Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Contains fulltext : 110505.pdf (publisher's version ) (Open Access)BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Advanced colorectal cancer resulting in acute bowel obstruction during pregnancy; a case report

Introduction: Abdominal pain is frequently found in the pregnant population; however life-threatening pathology such as colorectal cancer does occur rarely. As such, intestinal obstructions are usually attributed to pregnancy-related issues. We present the case of a young woman with an acute bowel obstruction caused by advanced colorectal carcinoma. Presentation of Case: A 34-year old pregnant woman was referred to our emergency department with complaints of severe upper abdominal pain. Initial investigations did not show abdominal pathology and conservative treatment for obstipation was commenced. However, complaints persisted and a near blowout of the colon was diagnosed, prompting a caesarean section and diagnostic laparotomy. An obstructing tumour was found and a left-sided hemi-colectomy was performed. Unfortunately, skeletal, lymphatic and additional hepatogenic metastasis were discovered during chemotherapy and treatment was discontinued. Discussion and conclusion: The mainstay of abdominal complaints during pregnancy can be attributed to normal physiological alterations associated with gravidity. Nonetheless serious pathology should be considered, especially when conservative treatment fails. On this note, diagnostic imaging during pregnancy should be used promptly upon suspicion of serious abdominal pathology

House of the Rising Flames:A Hands-on, Bug-centered Tutorial on Embedded Software Testing

For software testing teachers interested in extending their CS students' experience, we propose an innovative solution that adds two, less traditional-yet fascinating-ingredients: hardware and mistakes. Highlighted here are a few original components, including: (1) miniature, microcontroller-based systems-under-test that mimic real-life IoT devices, such as a smart home; (2) a gentle tutorial on how embedded systems work and fail, and (3) a bug-hunting game to assess students' testing skills. A first deployment to 96 Msc CS students showed that their frequent, unforgettable "Eureka!"moments richly compensate for (limited) accidental hardware damage and (substantial) technical and financial efforts. Future plans include extending the collection of systems and bugs, and sharing the design of this unusual-for-CS intervention with other interested educators. Our hope is that a new generation of professionals will emerge, better prepared to engineer the safe systems we all can rely on.</p

VU-BugZoo:A Persuasive Platform for Teaching Software Testing

Although key for safeguarding quality, software testing is generally considered an unattractive chore by CS students and IT professionals alike. In an attempt to remedy this situation, we have crafted VU-BugZoo, a digital platform to teach software testing, based on a repository of faulty (standalone and embedded) code. The innovation consists of engaging instructors and students in an exciting bug-hunting experience, where the trophies deserve the same attention as the weapons. This poster presents our work-in-progress

Agro-Nutri Monitor 2020 : Monitor prijsvorming voedingsmiddelen en analyse belemmeringen voor verduurzaming

Het ministerie van Landbouw, Natuur en Voedselkwaliteit (LNV) wil dat boeren en tuinders die duurzamer produceren daarbij geen problemen ondervinden die te maken hebben met de prijsvorming. De Agro-Nutri Monitor draagt hieraan bij door de prijsvorming in de keten inzichtelijk te maken en eventuele problemen bij de prijsvorming aan het licht te brengen die verduurzaming van de ketens belemmeren. De monitor vergelijkt de prijsvorming van een aantal gangbare producten met die van biologische varianten van het product, en kijkt ook in kwalitatieve zin naar een aantal duurzaamheidsvarianten binnen het gangbare segment

Agro-Nutri Monitor 2021 - Achtergrondrapport : Monitor prijsvorming voedingsmiddelen en analyse belemmeringen voor verduurzaming

In dit achtergrondrapport bij de Agro-Nutri Monitor 2021 worden voor een aantal belangrijke producten van de Nederlandse land- en tuinbouw de prijsvorming en de belemmeringen voor omschakeling naar producten met een duurzaamheidkeurmerk beschreven. De producten zijn consumptieaardappelen (met een focus op tafelaardappelen), uien, spruitkool, peren, tomaten, melk en varkensvlees. Deze producten vormen gezamenlijk een aantal casussen aan de hand waarvan in de Agro-Nutri Monitor 2021 de hoofdvragen van het onderzoek worden beantwoord

Agro-Nutri Monitor 2021 - Hoofdrapport : Monitor prijsvorming voedingsmiddelen en analyse belemmeringen voor verduurzaming

Deze Agro-Nutri Monitor is een vervolg op de vorig jaar verschenen eerste monitor. De monitor is in opdracht van de Autoriteit Consument & Markt (ACM) opgesteld door Wageningen Economic Research. Het doel van de monitor is om de prijsvorming in de keten, van boer tot de Nederlandse supermarkt, inzichtelijk te maken en eventuele problemen bij de prijsvorming aan het licht te brengen die verduurzaming van de ketens belemmeren