Evidence map›Paper›PMID 26968541›Full record

ArticleDrug safety2016

Universal Correction for QT/RR Hysteresis.

Marek Malik, Lars Johannesen, Katerina Hnatkova, Norman Stockbridge

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
3.6field-weighted citation impact, top 7% 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

25 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
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  4. Accurate QT correction method from transfer entropy.Cardiovascular digital health journal · 2023
    Article
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  14. Sources of QTc variability: Implications for effective ECG monitoring in clinical practice.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2020
    Review
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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

4 authors at 3 institutions in 3 countries.

Marek MalikNational Heart and Lung Institute, Imperial College, Dovehouse Street, London, SW3 6LY, United Kingdom, UK. marek.malik@btinternet.com.
Lars JohannesenDivision of Biomedical Physics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
Katerina HnatkovaNational Heart and Lung Institute, Imperial College, Dovehouse Street, London, SW3 6LY, United Kingdom, UK.
Norman StockbridgeDivision of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Imperial College London · GBCenter for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

British Heart Foundation PG/12/77/29857British Heart Foundation PG/13/54/30358
6 · The paper itself

Abstract

introductionClinical pharmacology QT/QTc studies can be smaller if they more efficiently use the data generated.

objectiveThe aim was to use large sets of electrocardiograms (ECGs) deposited at the US Food and Drug Administration to investigate the implications of heart rate measurement on the accuracy of QTc data.

methodsUsing the data of 80 thorough QT studies, we investigated whether placing study subjects in supine positions during short-term time points stabilizes heart rate (part I, based on 73 studies with 747,912 measured ECGs in 6786 healthy subjects) and whether heart rate measurements different from RR intervals captured simultaneously with QT intervals decrease QTc variability (part II, based on seven studies with 897,570 ECG measurements in 751 healthy subjects).

resultsIn the part I data, when subjects were placed in supine undisturbed positions, heart rate instability (max-min of repeatedly measured heart rates within the same study time point) exceeding 5 beats per minute (bpm) was observed 40 % of the time and exceeded 10 bpm 10 % of the time. In the part II data, even when including QT measurements preceded by variable heart rates, correction of QT durations for RR interval values derived through a simple QT/RR hysteresis model with 95 % adaptation in 120 s led to mean intra-subject standard deviation of QTc (Fridericia formula) of only 7.14 ± 1.98 and 6.38 ± 1.50 ms in women and men, respectively.

conclusionThe QT/RR hysteresis model with 95 % adaptation in 120 s is universally applicable to healthy subjects, providing small QTc variability. Supine positions do not generally stabilize heart rates in healthy subjects. Universally applicable QT/RR hysteresis correction allows clinical QT/QTc studies to include variable heart rate episodes in the time points.

Indexed as

Heart RateModels, CardiovascularDatabases, FactualDrug ApprovalElectrocardiographyHumansPharmacologyReproducibility of ResultsSupine PositionUnited States

Identifiers

PMID26968541
OpenAlexW2294020779

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.