The Philadelphia Episiotomy Intervention Study

OBJECTIVE: To lower the episiotomy rate through physician education and documentation of indication when episiotomy was performed. STUDY DESIGN: The intervention consisted of an evidence-based lecture recommending limited usage of episiotomy and requesting documentation of any episiotomy's indication. Data 3 months prior to the intervention were compared to those of the year following. Adjusted comparisons of episiotomy rates were completed using multivariate logistic regression models. RESULTS: For all vaginal deliveries, there was a 17% decrease in the rate of episiotomy, from 46.9% to 38.8%. For spontaneous vaginal deliveries, there was a 25% decrease in the episiotomy rate, from 40.8% to 30.8%. The most common indications for episiotomy reported were routine/elective, 41.0%; vacuum, 18.6%; forceps, 16.4%; and nonreassuring fetal heart tracing, 10.9%. CONCLUSION: Episiotomy rates may be effectively reduced through physician education and documentation of procedure indication.     

Chronic effects of nitrendipine on renal hemodynamics and tubular transport

The effects of nitrendipine (10 mg, during acute clearance experiments) given both acutely and after 2 weeks of administration were examined in normal and hypertensive subjects. At the initiation of therapy, nitrendipine caused an increase in glomerular filtration rate and effective renal plasma flow in the hypertensive, but not in the normal, group. Percentage excretion rates of sodium (%ENa) and phosphate (%EPi) and free water clearance (CW) increased in both groups at the initiation of therapy. After 2 weeks of nitrendipine therapy repeat acute clearance studies showed that the drug no longer increased glomerular filtration rate or effective renal plasma flow in hypertensive subjects, the increases in %ENa and CW persisted in normal subjects and trended upward in hypertensive subjects, and the increase in %EPi persisted in both normal and hypertensive individuals. We conclude that nitrendipine is not sodium retentive after chronic therapy and the acute increase in %ENa, %EPi, and CW after its initial administration suggests a proximal tubular effect.     

Influence of pupil size and other test variables on visual function assessment using visual evoked potentials in normal subjects

The purpose of this study was to assess the influence of pupil size and optical blur on measurements obtained with isolated-check visual evoked potential (icVEP). Two stimulus conditions of icVEP, +15 and −15% contrasts, were studied in normal subjects with normal (N), miotic (M), and dilated (D) pupils. The effects of optical blur were studied in subjects with normal pupil. Response to visual stimuli was quantified by a signal-to-noise (SNR) ratio. In 30 normal subjects, the mean age was 26.0 ± 3.4 years. Mean pupil diameters were N = 4.2 ± 0.6 mm, M = 2.7 ± 0.6 mm, and D = 7.3 ± 0.9 mm. For both +15 and −15% contrast levels, mean SNR values were reduced for dilated and constricted pupils when compared with normal pupils. Mean SNR values for optical blur with a +2 or +3 diopter lens placed over the distance correction were reduced when compared with SNR measurements obtained with best-corrected visual acuity under both +15 and −15% contrast levels. Statistical significance was found in comparisons of N versus M (P < 0.001) and N versus D (P = 0.002) for +15 and −15% contrast conditions, respectively. No statistical difference was seen for M versus D (P = −0.435). The effect of optical blur was statistically significant when compared to the normal pupils with best-corrected vision (P < 0.001). No statistically significant difference was found comparing +2 and +3 diopters lenses for optical blur testing. Visual evoked potential values are influenced by pupillary constriction and dilation, as well as optical blur. When obtaining icVEP measurements, the influence of pupil size and optical blur should be kept in mind for accurate interpretations.     

Restoration of intestinal continuity after colectomy for non-occlusive ischemic colitis

Background

Non-occlusive ischemic colitis (IC) is a rare and life-threatening abdominal disease associated with high rates of postoperative mortality. When surgery is performed, in patients with IC, either a Hartmann’s procedure (HP) or a total colectomy and ileostomy is required. The possibility of restoration of intestinal continuity in surviving patients is an important issue. The aim of the present study was to report the outcome of surgically managed IC patients and to identify predictive factors for restoration of intestinal continuity and to assess the results of this procedure.

Methods

Between January 1997 and May 2011, 96 IC patients underwent total colectomy and 68 underwent left colectomy. IC was spontaneous in 62 patients and occurred after prior surgery in 102. Eighty patients died during the postoperative period and nine died during the follow-up from an unrelated disease. Fifteen patients were lost to follow-up. The remaining 60 surviving patients were our study population.

Results

There were 44 men and 16 women with a mean age of 67 years ± 12 SD. Restoration of bowel continuity was performed in 24 patients (40 %). There were no predictive factors for restoration of intestinal continuity in terms of sex, age, IC etiology, and the extent of colon resection at primary surgery. The median interval between first surgery and restoration of bowel continuity was 7.9 months (range 0.2–35 months). There were no postoperative deaths and the overall morbidity rate was 45 % (11/24). No patients developed anastomotic leak or underwent unplanned reoperation.

Conclusions

Reversal of HP after IC is feasible in 40 % of surviving patients with acceptable mortality and morbidity rates. This restoration of intestinal continuity should therefore be discussed for every surviving IC patient.     

Benign obstruction of the common hepatic duct (Mirizzi syndrome): diagnosis and operative management

BACKGROUND: Mirizzi syndrome is a rare complication of prolonged cholelithiasis, characterized by narrowing of the common hepatic duct due to mechanical compression and/or inflammation due to biliary calculus impacted in the infundibula of the gallbladder or in the cystic duct. OBJECTIVES: To describe a series of eight consecutive patients with Mirizzi syndrome, at a single institution, submitted to surgical treatment and to comment on their aspects with emphasis on the diagnosis and treatment. METHODS: Four women and four men, with a mean age of 61.6 years (42 to 82 years), presenting Mirizzi syndrome were operated between 1997 and 2003. The following items were evaluated: clinical presentation, laboratory results, preoperative evaluation, operative findings, presence of choledocholithiasis, type of Mirizzi syndrome according to the classification by Csendes, choice of operative procedures, and complications. RESULTS: The most frequent symptoms were abdominal pain (87.5%) and jaundice (87.5%). All the patients presented altered hepatic function tests. The diagnosis of Mirizzi syndrome was intra-operative in seven (87.5%) patients, and preoperative in one (12.5%). Cholecystocholedochal fistula associated with choledocholithiasis was observed in three (37.5%) cases. Mirizzi syndrome was classified as Csendes type I in five (62.5%) patients, type II in one (12.5%), type III in one (12,5%) and type IV in another (12.5%). Cholecystectomy, as an isolated surgical procedure, was performed in four (50.0%) patients. One (12.5%) patient was submitted to partial cholecystectomy and closure of the fistulous orifice with the central part of the infundibula. Two (25.0%) patients were submitted to cholecystectomy and side-to-side choledochoduodenostomy and another (12.5%) to side-to-side choledochoduodenostomy remaining the gallbladder in situ. Seven (87.5%) patients had an uneventful recovery and were discharged in good conditions. One (12.5%) patient presented a postoperative sepsis due to a sub-hepatic abscess, and was reoperated. There was no operative mortality. CONCLUSION: The preoperative diagnosis of Mirizzi syndrome is difficult and an awarded suspicion is necessary to avoid lesions of the biliary tree. The problem may only become evident during the operation due to firm adherences around Calot's triangle. The success of the treatment is related to a precocious recognition of the condition, even at the time of surgery, and adapting the management considering to the individual characteristics of each case.     

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale,design, and baseline characteristics of a randomized,controlled trial

BackgroundThe prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles.HypothesisTo describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D.MethodsThis randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT‐001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real‐world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person‐to‐person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT‐001‐allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at‐home visits for physical measures and blood sample collection.ConclusionsThis randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.     

HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.