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Aim To determine whether inpatient diabetes management and education with improved transition to outpatient care (IDMET) improves glycemic control after hospital discharge in patients with uncontrolled type 2 diabetes (T2DM). Methods Adult inpatients with T2DM and HbA1c≥7.5% (11 mmol/mol) admitted for reasons other than diabetes to an academic medical center were randomly assigned to IDMET vs. usual care (UC). Linear mixed models estimated treatment-dependent differences in the change in HbA1c (measured at 3, 6, and 12 months) from baseline to 1 year follow-up. Results Thirty-one subjects had mean age 55 ± 12.6 years, with mean HbA1c of 9.7 ± 1.6% (82 ± 18 mmol/mol). Mean inpatient glucose was lower in the IDMET than in the UC group (176 ± 66 vs. 195 ± 74 mg/dl [9.7 vs. 10.8 mmol/l]), p=0.001. In the year after discharge, the average HbA1c reduction was greater in the IDMET compared to the UC group by 0.6% (SE 0.5%, [7 (SE 5) mmol/mol], p=0.3). Among patients newly discharged on insulin, the average HbA1c reduction was greater in the in the IDMET than in the UC group by 2.4% (SE 1.0%, [25 (SE 11) mmol/mol] p=0.04). Conclusions Inpatient diabetes management (IDMET) substantially improved glycemic control one year after discharge in patients newly discharged on insulin; patients previously treated with insulin did not benefit.
Surrogate and self-consent rates were similar. Surrogate unavailability was a major barrier to enrollment; overlap of staffing with usual visiting hours should be considered when planning trials in the ICU.
Introduction During a pregnancy complicated by diabetes, the placenta undergoes a number of functional and structural pathologic changes. However, differences across studies may reflect pathophysiologic differences of diabetes types under investigation. Methods We examined placental pathology from women ages 18–40 years with self-identified race/ethnicity; singleton, live births; and type 1 (T1DM; n=36), type 2 (T2DM; n=37), or gestational diabetes mellitus (GDM; n=126). Clinical data were abstracted from medical records. Placental diagnoses were independently re-reviewed by a perinatal pathologist. Multivariable analyses adjusting for race, gestational weight gain, gestational age, and systolic blood pressure were conducted. Results Women with T1DM compared with either T2DM or GDM had higher gestational weight gain (mean ± SD, T1DM vs. T2DM: 28.5 ± 12.4 vs. 20.5 ± 13.4 kg, p=0.03; or GDM: 21.3 ± 12.7 kg, p=0.009) and insulin use (T2DM: 100.0% vs. 85.3%, p=0.02; or GDM: 4.0%, p<0.001). Women with T1DM compared with either T2DM or GDM also had a similarly lower prevalence of placental infarcts in univariate analyses; however, these findings did not remain significant after multivariable adjustment. Also, placentas from women with T2DM compared to GDM had higher rates of decidual vasculopathy when excluding women with preeclampsia (10.3 vs. 1.6%, p=0.049) and diffuse chorangiosis (62.2 vs. 32.5%, p< 0.001) but a lower rate of villous immaturity (10.8 vs. 90.5%, p=0.007) after full adjustment. Discussion Placental vasculopathic abnormalities differ by maternal diabetes type, potentially reflecting underlying pathophysiologic mechanisms. Further research on placental pathology and metabolic derangements is warranted.
Introduction Screening and recruitment for clinical trials can be costly and time-consuming. Inpatient trials present additional challenges because enrollment is time-sensitive based on length of stay. We hypothesized that using an automated pre-screening algorithm to identify eligible subjects would increase screening efficiency and enrollment and be cost-effective compared to manual review of a daily admission list Methods Using a before-and-after design, we compared time spent screening, number of patients screened, enrollment rate, and cost-effectiveness of each screening method in an inpatient diabetes trial conducted at Massachusetts General Hospital. Manual Chart Review (CR) involved reviewing a daily list of admitted patients to identify eligible subjects. The automated pre-screening method (APS) used an algorithm to generate a daily list of patients with glucose levels ≥180 mg/dl, an insulin order, and/or admission diagnosis of diabetes mellitus. The census generated was then manually screened to confirm eligibility and eliminate patients who met our exclusion criteria. We determined rates of screening and enrollment and cost-effectiveness of each method based on study sample size. Results Total screening time (pre-screening and screening) decreased from 4 to 2 hours, allowing subjects to be approached earlier in the course of the hospital stay. The average number of patients pre-screened per day increased from 13 ± 4 to 30 ± 16 (P<0.0001). Rate of enrollment increased from 0.17 to 0.32 patients per screening day. Developing the computer algorithm added a fixed cost of $3,000 to the study. Based on our screening and enrollment rates, the algorithm was cost-neutral after enrolling 12 patients. Larger sample sizes further favored screening with an algorithm. By contrast, higher recruitment rates favored individual chart review. Limitations Because of the before-and-after design of this study, it is possible that unmeasured factors contributed to increased enrollment. Conclusion Using a computer algorithm to identify eligible patients for a clinical trial in the inpatient setting increased the number of patients screened and enrolled, decreased the time required to enroll them, and was less expensive. Upfront investment in developing a computerized algorithm to improve screening may be cost-effective even for relatively small trials, especially when the recruitment rate is expected to be low.
There were many similarities in placental histological findings between diabetes types. Still, one in five T2DM placentas displayed histological infarcts, consistent with a vascular, rather than glycemic, etiology of pregnancy complications, whereas T1DM placentas showed signs of abnormal development.
BACKGROUND: Recent series have raised concerns about the oncologic outcomes of transanal total mesorectal excision for mid and low rectal cancer. There is a paucity of large data sets from the United States to contribute to the ongoing international discourse. OBJECTIVE: This study aimed to investigate the rate of local recurrence and other oncologic outcomes in patients undergoing transanal total mesorectal excision for rectal adenocarcinoma. DESIGN: This study is a retrospective review of patients undergoing transanal total mesorectal excision for primary rectal cancer from January 2014 to December 2019. SETTINGS: This study was conducted at a single academic tertiary care medical center in the United States. PATIENTS: Consecutive patients aged ≥18 years undergoing surgical resection for primary rectal cancer were selected. INTERVENTION: The transanal total mesorectal excision procedures were performed utilizing a 2-team approach. MAIN OUTCOME MEASURES: Primary outcomes were pathologic quality, local and distant recurrence, treatment-related complications, and overall- and cancer-specific survival. RESULTS: Seventy-nine consecutive patients were included. The median age was 58 years (interquartile range, 50–64), and median BMI was 28 kg/m2 (interquartile range, 24.6–32.4). The mesorectum was complete in 69 patients (87.3%), nearly complete in 9 (11.4%), and incomplete in 1 (1.3%). There was circumferential resection margin involvement (<1 mm) in 4 patients (5.1%), and no patients had a positive distal margin (<1 mm) or intraoperative rectal perforation. Composite optimal pathology was achieved in 94.9% of specimens. Median follow-up was 29 months (range, 6–68). There were no local recurrences. Distant metastases were found in 10 (13.5%) patients and diagnosed after a median of 14 months (range, 0.6–53). Disease-free survival was 91.2% at 2 years, and overall survival was 94.7% at 2 years. LIMITATIONS: Retrospective design, a single center, and relatively short follow-up period were limitations of this study. CONCLUSION: The oncologic outcomes of this cohort support the use of transanal total mesorectal excision in the surgical management of mid to low rectal cancer at centers with appropriate expertise. See Video Abstract at http://links.lww.com/DCR/B723. RESULTADOS ONCOLÓGICOS DESPUÉS DE LA EXCISIÓN TOTAL DEL MESORRECTO POR VÍA TRANSANAL EN CASOS DE CÁNCER RECTAL ANTECEDENTES: Estudios recientes han suscitado preocupación sobre los resultados oncológicos de la excisión total del mesorecto por vía transanal en casos de cáncer de recto medio y bajo. Existe una gran escasez de conjuntos de datos en los Estados Unidos, para contribuir en el actual discurso internacional sobre el tema. OBJETIVO: Investigar la tasa de recurrencia local y otros resultados oncológicos en pacientes sometidos a una excisión total del mesorrecto por vía transanal por adenocarcinomas de recto. DISEÑO: Revisión retrospectiva de pacientes sometidos a excisión total del mesorecto por vía transanal en casos de cáncer de r...
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