Agenda

If you plan to attend a course on Wednesday, we strongly recommend that you register on Tuesday evening to avoid delays. 

Please arrive 24 hours before your presentation start time to upload or check your presentation. 

Please arrive 24 hours before your presentation start time to upload or check your presentation. 

Title of course: Adherence to Medication

Brief overview of course:
Adherence to medication is indispensable for achieving clinical goals. Non-adherence is a complex and multifactorial problem leading to poor clinical outcomes, increased morbidity and death rates, and unnecessary healthcare costs. Assessing (non-)adherence is challenging since both subjective and objective measures are applied. This unit is aimed at introducing students to the various constructs of adherence behaviour and techniques to evaluate (non-)adherence and data analysis.

Educational Objectives:
1. To understand the different constructs of adherence behaviour and techniques to assess them.
2. To describe strengths and limitations of different techniques with respect to validity and implementation.
3. To select the assessment technique(s) most appropriate for the research objective.
4. To understand issues linked to the use of (non-)adherence and biomedical outcomes and (non-) adherence itself as an outcome for intervention studies.

Target Audience:
Entry level.

Course Faculty/Presentations:

1. Principles of adherence. (Julie Lauffenburger)
Students will be introduced to the definitions and taxonomy of adherence to medication, as well as to the various types and causes of non-adherence. Subjective and objective measures used to quantify (non-)adherence, and challenges in the analysis of outcomes will be presented. How adherence research relates to pharmacoepidemiology will also be addressed.

2. Subjective measurements. (Jacqueline Hugtenburg)
Students will be introduced to the use of self-report techniques, such as structured interviews and questionnaires, used in adherence research. A variety of common questionnaires and what they assess will be discussed. An example of analysis of data using techniques from pharmacoepidemiology is presented.

[BREAK, 15 minutes]

3. Objective measurements. (Job van Boven)
Students will be introduced to the use of objective measurements, including pill counts, electronic measurements, and the use of prescription and refill databases. Techniques and considerations for analysing data taking the definitions and constructs of adherence (initiation, implementation, persistence) into account will be presented.

4. Measurement and modelling techniques. (Jessie Franklin)
Examples showing calculations and decisions to make using medication possession-based adherence measures (new users, prevalent users, which medications, follow up, metrics) as well as trajectory techniques to summarize adherence will be presented.

[BREAK, 15 minutes]

5. Interactive case study. (Petra Denig)
Using an example of a study among diabetes patients using multiple drugs, students are guided through the subsequent steps in making decisions concerning measurements and analyses of data. The influence of a variety of assumptions and decisions is shown, and students are guided through the process of data preparation and transformation needed for adherence calculations.

[WRAP UP, summarizing the strengths and limitations of different techniques]

Title of course: Effective Risk Management: Best Practices for Designing, Implementing and Evaluating Risk Minimization Programs

Brief overview of course:
This half-day course presents an overview of risk management principles, with a focus on best practice methods for designing, implementing and evaluating risk minimization programs. The didactic section will feature experts from regulatory, industry, academia and research organizations who will present the regulatory context, methods, and examples of effective risk minimization program design, implementation and evaluation techniques. The interactive workshop section will provide an opportunity for participants to actively apply what they have learned via a case study approach.

Educational Objectives:
1. To describe the current regulatory requirements for risk minimization programs in the United States and Europe;
2. To describe state-of-the-art approaches to designing risk minimization tools and programs;
3. To present concepts from implementation science to improve risk minimization program design, implementation, and evaluation;
4. To provide an overview of research designs and methods to use in evaluating risk minimization program effectiveness;
5. To provide an opportunity for applied learning in the design and evaluation of risk minimization measures in the United States and Europe via a case study approach.

Target Audience:
Intermediary. The target audience is epidemiologists with basic knowledge of risk management, responsible for developing risk management plans and/or designing, implementing or evaluating risk minimization tools and pharmacovigilance and regulatory professionals who are involved with reviewing, and negotiating risk management plans and their assessments. Prior completion of previous ICPE Introduction to Risk Management Course helpful but not mandatory. Supplementary pre-course materials will be available.

Course Presentations:

1. Background and Real-world examples of Risk Evaluation and Mitigation Strategies (REMS) in the US from a regulatory perspective
2. Designing Effective Global Risk Minimization Programs, from an industry perspective
3. Risk Communication and Implementation, Strategies for Developing Effective Risk Minimization tools
4. Risk Minimization Implementation Strategies, Examples in Europe
5. Considerations for Evaluation of the Effectiveness of Risk Minimization Tools

Introduction to Pharmacoepidemiology

Brief Overview of Course:

This course will provide participants with a succinct introduction to the basic principles, concepts, and study designs of pharmacoepidemiology. The course includes lectures on (1) cohort studies, (2) case-control studies, as well as (3) confounding and other sources of bias.

Educational Objectives:
• Appreciate the basic features of the cohort design and its application in pharmacoepidemiology.
• Appreciate the basic features of the case-control design and its application in pharmacoepidemiology.
• Recognize the basic types of bias (confounding, selection bias, measurement bias) in pharmacoepidemiological studies. Understand how these biases are introduced and how they can be avoided by design or controlled during analysis.

Target Audience:
Entry level. Designed for delegates who are new to pharmacoepidemiology or those who want a succinct refresher of the field's core concepts.

Course Faculty/Presentations:

1. Cohort studies (Almut Winterstein)
Students will be introduced to the basic features of the cohort study design and will appreciate how the design is implemented in pharmacoepidemiological studies.

2. Case-control studies (Sonia Hernandez-Diaz)
Students will be introduced to the basic features of the case-control study design (including self-controlled designs) and will appreciate how the design is implemented in pharmacoepidemiological studies.

3. Bias and confounding (Tobias Gerhard)
Students will be introduced to the three basic types of bias in pharmacoepidemiological studies (confounding, selection bias, and measurement bias). Students will appreciate how these biases are introduced and how they can be avoided by design or controlled during analysis.

Title of course: Pragmatic Trials: Design, Methods, and Implementation

Brief overview of course:

1. Course Aim

Pragmatic randomized clinical trials (pRCTs) require the expertise of pharmacoepidemiologists who understand considerations and methodologic challenges that arise with more “pragmatic” RCTs compared with traditional “explanatory” RCTs.  This course will highlight issues such as real-world site and patient identification, enrollment and retention, ethical review issues, approach to randomization, selection bias, and defining the appropriate comparator.  In addition, choice of study design including cluster randomization, step wedge design or individual randomization, and associated analytic considerations will be highlighted.  Randomizing patients to “standard of care (SOC)”, accounting for changes in therapies over time, and other methodological considerations will also be discussed.  Operational challenges and lessons learned from conducting pRCTs will be shared along with case examples from pRCTs funded by the Patient Centered Outcomes Research Institute (PCORI) and the Salford Lung Study, funded by GlaxoSmithKline.

2. Requisites Statement

Entry level, though familiarity with basic principles of observational and/or experimental study design and statistical methods is recommended.  Recommended pre-course reading material will also be provided.

3. Course Objectives

• To understand key design considerations for pRCTs and drivers of design choices (including cluster randomized vs. patient level randomization)
• To understand statistical issues for the analyses of pRCTs
• To understand considerations pertaining to primary data collection vs use of secondary data sources
• To identify and address operational considerations and challenges in implementing pRCTs

4. Syllabus Outline

1. Overview and Introduction to Pragmatic Trials-J Christian
To introduce attendees to the rationale and context for conducting pRCTs, a high level overview, explanation of the PRECIS criteria, pivotal studies and articles, and examples of impact with different stakeholders will be discussed.

2. Study designs for pragmatic trials – P Velentgas
The following topics related to study designs and outcome selection for pragmatic trials will be addressed: patient-level and cluster randomized designs, cross-over trials, blinding, inclusion and exclusion criteria, choice of comparators, data collection and outcome selection.

3. Statistical analyses for pragmatic trials – C Girman
Analytic methods related to pragmatic trials will be reviewed, including different considerations related to randomization, sample size estimation for cluster randomized and stepped wedge designs, appropriate analysis methods, and non-inferiority vs. superiority hypothesis testing.

4. Recent case examples of pragmatic trials funded by PCORI – A Trontell
Dr. Trontell will provide an overview of some of the recently completed PCORI-funded pragmatic trials, focusing on unique features of PCORI’s approach and challenges of implementation. Investigator feedback on challenges in pragmatic trials and a patient-centered approach to design of such trials will also be given.

5. Salford Lung Study Case Example – K Davis
Dr. Davis will provide a brief overview and description of the Salford Lung Study, a pioneering case example of a pragmatic trial, comprising two phase 3 real-world pragmatic randomized trials evaluating once-daily inhaled fluticasone furoate (FF) combined with vilanterol (VI) in patients with COPD or asthma in Salford, United Kingdom and leverages both primary data collection and an integrated EMR system.

Brief overview of course:
This course, sponsored by the Molecular Epidemiology, Biomarkers, and Pharmacogenomics (MEBP) SIG will focus on the essentials every pharmacoepidemiologist should know about real world applications of pharmacogenomics epidemiology including (1) the role of epidemiology in pharmacogenomics (pre-course video); (2) definitions of genetic terms and basic genetic concepts (pre-course video); (3) quality control and analytical procedures required in a pharmacogenetic analysis; (4) step-by-step planning guide to designing a pharmacogenomic analysis; (5) phenotyping considerations and breaking down examples of pharmacogenomic successes; (6) databases available to study pharmacogenomics; (7) designing a companion pharmacogenomic diagnostic in drug development; (8) designing a prospective observational cohort or case-control study of pharmacogenomics; (9) designing a clinical utility trial: a guide with examples; (10) clinical utility and policy issues: a debate.

Educational Objectives:
• To understand basic genetic and pharmacogenomic terminology.
• To understand how pharmacogenomics research relates to the current focus on Precision Medicine (aka Personalized Medicine), using real world examples.
• To better understand the study design and methodologic approaches, their strengths and weakness used in pharmacogenomic epidemiology, specifically in relation to clinical applications.
• To understand the role that pharmacogenomics can play in pharmacovigilance and comparative effectiveness research
• To gain knowledge about some available databases with linkage with genomic information
• To understand the benefits and challenges of pharmacogenomics in pharmacoepidemiology in both research and clinical practice applications.

Target Audience:
Entry level.

Attendees should have basic knowledge of pharmacogenomics, or have watched the pre-Course Videos (Available Online only)
• The convergence of Pharmacoepidemiology and Precision Medicine [Gillian Bartlett]
• A Primer on Genetic Terms and Basic Concepts [Geoffrey Liu]

Course Faculty/Presentations:

8:00 am-8:10am: Welcome and Introduction [Amalia Issa]
• Quick introduction of the topics and course logistics and faculty members.

8:15am-8:55am: Precision Medicine in the Real World Needs Pharmacogenomic Epidemiology [Amalia Issa]
• Will provide an overview of pharmacogenomics and how pharmacoepidemiologists can contribute meaningfully to precision medicine, including the methodologies, current status, and future direction.s Will discuss real-world examples, and share the experience of working as a pharmacoepidemiologist in industry, government, and academia.

8:55am-9:35am: What You Need to Consider When Applying Pharmacogenomic Research into Clinical Practice [Bruce Carleton]
• Will present up-to-date state of the science and describe real-world clinical applications.

9:35am-9:50pm: Bio Break
9:50am-10:30am: Pharmacoepidemiologic Methods in Genomics Research: It’s all about the application [Anke-Hilse Maitland van der Zee]
• Will discuss robust pharmacoepidemiologic methods for use in pharmacogenomics research.
• Will introduce different databases with both rich clinical, treatment, outcomes information and genomic information Will compare the pros and cons of different databases to guide future database selection and research.
10:30am-11:00am: Clinical Utility Research and Pharmacogenomics: Trials and Tribulations [Stephen Kimmel]
• Will share the roles, responsibilities and contributions of a pharmacoepidemiologist in pharmacogenomic clinical trials and provide up-to-date examples of recent and ongoing trials.
•
11:00am-11:10am: Bio Break
11:10am-11:55am: DEBATE: Clinical Utility and Policy Issues: The Many Meanings of “Utility” [Amalia Issa vs. Bruce Carleton]
• This popular feature of the course will focus on the latest hot topic related to clinical utility and will evolve as we get closer to the date of the course to reflect the latest findings. As always, it will be a highly engaging and interactive debate and discussion with ample active audience participation.

11:55am-12:10pm: Closing Remarks [Gillian Bartlett]
• Final summary of what are covered in the afternoon course, and collect ideas for future courses

Title of course: The Use of Pharmacoepidemiology to Study Rare Diseases during the Lifecycle of Drug Development

Brief overview of course:
There are over 7,000 rare diseases which affect more than 350 million people worldwide, only 5% of rare conditions have an FDA approved drug treatment. Over the past years, an increasing number of companies have devoted clinical programs to develop new treatments for patients with rare disorders. This creates the need for rare disease epidemiology, as a sub-specialty within pharmacoepidemiology. This unit is aimed at introducing students to the specific methodologic issues arising in rare disease epidemiology and practical approaches used to integrate pharmacoepidemiogic methods/research into rare disease drug development programs.

Educational Objectives:
1. Provide an overview of definitions and regulatory environments for rare disease therapeutic products
2. Highlight specific methodologic issues arising in rare disease epidemiology
3. Discuss establishment of disease registries for studying natural history of rare diseases and long-term outcomes of drug products
4. Discuss use of electronic medical records, claims databases, natural language processing and data linkage for rare disease research
5. Discuss use of biomarkers in drug development for rare diseases
6. Outline practical approaches used to integrate pharmacoepidemiologic methods into rare disease drug development programs

Target Audience:
Entry level.

Course Presentations:

1. Regulatory environment for rare disease drug development
Students will be introduced to the current regulatory environments for rare disease therapeutic products, including the FDA Orphan Drug Act and EMA Adaptive Pathway. These regulations support drug development in therapeutic areas where evidence generation is challenging and offer an approach to bringing promising medicines to patients with an unmet need in a timely manner.

2. Rare disease definitions and specific methodologic issues in rare disease epidemiology
Students will be introduced to the rare disease terminology and definitions around the world, as well as unique challenges for studying rare disease products throughout the life cycle of development. Challenges for rare disease drug development include: poorly characterized natural history of the disease, small numbers of patients, phenotypic diversity within a disorder which adds to its complexity, lack of well-defined and validated endpoints, outcomes measures and biomarkers, and ethical consideration for children in clinical trials.

3. Integration of pharmacoepidemiologic methods into rare disease drug development programs
Students will be intoduced to use of epidemiologic methods for rare disease drug development, including availability of disease registries for natural history of rare diseases, use of electronic medical records, and claims databases, and data linkage for rare disease research. Natural language processing method will also be discussed. This session will also present role of pharmacoepidemiology and application of research methods throughout the product life cycle of therapeutic products for rare diseases

4. Electronic medical record and healthcare databases for rare diseases epidemiology and natural history studies
Students will be introduced to European data resources, including electronic healthcare databases and registries, as well as their strengths and limitations in studying rare disease epidemiology and natural history. A case study on amyotrophic lateral sclerosis will be described.

5. Biomarkers in drug development for rare diseases
Students will be introduced to use of biomarkers in drug development for rare diseases, including serving as surrogate endpoints for disease diagnosis. Potentials and challenges of biomarkers in rare disease research will also be discussed.

Open to ISPE members; members may contact info@pharmacoepi.org if they would like to attend. 

Title of course: Cancer Pharmacoepidemiology and Genomics: What You Should Know in the Era of Precision Medicine

Brief overview of course:
This course, co-sponsored by the Molecular Epidemiology, Biomarkers, and Pharmacogenomics and Oncology SIGS, will focus on the essentials every pharmacoepidemiologist should know about real world applications of cancer personalized medicine including precision medicine, companion diagnostics, biomarkers and the biomarker development pipeline, and linking databases with genomic information.

Educational Objectives:
• To acquire an overview of pharmacogenomics in cancer research, and how epidemiologists and real world studies make contributions.
• To understand better target therapy in cancer research and oncology drug development, including the use of biomarkers and companion diagnostics
• To gain knowledge about oncology databases with linkage with genomic information
• To understand the benefits and challenges of cancer pharmacoepidemiology in both the research and clinical practice applications.

Target Audience:
Entry level. Attendees should have basic knowledge of pharmacogenomics, or have watched the pre-course Videos Available Online only
• The convergence of Pharmacoepidemiology and Precision Medicine [Gillian Bartlett]
• A Primer on Genetic Terms and Basic Concepts [Geoffrey Liu]
• Cancer Terminology and the Science of Cancer Drug Development [Geoffrey Liu]

Course Faculty/Presentations:

1:30pm-1:40pm Welcome and Introduction [Bruce Carleton]
• Quick introduction of the topics and faculty members for the afternoon courses.

1:40pm-2:20pm Pharmacogenomics in Cancer Research [Bruce Carleton]
• Will provide an overview of pharmacogenomics in cancer research, including the history, current status, and future directions of pharmacogenomics in cancer search. Will share examples of how pharmacogenomics research help cancer patients’ prevention, treatment, survival, and safety.

2:20pm-2:50pm Cancer Pharmacogenomics: It’s Not Just Germline Anymore [Andrew Freedman]
• Will introduce some unique aspects of cancer pharmacogenomics in comparing with other diseases, focusing on somatic biomarkers including mutations, gene or protein expressions, and target discovery and therapies.

2:50pm-3:00pm Bio Break
3:00pm-3:35pm Pharmacogenomics and target therapy in oncology drug development [Wei Zhou]
• Will introduce the basic concept of oncology drug development, pharmacogenomics and target therapy in oncology, and provide examples of epidemiologist’s contribution to oncology drug development

3:35pm-4:05pm Linking genomic information with databases in cancer research [Kelly Filipski]
• Will introduce different databases with both rich clinical, treatment, outcomes information and genomic information, and the rapid development and utilization of those databases in cancer research. Will compare the pros and cons of different databases to guide future database selection and research.

4:05pm-4:35pm The expanding roles of cancer pharmacoepidemiologists in industry [Leah Sansbury]
• Will share the roles and responsibilities of a cancer pharmacoepidemiologist in industry, real-world examples of what a pharmacoepidemiologist “does” supporting the oncology pipeline in industry, and sharing the experience of working as a pharmacoepidemiologist in industry, government, and academia

4:35pm-4:50pm Bio Break
4:50pm-5:20pm Precision Medicine in Cancer: Panel Discussion Q and A: [Moderators Gillian Bartlett and Geoffrey Liu]
• This is a panel discussion with all course faculty included. This will provide unique opportunities for students to ask questions on the topics included in the course, or any other topics they are interested. The course faculty will also prepare several questions and topics to stimulate the discussions, and may debate from different aspects and views.

5:20pm-5:30pm Closing Remarks [Andrew Freedman]
• Final summary of what are covered in the afternoon course, and collect ideas for future courses

Title of course: Comparative Effectiveness Research: Real-World Evidence in Health Technology Assessment

Brief overview of course:
Comparative effectiveness research (CER) is increasingly important for generating real-world evidence (RWE) to inform clinicians, patients, regulators, and other decision makers. Some policy makers are reluctant to use real-world evidence to inform health technology assessments (HTA). This year’s course will start with an overview of how CER and RWE can enhance HTA, describe CER methods for generating evidence using real-world data, and will discuss how real-world evidence can be used in the changing regulatory landscape. Multiple case studies will be used to facilitate an interactive group discussion and will address how observational, real-world data can be used to evaluate the properties, effects, and impacts of health technology.

Educational Objectives:
• Recognize growing opportunities for comparative effectiveness evidence in the context of health technology assessment
• Understand biases that commonly occur in comparative effectiveness evaluations and strategies for overcoming these biases
• Describe challenges to using comparative effectiveness and real-world evidence for informing treatment and policy decisions

Target Audience:
Entry level.

Course Presentations:

1. An overview of health technology assessment and the potential role for CER and RWE
This lecture will introduce the concept and role of HTA in policy decision-making. Students will be provided a high-level overview of CER and RWE, how it fits into the HTA framework, and the challenges facing RWE for decision-making.

2. Introduction to case studies
Course faculty will introduce the two cases studies that will be discussed later in the course. Participants will be asked to think about the case studies during the subsequent lecture.

3. Frequently observed biases and investigator errors that are avoidable in CER
This lecture will provide an overview of pharmacoepidemiologic approaches to CER using RWE. Special attention will be given to challenges and solutions facing the analysis of observational real-world data.

4. Case study 1 and interactive discussion
Course faculty will facilitate an interactive discussion in which participants will be able to apply the learnings of the previous lectures in the context of a real-world case study.

5. Case study 2 and interactive discussion
Course faculty will facilitate an interactive discussion in which participants will be able to apply the learnings of the previous lectures in the context of a real-world case study.

6. Discussion about future directions for real-world evidence
Course faculty will facilitate an interactive discussion about the future of real-world evidence in health technology assessment.

Title: ISPE Newcomers/Early Stage Investigator Pharmacoepidemiology Workshop 2018

South Hall 1

Ticket required.

Title of course: ISPE Newcomers/Early Stage Investigator Pharmacoepidemiology Workshop 2018

Brief overview of course:
This ICPE Pre-Conference Course is aimed at early stage pharmacoepidemiologists who have been in the field for less than 3 years. Participation will lead to enhancement in research skills (i.e., grant writing, research presentation, and manuscript writing) and professional development (development of mentor-mentee relationships, enhancing creativity/productivity, professional networking) that are crucial to early success in pharmacoepidemiology.

Educational Objectives:
• Establish more effective relationships with mentors for research and career development
• Improve delivery of oral research presentations 
• Improve writing skills for research manuscripts
• Enhance success in grant writing
• Develop productive strategies for success in the early stages of careers in pharmacoepidemiology

Target Audience:
Entry level.

Course Faculty/Presentations:

Workshop Session 1: The Pharmacoepidemiologist’s Toolbox: Important Research Skills (2 hours) 
Presentation 1: Effective research grant writing (30 min.) Almut Winterstein: This presentation will 
Presentation 2: Preparing an effective oral research presentation (30 min.) Tarek Hammad
Presentation 3: Tips for successful manuscript writing (30 min.) Darren Toh
Presentation 4: Managing your pharmacoepidemiology research team (30 min.) Vincent Lo Re
Break (5 min.)
Workshop Session 2: Developing a Successful Early Career in Pharmacoepidemiology (1¾ hours)
Presentation 5: Establishing productive mentor-mentee relationships (25 min.) Vincent Lo Re
Presentation 6: Enhancing creativity/productivity in pharmacoepidemiology (30 min) Vincent Lo Re
Presentation 7: Professional networking in pharmacoepidemiology (30 min) Caitlin Knox
Presentation 8: How to get the most out of the early stage of your career in pharmacoepidemiology (15 min) Nicolle Gatto
Panel Discussion - All Speakers (15 min)

Presenters:

• Ataher, Quazi
• Hammad, Tarek
• Knox, Caitlin
• Lo Re, III, Vincent
• Sengwee, Toh
• Winterstein, Almut

Title of course: Using Field Studies to Value-Add in Pharmacoepidemiology

Brief overview of course:
This course provides basic theory and practical tips in conducting pharmacoepidemiologic studies when required information is not captured in databases or when large databases are not available. Common study designs used to collect data through observations, medical records or questionnaires will be presented and the strengths and limitations of working without large databases discussed. Hands on experience via a workshop will expose course participants to different study designs and rich discussions on how to answer relevant questions about safety and utilization of medicines in primary and secondary care settings using field studies.

Educational Objectives:
• To analyze common study designs of pharmacoepidemiologic studies without large databases
• To discuss strengths and limitations of different study designs and data collection methods
• To identify strategies to improve quality and reliability of pharmacoepidemiological studies conducted without large databases

Target Audience:
Entry-level. Basic knowledge of pharmacoepidemiology required. No mandatory pre-course preparation necessary.

Course Faculty/Presentations:
In the first presentation, the students will be introduced to strengths and limitations of different study design and methods of data collections in pharmacoepidemiology. The following presentations highlight examples of research studies that use original data collection to augment the information availability via electronic database. The presentations are followed by a workshop in which students in small group design a study using original data collection to answer to given research question.
1. Annie Fourrier-Reglat, PhD, Inserm Unit 1219, University Bordeaux, France
Rationale, methodological considerations for studies done without large databases: experiences from a variety of diseases and health systems contexts
annie.fourrier-reglat@u-bordeaux-.fr

2. Katja Taxis, MSc, PhD, Department of Pharmacy, Unit of PharmacoTherapy-Epidemiology & -Economics, University of Groningen, The Netherlands
Common study designs used to collect data through observation, medical records or questionnaires
k.taxis@rug.nl

3. Lisa Pont, BSc, BPharm, PhD, Australian Institute of Health Innovation, Macquarie University, Australia
Field studies to value add in pharmacoepi: focus on efficiency in study design
Lisa.Pont@uts.edu.au

4. Veronika Wirtz, MSc, PhD, Boston University School of Public Health, USA
Course moderator and facilitator
vwirtz@bu.edu

Title of course: Using Pharmacoepidemiology Database Resources to Address Drug Safety Research

Brief overview of course:
Pharmacoepidemiology requires the utilization of database resources to evaluate drug safety. This course will define the different types of data resources available for pharmacoepidemiology and the selection criteria to select the most appropriate resource. The course focuses on the Guidelines for good database selection and use in pharmacoepidemiology research, provides an overview of available resources, addresses the need for outcome validation, and highlights data linkage considerations.

Educational Objectives:
• To review the Guidelines for Good Database Selection and use in Pharmacoepidemiology Research.
• To gain an understanding of available pharmacoepidemiology resources
• To develop the skills to select an appropriate resource to conduct pharmacoepidemiology research
• To examine validation methods for assessing the quality of electronic medical record and administrative data
• To provide an overview of data linkage of available pharmacoepidemiology resources particularly to patient registry data resources

Target Audience:
Intermediate level course. The course assumes attendees have either taken entry level pharmacoepidemiology courses at ISPE or through didactic course work.

Course Faculty/Presentations:

1. Overview of Database use in Pharmacoepidemiology {45 minutes}
Gillian Hall, PhD, Independent Consultant
The presentation will review the ISPE Guidelines for good database selection and use in pharmacoepidemiology research. The focus will be on application of the guidelines in a topically updated portfolio of pharmacoepidemiology studies.
2. Selection of Databases for Pharmacoepidemiology Research {45 minutes}
Matthew Reynolds, PhD, Vice President, Scientific Development, Evidera
The presentation will review available resources updated to reflect the dynamic changes to the availability of resources across an international landscape.
3. Database Selection Workshop Activity {15 minutes}
Kevin Haynes, PharmD, MSCE
An interactive coffee break in which participants are distributed index cards with database resources and pharmacoepidemiology specific aims and asked to mingle during the coffee break to pair up and report back on the pairs created.

4. Data Validation Approaches in Pharmacoepidemiology {45 minutes}
Daniel Beachler, PhD, HealthCore, Inc.
An overview of the various approaches available to conduct validation studies. The presentation will focus on the mechanics of medical record validation studies and the impact on bias analyses within pharmacoepidemiology studies.
5. Linking Pharmacoepidemiology Resources {45 minutes}
Sudha Raman, PhD, Duke University
The lecture will provide guidance on key aspects of data linkage appropriateness and feasibility necessary to plan useful and sustainable linkages that advance pharmacoepidemiology and patient safety. The presentation will highlight recent advances undertaken across the society.

Please arrive 24 hours before your presentation start time to upload or check your presentation. 

Title of course: Epidemiology of Vaccine Safety

Brief overview of course:
Background
Vaccines are key tools for global public health. Increasingly, pharmacoepidemiological studies are providing critical evidence needed for risk-benefit assessment to inform immunization policy, both for mature immunization programs and for low-and middle-income countries (LMIC) for which innovative vaccines against challenging diseases (e.g., dengue, Ebola, malaria, etc.) are under development. The annual ICPE has had vaccine-specific sessions for ~15 years and ISPE has a Vaccine Special Interest Group (VAXSIG) since 2014. One of the VAXSIG goals is to offer educational activities on vaccine-related epidemiology, in collaboration with the ISPE Education Committee. The VAXSIG pre-conference course has been offered since the 2015 ICPE.

Content
This half-day (~4 hours with break) course aims to establish an understanding of some of the ways in which vaccine safety and effectiveness are monitored after licensure, including passive surveillance methods with a focus on LMIC, innovative data-mining methods, common observational vaccine safety and effectiveness study designs, and statistical aspects. The course involves lectures with a combination of presentations and examples, and opportunities for audience participation (questions and discussion).

Educational Objectives:
Upon completing this course, participants will be able to:
1. Explain the need for vaccine safety and surveillance studies.
2. Understand the key concepts of vaccine safety surveillance in LMIC.
3. Understand the difference between spontaneous reporting systems and population-based linked data systems for conducting vaccine safety surveillance, and when each should be employed.
4. Understand the unique features of the data-mining method that uses the tree-temporal scan statistic.
5. Describe the most common observational vaccine study designs and understand the main study methods and challenges.
6. Describe in general terms the statistical methods used with the most common observational vaccine study designs, including self-control designs.

Target Audience:
Entry-level to Intermediate. assumes knowledge of basic epidemiologic concepts. Target audience will be ICPE attendees interested in gaining an understanding of the epidemiology of vaccine safety.

Course Presentations/Faculty:

• S. Rizwan Ahmad, MD, MPH, FISPE, FCP, Georgetown University, USA: Introduction to the course
• Robert T. Chen, MD, MA, Atlanta GA, USA : Introduction to vaccine preventable diseases and vaccine safety
• Rebecca E. Chandler, MD: UMC WHO, Sweden: Spontaneous reporting and safety surveillance in LMICs
• Katherine Yih PhD, MPH, Harvard Pilgrim Health Care Institute, USA: Data-mining for vaccine adverse events using the self-controlled tree-temporal scan statistic
• Patricia Saddier, MD, PhD, Merck, USA: Observational vaccine safety study designs
• Bruce H. Fireman, AB, Kaiser Permanente Vaccine Study Center, USA: New twists on statistical methods for surveillance of vaccine safety and effectiveness

Title of course: Intermediate Pharmacoepidemiology: Approaches to Unmeasured Confounders

Brief overview of course:
This half-day interactive course will introduce students to multiple approaches to addressing unmeasured confounders through study design and analysis, the requirements and assumptions of each, and an opportunity to compare these approaches through facilitated discussion of a case-study.

Educational Objectives:
1. Identify common unmeasured covariates in pharmacoepidemiology and the types of bias that can result.
2. Describe multiple approaches to addressing unmeasured covariates in pharmacoepidemiology through study design and analysis.
3. Understand the assumptions of each approach, ways of evaluating these assumptions, and when they are likely to be violated.
4. Compare these methods in a novel setting to identify trade-offs and considerations.

Target Audience:
Intermediate. A basic understanding of pharmacoepidemiology study designs, data sources, and confounding are needed for this intermediate-level course.

Course Presentations/Faculty:

1. Use of study design to control unmeasured confounding
During this group of presentations, Drs. Lund, Raman, and Gokhale will introduce three ways in which study design can be used to limit bias due to unmeasured confounding: a) the active comparator new user (ACNU) design, b) self-controlled designs, and c) instrumental variable designs. Faculty will provide foundational knowledge about each approach illustrated through real-world examples in a lecture format with an opportunity for discussion and questions.

2. Analytic approaches to unmeasured confounding
During the second group of presentations, Drs. Lund, Stürmer, and Jonsson Funk will introduce three analytic approaches to reduce bias due to unmeasured confounding: a) proxy measures, b) external control for confounding, and c) quantitative bias analysis. Faculty will provide foundational knowledge about each approach illustrated through real-world examples in a lecture format with an opportunity for discussion and questions.

3. Interactive Case Study.
Led by Dr. Jonsson Funk, the interactive case study will pose a hypothetical research question and engage students in thinking about the likely unmeasured covariates, considering how each of the approaches might be used in that setting, and weighing the pros/cons of each. This case-study will provide integration across the approaches and give students an opportunity to work through the selection of an appropriate strategy for addressing important unmeasured covariates in light of real-world constraints.

Title of course: Introduction to Drug Utilization Research

Brief overview of course:
This educational session provides an overview of drug utilization research (DUR) and presents essential methods used. The session includes interaction with participants, question, and answer sessions and discussion during and at the end of each presentation. At the end of the session, the participant will be exposed to:

• Description of the theoretical framework and practical applications of different methods illustrated using selected examples
• Classification systems used in drug utilization monitoring and research
• Limitations of data sources and methods
• Interpretation of aggregate and individual-based data, variation and change
• Using drug utilization research for public health and implications for policy decisions

Educational Objectives:
1. To provide an overview of Drug Utilization Research within the context of Pharmacoepidemiology, Health Services Research and Public Health
2. To describe fundamental principles for classifying and quantifying drug use and to provide an understanding of the methodological challenges
3. To provide the basic knowledge and understanding of epidemiological measures of drug use and study designs based on individual patient data
4. To describe methodological and policy issues in Drug Utilization Research

Target Audience:
Entry level. This course is targeted at:
1. New members of the DUR / health services research (HSR) Special Interest Group (SIG) and graduate students new to DUR/HSR
2. Those interested in drug utilization research who need an overview of the area
3. Those interested in monitoring of medicine use and quality assessment
4. Those working in health care organizations involved in payment and reimbursement of medicines, medicines policy areas, or planning of health services

Course Presentations/Faculty:

Welcome to DUR / HSR SIG from DUR Chair
Veronika Wirtz, Associate Professor, Department of Global Health, School of Public Health, Boston University

Lisa Pont, Associate Professor, University of Technology Sydney, Australia, University of Groningen, The Netherlands
Introduction to Drug Utilization Research: Methodological Framework and Skills Needed

Solveig Sakshaug, Senior Advisor, WHO Collaborating Centre for Drug Statistics Methodology, Norwegian Institute of Public Health, Oslo, Norway
The Anatomical Therapeutic Chemical Classification and the Defined Daily Dose Methodology: Classifying and Quantifying Drug Use.

Bjorn Wettermark, Professor, Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm, Sweden
Drug Utilization Research and Monitoring in Individual Based Registers – Study Designs and Epidemiological Measures of Drug Use.

Ria Benko, Institute of Clinical Pharmacy, University of Szeged
Drug Utilisation in Practice: Drug Utilisation to Inform Drug Policy-Eastern European Perspectives

Title of course: Modern Pregnancy Pharmacoepidemiology: Minimizing Biases in Various Study Designs

Brief overview of course:
In this half day course, students will be presented the various study designs that are used in research on drug safety in pregnancy. For each of the study designs, challenges with respect to the valid measurement of exposures, outcomes and confounding will be discussed, along with proposed solutions to minimize bias.

The course will consist of four presentations by faculty, with an interactive approach using mobile technology to engage course participants in the discussion. One publication illustrative of each study design will be proposed as pre-reading materials for course registrants a few weeks before the conference.

The content of this course has changed from previous years. In 2015, the course provided an overview of issues that are particular to drug safety research in pregnancy. In 2016, the course focused on challenges related to exposure measurement, and in 2017 the focus was on maternal and neonatal outcomes. This year, the focus will be on study designs, their challenges and solutions.

Educational Objectives:
1. To be better equipped to critically assess the validity of studies on drug safety in pregnancy
2. To be able to describe the specific advantages of different study designs
3. To gain knowledge and skills related to approaches to address potential biases in different study designs.
Target Audience:
Intermediate.

Course Presentations/Faculty:

1. Overview of study designs
This session will provide an overview of designs for drug safety in pregnancy and lay out challenges and potential biases related to exposure, outcome and confounding in these designs, and in studies that combine data sources with different designs. Specifics of each design will be explored in more detail in subsequent presentations.
Instructor: Andrea Margulis, RTI Health Solutions.
2. Pregnancy exposure registries and other prospective studies
This session will describe pregnancy exposure registries and other prospective studies, focusing on the topics of this course: biases related to exposure, outcome and confounding; approaches to reduce these potential biases will be discussed.
Instructor: Sonia Hernandez-Diaz, Harvard T.H. Chan School of Public Health
3. The role of case-control studies in medications in pregnancy research
During this session students will learn about the information case-control studies can provide and the important role it fills in providing doctors and their patients with a complete picture based on a variety of study designs. The advantages and challenges of this study design will be discussed, especially with regards to medication use and pregnancy outcomes.
Instructor: Jennita Reefhuis, Centers for Disease Control and Prevention
4. The role of large administrative databases in medications in pregnancy research
This lecture will describe the increasing role of large administrative databases when studying the safety of medications in pregnancy, and will discuss recommended approaches to minimize potential biases related to exposure and outcome assessment, as well as confounding in these secondary data. Special emphasis will be placed on opportunities and challenges with respect to the study of long-term outcomes.
Instructors: Brian Bateman and Krista Huybrechts, Brigham and Women’s Hospital, Harvard Medical School.

Title of course: Practical Skills in Protocol Writing and Statistical Analytic Programming Relevant to Pharmacoepidemiology

Brief overview of course:
Pharmacoepidemiologic studies that involve the use of electronic healthcare data have complex and unique characteristics that must be taken into consideration when planning and conducting these types of studies. This highly interactive course will engage participants in the following topics:
1. Pre-specifying study components of a protocol, including design, analysis, and reporting of the study, along with a science-based rationale for the choices pertaining to these components; and
2. Translating elements of the study protocol into a statistical analytic program.

Educational Objectives:
• To introduce a framework for translating study questions into a clear and detailed protocol supported by a rational thought process that is tailored to available data for pharmacoepidemiologic studies using electronic healthcare data
• To develop skills in health care data manipulation to support the conduct of a statistical analysis
• To translate a pharmacoepidemiologic study protocol into a statistical analytic program.

Target Audience:
Intermediate. An understanding of basic statistical programming language is required. The course content is complementary to the “Introduction to Pharmacoepidemiology” class. Prior attendance of the “Introduction to Pharmacoepidemiology” class is encouraged, although not required

Course Presentations:
The first part of the class will start with the presentation of an example protocol for a hypothetical case. Using this example, we will walk through a study protocol with substantial inadequacies. A short lecture will follow to address how to write a clear and detailed protocol. Students will form groups to discuss and present their suggestions and approaches to improve the protocol example. The second part of the course includes hands-on session for programing using the previously discussed example protocol.

Brief overview of course:
Issues of bias and confounding relate to study design and analysis in the setting of non-random treatment assignment where compared subjects might differ substantially with respect to comorbidities. Failing to address a lack of balance in the covariates between treated and comparison groups can produce confounded estimates of treatment effect.

Educational Objectives:
• Discuss how propensity scores are useful for observational research;
• Recognize research conditions where propensity scores offer advantages; and
• Explain how propensity scores may be applied in research (restriction, stratification, matching, modeling, and weighting), and the effect of each application on inference.

Target Audience:
Intermediate. Background in epidemiology and logistic regression modelling is assumed. No pre-course work is needed.

Course Presentations:

• Faculty will explain how propensity scores can be used to mitigate confounding through standard observational approaches (restriction, stratification, matching, regression, or weighting).

• The advantages and disadvantages of standard adjustment relative to propensity score-based methods will be discussed.

• Details of propensity score methodology (variable selection, use, and diagnostics) will also be discussed.

Brief overview of course:
This course will provide an overview of the methods and applications for studies that use primary data collection for patient registries and other prospective research, including regulatory submissions of real-world data for label approvals or expansions. Topics include data collection from clinicians, electronic health records, or directly from patients without use of clinicians, and will address methodological and logistical challenges with a focus on recruitment and retention. Examples will include working with patient communities, data collection through clinicians, call centers, and digital technologies, and integrating electronic health data, with applications in rheumatology, pregnancy and injury research, among others.

Educational Objectives:
1. To understand prospective studies including patient registries can be designed and used to support safety, effectiveness and value, including regulatory use
2. To describe the challenges of recruitment and retention; including strategies for optimization
3. To address challenges and benefits of direct data collection from study subjects without intervention of clinicians, including digital data collection and use of call centers
4. To be familiar with stakeholder expectations and the guides to assess quality in observational studies to enhance critical evaluation skills

Target Audience:
Entry level.

Course Presentations/Faculty:

1. Principles of patient registries and prospective research [Nancy Dreyer]
Students will be introduced to the purpose and scope of patient registries and other uses of primary data collection for safety and effectiveness, including regulatory use for approval of new medical products and label expansions as well for evidence of clinicians, patients and payers. Stakeholder expectations will be summarized along with guides to good practice.
2. The Role of Patient Communities for Study Recruitment [Aji Barot, HealthUnlocked]
The opportunities for using on-line patient communities for recruitment will be presented, including how these same resources can be used to enhance retention.

3. Working with trusted networks to enroll and retain patients in pregnancy registries [Christina Chambers]
Approaches to recruitment and enrollment in pregnancy registries that build on trusted networks will be presented. Methods for successfully engaging participants to enhance retention will be discussed, as well as barriers to successful recruitment and how these might be overcome.
4. Using digital patient-reported data [Will Dixon]
Theory and examples will be presented of using cell-phones for prospective data collection, including patient-reported data and other information that a mobile device can provide. Examples will come from arthritis research, including the UK national smartphone study “Cloudy with a Chance of Pain”). The presentation will also address selection bias, engagement patterns over time and analysis methods for temporally-rich data.
5. Using EHR and Call Centers for Data Collection [Christina Mack]
Principles of good practice for data acquisition and EHR curation will be provided and illustrated. Examples of methods and application of patient registries will be provided, showing the opportunities and challenges of direct data collection from patients using call centers. Data curation examples will be shown in the context of sports and orthopedic injury research.

Ticket Required.

By invitation only; registration required

Title of course: Advanced Drug Utilization Research

Brief overview of course:
This interactive educational program includes presentations, question and answer sessions and a final discussion with the faculty panel. The session will involve participants in the:
1. Methods for evaluating the effect of clinical or policy interventions
2. Interpretation of the evaluation data and dissemination of results
3. Application of principles derived from Health Services and Implementation Research to the design of a clinical intervention
4. Use of drug utilisation information from administrative health data to improve medicines use
5. Use of prescribing quality indicators to assess prescribing

Educational Objectives:
1. To gain an advanced understanding of planning, implementation and evaluation requirements for an effective quality use of medicines intervention
2. To provide an understanding of advanced drug utilization methods to evaluate complex interventions and appropriateness of prescribing
3. To develop an understanding of the significance and applications of DUR to translate research findings at the clinical and policy levels of the health system to improve health outcomes

Target Audience:
All levels of expertise, but specifically this course is targeted at:
1. Members of the DUR / HSR SIG
2. Graduate students interested in advanced methodologies
3. Those interested in quality development and implementation research, knowledge transfer, evaluation of interventions, health and medicines policy areas, health funds and third-party payers
4. Clinical pharmacoepidemiologists, health service planners, clinical guidelines developers, health practitioners

Course Presentations/Faculty:

Katja Taxis, Professor of Pharmacotherapy and Pharmaceutical Care, University of Groningen, The Netherlands
Designing Complex Interventions to Change Drug Utilization

Lisa Kalisch Ellett, NHMRC-ARC Dementia Research Development Fellow, Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia
Evaluating interventions on drug utilisation for funders and policy makers

Petra Denig, Professor, Faculty of Medical Sciences, University of Groningen, Groningen, Netherlands
Assessment of prescribing using quality indicators

Joris Komen, Division of Pharmacoepidemiology and Clinical Pharmacology of Utrecht Institute for Pharmaceutical Science, Utrecht University, The Netherlands
Evaluating Interventions on Drug Utilisation: Advanced methods-time series analysis

Title of course: Advanced Pharmacoepidemiology

Brief overview of course:

1. Course Aim

This half-day interactive course will address the interplay between observational studies and trials. This moderated course will include presentations about the intersection of interventional and non-interventional research, with examples such as the role of real-world comparators in single-armed trials; healthcare database analyses for regulatory decision making; and the restricted potential outcomes approach.

2. Requisites Statement

Advanced level: An advanced level of understanding of pharmacoepidemiology study designs, data sources, and biases are needed for this advanced-level course.

3. Course Objectives

1. To describe the use of non-interventional research approaches in drug development including the role of real-world comparators in single-arm trials
2. To understand the use of healthcare database analyses for regulatory decision making
3. To describe current debates about causal inference, in particular about the role of the restricted potential outcomes approach.

4. Syllabus Outline

This course will be moderated by Alec Walker, FISPE and the presentations include the topics below, which will be followed by Q&A and a discussion with the audience:

This half-day interactive course will address the interplay between observational studies and trials. This moderated course will include presentations about the intersection of interventional and non-interventional research, with examples such as the role of real-world comparators in single-armed trials; healthcare database analyses for regulatory decision making; and the restricted potential outcomes approach.  

• Non-interventional research approaches in drug development
Dr. Brian Bradbury
Non-interventional research approaches are increasingly being used across the drug development lifecycle to help inform regulatory decision-making, both in the pre- and post-approval setting. Regulators around the globe are considering, and in certain circumstances, acting on data obtained from real-world settings, and this has created considerable excitement and interest around using such approaches to expedite regulatory approval and lowering the costs of drug development. This presentation will describe the use of non-interventional approaches in drug development including real-world comparator arms for single arm trials.

• Healthcare database analyses for regulatory decision making.
Sebastian Schneeweiss, FISPE
When and how can we provide evidence on the effectiveness and safety of prescription drugs from healthcare database analyses with sufficient confidence for regulatory decision making? Several principles have emerged that go beyond data quality and analytic approaches to include transparency requirements and opportunity for reanalyses and may serve as guideposts that require empirical validation. This presentation will illustrate current thinking and paths forward.

• ‘Causal Inference’ is insufficient for causal inference.
Jan P. Vandenbroucke

‘Causal inference’ based on a restricted version of the potential outcomes approach reasoning is assuming an increasingly prominent place in the teaching and practice of epidemiology. This theory restricts the questions that epidemiologists may ask and the study designs that they may consider. It also restricts the evidence that may be considered acceptable to assess causality, and thereby the evidence that may be considered acceptable for scientific and public health decision making. Instead of a single approach to causality in epidemiology, we need a pluralistic approach, in which the assessment of causality is explained as a verdict that is arrived at by the integration of several and different sources of evidence.

Title of course: Medical Device Epidemiology

Brief overview of course:
Over the past few years, there has been increased focus on “real-world evidence” for medical products. Thus, medical product epidemiology is gaining visibility outside of ISPE. Medical device epidemiology uses methodologies similar to those seen with medicines. However, alternative strategies are often implemented due to the nature of the products, data sources, and situational use. With the changing regulatory and reimbursement environments, it is more important than ever for pharmacoepidemiology researchers to better understand the world of medical device epidemiology, both for study of medical devices and combination products. The nuances of methods may be applicable to other therapeutic products and the data sources may provide deeper understanding of benefits and risks in clinical context.

This course provides a foundation for medical device epidemiology and its current applications in the real world. It will comprise of a 4-hour session that will incorporate didactic lectures and interactive case studies that highlight novel medical devices and combination products.

Educational Objectives:
1. Understand existing data sources for medical device epidemiological research and how to access them
2. Explore methodologic considerations of research involving medical devices and combination products
3. Recount real-world examples of medical device epidemiology, in the context of comparative effectiveness research
4. Examine the dynamic regulatory environment for medical devices and how it differs from drugs/medications
5. Discuss the role of patients in medical device research, including understanding of benefits and risks
6. Learn about real-world medical devices and combination products in an interactive forum

Target Audience:
Entry level course. Topics covered will span entry-level, intermediate, and advanced topics in epidemiology.

Course Presentations/Faculty:

1. Overview of medical device epidemiology
Students will be introduced to the language and regulation of medical devices and combination products. Emphasis will be placed on regulatory expectations as related to the role of epidemiologists. An update of changes related to real-world evidence within North America and Europe will be discussed.

2. Overview of methods for medical device epidemiology
Students will discuss conceptual methods and study designs applicable to medical device epidemiology, including identification of exposures, comparators, and outcomes; assessing provider effects and learning curves; and, biases specific to epidemiology of medical devices.

3. Data sources for medical device epidemiology
Students will become familiar with data sources typically used for medical device epidemiology, with an emphasis on European data. Examples databases and research will be described.
4. Advances in medical device surveillance
Students will hear about surveillance for medical devices, including coordinated registry networks, use of real-world data for expansion of indications, and leveraging already-collected data to better understand safety and effectiveness of medical devices and combination products.
5. Benefit-risk assessment for medical devices and combination products
Students will be introduced to how benefit-risk balance is assessed for medical devices and combination products. Differences between US and European expectations will be outlined. Similarities and differences to expectations for medicines will be highlighted.
6. Cases studies
Students will participate in two separate case study experiences:
• The first case study will engage students in building a device registry suitable to address a regulatory commitment
• The second case study will engage students in developing the benefit-risk profile and surveillance efforts for a combination product

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 pediatric studies will be discussed. This half-day course will introduce participants who have a good understanding of pharmacoepidemiology to the specific methodologic issues arising in pediatric pharmacoepidemiology and operational approaches used to study medications in children.

Educational Objectives:

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
• Variables critical to pediatric pharmacoepidemiology such as growth and development

Target Audience:
Entry level, with some knowledge of epidemiology, pharmacoepidemiology and pediatrics.Reading: Ferrajolo et al, 2017 Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases, Drug Safety, 40(4):305-15.

Why Pediatric Pharmacoepidemiology? Age Sub-groups in Children: Methodologic Considerations
Students will be introduced to the purpose and scope of pediatric pharmacoepidemiology as a sub-specialty of pharmacoepidemiology. The session will review the historical background and reasons that few drugs have been adequately studied in children, and why information cannot always be extrapolated from adults to children. It will then address special issues around measurement of age in children and definition of age sub-groups.

Monitoring Drug Safety: Study Design, Data Sources and Case Study
This session will cover the epidemiologic study designs and data sources that are used in pediatric pharmacoepidemiology, with specific attention to the differentiators from adult studies.  Session will culminate in a case study describing the rationale, design, and unique challenges in designing and conducting a primary data collection post-approval commitment study in pediatric patients.

Growth and Development: Variables of Particular Importance in Pediatric Pharmacoepidemiology
This session will discuss the methodologic considerations regarding growth and development in pediatric pharmacoepidemiology. Following a clinical overview on assessing childhood growth and development, the session will review examples and implications of studying growth and development as key outcomes and as aspects of medication exposure (including dosage) and effect modifiers.

Interactive Discussion: Current Pediatric Pharmacoepidemiology
Course faculty and attendees will divide into breakout groups to discuss a recent pediatric pharmacoepidemiologic study (Ferrajolo et al, 2017 Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases, Drug Safety, 40(4):305-15 https://www.ncbi.nlm.nih.gov/pubmed/28025733). The groups will review and critique the article using the NIH Study Quality Assessment Tool for Case-Control Studies (https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools). Faculty will facilitate and provide additional points for discussion.

Title of course: Pharmacoepidemiologic Considerations for Biologics and Biosimilars

Brief overview of course:
This workshop will provide participants with information on the following topics:
• Background on biologics, biosimilars and differences from small molecules
• Naming and traceability issues for biologicals and biosimilars
• Interchangeability, switching, and automatic substitution from a regulatory, methodological, and clinical perspective
• Review country-specific regulatory guidelines, particularly focused on post-marketing monitoring, pharmacovigilance, and risk management requirements for biologics and biosimilars
• Conducting observational studies of biologics and biosimilars, including primary data collection and secondary use of data sources for evaluating patterns of use as well as comparative safety and effectiveness of biologics and biosimilars
• Special emphasis will be given to the methodological issues concerning post-marketing assessment of the interchangeability of biologics and corresponding biosimilars

Educational Objectives:
1. To gain an understanding of biologics and biosimilars
2. To understand evolving regulatory landscape for biologicals, including biosimilars
3. To learn how to design real-world studies for studying comparative benefit-risk profile of biologics and related biosimilars in post-marketing setting to integrate evidence on biosimilarity from premarketing studies

Target Audience:
Entry level. Fundamental understanding of pharmacoepidemiology required, but biologic and biosimilars topics will start from the basics.
Course Presentations/Faculty:

1. Biologics and Biosimilars: What, where, and why?
Students will be introduced to biologics and biosimilars terminology, the big picture, complexities in the marketplace that challenge researchers. Some recommended tips regarding planning pharmacoepidemiologic research studies will also be described.

2. Regulatory requirements and considerations for biologicals and biosimilars
This presentation will discuss the regulatory requirements for biologicals, including biosimilars. Specific emphasis will be placed on the post-marketing requirements and the specific challenges in the design and conduct of post-marketing studies for biologicals, including biosimilars from a regulatory point of view.

3. Methodological considerations for using prospective data and multiple data sources to generate evidence
This presentation will discuss stakeholder needs to generate fit-for-purpose evidence. Students will learn about different study design options and specific considerations when designing a pharmacoepidemiologic study of biologics and biosimilars. The presentation will include examples from published literature.

4. Lessons learned from observational studies of biosimilars in real world settings through secondary use of healthcare databases in Europe.
Overview of observational studies on biologics and biosimilars that have been carried out in Europe will be given. In particular, potential limitations of different data sources (e.g. claims databases and electronic medical records from various EU countries based on underlying National HealthCare System) in terms of addressing clinically relevant questions concerning biologics and biosimilars will be discussed. Special emphasis will be given on how to study switching practices of biologics/biosimilars and how to generate post-marketing evidence on interchangeability of reference product and corresponding biosimilar.

5. Methodological challenges when studying biologics/biosimilars using available U.S. secondary data sources
This presentation will focus on the use of U.S. secondary data sources, including administrative claims and electronic health records, for conducting comparative effectiveness and safety studies of biologics / biosimilars. The role of confounding by indication and misclassification biases will be discussed, leveraging examples from published literature.

Title of course: Regulatory Pharmacoepidemiology

Brief overview of course:
Medical product regulation increasingly relies on pharmacoepidemiologic analyses to assess the safety of medical products once they are marketed. This course is aimed at describing how pharmacoepidemiologic analyses are used in regulatory decision making, and the challenges that regulators face when using such analyses.

Educational Objectives:
1. Understand the role of pharmacoepidemiologic analyses in regulatory decision making.
2. Understand the strengths and limitations of pharmacoepidemiologic analyses in regulatory decision making.

Target Audience:
Intermediate.
Course Presentations/Faculty:
Presenter: Stephen Evans
Topic: Setting the Stage: Dissecting the regulatory context by a non-regulatory methodologist   
Students will be introduced to the key domains of pharmacoepidemiology using prominent examples involving medical product safety.   

Presenter: Michael Blum
Topic: Role of Pharmacoepidemiology in the US FDA decision making   
Students will discuss pharmacoepidemiology concepts with examples from regulatory environment in the United States.     

Presenter: June Munro Raine
Topic: European regulatory perspective on pharmacoepidemiology
Students will learn about European perspective on the use of pharmacoepidemiologic tools and data sources to address complex safety issues.

Presenter: Danica Marinac-Dabic,
Topic: Unleashing the power Medical Device Epidemiology for regulatory decisions throughout the device lifecycle (premarket and postmarket)
Students will hear about expanding role of medical device epidemiology in producing the Real-World Evidence (RWE) for a spectrum of regulatory uses (e.g., broadening indications, labeling updates post-approval studies and surveillance requirements).  The examples will feature current uses of patient registries, Coordinated Registry Networks (CRNs), international registry consortia linked to medical claims data and electronic health information and application of the principles of recent International Medical Device Regulators Forum (IMDRF) documents. 

Moderated discussion led by Stephen Evans
Students will be participating in the large and small group discussion

Title of course: Weighing the Benefits & Risks: The Science and Methods of Benefit-Risk Assessment in Drug Development

Brief overview of course:
Benefit-risk assessment is now a fundamental science for understanding and evaluating the development, approval, and continued marketing of drugs and devices. This course is aimed at introducing attendees to core concepts and tools of both the science and practice of benefit-risk assessment.
Educational Objectives:
• Develop an understanding of quantitative benefit-risk assessment methods and software tools
• Develop an understanding of how to successfully structure and present benefit-risk information for drug development decision-making and regulatory interactions, including the use of visual tools
• Develop an understanding of how pharmacoepidemiology and benefit-risk assessment intersects with patient engagement, by developing an understanding of the use of preference methods
Target Audience:
Entry-level to Intermediate. This is an introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of benefit-risk assessment methods and tools.
Course Presentations/Faculty:

Tarek A. Hammad, MD, PhD, MSc, MS, FISPE
Tarek Hammad will provide attendees with an overview of ICH expectations and analytical considerations for the development and presentation of benefit-risk information in new drug applications

Juhaeri Juhaeri, PhD
Juhaeri Juhaeri will provide attendees with an overview of leading quantitative methods (e.g., MCDA, SMAA) for the development and presentation of benefit-risk assessment information
Brett Hauber, PhD
Brett Hauber will provide attendees with an overview of leading methods (e.g., discrete choice, direct elicitation, threshold, contingent valuation ) for the elicitation, analysis and presentation of patient preference information

Full meeting registration includes food, drink and entertainment.

Registration required -- limited capacity.
Organized by the Student Council. Please contact SISPEchair@gmail.com for more information, and to RSVP.

Open to all participants

• Africa: Zoom
• Brazil:  Club A
• FarmacoepiEnRed:  Club E
• Gulf Region:  Terrace 2 A
• Latin America Terrace 2 B

Congress Foyer 2 A (Poster Session) & Congress Foyer 3A (Spotlight) 

Please arrive 24 hours before your presentation start time to upload or check your presentation. 

Keynote speakers: Dr. Alison Cave, EMA and Prof. Miriam Sturkenboom, UMCU

Large volumes of data are becoming available through various sources (routine health care date, patient reported data, wearables, surveys, etc.) allowing to develop new evidence that may substantially add to the benefit/risk assessment throughout the lifecycle of medicines. While creating huge opportunities, there are also significant challenges in the application of these data. In particular in Europe, data sources are heterogeneous and understanding strengths and limitations of new analytical methods to integrate and analyse these datasets in order to generate valid conclusions which contribute to regulatory decision making is challenging. Fast access to data and at the same time compliance with data protection legislation to protect patient confidentiality is critical for securing patient trust.

Approach:
Dr. Alison Cave is Principal Scientific Administrator and co-chair of the HMA/EMA task force on Big Data and she will be able to give a Unique European regulatory perspective on the need, challenges, and opportunities of data networks in Europe.
Prof. Miriam Sturkenboom, FISPE, is past president of ISPE. She has extended experience as principal investigator of many European projects on multi-country, multi-database studies and steered the development and testing of workflows to implement these types of studies in the EU. She will be able to provide an overview of the scientific and technical challenges of European networks and the lessons learned from these initiatives for future studies.

Learning objectives: To learn key challenges and opportunities for establishing a European Network of data sources and how this can contribute to benefit risk assessment of medicines and regulatory decision making.
Why is this topic of interest to the broad ISPE membership? Both the regulatory and scientific perspectives on the potential of multi-national data source networks and in particular the European situations (including central and eastern Europe) will be of great interest to the ICPE audience.

Speakers

• Alison Cave, EMA

Dr. Alison Cave is Principal Scientific Administrator and co-chair of the HMA/EMA task force on Big Data and she will be able to give a Unique European regulatory perspective on the need, challenges, and opportunities of data networks in Europe

• Miriam Sturkenboom, FISPE, University Medical Center Utrecht

Prof. Miriam Sturkenboom, FISPE, is a past president of ISPE. She has extended experience as principal investigator of many European projects on multi-country, multi-database studies and steered the development and testing of workflows to implement these types of studies in the EU. She will be able to provide an overview of the scientific and technical challenges of European networks and the lessons learned from these initiatives for future studies.

Open to all participants; lunch available.

• Education:  Club E
• Finance:  Club A
• Membership:  Zoom

Spotlight Poster Session A: Asian Pharmacoepidemiology Network (AsPEN); Adherence; Biologics & Biosimilars; Comparative Effectiveness Research (CER); & Digital Epidemiology

Moderators: Cristiano Moura & Jaclyn Bosco

1:30 PM - A Real-World Comparison of Effectiveness and Safety Outcomes Between Clinical Trial Eligible and Ineligible Patients in the British Association of Dermatologists Biologic Interventions Register (BADBIR) [30]

• Kayleigh J Mason. (United Kingdom)

1:45 PM - The Risk of Keratinocyte Carcinoma (KC) in Psoriasis Patients Receiving Biologic Therapy Compared to Conventional Systemic Therapy: Results From the British Association of Dermatologists Biologic Interventions Register (BADBIR) [31]

• Kayleigh J Mason. (United Kingdom)

2:00 PM - Comparative Effectiveness of Tumour Necrosis Factor Inhibitor Therapy Vs. Conventional Synthetic Dmards on Need for Joint Replacement Among Rheumatoid Arthritis Patients: a Propensity Score Matched Analysis of UK Registry Data [32]

• Samuel Hawley, M. Sanni Ali, Rene Cordtz, Lene Dreyer, Christopher J Edwards, Nigel K Arden, Cyrus Cooper,                Andrew Judge, Kimme Hyrich, Daniel Prieto-Alhambra. (United Kingdom)

2:15 PM - The Association of Biologic Drug-Levels With Infection Risk: Results From the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis [33]

• Meghna Jani, William G Dixon, Mark Lunt, Diederik DeCock, John Isaacs, Ann W Morgan, Anthony G Wilson, Kath Watson, Anne Barton, Kimme Hyrich. (United Kingdom)

2:30 PM - Tumor Necrosis Factor-Alpha Inhibitors and Risk of Non-Hodgkin Lymphoma in a Cohort of Adults With Rheumatologic Conditions [34]

• Gregory S Calip, Pritesh R. Patel, Sruthi Adimadhyam, Shan Xing, Zhaoju Wu, Karen Sweiss, Glen T. Schumock, Todd A. Lee, Brian C. Chiu. (United States)

2:45 PM - Methotrexate Use and the Risk for Cardiovascular Disease Among Rheumatoid Patients Initiating Biologic Disease-Modifying Antirheumatic Drugs [35]

• Fenglong Xie, Lang Chen, Huifeng Yun, Emily Levitan, Paul Muntner, Jeffrey R Curtis. (United States)

Moderators: Dorothee Bartels, FISPE & Kristian Filion                                      

1:30 PM - Risk of Major and Clinically Relevant Non-Major (CRNM) Bleeding in Patients Prescribed Rivaroxaban for Stroke Prevention in Non-Valvular AF (SPAF) and the Prevention and/or Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism (DVT/PE) in Primary Care in England [12]

• Sandeep Dhanda, Miranda Davies, Debabrata Roy, Lesley Wise, Saad Shakir. (United Kingdom)

1:45 PM - Association Between Proton Pump Inhibitor Use and Gastrointestinal Bleeds in NOAC Treated AF Patients [13]

• Joris Komen, Tomas Forslund, Bjorn Wettermark, Paul Hjemdahl, Olaf Klungel, Aukje Mantel - Teeuwisse. (Netherlands)

2:00 PM - Frailty and Benefit of Dabigatran versus Warfarin in Older Adults With Atrial Fibrillation [14]

• Dae Kim, Robert Glynn, Jerry Avorn, Sara Dejene, Sebastian Schneeweiss. (United States)

2:15 PM - Benefit-Risk Profile of Dabigatran Compared With Vitamin-K Antagonists in Elderly Patients With Non-Valvular Atrial Fibrillation: a Cohort Study in the French Nationwide Claims Database [15]

• Patrick Blin, Caroline Dureau-Pournin, Abdelilah Abouelfath, Régis Lassalle, Jacques Bénichou, Yves Cottin, Patrick Mismetti, Cécile Droz-Perroteau, Nicholas Moore. (France)

2:30 PM - Drug Interactions With Oral Anticoagulants in German Nursing Home Residents - a Comparison Between Vitamin K Antagonists (VKA) and Non-VKA Oral Anticoagulants [16]

• Kathrin Jobski, Falk Hoffmann, Stefan Herget-Rosenthal, Michael Dörks. (Germany)

2:45 PM - Dabigatran versus Rivaroxaban for Secondary Stroke Prevention in Patients With Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities [17]

• Matthew Alcusky, Anne L Hume, Marc Fisher, Jennifer Tjia, Robert J Goldberg, David D McManus, Kate L Lapane. (United States)

Moderators: Brian Bateman & Vera Ehrenstein

1:30 PM - Gabapentin Use in Pregnancy and the Risk of Maternal and Neonatal Outcomes [24]

• Elisabetta Patorno, Sonia Hernández-Díaz, Krista F. Huybrechts, Jacqueline M. Cohen, Rishi J. Desai, Helen Mogun, Brian T Bateman. (United States)

1:45 PM - Infections in Children After Prenatal Exposure to Methadone and Buprenorphine: NordicRegistry Study [25]

• Milada Mahic, Sonia Hernandez-Diaz, Mollie Wood, Ingvild Odsbu, Mette Nørgaard, Helle Kieler, Svetlana Skurtveit, Marte Handal. (United States)

2:00 PM - Ondansetron and the Risk of Congenital Malformations [26]

• Krista F Huybrechts, Sonia Hernandez-Diaz, Loreen Straub, Kathryn Gray, Elisabetta Patorno, Rishi Desai, Helen Mogun, Brian T Bateman. (United States)

2:15 PM - Rurality and Variability in Opioid Use Among Pregnant Women [27]

• Sarah Osmundson, Marie R Griffin, Jea-Young Min, Ed Mitchel, Carlos G Grijalva. (United States)

2:30 PM - Comparative Safety of Ondansetron Use During Pregnancy [28]

• Elizabeth A Suarez, Michele Jonsson Funk. (United States)

2:45 PM - Opioid Dispensing After Vaginal Delivery [29]

• Malavika Prabhu, Elizabeth Garry, Sonia Hernandez-Diaz, Sarah C. MacDonald, Krista F. Huybrechts, Brian T. Bateman. (United States)

Moderators: Darren Toh, FISPE  &  Xiaojuan Li

1:30 PM - Validation of the Reverse Parametric Waiting Time Distribution and Standard Methods to Estimate Prescription Durations for Warfarin [6]

• Julie M Petersen, Henrik Støvring, Maja Hellfritzsch, Jesper Hallas, Anton Pottegård. (Denmark)

1:45 PM - Correcting for Differential Depletion of Susceptibles in Time-To-Event Data Using Time-Specific Propensity Scores [7]

• Richard Wyss, Joshua J. Gagne, Shirley V. Wang, Rishi J. Desai, Jessica M. Franklin, Sebastian Schneeweiss, Yueqin Zhao, Esther H. Zhao, Sengwee Toh, Margaret Johnson, Bruce Fireman. (United States)

2:00 PM - Analysis of Registry-Based Case-Control Studies With a Joint Exposure and Outcome Model Based on the Reverse Waiting Time Distribution [8]

• Henrik Støvring, Anton Pottegård, Jesper Hallas. (Denmark)

2:15 PM - Amiodarone Use and the Risk of Acute Pancreatitis: Influence of Different Exposure Definitions on Risk Estimation [9]

• Mirjam Hempenius, Helga Gardarsdottir, Anthonius de Boer, Olaf Klungel, Rolf Groenwold. (Netherlands)

2:30 PM - Estimating Cumulative Risk in the Presence of Competing Events and Dependent Censoring in Pharmacoepidemiology Studies [10]

• Sara Levintow, Leah McGrath, M. Alan Brookhart. (United States)

2:45 PM - Diagnostics for Informative Censoring: Application to Antipsychotic Trials With High Dropout Rates [11]

• John Jackson. (United States)

Moderators: Maribel Salas, FISPE & Jason Hsu

1:30 PM - Agomelatine and Other Antidepressants and the Risk of Acute Liver Injury (ALI), a Pass in Four European Countries [36]

• Manel Pladevall, Jesper Hallas, Tania Schink, Johan Reutfors, Rosa Morros, Beatriz Poblador-Plou, Joan Forns, Maja Hellfritzsch, Tammo Reinders, David Hägg, Maria Giner-Soriano, Alexandra Prados-Torres, Miguel Cainzos-Achirica, Anton Pottegård, Bianca Kollhorst, Lena Brandt, Jordi Cortés, Jaume Aguado, Gabriel Perlemuter, Jordi Castellsagué, Emmanuelle Jacquot, Nicolas Deltour, Susana Perez-Gutthann. (Spain)

1:45 PM - Risk of Traumatic Brain Injury in Elderly New Users of Antidepressants [37]

• Federica E Pisa, Jonas Reinold, Bianca Kollhorst, Ulrike Haug, Tania Schink. (Germany)

2:00 PM - Zolpidem Use and Suicide Death in South Korea: a Population-Based Case-Control Study [38]

• BongKyoo Choi, Hi Gin Sung, Jin Hyun Nam, Ju-Young Shin. (Korea, Republic of)

2:15 PM - Evaluation of Opioid Overutilization Criteria Suggested by Centers for Medicare and Medicaid Services Among Privately Insured or Medigap Population [327]

• Amir Sarayani, Almut G Winterstein, Cheng Chen, Yu-Jung "Jenny" Wei. (United States)

2:30 PM - Degree of Serotonin Reuptake Inhibition of Antidepressants and the Risk of Ischemic Stroke and Myocardial Infarction [40]

• Antonios Douros, Sophie Dell'Aniello, Golsa Dehghan, Jean-François Boivin, Christel Renoux. (Canada)

2:45 PM - Risk of Suicide With Concurrent Use of Benzodiazepine, Antidepressant, Opioid Analgesic and Zolpidem: a Population Based Case-Control and Case-Crossover Study [41]

• Hi Gin Sung, junquing Li, Jin Hyun Nam, BongKyoo Choi, Ju-Young Shin. (Korea, Republic of)

Moderators: Wan-Ting Huang & Katherine Yih                                              

1:30 PM - National Impact of Prevnar 13® Vaccine on Ambulatory Care Visits for Otitis Media in Children Under 5 Years in the United States [18]

• Xiaofeng Zhou, Cynthia de Luise, Michael Gaffney, Catharine W Burt, Daniel A Scott, Nicolle Gatto, Kimberly J Center. (United States)

1:45 PM - Safety of Newly Adjuvanted Vaccines Among Older Adults, a Systematic Literature Review and Meta-Analysis [19]

• Marc Baay, Kaatje Bollaerts, Thomas Verstraeten. (Belgium)

2:00 PM - Hospital-Diagnosed Adverse Events After HPV Vaccination: a Self-Controlled Case Series Analysis [20]

• Sia K Nicolaisen, Reimar W Thomsen, Irene Petersen, Buket Öztürk, Kim Varming, Jørn Olsen, Henrik T Sørensen, Lars Pedersen. (Denmark)

2:15 PM - Advance System Testing: Benefit-Risk Analysis of a Marketed Vaccine Using Cohort Modelling and MCDA Swing Weighting [21]

• Kaatje Bollaerts, Eduoard Ledent, Tom De Smedt, Daniel Weibel, Hanne-Dorthe Emborg, Klara Berensci, Ana Correa, Giorgia Danieli, Talita Duarte-Salles, Consuelo Huerta, Elisa Martin, Gino Picelli, Lara Tram, Lina Titievsky, Lina Titievsky, Miriam Sturkenboom, Vincent Bauchau. (Belgium)

2:30 PM - Evidence From a Quasi-Experimental Study for the Effectiveness of the Influenza Vaccination Against Myocardial Infarction in UK Adults Aged at Least 65y [22]

• Adam J. Streeter, William E Henley. (United Kingdom)

2:45 PM - Real-World Effectiveness of Influenza Vaccination in Older Adults in the UK From 1997-2012: a Quasi-Experimental Cohort Study [23]

• Dr. Henley, Dr. Streeter. (United Kingdom)

Moderators:  Cynthia Girman, FISPE & Gregory Nichols                                           

5:00 PM - Association Between Glycaemic Control and Fracture Risk in Diabetic Patients: a Nested Case Control Study [71]

• Janina Vavanikunnel, Sarah Charlier, Claudia Becker, Cornelia Schneider, Susan Jick, Christoph R Meier, Christian Meier. (Switzerland)

5:15 PM - Sodium-Glucose Cotransporter-2 Inhibitor Use and Lower-Extremity Amputation Risk Among Commercially-Insured U.S. Patients, 2013-2015 [72]

• Jeff Y. Yang, John B. Buse, Emily W. Gower, Virginia Pate, Tiansheng Wang, Til Stürmer. (United States)

5:30 PM - Delays in Anti-Hyperglycemic Treatment Intensification Impacts Risk of Diabetes Complications [73]

• Gregory A Nichols, Victoria Romo-LeTourneau, Suma Vupputuri, Sheila Thomas. (United States)

5:45 PM - Risk of Amputations Associated With SGLT2 Inhibitors: a Propensity-Matched Cohort Study [74]

• Sruthi Adimadhyam, Todd A. Lee, Gregory S. Calip, Daphne E. Smith Marsh, Brian T. Layden, Glen T. Schumock. (United States)

6:00 PM - A Safety Signal of Venous Thromboembolic Events With the Use of DPP-4 Inhibitors: a Pharmacovigilance Disproportionality Analysis [75]

• Amandine Gouverneur, Athénaïs Lair, Mickael Arnaud, Bernard Bégaud, Frantz Thiessard, Antoine Pariente, Francesco Salvo. (France)

6:15 PM - Frailty and Risk of Adverse Events Associated With Dipeptidyl Peptidase-4 Inhibitors versus Sulfonylureas in Older Adults With Type 2 Diabetes [76]

• Dae Kim, Janet Sultana, Sebastian Schneeweiss, Robert Glynn, Julie Barberio, Elisabetta Patorno. (United States)

Moderators: Nicholas Moore, FISPE & Eileen Ming

5:00 PM - Direct Oral Anticoagulants Versus Low-Molecular-Weight Heparins for Venous Thromboembolism Prevention Following Total Hip Replacement: Comparative Effectiveness and Medical Costs From a French Nationwide Cohort Study of Around 120,000 Patients  [65]

• Patrick Blin, Charles-Marc Samama, Alain Sautet, Patrick Mismetti, Jacques Benichou, Séverine Lignot-Maleyran, Stéphanie Lamarque, Simon Lorrain, Régis Lassalle, Anne-Françoise Gaudin, François-Emery Cotte, Cécile Droz-Perroteau, Nicholas Moore. (France)

5:15 PM - Serious Bleeding and Use of Warfarin in Combination With Sulfonylureas Or Metformin [66]

• Young Hee Nam, Colleen M. Brensinger, Warren B. Bilker, Charles E. Leonard, Xu Han, Sean Hennessy. (United States)

5:30 PM - Sodium-Glucose Co-Transporter-2 Inhibitors and the Risk of Cardiovascular Outcomes and Adverse Events [67]

• Jacob Udell, Greg Carney, Michael Paterson, Kristian Filion, Amit Garg, Lorraine Lipscombe, David Juurlink, Muhammad Mamdani, Colin Dormuth. (Canada)

5:45 PM - Benefit-Risk of Rivaroxaban 20 Or 15mg Compared to Vitamin-K Antagonists in Patients With Non-Valvular Atrial Fibrillation: a Cohort Study in the French Nationwide Claims Database [68]

• Patrick Blin, Caroline Dureau-Pournin, Marie-Agnès Bernard, Régis Lassalle, Laurent Fauchier, Frédéric Sacher, Jean Dallongeville, Cécile Droz-Perroteau, Nicholas Moore. (France)

6:00 PM - Comparative Effectiveness of Apixaban versus Rivaroxaban for the Prevention of Cardiovascular Diseases and Recurrent Venous Thromboembolism [69]

• Ghadeer Dawwas, Haesuk Park. (United States)

6:15 PM - Comparative Effectiveness and Safety of Low-Dose Non-Vitamin K Oral Anticoagulants and Acenocoumarol in Patients With Atrial Fibrillation in Valencia Spain [70]

• Yared Santa-Ana-Tellez, Clara L Rodríguez-Bernal, Aníbal García-Sempere, Salvador Peiró, Gabriel Sanfélix-Gimeno. (Spain)

Moderators: Stephan Lanes & Nicolle Gatto, FISPE

5:00 PM - Performance of a Distributed Regression Analysis Software and Workflow [53]

• Qoua Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Sengwee Toh. (United States)

5:15 PM - Performance of Fixed and All-Available Look-Back Approaches in Claims Database Studies: a Plasmode Simulation [54]

• Mitchell M Conover, Til Stürmer, Charles Poole, Robert J Glynn, Ross J Simpson, Michele Jonsson Funk. (United States)

5:30 PM - Do Gaps in Enrolment Matter? a Study of the Effect of Strict Enrolment Criteria in US Commercial and Medicaid Databases on Population Representativeness and the Prevalence of COPD and Asthma [55]

• Harriet A Dickinson, John Logie. (United Kingdom)

5:45 PM - Assessment of Misclassification Bias Due to Short Look-Back Periods in Epidemiological Studies of Chronic Disease Incidence [56]

• Nils Ekström, Michael Törnblom, Lina Titievsky, Viktor Wintzell, James Stark, Mats Rosenlund. (Sweden)

6:00 PM - Privacy-Protecting Analytic Methods Using Only Aggregate-Level Data for Multivariable-Adjusted Analysis in Distributed Data Networks [57]

• Xiaojuan Li, Bruce H Fireman, Jeffrey R Curtis, David E Arterburn, David Fisher, Erick Moyneur, Mia Gallagher, Marsha A Raebel, W Benjamin Nowell, Lindsay Lagreid, Sengwee Toh. (United States)

6:15 PM - Multi-Database Multiple Imputation Within a Distributed Data Drug Safety Network: a Simulation Study and Real-World Data Example [58]

• Matthew H Secrest, Robert W Platt, Pauline Reynier, Colin R Dormuth, Andrea Benedetti, Kristian B Filion. (United States)

Moderators: Sarah-Jo Sinnott & Partick Souverein                                   

5:00 PM - Real-World Persistence for Newly Prescribed HIV-1 Treatment: Single versus Multiple Tablet Regimen Comparison [77]

• Joshua Cohen, Anne Beaubrun, Richa Bashyal, Ahong Huang, Teng Huang, Onur Baser. (United States)

5:15 PM - Epidemiology and Predictors of Barriers to Medication Adherence Using Administrative Clains and Electronic Health Record Data (1113)

• Julie Lauffenburger, Romit Bhattacharya, Chandrasekar Gopalakrishnan, Jessica Lee, Julie Barberio, Thomas Isaac, Thomas Sequist, Niteesh Choudhry. (United States)

5:30 PM - Predictors of Persistent Prescription Opioid Analgesic Use Among People Without Cancer in Australia: a Retrospective Cohort Study [79]

• Samanta Lalic, Natasa Gisev, J Simon Bell, Maarit J Korhonen, Jenni Ilomäki. (Australia)

5:45 PM - Time-Varying Measures of Adherence to Other Medications to Predict Persistence to Statin Treatment [80]

• Yaa-Hui Dong, Zhigang Lu, Yinzhu Jin, Moa P. Lee, Gregory Brill, Hiraku Kumamaru, Joshua J. Gagne. (Taiwan)

6:00 PM - The Impact of the Duration of Bisphosphonate Drug Holidays on Hip Fracture Rates [81]

• Jeffrey R Curtis, Rui Chen, Li Zixu, Tarun Arora, Kenneth G Saag, Nicole Wright, Shanette Daigle, Meredith Kilgore, Elizabeth Delzell. (United States)

6:15 PM - Adherence Trajectories to Essential Medications After Acute Coronary Syndrome and Their Impact on Clinical Outcomes. a Population-Based Cohort Study [82]

• Daniel Bejarano-Quisoboni, Isabel Hurtado, Clara L Rodriguez-Bernal, Anibal García-Sempere, Sofia Bauer-Izquierdo, Julian Librero, Salvador Peiró, Gabriel Sanfélix-Gimeno. (Spain)

Moderators: Olaf Klungel, FISPE & Jeremy Rassen

5:00 PM - Propensity Score Matching versus Propensity Score Fine Stratification and Coarsened Exact Matching in Claims Data [47]

• John E Ripollone, Krista F Huybrechts, Kenneth J Rothman, Ryan E Ferguson, Jessica M Franklin. (United States)

5:15 PM - Propensity Score Diagnostics: the Challenges We Face When Providing Evidence That a Propensity Based Estimate Is Unbiased [48]

• Emily Granger, Jamie C Sergeant, Mark Lunt. (United Kingdom)

5:30 PM - Evaluation of Treatment Effect Modification in Propensity Score Matching: An Empirical Example [49]

• M Sanni Ali, Ian J Douglas, Elizabeth Williamson, Daniel Prieto-Alhambra, Liam Smeeth. (United Kingdom)

5:45 PM - Covariate Balance Assessment in Propensity Score Matching After Multiple Imputation With Chained Equations: An Empirical Example [50]

• M Sanni Ali, Danielle E Robinson, Sara Khalid, Ian Douglas, Liam Smeeth, Daniel Prieto-Alhambra. (United Kingdom)

6:00 PM - Extension of Disease Risk Score Based Confounding Adjustments for Multiple Outcomes of Interest: An Empirical Evaluation [51]

• Rishi J Desai, Richard Wyss, Yinzhu Jin, Justin Bohn, Sengwee Toh, Austin Cosgrove, Adee Kennedy, Jessica Kim, Clara Kim, Rita Ouellet-Hellstrom, Sara Karami, Jacqueline Major, Aaron Niman, Shirley Wang, Joshua Gagne. (United States)

6:15 PM - A Joint Application of Disease Risk Score and Propensity Score to Control for Confounding: a Clinical Example [52]

• M Sanni Ali, Ian J Douglas, Elizabeth Williamson, Daniel Prieto-Alhambra, Liam Smeeth. (United Kingdom)

Moderators: Jennita Reefhuis, FISPE & Alison Kawai                                         

5:00 PM - Oral Fluconazole in Pregnancy and Risk of Stillbirth and Neonatal Death [59]

• Björn Pasternak, Viktor Wintzell, Kari Furu, Anders Engeland, Martin Neovius, Olof Stephansson. (Sweden)

5:15 PM - Tnf Inhibitor Treatment During Pregnancy and Risk of Preterm Birth [60]

• Gabriella Bröms, Helle Kieler, Anders Ekbom, Karin Hellgren, Mika Gissler, Anna-Maria Lahesmaa-Korpinen, Lars Pedersen, Marcus Schmitt-Egenolf, Henrik T Sørensen, Fredrik Granath. (Sweden)

5:30 PM - Impact of Maternal Infection and Antibiotic Use in Pregnancy on the Risk of Childhood Obesity: a Study of 203,999 Mother-Child Pairs With Up to 12 Years of Follow-Up [61]

• De-Kun Li, Hong Chen, Jeannette R. Ferber, Roxana Odouli. (United States)

5:45 PM - Disparities in Asthma Prevalence, Severity, and Control in Pregnancy. Evidence From Two Healthcare Databases in the United States [62]

• Jacqueline M Cohen, Brian T. Bateman, Krista F. Huybrechts, Michael Schatz, Keele E Wurst, Sonia Hernandez-Diaz. (Norway)

6:00 PM - Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States [63]

• Danijela Stojanovic, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Genna Panucci, Rajani Rajbhandari, Lockwood Taylor. (United States)

6:15 PM - Uncontrolled Maternal Chronic Respiratory Diseases in Pregnancy Increase the Risk of Anorectal Malformations in Offspring [64]

• Romy van de Putte, Ivo de Blaauw, Rianne Boenink, Monique H Reijers, Paul M. Broens, Cornelius E. Sloots, Arno F. van Heijst, Marleen M. van Gelder, Nel Roeleveld, Iris A. van Rooij. (Netherlands)

Open to all participants.

Adherence:  South Hall 2 B

Asian Pharmacoepidemiology Network (AsPEN): Zoom

Benefit Risk Assessment, Communication and Evaluation (BRACE):  South Hall 3 A

Biologics and Biosimilars:  South Hall 2 A

Comparative Effectiveness Research (CER):  South Hall 1 AB

Databases:  Panorama Hall

Digital Epidemiology:  Club A

Drug Utilization/Health Services Research:  South Hall 3 B

Medical Devices:  Chamber Hall

Medicines in Pregnancy:  Terrace 2 A

Molecular Epi/Biomarkers/Pharmacogenetics:  Dressing Room 222

Oncology:  Dressing Room 223

Pediatrics:  Terrace 2 B

Rare Disease:  Dressing Room 224

Vaccines:  Club E 

Open to all participants

Moderators: Daniel Weibel & Anne Butler

8:00 AM - Effectiveness of Prenatal Tdap in the Prevention of Infant Pertussis in the US [368]

• Sylvia Becker-Dreps, Anne M. Butler, Leah J. McGrath, Kim A. Boggess, David J. Weber, Dongmei Li, Michael G. Hudgens, J. Bradley Layton. (United States)

8:15 AM - Advance System Testing: Feasibility of Using a Network of Health Data Bases for Vaccine Safety Studies [369]

• Daniel Weibel, Caitlin Dodd, Olivia Mahaux, Francois Haguinet, Tom De Smedt, Talita Duarte-Salles, Gino Picelli, Lara Tramontan, Giorgia Danieli, Ana Correa, Elisa Martin, Consuelo Huerta, Klara Berensci, Benedikt Becker, Hanne-Dorthe Emborg, Myint Tin Tin Htar, Kaatje Bollaerts, Vincent Bauchau, Lina Titievsky, Miriam Sturkenboom. (Netherlands)

8:30 AM - Determining Which of Several Concomitantly Administered Vaccines Increase Risk of An Adverse Event [370]

• Shirley V Wang, Kristina Stefanini, Edwin Lewis, Sophia R Newcomer, Bruce Fireman, Matthew F Daley, Jason M Glanz, Martin Kulldorff. (United States)

8:45 AM - Epilepsy in Children Following Pandemic Influenza Vaccination [371]

• Siri Eldevik Haberg, Kari M Aaberg, Pål Surèn, Lill Trogstad, Sara Ghaderi, Camilla Stoltenberg, Per Magnus, Inger Johanne Bakken. (Norway)

9:00 AM - Risk Factors of Zoster Vaccine Failure Among Elderly in England [372]

• Maria Alexandridou, Thomas Verstraeten, Kaatje Bollaerts. (Belgium)

9:15 AM - Hpv Vaccines and Risk of Thyroid Disorders in Young Girls [373]

• Cedric Collin, Sara Miranda, Christophe Chaignot, Amelie Poidvin, Paul De-Boissieu, Alain Weill, Mahmoud Zureik, Rosemary Dray-Spira. (France)

Moderators:  Christian Hampp, FISPE & Andrea Margulis                                           

8:00 AM - Antidiabetic Medication in Pregnancy: An International Drug Utilization Study [386]

• Carolyn E Cesta, Jacqueline M Cohen, Laura Pazzagli, Brian T Bateman, Gabriella Bröms, Kristjana Einarsdóttir, Kari Furu, Mika Gissler, Anna Heino, Sonia Hernandez-Diaz, Krista F Huybrechts, Øystein Karlstad, Jiong Li, Johan Reutfors, Randi Selmer, Yongfu Yu, Helga Zoega, Ingvild Odsbu. (Sweden)

8:15 AM - Clinical Effectiveness of Sitagliptin Compared to Sulphonylureas for Type 2 Diabetes [387]

• Manuj Sharma, Irwin Nazareth, Irene Petersen. (United Kingdom)

8:30 AM - Hepatic Safety of Vildagliptin: Multi-Database, Non-Interventional Safety Study [388]

• Rachael Williams, Frank de Vries, Wolfgang Kothny, Carmen Serban, Sandra Lopez-Leon, Païvi Paldánius, Raymond Schlienger. (Switzerland)

8:45 AM - Incretin-Based Drugs and the Risk of Cholangiocarcinoma Among Patients With Type 2 Diabetes [389]

• Devin Abrahami, Antonios Douros, Hui Yin, Jean-Luc Faillie, Oriana Yu, Nathaniel Bouganim, Robert Platt, Laurent Azoulay. (Canada)

9:00 AM - Time to Treatment Intensification in Patients on Dual Pharmacotherapy for Type 2 Diabetes [390]

• Giuseppe Roberto, Francesco Barone-Adesi, Francesco Giorgianni, Valeria Pizzimenti, Claudia Bartolini, Corrado Magnani, Marina Maggini, Roberto Da Cas, Stefania Spila-Alegiani, Carmen Ferrajolo, Paolo Francesconi, Gianluca Trifirò, Elisabetta Poluzzi, Fabio Baccetti, Rosa Gini. (Italy)

9:15 AM - Risk of Uroseptic Hospitalizations Among Patients Initiating Sodium-Glucose Co-Transporter 2 Inhibitors: a Retrospective Cohort Study [391]

• Chintan Dave, Sebastian Schneeweiss, Michael Fralick, Dae Kim, Elisabetta Patorno. (United States)

Moderators: Daniel Prieto-Alhambra, FISPE & Dana Teltsch

8:00 AM - Variation in Risk Estimates From Different Cohort Selection Strategies When Using Recurrent Index Events [362]

• Henry T Zhang, Mitchell M Conover, Til Stürmer. (United States)

8:15 AM - Implementation of the Prevalent New User Study Design in the Us Medicare Population: Benefit versus Harm [363]

• Elizabeth Garry, John B Buse, Mugdha Gokhale, Jennifer L. Lund, Virginia Pate, Til Stürmer. (United States)

8:30 AM - The Case-Crossover Design for Drug Interaction Studies: Interaction Term Model versus a Novel Fully Saturated Model [364]

• Katsiaryna Bykov, Robert J. Glynn, Murray A. Mittleman, Sebastian Schneeweiss, Joshua J. Gagne. (United States)

8:45 AM - Minor Differences, Major Consequences? Lessons Learned From Replication of a Claims-Based Drug Safety Assessment [365]

• Ting-Ying Huang, Laura Hou, Laura Shockro, Ella Pestine, Michael Nguyen, Judith C Maro, Rima Izem. (United States)

9:00 AM - Strategies for Selecting Start of Follow-Up in Longitudinal Studies With Multiple Eligible Index Opportunities [366]

• Mitchell M Conover, Henry T Zhang, Til Stürmer, Robert J Glynn, Charles Poole, Michele Jonsson Funk. (United States)

9:15 AM - Implementation of the Trend-In-Trend Study Design in a Setting With Cross-Over of Preferred Treatment Choice: An Example of Second-Line Antidiabetics [367]

• Phyo T Htoo, John Buse, Virginia Pate, Til Stürmer. (United States)

Moderators: Jason C. Hsu & Patrick Blin                                          

8:00 AM - Fluoroquinolone Use and Risk of Aortic Aneurysm and Dissection: Nationwide Cohort Study in Sweden [380]

• Björn Pasternak, Malin Inghammar, Henrik Svanström. (Sweden)

8:15 AM - Non-Vitamin K Antagonist Oral Anticoagulants and Risk of Liver Injury [381]

• Antonios Douros, Laurent Azoulay, Hui Yin, Samy Suissa, Christel Renoux. (Canada)

8:30 AM - Does Comorbidity Interact With Acute Myocardial Infarction to Increase Mortality? [382]

• Erzsébet Horváth-Puhó, Morten Schmidt, Anne Gulbech Ording, Hans Erik Bøtker, Timothy L. Lash, Henrik Toft Sørensen. (Denmark)

8:45 AM - Risk Factors for Stroke and Choice of Oral Anticoagulant in Atrial Fibrillation [383]

• Lars J Kjerpeseth, Hanne Ellekjær, Randi Selmer, Inger Ariansen, Kari Furu, Eva Skovlund. (Norway)

9:00 AM - Effect of Migraine on Cardiovascular Diseases [384]

• Szimonetta Komjáthiné Szépligeti, Kasper Adelborg, Louise Holland-Bill, Vera Ehrenstein, Erzsébet Horváth-Puhó, Victor W Henderson, Henrik Toft Sørensen. (Denmark)

9:15 AM - Long-Term Clinical Outcomes Following a Myocardial Infarction Among the General Population in England [385]

• Anna Schultze, Rikisha Shah, Andrew Tershakovec, Tarek A Hammad, Tommi Tervonen, Cathy Anne Pinto, Dimitra Lambrelli. (United Kingdom)

Moderators: Bjorn Wettermark, Gianluca Trifiro

8:00 AM - Estimating the Optimal Duration of Initial Opioid Analgesic Prescriptions in Post-Surgical Populations Using FDA’s Sentinel Distributed Database [392]

• Mallika L. Mundkur, Tamra Meyer, Talia Menzin, Judy Staffa, Corinne Woods, Judith C. Maro, Justin Bohn. (United States)

8:15 AM - Prescription Opioid Use and Concurrent Psychotropic Drug Use During Pregnancy: a Population-Based Retrospective Cohort Study Utilizing Linked Administrative Data [393]

• Dan Chateau, Deepa Singal, Ana Hanlon-Dearman, Chelsea Ruth, Laurence Katz, Marni Brownell. (Canada)

8:30 AM - Identifying Off-Label Pharmaceutical Company Promotion of Opioids for Cancer Pain Management [394]

• Shelley A. Jazowski, Stephen Patrick, Stacie B Dusetzina. (United States)

8:45 AM - Using Trajectory Models to Assess Effect of Hydrocodone Up-Scheduling on Chronic Opioid Users [395]

• Irene B. Murimi, Hsien-Yen Chang, Christopher M. Jones, Mark Bicket, G. Caleb Alexander. (United States)

9:00 AM - Predictors of Opioid Tapering Success  [396]

• David H. Smith, Jennifer Kuntz, John F. Dickerson, Xiuhai Yang, Lynn L. DeBar, Lou Ann Thorsness, Jennifer L. Schneider, Allison J. Firemark, Dea Papajorgji-Taylor, Mark D. Sullivan. (United States)

9:15 AM - Assessing Association Between Cash Payment and Potential Opioid Misuse Among Patients on Chronic Opioid Therapy [397]

• Hilary A Aroke, Xuerong Wen, Ashley L Buchanan, Stephen S Kogut. (United States)

Moderators: Jacqueline Cohen & Maqura Shinde

8:00 AM - Maternal Use of Atypical Antipsychotics and Gestational Weight Gain [374]

• Yanmin Zhu, Dikea Roussos-Ross, Christian Hampp, Yu-Jung Wei, Babette Brumback, Almut G. Winterstein. (United States)

8:15 AM - Maternal Use of Benzodiazepines and Z-Hypnotics During Pregnancy and Developmental Outcomes in Offspring at 5 Years of Age [375]

• Angela Lupattelli, Christina D Chambers, Gretchen Bandoli, Marte Handal, Svetlana Skurtveit, Hedvig Nordeng. (Norway)

8:30 AM - Self-Reported Postnatal Depressive Symptom Severity After Treatment With Antidepressants in Pregnancy:A Cross-Sectional Study in 12 European Countries Using the Edinburgh Postnatal Depression Scale [376]

• Angela Lupattelli, Michael J Twigg, Ksenia Zagorodnikova, Myla M Moretti, Mariola Drozd, Alice Panchaud, Andre Rieutord, Romana Gjergja Juraski, Marina Odalovic, Debra Kennedy, Gorazd Rudolf, Herbert Juch, Hedvig Nordeng. (Norway)

8:45 AM - Association of Antidepressant Continuation in Pregnancy With Maternal Gestational Weight Gain and Gestational Diabetes [377]

• Paige D Wartko, Noel S. Weiss, Daniel A. Enquobahrie, Beth A. Mueller, Gary K. Chan, Alyssa Stephenson-Famy, Sascha Dublin. (United States)

9:00 AM - Are Associations Between Prenatal Antidepressant Exposure and Toddler Neurodevelopment Mediated by Gestational Age at Birth? [378]

• Mollie E Wood, Sonia Hernandez-Diaz, Hedvig M Nordeng. (United States)

9:15 AM - Psychotropic Polytherapy Among Publicly Insured Pregnant Women in the United States [379]

• Anna Cantarutti, Brian T. Bateman, Elisabetta Patorno, Rino Bellocco, Stephanie White-Bateman, Sonia Hernández-Díaz, Krista F. Huybrechts. (Italy)

Data science has emerged as a new discipline with growing impact. It has links and overlaps with epidemiology, and there are areas of possible synergy. An important characteristic of data science is its open embrace of novel computational and analytical approaches such as machine learning and artificial intelligence.

The objectives of this session are to illustrate what machine learning and artificial intelligence have recently achieved in other domains, to share experiences of their application in the analysis of real-world evidence, and to discuss barriers and success factors for their use to achieve better patient outcomes.

While artificial neural networks have been known and used for decades, recent years have seen a surge in performance following improved computational power and theoretical developments, which have inspired a new class of so-called deep neural networks. These have been found to outperform human reviewers on classification tasks such as image and speech recognition. At the same time, these methods are typically applied in the setting of supervised learning which requires large amounts of reliable training data that will often be hard to come by in our domain, and any use of complex predictive models in a medical context requires extra care.

Speakers

John Rigg, Senior Principal, Predictive Analytics, IQVIA: The future of healthcare – how machine learning may enhance our analysis of real-world evidence

Johan Ellenius, Senior Researcher and Team Manager, Uppsala Monitoring Centre: Barriers and success factors for machine learning to improve patient outcomes

Open to all participants; lunch available.

• Development:  Club C
• Global Development:  Zoom
• History & Archives:  Club H
• Publications & Communications:  Terrace 2A
• Public Policy:  Terrace 2B

Spotlight Poster Session B:  Benefit Risk Assessment, Communication & Evaluation (BRACE); Databases; Drug Utilization Research/Health Services Research; Medical Devices; & Rare Diseases 

Moderators: Jodi Segal, FISPE & Jennifer Lund

1:00 PM - Cognitive and Other Neuropsychological Assessments Documented in Electronic Health Records Prior to Or at Alzheimer’s Disease Diagnosis [416]

• Nancy N. Maserejian, Jin Wang, Henry Krzywy, Maneesh Juneja, Judith Jaeger. (United States)

1:15 PM - Improving Claims-Based Frailty Prediction in the Medicare Population Using STOPPFrail Drug Criteria [417]

• Sophie E Mayer, Virginia Pate, Laura C Hanson, Michele Jonsson Funk, Keturah R Faurot, Til Stürmer, Jennifer L Lund. (United States)

1:30 PM - Anticholinergic Safety in US Nursing Home Residents With Dementia: Risk of Delirium and Mortality [418]

• Izumi Sato, Isao Iwata, Tobias Gerhard, Stephen Crystal, Daniel B Horton, Soko Setoguchi. (United States)

1:45 PM - Can Treatments for Hypertension Be Repurposed for the Treatment of Dementia? [419]

• Venexia M Walker, Neil M Davies, Patrick G Kehoe, Richard M Martin. (United Kingdom)

2:00 PM - Effect of Bisphosphonates on Nonvertebral Fracture Among Older Nursing Home Residents [420]

• Andrew R Zullo, Yoojin Lee, Tingting Zhang, Kevin W McConeghy, Lori A Daiello, Douglas P. Kiel, Vincent Mor, Sarah D. Berry. (United States)

2:15 PM - Medication Appropriateness for Elderly Nursing Home Residents With a Limited Remaining Life Expectancy: Adjusting the Start/Stopp Criteria by Means of a Delphi Consensus Study [421]

• C A Pouw, M Smalbrugge, C M Hertogh, R J van Marum, Jacqueline G Hugtenburg. (Netherlands)

Moderators: Helga Gardarsdottir, FISPE & Stella Blackburn, FISPE                                  

1:00 PM - Prevalence of Systemic Sclerosis in Europe and North-America: Reducing Uncertainty for Improving Decision Making [410]
Laura Perez, Sandro Gsteiger. (Switzerland)

1:15 PM - Moderate and Severe Systemic Lupus Erythematosus Is Associated With Greater Health Care Utilization and Costs: Analysis of the Integrated Optum Claims Data 2011-2015 [411]

• Irene B. Murimi, Dora H. Lin, Jonothan C Tierce, Xia Wang, Henk Nab, Barnabas Desta, G. Caleb Alexander, Edward R. Hammond. (United States)

1:30 PM - Prediction of Cardiovascular Events in Rheumatoid Arthritis Patients Using a Multibiomarker of Disease Activity [412]

• Fenglong Xie, Lang Chen, Huifeng Yun, Jeffrey R Curtis. (United States)

1:45 PM - Propensity Score Methods: the Study of the Effect of β-Interferon and Glatiramer Acetate on Multiple Sclerosis Disability [413]

• Mathilde Lefort, Gilles Edan, Emmanuelle Leray. (France)

2:00 PM - Herpes Zoster in Tofacitinib-Treated Rheumatoid Arthritis Patientsaccording to Concomitant Glucocorticoid and Methotrexate Use [414]

• Jeffry R Curtis, Fenglong Xie, Lang Chen, Huifeng Yun, Sasha Bernatsky, Kevin Winthrop. (United States)

2:15 PM - Marginal Structure Modeling of Association Between Disease Activity and Hospitalized Infection Among Patients in a Rheumatoid Arthritis Registry [415]

• Huifeng Yun, Lang Chen, Jason Roy, Jeffrey D Greenberg, Jeffrey R Curtis. (United States)

Moderator: Charles Leonard & Ursula Kirchmayer

1:00 PM - Comparative Safety and Effectiveness of Alendronate versus Raloxifene in Women With Osteoporosis [398]

• Yuxi Tian, Yeesuk Kim, Jianxiao Yang, Vojtech Huser, Peng Jin, Christophe Lambert, Hojun Park, Rae Woong Park, Peter Rijnbeek, Mui Van Zandt, Rohit Vashisht, Yonghui Wu, Seng Chan You, Jon Duke, George Hripcsak, David Madigan, Christian Reich, Nigam Shah, Patrick Ryan, Martijn Schuemie, Marc Suchard. (United States)

1:15 PM - The Effect of Oral Bisphosphonates on Acute Kidney Injury, Gastrointestinal Events and Hypocalcaemia in Patients With Chronic Kidney Disease [399]

• M Sanni Ali, Danielle E Robinson, Natalia Pallares, Christian Tebe, Cyrus Cooper, Bo Abrahamsen, Fergus Caskey, Yoav Ben-Shlomo, Antonella Delmestri, Andrew Judge, M Kassim Javaid, Adolfo Diez-perez, Daniel Prieto-Alhambra. (United Kingdom)

1:30 PM - Risk of Age-Related Macular Degeneration and Cataract Surgery After Initiation of Denosumab versus Zoledronic Acid for Osteoporosis: a Multi-Database Cohort Study [400]

• Yinzhu Jin, Theodore N Tsacogianis, Miin Roh, Sangshin Park, Nam-Kyong Choi, Seoyoung Kim. (United States)

1:45 PM - Oral Bisphosphonate Use and All-Cause Mortality in Patients With Advanced (stage IIIB+) Chronic Kidney Disease: a Propensity Score Analysis [401]

• Dunia Alarkawi, Dana Bliuc, Natalia Pallares, Cristian Tebe, Cyrus Cooper, Fergus Caskey, Yoav Ben-Shlomo, Andrew Judge, Kassim Javaid, Adolfo Diez-Perez, Jacqueline Center, A/Prof. Daniel Prieto-Alhambra. (United Kingdom)

2:00 PM - Oral Bisphosphonate Use and Latent Class Trajectories of Kidney Function: a Cohort Study [402]

• Victoria Y Strauss, Danielle E Robinson, M Sanni Ali, Laurie Tomlinson, Cyrus Cooper, Fergus Caskey, Yoav Ben-Shlomo, Antonella Delmestri, Andrew Judge, M Kassim Javaid, Daniel Prieto-Alhambra. (United Kingdom)

2:15 PM - Comparative Cardiovascular Safety of Strontium Ranelate and Bisphosphonates Amongst Patients With No Contraindications: a Multi-Database Study in 5 EU Countries by the EU-ADR Alliance [403]

• M Sanni Ali, Klara Berencsi, Karine Marnier, Nicolas Deltour, Lars Pedersen, Peter Rijnbeek, Francesco Lapi, Monica Simonetti, Miriam Sturkenboom, Johan Van der Lei, Johan Van der Lei, Daniel Prieto-Alhambra. (United Kingdom)

Moderators: Andrea Margulis & Susan dosReis, FISPE

1:00 PM - Association Between Azathioprine Use and Risk of Acute Pancreatitis in Pediatric Inflammatory Bowel Disease: a Nationwide Swedish Cohort Study [422]

• Viktor Wintzell, Henrik Svanström, Ola Olén, Mads Melbye, Jonas F Ludvigsson, Björn Pasternak. (Sweden)

1:15 PM - Cost Effectiveness of Early Treatment in Pediatric Patients With Hepatitis C Virus Infection [423]

• Joehl T Nguyen, A. Sidney Barritt, Ravi Jhaveri. (United States)

1:30 PM - A Statistical Model of RSV Disease in Neonates and Efficacy Prediction for Maternal Vaccines [424]

• Bing Cai, Yili Chen, Meichun Ding, Yasmeen Agositi, Kena A Swanson, Beate Schmoele-Thoma, William C Gruber, Philip R Dormitzer. (United States)

1:45 PM - Association Between Oseltamivir and Suicide Among Children: a Case-Crossover Study [425]

• Rachel L Harrington, Sruthi Adimadhyam, Todd A Lee, Glen T Schumock, James W Antoon. (United States)

2:00 PM - Gabapentin Use for Hospitalized Neonates [426]

• Hibo Abdi, Nathalie L Maitre, Kristen L Benninger, Jonathan L Slaughter. (United States)

2:15 PM - Relational Patient-Provider Continuity of Care and the Risk of Emergency Department Use Among U.S. Medicaid-Insured Youth With Mental Health Diagnosis [427]

• Dinci Pennap, Julie M. Zito, Eberechukwu O. Onukwugha. (United States)

Moderators: Rachel Sobel, FISPE & Rachel DiSantostefano         

1:00 PM - Use of Real-World Evidence in Personalized Benefit Risk Assessment: Closing the Knowledge Gap [404]

• Cathy Anne Pinto, Tommi Tervonen, Kevin Marsh, Dimitra Lambrelli, Anna Schultze, Andy Tershakovec, Johanna Hyacinthe, Thibaud Prawitz, Tarek Hammad. (United States)

1:15 PM - Quality of Reporting on Risk Minimization Evaluation Studies: a Systematic Review [405]

• Andrea M Russell, Rebecca J Mullen, Elaine H Morrato, Meredith Y Smith. (United States)

1:30 PM - Impact of Schedule IV Controlled Substance Classification on the Use of Carisoprodol in the United States [406]

• Yan Li, Chris Delcher, Joshua Brown, Gary M. Reisfield, Yu-Jung Wei, Xi Wang, Almut G. Winterstein. (United States)

1:45 PM - Impact of Risk Evaluation and Mitigation Strategies (REMS) on Erythropoiesis Stimulating Agent Use [407]

• Mengdong He, Joshua J. Gagne, Aaron S. Kesselheim, Ameet Sarpatwari. (United States)

2:00 PM - Impact of Risk Minimisation Measures on the Use of Strontium Ranelate: a Multi-National Cohort Study in 5 EU Countries by the EU-ADR Alliance [408]

• Klara Berencsi, M Sanni Ali, Karine Marinier, Nicolas Deltour, Samuel Hawley, Lars Pedersen, Peter Rijnbeek, Johan Van der Lei, Francesco Lapi, Monica Simonetti, Carlen Reyes, Miriam Sturkenboom, Daniel Prieto-Alhambra. (United Kingdom)

2:15 PM - Fda's Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate Release Fentanyls (TIRFS) [409]

• Jeffrey E. Rollman, James Heyward, G. Caleb Alexander. (United States)

Moderators: Patrick Blin & Thomas Ahern

1:00 PM - Breast Cancer Risk in Chronic Users of Phthalate-Containing Medications: a Danish Nationwide Cohort Study [428]

• Thomas P. Ahern, Deirdre Cronin-Fenton, Anne Broe, Sinna P. Ulrichsen, Bernard F. Cole, Timothy L. Lash, Peer M. Christiansen, Henrik Toft Sørensen, Rulla M. Tamimi, Per Damkier. (United States)

1:15 PM - Use of Vitamin K Antagonists and Prostate Cancer Risk: a Danish Nationwide Study [429]

• Kasper Bruun Kristensen, Patricia Hjorslev Jensen, Charlotte Skriver, Søren Friis, Anton Pottegård. (Denmark)

1:30 PM - Use of Valproic Acid and Risk of Skin Cancer [430]

• Kasper Bruun Kristensen, Sidsel Arnspang Pedersen, Sigrun Alba Schmidt, Anton Pottegård. (Dominica)

1:45 PM - Testosterone Supplementation in Relation to Prostate Cancer in a US Commercially-Insured Claims Database [431]

• Daniel C Beachler, Lauren E Parlett, Stephan Lanes, Robert N Hoover, Michael B Cook. (United States)

2:00 PM - Use of Proton Pump Inhibitors and Risk of Pancreatic Cancer [432]

• Blánaid Hicks, Søren Friis, Anton Pottegård. (United Kingdom)

2:15 PM - Development of Predictive Models to Identify Advanced-Stage Cancer Patients in a US Administrative Claims Database [433]

• Daina Esposito, Leo Russo, Francois-Xavier Lamy, Ruihua Yin, Vibha Desai, Patrice Verpillat, Jose Peñalvo, Dina Oksen, Stephan Lanes. (United States)

Open to all participants.

▪ Annual Meeting of ISPE Members
▪ Awards Ceremony
▪The Ronald D. Mann Best PDS Article Awards
▪ ISPE Awards
* 34th ICPE Awards- Andrew McAfee Award
- John Snow Award
- Student Awards
- Stanley A. Edlavitch Award & Oral Presentation
▪ Induction of ISPE Fellows
▪ Induction of New Officers & Directors

Chairs

Dr Sinéad Langan, Wellcome Senior Clinical Fellow, London School of Hygiene and Tropical Medicine

Dr Eric Benchimol, Associate Professor of Pediatrics and Epidemiology, University of Ottawa

Speakers

4.00-4.05pm

Dr Sinéad Langan

Introduction

4.05-4.20pm

Dr Eric Benchimol

Development and utilisation of RECORD guidelines

4.20-4.35pm

Dr Sinéad Langan

Introducing RECORD for pharmacoepidemiology

4.35-4.50pm

Dr Eric Benchimol

Introducing the concept of a methods centre for RCD

4.50-5.20pm

Professor Stephen Evans, Professor of Pharmacoepidepidemiology, London School of Hygiene and Tropical Medicine

Discussion and Audience Interaction: Evaluating the need for a methods centre for RCD

5.20-5.30pm

Final summary and next steps

• Academic:  Panorama Hall
• Government/Regulatory:  South Hall 1 AB
• Industry/Service Provider:  South Hall 2A
• Student Council & Chapters:  South Hall 2B

Open to all participants.

Full meeting registration includes food and entertainment, shuttle bus to/from the Convention Centre & Municipal House. Cash bar is available.

Shuttle bus begins at 7:00pm from Entrance 10/Congress Centre

Moderators: Robert Platt & Soko Setoguchi, FISPE

8:30 AM - Statins and All-Cause Mortality Among Patients With Heart Failure: Minimizing Immeasurable Time Bias in the Setting of a Nested Case-Control Study [750]

• In-sun Oh, Kristian B. Filion, Ju-young Shin. (Korea, Republic of)

8:45 AM - A Word of Caution: All-Cause Mortality and Residual Confounding in Medicare Claims Data [751]

• Xabier García-Albéniz, John Hsu, Miguel A Hernán. (Spain)

9:00 AM - Use of Real-World Evidence in Personalized Benefit-Risk Assessment: Detecting Treatment Patterns Using Gaussian Mixture Models [752]

• Tommi Tervonen, Cathy Anne Pinto, Kevin Marsh, Dimitra Lambrelli, Anna Schultze, Thibaud Prawitz, Andrew Tershakovec, Tarek A Hammad. (United Kingdom)

9:15 AM - The Use of Propensity Score Distributions to Gain Understanding on Drug Utilization in Routine Clinical Practice: a Case Study on Newer vs Older Oral Anticoagulants [753]

• Clementine Nordon, Lucien Abenhaim, Lamiae Grimaldi-Bensouda. (France)

9:30 AM - Observational Studies on Non-Specific Effects (NSE) of Diphtheria-Tetanus-Pertussis Vaccination (DTP) in Low-Income Countries: Assessing the Impact of Bias and Confounding by Using Meta-Regression [754]

• Kaatje Bollaerts, Thomas Verstraeten, Catherine Cohet. (Belgium)

9:45 AM - Quantification of Unmeasured Confounding in a Post-Marketing Drug Monitoring Program  [755]

• Elisabetta Patorno, Chandrasekar Gopalakrishnan, Kimberly G Brodovicz, Andrea Meyers, Dorothee B Bartels, Julie Barberio, Jun Liu, Sebastian Schneeweiss. (United States)

Moderators: Lesley Wise & Jessica Jalbert                                          

8:30 AM - Treatment for Older Diffuse Large B-Cell Lymphoma Patients With Cognitive Impairment and Dementia [780]

• Christopher D. Saffore, Naomi Y. Ko, Holly M. Holmes, Pritesh R. Patel, Karen Sweiss, Sruthi Adimadhyam, Brian C. Chiu, Gregory S. Calip. (United States)

8:45 AM - Understanding Treatment Pathways for HER2-Positive Metastatic Breast Cancer (HER2+MBC) Patients: Analysis Using Group-Based Trajectory Models (GBTM) [781]

• Benjamin Daniels, Sallie-Anne Pearson. (Australia)

9:00 AM - Potential for Using External Control Arms Derived From Electronic Health Records to Replace Control Arms From Randomized Controlled Trials [782]

• Gillis Carrigan, Samuel Whipple, William B Capra, Michael D Taylor, Michael Lu, Brandon Arnieri, Jeffrey S Brown, Amy P Abernethy, Ryan Copping, Kenneth J Rothman. (United States)

9:15 AM - Using Group Based Trajectory Models and Propensity Score Weighting to Detect Heterogeneous Treatment Effects: the Case Study of Generic Hormonal Therapy for Women With Breast Cancer [783]

• Aaron N Winn, Nicole Fergestrom, Joan M Neuner. (United States)

9:30 AM - Characterization of Chronic Lymphocytic Leukemia (Cll) Patients in Real-Life Clinical Practice in Helsinki, Finland 2005-2015 [784]

• Vesa Lindström, Juha Mehtälä, Riho Klement, Amy Leval, Tiina Järvinen. (Finland)

9:45 AM - Developing a Model of Theory Based Behavioural Influences on Endocrine Therapy Medication Taking Behaviour in Women With Breast Cancer [785]

• Caitriona Cahir, Stephan U Dombrowski, Linda Sharp, Kathleen Bennett. (Ireland)

Moderators: Sascha Dublin & Angela Lupattelli                                        

8:30 AM - Metformin versus Insulin for Initial Treatment of Gestational Diabetes: Maternal and Neonatal Outcomes [768]

• Suzanne Landi, Sarah Radke, Kim Boggess, Stephanie M Engel, Til Stürmer, Anne S Howe, Michele Jonsson Funk. (United States)

8:45 AM - Child Growth and Developmental Outcomes Following In-Utero Exposure to Metformin versus Insulin for Treatment of Gestational Diabetes [769]

• Suzanne N Landi, Sarah Radke, Stephanie M Engel, Til Stürmer, Kim Boggess, Anne S Howe, Michele Jonsson Funk. (United States)

9:00 AM - First Trimester Exposure to Varenicline Was Not Associated With Increased Risk of Major Birth Defects: Findings From the Smoking Mums (Maternal Use of Medications and Safety) Study [770]

• Duong T Tran, David B Preen, Kristjana Einarsdottir, Anna Kemp-Casey, Deborah Randall, Stephanie Choi, Louisa R Jorm, Alys Havard. (Australia)

9:15 AM - Algorithms to Estimate the Timing of Pregnancy for Stillbirths in Pregnancy Safety Studies [771]

• Anna Cantarutti, Brian T. Bateman, Sonia Hernández-Díaz, Kathryn J. Gray, Elisabetta Patorno, Giovanni Corrao, Rishi J. Desai, Krista Huybrechts. (Italy)

9:30 AM - The Impact of Naive Identification of Pregnancies on Cohort Inclusion and Misclassification of Person-Time in Insurance Claims Data [772]

• Dana Y Teltsch, Natalia Petruski-Ivleva, Liza R. Gibbs, Emma R. Payne. (United States)

9:45 AM - Periconceptional Oral Contraceptive Use and Adverse Perinatal Outcomes: the Pride Study [773]

• Marleen M. van Gelder, Ibtissam Mokadem, Marc E. Spaanderman, Nel Roeleveld. (Netherlands)

Moderators: David Miller, FISPE & Marina Machado

8:30 AM - The Association Between Treatment With Systemic Prednisolone and Insomnia - a Symmetry Analysis [774]

• Daniel P. Henriksen, Jesper Hallas. (Denmark)

8:45 AM - Safety of Baclofen for Alcohol Use Disorders: Comparison With Nalmefene, Acamprosate and Naltrexone in a Cohort Study of 165,334 Patients Between 2009 and 2015 in France  [775]

• Christophe Chaignot, Mahmoud Zureik, Gregoire Rey, Rosemary Dray-Spira, Joël Coste, Alain Weill. (France)

9:00 AM - Evaluating the Assumptions of the Self-Controlled Case Series Design in Studies Investigating the Risks of Antipsychotic Use in the Older Population  [776]

• Emmae Ramsay, Nicole Pratt, Anna Moffat, Lisa Kalisch-Ellett, Elizabeth Roughead. (Australia)

9:15 AM - Comparative Effectiveness of Adjunctive Psychotropic Medications in Schizophrenia [777]

• Tobias Gerhard, T. Scott Stroup, Stephen Crystal, Cecilia Huang, Zhiqiang Tan, Melanie A Wall, Chacku Mathai, Mark Olfson. (United States)

9:30 AM - Latent Class Analysis of Anticholinergic and Sedative Medication Use: a National Population Study [778]

• Helene van der Meer, Hans Wouters, Martina Teichert, Fabienne Griens, Lisa Pont, Katja Taxis. (Netherlands)

9:45 AM - The Risk of Alzheimer’s Disease Associated With Benzodiazepines and Related Drugs: a Nationwide Nested Case-Control Study [779]

• Vesa Tapiainen, Heidi Taipale, Antti Tanskanen, Jari Tiihonen, Sirpa Hartikainen, Anna-Maija Tolppanen. (Finland)

Moderators: Daniel Mines & Yea-Huei Yang, FISPE

8:30 AM - Risk and Prognosis of Acute Kidney Injury in Bisphosphonate Users Undergoing Hip Fracture Surgery [762]

• Christian Fynbo Christiansen, Nisha Shetty, Uffe Heide-Jørgensen, Henrik Toft Sørensen, Vera Ehrenstein, Alma Becic Pedersen. (Denmark)

8:45 AM - Optimal Plasma Potassium Ranges for Mortality Prediction Across Chronic Kidney Disease Stages; the Stockholm Creatinine Measurements (Scream) Project [763]

• Hairong Xu, Alessandro Gasparini, Marie Evans, Juan-Jesus Carrero. (United States)

9:00 AM - Influence of Statin Potency on the Risk of Renal Failure - a Nationwide Cohort Study Using Laboratory Data [764]

• Anna Citarella, Marie Linder, Simona Cammarota, Anders Sundström, Helle Kieler. (Italy)

9:15 AM - Tacrolimus Pharmacogenetics and Acute Kidney Injury After Lung Transplantation [765]

• Todd Miano, Judd Flesch, Joshua Diamond, Jason Christie, Rui Feng, Caitlin Forker, Melanie Brown, Michelle Oyster, Edward Cantu, Mary Porteus, Laurel Kalman, Melanie Rushefski, Russel Localio, Michael Shashaty. (United States)

9:30 AM - Comparative Safety of Calcium-Free Phosphate Binders Vs Calcium-Based Phosphate Binders in Patients With End-Stage Renal Disease Requiring Maintenance Hemodialysis [766]

• Julia Spoendlin, Julie M Paik, Theodore Tsacogianis, Seoyoung C Kim, Sebastian Schneeweiss, Rishi J Desai. (United States)

9:45 AM - Lithium Treatment and Risk of Chronic Kidney Disease - a Danish Population-Based Case-Control Study [767]

• Daniel P Henriksen, Anton Pottegård, Jesper Hallas, Mads Nybo, Per Damkier. (Denmark)

Moderators: Gianluca Trifiro & Daniel Prieto-Alhambra, FISPE                                         

8:30 AM - Deep Learning to Detect Features of a Population of Anti-Osteoporosis Drug Users [756]

• Sara Khalid, M Sanni Ali, Peter Rijnbeek, Daniel Prieto-Alhambra. (United Kingdom)

8:45 AM - Does Hyperparameter Tuning Improve the Performance of Super Learning for Predicting When Antidepressants Are Prescribed for Indications Other Than Depression? [757]

• Jenna Wong, Travis Manderson, Michal Abrahamowicz, David Buckeridge, Robyn Tamblyn. (United States)

9:00 AM - Signal Detection Using Tree-Temporal Scan Statistics in the Sentinel System [758]

• Judith C. Maro, Michael D. Nguyen, Rima Izem, Ya-Hui Hsueh, Inna Dashevsky, Austin Cosgrove, S. Christopher Jones, Jacqueline M. Major, Esther H. Zhou, Elande Baro, Joshua J. Gagne, Shirley V. Wang, Martin Kulldorff. (United States)

9:15 AM - Data Mining for Adverse Drug Events With a Propensity Score Matched Tree-Based Scan Statistic [759]

• Shirley V Wang, Judith C Maro, Elande Baro, Rima Izem, Inna Dashevsky, James R Rogers, Michael Nguyen, Joshua J Gagne, Elisabetta Patorno, Krista F Huybrechts, Jacqueline M Major, Esther Zhou, Megan Reidy, Austin Cosgrove, Sebastian Schneeweiss, Martin Kulldorff. (United States)

9:30 AM - Probabilistic Record Linkage to Detect Duplicated Content in Twitter Prior to Pharmacovigilance Analyses [760]

• Tomas Bergvall, Lucie Gattepaille, Sara Vidlin, Niklas Norén. (Sweden)

9:45 AM - Time-To-Onset in Statistical Signal Detection of ADRs: a Follow-Up Study [761]

• Joep Scholl, Florence van Hunsel, Eelko Hak, Eugène van Puijenbroek. (Netherlands)

Open to ISPE members; members may contact info@pharmacoepi.org if they would like to attend. 

Moderators: Rosa Gini &  Zhiqiang Lu                                                                                           

1:30 PM - Identification of Binge-Eating Disorder Patients in Electronic Health Record Data [809]

• Monica L. Bertoia, William M. Spalding, Karen Yee, Judith C. Kando, Cynthia M. Bulik, John D. Seeger. (United States)

1:45 PM - Methods to Detect Dementia in Electronic Health Data: Comparing Cognitive Tests Scores With Algorithms for Dementia [810]

• Barbara N Harding, Jeffrey F. Scherrer, James Floyd, Susan A Farr, Sascha Dublin. (United States)

2:00 PM - How Valid Are the Codes Used to Identify Acute Liver Injury (ALI)? a Study in 3 European Data Sources [811]

• Joan Forns, Miguel Cainzos-Achirica, Maja Hellfritzsch, Maria Giner-Soriano, Beatriz Poblador-Plou, Jesper Hallas, Rosa Morros, Alexandra Prados-Torres, Anton Pottegård, Jordi Cortés, Jaume Aguado, Jordi Castellsagué, Emmanuelle Jacquot, Nicolas Deltour, Susana Perez-Gutthann, Manel Pladevall. (Spain)

2:15 PM -Classifying and Analyzing Immunocompromise Status in Observational Studies [812]

• Laurie Aukes, Joan Bartlett, Bruce Fireman, John Hansen, Edwin Lewis, Elizabeth Earley, Morgan A. Marks, Nicola P. Klein, Patricia Saddier. (United States)

2:30 PM - Incorporating Time-Varying Clinical Data Into a Machine Learning Algorithm to Detect Atrial Fibrillation and Flutter [813]

• Nathan Hill, Daniel Ayoubkhani, Matthew Lumley, Steven Lister, Usman Farooqui, Phil McEwan, Jason Gordon, Mark O'Neil, David Clifton. (United Kingdom)

2:45 PM - Algorithms to Predict Left Ventricular Ejection Fraction Class in Patients With Heart Failure Using Medicare Claims Data [814]

• Rishi J Desai, Kueiyu J Lin, Elisabetta Patorno, Julie Barberio, Moa Lee, Raisa Levin, Thomas Evers, Shirley Wang, Sebastian Schneeweiss. (United States)

Moderators: Emily Brouwer & Annlouise Regina Assaf, FISPE

1:30 PM - Drug-Drug Interaction of Non-Potassium-Sparing Diuretics and Laxatives Is Associated With Cardiovascular Mortality in Hypertension-Treated Subjects [791]

• Liesa K Hoppe, Clarissa Muhlack, Hermann Brenner, Ben Schöttker. (Germany)

1:45 PM - The Use of Propensity Score Distributions to Gain Understanding on Drug Utilization in Routine Clinical Practice: a Case Study on Newer vs Older Antiplatelet Agents [792]

• Clementine Nordon, Lucien Abenhaim, Lamiae Grimaldi-Bensouda. (French Guiana)

2:00 PM - Preadmission Use of Aspirin Or Clopidogrel on Sepsis Outcome a Population-Based Cohort Study [793]

• Chien-Chang Lee. (Taiwan)

2:15 PM - Utilization and Clinical Outcomes of Ticagrelor in Patients Following Percutaneous CoronaryIntervention [794]

• Nicholas Belviso, Herbert Aronow, Marilyn Barbour, David Louis, Dhaval Kolte, Michelle Caetano, Xuerong Wen. (United States)

2:30 PM - Comparative Effectiveness of Prasugrel versus Ticagrelor for the Prevention of Cardiovascular Diseases in Patients With Acute Coronary Syndrome [795]

• Ghadeer Dawwas, Eric Dietrich, David E Winchester, Almut G Winterstein, Richard Segal, Haesuk Park. (United States)

2:45 PM - Preventive Effects of Single and Dual Anti-Platelets Use on Long Term Survival Among Out Hospital Cardiac Arrest Survivors [796]

• Dr. Szu-Ta Chen, Tzu-Chun Hsu, Chien-Chang Lee. (United States)

Moderators: Luciane Lopes & Katja Taxis                                      

1:30 PM - Prescribing Antimicrobial Drugs for Urinary Tract Infections in Primary Care in the Netherlands [797]

• Marlies Mulder, Esmee Baan, Annelies Verbon, Bruno Stricker, Katia Verhamme. (Netherlands)

1:45 PM - National Estimates for Gabapentin- and Pregabalin-Involved Deaths From 2010 to 2015 Using a Novel Data Resource [798]

• Richard Swain, Alex Secora, Yulan Ding, James Trinidad, Jaqueline Puigbo, Jennie Wong, Rajdeep Gill, Cynthia Kornegay, Judy Staffa. (United States)

2:00 PM - Multi-Level Modelling to Investigate Factors Impacting Prescribing Variability [799]

• Debabrata Roy, Lesley Wise, Saad Shakir. (United Kingdom)

2:15 PM - The Introduction of New Anticoagulation Therapy in the European Union: the Case of Rivaroxaban  [800]

• Irene Bezemer, Tania Schink, Luis Alberto García Rodríguez, Leif Friberg, Yanina Balabanova, Gunnar Brobert, Kiliana Suzart-Woischnik, Pareen Vora, Ana Ruigómez, Ron Herings. (Netherlands)

2:30 PM - The Right-Rx Medication Reconciliation Trial: Impact on Potential Adverse Drug Events [801]

• Robyn Tamblyn, Allen R Huang, Aude Motulsky, Ari N Meguerditchian, Nancy E Winslade, David L Buckeridge, Alan Forster, Todd Lee, Andre Bonnici, Isabelle Couture. (Canada)

2:45 PM - Evaluation of Switching Patterns in Fda’S Sentinel System - a New Tool to Assess the Substitutability of Generic Drugs [802]

• Dr. Sarah K Dutcher, Jennifer R Popovic, Michael Nguyen, Sukhminder K Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B Petrone, Anita K Wagner, Joshua J Gagne. (United States)

Moderators: J Bradley Layton & Christian Hampp, FISPE

1:30 PM - Prevalence of Thrombocytopenia Upon Acute Hospital Admission: a Study in Denmark [821]

• Guillaume Moulis, Christian Fynbo Christiansen, Bianka Darvalics, Henrik Toft Sørensen, Mette Nørgaard. (Denmark)

1:45 PM - Association Between Fluoroquinolone Use and Anterior Cruciate Ligament Injury in the United States [822]

• Mackenzie M Herzog, Jennifer L Lund, Virginia Pate, Jeffrey T Spang, Stephen W Marshall. (United States)

2:00 PM - The Impact of An In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: a Randomized Clinical Trial [823]

• Lene Vestergaard Ravn-Nielsen, Marie-Louise Duckert, Mia Lolk Lund, Jolene Pilegaard Henriksen, Michelle Lyndgaard Nielsen, Christina Skovsende Eriksen, Thomas Croft Buck, Anton Pottegård, Morten Rix Hansen, Jesper Hallas. (Denmark)

2:15 PM - Impact of the New Reimbursement Limitations of Palivizumab Prophylaxis in Italy [824]

• Valeria Belleudi, Francesco Trotta, Silvia Narduzzi, Luigi Pinnarelli, Marina Davoli, Antonio Addis. (Italy)

2:30 PM - Systematic Review of the Applicability to Real-World Populations of Randomised Controlled Trial Evidence of Treatments for Physical Health Conditions [825]

• Daniel R Morales, Davy He, Bruce Guthrie. (United Kingdom)

2:45 PM - Comparative Effectiveness of Antibiotic Therapy for the Treatment of Urinary Tract Infections [826]

• Anne M. Butler, Matthew R. Keller, Michael J. Durkin, Vikas R. Dharnidharka, Margaret A. Olsen. (United States)

Moderators: Kevin Haynes, FISPE & Katherine Donegan                                           

1:30 PM - Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments [803]

• Ting-Ying Huang, Emily C Welch, Margie Goulding, David J Graham, Rongmei Zhang, Marie Bradley. (United States)

1:45 PM - Intussusception Risk After Pentavalent Rotavirus Vaccination in Finnish Infants: Validity Study Comparing Results From Patient File Verified and Register-Based Data in Finland [804]

• Dr. Miia Artama, Tuomo Nieminen, Jukka Jokinen, Tuija Leino, Arto Palmu. (Finland)

2:00 PM - Validation of Transfusion Administrations Among Potential Transfusion-Related Acute Lung Injury (TRALI) Patients Included in the Sentinel Distributed Database [805]

• Mayura U Shinde, Meghan A Baker, Caren Spencer-Smith, Lesley H Curtis, Steven A Anderson, Austin Cosgrove, Richard Forshee, Jason Hickok, Adee Kennedy, David J Mohlman, Mikhail Menis, Karla M Miller, Manette Niu, Joyce Obidi, Wendy Paul, Russell Poland, Robert Rosofsky, Kimberly Smith, Salim Surani, Vinod Easwaran Nambudiri, Craig Zinderman, Azadeh Shoaibi, Candace C Fuller. (United States)

2:15 PM - Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations [806]

• Justin Bohn, Emily C Welch, Jenny W. Sun, Joshua J. Gagne, Sengwee Toh. (United States)

2:30 PM - Validating Prescription Registry Data on Statins Use by Blood Measurements [807]

• Anders Hammerich Riis, Rune Erichsen, Eva B. Ostenfeld, Carsten S. Højskov, Ole Thorlacius-Ussing, Mogens Stender, Timothy L. Lash, Holger Jon Møller. (Denmark)

2:45 PM - Documenting Diagnosis: Comparing Mild Cognitive Impairment Diagnosis Rates From ICD Codes vs. Clinical Notes [808]

• Aaron W Kamauu, Olga V Patterson, Todd Johnson, Andrew Wilson, John R Holmen, Nicole M Bailey, Patrick R Alba, Benjamin Viernes, Kristine E Lynch, Scott L DuVall. (United States)

Moderators: Bjorn Wettermark & Jason C. Hsu                                   

1:30 PM - A Novel Claims-Based Algorithm to Predict Opioid Overdose in the US [815]

• Jenny W Sun, Jessica M Franklin, Kathryn Rough, Rishi J Desai, Sonia Hernandez-Diaz, Krista F Huybrechts, Brian T Bateman. (United States)

1:45 PM - Long-Acting Opioid Selection and the Risk of Serious Infections [816]

• Marie R Griffin, C. Michael Stein, William Schaffner, Robert Greevy, Ed Mitchel, Carlos G Grijalva. (United States)

2:00 PM - Geographic Variation of High-Risk Opioid Use and Risk of Overdose Among Disabled Medicare Beneficiaries in the US From 2011 to 2015 [817]

• Weihsuan Lo-Ciganic, Walid Gellad, Lili Zhou, Julie Donohue, Anne Roubal, Lisa Hines, Jeremiah Lindemann, Daniel Malone, Sandipan Bhattacharjee, C. Kent Kwoh. (United States)

2:15 PM - Incident Opioid Use and Risk of Hip Fracture Among Persons With Alzheimer’s Disease, a Nationwide Matched Cohort Study [818]

• Heidi Taipale, Aleksi Hamina, Niina Karttunen, Marjaana Koponen, Antti Tanskanen, Jari Tiihonen, Sirpa Hartikainen, Anna-Maija Tolppanen. (Finland)

2:30 PM - Comparative Safety of Commonly-Used Opioids and Fracture Hospitalizations in United States Nursing Homes [819]

• Jacob Hunnicutt, Shao-Hsien Liu, Christine Ulbricht, Anne Hume, Kate Lapane. (United States)

2:45 PM - Prevalence and Incidence Trends of Opioid Use Disorder and Prior Prescription Opioid Utilization, 2005-2015 [820]

• Yu-Jung Jenny Wei, Cheng Chen, Amir Sarayani, Almut G Winterstein. (United States)

Since Feinstein’s 1971 paper on “Sources of ‘chronology bias’ in cohort statistics”, epidemiologist have discussed the potential pitfalls of defining cohorts by past exposures. Pharmacoepidemiologists have made key contributions to highlighting the importance of new user designs from Kramer et al. in 1987, to Ray et al in 2003, and Hernan et al. in 2008. New user designs have since become the widely accepted standard in pharmacoepidemiology. Recently, however, the supremacy of the new user design has been questioned. In a point-counterpoint published in the American Journal of Epidemiology 2015, Vandenbroucke and Pearce asked whether limiting studies to new users damages epidemiology and in 2017, Suissa et al. proposed prevalent new-user cohort designs when comparing new drugs with older drugs.

In this hot topic session, we propose to have two speakers presenting the importance of the new user design and the importance of the inclusion of prevalent users in 20 minutes each. These talks will be followed by a 20-minute talk identifying the implicit assumptions needed for including prevalent users in pharmacoepidemiologic studies and the plausibility of these assumptions in selected settings. The remaining 30 minutes will include a moderated discussion with the audience. The goal of the moderator will be to lead the discussion with the audience to go beyond an exchange of arguments towards a broader understanding of the underlying the assumptions, areas of common ground, and identification of next steps in the research agenda. We therefore do not propose a podium discussion with the previous speakers. Instead, the objective of the proposed hot topic session is to generate discussion and ultimately guidance that can be used by all pharmacoepidemiologists when making decisions on whether their studies need to be principled and when they might consider being more pragmatic.

Speakers

• Sonia Hernandez-Diaz, FISPE, Harvard School of Public Health, New User
• Jan Vandenbroucke, Leiden University Medical Center, Prevalent User
• Til Sturmer, FISPE, Gillings School of Global Public Heath, University of North Carolina-Chapel Hill, Assumptions
• Jesper Hallas, FISPE, University of Southern Denmark, Discussion Moderator

34^th ICPE Awards

            Olaf Klungel, FISPE, Chair, 2018 Scientific Program Committee

• Charles Leonard, Newcomer Track
• Ian Douglas, Newcomer Track
• Bradley Layton, Spotlight Poster Sessions
• Mary Ritchey, Moderator Subcommittee
• Krista Huybrechts, FISPE, Moderator Subcommittee

Spotlight Poster Awards

• Bradley Layton, Chair, Spotlight Poster Sessions

2019 Meetings

• Mid-Year Meeting – Rome
  • Ursula Kirchmayer, Co-Chair, Program Planning Committee
  • Gianluca Trifirò, Co-Chair, Program Planning Committee
• 35^th ICPE – Philadelphia
  • Vin Lo Re, III, FISPE, Chair, 2019 Scientific Program Committee
  • Daniel Horton, Chair, 2019 Local Host Committee
• Drawing for complimentary registrations to ICPE 2019 – must be present to win

Adjournment of the ICPE 2018

                        Olaf Klungel, FISPE, Chair, 2018 Scientific Program Committee

Open to ISPE members