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Reno Rudiman
Types of studies
Observational studies
Case report Case series Case control Cohort
Experimental studies
Case series: same thing as a case report, only with more people in it.
I had 10 patients with a cold who drank orange juice.
Inferential studies
Most research is done not to generate hypothesis but to test them or make an inference from the results When setting up a question, usually start with NULL HYPOTHESIS Null hypothesis is that the treatment has NO effect (remember that null = no) If the study shows an effect then you REJECT the null hypothesis
Results
Cases (Reyes) # who use ASA 26 Controls 53
# who didnt
TOTAL
1
27
87
140
Cohort studies
Studies whether exposure to a risk factor is associated with a subsequent outcome Select two populations who seem the same except for the hypothesized risk factor Follow them ahead in time and see how many have the outcome or disease Important concept: Start with the risk, then look for the outcome
Example
In late 1840s/early 1850s London had several outbreaks of cholera Snow hypothesized that the source of water from a polluted area of the Thames was the cause of the cholera He identified three water companies that supplied the same neighborhoods in London: 2 got their water from one site on the Thames, the other from a different area
Results
Southwark & Vauxhall Cos
Lambeth Co # houses 40,046 # deaths Rate 1,263 3.15%
26,107
98
0.37%
Study design
Investigators went back to records from 1947-1955 and identified patients with PV They categorized patients into 4 groups: (1) No radiation treatment, (2) Treatment with x-rays, (3) Treatment with a radioactive isotope, (4) Treatment with both x-ray and isotope They then looked ahead 25 years (in 1980) to see how many in each group got leukemia
Results
Leukemia rate PV without treatment 1.0% X-ray treatment 9.2% Radioisotope treatment 11.8% X-ray & radioisotope 17.3%
Expressing results
Study results are usually expressed as a ratio or rate Cohort studies: relative risk Case control studies: odds ratio (which is the same as relative risk for large groups and uncommon outcomes)
Calculate RR
Relative risk= (152/3,454) / (9/19,254) RR= 98.4 Interpretation: patients with hepatitis B are 98 times more likely to develop hepatocellular cancer
Example
7% patients exposed to smoking get cancer in their lifetime compared to 3.5% who dont smoke (RR=2) 1% of patients exposed to radiation get thyroid cancer compared to 0.25% of people not exposed (RR=4) Which exposure hurts more people?
Experimental design
Investigator controls exposure to the risk or treatment by assigning subjects to one group (experimental group) or another (control group) Assignment to experimental or control attempts to make sure both group are similar in all ways except the experimental manipulation
Randomization of subjects
To help assure that groups are similar, subjects are randomly assigned to experimental or control groups Randomization is performed to increase the likelihood that groups are matched in other, non-experimental ways Randomization does not assure that the groups are the same: still need to assess whether they are
Blinding
Even after randomization, it is possible that experimental subjects may be treated differently than controls To combat this, blinding is often used Blinding means that the subject, investigator, or both do not know what group the subject is assigned to
Placebos
Placebos are another way of trying to make both groups similar A placebo is a biologically inactive substance given to the control group so that they think they are being treated Placebo effect is important: many patients in the placebo group report getting better simply because they are taking the placebo!
P and power
P is the probability that any difference between groups happened just by chance (i.e. probability of making a Type I error) Power is the probability that the two groups are the same (i.e. probability of not making a Type II error)
Whats a good P
If you are to believe that two groups are really different, the P (probability that this happened just by chance) should be low 0.05 (of a 5% probability that the results differ just by chance) is accepted as a standard cut-off
What influences P?
The P value is related to the difference between the groups, the sample size, and the variability within the sample P ONLY tells you about the probability that the difference occurred by chance It DOES NOT tell you anything about the size of the difference between two groups
Is P <0.05?
YES 2 are different Is Power 80% YES 2 groups the same NO Lousy study NO