Evidence map›Paper›PMID 25283757›Full record

Trial reportDeutsches Arzteblatt international2014

Educating orally anticoagulated patients in drug safety: a cluster-randomized study in general practice.

Stefan Viktor Vormfelde, Manar Abu Abed, Thanh Duc Hua, Simon Schneider, Tim Friede, Jean-François Chenot

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Deutsches Arzteblatt international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 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

13 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Stefan Viktor VormfeldeDepartment of Clinical Pharmacology, University Medical Center Göttingen, Department of General Practice, University Medical Center Göttingen, Department of Medical Statistics University Medical Center Göttingen, Institute for Community Medicine, Section General Practice and Family Medicine, University of Greifswald.
Manar Abu Abed
Thanh Duc Hua
Simon Schneider
Tim Friede
Jean-François Chenot

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOrally anticoagulated patients with insufficient knowledge about their treatment have a higher risk of complications. Standardized patient education could raise their level of knowledge and improve time spent within target INR range.

methodsThis cluster randomized trial included 319 anticoagulated patients drawn from 22 general medical practices. 185 patients received patient education, conducted by practice nurses, consisting of a video, a brochure, and a questionnaire; 134 control patients received only the brochure. The primary endpoint was knowledge about treatment six months after the patient education session. The secondary endpoints were time in the INR (international normalized ratio) target range and complications of anticoagulation.

resultsPatients in the intervention and control groups were of comparable mean age (73 vs. 72 years). They answered a comparable number of questions correctly before the intervention (6.8 ± 0.2 vs. 6.7 ± 0.2) but differed significantly on this measure at six months (9.9 ± 0.2 vs. 7.6 ± 0.2, mean difference 2.3 questions, 95% confidence interval [CI] 1.5-3.1, p< 0.001). In the six months prior to the intervention, the INR was in the target range 65 ± 2% vs. 66 ± 3% of the time; in the six months afterward, 71 ± 1% vs. 64 ± 3% of the time (mean difference 7 percentage points, 95% CI -2 to -16 percentage points, p = 0.11). The complication rates were comparable in the two groups (12% vs. 16%, p = 0.30). Patients in the intervention group approved of patient education sessions to a greater extent than control patients (87% vs. 56%).

conclusionPatient education was found to be practical, to improve knowledge relating to patient safety in a durable manner, and to meet with the approval of the patients who received it. There was a statistically non-significant trend toward an improvement of the time spent in the INR target range. In view of the major knowledge deficits of orally anticoagulated patients, standardized patient education ought to be made a part of their routine care.

Indexed as

Administration, OralAnticoagulantsCluster AnalysisConsumer Health InformationDrug-Related Side Effects and Adverse ReactionsFemaleGeneral PracticeGermanyHealth LiteracyHumansInternational Normalized RatioMaleMiddle AgedPatient Education as TopicPrevalenceRisk FactorsAnticoagulants

Identifiers

PMID25283757
PMCPMC4187020

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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.