Personalized labeling: A strategy for supporting self-medicating patients’ decision-making during selection and use

Abstract Interactions between self-medicating consumers and labeling of Over-the-Counter medications (OTC) influence the quality of information processing and, hence, appropriateness of decisions. Our previous work yielded evidence that during the early stages of information processing important regulatory information was frequently unnoticed and that decision-making related to OTCs could be improved. We postulated the concept of “personalized labeling” would address recognized shortcomings affiliated with current OTC labels. sThis strategy uses an augmented reality interface to present users with a recommendation related to an OTC’s appropriateness for the individual’s use while the product is being viewed through their smart phone. In doing so, it advises decisions specific to the user’s health history and medication usage, assisting with appropriate decision making. To develop data in support of a proof of concept for this strategy, we utilized an absolute judgement test. Seventy-two participants divided into two cohorts (educated to the personalized labeling strategy vs control) made binary decisions related to a drug’s appropriateness for use by a theoretical patient considering single-ingredient products. Response variables measured the approach’s effectiveness (response accuracy) and efficiency (time to accurate decision). When educated to the personalized labeling concept, participants made decisions significantly more accurately (personalized: ME=0.977, SE=0.007; standard: ME=0.933, SE=0.017; p=0.002) and faster (personalized: ME=9.584s, SE=0.854; standard: ME=19.052s, SE=2.322; p<0.001) for trials with personalized Front-of-Pack (FOP) labels compared to trials composed of the current commercial standard. This suggests that personalized labeling has the potential to improve consumer decision making related to OTC selection and use. Future studies are needed utilizing a broader range of populations, package types, and use contexts. Competing Interest Statement Consumer Healthcare Products Association has funded Dr. Bix's travel to speak at their annual conference. They funded Lanqing Liu's Master's work (not published here-- this is his PhD work) and provided the fees for open source publishing and a fellowship to D. Wongthanaroj Clinical Trial This work was conducted under Institutional Review Board approval by the Michigan State University Office of Regulatory Affairs Human Research Protection Program (STUDY00005057). Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This work was conducted under Institutional Review Board approval by the Michigan State University Office of Regulatory Affairs Human Research Protection Program (STUDY00005057). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability The data underlying the results presented in the study are available, in deidentified form upon request to the corresponding author (bixlaura{at}msu.edu).