Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial.

Background: The effect of conservative vs. liberal oxygen therapy on outcomes of intensive care unit (ICU) patients with hypoxic ischaemic encephalopathy (HIE) is uncertain and will be evaluated in the Low Oxygen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial. Objective: The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial. Design setting and participants: LOGICAL is a randomised clinical trial in adults in the ICU who are comatose with suspected HIE (i.e., those who have not obeyed commands following return of spontaneous circulation after a cardiac arrest where there is clinical concern about possible brain damage). The LOGICAL trial will include 1400 participants and is being conducted as a substudy of the Mega Randomised registry trial comparing conservative vs. liberal oxygenation targets in adults receiving unplanned invasive mechanical ventilation in the ICU (Mega-ROX). Main outcome measures: The primary outcome is survival with favourable neurological function at 180 days after randomisation as measured with the Extended Glasgow Outcome Scale (GOS-E). A favourable neurological outcome will be defined as a GOS-E score of lower moderate disability or better (i.e. a GOS-E score of 5-8). Secondary outcomes include survival time, day 180 mortality, duration of invasive mechanical ventilation, ICU length of stay, hospital length of stay, the proportion of patients discharged home, quality of life assessed at day 180 using the EQ-5D-5L, and cognitive function assessed at day 180 using the Montreal Cognitive Assessment (MoCA-blind). Conclusions: The LOGICAL trial will provide reliable data on the impact of conservative vs. liberal oxygen therapy in ICU patients with suspected HIE following resuscitation from a cardiac arrest. Prepublication of the LOGICAL protocol and statistical analysis plan prior to trial conclusion will reduce the potential for outcome-reporting or analysis bias. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).

Primary and Periprosthetic Distal Femur Fractures in Older Adults: No Difference in 12-Month Mortality and Patient-Reported Outcomes.

OBJECTIVES: To compare fracture incidence, mortality, and patient-reported health outcomes at 6 and 12 months postinjury between primary and periprosthetic distal femur fractures in older adults. METHODS: A registry-based cohort study was conducted including all adults 70 years of age or older registered by the Victorian Orthopaedic Trauma Outcomes Registry who experienced a primary or periprosthetic distal femur fracture between 2007 and 2017. Outcomes included mortality and health status (Three-Level European Quality of Life-Five Dimensions Scale [EQ-5D-3L]) collected at 6 and 12 months postinjury. All distal femur fractures were confirmed by radiological review. Multivariable logistic regression was conducted to report associations between fracture type and mortality and health status. RESULTS: A final cohort of 292 participants was identified. Overall mortality for the cohort was 29.8%, and no significant differences were found in mortality rate or EQ-5D-3L outcomes between fracture types (ie, primary vs. periprosthetic). A large proportion of participants reported problems across all EQ-5D-3L domains at 6 and 12 months postinjury, with slightly worse outcomes in the primary fracture group. CONCLUSIONS: This study reports high mortality and poor 12-month outcomes in an older adult cohort with both periprosthetic and primary distal femur fractures. Given these poor outcomes, fracture prevention and a greater focus on long-term rehabilitation is needed in this cohort. In addition, the involvement of an ortho-geriatrician should be considered as a routine component of care. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Perceptions of an Interactive Trauma Recovery Information Booklet.

BACKGROUND: Previous research has shown that people with traumatic injuries have unmet information needs with respect to their injuries, management, and recovery. An interactive trauma recovery information booklet was developed and implemented to address these information needs at a major trauma center in Victoria, Australia. OBJECTIVE: The aim of this quality improvement project was to explore patient and clinician perceptions of a recovery information booklet introduced into a trauma ward. METHODS: Semistructured interviews with trauma patients, family members, and health professionals were undertaken and thematically analyzed using a framework approach. In total, 34 patients, 10 family members, and 26 health professionals were interviewed. RESULTS: Overall, the booklet was well accepted by most participants and was perceived to contain useful information. The design, content, pictures, and readability were all positively appraised. Many participants used the booklet to record personalized information and to ask health professionals questions about their injuries and management. CONCLUSION: Our findings highlight the usefulness and acceptability of a low-cost interactive booklet intervention to facilitate the provision of quality of information and patient-health professional interactions on a trauma ward.

Can a new ward environment and intensive allied health staffing model enhance therapeutic opportunities in trauma care? A behavioural mapping study of patients' activities and interactions.

OBJECTIVE: The aim of this study was to assess changes in patient activities and interactions observed in response to a new trauma ward at a level 1 trauma centre, and subsequently, a new allied health staffing model. DESIGN: Explorative case study using behavioural mapping. SETTING: Level 1 trauma centre in Melbourne, Australia. PARTICIPANTS: Hospitalised trauma patients. MAIN MEASURES: Behavioural mapping of patients' activities and interactions was conducted by two observers over three 4-day observation phases: (i) at baseline, (ii) on the new ward and (iii) with the new staffing model. Changes in activities and interactions were assessed via negative binomial regression models and reported as incident rate ratios. RESULTS: In total, 1264 patient observations were recorded over an 18-month period. After moving to the new ward, patients were observed performing activities of daily living at a 2.1-fold higher rate than at baseline (95% confidence interval: 1.18, 3.81) but walking/standing/climbing stairs 54% less (95% confidence interval: 0.22, 0.94). Subsequent to the new staffing model, patients were observed in the gym at a 4.1-fold higher rate (95% confidence interval: 1.60, 10.32) and interacting with allied health professionals at a 9.1-fold higher rate (95% confidence interval: 4.88, 16.98), than at baseline. After COVID-19 restrictions were introduced, patients were observed lying down 22% more (95% confidence interval: 1.04, 1.43), with 73% fewer visitor interactions (95% confidence interval: 0.17, 0.43). CONCLUSIONS: Greater engagement in physical and social activities was observed following the implementation of the new allied health staffing model at a level 1 trauma centre. Whether these changes translate to improved trauma outcomes is important to investigate.

Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness.

Rationale: The outcomes of survivors of critical illness due to coronavirus disease (COVID-19) compared with non-COVID-19 are yet to be established. Objectives: We aimed to investigate new disability at 6 months in mechanically ventilated patients admitted to Australian ICUs with COVID-19 compared with non-COVID-19. Methods: We included critically ill patients with COVID-19 and non-COVID-19 from two prospective observational studies. Patients were eligible if they were adult (age ⩾ 8 yr) and received ⩾24 hours of mechanical ventilation. In addition, patients with COVID-19 were eligible with a positive laboratory PCR test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Measurements and Main Results: Demographic, intervention, and hospital outcome data were obtained from electronic medical records. Survivors were contacted by telephone for functional outcomes with trained outcome assessors using the World Health Organization Disability Assessment Schedule 2.0. Between March 6, 2020, and April 21, 2021, 120 critically ill patients with COVID-19, and between August 2017 and January 2019, 199 critically ill patients without COVID-19, fulfilled the inclusion criteria. Patients with COVID-19 were older (median [interquartile range], 62 [55-71] vs. 58 [44-69] yr; P = 0.019) with a lower Acute Physiology and Chronic Health Evaluation II score (17 [13-20] vs. 19 [15-23]; P = 0.011). Although duration of ventilation was longer in patients with COVID-19 than in those without COVID-19 (12 [5-19] vs. 4.8 [2.3-8.8] d; P < 0.001), 180-day mortality was similar between the groups (39/120 [32.5%] vs. 70/199 [35.2%]; P = 0.715). The incidence of death or new disability at 180 days was similar (58/93 [62.4%] vs. 99/150 [66/0%]; P = 0.583). Conclusions: At 6 months, there was no difference in new disability for patients requiring mechanical ventilation for acute respiratory failure due to COVID-19 compared with non-COVID-19. Clinical trial registered with www.clinicaltrials.gov (NCT04401254).

The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study.

BACKGROUND: There are few reports of new functional impairment following critical illness from COVID-19. We aimed to describe the incidence of death or new disability, functional impairment and changes in health-related quality of life of patients after COVID-19 critical illness at 6 months. METHODS: In a nationally representative, multicenter, prospective cohort study of COVID-19 critical illness, we determined the prevalence of death or new disability at 6 months, the primary outcome. We measured mortality, new disability and return to work with changes in the World Health Organization Disability Assessment Schedule 2.0 12L (WHODAS) and health status with the EQ5D-5LTM. RESULTS: Of 274 eligible patients, 212 were enrolled from 30 hospitals. The median age was 61 (51-70) years, and 124 (58.5%) patients were male. At 6 months, 43/160 (26.9%) patients died and 42/108 (38.9%) responding survivors reported new disability. Compared to pre-illness, the WHODAS percentage score worsened (mean difference (MD), 10.40% [95% CI 7.06-13.77]; p < 0.001). Thirteen (11.4%) survivors had not returned to work due to poor health. There was a decrease in the EQ-5D-5LTM utility score (MD, - 0.19 [- 0.28 to - 0.10]; p < 0.001). At 6 months, 82 of 115 (71.3%) patients reported persistent symptoms. The independent predictors of death or new disability were higher severity of illness and increased frailty. CONCLUSIONS: At six months after COVID-19 critical illness, death and new disability was substantial. Over a third of survivors had new disability, which was widespread across all areas of functioning. Clinical trial registration NCT04401254 May 26, 2020.