BMJ open
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Multicenter Study Comparative Study Pragmatic Clinical Trial
Hughes Abdominal Repair Trial (HART)-abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial.
Incisional hernias are common complications of midline abdominal closure. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial. ⋯ The feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.
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We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. ⋯ The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.
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As the number of cancer survivors is rapidly increasing with the increased incidence of the disease and improved survival of patients, the prevalence of, and risk factors for, mental health problems and suicidality among cancer survivors should be examined. ⋯ Our results reveal an increased risk of suicide attempts among cancer survivors diagnosed early in life and in those for whom more than 10 years has passed since the diagnosis, suggesting the need for intensive monitoring and support for mental health problems and suicidal risks in this population.
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Female genital mutilation (FGM) is an issue of global concern. High levels of migration mean that healthcare systems in higher-income western countries are increasingly being challenged to respond to the care needs of affected communities. Research has identified significant challenges in the provision of, and access to, FGM-related healthcare. There is a lack of confidence and competence among health professionals in providing appropriate care, suggesting an urgent need for evidence-based service development in this area. This study will involve two systematic reviews of qualitative evidence to explore the experiences, needs, barriers and facilitators to seeking and providing FGM-related healthcare in high-income (Organisation for Economic Cooperation and Development) countries, from the perspectives of: (1) women and girls who have undergone FGM and (2) health professionals. ⋯ CRD42015030001: 2015 and CRD42015030004: 2015.
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Randomized Controlled Trial Multicenter Study
Protocol for a randomised pilot multiple centre trial of conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU).
Optimal targets for systemic oxygenation in paediatric critical illness are unknown. Observational data indicate that high levels of arterial oxygenation are associated with poor outcomes in resuscitation of the newborn and in adult critical illness. Within paediatric intensive care units (PICUs), staff prevent severe hypoxia wherever possible, but beyond this there is no consensus. Practice varies widely with age, diagnosis, treating doctor and local or national guidelines followed, though peripheral blood oxygen saturations (SpO2) of >95% are often targeted. The overall aim of this pilot study is to determine the feasibility of performing a randomised trial in critically ill children comparing current practice of liberal SpO2 targets with a more conservative target. ⋯ The trial received Health Research Authority approval on 1 June 2017 (16/SC/0617). Study findings will be disseminated in national and international conferences and peer-reviewed journals.