Median Percentage Of Time Research Articles

Changing Glucose Levels During the Menstrual Cycle as Observed in Adults in the Type 1 Diabetes Exercise Initiative Study

ObjectivesEvidence suggests that glucose levels in menstruating females with type 1 diabetes change throughout the menstrual cycle, reaching a peak during the luteal phase. The Type 1 Diabetes Exercise Initiative (T1DEXI) study provided the opportunity to assess glycemic metrics between early and late phases of the menstrual cycle, and whether differences could be explained by exercise, insulin, and carbohydrate intake. MethodsOne hundred seventy-nine women were included in our analysis. Glycemic metrics, carbohydrate intake, insulin requirements, and exercise habits during the early vs late phases of their menstrual cycles (i.e. 2 to 4 days after vs 2 to 4 days before reported menstruation start date) were compared. ResultsMean glucose increased from 8.2±1.5 mmol/L (148±27 mg/dL) during the early follicular phase to 8.6±1.6 mmol/L (155±29 mg/dL) during the late luteal phase (p<0.001). Mean percent time-in-range (3.9 to 10.0 mmol/L [70 to 180 mg/dL]) decreased from 73±17% to 70±18% (p=0.002), and median percent time >10.0 mmol/L (>180 mg/dL) increased from 21% to 23% (p<0.001). Median total daily insulin requirements increased from 37.4 units during the early follicular phase to 38.5 units during the late luteal phase (p=0.02) and mean daily carbohydrate consumption increased slightly from 127±47 g to 133±47 g (p=0.05); however, the difference in mean glucose during early follicular vs late luteal phase was not explained by differences in exercise duration, total daily insulin units, or reported carbohydrate intake. ConclusionsGlucose levels during the late luteal phase were higher than those of the early follicular phase of the menstrual cycle. These glycemic changes suggest that glucose management for women with type 1 diabetes may need to be fine-tuned within the context of their menstrual cycles.

Continuous Glucose Monitoring Profiles in Pregnancies With and Without Gestational Diabetes Mellitus.

To determine whether continuous glucose monitoring (CGM)-derived glycemic patterns can characterize pregnancies with gestational diabetes mellitus (GDM) as diagnosed by standard oral glucose tolerance test at 24-28 weeks' gestation compared with those without GDM. The analysis includes 768 individuals enrolled from two sites prior to 17 weeks' gestation between June 2020 and December 2021 in a prospective observational study. Participants wore blinded Dexcom G6 CGMs throughout gestation. Main outcome of interest was a diagnosis of GDM by oral glucose tolerance test (OGTT). Glycemic levels in participants with GDM versus without GDM were characterized using CGM-measured glycemic metrics. Participants with GDM (n = 58 [8%]) had higher mean glucose (109 ± 13 vs. 100 ± 8 mg/dL [6.0 ± 0.7 vs. 5.6 ± 0.4 mmol/L], P < 0.001), greater glucose SD (23 ± 4 vs. 19 ± 3 mg/dL [1.3 ± 0.2 vs. 1.1 ± 0.2 mmol/L], P < 0.001), less time in range 63-120 mg/dL (3.5-6.7 mmol/L) (70% ± 17% vs. 84% ± 8%, P < 0.001), greater percent time >120 mg/dL (>6.7 mmol/L) (median 23% vs. 12%, P < 0.001), and greater percent time >140 mg/dL (>7.8 mmol/L) (median 7.4% vs. 2.7%, P < 0.001) than those without GDM throughout gestation prior to OGTT. Median percent time >120 mg/dL (>6.7 mmol/L) and time >140 mg/dL (>7.8 mmol/L) were higher as early as 13-14 weeks of gestation (32% vs. 14%, P < 0.001, and 5.2% vs. 2.0%, P < 0.001, respectively) and persisted during the entire study period prior to OGTT. Prior to OGTT at 24-34 weeks' gestation, pregnant individuals who develop GDM have higher CGM-measured glucose levels and more hyperglycemia compared with those who do not develop GDM.

Hypoglycemia and Hyperglycemia According to Type of Diabetes: Observations During Fully Closed-Loop Insulin Delivery in Adults With Type 1 and Type 2 Diabetes.

CamAPS HX fully closed-loop (FCL) system, with no user input required at mealtimes, has been shown to be safe and effective in adults with type 1 and type 2 diabetes. We assessed whether time spent in hypoglycemia and hyperglycemia during FCL insulin delivery in adults varied by type of diabetes over the 24-hour period. We retrospectively analyzed eight weeks of data from 52 participants (adults with type 1 diabetes and adults with insulin-treated type 2 diabetes) recruited to two single-center randomized controlled studies using FCL insulin delivery during unrestricted-living conditions. Key outcomes were time spent in hypoglycemia <70 mg/dL and marked hyperglycemia >300 mg/dL by type of diabetes. The median percentage of time spent in hypoglycemia <70 mg/dL over the 24-hour period was lower for those with type 2 diabetes than for those with type 1 diabetes (median [interquartile range (IQR)] 0.43% [0.20-0.77] vs 0.86%, [0.54-1.46]; mean difference 0.46 percentage points [95% CI 0.23-0.70]; P < .001). Median percentage time in marked hyperglycemia >300 mg/dL was lower for those with type 2 diabetes than for those with type 1 diabetes (median [IQR] 1.8% [0.6-3.5] vs 9.3% [6.9-11.8]; mean difference 7.8 percentage points [95% CI 5.5-10.0]; P < .001). Using the FCL system, hypoglycemia and marked hyperglycemia exposure were lower in type 2 diabetes than in type 1 diabetes.

Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes.

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results

Objective. To further evaluate glycemic outcomes during the observational extension phase of the Continuous Glucose Monitoring (CGM) Intervention for Teens and Young Adults randomized clinical trial (RCT). Subjects and Methods. Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to &lt;25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM–CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM–CGM cohort) for an additional 26 weeks. Results. In the CGM–CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks ( p &lt; 0.001 ); however, significant improvement in time in target range (TIR) 70–180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time &lt;70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks ( p &lt; 0.001 ). In the BGM–CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use ( p &lt; 0.001 ) and mean TIR increased from 34% ± 12% to 38% ± 15% ( p = 0.01 ). The median percent time &lt;70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use ( p &lt; 0.001 ). No participants discontinued CGM use during the extension phase. Conclusions. This further evaluation of CGM supports the findings of the preceding RCT that use of CGM improves glycemic control and reduces hypoglycemia in adolescents and young adults with type 1 diabetes. This trial is registered with NCT03263494.

Standard Versus Individualized Blood Pressure Targets During Thrombectomy: A Randomized Controlled Pilot Trial

Background The optimal blood pressure management strategy in patients undergoing endovascular therapy for acute ischemic stroke is unknown. This pilot study aimed to assess the feasibility of a standard versus individualized blood pressure management strategy during endovascular therapy. Methods This randomized controlled pilot trial included adult patients with acute ischemic stroke with large‐vessel occlusion in the anterior circulation undergoing endovascular therapy. Patients were randomized to either standard (mean arterial blood pressure [MABP] targeted between 70 and 90 mm Hg) or individualized (MABP targeted ±10% of a baseline value measured in the neurointerventional suite) blood pressure targets until reperfusion or removal of groin sheath. The main outcome was the modified Rankin Scale score at 90 days. Secondary outcomes included feasibility outcomes, 90‐day dichotomized modified Rankin Scale score (0–2 versus 3–6), and reperfusion rates. Results Between April 2021 and February 2022, 60 patients (median [interquartile range] age, 76 [66–84] years) were randomly assigned to standard (n=30) or individualized (n=30) blood pressure targets. Median (interquartile range) National institutes of Health Stroke Scale score was 15 (10–18). Mean (SD) MABP, mean (SD) systolic blood pressure, and median (interquartile range) cardiac output were significantly higher in the individualized group compared with the standard group (MABP: 94 [9] versus 88 [9] mm Hg; P =0.012; systolic blood pressure: 149 [21] versus 139 [17] mm Hg; P =0.032; and cardiac output: 5.82 [4.22–7.23] versus 4.35 [3.73–5.1] L/min; P =0.02). The odds ratio for improved outcome in the individualized group was 1.37 (95% CI, 0.56–3.36). The relative risk for improved dichotomized outcome in the individualized group was 1.31 (95% CI, 0.87–1.98). Full reperfusion rates were comparable between the standard and individualized groups (90% versus 93%; P =0.64). The median percentage of time outside the MABP targets was 54.3% in the standard group versus 61.4% in the individual group ( P =0.30) and did not meet the feasibility target. Recruitment rate, data completeness, and safety were within feasibility limits. Conclusions The feasibility criteria were not met in this study because of difficulties in achieving the desired blood pressure targets. These findings do not support continuing with a large trial using the current protocol.

Is melancholia a distinct syndrome? Recurrence, chronicity, and severity give evidence in the 50 year follow-up of the Lundby Study.

Whether melancholia is a distinct syndrome has long been debated. One aspect of a valid syndrome is whether it allows for determination of a prognosis. The aim of this study is to investigate the course of melancholic depression versus non-melancholic depression with a focus on: (i) time to and probability of recovery from the first depressive episode, (ii) time to and risk of the first recurrence, (iii) rate of recurrence, (iv) time with depression or antidepressant medication, and (v) suicide risk. The Lundby Study is a longitudinal community study on mental health that followed a geographically defined population (N = 3,563) for up to 50 years, 1947-1997. Subjects with first onset depression were assessed as melancholic (N = 46) or non-melancholic (N = 381) using the DSM-IV melancholic specifier. These diagnoses were made in retrospect using all available information from semi-structured interviews by psychiatrists, key informants, registers, and patient records. We found no significant difference between melancholic- and non-melancholic depression in time to and probability of recovery from the first depressive episode. The time to first recurrence was shorter in melancholic than in non-melancholic depression and the risk of first recurrence for the melancholic group was 2.77 (95% confidence interval [CI] 1.83-4.20) times the risk in the non-melancholic group. The median rate of recurrence was higher in the melancholic group, at 0.19 recurrences per year at risk (interquartile range [IQR] 0.08-0.47), compared to the non-melancholic group, at 0.10 recurrences per year at risk (IQR 0.05-0.21) (p < 0.03). The median percentage of time being depressed or on antidepressant medication was higher in the melancholic group, 17% (IQR 3-20%), compared to the non-melancholic group, 8% (IQR 7-33%) (p < 0.001). The risk of suicide was higher in the melancholic group, hazard ratio 4.13 (95% CI 1.49-11.48, p < 0.01). To conclude, melancholic depression had a more recurrent, chronic, and severe course with a higher suicide risk than did non-melancholic depression in the Lundby population. Although our use of retrospective diagnosis might limit interpretation of results, the findings indicate that melancholia may be useful in determining prognosis and may be a valid psychopathological syndrome.

Variables affecting surgeons' use of, and preferences for, instrumentation in veterinary laparoscopy.

To investigate the impact of variables on use and preference of common laparoscopic instruments. Online survey. Surgeons (n = 140) with 3 years or more laparoscopic experience. Electronic survey distributed via specialty group LISTSERVEs and Facebook groups. Responses collected included surgeon attributes, preferences, and surgical practice data. Statistical analysis was performed using Fishers exact, ANOVA, Tukey Kramer honestly significant difference (HSD) test, linear regression, and logistic regression. Ninety-eight of 140 respondents answered instrument-related questions and the completion rate of these questions was 76%: 48% of females and 49% of males responded to the survey. The median glove size of respondents was size 7 (range, 5.5 to 8.5). Closing laparoscopic Babcock forceps (p = .018), rotating cup biopsy forceps (p = .003), and manipulating endoscopic staplers (p < .001) were more difficult for surgeons with smaller glove sizes. The median difficulty score for the endoscopic stapler was 4/10 and the median percentage of time this was found difficult was 25%. Reusable instruments were preferred over disposable single-use instruments. The pistol grip was preferred for grasping and retracting (54/98, 55%) and fine dissection (46/96, 48%), while the axial grip was preferred for suturing and knot tying (61/98, 62%). Surgeons with smaller glove sizes (<6.5) experience more difficulty when using common laparoscopic instruments. The endoscopic stapler was the most difficult to use. When purchasing laparoscopic instrumentation, surgeons should review all available options in handle size and design to improve ergonomics during minimally invasive procedures.

Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support

ObjectiveTo evaluate the efficacy of automatic oxygen control (A-FiO2) in reducing the extremes of oxygen saturations (SpO2<80% and SpO2>98%) in preterm infants on high-flow nasal cannula (HFNC) respiratory support using...

172-OR: Normative CGM Glucose Levels throughout Gestation in Patients with Uncomplicated Pregnancies

Glycemic patterns throughout pregnancy are not well described, particularly early pregnancy. CGM used throughout the gestational period in uncomplicated pregnancies may help describe glycemic patterns in more detail. Blinded CGM data were collected throughout pregnancy from 760 pregnant patients ≥18 years old, with HbA1c &amp;lt;6.5%, no known diabetes, and gestational age &amp;lt;17 weeks. CGM data from uncomplicated pregnancies (pregnancy without gestational diabetes, large for gestational age birth, or hypertensive disorder of pregnancy) established the normative data set. Uncomplicated pregnancies (n=427, mean±SD age 32±4 years, 73% White non-Hispanic, mean HbA1c 5.1±0.3%) showed mean glucose during the entire gestational period was 99±7 mg/dL. Trimester specific mean glucose was: 103±7, 98±7 and 98±8 mg/dL for 1st, 2nd, 3rd trimesters. Figure 1 shows mean glucose by hour/trimester. Median (quartiles) percent time in range (TIR) 63-120 mg/dL was 86% (82-89%) for gestational period, and 84% (79-89%), 87% (82-90%), and 85% (80-90%) for 1st, 2nd, 3rd trimesters. Figure 2 shows TIR 63-120 mg/dL by 4-week periods. In uncomplicated pregnancies, mean glucose and TIR 63-120 mg/dL remained consistent throughout the gestational period. These normative CGM data will help set pregnancy-specific glycemic targets and will be important to compare to those 333 women in this study with complicated pregnancies. Disclosure A.L.Carlson: Advisory Panel; MannKind Corporation, Novo Nordisk, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk, Insulet Corporation, UnitedHealth Group, Sanofi. J.Sibayan: None. P.Calhoun: None. C.Durnwald: None. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. Z.Li: None. E.Norton: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. S.Dunnigan: None. M.Banfield: None. K.J.Krumwiede: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; United Health Group

Short communication: Differences in clinical outcomes according to the healthcare regime in Colombian patients with rheumatoid arthritis

Introduction/ObjectivesRheumatoid arthritis (RA) is a burdensome disease from both individual and societal perspectives, in which access to a rheumatologist plays a pivotal role in disease activity and reduction of its impact. We describe preliminary results of our study aimed at exploring whether healthcare regime affiliation influences disease outcomes of Colombian patients with RA. Materials and methodsWe performed a retrospective observational study of RA patients (2010 ACR/EULAR classification criteria) with at least 3 assessments in rheumatology clinics from different healthcare regimes: Contributory (CR), Subsidized (SR), a centre of clinical excellence (C3) that follows CR patients. We retrieved data from clinical charts including a follow-up period of 2 years. ResultsWe included one hundred and sixty patients (C3: 79 [49.4%], CR: 26 [16.2%], SR: 55 [34.2%]). Median initial age was 54 years (IQR 48–62) and most patients were women (77.8%). Of the patients, 79% had established RA and 70% had high disease activity at the beginning of the follow-up. We observed statistical differences between groups with regards to (1) median time to scheduled visits, (2) percentage of visits accomplished in scheduled time, (3) median time to real visit, (4) adherence, (5) median percentage of time in high disease activity, and (6) percentage of patients in high disease activity at the end of follow-up. The best outcomes were observed in the C3 cohort. ConclusionsAccess opportunity and clinical outcomes of Colombian patients with RA appear to differ between healthcare regimes. Although systematic bias may be present due to sample size, these data imply the healthcare regime is a major determinant of disease outcomes.

Warfarin-Rifampin-Gene (WARIF-G) Interaction: ARetrospective, Genetic, Case-Control Study.

Warfarin is extensively metabolized by cytochrome P450 2C9 (CYP2C9). Concomitant use with the potent CYP2C9 inducer, rifampin, requires close monitoring and dosage adjustments. Although, in theory, warfarin dose increase should overcome this interaction, most reported cases over the last 50 years have not responded even to high warfarin doses, but some have responded to modest doses. To investigate the genetic polymorphisms' impact on this unexplained interpatient variability, we performed genotyping of CYP2C9, VKORC1, and CYP4F2 for warfarin and rifampin concomitant receivers from 2016 to 2022 at Hamad Medical Corporation, Doha, Qatar. We identified and included 36 patients: 22 responders and 14 nonresponders. Warfarin-responders were significantly more likely to have one or more warfarin-sensitizing CYP2C9/VKORC1 alleles than nonresponders (odds ratio=23.2, 95% confidence interval=3.2-195.6; P=0.0001). The mean genetic-based pre-interaction calculated dose was significantly lower for responders than for nonresponders (P < 0.001); and was negatively correlated with warfarin sensitivity index (WSI) (r=-0.58; P=0.0002). The median percentage time in therapeutic range and mean WSI were significantly higher in the warfarin-sensitizing CYP2C9/VKORC1 alleles carriers than noncarriers (P=0.017 and 0.0004, respectively). Whereas the warfarin-sensitizing CYP2C9/VKORC1 genotypes were associated with modest on-rifampin warfarin dose requirements, the noncarriers would have required more than double these doses to respond. Warfarin-sensitizing CYP2C9/VKORC1 genotypes and low genetic-based warfarin calculated doses were associated with higher warfarin sensitivity and better anticoagulation quality in patients receiving rifampin concomitantly.

One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany.

The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting. We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage. In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%). This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.

NEIGHBORHOOD WALKABILITY IS ASSOCIATED WITH GPS-DERIVED LIFE-SPACE MOBILITY OF OLDER ADULTS

Abstract For community-dwelling older adults, living in a more walkable neighborhood may encourage greater travel outdoors (i.e., life-space mobility). We assessed associations between neighborhood walkability and objective, GPS-derived life-space mobility. Participants were 149 adults (Age: M=77.1±6.5, 67% women) from a randomized trial to improve walking in older individuals. Participants carried a GPS at baseline that passively collected real-time location data for 5-7 days. Life-space mobility was quantified using median percentage time spent outside of home (pTOH). Neighborhood walkability was assessed using a modified Active Neighborhood Checklist and Google Street View, and a composite factor score was derived (M=-0.13±0.90, greater score=less slopes, more mixed residential/commercial land use). Each 1-point higher walkability score was associated with 2.5% greater pTOH (95%CI: 0.21-4.69, β=.23, p=.032), after adjusting for age, sex, race, device, season, and clustering on Census tract. Future work will examine how neighborhood walkability and functional status may interact to influence life-space mobility.

Progression of Atrial Fibrillation after Cryoablation or Drug Therapy

BackgroundAtrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation.MethodsWe report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected.ResultsA total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group.ConclusionsInitial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.)

Secondary use of data extracted from a clinical information system to assess the adherence of tidal volume and its impact on outcomes

ObjectivesTo extract data from clinical information systems to automatically calculate high-resolution quality indicators to assess adherence to recommendations for low tidal volume. DesignWe devised two indicators: the percentage of time under mechanical ventilation with excessive tidal volume (>8mL/kg predicted body weight) and the percentage of patients who received appropriate tidal volume (≤8mL/kg PBW) at least 80% of the time under mechanical ventilation. We developed an algorithm to automatically calculate these indicators from clinical information system data and analyzed associations between them and patients’ characteristics and outcomes. SettingsThis study has been carried out in our 30-bed polyvalent intensive care unit between January 1, 2014 and November 30, 2019. PatientsAll patients admitted to intensive care unit ventilated >72h were included. InterventionUse data collected automatically from the clinical information systems to assess adherence to tidal volume recommendations and its outcomes. Main variables of interestMechanical ventilation days, ICU length of stay and mortality. ResultsOf all admitted patients, 340 met the inclusion criteria. Median percentage of time under mechanical ventilation with excessive tidal volume was 70% (23%–93%); only 22.3% of patients received appropriate tidal volume at least 80% of the time. Receiving appropriate tidal volume was associated with shorter duration of mechanical ventilation and intensive care unit stay. Patients receiving appropriate tidal volume were mostly male, younger, taller, and less severely ill. Adjusted intensive care unit mortality did not differ according to percentage of time with excessive tidal volume or to receiving appropriate tidal volume at least 80% of the time. ConclusionsAutomatic calculation of process-of-care indicators from clinical information systems high-resolution data can provide an accurate and continuous measure of adherence to recommendations. Adherence to tidal volume recommendations was associated with shorter duration of mechanical ventilation and intensive care unit stay.

Remimazolam besylate versus propofol for long-term sedation during invasive mechanical ventilation: a pilot study

ObjectiveThe aim of this study was to evaluate the efficacy and safety of remimazolam besylate compared with propofol in maintaining mild-to-moderate sedation in patients receiving long-term mechanical ventilation.MethodsIn this single-centered randomized pilot study, adult patients mechanically ventilated longer than 24 h were randomized to receive remimazolam besylate or propofol. The target sedation range was − 3 to 0 on the Richmond Agitation and Sedation Scale (RASS). The primary outcome was the percentage of time in the target sedation range without rescue sedation. The secondary outcomes were ventilator-free days at day 7, the length of ICU stay and 28-day mortality.ResultsThirty patients were assigned to each group. No difference was identified between the remimazolam group and propofol group in median age [60.0 (IQR, 51.5–66.3) years vs. 64.0 (IQR, 55.0–69.3) years, respectively, p = 0.437] or the median duration of study drug infusion [55.0 (IQR, 28.3–102.0) hours vs. 41.0 (IQR, 24.8–74.3) hours, respectively, p = 0.255]. The median percentage of time in the target RASS range without rescue sedation was similar in remimazolam and propofol groups [73.2% (IQR, 41.5–97.3%) vs. 82.8% (IQR, 65.6–100%), p = 0.269]. No differences were identified between the two groups in terms of ventilator-free days at day 7, length of ICU stay, 28-day mortality or adverse events.ConclusionsThis pilot study suggested that remimazolam besylate was effective and safe for long-term sedation in mechanically ventilated patients compared with propofol.

In the classroom but absent: Evidence of sickness presenteeism among teachers at four public schools

ObjectiveEvidence regarding sickness presenteeism (SP) in low-and middle-income countries and in vulnerable groups such as teachers is relatively scarce. To provide evidence addressing this research gap, we examined the prevalence and predictors, and estimated the productivity loss impairment due to SP among teachers in Leon, Nicaragua. MethodsThis was a cross-sectional study. Four public schools in Leon, Nicaragua, were selected, and 132 teachers were included in the final sample. Predictors influencing SP were identified through multivariable logistic regression. By using the Work Productivity and Activity Impairment Questionnaire, we converted the productivity loss impairment to 2018 US dollars (1 US dollar = 31.78 Cordobas). ResultsOverall, the prevalence of SP was 65.2% (95% C.I.: 56.53–72.87), and no differences were found in sociodemographic characteristics. We observed a negative relationship between director/supervisor support and SP (p<0.001). Moreover, teachers without suitable household conditions for resting had a 1.28 times higher probability of SP (95% C.I.: 1.03–1.59). The median percentage time missed for all health reasons was 14.3%. The median percentage productivity loss impairment due to health conditions was 30%. The median per-capita cost of SP during the prior week was 20 US dollars, and the overall cost was 1805 US dollars. ConclusionAmong teachers, SP has a relatively high prevalence and is associated with a high economic toll. Interventions aimed at promoting healthful lifestyles are needed.

Continuous Glucose Monitoring Profiles in Healthy, Nondiabetic Young Children.

ContextContinuous glucose monitoring (CGM) is increasingly being used both for day-to-day management in patients with diabetes and in clinical research. While data on glycemic profiles of healthy, nondiabetic individuals exist, data on nondiabetic very young children are lacking.ObjectiveThis work aimed to establish reference sensor glucose ranges in healthy, nondiabetic young children, using a current-generation CGM sensor.MethodsThis prospective observational study took place in an institutional practice with healthy, nondiabetic children aged 1 to 6 years with normal body mass index. A blinded Dexcom G6 Pro CGM was worn for approximately 10 days by each participant. Main outcome measures included CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability.ResultsThirty-nine participants were included in the analyses. Mean average glucose was 103 mg/dL (5.7 mmol/L). Median percentage time between 70 and 140 mg/dL (3.9-7.8 mmol/L) was 96% (interquartile range, 92%-97%), mean within-individual coefficient of variation was 17 ± 3%, median time spent with glucose levels greater than 140 mg/dL was 3.4% (49 min/day), and median time less than 70 mg/dL (3.9 mmol/L) was 0.4% (6 min/day).ConclusionCollecting normative sensor glucose data and describing glycemic measures for young children fill an important informational gap and will be useful as a benchmark for future clinical studies.

Quantification of gastroesophageal regurgitation in brachycephalic dogs.

BackgroundGastroesophageal reflux and regurgitation occurs in brachycephalic dogs, but objective assessment is lacking.ObjectivesQuantify reflux in brachycephalic dogs using an esophageal pH probe and determine the association with scored clinical observations.AnimalsFifty‐one brachycephalic dogs.MethodsCase review study. Signs of respiratory and gastrointestinal disease severity were graded based on owner assessment. An esophageal pH probe with 2 pH sensors was placed for 18‐24 hours in brachycephalic dogs that presented for upper airway assessment. Proximal and distal reflux were indicated by detection of fluid with a pH ≤4. The median reflux per hour, percentage time pH ≤4, number of refluxes ≥5 minutes and longest reflux event for distal and proximal sensors were recorded. Association of preoperative respiratory and gastrointestinal grade, laryngeal collapse grade, and previous airway surgery with the distal percentage time pH ≤4 was examined using 1‐way ANOVA.ResultsA total of 43 of 51 dogs (84%; 95% confidence interval 72‐92) displayed abnormal reflux with a median (range) distal percentage time pH ≤4 of 6.4 (2.5‐36.1). There was no significant association between the distal percentage time pH ≤4 and respiratory grade, gastrointestinal grade, laryngeal collapse grade, or previous upper airway surgery.Conclusions and Clinical ImportanceThe occurrence of reflux is not associated with owner‐assessed preoperative respiratory and gastrointestinal grade, laryngeal collapse grade, and previous airway surgery. Esophageal pH measurement provides an objective assessment tool before and after surgery.