Evidence map›Paper›PMID 34135034›Full record

ArticleBMJ open2021

Pharmacogenetics to Avoid Loss of Hearing (PALOH) trial: a protocol for a prospective observational implementation trial.

John Henry McDermott, Rachel Mahood, Duncan Stoddard, Ajit Mahaveer, Mark A Turner, Rachel Corry, Julia Garlick, Gino Miele, Shaun Ainsworth, Laura Kemp and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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

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

  1. Guideline
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. The Implementation of Pharmacogenetics in the United Kingdom.Handbook of experimental pharmacology · 2023
    Article
  8. Integrating pharmacogenomics into clinical trials of hearing disorders.The Journal of the Acoustical Society of America · 2022
    Article
  9. 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

19 authors.

John Henry McDermottManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK john.mcdermott2@mft.nhs.uk.ORCID 0000-0002-5220-8837
Rachel MahoodManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Duncan StoddardManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Ajit MahaveerNeonatal Intensive Care Unit, Manchester University NHS Foundation Trust, Manchester, UK.
Mark A TurnerNeonatal Intensive Care Unit, Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.
Rachel CorryManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Julia GarlickManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Gino MieleGenedrive plc, Manchester, UK.
Shaun AinsworthGenedrive plc, Manchester, UK.
Laura KempGenedrive plc, Manchester, UK.
Iain BrucePaediatric ENT Department, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
Richard BodyEmergency Department, Manchester University NHS Foundation Trust, Manchester, UK.
Fiona UlphDivision of Psychology & Mental Health, University of Manchester, Manchester, UK.
Rhona MacleodManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Karen HarveyNeonatal Intensive Care Unit, Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.
Nicola BoothNeonatal Intensive Care Unit, Manchester University NHS Foundation Trust, Manchester, UK.
Peter RobertsMarket Access & Reimbursement Solutions, Manchester, UK.
Paul WilsonAlliance Manchester Business School, University of Manchester, Manchester, UK.ORCID 0000-0002-2657-5780
William G NewmanManchester Centre for Genomic Medicine, Manchester University NHS Foundation Trust, Manchester, UK.

Funding

Department of Health II-LB-0417-20002
6 · The paper itself

Abstract

introductionIn conjunction with a beta-lactam, aminoglycosides are the first-choice antibiotic for empirical treatment of sepsis in the neonatal period. The m.1555A>G variant predisposes to ototoxicity after aminoglycoside administration and has a prevalence of 1 in 500. Current genetic testing can take over 24 hours, an unacceptable delay in the acute setting. This prospective-observational trial will implement a rapid point of care test (POCT), facilitating tailored antibiotic prescribing to avoid hearing loss. METHODS AND ANALYSIS: The genedrive POCT can detect the m.1555A>G variant in 26 min from buccal swab. This system will be integrated into the clinical pathways at two large UK neonatal centres over a minimum 6-month period. The primary outcome is the number of neonates successfully tested for the variant out of all babies prescribed antibiotics. As a secondary outcome, clinical timings will be compared with data collected prior to implementation, measuring the impact on routine practice. ETHICS AND DISSEMINATION: Approval for the trial was granted by the Research Ethics Committee (REC) and Human Research Authority in August 2019. Results will be published in full on completion of the study. TRIAL REGISTRATION NUMBER: ISRCTN13704894. PROTOCOL VERSION: V 1.3.

Indexed as

DeafnessPharmacogeneticsHearingHumansInfant, NewbornObservational Studies as TopicPoint-of-Care TestingProspective Studiesadverse eventsaudiologygeneticsneonatal intensive & critical carepreventive medicine

Identifiers

PMID34135034
PMCPMC8211036

What OpenQuestion holds

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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.