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谈论安慰剂:一项关于患者对在临床实践中实施开放标签安慰剂态度的定性研究。

Talking placebo: a qualitative study of patients' attitudes toward open-label placebo implementation into clinical practice.

作者信息

Frey Nascimento Antje, Bakis Berfin, Gaab Jens, Schneider Tobias, Papadopoulou Athina, Ritter Milena, Bernstein Michael H, Blease Charlotte R, Locher Cosima

机构信息

Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.

Pain Unit, Clinic for Anesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.

出版信息

Front Psychol. 2025 Jul 31;16:1533663. doi: 10.3389/fpsyg.2025.1533663. eCollection 2025.

Abstract

BACKGROUND

For more than a decade, studies have supported the efficacy and safety of placebos without deception-so-called open-label placebos (OLPs)-to harness placebo effects in primary care while aligning with key ethical principles. Since treatment acceptance, feasibility, and successful implementation of novel interventions into clinical practice depend on patients' attitudes, patients' perspectives, perceived obstacles, and ideas on OLP use in clinical practice have yet to be elucidated. Therefore, patient and public involvement is increasingly demanded in research and its implementation into clinical practice. Qualitative research offers a unique opportunity to comprehensively understand attitudes, expectations, perceived benefits, and barriers from a patient's point of view. Thus, we studied patients' attitudes, concerns, and ideas toward OLP implementation into clinical practice with focus group discussions (FGDs).

METHODS

In 2022, three exploratory online FGDs, each including two patients with the same condition, were conducted with adult patients affected by chronic back pain ( = 2), chronic migraine ( = 2), or chemotherapy-induced emesis/nausea ( = 2). Physicians recruited participants in three outpatient clinics at the University Hospital Basel in Switzerland. The FGDs were held online for 60 min. Qualitative data was analyzed using applying an inductive-deductive hybrid approach within a social constructivist framework.

RESULTS

In total, five semantic-latent subthemes were identified, entailing: (i) ; (ii) ; (iii) ; (iv) ; (v) The themes reflect an in-depth discussion of the usage of OLPs in the clinical context, accompanied by different ambivalences regarding implementation, prerequisites, and the provider role.

CONCLUSION

The FGDs provided insights into distinct attitudes, concerns, varying acceptance, and patients' ideas regarding the clinical implementation of OLP interventions. While some patients displayed high acceptance, several concerns regarding ethical and practical issues have been expressed. OLP acceptance and attitudes toward practical issues of OLP intake differed between groups and within the same clinical condition.

TRAIL REGISTRATION

ClinicalTrials.gov, identifier NCT05166213.

摘要

背景

十多年来,多项研究支持了无欺骗性安慰剂(即所谓的开放标签安慰剂,OLP)在初级保健中利用安慰剂效应的有效性和安全性,同时符合关键的伦理原则。由于新干预措施在临床实践中的治疗接受度、可行性和成功实施取决于患者的态度,因此患者对OLP在临床实践中的看法、感知到的障碍和想法尚未得到阐明。因此,研究及其在临床实践中的实施越来越需要患者和公众的参与。定性研究提供了一个独特的机会,可以从患者的角度全面了解态度、期望、感知到的益处和障碍。因此,我们通过焦点小组讨论(FGD)研究了患者对OLP在临床实践中实施的态度、担忧和想法。

方法

2022年,对患有慢性背痛(n = 2)、慢性偏头痛(n = 2)或化疗引起的呕吐/恶心(n = 2)的成年患者进行了三次探索性在线FGD,每次FGD包括两名患有相同疾病的患者。医生在瑞士巴塞尔大学医院的三个门诊诊所招募参与者。FGD在线进行60分钟。定性数据在社会建构主义框架内采用归纳 - 演绎混合方法进行分析。

结果

总共确定了五个语义 - 潜在子主题,即:(i);(ii);(iii);(iv);(v)这些主题反映了对OLP在临床环境中使用的深入讨论,同时伴随着对实施、前提条件和提供者角色的不同矛盾态度。

结论

FGD提供了关于患者对OLP干预临床实施的不同态度、担忧、不同接受程度和想法的见解。虽然一些患者表现出高度接受,但也表达了对伦理和实际问题的一些担忧。不同组之间以及同一临床疾病患者内部对OLP的接受程度和对OLP摄入实际问题的态度存在差异。

试验注册

ClinicalTrials.gov,标识符NCT05166213。

原文中部分内容缺失,已按格式完整翻译现有内容。

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