PHARMCARE 5
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| 🇬🇧 | 🇬🇧 |
| 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 |
| 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 |
| Superseded by other technologies or demonstrated to be ineffective or harmful | Obsolete/outmoded/abandoned |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 |
| 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 |
| 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 |
| 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 |
| Can be microeconomic and macroeconomic. | Economic attributes or impacts |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| (means they are not aware who is assigned with an intervention or treatment) | Blinding of patients |
| The extent to which the result of the study conducted under a particular circumstance can be generalized to other patients or population. | External 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 |
| 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 |
| (refers the ability to use differences in a measure of a construct to predict future events or outcomes) | Predictive validity (UNDER Criterion validity) |
| 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) |
| 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 |
| Types of Bias | 1 Selection bias 2 Performance bias 3 Detection bias 4 Attrition bias 5 Reporting bias |