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Lecture 8

CHSC 4P99 Lecture 8: Therapeutic Trials II.pdf

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Health Sciences
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Brent Faught

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Therapeutic Trials II March-10-15 2:00 PM Therapeutic Literature 1. Was the assignment of patient to treatments really randomized? ○ Known probability of receiving one or the other treatments ○ Terms such as randomized trial or Radom allocation should appear in abstract, the methods, or even the title ○ Beware articles that state "patient were assigned at random"  Systematic bias □ Prognosis stratification ○ Non-randomized studies are vulnerable to showing larger false-positive treatment effects  Subject to systematic bias 2. Were all clinically relevant outcomes reported ○ Consider all outcomes:  Quality of life(QOL)  Total mortality (PYLL-potential years of life lost) (75-the age you die)  Return to work ○ Necessity for explicit, objective criteria for the clinical outcomes at interest ○ Double blind study  Influence if the physician knows the group you're in 3. Were the study patients recognizably similar to your own? ○ The clinical and demographic status must be described in detail for you to judge if subjects are similarto your patients ○ The value of knowing your age/type of your subjects is important 4. Did the authors consider both clinical and statistical significance Clinical significance Statistical significance Examines magnitude of difference (effect Determines whether the effect sizeis likely to be size) between treated and control patient truthful Determines if a patient is better or worse for Considered with avoiding type I (false-positive, having taken the treatment alpha error, 5%) and type II error (false-negative, beta error, 20%) error •Type I error cost time •Type II error doesn't cost time (because you
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