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).

Changes in Sex Related Mortality after Revascularisation for Chronic Limb Threatening Ischaemia: A National Observational Study 1994 - 2018.

OBJECTIVE: The aim of this study was to compare all cause mortality across three time periods with a focus on sex differences after revascularisation for chronic limb threatening ischaemia between 1994 and 2013 in Sweden. METHODS: In this observational registry study, patients registered in the Swedish vascular registry (Swedvasc), revascularised between 1994 and 2013 with open or endovascular infra-inguinal procedures, were divided into three time periods: 1994 - 1999, 2000 - 2006, and 2007 - 2013. Patients were followed for five years. Poisson regression was used to compare 30 day mortality, presented as adjusted relative risk ratio (aRR). Adjusted restricted mean survival time (aRMST) differences at five years were compared with a generalised linear model. The analyses were adjusted for age, comorbidities, and endovascular or open surgery. Comparison with the general Swedish population was also conducted with age adjusted standardised mortality ratios. Results are presented with the 95% confidence interval (CI). RESULTS: The study showed increasing 30 day mortality, with an aRR of 1.47 (95% CI 1.31 - 1.65) for women and aRR of 1.20 (95% CI 1.06 - 1.35) for men, per time period. In women, the five year RMST decreased from the first to the third period, with an aRMST of -45 (95% CI -59 - -32) days per period. In men, the aRMST increased 32 (95% CI 18 - 47) days per period. When comparing sexes, women showed lower 30 day mortality and higher five year survival than men in the first time period, but a significantly worse development over time periods than for men. Corresponding findings were observed in comparison with the general Swedish population. CONCLUSION: This study showed an increased 30 day mortality in women and men across the periods, most evident in women. Men showed an increased five year survival across the periods, whereas opposite findings were recorded for women. The dismal trend over time for women could not be explained by increased age or a higher prevalence of comorbidities.

Immediate mobilization in post-anesthesia care unit does not increase overall postoperative physical activity after elective colorectal surgery: A randomized, double-blinded controlled trial within an enhanced recovery protocol.

BACKGROUND: The level of post-operative mobilization according to Enhanced Recovery After Surgery (ERAS) guidelines is not always achieved. We investigated whether immediate mobilization increases postoperative physical activity. The objective was to evaluate the effects of immediate postoperative mobilization in the post-anesthesia care unit (PACU) compared to standard care. METHODS: This randomized controlled trial, involved 144 patients, age ≥18 years, undergoing elective colorectal surgery. Patients were randomized to mobilization starting 30 min after arrival in the PACU, or to standard care. Standard care consisted of mobilization a few hours later at the ward according to ERAS guidelines. The primary outcome was physical activity, in terms of number of steps, measured with an accelerometer during postoperative days (PODs) 1-3. Secondary outcomes were physical capacity, functional mobility, time to readiness for discharge, complications, compliance with the ERAS protocol, and physical activity 1 month after surgery. RESULTS: With the intention-to-treat analysis of 144 participants (median age 71, 58% female) 47% underwent laparoscopic-or robotic-assisted surgery. No differences in physical activity during hospital stay were found between the participants in the intervention group compared to the standard care group (adjusted mean ratio 0.97 on POD 1 [95% CI, 0.75-1.27], p = 0.84; 0.89 on POD 2 [95% CI, 0.68-1.16], p = 0.39, and 0.90 on POD 3 [95% CI, 0.69-1.17], p = 0.44); no differences were found in any of the other outcome measures. CONCLUSIONS: Addition of the intervention of immediate mobilization to standard care did not make the patients more physically active during their hospital stay. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC 03357497.

Previous pre-eclampsia, gestational diabetes mellitus and the risk of cardiovascular disease: A nested case-control study in Sweden.

OBJECTIVE: Pre-eclampsia and gestational diabetes mellitus (GDM) are two common pregnancy complications that affect birth outcomes and are associated with a long-term risk of cardiovascular disease (CVD). The aims of this study were to investigate if the pre-eclampsia association with CVD is independent of GDM and modified by body mass index (BMI) or GDM. DESIGN: Case-control study. SETTING: Sweden. POPULATION: Cases were women with a first CVD event between 1991 and 2008 and a previous pregnancy who were matched with controls without CVD (1:5) by year of birth, age and region of birth. METHODS: Conditional logistic regression was used to evaluate the associations of GDM, pre-eclampsia and maternal BMI with CVD adjusted for potential confounders and effect modifications with interaction tests. MAIN OUTCOME MEASURES: CVD. RESULTS: There were 2639 cases and 13 310 controls with complete data. Pre-eclampsia and GDM were independent risk factors for CVD (adjusted odds ratio [aOR] 2.59, 95% CI 2.12-3.17 and aOR 1.47, 95% CI 1.04-2.09, respectively). After stratifying by maternal BMI, the adjusted association of pre-eclampsia with CVD did not differ notably between BMI groups: normal weight (aOR 2.65, 95% CI 1.90-3.69), overweight (aOR 2.67, 95% CI 1.52-4.68) and obesity (aOR 3.03, 95% CI 0.74-12.4). Similar findings were seen when stratifying on GDM/non-GDM. CONCLUSIONS: Pre-eclampsia and GDM are independent risk factors for later CVD and having both during pregnancy is a major risk factor for later CVD. The association between pre-eclampsia and CVD is not modified by BMI. Effective CVD preventive programs for high-risk women are urgently needed in order to improve women's long-term health.

Balloon dilatation is superior to CO2 laser excision in the treatment of subglottic stenosis.

INTRODUCTION: Endoscopic treatment of subglottic stenosis (SGS) is regarded as a safe procedure with rare complications and less morbidity than open surgery yet related with a high risk of recurrence. The abundance of techniques and adjuvant therapies complicates a comparison of the different surgical approaches. The primary aim of this study was to investigate disease recurrence after CO2 laser excisions and balloon dilatation in patients with SGS and to identify potential confounding factors. MATERIALS AND METHODS: In a tertiary referral center, two cohorts of previously undiagnosed patients treated for SGS were retrospectively reviewed and followed for 3 years. The CO2 laser cohort (CLC) was recruited between 2006 and 2011, and the balloon dilatation cohort (BDC) between 2014 and 2019. Kaplan‒Meier and multivariable Cox regression analyzed time to repeated surgery and estimated hazard ratios (HRs) for different variables. RESULTS: Nineteen patients were included in the CLC, and 31 in the BDC. The 1-year cumulative recurrence risk was 63.2% for the CLC compared with 12.9% for the BDC (HR 33.0, 95% CI 6.57-166, p < 0.001), and the 3-year recurrence risk was 73.7% for the CLC compared with 51.6% for the BDC (HR 8.02, 95% CI 2.39-26.9, p < 0.001). Recurrence was independently associated with overweight (HR 3.45, 95% CI 1.16-10.19, p = 0.025), obesity (HR 7.11, 95% CI 2.19-23.04, p = 0.001), and younger age at diagnosis (HR 8.18, 95% CI 1.43-46.82, p = 0.018). CONCLUSION: CO2 laser treatment is associated with an elevated risk for recurrence of SGS compared with balloon dilatation. Other risk factors include overweight, obesity, and a younger age at diagnosis.

Three-dimensional comparison of tooth-borne and tooth-bone-borne RME appliances: a randomized controlled trial with 5-year follow-up.

OBJECTIVES: To compare the long-term skeletal effects of tooth-borne (TB) and tooth-bone-borne (TBB) rapid maxillary expansion in growing children, using 3D imaging. MATERIALS AND METHODS: In total, 52 consecutive patients who met the eligibility criteria were recruited and allocated to either the TB group, mean age 9.3 years (SD 1.3), or the TBB group, mean age 9.5 years (SD 1.2). Cone-beam computed tomography records and plaster models were taken before (T0), directly after (T1), 1 year after (T2), and 5 years after expansion (T3). RANDOMIZATION: Participants were randomly allocated in blocks of different sizes, using the concealed allocation principle in a 1:1 ratio. The randomization list was also stratified by sex to ensure homogeneity between groups. BLINDING: Due to clinical limitations, only the outcome assessors were blinded to the groups to which the patients were allocated. RESULTS: At T1, the midpalatal suture at its anterior part showed a statistically significant difference between the groups with a mean of 0.6 mm (CI 0.2-1.1) more expansion in the TBB group (P < 0.01). This difference was also more evident in boys at T1 with a mean of 0.8 mm (CI 0.2-1.4) (P < 0.01). These differences, however, blotted out at T2 and T3. The nasal width also showed similar differences between the groups, with a significantly larger expansion in the TBB group by a mean of 0.7 mm (CI 0.1-1.4) (P = 0.03). This group difference in favour of the TBB group was maintained at T2 (1.6 mm) and T3 (2.1 mm) (P < 0.01 T2 and T3, respectively). CONCLUSIONS: Skeletal expansion in the midpalatal suture was significantly higher in the TBB group; however, the magnitude of this expansion was around 0.6 mm more and may not be clinically significant. Skeletal expansion at the level of the nasal cavity was significantly higher in the TBB group. There were no differences between boys and girls with regard to skeletal expansion. TRIAL REGISTRATION: This trial was not registered on any external sites.

Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial.

BACKGROUND: Quad Helix (QH) is the appliance most preferred by orthodontists to correct unilateral posterior crossbite in the early mixed dentition while other orthodontists suggest rapid maxillary expansion (RME) on deciduous teeth in these patients. OBJECTIVES: To evaluate and compare perceived pain intensity, discomfort, functional jaw impairment, and analgesic consumption during the first week of treatment with either RME or QH appliances. TRIAL DESIGN: Two-arm parallel group, two-centre, randomized controlled trial. MATERIAL AND METHODS: Seventy-two patients, mean age 9.5 (SD ±0.8) years, with unilateral posterior crossbite requiring maxillary expansion were randomly allocated to either the RME (22 boys, 14 girls) or QH (22 boys, 14 girls) group. Validated questionnaires were used to assess pain intensity, discomfort, jaw function impairment, and analgesic consumption, on the first, fourth, and seventh days after appliance insertion and activation. BLINDING: Due to clinical limitations, only the outcome assessors were blinded to the groups to which the patients were allocated. RESULTS: Seventy patients completed the questionnaires. Pain from the tongue and chafe from the appliance were significantly higher in the QH group on the first day of treatment (P = 0.003 and P = 0.000, respectively). On the fourth day, the chafe from the appliance was still significantly higher in the QH group (P = 0.007). Speech was affected in both groups on day 1; this impairment continued and was significantly higher in the RME group days 4 and 7. No significant difference in analgesic consumption was found between the groups at any time. The analgesic consumption was highest at day 1 of treatment. HARMS: No harm was observed in any patient. LIMITATIONS: Double blinding was not possible due to the clinical limitations. CONCLUSION: During the initial 4 days of treatment, pain from the tongue and chafe from the appliance caused the most reported inconvenience in the patients in the QH group. A majority of reported visual analogue scale values were in the lower mid-range, suggesting low to moderate pain and discomfort in both groups. CLINICAL TRIAL REGISTRATION: NCT04458506.

Factors associated with failed epidural blood patch after accidental dural puncture in obstetrics: a prospective, multicentre, international cohort study.

BACKGROUND: Epidural blood patch is commonly used for management of post-dural puncture headache after accidental dural puncture. The primary aim was to determine factors associated with failed epidural blood patch. METHODS: In this prospective, multicentre, international cohort study, parturients ≥18 yr receiving an epidural blood patch for treatment of post-dural puncture headache were included. Failed epidural blood patch was defined as headache intensity numeric rating scale (NRS) score ≥7 in the upright position at 4, 24, or 48 h, or the need for a second epidural blood patch, and complete success by NRS=0 at 0-48 h after epidural blood patch. All others were considered partial success. Multinominal logistic regression was used for statistical analyses with P<0.01 considered statistically significant. RESULTS: In all, 643 women received an epidural blood patch. Complete data to classify failure were available in 591 (91.9%) women. Failed epidural blood patch occurred in 167 (28.3%) patients; 195 (33.0%) were completely successful and 229 (38.7%) partially successful. A total of 126 women (19.8%) received a second epidural blood patch. A statistically significant association with failure was observed in patients with a history of migraine, when the accidental dural puncture occurred between lumbar levels L1/L3 compared with L3/L5 and when epidural blood patch was performed <48 h compared with ≥48 h after accidental dural puncture. In patients having radiological investigations, three intracranial bleeds were diagnosed. CONCLUSIONS: Failed epidural blood patch occurred in 28.3% of women. Independent modifiable factors associated with failure were higher lumbar level of accidental dural puncture and short interval between accidental dural puncture and epidural blood patch. A history of migraine was associated with a higher risk of second epidural blood patch. CLINICAL TRIAL REGISTRATION: NCT02362828.

Effects of remifentanil on pharyngeal swallowing and esophageal motility: no impact of different bolus volumes and partial antagonism by methylnaltrexone.

Remifentanil impairs swallowing, and disturbed accommodation to bolus volume may be one of the underlying causes. It is not fully understood whether remifentanil-induced swallowing dysfunction is mediated by peripheral or central mechanisms. So, this study aimed to investigate if remifentanil-induced swallowing dysfunction is dependent on the bolus volume and whether the effect of remifentanil could be counteracted by methylnaltrexone, a peripherally acting opioid antagonist. Nineteen healthy volunteers were included in this double-blinded, randomized, placebo-controlled, crossover study. Study participants received target-controlled remifentanil infusions and placebo infusions in a randomized order. Methylnaltrexone was administered by intravenous injection of doses of 0.3 mg/kg. Recordings of pressure and impedance data were acquired using a combined manometry and impedance solid-state catheter. Data were analyzed from three series of bolus swallows, baseline, during study medication exposure, and 15 min after methylnaltrexone. Remifentanil induced significant effects on multiple pharyngeal and esophageal function parameters. No significant differences in remifentanil-induced swallowing dysfunction related to different bolus volumes were found. Pharyngeal effects of remifentanil were not significantly counteracted by methylnaltrexone, whereas on the distal esophageal level, effects on distension pressures were counteracted. Changes in pharyngeal and esophageal pressure flow variables were consistent with previous results on remifentanil-induced swallowing dysfunction and uniform across all bolus volumes. The effects of remifentanil on the pharyngeal level and on the proximal esophagus appear to be predominantly centrally mediated, whereas the effects of remifentanil on the distal esophagus may be mediated by both central and peripheral mechanisms.NEW & NOTEWORTHY In this randomized controlled trial, we used the "Swallow Gateway" online platform to analyze the effects of remifentanil on pharyngeal and esophageal swallowing. It is not fully understood whether remifentanil-induced swallowing dysfunction is mediated by peripheral or central mechanisms. By using methylnaltrexone, we demonstrated that effects of remifentanil on pharyngeal swallowing were predominantly centrally mediated, whereas its effects on the distal esophagus may be mediated by both central and peripheral mechanisms.

Comparison between epidural and intravenous analgesia effects on disease-free survival after colorectal cancer surgery: a randomised multicentre controlled trial.

BACKGROUND: Thoracic epidural analgesia (TEA) has been suggested to improve survival after curative surgery for colorectal cancer compared with systemic opioid analgesia. The evidence, exclusively based on retrospective studies, is contradictory. METHODS: In this prospective, multicentre study, patients scheduled for elective colorectal cancer surgery between June 2011 and May 2017 were randomised to TEA or patient-controlled i.v. analgesia (PCA) with morphine. The primary endpoint was disease-free survival at 5 yr after surgery. Secondary outcomes were postoperative pain, complications, length of stay (LOS) at the hospital, and first return to intended oncologic therapy (RIOT). RESULTS: We enrolled 221 (110 TEA and 111 PCA) patients in the study, and 180 (89 TEA and 91 PCA) were included in the primary outcome. Disease-free survival at 5 yr was 76% in the TEA group and 69% in the PCA group; unadjusted hazard ratio (HR): 1.31 (95% confidence interval [CI]: 0.74-2.32), P=0.35; adjusted HR: 1.19 (95% CI: 0.61-2.31), P=0.61. Patients in the TEA group had significantly better pain relief during the first 24 h, but not thereafter, in open and minimally invasive procedures. There were no differences in postoperative complications, LOS, or RIOT between the groups. CONCLUSIONS: There was no significant difference between the TEA and PCA groups in disease-free survival at 5 yr in patients undergoing surgery for colorectal cancer. Other than a reduction in postoperative pain during the first 24 h after surgery, no other differences were found between TEA compared with i.v. PCA with morphine.

Skeletal and dentoalveolar effects using tooth-borne and tooth-bone-borne RME appliances: a randomized controlled trial with 1-year follow-up.

OBJECTIVES: To evaluate and compare the skeletal and dentoalveolar effects of tooth-borne (TB) and tooth-bone-borne (TBB) rapid maxillary expansion (RME). MATERIALS AND METHODS: Fifty-two consecutive patients who met the eligibility criteria were recruited and allocated to either the TB group, mean age 9.3 years [standard deviation (SD) 1.3], or the TBB group, mean age 9.5 years (SD 1.2). Cone-beam computed tomography (CBCT) records and plaster models were taken before (T0), directly after (T1), and 1 year after expansion (T2). Dentoalveolar and skeletal measurements were made on the CBCT images. The dental expansion was also measured on the plaster models. RANDOMIZATION: Participants were randomly allocated in blocks of different sizes using the concealed allocation principle in a 1:1 ratio. The randomization list was also stratified by sex to ensure homogeneity between groups. BLINDING: Due to clinical limitations, only the outcomes assessors were blinded to the groups to which the patients were allocated. RESULTS: Skeletal expansion in the midpalatal suture and at the level of the nasal cavity was significantly higher in the TBB group. However, the magnitude of the expansion in the midpalatal suture was around 1 mm [95 per cent confidence interval (CI) 0.5-1.7, P = 0.001] more and perhaps not clinically significant. The magnitude of the expansion at the level of the nasal cavity was almost two times higher in the TBB group (95 per cent CI 0.7-2.6, P = 0.001). The dental expansion, alveolar bending, tipping of the molars, and stability 1 year post-expansion did not show any statistically significant differences between the groups. The actual direct cost of the treatment for the TBB group was approximately €300 higher than TB group. LIMITATIONS: Double blinding was not possible due to the clinical limitations. CONCLUSIONS: In young preadolescents with constricted maxilla and no signs of upper airway obstruction, it seems that conventional TB RME achieves the same clinical results with good stability 1 year post-expansion at lower cost. TRIAL REGISTRATION: The trial was not registered.

Open vs closed surgical exposure of palatally displaced canines: a comparison of clinical and patient-reported outcomes-a multicentre, randomized controlled trial.

OBJECTIVES: To compare treatment time, patients' perceptions during orthodontic treatment, dental fear and side effects, between open and closed surgical exposures in patients with palatally displaced canines (PDCs). TRIAL DESIGN: Multicentre, randomized controlled trial, with random 1:1 allocation of two parallel groups. MATERIALS AND METHODS: One hundred and twenty patients from three different orthodontic centres were randomized into one of the two intervention arms, open or closed surgical exposure. Both techniques had mucoperiosteal flaps raised and bone removed above the PDCs. In open exposure, tissue was removed above the canine, and glass ionomer - reaching above soft tissue - was built on the crown. The canine was then left to erupt spontaneously, prior to orthodontic alignment. At closed exposure, a chain was bonded to the canine and orthodontic traction was applied under the mucosa until eruption. Orthodontic alignment of the canines was undertaken after eruption into the oral cavity, with fixed appliances in both groups. All participants were treated according to intention to treat (ITT). BLINDING: Due to the nature of this trial, only outcome assessors could be blinded to the intervention group. RESULTS: One hundred and seventeen patients completed the trial. All PDCs were successfully aligned. Total treatment time was equal in the two techniques, mean difference -0.1 months (95% CI -3.2 to 2.9, P = 0.93). The closed group experienced more pain and discomfort during the active orthodontic traction. Dental fear, root resorption and periodontal status did not show any clinically significant differences between the groups. GENERALIZABILITY: Results of this randomized controlled trial (RCT) can be generalized only to a similar population aged 9-16 years, if exclusion criteria are met. CONCLUSION: The closed exposure group experienced more pain and discomfort mostly during active orthodontic traction. All other studied outcomes were similar between the two exposure groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02186548 and Researchweb.org, ID: 127201.

A combination of the activation marker CD86 and the immune checkpoint marker B and T lymphocyte attenuator (BTLA) indicates a putative permissive activation state of B cell subtypes in healthy blood donors independent of age and sex.

BACKGROUND: The use of anti-B cell based therapies in immune-mediated diseases targeting general B cell markers or molecules important for B cell function has increased the clinical needs of monitoring B cell subpopulations. RESULTS: We analyzed the expression profile of cell surface markers CD86 and B and T lymphocyte attenuator (BTLA) in B cell subtypes using flow cytometry, including naïve, transitional, switched memory, non-switched memory and double-negative memory B cells and plasmablasts, and investigated the dependence of age and sex in a healthy adult blood donor population. The switched memory B cell subtype displayed a divergent expression of the markers, with increased CD86 and decreased BTLA as compared to non-switched and double negative memory cells, as well as compared to naïve B cells. Plasmablasts expressed highly increased CD86 compared to all other subtypes and a decreased expression of BTLA compared to naïve cells, but still higher compared to the memory cell populations. Transitional B cells had CD86 and BTLA expression similar to the other naïve cells. CONCLUSIONS: We show divergent expression of CD86 and BTLA in memory cells and plasmablasts compared to naïve B cells independent of age and sex. Furthermore, a similarly divergent difference of expression pattern was seen between the memory cell subtypes, altogether indicating that the combination of CD86 and BTLA might be markers for a permissive activation state. We suggest the combination of CD86 and BTLA expression on B cell subtypes as a potentially important tool in monitoring the status of B cell subtypes before and after treatments influencing the B cell compartment.

Management practices for postdural puncture headache in obstetrics: a prospective, international, cohort study.

BACKGROUND: Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache (PDPH). We aimed to describe management practices and outcomes after PDPH treated by epidural blood patch (EBP) or no EBP. METHODS: Following ethics committee approval, patients who developed PDPH after accidental dural puncture were recruited from participating countries and divided into two groups, those receiving EBP or no EBP. Data registered included patient and procedure characteristics, headache symptoms and intensity, management practices, and complications. Follow-up was at 3 months. RESULTS: A total of 1001 patients from 24 countries were included, of which 647 (64.6%) received an EBP and 354 (35.4%) did not receive an EBP (no-EBP). Higher initial headache intensity was associated with greater use of EBP, odds ratio 1.29 (95% confidence interval 1.19-1.41) per pain intensity unit increase. Headache intensity declined sharply at 4 h after EBP and 127 (19.3%) patients received a second EBP. On average, no or mild headache (numeric rating score≤3) was observed 7 days after diagnosis. Intracranial bleeding was diagnosed in three patients (0.46%), and backache, headache, and analgesic use were more common at 3 months in the EBP group. CONCLUSIONS: Management practices vary between countries, but EBP was more often used in patients with greater initial headache intensity. EBP reduced headache intensity quickly, but about 20% of patients needed a second EBP. After 7 days, most patients had no or mild headache. Backache, headache, and analgesic use were more common at 3 months in patients receiving an EBP.

Plasma concentrations of secretory leukocyte protease inhibitor (SLPI) differ depending on etiology and severity in community-onset bloodstream infection.

The severity of bloodstream infections (BSI) depends on pathogen, source, and host factors. Secretory leukocyte protease inhibitor (SLPI) counteracts tissue damage, balances inflammation, and is increased in pneumonia and sepsis. We aimed to evaluate whether SLPI production differs depending on etiology, disease severity, and sex in BSI and to correlate SLPI with markers of inflammation and immunosuppression. Of the adult patients with BSI, 109 were included and sampled repeatedly, from hospital admission through day 28. Controls (blood donors) were sampled twice. SLPI in plasma was measured with enzyme-linked immunosorbent assay (ELISA) technique. Streptococcus pneumoniae and Staphylococcus aureus etiology were associated with higher SLPI than Escherichia coli on days 1-2 and 3. On day 1-2, subjects with sepsis had higher SLPI concentrations than those with non-septic BSI. Pneumonia was associated with higher SLPI than a non-pulmonary source of infection. SLPI co-varied with inflammatory markers. SLPI concentrations did not differ with regard to sex in the full cohort, but men with pneumonia had higher SLPI than women on day 1-2. S. pneumoniae and S. aureus BSI were associated with higher SLPI, when compared to E. coli. Severity and pneumonia, as well as male sex in the pneumonia sub-cohort, were factors independently associated with higher SLPI.

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).

Effect of positive end-expiratory pressure on gastric insufflation during induction of anaesthesia when using pressure-controlled ventilation via a face mask: A randomised controlled trial.

BACKGROUND: Face mask ventilation (FMV) during induction of anaesthesia is associated with risk of gastric insufflation that may lead to gastric regurgitation and pulmonary aspiration. A continuous positive airway pressure (CPAP) has been shown to reduce gastric regurgitation. We therefore hypothesised that CPAP followed by FMV with positive end-expiratory pressure (PEEP) during induction of anaesthesia would reduce the risk of gastric insufflation. OBJECTIVE: The primary aim was to compare the incidence of gastric insufflation during FMV with a fixed PEEP level or zero PEEP (ZEEP) after anaesthesia induction. A secondary aim was to investigate the effects of FMV with or without PEEP on upper oesophageal sphincter (UES), oesophageal body and lower oesophageal sphincter (LES) pressures. DESIGN: A randomised controlled trial. SETTING: Single centre, Department of Anaesthesia and Intensive Care, Örebro University Hospital, Sweden. PARTICIPANTS: Thirty healthy volunteers. INTERVENTIONS: Pre-oxygenation without or with CPAP 10 cmH2O, followed by pressure-controlled FMV with either ZEEP or PEEP 10 cmH2O after anaesthesia induction. MAIN OUTCOME MEASURES: A combined impedance/manometry catheter was used to detect the presence of gas and to measure oesophageal pressures. The primary outcome measure was the cumulative incidence of gastric insufflation, defined as a sudden anterograde increase in impedance of more than 1 kΩ over the LES. Secondary outcome measures were UES, oesophageal body and LES pressures. RESULTS: The cumulative incidence of gastric insufflation related to peak inspiratory pressure (PIP), was significantly higher in the PEEP group compared with the ZEEP group (log-rank test P < 0.01). When PIP reached 30 cmH2O, 13 out of 15 in the PEEP group compared with five out of 15 had shown gastric insufflation. There was a significant reduction of oesophageal sphincter pressures within groups comparing pre-oxygenation to after anaesthesia induction, but there were no significant differences in oesophageal sphincter pressures related to the level of PEEP. CONCLUSION: Contrary to the primary hypothesis, with increasing PIP the tested PEEP level did not protect against but facilitated gastric insufflation during FMV. This result suggests that PEEP should be used with caution after anaesthesia induction during FMV, whereas CPAP during pre-oxygenation seems to be safe. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02238691.

Are panoramic radiographs good enough to render correct angle and sector position in palatally displaced canines?

OBJECTIVES: The early interceptive treatment of palatally displaced canines (PDCs) has for decades been based on their position in panoramic radiographs. In the 1990s, cone-beam computed tomography (CBCT) started to become popular in cases with PDCs. The aims of this prospective study were to evaluate the agreement of PDC sector position and angle to midline between panoramic radiographs and CBCT scans. METHODS: PDC sector and angle to midline were measured in panoramic radiographs and CBCT scans in 58 consecutive patients with 64 PDCs. Kappa with linear weighting was used to assess the agreement between the measurements of PDC sector position and Bland-Altman limits of agreement to assess the agreement between the PDC angular measurements in the 2 methods. RESULTS: PDC sector position and angle to midline had systematically higher values in panoramic radiographs compared with those in the CBCT scans. The agreement of sector position between the methods was fair: weighted kappa 0.36 (95% CI 0.24-0.49). The mean difference in angle was almost 7° (95% CI 5.9°-7.9°) higher in panoramic radiographs compared with CBCT. CONCLUSIONS: Panoramic radiographs overestimate PDC sector and angle to midline position, compared with the use of CBCT scans, but clinically the differences are quite modest. Panoramic radiographs could be considered good enough for rendering PDC position when the need for 3D information is not crucial for treatment planning.