Aycock Dawn M, Hayat Matthew J, Helvig Ashley, Dunbar Sandra B, Clark Patricia C
Byrdine F. Lewis School of Nursing, Georgia State University, Atlanta, Georgia.
School of Public Health, Georgia State University, Atlanta, Georgia.
Res Nurs Health. 2018 Jun;41(3):320-328. doi: 10.1002/nur.21870.
Attention control groups strengthen randomized controlled trials of behavioral interventions, but researchers need to give careful consideration to the attention control activities. A comparative effectiveness research framework provides an ideal opportunity for an attention control group as a supplement to standard care, so participants potentially receive benefit regardless of group assignment. The anticipated benefit of the control condition must be independent of the study outcome. Resources needed for attention control activities need to be carefully considered and ethical considerations carefully weighed. In this paper we address nine considerations for the design and implementation of attention control groups: (1) ensure attention control activities are not associated with the outcome; (2) avoid contamination of the intervention or control group; (3) design comparable control and intervention activities; (4) ensure researcher training to adequately administer both treatment arms; (5) design control activities to be interesting and acceptable to participants; (6) evaluate attention control activities; (7) consider additional resources needed to implement attention control activities; (8) quantifying the effects of attention control and intervention groups; and (9) ethical considerations with attention control groups. Examples from the literature and ongoing research are presented. Careful planning for the attention control group is as important as for the intervention group. Researchers can use the considerations presented here to assist in planning for the best attention control group for their study.
注意力控制组加强了行为干预的随机对照试验，但研究人员需要仔细考虑注意力控制活动。比较效果研究框架为作为标准护理补充的注意力控制组提供了理想机会，这样无论分组如何，参与者都可能从中受益。对照条件的预期益处必须独立于研究结果。注意力控制活动所需资源需要仔细考虑，伦理考量也需谨慎权衡。在本文中，我们阐述了设计和实施注意力控制组的九个考量因素：（1）确保注意力控制活动与结果无关；（2）避免干预组或对照组受到污染；（3）设计可比的对照和干预活动；（4）确保研究人员接受培训以充分管理两个治疗组；（5）设计让参与者感兴趣且可接受的对照活动；（6）评估注意力控制活动；（7）考虑实施注意力控制活动所需的额外资源；（8）量化注意力控制组和干预组的效果；以及（9）注意力控制组的伦理考量。文中给出了文献和正在进行的研究中的实例。对注意力控制组进行仔细规划与对干预组同样重要。研究人员可以利用这里提出的考量因素来帮助为其研究规划最佳的注意力控制组。
