Development of an enhanced scoring system to predict ICU readmission or in-hospital death within 24 hours using routine patient data from two NHS Foundation Trusts.

RATIONALE: Intensive care units (ICUs) admit the most severely ill patients. Once these patients are discharged from the ICU to a step-down ward, they continue to have their vital signs monitored by nursing staff, with Early Warning Score (EWS) systems being used to identify those at risk of deterioration. OBJECTIVES: We report the development and validation of an enhanced continuous scoring system for predicting adverse events, which combines vital signs measured routinely on acute care wards (as used by most EWS systems) with a risk score of a future adverse event calculated on discharge from the ICU. DESIGN: A modified Delphi process identified candidate variables commonly available in electronic records as the basis for a 'static' score of the patient's condition immediately after discharge from the ICU. L1-regularised logistic regression was used to estimate the in-hospital risk of future adverse event. We then constructed a model of physiological normality using vital sign data from the day of hospital discharge. This is combined with the static score and used continuously to quantify and update the patient's risk of deterioration throughout their hospital stay. SETTING: Data from two National Health Service Foundation Trusts (UK) were used to develop and (externally) validate the model. PARTICIPANTS: A total of 12 394 vital sign measurements were acquired from 273 patients after ICU discharge for the development set, and 4831 from 136 patients in the validation cohort. RESULTS: Outcome validation of our model yielded an area under the receiver operating characteristic curve of 0.724 for predicting ICU readmission or in-hospital death within 24 hours. It showed an improved performance with respect to other competitive risk scoring systems, including the National EWS (0.653). CONCLUSIONS: We showed that a scoring system incorporating data from a patient's stay in the ICU has better performance than commonly used EWS systems based on vital signs alone. TRIAL REGISTRATION NUMBER: ISRCTN32008295.

Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial.

INTRODUCTION: Delirium is common in critically ill patients and is associated with longer hospital stays, increased mortality and higher healthcare costs. A number of risk factors have been identified for the development of delirium in intensive care, two of which are sleep disturbance and immobilisation. Non-pharmacological interventions for the management of intensive care unit (ICU) delirium have been advocated, including sleep protocols and early mobilisation. However, there is a little published evidence evaluating the feasibility and acceptability of evening mobilisation. METHODS AND ANALYSIS: Mobilisation in the EveNing to TreAt deLirium (MENTAL) is a two-centre, mixed-methods feasibility randomised controlled trial (RCT). Sixty patients will be recruited from ICUs at two acute NHS trusts and randomised on a 1:1 basis to receive additional evening mobilisation, delivered between 19:00 and 21:00, or standard care. The underpinning hypothesis is that the physical exertion associated with evening mobilisation will promote better sleep, subsequently having the potential to reduce delirium incidence. The primary objective is to assess the feasibility and acceptability of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semi-structured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial. ETHICS AND DISSEMINATION: Ethical approval has been obtained through the Wales Research and Ethics Committee 6 (22/WA/0106). Participants are required to provide written informed consent. We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media. TRIAL REGISTRATION NUMBER: NCT05401461.

LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK.

INTRODUCTION: Long COVID, a new condition whose origins and natural history are not yet fully established, currently affects 1.5 million people in the UK. Most do not have access to specialist long COVID services. We seek to optimise long COVID care both within and outside specialist clinics, including improving access, reducing inequalities, helping self-management and providing guidance and decision support for primary care. We aim to establish a 'gold standard' of care by systematically analysing current practices, iteratively improving pathways and systems of care. METHODS AND ANALYSIS: This mixed-methods, multisite study is informed by the principles of applied health services research, quality improvement, co-design, outcome measurement and learning health systems. It was developed in close partnership with patients (whose stated priorities are prompt clinical assessment; evidence-based advice and treatment and help with returning to work and other roles) and with front-line clinicians. Workstreams and tasks to optimise assessment, treatment and monitoring are based in three contrasting settings: workstream 1 (qualitative research, up to 100 participants), specialist management in 10 long COVID clinics across the UK, via a quality improvement collaborative, experience-based co-design and targeted efforts to reduce inequalities of access, return to work and peer support; workstream 2 (quantitative research, up to 5000 participants), patient self-management at home, technology-supported monitoring and validation of condition-specific outcome measures and workstream 3 (quantitative research, up to 5000 participants), generalist management in primary care, harnessing electronic record data to study population phenotypes and develop evidence-based decision support, referral pathways and analysis of costs. Study governance includes an active patient advisory group. ETHICS AND DISSEMINATION: LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS study is sponsored by the University of Leeds and approved by Yorkshire & The Humber-Bradford Leeds Research Ethics Committee (ref: 21/YH/0276). Participants will provide informed consent. Dissemination plans include academic and lay publications, and partnerships with national and regional policymakers. TRIAL REGISTRATION NUMBER: NCT05057260, ISRCTN15022307.

Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

OBJECTIVE: To identify the most appropriate format for results dissemination to maximise understanding of trial results. DESIGN: Qualitative. SETTING: Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. PARTICIPANTS: All participants from these centres were eligible. All 343 participants were sent questionnaires. PRIMARY AND SECONDARY OUTCOME MEASURES: The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. RESULTS: All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. CONCLUSIONS: The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.