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60 Cards in this Set
- Front
- Back
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Theory |
looking at, viewing
a model that provides a way to look at the world may cover many aspects
a method for trying to explain a phenomenon tentative insight into natural world well-substantiated explanation of some aspect of the natural world
used in lay terms to mean having a hunch or speculation about how something works |
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theory & proof |
theories can be disproved or not disproved never proven
theory may evolve into law given sufficient evidence, i.e. gravity
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Germ theory |
initially met with high opposition
there now exists an abundance of data that doesn't disprove it
would take much more to evolve into a law will never be proven
helped to disprove blood letting |
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theory & belief |
theory can guide belief
e.g. studying improves test scores |
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process of theory |
much like the scientific method
Reflection upon experience & logical speculation lead to
Theory
Theory generates research
Research drives -Changes in practice -Revised theory
Revised theory may -change practice -cause more research
Changes in practice in turn drive Reflection & logical speculation |
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5 characteristics of theory |
Economical Can draw something out with a model
Thorough Can generalize & explain all cases
Rational Makes sense
Important What's the point of theorizing about meaningless things
Fluid Allowed to evolve |
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purposes of theory |
organize collections of facts & observations -summarize & explain existing knowledge
imbue those collections with meaning
allows making predictions
stimulate development of new knowledge
abstractness exists as a construct rather than as material |
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3 ways to classify theory |
restrictiveness
tentativeness
testability |
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restrictiveness |
Least seeks to characterize phenomena Descriptive ad hoc, as greater refinement is sought categorical, seeking to identify the characteristics of a phenomena
Moderate seeks to specify relationships between constructs Predictive Construct: abstract phenomenon Concept: concrete phenomenon allows hypothesis, is testable
Most seeks to specify relationships and form a deductive system Explicative - demonstrates causality A series of propositions regarding interrelationships among concepts from which a large number of empirical observations can be deduced
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proposition |
statement about a concept or the relationship between concepts |
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hypothesis |
conjectural statement of the relationship between variables |
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deductive system |
formed of if-then statements
explanatory theory tested by testing relationships between concepts and by testing the deductive system |
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deductive v inductive |
deductive top-down approach that moves from a broad spectrum of information to a specific conclusion
inductive bottom-up approach that moves from specific observations to broader generalizations & theories |
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tentativeness |
theory is not absolute
modifiable as knowledge is gained |
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testability |
in order to be theory, it must be constructed in such a way as to allow testing
Popper's concept of falsifiability |
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3 scopes of theory |
meta theorizing about theory
grand broad conceptualization of phenomena
general/middle-range general frameworks for action
practice application of grand / general theory
may be able to measure scope by how much stuff is contained within a theory |
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examples of theory scope |
clinical research is general or practice
qualitative is meta or grand |
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developing practice from theory |
develop an answerable question
Find a topic and problem
select a theoretical framework
formulate the question |
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Evidence-based medicine |
EBM integrates research evidence with clinical expertise & pt values
pt values often forgotten
done for the purpose of optimizing pt outcomes and QOL |
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Evidence-based practice v EBM |
practice v research
similar to EBM, but is about applying evidence to patient situations |
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defining good evidence |
RCT's thought of as the gold standard not always possible or practical
quantitative
qualitative |
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5 steps of EBP |
Formulate an answerable question (PICO)
Find the best evidence
Appraise the evidence critically for validity, applicability, clinical relevance
Individualize it, based on clinical expertise & pt needs
Evaluate your own performance |
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PICO (or PIO) |
P: population / problem In young adult males (population) with ESRD (problem)...
I: intervention / indicator / index (diagnostic test) ... does Game Ready (intervention) reduce swelling associated with a sprained ankle (indicator)...
C: comparator, this is optional could be additional levels of an independent variable, a control group, an exposure, etc. ... more than cold therapy alone (compared to)
O: outcome treatment goal, pt concern the reduction of swelling associated with a sprained ankle |
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PICO v PIO |
PICO tends to be more research while PIO tends to be more prognostic |
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Uses of PICO |
therapeutic In P, what is the effect of I on O compared with C?
etiological Are P who have I at in/decreased risk for/of O compared with P with/without C?
diagnostic Is I more accurate in diagnosing P compared with C for O?
preventative For P, does the use of I reduce the future risk of O compared with C?
prognostic Does I influence O in patients who have P? |
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ethics in research |
especially important with human participants
issues are complex at many levels
requires careful thought by researchers and participants |
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informed consent |
must cover possible risks, possible benefits, alternative treatments, possible consequences of doing nothing |
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intent |
the intended goal
in practice, to help the patient
in research, to expand the body of knowledge |
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practice v research |
Goals practice: individual patients research: populations, generate knowledge
gray zone between the two in the use of not-yet-approved therapies in human patients typically these are innovative, intended to benefit the individual, and generate knowledge Ebola & Zmapp polyheme & community consent |
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innovation: practice v research |
research: using interventions that differ from standard practice
risks differ from standard practice |
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plan: practice v research |
research involves greater level of control & standardization protocols are not modified for the individual
practice involves tailoring standard practice for the each patient |
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responsibilities of researcher |
educate participants as to risks & benefits
obtain informed consent prior to participation
keep participants informed |
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5 principles of ethics |
nonmaleficence beneficence utility autonomy justice
be able to explain ethical breeches in terms of these principles |
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nonmaleficence |
first, do no harm
act in ways that avoid needless harm unintentional harm: carelessness, accidents, adverse events intentional harm: maliciousness, lack of due care
do no harm can't be an absolute edict all research & treatment carries some risk consider risk/benefit ratio inform patients |
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beneficence |
promote the welfare of others, including participants & pts
researcher must secure the well-being of participants
protect others
for researcher, ensure participants experience the possible benefits of involvement in the case overwhelming evidence as to the efficacy/harm of a treatment, may shift participants between control & intervention arms HRT study stopped early |
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utility |
maximize good for the greatest number while minimizing cost
economical, always seeking a balance between risk, benefit, and cost |
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special interests |
may violate any/all ethical principles
personal relationship may pressure participation lack of blinding may allow researcher to assign someone to a particular arm |
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autonomy |
self-determination
give others the information, time, opportunity, and respect to make their own decisions
requires being informed, lack of duress
especially strict for protected populations
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protected populations |
those in whom autonomy is reduced for some reason
prisoners, children, elderly, cognitively impaired these may be easily coerced or incapable of understanding
requires higher standard of IRB review
very hard to get approval
these are commonly used as exclusion criteria |
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justice |
risk, benefit, and cost must be equitably distributed
calls into question inclusion and exclusion criteria
shouldn't be based on SES, cultural, religious, ethnic, race, sex, etc. - unless study particularly requires one of those items
PT research injustices: mostly men, mostly white leads to questions of generalizability |
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power dynamics |
clinician-patient & teacher-student
power differential, whether perceived or actual, may reduce autonomy
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3 requirements of informed consent |
voluntariness
comprehension
disclosure
implicit is that the patient/subject must explicitly agree to treatment/participation, and continue to do so throughout |
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voluntariness |
indicates autonomy & capacity to have autonomy
can't use coercion or duress use of gifts or entitlements is questionable inform subjects individually - as a group, might be peer pressure to agree
be cognizant of power differentials
in the case of legal guardians, consent may be given by proxy parent for child, adult child for now-incompetent parent |
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comprehension |
also speaks to autonomy
does the person have the capacity to understand, do they understand have they been supplied with all relevant information |
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disclosure |
purpose of study
reasonably foreseeable risks to individual potential benefits to individual or others
alternatives to research protocol / treatment
extent of confidentiality protections for the individual
compensation in case of protocol-induced injury
contact information for questions, participants' rights, in case of injury
conditions of participation, right to withdraw without penalty
Disclose such that a reasonable person is provided the information needed to make an informed decision |
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reasonable person |
can be subjective
be aware of language, culture, ethics |
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Nuremberg Code |
1946
1st internationally recognized code of research ethics
issued by Nazi war crimes tribunal as a result of the Nuremberg trials |
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Tuskegee Syphilis study |
1940's through ??? revealed in 1972
studied the natural history of syphilis in poor black men who were not told of their disease and were not given treatment even after penicillin became available |
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Kefauver-Harris bill |
1962
to ensure greater drug safety
in response to the thalidomide babies |
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Helsinki report |
1964
18th world medical assembly met in Finland
issued recommendations to guide physicians in biomedical research using human subjects |
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Henry K. Beecher |
1966
Harvard physician & faculty
published documentation of unethical use of humans in research
humans used without their knowledge and without knowledge of the risks they faced |
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National Commission for the Protection of Human Subjects of Biomedical and Behavioral research |
est. 1974
National Research Act passed by congress
prompted establishment of IRB's at the local level required IRB review & approval for human research receiving federal funds
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Belmont report |
pub. 1979
by Nat'l Comm for Protection of Human Subjects...
subtitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research
guide for US research with human subjects |
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secret radiation experiments |
1993 by Albuquerque Tribune
revealed injection of plutonium into human subjects, other secret rads experiments
indigent patients and mentally retarded children were deceived about the nature of their treatment |
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National Bioethics Advisory Commission |
1994 created by Bill Clinton
1995 states some of the 1940's human rads experiments were unethical
1997 Clinton apologizes to Tuskegee |
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Have all these measures helped protect human subjects? |
Yes, but misconduct still occurs
researchers falsify results (Poehlman at UVM) coercion/duress (Kennedy-Kreuger lead paint)
questionable practices exist concept of community concept with individual opt-out in the polyheme trials |
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designing an ethical study |
informed consent (autonomy)
design justifies the study (justice) can't expose people if design is so bad that a useful outcome is unlikely
avoid suffering & injury (nonmaleficence)
risk consistent with benefits (utility)
independent review of research proposal
integrity of disseminated results, requires disclosure of potential & actual conflicts of interest
pay attention to ethical principles throughout |
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IRB |
Institutional Review Board
required at any college where human research is performed
required for any human research in the US
purpose: protect rights of potential subjects
review the proposals & informed consent procedures of potential studies
result: approve, reject, request revision some studies go through several rounds |
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research risks |
physical harm disclose potential risks, inform of alternative treatments
psychological harm anxiety regarding participation or end of participation may have hoped to be in intervention arm, find out at the end that they were in the control arm, and thus are still at risk
social harm breach of confidentiality
economic harm loss of income d/t participation (whether d/t reduced income or increased expenditures) cost of care related to harm |
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analyzing an ethical dilemma |
what is the situation?
what principles are involved?
what are the sides of the dilemma?
could it be avoided or resolved? |
