A retrospective study of outcomes and the validation of the Sheffield Gastrostomy Score in PEGs, RIGs and PIGs.

INTRODUCTION: There are limited studies comparing the safety and effectiveness of Radiologically Assisted Gastrostomies (RAGs) against Percutaneous Endoscopic Gastrostomies (PEGs). The Sheffield Gastrostomy Score (SGS) can be used to help predict 30-day mortality, more information is needed on its validity in RAGs. Our aim is to compare mortality between RAGs (Radiologically Inserted Gastrostomies (RIGs) and Per-oral Image Guided Gastrostomies (PIGs)) with PEGs and validate the SGS. METHOD: Data on gastrostomies newly inserted in three hospitals from 2016-2019 were retrospectively collected. Demographics, indication, insertion date, date of death, inpatient status and blood tests (albumin, CRP and eGFR) were recorded. RESULTS: 1977 gastrostomies were performed: Gastrostomy mortality at 7 days was 1.3% and at 30 days was 6%. There was a 5% 30-day mortality for PEGs, 5.5% RIGs, 7.2% PIGs (p = 0.215). Factors increasing 30 day mortality were age ≥60 years (p = 0.039), albumin <35 g/L (p = 0.005), albumin <25 g/L (p < 0.001) and CRP ≥10 mg/L (p < 0.001). For patients who died within 30 days; 0.6% had an SGS of 0, 3.7% = 1, 10.2% = 2 and 25.5% = 3, with similar trends for RAGs and PEGs. ROC curves showed the area under the curve for all gastrostomies, RAGs and PEGs as 0.743, 0.738, 0.787 respectively. DISCUSSION: There was no significant difference between 30-day mortality for PEGs, RIGs and PIGs. Factors predicting risk include age ≥60 years, albumin <35 g/L, albumin <25 g/L and CRP ≥10 mg/L. The SGS has been validated in this study for PEGs and for the first time in RAGs as well..

The adjuvant GLA-AF enhances human intradermal vaccine responses.

Adjuvants are key to shaping the immune response to vaccination, but to date, no adjuvant suitable for human use has been developed for intradermal vaccines. These vaccines could be self-administered and sent through the mail as they do not require long needles or technical expertise in immunization. In the event of a pandemic outbreak, this approach could alleviate the congregation of patients in health centers and thus reduce the potential of these centers to enhance the spread of lethal infection. A reliable and potent vaccine system for self-administration would provide an effective countermeasure for delivery through existing product distribution infrastructure. We report results from preclinical and clinical trials that demonstrate the feasibility of an adjuvanted, intradermal vaccine that induced single shot protection in ferrets and seroprotection in humans against one of the more lethal strains of pandemic flu, Indonesia H5N1. In the human trial, the vaccine was safe and clinical responses were above approvable endpoints for a protective flu vaccine. Inclusion of a modern TLR4 (Toll-like receptor 4) agonist-based adjuvant was critical to the development of the response in the intradermal groups. In humans, this is the first report of a safe and effective intradermal adjuvant, GLA-AF (aqueous formulation of glucopyranosyl lipid adjuvant), and provides a future path for developing a vaccine-device combination for distribution by mail and self-administration in case of a pandemic.