154 research outputs found

    The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers

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    To evaluate continuous diffusion of oxygen therapy (CDO) on cytokines, perfusion, and bacterial load in diabetic foot ulcers we evaluated 23 patients for 3 weeks. Tissues biopsies were obtained at each visit to evaluate cytokines and quantitative bacterial cultures. Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. We used paired T tests to compare continuous variables and independent T tests to compare healers and nonhealers. There was an increase from baseline to week 1 in TGF-β (P =.008), TNF-α (P =.014), VEGF (P =.008), PDGF (P =.087), and IGF-1 (P =.058); baseline to week 2 in TGF-β (P =.010), VEGF (P =.051), and IL-6 (P =.031); and baseline to week 3 with TGF-β (P =.055) and IL-6 (P =.054). There was a significant increase in transcutaneous oxygen after 1 week of treatment on both medial and lateral foot (P =.086 and.025). Fifty-three percent of the patients had at least a 50% wound area reduction (healers). At baseline, there were no differences in cytokines between healers and nonhealers. However, there was an increase in CXCL8 after 1 week of treatment (P =.080) and IL-6 after 3 weeks of treatment in nonhealers (P =.099). There were no differences in quantitative cultures in healers and nonhealers

    Lyopreserved amniotic membrane is cellularly and clinically similar to cryopreserved construct for treating foot ulcers

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    We compared cellular viability between cryopreserved and lyopreserved amniotic membranes and clinical outcomes of the lyopreserved construct in a prospective cohort study of 40 patients with neuropathic foot ulcers. Patients received weekly application of lyopreserved membrane for 12 weeks with standard weekly debridement and offloading. We evaluated the proportion of foot ulcers that closed, time to closure, closure trajectories, and infection during therapy. We used chi-square tests for dichotomous variables and independent t-tests for continuous variables with an alpha of α =.10. Cellular viability was equivalent between cryo- and lyopreserved amniotic tissues. Clinically, 48% of subjects' wounds closed in an average of 40.0 days. Those that did not close were older (63 vs 59 years, P =.011) and larger ulcers at baseline (7.8 vs 1.6 cm2, P =.012). Significantly more patients who achieved closure reached a 50% wound area reduction in 4 weeks compared with non-closed wounds (73.7% vs 47.6%, P =.093). There was no difference in the slope of the wound closure trajectories between closed and non-closed wounds (0.124 and 0.159, P =.85), indicating the rate of closure was similar. The rate of closure was 0.60 mm/day (SD = 0.47) for wounds that closed and 0.50 mm/day (SD = 0.58) for wounds that did not close (P =.89)

    Introducing the revised framework for developing and evaluating complex interventions : A challenge and a resource for nursing research

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    This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research

    Examining virtual driving test performance and its relationship to individuals with HIV-associated neurocognitive disorders

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    SIGNIFICANCE: Existing screening tools for HIV-associated neurocognitive disorders (HAND) are often clinically impractical for detecting milder forms of impairment. The formal diagnosis of HAND requires an assessment of both cognition and impairment in activities of daily living (ADL). To address the critical need for identifying patients who may have disability associated with HAND, we implemented a low-cost screening tool, the Virtual Driving Test (VDT) platform, in a vulnerable cohort of people with HIV (PWH). The VDT presents an opportunity to cost-effectively screen for milder forms of impairment while providing practical guidance for a cognitively demanding ADL. OBJECTIVES: We aimed to: (1) evaluate whether VDT performance variables were associated with a HAND diagnosis and if so; (2) systematically identify a manageable subset of variables for use in a future screening model for HAND. As a secondary objective, we examined the relative associations of identified variables with impairment within the individual domains used to diagnose HAND. METHODS: In a cross-sectional design, 62 PWH were recruited from an established HIV cohort and completed a comprehensive neuropsychological assessment (CNPA), followed by a self-directed VDT. Dichotomized diagnoses of HAND-specific impairment and impairment within each of the seven CNPA domains were ascertained. A systematic variable selection process was used to reduce the large amount of VDT data generated, to a smaller subset of VDT variables, estimated to be associated with HAND. In addition, we examined associations between the identified variables and impairment within each of the CNPA domains. RESULTS: More than half of the participants ( CONCLUSION: We identified a subset of VDT performance variables that are associated with HAND and assess relevant functional abilities among individuals with HAND. Additional research is required to develop and validate a predictive HAND screening model incorporating this subset

    Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

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    BACKGROUND: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. METHODS: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. RESULTS: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six 'core elements' that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. LIMITATIONS: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. CONCLUSIONS: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as 'events in systems' that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. FUTURE WORK: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. FUNDING: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514)

    A Complete Redesign of the Cardiopulmonary Resuscitation (CPR) and Automated External Defibrillator (AED) Learning Experience

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    Survival following sudden cardiac arrest in the community can be framed as a complex systems problem for which systems thinking and design methodologies may be applied. Focusing on the subsystem of the learning experience of cardiopulmonary resuscitation and use of an automated external defibrillator (CPR/AED), we used a systems approach to understand the current state of learning and a design methodology to identify improvements. A systems diagnosis identified six elements within the learning experience - need for training, opportunity for training, training class characteristics, perceived competence, anticipated event characteristics, and perceived readiness to act – each of which had positive and negative meanings and outcomes. As the elements are interactive and complex, the expected central property of learning – likelihood to act - may not be realized because of significant conflicts and obstructions. Design methodology identified 250 elements for an ideal CPR/AED learning experience which could be arranged as a containing system with eight interactive categories. Based on a system thinking and design methodology approach we suggested ten changes to improve the current state of the CPR/AED learning experience

    Success of an International Learning Health Care System in Hematopoietic Cell Transplantation: The American Society of Blood and Marrow Transplantation Clinical Case Forum

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    The ASBMT Clinical Case Forum (CCF) was launched in 2014 as an online secure tool to enhance interaction and communication among hematopoietic cell transplantation (HCT) professionals worldwide through the discussion of challenging clinical care issues. After 14 months, we reviewed clinical and demographical data on cases posted in the CCF from 1/29/2014 to 3/18/2015. A total of 137 cases were posted during the study period. Ninety-two cases (67%) were allogeneic HCT, 29 (21%) autologous HCT and in 16 (12%) the type of transplant (auto vs. allo) was still under consideration. The diseases most frequently discussed included non-Hodgkin lymphoma (NHL; n = 30, 22%), acute myeloid leukemia (AML; n = 23, 17%) and multiple myeloma (MM; n = 20, 15%). When compared with the US transplant activity reported by the US Department of Health and Human Services, NHL and acute lymphoblastic leukemia cases were overrepresented in the CCF while myeloma was underrepresented (P < 0.001). A total of 259 topics were addressed in the CCF with a median of two topics/case (range 1-6). Particularly common topics included whether transplant was indicated (n = 57, 41%), conditioning regimen choice (n = 44, 32%), and post-HCT complications after day 100 (n = 43, 31%). The ASBMT CCF is a successful tool for collaborative discussion of complex cases in the HCT community worldwide and may allow identification of areas of controversy or unmet need from clinical, educational and research perspectives

    First evidence of Renlandian (c. 950–940 Ma) orogeny in mainland Scotland:Implications for the status of the Moine Supergroup and circum-North Atlantic correlations

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    Central problems in the interpretation of the Neoproterozoic geology of the North Atlantic region arise from uncertainties in the ages of, and tectonic drivers for, Tonian orogenic events recorded in eastern Laurentia and northern Baltica. The identification and interpretation of these events is often problematic because most rock units that record Tonian orogenesis were strongly reworked at amphibolite facies during the Ordovician-Silurian Caledonian orogeny. Lu-Hf and Sm-Nd geochronology and metamorphic modelling carried out on large (>1 cm) garnets from the Meadie Pelite in the Moine Nappe of the northern Scottish Caledonides indicate prograde metamorphism between 950 and 940 Ma at pressures of 6–7 kbar and temperatures of 600 °C. This represents the first evidence for c. 950 Ma Tonian (Renlandian) metamorphism in mainland Scotland and significantly extends its geographic extent along the palaeo-Laurentian margin. The Meadie Pelite is believed to be part of the Morar Group within the Moine Supergroup. If this is correct: 1) the Morar Group was deposited between 980 ± 4 Ma (age of the youngest detrital zircon; Peters, 2001, youngest published zircon date is 947 ± 189 (Friend et al., 2003)) and c. 950 Ma (age of regional metamorphism reported here), 2) an orogenic unconformity must separate the Morar Group from the 883 ± 35 Ma (Cawood et al., 2004) Glenfinnan and Loch Eil groups, and 3) the term ‘Moine Supergroup’ may no longer be appropriate. The Morar Group is broadly correlative with similar aged metasedimentary successions in Shetland, East Greenland, Svalbard, Ellesmere Island and northern Baltica. All these successions were deposited after c. 1030 Ma, contain detritus from the Grenville orogen, and were later deformed and metamorphosed at 950–910 Ma during accretionary Renlandian orogenesis along an active plate margin developed around this part of Rodinia
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