Research in Medicine Flashcards

1
Q

Define

Evidence-based medicine (EBM)

A

the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients

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2
Q

Define

Systematic Review

A

a review of a clearly formulated question that uses systematic and reproducible methods to identify, select and critically appraise all relevant research, and to collect and analyse data from the studies that are included in the review

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3
Q

Define

National Health Priority Areas

A

diseases and conditions given focused attention because of their significant contribution to the burden of illness and injury in the Australian community.

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4
Q

Define

Selection bias

A

Systematic differences between baseline characteristics of groups compared

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5
Q

Define

Performance bias

A

Systematic differences in the care provided to the groups after enrolment

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6
Q

Define

Detection bias

A

Systematic differences between how outcomes are determined

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7
Q

Define

Attrition bias

A

Systematic differences due to withdrawals and incomplete data

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8
Q

Define

Reporting bias

A

Systematically different reporting methods that favour significant findings

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9
Q

Define

Publication bias

A

Published results are systematically different from unpublished reports

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10
Q

Definition

the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients

A

Evidence-based medicine (EBM)

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11
Q

Definition

a review of a clearly formulated question that uses systematic and reproducible methods to identify, select and critically appraise all relevant research, and to collect and analyse data from the studies that are included in the review

A

Systematic Review

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12
Q

Definition

diseases and conditions given focused attention because of their significant contribution to the burden of illness and injury in the Australian community.

A

National Health Priority Areas

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13
Q

Definition

Systematic differences between baseline characteristics of groups compared

A

Selection bias

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14
Q

Definition

Systematic differences in the care provided to the groups after enrolment

A

Performance bias

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15
Q

Definition

Systematic differences between how outcomes are determined

A

Detection bias

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16
Q

Definition

Systematic differences due to withdrawals and incomplete data

A

Attrition bias

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17
Q

Definition

Systematically different reporting methods that favour significant findings

A

Reporting bias

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18
Q

Definition

Published results are systematically different from unpublished reports

A

Publication bias

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19
Q

What are the three myths of medicine research that cause a lot of preventable heartache?

A
  1. Every symptom has a diagnosis
  2. Every diagnosis has a treatment
  3. Every treatment is a cure
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20
Q

What are the values of biomedical research?

A

Improving Health
– Biomedical Research in Australia has improved treatment and prevention of
several cancers, infectious diseases and heart failure.
§ Training the next generation of scientists
– Research grants provide opportunities for graduate and post-doctoral students
to gain hands-on laboratory experience
§ Increasing knowledge
– Eight Australian biomedical researchers have been awarded a Nobel Prize in
Physiology/Medicine
§ Strengthening the economy
– Basic research supports the growth of a healthy and robust economy from
creating new industries to improving quality of life
– for every $1 spent on research, $2.17 was generated in additional
economic/health benefits
§ Developing new technologies, products, and industri

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21
Q

What does evidence-based medicine integrate?

A

Clinical experience

Patient values and preferences

Best available research information

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22
Q

What is the value of systematic reviews in medicine?

A
  • Draws together all information relevant to a clinical question
  • Conclusion lays out the facts as we know them following comprehensive and balanced review of the evidence
  • Much more efficient for a practitioner to read a review than to try to find and evaluate every paper relevant to a clinical question
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23
Q

What are the different types of systematic reviews?

A
  • Intervention
  • Diagnostic test accuracy (DTA)
  • Prognostic
  • Methodological
  • Qualitative
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24
Q

What are the steps of a systematic review?

A
  1. define the question / clear objective
  2. plan eligibility criteria
  3. plan methods
  4. publish protocol
  5. search for studies
  6. apply eligibility criteria
  7. collect data
  8. assess studies for risk of bias
  9. analyse and present results
  10. interpret results and draw conclusions
  11. improve and update review
25
Q

How do meta-analyses differ from systematic reviews?

A

Meta-analysis only refers to the statistical analysis of data from multiple studies

Systematic reviews may or may not include meta-analysis

Meta-analyses can be selective with the studies they include whereas systematic reviews can not

26
Q

What is Cochrane?

A

an international not-for-profit organisation which aims to help people make well-informed decisions about healthcare by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of health care interventions

27
Q

What types of bias are explored by a systematic review?

A

Selection bias

Performance bias

Detection bias

Attrition bias

Reporting bias

Publication bias

28
Q

Define

Ethics

A

Moral principles that govern a person’s behaviour or the conducting of an activity

29
Q

Define

Reduction

A

Any strategy that will result in fewer animals being used in research

30
Q

Define

Refinement

A

Modification of experimental procedures to minimise pain

31
Q

Define

Replacement

A

Methods which avoid or replace the use of animals in research

32
Q

Define

Amnion Epithelial Cells (hAEC)

A

a subset of placental-derived stem cells that display plasticity and immunomodulation, and possess advantages over the other populations of stem cell-like cells in the placental tissues

33
Q

Definition

Moral principles that govern a person’s behaviour or the conducting of an activity

A

Ethics

34
Q

Definition

Any strategy that will result in fewer animals being used in research

A

Reduction

35
Q

Definition

Modification of experimental procedures to minimise pain

A

Refinement

36
Q

Definition

Methods which avoid or replace the use of animals in research

A

Replacement

37
Q

Definition

a subset of placental-derived stem cells that display plasticity and immunomodulation, and possess advantages over the other populations of stem cell-like cells in the placental tissues

A

Amnion Epithelial Cells (hAEC)

38
Q

What is the value of biomedical research?

A

Improving health

Training the next generation of scientists

Increasing knowledge

Strengthening the economy

Developing new technologies, products, and industries

39
Q

How can we decrease the amount of time it takes to approve a drug?

A
  • Remove red tape and improve processes
  • Open interactions among researchers, and more effective relations among companies, government, foundations, and universities
  • Increase resources
  • Have researchers/clinicians working in parallel
  • Less focus on mechanisms
40
Q

Why are many scientists unable to replicate their own key scientic findings?

A
  • False positive data
    • Low statistical data
    • Poor experimental design
  • “Trimming and cooking the data”
    • failing to report all the data
  • Publish or perish
    • Impact publications
    • Number of publications
  • Decreased funding
41
Q

What are the 10 strategic imperatives to strengthen health & medical research?

A
  1. A healthy & empowered community
  2. Encourage giving
  3. Research active health services deliver higher quality care
  4. Developing implementation science – turning evidence into action
  5. Collaborating for success
  6. World class research needs world class researchers
  7. Funding research
  8. Encourage commercial investment in R&D
  9. A strategic national approach
  10. Reduce red tape
42
Q

What does questionable research integrity include?

A
  • Plagiarism
  • Falsifying/fabricating data
  • Duplicating results
  • Inappropriate finance management
  • Concealing conflicts of interest
  • Stealing other peoples research
43
Q

What happens to a paper if the research integrity is compromised?

A

It gets retracted

44
Q

Why has there been a progressive increase in publication retraction?

A

Increased pressure to publish

45
Q

By law, and in accord with Code, Animal ethics committe AECs must have at least one member from which categories?

A
  • A veterinarian (Category A)
  • An animal researcher (Category B)
  • A welfare member (Category C, “a person with demonstrable commitment to, and established experience, in furthering the welfare of animals”)
  • An independent lay person (Category D, “an independent person who does not currently and has not previously conducted scientific or teaching activities using animals”).

Each AEC also has the Animal Facility Manager or an animal technician as a member and the Animal Ethics Officer or Animal Welfare Officer in attendance. The C and D members are not employed by the institution.

Monash adheres to the Victorian Prevention of Cruelty to Animals Act and Regulations 1986 (the law), and the NHMRC Australian Code for the Care and Use of Animals for Scientific Purposes (8th edition, 2013).

46
Q

What are the three R’s?

A

Reduction

Refinement

Replacement

47
Q

What things do animal ethics committees need to consider when evaluating research requests?

A
  • the justification for the research
  • its likely impact on the animals
  • procedures for preventing or alleviating pain and distress.
48
Q

What must a researcher in Australia do if they want to use embryonic stem cells?

A

In Australia, a researcher must obtain a licence from the NHMRC Licencing Committee to use excess human IVF embryos for research, including the derivation of new embryonic stem cell lines

49
Q

What are the characterisitics of amnion epithelial cells?

A

Pluripotent properties

Readily available

Immunomodulatory properties

Lack tumorigenicity

Low immunigenicity

Non invasive extraction procedures

50
Q

Why Does It Take So Long From Bench To Bedside?

A
51
Q

Australian Innovation Delivers a Life-changing Return on Investment

A

§ Australia funds more than 700 clinical trials and
invests more than $1 billion annually in research
and development.
§ Of the 795 medicines approved for use in Australia
over the last 10 years, 224 were a breakthrough
using a newly discovered molecule.
§ These 224 breakthroughs:
– were an average of 15 years in the making – requiring
testing of 10,000 new molecules
– were a $1.4 billion investment in research and
development.
– have changed the way 52 diseases are treated.

52
Q

Dubious and/or Conflicting Biomedical Value

A

§ Inappropriate Commercial Exploitation
– vitamins and nutritional supplements
– Funding ie. tobacco or alcohol industry
§ Conflicting findings
– Reproducibility

53
Q

Translation From animal models to humans

A

• Disparate animal species and strains, with a variety of
metabolic pathways and drug metabolites, leading to
variation in efficacy and toxicity;
• Different models for inducing illness or injury, with varying similarity to the human condition;
• Variations in drug dosing schedules and regimens of uncertain relevance to the human condition;
• Small experimental groups with inadequate statistical power; simple statistical analyses
• Nuances in laboratory technique that may influence results, for example, methods for blinding investigators, being neither recognized nor reported;
• Selection of outcome measures, which being surrogates or precursors of disease, are of uncertain relevance to the human clinical condition;

54
Q

Publishing Negative Data

A

§ Since researchers are engaged in competition for positions and funding, many are choosing not to publish their non-significant findings that have:
– less scientific interest
– fewer citations
– can generally only be published in lesser impact journals.
§ The amount of non-significant data reported is progressively declining
§ Negative findings are a valuable component of the scientific literature because
– they force us to critically evaluate and validate our current
thinking, and fundamentally move us towards unabridged
science.

Reducing the positive bias in the scientific literature

55
Q

In 2007 the National Health and Medical Research Council, the Australian Research Council and Universities Australia released the Australian Code for the Responsible Conduct of Research.

What is the Purpose of this code ?

A

The purpose of the Code is to guide both institutions and researchers by describing what is considered to be the underpinning values of “good research practice” and provide institutions with a framework to resolve allegations of research misconduct.

56
Q

Research Integrity- Example of bad research practice

A

§ Plagiarism
§ Falsifying/fabricating data
§ Duplicating results
§ Inappropriate finance management
§ Concealing conflicts of interest
§ Stealing other peoples research

57
Q

Proportion of Animals Used For Studies of Diseases

A
58
Q

Using Stem cells for Biomedical Research – Is it ethical?

A

In Australia, a researcher must obtain a licence from the NHMRC Licencing Committee to use excess human IVF embryos for research, including the derivation of new embryonic stem cell lines

• All research that uses human tissues of any kind must be
conducted under the highest ethical standards. This includes;
• embryonic stem cells
• adult stem cells
• induced pluripotent stem cells
• John B. Gurdon and Shinya Yamanaka (2012 Nobel Prize)
• While some forms of stem cells are more widely accepted
by the community, they all use donated human tissue and
should be subject to the highest level of scrutiny.