Ling Protocol #8 - Provision of reproductive health care in adolescents with rheumatologic conditions taking teratogenic medications

Ling Protocol #8 - Provision of reproductive health care in adolescents with rheumatologic conditions taking teratogenic medications

by Nicole Ling -
Number of replies: 2

Intervention: In clinic, PNP/obgyn/adolescent medicine consult for all female patients of reproductive age in pediatric rheumatology clinic.

1. Describe the study design you will employ in order to determine if your intervention has had an effect on the outcome variable of interest.

Interrupted time series will be used to measure the effect of intervention on patient knowledge, rates of contraception counseling and prescription, with multiple observations before and after the intervention, employed in different pediatric rheumatology clinics (different attendings) launched in a step wedge fashion at UCSF.

2. Define the unit-of-analysis for your main outcome evaluation, the minimum meaningful effect size, and the sample size necessary to detect this effect size.

Main outcome evaluation: patient knowledge based on a series of questions given before and after intervention (patient level)  

Minimal meaningful effect size: 20 points/100 total points (20%) for given knowledge evaluation.

Sample size will be limited by the number of clinics that will actually be able to roll out clinics with consults available. For this reason, it was not feasible to "randomize" clusters of clinics (will be a planned thing, and likely to start in Lupus Clinic on wednesday - due to allocation of resources within the division.  However, with autocorrelation of 0.5 with 3 observations before and after intervention, Variance with no autocorrelation is 0.67 and variance with AR(1) correlation is 0.88 and ratio of required sample sizes is 1.32.

In reply to Nicole Ling

Re: Ling Protocol #8 - Provision of reproductive health care in adolescents with rheumatologic conditions taking teratogenic medications

by Christina Mangurian -

Dear Nicole,

This is great.  I'm wondering if you thougth about clustering by provider (not clinic).  Might be a way to randomize rather than using an interrupted time series method.

In reply to Christina Mangurian

Re: Ling Protocol #8 - Provision of reproductive health care in adolescents with rheumatologic conditions taking teratogenic medications

by Nicole Ling -

Thanks Christina,

Yeah, I was trying to avoid interrupted time series but the logistics of having a provider in lupus clinic is a once a week thing with only two providers (so randomization of attendings will not be enough to account for variability in style between the two...)

I think of this is more of a pilot since I am so limited at this point with resources.