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. 2020 Apr:131:109965.
doi: 10.1016/j.jpsychores.2020.109965. Epub 2020 Feb 13.

How do people feel about the possibility that a treatment might not outperform simulated and inert treatments?

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How do people feel about the possibility that a treatment might not outperform simulated and inert treatments?

David L J I Bandell et al. J Psychosom Res. 2020 Apr.

Abstract

Background: Many treatments in common use are not proved better than simulated or inert treatments. While some clinicians express little concern about whether a particular treatment has a direct effect on the pathophysiology believed to be causing symptoms, we wonder if patients would agree.

Questions/purposes: Are there factors independently associated with the affirmation that it is OK if a treatment is proved not to outperform simulated or inert treatment (a placebo) measured on an 11-point ordinal scale, including the risk and invasiveness of the treatment? And, are there factors independently associated with the affirmation that the clinician should inform a patient about the degree to which a given treatment is known to outperform simulated or inert treatments?

Patients and methods: We asked 763 English-speaking people their willingness to accept unproved treatment, depending on variations in risk, and invasiveness and their opinion regarding the importance of clinicians informing them whether a given treatment is proved to outperform simulated and inert (placebo) treatment.

Results: Acceptance of the unproved treatment was quite low, more so with greater risk and invasiveness. Lower acceptance of unproved treatment was associated with older age, more education, and unemployment. People rated it quite important (mean 7.3 out of 10) that clinicians inform patients if treatments are no better than placebo, no matter the risk of the treatment.

Conclusions: People want to be informed if a treatment is not proved to outperform nonspecific effects such as the placebo effect.

Level of evidence: Not applicable.

Keywords: Ethics; Inform; Invasiveness; Placebo treatment; Risk; Unproved.

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Conflict of interest statement

Declaration of Competing Interest One of the authors (DR) received royalties from Tornier (Memphis, TN, USA) (formerly Wright Medical) for elbow plates in the amount of less than USD 10,000 per year and from Skeletal Dynamics for an internal joint stabilizer elbow in the amount of less than USD 100,000 per year. One of the authors certifies that he (DR) is a Deputy Editor for Hand and Wrist, Journal of Orthopaedic Trauma, and Clinical Orthopaedics and Related Research® and has received or may receive payments or benefits in the amount of USD 5000 per year. Other authors (DB, JK, JM) have nothing to disclose.

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