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Cochrane Database of Systematic Reviews

Análisis moleculares para el diagnóstico de la sepsis en los recién nacidos

Información

DOI:
https://doi.org/10.1002/14651858.CD011926.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 25 febrero 2017see what's new
Tipo:
  1. Diagnostic
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Neonatología

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Mohan Pammi

    Correspondencia a: Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Houston, USA

    [email protected]

  • Angela Flores

    Pediatrix Medical Group ‐ NW Houston Practice, The Woodlands, USA

  • James Versalovic

    Pathology, Texas Children’s Hospital and Baylor College of Medicine, Houston, USA

  • Mariska MG Leeflang

    Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands

Contributions of authors

MP conceived the project, searched literature, extracted and analyzed data, and wrote the review.

AF participated in the design, searched literature, extracted data, performed the QUADAS evaluation of included studies and assisted in writing the review.

JV provided critical intellectual input and revised the review.

ML provided critical intellectual input and revised the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA.

    Editorial support of the Cochrane Neonatal Review Group has been funded with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN275201100016C

Declarations of interest

Mohan Pammi, Angela Flores, James Versalovic and Mariska MG Leeflang have no financial or other conflicts of interest to disclose.

Acknowledgements

The Cochrane Neonatal Group has been funded in part with federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN267200603418C. We acknowledge the help of Nha Huynh, librarian at the Texas Medical Center library in Houston, TX, USA and Milagros De Jesus, librarian at Texas Technical University Health Sciences Center, Lubbock, TX, USA for invaluable help with search strategy.

We acknowledge the help of Joe Hagan, statistician, Section of Neonatology at Baylor College of Medicine in creating the Deeks' funnel plot and checking the statistics for the hierarchical summary receiver operating characteristic (HSROC) and the bivariate model.

Version history

Published

Title

Stage

Authors

Version

2017 Feb 25

Molecular assays for the diagnosis of sepsis in neonates

Review

Mohan Pammi, Angela Flores, James Versalovic, Mariska MG Leeflang

https://doi.org/10.1002/14651858.CD011926.pub2

2015 Nov 05

Molecular assays for the diagnosis of sepsis in neonates

Protocol

Mohan Pammi, Angela Flores, James Versalovic, Mariska MG Leeflang

https://doi.org/10.1002/14651858.CD011926

Differences between protocol and review

1. We decided post‐hoc to present quality of evidence using GRADE methodology recommended for diagnostic tests.

2. Some studies did not include an upper limit for age and hence some infants were over 28 days of age. We made a post‐hoc decision that we would include studies where an upper age limit was not specified but where more than 50% of the samples were from newborn less than 28 days of age. Our decision was supported by the reasoning that LOS extends up to three months of age and participant characteristics are similar in the first two to three months of age.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans; Infant, Newborn;

Study flow diagram.
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Figure 1

Study flow diagram.

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Deeks' funnel plot for publication bias.
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Figure 2

Deeks' funnel plot for publication bias.

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Risk of bias and applicability concerns graph: review authors' judgments about each domain presented as percentages across included studies.
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Figure 3

Risk of bias and applicability concerns graph: review authors' judgments about each domain presented as percentages across included studies.

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Risk of bias and applicability concerns summary: review authors' judgments about each domain for each included study.
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Figure 4

Risk of bias and applicability concerns summary: review authors' judgments about each domain for each included study.

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Forest plot of 1 All molecular tests. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Figure 5

Forest plot of 1 All molecular tests. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.

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Summary receiver operating characteristic plot of all molecular tests.
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Figure 6

Summary receiver operating characteristic plot of all molecular tests.

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Summary receiver operating characteristic plot by type of molecular test. PCR: polymerase chain reaction.
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Figure 7

Summary receiver operating characteristic plot by type of molecular test. PCR: polymerase chain reaction.

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Summary receiver operating characteristic plot subgrouped by sepsis onset.
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Figure 8

Summary receiver operating characteristic plot subgrouped by sepsis onset.

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Summary receiver operating characteristic plot subgrouped by gestational age.
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Figure 9

Summary receiver operating characteristic plot subgrouped by gestational age.

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Forest plot of all molecular tests sorted in order of prevalence. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Figure 10

Forest plot of all molecular tests sorted in order of prevalence. CI: confidence interval; FN: false negative; FP: false positive; TN: true negative; TP: true positive.

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Summary receiver operating characteristic plot of all molecular tests where the size of the study symbol is directly proportional to the prevalence of sepsis in the study.
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Figure 11

Summary receiver operating characteristic plot of all molecular tests where the size of the study symbol is directly proportional to the prevalence of sepsis in the study.

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Summary receiver operating characteristic plot of studies that performed molecular tests on blood samples only.
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Figure 12

Summary receiver operating characteristic plot of studies that performed molecular tests on blood samples only.

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Summary receiver operating characteristic plot of molecular tests with good methodologic quality.
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Figure 13

Summary receiver operating characteristic plot of molecular tests with good methodologic quality.

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All molecular tests.
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Test 1

All molecular tests.

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Molecular tests: blood samples only.
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Test 2

Molecular tests: blood samples only.

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Molecular tests with good methodologic quality.
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Test 3

Molecular tests with good methodologic quality.

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Summary of findings Summary of findings table

Groups

Number of studies

Sensitivity

(95% CI)

Specificity

(95% CI)

Quality of evidence using GRADE

All studies

‐

35

0.90 (0.82 to 0.95)

0.93 (0.89 to 0.96)

Moderate quality evidence*

Type of test

Broad‐range PCR

9

0.97 (0.86 to 1.00)

0.93 (0.77 to 0.98)

Moderate quality evidence*

Real‐time PCR

9

0.86 (0.59 to 0.96)

0.94 (0.90 to 0.97)

Moderate quality evidence*

Post‐PCR processing

5

0.97 (0.40 to 1.00)

0.96 (0.93 to 0.98)

Low quality evidence**

Multiplex PCR

6

0.76 (0.60 to 0.88)

0.81 (0.70 to 0.89)

Low quality evidence**

Staphylococcal PCR*

2

‐

‐

Low quality evidence**

Fungal PCR*

4

‐

‐

Low quality evidence**

Type of sepsis

EOS*

2

‐

‐

Low quality evidence**

LOS

10

0.79 (0.69 to 0.86)

0.94 (0.85 to 0.98)

Low quality evidence**

Mixed EOS and LOS

23

0.94 (0.84 to 0.98)

0.92 (0.87 to 0.95)

Moderate quality evidence*

Gestational age

Preterm

5

0.89 (0.75 to 0.96)

0.87 (0.71 to 0.94)

Low quality evidence**

Mixed term and preterm

30

0.90 (0.80 to 0.96)

0.94 (0.90 to 0.96)

Moderate quality evidence*

Prevalence

< 15%

20

0.94 (0.80 to 0.99)

0.95 (0.92 to 0.97)

Moderate quality evidence*

15% to 30%

8

0.85 (0.67 to 0.94)

0.88 (0.79 to 0.94)

Low quality evidence**

>30%

7

0.87 (0.75 to 0.93)

0.93 (0.64 to 0.99)

Low quality evidence**

Specimen

Blood only

32

0.92 (0.84 to 0.96)

0.93 (0.89 to 0.95)

Low quality evidence**

Blood and CSF*

3

‐

‐

Moderate quality evidence*

Quality

Good methodologic studies only

22

0.90 (0.78 to 0.96)

0.93 (0.88 to 0.96)

Moderate quality evidence*

CI: confidence interval; CSF: cerebrospinal fluid; EOS: early‐onset sepsis; LOS: late‐onset sepsis; PCR: polymerase chain reaction.

Summary estimates of sensitivity and specificity were derived from meta‐analyses using the bivariate random‐effects model using statistical software STATA. Summary estimates for the subgroups are presented, where number of studies ≥ 4. *Summary estimates of sensitivity and specificity could not be calculated using STATA if number of studies ≤ 4.

GRADE rating of evidence: reasons for downgrading quality of evidence (Gopalakrishna 2014)

* Evidence downgraded one level for inconsistency of evidence.

** Evidence downgraded two levels for inconsistency and imprecision.
Figuras y tablas -
Summary of findings Summary of findings table
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Table Tests. Data tables by test

Test

No. of studies

No. of participants

1 All molecular tests Show forest plot

35

7339

2 Molecular tests: blood samples only Show forest plot

32

6999

3 Molecular tests with good methodologic quality Show forest plot

22

4150
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Table Tests. Data tables by test
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