Ecological Systems Affecting Urban Childbearing Puerto Rican Women in the City of Philadelphia

Maternal and Child Health Journal - The purpose of this study was to explore socio-ecological influences affecting the daily lives of urban, pregnant Puerto Rican women and factors negatively...     

Clinical Transformation: Manager’s Perspectives on Implementation of Evidence-Based Practice

Implementation of evidence-based practices (EBPs) is highly encouraged within mental health services. This single case study examines the process of an EBP implementation effort, guided by the National Implementation Research Network (NIRN) implementation model, from the perspective of behavioural healthcare managers in a child and youth mental health provider organization. Qualitative methods identified process themes emerging over 3 years of an organizational change process that support and refine the NIRN model. Dedicated management oversight and implementation teams are essential for EBP implementation; practice leads and practice coaches are useful implementation innovations; and organizations seeking to implement several EBPs simultaneously must guard against organizational absorptive capacity. These findings can guide EBP implementation in child and youth behavioural healthcare.     

Fludarabine-based cytoreductive regimen and T-cell-depleted grafts from alternative donors for the treatment of high-risk patients with Fanconi anaemia

Eighteen consecutive patients aged 5·5–24 years with Fanconi anaemia and diagnoses of aplastic anaemia ( n  = 8), myelodysplastic syndrome ( n  = 4), acute myeloid leukaemia ( n  = 6), received allogeneic haematopoietic stem cell transplants from alternative donors. All patients had been transfused, 13 had previously been treated with androgens and 14 had a history of infection. Donors were related human leucocyte antigen (HLA) mismatched for eight patients, unrelated HLA mismatched for seven patients and unrelated HLA matched for three patients. Cytoreduction included single dose total body irradiation (450 cGy), fludarabine (150 mg/m²) and cyclophosphamide (40 mg/kg). Immunosuppression included antithymocyte globulin and tacrolimus. Grafts were granulocyte colony-stimulating factor-mobilized, CD34⁺ T-cell-depleted peripheral blood stem cells in 15 patients and T-cell-depleted marrows in three. All 18 patients engrafted with 100% donor chimaerism; only one patient developed graft-versus-host disease (GVHD). With a median follow-up of 4·2 years, 13/18 patients were alive, 12 of these were disease-free. Five-year overall survival and disease-free survival were 72·2% and 66·6% respectively. Immune reconstitution was achieved at approximately 6 months post-transplant for most patients. These are encouraging results of T-cell-depleted transplants from alternative donors using fludarabine-based cytoreduction in 18 high-risk patients with Fanconi anaemia, with no evidence of rejection and minimal GVHD.     

Long-term follow-up evaluation of endoscopic sclerotherapy for dilated gastrojejunostomy after gastric bypass

Background

Endoscopic sclerotherapy using sodium morrhuate has been used to treat patients with weight regain after Roux-en-Y gastric bypass whose presumed etiology is loss of restriction due to gastrojejunostomy dilation. Weight loss and stability have been demonstrated in several studies with short-term follow-up evaluation.

Methods

This retrospective review evaluated all the patients who underwent sclerotherapy for a dilated gastrojejunostomy between 2007 and 2012.

Results

The study identified 48 patients with a mean follow-up period of 22 months (range 12–60 months). The mean age of these patients was 47.5 ± 10.5 years, and 92 % were women. The average weight loss from the primary procedure was 132.5 ± 54.82 lb, and the average weight regain from the lowest weight to the maximum weight before sclerotherapy was 46 ± 40.32 lb. The median number of sclerotherapy sessions was two (range 1–4). The pre-procedure mean gastrojejunostomy diameter was 20 ± 3.6 mm, and the mean volume of sodium morrhuate injected per session was 12.8 ± 3.7 ml. The average weight loss from sclerotherapy to the final documented weight was 3.17 ± 19.70 lb, which was not statistically significant. The following variables in the multivariate analysis were not associated with statistically significant weight loss: volume of sodium morrhuate, patient age, gastrojejunostomy diameter, number of sclerotherapy sessions, decrease in gastrojejunostomy diameter between the first and second sessions, and number of follow-up years. Weight stabilization or loss was achieved by 58 % of our cohort, with a mean weight loss of 15.9 ± 14.6 lb in this subgroup.

Conclusion

The long-term follow-up evaluation of patients undergoing sclerotherapy of the gastrojejunostomy for weight regain after gastric bypass showed only a marginal weight loss, which was not statistically significant in our study population, although more than 50 % of the patients achieved weight loss or stabilization.     

Use of endoscopic stents to treat anastomotic complications after bariatric surgery

BACKGROUND: Complications after bariatric surgery often require longterm parenteral nutrition to achieve healing. Recently, endoscopic treatments have become available that provide healing while allowing for oral nutrition. The purpose of this study was to present outcomes of the largest series to date treating staple line complications after bariatric surgery with endoscopic covered stents. STUDY DESIGN: A retrospective evaluation was performed of all patients treated for staple line complications after bariatric surgery at a single tertiary care bariatric center. Acute postoperative leaks, chronic gastrocutaneous fistulas, and anastomotic strictures refractory to endoscopic dilation after both gastric bypass and sleeve gastrectomy were included. RESULTS: From January 2006 to June 2007, 19 patients (11 with acute leaks, 2 with chronic fistulas, and 6 with strictures) were treated with a total of 34 endoscopic silicone covered stents (23 polyester, 11 metal). Mean followup was 3.6 months. Immediate symptomatic improvement occurred in 90% (91% of acute leaks, 100% of fistulas, and 84% of strictures). Oral feeding was started in 79% of patients immediately after stenting. Resolution of leak or stricture after stent treatment occurred in 16 of 19 patients (84%). Healing of leak, fistula, and stricture occurred at means of 33 days, 46 days, and 7 days, respectively. Three patients (1 with leak, 1 with fistula, and 1 with stricture) had unsuccessful stent treatment. Migration of the stent occurred in 58% of 34 stents placed. Most migration was minimal, but three stents were removed surgically after distal small bowel migration. There was no mortality. CONCLUSIONS: Treatment of anastomotic complications after bariatric surgery with endoscopic covered stents allows rapid healing while simultaneously allowing for oral nutrition. The primary morbidity is stent migration.     

A systematic review of diabetes self-care interventions for older,African American,or Latino adults

PURPOSE: This study systematically identified and examined published self-care interventions designed to improve glycemic control or quality of life (QoL) among older, African American, or Latino adults. METHODS: Six electronic databases were searched. Eligible publications were those that described an intervention to change knowledge, beliefs, or behavior among adults with diabetes who were either older than 55 years, African American, or Latino, and that measured the outcomes of glycemic control or QoL. RESULTS: Twelve studies met the inclusion criteria, of which 8 were randomized controlled trials (RCTs). Of the 8 RCTs, improved glycemic control was reported in the intervention arm of 5 RCTs compared with the control arm. Of the 4 RCTs that examined QoL, improved QoL was reported in the intervention arm of 1 study. Characteristics of successful interventions included poor glycemic control at baseline (A1C > 11%), cultural or age-tailoring the intervention, use of group counseling or support, and involvement of spouses and adult children. CONCLUSIONS: Large-scale clinical trials designed according to cultural and age criteria specific for older Latinos and African Americans with diabetes are needed to determine how best to address this growing public health problem.     

Regulatory aspects of noninvasive glucose measurements

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.