18 research outputs found

    Creative Ideas

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    This book describes some of the processes, activities and approaches we have developed over the last 18 months as part of the Creative IDEAS knowledge exchange project undertaken by ImaginationLancaster, a creative research lab at Lancaster University. It also articulates the philosophy we are developing around design and its engagement with knowledge exchange. Our approach has a few defining characteristics: - We design knowledge exchange, using both new and well proven design processes and methods. We facilitate knowledge exchange activity that responds to a specific context and so is different every time, rather than adopting standard approaches and mechanisms. - We research human to human interaction (knowledge exchange). Our activities are informed and inform academic research in design, management and knowledge exchange. - We have no interest in multiple delivery of an approach beyond one or two iterations to hone and establish the effectiveness of an approach. We do not occupy the same position in the knowledge exchange ecology as consultants, rather we write the papers and books that consultants draw from. - We use visualisation as one of our core strategic activities in the development and also the delivery of activities with communities, academics, and most of all, business. This places us at an important crossroads where academic research and business interact to create impact. We aim to remove the tensions between excellent research and highly effective business engagement, developing both in a mutually supporting virtuous circle of reflection and application.

    Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study

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    BackgroundSite performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minimising their impact.The aim of this study was to identify and agree a core set of key performance metrics for managing multicentre randomised trials.MethodsWe used a mixed methods approach to identify potential metrics and to achieve consensus about the final set, adapting methods that are recommended by the COMET Initiative for developing core outcome sets in health care.We used performance metrics identified from our systematic search and focus groups to create an online Delphi survey. We invited respondents to score each metric for inclusion in the final core set, over three survey rounds. Metrics scored as critical by ≥70% and unimportant by 50% of participants voting for inclusion were retained.ResultsRound 1 of the Delphi survey presented 28 performance metrics, and a further six were added in round 2. Of 294 UK-based stakeholders who registered for the Delphi survey, 211 completed all three rounds.At the consensus meeting, 17 metrics were discussed and voted on: 15 metrics were retained following survey round 3, plus two others that were preferred by consensus meeting participants. Consensus was reached on a final core set of eight performance metrics in three domains: (1) recruitment and retention, (2) data quality and (3) protocol compliance. A simple tool for visual reporting of the metrics is available from the Nottingham Clinical Trials Unit website.ConclusionsWe have established a core set of metrics for measuring the performance of sites in multicentre randomised trials. These metrics could improve trial conduct by enabling researchers to identify and address problems before trials are adversely affected. Future work could evaluate the effectiveness of using the metrics and reporting tool

    Clinical outcomes and response to treatment of patients receiving topical treatments for pyoderma gangrenosum: a prospective cohort study

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    Background: pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. Objective: to estimate the effectiveness of topical therapies in the treatment of PG. Methods: prospective cohort study of UK secondary care patients with a clinical diagnosis of PG suitable for topical treatment (recruited July 2009 to June 2012). Participants received topical therapy following normal clinical practice (mainly Class I-III topical corticosteroids, tacrolimus 0.03% or 0.1%). Primary outcome: speed of healing at 6 weeks. Secondary outcomes: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality-of-life; treatment failure and recurrence. Results: Sixty-six patients (22 to 85 years) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28/66 (43.8%) of ulcers healed by 6 months. Median time-to-healing was 145 days (95% CI: 96 days, ∞). Initial ulcer size was a significant predictor of time-to-healing (hazard ratio 0.94 (0.88;80 1.00); p = 0.043). Four patients (15%) had a recurrence. Limitations: No randomised comparator Conclusion: Topical therapy is potentially an effective first-line treatment for PG that avoids possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone

    Dipeptidyl peptidase-1 inhibition in patients hospitalised with COVID-19: a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial

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    Background Neutrophil serine proteases are involved in the pathogenesis of COVID-19 and increased serine protease activity has been reported in severe and fatal infection. We investigated whether brensocatib, an inhibitor of dipeptidyl peptidase-1 (DPP-1; an enzyme responsible for the activation of neutrophil serine proteases), would improve outcomes in patients hospitalised with COVID-19. Methods In a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial, across 14 hospitals in the UK, patients aged 16 years and older who were hospitalised with COVID-19 and had at least one risk factor for severe disease were randomly assigned 1:1, within 96 h of hospital admission, to once-daily brensocatib 25 mg or placebo orally for 28 days. Patients were randomly assigned via a central web-based randomisation system (TruST). Randomisation was stratified by site and age (65 years or ≥65 years), and within each stratum, blocks were of random sizes of two, four, or six patients. Participants in both groups continued to receive other therapies required to manage their condition. Participants, study staff, and investigators were masked to the study assignment. The primary outcome was the 7-point WHO ordinal scale for clinical status at day 29 after random assignment. The intention-to-treat population included all patients who were randomly assigned and met the enrolment criteria. The safety population included all participants who received at least one dose of study medication. This study was registered with the ISRCTN registry, ISRCTN30564012. Findings Between June 5, 2020, and Jan 25, 2021, 406 patients were randomly assigned to brensocatib or placebo; 192 (47·3%) to the brensocatib group and 214 (52·7%) to the placebo group. Two participants were excluded after being randomly assigned in the brensocatib group (214 patients included in the placebo group and 190 included in the brensocatib group in the intention-to-treat population). Primary outcome data was unavailable for six patients (three in the brensocatib group and three in the placebo group). Patients in the brensocatib group had worse clinical status at day 29 after being randomly assigned than those in the placebo group (adjusted odds ratio 0·72 [95% CI 0·57–0·92]). Prespecified subgroup analyses of the primary outcome supported the primary results. 185 participants reported at least one adverse event; 99 (46%) in the placebo group and 86 (45%) in the brensocatib group. The most common adverse events were gastrointestinal disorders and infections. One death in the placebo group was judged as possibly related to study drug. Interpretation Brensocatib treatment did not improve clinical status at day 29 in patients hospitalised with COVID-19

    Learning by design:How engagement practitioners use tools to stretch the creative potential of their citizen participation practice

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    Engagement practitioners (EP) work in diverse settings for UK public service providers in the UK to increase citizen participation in decision-making for those services. They use participation tools, including pro-formas and worksheets to aid participatory activities. We identify a tension between participation tool literature advocating for design of tools to disseminate participation methods to EPs, and tooluse literature demonstrating how tools can be modified in use. We ask how are participation tools used by EPs? What roles do instruction and flexibility of use play? How can EPs develop their participation practice through tool-use; and, how can those insights inform future tool design? In answer, findings and insights are presented from interviews with fifteen UK-based EPs conducted between October 2017 and May 2018. Three recommendations are made for the design of participation tools. This research has implications for social designers working in areas including participatory design, co-design or service design contexts

    Correlations of Perceived Deficits Questionnaire of multiple sclerosis quality of life inventory with Beck Depression Inventory and neuropsychological tests

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    The Perceived Deficits Questionnaire (PDQ) is a part of the Multiple Sclerosis (MS) Quality of Life Inventory that assesses self-perceived cognitive difficulties. We used baseline data from 49 MS subjects participating in a clinical trial to evaluate the correlation of the PDQ with two measures of cognitive impairment, the Paced Auditory Serial Addition Test (PASAT) and the California Verbal Learning Test, 2nd edition (CVLT-II), total score, and one measure of depression, the Beck Depression Inventory-Amended (BDI-IA). The PDQ correlated significantly (r = 0.42; 95% confidence interval [CI], 0.15 to 0.62; p = 0.003) with the BDI-IA scores but not with either the PASAT (r = - 0.22; 95% CI, - 0.48 to 0.06; p = 0.2) or the CVLT-II total (r = - 0.17; 95% CI, -0.43 to 0.12; p = 0.25). A subset of 38 of these subjects who scored worse than 0.5 standard deviation below the mean on the PASAT or CVLT-II received a more extensive neuropsychological battery of tests. No significant correlations were found between any of these tests and the PDQ. These results suggest that self-perceived cognitive dysfunction relates more to depression than to objective cognitive dysfunction

    Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women

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    Background: Despite a reduction in the prevalence of vaccine-preventable types of human papillomavirus (HPV), attributed to increased HPV vaccine uptake, HPV continues to be a major cause of cancer in the United States. Methods: We assessed factors associated with self-reported HPV vaccine uptake, HPV vaccination effectiveness, using DNA testing to assess HPV types 16 and/or 18 (HPV 16/18) positivity, and patterns of HPV vaccination in 375 women aged 21–29 years who were eligible to receive catch-up vaccination, using baseline data collected from March 2012 to December 2014 from a randomized controlled trial evaluating a novel approach to cervical cancer screening. Results: More than half (n = 228, 60.8%) of participants reported receipt of at least one HPV vaccine dose and 16 (4.3%) tested positive for HPV 16/18 at baseline. College-educated participants were four times more likely to have been vaccinated than those reporting high school education or less. 56.5% of HPV-vaccinated participants reported first dose after age 18 and 68.4% after first vaginal intercourse. Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance. Conclusions: HPV vaccination is common among college-educated women in the catch-up population but less common among those without college education. Contrary to current guidelines, catch-up females frequently obtain HPV vaccination after age 18 and first vaginal intercourse. Women without a college education represent an ideal population for targeted HPV vaccination efforts that emphasize vaccination before sexual debut
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