Evidence map›Paper›PMID 28281228›Full record

Observational studyInternational journal of clinical pharmacy2017

Development of a risk score for QTc-prolongation: the RISQ-PATH study.

Eline Vandael, Bert Vandenberk, Joris Vandenberghe, Isabel Spriet, Rik Willems, Veerle Foulon

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in International journal of clinical pharmacy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02068170 (Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 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.

NCT02068170 completednot on this map

Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital

TypeobservationalSponsorKU LeuvenRan2014 to 2015Enrolled178ConditionsDelirium, QT-prolongationArmsHaloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  4. Article
  5. Review
  6. [Drug interactions in uro-oncology].Urologie (Heidelberg, Germany) · 2026
    Review
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  8. Article
  9. Article
  10. Observational
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  12. Article
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  16. Observational
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  20. Study of the indications for macrolide prescriptions in a Colombian populationBiomedica : revista del Instituto Nacional de Salud · 2022
    Article
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

6 authors.

Eline VandaelDepartment of Pharmaceutical and Pharmacological Sciences, Clinical Pharmacology and Pharmacotherapy, KU Leuven, Herestraat 49, Box 521, 3000, Leuven, Belgium. Eline.Vandael@kuleuven.be.ORCID http://orcid.org/0000-0001-7003-7448
Bert VandenberkDepartment of Cardiovascular Sciences, KU Leuven, 3000, Leuven, Belgium.
Joris VandenbergheDepartment of Neurosciences, KU Leuven, 3000, Leuven, Belgium.
Isabel SprietDepartment of Pharmaceutical and Pharmacological Sciences, Clinical Pharmacology and Pharmacotherapy, KU Leuven, Herestraat 49, Box 521, 3000, Leuven, Belgium.
Rik WillemsDepartment of Cardiovascular Sciences, KU Leuven, 3000, Leuven, Belgium.
Veerle FoulonDepartment of Pharmaceutical and Pharmacological Sciences, Clinical Pharmacology and Pharmacotherapy, KU Leuven, Herestraat 49, Box 521, 3000, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background More than 170 drugs are linked with QTc-prolongation, which in extreme cases can lead to Torsade de Pointes. Monitoring of this potential side effect is an important challenge in clinical practice. Objective To investigate the risk of QTc-prolongation in hospital patients who started a QTc-prolonging drug, and to develop a risk score to identify patients at high/low risk for QTc-prolongation. Setting University Hospitals Leuven, Belgium. Method All patients starting with haloperidol or a QTc-prolonging antibiotic/antimycotic were eligible for this observational study. Twelve-lead electrocardiograms were recorded at baseline and follow-up (steady state). Demographic, medical and drug data were collected. The obtained data were used to calculate the performance characteristics of a preliminary risk score (RISQ-PATH score), based on a systematic review of risk factors. ROC analysis determined a score of <10 points as a low risk for QTc-prolongation. Main outcome measure QTc-interval in a baseline and follow-up electrocardiogram. Results 178 patients (46.6% female; mean age 69 ± 14 years) were included (levofloxacin: N = 80; haloperidol: N = 41; fluconazole: N = 41). Overall, no significant difference between the mean QTc-values at baseline (425.7 ± 31.7 ms) and follow-up (428.0 ± 30.7 ms) was found (p = 0.328). However, 26 patients (14.6%) did develop a prolonged QTc-interval (≥450(♂)/470(♀) ms) of whom 25 with a RISQ-PATH score ≥10. This score had a sensitivity of 96.2% (95% CI 78.4-99.8%) and a negative predictive value of 98.0% (95% CI 88.2-99.9%). Conclusion This RISQ-PATH score is able to rule out low-risk patients with a negative predictive value of 98.0% and is promising to exclude patients from further follow-up when starting QTc-prolonging drugs. Clinicaltrials.gov Registration Number: NCT02068170.

Indexed as

Predictive Value of TestsAgedFemaleFluconazoleHaloperidolHumansLevofloxacinLong QT SyndromeMaleModels, StatisticalRisk FactorsROC CurveFluconazoleHaloperidolLevofloxacinObservational studyQTc-prolongationRisk managementRisk score

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Registered trials

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.