OHDSI News Updates

Hospitalized COVID-19 Patients Shown To Be Younger, Healthier Than Influenza Patients Per Recent Global Observational Health Study

Patients hospitalized with COVID-19 were more likely male, younger, and, in both the US and Spain, had fewer comorbidities and lower medication use than hospitalized influenza patients according to a recent study published by the Observational Health Data Sciences and Informatics (OHDSI) community.

This global network study, which included more than 34,000 COVID-19 patients from across three continents, is intended to provide greater detail about the characteristics of patients suffering from the disease, and also to help inform decision-making around the care of hospitalized patients.

The study “Deep phenotyping of 34,128 adult patients hospitalized with COVID-19 in an international network study” was published Oct. 6 by Nature Communications and is available here.

Patients hospitalized with COVID-19 were more typically male in the US and Spain, but more often female in South Korea. The ages of patients varied, but in Spain and the US, the most common age groups were between 60 to 75. Patients hospitalized with influenza were typically older than those hospitalized with COVID-19, and more likely to be female.

OHDSI Symposium Panel – Building Trust: Evidence and its Communication

Leaders from around the healthcare community will share their insights during a panel discussion entitled “Building Trust: Evidence and its Communication” during a highlight event of the 2020 OHDSI Global Symposium, which will be held Oct. 19, 2020. The panel will be held at 1 pm ET during the symposium, which is free for all attendees.

This panel is scheduled to include:

• Amy Abernethy, MD, PhD, the Principal Deputy Commissioner of the U.S. FDA
• Patti Brennan, RN, PhD, the Director of the National Library of Medicine, NIH
• Magdalena Skipper, PhD, Editor in Chief, Nature
• Deborah Nelson, JD, Associate Professor of Investigative Journalism, University of Maryland
• Roni Caryn Rabin, MS, science reporter for the New York Times

George Hripcsak, MD, MS, Professor of Biomedical Informatics at Columbia University, will serve as moderator for this panel, which will take place at 1 pm ET during the main symposium

OHDSI Announces 18-Hour Global Symposium Schedule

The OHDSI community will welcome both network veterans and newcomers from all parts of the world to join in an 18-hour celebration of open science, international collaboration, and community fun on Monday, Oct. 19 during the 2020 OHDSI Global Symposium.

Part of a four-day event that will include both a day of tutorials on Oct. 18 and a two-day study-a-thon on Oct. 20-21, the global symposium will include many of the events that OHDSI veterans look forward to each year at the annual symposium … and a few surprises as well.

The symposium will be held virtually over Microsoft Teams, and registration is available here. Once again, there is no charge to attending the OHDSI Symposium.

Starting at midnight ET, our international community will have the opportunity to experience the full excitement of our 2020 symposium. Our Asia-Pacific collaborators will start in the afternoon, while the early risers in Europe can get a jump on their day with the state of the community address. As the symposium continues through the day, our European friends can enjoy panel discussions, poster sessions and a game show in the evening as our North American collaborators are in the middle of their symposium journey!

Collaborator Spotlight: Mui Van Zandt

Mui Van Zandt discussed the incredible growth of OHDSI in Asia during the 2019 Symposium.

Mui Van Zandt is a Director of Product Development at IQVIA, and she manages the OMOP Factory. Mui’s areas of expertise include software development, data conversions, agile process, and project management. Mui has gained extensive knowledge working on large patient databases in the OMOP model and the standard vocabularies that are needed to support these conversions.

Mui is an active contributor to the community through various OHDSI working groups. She is one of the co-leaders of the China OMOP CDM/Vocabulary working group. She leads two of the sub-working groups within the THEMIS working group. She has and continues to perform OMOP tutorial training to many different organizations and conferences, such as the OHDSI Symposiums, the China Hackathons, and individual universities.

A veteran of the OHDSI community, Mui recently shared some thoughts on her journey with the community, her work on the CDM and vocabularies, OHDSI progress, and more during the latest edition of the Collaborator Spotlight.

Podcast: Jenny Lane on the OHDSI Hydroxychloroquine Study

Jenny Lane, co-lead author of the recently published “Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study,” discussed the study and the 2020 journey of hydroxychloroquine during the debut episode of the OHDSI podcast, which is available below, as well as on Apple Podcasts, Podbean and other podcast apps.

Lane opens with a discussion on everything that went into the study, which was generated during the OHDSI COVID-19 study-a-thon in March, but she also talks about her own personal connection to hydroxychloroquine and its connection with rheumatoid arthritis, as well as the early clinical and methodological impact of the study during its preprint stage. She also discusses how open science and collaboration impacted this global study, and she provided insight on a recent OHDSI preprint she led, a study on the risk of depression, suicide and other psychological impacts in hydroxychloroquine treatment.

You can read more about the study here.

You can listen to the podcast below. Following a brief introduction, Jenny Lane joins the podcast at the 1:55 mark.

OHDSI Collaborators Publish 10 Principles Of LEGEND Project

Evidence derived from existing health-care data, such as administrative claims and electronic health records, can fill evidence gaps in medicine. However, many claim such data cannot be used to estimate causal treatment effects because of the potential for observational study bias; for example, due to residual confounding. Other concerns include P hacking and publication bias.

In response, an international group of OHDSI collaborators launched the Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND) research initiative. Its mission is to generate evidence on the effects of medical interventions using observational health-care databases while addressing the aforementioned concerns by following a recently proposed paradigm. We define 10 principles of LEGEND that enshrine this new paradigm, prescribing the generation and dissemination of evidence on many research questions at once; for example, comparing all treatments for a disease for many outcomes, thus preventing publication bias. These questions are answered using a prespecified and systematic approach, avoiding P hacking. Best-practice statistical methods address measured confounding, and control questions (research questions where the answer is known) quantify potential residual bias. Finally, the evidence is generated in a network of databases to assess consistency by sharing open-source analytics code to enhance transparency and reproducibility, but without sharing patient-level information.

Here we detail the LEGEND principles and provide a generic overview of a LEGEND study. Our companion paper highlights an example study on the effects of hypertension treatments, and evaluates the internal and external validity of the evidence we generate.

Largest Global Study on Hydroxychloroquine Safety Finds Increased Cardiovascular Risk with Azithromycin

Source-specific and meta-analytic-specific severe adverse event risk estimates for HCQ versus SSZ and HCQ plus AZM versus HCQ plus AMX new users during 30-day (intention-to-treat) follow-up

The combination of hydroxychloroquine (HCQ) and azithromycin (AZM) has been linked to significant cardiovascular risks, including mortality, in the largest safety study ever performed on both HCQ and HCQ+AZM. This network study, led by the Observational Health Data Sciences and Informatics community, was recently published in Lancet Rheumatology.

In patients with rheumatoid arthritis, HCQ treatment in the short term (30 days) was found to not carry an excess risk of complications associated with its use, but HCQ treatment in the long term had a 65% relative increase in cardiovascular-related mortality, compared to sulfasalazine.

HCQ + AZM had a cardiovascular mortality risk that was more than twice (2.19) as high as the comparative treatment even in the short term based on findings from more than 320,000 users of that combination therapy. This treatment also produced a 15-20% increased rate of angina/chest pain and heart failure.

The full paper is available here.

OHDSI Obtains Grant Towards Global Research On COVID-19 Treatments

An international cohort of OHDSI collaborators obtained a grant from the COVID-19 Therapeutics Accelerator to lead an effort to compare the effectiveness of treatments, including corticosteroids such as dexamethasone, under current evaluation for COVID-19 across an international observational data network. The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments.

Researchers from the University of Oxford, Columbia University, UCLA and Erasmus University Medical Center are leading this work through Project SCYLLA (SARS-Cov-2 Large-scale Longitudinal Analyses), one of the emerging efforts to come from OHDSI’s global work surrounding COVID-19 research.

“We are so appreciative that the donors of the Therapeutics Accelerator support our work around studying the effectiveness and safety of potential COVID-19 medicines,” says Daniel Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology at Oxford and co-PI on the project. “Their funding will help us learn which treatments are showing potential throughout an international cohort of patients. Every ounce of knowledge is a building block that will eventually lead us out of this global crisis.”

Collaborator Spotlight: Anthony Sena

Anthony Sena is an Associate Director of Epidemiology Analytics at Janssen Research and Development where he architects software solutions and data platforms for the analysis and application of observational data sources. Anthony’s areas of expertise include web application development, data modeling, information visualization, technology infrastructure, project management, and informatics. A collaborator on a number of open-source software solutions in OHDSI and one of the co-leads of the ATLAS & WebAPI working group, he has taken a prominent role in the recent CHARYBDIS Project, a characterization study to understand the disease natural history of COVID-19. His focus is on expanding the capabilities of the OHDSI open-source solution architecture to enable transparent and reproducible research using observational data.

Prior to joining Janssen Research and Development, Anthony held many leadership and technical roles of increasing responsibility across a range of business sectors including energy, pharmaceuticals, retail and financial services. He recently discussed his journey to OHDSI, his work with open-source tools, and some of his most important projects, during the latest Collaborator Spotlight.

EMA Announces Partnership With EHDEN To Monitor COVID-19 Treatments 

The European Medicines Agency recently announced an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. The EMA will work with EHDEN on this initiative to establish a European framework and research network for the conduct of multicenter cohort studies on the use of medicines in COVID-19 patients.

This will be a one-year EMA-funded project, which includes data sources from eight European countries standardized to the OMOP-Common Data Model, and is contracted to IQVIA as the coordinating partner. OHDSI and EHDEN leaders from both the Erasmus Medical Center and the University of Oxford will help drive this important work.

“This is precisely what EHDEN was set up for,” says Peter Rijnbeek, associate professor at Erasmus. “We are creating an international, open science network in Europe, based on a common data model, standardized analytics, tools, and methodologies. It’s exciting to participate in this project and further strengthen our collaboration with the EMA.”

EMA References OHDSI Efforts In Latest Revision Of Scientific Best Practices In Observational Research

The European Medicines Agency (EMA) provided guidance for scientific best practices in observational research in the recently released 8th revision of its guidelines. This work aligns with OHDSI’s mission, and our global community was proud to see multiple OHDSI efforts, including a pair of COVID-19 studies, have informed and supported their recommendations.

The foreword in “The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology” highlighted a pair of community preprints currently undergoing peer review.

2020 EU Symposium Collaborators Share Research As Part Of Virtual Showcase

Though the 2020 European Symposium was canceled and replaced with the COVID-19 Study-A-Thon, many community members still shared their research that had been accepted for the Collaborators Showcase. Those posters, along with abstracts and other links, were highlighted over the OHDSI social platforms, and are all available here.

This research comes from around the world and highlights the breadth and variety of OHDSI research in a pre-COVID world.

No Clear Risk For COVID-19 Diagnosis or Hospitalization From ACE/ARB Use According To Recent OHDSI Preprint

The Observational Health Data Sciences and Informatics (OHDSI) collaboration released a preprint entitled “Renin-angiotensin system blockers and susceptibility to COVID-19: a multinational open science cohort study.”

Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

The preprint is available here.

There was no clear increased risk of COVID-19 diagnosis, hospitalization, or subsequent complications found for users of either angiotensin-converting enzyme inhibitors (ACEs) or angiotensin receptor blockers (ARBs) among a multinational cohort of more than 1.1 million patients using antihypertensives.

This study, the most comprehensive one to date of COVID-19 susceptibility risks for antihypertensive users, examined electronic health records from a trio of data sources from the United States and Spain (Columbia University Irving Medical Center, the Department of Veteran Affairs and SIDIAP) to conduct a systematic cohort study of ACE, ARB, calcium channel blocker (CCB) and thiazide diuretic (THZ) users.

“We currently lack reliable, transparent and generalizable evidence to inform antihypertensive choice in light of COVID-19,” says Dr. Marc Suchard, a professor at UCLA and research team leader. “This work strives to openly and reproducibly leverage real-world data to help.”

As a consequence, the study, powered by open-source tools and global collaboration within the OHDSI community, reinforces current clinical guidelines surrounding antihypertensive therapy. The findings indicate that patients should continue their ACE or ARB therapy, despite early concerns about potential risks.

Furthermore, the findings showed no clinical reason to switch from an ARB to ACE to minimize COVID-19 risk.  “Based on our results, if there is a risk difference, it’s marginal and would be very challenging to further refine outside such a large-scale international study,” Dr. Suchard says.

The International COVID-ACE Receptor Inhibition Utilization and Safety (ICARIUS) protocol, code, and results are all available for further exploration at https://github.com/ohdsi-studies/Covid19Icarius.

Collaborator Spotlight: Kees van Bochove

Kees van Bochove is the founder and CEO of The Hyve, a 40-person international company dedicated to the support and facilitation of open source, open standards, and open data in biomedical research. He studied Computer Science at the University of Utrecht and Bioinformatics at VU University Amsterdam and Tufts University in Boston. Kees is active in many open-source software development communities such as i2b2/tranSMART, cBioPortal, OHDSI, RADAR, Galaxy, etc. Through his many years of experience in open source software and standards development in biomedical informatics, Kees has gained a deep understanding of all aspects of collaborative open source development and open data science, including open source community building and governance, software quality, and sustainability requirements, data workflows, etc.

Kees has been involved in OHDSI initially via the IMI EMIF project starting in 2013 and has been building a team around OMOP/OHDSI through the EMIF collaboration, working with a.o. Janssen and ErasmusMC as well as by providing OMOP mapping and OHDSI installation and support services to several pharmaceutical companies. Kees was also involved in planning the first OHDSI Europe meeting in March 2018, and he hosted a subsequent follow-up workshop to introduce OHDSI to a number of European national health-data initiatives (from a.o. The Netherlands, Germany, Switzerland, and Denmark) in May 2018. The Hyve is also leading WP4 in the IMI EHDEN project, which is one of the largest components of this important project, laying the technical groundwork and building data conversion and quality management tools for further developing the European and global OHDSI community.

(Click the link in the headline for a Q&A with Kees)

OHDSI Presents Study-A-Thon Findings At 2020 EULAR E-Congress

OHDSI collaborators shared important findings generated from the 2020 Barcelona Study-A-Thon at the recent 2020 EULAR E-Congress, held June 3-6, 2020.

“It was an honor for our team to share our findings at the 2020 EULAR Congress,” said Daniel Prieto-Alhambra, who led the Barcelona Study-A-Thon, and who also served on the EULAR Congress Programme Committee. “The experience in Barcelona was an enjoyable event, but the real-world studies and findings generated from that week can have a powerful impact on the field of rheumatology, and we couldn’t be prouder of that.”

Posters, slides and Cynthia Yang’s oral presentation can all be found by clicking here.

Seek COVER, First COVID-19 Prediction Study Generated During OHDSI Study-A-Thon, Released in OHDSI Preprint

The first Patient-Level Prediction paper has been sent to MedRxiv and is being submitted for peer review. This study “Seek COVER: Development and validation of a personalized risk calculator for COVID-19 outcomes in an international network” is designed to inform individual behavioral choices and help design shielding strategies during de-confinement.

Led by co-first authors Ross Williams and Aniek Markus, the team designed a nine-predictor COVID-19 Estimated Risk (COVER) model that was validated using more than 43,000 COVID patients (following initial development and validation using more than 6.8 million patients with influenza or flu-like symptoms). This model predicts hospitalization, intensive services, and death, and can help provide reassurance for low-risk patients, while shielding high-risk patients, as many start to enter the de-confinement stage of the pandemic.

Peter Rijnbeek is the corresponding author, and both he and Jenna Reps are co-last authors. Overall there are 43 authors involved in the study, once again highlighting the global collaborative nature of the OHDSI community. Congratulations to all who were involved in this work.

Collaborator Spotlight: Kristin Kostka

Kristin Kostka is an Associate Director at IQVIA running the OMOP Data Network and a perennial collaborator in the OHDSI community. In her work, Kristin partners with hospitals, payers and healthcare providers to help organizations unlock the power of institutional data and connect with the world’s largest observational health data network.

Kristin has over 10 years of experience leading real-world evidence generation studies, designing and implementing enterprise patient data lakes, conducting large-scale multinational clinical trials and preparing regularly submissions. Within OHDSI, Kristin sits on the OHDSI Steering Committee, the US Symposium Scientific Committee, the Women of OHDSI group, the OHDSI Study Nurture Committee and regularly leads OHDSI network studies. Kristin co-authored three chapters of the Book of OHDSI (Where to BeginDefining Cohorts and OHDSI Network Research). Her OHDSI passion project is the idea of “studies on studies” — evaluating the best way to disseminate evidence once its generated. Kristin currently serves as a member of the OHDSI COVID-19 Study-a-thon Core Team facilitating follow-on work from the recent virtual study-a-thon. She is also a Co-Principal Investigator on Project CHARYBDIS (Characterizing Health Associated Risks, and Your Baseline Disease In SARS-COV-2).

Kristin is a recipient of many industry awards, including the 2020 Elon University Young Alumni Council “Top 10 Under 10” Alumni Award, a 2018 OHDSI Titan Award for Community Collaboration, a 3-time recipient of Deloitte Outstanding Performance Award and an 8-time recipient of the Deloitte Applause Award for exceptional client service. She holds a Bachelor’s degree in Exercise Science from Elon University and a Master’s in Public Health in Epidemiology from Boston University School of Public Health.

(Click the link in the headline for a Q&A with Kristin)

Multi-Institutional Characterization Study on Hospitalized COVID Patients, And Comparison To Hospitalized Influenza Patients, Released in OHDSI Preprint

The Observational Health Data Sciences and Informatics (OHDSI) collaboration released a preprint on an international characterization of patients hospitalized with COVID-19 and a comparison with those previously hospitalized with influenza.

Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

The preprint is available here.

The characteristics (demographics, prior conditions and medication use) of more than 6,800 COVID-positive patients from four databases (Columbia, Stanford, the Department of Veterans Affairs and the South Korean Health Insurance Review & Assessment) were reported in this study and were compared to more than 52,000 patients hospitalized with influenza between 2014-19.

Compared to 52,422 individuals hospitalized with influenza, patients admitted with COVID-19 were more likely male, younger, and, in the US, had fewer comorbidities and lower medication use.

These are preliminary findings that are currently in the peer-review process. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

OHDSI is a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics. All solutions are open-source. OHDSI has established an international network of researchers and observational health databases with a central coordinating center housed at Columbia University.

All updates on OHDSI efforts on COVID-19 will be posted here and within OHDSI community forums, as well as shared on both the community Twitter and LinkedIn feeds.

EHDEN Academy Goes Live as Free Resource in Real-World Health Research

The European Health Data & Evidence Network (EHDEN) today announced the launch of the EHDEN Academy in Europe as an online educational resource for anyone working in the domain of real-world data use, and real-world evidence generation, with the aim of becoming a primary resource.

An IMI2 (Innovative Medicines Initiative) EHDEN project, the EHDEN Academy’s goal is to build upon the foundations of the EHDEN project and its collaboration with the Observational Health Data Science & Informatics (OHDSI) community. The EHDEN Academy aims to be a resource for all those who generate and utilize data, work technically with it (e.g. ETL and mapping of data to the OMOP common data model), and are involved in the methodological development and use of standardized analytical tools within the OHDSI framework.

As the current SARS-CoV-2 pandemic is showing us, the ability to collaborate and work with real-world data is critical to clinical decision-making, planning, and management decisions. As such, EHDEN is responding to the pandemic via its involvement in the OHDSI COVID-19 Virtual Study-a-thon, a COVID-19 Data Partner call, also supporting education in using real-world evidence at this critical time via the EHDEN Academy.

88 Hours: OHDSI’s Signature Moment

The time was meant for highlighting OHDSI capabilities, not testing them. The hours were meant to sharing global research, not sharing in global research.

The Observational Health Data Sciences and Informatics (OHDSI) community held a COVID-19 global, virtual study-a-thon March 26-29, believing that a network of people who valued both collaboration and open science could make a meaningful impact on the current global pandemic.

How? Nobody was quite sure in the moment, but they were confident they would figure it out.

“We chose an ambitious path and relied on our community and infrastructure to lead the way,” said Patrick Ryan. “In simple terms, efforts within our community over the past 88 months set the foundation for OHDSI’s most important and impactful 88 hours.”

(Click here for the full feature story on the OHDSI COVID-19 study-a-thon)

Largest Observational Study on Hydroxychloroquine Safety Profile Released in OHDSI Preprint

The Observational Health Data Sciences and Informatics (OHDSI) collaboration released a preprint on preliminary findings from the largest study ever completed on the safety profile of hydroxychloroquine, a drug currently being evaluated as a potential treatment for COVID-19.

Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

The preprint is available here.

The combined short-term use of hydroxychloroquine and azithromycin resulted in nearly 60% higher rate of cardiovascular-related mortality (calHR 2.19; (1.22-3.94)) than the combined use of hydroxychloroquine and amoxicillin. While not as high, there was also an advanced risk for both chest pain/angina (calHR 1.15 (1.05-1.26)) and heart failure (calHR 1.22 (1.02-1.45)) when azithromycin was added to hydroxychloroquine treatment.

These findings were generated from an international database of more than 950,000 users of hydroxychloroquine, including approximately 320,000 who used it in combination with azithromycin.

The short-term effect of hydroxychloroquine as a treatment drug was not found to have an excess risk by itself when compared to sulfasalazine among a large set of patients (950,769 and 306,706, respectively) being treated for rheumatoid arthritis.

Patients from five different countries (Germany, Japan, Spain, the United State, and the United Kingdom) were included in this study, the first to be shared via preprint from a four-day OHDSI COVID-19 study-a-thon, which brought together a global community to design and execute observational studies to generate real-world evidence and help inform the current global pandemic.

These are preliminary findings that are currently in the peer-review process. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

OHDSI Collaboration Designs COVID-19 Studies For International Observational Data Network

A four-day global collaboration within the Observational Health Data Sciences and Informatics (OHDSI) community designed and began executing studies on an international set of observational health databases (including insurance claims and electronic health records) to aid decision-making during the current COVID-19 pandemic.

One study is the first large-scale characterization of COVID-19 patients in both the United States and Asia; six databases with COVID-19 patients located in both the U.S. and South Korea already started running data on this project, and other databases are being sought to collaborate in this network study.

The largest study ever conducted on the safety of hydroxychloroquine was designed and executed across an international set of databases. This study of more than 130,000 patients from the USA, England, Germany and South Korea focuses on the overall safety profile of hydroxychloroquine, a drug currently being evaluated as a potential treatment for COVID-19.

The third study designed the first prediction model externally validated on COVID-19 patients to support triage decisions in an effort to ‘flatten the curve’. This model, which determines which patients presenting with symptoms are most likely to require hospitalization, was developed against US data and then tested on South Korean data.

More than 330 people from 30 nations registered to collaborate in this 88-hour virtual study-a-thon, which concluded March 29 with a global presentation from multiple study leads to announce both designs and preliminary findings. Results are currently being evaluated and papers are actively being submitted to journals for peer review.

OHDSI Kicks Off International Collaborative to Generate Real-World Evidence on COVID-19 with Virtual Study-a-thon March 26-29

The Observational Health Data Sciences and Informatics (OHDSI) international community will host a COVID-19 virtual study-a-thon this week (March 26-29) to inform healthcare decision-making in response to the current global pandemic.

More than 290 people from 29 different countries have registered for the four-day online event, which will be led by researchers from Oxford University, Erasmus Medical Center, Columbia University, UCLA, Ajou University, Janssen Research and Development, and IQVIA, with active participation across government, industry, and academia.

Held in lieu of the canceled OHDSI European Symposium, this event is structured to have two main goals: (1) to generate immediate real-world evidence on prioritized questions shared by national governments, public health agencies, health-related institutions, and community members; and (2) to design COVID-19-specific studies that can be validated and available to run when such data is available.

Cervical Cancer Risk Decreases In Users Of Copper IUDs vs. Hormonal IUDs; Research Team Seeks Community Involvement For Network Study

Patients who used copper intrauterine devices (Cu IUD) were found to have a lower risk of high-grade cervical neoplasms (cervical cancer) compared to users of the levonorgestrel-releasing intrauterine system (LNG-IUS), according to a Columbia study recently published in Obstetrics & Gynecology.

Studies from the 1980s suggested a reduced risk of cervical cancer among women who used an intrauterine contraceptive, though those studies did not differentiate between the varying types of IUDs. Furthermore, much of the data from those studies was collected prior to the availability of most hormonal IUDs (LNG-IUS).

Spotnitz noted that the research team hopes to lead a network study across other databases within the OHDSI network, which spans 19 countries, 133 unique databases converted to the OMOP CDM, and more than one billion patient records. For more information on the study, check out this forum post, or email him directly at mes2165@cumc.columbia.edu.

OHDSI Korea Symposium Page Is Live, Includes Video Of All Sessions, Photo Recap

The 2019 OHDSI Korea Symposium took place Dec. 12-14 at the Konjiam Resort in Gwangju and attracted 330 people to the main symposium on Dec. 13. It was another great gathering of OHDSI collaborators — both veterans and those just starting on the journey — to learn from each other, present their own research, and network together.

This page includes a photo gallery from the event, as well as videos all five sessions from the main symposium, as well as tutorials. Sessions included an introduction to both OHDSI and EHDEN, multiple presentations on OHDSI Community in Action, and sharing the international experience from the Asian-Pacific Region.

Recommended Diuretic Causes More Side Effects than Similar Hypertension Drug, Per Recent LEGEND Study

Chlorthalidone, the guideline-recommended diuretic for lowering blood pressure, causes more serious side effects than hydrochlorothiazide, a similarly effective diuretic, according to a recent OHDSI study. The findings, published in JAMA Internal Medicine, contrast with current treatment guidelines recommending chlorthalidone over hydrochlorothiazide.

The researchers found that patients taking chlorthalidone had nearly three times the risk of developing dangerously low levels of potassium and a greater risk of other electrolyte imbalances and kidney problems compared with those taking hydrochlorothiazide. Information from the largest individual database studied by the team revealed that 6.3% of patients treated with chlorthalidone experienced hypokalemia (low blood potassium), compared with 1.9% of patients who were treated with hydrochlorothiazide.

“Doctors prescribing chlorthalidone should monitor for certain side effects in their patients,” says George Hripcsak, MD, MS, chair and Vivian Beaumont Allen Professor of Biomedical Informatics at Columbia University and lead author of the study.

Methods Benchmark Can Aid Trust In Observational Research, Per Recent OHDSI Study

The prevalence of electronic healthcare data allows researchers the opportunity to study the effects of medical treatments. However, confidence in the results of such observational research is typically low, for example, because different studies on the same question often produce conflicting results, even when using the same data. We need to answer the question “to what extent can we trust observational research?”

Led by Martijn Schuemie, OHDSI researchers recently published “How Confident Are We About Observational Findings in Healthcare: A Benchmark Study” in the Harvard Data Science Review to tackle this important issue. This paper presents the OHDSI Methods Benchmark to evaluate five methods commonly used in observational research (new-user cohort, self-controlled cohort, case-control, case-crossover, and self-controlled case series designs) over a network of four large databases standardized to the OMOP Common Data Model.

Using both negative and positive controls (questions where the answer is known), a set of metrics and open-source software tools developed within the OHDSI community, the research team determined that most commonly used approaches to effect-estimation observational studies are falling short of expected confidence levels. Selection bias, confounding, and misspecification are among the sources of systematic error that plagues the validity of potentially important findings within the healthcare community.

OHDSI Q&A: Dani Prieto-Alhambra Discusses RA Study-A-Thon, EU Symposium

When Dani Prieto-Alhambra discussed the Oxford Study-A-Thon at the 2019 U.S. Symposium, he introduced his talk as the “conversion of himself and 30-35 colleagues to the OMOP Common Data Model and to the OHDSI way of doing things.”

After sharing the incredible research that would eventually lead to a published study in The Lancet Rheumatology, he didn’t wait long to welcome new converts to the OHDSI community. Prieto-Alhambra coordinated the 2020 Barcelona Study-A-Thon on rheumatoid arthritis (RA); you can read the OHDSI release about the event here.

He recently discussed several aspects of the study-a-thon with OHDSI.org, and he also touched on the 2020 OHDSI European Symposium, which will be held March 27-29 at Oxford. Abstracts for the Symposium are due Friday, Feb. 14; more information on abstract submission and other areas of participation is available here.

EHDEN Launches Second Open Call For SMEs

The OHDSI community has been a proud collaborator with the European Health Data & Evidence Network (EHDEN) since the EHDEN launch in 2018. An IMI 2 consortium, EHDEN looks standardize more than 100 million patient records across Europe from different geographic areas and different data sources over the coming five years. Mapping of healthcare data to the OMOP-CDM will facilitate the re-use for a variety of purposes, enhancing and accelerating research and healthcare decision-making for global benefit. To this end, EHDEN will create an SME eco-system in Europe that supports data sources and other stakeholders in mapping and using data.

EHDEN recently announced that it has launched the second open call for SMEs to apply for training and certification to convert health data from various formats to the OMOP common data model. This second open call will run throughout the month of February, concluding on the 29th (17:00 CET).

If this prospect interests you, visit the EHDEN open call for SMEs page for more details and to submit your application. The EHDEN Consortium is looking forward to your potential application and to collaborate with you.

Invested Stakeholders, OHDSI Tools/Practices Drive Successful Rheumatoid Arthritis Study-A-Thon In Barcelona

One year after a similar study-a-thon at Oxford resulted in a knee replacement study published by The Lancet Rheumatology, 40 stakeholders from across industry, academia, and health systems — representing 10 different nations and 14 observational databases — gathered to participate in a OHDSI-EHDEN Study-a-thon and run the world’s largest network studies on Rheumatoid Arthritis (RA).

The Study-a-thon was held at the Barcelona Biomedical Research Park Jan. 13-17 and focused on three areas during the five-day gathering: (1) characterizing drug treatment patterns; (2) developing a population-level effect estimation, examining the comparative safety of first-line Disease Modifying Anti Rheumatic Drugs (DMARDs) for safety profiles and multiple adverse outcomes; and (3) creating a patient-level prediction analysis to determine high-risk RA patients for specific adverse outcomes. The OHDSI-EHDEN community conducted observational analyses across a secure, distributed network of electronic health records and insurance claims data, collectively representing more than 1.1 million patients with RA.

“It was an honor to collaborate with so many leaders in the battle against RA, and I truly believe we made a meaningful difference within one week,” said Patrick Ryan. “I am continually amazed at what can be accomplished when you combine invested stakeholders and high-level analytic tools in an open-science setting.”

EHDEN Academy Shows Early Success, Could Provide Educational Foundation For OHDSI Network In 2020

As an associate professor at Erasmus Medical Center, Peter Rijnbeek appreciates the importance of a strong, effective educational program. He has been pleased with the early progress of the EHDEN Academy, a program that should provide a broad impact for the OHDSI community once it becomes publicly available in early 2020.

The EHDEN Academy, an E-learning environment developed by the EHDEN (European Health Data & Evidence Network) Consortium, was initially developed to educate SMEs (Small and Medium Enterprises) about the tools and best practices used by both EHDEN and OHDSI. There are five training courses Rijnbeek and his EHDEN colleagues felt would provide a baseline of knowledge needed to certify a support network to map a growing set of European databases to the OMOP common data model.

Book Of OHDSI, Now Available In English/Korean Versions, Provides Central Knowledge Repository For Collaborators

One memorable moment (during a day full of them) at the 2019 OHDSI U.S. Symposium came during Martijn Schuemie’s talk on best practices within the community. With a significant number of first-timers in the Bethesda North Marriott ballroom that day, Schuemie may have caused a moment of panic for some by noting all the different locations collaborators could search to follow the preferred OHDSI methods. The panic quickly turned to celebration.

The unveiling of The Book of OHDSI at the 2019 U.S. Symposium was the culmination of months of community work, and it serves to provide the community with a central knowledge repository for all aspects of OHDSI. Twenty chapters within five sections (the OHDSI Community, Uniform Data Representation, Data Analytics, Evidence Quality, and OHDSI Studies) were written to empower any new researcher with the ability to generate real-world evidence to improve the healthcare community.

2019 Symposium Tutorials Available, Provide Education On Multiple Tools, Practices Within Community

While OHDSI collaborators continue to seek new and innovative ways to train the growing community in the tools and best practices of the network, face-to-face tutorials remain an effective method for educating both newcomers and veterans. During the 2019 OHDSI U.S. Symposium, there were six tutorials held, and you can watch any or all of them now on the OHDSI YouTube channel.

Use the headline link to get access to all six tutorials, including videos, materials, information and more.

First Korea Tutorial, OHDSI Japan Formation Highlight Exciting Asian Progress Before Korea Symposium

The first official OHDSI Korea tutorial was held Oct. 23 in the Grand Ambassador Seoul, and it served as an important lead event for the upcoming OHDSI Korea Symposium, which takes place Dec. 12-14 at the Konjiam Resort in Gyeonggi-Do, Korea. The enthusiasm in the room was palpable, and the energy that has been building in Korea should lead to an exciting Symposium.

While Korea first started working with OHDSI and the OMOP Common Data Model in 2014, workshops in the country had been limited to smaller Ajou University-sessions within hospitals. This was the first event that was formalized by OHDSI collaborators and open to all. There was a heavy morning focus on how to run a network study, which followed an OHDSI Introduction by Mui Van Zandt.

OHDSI Introduction At Georgia Tech Educates Both Students And Professor

The first-ever OHDSI block of the CS6440 course at Georgia Tech, held over a six-week span this past fall, was both educational and inspiring, and it reinforced the strengths that have carried OHDSI from concept to major player in the real-world analytics ecosystem.

The professor felt it from the students, but he felt it himself as well.

Jon Duke, MD, MS, an OHDSI veteran who collaborated on the LEGEND hypertension study published recently in Lancet, is Director of Health Informatics at Georgia Tech, home of the largest computer science graduate program in the nation. When he took over the Intro to Health Informatics course in 2018, he decided to introduce population-level analytics to a rising generation of data scientists.

EHDEN Knee Replacement Study Results Published In Lancet Rheumatology; OHDSI Tools, Collaborators Helped Lead Important Study

The IMI European Health Data & Evidence Network (EHDEN) project is pleased to announce the publication of the results of its first ‘study-a-thon’ in Lancet Rheumatology the effectiveness and safety associated with unicompartmental versus total knee replacement, a milestone after its first year.1

The choice of which type of knee replacement to recommend remains difficult for surgeons, and there remains insufficient information to inform them and patients of the best approach, dependent on the patient’s personal context.

Researchers associated with the Observational Health Data Sciences and Informatics (OHDSI) network and EHDEN met in Oxford for five days in December 2018 to design, analyze and draft a report of the study results. The resulting study emulated to the extent possible, the design of the five year Total or Partial Knee Arthroplasty Trial (TOPKAT). The study-a-thon assessed whether the efficacy results seen in the trial translated into effectiveness in real-world settings and provided further consideration of safety outcomes that were too uncommon to assess in TOPKAT.

Lancet Paper Shows Most Popular Hypertension Drug Isn’t Most Effective, Per OHDSI’s LEGEND Study

Thiazide diuretics demonstrate better effectiveness and cause fewer side effects than ACE inhibitors as first-line antihypertensive drugs, according to a report published Oct. 24 in The Lancet. The study factors insurance claim data and electronic health records from 4.9 million patients across nine observational databases, making it the most comprehensive one ever on first-line antihypertensives, and it provides additional context to the 2017 guidelines for high blood pressure treatment developed by the American College of Cardiology (ACC) and American Heart Association (AHA).

Collaborators in the Observational Health Data Sciences and Informatics (OHDSI) network produced the paper “Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis” as part of the collaborative’s ongoing Large-Scale Evidence Generation and Evaluation across a Network of Databases (LEGEND) project, which applies high-level analytics to perform observational research on hundreds of millions of patient records within OHDSI’s international database network.

OHDSI researchers believe LEGEND will continue to significantly enhance how real-world evidence is used to study important healthcare questions that impact millions of patients worldwide.

Symposium Research Will Be Virtually Unveiled During #OHDSISocialShowcase

There were more than 80 research highlights presented during the Collaborator Showcase at the 2019 OHDSI U.S. Symposium. For those who couldn’t attend, or who want to check out all the OHDSI innovations over the last year, you’ll have your chance on the OHDSI Twitter and LinkedIn platforms. Each weekday, a different poster will be highlighted with an individual URL. You’ll be able to check out the poster, as well as other materials the author may have included (abstract, software demo, lightning talk, etc.).

Book of OHDSI Introduced At Symposium As Central Respository For Current, Potential Collaborators

Martijn Schuemie, PhD, took the stage at the 2019 OHDSI U.S. Symposium and laid out a collection of internet locations where potential collaborators could learn about the tools and best practices developed within the community. To an audience that included about 200 first-time attendees, it must have been a daunting moment.

That feeling wouldn’t last long, as Schuemie followed by reaching under a white cover and pulling out the first version of the Book of OHDSI, the product of a year-long collaborative effort within the community to provide the best documentation for all aspects of OHDSI. Twenty chapters within five sections (the OHDSI Community, Uniform Data Representation, Data Analytics, Evidence Quality, and OHDSI Studies) were written to empower any new researcher with the ability to generate real-world evidence to improve the healthcare community.

For those who didn’t attend the Symposium, the Book of OHDSI is available here as HTML, as well as EPUB and PDF (click the small download icon at the top). Anybody who wants an actual copy of the book can order it through Amazon at cost price.

Check Out Our All-Encompassing 2019 Symposium Recap Page!

The fifth annual OHDSI Symposium was a tremendous success. From the insightful talks and impressive poster presentations on Monday to the spectacular Women in Real-World Analytics Leadership Forum and the six tutorials, there is no shortage of important material that is now available from this event (including videos of all speeches and tutorials, as well as slides from the presentations). The page also includes video and photo recaps from the weekend, as well as the virtual collaborator showcase, which highlights more than 80 posters and software demos from the event.

A Look Inside What Is Coming at the 2019 OHDSI Symposium

Using real-world evidence to meaningfully impact the healthcare community will be the prevailing theme Sept. 15-17 during the 5th annual OHDSI U.S. Symposium. Collaborators from around the world will discuss both the direction of the OHDSI community, as well as some of its most important research achievements of the past year, in the highlight event on the OHDSI calendar.

The symposium takes place at the Bethesda North Marriott Hotel & Conference Center, and for the first time, it will include a Women in Real-World Analytics Leadership Forum, hosted Sunday night by the Women of OHDSI. This free event, which is open to all symposium attendees (you can RSVP here), will feature four prominent leaders in the real-world analytics community (Noémie Elhadad, Violanda Grigorescu, Janet Woodcock, and Joanne Waldstreicher), each of whom will share thoughts on their own journey, where they see this emerging discipline headed, and how OHDSI collaborators can improve healthcare in the future.

OHDSI FYI: How To Start A New Working Group

There has been interest recently in developing new working groups within the OHDSI community, but many have wondered what it takes to actually start a new working group. This was addressed previously in an OHDSI forum post, but we wanted to share the steps with you again.

An OHDSI working group represents a group of OHDSI collaborators who hold regular meetings with the purpose of developing shared solutions to tackle a common problem or address a knowledge/technology gap. A group of collaborators aiming to complete a network research study can be considered a study working group and are encouraged to follow these guidelines.

PheValuator Paper Highlights Potential For Reliable Phenotype Evaluation In Future Research

Constructing phenotype algorithms (PAs) is a primary method for both defining diseases and identifying subjects at risk for disease in observational research. While the role of PAs is crucial for effective, reproducible research, the ability to complete detailed PA evaluations has traditionally been limited due to both cost and efficiency.

Lead author Joel Swerdel provided a potential solution to this challenge in PheValuator: Development and evaluation of a phenotype algorithm evaluator, published in the latest issue of the Journal of Biomedical Informatics. Utilizing tools within the OHDSI Network, the research team developed a method that showed promise for reliable phenotype evaluation without reliance on manual review of patient data.

Phenotype Sharing Feasibility Through OMOP Demonstrated In Recent JBI Paper

Traditional methods of identifying phenotypes over varied networks of electronic health record (EHR) databases is challenging. The recently published “Facilitating Phenotype Transfer Using A Common Data Model” paper in the Journal of Biomedical Informatics demonstrated success in creating a systematic process for sharing disease definitions—known as phenotypes—across a network using the Observational Health Data Sciences and Informatics (OHDSI) OMOP Common Data Model, which could lead to dramatic improvements in the ability to study diseases in the future.

George Hripcsak, MD, MS, the co-PI of the OHDSI Coordinating Center at Columbia University, served as lead author for a paper that demonstrated an efficient alternative to phenotype sharing that allows for rapid exchange and execution across different medical centers, improving the speed and reproducibility of the research process.

China Symposium, Tutorials Welcome Potential Collaborators To OHDSI Community

The 2019 China Symposium introduced top scholars, practioners, researchers and more to the potential of OHDSI collaboration.

The annual OHDSI China Symposium, which took place June 27-29 at Shanghai Jiaotong University, reinforced the impressive potential of the OHDSI network via the collaboration of multiple, motivated stakeholders.

Attendees of the symposium included experts and scholars from major universities in China, medical information-related practitioners of various medical and health institutions, medical-related scientific research personnel, and workers interested in big data in the pharmaceutical industry.

The symposium led off with a pair of keynote addresses, including one entitled “FEEDERNET: Evolution of Distributed Research Network in Korea” by OHDSI collaborator Rae Woong Park. Park is a top advocate for the development of OHDSI in Korea, and his presentation helped demonstrate the unique possibilities of the network.

OHDSI Provides Oxford Tutorial, Leads One-Day Study That Posts Impressive Results

OHDSI collaborated with the Oxford Summer School session for a tutorial on tools and a one-day study.

The boundless potential to create real-world evidence through OHDSI was demonstrated for a second time in as many weeks, as collaborators from both sides of the Atlantic met in England during the Real World Epidemiology: Oxford Summer School session.

Peter Rijnbeek and Patrick Ryan led the June 27 session on the OMOP common data model, OHDSI, and the analytical use case of patient-level prediction.

Rijnbeek and Ryan supported the mission of OHDSI collaborator and Oxford professor Dani Prieto-Alhambra. The previous week, Rijnbeek and Ryan supported OHDSI collaborators Iannis Drakos and Ismail Gögenur during a three-day seminar for the Denmark Center for Surgical Sciences (CSS).

“It was great to have OHDSI join our summer school,” Prieto-Alhambra said. “Forty people’s jaws dropped whilst learning what can be achieved through open science, community and a common data model!”

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