Ethics/Law/Clinical Studies

Prospective interventional trial where pts are randomized into intervention group and CONTROL group. Double blind further decrases bias; randomization blunts effects of confounding factors

Population is divided by exposure status. Requires large population; can study multiple effects by exposure. Can be prospective or retrospective.

Pts divided into those with dz (cases) and those w/o (control. Fewer pts are needed (good for rare dz). Can study correlation of multiple exposures. Gives ODDS RATIO. ALWAYS RETROSPECTIVE.

Risk of developing dz for ppl with KNOWN exposure compared to risk of developing dz w/o exposure. From cohort study

Appoximates relative risk by comparing odds of developing dz in exposed pts to odds of developing dz in unexposed pts. From case control study.

Estimate of the variability of each individiual data point from the mean.

Null hypothesis is rejected even though it is true (study says it works but it only appears to work b/c of random chance.)

Must satisfy 4 "D"s
1. Dereliction (deviation from SOC)
2. Duty (phy-pt relationship with duty to threat)
3. Damages (injury or measurable)
4. Directly (injury or damages directly resulting from physicians actions/inactions)

Termination of the relationship by the physician w/o reasonable notice to the pt and w/o opportunity to make arrangements for appropriate continuation and FU care.

Intentional and unauthorized touching of a person, directly or indirectly, w/o consent. A surgical procedure w/o expressed or implied consent unless it is done to save life in emergency situation.

Any TX that either offers no reasonable hope of benefit or is too burdensome for the pt or others.

Person in a position of confidence or trust who undertakes a duty to act for the benefit of another under a given set of circumstances.

Efforts to acheive a result that is unreasonable or impossible.

Enacted in all 50 states which exempts from liability a person who voluntarily aids an injured person but who negligently causes injury while aiding.

Primun Non Nocere

1991 Federal Law that requires patients are informed about their right to participate in health care decisions including right for advanced directives