Hallfors Denise, Cho Hyunsan, Sanchez Victoria, Khatapoush Shereen, Kim Hyung Min, Bauer Daniel
Pacific Institute for Research and Evaluation, Chapel Hill, NC, USA.
Am J Public Health. 2006 Dec;96(12):2254-9. doi: 10.2105/AJPH.2005.067462. Epub 2006 Jun 29.
The US Department of Education requires schools to choose substance abuse and violence prevention programs that meet standards of effectiveness. The Substance Abuse and Mental Health Services Agency certifies "model" programs that meet this standard. We compared findings from a large, multisite effectiveness trial of 1 model program to its efficacy trial findings, upon which the certification was based.
1370 high-risk youths were randomized to experimental or control groups across 9 high schools in 2 large urban school districts. We used intent-to-treat and on-treatment approaches to examine baseline equivalence, attrition, and group differences in outcomes at the end of the program and at a 6-month follow-up.
Positive efficacy trial findings were not replicated in the effectiveness trial. All main effects were either null or worse for the experimental than for the control group.
These findings suggest that small efficacy trials conducted by developers provide insufficient evidence of effectiveness. Federal agencies and public health scientists must work together to raise the standards of evidence and ensure that data from new trials are incorporated into ongoing assessments of program effects.
美国教育部要求学校选择符合有效性标准的药物滥用和暴力预防项目。药物滥用和心理健康服务局认证符合该标准的“示范”项目。我们将一个示范项目的大型多地点有效性试验结果与其认证所依据的疗效试验结果进行了比较。
1370名高危青少年被随机分配到2个大型城市学区的9所高中的实验组或对照组。我们采用意向性分析和实际治疗分析方法，来检验项目结束时及6个月随访时的基线等效性、损耗率和结果的组间差异。
疗效试验的阳性结果在有效性试验中未得到重复。所有主要效应要么无效，要么实验组比对照组更差。
这些结果表明，开发者进行的小型疗效试验提供的有效性证据不足。联邦机构和公共卫生科学家必须共同努力提高证据标准，并确保新试验的数据纳入正在进行的项目效果评估中。
