An imputation method for non-ignorable missing data in studies of blood pressure.

In studies with repeated measures of blood pressure (BP), particularly in trials of hypertension prevention, BP measurements often become censored once a participant commences antihypertensive medication. When prescribed by non-study physicians under uncontrolled conditions, the missing data mechanism is non-ignorable and may bias the BP effects of interest. I propose a method that models the distribution of BPs measured by non-study physicians and their relation to study BPs using random effects models. If treated for hypertension, I assume that BP measured outside the study is greater than a clinical cutpoint, such as diastolic BP > or = 90 mmHg. I then compute estimates for the missing study BPs conditional on previously observed study BPs and treatment for hypertension. Multiple imputation is used to model the variability of the BP values and adjust the standard error estimates of the parameters. Examples are given using simulated data and data from the weight loss intervention of phase I of the Trials of Hypertension Prevention.