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.
Objective: To investigate if Cochrane reviews that assess screening interventions address their major harms. Study design and setting: A systematic search for Cochrane reviews that assess screening interventions was performed. Two authors independently screened abstracts, assessed full-texts, and extracted data from included reviews. For each review, two authors judged whether each predefined harm was relevant. When the harm was judged as of questionable relevance, the review was excluded from the denominator in our calculations. Results: Forty-seven reviews were included. Overdiagnosis was addressed in 6 of 39 (15%), overtreatment in 7 of 43 (16%), and psychosocial consequences in 30 of 47 (64%) of reviews where this was judged relevant. When data on harms were included, they were generally not treated with the same methodological rigor as the benefits, with no assessment of the risk of bias or certainty of the evidence. About half of the Abstracts, Plain Language Summaries, and Summary of Findings tables did not include any harms. Conclusion: The underreporting of harms of screening in Cochrane reviews likely reflects primary research and is problematic. We call for broad collaboration to develop reporting guidelines and core outcome sets for studies of screening interventions.
http://www.diva-portal.org This is the published version of a paper published in Cochrane Database of Systematic Reviews.
http://www.diva-portal.org This is the published version of a paper published in Cochrane Database of Systematic Reviews.
http://www.diva-portal.org This is the published version of a paper published in Cochrane Database of Systematic Reviews.
Aim:We reviewed the literature on cooling methods during transport of newborn infants with hypoxic-ischaemic encephalopathy (HIE) born in a non-tertiary centre and transferred to a neonatal intensive care unit for therapeutic hypothermia. Methods:The electronic databases CENTRAL, MEDLINE, Embase, CINAHL, and Scopus were searched from inception up to 8 March 2022 for studies comparing cooling versus no cooling, active versus passive cooling, and servo-controlled versus non-servo-controlled cooling. Odds ratio and confidence of interval were calculated for dichotomous outcomes and mean difference and confidence interval for continuous outcomes. Results:The final analysis included 14 studies, 1 randomised and 13 non-randomised, involving 1098 newborn infants. Compared with the other cooling methods, servocontrolled active cooling was more likely to maintain body temperature within the target range of 33°C-34°C on arrival at a neonatal intensive care unit: odds ratio 13.58, 95% confidence interval 4.32-42.66, risk difference 0.33, 95% confidence interval 0.19-0.46; 224 participants; three studies; I 2 0%. The certainty of evidence was low. Only five studies reported mortality rates. Conclusion:Servo-controlled active cooling may be the preferred method during transport of newborn infants with HIE. A future area of focus should be long-term neurodevelopmental outcomes after servo-controlled active cooling.
Background Very preterm infants are at high risk of developing chronic lung disease, which requires respiratory support and might have long-term sequelae. As lung inflammation plays an important role in pathogenesis, antileukotrienes have been explored in both clinical and animal studies. We aimed to assess the benefits and harms of antileukotrienes for the prevention and treatment of respiratory morbidity and mortality in very preterm newborns. Methods In this systematic review, we included randomized trials and non-randomized studies in humans and animals reporting the effects of antileukotrienes in very preterm infants or other mammals within 10 days of birth. Our pre-specified primary outcomes were all-cause mortality and any harm, and, for the clinical studies, incidence of chronic lung disease. Included studies underwent risk of bias-assessment and data extraction performed by two authors independently. There were no language restrictions. Results Fifteen studies totally met our inclusion criteria: one randomized trial and four non-randomized studies in humans and 10 animal studies (five in rodents, two in lambs and one in either guinea pigs, rabbits or caprinae). All five clinical studies used montelukast and had a small sample size, ranging from 4 to 77 infants. The randomized trial (n = 60) found no difference in the incidence of chronic lung disease between the groups. Only one clinical study, which enrolled four very preterm infants and had a critical overall risk of bias, reported long-term outcomes. All other studies had unclear or greater overall risk of bias and meta-analyses were therefore deemed unfeasible. Eight of ten animal studies used leukotriene receptor antagonists as antileukotriene (montelukast in three of ten studies) and seven had an experimental study design (i.e. some animals were not exposed to antileukotrienes but no randomization). Three of the ten animal studies assessed different doses. Animal studies found no effect on the outcomes mortality, growth, or lung function related surrogate outcomes. Conclusions Use of antileukotrienes in very preterm infants to prevent or treat chronic lung disease is not supported by the available evidence. Large randomized trials focusing on outcomes relevant to patients, including long-term outcomes, are needed. Studies should also minimize risk of bias.
Background and objectives Continuous 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 sources A 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 extraction Risk 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. Results Among 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. Conclusions CGM devices demonstrated low sensitivity for detecting hypoglycaemia in preterm infants, however, provided high accuracy for detection of hyperglycaemia. PROSPERO registration number CRD42020152248.
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