Children with Moderate Acute Malnutrition with No Access to Supplementary Feeding Programmes Experience High Rates of Deterioration and No Improvement: Results from a Prospective Cohort Study in Rural Ethiopia

Background: Children with moderate acute malnutrition (MAM) have an increased risk of mortality, infections and impaired physical and cognitive development compared to well-nourished children. In parts of Ethiopia not considered chronically food insecure there are no supplementary feeding programmes (SFPs) for treating MAM. The short-term outcomes of children who have MAM in such areas are not currently described, and there remains an urgent need for evidence-based policy recommendations. Methods: We defined MAM as mid-upper arm circumference (MUAC) of ≥11.0cm and <12.5cm with no bilateral pitting oedema to include Ethiopian government and World Health Organisation cut-offs. We prospectively surveyed 884 children aged 6–59 months living with MAM in a rural area of Ethiopia not eligible for a supplementary feeding programme. Weekly home visits were made for seven months (28 weeks), covering the end of peak malnutrition through to the post-harvest period (the most food secure window), collecting anthropometric, socio-demographic and food security data. Results: By the end of the study follow up, 32.5% (287/884) remained with MAM, 9.3% (82/884) experienced at least one episode of SAM (MUAC <11cm and/or bilateral pitting oedema), and 0.9% (8/884) died. Only 54.2% of the children recovered with no episode of SAM by the end of the study. Of those who developed SAM half still had MAM at the end of the follow up period. The median (interquartile range) time to recovery was 9 (4–15) weeks. Children with the lowest MUAC at enrolment had a significantly higher risk of remaining with MAM and a lower chance of recovering. Conclusions: Children with MAM during the post-harvest season in an area not eligible for SFP experience an extremely high incidence of SAM and a low recovery rate. Not having a targeted nutrition-specific intervention to address MAM in this context places children with MAM at excessive risk of adverse outcomes. Further preventive and curative approaches should urgently be considered

Production Costs and Expected Returns; Alternative Crop and Livestock Enterprises; Clay Soils in the Northern Portion of the Rolling Plains of Texas.

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The comparative responsiveness of Hospital Universitario Princesa Index and other composite indices for assessing rheumatoid arthritis activity

Objective To evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria. Methods Secondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Delta) of HUPI with Delta in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (Delta GDA-Phy). Results Delta HUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI's standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using Delta GDA-Phy as gold standard. Conclusion HUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR''s

Advent (Video)

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Advent

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Barriers to phase I clinical trial protocol IRB approval at KCI

9080 Phase I oncology clinical trials are critical in the oncology drug development process. To protect human subjects, every phase 1 protocol must be approved by an institutional review board (IRB) to assure safety before patient accrual. As the volume and complexity of phase 1 trials have increased, the amount of time spent on IRB protocol reviews have also increased for various reasons. Objectives: 1) Determine the average time spent on protocol approval by IRB at KCI/WSU; 2) Identify potential issues raised by IRB resulting in approval delays; 3) Identify the redundancies for which “standard language” implementation could facilitate future IRB applications thereby expediting approval. Methods: 96 Phase 1 research IRB applications at KCI/WSU between 8/1/2005 and 10/31/2006 were reviewed. These applications were stratified based on submission (new protocol versus amendment) and IRB approval (tabled, provisional or approved) status. Concerns frequently brought up by the IRB were identified. Results: The average and median time spent from initial submission to final approval of all 96 applications were 41.4 days and 43 days, respectively. Forty eight of 96 applications (50%) were provisionally approved from the initial review. Average and median time of obtaining final approval were 52.5 days and 52 days. Nine of 96 (9.4%) protocols were tabled with their average approval 83 days. The most common concerns raised by IRB were risks/benefit issues. These concerns were an even greater approval barrier when protocols involved specialized technologies of molecular therapeutics or complicated study designs. Regulatory policy changes issued by oversight organizations also required “real-time” updates into protocols and consent form amendments. Areas of “standard language” for future IRB applications are being compiled and will be discussed upon presentation. Conclusion: Phase 1 clinical trials are essential to anti-cancer drug development. The complicated ethical issues and science warrant an ongoing constructive collaboration of both parties. Identification of commonalities that delay IRB approval will lead to more expeditious IRB approval not only at our institution, but could also benefit other institutions. No significant financial relationships to disclose. </jats:p

Performance Monitoring of a Nearshore Berm at Ft. Myers Beach, Florida: Final Report

This report documents the placement and monitoring of an active nearshore berm at Ft. Myers Beach, Florida. From May to July 2009, mixed sand and finer sediment dredged from a nearby inlet were placed in the active littoral zone in the form of a bar-shaped nearshore berm. Six sets of beach-nearshore profile surveys and two periods of sediment sampling along profiles were collected. The Ft. Myers Beach nearshore berm migrated onshore roughly 300 ft during the first 2 years. The elevation of the berm crest increased up to 2 ft. Nearly half of the onshore migration occurred during the first 9 months post-construction. Greater distances of onshore migration were measured during the more energetic winter seasons than during calmer summer seasons. No offshore migration was measured during the entire 2-year study period. The shape of the nearshore berm evolved from a roughly symmetrical bell-shaped bar to a highly asymmetrical shape with a steep landward slope, typical of a landward migrating bar. At the end of the 2-year period, the berm migrated to roughly 150 to 200 ft from mean sea level shoreline. The dry beach landward of the berm and along the adjacent beaches remained stable over the 2-year period. A primary concern of this project was the dispersion of fine sediment following placement. Results of sediment sampling indicated that some of the fine material initially migrated in to the nearshore trough and was then dispersed further offshore after several months. Onshore-directed transport and deposition of coarser sand fractions and offshore-directed transport and deposition of fine fractions were observed. The nearshore berm had negligible influence on the characteristics of the dry beach sediment, which remained to be well-sorted, fine sand. The constructed berm showed considerable longshore variation in morphology, including several gaps/depressions. These gaps were maintained over the 2-year period, although longshore and cross-shore migrations were measured. Future studies should include continued monitoring to document potential attachment of the nearshore berm to the dry beach

Long-Term Efficacy and Safety of Deferasirox (Exjade®, ICL670), a Once-Daily Oral Iron Chelator, in Patients with Sickle Cell Disease (SCD).

Abstract Background: Many patients with SCD require acute or chronic transfusions to manage serious crises or prevent stroke. With age, there is also a risk of progressive renal dysfunction. A 1-year comparative study (109) in iron-overloaded patients with SCD demonstrated similar dose-dependent liver iron concentration (LIC) reductions with once-daily oral deferasirox and deferoxamine (DFO). This analysis presents cumulative long-term efficacy and safety data for patients with SCD receiving deferasirox treatment in a 4-year extension trial. Methods: In the 1-year core phase, deferasirox and DFO doses were assigned according to baseline LIC. In the extension study, patients either continued treatment with deferasirox (deferasirox cohort) or crossed over from DFO to deferasirox (crossover cohort). Patients with abnormal renal function were excluded. Dose adjustments during the extension phase were based on weight changes, serum ferritin (SF), creatinine, liver function tests and skin rash. Efficacy was determined by monthly SF; safety assessments included all adverse event (AE) monitoring, lab parameters, and ocular, auditory, and physical exams. Data were analyzed with a cut-off of 31 March 2007. Results: 185 patients entered the extension phase, 132 patients in the deferasirox cohort and 53 patients in the crossover cohort. Patients in the deferasirox cohort have received treatment for a median of 2.1 years. There have been 33 discontinuations (26 deferasirox, 7 crossover patients; 18%) due to: AEs (10), consent withdrawal (12), lost to follow-up (8), unsatisfactory chelation (2), and other (1). Only 1 patient has discontinued in the past 12 months due to pregnancy. No deaths have occurred during this study. In the deferasirox cohort, patients who initially received deferasirox 5/10 mg/kg/d had an increase from baseline in median SF levels at 12 months (+50 ng/mL; baseline 2805 ng/mL), which gradually declined and reached baseline at 24 months (−140 ng/mL) following a dose increase to approximately 20 mg/kg/d (starting at 12 months). SF was either maintained or reduced from baseline in the initial 20 and 30 mg/kg/d dose groups. Patients continue to receive deferasirox treatment in the extension phase trial and, as more data accumulate, the long-term effect of deferasirox at doses of 20–30 mg/kg/day will continue to be assessed. There were no significant changes in markers of liver or renal function in either cohort, and no cases of progressive increases in serum creatinine. The most frequent AEs were vomiting (n=10), nausea (n=23), and diarrhea (n=19); 9 patients experienced skin rash. Most AEs were mild and occurred during the core phase, with a steady decrease in incidence during the extension. No new AEs or safety concerns have been reported thus far in the extension study. Conclusions: Deferasirox demonstrates dose-dependent efficacy in patients with SCD, with a manageable tolerability profile and no new AEs reported over a median of 2.1 years of treatment.</jats:p