Dustin Borg, ME Patrick Henley, BME Ali Husain, BME Nick Stroeher, BME Advisor: Dr. Paul King
BME 301 Lecture Twenty-Four. TV’s hit quiz show comes to BME301. Final Exam Edition.
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Transcript of BME 301 Lecture Twenty-Four. TV’s hit quiz show comes to BME301. Final Exam Edition.
Rules Contestants answer multiple choice questions:
Increasing level of difficulty Increasing number of bonus points toward final
exam AUTOMATIC 100% ON FINAL!!!
Three lifelines: 50/50 – take away two incorrect answers Ask the audience – class votes Phone a friend – ask a friend in class
If contestant answers question incorrectly: Play stops Contestant loses all points
Contestant can stop at any time, even after seeing question
Rules Bonus point values:
1 bonus point 2 bonus points 3 bonus points 4 bonus points 5 bonus points 6 bonus points 10 bonus points 15 bonus points 20 bonus points 100 bonus points
Qualifying Round
Contestants selected in qualifying round Rank order
answers to question + YOUR NAME
Contestant with first correct answer pulled out of the hat gets to play
Qualifying Question #1 Rank the four countries in order of life
expectancy, giving the country with the longest life expectancy first: USA Botswana Canada Germany Russia
Qualifying Answer #1
Rank the four countries in order of life expectancy, giving the country with the longest life expectancy first: Canada Germany USA Russia Botswana
Question 1: 1 Bonus Point
What is the leading cause of mortality of people aged 15-44 in developing countries? Road Accidents Heart Disease HIV/AIDS Cancer
50/50Next qualifying round
Leading Causes of Mortality Ages 15-44
Developing World1. HIV/AIDS2. Road accidents3. Inter-personal violence
Developed World1. Road accidents2. Self-inflicted injuries3. Inter-personal violence
Question 2: 2 Bonus Points
Which of the following is not a major cause of the increase in cost of health care in the U.S.? Physician income Aging population New technology development Prescription drugs
50/50Next qualifying round
What Drives Increased Costs?
Administrative Costs US spends 25-30% of health care budget on administrative
overhead 27% of US health care workers do “mostly paperwork”
Technology New technology can increase/reduce health care costs From 2001-2002, new technology was responsible for 22% of increase Increased utilization of technology increases costs
Aging Population “Baby boomers” will strain health care system
Felt most in 2011-2030 Greatest single demand country has ever faced for long term
care Elderly account for much of health care spending
Prescription Drugs Fastest growing category of health spending Some reasons:
Direct marketing of drugs to the general population (increased costs, increased usage)
Drug company profits
Question 3: 3 Bonus Points
Which of the following is not one of the routinely screened types of cancer? Cervical cancer Colon and rectal cancer Prostate cancer Lung cancer
50/50Next qualifying round
Cancer Screening
We routinely screen for 4 cancers: Female breast cancer
Mammography Cervical cancer
Pap smear Prostate cancer
Serum PSA Digital rectal examination
Colon and rectal cancer Fecal occult blood Flexible sigmoidoscopy, Colonoscopy
Question 4: 4 Bonus Points
Which of the following is defined as, “Probability that given disease, the patient tests positive”? Specificity Efficacy Sensitivity Positive Predictive Value
50/50Next qualifying round
Sensitivity & Specificity
Sensitivity Probability that given DISEASE, patient
tests POSITIVE Ability to correctly detect disease 100% - False Negative Rate
Specificity Probability that given NO DISEASE,
patient tests NEGATIVE Ability to avoid calling normal things
disease 100% - False Positive Rate
Question 5: 5 Bonus Points Which of the following statements
about the advantages of using optical technologies, in developing countries, for cervical cancer detection is NOT true? It doesn’t require highly trained
clinicians It is portable for use in remote
populations Doesn’t require a large infrastructure Doesn’t have to follow the guidelines of
the Belmont report50/50Next qualifying round
Why Use Optical Technologies for Cervical
Cancer Detection? Developed World:
Combine screening, diagnosis & treatment
Reduce Cost Reduce Loss to Follow Up
Developing World: Enable screening in resource-poor
settings Don’t require large infrastructure Portable for remote population centers Don’t require highly trained clinicians
Save lives of women
Belmont Report: 1979
From Dept. of Health, Education & Welfare
Statement of: Basic ethical principles and guidelines to
resolve ethical problems associated with conduct of research with human subjects
Three basic ethical principles: Respect for persons Beneficence Justice
Question 6: 6 Bonus Points
The amount of blood pumped by the ventricle with each heart beat is defined as: Stroke Volume Ejection Fraction Cardiac Output Lub from Lub-Dub
50/50Next qualifying round
Quantifying Heart Performance
Heart Rate (HR) Number of heart beats per minute Normal value is 60-90 bpm at rest
Stroke Volume (SV) Amount of blood pumped by ventricle with each heart
beat Normal value is 60-80 ml
Cardiac output (CO) Total volume of blood pumped by ventricle per minute CO = HR x SV Normal value is 4-8 L/min
Blood volume Total volume of blood in circulatory system Normal value is ~5 L Total volume of blood is pumped through our heart each
minute!!
Question 7: 10 Bonus Points
Which of the following is not true about vaccines? Vaccines can artificially induce immunity Vaccines are a very cost effective health
intervention Vaccines are experimentally being used
to treat some types of cancer Vaccines all involve receiving an
infectious, but less virulent form, of the disease
50/50Next qualifying round
Types of Vaccines Non-infectious vaccines
No danger of infection Does not stimulate cell mediated immunity Usually need booster vaccines
Live, attenuated bacterial or viral vaccines Makes memory B cells, memory helper T cells, AND memory
killer T cells Usually provides life-long immunity Can produce disease in immuno-compromised host
Carrier Vaccines Makes memory B cells, memory helper T cells, AND memory
killer T cells Does not pose danger of real infection Immuno-compromised individuals can get infection from
carrier DNA Vaccines
DNA injections can produce memory B cells and memory T killer cells
Make a DNA vaccine from a few viral genes No danger that it would cause infection
Question 8: 15 Bonus Point
In 1994, what percentage of the world’s children received basic vaccines? 100 80 50 20
50/50Next qualifying round
Effects of Vaccination Smallpox
First human disease eradicated from the face of the earth by a global immunization campaign
1974 Only 5% of the world’s children received
6 vaccines recommended by WHO 1994
>80% of the world’s children receive basic vaccines
Each year: 3 million lives saved
Question 9: 20 Bonus Points
A diagnostic test is 92% sensitive and 94% specific. A test group is comprised of 500 people known to have the disease and 500 people known to be free of the disease. How many of the known positives would actually test positive? 450 people 460 people 470 people 480 people
50/50Next qualifying round
Sensitivity
Probability that given DISEASE, patient tests POSITIVEAbility to correctly detect disease100% - False Negative Rate
SpecificityProbability that given NO DISEASE, patient tests NEGATIVEAbility to avoid calling normal things disease100% - False Positive Rate
500 x 0.92 = 460
Question 10: 100 Bonus Points
You are designing a clinical trial of a new stent. You expect a restenosis rate in the group treated with the new drug eluting stent of 10%, while the expected restenosis rate in the group treated with the current stent is 45%. You calculate a standardized difference of 0.75. If you can tolerate a 10% risk of type II error and a 5% risk of type I error, how many patients are needed in the trial?
55 65 75 95
50/50Next qualifying round
Qualifying Question #2 Rank the following treatments in order of
$$ spent/QALY gained, giving the treatment with the lowest $$/QALY first: PAP smear screening Childhood immunization Screening and treatment for HIV in low risk
populations Chemotherapy for 75 year old woman with
breast cancer Driver’s side air bag
Qualifying Answer #2
Rank the following treatments in order of $$ spent/QALY gained, giving the treatment with the lowest $$/QALY first: Childhood immunization PAP smear screening Driver’s side air bag Chemotherapy for 75 year old woman
with breast cancer Screening and treatment for HIV in low
risk populations
League Table
Therapy Cost per QALY
Motorcycle helmets, Seat belts, Immunizations Cost-saving
Anti-depressants for people with major depression
$1,000
Hypertension treatment in older men and women
$1,000-$3,000
Pap smear screening every 4 years (vs none) $16,000
Driver’s side air bag (vs none) $27,000
Chemo in 75 yo women with breast CA (vs none)
$58,000
Dialysis in seriously ill patients hospitalized with renal failure (vs none)
$140,000
Screening and treatment for HIV in low risk populations
$1,500,000
Question 1: 1 Bonus Point
What fraction of people in the United States have private health insurance? 16% 56% 74% 86%
Next qualifying round50/50
Centers for Medicare & Medicaid Services
Table 1.4Sources of Health Insurance Coverage for the
Under 65 Population, 1980-2000
Notes: ESI - Employer Sponsored Insurance. Any Private includes ESI and individually purchased insurance. Any government includes Medicare for the disabled population.
Source: Tabulations of the March Current Population Survey files by Actuarial Research Corporation, incorporating their historical adjustments.
Over the last two decades, private coverage has declined, public coverage has stayed about the same, and the uninsured have grown.
74%
83%
8%
15%
10%
0
10
20
30
40
50
60
70
80
90
1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
ESI
Any Private
Medicaid
Any Government Uninsured
74%
69%
16%
14%
9%
Question 2: 2 Bonus Points Which of the following is NOT one of the
five principles of the Canadian health care system: Comprehensiveness Universality Portability Accessibility Two Tiered System
Next qualifying round 50/50
Canadian Health Care System
Five Principles Comprehensiveness, Universality, Portability,
Accessibility, Public administration Features
All 10 provinces have different systems (local control)
One insurer - the Provincial government costs shared by federal & provincial govts
Patients can choose their own doctors Doctors work on a fee for service basis, fees are
capped
Question 3: 3 Bonus Points Which of the following is NOT a
characteristic of bacteria: Cells with membrane and cell wall (usually) Can survive outside host Use host intracellular machinery to reproduce Can be killed or inhibited by antibiotics
Next qualifying round 50/50
Types of Pathogens Bacteria
Cells with membrane and cell wall (usually) Can survive outside host Can reproduce without a host Can be killed or inhibited by antibiotics
Viruses Nucleic acid core with protein envelope Use host intracellular machinery to
reproduce Cannot be killed with antibiotics >50 different viruses that can infect humans
Question 4: 4 Bonus Points In 1992, there was a large increase in the
incidence of prostate cancer reported in the United States. The cause of this increase is believed to be due to: The aging population An increase in exposure to carcinogens
associated with smoking The introduction of mass spectrometry to
screen for cancer-related serum proteins The introduction of a serum PSA screening test
Next qualifying round 50/50
Cancer Incidence Rates* for Men, US, 1975-2000
*Age-adjusted to the 2000 US standard population.Source: Surveillance, Epidemiology, and End Results Program, 1975-2000, Division of Cancer Control and Population Sciences, National Cancer Institute, 2003.
0
50
100
150
200
25019
75
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
Prostate
Lung
Colon and rectum
Urinary bladder
Non-Hodgkin lymphoma
Rate Per 100,000
Question 5: 5 Bonus Points When did Margaret Heckler, Secretary of
HEW, predict we would have an HIV/AIDS vaccine? 1982 1984 1986 1988
Next qualifying round 50/50
History of HIV/AIDS Vaccines 1984:
Robert Gallo discovers virus that causes HIV Margaret Heckler, Secretary of HEW, predicts
we will have vaccine within 2 years 1997:
President Clinton declares, “an HIV vaccine will be developed in a decade’s time.”
2003: President Bush asks congress to appropriate
$15B to combat the spread of HIV in Africa and the Caribbean
Today: Where is the vaccine?
Question 6: 6 Bonus Points If they find an invader, they become
“activated”. Once activated they: send signals to recruit others, they become vicious killers, and they present the antigen to adaptive immune system. What, specifically, are they? Memory B Cells Neutrophils Macrophages Antibodies
50/50Next qualifying round
Components of Innate Immune System
1) Macrophages: Sentinels that patrol periphery If they find an invader, they become
“activated” If activated, they:
Send signals to recruit other immune system cells (Neutrophils)
Become vicious killers Present antigen to adaptive immune system
Question 7: 10 Bonus Points
A diagnostic test is 92% sensitive and 94% specific. A test group is comprised of 500 people known to have the disease and 500 people known to be free of the disease. How many of the known negatives would actually test negative? 450 people 460 people 470 people 480 people
Next qualifying round 50/50
Sensitivity
Probability that given DISEASE, patient tests POSITIVEAbility to correctly detect disease100% - False Negative Rate
SpecificityProbability that given NO DISEASE, patient tests NEGATIVEAbility to avoid calling normal things disease100% - False Positive Rate
500 x 0.94 = 470
Question 8: 15 Bonus Points You design a clinical trial of
a new stent. You expect a restensosis rate in the group treated with the drug eluting stent of 10%, while the expected restenosis rate in the group treated with the current stent is 45%. You calculate a standardized difference of 0.75. If you can tolerate a 20% risk of type II error and a 5% risk of type I error, how many patients are needed in the trial?
55 65 75 95
50/50Next qualifying round
Question 9 : 20 Bonus Points
A diagnostic test is 97% sensitive and 84% specific. The test group is comprised of 500 people known to have the disease and 500 people known to be free of the disease. How many patients would receive a false positive test result? 3 15 27 80
50/50Next qualifying round
Question 9: 20 Bonus PointsSensitivity = TP / # of people with diseaseSpecificity = TN / # of people without disease
97% or 0.97 = TP / 500 peopleTP = 0.97 * 500 people = 485 people
84% or 0.84 = TN / 500 peopleTN = 0.84 * 500 people = 420 people
420 of 500 negative people would test negative.
80 of 500 negative people would test FP.
Question 10: 100 Bonus Points
A test with 99.9% sensitivity and 99% specificity is used to screen a population of 100,000 people for a disease with .1% prevalence. What would be the positive predictive value of this test? 99% 50% 9% .01% 50/50Next qualifying round
Question 10 : 100 Bonus Points
# of people w/disease = (# people)(prevalence) = (100,000)(.001) = 100# of people w/o disease = 100,000 – 100 =
99,900
Sensitivity = 0.999 = TP / 100 peopleTP = 99.9 people
Specificity = 0.99 = TN / 99,900 peopleTN = 98,901 people
FP = Number of people w/o disease – TN FP = 99,900 people – 98,901 people = 999
people
PPV = TP / (TP + FP) PPV = 99.9 people / (99.9 people + 999 people)
= .0909 or about 9%
Qualifying Question #3 List the steps in the engineering design
method in the proper order: Evaluate solutions Communicate results Develop solutions Identify a need Define the problem (goals, constraints) Gather information
Qualifying Answer #3
List the steps in the engineering design method in the proper order: 1. Identify a need 2. Define the problem (goals,
constraints) 3. Gather information 4. Develop solutions 5. Evaluate solutions 6. Communicate results
Engineering Design Method Fashioning a product made for a
practical goal in the presence of constraints
Six design steps: 1. Identify a need 2. Define the problem (goals, constraints) 3. Gather information 4. Develop solutions 5. Evaluate solutions 6. Communicate results
Papers, patents, marketing
Refine Design
SPECS
FMEA
Question 1: 1 Bonus Point
What are the components of blood? Plasma, red blood cells, platelets Plasma, red & white blood cells,
platelets Plasma, pluripotent cells Erythrocytes
50/50Next qualifying round
Blood Plasma Cells
Red blood cells White blood cells Platelets
Cells made in bone marrow from pluripotent hematopoeitic stem cells
Question 2: 2 Bonus Points What is the primary cause of the swelling
when you get a splinter? 1. Recruitment of phagocytes 2. Increase in permeability of local blood vessels 3. Rapid cloning of memory cells 4. Increase in temperature of the localized
tissue
50/50Next qualifying round
What happens when you get a splinter?
Macrophages eat bacteria on splinter Phagocytosis Produce chemicals which:
Increase local blood flow Redness Heat
Increase permeability of blood vessels Swelling
Recruit other phagocytes to site of infection Pus
Question 3: 3 Bonus Points
50/50Next qualifying round
In Love in the Driest Season, Neely Tucker adopts a baby from Zimbabwe. What is her name? Vita Chipo Emily Mugabe
Question 4: 4 Bonus Points
Which of the following is NOT true about B cells? Make antibodies Have no nucleus Have a wide variety of receptors on cell
surfaces Can rapidly clone to increase numbers
50/50Next qualifying round
Antibodies How are antibodies made?
B cells Lymphocytes that make antibodies Have B cell receptors on surface 100 million different types of B cells, each
with different surface receptors B cell receptors are so diverse they can
recognize every organic molecule When a B cell binds antigen:
Proliferates - In one week, clone of 20,000 identical B cells
Secretes antibody
Question 5: 5 Bonus Points Which of the following is NOT a
reason for new technologies being abandoned? Poor technical performance High cost Ethics, legal and social issues Inventor perceived as weird, maverick
50/50Next qualifying round
Question 6: 6 Bonus Points
Which of the following is NOT true about laparoscopic cholecystectomy? Rapid diffusion rate Increased overall rate of
cholecystectomy Reduced hospital stay of patients Causes a side effect of the surgery
called “pump head”
50/50Next qualifying round
Diffusion of Lap Choly Diffusion of laparoscopic cholecystectomy
in health care is unprecedented Since its introduction in 1989:
the laparoscopic procedure has rapidly become the most widely used treatment for gallstone disease
By 1992: laparoscopic cholecystectomy accounted for
50% of all cholecystectomies in Medicare populations
75% to 80% of all cholecystectomies in younger populations
Increased overall rate of cholecystectomy: Increase observed in fee-for-service, Medicare,
and for-profit HMO systems. Ranged from 28% to 59%
Question 7: 10 Bonus Points
Which of the following is NOT true of pancreatic cancer? Fourth leading cause of cancer deaths in
men and women One year survival is less than 20% The incidence and mortality are very
similar The incidence and mortality are very
different
50/50Next qualifying round
Pancreatic Cancer
Incidence: 31,860 people in the US will be found to
have pancreatic cancer in 2004 Mortality:
31,270 will die of the disease in 2004 Fourth leading cause of cancer death in
men and women Survival:
One year survival: 15-20% Five year survival: few percent
Question 8: 15 Bonus Points Which of the following sequences is a
correct order for the progression of heart disease? Arteriosclerosis, ischemia, stroke, high
blood pressure Heart failure, heart attack, stroke,
ischemia High blood pressure & high cholesterol,
atherosclerosis, heart attack, heart failure Heart failure, stroke, high cholesterol,
high blood pressure50/50Next qualifying round
Progression of Heart Disease
High Blood PressureHigh Cholesterol Levels
Atherosclerosis
Ischemia
Heart Attack
Heart Failure
Question 9: 20 Bonus Points
Amniocentesis can detect fetal chromosomal abnormalities. The sensitivity of amnio is 89% and its specificity is 99.3%. The prevalence of chromosomal abnormalities is 0.28% in children born to 20 yo mothers. If a 20 yo woman has a positive amnio, what is the likelihood that the fetus has a chromosomal abnormality? 2% 26% 38% 50%
50/50Next qualifying round
Possible Test Results
Test Positive
Test Negative
Disease Present
2.5 .3 # with Disease = 2.8
Disease Absent
6.98 990.2 #without Disease =
997.2
# Test Pos = 9.48
# Test Neg = 990.5
Total Tested = 1,000
Se = 2.5/2.8 = 89.3% Sp 990.2/997.2= 99.3%
PPV = 2.5/9.48 = 26.3% NPV =990.2/990.5 = 99.97%
Question 10: 10 Bonus Points
In heart failure, the ejection fraction typically drops from a normal value of 60% to approximately 15%. If the heart rate remains constant at 80 bpm, by what fraction does the end diastolic volume need to increase in order to maintain a cardiac output of 5 L/min? 10% 60% 200% 350% 400% 50/50Next qualifying round
CO = HR x SV EF = SV/EDV CO = HR x (EF)(EDV) Normal:
5L = 80 bpm x (0.6)(EDV) EDV = 0.1L
Heart Failure: 5L = 80 bpm x (0.15)(EDV) EDV = 0.4L 400% increase
Qualifying Round Four
Put the following vaccines in order of when they were first developed, starting from the earliest to the latest. Influenza vaccine Pneumonia vaccine Rabies vaccine Smallpox vaccine Rotavirus vaccine
Qualifying Round Four: Answer
Put the following vaccines in order of when they were first developed, starting from the earliest to the latest. Smallpox vaccine - 1796 Rabies vaccine - 1882 Influenza vaccine - 1945 Pneumonia vaccine - 1977 Rotavirus vaccine - 1998
Question 1: 1 Bonus Point
Of the following which is not a standard method used in the testing of vaccines? Lab/Animal testing Post-licensure surveillance Phase I-III human testing Hope and pray
50/50
Vaccines How do vaccines work?
Stimulate immunity without causing disease How are vaccines made?
Non-infectious vaccines Live, attenuated bacterial or viral vaccines Carrier Vaccines DNA Vaccines
How are vaccines tested? Lab/Animal testing Phase I-III human testing Post-licensure surveillance
Question 2: 2 Bonus Points
Which of the following is not one of the three basic ethical principles laid out in the Belmont report? Get them before they get you Beneficence Justice Respect for Persons
50/50
Belmont Report: 1979
From Dept. of Health, Education & Welfare
Statement of: Basic ethical principles and guidelines to
resolve ethical problems associated with conduct of research with human subjects
Three basic ethical principles: Respect for persons Beneficence Justice
Question 3: 3 Bonus Points
It was in this year that Robert Gallo discovered the virus that causes HIV/AIDS. 1979 1984 1990 2001
50/50
History of HIV/AIDS Vaccines 1984:
Robert Gallo discovers virus that causes HIV Margaret Heckler, Secretary of HEW, predicts
we will have vaccine within 2 years 1997:
President Clinton declares, “an HIV vaccine will be developed in a decade’s time.”
2003: President Bush asks congress to appropriate
$15B to combat the spread of HIV in Africa and the Caribbean
Today: Where is the vaccine?
Question 4: 4 Bonus Points
In Uganda the average life span has decreased by approximately how many years since the emergence of HIV? 5 10 20 30
50/50
Health Data: Uganda Stable political situation African country most willing to openly confront HIV Adult HIV infection rate:
Ten years ago: 20% Today: 6% Each of the past 10 yrs: Fewer infections than yr before
Life Expectancy: Before HIV: 64 years Today: 42 years
Annual Income: $300 per person
Annual Health Expenditures: $6 per person
Vaccination rate 1995: 47% 2002: 37%
Question 5: 5 Bonus Points About what percentage of cancers
are caused by infectious agents in developing countries worldwide? 12% 25% 40% 65%
50/50
Worldwide Burden of Cancer
23% of cancers in developing countries caused by infectious agents Hepatitis (liver) HPV (cervix) H. pylori (stomach)
Vaccination could be key to preventing these cancers
Question 6: 6 Bonus Points
The mission of the World Health Organization is: “Attainment by all peoples of the
highest possible level of health” Provide epidemiologic information to
countries Develop international standards for
vaccines Identify and track outbreaks of new
disease50/50
World Health Organization
Established by charter of the UN after World War II
Headquartered in Geneva Mission:
“Attainment by all peoples of the highest possible level of health”
Website: http://www.who.int/en/
Functions of the WHO Services to governments:
Epidemiologic intelligence International standardization of vaccines Reports of expert committees Data on world health problems
Member countries must provide certain info in regular reports Disease outbreaks Health of population Steps to improve health
Question 7: 10 Bonus Points
In 1937 this was added to Sulfanilimide to make it easier for children to take. It was tested for appearance, taste, and fragrance but not toxicity. Within weeks many children had died. What was it? Turpentine Ethylene glycol Ethanol Ether 50/50
History of Supplements 1937:
Sulfanilimide, antibiotic for streptococcal infections, used safely as a pill for years
Most children can’t swallow pills One company in Tennessee found they
could dissolve drug in ethylene glycol (antifreeze)
Tested for flavor, appearance, fragrance, NOT for toxicity
Shipped it all over the country Within weeks, scores of children were
dead
Question 8: 15 Bonus Point Medical device classes were established
by the device amendments to the FD&C Act. Which class of medical device does this describe:
Not life sustaining, but must meet performance standards Examples include blood pressure monitors, guide wires Includes 60% of devices
Class I Class II Class III Class IV
50/50
1976: Device amendments to FD&C Act
Three classes of devices: Class I:
Pose least risk to patient Not life sustaining GMP, proper record keeping required 30% of devices X-ray film, tongue depressors, stethoscopes
Class II: Not life sustaining, but must meet performance
standards Blood pressure monitors, Catheter guide wires 60% of devices
Class III: Pose greatest risk to patient For use in supporting or sustaining human life 10% of devices Stents, heart valves, LVADs Require GMP, failure modes analysis, animal tests,
human clinical studies under IDE
Question 9: 20 Bonus Points
A clinical trial of a new automated mammography system was carried out in 50,000 women known to have breast cancer. If 37,500 women received a positive test result, what would the specificity of the new test be? 50% 75% 85% Cannot determine from this trial
50/50
Sensitivity = TP/# of people with disease
Specificity = TN/# of people without disease
Since we do not know what happens when this test is used on women without disease we cannot evaluate its specificty.
Question 10: 100 Bonus Points
How many licks does it take to get to the center of a tootsie-pop? 1 2 3 The world may never know
50/50
Question 10: 100 Bonus Points
Vitamin C was initially used to prevent scurvy in 1601. How many years later did the British Navy adopt this intervention? 1 year later 25 years later 265 years later 500 years later
50/50
Diffusion is historically slow…. 1497: Vasco Da Gama lost 100 out of 160 crew
members to scurvy sailing around Cape of Good Hope
1601: British Navy Captain James Lancaster was in command of 4 ships traveling from England to India Required sailors to take 3 tsp of lemon juice daily on 1
ship The other 3 ships served as the control Results:
110/278 sailors died in control group 0 deaths in the experimental group
1747: British Navy Physician James Lind repeated study with similar results
1865: British Navy finally adopted innovation, 264 years after first recorded evidence
Berwick, Donald M., Disseminating Innovations in Health Care. JAMA April 16, 2003 – Vol 289, No. 15