2,505 research outputs found

    Designing clinical trials in trauma surgery: overcoming research barriers.

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    The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. This is in part due to the absence of a strong research culture, however it is also due to a multitude of barriers encountered in clinical research; particularly those involving surgical interventions. 'Trauma' amplifies these barriers, owing to the unplanned nature of care, unpredictable work patterns, the emergent nature of treatment and complexities in the consent process. This review discusses the barriers to clinical research in surgery, with a particular emphasis on trauma. It considers how barriers may be overcome, with the aim to facilitate future successful clinical research

    The Warwick Hip Trauma Evaluation Two - an abridged protocol for the WHiTE Two Study AN EMBEDDED RANDOMISED TRIAL COMPARING THE DUAL-MOBILITY WITH POLYETHYLENE CUPS IN HIP ARTHROPLASTY FOR FRACTURE

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    Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. Controversy exists regarding the optimal treatment for independent patients with displaced intracapsular fractures of the proximal femur. The recognised alternatives are hemiarthroplasty and total hip replacement. At present there is no established standard of care, with both types of arthroplasty being used in many centres. The principal advantages of total hip replacement are a functional benefit over hemiarthroplasty and a reduced risk of revision surgery. The principal criticism is the increased risk of dislocation. We believe that an alternative acetabular component may reduce the risk of dislocation but still provide the functional benefit of total hip replacement in these patients. We therefore propose to investigate the dislocation risk of a dual-mobility acetabular component compared with standard polyethylene component in total hip replacement for independent patients with displaced intracapsular fractures of the proximal femur within the framework of the larger WHiTE (Warwick Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article: Bone Joint Res 2013;2:210–13

    Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: Analysis from the DRAFFT trial

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    We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius. The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care. There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89 322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30 000. Compared with locking-plate fixation, K-wire fixation is a 'cost saving' intervention, with similar health benefits

    Effectiveness and safety of cemented and uncemented hemiarthroplasty for the treatment of intracapsular hip fractures:a systematic review and meta-analysis of randomised controlled trials

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    Aims We conducted a systematic review and meta-analysis to compare the mortality, morbidity, and functional outcomes of cemented versus uncemented hemiarthroplasty in the treatment of intracapsular hip fractures, analyzing contemporary and non-contemporary implants separately. Methods PubMed, Medline, EMBASE, CINAHL, and Cochrane Library were searched to 2 February 2020 for randomized controlled trials (RCTs) comparing the primary outcome, mortality, and secondary outcomes of function, quality of life, reoperation, postoperative complications, perioperative outcomes, pain, and length of hospital stay. Relative risks (RRs) and mean differences (with 95% confidence intervals (CIs)) were used as summary association measures. Results A total of 18 studies corresponding to 16 non-overlapping RCTs with a total of 2,819 intracapsular hip fractures were included. Comparing contemporary cemented versus uncemented hemiarthroplasty, RRs (95% CIs) for mortality were 1.32 (0.44 to 3.99) perioperatively, 1.01 (0.48 to 2.10) at 30 days, and 0.90 (0.71 to 1.15) at one year. The use of contemporary cemented hemiarthroplasty reduced the risk of intra- and postoperative periprosthetic fracture. There were no significant differences in the risk of other complications, function, pain, and quality of life. There were no significant differences in perioperative outcomes except for increases in operating time and overall anaesthesia for contemporary cemented hemiarthroplasty with mean differences (95% CIs) of 6.67 (2.65 to 10.68) and 4.90 (2.02 to 7.78) minutes, respectively. The morbidity and mortality outcomes were not significantly different between non-contemporary cemented and uncemented hemiarthroplasty. Conclusion There are no differences in the risk of mortality when comparing the use of contemporary cemented with uncemented hemiarthroplasty in the management of intracapsular hip fractures. Contemporary cemented hemiarthroplasty is associated with a substantially lower risk of intraoperative and periprosthetic fractures

    The comprehensive cohort model in a pilot trial in orthopaedic trauma

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    Background: The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in improving the accuracy of this estimate within an orthopaedic trauma setting. Methods: Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre. Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI; primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six weeks, three months, six months and nine months after initial injury. Results: At nine months, there was no significant difference in DRI between patients randomised to operative or non-operative management. There was no difference in DRI between the randomised group and the parallel patient preference group. The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management. Conclusions: Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult; especially within the trauma setting. Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions

    The experience of long-term opiate maintenance treatment and reported barriers to recovery: A qualitative systematic review

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    Background/Aim: To inform understanding of the experience of long-term opiate maintenance and identify barriers to recovery. Methods: A qualitative systematic review. Results: 14 studies in 17 papers, mainly from the USA (65%), met inclusion criteria, involving 1,088 participants. Studies focused on methadone prescribing. Participants reported stability; however, many disliked methadone. Barriers to full recovery were primarily ‘inward focused'. Conclusion: This is the first review of qualitative literature on long-term maintenance, finding that universal service improvements could be made to address reported barriers to recovery, including involving ex-users as positive role models, and increasing access to psychological support. Treatment policies combining harm minimisation and abstinence-orientated approaches may best support individualised recovery

    Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon : protocol for UK Study of Tendo Achilles Rehabilitation (UK STAR)

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    Introduction Achilles tendon rupture affects over 11,000 people yearly in the UK, and the incidence is increasing. Controversy remains with regards the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multi-centre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture. Methods and analysis All adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the NHS. Standardised protocols will be followed, but details of plaster material and brace will be as per the site’s usual practice. A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Rupture Score (ATRS) at 9 months. Quality of life and resource use will also be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. Results are expected to be available in the summer of 2019. Ethics and dissemination. National Research Ethic Committee approved this study on the 18th of March 2016 (16/SC/0109). The NIHR Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted upon 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

    High-latitude marginal reefs support fewer but bigger corals than their tropical counterparts

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    Anthropogenic impacts are typically detrimental to tropical coral reefs, but the effect of increasing environmental stress and variability on the size structure of coral communities remains poorly understood. This limits our ability to effectively conserve coral reef ecosystems because size specific dynamics are rarely incorporated. Our aim is to quantify variation in the size structure of coral populations across 20 sites along a tropical-to-subtropical environmental gradient on the east coast of Australia (~ 23 to 30°S), to determine how size structure changes with a gradient of sea surface temperature, turbidity, productivity and light levels. We use two approaches: 1) linear regression with summary statistics (such as median size) as response variables, a method frequently favoured by ecologists and 2) compositional functional regression, a novel method using entire size–frequency distributions as response variables. We then predict coral population size structure with increasing environmental stress and variability. Together, we find fewer but larger coral colonies in marginal reefs, where conditions are typically more variable and stressful, than in tropical reefs. Our model predicts that coral populations may become gradually dominated by larger colonies (> 148 cm2) with increasing environmental stress. Fewer but bigger corals suggest low survival of smaller corals, slow growth, and/or poor recruitment. This finding is concerning for the future of coral reefs, as it implies that current marginal populations, or future reefs in increasingly stressful environmental conditions may have low recovery potential. We highlight the importance of continuously monitoring changes to population structure over biogeographic scales

    “There’s a Catch-22”. The complexities of pain management for people with advanced dementia nearing the end of life: a qualitative exploration of physicians’ perspectives

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    Background: Pain management is a cornerstone of palliative care. The clinical issues encountered by physicians when managing pain in patients dying with advanced dementia, and how these may impact on prescribing and treatment, are unknown. Aim: To explore physicians’ experiences of pain management for patients nearing the end of life, the impact of these on prescribing and treatment approaches, and the methods employed to overcome these challenges. Design: Qualitative, semi-structured interview study exploring: barriers to and facilitators of pain management, prescribing and treatment decisions, and training needs. Thematic analysis was used to elicit key themes. Settings/Participants: Twenty-three physicians, responsible for treating patients with advanced dementia approaching the end of life, were recruited from primary care (n=9), psychiatry (n=7) and hospice care (n=7). Results: Six themes emerged: diagnosing pain, complex prescribing and treatment approaches, side-effects and adverse events, route of administration, importance of sharing knowledge and training needs. Knowledge exchange was often practised through liaison with physicians from other specialties. Cross-specialty mentoring, and the creation of knowledge networks were believed to improve pain management in this patient population. Conclusions: Pain management in end-stage dementia is complex, requiring cross-population of knowledge between palliative care specialists and non-specialists, in addition to collateral information provided by other health professionals and patients’ families. Regular, cost- and time-effective mentoring and ongoing professional development are perceived to be essential in empowering physicians to meet clinical challenges in this area
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