Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden: A stepped wedge cluster randomised trial.

BACKGROUND: The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes. METHODS AND FINDINGS: A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations. CONCLUSIONS: In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term. TRIAL REGISTRATION: The trial is registered with ISRCTN (41918550).

Swedish guidelines for type 1 diabetes and pregnancy outcomes: A nationwide descriptive study of consensus and adherence.

AIMS: Type 1 diabetes (DM1) during pregnancy and labor is associated with an increased risk of maternal and fetal complications. Evidence-based care is therefore provided in accordance with guidelines. In this study, we aimed to compare all the Swedish guidelines for DM1 during pregnancy and labor in terms of the variables emphasized in the national guidelines from the US and from England and Wales. The second aim was to measure adherence to local guidelines at the four hospitals in Stockholm that cared for pregnant women with DM1 during 2016 and to describe the pregnancy and labor outcomes. METHODS: All the Swedish guidelines for DM1 during pregnancy and labor were reviewed on 31 variables. The medical records of 114 women were reviewed according to whether ≥70% of 22 variables in the guidelines were followed. RESULTS: No consensus was found in the Swedish guidelines for any of the 31 variables. Some guidelines were contradictory. The pregnancy guidelines were followed in 17.5% of the medical records, 18.4% followed the labor guidelines, and 5.3% followed both guidelines. The onset of labor, mode of delivery and HbA1c in the third trimester varied significantly, depending on the adherence to guidelines. CONCLUSIONS: The Swedish guidelines for DM1 during pregnancy and labor lack both consensus and adherence. A national guideline on DM1 during pregnancy and childbirth with high adherence could improve care for pregnant Swedish women with DM1 and their fetuses.

Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol.

BACKGROUND: The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden ( www.cdc4g.se/en ) is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. METHODS: This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. DISCUSSION: The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child. TRIAL REGISTRATION: CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).

Deliberate self-harm patients in the emergency department: factors associated with repeated self-harm among 1524 patients.

OBJECTIVES: (1) investigate risk factors associated with repeated deliberate self-harm (DSH) among patients attending the emergency department due to DSH, (2) stratify these patients into risk categories for repeated DSH and (3) estimate the proportion of repeated DSH within 12 months. DESIGN: A consecutive series of individuals who attended one of Scandinavia's largest emergency departments during 2003-2005 due to DSH. Data on sociodemographic factors, diagnoses and treatment, previous DSH at any healthcare facility in Sweden (2002-2005) and circumstances of the index DSH episode were collected from hospital charts and national databases. A nationwide register based on follow-ups of any new DSH or death by suicide during 2003-2006. MAIN OUTCOME MEASURE: Repeated DSH episode or suicide. RESULTS: 1524 patients were included. The cumulative incidence for patients repeating DSH within 12 months after the index episode was 26.8% (95% CI: 24.6 to 29.0). Risk factors associated with repeating DSH included previous DSH, female gender, self-injury as a method for DSH and if the self-injury required a surgical procedure, current psychiatric or antidepressant treatment and if the patient suffered from a substance use disorder or adult personality disorder or did not have children under the age of six. CONCLUSION: Patients attending an emergency department due to DSH have a high risk of repeating their self-harm behaviour. We present a model for risk stratification for repeated DSH describing low-risk (18%), median-risk (28% to 32%) and high-risk (47% to 72%). Our results might help caretakers to direct optimal resources to these groups.

Influence of cigarette smoking on melatonin levels in man.

OBJECTIVE: Polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450(CYP)1A2, which is involved in the hepatic metabolism of melatonin (MT). This suggests that habitual smokers may have low serum MT levels during smoking compared with a non-smoking period. We decided to investigate whether this suggestion is correct. METHODS: Eight habitual smokers were tested on two occasions. They had smoked prior to the first occasion but had not smoked for 7 days prior to the second. Each test was divided into two parts. The first part spanned the night between 2000 hours and 0800 hours. Venous blood samples were collected every second hour during this period for analysis of endogenous serum MT. The second part was performed the subsequent day. At 0930 hours, 25 mg MT was ingested orally, and blood samples for exogenous serum MT analysis were collected every hour between 1000 hours and 1600 hours. Endogenous and exogenous areas under the serum MT-time curve (MT-AUCs) were calculated. RESULTS: Endogenous serum MT-AUCs were similar during the two periods. Oral administration of MT induced supraphysiological levels of serum MT. Moreover, exogenous serum MT-AUCs were significantly smaller before than after smoking abstinence (7.34+/-1.85 versus 21.07+/-7.28 nmol/lxh; P<0.02; means+/-SEM). CONCLUSION: This investigation shows that exogenous, but not endogenous (at night), serum MT levels are influenced by cigarette smoking. When the MT levels are low, the influence of CYP1A2 levels appears to be less pronounced than when they are high, and the enzyme capacity hugely utilized. These findings implicate that interactions between exogenous MT, and substrates metabolized by CYP1A2, may differ in individuals before and after smoking abstinence.