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Estimating the efficacy of an interstitial cystitis/painful bladder syndrome medication in a randomized trial with both non‐adherence and loss to follow‐up
Author(s) -
Yang Wei,
Propert Kathleen J.,
Richard Landis J.
Publication year - 2012
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.5702
Subject(s) - amitriptyline , interstitial cystitis , medicine , randomized controlled trial , logistic regression , clinical trial , physical therapy , urinary system
We are motivated by a randomized clinical trial evaluating the efficacy of amitriptyline for the treatment of interstitial cystitis and painful bladder syndrome in treatment‐naïve patients. In the trial, both the non‐adherence rate and the rate of loss to follow‐up are fairly high. To estimate the effect of the treatment received on the outcome, we use the generalized structural mean model (GSMM), originally proposed to deal with non‐adherence, to adjust for both non‐adherence and loss to follow‐up. In the model, loss to follow‐up is handled by weighting the estimation equations for GSMM with one over the probability of not being lost to follow‐up, estimated using a logistic regression model. We re‐analyzed the data from the trial and found a possible benefit of amitriptyline when administered at a high‐dose level. Copyright © 2012 John Wiley & Sons, Ltd.