Considerations for pharmacoepidemiological analyses in the <scp>SARS‐CoV</scp>‐2 pandemic

Pottegård, Anton; Kurz, Xavier; Moore, Nicholas; Christiansen, Christian Fynbo; Klungel, Olaf H.

doi:10.1002/pds.5029

Cited by 37 publications

(43 citation statements)

References 36 publications

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“…The Danish SARS-CoV-2 test strategy was subject to marked changes from a limited capacity setting in the beginning of the study period to a setting where widespread testing was available at the end of the study period. To account for this [25], we included calendar week of the test date as a forced matching variable. This decision was made post hoc, i.e., not included in the protocol.…”

Section: Propensity Score Matchingmentioning

confidence: 99%

Adverse outcomes and mortality in users of non-steroidal anti-inflammatory drugs who tested positive for SARS-CoV-2: A Danish nationwide cohort study

et al. 2020

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Background Concerns over the safety of non-steroidal anti-inflammatory drug (NSAID) use during severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have been raised. We studied whether use of NSAIDs was associated with adverse outcomes and mortality during SARS-CoV-2 infection. Methods and findings We conducted a population-based cohort study using Danish administrative and health registries. We included individuals who tested positive for SARS-CoV-2 during the period 27 February 2020 to 29 April 2020. NSAID users (defined as individuals having filled a prescription for NSAIDs up to 30 days before the SARS-CoV-2 test) were matched to up to 4 nonusers on calendar week of the test date and propensity scores based on age, sex, relevant comorbidities, and use of selected prescription drugs. The main outcome was 30-day mortality, and NSAID users were compared to non-users using risk ratios (RRs) and risk differences (RDs). Secondary outcomes included hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and acute renal replacement therapy. A total of 9,236 SARS-CoV-2 PCR-positive individuals were eligible for inclusion. The median age in the study cohort was 50 years, and 58% were female. Of these, 248 (2.7%) had filled a prescription for NSAIDs, and 535 (5.8%) died within 30 days. In the matched analyses, treatment with NSAIDs was not associated with 30-day mortality (RR 1.02, 95% CI 0.57 to 1.82, p = 0.95; RD 0.1%, 95% CI −3.5% to 3.7%, p = 0.95), risk of hospitalization (RR 1.16, 95% CI

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Section: Propensity Score Matchingmentioning

confidence: 99%

Adverse outcomes and mortality in users of non-steroidal anti-inflammatory drugs who tested positive for SARS-CoV-2: A Danish nationwide cohort study

et al. 2020

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“…This variation needs to be handled in studies using these data. 31 If testing strategies are changed further, a description of these changes will be made available at the project's website (www.DKMA.dk/DACCOVID).…”

Section: Danish Covid-19 Testing Strategiesmentioning

confidence: 99%

<p>Existing Data Sources in Clinical Epidemiology: The Danish COVID-19 Cohort</p>

Pottegård¹,

Kristensen²,

Reilev³

et al. 2020

CLEP

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Background: To facilitate research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a prospective cohort of all Danish residents tested for SARS-CoV-2 in Denmark is established. Data Structure: All Danish residents tested by reverse transcriptase polymerase chain reactions (RT-PCR) for SARS-CoV-2 in Denmark are included. The cohort is identified using the Danish Microbiology Database. Individual-level record linkage between administrative and health-care registries is facilitated by the Danish Civil Registration System. Information on outcomes related to SARS-CoV-2 infection includes hospital admission, intensive care unit admission, mechanical ventilation, and death and is retrieved from the five administrative Danish regions, the Danish National Patient Registry, and the Danish Register of Causes of Death. The Patient Registry further provides a complete hospital contact history of somatic and psychiatric conditions and procedures. Data on all prescriptions filled at community pharmacies are available from the Danish National Prescription Registry. Health-care authorization status is obtained from the Danish Register of Healthcare Professionals. Finally, selected laboratory values are obtained from the Register of Laboratory Results for Research. The cohort is governed by a steering committee with representatives from the Danish Medicines Agency, Statens Serum Institut, the Danish Health Authority, the Danish Health Data Authority, Danish Patients, the Faculties of Health Sciences at the Danish universities, and Danish regions. The steering committee welcomes suggestions for research studies and collaborations. Research proposals will be prioritized based on timeliness and potential clinical and public health implications. All research protocols assessing specific hypotheses for medicines will be made publicly available using the European Union electronic Register of Post-Authorisation Studies. Conclusion: The Danish COVID-19 cohort includes all Danish residents with an RT-PCR test for SARS-CoV-2. Through individual-level linkage with existing Danish health and administrative registries, this is a valuable data source for epidemiological research on SARS-CoV-2.

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“…"Overall, in my reading of observational papers, there has certainly been very large variation in the quality of papers published," says Anton Pottegård, a pharmacoepidemiologist at the University of Southern Denmark in Odense. In May, Pottegård, together with colleagues from across Europe, published a checklist detailing eight methodological "considerations" for real-world drug studies related to COVID-19 (2). Five months on, however, many researchers seem not to have taken notice, as evidenced by a "substantial number" of reports with "clearly flawed methodologies," he says.…”

Section: Getting Realmentioning

confidence: 99%

The pandemic is prompting widespread use—and misuse—of real-world data

Dolgin¹

2020

Proc. Natl. Acad. Sci. U.S.A.

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COVID-19 has swept across the world, overwhelming healthcare systems and raising countless questions about how best to diagnose patients, treat infections, save lives, and contain the pandemic. In short order, researchers have launched randomized trials to uncover pharmacologic interventions that hold the promise of preventing or lessening the severity of the disease. But getting results takes time. And time was a luxury that doctors on the frontlines of the coronavirus fight could ill afford in the early months of the pandemic. Desperate for medical insights without delay-and hoping to address other questions not answerable in a specialized research environment-researchers, pharmaceutical companies, and government agencies immediately turned to health information captured through insurance claims, electronic medical records, patient registries, and other so-called "real-world" data sources. By analyzing trends in COVID-19 datasets, the research community rapidly helped fill in knowledge gaps around disease symptoms, risk factors, racial disparities, and more. Such observational methods also hinted at which treatments seemed to be making an impact-and which were not-all in near real time. But harnessing this type of real-world data is a tricky business. It requires high-quality data collection and proper methodological considerations. There are established guidelines on how best to plan, execute, and report observational studies in a way that ensures The dangers of COVID-19 present an unprecedented opportunity to leverage diverse, real-world data sources to inform medical and regulatory responses. But researchers and clinicians must be careful not to sacrifice methodological rigor. Image credit: Shutterstock/keyframelab.

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Considerations for pharmacoepidemiological analyses in the SARS‐CoV‐2 pandemic

Cited by 37 publications

References 36 publications

Adverse outcomes and mortality in users of non-steroidal anti-inflammatory drugs who tested positive for SARS-CoV-2: A Danish nationwide cohort study

Adverse outcomes and mortality in users of non-steroidal anti-inflammatory drugs who tested positive for SARS-CoV-2: A Danish nationwide cohort study

<p>Existing Data Sources in Clinical Epidemiology: The Danish COVID-19 Cohort</p>

The pandemic is prompting widespread use—and misuse—of real-world data

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