Shared Flashcard Set

Details

OPC Block 2
KYCOM Block 2
184
Medical
Graduate
09/28/2012

Additional Medical Flashcards

 


 

Cards

Term
what is the most legitimate human subject experimentation
Definition
medical
Term
what is the most dubious human subject experimentation
Definition
psychological
Term
what is the most dangerous human subject experimentation
Definition
biological
Term
describe benefience in regards to human experimentation
Definition
do not harm. maximize possible benifits, minimize possible harm
Term
what is justuce in regards to human experimentation (also give examples)
Definition
fairness in treatment (including haves and have nots), equality in distribution (randomization of placebos)
Term
what is an injustice when related to human subject experimentation
Definition
when a benefit entitled is denied without reason when some burden is imposed unduly
Term
when doing human subject experimentation wat is required
Definition
independent review, vaildity and value in research purpose and design, minimize risk, maxamize safety, fully inform each subect or authorized representitive, disclose any conflicts of interest, HIPAA authorization
Term
what is the fundimental principal in regards to human subject experimentation
Definition
independent review
Term
what is the definition of a human subject
Definition
living indivigual whom a research investigator obtains data through intervention or interaction with the individual or from individually identifiable information
Term
what is the definition of intervention
Definition
manipulation of the subject or the subject's enivornment
Term
what is the definition of private information and an example
Definition
interpersonal contact between investigator and subject (physical exam)
Term
what is the definition of identifiable information (give examples)
Definition
identity of the subject can be ascentained by the investigator or information associated with the subject (assigning a number, specific demographic)
Term
when are placebo controlls allowed
Definition
when scientifically or methodological reason, when study adresses a minor condition and the patient's recieving will not be subject to additional risk or irreversible harm
Term
how can you make sure your medical therapy human subject experimentation is in the best interest of the patient and all risks have been considered
Definition
appreach with peers, institutional review board, and other expert groups
Term
what does it mean when it is said that psychological research is more dubious
Definition
more often questioned
Term
what is the difference between medical and biological research
Definition
biological is more dangerous, medical is more ledegitamite and less invasive
Term
describe respect in regards to human subjects
Definition
subject must have the capacity to represent their own interest and free to say stop treatment, make sure not to exploit people, make sure people who are volurnable are protected, make sure subject is willing and there are no hidden contingencies (like prisoners have)
Term
what does it mean when said that human subject research must be valid and valuable
Definition
degree to which the research measures what it says it will, can be repeated with consistancy, able to be generalized for many populations, outcome improves treatment or prepares to improve it
Term
what are the types of human subject research
Definition
intervention, private information, identifiable information
Term
describe the Joseph Memgle studies
Definition
twin studies done by Nazis, injected blue dye to change eye color, forced male and female twins to reproduct, exchanged blood between twins, boiled bodies to preserve hunch back father and son
Term
describe the Tuskege research
Definition
men REPORTEDLY had LATENT syphillis, poor black men told they were being treated but ~200 were not treated at all, given meals and culturally sensitive mathods (funeral money) as incentives, NOT injected with syphillis,
Term
who put on the tuskege research and when
Definition
US public health in 1932
Term
why does the year the tuskege research started cause alarm
Definition
because a syphilis treatment was found in 1930 and was not offered to the subjects, it was kind of dangerous but worked
Term
what was the second point in time during the tuskege research that caused alarm
Definition
in 1943 penicillin was found to be a safer way to treat syphillis but they did not give the subjects the option to take it and gave them incentives not to
Term
who lead the fight against the tuskege research, describe the story how
Definition
Peter Buxton spoke with a subject and was concerned he was not getting penicillin, he wrote the CDC and they had a comittee meeting that said the research was once in a life time and must be continued, his GF wrote about it in the newspaper and another comittee viewed it as fine before penicillin but not ok now, congress made laws against bad research in result
Term
describe the harvard case
Definition
research was whistle blower and showed reliability and validity issues and altered data, it was moved from lower to circut cort and is still in trial
Term
what is a key point in regards to human research:
A. respect, harm, care
B. justice, humanity, truth
C. cecil, herbert, sinfield
D. respect, benifience, justice
Definition
D
Term
research should be reviewed by"
A. experts and the IRB
B. no one
C. only in limited circumstances
Definition
A
Term
what does the picture of soldiers represent:
A. troops exposed to TNT
B. radiation experiments
C. troops watching experiments
D. troops exposed to agent organge
Definition
B
Term
what is the definition of evidence based medicine
Definition
concencious and judicious use of current best evidence in making decisions about patient indivigual care
Term
what is the fancy definition for how one practices evidence based medicine
Definition
combine study results with clinical judgement and patient preferences
Term
what does evidence based medicine lead to
Definition
improved quality of care
Term
explain the example about how catheters in the hospital used evidence based medicine and the result
Definition
we used to put them in everyone this led to infections, they used a bacterial agent to get rid of the infections which led to resistance. studies were done saying this is stupid and we don't do it as often anymore and now bacteria are weaker, people are healthier, overall improved quality of care
Term
what is evidence based medicine considered "cookbook medicine", what is the flaw
Definition
because if you follow the rules how can they sue you? people will still find a way but it is less likley
Term
where do the protocols in evidence based medicine come from
Definition
socities and expert pannels
Term
what are the reasons for development of evidence based medicine
Definition
to cope with information overload, cost control, public is impatient for the best diagnosis and treatment
Term
in the reasons for evidence based medicine, what does it mean by information overload
Definition
physicians are faced with increases in biomedical journals and textbooks and cannot keep up with them due to quantity and time. most dont meet the minimum standards of apprasal anyways, they are inadequate and misleading
Term
in the reasons for evidence based medicine, what does it mean by it being driven by increased health care costs
Definition
costs are increasing and cost control is needed to limit it, we need to make the best use of limited resources
Term
in the reasons for evidence based medicine, what does it mean by public impatience
Definition
the public is more educated and can find stuff more easily, they want the best diagnosis and therapy, dont want to wait, quality isnt important
Term
what things ranked higher than quality in the eyes of patients
Definition
convience, coverage, access, health plans
Term
what is the goal of evidence based medicine
Definition
make the best clinical decisions, appropirate, efficient, and effective
Term
how can we improve the quality of catr
Definition
clinical practive guidelines, care maps, outcome measures (what changes have you made to improve)
Term
what are the steps of evidence based medicine
Definition
1. decide what information is needed
2. make a question that can be answered with research
3. search published literature
4. decide which studies are valid and appropirate
5. apply to patient
6. re-evaluate
Term
what are the integrated care pathways
Definition
pathways of care, care maps, and collaborative care pathways
Term
why do we have clinical pathways, what does it include
Definition
provide guidance for each stage in the management of a patient: treatments, interventions. includes progress and outcome detials
Term
what are clinical practice guidelines
Definition
systematically developed statments to assist practitioner and patient decisions about appropirate healthcare for specific clinical circumstances
Term
what can make better quaility guidelines
Definition
greater strength in evidence
Term
what does it mean when we say clinical practice guidelines provide an agreement with how patients should be treated
Definition
provides them with a greater consistance of care, helps patients make more informed choices, influences public policy by drawing attention to deficiencies
Term
how do some people thik about clinical pathways
Definition
viewed as algorithms, not really practive guidelines
Term
what does it mean when people say they view clinical pathways as algorithms
Definition
offers a flow chart format of the decisions to be made
Term
what does it mean when people say they view clinical pathways are not really practice guidelines
Definition
utilized by a multidiciplinary team, ahve a focus on the quaility and coordination of care
Term
what are the components of clinical pathways
Definition
timeline, categories of care or activities/interventions, intermediate and long term outcome criteria, variance record
Term
what is a clinical map
Definition
a critical pathway document not that much different than a clinical pathway, it is a grid you can follow to improve care
Term
what does the care map measure
Definition
readily obtained outcomes
Term
what does a care map reflect
Definition
the progress of a pathway
Term
how is a care map set up, physically
Definition
formulated as a grid with categories of care given specific time segments
Term
what do care maps rely on, why
Definition
quaility evidence, it needs to evaluate if it is optomizing the process and improving efficiency of care
Term
what is the assessment of outcomes, what does it provide
Definition
a guide to effectiveness of care that provides information for further assessment of the initial appropirateness of care
Term
what does the assessment of outcome suggest, what is it assessing
Definition
review and updating of the clinical practice guidelines
Term
what is efficacy
Definition
the ability of a procedure or test to achieve the desired clinical purpose under controlled circumstances of a controlled group of patients
Term
what is effectiveness
Definition
the treatment effect must be demonstrated in a larger population verifying its value in the situation of usual clinical practice
Term
what questions should be asked in clinical apprasal
Definition
was the assignment of patients to treat randomized
was the follow up complete
how were those who withdrew or dropped out of the study handled
was the study properly blinded
were the study groups similar when the trial began (age, gender, race, procession)
were all groups treated equally apart from medication or the procedure being tested
can the results be applied to my practice
were all the clinically important outcomes considered
is the treatment benifits worth the risk / cost
will the treatment bring harm
Term
what are the types of studies, begin with most broad
Definition
animal, case series, case control, cohort, randomized controlled trial, systematic review, meta-analysis
Term
what is a systematic review
Definition
concise summary of the best available evidence from primary studies using explicit, rigrous, and reproductable methods to find critically review, and synthezise the evidence
Term
what is meta-analysis
Definition
uses statistical methods to combine multiple studies of similar design into a statistical combination of data
Term
what is consort stand for
Definition
consolidated standards of reporting trials
Term
what is the purpose of consort
Definition
to eliminate bias and move away from narrative and selective form of review used by researchers, people were not collaborating
Term
give examples of a studies that resulted in consort being formed, tell the story
Definition
Linus Pauling a nobel prize winnder said vitamin c helps us live longer and have a better life using 2 studies, but many more studies said it didnt. utilization of vitamin c went up dramatically.
vaccinations are linked to autism in children prevented vaccinations.
antibody induction through vaccination and do not give immunity, antibodies are needed to protect against disease, induction through macrophage production.
Term
what did AT Still develope the osteopathic principals on
Definition
anatomical and physological principals
Term
what is the main reason for the growth of osteopathy
Definition
OMT
Term
tell the story about how AT Still first did some osteopathic medicine
Definition
people didnt do a lot of research back then and opium was perscribed a lot because it made people feel good, Still didnt like it and began to do OMT. over time the pharmacy got better drugs and osteopathy didnt take off just yet
Term
what were the main drugs of the early pharmacy
Definition
opium, mercurials, alcohol, cinchona (quinine)
Term
what were the challenges in the development of osteopathic medicine
Definition
growth of the pharmaceutical industry, regulation of safety and efficacy of new drugs leading to randomized controlled studies, traditional epidemiologic research methods for public health began to apply to clinical populations, growth and availbility of computers and support software made health based databases, eventual demonstration of cost effectiveness
Term
what are the challenges in osteopathic research
Definition
DOs were physicians not researchers, research money shifted to pharmacy, development of penicillin, randomized controlled studies, OMT was only studied by DOs
Term
describe the challenges that the research in kirksville had
Definition
there was no research to demonstrate the effectiveness of the osteopathic methods, they did early studies on neuromscular relationships, not sustanied and expanded over time, scarcity of basic mechanistic and traditional research
Term
what are some of the advances in osteopathic research
Definition
low back pain, meta-analysis advances
Term
what are the meta-analysis advances in osteopathic research
Definition
omt affords greater pain reduction than active placebo control treatments, effects of omt are comparable reguardless of wethere treatment is provided by a fully lisenced DO in the IS or uK, effects of omt increase over time
Term
why do some critisize the promotion of OMT
Definition
percieved lack of evidence regaarding efficacy, belief in efficacy in OMT is based on more faith than evidence
Term
what information combats the critics of the promotion of OMT
Definition
same criticims can be said about elegant case controlled studies: non-pharacological interventions, specific surgical procedures, psychotherapeutic inerventions. no one tool fixes everything
Term
what are some of the existing trials in osteopathic research
Definition
NIH, osteopathic heratige foundations, osteopathic research center
Term
what are some of the things the osteopathic research center are working on
Definition
multi-center osteopathic pneumonia study in the elderly, omt in low back pain in military, omt to treat carpal tunnel, multicenter osteopathic otitis media study
Term
what are some of things the agency for health care policy and research are working on, what are the results
Definition
research on spinal manipulation for low back pain including DOs, DCs, and physical therapists, most of the treatments favored OMT vs the control studies
Term
why are statistics necessary
Definition
to understand the potential influence on experimental results and show that the treatment and only the treatment cause the effect or that the frequency of an event is attributable to a given factor.
Term
what does an experiment tell us about the effect of a treatment
Definition
it can only ESTIMATE the underlying effect of a treatment
Term
what is a hypothesis
Definition
a clear statment of what the investigators expect the study to find, testable
Term
what used to be the paradigm for statistical inference
Definition
hypothesis testing
Term
what is the null hypothesis
Definition
there is no difference between outcomes due to the treatments being compared, in most research this is what you start out with, what you set to test
Term
what is the goal of hypothesis testing
Definition
calculate the probability of getting the observed results if the null hypothesis is true
Term
what is a type 1 error
Definition
in reality the null hypothesis is true but in experiment it suggests that an alternative hypothesis is true
Term
what does the P value show
Definition
tells how unlikley it is that the result occured simply by chance if the null hypothesis is true
Term
what P values are considered statistically significant
Definition
<0.05
Term
what is a type two error
Definition
in reality there is a difference between the two groups but when you do the research it says there isnt
Term
what happens to error when the sample size is too small
Definition
increased risk of type 2 error
Term
what happens to the error when the sample size is large
Definition
less risk of type two error
Term
what is power
Definition
the probability of not comitting type 2 error
Term
what are the limitations to hypothesis testing
Definition
limits decision to yes or no, choice of p value significance seems arbitrary, cant inform as to wether or not the sample size is sufficient or if the results are definitive
Term
what is a confidence interval based on
Definition
observed result and the size of the sample
Term
what information does a confidence interval provide, how is it presented
Definition
gives range of possibilities in which the true probability would like within the 95% of the time
Term
what is the relation of confidence intervals to power
Definition
can determine if there is adequate power to make the results definitive, lets you know if there was enough people in the sample to make the study meaningful
Term
what does it mean when a conficence interval is not difinitive
Definition
the range is less than you stated. For example: you said it would be greater than a 5% difference but the CI shows a 2-10% difference
Term
what does it mean when a confidence interval is difinitive
Definition
the results fall within your projected value. for example: you say there 5% or greater difference and the CI shows 5-10%
Term
what is a positive trial
Definition
if the lower boundry of a CI is greater than the smallest difference clinically significant, it is difinitive. if it is less it needs more trials
Term
what is a negative trial
Definition
if less than the smallest difference that is clinically significant, it is definitive. if greater then more trials are needed
Term
what is relative risk
Definition
risk of the event after treatment as a percentage of the origional task
Term
what is absolute risk reduction
Definition
difference in the risk of the outcome between the two groups, aka risk difference
Term
what is relative risk reduction
Definition
estimates the percent of baseline risk that is removed as a result of the therapy
Term
what are the measures of association
Definition
absolute risk reduction, relative risk reduction, relative risk, odds ratio
Term
what measures of association stay the same no matter what group you look at (high risk or low risk patients)
Definition
relative risk reduction and relative risk
Term
what is the odds ratio
Definition
estimates the odds of an event occuring
Term
what types of studies are odds ratio used in
Definition
case control
Term
what is NNT
Definition
number needed to treat
Term
what is NNT derived from
Definition
the ARR, absolute risk reduction
Term
what does a NNT of 6 mean
Definition
for every 6 good procedures you do you prevent a death from the old bad one
Term
what is a case control study
Definition
participants are selected based on an outcome or if they have experienced an event
Term
what does an odds ratio of 1 mean
Definition
there is no difference between the groups
Term
what does an odds ratio of > 1.2 mean
Definition
statistically signifianct difference between groups
Term
what is a recall bias
Definition
you are more likley to disclose or remember information based on your disease
Term
what measure of association is the best in randomized and cohort studies
Definition
ARR
Term
what do RR and RRR not count for
Definition
baseline risk
Term
which measure of association is the best for case control studies
Definition
OR
Term
what does correlation and regression help us understand
Definition
relationship between variables, enables us to make perdictions about a given patient
Term
what is correlation
Definition
the magnitude of the relationship between different variables, neither variable is the target
Term
what is regression
Definition
makes a perdiction or casual inference, one variable is the target
Term
what does a correation of -1 mean, what does it look like
Definition
strong negative correlation, line from upper left to bottom right
Term
what does a correlation of 1 mean, what does it look like
Definition
strong positive correlation, bottom left to top right
Term
what does a correlation of 0 mean, what does it look like
Definition
no correlation, scattered
Term
what can a correlation not distinguish
Definition
between cause and effect
Term
what is a multivariate regression
Definition
considers all of the independet variables in a mathematical model
Term
what conclusions should we take from the lecture (3)
Definition
make friends with statiticians, dont take statistical competence or honesty of authors for granted, shoot for proficiency in hypothesis testing, confiedence intervals, measures of association, and correlation and regression
Term
what questions should you ask in a study design check list
Definition
is the study relivent
does the study add anything new
what type of research question is beiing asked
was the study design appropirate
did the study methods address the most important potential sources of bias
was the study performed according to the origional protocol
does the study test a stated hypothesis
were the statistical analyses performed correctly
do the data justify the conclusions
are there any conflicts of interest
Term
what are the two primary concerns for a study
Definition
is the study question relivant
does the study add anything new
Term
what three things do you look at to see if a study is relivent
Definition
correlation, association, causation
Term
what is the relationship between correlation and association
Definition
correlation does not imply association
Term
what is association
Definition
a logical connection
Term
what is power
Definition
the probability the test will reject the null hypothesis
Term
list the steps in human study heirarchy begining at the bottom
Definition
case report/study, controlled case study, cohort study, randomized study, practice guidelines, systematic review, meta analysis
Term
what does a systematic review lack
Definition
does not analyze the statistics
Term
what is a parallel study
Definition
people are put into two or more groups randomly and given different treatmet
Term
what is a cross over study
Definition
group gets a drug for some time then the next group does
Term
what is a cohort study
Definition
group a has a disease, group b does not
Term
what is a controlled case study
Definition
off labaled drug use on a patient
Term
what studies have to do with raw data collection
Definition
randomized, cohort, controlled case, case report
Term
what studies have to do with reviews
Definition
meta analysis, systematic review, practice guidelines
Term
what studies are weighted by power
Definition
pilot and full
Term
what are the components of a descriptive study
Definition
population and outcome
Term
what is a descriptive study
Definition
identifies characteristics of the group without collecting scientific data, a raw data collection
Term
what are the types of descriptive studies
Definition
survey and qualitative
Term
what is an analytic study
Definition
doing something with the data, gather data and check it, fact controlled
Term
what are the types of analytic studies
Definition
experimental and observational
Term
what are the experimental studies
Definition
randomized parallel group, randomized crossover
Term
what are the observational studies
Definition
cohort studies, cross sectional (analytic), case controlled
Term
what studies have to do with correlation
Definition
descriptive and ovservational (analytic branch)
Term
what studies have to do with causation
Definition
analytical branch experimental
Term
what is a hypothesis
Definition
does x do y
Term
what is a null hypothesis
Definition
what are the chances your wrong, x does not do y
Term
what type of data in regards to a hypothesis is suspicious
Definition
data irrelivent to the hypothesis
Term
name the 14 steps of experimental design
Definition
1. select a problem
2. determine the dependent variables
3. determine the independent variable
4. determine the number of levels of independent variables
5. determine the possible combinations
6. determine the number of observations
7. redesign if necessary
8. randomize participants
9. meet ethical and legal requirements
10. mathematical model
11. data collection
12. data reduction
13. data verification (outliers)
14. data interpertation
Term
what is a dependent variable
Definition
what you will measure
Term
what is the independent variable
Definition
not manipulated in the experiment
Term
what are examples of independent variables
Definition
age, sex, vision, education, work experience
Term
what is the first experiment design called
Definition
pilot study
Term
what can bias cause in regards to chance
Definition
sampline errors, random error
Term
what is random error
Definition
reduces percision, error multiplies every time you make one not adds
Term
what is sampling error
Definition
can bias results one way or another
Term
what are the systematic errors caused by bias
Definition
choice of participants, which data to collect, conformity of bias (twisting data), technological
Term
what are examples of sampling bias
Definition
socioecnomic bias, genetic bias, age bias, nutritional bias, sex bias, disease bias
Term
what is data collection bias
Definition
only collecting supporting data, equipment not capable of collecting differences
Term
what is survey bias
Definition
interviewer bias (non verbal cues), subject bias (norality, please interviewer)
Term
what is the relationship between effect and sample size
Definition
the bigger the effect, the less you have to sample
Term
what is the correlation between sample size and power
Definition
sample size = power
Term
wat is reliability
Definition
consistancy in human experimentation over time an repeatability
Term
what is a patent
Definition
a temporary monoply to the owner in retun for availability to the public
Term
what is ownership
Definition
indiviguals who contribute to invention or medical treatment unless otherwise assigned
Term
why is unless otherwise assigned a part of ownership
Definition
because sometimes people sign away ownership like to an organization, it then becomes their property
Term
what is ownership truly about, what does it give to the owner
Definition
who has control of things like sale, marketing, and delivery of the invention
Term
what is the difference between acknowledgement and ownership
Definition
you may be required to acknowledge someone's efforts towards an idea but if they dont have control over it they dont own any of it. someone who is just acknowledged will not be on the patent
Term
if there are two owners, can each do what they want? explain why one wouldnt be able to
Definition
they can both do what they want with the idea. the only way they cant is if one sined a paper giving the other control despite their ownership on the patent
Term
what are examples of conflict of interest
Definition
gifts and favors, honorariums
Term
how can we limit the conflict that comes with gifts and favors
Definition
put an amount alowed to spend
Term
what are examples of situations where gifts and favors could cause conflict of interest
Definition
pharmacies and non-profit organizations give free products and you use them in favor of others
Term
what is an honorarium
Definition
adding gifts to a sanctioned event
Term
what is an example of an honorarium
Definition
getting asked to be on a comittee and getting a free vacation out of the time you have to be at it, telling experiences about using a new drug with patients and the line between that and being a rep for the new drug
Term
in the event of an infringement lawsuit, how is patient privacy affected
Definition
it may be invaded if patentee has access to medical records
Term
why do many countries not patent
Definition
medical law extended from the oath that physicians take, the goal is preservation of life not to award inventions and no manufacturing or commerical value is attached
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