Reactions to treatment debriefing among the participants of a placebo controlled trial

Blasi, Zelda Di; Crawford, Fay; Bradley, Colin; Kleijnen, Jos

doi:10.1186/1472-6963-5-30

Cited by 31 publications

(31 citation statements)

References 26 publications

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“…Others have similarly suggested that patients should be informed of the possible effects of placebos at the informed consent stage, so that they focus on these possible effects rather than seeing the placebo as merely a “dummy” treatment (Di Blasi et al, 2005; Fassler et al, 2009). RCT participants may be open to viewing placebos in more positive ways, as this would be broadly consistent with the therapeutic misconception: offering two treatments that can give health benefits (compared to offering one such treatment and one “dummy” treatment) is more consistent with the idea that trial personnel and procedures are interested in achieving health benefits for the individual participant as well as conducting scientific research.…”

Section: Discussionmentioning

confidence: 99%

Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos

Bishop

Jacobson

Shaw

et al. 2012

Social Science & Medicine

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Placebos are an essential tool in randomised clinical trials, where they are used to control for contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants’ conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should improve methods of providing participants with full accurate information about placebos and their effects.

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Section: Discussionmentioning

confidence: 99%

Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos

Bishop

Jacobson

Shaw

et al. 2012

Social Science & Medicine

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“…The question of whether research participants should routinely be provided with individualised data is an important one that requires further exploration, particularly given the strength of feeling expressed in our study. Research activity and debate around the issue of treatment debriefing are increasing,20 although there are as yet no signs of an emerging consensus on best practice. In the area of genetic epidemiology, current international guidance21 says that, in general, participants should not be provided with information on their genotype.…”

Section: Discussionmentioning

confidence: 99%

Receiving a summary of the results of a trial: qualitative study of participants' views

Dixon‐Woods

Jackson

Windridge³

et al. 2006

BMJ

104

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Objective To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy. Design Qualitative study with semistructured interviews. Participants 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results. Results Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings. Conclusions Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

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“…The few studies referring to hope parenthetically note that it is often mentioned by patients when asked about their expectations, but is not easily defined or investigated. 4-6 Several researchers have pointed out that conceptualizing hope as a type of expectation is problematic and that increased conceptual clarity is needed. 7-9 The goal of the present analysis is to explore hope in the context of the lived experience of chronic pain.…”

Section: Introductionmentioning

confidence: 99%

Modes of Hoping: Understanding Hope and Expectation in the Context of a Clinical Trial of Complementary and Alternative Medicine for Chronic Pain

Eaves

Ritenbaugh

Nichter

et al. 2014

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This article explores the role of hope in participants’ assessments of their expectations, experiences and treatment outcomes. Data analysis focused on semi-structured, open-ended interviews with 44 participants, interviewed 3-5 times each over the course of a study evaluating Traditional Chinese Medicine (TCM) for Temporomandibular Disorders (TMD, a form of chronic orofacial pain). Transcripts were coded and analyzed using qualitative and ethnographic methods. A “Modes of Hoping”1 framework informed our analysis. Five modes of hoping emerged from participant narratives: Realistic Hope; Wishful Hope; Utopian Hope; Technoscience Hope; and Transcendent Hope. Using this framework, hope is demonstrated as exerting a profound influence over how participants assess and report their expectations. This suggests that researchers interested in measuring expectations and understanding their role in treatment outcomes should consider hope as exercising a multifaceted and dynamic influence on participants’ reporting of expectations and their experience and evaluation of treatment.

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Reactions to treatment debriefing among the participants of a placebo controlled trial

Cited by 31 publications

References 26 publications

Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos

Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos

Receiving a summary of the results of a trial: qualitative study of participants' views

Modes of Hoping: Understanding Hope and Expectation in the Context of a Clinical Trial of Complementary and Alternative Medicine for Chronic Pain

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