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

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

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)

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

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

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

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

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

Each curve shows the cumulative survival rate over time

Cumulative probabilities drop when there is a death

No significant difference

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

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?