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26 Cards in this Set

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Vulnerable populations + cant speak for self
Dying
brain dead
fetuses
infants
illerates
vulnerable populations + 'illegal' or immoral activites
drug users
illegal aliens
prostitutes
"unfaithful" spouses
Institutionalized populations
Prisoners
Mentally Ill
Mentally retarded
Elderly in nursing homes
hospitalized
Cox model for competence
Informability
Cognitive and Affective Capability
Ability to choose
Ability to recount one's decision-making process
Drakes sliding scale
Standard 1: use for simple medical problems, therapies, minor injury, non-risky research. Low risk
Standard 2: use for chronic conditions; uncertain treatments. Risky
Standard 3: use for very serious medical situations, life threatening treatments. Very risky
Assessing Compentence
Hopkins Competency Assessment Test (HCAT)
Mini Mental State Examination (MMSE)
HCAT
Determine if person copetent to make medical decisions
1.short essay to read
2.series of questions
score 4 or above (out of 10)= competent
MMSE
Orientation, memory, attention/calculation, language/writing/drawing
Cutoffs different for purposes
2 types of trials
Community (less frequent)
Clinical
Community
do not always involve knowledge and consent
always preventitive in nature
Community trial examples
Health promotion campaigns (anit smoking,seatbelt)
Local Health promotion (stress, weight managment)
Clinical trials types
Preventitive (primary prevention):evaluate of those who dont have disease
Therapeutic (secondary prevention): evaluate of those who already have disease
Essentials of good clinical trial
Use of concurrent controls (drawn from same population as treated)
Blinding (subjects do not know which "arm" they are in)
Randomization (no bias)
AZT trial
Shorter/cheaper therapy prevent transmission of AIDs?
Double-blind, placebo
Investigators knew placebo group would have HIV-positive infants (some would die)
AZT results
Short course therapy reduced transmission by 51%
Placebo: 19% of babies got HIV; 9.2% when AZT was given
Equipoise
=state of uncertainty regarding value of treatments in all arms of a clinical trial
If clinicians dont know which is better (treatment vs.none)
World Medical Association
Restore integrity to medical profession
Declaration of Helsinki
allowed placebo controlled trials when no evidence of a better alternative.
Revision of ATZ
allow use of placebos where standard level of care is not possible (developing countries)
Hellman & Hellman
opposed randomized controlled exp.
Rights-based Moral Philosophy
Immanuel Kant
-ppl have rational
-ppl have dignity
-ppl are not means to ends
-right is what preserves one's autonomy and well-being
Utilitarian-based Moral philosophy
John Stuart Mill
-ppl are members of a society
-individuals serve society
-society is primary
-right is greatest good for greatest number
H&H contrast obligations
Clinician: patient/ treatment oriented, free to modify treatment
Researcher: science/ hypothesis oriented, inflexible re treatment protocol

Clinicians should not use randomized exp, should not be blinded;unethical
H&H Recommendations
Use other research designs (w/out randomization, with matched-pairs)
More Confimatory Studies (case control)
Larger sample sizes in non-exp research
Freeman
supports randomization
Clinicians should not be allowed to know preliminary results of RCTs (will distrub equipoise)
Equipoise is the preferred moral basis for RCTs
Freeman Clinical vs. Theoretical equipoise
Clinical: lack of complete consensus regarding treatment A or B; can assign A or B w/out ethical qualms
Theortical: exact balance of evidence for treatment A or B, "fragile"