接受或拒绝参与临床试验的阿片类药物使用孕妇的特征：来自 MOTHER 研究的筛选结果。
Characteristics of opioid-using pregnant women who accept or refuse participation in a clinical trial: screening results from the MOTHER study.
机构信息
Substance Abuse Research Division, Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, 2761 E. Jefferson Ave., Detroit, MI 48207, USA.
出版信息
Am J Drug Alcohol Abuse. 2009;35(6):429-33. doi: 10.3109/00952990903374080.
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.
背景
虽然人们对随机对照试验（RCT）的结果推广性存在担忧，但很少有研究系统地探讨这个问题。
目的
本研究比较了参与多中心阿片类药物（即 MOTHER 研究）激动剂药物临床试验的 427 名阿片类药物使用者中同意（n = 208）和不同意（n = 219）入组的 427 名孕妇的特征。
方法
使用逻辑回归模型比较同意者和不同意者，以检查筛选变量对同意可能性的影响。
结果
在检查的九个特征中，大多数差异没有达到统计学意义。与不同意的女性相比，同意的参与者目前更不可能参加美沙酮维持治疗计划（74.5%对 84.5%，p =.01）。
结论和科学意义
这些数据表明，参加密集型 RCT 的药物依赖孕妇的招募样本代表了接受治疗的阿片类药物依赖患者的更大人群，支持了随机对照试验在该人群中的推广性。
Zotero 插件