Wilhelm Marcel, Rief Winfried, Doering Bettina K
Department of Clinical Psychology and Psychotherapy, University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.
Department of Clinical and Biological Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.
Int J Behav Med. 2018 Aug;25(4):381-389. doi: 10.1007/s12529-018-9726-z.
Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects.
Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation.
Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects.
Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.
告知患者治疗副作用会增加副作用的发生率和严重程度。由于药物治疗中强制性的知情同意程序要求透明度，且反安慰剂研究表明药物的知情同意会导致上述副作用发生率增加，因此本概念验证研究的目的是确定两种不同框架的知情同意对副作用的发生率、严重程度和感知威胁的影响。
健康男性参与者（n = 80）被随机分为两个框架组之一。积极框架组被告知常见副作用头晕是药物开始起效的迹象，而中性框架组被告知头晕是一种不愉快但众所周知的副作用。在给予降压药美托洛尔后测量副作用。事后调节分析研究了预先存在的对药物总体危害的负面信念对框架操纵的影响。
在积极框架组中，美托洛尔特定的药物归因副作用被评为威胁性显著较低。组间效应大小（科恩d值）较小（d = 0.38，p = 0.049）。探索性事后调节分析表明，与药物归因副作用的中性框架相比，那些认为药物是有害影响来源的参与者从积极框架中受益。
积极框架在降低特定副作用指标方面部分有效，特别是在倾向于认为药物有害的参与者中。因此，知情同意程序应个性化，关注有负面治疗信念的患者。
