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Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.

ABSTRACT: To alleviate anti-cancer treatment burden in advanced breast cancer, patient-clinician communication strategies based on nocebo-effect mechanisms are promising. We assessed distinct/combined effects on psychological outcomes (e.g. anxiety; main outcome) and side-effect expectations of (1) nocebo information about the (non)pharmacological origin of side effects, and (2) clinician-expressed empathy through reassurance of continuing support. Furthermore, we explored whether information and empathy effects on side-effect expectations were mediated by decreased anxiety. In a two-by-two experimental video-vignette design, 160 cancer patients/survivors and healthy women watched one of four videos differing in level of nocebo information (±) and empathy (±). Regression and mediation analysis were used to determine effects of information/empathy and explore anxiety's mediating role. Anxiety was not influenced by empathy or information (Stai-state: p = 0.295; p = 0.390, VAS p = 0.399; p = 0.823). Information improved (specific) side-effect coping expectations (p < 0.01). Empathy improved side-effect intensity expectations (p < 0.01 = specific; p < 0.05 = non-specific/partial) and specific side-effect probability expectations (p < 0.01), and increased satisfaction, trust, and self-efficacy (p < 0.001). No mediating effects were found of anxiety on expectations. Mainly empathy, but also nocebo information improved psychological outcomes and-mainly specific-side-effect expectations. Exploring the power of these communication elements in clinical practice is essential to diminish the anti-cancer treatment burden in advanced breast cancer.

SUBMITTER: Meijers MC

PROVIDER: S-EPMC9515213 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.

Meijers M C MC Stouthard J J Evers A W M AWM Das E E Drooger H J HJ Jansen S J A J SJAJ Francke A L AL Plum N N van der Wall E E Nestoriuc Y Y Dusseldorp E E van Vliet L M LM

Scientific reports 20220927 1

To alleviate anti-cancer treatment burden in advanced breast cancer, patient-clinician communication strategies based on nocebo-effect mechanisms are promising. We assessed distinct/combined effects on psychological outcomes (e.g. anxiety; main outcome) and side-effect expectations of (1) nocebo information about the (non)pharmacological origin of side effects, and (2) clinician-expressed empathy through reassurance of continuing support. Furthermore, we explored whether information and empathy ...[more]

PMID: 36167876

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Project description:BackgroundNocebo effects ('negative placebo' effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). Misattributing nocebo effects to the medicinal intervention can lead to participants experiencing harmful nocebo effects and may result in distortion of adverse effect reporting. However, little is known about how information on potential side effects is provided to trial participants. There is increasing concern that the way in which potential side effects in clinical trials are described to patients in participant information leaflets (PIL) can in itself cause harm by either increased anxiety, poor adherence or inducing the side effect itself. In this study, we aimed to explore these concerns and identify the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants.MethodsTrials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry (a primary registry of the WHO International Clinical Trials Registry Platform (ICTRP)). Eligible studies were placebo-controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11.ResultsMost of the patient information leaflets were ranked as 'fairly difficult to read' or 'difficult to read' according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33, 64%).DiscussionParticipant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. By comparison, potential benefits from the intervention and/or study were described less often, by shorter text, and only after information about harms.

Project description:Background and aimSelf-management support is an integral part of current chronic care guidelines. The success of self-management interventions varies between individual patients, suggesting a need for tailored self-management support. Understanding the role of patient factors in the current decision making of health professionals can support future tailoring of self-management interventions. The aim of this study is to identify the relative importance of patient factors in health professionals' decision making regarding self-management support.MethodA factorial survey was presented to primary care physicians and nurses. The survey consisted of clinical vignettes (case descriptions), in which 11 patient factors were systematically varied. Each care provider received a set of 12 vignettes. For each vignette, they decided whether they would give this patient self-management support and whether they expected this support to be successful. The associations between respondent decisions and patient factors were explored using ordered logit regression.ResultsThe survey was completed by 60 general practitioners and 80 nurses. Self-management support was unlikely to be provided in a third of the vignettes. The most important patient factor in the decision to provide self-management support as well as in the expectation that self-management support would be successful was motivation, followed by patient-provider relationship and illness perception. Other factors, such as depression or anxiety, education level, self-efficacy and social support, had a small impact on decisions. Disease, disease severity, knowledge of disease, and age were relatively unimportant factors.ConclusionThis is the first study to explore the relative importance of patient factors in decision making and the expectations regarding the provision of self-management support to chronic disease patients. By far, the most important factor considered was patient's motivation; unmotivated patients were less likely to receive self-management support. Future tailored interventions should incorporate strategies to enhance motivation in unmotivated patients. Furthermore, care providers should be better equipped to promote motivational change in their patients.

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Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.

Publications

Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.

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