Abnormal glucose tolerance in women with prior gestational diabetes mellitus: a 4-year follow-up study.

BACKGROUND: Adoption of the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria for diagnosis of gestational diabetes mellitus (GDM) varies worldwide. Early detection of women at increased risk of developing type 2 diabetes mellitus (T2DM) following GDM enables initiation of measures to delay disease onset. OBJECTIVES: To determine the 4-year cumulative incidence and risk factors for developing abnormal glucose tolerance (AGT) among women with previous GDM using modified IADPSG criteria. Additionally, to review post-natal attendance at diabetes screening and the impact of post-partum lifestyle modifications and breastfeeding on the risk of T2DM development. METHODS: Four hundred twenty-six women with a prior history of GDM were invited to participate in the study, 4 years after the index pregnancy. The following were completed: body measurements, oral glucose tolerance test (OGTT), glycated haemoglobin (HbA1c), vitamin D, and other biochemistry measurements. Participants also completed a lifestyle questionnaire. RESULTS: Of the 74 women who participated, 15 (20%) had AGT. Predictive factors for AGT development were as follows: fasting glucose levels (p = 0.004), HbA1c (p = 0.008) at GDM diagnosis, and early pregnancy BMI (p = 0.001). Thirty-three (45%) women had not attended their postnatal screening. The odds ratio of the association between breastfeeding and AGT development was 0.16 (95% CI: 0.05 to 0.53). CONCLUSION: The proportion of women who develop AGT after a diagnosis of GDM remains high. The factors associated with progression to AGT are available at GDM diagnosis. Preventing AGT in this group is possible by supporting breastfeeding. Attendance at post-natal screening should also be encouraged.

Improved global response outcome after intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder.

We report on the first regulatory approved clinical trial of a prospective open-label physician-initiated study assessing the safety and efficacy of intradetrusor injected Autologous Muscle Derived Cells (AMDC) treatment for underactive bladder (UAB). 20 non-neurogenic UAB patients were treated. Approximately 50-250 mg of quadriceps femoris muscle was collected using a spirotome 8-gauge needle. The muscle biopsy samples were sent to Cook MyoSite (Pittsburgh, PA) for processing, isolation, and propagation of cells. Research patients received approximately 30 intradetrusor injections of 0.5 mL delivered to the bladder, for a total of 15 mL and 125 million AMDC, performed utilizing a flexible cystoscope under direct vision using topical local anesthesia. Follow-up assessments included adverse events and efficacy via voiding diary and urodynamic testing at 1, 3, 6 and 12 months post-injection. An optional second injection was offered at the end of the 6 months visit. 20 patients received the first injection and all 20 patients requested and received a second injection. Median patient age was 65 years old (range 41-82 years). There were 16 male (80%) and 4 female (20%) patients. Etiology included 7 men (35%) with persistent urinary retention after transurethral resection of the prostate for benign prostatic hyperplasia and 13 patients (65%) with idiopathic chronic urinary retention. At the primary outcome time point of 12 months, 11/19 patients (58%) reported a global response assessment (GRA) ≥ 5, showing slight to marked improvement in their UAB symptoms, compared to 6/20 (30%) patients at 3 months post-injection. No serious procedure or treatment-related adverse events occurred. Noted improvements included: decreased post void residual urine volume, increased voiding efficiency, and decreased catheter use. Intradetrusor-injected AMDC as a treatment for UAB was successfully completed in a 20-patient trial without serious adverse event and with signal of efficacy. Cellular therapy may be a promising novel treatment for catheter-dependent chronic urinary retention. A multicenter controlled trial is needed to further assess the promise of regenerative medicine in the treatment of lower urinary tract dysfunction.

Reducing Caesarean Section Surgical Site Infection (SSI) by 50%: A Collaborative Approach.

OBJECTIVE: Caesarean section surgical site infection (SSI) is a surgical wound site infection occurring within 30 days of surgery with a reported incidence of 3-15%. This quality improvement (QI) project aimed to reduce caesarean section SSI by 50% in a tertiary maternity center. METHODS: Using multidisciplinary team approach, the project was designed with evidence-based interventions. The Royal College of Physicians of Ireland/Royal College of Surgeons in Ireland "Preventing Surgical Site Infections Key Recommendations for Practice" guideline was used as standard perioperative care. A care bundle was designed targeting preoperative personal patient preparation, preoperative prophylactic antibiotics, and strict skin preparation technique, all measured using a patient survey. The rate of SSI was followed for 14 months. The Model for Improvement methodology was used to implement change. RESULTS: Surgical site infection rate decreased from 6.7% (n = 684 caesarean sections, n = 46 SSI) to 3.45% (n = 3,206 caesarean sections, n = 110 SSI), p = .0006. Reduction occurred in both elective (4.4%-2.7%) and emergency (9.1%-4.1%) caesarean section groups. There was excellent adherence to all three elements of the care bundle. The 50% reduction in caesarean section SSI was sustained over the 14-month period, significantly reducing maternal morbidity. CONCLUSIONS: The success of this QI project is attributable to frontline ownership and empowerment of patients and staff.

A comparison of bladder volumes based on treatment planning CT and BladderScan® BVI 6100 ultrasound device in a prostate radiation therapy population.

OBJECTIVE:: The aim of this study is to investigate if a handheld ultrasound device (BladderScan® BVI 6100) can accurately measure bladder volumes in prostate radiotherapy (RT) patients. METHODS:: A comparison was made of contoured bladder volumes based on treatment planning CT (TPCT) and BladderScan® BVI 6100 ultrasound device in a large prostate RT population. Three bladder volume (BV) measurements were taken using the bladder volume instrument (BVI) device on prostate RT patients immediately prior to TPCT (n = 190). The CT delineation bladder volumes were also recorded. The mean of the three BVI readings (BVImean) and the maximum (BVImax) of the readings were considered for a comparative analysis. RESULTS:: There was a strong positive correlation between the BVI and CT delineated bladder volumes (BVImean r = 0.825; BVImax r = 0.830). The mean difference [± standard deviation (SD)] was an underestimation of BV for both BVImean and BVImax (44.8 ± 88.2 ml and 32.9 ± 87.5 ml, respectively). CONCLUSION:: This is the largest study to date (n = 190), assessing the accuracy of the BladderScan® BVI 6100 in the prostate RT population. The BVI 6100 provides an acceptable indication of BV for use in prostate RT patients for the purposes of monitoring BV. ADVANCES IN KNOWLEDGE:: The BladderScan® BVI 6100 provides a convenient and non-irradiating method of indicating BV for use in prostate RT patients.

Dosimetric comparison of 3-dimensional conformal radiation therapy and intensity modulated radiation therapy and impact of setup errors in lower limb sarcoma radiation therapy.

PURPOSE: This study compared dosimetric data between 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) plans in a population of patients with lower limb sarcoma immobilized with an in-house device and quantified the impact of systematic and random errors on these techniques. The dosimetric effects of displacements on target coverage and organs at risk (OARs) were considered. METHODS AND MATERIALS: Plans were created for 11 postoperative patients using both 3DCRT and IMRT. The techniques were compared dosimetrically. Population-based systematic and random errors were applied and the results compared with the initial plans. RESULTS: Higher target D95, D2, D98, and D50 and the best homogeneity index resulted with IMRT compared with 3DCRT. Systematic errors increased target D2 in IMRT. Random errors decreased target homogeneity in IMRT. Maximum bone dose was higher in IMRT than in 3DCRT. Neither error type increased OAR dose for either technique. CONCLUSIONS: IMRT could become the favored lower limb sarcoma radiation therapy technique because of superior target coverage and homogeneity. Offline imaging can adequately correct for systematic errors in these patients when an in-house immobilization device is used.

The role of galectin-3 and galectin-3-binding protein in venous thrombosis.

Galectin-3-binding protein (gal3bp) and its receptor/ligand, galectin-3 (gal3), are secreted proteins that initiate signaling cascades in several diseases, and recent human proteomic data suggest they may play a role in venous thrombosis (VT). We hypothesized that gal3bp and gal3 may promote VT. Using a mouse stasis model of VT, we found that gal3bp and gal3 were localized on vein wall, red blood cells, platelets, and microparticles, whereas leukocytes expressed gal3 only. Gal3 was dramatically increased during early VT and gal3bp:gal3 colocalized in the leukocyte/endothelial cell interface, where leukocytes were partially attached to the vein wall. Thrombus size correlated with elevated gal3 and interleukin-6 (IL-6) vein wall levels. Recombinant gal3 promoted VT and increased vein wall IL-6 mRNA. Although recombinant gal3 restored the VT size in gal3(-/-) mice, it had no effect on IL6(-/-) mice, suggesting that gal3:gal3bp promotes VT through IL-6. Moreover, significantly fewer activated neutrophils were present in the gal3(-/-) vein walls. In a group of human patients, elevated circulating gal3bp correlated with acute VT. In conclusion, gal3bp:gal3 play a critical role in VT, likely via IL-6 and PMN-mediated thrombotic mechanisms, and may be a potential biomarker in human VT.

A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy.

PURPOSE: Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients' satisfaction with the bladder-filling instructions. METHODS AND MATERIALS: One hundred ten patients were randomly assigned to 1 of 2 bladder-filling protocols; 540 mL (3 cups) of water or 1080 mL (6 cups) of water, in a single institution trial. A portable ultrasound device, BladderScan BVI 6400 (Verathon Inc, Bothell, WA), measured BVs at treatment planning computed tomography (TPCT) scan and 3 times per week during RT. Maximum bladder dose and BV receiving ≥ 50, 60, and 70 Gy were recorded. Acute and late GU and GI toxicity were evaluated, as were patients' comfort, perception of urinary symptoms, and quality of life (QoL). RESULTS: There was significantly less BV variation in the 540 mL arm when compared with 1080 mL (median: 76 mL vs 105 mL, P = .003). Larger BVs on initial TPCT correlated with larger BV variations during RT (P < .0005). There were no statistically significant associations between arm and GU/GI toxicity, dose median comfort scores, or median QoL scores. CONCLUSIONS: The 540 mL bladder-filling arm resulted in reproducible BVs throughout a course of RT, without any deterioration in QoL or increase in toxicities for prostate patients.