Validating clinical practice guidelines for the management of children with non-blanching rashes in the UK (PiC): a prospective, multicentre cohort study.
Child, Preschool
DNA, Bacterial
/ isolation & purification
Diagnosis, Differential
Exanthema
/ diagnosis
Female
Fever
/ diagnosis
Humans
Infant
Male
Meningococcal Infections
/ complications
Meningococcal Vaccines
/ administration & dosage
Neisseria meningitidis
/ genetics
Practice Guidelines as Topic
Prospective Studies
Real-Time Polymerase Chain Reaction
United Kingdom
Journal
The Lancet. Infectious diseases
ISSN: 1474-4457
Titre abrégé: Lancet Infect Dis
Pays: United States
ID NLM: 101130150
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
24
02
2020
revised:
20
04
2020
accepted:
22
05
2020
pubmed:
14
11
2020
medline:
15
4
2021
entrez:
13
11
2020
Statut:
ppublish
Résumé
No previous studies have validated current clinical practice guidelines for the management of non-blanching rashes in children who have received meningococcal B and C vaccinations. The aim of this study was to evaluate the performance of existing clinical practice guidelines in the diagnosis of invasive meningococcal disease in children presenting with a fever and non-blanching rash in the UK. The Petechiae in Children (PiC) study was a prospective, multicentre cohort study involving children (aged <18 years) presenting to 37 paediatric emergency departments in the UK with a fever (≥38°C) and a new-onset non-blanching rash or features suggestive of meningococcal infection. Children with pre-existing haematological conditions (ie, haematological malignancy, idiopathic thrombocytopenic purpura, or coagulopathy) or an existing diagnosis of Henoch-Schonlein purpura were excluded. Invasive meningococcal disease was confirmed by positive culture or a quantitative PCR test for Neisseria meningitidis from either blood or cerebrospinal fluid samples. The primary outcome was the performance of six tailored clinical practice guidelines from participating centres (London, Nottingham, Newcastle-Birmingham-Liverpool, Glasgow, Chester, and Bristol) and two clinical practice guidelines from the National Institutes for Health and Care Excellence (NICE; CG102 and NG51) in identifying children with invasive meningococcal disease, assessed by the sensitivity and specificity of each clinical practice guideline. This study is registered with ClinicalTrials.gov, NCT03378258. Between Nov 9, 2017, and June 30, 2019, 1513 patients were screened, of whom 1329 were eligible and were included in the analysis. The median age of patients was 24 months (IQR 12-48). 1137 (86%) of 1329 patients had a blood test and 596 (45%) received parenteral antibiotics. 19 (1%) patients had confirmed meningococcal disease. All eight clinical practice guidelines had a sensitivity of 1·00 (95% CI 0·82-1·00) for identifying meningococcal disease. The specificities of NICE guidelines CG102 (0·01 [95% CI 0·01-0·02]) and NG51 (0·00 [0·00-0·00]) for identifying meningococcal disease were significantly lower than that of tailored clinical practice guidelines (p<0·0001). The best performing clinical practice guidelines for identifying meningococcal disease were the London (specificity 0·36 [0·34-0·39]) and Nottingham (0·34 [0·32-0·37]) clinical practice guidelines. Invasive meningococcal disease is a rare cause of non-blanching rashes in children presenting to the emergency department in the UK. Current NICE guidelines perform poorly when compared with tailored clinical practice guidelines. These findings suggest that UK national guidance could be improved by shifting towards a tailored approach. Public Health Agency.
Sections du résumé
BACKGROUND
No previous studies have validated current clinical practice guidelines for the management of non-blanching rashes in children who have received meningococcal B and C vaccinations. The aim of this study was to evaluate the performance of existing clinical practice guidelines in the diagnosis of invasive meningococcal disease in children presenting with a fever and non-blanching rash in the UK.
METHODS
The Petechiae in Children (PiC) study was a prospective, multicentre cohort study involving children (aged <18 years) presenting to 37 paediatric emergency departments in the UK with a fever (≥38°C) and a new-onset non-blanching rash or features suggestive of meningococcal infection. Children with pre-existing haematological conditions (ie, haematological malignancy, idiopathic thrombocytopenic purpura, or coagulopathy) or an existing diagnosis of Henoch-Schonlein purpura were excluded. Invasive meningococcal disease was confirmed by positive culture or a quantitative PCR test for Neisseria meningitidis from either blood or cerebrospinal fluid samples. The primary outcome was the performance of six tailored clinical practice guidelines from participating centres (London, Nottingham, Newcastle-Birmingham-Liverpool, Glasgow, Chester, and Bristol) and two clinical practice guidelines from the National Institutes for Health and Care Excellence (NICE; CG102 and NG51) in identifying children with invasive meningococcal disease, assessed by the sensitivity and specificity of each clinical practice guideline. This study is registered with ClinicalTrials.gov, NCT03378258.
FINDINGS
Between Nov 9, 2017, and June 30, 2019, 1513 patients were screened, of whom 1329 were eligible and were included in the analysis. The median age of patients was 24 months (IQR 12-48). 1137 (86%) of 1329 patients had a blood test and 596 (45%) received parenteral antibiotics. 19 (1%) patients had confirmed meningococcal disease. All eight clinical practice guidelines had a sensitivity of 1·00 (95% CI 0·82-1·00) for identifying meningococcal disease. The specificities of NICE guidelines CG102 (0·01 [95% CI 0·01-0·02]) and NG51 (0·00 [0·00-0·00]) for identifying meningococcal disease were significantly lower than that of tailored clinical practice guidelines (p<0·0001). The best performing clinical practice guidelines for identifying meningococcal disease were the London (specificity 0·36 [0·34-0·39]) and Nottingham (0·34 [0·32-0·37]) clinical practice guidelines.
INTERPRETATION
Invasive meningococcal disease is a rare cause of non-blanching rashes in children presenting to the emergency department in the UK. Current NICE guidelines perform poorly when compared with tailored clinical practice guidelines. These findings suggest that UK national guidance could be improved by shifting towards a tailored approach.
FUNDING
Public Health Agency.
Identifiants
pubmed: 33186517
pii: S1473-3099(20)30474-6
doi: 10.1016/S1473-3099(20)30474-6
pii:
doi:
Substances chimiques
DNA, Bacterial
0
Meningococcal Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT03378258']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
569-577Investigateurs
Amy Kitching
(A)
Matthew Rotheram
(M)
Gisela Robinson
(G)
Paula Brassey
(P)
Stuart Hartshorn
(S)
Rachel Wane
(R)
Mark Lyttle
(M)
Jo Dangerfield
(J)
Michael Hayes
(M)
Rebecca McFarlane
(R)
Helen Armstrong
(H)
Damian Roland
(D)
Sally Smith
(S)
Carl VanHeyningen
(C)
Sally Smith
(S)
Esther Wilson
(E)
Lisa Kehler
(L)
Christopher Gough
(C)
Fraser Scott
(F)
Claire Backhouse
(C)
Sylvester Gomes
(S)
Darryl Wood
(D)
Julie-Ann Maney
(JA)
Graham Johnson
(G)
Steven Foster
(S)
Ben Bloom
(B)
Andrew Lancaster
(A)
Sebastian Gray
(S)
Shammi Ramlakhan
(S)
Sharryn Gardner
(S)
Sharon Floyd
(S)
Chris Cleaver
(C)
Susan MacFarlane
(S)
Claire Bell
(C)
Maggie Nyirenda
(M)
Jane Bayreuther
(J)
Asim Ijaz
(A)
Natalie Rogers
(N)
Sarah Wilson
(S)
Sarah Diment
(S)
Caroline Boulind
(C)
Kathryn Allison
(K)
Thomas Waterfield
(T)
Derek Fairley
(D)
James McKenna
(J)
Michael Corr
(M)
Lisa McFetridge
(L)
Hannah Mitchell
(H)
Kerry Woolfall
(K)
Fiona Lynn
(F)
Bethany Petenall
(B)
Michael Shields
(M)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
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Informations de copyright
Copyright © 2021 Elsevier Ltd. All rights reserved.