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

根据欧盟指令，与包装说明书相比，中性配制的说明书或仅口头信息：一项随机对照试验，分析对反安慰剂效应和不依从性的影响

• 批准号: 338417115
• 负责人: Dr. Tim Mathes
• 金额: --
• 依托单位: Institut für Medizinische Statistik
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2017
• 资助国家: 德国
• 起止时间: 2016-12-31 至 2019-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/338417115?language=en
• 关键词: Neutral; formulated; package; insert; only

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.

反安慰剂效应描述了预期的负面影响（例如副作用）与实际发生的负面影响之间的关联。研究表明，反安慰剂效应可以受到（风险）沟通的影响。到目前为止，还没有研究比较不同类型的信息对不良事件的强度反安慰剂effectives.The试点随机对照试验的目的是分析不同的通信类型的影响的频率和强度的不良事件和遵守。为了增加的相关性和适用性的结果，研究干预建立在包装插页，因为这些是最广泛的形式的信息的副作用.MethodsPatientsInclusion criteria：-选择性骨科干预-至少18岁-没有严重的合并症-摄入术后止痛药（布洛芬）-计划在hospitalIt的后续计划包括60例患者在study.Intervention-修改包装插页：简化和集中在中性风险感知。陈述和公式是基于循证患者信息和风险沟通研究的结果。包装说明书包含与法定包装说明书相同的信息，以确保其符合法律的要求。-关于副作用的口头信息：口头告知患者关于副作用，并且不接收任何包装说明书。根据欧盟指令2001/83 / EC控制包装说明书（通常包装说明书）。结局-患者报告的不良事件数量（主要结局）。依从性（正确开始治疗，正确摄入量，提前停止治疗）。研究类型单中心、结果评估者、三臂、随机对照试验评价为了检验研究组之间报告的不良事件（主要结果）的统计学显著差异，将使用平均累积函数（MCF）。