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Data visualization tools become mainstream

We’ve come a long way from the hand drawn and photographed black and white graphs that were used to illustrate a key point in the days before computer graphics.

The techies among us were the first to play with color, line and movement to make data more intriguing, entertaining, and attractive, and data visualizations have progressed to the point of becoming reference resources rich in data about a given topic.

The Institute for Health Metrics and Evaluation has produced data visualizations on a range of topics. Particularly timely in the US, is this visualization showing personal health care spending by disease, type of care (ambulatory, inpatient, prescribed pharmaceutical, nursing facility, dental, and emergency), year, gender, and age group. We can see that in 2013 $18 billion was spent for pharmaceuticals for those under 20, compared to $112 billion spent for those 65 and over. In the group under 20, the greatest amounts were spent on mental and substance use disorders, followed by chronic respiratory diseases. In the group 65 and over, diabetes, treatment of risk factors, and cardiovascular diseases led the way.

Data visualizations keep coming

And publications are pouring out of these data visualization tools. A good example is the article by Roth et al, “Trends and patterns of geographic variation in cardiovascular mortality among US counties, 1980–2014” published in JAMA this past May. They estimate age-standardized mortality rates by county from cardiovascular diseases (CVD) for the United States.

Data visualizations help us understand causes of mortality.

US County-Level Mortality From Cardiovascular Diseases A, Age-standardized mortality rate for both sexes combined in 2014. B, Percent change in the age-standardized mortality rate for both sexes combined between 1980 and 2014

Making Real-World Evidence (RWE) Work for Kids

The increased attention given to Real-World Evidence is a welcome development

The National Academies of Science held a workshop last October, “Real-World Evidence Generation and Evaluation of Therapeutics—A Workshop”, bringing together key thinkers to examine opportunities and challenges for incorporating real-world evidence into evaluation of medical products. Regulatory experts and FDA scientists followed-up with a cogent discussion of RWE and its use in the regulatory setting published in the New England Journal of Medicine, “Real-World Evidence — What Is It and What Can It Tell Us?” They reported that “the FDA is developing guidance on the use of ‘real-world evidence’ — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.”

Real-world evidence and the regulatory process

NAS workshop reviews RWE

Kids stand to benefit

Real-world evidence is of special importance to children because we can’t always conduct randomized clinical trials in pediatric populations. Real-world evidence, from large databases, electronic health records, and similar sources, may be the only evidence we have about medications or devices used by children. All the more reason to make sure that real-world evidence meets the unique needs we have when studying children: adequate sample sizes for all age sub-groups, critical data such as birth date, birth weight, and gestational age, ability to link to parental (and even sibling) data, and linkage with school performance metrics.

As efforts increase to address the challenge of developing high-quality RWE, we must consider and address the special considerations and challenges in using RWE to answer questions about the effects of medications in children. Asking these questions now will ensure that advances in the use of RWE will benefit children as well as other sectors of the population.

See Tamar Lasky’s editorial in the journal Drugs – Real World Outcomes, “In the Real-World, Kids Use Medications and Devices”.

When genomic info is linked to the EHR record

We can explore associations between genes and phenotypes

Genomic information plus clinical information in a large database allows us to identify genes associated with disease variants and truly begin precision medicine. In pharmacoepidemiology this will mean that we can identify patients who benefit most or are at greatest risk of an adverse event from a specific treatment.

The power of linking genomic information with clinical information is demonstrated in a recent study by Karnes et al 2017. They examined variations in major histocompatibility complex (MHC) and human leukocyte antigen (HLA) genes by linking information from DNA biobanks databases with EHR records for almost 30,000 people. Most importantly, they discovered previously unidentified associations between gene variation and disease severity for several conditions. They identified associations with type 1 diabetes and ankylosing spondylitis, among other conditions. Most importantly, they discovered several previously unidentified associations with MS and cervical cancer, as well as associations between gene variation and disease severity for several conditions.

The heatmap crosstabulates HLA alleles with a range of disease diagnoses with darker reds being stronger positive associations (the allele increases the probability of having the disease or phenotype) and darker blues being stronger negative associations (the allele is associated with a protective effect against the disease or phenotype).

The authors note that this is one of the first systematic studies of clinical phenotypes with HLA variation in a single population.

Genomics EHR database

Heatmap of four-digit HLA allelic associations with P < 1 × 10?5.

Data are publicly available www.phewascatalog.org

Drug Utilization Research: Methods and Applications

New Text – a Valuable Resource

The recently published text, Drug Utilization Research: Methods and Applications, represents a formidable accomplishment, pulling together a comprehensive range of information on all topics related to this key area. With 48 chapters, it addresses study design, data collection, secondary data sources, classification systems, measurement units, drug expenditures, statistical methods, data visualization, and much more. I was happy to see a chapter addressing issues around pediatric drug utilization, and chapters on drug utilization of pregnant women and older populations, as well.

From the publisher’s website:

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics.

Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

The only way to assemble such a book is with a strong group of editors, Monique Elseviers, Björn Wettermark, Anna Birna Almarsdóttir, Morten Andersen, Ria Benko, Marion Bennie, Irene Eriksson, Brian Godman, Janet Krska, Elisabetta Poluzzi, Katja Taxis, Vera Vlahovi?-Pal?evski, Robert Vander Stichele are all accomplished researchers in this field.

Pediatric Pharmacoepidemiology at ICPE 2017 Annual Meeting

For the third year, the ISPE annual meeting (ICPE 2017 Montreal) will offer the pre-conference course in Pediatric Pharmacoepidemiology.

Mark your calendars for Sunday, August 27, 2017 (register here).

Brief Overview of Course

The increasing use of medications by children and the history of excluding children from clinical trials have created the need for pediatric pharmacoepidemiology, a sub-specialty within pharmacoepidemiology. Unique challenges in studying children, accessing data, defining outcomes, and designing studies require specialized methodologic skills and operational approaches. This half-day course will introduce participants who have a good understanding of pharmacoepidemiology to the specialized methodologic and operational approaches used to study medications in children.

Pediatric Pharmacoepidemiology

Age is not a simple variable when studying children

Educational Objectives

The course will be taught in an interactive format with ample opportunities for questions and discussion. Regulatory issues around use of medications in children will be highlighted throughout the course. Participants will gain an understanding of key issues in pediatric pharmacoepidemiology including:

  • An overview of pediatric pharmacoepidemiology and how it differs from pharmacoepidemiology in older age groups
  • Study design and databases to monitor safety
  • Defining, measuring and validating outcomes in pediatric pharmacoepidemiology
  • Variables critical to pediatric pharmacoepidemiology such as month of birth, seasonality, growth and development

Target Audience

ICPE attendees interested in gaining a basic understanding of the need for and approaches to pediatric pharmacoepidemiology.

Course Faculty/Presentations

  • Tamar Lasky, PhD Owner, MIE Resources Why Pediatric Pharmacoepidemiology? Age Sub-groups in Children: Methodologic Considerations
  • Alan Kinlaw, PhD Post-doctoral Research Fellow, Sheps Center for Health Services Research, University of North Carolina at Chapel Hill Leveraging granular birthdate information for studies of young children
  • Rachel E. Sobel, DrPH Senior Director, Epidemiology, Worldwide Research and Development / Pfizer Inc. Monitoring Drug Safety: Study Design, Data Sources and Case Study
  • Timothy Beukelman, MD, MSCE Associate Professor of Pediatrics, Division of Pediatric Rheumatology, Department of Pediatrics, University of Alabama at Birmingham The Need for Validation in Pediatric Outcomes
  • Daniel B. Horton, MD, MSCE Assistant Professor of Pediatrics and Epidemiology, Rutgers University Growth and Development: Variables of Particular Importance in Pediatric Pharmacoepidemiology

 

 

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