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

Corporalidade e desejo: Tudo sobre minha mãe e o gênero na margem Embodiment and desire: All About My Mother and gender in the margin

Análise do filme Tudo sobre minha mãe, do cineasta espanhol Pedro Almodóvar, enfocando a personagem travesti Agrado. Depois de uma comparação com outros filmes que abordam o fenômeno transgênero, é feita uma discussão em torno da noção de corporalidade e da construção do sujeito, dialogando sobretudo com as teorias do corpo da etnologia ameríndia brasileira. O ensaio busca propor alguns elementos para uma reflexão sobre a importância da análise de experiências de margem na renovação teórica no campo dos estudos feministas e de gênero. A experiência corporificada de 'tornar-se outro' dramatiza os mecanismos de construção da diferença e se apresenta como um empreendimento anti-hierárquico desestabilizador de políticas dominantes da subjetividade.<br>This essays does a reading of Pedro Almodovar's film All About My Mother, focusing on the transvestite character, Agrado. After drawing a comparison with other films on the subject of transgendering, I discuss notions of embodiedness and the construction of the subject by placing them in the context of theories about the body in Brazilian ethnology. My purpose is to offer some elements for a reflection on the experiences at/of the margins as a way of renewing the theoretical debates in feminist and gender studies. The bodily experience of 'becoming the other' dramatizes the mechanisms that are in play in the construction of difference and can be seen as an anti-hierarchical force destabilizing dominant politics of subjectivity