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Accuracy of LightCycler(R) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis : a systematic review protocol

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Dark, Paul, Wilson, Claire, Blackwood, Bronagh, McAuley, Daniel F., Perkins, Gavin D., McMullan, Ronan, Gates, Simon and Warhurst, Geoffrey. (2012) Accuracy of LightCycler(R) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis : a systematic review protocol. BMJ Open, Vol.2 (No.1). e000392-e000392. ISSN 2044-6055

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Abstract

Background There is growing interest in the potential utility of molecular diagnostics in improving the detection of life-threatening infection (sepsis). LightCycler® SeptiFast is a multipathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here the protocol of the first systematic review of published clinical diagnostic accuracy studies of this technology when compared with blood culture in the setting of suspected sepsis.

Methods/design Data sources: the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), The Cochrane Library, MEDLINE, EMBASE, ISI Web of Science, BIOSIS Previews, MEDION and the Aggressive Research Intelligence Facility Database (ARIF). Study selection: diagnostic accuracy studies that compare the real-time PCR technology with standard culture results performed on a patient's blood sample during the management of sepsis. Data extraction: three reviewers, working independently, will determine the level of evidence, methodological quality and a standard data set relating to demographics and diagnostic accuracy metrics for each study. Statistical analysis/data synthesis: heterogeneity of studies will be investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in Receiver Operator Characteristic (ROC) space. Bivariate model method will be used to estimate summary sensitivity and specificity. The authors will investigate reporting biases using funnel plots based on effective sample size and regression tests of asymmetry. Subgroup analyses are planned for adults, children and infection setting (hospital vs community) if sufficient data are uncovered.

Dissemination Recommendations will be made to the Department of Health (as part of an open-access HTA report) as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy potential to move forward to efficacy testing during the provision of routine clinical care.

Item Type: Journal Article
Subjects: R Medicine > RB Pathology
Divisions: Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Septicemia -- Molecular diagnosis, Polymerase chain reaction -- Diagnostic use
Journal or Publication Title: BMJ Open
Publisher: BMJ
ISSN: 2044-6055
Official Date: 2012
Volume: Vol.2
Number: No.1
Page Range: e000392-e000392
Identification Number: 10.1136/bmjopen-2011-000392
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: National Institute for Health Research (Great Britain) (NIHR), Greater Manchester Comprehensive Local Research Network, Intensive Care Society (Great Britain) (ICS)
Grant number: HTA 08/13/16 (NIHR)
References:

1. Cohen J. The immunopathogenesis of sepsis. Nature
2002;420:885e91.
2. Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis.
N Engl J Med 2003;348:138e50.
3. Calandra T, Cohen J. The international sepsis forum consensus
conference on definitions of infection in the intensive care unit. Crit
Care Med 2005;33:1538e48.
4. Dellinger RP, Levy MM, Carlet JM, et al. Surviving Sepsis Campaign:
international guidelines for management of severe sepsis and septic
shock: 2008. Crit Care Med 2008;36:296e327.
5. Health Protection Agency. Investigation of Blood Cultures (For
Organisms Other than Mycobacterium Species). National Standard
Method. London: Standards Unit, 2005.
6. Kollef MH, Sherman G, Ward S, et al. Inadequate antimicrobial
treatment of infections: a risk factor for hospital mortality among
critically ill patients. Chest 1999;115:462e74.
7. Kumar A, Roberts D, Wood KE, et al. Duration of hypotension
before initiation of effective antimicrobial therapy is the critical
determinant of survival in human septic shock. Crit Care Med
2006;34:1589e96.
8. Comptroller Auditor General. Reducing healthcare associated
infection in hospitals in England. HC 560 Session 2008e2009. ISBN
978 0 10 295504 0. In: Office NA, ed. London: The Stationery Office,
2009.
9. Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care
2010;14:R15.
10. Aarts MA, Brun-Buisson C, Cook DJ, et al. Antibiotic management of
suspected nosocomial ICU-acquired infection: does prolonged
empiric therapy improve outcome? Intensive Care Med
2007;33:1369e78.
11. Peters RP, van Agtmael MA, Danner SA, et al. New developments in
the diagnosis of bloodstream infections. Lancet Infect Dis
2004;4:751e60.
12. Dark PM, Dean P, Warhurst G. Bench-to-bedside review: the promise
of rapid infection diagnosis during sepsis using polymerase chain
reaction-based pathogen detection. Crit Care 2009;13:217.
13. Lehmann LE, Hunfeld KP, Emrich T, et al. A multiplex real-time PCR
assay for rapid detection and differentiation of 25 bacterial and fungal
pathogens from whole blood samples. Med Microbiol Immunol
2008;197:313e24.
14. Dark PM, Dunn G, Chadwick P, et al. The clinical diagnostic accuracy
of rapid detection of healthcare-associated bloodstream infection in
intensive care using multi-pathogen real-time polymerase chain
reaction (real-time PCR) technology. BMJ Open 2011;1:e000181.
15. Dark P, Wilson C, Blackwood B, et al. Accuracy of LightCycler�
SeptiFast for the Detection and Identification of Pathogens in Blood of
Patients with Suspected Sepsis: A Systematic Review. PROSPERO,
2011;CRD42011001289. http://www.crd.york.ac.uk/PROSPERO/
full_doc.asp?ID¼CRD42011001289
16. Levy MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/
ATS/SIS international sepsis definitions conference. Intensive Care
Med 2003;29:530e8.
17. Phillips B, Ball C, Sackett D, et al. Oxford Centre for Evidence-based
Medicine Levels of Evidence. 2001. http://www.cebm.net/index.aspx?
o¼1025 (accessed 6 Jan 2012).
18. Whiting P, Rutjes AW, Reitsma JB, et al. The development of
QUADAS: a tool for the quality assessment of studies of diagnostic
accuracy included in systematic reviews. BMC Med Res Methodol
2003;3:25.
19. Reitsma JB, Glas AS, Rutjes AW, et al. Bivariate analysis of
sensitivity and specificity produces informative summary measures in
diagnostic reviews. J Clin Epidemiol 2005;58:982e90.
20. Deeks JJ, Macaskill P, Irwig L. The performance of tests of publication
bias and other sample size effects in systematic reviews of diagnostic
test accuracy was assessed. J Clin Epidemiol 2005;58:882e93.
URI: http://wrap.warwick.ac.uk/id/eprint/44743

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