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Point-of-care tests for infectious diseases: Barriers to implementation across three London teaching hospitals

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Existing Point-of-care tests (POCT) to help identify infection-related causes of illness can complement diagnostic and disposition decisions in children attending emergency departments.(1) Evidence-based clinical algorithms can integrate such POCT to aid in the admission and discharge decision process. Paediatric studies validating these tools are scarce, with very few studies conducted in UK centres.(2-5) POCT can be based on host infection markers (e.g. finger prick tests for C-reactive protein (CRP) to help decide if the patient has a bacterial or viral infection) or pathogen detection tests (e.g. throat/nose swabs to rapidly diagnose viral infections such as RSV or influenza). This article is protected by copyright. All rights reserved.
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SHORT COMMUNICATION
Point-of-care tests for infectious diseases: barriers to implementation across
three London teaching hospitals
Amaya L. Bustinduy (Amaya.Bustinduy@lshtm.ac.uk)
1,2
, Dakshika Jeyaratnam
3
, Sam Douthwaite
4
, Sarah Tonkin-Crine
5
, Rebecca Shaw
1
,
Laura Hyrapetian
6
, Nick Sevdalis
7
, Simon Goldenberg
8,9
, Elisabeth J. Adams
10
, Mike Sharland
1
, CLAHRC South London; Paediatric Infection Network
1.Paediatric Infectious Diseases Research Group, Infection and Immunity Institute, St George’s University of London, London, UK
2.Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
3.Department of Microbiology, King’s College Hospital NHS Foundation Trust, London, UK
4.Virology Department, Guy’s and St Thomas’ NHS trust, London, UK
5.Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
6.St George’s NHS trust, London, UK
7.Health Service & Population Research Department, King’s College London, London, UK
8.Centre for Clinical Infection and Diagnostics Research, King’s College, London, UK
9.Guy’s & St Thomas’ NHS Foundation Trust, London, UK
10.Aquarius Population Health, London, UK
Correspondence
Amaya Bustinduy, Clinical Research Department,
London School of Hygiene & Tropical Medicine,
Keppel Street, WC1 London, UK.
Tel: +44(0)79272642 |
Email: Amaya.Bustinduy@lshtm.ac.uk
Received
12 October 2016; revised 3 February 2017;
accepted 30 March 2017.
DOI:10.1111/apa.13867
Existing point-of-care tests (POCT) to help identify infec-
tion-related causes of illness can complement diagnostic
and disposition decisions in children attending emergency
departments (1). Evidence-based clinical algorithms can
integrate such POCT to aid in the admission and discharge
decision process. Paediatric studies validating these tools
are scarce, with very few studies conducted in UK centres
(25). POCT can be based on host infection markers (e.g.
finger prick tests for C-reactive protein (CRP) to help decide
whether the patient has a bacterial or viral infection) or
pathogen detection tests (e.g. throat/nose swabs to rapidly
diagnose viral infections such as RSV or influenza). The use
of POCT may reduce time in the emergency department (6),
help rationalise antibiotic prescribing (4) and reduce
investigations in these children (1,5). On admission to the
ward, POCT can also help with infection control proce-
dures to reduce the risk of transmission of hospital-related
infections. These benefits, however, have been mostly
documented in adults (7).
We present the experience across three paediatric tertiary
centres in South London with different POCT implemen-
tation strategies, research driven, during one respiratory
disease season (winter 2014spring 2015) with the aim of
improving paediatric clinical process outcomes and poten-
tially reducing antibiotic use, and primarily focusing on the
barriers encountered for implementation.
At St George’s NHS trust, a service evaluation of febrile
children presenting to emergency department (ED) was
undertaken from October 2014 to March 2015. The aim of
the study was to collect clinical information on febrile
children and to develop an evidence-based tool to reduce
avoidable admissions in those with low-risk infections.
Results from the main study are reported elsewhere (8).
Outcome data included disposition of the patient, antibiotic
use and re-attendance to the ED within 28 days. As a
secondary outcome, ED staff were trained on the use of
three POCT that were introduced by company-provided
training: Alere-Afinion
TM
CRP test (four minutes), Alere i
influenza A/B
TM
(10 minutes) and Alere BinaxNOW
â
RSV
card (15 minutes). ED nurses and doctors were interviewed
about their experience of managing febrile children, fol-
lowing national guidelines (9), and their perceptions on
using POCT. Semistructured interviews were carried out
following an interview guide, and interviews were audio-
recorded and transcribed verbatim. At King’s College
Hospital (KCH), an observational study of children
Abbreviations
AMR, Antimicrobial resistance; CRP, C-reactive protein; ED,
Emergency department; GSTT, Guy’s and St Thomas’ Hospital;
KCH, King’s College Hospital; NHS, National Health Service;
PCR, Polymerase chain reaction; POCT, Point-of-care tests; RSV,
Respiratory syncytial virus; SGH, St George’s Hospital.
©2017 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd 1
Acta Pædiatrica ISSN 0803-5253
presenting with symptoms or signs of upper respiratory tract
infection was undertaken from January to July 2015. A
ward-based diagnostic platform called BioFire Filmarray
(bioM
erieux, Marcy-l’
Etoile, France) was used with com-
pany-provided training. Ward staff were trained to perform
the respiratory pathogen assay which detects 17 respiratory
viruses and three bacteria by polymerase chain reaction
(PCR) in 70 minutes. A staff satisfaction questionnaire was
used with a graded response of 1–5 on ease of use and
utility. Questionnaires were distributed trust-wide. At Guy’s
and St Thomas’ NHS trust Evelina Children’s Hospital
(GSTT),a ward-based service evaluation was conducted
from October 2014 to March 2015, using the Enigma
â
MiniLab
TM
FluAB-RSV PCR assay (Enigma Diagnostics Ltd,
Salisbury, UK), a fully automated molecular platform able
to detect influenza A and B and RSV in 90 minutes (911).
The platform was introduced by company-provided training
of staff with a competency assessment and then by the
research nurse at which point staff got a barcode for the
machine. Relevant staff were identified by ward matron and
interested clinical teams. Ward staff were trained to perform
the test on any child with signs or symptoms of upper or
lower respiratory tract infection. Duplicate samples were
obtained in viral transport medium and tested in parallel
with the standard laboratory-based assay (RVP Fast v2,
Luminex, Austin, TX, USA). Diagnostic accuracy, error
rate, turnaround time and use of hospital resources were
measured and compared with the previous influenza season
in which only the RVP was used. A staff satisfaction
questionnaire was offered to all ward staff (trained or
untrained in the use of the test) contacted through an
electronic trust-wide email distribution list, and they were
asked to provide quantitative and qualitative feedbacks
about their experience of using the Enigma test.
A total of 942 paediatric patients had a POCT performed
across the three centres during October 2014 to July 2015.
(Table 1) At St. George’s ED, POCT uptake was 30% less
than the laboratory counterpart test for CRP and viral
respiratory panel, with 102 POCT compared to 341 labo-
ratory-based tests. This was mainly for serum CRP samples,
whereby 225 were sent to the laboratory compared to 41
tested by POCT. Fifteen medical ED staff including three
consultants, five junior doctors, four senior registrars and
clinical fellows and three nurses were interviewed to
explore individual perceptions on the use of these tests.
Overall, the concerns about using the CRP POCT were
being unsure about performance of the test, missing the
‘odd sick child’ and using the test in isolation. The
advantages mentioned were the immediateness of the result
available in four minutes, the ease of use and being a blood-
sparing procedure. For the respiratory viruses POCT, they
were highly appreciated for the possibility of quickly
cohorting patients, decreasing antibiotic use and being able
to reassure parents. Downfalls mentioned included ques-
tions about performance of the test, error messages and
sample duplication.
At KCH, 460 tests were performed on the ward. The
BioFire platform was well received. Any concerns from staff
members were shared with the PI. Thirty-four respondents,
a mixture of nursing staff and paediatric consultants,
completed the survey. Highlighted advantages included fast
results in one hour, good tests for infection control, early
treatment and reduction in length of stay. Concerns
included a limitation on space to house the equipment,
needed for additional trained staff and high cost of the test.
In the GSTT paediatric ward, the ENIGMA platform
POCT used had a good uptake among staff. More POCT
were conducted compared to routine laboratory testing
(462 patients tested by POCT vs 370 patients tested by
routine laboratory). Results from the free-text portion of the
questionnaire from 34 staff who completed it were analysed
for themes. Advantages included parental anxiety reduc-
tion, better bed allocation, fast cohorting or isolation,
increased safety and reduction in antibiotic use. Concerns
raised by staff members included difficulty handling dis-
crepant results (POCT laboratory), more people needed to
be trained and no changes to patient care observed.
We have described three hospitals across South London
with different settings (ED and ward-based) and testing/
clinical protocols but that all implemented a POCT to
improve process outcomes and complement antibiotic
stewardship programmes. In the two ward-based centres,
Table 1 Number of patients tested within the study period by POCT and in the
reference laboratory
POCT Main laboratory
St George’s NHS trust (Children’s ED) 102 341
King’s College Hospital (Paediatric ward) 460 520
Guy’s and St Thomas’ trust (Paediatric ward) 462 370
Figure 1 Proposed stepwise process for the full integration of POCT into
paediatric clinical practice. Randomised control trials (RCT) with integrated cost-
effectiveness analysis. Training of medical staff to increase uptake leading to
practice change.
2©2017 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd
Implementation barriers for POCT Bustinduy et al.
although staff overall welcomed the POCT, the main issue
was not having enough trained personnel in all shifts. As the
uptake of their test increased beyond the ward where the
machines were housed, excessive demands were placed on
the trained staff to run tests from patients outside their
ward, leading to a queue of tests to be run. The decision by
the KCH and GSTT trusts to implement such a POCT will
ultimately depend on impact on length of stay, antibiotic
use and cost-effectiveness analysis (analysis awaited). In the
ED-based study (St. George’s ED), implementation barriers
were centred around the clinician’s uncertainty about the
test and fear of underinvestigating a potentially sick child.
Other problems included running a new technology within
a busy service that was not yet integrated into the depart-
mental clinical care pathways. Particular reticence was
found with the implementation of CRP and the fear of a
poor negative predictive value as a rule-out test, despite the
growing evidence that this is not the case (12). Overall, the
ward-based implementation had a more positive feedback
from the staff; however, parallel sampling for laboratory
testing makes this platform difficult to justify its cost.
This report is set within context of the global threat of
antimicrobial resistance (AMR) and the growing recogni-
tion on the value of POCT as valuable rapid diagnostic tools
(13,14). Scaling up of these tests may help reduce unnec-
essary empiric antibiotic use and reduce invasive investiga-
tions often performed to overcome diagnostic uncertainty
(15). Implementing these tests, however, is challenging (2).
Behaviour changes are needed to modify long-established
ways of providing clinical care and empirically prescribing
antibiotics for febrile children (16). New technology needs
time to become established as part of routine care and to
build evidence on its potential benefits (17). The need to
shift practice and integrate POCT into paediatric care as in
adult settings is clear and will require a multistage
approach. Overcoming implementation barriers is para-
mount in order to succeed in this approach and to make
local and national recommendations (18).
We propose a stepwise framework to integrate POCT
into paediatric clinical practice based on the three major
areas identified from the different centres as summarised in
Figure 1. (i) POCT RCT paediatric studies: multicentred
studies with cost-effective analysis to demonstrate
improved outcomes; (ii) increasing staff knowledge and
confidence to decrease uncertainty on the tests: need for
more comprehensive teaching and training on the different
devices, with particular emphasis on their evidence-based
efficacy; (iii) integration: integrate POCT into existing care
pathways and guidelines.
Qualitative assessments on the impact of interventions
are helpful to understand implementation difficulties and
can help pave the way for future integration of novel
interventions such as POCT into paediatric practice.
ACKNOWLEDGEMENTS
We would like to thank the ED staff members at St George’s
Children’s ED that contributed to the work presented; To
Alere
TM
for the donation of the POCT and reagents for the
study; Enigma Diagnostics for funding the GSTT Project; A
Vecino and C Mak for help on the survey and data analysis
at GSTT; and Evelina London Mountain ward staff,
patients and parents for support and feedback. We thank
staff and patients of the paediatric (especially Toni and
Guy) wards and bioM
erieux for the diagnostic platforms
and tests. We thank Dr. Adam Irwin for his instightful
review of the manuscript.
COMPETING INTERESTS AND FUNDING
DJ Project received funding from bioM
erieux. SD and EA
received funding from Enigma Diagnostics. NS’ research is
funded by the NIHR via the ‘Collaboration for Leadership
in Applied Health Research and Care South London’ at
King’s College Hospital NHS Foundation Trust, London,
UK. The views expressed are those of the authors and not
necessarily those of the NHS, the NIHR or the Department
of Health. Sevdalis is also a member of King’s Improvement
Science, which is part of the NIHR CLAHRC South
London and comprises a specialist team of improvement
scientists and senior researchers based at King’s College
London. Its work is funded by King’s Health Partners
(Guy’s and St Thomas’ NHS Foundation Trust, King’s
College Hospital NHS Foundation Trust, King’s College
London and South London and Maudsley NHS Founda-
tion Trust), Guy’s and St Thomas’ Charity, the Maudsley
Charity and the Health Foundation. The views expressed in
this publication are those of the authors and not necessarily
those of the NHS, the National Institute for Health
Research or the UK Department of Health. NS is also the
Director of London Safety and Training Solutions Ltd,
which provides quality and safety training and advisory
services on a consultancy basis to healthcare organisations
globally.
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Implementation barriers for POCT Bustinduy et al.
... [12][13][14][15][16][17][18][19] To the best of our knowledge, only one study pertains to the perceptions of hospital-based healthcare workers regarding the use of POCTs in children. 20 The aim of this study was to explore the experiences and attitudes of hospital-based doctors and nurses regarding the use of POCTs in children with acute infections and to identify factors that influence their use. ...
... Participants valued their ease and speed of use, which enabled early treatment, cohorting, decreasing antibiotic prescription and better communication with parents. 20 Some participants were also concerned about the accuracy of the tests and about the limited changes in clinical management enabled by POCTs. ...
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Objectives The use of rapid point-of-care tests (POCTs) has been advocated for improving patient management and outcomes and for optimising antibiotic prescribing. However, few studies have explored healthcare workers’ views about their use in febrile children. The aim of this study was to explore the perceptions of hospital-based doctors and nurses regarding the use of POCTs in England. Study design Qualitative in-depth interviews with purposively selected hospital doctors and nurses. Data were analysed thematically. Setting Two university teaching hospitals in London and Newcastle. Participants 24 participants (paediatricians, emergency department doctors, trainee paediatricians and nurses). Results There were diverse views about the use of POCTs in febrile children. The reported advantages included their ease of use and the rapid availability of results. They were seen to contribute to faster clinical decision-making; the targeting of antibiotic use; improvements in patient care, flow and monitoring; cohorting (ie, the physical clustering of hospitalised patients with the same infection to limit spread) and enhancing communication with parents. These advantages were less evident when the turnaround for results of laboratory tests was 1–2 hours. Factors such as clinical experience and specialty, as well as the availability of guidelines recommending POCT use, were also perceived as influential. However, in addition to their perceived inaccuracy, participants were concerned about POCTs not resolving diagnostic uncertainty or altering clinical management, leading to a commonly expressed preference for relying on clinical skills rather than test results solely. Conclusion In this study conducted at two university teaching hospitals in England, participants expressed mixed opinions about the utility of current POCTs in the management of febrile children. Understanding the current clinical decision-making process and the specific needs and preferences of clinicians in different settings will be critical in ensuring the optimal design and deployment of current and future tests.
... The growing number of clinical trials primarily from highincome contexts thereby indicates moderate effectiveness of CRP testing in reducing clinically unnecessary antibiotic prescriptions (Aabenhus et al., 2014;Cals et al., 2010;Cooke et al., 2015;Do et al., 2016), making these point-of-care tests a promising and economical addition to a necessarily broad portfolio of strategies to address antimicrobial resistance in LMIC settings with resource constraints and scarce laboratory capacity (Aabenhus and Jensen, 2016;Drain et al., 2014;Lubell and Althaus, 2017). A small number of clinically oriented qualitative and mixed-method studies from high-income countries complement the clinical trials, focusing on CRP POCT adoption barriers and the attitudes and practices of participating healthcare workers (Bustinduy et al., 2017;Hardy et al., 2017;Huddy et al., 2016;Van den Bruel et al., 2016). ...
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Children admitted to Emergency Departments (EDs) with fever and respiratory symptoms represent a major burden to the health care system, as well as significant anxiety and expense to parents and caregivers. Physicians often order diagnostic tests, and may prescribe antibiotics when they are unsure of the cause of the illness and are concerned about the possibility of serious bacterial infection. However, in most cases, fever and respiratory symptoms are caused by viruses. In addition, in children in whom a virus is found to be the cause of their illness, the risk of serious bacterial infection is very low. We conducted this review to assess whether a rapid viral test, done in the ED, changes what physicians do when treating these children. We found, based on four studies involving 759 study participants, that in previously healthy children coming to the ED with fever and respiratory symptoms, a rapid viral test reduces the use of chest X-rays, and that there is a trend toward less antibiotic usage, and blood and urine investigations. The true impact of this intervention on the latter three outcomes (antibiotic usage, blood investigations, and urine investigations) requires trials with larger enrollment numbers.
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Background: Pediatric acute respiratory infections (ARIs) represent a significant burden on pediatric Emergency Departments (EDs) and families. Most of these illnesses are due to viruses. However, investigations (radiography, blood, and urine testing) to rule out bacterial infections and antibiotics are often ordered because of diagnostic uncertainties. This results in prolonged ED visits and unnecessary antibiotic use. The risk of concurrent bacterial infection has been reported to be negligible in children over three months of age with a confirmed viral infection. Rapid viral testing in the ED may alleviate the need for precautionary testing and antibiotic use. Objectives: To determine if the use of a rapid viral detection test for children with an acute respiratory infection (ARI) in Emergency Departments (EDs) changes patient management and resource use in the ED, compared to not using a rapid viral detection test. We hypothesized that rapid viral testing reduces antibiotic use in the ED as well as reduces the rate of ancillary testing and length of ED visits. Search methods: We searched CENTRAL (2014, Issue 6), MEDLINE (1950 to July week 1, 2014), MEDLINE In-Process & Other Non-Indexed Citations (15 July 2014), EMBASE.com (1988 to July 2014), HealthStar (1966 to 2009), BIOSIS Previews (1969 to July 2014), CAB Abstracts (1973 to July 2014), CBCA Reference (1970 to 2007) and ProQuest Dissertations and Theses (1861 to 2009). Selection criteria: Randomized controlled trials (RCTs) of rapid viral testing for children with ARIs in the ED. Data collection and analysis: Two review authors used the inclusion criteria to select trials, evaluate their quality, and extract data. We obtained missing data from trial authors. We expressed differences in rate of investigations and antibiotic use as risk ratios (RRs), and expressed difference in ED length of visits as mean differences (MDs), with 95% confidence intervals (CIs). Main results: No new trials were identified in this 2014 update. We included four trials (three RCTs and one quazi-RCT), with 759 children in the rapid viral testing group and 829 in the control group. Three out of the four studies were comparable in terms of young age of participants, with one study increasing the age of inclusion up to five years of age. All studies included either fever or respiratory symptoms as inclusion criteria (two required both, one required fever or respiratory symptoms, and one required only fever). All studies were comparable in terms of exclusion criteria, intervention, and outcome data. In terms of risk of bias, one study failed to utilize a random sequence generator, one study did not comment on completeness of outcome data, and only one of four studies included allocation concealment as part of the study design. None of the studies definitively blinded participants.Rapid viral testing resulted in a trend toward decreased antibiotic use in the ED, but this was not statistically significant. We found lower rates of chest radiography (RR 0.77, 95% CI 0.65 to 0.91) in the rapid viral testing group, but no effect on length of ED visits, or blood or urine testing in the ED. No study made mention of any adverse effects related to viral testing. Authors' conclusions: There is insufficient evidence to support routine rapid viral testing to reduce antibiotic use in pediatric EDs. Rapid viral testing may or may not reduce rates of antibiotic use, and other investigations (urine and blood testing); these studies do not provide enough power to resolve this question. However, rapid viral testing does reduce the rate of chest X-rays in the ED. An adequately powered trial with antibiotic use as an outcome is needed.
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