PFD.txt

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emm64
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142850
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PFD.txt
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2012-03-20 22:32:01
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PFD Garrett
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PFD Garrett
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  1. What are the critical elements of a standardized (systematic, structured) review?
    • Ask answerable questions
    • Search for the best evidence
    • Critically appraise the evidence
    • Apply the evidence to patient care
    • Evaluate the outcome
  2. What might be exclusion criteria for articles considered for inclusion in the review?
    • Time too short
    • n too low
    • Anecdotal or ambiguous reporting of results
    • Cross-sectional, case-control, and "failing implants" studies
    • Report limited to description of techniques for fabrication of provisional prosthese
    • Observation period less than 1 year
    • Published in a journal produced by a manufacturer
    • Less than 5 patients
    • Only abstract published
    • Old implant technology (before 1985)
    • Post hoc analyses of prior publications
    • single-technique case series without a comparison group
  3. Be able to interpret the forest plot elements and describe results based on the plot.
    • relative strength of treatment effects
    • graphically representing a meta-analysis of the results of randomized controlled trials
    • left-hand column=names of RCT and epidemiological study in chronological order
    • right-hand column = plot of the measure of effect (e.g. an odds ratio) incorporating confidence interval
    • the confidence intervals are symmetrical about the means from each study and to ensure undue emphasis is not given to odds ratios greater than 1 when compared to those less than 1.
    • Area of each square is proportional to the study's weight in the meta-analysis
    • overall meta-analysed measure of effect is often represented on the plot as a vertical line. This meta-analysed measure of effect is commonly plotted as a diamond, the lateral points of which indicate confidence intervals for this estimate.
    • vertical line representing no effect is also plotted
    • An example forest plot of five odds ratios (squares, proportional to weights used in meta-analysis), with the summary measure (centre line of diamond) and associated confidence intervals (lateral tips of diamond), and solid vertical line of no effect. Names of (fictional) studies are shown on the left, odds ratios and confidence intervals on the right.
  4. What are the 5 key elements of the Nuremburg code?
    • Voluntary Consent
    • Yield benefit to society
    • Must be justified
    • Avoid unnecessary suffering
    • Cannot be expected to result in death or disability
    • Degree of risk cannot exceed the benefit to humanity
    • Provision of emergency care in case of injury/death/disability
    • Subject can stop
    • Investigator can stop participation
  5. Be able to define the 3 guiding principles in the Belmont report and how they impact clinical (human) research.
    • a. Respect for persons
    • b. Beneficence
    • c. Justice
    • Respect for persons (1 Belmont)
    • Autonomous agent – self determination
    • Protect those not capable of self determination (prisoners, institutionalized, mentally/phys challenged, children)
    • Beneficence (2 Belmont)
    • "Do no harm" and "maximize benefits to risks"
    • “learning what will benefit may require exposing a person to risks”
    • How much risk is acceptable?
    • How do you interpret risk/benefit ratio?
    • Fairness in distribution (3 Belmont)
    • Burden & Benefits
    • Burden – poor or disadvantaged
    • Benefits of improved care – patients with insurance
  6. Respect for persons (1 Belmont)
    • Autonomous agent – self determination
    • Protect those not capable of self determination (prisoners, institutionalized, mentally/phys challenged, children)
  7. Beneficence (2 Belmont)
    • "Do no harm" and "maximize benefits to risks"
    • “learning what will benefit may require exposing a person to risks”
    • How much risk is acceptable?
    • How do you interpret risk/benefit ratio?
  8. Fairness in distribution (3 Belmont)
    • Burden & Benefits
    • Burden – poor or disadvantaged
    • Benefits of improved care – patients with insurance
  9. If I tell you about a project being conducted on elderly, financially disadvantaged , institutionalized individuals, what provisions of the Belmont Report are likely to be violated?
    • Most likely A, also C
    • a. Respect for persons
    • b. Beneficence
    • c. Justice
    • Informed Consent (Respect)
    • Information
    • Comprehension
    • Voluntary
    • Assessment of risk/benefit (Beneficence)
    • Benefit to individual or society (tangible – usually health or welfare)
    • Risks – physical, psychological, financial, legal, etc.
    • Ratio “balanced” or “favorable”
    • Justifiable?
    • Selection of Subjects (Justice)
    • Social (In)Justice – inclusion/exclusions based on social, racial sexual, cultural characteristics
    • Excessive burden on minorities, elderly, disadvantaged, institutionalized
  10. What is the IRB and its mission?
    • UCLA Institutional Review Board (IRB)
    • Mission:
    • • To determine and certify that all projects that involve human subjects at the institution conform to federal and state regulations and institutional policies regarding health, welfare safety, rights
    • • To assist investigators in conducting ethical research t fulfill the requirements stated above
  11. Describe the key elements the IRB focuses on when reviewing a study
    • Risk vs. Benefit ratio for study participants
    • Required elements for consent
    • Scientific validity
  12. Identify the ethical problems in the study: In 1963, live cancer cells were injected into senile patients in a chronic disease hospital, as part of a study on cancer immunity. The patients had no knowledge of what they were being injected with. Since the investigators believed the cells would be rejected, the researchers did not inform the patients or seek consent, because they did not want to frighten them.
    • Lack of informed consent
    • Deception
    • Withholding information
    • Putting subjects at risk
    • Exploitation of a vulnerable group
    • Risks to subjects outweighted benefits
  13. What is the level of industry support for clinical research on drugs and how does it relate to federal/foundation support?
    70% of the funding from Industry NOT NIH!
  14. What are 3 ways that a study may be designed that could result in a biased outcome for a sponsor’s drug or device?
    • Test drug in healthier population
    • Compare NEW with lower dose of competing product->greater efficacy
    • Collect many outcome measures and only use that favor product (some may not be clinically relevant surrogate measures)
  15. How might company support impact publication of study results?
    • Without FDA approval – no publication has value to the company!
    • Contracts with investigators have publishing clause
    • Veto power
    • Review period(like filibustering)
  16. Are industry sponsored trials more likely to produce results favorable to the sponsor’s product (based on the studies presented in class)? If so, why do you think this is happening?
    • Research funded by drug company less likely to be published or reported
    • Took longer to be published
    • 13/13 industry funded trials did not have poorer study design or statistical analysis
    • 13/16 reviews found research results consistently favored the sponsors product
    • •Industry sponsorship more likely to produce results favoring the company than studies funded from other sources
    • Selectively find superior drugs to start?
    • •Positive results due to poor research quality? (quality was as good, but poor research question)
    • •Inappropriate comparison?
    • •Publication bias? (researchers don't want to bite the hand that feeds them)
    • •Non-peer reviewed journals
    • Similar results for nutrition (drinks)

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