Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials.

ABSTRACT:

Background

Nocebo 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

SUBMITTER: Kirby N 

PROVIDER: S-EPMC7368797 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature