Characteristics of opioid-using pregnant women who accept or refuse participation in a clinical trial: screening results from the MOTHER study
Susan M Stine, Sarah H Heil, Karol Kaltenbach, Peter R Martin, Mara G Coyle, Gabriele Fischer, Amelia M Arria, Peter Selby, Hendree E Jones, Susan M Stine, Sarah H Heil, Karol Kaltenbach, Peter R Martin, Mara G Coyle, Gabriele Fischer, Amelia M Arria, Peter Selby, Hendree E Jones
Abstract
Background: Although concerns arise about the generalizability of results from Randomized Controlled Trials (RCTs), few studies systematically examine this issue.
Objectives: This study compared the characteristics of 427 opioid-using pregnant women who did (n = 208) and did not consent (n = 219) to enrollment in a multicenter clinical trial of agonist medications (i.e., the MOTHER study).
Methods: Logistic regression models were used to compare consenters and non-consenters to examine the effect of screening variables on the likelihood of consenting.
Results: Of nine characteristics examined, most differences did not reach statistical significance. Consenting participants were less likely than non-consenting women to be currently enrolled in a methadone maintenance program (74.5% vs. 84.5%, p =.01).
Conclusion and scientific significance: These data show that the recruited sample of drug-dependent pregnant women enrolled in an intensive RCT is representative of the larger population of treated opioid-dependent patients and supports the generalizability of randomized controlled trials in this population.
Source: PubMed