1. Martha A. Wojtowycz, PhD February 26, 2016
Journal Club Notes
Martha A. Wojtowycz, PhD
February 26, 2016

2. Othman K, et al., “Intrauterine Contraception among women living with Human Immunodeficiency Virus”, Obstetrics and Gynecology, vol. 126, no. 5, November 2015.

3. Type of Study Design - RCT
Parallel, double-masked RCT
Parallel clinical trial compares two treatments
Copper IUD and Levonorgestrel IUD
Masking = Blinding
Study participants, research team and statistician all blinded
Trained midwives inserted the IUDs (not part of research team)

4. RCT – Recommended Practice
Allocation concealment
Person randomizing the patient does not know what the next treatment allocation will be
Sequentially numbered, opaque, sealed envelops

5. Sample Size Calculation
Need to know:
Rate in the control or reference group
Discontinuation rate for the copper IUD – 18%
Prob of Type I error
α = .05; 95% Confidence interval
Power set at 80%
Prob of Type II error is β = .20
Difference you want to be able to detect
10% absolute difference
Percent lost to follow-up
20% loss to follow-up

6. T- test
Chi-square or Fisher exact
T-test
Chi-square or Fisher exact test

7. No statistically significant differences in Table 1
No statistically significant differences in Table 1. Randomization worked!

8. Kaplan-Meier method Commonly used for survival analysis
Shows cumulative rates over time
Typical example would look at cumulative survival probabilities over time
In this article they looked at cumulative failure probabilities
Compared the discontinuation rates of the two different types of IUDs

9. Each curve shows the cumulative survival rate over time

10. Cumulative probabilities drop when there is a death

11. No significant difference

12. Same as Relative Risk. For Heavy menstrual bleeding (1.8/2.4) = .8

13. Consider the following
Low IUD discontinuation rates with no differences between groups
Both methods effective and well tolerated
Minimal complications
BUT – This was under experimental conditions
Done by trained experienced providers in a medical center setting
Think about where many women in sub-Saharan African may received family planning services
Who can these results be generalized to?