The elderly and OTC labeling information: A randomized controlled experiment test

描述（由申请人提供）：总体研究目标是了解老年人如何利用非处方药（OTC）包装标签上的风险信息形成其使用OTC药品的总体风险认知，并确定其药物信息来源。本研究还探讨了风险标签信息的存在和缺失对老年人OTC决策的影响。具体而言，研究目标是：（1）提出一个消费者的感知风险模型，以评估OTC风险标签信息，在特定情况下使用OTC产品;（2）测试消费者的整体风险感知和信息来源的模型。本文借鉴Bettman（1973）、Dowling和Staelin（1994）的营销研究框架，提出感知风险由三个风险组成：（a）产品类别风险（PCR），定义为与产品类别相关的风险;（B）产品特定风险（PSR），定义为与特定产品特征相关的风险;以及（c）特定情况风险（SSR），定义为与用户特征相关的风险。本研究将采用完全随机对照的2 x 2 x 2 x 2析因设计来检验所提出的感知风险模型的效果。将有16个治疗组和2个对照组。每种治疗的操作风险水平如下：（1）PCR（低风险=感冒产品vs.高风险=止痛药）;（2）PSR（低风险= 2个副作用vs.高风险= 4个副作用）;（3）SSR（低风险=皮肤干燥vs.高风险=糖尿病）;（4）标签上是否存在SSR信息（是vs.否）。有两个相关的因变量：（1）使用OTC产品的总体感知风险，可操作性包括两个维度：不确定性和不良后果;（2）信息来源，可操作性包括搜索标签之外的其他信息的可能性，以及使用、信任和偏好特定信息来源的可能性。将从美国65岁及以上成年人的全国商业消费者邮寄名单中随机选择1,620名受试者。将在612名受试者的样本中进行初步试点研究，以测试该工具。每名受试者将被随机分配到治疗组或对照组，并根据其分配的组邮寄18个版本的调查数据包之一。每个调查包将包含一封求职信，一份7页的问卷和一个预付的回邮信封。要求受试者回答关于他们对使用假设OTC产品的风险感知以及他们在阅读产品标签和使用该产品的健康场景后将使用的药物信息来源的问题。该研究有助于更好地了解老年消费者如何在非处方药决策中利用非处方药风险标签信息，以提高老年人非处方药使用的质量和安全性。研究的意义包括改进OTC包装标签和制定策略，以纠正公众对OTC的误解。此外，了解老年人对非处方药信息来源的选择将有助于从事非处方药咨询的医疗保健专业人员更好地处理患者的问题和担忧。

DESCRIPTION (Provided by Applicant): The overall study goal is to understand how the elderly utilize risk information on Over-the-Counter (OTC) package labels to form their overall risk perceptions of using an OTC drug product, and to determine their sources of drug information. This study also examines the effects of the absence and presence of risk labeling information on older adults' OTC decisions. Specifically, study objectives are: (1) to propose a consumer's perceived risk model in evaluating OTC risk labeling information for the use of an OTC product in a particular situation; and (2) to test the model on consumers' overall risk perceptions and information sources. Adapting from the Bettman (1973), and Dowling and Staelin (1994) frameworks in marketing research, perceived risk is proposed to consist of 3 risk components: (a) Product Category Risk (PCR) defined as risk associated with a product class; (b) Product Specific Risk (PSR) defined as risk associated with a specific product's characteristics; and (c) Situation Specific Risk (SSR) defined as risk associated with the user's characteristics. This study will employ a completely randomized controlled 2 x 2 x 2 x 2 factorial design to test the effects of the proposed perceived risk model. There will be 16 treatment groups and 2 control groups. Each treatment is operationalized with the following levels of risk: (1) PCR (low risk = cold products vs. high risk = pain relievers); (2) PSR (low risk = 2 side effects vs. high risk = 4 side effects); (3) SSR (low risk = dry skin vs. high risk = diabetes); and (4) presence of SSR information on label (yes vs. no). There are two dependent variables of interest: (1) overall perceived risk of using the OTC product operationalized as consisting of two dimensions: uncertainty and adverse consequences; and (2) information sources operationalized as the likelihood of searching for additional information beyond the label, and the likelihood of using, trusting, and preferring particular sources of information. A sample of 1,620 subjects will be randomly selected from a national commercial consumer mailing list of U.S. adults aged 65 years and older. An initial pilot study will be conducted in a sample of 612 subjects to test the instrument. Each subject will be randomized to a treatment or control group, and mailed one of the 18 versions of a survey packet depending on their assigned group. Each survey packet will contain a cover letter, a 7-page questionnaire and a prepaid return envelope. Subjects are asked to answer questions on their risk perceptions of using a hypothetical OTC product and the sources they would use for drug information after reading a product label and a health scenario for which the product is to be used. The study is relevant to better understanding how elderly consumers make use of OTC risk labeling information in their OTC decisions in order to improve the quality and safety of OTC medication use by the older adults. Study implications include improving OTC package labeling and developing strategies to correct public misconceptions of OTCs. Furthermore, knowledge of the elderly population's choice of OTC drug information sources would be of help to health care professionals engaged in OTC counseling in better handling of patients' questions and concerns.