Diagnostic Accuracy of IgA Anti-Transglutaminase and IgG Anti-Deamidated Gliadin for Diagnosis of Celiac Disease in Children under Two Years of Age: A Systematic Review and Meta-Analysis

The need of adding the determination of anti-deamidated gliadin peptide (DGP) IgG to anti-transglutaminase (TTG) IgA antibodies for diagnosis of celiac disease (CD) in children <2 years of age is controversial. We performed a systematic review and meta-analysis to evaluate, by head-to-head comparison, the diagnostic accuracy of TTG IgA and DGP IgG antibodies. We searched PubMed, MEDLINE, and Embase databases up to January 2021. The diagnostic reference was intestinal biopsy. We calculated the sensitivity and specificity of these tests and the odds ratio (OR) between the tests. Fifteen articles were eligible for the systematic review and ten were eligible for the meta-analysis. Sensitivity and specificity were 0.96 (95% confidence interval (CI), 0.91–0.98) and 0.96 (95% CI, 0.85–0.99) for DGP IgG and 0.93 (95% CI, 0.88–0.97) and 0.98 (95% CI, 0.96–0.99) for TTG IgA, respectively. TTG IgA specificity was significantly higher (OR 9.3 (95% CI, 2.3–37.49); p < 0.001) while the sensitivity of DGP IgG was higher without reaching statistical significance (OR: 0.6 (95% CI, 0.24–1.51); p = 0.28). Both the meta-analysis and the systematic review showed that some children with early CD are missed without the DGP IgG test. In children <2 years of age, TTG IgA is the best CD screening test; however, the addition of DGP IgG may increase the diagnostic sensitivity.

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Performance of rapid rk39 tests for the diagnosis of visceral leishmaniasis in Ethiopia: a systematic review and meta-analysis

BMC Infectious Diseases ◽

10.1186/s12879-021-06826-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Dawit Gebreegziabiher Hagos ◽

Henk D. F. H. Schallig ◽

Yazezew K. Kiros ◽

Mahmud Abdulkadir ◽

Dawit Wolday

Keyword(s):

Systematic Review ◽

Visceral Leishmaniasis ◽

Diagnostic Accuracy ◽

Diagnostic Test ◽

Sensitivity And Specificity ◽

Leishmania Donovani ◽

Meta Analysis ◽

Statistical Significance ◽

Cold Chain ◽

Wide Range

Abstract Background Visceral Leishmaniasis (VL) is a severely neglected disease affecting millions of people with high mortality if left untreated. In Ethiopia, the primary laboratory diagnosis of VL is by using an antigen from a 39-amino acid sequence repeat of a kinesin-related (rK39) of leishmania donovani complex (L. donovani), rapid diagnostic tests (RDT). Different rk39 RDT brands are available with very variable performance and studies from Ethiopia showed a very wide range of sensitivity and specificity. Therefore, a systematic review and meta-analysis were conducted to determine the pooled sensitivity and specificity of rk39 RDT in Ethiopia. Method PUBMED, EMBASE, and other sources were searched using predefined search terms to retrieve all relevant articles from 2007 to 2020. Heterogeneity was assessed by visually inspecting summary receiver operating curves (SROC), Spearman correlation coefficient (rs), Cochran Q test statistics, inconsistency square (I2) and subgroup analysis. The presence and statistical significance of publication bias were assessed by Egger's test at p < 0.05, and all the measurements showed the presence of considerable heterogeneity. Quality assessment of diagnostic accuracy studies (QUADAS-2) checklists was used to check the qualities of the study. Results A total of 664 articles were retrieved, and of this 12 articles were included in the meta-analysis. Overall pooled sensitivity and specificity of the rk39 RDT to diagnose VL in Ethiopia were 88.0% (95% CI 86.0% to 89.0%) and 84.0% (95% CI 82.0% to 86.0%), respectively. The sensitivity and specificity of the rk39 RDT commercial test kits were DiaMed: 86.9% (95% CI 84.3% to 89.1%) and 82.2% (95% CI 79.3% to 85.0%), and InBios: 80.0% (95% CI 77.0% to 82.8%) and 97.4% (95% CI 95.0% to 98.8%), respectively. Conclusion Referring to our result, rk39 RDT considered an essential rapid diagnostic test for VL diagnosis. Besides to the diagnostic accuracy, the features such as easy to perform, quick (10–20 min), cheap, equipment-free, electric and cold chain free, and result reproducibility, rk39 RDT is advisable to remains in practice as a diagnostic test at least in the remote VL endemic localities till a better test will come.

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Comparative accuracy of pleural fluid unstimulated interferon-gamma and adenosine deaminase for diagnosing pleural tuberculosis: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0253525 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0253525

Author(s):

Ashutosh Nath Aggarwal ◽

Ritesh Agarwal ◽

Sahajal Dhooria ◽

Kuruswamy Thurai Prasad ◽

Inderpaul Singh Sehgal ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Adenosine Deaminase ◽

Pleural Fluid ◽

Sensitivity And Specificity ◽

Interferon Gamma ◽

Meta Analysis ◽

Paired Data ◽

Ifn Γ ◽

Meta Regression

Objective We compared diagnostic accuracy of pleural fluid adenosine deaminase (ADA) and interferon-gamma (IFN-γ) in diagnosing tuberculous pleural effusion (TPE) through systematic review and comparative meta-analysis. Methods We queried PubMed and Embase databases to identify studies providing paired data for sensitivity and specificity of both pleural fluid ADA and IFN-γ for diagnosing TPE. We used hierarchical summary receiver operating characteristic (HSROC) plots and HSROC meta-regression to model individual and comparative diagnostic performance of the two tests. Results We retrieved 376 citations and included 45 datasets from 44 publications (4974 patients) in our review. Summary estimates for sensitivity and specificity for ADA were 0.88 (95% CI 0.85–0.91) and 0.91 (95% CI 0.89–0.92), while for IFN-γ they were 0.91 (95% CI 0.89–0.94) and 0.96 (95% CI 0.94–0.97), respectively. HSROC plots showed consistently greater diagnostic accuracy for IFN-γ over ADA across the entire range of observations. HSROC meta-regression using test-type as covariate yielded a relative diagnostic odds ratio of 2.22 (95% CI 1.68–2.94) in favour of IFN-γ, along with better summary sensitivity and specificity figures. No prespecified subgroup variable significantly influenced the summary diagnostic accuracy estimates. Conclusion Pleural fluid IFN-γ estimation has better diagnostic accuracy than ADA estimation for diagnosis of TPE.

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Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2017-018132 ◽

2018 ◽

Vol 8 (2) ◽

pp. e018132 ◽

Cited By ~ 5

Author(s):

Carmen Phang Romero Casas ◽

Marrissa Martyn-St James ◽

Jean Hamilton ◽

Daniel S Marinho ◽

Rodolfo Castro ◽

...

Keyword(s):

Systematic Review ◽

High Risk ◽

Diagnostic Accuracy ◽

Pregnant Women ◽

Sensitivity And Specificity ◽

Methodological Quality ◽

Meta Analysis ◽

Risk Of Bias ◽

Antenatal Clinics

ObjectivesTo undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women.MethodsFive electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot.ResultsThe methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively.ConclusionsThis review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.PROSPERO registration numberCRD42016036335.

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Diagnostic Accuracy of Stool Xpert MTB/RIF for Detection of Pulmonary Tuberculosis in Children: a Systematic Review and Meta-analysis

Journal of Clinical Microbiology ◽

10.1128/jcm.02057-18 ◽

2019 ◽

Vol 57 (6) ◽

Cited By ~ 18

Author(s):

Emily MacLean ◽

Giorgia Sulis ◽

Claudia M. Denkinger ◽

James C. Johnston ◽

Madhukar Pai ◽

...

Keyword(s):

Systematic Review ◽

Pulmonary Tuberculosis ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Target Population ◽

Nucleic Acid Amplification ◽

Reference Standard ◽

Noninvasive Method ◽

High Data

ABSTRACT Invasive collection methods are often required to obtain samples for the microbiological evaluation of children with presumptive pulmonary tuberculosis (PTB). Nucleic acid amplification testing of easier-to-collect stool samples could be a noninvasive method of diagnosing PTB. We conducted a systematic review and meta-analysis to evaluate the diagnostic accuracy of testing stool with the Xpert MTB/RIF assay (“stool Xpert”) for childhood PTB. Four databases were searched for publications from January 2008 to June 2018. Studies assessing the diagnostic accuracy among children of stool Xpert compared to a microbiological reference standard of conventional specimens tested by mycobacterial culture or Xpert were eligible. Bivariate random-effects meta-analyses were performed to calculate pooled sensitivity and specificity of stool Xpert against the reference standard. From 1,589 citations, 9 studies (n = 1,681) were included. Median participant ages ranged from 1.3 to 10.6 years. Protocols for stool processing and testing varied substantially, with differences in reagents and methods of homogenization and filtering. Against the microbiological reference standard, the pooled sensitivity and specificity of stool Xpert were 67% (95% confidence interval [CI], 52 to 79%) and 99% (95% CI, 98 to 99%), respectively. Sensitivity was higher among children with HIV (79% [95% CI, 68 to 87%] versus 60% [95% CI, 44 to 74%] among HIV-uninfected children). Heterogeneity was high. Data were insufficient for subgroup analyses among children under the age of 5 years, the most relevant target population. Stool Xpert could be a noninvasive method of ruling in PTB in children, particularly those with HIV. However, studies focused on children under 5 years of age are needed, and generalizability of the evidence is limited by the lack of standardized stool preparation and testing protocols.

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Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

BMJ ◽

10.1136/bmj.m2516 ◽

2020 ◽

pp. m2516 ◽

Cited By ~ 111

Author(s):

Mayara Lisboa Bastos ◽

Gamuchirai Tavaziva ◽

Syed Kunal Abidi ◽

Jonathon R Campbell ◽

Louis-Patrick Haraoui ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Symptom Onset ◽

Serological Test ◽

Point Of Care ◽

Meta Analysis ◽

Risk Of Bias ◽

Serological Tests ◽

Immunoglobulin Class

AbstractObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

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Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis

Journal of Clinical Microbiology ◽

10.1128/jcm.01816-15 ◽

2015 ◽

Vol 53 (12) ◽

pp. 3738-3749 ◽

Cited By ~ 87

Author(s):

Caroline Chartrand ◽

Nicolas Tremblay ◽

Christian Renaud ◽

Jesse Papenburg

Keyword(s):

Systematic Review ◽

Respiratory Syncytial Virus ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Reference Standard ◽

Rt Pcr ◽

Test Sensitivity ◽

Subgroup Analyses ◽

Syncytial Virus

Respiratory syncytial virus (RSV) rapid antigen detection tests (RADT) are extensively used in clinical laboratories. We performed a systematic review and meta-analysis to evaluate the accuracy of RADTs for diagnosis of RSV infection and to determine factors associated with accuracy estimates. We searched EMBASE and PubMed for diagnostic-accuracy studies of commercialized RSV RADTs. Studies reporting sensitivity and specificity data compared to a reference standard (reverse transcriptase PCR [RT-PCR], immunofluorescence, or viral culture) were considered. Two reviewers independently extracted data on study characteristics, diagnostic-accuracy estimates, and study quality. Accuracy estimates were pooled using bivariate random-effects regression models. Heterogeneity was investigated with prespecified subgroup analyses. Seventy-one articles met inclusion criteria. Overall, RSV RADT pooled sensitivity and specificity were 80% (95% confidence interval [CI], 76% to 83%) and 97% (95% CI, 96% to 98%), respectively. Positive- and negative-likelihood ratios were 25.5 (95% CI, 18.3 to 35.5) and 0.21 (95% CI, 0.18 to 0.24), respectively. Sensitivity was higher in children (81% [95% CI, 78%, 84%]) than in adults (29% [95% CI, 11% to 48%]). Because of this disparity, further subgroup analyses were restricted to pediatric data (63 studies). Test sensitivity was poorest using RT-PCR as a reference standard and highest using immunofluorescence (74% versus 88%;P< 0.001). Industry-sponsored studies reported significantly higher sensitivity (87% versus 78%;P= 0.01). Our results suggest that the poor sensitivity of RSV RADTs in adults may preclude their use in this population. Furthermore, industry-sponsored studies and those that did not use RT-PCR as a reference standard likely overestimated test sensitivity.

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Diagnostic Accuracy of Confocal Laser Endomicroscopy for the Diagnosis of Oral Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182312390 ◽

2021 ◽

Vol 18 (23) ◽

pp. 12390

Author(s):

Sneha Sethi ◽

Xiangqun Ju ◽

Richard M. Logan ◽

Paul Sambrook ◽

Robert A. McLaughlin ◽

...

Keyword(s):

Systematic Review ◽

Squamous Cell Carcinoma ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

High Sensitivity ◽

Risk Of Bias ◽

Confocal Laser Endomicroscopy ◽

Confocal Laser ◽

Likelihood Ratios

Background: Advances in treatment approaches for patients with oral squamous cell carcinoma (OSCC) have been unsuccessful in preventing frequent recurrences and distant metastases, leading to a poor prognosis. Early detection and prevention enable an improved 5-year survival and better prognosis. Confocal Laser Endomicroscopy (CLE) is a non-invasive imaging instrument that could enable an earlier diagnosis and possibly help in reducing unnecessary invasive surgical procedures. Objective: To present an up to date systematic review and meta-analysis assessing the diagnostic accuracy of CLE in diagnosing OSCC. Materials and Methods. PubMed, Scopus, and Web of Science databases were explored up to 30 June 2021, to collect articles concerning the diagnosis of OSCC through CLE. Screening: data extraction and appraisal was done by two reviewers. The quality of the methodology followed by the studies included in this review was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. A random effects model was used for the meta-analysis. Results: Six studies were included, leading to a total number of 361 lesions in 213 patients. The pooled sensitivity and specificity were 95% (95% CI, 92–97%; I2 = 77.5%) and 93% (95% CI, 90–95%; I2 = 68.6%); the pooled positive likelihood ratios and negative likelihood ratios were 10.85 (95% CI, 5.4–21.7; I2 = 55.9%) and 0.08 (95% CI, 0.03–0.2; I2 = 83.5%); and the pooled diagnostic odds ratio was 174.45 (95% CI, 34.51–881.69; I2 = 73.6%). Although risk of bias and heterogeneity is observed, this study validates that CLE may have a noteworthy clinical influence on the diagnosis of OSCC, through its high sensitivity and specificity. Conclusions: This review indicates an exceptionally high sensitivity and specificity of CLE for diagnosing OSCC. Whilst it is a promising diagnostic instrument, the limited number of existing studies and potential risk of bias of included studies does not allow us to draw firm conclusions. A conclusive inference can be drawn when more studies, possibly with homogeneous methodological approach, are performed.

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Cross-cultural dementia screening using the Rowland Universal Dementia Assessment Scale: a systematic review and meta-analysis

International Psychogeriatrics ◽

10.1017/s1041610220000344 ◽

2020 ◽

Vol 32 (9) ◽

pp. 1031-1044

Author(s):

T. R. Nielsen ◽

Kasper Jørgensen

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Diagnostic Performance ◽

Formal Education ◽

Meta Analysis ◽

Assessment Scale ◽

Screening Instruments ◽

Middle Income ◽

Brief Screening

ABSTRACTObjectives:To quantitatively synthesize data on the accuracy of the Rowland Universal Dementia Assessment Scale (RUDAS) in different sociocultural settings and compare its performance to other brief screening instruments for the detection of dementia.Design:Systematic review and meta-analysis. Literature searches were performed in PubMed, EMBASE, and CINAHL from January 1, 2004 until September 1, 2019.Setting:Community, outpatient clinic, and hospital settings in high-, and low- and middle-income countries.Participants:Twenty-six studies reporting diagnostic accuracy of the RUDAS were included with almost 4000 participants, including approximately 1700 patients with dementia.Measurements:Procedures for translation and cultural adaption of the RUDAS, and influence of demographic variables on diagnostic accuracy, were compared across studies. Bivariate random-effects models were used to pool sensitivity and specificity results, and diagnostic odds-ratios and the area under the hierarchical summary receiver operator characteristic curve were used to present the overall performance.Results:The pooled sensitivity and specificity for the detection of dementia were .82 (95% CI, .78–.86) and .83 (95% CI, .78–.87), respectively, with an area under the curve of .89. Subgroup analyses revealed that the RUDAS had comparable diagnostic performances across high-, and low- and middle-income settings (z = .63, P = .53) and in samples with a lower and higher proportion of participants with no formal education (z = −.15, P = .88). In 11 studies making direct comparison, the diagnostic performance of the RUDAS was comparable to that of the Mini-Mental State Examination (z = −.82, P = .41), with areas under the curve of .88 and .84, respectively.Conclusions:The RUDAS has good diagnostic performance for detecting dementia in different sociocultural settings. Compared to other brief screening instruments, advantages of the RUDAS include its limited bias in people with limited or no formal education and a minimal need for cultural or language adaptation.

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Standard echocardiography versus handheld echocardiography for the detection of subclinical rheumatic heart disease: protocol for a systematic review

BMJ Open ◽

10.1136/bmjopen-2017-020140 ◽

2018 ◽

Vol 8 (2) ◽

pp. e020140 ◽

Cited By ~ 3

Author(s):

Lisa H Telford ◽

Leila H Abdullahi ◽

Eleanor A Ochodo ◽

Liesl J Zühlke ◽

Mark E Engel

Keyword(s):

Systematic Review ◽

Developing Countries ◽

Heart Disease ◽

Diagnostic Accuracy ◽

Rheumatic Heart Disease ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

High Specificity ◽

Asymptomatic Patients ◽

Rheumatic Heart

IntroductionRheumatic heart disease (RHD) is a preventable and treatable chronic condition which persists in many developing countries largely affecting impoverished populations. Handheld echocardiography presents an opportunity to address the need for more cost-effective methods of diagnosing RHD in developing countries, where the disease continues to carry high rates of morbidity and mortality. Preliminary studies have demonstrated moderate sensitivity as well as high specificity and diagnostic odds for detecting RHD in asymptomatic patients. We describe a protocol for a systematic review on the diagnostic performance of handheld echocardiography compared to standard echocardiography using the 2012 World Heart Federation criteria for diagnosing subclinical RHD.Methods and analysisElectronic databases including PubMed, Scopus, Web of Science and EBSCOhost as well as reference lists and citations of relevant articles will be searched from 2012 to date using a predefined strategy incorporating a combination of Medical Subject Heading terms and keywords. The methodological validity and quality of studies deemed eligible for inclusion will be assessed against review specific Quality Assessment of Diagnostic Accuracy Studies 2 criteria and information on metrics of diagnostic accuracy and demographics extracted. Forest plots of sensitivity and specificity as well as scatter plots in receiver operating characteristic (ROC) space will be used to investigate heterogeneity. If possible, a meta-analysis will be conducted to produce summary results of sensitivity and specificity using the Hierarchical Summary ROC method. In addition, a sensitivity analysis will be conducted to investigate the effect of studies with a high risk of bias.Ethics and disseminationEthics approval is not required for this systematic review of previously published literature. The planned review will provide a summary of the diagnostic accuracy of handheld echocardiography. Results may feed into evidence-based guidelines and should the findings of this review warrant a change in clinical practice, a summary report will be disseminated among leading clinicians and healthcare professionals in the field.PROSPERO registration numberCRD42016051261.

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Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-045335 ◽

2020 ◽

Vol 10 (12) ◽

pp. e045335

Author(s):

Chiara Nava ◽

Astrid Modiano Hedenmalm ◽

Franciszek Borys ◽

Lotty Hooft ◽

Matteo Bruschettini ◽

...

Keyword(s):

Systematic Review ◽

Blood Glucose ◽

Diagnostic Accuracy ◽

Preterm Infants ◽

Sensitivity And Specificity ◽

Continuous Glucose Monitoring ◽

Meta Analysis ◽

Glucose Monitoring ◽

Glucose Testing ◽

Logistic Mixed Effects Model

Background and objectivesContinuous glucose monitoring (CGM) could be a valuable instrument for measurement of glucose concentration in preterm neonate. We undertook a systematic review and meta-analysis to compare the diagnostic accuracy of CGM devices to intermittent blood glucose evaluation methods for the detection of hypoglycaemic or hypoglycaemic events in preterm infants.Data sourcesA structured electronic database search was performed for studies that assessed the accuracy of CGM against any intermittent blood glucose testing methods in detecting episodes of altered glycaemia in preterm infants. No restrictions were used. Three review authors screened records and included studies.Data extractionRisk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. From individual patient data (IPD), sensitivity and specificity were determined using predefined thresholds. The mean absolute relative difference (MARD) of the studied CGM devices was assessed and if those satisfied the accuracy requirements (EN ISO 15197). IPD datasets were meta-analysed using a logistic mixed-effects model. A bivariate model was used to estimate the summary receiver operating characteristic curve (ROC) curve and extract the area under the curve (AUC). The overall level of certainty of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.ResultsAmong 4481 records, 11 were included. IPD datasets were obtained for five studies. Only two of the studies showed an MARD lower than 10%, with none of the five CGM devices studied satisfying the European Union (EU) ISO 15197 requirements. Pooled sensitivity and specificity of CGM devices for hypoglycaemia were 0.39 and 0.99, whereas for hyperglycaemia were 0.87 and 0.99, respectively. The AUC was 0.70 and 0.86, respectively. The certainty of the evidence was considered as low to moderate. Limitations primarily related to the lack of representative population, reference standard and CGM device.ConclusionsCGM devices demonstrated low sensitivity for detecting hypoglycaemia in preterm infants, however, provided high accuracy for detection of hyperglycaemia.PROSPERO registration numberCRD42020152248.

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