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Leadership in a crisis: doing things differently, doing different things.
No full textThis article summarises the findings from a review of publications related to healthcare leadership that were published during the first wave of the COVID-19 crisis in 2020. The review discusses a range of strategies for leaders to adopt in challenging situations and identifies three aspects of leadership which are considered essential when leading teams during a crisis: 1) communication, 2) decision making and 3) mental health and wellbeing. This article identifies key principles for each of these three aspects and provides practical tips for how leaders can use the lessons learned from the pandemic in their own contexts
Test evaluation trials present different challenges for trial managers compared to intervention trials.
No full textINTRODUCTION
Test evaluation trials present different challenges for trial managers compared to intervention trials. There has been very little research on the management of test evaluation trials and how this impacts on trial success, in comparison with intervention trials. Evaluations of medical tests present specific challenges, because they are a pivot point bridging the complexities of pathways prompting testing with treatment decision-making. We systematically explored key differences in the trial design and management of test evaluation trials compared to intervention trials at the different stages of study design and delivery. We identified challenges in test evaluation trials that were more pronounced than in intervention trials, based on experience from 10 test evaluation trials.
METHODS
We formed a focus group of 7 trial managers and a statistician who had been involved in the day-to-day management of both test evaluation trials and intervention trials. We used discussion and content analysis to group challenges from 10 trials into a structured thematic format. The trials covered a range of medical conditions, diagnostic tests, clinical pathways and conditions including chronic kidney disease, chronic pelvic pain, colitis, detrusor over-activity, group B streptococcal colonisation, tuberculosis and colorectal, lung, ovarian and thyroid cancers.
RESULTS
We identified 10 common themes underlying challenges that are more pronounced in test evaluation compared to intervention trials. We illustrate these themes with examples from 10 trials, including with 31 specific challenges we experienced. The themes were ethics/governance; accessing patient populations; recruitment; patient preference; test processes, clinical pathways and samples storage; uncertainty of diagnostic results; verifying diagnosis (reference standard); follow-up; adverse effects; and diagnostic impact.
CONCLUSION
We present 10 common themes, including 31 challenges, in test evaluation trials that will be helpful to others designing and managing future test evaluation trials. Proactive identification of potential challenges at the design and planning stages of test evaluation trials will enable strategies to improve trial design and management that may be different from standard strategies used for intervention trials. Future work could extend this topic to include challenges for other trial stakeholders including participants, clinicians, statisticians and funders.
TRIAL REGISTRATION
All trials reviewed in this project were registered and are provided in Table 1
Volume overload in hemodialysis: diagnosis, cardiovascular consequences, and management.
No full textVolume overload in haemodialysis (HD) patients associates with hypertension and cardiac dysfunction and is a major risk factor for all-cause and cardiovascular mortality in this population. The diagnosis of volume excess and estimation of dry weight is based largely on clinical criteria and has a notoriously poor diagnostic accuracy. The search for accurate and objective methods to evaluate dry weight and to diagnose subclinical volume overload has been intensively pursued over the last 3 decades. Most methods have not been tested in appropriate clinical trials and their usefulness in clinical practice remains uncertain, except for bioimpedance spectroscopy and lung ultrasound (US). Bioimpedance spectroscopy is possibly the most widely used method to subjectively quantify fluid distributions over body compartments and produces reliable and reproducible results. Lung US provides reliable estimates of extravascular water in the lung, a critical parameter of the central circulation that in large part reflects the left ventricular end-diastolic pressure. To maximize cardiovascular tolerance, fluid removal in volume-expanded HD patients should be gradual and distributed over a sufficiently long time window. This review summarizes current knowledge about the diagnosis, prognosis and treatment of volume overload in HD patients
Calculating the economic burden of presumed microbial keratitis admissions at a tertiary referral centre in the UK.
No full textPURPOSE
Microbial keratitis (MK) is the most common non-surgical ophthalmic emergency admission in the UK. However, few prospective health-economic studies of MK have been performed, and no specific healthcare resources group (HRG) code exists. This study is designed to determine the feasibility of a data collection tool derived from the microbiology ophthalmology group (MOG) clinical record form, to enable quantification of direct costs of inpatient care, as well as prospective capture of epidemiological data relating to outcomes of MK.
METHODS
Clinical, demographic and economic data were collected retrospectively between January and December 2013 for 101 consecutive patients admitted with MK, using an adaption of the MOG toolset. The direct cost of admission (COA) was calculated using national reference costs and compared to actual income to generate profit/deficit profiles for individual patients. Indices of multiple deprivation were used to assess effect of deprivation on the COA.
RESULTS
The total income generated through discharge coding was £252,116, compared to a COA of £357,075, yielding a deficit of £104,960 (median: £754 per patient). The cost deficit increased significantly with length of stay (LOS, p < 0.001), whilst patients with short LOS were income generators; cost neutrality occurred at 4.8 days. Greater socioeconomic deprivation was also associated with a significantly higher cost deficit.
CONCLUSION
LOS is the key driver for COA of care for MK admissions. Protocols should encourage discharge of patients who are able to self-administer treatment after the sterilisation phase. The MOG-derived data collection toolset captures pertinent clinical data for quantification of COA. Further development into a multiuser and multisite platform is required for robust prospective testing, together with expansion to capture indirect costs of disease burden, including impact of treatment, visual morbidity and quality of life
Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era.
No full textBACKGROUND
The UK Severe Asthma Registry (UKSAR) is the world's largest national severe asthma registry collecting standardised data on referrals to UK specialist services. Novel biologic therapies have transformed the management of type 2(T2)-high severe asthma but have highlighted unmet need in patients with persisting symptoms despite suppression of T2-cytokine pathways with corticosteroids.
METHODS
Demographic, clinical and treatments characteristics for patients meeting European Respiratory Society / American Thoracic Society severe asthma criteria were examined for 2225 patients attending 15 specialist severe asthma centres. We assessed differences in biomarker low patients (fractional exhaled nitric oxide (FeNO) <25 ppb, blood eosinophils <150/μL) compared with a biomarker high population (FeNO ≥25 ppb, blood eosinophils ≥150/µL).
RESULTS
Age (mean 49.6 (14.3) y), age of asthma onset (24.2 (19.1) y) and female predominance (62.4%) were consistent with prior severe asthma cohorts. Poor symptom control (Asthma Control Questionnaire-6: 2.9 (1.4)) with high exacerbation rate (4 (IQR: 2, 7)) were common despite high-dose treatment (51.7% on maintenance oral corticosteroids (mOCS)). 68.9% were prescribed biologic therapies including mepolizumab (50.3%), benralizumab (26.1%) and omalizumab (22.6%). T2-low patients had higher body mass index (32.1 vs 30.2, p<0.001), depression/anxiety prevalence (12.3% vs 7.6%, p=0.04) and mOCS use (57.9% vs 42.1%, p<0.001). Many T2-low asthmatics had evidence of a historically elevated blood eosinophil count (0.35 (0.13, 0.60)).
CONCLUSIONS
The UKSAR describes the characteristics of a large cohort of asthmatics referred to UK specialist severe asthma services. It offers the prospect of providing novel insights across a range of research areas and highlights substantial unmet need with poor asthma control, impaired lung function and high exacerbation rates. T2-high phenotypes predominate with significant differences apparent from T2-low patients. However, T2-low patients frequently have prior blood eosinophilia consistent with possible excessive corticosteroid exposure
Antibody response to SARS-CoV-2 infection in humans: A systematic review.
No full textBACKGROUND
Progress in characterising the humoral immune response to Severe Acute Respiratory Syndrome 2 (SARS-CoV-2) has been rapid but areas of uncertainty persist. Assessment of the full range of evidence generated to date to understand the characteristics of the antibody response, its dynamics over time, its determinants and the immunity it confers will have a range of clinical and policy implications for this novel pathogen. This review comprehensively evaluated evidence describing the antibody response to SARS-CoV-2 published from 01/01/2020-26/06/2020.
METHODS
Systematic review. Keyword-structured searches were carried out in MEDLINE, Embase and COVID-19 Primer. Articles were independently screened on title, abstract and full text by two researchers, with arbitration of disagreements. Data were double-extracted into a pre-designed template, and studies critically appraised using a modified version of the Public Health Ontario Meta-tool for Quality Appraisal of Public Health Evidence (MetaQAT) tool, with resolution of disagreements by consensus. Findings were narratively synthesised.
RESULTS
150 papers were included. Most studies (113 or 75%) were observational in design, were based wholly or primarily on data from hospitalised patients (108, 72%) and had important methodological limitations. Few considered mild or asymptomatic infection. Antibody dynamics were well described in the acute phase, up to around three months from disease onset, but the picture regarding correlates of the antibody response was inconsistent. IgM was consistently detected before IgG in included studies, peaking at weeks two to five and declining over a further three to five weeks post-symptom onset depending on the patient group; IgG peaked around weeks three to seven post-symptom onset then plateaued, generally persisting for at least eight weeks. Neutralising antibodies were detectable within seven to 15 days following disease onset, with levels increasing until days 14-22 before levelling and then decreasing, but titres were lower in those with asymptomatic or clinically mild disease. Specific and potent neutralising antibodies have been isolated from convalescent plasma. Cross-reactivity but limited cross-neutralisation with other human coronaviridae was reported. Evidence for protective immunity in vivo was limited to small, short-term animal studies, showing promising initial results in the immediate recovery phase.
CONCLUSIONS
Literature on antibody responses to SARS-CoV-2 is of variable quality with considerable heterogeneity of methods, study participants, outcomes measured and assays used. Although acute phase antibody dynamics are well described, longer-term patterns are much less well evidenced. Comprehensive assessment of the role of demographic characteristics and disease severity on antibody responses is needed. Initial findings of low neutralising antibody titres and possible waning of titres over time may have implications for sero-surveillance and disease control policy, although further evidence is needed. The detection of potent neutralising antibodies in convalescent plasma is important in the context of development of therapeutics and vaccines. Due to limitations with the existing evidence base, large, cross-national cohort studies using appropriate statistical analysis and standardised serological assays and clinical classifications should be prioritised
Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study.
No full textOBJECTIVE
Patients with ANCA associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomised controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients.
METHODS
AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥) were randomly allocated to intervention or standard care in this single-centre open-label randomised controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop-go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention.
RESULTS
248 patients were screened and 134 were eligible to participate (54%). Stop-go criteria were amber for recruitment; 43/134 (32%, 95% CI 24-40) eligible participants randomised, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI 29-71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI 0-11). Qualitative results suggested the intervention was acceptable.
CONCLUSION
This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. Clinical Trial Registration Number ISRCTN11929227
Physiological tests of small airways function in diagnosing asthma: a systematic review.
No full textBACKGROUND
Asthma is a common, heterogeneous disease that is characterised by chronic airway inflammation and variable expiratory airflow limitation. Current guidelines use spirometric measures for asthma assessment. This systematic review aimed to assess whether the most commonly reported tests of small airways function could contribute to the diagnosis of asthma.
METHODS
Standard systematic review methodology was used, and a range of electronic databases was searched (Embase, MEDLINE, CINAHL, CENTRAL, Web of Science, DARE). Studies that included physiological tests of small airways function to diagnose asthma in adults were included, with no restrictions on language or date. The risk of bias and quality assessment tools used were Agency for Healthcare Research and Quality tool for cross-sectional studies and Quality Assessment of Diagnostic Accuracy Studies 2 for diagnostic test accuracy (DTA) studies.
RESULTS
7072 studies were identified and 10 studies met review criteria. 7 included oscillation techniques and 5 included maximal mid-expiratory flow (MMEF). Studies were small and of variable quality. In oscillometry, total resistance (R5) and reactance at 5 Hz (X5) was altered in asthma compared with healthy controls. The percentage predicted of MMEF was lower in patients with asthma compared with controls in all studies and lower than the % predicted forced expiratory volume in 1 s. In DTA of oscillometry, R5 showed a sensitivity between 69% and 72% and specificity between 61% and 86%.
CONCLUSION
There were differences in the results of physiological tests of small airway function in patients with asthma compared with controls. However, studies are small and heterogeneous. Further studies are needed to assess the effectiveness of these tests on a larger scale, including studies to determine which test methodology is the most useful in asthma
Distally-based Peroneus Brevis Turnover Muscle Flap in the Reconstruction of Soft Tissue Defects.
No full textReconstruction of the distal 3rd of the lower leg requires either local or free flap coverage if tendons or bones are exposed. The distally based, pedicled peroneus brevis (PB) flap has been shown to be a valid option in the management of distal 3rd lower limb injuries. Herein, we present 21 cases treated with distally-based PB muscle flaps between May 2017 and September 2019. The defect location varied, and included defects over the lateral and medial malleolar areas, distal tibia (middle and distal 3rd junction, and the distal 3rd), and Achilles tendon area.
Methods
The PB was dissected from the lateral fibula and intermuscular septa in a cephalic to caudal direction, to a point no lower than 7 cm proximal to the lateral malleolus tip. This preserved most distal vascular perforators to the muscle, and afforded sufficient mobilization to allow successful turn-over of the muscle, with transposition into the defect within 30 minutes of tourniquet time. A meshed skin graft completed the intervention.
Results
The metalwork was removed in all chronic cases (10/21), as bone union had occurred. All flaps survived completely. One patient partially lost the skin graft; the wound was healed by secondary intention. No major complications occurred and no significant patient discomfort was noted. All wounds healed completely by 9 weeks of follow-up.
Conclusion
The PB turnover muscle flap is a versatile flap, ideally suited to manage up to moderately sized defects of the distal 3rd of the lower leg, with negligible postoperative morbidity
Sarcopenia in nonalcoholic fatty liver disease: new challenges for clinical practice.
No full text: Sarcopenia is increasingly recognized in patients with nonalcoholic liver disease (NAFLD). Initially recognized as a consequence of advanced liver disease, there is now emerging evidence that sarcopenia may be a novel risk factor for the development of NAFLD, with a role in fibrosis and disease progression.: This review examines the epidemiology, pathogenesis, and complex interplay between NAFLD and sarcopenia. Furthermore, the authors discuss the challenges with diagnosis of sarcopenia in the clinic and the evidence-based management of sarcopenia in patients with NAFLD. A MEDLINE and PubMed search was undertaken using the terms; 'sarcopenia,' 'frailty,' 'muscle,' 'obesity,' 'non-alcoholic fatty liver disease,' 'non-alcoholic steatohepatitis', and 'cirrhosis' up to 31 September 2019.: Sarcopenia may be masked by the co-existence of morbid obesity, which is most notable in patients with NAFLD. Sarcopenia is a key indicator of adverse outcomes in patients with cirrhosis, such as hepatic decompensation, poor quality of life and premature mortality. Patients with NAFLD and advanced fibrosis/cirrhosis should undergo anthropometric measures (handgrip strength), dry body mass index, and measures of physical frailty (including muscle function, not just mass) to enable targeted early interventions of nutrition (low fat, 1.5 g/kg/day protein intake, 2-3 hourly food intake) and exercise (combined resistance and aerobic)