Exploring Novel Computable Knowledge in Structured Drug Product Labels.

This paper introduces a database derived from Structured Product Labels (SPLs). SPLs are legally mandated snapshots containing information on all drugs released to market in the United States. Since publication is not required for pre-trial findings, we hypothesize that SPLs may contain knowledge absent in the literature, and hence "novel." SemMedDB is an existing database of computable knowledge derived from the literature. If SPL content could be similarly transformed, novel clinically relevant assertions in the SPLs could be identified through comparison with SemMedDB. After we derive a database (containing 4,297,481 assertions), we compare the extracted content with SemMedDB for recent FDA drug approvals. We find that novelty between the SPLs and the literature is nuanced, due to the redundancy of SPLs. Highlighting areas for improvement and future work, we conclude that SPLs contain a wealth of novel knowledge relevant to research and complementary to the literature.

Comparing a Mobile Decision Support System Versus the Use of Printed Materials for the Implementation of an Evidence-Based Recommendation: Protocol for a Qualitative Evaluation.

BACKGROUND: The distribution of printed materials is the most frequently used strategy to disseminate and implement clinical practice guidelines, although several studies have shown that the effectiveness of this approach is modest at best. Nevertheless, there is insufficient evidence to support the use of other strategies. Recent research has shown that the use of computerized decision support presents a promising approach to address some aspects of this problem. OBJECTIVE: The aim of this study is to provide qualitative evidence on the potential effect of mobile decision support systems to facilitate the implementation of evidence-based recommendations included in clinical practice guidelines. METHODS: We will conduct a qualitative study with two arms to compare the experience of primary care physicians while they try to implement an evidence-based recommendation in their clinical practice. In the first arm, we will provide participants with a printout of the guideline article containing the recommendation, while in the second arm, we will provide participants with a mobile app developed after formalizing the recommendation text into a clinical algorithm. Data will be collected using semistructured and open interviews to explore aspects of behavioral change and technology acceptance involved in the implementation process. The analysis will be comprised of two phases. During the first phase, we will conduct a template analysis to identify barriers and facilitators in each scenario. Then, during the second phase, we will contrast the findings from each arm to propose hypotheses about the potential impact of the system. RESULTS: We have formalized the narrative in the recommendation into a clinical algorithm and have developed a mobile app. Data collection is expected to occur during 2018, with the first phase of analysis running in parallel. The second phase is scheduled to conclude in July 2019. CONCLUSIONS: Our study will further the understanding of the role of mobile decision support systems in the implementation of clinical practice guidelines. Furthermore, we will provide qualitative evidence to aid decisions made by low- and middle-income countries' ministries of health about investments in these technologies.

Developing User Personas to Aid in the Design of a User-Centered Natural Product-Drug Interaction Information Resource for Researchers.

Pharmacokinetic interactions between natural products and conventional drugs can adversely impact patient outcomes. These complex interactions present unique challenges that require clear communication to researchers. We are creating a public information portal to facilitate researchers' access to credible evidence about these interactions. As part of a user-centered design process, three types of intended researchers were surveyed: drug-drug interaction scientists, clinical pharmacists, and drug compendium editors. Of the 23 invited researchers, 17 completed the survey. The researchers suggested a number of specific requirements for a natural product-drug interaction information resource, including specific information about a given interaction, the potential to cause adverse effects, and the clinical importance. Results were used to develop user personas that provided the development team with a concise and memorable way to represent information needs of the three main researcher types and a common basis for communicating the design's rationale.