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500 patients will be recruited over a two year period. Baseline assessments will be recorded. At the end of the 6-month follow-up period, toxicity data will be retrospectively collected. A descriptive analysis of the recruited population will be performed. check details The validity of the CARG model will be analysed using receiver-operating characteristic curves and calculation of the area under the curve (c-statistic).

The study has received ethical approval from the East of Scotland Research Ethics Service 20/ES/0114. Results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

The study has received ethical approval from the East of Scotland Research Ethics Service 20/ES/0114. Results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

Cerebral visual impairment (CVI) comprises a heterogeneous group of brain-related vision problems. A core outcome set (COS) represents the most important condition-specific outcomes according to patients, carers, professionals and researchers. We aimed to produce a COS for studies evaluating interventions for children with CVI, to increase the relevance of research for families and professionals and thereby to improve outcomes for affected children.

We used methods recommended by the Core Outcome Measures in Effectiveness Trials Initiative. These included a proportionate literature review of outcomes used in previous studies; qualitative interviews with children and families; a two-round Delphi survey involving parents, children and professionals and a consensus meeting to ratify the most important outcomes.

Telephone interviews and online Delphi surveys of participants who all lived in UK or Eire.

Eighteen parents and six young people were interviewed. Delphi participants (n=80 did both rounds) included professionals working with children who have CVI (teachers, orthoptists, ophthalmologists, optometrists, qualified teachers for visually impaired, family members (parents and siblings) and affected children.

The literature review included 13 studies yielding 37 outcomes. Qualitative interviews provided 22 outcomes. After combining and refining similar items, the first round contained 23 outcomes and the second 46. At the consensus meeting, 5 attendees recommended 27 outcomes for inclusion in the CVI COS, of which 15 were ratified as most important, including 4 related to vision; 1 to family well-being; 1 to adults around the child being informed about CVI and the rest to the child’s abilities to engage with people and surroundings.

Good engagement from participants led to the development of a COS. Future research will be useful to identify the best ways to measure COS items and potentially to update this COS as more interventions for CVI are developed.

ISRCTN13762177.

ISRCTN13762177.

Severity of a first pulmonary embolism (PE) is sometimes proposed as a criterion for prolonging anticoagulant treatment. However, little evidence supports this idea. We attempted to determine the connection between severity of first PE and the risk of recurrence.

Patients admitted with PE between 2012 and 2018 and for whom anticoagulant treatment had been discontinued were followed. PEs were classified according to the severity into the following two groups those with associated cardiac involvement (increased cardiac biomarker(s) and/or echocardiographic right ventricular dysfunction) and those with no cardiac involvement which were classified as non-severe. Recurrence-free survivals were estimated using the Kaplan-Meier method and compared using the log-rank test.

417 patients with PEs (186 with cardiac involvement) were followed for at least 1 year after discontinuation of treatment with a mean follow-up of 3.5±1.9 years. 72 patients (17.3%) experienced venous thromboembolism recurrence 24 (5.8%), 44 (12 %) and 72 (28.3 %) respectively, at 1, 2 and 5 years. In 63 patients (88%), recurrence was a PE. Mean time to onset of recurrence was 24.9±19.9 months. At 5 years, the recurrence rate is higher when the first PE was associated with cardiac involvement p=0.043. In contrast, in patients with provoked PE, the recurrence rate is higher when the first PE event was associated with cardiac involvement p=0.032. Multivariate analysis demonstrates that PE severity is an independent factor of recurrence (HR 1.634 (1.015-2.632), p=0.043).

We report for the first time a possible link between a higher recurrence rate and the severity of the first PE. This result which must be confirmed in a dedicated prospective trial could become an important criterion for the duration of anticoagulant therapy after a PE.

NCT04980924.

NCT04980924.

Health systems worldwide have had to prepare for a surge in volume in both the outpatient and inpatient settings since the emergence of COVID-19. Early international healthcare experiences showed approximately 80% of patients with COVID-19 had mild disease and therfore could be managed as outpatients. However, SARS-CoV-2 can cause a biphasic illness with those affected experiencing a clinical deterioration usually seen after day 4 of illness.

We created an online tool with the primary objective of allowing for virtual disease triage among the increasing number of outpatients diagnosed with COVID-19 at our hospital. Secondary aims included COVID-19 education and the promotion of official COVID-19 information among these outpatients, and analysis of reported symptomatology.

Outpatients with acute COVID-19 disease received text messages from the hospital containing a link to an online symptom check-in tool which they were invited to complete.

296 unique participants (72%) from 413 contacted by text comple to participants and saw high levels of engagement and satisfaction. Symptomatology findings highlight the variety and persistence of symptoms experienced by those with confirmed COVID-19 disease.

The online symptom check-in tool was found to be acceptable to participants and saw high levels of engagement and satisfaction. Symptomatology findings highlight the variety and persistence of symptoms experienced by those with confirmed COVID-19 disease.

This study aims to understand the caregiver burden experienced by the primary caregivers of patients with amyotrophic lateral sclerosis (ALS), and to explore the factors influencing caregiver burden.

A cross-sectional survey design was used.

This study was conducted with ALS inpatients and follow-up outpatients at the neurology department of a tertiary general hospital in Taiyuan, Shanxi, China and their caregivers.

Patients with ALS and their caregivers (N=120 pairs) participated in a face-to-face interview.

Primary outcome measures included the Zarit Burden Interview scores and personal/role burden scores. There were no secondary outcomes.

Multiple linear and logistic regression analyses were performed to examine the factors influencing burden in ALS patient’s caregivers. Multiple linear regression showed that caregivers with higher Anxiety Index (AI) experienced greater personal (β=0.089, p<0.001), role (β=0.065, p<0.001) and overall (β=0.200, p<0.001) burden. Logistic regression analysis showed that AI (p=0.025; OR 1.351, 95% CI 1.038 to 1.759) and disease knowledge level (p=0.033; OR 0.305, 95% CI 0.107 to 0.593) are the influencing factors of ALS load classification.

Higher AI scores were associated with greater caregiver burden. Caregiver burden of caregivers who had no knowledge of the patient’s disease was 0.305 times that of those who had good knowledge. The level of disease knowledge and AI score can serve as key predictors of caregiver burden in ALS.

Higher AI scores were associated with greater caregiver burden. Caregiver burden of caregivers who had no knowledge of the patient’s disease was 0.305 times that of those who had good knowledge. The level of disease knowledge and AI score can serve as key predictors of caregiver burden in ALS.

There is currently only one approved medication effective at improving walking distance in people with intermittent claudication. Preclinical data suggest that the β

-adrenergic receptor agonist (mirabegron) could be repurposed to treat intermittent claudication associated with peripheral artery disease. The aim of the Stimulating β

-Adrenergic Receptors for Peripheral Artery Disease (STAR-PAD) trial is to test whether mirabegron improves walking distance in people with intermittent claudication.

The STAR-PAD trial is a Phase II, multicentre, double-blind, randomised, placebo-controlled trial of mirabegron versus placebo on walking distance in patients with PAD. A total of 120 patients aged ≥40 years with stable PAD and intermittent claudication will be randomly assigned (11 ratio) to receive either mirabegron (50 mg orally once a day) or matched placebo, for 12 weeks. The primary endpoint is change in peak walking distance as assessed by a graded treadmill test. Secondary endpoints will include (i) initial claudication distance; (ii) average daily step count and total step count and (iii) functional status and quality of life assessment. Mechanistic substudies will examine potential effects of mirabegron on vascular function, including brachial artery flow-mediate dilatation; MRI assessment of lower limb blood flow, tissue perfusion and arterial stiffness and numbers and angiogenesis potential of endothelial progenitor cells. Given that mirabegron is safe and clinically available for alternative purposes, a positive study is positioned to immediately impact patient care.

The STAR-PAD trial is approved by the Northern Sydney Local Health District Human Research Ethics Committee (HREC/18/HAWKE/50). The study results will be published in peer-reviewed medical or scientific journals and presented at scientific meetings, regardless of the study outcomes.

ACTRN12619000423112; Results.

ACTRN12619000423112; Results.

To compare costs associated with different models of outpatient parenteral antimicrobial therapy (OPAT) delivery with costs of inpatient (IP) care across key infection groups managed via OPAT in the UK.

A cost-minimisation design was used due to evidence of similarities in patient and treatment outcomes between OPAT and IP care. A bottom-up approach was undertaken for the evaluation of OPAT associated costs. The British Society of Antimicrobial Chemotherapy National Outcomes Registry System was used to determine key infection diagnoses, mean duration of treatment and most frequent antibiotics used.

Several OPAT delivery settings were considered and compared with IP care.

OPAT models considered were OP clinic model, nurse home visits, self (or carer)-administration by a bolus intravenous, self-administration by a commercially prefilled elastomeric device, continuous intravenous infusion of piperacillin with tazobactam or flucloxacillin with elastomeric device as OP once daily and, specifically for boneAT is a cost-effective use of National Health Service resources for the treatment of a range of infections in the UK in patients who can be safely managed in a non-IP setting.

Intensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome-family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.

This multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 11 ratio to either the intervention or control group.