Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial

Background: Each year approximately 3000 patients in the United Kingdom undergo surgery for esophagogastric cancer. Jejunostomy feeding tubes, placed at the time of surgery for early postoperative nutrition, have been shown to have a positive impact on clinical outcomes in the short term. Whether feeding out of hospital is of benefit is unknown. Local experience has identified that between 15 and 20% of patients required ‘rescue’ jejunostomy feeding for nutritional problems and weight loss while at home. This weight loss and poor nutrition may contribute to the detrimental effect on the overall quality of life (QoL) reported in these patients. Methods/Design: This randomized pilot and feasibility study will provide preliminary information on the routine use of jejunostomy feeding after hospital discharge in terms of clinical benefits and QoL. Sixty participants undergoing esophagectomy or total gastrectomy will be randomized to receive either a planned program of six weeks of home jejunostomy feeding after discharge from hospital (intervention) or treatment-as-usual (control). The intention of this study is to inform a multi-centre randomized controlled trial. The primary outcome measures will be recruitment and retention rates at six weeks and six months. Secondary outcome measures will include disease specific and general QoL measures, nutritional parameters, total and oral nutritional intake, hospital readmission rates, and estimates of healthcare costs. Up to 20 participants will also be enrolled in a qualitative sub-study that will explore participants’ and carers’ experiences of home tube feeding. The results will be disseminated by presentation at surgical, gastroenterological and dietetic meetings and publication in appropriate peer review journals. A patient-friendly lay summary will be made available on the University of Leicester and the University Hospitals of Leicester NHS Trust websites. The study has full ethical and institutional approval and started recruitment in July 2012. Trial registration: UKClinical Research Network ID #12447 (Main study); UKCRN ID#13361 (Qualitative sub study); ClinicalTrials.gov #NCT01870817 (First registered 28 May 2013

A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

BACKGROUND: Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients. METHODS: Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences. RESULTS: Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking part, and 3) uncertainty of the study process. CONCLUSIONS: This study demonstrated that home enteral feeding by jejunostomy was feasible, safe and acceptable to patients and their carers. Whether home enteral feeding as 'usual practice' is a cost-effective therapy would require confirmation in an appropriately powered, multi-centre study. TRIAL REGISTRATION: UK Clinical Research Network ID 12447 (main trial, first registered 30 May 2012); UK Clinical Research Network ID 13361 (qualitative substudy, first registered 30 May 2012); ClinicalTrials.gov NCT01870817 (first registered 28 May 2013)

The Finance Act 1956 and the switching of Pension Schemes

The word ‘switch’ has come to be used to describe a variety of operations in connexion with pension schemes. A scheme may be ‘switched’ from one life office to another; a scheme may be ‘switched’ from without-profits to with-profits; or the two operations may be combined. This paper attempts to deal, however, with an operation which is the direct result of the Finance Act 1956—the switching of a scheme approved under Section 388(1) of the Income Tax Act 1952 to a scheme approved under Section 379 of the same Act—and it is assumed that the operation takes place within the one life office.The operation in question has its origin in the somewhat detached view of life taken by our legislators and by the administrators whose duty it is to advise them.</jats:p

A Supported Primary Health Pathway for Mild Traumatic Brain Injury: Quality Improvement Report

Introduction: Best-practice guidelines recommend that patients are followed-up to check if they have recovered following a mild traumatic brain injury (mTBI) and to refer to concussion services, if needed. However, in New Zealand, rates of follow-up are low and access to concussion services can be delayed. Aim: We aimed to improve rates of follow-up and access to concussion services for mTBI patients aged ≥8 years by the implementation of a supported health pathway and test its success. Methods: The pathway included a decision support tool, funded follow-up appointments, clinician training and a patient education resource. Sociodemographics, injury details and proportions of patients receiving a follow-up by type and time were extracted from the Accident Compensation Corporation (ACC) database between 18 May 22 and 30 June 23 and compared to national ACC data prior to implementation. Results: Data were extracted for 220 patients, with a mean age of 31.5 years, 51.4% female and 21.4% Māori and Pacific. There was an increase in the proportion of patients receiving a follow-up from 36% pre-implementation to 56.8% post-implementation. Sixty-three patients (28.6%) accessed a concussion service post-implementation compared to 10% pre-implementation. Time to concussion service reduced from an average of 55 (s.d. = 65.4) to 37 days (29.5). Discussion: Risk factor criteria within the decision support tool need to be weighted to improve specificity of referrals. Timing from injury to medical review in primary care needs to be considered. This quality improvement project provides preliminary evidence for implementation of a supported health care pathway for mTBI