Comparison of Early-Onset Sepsis Risk-Stratification Algorithms in Neonates in a Kenyan Nursery.

BACKGROUND AND OBJECTIVES: Risk stratification algorithms (RSAs) can reduce antibiotic duration (AD) and length of stay (LOS) for early-onset sepsis (EOS). Because of higher EOS and antibiotic resistance rates and limited laboratory capacity, RSA implementation may benefit low- and middle-income countries (LMIC). Our objective was to compare the impact of 4 RSAs on AD and LOS in an LMIC nursery. METHODS: Neonates <5 days of age admitted for presumed sepsis to a Kenyan referral hospital in 2019 (n = 262) were evaluated by using 4 RSAs, including the current local sepsis protocol ("local RSA"), a simplified local protocol ("simple RSA"), an existing categorical RSA that uses infant clinical examination and maternal risk factors (CE-M RSA) clinical assessment, and the World Health Organization's Integrated Management of Childhood Illness guideline. For each RSA, a neonate was classified as at high, moderate, or low EOS risk. We used к coefficients to evaluate the agreement between RSAs and McNemar's test for the direction of disagreement. We used the Wilcoxon rank test for differences in observed and predicted median AD and LOS. RESULTS: Local and simple RSAs overestimated EOS risk compared with CE-M RSA and the Integrated Management of Childhood Illness guideline. Compared with the observed value, CE-M RSA shortened AD by 2 days and simple RSA lengthened AD by 2 days. LOS was shortened by 4 days by using CE-M RSA and by 2 days by using the local RSA. CONCLUSIONS: The local RSA overestimated EOS risk compared with CE-M RSA. If implemented fully, the local RSA may reduce LOS. Future studies will evaluate the prospective use of RSAs in LMICs with other interventions such as observation off antibiotics, biomarkers, and bundled implementation.

Screening tests for gestational diabetes: a systematic review for the U.S. Preventive Services Task Force.

BACKGROUND: A 50-g oral glucose challenge test (OGCT) is a widely accepted screening method for gestational diabetes mellitus (GDM), but other options are being considered. PURPOSE: To systematically review the test characteristics of various screening methods for GDM across a range of recommended diagnostic glucose thresholds. DATA SOURCES: 15 electronic databases from 1995 to May 2012, reference lists, Web sites of relevant organizations, and gray literature. STUDY SELECTION: Two reviewers independently identified English-language prospective studies that compared any screening test for GDM with any reference standard. DATA EXTRACTION: One reviewer extracted and a second reviewer verified data from 51 cohort studies. Two reviewers independently assessed methodological quality. DATA SYNTHESIS: The sensitivity, specificity, and positive and negative likelihood ratios for the OGCT at a threshold of 7.8 mmol/L (140 mg/dL) were 70% to 88%, 69% to 89%, 2.6 to 6.5, and 0.16 to 0.33, respectively. At a threshold of 7.2 mmol/L (130 mg/dL), the test characteristics were 88% to 99%, 66% to 77%, 2.7 to 4.2, and 0.02 to 0.14, respectively. For a fasting plasma glucose threshold of 4.7 mmol/L (85 mg/dL), they were 87%, 52%, 1.8, and 0.25, respectively. Glycated hemoglobin level had poorer test characteristics than fasting plasma glucose level or the OGCT. No studies compared the OGCT with International Association of the Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria. LIMITATIONS: The lack of a gold standard for confirming GDM limits comparisons. Few data exist for screening tests before 24 weeks' gestation. CONCLUSION: The OGCT and fasting plasma glucose level (at a threshold of 4.7 mmol/L [85 mg/dL]) by 24 weeks' gestation are good at identifying women who do not have GDM. The OGCT is better at identifying women who have GDM. The OGCT has not been validated for the IADPSG diagnostic criteria.

Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research.

BACKGROUND: Outcomes of treating gestational diabetes mellitus (GDM) are not well-established. PURPOSE: To summarize evidence about the maternal and neonatal benefits and harms of treating GDM. DATA SOURCES: 15 electronic databases from 1995 to May 2012, gray literature, Web sites of relevant organizations, trial registries, and reference lists. STUDY SELECTION: English-language randomized, controlled trials (n = 5) and cohort studies (n = 6) of women without known preexisting diabetes. DATA EXTRACTION: One reviewer extracted data, and a second reviewer verified them. Two reviewers independently assessed methodological quality and evaluated strength of evidence for primary outcomes by using a Grading of Recommendations Assessment, Development and Evaluation approach. DATA SYNTHESIS: All studies compared diet modification, glucose monitoring, and insulin as needed with no treatment. Women who were treated had more prenatal visits than those in control groups. Moderate evidence showed fewer cases of preeclampsia, shoulder dystocia, and macrosomia in the treated group. Evidence was insufficient for maternal weight gain and birth injury. Low evidence showed no difference between groups for neonatal hypoglycemia. Evidence was insufficient for long-term metabolic outcomes among offspring. No difference was found for cesarean delivery (low evidence), induction of labor (insufficient evidence), small-for-gestational-age neonates (moderate evidence), or admission to a neonatal intensive care unit (low evidence). LIMITATIONS: Evidence is low or insufficient for many outcomes of greatest clinical importance. The strongest evidence supports reductions in intermediate outcomes; however, other factors (for example, maternal weight and gestational weight gain) may impart greater risk than GDM, particularly when glucose levels are modestly elevated. CONCLUSION: Treating GDM results in less preeclampsia, shoulder dystocia, and macrosomia; however, current evidence does not show an effect on neonatal hypoglycemia or future poor metabolic outcomes. There is little evidence of short-term harm of treating GDM other than an increased demand for services.

Screening and diagnosing gestational diabetes mellitus.

BACKGROUND: There is uncertainty as to the optimal approach for screening and diagnosis of gestational diabetes mellitus (GDM). Based on systematic reviews published in 2003 and 2008, the U.S. Preventive Services Task Force concluded that there was insufficient evidence upon which to make a recommendation regarding routine screening of all pregnant women. OBJECTIVES: (1) Identify properties of screening tests for GDM, (2) evaluate benefits and harms of screening for GDM, (3) assess the effects of different screening and diagnostic thresholds on outcomes for mothers and their offspring, and (4) determine the benefits and harms of treatment for a diagnosis of GDM. DATA SOURCES: We searched 15 electronic databases from 1995 to May 2012, including MEDLINE and Cochrane Central Register of Controlled Trials (which contains the Cochrane Pregnancy and Childbirth Group registry); gray literature; Web sites of relevant organizations; trial registries; and reference lists. METHODS: Two reviewers independently conducted study selection and quality assessment. One reviewer extracted data, and a second reviewer verified the data. We included published randomized and nonrandomized controlled trials and prospective and retrospective cohort studies that compared any screening or diagnostic test with any other screening or diagnostic test; any screening with no screening; women who met various thresholds for GDM with those who did not meet various criteria, where women in both groups did not receive treatment; any treatment for GDM with no treatment. We conducted a descriptive analysis for all studies and meta-analyses when appropriate. Key outcomes included preeclampsia, maternal weight gain, birth injury, shoulder dystocia, neonatal hypoglycemia, macrosomia, and long-term metabolic outcomes for the child and mother. RESULTS: The search identified 14,398 citations and included 97 studies (6 randomized controlled trials, 63 prospective cohort studies, and 28 retrospective cohort studies). Prevalence of GDM varied across studies and diagnostic criteria: American Diabetes Association (75 g) 2 to 19 percent; Carpenter and Coustan 3.6 to 38 percent; National Diabetes Data Group 1.4 to 50 percent; and World Health Organization 2 to 24.5 percent. Lack of a gold standard for the diagnosis of GDM and little evidence about the accuracy of screening strategies for GDM remain problematic. The 50 g oral glucose challenge test with a glucose threshold of 130 mg/dL versus 140 mg/dL improves sensitivity and reduces specificity. Both thresholds have high negative predictive values (NPV) but variable positive predictive values (PPVs) across a range of prevalence. There was limited evidence for the screening of GDM diagnosed less than 24 weeks' gestation (three studies). One study compared the International Association of Diabetes in Pregnancy Study Groups' (IADPSG) diagnostic criteria with a two-step strategy. Sensitivity was 82 percent, specificity was 94 percent. Only two studies examined the effects on health outcomes from screening for GDM. One retrospective cohort study (n=1,000) showed more cesarean deliveries in the screened group. A survey within a prospective cohort study (n=93) found the same incidence of macrosomia (≥4.3 kg) in screened and unscreened groups (7 percent each group). Thirty-eight studies examined health outcomes for women who met different criteria for GDM and did not undergo treatment. Methodologically strong studies showed a continuous positive relationship between increasing glucose levels and the incidence of primary cesarean section and macrosomia. One of these studies also found significantly fewer cases of preeclampsia, cesarean section, shoulder dystocia and/or birth injury, clinical neonatal hypoglycemia, and hyperbilirubinemia for women without GDM compared with those meeting IADPSG criteria. Among the other studies, fewer cases of preeclampsia were observed for women with no GDM and women who were false positive versus those meeting Carpenter and Coustan criteria. For maternal weight gain, few comparisons showed differences. For fetal birth trauma, single studies showed no differences for women with Carpenter and Coustan GDM and World Health Organization impaired glucose tolerance versus women without GDM. Women diagnosed based on National Diabetes Data Group GDM had more fetal birth trauma compared with women without GDM. Fewer cases of macrosomia were seen in the group without GDM compared with Carpenter and Coustan GDM, Carpenter and Coustan 1 abnormal oral glucose tolerance test, National Diabetes Data Group GDM, National Diabetes Data Group false positives, and World Health Organization impaired glucose tolerance. Fewer cases of neonatal hypoglycemia were found among patient groups without GDM compared with those meeting Carpenter and Coustan criteria. There was more childhood obesity for Carpenter and Coustan GDM versus patient groups with no GDM. Eleven studies compared diet modification, glucose monitoring, and insulin as needed with no treatment. Moderate evidence showed fewer cases of preeclampsia in the treated group. The evidence was insufficient for maternal weight gain and birth injury. Moderate evidence found less shoulder dystocia with treatment for GDM. Low evidence showed no difference for neonatal hypoglycemia between treated and untreated GDM. Moderate evidence showed benefits of treatment for reduction of macrosomia (>4,000 g). There was insufficient evidence for long-term metabolic outcomes among offspring. Five studies provided data on harms of treating GDM. No difference was found for cesarean delivery, induction of labor, small for gestational age, or admission to a neonatal intensive care unit. There were significantly more prenatal visits among those treated. CONCLUSIONS: While evidence supports a positive association with increasing plasma glucose on a 75 g or 100 g oral glucose tolerance test and macrosomia and primary cesarean section, clear thresholds for increased risk were not found. The 50 g oral glucose challenge test has high NPV but variable PPV. Treatment of GDM results in less preeclampsia and macrosomia. Current evidence does not show that treatment of GDM has an effect on neonatal hypoglycemia or future poor metabolic outcomes. There is little evidence of short-term harm from treating GDM other than an increased demand for services. Research is needed on the long-term metabolic outcome for offspring as a result of GDM and its treatment, and the "real world" effects of GDM treatment on use of care.