BMJ open
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Multicenter Study Observational Study
Protocol for the derivation and external validation of a 30-day mortality risk prediction model for older patients having emergency general surgery (PAUSE score-Probability of mortality Associated with Urgent/emergent general Surgery in oldEr patients score).
People 65 years and older represent the fastest growing segment of the surgical population. Older age is associated with doubling of risk when undergoing emergency general surgery (EGS) procedures and often coexists with medical complexity and considerations of end-of-life care, creating prognostic and decisional uncertainty. Combined with the time-sensitive nature of EGS, it is challenging to gauge perioperative risk and ensure that clinical decisions are aligned with the patient values. Current preoperative risk prediction models for older EGS patients have major limitations regarding derivation and validation, and do not address the specific risk profile of older patients. Accurate and externally validated models specific to older patients are needed to inform care and decision making. ⋯ Ethics for NSQIP data use was obtained from the Ottawa Hospital Research Ethics Board; external validation will use routinely collected anonymised data legally exempt from research ethics review. The final risk score will be published in a peer-reviewed journal. We plan to further disseminate the model as an online calculator or application for clinical use. Future research will be required to test the clinical application of the final model.
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Clinical guidelines recommend non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) for stroke prevention in most patients with atrial fibrillation (AF). Frail elderly were under-represented in the landmark NOAC-trials, leaving a knowledge gap on the optimal anticoagulant management (VKA or NOAC) in this increasing population. The aim of the Frail-AF (FRAIL-AF) study is to assess whether switching from international normalised ratio (INR)-guided VKA-management to a NOAC-based treatment strategy compared with continuing VKA-management is safe in frail elderly patients with AF. ⋯ The protocol was approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands and by the Central Committee on Research Involving Human Subjects, the Netherlands. All patients are asked written informed consent. Results are expected in 2022 and will be disseminated through peer-reviewed journals as well as presentations at national and international conferences.
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Randomized Controlled Trial Multicenter Study
Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial.
Few treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE. ⋯ The protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available at https://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences.
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Randomized Controlled Trial Multicenter Study
Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.
The current study aimed to evaluate the effects of a multi-component in-hospital intervention on the door-to-needle time for intravenous thrombolysis in acute ischaemic stroke. ⋯ Across these primary stroke care centres in Australia, a secular trend towards shorter door-to-needle times across both intervention and control hospitals was evident, however the TIPS (Thrombolysis ImPlementation in Stroke) intervention showed no overall effect on door-to-needle times in the randomised comparison.
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Multicenter Study
Development of a revised Jalowiec Coping Scale for use by emergency clinicians: a cross-sectional scale development study.
The aim of this study was to develop and validate a scale to measure the coping strategies used by emergency staff in response to workplace stress. To achieve this aim, we developed a refined Jalowiec Coping Scale (JCS), termed the Jalowiec Coping Scale-Emergency Department (JCS-ED) and validated this scale on a sample of emergency clinicians. ⋯ The JCS-ED assesses maladaptive coping strategies along with problem-focussed and emotion-focussed coping styles. It is a short instrument that is likely to be useful in measuring the types of coping strategies employed by staff.