Clinical Center Nursing Department.
National Center for Complementary and Integrative Health.
Pain Med. 2020 Apr 1;21(4):794-802. doi: 10.1093/pm/pnz081.
Little is known about the perceptions and attitudes of participants who volunteer in studies involving authorized deception. Thus, this cross-sectional pilot study measured, for the first time, the perceptions about participation in an authorized-deception placebo analgesia study in chronic pain patients with fibromyalgia and assessed whether their perceptions differed from healthy controls.
An anonymous survey with questions about trust in research and willingness to participate in future research involving deception was mailed to participants in both groups after completion of the parent study. Statistical analyses were performed using the Mann-Whitney U and chi-square tests (31 controls and 16 fibromyalgia patients were included in the analyses).
The majority of participants expressed little or no concern about the deception, still trusted the scientific process, and found the debriefing procedure helpful and worthwhile. Group differences were found in willingness to 1) participate in the parent study had the deceptive element been disclosed in advance (controls = definitely, fibromyalgia patients = probably, U = 341.5, P = 0.01) and 2) participate in future studies (controls = definitely, fibromyalgia patients = probably, U = 373, P < 0.001).
Despite slightly less favorable responses of fibromyalgia patients and the relatively small size of the study, these findings suggest that attitudes and perceptions about participating in an authorized placebo study remain positive in both healthy and chronic pain populations.
对于参与涉及授权欺骗的研究的志愿者的看法和态度知之甚少。因此,这项横断面试点研究首次测量了慢性疼痛纤维肌痛患者对参与授权欺骗安慰剂镇痛研究的看法,并评估了他们的看法是否与健康对照组不同。
在完成主要研究后,向两组参与者邮寄了一份关于对研究的信任和参与未来涉及欺骗的研究的意愿的匿名调查,调查中包含了有关信任研究和参与未来涉及欺骗的研究的意愿的问题。使用 Mann-Whitney U 和卡方检验(分析中包括 31 名对照组和 16 名纤维肌痛患者)进行统计分析。
大多数参与者对欺骗表示很少或没有担忧,仍然信任科学过程,并且发现汇报程序有帮助且值得。在以下方面发现了组间差异:1)如果事先披露了欺骗性元素,参与者是否愿意参与主要研究(对照组=肯定,纤维肌痛患者=可能,U=341.5,P=0.01)和 2)是否愿意参与未来的研究(对照组=肯定,纤维肌痛患者=可能,U=373,P<0.001)。
尽管纤维肌痛患者的反应略差,且研究规模相对较小,但这些发现表明,在健康人群和慢性疼痛人群中,参与授权安慰剂研究的态度和看法仍然是积极的。