427 research outputs found

    A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

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    BACKGROUND: Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken. METHODS: Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months. RESULTS: All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC. CONCLUSIONS: A definitive trial comparing the efficacy of nutritional support interventions in increasing weight and BMI in malnourished care home residents can be conducted. However, whilst the design was feasible, this trial has highlighted the lack of clinically and patient-relevant outcome measures that are appropriate for use in this setting for both research and clinical practice. In particular, this trial identified a need for a more simple measure of functional status, which considers the limitations of functional tests in the care home population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38047922, Date assigned: 22 April 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0952-2) contains supplementary material, which is available to authorized users

    Impact of Interprofessional Student Teams at a Remote Area Medical Event in Rural Appalachia

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    Introduction: Education in interprofessional collaboration is vital to expand healthcare access, especially in areas of higher disparity. To address this need, interprofessional faculty collaborators incorporated undergraduate and graduate health profession students into teams at an annual Remote Area Medical event in rural Appalachia between 2017 and 2020. Purpose: This article evaluates the impact of an interprofessional student teams model on both patient care experience and students’ interprofessional collaboration attitudes and behaviors. Methods: Student volunteers completed pre- and post-event surveys containing questions about demographics, open-ended questions, and questions from two instruments: the Student Perceptions of Interprofessional Clinical Education-Revised Instrument, Version 2 (SPICE-R2) and the Interprofessional Collaborative Competency Attainment Scale-Revised (ICCAS-R). Quantitative data were analyzed statistically; qualitative data thematically. Tally forms collected patient care interventions that were compared to regional health disparities. Two years of survey data and four years of intervention data were analyzed. Results: There was an increase (p \u3c 0.001) in the post-event survey SPICE-R2 factors (teamwork, healthcare outcomes, and roles and responsibilities) in 2020 but not in 2019. ICCAS-R mean post-event composite scores increased (p \u3c 0.05) in both 2019 and 2020. Qualitative coding of open-ended responses revealed interprofessional competency themes and provided event feedback. Over 5,900 health-disparity-focused interventions were completed between 2017 and 2020. Implications: Students participating in interprofessional teams demonstrate changes in attitudes towards the interprofessional approach to care, an improved ability to collaborate interprofessionally, and a positive impact on patient care interventions. The findings allow educators to understand how experiential interprofessional education influences students’ interprofessional attitudes and beliefs while benefitting patient care

    Wildlife collection for scientific purposes

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    Illegal transfer of wildlife has 2 main purposes: trade and scientific research. Trade is the most common, whereas scientific research is much less common and unprofitable, yet still important. Biopiracy in science is often neglected despite that many researchers encounter it during their careers. The use of illegally acquired specimens is detected in different research fields, from scientists bioprospecting for new pharmacological substances, to taxonomists working on natural history collections, to researchers working in zoos, aquariums, and botanical gardens. The practice can be due to a lack of knowledge about the permit requirements in different countries or, probably most often, to the generally high level of bureaucracy associated with rule compliance. Significant regulatory filters to avoid biopiracy can be provided by different stakeholders. Natural history collection hosts should adopt strict codes of conduct; editors of scientific publications should require authors to declare that all studied specimens were acquired legally and to cite museum catalog numbers as guarantee of best practices. Scientific societies should actively encourage publication in peer-reviewed journals of work in which specimens collected from the wild were used. The International Commission on Zoological Nomenclature could require newly designated types based on recently collected specimens to be accompanied by statements of deposition in recognized scientific or educational institutions. We also propose the creation of an online platform that gathers information about environmental regulations and permits required for scientific activities in different countries and respective responsible governmental agencies and the simplification of the bureaucracy related to regulating scientific activities. This would make regulations more agile and easier to comply with. The global biodiversity crisis means data need to be collected ever faster, but biopiracy is not the answer and undermines the credibility of science and researchers. It is critical to find amodus vivendithat promotes compliance with regulations and scientific progress.Peer reviewe

    Medication Management Program Among Elderly at a Residential Facility

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    Abstract This quality improvement project aimed to address medication management-related issues at a residential facility. The project\u27s population was elderly residents who self- administered their medications. A root cause analysis and SWOT analysis identified multiple factors contributing to medication management errors, including lack of resident education, resident competency, and technology limitations. An intervention plan was developed and implemented in two phases. Phase 1 involved conducting medication reconciliation, assessing resident competency, and 1:1 educational sessions with the residents. Educational retention was assessed by using a pre-test and a post-test. Phase 2, to be implemented in the future, will address technology limitations, incorporate an electronic medical records (EMR) system, and provide ongoing staff education. Results from Phase 1 include 80% recalled new information while 20% showed no change after completion of the educational session and the pre/post-test; from those residents assessed with the Medi-Cog, 55% scored above 8 out of 10 while 45% scored below the cutoff score of 8, and last 100% of the Medication Administration Records (MAR) were reviewed. Although time constraints prevented Phase 2 interventions from being implemented, implementing an EMR system and a professional development plan for staff education are expected to contribute to further improvements in medication management at the residential facility. Continued monitoring and collaboration with the residents and staff are vital for sustained success

    Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot):study protocol for a randomized controlled trial

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    Background: Parkinson’s disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson’s disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control. Methods/Design: The PD COMM pilot is a three arm, assessor-blinded, randomized controlled trial. Randomization will be computer-generated with participants randomized at a ratio of 1:1:1. Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist. The target population are patients with a confirmed diagnosis of idiopathic Parkinson’s disease who have problems with their speech or voice. The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60 minutes in length over four weeks, with extra home practice. The standard speech and language therapy intervention group will receive a dose determined by patients’ individual needs, but not exceeding eight weeks of treatment. The control group will receive standard care with no speech and language therapy input for at least six months post-randomization. Outcomes will be assessed at baseline (pre-randomization) and post- randomization at three, six, and 12 months. The outcome measures include patient-reported voice measures, quality of life, resource use, and assessor-rated speech recordings. The recruitment aim is at least 60 participants over 21 months from 11 sites, equating to at least 20 participants in each arm of the trial. This trial is ongoing and recruitment commenced in May 2012. Discussion: This study will provide information on the feasibility and acceptability of randomizing participants to different speech and language therapies or control/deferred treatment. The findings relating to recruitment, treatment compliance, outcome measures, and effect size will inform a future phase III randomized controlled trial

    Cochrane systematic review and meta-analysis of Botulinum toxin for the prevention of migraine

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    Objectives To assess the effects of botulinum toxin for prevention of migraine in adults.Design Systematic review and meta-analysis.Data sources CENTRAL, MEDLINE, Embase and trial registries.Eligibility criteria We included randomised controlled trials (RCTs) of botulinum toxin compared with placebo, active treatment or clinically relevant different dose for adults with chronic or episodic migraine, with or without the additional diagnosis of medication overuse headache.Data extraction and synthesis Cochrane methods were used to review double-blind RCTs. Twelve week post-treatment time-point data was analysed.Results Twenty-eight trials (n=4190) were included. Trial quality was mixed. Botulinum toxin treatment resulted in reduced frequency of −2.0 migraine days/month (95% CI −2.8 to −1.1, n=1384) in chronic migraineurs compared with placebo. An improvement was seen in migraine severity, measured on a numerical rating scale 0 to 10 with 10 being maximal pain, of −2.70 cm (95% CI −3.31 to −2.09, n=75) and −4.9 cm (95% CI −6.56 to −3.24, n=32) for chronic and episodic migraine respectively. Botulinum toxin had a relative risk of treatment related adverse events twice that of placebo, but a reduced risk compared with active comparators (relative risk 0.76, 95% CI 0.59 to 0.98) and a low withdrawal rate (3%). Although individual trials reported non-inferiority to oral treatments, insufficient data were available for meta-analysis of effectiveness outcomes.Conclusions In chronic migraine, botulinum toxin reduces migraine frequency by 2 days/month and has a favourable safety profile. Inclusion of medication overuse headache does not preclude its effectiveness. Evidence to support or refute efficacy in episodic migraine was not identified

    A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol

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    BACKGROUND: Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%–42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability. METHODS: Trial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20–25 g. RESULTS: The primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite. CONCLUSIONS: The complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this feasibility trial will be used to inform the development and design of a future cluster randomised controlled trial to compare food-based intervention with prescribed oral nutritional supplements (ONS) in the treatment of malnutrition within the care home population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38047922 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/2055-5784-1-3) contains supplementary material, which is available to authorized users

    Botulinum toxins for the prevention of migraine in adults

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    BackgroundMigraine occurs in around 15% of adults and is ranked as the seventh most disabling disease amongst all diseases globally. Despite the available treatments many people suffer prolonged and frequent attacks which have a major impact on their quality of life. Chronic migraine is defined as 15 or more days of headache per month, at least eight of those days being migraine. People with episodic migraine have fewer than 15 headache days per month. Botulinum toxin type A has been licensed in some countries for chronic migraine treatment, due to the results of just two trials.ObjectivesTo assess the effects of botulinum toxins versus placebo or active treatment for the prevention or reduction in frequency of chronic or episodic migraine in adults.Search methodsWe searched CENTRAL, MEDLINE & MEDLINE in Process, Embase, ClinicalTrials.gov and World Health Organization International Clinical Trials Registry (to December 2017). We examined reference lists and carried out citation searches on key publications. We sent correspondence to major manufacturers of botulinum toxin.Selection criteriaRandomised, double‐blind, controlled trials of botulinum toxin (any sero‐type) injections into the head and neck for prophylaxis of chronic or episodic migraine in adults. Eligible comparators were placebo, alternative prophylactic agent or different dose of botulinum toxin.Data collection and analysisTwo review authors independently selected trials and extracted data. For continuous outcomes we used mean change data when available. For dichotomous data we calculated risk ratios (RRs). We used data from the 12‐week post‐treatment follow‐up time point. We assessed the evidence using GRADE and created two 'Summary of findings' tables.Main resultsDescription of trialsWe found 90 articles describing 28 trials (4190 participants), which were eligible for inclusion. The longest treatment duration was three rounds of injections with three months between treatments, so we could not analyse long‐term effects. For the primary analyses, we pooled data from both chronic and episodic participant populations. Where possible, we also separated data into chronic migraine, episodic migraine and ‘mixed group’ classification subgroups. Most trials (21 out of 28) were small (fewer than 50 participants per trial arm). The risk of bias for included trials was low or unclear across most domains, with some trials reporting a high risk of bias for incomplete outcome data and selective outcome reporting.Botulinum toxin versus placeboTwenty‐three trials compared botulinum toxin with placebo. Botulinum toxin may reduce the number of migraine days per month in the chronic migraine population by 3.1 days (95% confidence interval (CI) ‐4.7 to ‐1.4, 4 trials, 1497 participants, low‐quality evidence). This was reduced to ‐2 days (95% CI ‐2.8 to ‐1.1, 2 trials, 1384 participants; moderate‐quality evidence) when we removed small trials.A single trial of people with episodic migraine (N = 418) showed no difference between groups for this outcome measure (P = 0.49).In the chronic migraine population, botulinum toxin reduces the number of headache days per month by 1.9 days (95% CI ‐2.7 to ‐1.0, 2 trials, 1384 participants, high‐quality evidence). We did not find evidence of a difference in the number of migraine attacks for both chronic and episodic migraine participants (6 trials, N = 2004, P = 0.30, low‐quality evidence). For the population of both chronic and episodic migraine participants a reduction in severity of migraine rated during clinical visits, on a 10 cm visual analogue scale (VAS) of 3.3 cm (95% CI ‐4.2 to ‐2.5, very low‐quality evidence) in favour of botulinum toxin treatment came from four small trials (N = 209); better reporting of this outcome measure from the additional eight trials that recorded it may have improved our confidence in the pooled estimate. Global assessment and quality‐of‐life measures were poorly reported and it was not possible to carry out statistical analysis of these outcome measures. Analysis of adverse events showed an increase in the risk ratio with treatment with botulinum toxin over placebo 30% (RR 1.28, 95% CI 1.12 to 1.47, moderate‐quality evidence). For every 100 participants 60 experienced an adverse event in the botulinum toxin group compared with 47 in the placebo group.Botulinum toxin versus other prophylactic agentThree trials studied comparisons with alternative oral prophylactic medications. Meta‐analyses were not possible for number of migraine days, number of headache days or number of migraine attacks due to insufficient data, but individually trials reported no differences between groups for a variety of efficacy measures in the population of both chronic and episodic migraine participants. The global impression of disease measured using Migraine Disability Assessment (MIDAS) scores were reported from two trials that showed no difference between groups. Compared with oral treatments, botulinum toxin showed no between‐group difference in the risk of adverse events (2 trials, N = 114, very low‐quality evidence). The relative risk reduction (RRR) for withdrawing from botulinum toxin due to adverse events compared with the alternative prophylactic agent was 72% (P = 0.02, 2 trials, N = 119).Dosing trialsThere were insufficient data available for the comparison of different doses.Quality of the evidenceThe quality of the evidence assessed using GRADE methods was varied but mostly very low; the quality of the evidence for the placebo and active control comparisons was low and very low, respectively for the primary outcome measure. Small trial size, high risk of bias and unexplained heterogeneity were common reasons for downgrading the quality of the evidence.Authors' conclusionsIn chronic migraine, botulinum toxin type A may reduce the number of migraine days per month by 2 days compared with placebo treatment. Non‐serious adverse events were probably experienced by 60/100 participants in the treated group compared with 47/100 in the placebo group. For people with episodic migraine, we remain uncertain whether or not this treatment is effective because the quality of this limited evidence is very low. Better reporting of outcome measures in published trials would provide a more complete evidence base on which to draw conclusions
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