Erlen Judith A, Tamres Lisa K, Reynolds Nancy, Golin Carol E, Rosen Marc I, Remien Robert H, Banderas Julie W, Schneiderman Neil, Wagner Glenn, Bangsberg David R, Liu Honghu
University of Pittsburgh, PA, USA
University of Pittsburgh, PA, USA.
West J Nurs Res. 2015 Mar;37(3):288-98. doi: 10.1177/0193945914526001. Epub 2014 Mar 12.
Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in Multisite Adherence Collaboration in HIV (MACH 14), a multisite collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support earlier work that calls for systematic assessments of usual care within the study design, inclusion of descriptions of usual care in reports of the study, and the influence of usual care on the experimental condition in clinical trials.
设计临床试验的研究人员通常将参与者接受的常规护理指定为对照条件，期望所有参与者无论分组如何都能接受常规护理。假设是研究中的各组受到的影响相似。我们描述了在多中心抗逆转录病毒治疗依从性协作研究（MACH 14）中的16项研究里对常规护理的评估，MACH 14是一项关于抗逆转录病毒治疗依从性的多中心协作研究。MACH 14中只有五项研究评估了常规护理。评估方案各不相同，评估的时间和频率也不一样。所有常规护理评估都涉及针对艾滋病毒、艾滋病毒药物和药物依从性的患者教育。我们的研究结果支持了早期的工作，即呼吁在研究设计中对常规护理进行系统评估，在研究报告中纳入常规护理的描述，以及常规护理对临床试验中实验条件的影响。
