Proposed follow up programme after curative resection for lower third oesophageal cancer

The incidence of oesophageal adenocarcinoma has risen throughout the Western world over the last three decades. The prognosis remains poor as many patients are elderly and present with advanced disease. Those patients who are suitable for resection remain at high risk of disease recurrence. It is important that cancer patients take part in a follow up protocol to detect disease recurrence, offer psychological support, manage nutritional disorders and facilitate audit of surgical outcomes. Despite the recognition that regular postoperative follow up plays a key role in ongoing care of cancer patients, there is little consensus on the nature of the process. This paper reviews the published literature to determine the optimal timing and type of patient follow up for those after curative oesophageal resection

A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

Position paper: The potential role of optical biopsy in the study and diagnosis of environmental enteric dysfunction

Environmental enteric dysfunction (EED) is a disease of the small intestine affecting children and adults in low and middle income countries. Arising as a consequence of repeated infections, gut inflammation results in impaired intestinal absorptive and barrier function, leading to poor nutrient uptake and ultimately to stunting and other developmental limitations. Progress towards new biomarkers and interventions for EED is hampered by the practical and ethical difficulties of cross-validation with the gold standard of biopsy and histology. Optical biopsy techniques — which can provide minimally invasive or noninvasive alternatives to biopsy — could offer other routes to validation and could potentially be used as point-of-care tests among the general population. This Consensus Statement identifies and reviews the most promising candidate optical biopsy technologies for applications in EED, critically assesses them against criteria identified for successful deployment in developing world settings, and proposes further lines of enquiry. Importantly, many of the techniques discussed could also be adapted to monitor the impaired intestinal barrier in other settings such as IBD, autoimmune enteropathies, coeliac disease, graft-versus-host disease, small intestinal transplantation or critical care

Clinical and economic burden of procedural sedation-related adverse events and their outcomes: analysis from five countries

Rhodri Saunders,1 Jason A Davis,1 Peter Kranke,2 Rachel Weissbrod,3 David K Whitaker,4 Jenifer R Lightdale5 1Coreva Scientific GmbH &amp; Co KG, Freiburg, Germany; 2Department of Anaesthesia and Critical Care, University of W&uuml;rzburg, W&uuml;rzburg, Germany; 3Medical Affairs, Medtronic, Jerusalem, Israel; 4Department of Anaesthesia, Manchester Royal Infirmary, Manchester, UK; 5Pediatric Gastroenterology, Hepatology and Nutrition, University of Massachusetts, Worcester, MA, USA Background: Studies have reported on the incidence of sedation-related adverse events (AEs), but little is known about their impact on health care costs and resource use.Methods: Health care providers and payers in five countries were recruited for an online survey by independent administrators to ensure that investigators and respondents were blinded to each other. Surveys were conducted in the local language and began with a &ldquo;screener&rdquo; to ensure that respondents had relevant expertise and experience. Responses were analyzed using Excel and R, with the Dixon&rsquo;s Q statistic used to identify and remove outliers. Global and country-specific average treatment patterns were calculated via bootstrapping; costs were mean values. The sum product of costs and intervention probability gave a cost per AE.Results: Responses were received from 101 providers and 26 payers, the majority having &gt;5&nbsp;years of experience. At a minimum, the respondents performed a total of 3,430 procedural sedations per month. All AEs detailed occurred in clinical practice in the last year and were reported to cause procedural delays and cancellations in some patients. Standard procedural sedation costs ranged from &euro;74 (Germany) to $2,300 (US). Respondents estimated that AEs would increase costs by between 16$43 (27–68). Other frequent AEs, including mild hypotension, bradycardia, tachycardia, mild oxygen desaturation, hypertension, and brief apnea, were estimated to increase health care spending on procedural sedation by $2.2 billion annually in the US.Conclusion: All sedation-related AEs can increase health care costs and result in substantial delays or cancellations of subsequent procedures. The prevention of even minor AEs during procedural sedation may be crucial to ensuring its value as a health care service. Keywords: costs, complications, moderate sedation, questionnaire, survey, health care payer