or data collection instrument measures what it is intended to measure Understanding different aspects of this will help us in comparing the strengths and also weaknesses of the alternative study designs and also our confidence in the findings generated by those studies.

Validity

Types of Validity in Methods and Measurement

1 Internal validity 2 External validity 3 Construct Validity 4 Content validity 5 Criterion validity 6 Convergent validity

The extent to which the design and conduct of a study minimizes the risk of any systematic error or biases in the study results. the __ can be the suspect when biases in the design or conduct of a clinical trial or other studies could have affected the outcomes by causing the study results to deviate from the true magnitude of the treatment effect.

Internal validity

Usually the result of the study may be limited when the circumstances of a particular studies such as patient characteristics or the technique of delivering a treatment, the setting of care differ from the circumstances of the rest. the extent to which the result of the study conducted under a particular circumstance can be generalized to other patients or population. chatgpt explained: For instance, if a study is conducted on a specific group of people, the question becomes whether the findings of that study can be applied to a broader population beyond the group studied.

External validity

How well a measure is correlated with other accepted measures of the construct of interest, and discriminates between groups known to differ evaluates the extent to which a measurement instrument (such as a test, questionnaire, or assessment tool) accurately measures the theoretical construct or concept it claims to measure. In other words, it assesses whether the scores obtained from the instrument truly reflect the underlying construct of interest.

Construct Validity

This is the ability of a measure to REPRESENT reasonably as judged by someone with knowledge or expertise in the construct. For example, acceptable or a construct like in base of concept, trait, domain of interest.

Face validity (Under construct validity)

The degree to which the set of items of a data collection instrument is known to represent the range or universe of meanings or dimensions of a construct of interest. For example, how well do the domains of a health-related quality of life index for rheumatic arthritis represent the aspect of quality of life or daily functioning that are important to patients. focuses on how well a measurement instrument (such as a test, questionnaire, or assessment tool) covers the full range of content or domain that it is intended to measure. In other words, it evaluates whether the items or questions included in the instrument are representative of the entire construct being measured.

Content validity

O how well a measure, including its various domains or dimensions, is correlated with a known gold standard or definitive measurement, if one exists

Criterion validity

(it refers to how well a measure correlates with a PREVIOUSLY VALIDATED one and the ability of the measure to accurately differentiate between different groups at the time measure is applied)

Concurrent validity (UNDER Criterion validity)

(refers the ability to use differences in a measure of a construct to predict future events or outcomes)

Predictive validity (UNDER Criterion validity)

O the extent to which DIFFERENT MEASURES that are intended to measure the same construct actually YIELD SIMILAR RESULTS, such as two measures of quality of life simple explanation: different measures, same purpose, yield the same results

Convergent validity

It concerns whether the different measures are intended to measure different constructs actually fail to be positively associated with each other simple explanation: different measures, different purpose, yield different results

Discriminant validity (UNDER Convergent validity)

Usually occurs when any factor that is associated with an intervention has an impact on an outcome that is independent of the impact of the intervention. MASK TRUE IMPACT OF INTERVENTION. can arise due to differences between the intervention and controlled groups such as there is differences in the baseline risk factors at the start of a trial or there are different exposure during the trial that could also affect outcomes

Confounding

Control groups for confounding factors (to address confounding factors) Controlled studies:

Controlled studies: 1 Contemporaneous control with intervention groups 2 Historical control groups 3 Crossover design study 4 Randominization (pseudorandominization)

(planned and implemented by investigators using real time data collection) subjected to confounding; more biased than retrospective more suited to investigating health problems that are prevalent and yield health outcomes or other events that occur relatively frequently and within short follow up periods

Prospective design

Collect samples of data from past interventions and outcomes involving one or more patient groups more subject to selection biased than prospective; dependence on existing data; designed to extract data from longer time spans and they can also offer the advantage of being able to canvas large volumes of data over extended time periods

Retrospective design

Can be designed to reduce biased such as selection biased and detection biased which is advantage over most retrospective studies

Patient enrollment and data collection

Any systematic deviation in an observation from the true nature of the event

Bias

Types of Bias

1 Selection bias 2 Performance bias 3 Detection bias 4 Attrition bias 5 Reporting bias