Evidence map›Paper›PMID 31271151›Full record

ArticleJMIR medical informatics2019

A Web-Based Clinical System for Cohort Surveillance of Specific Clinical Effectiveness and Safety Outcomes: A Cohort Study of Non-Vitamin K Antagonist Oral Anticoagulants and Warfarin.

Fong-Ci Lin, Shih-Tsung Huang, Rung Ji Shang, Chi-Chuan Wang, Fei-Yuan Hsiao, Fang-Ju Lin, Mei-Shu Lin, Kuan-Yu Hung, Jui Wang, Li-Jiuan Shen and 2 more

Open access · goldAbstract read
In one paragraph

Article in JMIR medical informatics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Fong-Ci Lin *Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0001-9031-7113
Shih-Tsung Huang *Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-1738-5571
Rung Ji ShangInformation Technology Office, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0003-1088-4180
Chi-Chuan WangGraduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-4597-4859
Fei-Yuan HsiaoGraduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0003-1660-9120
Fang-Ju LinGraduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-8249-7481
Mei-Shu LinDepartment of Development and Planning, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-1607-9337
Kuan-Yu HungDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0003-3472-5512
Jui WangInstitute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0003-4800-5276
Li-Jiuan ShenGraduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0002-2854-3205
Feipei LaiDepartment of Computer Science & Information Engineering, National Taiwan University, Taipei, Taiwan.ORCID http://orcid.org/0000-0001-7147-8122
Chih-Fen HuangDepartment of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0003-1311-8828
National Taiwan University · TWNational Taiwan University Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConventional systems of drug surveillance lack a seamless workflow, which makes it crucial to have an active drug surveillance system that proactively assesses adverse drug events.

objectiveThe aim of this study was to develop a seamless, Web-based workflow for comparing the safety and effectiveness of drugs in a database of electronic medical records.

methodsWe proposed a comprehensive integration process for cohort surveillance using the National Taiwan University Hospital Clinical Surveillance System (NCSS). We studied a practical application of the NCSS that evaluates the drug safety and effectiveness of novel oral anticoagulants (NOACs) and warfarin by cohort tree analysis in an efficient and interoperable platform.

resultsWe demonstrated a practical example of investigating the differences in effectiveness and safety between NOACs and warfarin in patients with nonvalvular atrial fibrillation (AF) using the NCSS. We efficiently identified 2357 patients with nonvalvular AF with newly prescribed oral anticoagulants between 2010 and 2015 and further developed 1 main cohort and 2 subcohorts for separately measuring ischemic stroke as the clinical effectiveness outcome and intracranial hemorrhage (ICH) as the safety outcome. In the subcohort of ischemic stroke, NOAC users exhibited a significantly lower risk of ischemic stroke than warfarin users after adjusting for age, sex, comorbidity, and comedication in an intention-to-treat (ITT) analysis (P=.01) but did not exhibit a significantly distinct risk in an as-treated (AT) analysis (P=.12) after the 2-year follow-up. In the subcohort of ICH, NOAC users did not exhibit a different risk of ICH both in ITT (P=.68) and AT analyses (P=.15).

conclusionsWith a seamless and Web-based workflow, the NCSS can serve the critical role of forming associations between evidence and the real world at a medical center in Taiwan.

Indexed as

anticoagulantsdrug safetypharmacovigilancepublic health surveillancewarfarin

Identifiers

PMID31271151
PMCPMC6636345
OpenAlexW2946538599

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.