Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, Rhode Island, USA.
Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Int J Methods Psychiatr Res. 2018 Sep;27(3):e1603. doi: 10.1002/mpr.1603. Epub 2018 Jan 4.
Substance use may influence study results in human subjects research. This study aims to report the concordance between self-report and biochemical assessments of substance use and test the effect of methods to reduce false reports of abstinence in trauma-exposed women participating in a research study.
In this pilot study, substance use was assessed during telephone prescreening and via self-report and biochemical verification (i.e., urine toxicology and alcohol breathalyzer tests) at an in-person evaluation. Due to the high number of participants who tested positive for substances despite self-reporting abstinence during prescreening, study procedures were modified to disincentivize false self-reports of substance use two thirds of the way through recruitment. New potential participants were explicitly informed during prescreening and informed consent that a positive drug or alcohol test during screening would result in exclusion from the study and withholding of payment.
Prior to modifying study methods, 20% of participants who had reported abstinence during the telephone prescreen had a positive substance use test at the in-person visit. Modifying study procedures resulted in an 81% decrease in positive substance use assessments.
Adoption of this methodology may decrease inadvertent confounding of clinical research outcomes by undetected and/or misreported substance use.
物质使用可能会影响人体研究的研究结果。本研究旨在报告物质使用的自我报告和生化评估之间的一致性，并测试在参与研究的创伤暴露女性中减少虚假戒断报告的方法对测试的影响。
在这项初步研究中，在面对面评估时，通过电话预筛选和自我报告以及生化验证（即尿液毒理学和酒精呼气测试）来评估物质使用情况。由于在预筛选期间自我报告戒断的参与者中有很大一部分检测出物质呈阳性，因此研究程序被修改，以在招募过程中三分之二的时候减少虚假的物质使用自我报告。在预筛选和知情同意过程中，新的潜在参与者被明确告知，如果在筛查期间药物或酒精检测呈阳性，将被排除在研究之外，并且不支付报酬。
在修改研究方法之前，有 20%的在电话预筛选期间报告戒断的参与者在面对面访问时检测出物质使用呈阳性。修改研究程序使阳性物质使用评估减少了 81%。
采用这种方法可能会减少未被发现和/或错误报告的物质使用对临床研究结果的意外混杂。
