Neutral formulated package insert or only verbal information compared to package insert according EU-directive: a pilot randomised controlled trial to analyse the influence on the nocebo effect and non-adherence

• Applicant: Dr. Tim Mathes
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine
• Term: from 2017 to 2020
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 338417115

The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.MethodsPatientsInclusion criteria:- elective orthopaedic intervention- at least 18 years old- no serious comorbidity - intake of postoperative pain medication (ibuprofen)- planned follow-up in the hospitalIt is planned to include 60 patients in the study.Intervention- Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.- Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.ControlPackage insert according to EU Directive 2001/83 / EC (usual package insert).Outcomes- Number of patient reported adverse events (primary outcome).- Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).- Resource use (e.g. provider contacts).Type of studyMonocentric, outcome assessor, three-arm, randomised controlled pilot trial.EvaluationTo test for statistically significant differences in reported adverse events (primary outcome) between the study groups a mean cumulative function (MCF) will be used.

• DFG Programme: Research Grants