Evidence map›Paper›PMID 29522647›Full record

Observational studyBritish journal of clinical pharmacology2018

Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants: a prospective study.

Anne-Laure Sennesael, Anne-Sophie Larock, Bérangère Devalet, Valérie Mathieux, Franck Verschuren, Xavier Muschart, Olivia Dalleur, Jean-Michel Dogné, Anne Spinewine

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. [Pain treatment in old age: special features and recommendations].Zeitschrift fur Gerontologie und Geriatrie · 2021
    Review
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  9. Observational
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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

9 authors.

Anne-Laure SennesaelLouvain Drug Research Institute, Clinical Pharmacy Research Group, Université catholique de Louvain, Brussels, Belgium.ORCID 0000-0003-3499-1466
Anne-Sophie LarockCHU UCL Namur, Namur Thrombosis and Hemostasis Center, Department of Pharmacy, Université catholique de Louvain, Yvoir, Belgium.
Bérangère DevaletCHU UCL Namur, Namur Thrombosis and Hemostasis Center, Department of Hematology, Université catholique de Louvain, Yvoir, Belgium.
Valérie MathieuxCHU UCL Namur, Namur Thrombosis and Hemostasis Center, Department of Hematology, Université catholique de Louvain, Yvoir, Belgium.
Franck VerschurenInstitute of Experimental and Clinical Research, Cliniques Universitaires Saint-Luc, Department of Emergency Medicine, Université catholique de Louvain, Brussels, Belgium.
Xavier MuschartCHU UCL Namur, Department of Emergency Medicine, Université catholique de Louvain, Yvoir, Belgium.
Olivia DalleurLouvain Drug Research Institute, Clinical Pharmacy Research Group, Université catholique de Louvain, Brussels, Belgium.
Jean-Michel DognéNamur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, Department of Pharmacy, University of Namur, Namur, Belgium.
Anne SpinewineLouvain Drug Research Institute, Clinical Pharmacy Research Group, Université catholique de Louvain, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo determine the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs), and to explore contributing factors to preventable ADRs. Results were compared with vitamin K antagonists (VKAs).

methodsWe conducted a prospective observational study in the emergency departments of two teaching hospitals from July 2015 to January 2016. Patients admitted with a thrombotic or bleeding event while under DOAC or VKA were included. Four independent reviewers assessed causality, seriousness and preventability of ADRs using pilot-tested scales. For cases of serious and potentially preventable ADRs, we performed semi-structured interviews with general practitioners to identify contributing factors to ADRs. The primary outcome was the proportion of serious ADRs that were potentially preventable.

resultsThe analysis included 46 DOAC and 43 VKA patients (median age 79 years). Gastrointestinal (n = 34) and intracranial (n = 16) bleedings were the most frequent ADRs. Results were that 53% of DOAC- and 61% of VKA-related serious ADRs were deemed potentially preventable. Prescribing issues and inadequate monitoring were frequent for DOAC and VKA respectively. We identified many causes of preventable ADRs that applied to all oral anticoagulants, such as pharmacodynamic drug interactions and lack of communication.

conclusionsMore than half of serious ADRs were potentially preventable for both DOACs and VKAs. Interventions focusing on prescribing, patient education and continuity of care should help improve the use of DOACs in practice.

Indexed as

Administration, OralAgedAged, 80 and overAnticoagulantsAtrial FibrillationContinuity of Patient CareEmergency Service, HospitalFemaleGastrointestinal HemorrhageHospitalizationHumansIntracranial HemorrhagesMalePatient Education as TopicProspective StudiesStrokeAnticoagulantsVitamin Kadverse drug reactionsmedication errorsoral anticoagulantspatient safetyqualitative research

Identifiers

PMID29522647
PMCPMC6005616

What OpenQuestion holds

Textmetadata
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.