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© 2019 Elsevier Ltd Purpose: This qualitative study was conducted as part of a feasibility study for TrAFFix, (ISRCTN92089567), a randomised controlled trial that will compare two surgical interventions used to fix distal femoral fractures. Our aim was to understand patients’ experiences of treatment and the early phase of recovery after a distal femoral fracture. While, much is known about the experience of recovery from hip fracture, little is known about whether patients with other lower limb fragility fractures experience the same concerns and challenges. Materials and Methods: Semi-structured interviews were conducted with 11 patients participating in TrAFFix or their relative. Interviews were conducted face to face or by telephone. With agreement from participants, interviews were audio recorded and transcribed. Transcripts were analysed inductively using thematic analysis. As part of the user involvement for TrAFFix, we held a focus group with PPI representatives who had experience or knowledge of lower limb fractures, to learn about factors that might influence patients’ recovery after a fragility facture. Data from the focus group relevant to themes from our thematic analysis are also presented. Results: Three themes were identified within patients’ accounts of their experience. Our data revealed that: i) being informed about treatment and recovery was important to patients; ii) patients muddled through and found ways to manage at home, often needing the support of others; and iii) rehabilitation was arduous for patients who received limited rehabilitative support and at times lacked confidence to follow the instructions that they were given. Conclusions: Our findings highlight the struggle patients endure while recovering after a distal femoral fracture and the limited rehabilitative support they receive after discharge from hospital. They reinforce the need to ensure a patient feels informed about their treatment and recovery and the need for greater support for patients to manage at home and move with confidence.
Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT
BACKGROUND: Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. OBJECTIVES: This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. DESIGN: A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. SETTING: Seven NHS hospitals. PARTICIPANTS: Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. INTERVENTIONS: Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. OUTCOMES: The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. RESULTS: The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n = 11; plate, n = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). CONCLUSIONS: This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25)], which delivered to target and budget. FUTURE WORK: A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. REGISTRATION: Current Controlled Trials ISRCTN92089567. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.
Surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: Protocol for Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2)
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Introduction Optimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures. Methods and analysis Adult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-Articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either 'manipulation and surgical fixation with K-wires' or 'manipulation and plaster casting'. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications. Ethics and Dissemination The National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462). The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. Trial registration number ISRCTN11980540; Pre-results.
©2019 The British Editorial Society of Bone & Joint Surgery. Aims This study sought to determine the proportion of older adults with hip fractures captured by a multicentre prospective cohort, the World Hip Trauma Evaluation (WHiTE), whether there was evidence of selection bias during WHiTE recruitment, and the extent to which the WHiTE cohort is representative of the broader population of older adults with hip fractures. Patients and Methods The characteristics of patients recruited into the WHiTE cohort study were compared with those treated at WHiTE hospitals during the same timeframe and submitted to the National Hip Fracture Database (NHFD). Results Patients recruited to WHiTE were more likely to be admitted from their own home (83.5% vs 80.2%; p < 0.001) and to have a higher median Abbreviated Mental Test Score (AMTS) (9 (interquartile range (IQR) 6 to 10) vs 9 (IQR 5 to 10); p < 0.001) than those who were not recruited. In terms of WHiTE cohort generalizability, participating hospitals included a greater proportion of Major Trauma Centres (47.8% vs 7.8%) and large hospitals (997 (IQR 873 to 1290) vs 707 (459 to 903) beds) with high-volume Emergency Departments (median annual attendances of 43 981 (IQR 37 147 to 54 385) vs 35 964 (IQR 26 229 to 50 551)). However, there were few differences in baseline characteristics between patients in the WHiTE cohort and those recorded in the NHFD. Conclusion There is evidence of a weak selection bias towards recruiting fitter patients within the WHiTE cohort, which will help to put into context the findings of future studies. We conclude that the patients within the WHiTE cohort are representative of the national population of older adults with hip fractures throughout England, Wales, and Northern Ireland.
Economic evaluation plan of a randomised controlled trial of intra-nodular injection of anti-TNF and placebo among patients with early Dupuytren’s disease: Repurposing Anti-TNF for treating dupuytren’s disease (RIDD) [version 1; referees: 2 approved]
© 2018 Png ME et al. Dupuytren’s disease (DD) is a common fibroproliferative condition of the palmar and digital fascia of the hand; however, there is currently no approved treatment for early stage DD. The objective of this paper is to describe the methods applied to assess the cost-effectiveness of adalimumab injections compared to placebo for controlling the progression of early stage DD in the Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD) trial. Measure of effectiveness and resource use will be obtained from a randomised clinical trial, carried out in three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD. Resource use and utility measures (quality-adjusted life years) will be collected at 3, 6, 9, 12 (primary outcome endpoint) and 18 months post-randomisation. A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs. The analysis will be performed from a health system (National Health Service and personal social services) perspective. Sensitivity analysis will be conducted to assess the robustness of the results. RIDD is the first randomised controlled trial with an economic evaluation conducted among patients with early stage DD. The protocol described here records our intent to conduct both a within-trial CUA alongside the RIDD study and a lifetime CUA using decision-analytic modelling.
Conceptualising the Integration of Strategies by Clinical Commissioning Groups in England towards the Antibiotic Prescribing Targets for the Quality Premium Financial Incentive Scheme: A Short Report.
Background: In order to tackle the public health threat of antimicrobial resistance, improvement in antibiotic prescribing in primary care was included as one of the priorities of the Quality Premium (QP) financial incentive scheme for Clinical Commissioning Groups (CCGs) in England. This paper briefly reports the outcome of a workshop exploring the experiences of antimicrobial stewardship (AMS) leads within CCGs in selecting and adopting strategies to help achieve the QP antibiotic targets. Methods: We conducted a thematic analysis of the notes on discussions and observations from the workshop to identify key themes. Results: Practice visits, needs assessment, peer feedback and audits were identified as strategies integrated in increasing engagement with practices towards the QP antibiotic targets. The conceptual model developed by AMS leads demonstrated possible pathways for the impact of the QP on antibiotic prescribing. Participants raised a concern that the constant targeting of high prescribing practices for AMS interventions might lead to disengagement by these practices. Most of the participants suggested that the effect of the QP might be less about the financial incentive and more about having national targets and guidelines that promote antibiotic prudency. Conclusions: Our results suggest that national targets, rather than financial incentives are key for engaging stakeholders in quality improvement in antibiotic prescribing.
©Seb John Bacon, Ben Goldacre. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.01.2020. Open data is information made freely available to third parties in structured formats without restrictive licensing conditions, permitting commercial and noncommercial organizations to innovate. In the context of National Health Service (NHS) data, this is intended to improve patient outcomes and efficiency. EBM DataLab is a research group with a focus on online tools which turn our research findings into actionable monthly outputs. We regularly import and process more than 15 different NHS open datasets to deliver OpenPrescribing.net, one of the most high-impact use cases for NHS England's open data, with over 15,000 unique users each month. In this paper, we have described the many breaches of best practices around NHS open data that we have encountered. Examples include datasets that repeatedly change location without warning or forwarding; datasets that are needlessly behind a "CAPTCHA" and so cannot be automatically downloaded; longitudinal datasets that change their structure without warning or documentation; near-duplicate datasets with unexplained differences; datasets that are impossible to locate, and thus may or may not exist; poor or absent documentation; and withholding of data for dubious reasons. We propose new open ways of working that will support better analytics for all users of the NHS. These include better curation, better documentation, and systems for better dialogue with technical teams.
Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. INTRODUCTION: Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse. TRIAL DESIGN: An unblinded parallel randomised controlled trial. METHODS: Participants were adult smokers with a body mass index greater or equal to 23 kg/m2. Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation. RESULTS: Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported. CONCLUSION: In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme. TRIAL REGISTRATION NUMBER: ISRCTN65705512.
<sec> <title>UNSTRUCTURED</title> <p>Open data is information made freely available to third parties in structured formats without restrictive licensing conditions, permitting commercial and noncommercial organizations to innovate. In the context of National Health Service (NHS) data, this is intended to improve patient outcomes and efficiency. EBM DataLab is a research group with a focus on online tools which turn our research findings into actionable monthly outputs. We regularly import and process more than 15 different NHS open datasets to deliver OpenPrescribing.net, one of the most high-impact use cases for NHS England’s open data, with over 15,000 unique users each month. In this paper, we have described the many breaches of best practices around NHS open data that we have encountered. Examples include datasets that repeatedly change location without warning or forwarding; datasets that are needlessly behind a “CAPTCHA” and so cannot be automatically downloaded; longitudinal datasets that change their structure without warning or documentation; near-duplicate datasets with unexplained differences; datasets that are impossible to locate, and thus may or may not exist; poor or absent documentation; and withholding of data for dubious reasons. We propose new open ways of working that will support better analytics for all users of the NHS. These include better curation, better documentation, and systems for better dialogue with technical teams.</p> </sec>