Term
what is the most legitimate human subject experimentation |
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Definition
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Term
what is the most dubious human subject experimentation |
|
Definition
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Term
what is the most dangerous human subject experimentation |
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Definition
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Term
describe benefience in regards to human experimentation |
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Definition
do not harm. maximize possible benifits, minimize possible harm |
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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) |
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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 |
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Term
when doing human subject experimentation wat is required |
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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 |
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Term
what is the fundimental principal in regards to human subject experimentation |
|
Definition
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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 |
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Term
what is the definition of intervention |
|
Definition
manipulation of the subject or the subject's enivornment |
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Term
what is the definition of private information and an example |
|
Definition
interpersonal contact between investigator and subject (physical exam) |
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Term
what is the definition of identifiable information (give examples) |
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Definition
identity of the subject can be ascentained by the investigator or information associated with the subject (assigning a number, specific demographic) |
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Term
when are placebo controlls allowed |
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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 |
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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 |
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Definition
appreach with peers, institutional review board, and other expert groups |
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Term
what does it mean when it is said that psychological research is more dubious |
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Definition
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Term
what is the difference between medical and biological research |
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Definition
biological is more dangerous, medical is more ledegitamite and less invasive |
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Term
describe respect in regards to human subjects |
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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) |
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Term
what does it mean when said that human subject research must be valid and valuable |
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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 |
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Term
what are the types of human subject research |
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Definition
intervention, private information, identifiable information |
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Term
describe the Joseph Memgle studies |
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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 |
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Term
describe the Tuskege research |
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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, |
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Term
who put on the tuskege research and when |
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Definition
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Term
why does the year the tuskege research started cause alarm |
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Definition
because a syphilis treatment was found in 1930 and was not offered to the subjects, it was kind of dangerous but worked |
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Term
what was the second point in time during the tuskege research that caused alarm |
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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 |
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Term
who lead the fight against the tuskege research, describe the story how |
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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 |
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Term
describe the harvard case |
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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 |
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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 |
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Definition
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Term
research should be reviewed by" A. experts and the IRB B. no one C. only in limited circumstances |
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Definition
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|
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 |
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Definition
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|
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 |
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|
Term
what is the fancy definition for how one practices evidence based medicine |
|
Definition
combine study results with clinical judgement and patient preferences |
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|
Term
what does evidence based medicine lead to |
|
Definition
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|
Term
explain the example about how catheters in the hospital used evidence based medicine and the result |
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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 |
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|
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 |
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|
Term
where do the protocols in evidence based medicine come from |
|
Definition
socities and expert pannels |
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|
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 |
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|
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 |
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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 |
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|
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 |
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Term
what things ranked higher than quality in the eyes of patients |
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Definition
convience, coverage, access, health plans |
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|
Term
what is the goal of evidence based medicine |
|
Definition
make the best clinical decisions, appropirate, efficient, and effective |
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|
Term
how can we improve the quality of catr |
|
Definition
clinical practive guidelines, care maps, outcome measures (what changes have you made to improve) |
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|
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 |
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|
Term
what are the integrated care pathways |
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Definition
pathways of care, care maps, and collaborative care pathways |
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|
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 |
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|
Term
what are clinical practice guidelines |
|
Definition
systematically developed statments to assist practitioner and patient decisions about appropirate healthcare for specific clinical circumstances |
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|
Term
what can make better quaility guidelines |
|
Definition
greater strength in evidence |
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|
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 |
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|
Term
how do some people thik about clinical pathways |
|
Definition
viewed as algorithms, not really practive guidelines |
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|
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 |
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|
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 |
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|
Term
what are the components of clinical pathways |
|
Definition
timeline, categories of care or activities/interventions, intermediate and long term outcome criteria, variance record |
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|
Term
|
Definition
a critical pathway document not that much different than a clinical pathway, it is a grid you can follow to improve care |
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|
Term
what does the care map measure |
|
Definition
readily obtained outcomes |
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|
Term
what does a care map reflect |
|
Definition
the progress of a pathway |
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|
Term
how is a care map set up, physically |
|
Definition
formulated as a grid with categories of care given specific time segments |
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|
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 |
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|
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 |
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|
Term
what does the assessment of outcome suggest, what is it assessing |
|
Definition
review and updating of the clinical practice guidelines |
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|
Term
|
Definition
the ability of a procedure or test to achieve the desired clinical purpose under controlled circumstances of a controlled group of patients |
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|
Term
|
Definition
the treatment effect must be demonstrated in a larger population verifying its value in the situation of usual clinical practice |
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|
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 |
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|
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 |
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|
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 |
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|
Term
|
Definition
uses statistical methods to combine multiple studies of similar design into a statistical combination of data |
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|
Term
what is consort stand for |
|
Definition
consolidated standards of reporting trials |
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|
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 |
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|
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. |
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|
Term
what did AT Still develope the osteopathic principals on |
|
Definition
anatomical and physological principals |
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|
Term
what is the main reason for the growth of osteopathy |
|
Definition
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|
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 |
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|
Term
what were the main drugs of the early pharmacy |
|
Definition
opium, mercurials, alcohol, cinchona (quinine) |
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|
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 |
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|
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 |
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|
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 |
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|
Term
what are some of the advances in osteopathic research |
|
Definition
low back pain, meta-analysis advances |
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|
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 |
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|
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 |
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|
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 |
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|
Term
what are some of the existing trials in osteopathic research |
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Definition
NIH, osteopathic heratige foundations, osteopathic research center |
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|
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 |
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|
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 |
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|
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. |
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|
Term
what does an experiment tell us about the effect of a treatment |
|
Definition
it can only ESTIMATE the underlying effect of a treatment |
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|
Term
|
Definition
a clear statment of what the investigators expect the study to find, testable |
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|
Term
what used to be the paradigm for statistical inference |
|
Definition
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|
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 |
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|
Term
what is the goal of hypothesis testing |
|
Definition
calculate the probability of getting the observed results if the null hypothesis is true |
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|
Term
|
Definition
in reality the null hypothesis is true but in experiment it suggests that an alternative hypothesis is true |
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|
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 |
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|
Term
what P values are considered statistically significant |
|
Definition
|
|
Term
|
Definition
in reality there is a difference between the two groups but when you do the research it says there isnt |
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|
Term
what happens to error when the sample size is too small |
|
Definition
increased risk of type 2 error |
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|
Term
what happens to the error when the sample size is large |
|
Definition
less risk of type two error |
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|
Term
|
Definition
the probability of not comitting type 2 error |
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|
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 |
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|
Term
what is a confidence interval based on |
|
Definition
observed result and the size of the sample |
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|
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 |
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|
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 |
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|
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 |
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|
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% |
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|
Term
|
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 |
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|
Term
|
Definition
if less than the smallest difference that is clinically significant, it is definitive. if greater then more trials are needed |
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|
Term
|
Definition
risk of the event after treatment as a percentage of the origional task |
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|
Term
what is absolute risk reduction |
|
Definition
difference in the risk of the outcome between the two groups, aka risk difference |
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|
Term
what is relative risk reduction |
|
Definition
estimates the percent of baseline risk that is removed as a result of the therapy |
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|
Term
what are the measures of association |
|
Definition
absolute risk reduction, relative risk reduction, relative risk, odds ratio |
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|
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 |
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|
Term
|
Definition
estimates the odds of an event occuring |
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|
Term
what types of studies are odds ratio used in |
|
Definition
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|
Term
|
Definition
|
|
Term
|
Definition
the ARR, absolute risk reduction |
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|
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 |
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|
Term
what is a case control study |
|
Definition
participants are selected based on an outcome or if they have experienced an event |
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|
Term
what does an odds ratio of 1 mean |
|
Definition
there is no difference between the groups |
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|
Term
what does an odds ratio of > 1.2 mean |
|
Definition
statistically signifianct difference between groups |
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|
Term
|
Definition
you are more likley to disclose or remember information based on your disease |
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|
Term
what measure of association is the best in randomized and cohort studies |
|
Definition
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|
Term
what do RR and RRR not count for |
|
Definition
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|
Term
which measure of association is the best for case control studies |
|
Definition
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|
Term
what does correlation and regression help us understand |
|
Definition
relationship between variables, enables us to make perdictions about a given patient |
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|
Term
|
Definition
the magnitude of the relationship between different variables, neither variable is the target |
|
|
Term
|
Definition
makes a perdiction or casual inference, one variable is the target |
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|
Term
what does a correation of -1 mean, what does it look like |
|
Definition
strong negative correlation, line from upper left to bottom right |
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|
Term
what does a correlation of 1 mean, what does it look like |
|
Definition
strong positive correlation, bottom left to top right |
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|
Term
what does a correlation of 0 mean, what does it look like |
|
Definition
no correlation, scattered |
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|
Term
what can a correlation not distinguish |
|
Definition
|
|
Term
what is a multivariate regression |
|
Definition
considers all of the independet variables in a mathematical model |
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|
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 |
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|
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 |
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|
Term
what are the two primary concerns for a study |
|
Definition
is the study question relivant does the study add anything new |
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|
Term
what three things do you look at to see if a study is relivent |
|
Definition
correlation, association, causation |
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|
Term
what is the relationship between correlation and association |
|
Definition
correlation does not imply association |
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|
Term
|
Definition
|
|
Term
|
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 |
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|
Term
what does a systematic review lack |
|
Definition
does not analyze the statistics |
|
|
Term
|
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 |
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|
Term
|
Definition
group a has a disease, group b does not |
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|
Term
what is a controlled case study |
|
Definition
off labaled drug use on a patient |
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|
Term
what studies have to do with raw data collection |
|
Definition
randomized, cohort, controlled case, case report |
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|
Term
what studies have to do with reviews |
|
Definition
meta analysis, systematic review, practice guidelines |
|
|
Term
what studies are weighted by power |
|
Definition
|
|
Term
what are the components of a descriptive study |
|
Definition
|
|
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
|
|
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 |
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|
Term
what are the experimental studies |
|
Definition
randomized parallel group, randomized crossover |
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|
Term
what are the observational studies |
|
Definition
cohort studies, cross sectional (analytic), case controlled |
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|
Term
what studies have to do with correlation |
|
Definition
descriptive and ovservational (analytic branch) |
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|
Term
what studies have to do with causation |
|
Definition
analytical branch experimental |
|
|
Term
|
Definition
|
|
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
|
|
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 |
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|
Term
what is the first experiment design called |
|
Definition
|
|
Term
what can bias cause in regards to chance |
|
Definition
sampline errors, random error |
|
|
Term
|
Definition
reduces percision, error multiplies every time you make one not adds |
|
|
Term
|
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
|
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
|
|
Term
|
Definition
consistancy in human experimentation over time an repeatability |
|
|
Term
|
Definition
a temporary monoply to the owner in retun for availability to the public |
|
|
Term
|
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 |
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Term
what are examples of conflict of interest |
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Definition
gifts and favors, honorariums |
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Term
how can we limit the conflict that comes with gifts and favors |
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Definition
put an amount alowed to spend |
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Term
what are examples of situations where gifts and favors could cause conflict of interest |
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Definition
pharmacies and non-profit organizations give free products and you use them in favor of others |
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Term
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Definition
adding gifts to a sanctioned event |
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Term
what is an example of an honorarium |
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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 |
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Term
in the event of an infringement lawsuit, how is patient privacy affected |
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Definition
it may be invaded if patentee has access to medical records |
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Term
why do many countries not patent |
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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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