Academic Journal
ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs
| العنوان: | ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs |
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| المؤلفون: | Sarri, G., Bennett, D., Debray, T., Deruaz-Luyet, A., Soriano Gabarró, M., Largent, J.A., Li, X., Liu, W., Lund, J.L., Moga, D.C., Gokhale, M., Rentsch, C.T., Wen, X., Yanover, C., Ye, Y., Yun, H., Zullo, A.R., Lin, K.J. |
| المصدر: | Clinical Pharmacology and Therapeutics, 112(5) |
| سنة النشر: | 2022 |
| المجموعة: | Carolina Digital Repository (UNC - University of North Carolina) |
| مصطلحات موضوعية: | selection bias, statistical analysis, dipeptidyl carboxypeptidase inhibitor, medical information, drug efficacy, infection prevention, Article, vaccination, clinical research, patient care, comparative effectiveness, outcome assessment, Pharmacoepidemiology, pandemic, confounding bias, clinical outcome, Comparative Effectiveness Research, Humans, procedures, drug exposure, human, Pandemics, drug repositioning, long term care, Electronic Health Records, COVID-19, SARS-CoV-2 vaccine, health care quality, coronavirus disease 2019, study design |
| الوصف: | As the scientific research community along with healthcare professionals and decision makers around the world fight tirelessly against the coronavirus disease 2019 (COVID-19) pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly under-represent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: (1) study population identification based on exposure status; (2) ascertainment of outcomes; (3) common biases and potential solutions; and (iv) data operational challenges specific to COVID-19 CER using EHRs. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE). |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | https://doi.org/10.17615/h7nx-9c72; https://cdr.lib.unc.edu/downloads/mp48sp84n?file=thumbnail; https://cdr.lib.unc.edu/downloads/mp48sp84n |
| DOI: | 10.17615/h7nx-9c72 |
| الاتاحة: | https://doi.org/10.17615/h7nx-9c72 https://cdr.lib.unc.edu/downloads/mp48sp84n?file=thumbnail https://cdr.lib.unc.edu/downloads/mp48sp84n |
| Rights: | http://rightsstatements.org/vocab/InC/1.0/ |
| رقم الانضمام: | edsbas.D517C85F |
| قاعدة البيانات: | BASE |
| DOI: | 10.17615/h7nx-9c72 |
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