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26 Cards in this Set
- Front
- Back
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Vulnerable populations + cant speak for self
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Dying
brain dead fetuses infants illerates |
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vulnerable populations + 'illegal' or immoral activites
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drug users
illegal aliens prostitutes "unfaithful" spouses |
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Institutionalized populations
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Prisoners
Mentally Ill Mentally retarded Elderly in nursing homes hospitalized |
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Cox model for competence
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Informability
Cognitive and Affective Capability Ability to choose Ability to recount one's decision-making process |
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Drakes sliding scale
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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 |
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Assessing Compentence
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Hopkins Competency Assessment Test (HCAT)
Mini Mental State Examination (MMSE) |
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HCAT
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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 |
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MMSE
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Orientation, memory, attention/calculation, language/writing/drawing
Cutoffs different for purposes |
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2 types of trials
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Community (less frequent)
Clinical |
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Community
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do not always involve knowledge and consent
always preventitive in nature |
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Community trial examples
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Health promotion campaigns (anit smoking,seatbelt)
Local Health promotion (stress, weight managment) |
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Clinical trials types
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Preventitive (primary prevention):evaluate of those who dont have disease
Therapeutic (secondary prevention): evaluate of those who already have disease |
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Essentials of good clinical trial
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Use of concurrent controls (drawn from same population as treated)
Blinding (subjects do not know which "arm" they are in) Randomization (no bias) |
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AZT trial
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Shorter/cheaper therapy prevent transmission of AIDs?
Double-blind, placebo Investigators knew placebo group would have HIV-positive infants (some would die) |
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AZT results
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Short course therapy reduced transmission by 51%
Placebo: 19% of babies got HIV; 9.2% when AZT was given |
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Equipoise
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=state of uncertainty regarding value of treatments in all arms of a clinical trial
If clinicians dont know which is better (treatment vs.none) |
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World Medical Association
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Restore integrity to medical profession
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Declaration of Helsinki
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allowed placebo controlled trials when no evidence of a better alternative.
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Revision of ATZ
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allow use of placebos where standard level of care is not possible (developing countries)
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Hellman & Hellman
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opposed randomized controlled exp.
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Rights-based Moral Philosophy
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Immanuel Kant
-ppl have rational -ppl have dignity -ppl are not means to ends -right is what preserves one's autonomy and well-being |
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Utilitarian-based Moral philosophy
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John Stuart Mill
-ppl are members of a society -individuals serve society -society is primary -right is greatest good for greatest number |
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H&H contrast obligations
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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 |
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H&H Recommendations
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Use other research designs (w/out randomization, with matched-pairs)
More Confimatory Studies (case control) Larger sample sizes in non-exp research |
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Freeman
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supports randomization
Clinicians should not be allowed to know preliminary results of RCTs (will distrub equipoise) Equipoise is the preferred moral basis for RCTs |
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Freeman Clinical vs. Theoretical equipoise
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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" |
