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HTA PROCESS & METHODS - Coggle Diagram

- - - - Case report, case series, narrative reviews
      - Economic evaluation studies, including measuring costs and outcomes
        
        Is the comparative analysis of alternative courses of action, in terms of both their costs (resource use) and consequences (outcomes and effects).
        Expensive research estimated at ₱500,000.
        
        prospective health
        
        Cost-effectiveness study alongside clinical trial
        
        Intervention vs. Control cohorts
        
        Time- and resource-consuming
        
        HTA results are only valuable and relevant if they are timely for our decision-makers
        
        piggybacks on RCTs
        
        collect data about the cost and outcomes
        
        model-based health
        
        Use of decision models that combine with other data (input parameters)
        
        Hypothetical cohorts
        
        More commonly applied → less resources used
        
        Long-term impact can be assessed beyond the trial data
        
        Inform resource allocation decisions in the absence of “hard data”
        
        Types
        
        Cost-minimization analysis (CMA)
        
        cost: PHP
        outcome: usually clinical values
        sample results: cost per case; cost per drug
        
        outcomes are equal
        
        cost-benefit analysis (CBA)
        
        cost: PHP
        outcome: PHP
        sample results: net benefit; benefit-to-cost ratio; return on investment
        
        outcome is monetary value
        
        cost-effectiveness analysis (CEA)
        
        cost: PHP
        outcome: clinical values
        sample results: ICER (cost per LYG)
        
        ICER: cost-effectiveness threshold; less than is cost-effective (mababa cost but maraming benefits)
        
        is calculated by dividing the difference in costs between two interventions by the difference in their effectiveness.
        
        cost-utility analysis (CUA)
        
        cost: PHP
        outcome: QALY, DALY
        sample results: ICER (cost per QALY or DALY)
        
        Measuring cost
        
        types
        
        direct
        
        Any cost incurred due to the illness
        
        Direct medical cost
        
        Direct non-medical cost
        
        indirect
        
        Inability to attend to work due to illness
        Premature mortality
        
        cost lost due to decrease productiveness
        
        intangible cost
        
        Pain due to the disease
        
        Suffering due to the disease
        
        Emotional damage
        
        Cost because of stress and anxiety
        
        measuring outcomes
        
        processes of outcome assessment
        
        identification
        
        Morbidity and mortality; quality of life
        
        measurement
        
        Measures in natural units (e.g., no. of deaths averted)
        
        valuation
        
        Value benefits (if appropriate)
        
        types
        
        Measuring health in a natural or clinical unit
        
        Length of life (e.g., morbidity and mortality rate, life expectancy, life years lost)
        
        Measuring health in a common unit
        
        Quality of life measures
        Measures health in monetary-units
        
        Valuing health into monetary units
        
        Willingness to pay
        
        Utility or preference assessment
        
        Quality adjusted life years
        
        utility
        
        satisfaction/well-being that reflects a consumers (weighted) preferences
        
        utility weights
        
        are necessarily subjective they elicit an individual’s preferences for or value of one or more health states
        
        types of utiltues
        
        specific
        
        Disease specific: e.g. AIDS, arthritis, cancer
        
        Population specific: e.g. for children
        
        Function specific: e.g. for sleep or sexual function
        
        Condition or problem specific: e.g. for pain
        
        generic
        
        Health profiles: comprised of multiple items that are grouped into different domains of functioning e..g, Sickness Impact Profile, Medical Outcomes Study
        Utility measurement or preference-based measures: direct (time trade off, standard gamble, rating scale) and indirect (EQ-5D, health utility index, quality of well being
      - Non experimental, observational studies
        
        Natural allocation, you simply observe what is happening to the study population.
        
        Focuses on observing the behavior of a subject in a setting
        
        Lacks the manipulation of independent variables
        
        Aims to explore and make inferences about cause and effect relationships among variables
        
        Is conducted due to some limitations in experimental study
        
        if you cant assign an exposure of interest (e.g, surgery)
        
        examples
        
        cross-sectional
        
        Measure exposure and outcome simultaneously
        
        Weak relationship in terms of cause and effect
        
        Samples are defined according to exposure and disease at one point in time or over short period of time, can be used to calculate for the prevalence
        
        case-control
        
        Samples are defined according to the disease (cases)
        
        outcome is measure then followed by exposure
        
        can be used to calculate for the odds ratio
        
        some sort of cause and effect
        
        Odds ratio as outcome measurement
        
        cohort
        
        Samples are defined according to exposure; then followed up for the disease; can be used to calculate for the incidence and the relative risk
        Measures incidence (morbidity of measure; diff from prevalence as it is the risk of acquiring the disease; number of new cases /number of people at risk of acquiring the disease)
        
        prevalence: no. of existing cased /total pop
        incidence: no. of new cases/ pop at risk (pop - existing cases)
        
        types
        
        prospective
        
        ex. RCT
        
        retrospective
        
        Relative risk as outcome measurement
        
        greater than 1 greater incidence
        
        =1 no association
        
        <1 protective
        
        exposure is measured then outcome
        
        ecological
        
        observations of groups of people
        
        vs cohort, cross-sectional (patient lvl): pooled groups; means of comparison is groups of people (if per student, then it's cross sectional)
      - Experimental studies (RCTs)
        
        Common for pharm sci
        
        With interventions, you can manipulate treatment or health technology of interest
        
        A set of observations, which is conducted under controlled circumstances; researcher manipulates the conditions to ascertain what effect it has on the observations → Study of cause-effect association
        
        main features
        
        There must be a control group
        
        Both groups must have a similar pre-intervention risk or probability of developing the outcomes
        
        same prognosis, all conditions are ideal and controlled to make sure that the outcome is attributed to the exposure of interest not because of the cofounder's variable
        
        ex. wt management (externals should be controlled like diet)
        
        Researchers manipulate the assignment of exposure to study participants to ensure similar prognosis between groups
      - Systemic review, MA, network MA
        
        Collates all empirical evidence that fits pre-specified inclusion criteria to answer a specific research question
        Uses explicit, systematic methods that are selected to minimize bias, thus, providing reliable findings from which conclusions can be drawn and decisions may be made
        
        to assess therapeutic efficacy -> use RCTs
        
        processs
        
        scoping and reviewing of literature
        
        check if the existing SRMA is updated or not
        
        Forming a team, and declaring and managing potential conflict of interest
        
        Formulation of the research questions and development of the protocol
        
        Systematic search of the literature
        
        Critical appraisal of included studies
        
        Data extraction
        
        Data synthesis
        
        quantitative -> MA
        
        qualitaitive -> SR
        
        Interpretation and presentation of the results
        
        forest plot
        
        parts
        
        Diamond
        
        pooled result (provides the overall summary estimate)
        
        Vertical Line
        
        value of no effect
        
        Point Estimate
        
        middle of each line
        
        Branches (extending from the box)
        
        confidence interval
        
        Box Size
        
        sample size
        
        Number of Horizontal Lines
        
        number of studies
        
        mean difference: >0 superior; mean ratio >1 superior
        
        network analysis
        
        When a head-to-head study does not exist, indirect comparisons may be necessary.
        
        Combines indirect (triangular approach) and direct comparison (pair-wise approach); creates a web-like analysis called a Network Diagram or Network Comparison
        
        In many guidelines, evidence from indirect comparisons is placed above observational study but below head-to-head RCTs
        
        A network map is made if more health technologies are being compared
      - Qualitative
        
        an inductive apporach
        
        Focuses on non-numerical data
        
        Explores, understands or explains an issue
        
        Observes specific cases in depth to generalize patterns → hypothesis → theories
        
        Usually inductive but deductive approach can also be done
        
        From specific cases to general theories
        
        vs quantitaive
        
        Philosophical assumption is based on social constructivism
        
        how the individual perceived them
        
        Research setting is of naturalistic inquiry
        
        Research designs are emergent and flexible
        
        Researchers are engaged to participants
        
        key characteristics
        
        Sampling method: Smaller sample size with purposeful sampling
        Collection of data (words, image, objects) until saturation
        
        data collection method
        
        Participation observation
        
        In depth interview:
        
        Structured: questionnaire/checklist
        
        Semistructure: u can do follow qs up, ask to expound
        
        Unstructured: no questionnaire/checklist, discouraged bc it’s not very focused
        
        Focus group discussion
        
        cons for people with strong personality
        
        Documents, audio, and visual materials
        
        thematic analysis
        
        transcription
        
        key components
        
        To organize the data (data management)
        
        To identify patterns of the data (coding)
        
        To interpret and verify the patterns (interpretation and verification)
      - Mix methods
        
        Combines elements of quantitative and qualitative research approaches in an angle study, to widen and deepen understanding of the research problem and enhance the quality of evidence.
        
        types of data based on timing
        
        concurrent
        
        data collection in the concurrent strands (at the same time).
        
        If you want to explore issue or develop instruments
        
        Even though data collection happens at the same time, the discussion of the data should be integrated together.
        
        Compare and Relate — Comparison and relation of qualitative and quantitative data findings, for example, quantitative data suggests good results, in contrast, qualitative data suggests deviation from good results.
        
        Analyze and Interpret — Analysis whether there are contrary statements, differences, or if the qualitative and quantitative data findings in congruence to their results
        
        sequential
        
        data collection and analysis in specific sequence (order) and into 2 distinct phases.
        
        Used when you want to explain the findings
        
        More in depth
        
        Something always comes first. Either qualitative or quantitative comes first, compared to concurrent which happens at the same time.
  - - - science behind coming up on the decision based on multiple criteria
      - process of choosing or prioritizing values or interest
        
        it doesnt mean that the evidnece is strong, the recommendation is also strong
        
        you are also taking account different dimensions of values
      - involves the development of performance matrix
        
        criteria of judging
      - process
        
        Planning and getting started
        
        Identifying and involving stakeholders
        
        Identifying a set of criteria for prioritization
        
        Making performance matrix
        
        Reaching consensus
      - data
        
        contextualize
        
        informatin
        
        compare
        
        evidence
        
        consensus
        
        1 more item...
      - healthcare data
        
        nominal
        
        categorize discrete characteristics (special case: dichotomous or binary)
        
        ordinal
        
        categorize characteristics that have an inherent order
        
        numerical
        
        measure the amount or quantity of a variable (interval or ratio)
        
        sources
        
        surveys
        
        Collection of health and social science data from a sample of people (patients, providers) in a standardized way (e.g., questionnaires, in-depth interviews)
        
        Used for patient-reported outcomes (PROs), patient-reported outcome measures (PROMs) and patient reported experience measures (PREMs)
        
        Usually cross-sectional data
        
        Qualitative or quantitative approach
        
        advantage:
        
        Can collect empirical data in a relatively short period of time (fast)
        
        disadvantage:
        
        Overuse may lead to degradation in the quality of responses (i.e. respondents get tired of answering)
        
        Difficult to get detailed information in a survey
        
        Cannot remember important details correctly or at all (recall bias)
        
        medical records
        
        Track events and transactions between patients and providers
        
        Offer information on diagnoses, procedures, lab tests, and other services
        
        Measure and analyze trends in healthcare use, patient characteristics, and quality of care
        
        advantage
        
        Accurate and detailed because they come from health care providers
        
        In PGH, medical records are already electronic i.e. RADISH
        
        Automatically collected, including information that patients might not think to add or feel comfortable sharing through other data sources, like surveys.
        
        disadvantage
        
        Since the information is written down in a specific context, it can be misinterpreted if taken out of context
        
        It may be possible that the recorded information is an ADR instead of the primary disease or condition of the patient
        
        Only available for people who can get medical care
        
        Only people that undergo check ups have medical records
        
        clinical registries
        
        Meant for public health surveillance
        
        A type of public health surveillance that allows people to collect, store, retrieve, analyze, and disseminate information about people with a specific disease or condition.
        
        Ex. COVID Dashboard
        
        Estimate how large a health problem is, determine disease incidence, and study trends over time, and evaluate effects of certain exposures
        
        Provide information to improve the quality and safety of care, and allow for comparison of treatments
        
        AKA disease registries
        
        advantage
        
        Broader population coverage and have larger number of patients
        
        More generalizable to wide range of patients as compared with RCTs (i.e., homogeneous populations; ideal conditions)
        
        Solid exposure and outcome measures
        
        Rich clinical data available to adjust for confounding variables
        
        Provide opportunity to evaluate the effectiveness of HTs in which randomization is unethical or impractical
        
        disadvantage
        
        Can be subjected to selection bias
        
        Happens if there is limited registration
        
        Often limited in terms of their targeted population and focuses on certain diseases or conditions
        
        Lack of follow-up data beyond hospital discharge or the acute episode of care (i.e., data may not be applicable to intermediate or long-term outcomes)
        
        Since diseases may change definitions, it can be difficult to accurately track trends
        
        administrative or clains data
        
        Generated and gathered for some administrative purposes, such as medical billing upon hospital discharge or provision of other healthcare services
        
        Include patient demographics, diseases diagnoses, and medications or procedures, doctors’ appointments, bills, insurance information, and other patient-provider communications
        
        Data used for billing or costing
        
        Problem with this is not meant for healthcare
        
        Examples:
        
        Medicare datasets
        
        Agencies for healthcare research and quality
        
        Commercial insurance claims
        
        PhilHealth
        
        advantage
        
        Broadest population coverage
        
        Findings can be easily implemented in the real-world settings
        
        Since datasets are large, it is possible to focus on groups underrepresented in other data sources, and for rare illnesses
        
        More efficient to obtain since no additional primary data collection is needed
        
        disadvantage
        
        The data can be “dirty” and may be less accurate since they are gathered for the purpose of medical billing (not really meant for checking clinical outcomes)
        
        Important clinical details, such as secondary diagnoses and procedures are under-coded
        
        Costing can be overestimated because profit is already added to the costing data
        
        vital records
        
        Include births, deaths, marriages, divorces, and fetal deaths
        Record information about the cause of death, or details of the birth
        
        advantage
        
        Offer detailed information, including information about rare disorders that end in death
        
        disadvantage
        
        Since there may be many local governments collecting this information, records may be inconsistent
        
        Recording and reporting may be lacking (e.g. maternal deaths are not properly monitored)
        
        Only provide information on diseases and illnesses that end in death
        
        trial databases
        
        Involves the secondary use of existing data from clinical trials databases
        Example: researchers can transfer data from the original RCT design and evaluate them for other intended purposes
        
        advantage
        
        Since data came from RCT → reliable and robust database for research
        
        disadvantage
        
        Population included in an RCT is narrowly selected -> results not generalizable to patients who will eventually use the HT in real-world settings
  - - - comparator
        
        relevant standard practice used or placebo
        
        for vaccine, comparator is placebo
        
        outcome
        
        timeframe
        
        how long to measure the cost of outcomes
        
        for vaccine, the timeframe is lifetime because the vaccine preventable diseases are experienced when we became older to capture the outcome (which is to prevent disease)
        
        for flu vaccine, the timeframe is one
        
        interventions
        
        the new HT considered for assessment
        
        population of interest
      - guide questions on how to develop good research questions
        
        does the question address a significant unment need?
        
        is the research question complete?
        
        is the population well defined?
        
        is the comparator identified (for analytical studies)
        
        are the outcomes appropriate and measurable
        
        is the research question clear and precise?
        
        is the study that will be used to answer the research question feasible to conduct or implement
    - - search for best available evidence
        
        infromation sources
        
        primary and secondary sources
        
        systems
        
        ex. UptoDate
        
        synopsis
        
        summaries
        
        ex. Cochrane review
        
        others (hand search, grey literature, personal contact, etc.)
        
        search and selection are based on
        
        soundness of evidence-based approach
        
        sensitivity or specificity
        
        sensitive: the likelihood of getting relevant items
        
        specific: likelihood of excluding irrelevant items
        
        ease of use
        
        availability
    - - critical appraisal
        
        A systematic method to evaluate the methodological quality of studies → leading to the judgment on the validity and the reliability of the study’s findings and conclusions
        
        Vital in determining the extent of how biases affect results -> overestimation or underestimation of effects of HTs
  - - - clinical
        
        Critical Appraisal of synthesized clinical evidence; OR
        Systematic review (with or without Meta-analysis/Network Meta-analysis) on clinical evidence
      - economic
        
        Economic evaluations (e.g., cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), Budget impact analysis
      - ethical, legal, social impact, and health systems
        
        Cross-sectional surveys;
        Qualitative methods (e.g., participant observation, in-depth interviews, focus group discussion)
  - - - narrative review
        
        Non-systematic review of literature or summary of articles determined to be relevant by the reviewer
        Usually used when searching of articles is based on convenience
      - systematic review
        
        Comprehensive and systematic search and synthesis of relevant studies on a focused question
      - meta analysis
        
        Application of statistical techniques to combine results of several, suitably similar studies into a single, pooled, numerical summary estimate
      - rapid review
        
        Follows the SR process, but the components of the process are simplified or omitted to produce information in a timely manner