Talk is cheap: Measuring drinking outcomes in clinical trials

Talk is cheap: Measuring drinking outcomes in clinical trials
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DOI:
10.15288/jsa.2000.61.55
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发表时间:
2000-01-01
期刊:
JOURNAL OF STUDIES ON ALCOHOL
影响因子:
--
通讯作者:
Del Boca, F
Del Boca, F
中科院分区:
其他
文献类型:
--
作者:
Babor, TF;Steinberg, K;Del Boca, F

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目的:评估自我报告饮酒、标准生物指标和间接知情人报告的测量结果之间的对应关系,并确定与这三种研究数据来源之间观察到的差异相关的患者特征。使用从与酗酒者匹配治疗的大规模临床试验中收集的数据(N = 1,726),在入院治疗时和治疗结束后12个月比较这三种替代结局指标。结果:患者自我报告和间接报告同意大多数(97.1%)在治疗入院时,大量饮酒是不太可能被否认。相反,肝功能检查相对不敏感,只有39.7%的重度饮酒者血清γ-谷氨酰转肽酶(GGTP)值呈阳性。在15个月随访时,客户自我报告和侧支报告之间的一致性下降至84.7%,但与血液化学值的一致性增加至51.6%。当出现差异时,他们仍然表示,客户的自我报告对饮酒量比生化指标更敏感。出现不一致结果的患者往往有更严重的饮酒问题,更多的既往治疗,更高水平的治疗前饮酒和显着更高水平的认知障碍,所有这些都可能干扰准确的回忆。结论:在使用自我选择的研究志愿者的临床试验中,生化测试和间接线人报告不足以增加自我报告测量的准确性,以保证其常规使用。将用于收集这些替代性结果数据来源的资源更好地投资于旨在提高自我报告信息有效性的访谈程序。
Objective: To evaluate the correspondence among measures of self-reported drinking, standard biological indicators and the reports of collateral informants, and to identify patient characteristics associated with observed discrepancies among these three sources of research data Method: Using data collected from a large-scale clinical trial of treatment matching with alcoholics (N = 1,726), these three alternative Outcome measures were compared at the time of admission to treatment and at 12 months after the end of treatment. Results: Patient self-reports and collateral reports agreed most (97.1%) at treatment admission when heavy drinking was unlikely to be denied. In contrast, liver function tests were relatively insensitive, with positive serum gamma-glutamyl transpeptidase (GGTP) values obtained from only 39.7% of those who admitted to heavy drinking. At 15-month follow-up the correspondence between client self-report and collateral report decreased to 84.7%, but agreement with blood chemistry values increased to 51.6%. When discrepancies occurred, they still indicated that the client's self-report is more sensitive to the amount of drinking than the biochemical measures. Patients who presented discrepant results tended to have more severe drinking problems, more previous treatments, higher levels of pretreatment drinking and significantly greater levels of cognitive impairment, all of which could potentially interfere with accurate recall. Conclusions: In clinical trials using self-selected research volunteers, biochemical tests and collateral informant reports do not add sufficiently to self-report measurement accuracy to warrant their routine use. Resources devoted to collecting these alternative sources of outcome data might be better invested in interview procedures designed to increase the validity of self-report information.