17 research outputs found

    Development of a Core Outcome Set for Use in Research Evaluations of Interventions Used for Venous Leg Ulceration

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    Background: Venous leg ulceration is a recurring condition causing pain, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified that the outcomes important to all stakeholders are not always reported. Research has also identified that there are a large number of different outcomes being reported, impacting synthesis of results, and clinical decision-making. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. Aim: To develop a core outcome set for research evaluations of interventions used for venous leg ulceration. Methods: 1) A scoping review identified the outcome domains and outcomes that have been reported in randomised controlled trials and qualitative research. 2) eDelphi consensus study on the outcome domains. 3) eDelphi consensus study on the outcomes. Results: 1) The scoping review identified 807 different outcomes that have been reported in the venous leg ulcer randomised controlled trials included in the review. Fifteen outcomes were identified from qualitative studies. 2) Ten outcome domains were rated as core by participants in the consensus study. 3) The consensus study on the outcomes refined the outcome domains to produce a core outcome domain set comprising of 5 outcome domains. Eleven outcomes were rated as core by participants in the consensus study. Conclusion: A core outcome domain set and a set of 11 candidate outcomes have been developed. The development of a core outcome set has the potential to reduce research waste, improve the utility of trials, reduce outcome reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based guidelines

    Debiased ambient vibrations optical coherence elastography to profile cell, organoid and tissue mechanical properties

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    The role of the mechanical environment in defining tissue function, development and growth has been shown to be fundamental. Assessment of the changes in stiffness of tissue matrices at multiple scales has relied mostly on invasive and often specialist equipment such as AFM or mechanical testing devices poorly suited to the cell culture workflow.In this paper, we have developed a unbiased passive optical coherence elastography method, exploiting ambient vibrations in the sample that enables real-time noninvasive quantitative profiling of cells and tissues. We demonstrate a robust method that decouples optical scattering and mechanical properties by actively compensating for scattering associated noise bias and reducing variance. The efficiency for the method to retrieve ground truth is validated in silico and in vitro, and exemplified for key applications such as time course mechanical profiling of bone and cartilage spheroids, tissue engineering cancer models, tissue repair models and single cell. Our method is readily implementable with any commercial optical coherence tomography system without any hardware modifications, and thus offers a breakthrough in on-line tissue mechanical assessment of spatial mechanical properties for organoids, soft tissues and tissue engineering

    Research and policy priorities for addressing prenatal exposure to opioids in Alaska

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    The current opioid crisis in Alaska and the USA will negatively affect the health and wellbeing of future generations. The increasing number of infants born with neonatal opioid withdrawal syndrome (NOWS) has had a profound impact on families, health care providers and the child welfare system. This manuscript summarises the main themes of a Symposium held in Anchorage, Alaska with health care providers, researchers, elders and public health officials that focused on identifying emerging challenges, trends and potential solutions to address the increasing number of infants and children affected by maternal opioid use. Five areas of importance for research and policy development that would direct improvement in the care of infants with NOWS in Alaska are outlined with the goal of supporting a research agenda on opioid misuse and child health across the circumpolar north. Abbreviations: NOWS - neonatal opioid withdrawal syndrome; NAS - neonatal abstinence syndrome; MAT - medication-assisted treatment; NICU - neonatal intensive care unit; OATs - opioid agonist treatments; OCS - office of children's services; ANTHC - Alaska Native Tribal Health Consortium; OUD - opioid use disorder; SBIRT - screening, brief intervention and referral to treatment; ISPCTN - IDeA States Pediatric Clinical Trials Network; NIH - National Institutes of Health; ANMC - Alaska Native Medical Center; DHSS - Department of Health and Social Services; AAPP - All Alaska Pediatric Partnershi

    Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

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    Background : A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. Aim : The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. Methods : Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports

    Development of a core outcome set for use in research evaluations of interventions for venous leg ulceration: international eDelphi consensus

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    INTRODUCTION: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU.AIM: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.METHOD: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.RECOMMENDATIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).</p
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