Dual bronchodilators in Bronchiectasis study (DIBS): protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis.

INTRODUCTION: Bronchiectasis is a long-term lung condition, with dilated bronchi, chronic inflammation, chronic infection and acute exacerbations. Recurrent exacerbations are associated with poorer clinical outcomes such as increased severity of lung disease, further exacerbations, hospitalisations, reduced quality of life and increased risk of death. Despite an increasing prevalence of bronchiectasis, there is a critical lack of high-quality studies into the disease and no treatments specifically approved for its treatment. This trial aims to establish whether inhaled dual bronchodilators (long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA)) taken as either a stand-alone therapy or in combination with inhaled corticosteroid (ICS) reduce the number of exacerbations of bronchiectasis requiring treatment with antibiotics during a 12 month treatment period. METHODS: This is a multicentre, pragmatic, double-blind, randomised controlled trial, incorporating an internal pilot and embedded economic evaluation. 600 adult patients (≥18 years) with CT confirmed bronchiectasis will be recruited and randomised to either inhaled dual therapy (LABA+LAMA), triple therapy (LABA+LAMA+ICS) or matched placebo, in a 2:2:1 ratio (respectively). The primary outcome is the number of protocol defined exacerbations requiring treatment with antibiotics during the 12 month treatment period. ETHICS AND DISSEMINATION: Favourable ethical opinion was received from the North East-Newcastle and North Tyneside 2 Research Ethics Committee (reference: 21/NE/0020). Results will be disseminated in peer-reviewed publications, at national and international conferences, in the NIHR Health Technology Assessments journal and to participants and the public (using lay language). TRIAL REGISTRATION NUMBER: ISRCTN15988757.

The Infant KIdney Dialysis and Utrafiltration (I-KID) Study: A Stepped-Wedge Cluster-Randomized Study in Infants, Comparing Peritoneal Dialysis, Continuous Venovenous Hemofiltration, and Newcastle Infant Dialysis Ultrafiltration System, a Novel Infant Hemodialysis Device.

OBJECTIVES: Renal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformité Européenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH). DESIGN: Nonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence. SETTING: Clusters were six U.K. PICUs. PATIENTS: Babies less than 8 kg requiring RRT for fluid overload or biochemical disturbance. INTERVENTIONS: In controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances. MEASUREMENTS AND MAIN RESULTS: At closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd ) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between. CONCLUSIONS: NIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.

Survey of Diagnostic and Management Practices in Small Bowel Obstruction: Individual and Generational Variation Despite Practice Guidelines.

Background: Small bowel obstruction (SBO) is a common disorder managed by surgeons. Despite extensive publications and management guidelines, there is no universally accepted approach to its diagnosis and management. We conducted a survey of acute care surgeons to elucidate their SBO practice patterns.Methods: A self-report survey of SBO diagnosis and management practices was designed and distributed by email to AAST surgeons who cared for adult SBO patients. Responses were analyzed with descriptive statistics and Chi-square test of independence at α = .05.Results: There were 201 useable surveys: 53% ≥ 50 years, 77% male, 77% at level I trauma centers. Only 35.8% reported formal hospital SBO management guidelines. Computed tomography (CT) scan was the only diagnostic exam listed as "essential" by the majority of respondents (82.6%). Following NG decompression, 153 (76.1%) would "always/frequently" administer a water-soluble contrast challenge (GC). There were notable age differences in approach. Compared to those ≥50 years, younger surgeons were less likely to deem plain abdominal films as "essential" (16.0% vs 40.2%; P < .01) but more likely to require CT scan (88.3% vs 77.6%; P = .045) for diagnosis and to "always/frequently" administer GC (84.0% vs 69.2%; P < .01). Younger surgeons used laparoscopy "frequently" more often than older surgeons (34.0% vs 21.5%, P = .05).Discussion: There is significant variation in diagnosis and management of SBO among respondents in this convenience sample, despite existing PMGs. Novel age differences in responses were observed, which prompts further evaluation. Additional research is needed to determine whether variation in practice patterns is widespread and affects outcomes.

Findings on Repeat Posttraumatic Brain Computed Tomography Scans in Older Patients With Minimal Head Trauma and the Impact of Existing Antithrombotic Use.

STUDY OBJECTIVE: Evaluate the utility of routine rescanning of older, mild head trauma patients with an initial negative brain computed tomography (CT), who is on a preinjury antithrombotic (AT) agent by assessing the rate of delayed intracranial hemorrhage (dICH), need for surgery, and attributable mortality. METHODS: Participating centers were trained and provided data collection instruments per institutional review board-approved protocols. Data were obtained from manual chart review and electronic medical record download. Adults ≥55 years seen at Level I/II Trauma Centers, between 2017 and 2019 with suspected head trauma, Glasgow Coma Scale 14 to 15, negative initial brain CT, and no other Abbreviated Injury Scale injuries >2 were identified, grouped by preinjury AT therapy (AT- or AT+) and compared on dICH rate, need for operative neurosurgical intervention, and attributable mortality using univariate analysis (α=.05). RESULTS: A total of 2,950 patients from 24 centers were enrolled; 280 (9.5%) had a repeat brain CT. In those rescanned, the dICH rate was 15/126 (11.9%) for AT- and 6/154 (3.9%) in AT+. Assuming nonrescanned patients did not suffer clinically meaningful dICH, the dICH rate would be 15/2001 (0.7%) for AT- and 6/949 (0.6%) for AT+. No surgical operations were done for dICH. All-cause mortality was 9/2950 (0.3%) and attributable mortality was 1/2950 (0.03%). The attributable death was an AT+, dICH patient whose family declined intervention. CONCLUSION: In older patients with an initial Glasgow Coma Scale of 14 to 15 and a negative initial brain CT scan, the dICH rate is low (<1%) and of minimal clinical consequence, regardless of AT use. In addition, no patient had operative neurosurgical intervention. Therefore, routine rescanning is not supported based on the results of this study.

The burden of geriatric traumatic brain injury on trauma systems: Analysis of 348,800 Medicare inpatient claims.

BACKGROUND: Traumatic brain injury (TBI) is a leading cause of death and disability in older adults. The aim of this study was to characterize the burden of TBI in older adults by describing demographics, care location, diagnoses, outcomes, and payments in this high-risk group. METHODS: Using 2016-2019 Centers for Medicare & Medicaid Services (CMS) Inpatient Standard Analytical Files (IPSAF), patients >65 years with TBI (>1 injury ICD-10 starting with "S06") were selected. Trauma center levels were linked to the IPSAF file via American Hospital Association Hospital Provider ID and fuzzy-string matching. Patient variables were compared across trauma center levels. RESULTS: Three hundred forty-eight thousand eight hundred inpatients (50.4% female; 87.1% white) from 2963 US hospitals were included. Level I/II trauma centers treated 66.9% of patients; non-trauma centers treated 21.5%. Overall inter-facility transfer rate was 19.2%; in Level I/II trauma centers transfers-in represented 23.3% of admissions. Significant TBI (Head AIS ≥3) was present in 70.0%. Most frequent diagnoses were subdural hemorrhage (56.6%) and subarachnoid hemorrhage (30.6%). Neurosurgical operations were performed in 10.9% of patients and operative rates were similar regardless of center level. Total unadjusted mortality for the sample was 13.9%, with a mortality of 8.1% for those who expired in-hospital, and an additional 5.8% for those discharged to hospice. Medicare payments totaled $4.91B, with the majority (73.4%) going to Level I/II trauma centers. CONCLUSIONS: This study fills a gap in TBI research by demonstrating that although the majority of older adult TBI patients in the United States receive care at Level I/II trauma centers, a substantial percentage are managed at other facilities, despite 1 in 10 requiring neurosurgical operation regardless of level of trauma center. This analysis provides preliminary data on the function of regionalized trauma care for older adult TBI care. Future studies assessing the efficacy of early care guidelines in this population are warranted.

Preferences for dietary oils and fats in cooking and food preparation methods: a cross-sectional analysis of Australian adults.

Dietary oils and fats contain different fatty acid compositions that are associated with cardiometabolic disease risk. Despite their influence on disease outcomes, the types of dietary oils and fats predominately used in Australian households remain unknown. The aim of this study was to investigate the use of dietary oils and fats in cooking and food preparation in Australia. Adults living in Australia completed a cross-sectional online survey outlining their current household oil and fat use from July to December 2021. The survey was disseminated via social media platforms and included questions about the types of dietary oils and fats used for different cooking methods and the perceived motivators for choosing the main household oil. A total of 1248 participants responded to the survey. Participants were mostly female (91·6 %) aged between 25 and 44 years (56·7 %). The majority of participants (84·5 %) reported using some form of olive oil as their main source of oil for cooking and food preparation. Almost two-thirds of the sample (65·4 %) reported using extra virgin olive oil (EVOO), mainly in raw food preparation (71·5 %) or savoury baking and roasting (58 %). Fewer households reported using rice bran oil (4·6 %), canola oil (4·3 %) and vegetable oil (1·8 %). Almost half of all participants (49·6 %) identified perceived health benefits as the primary motivating factor for their main choice of oil, followed by sensory preference (46·7 %), versatility (10·2 %) and convenience (8·8 %). Australian adults frequently use olive oil, specifically EVOO, as the main oil for cooking and food preparation in the household.

Low Prevalence but High Impact of COVID-19 Positive Status in Adult Trauma Patients: A Multi-institutional Analysis of 28 904 Patients.

BACKGROUND: Few large investigations have addressed the prevalence of COVID-19 infection among trauma patients and impact on providers. The purpose of this study was to quantify the prevalence of COVID-19 infection among trauma patients by timing of diagnosis, assess nosocomial exposure risk, and evaluate the impact of COVID-19 positive status on morbidity and mortality. METHODS: Registry data from adults admitted 4/1/2020-10/31/2020 from 46 level I/II trauma centers were grouped by: timing of first positive status (Day 1, Day 2-6, or Day ≥ 7); overall Positive/Negative status; or Unknown if test results were unavailable. Groups were compared on outcomes (Trauma Quality Improvement Program complications) and mortality using univariate analysis and adjusted logistic regression. RESULTS: There were 28 904 patients (60.7% male, mean age: 56.4, mean injury severity score: 10.5). Of 13 274 (46%) patients with known COVID-19 status, 266 (2%) were Positive Day 1, 119 (1%) Days 2-6, 33 (.2%) Day ≥ 7, and 12 856 (97%) tested Negative. COVID-19 Positive patients had significantly worse outcomes compared to Negative; unadjusted comparisons showed longer hospital length of stay (10.98 vs 7.47;P < .05), higher rates of intensive care unit (57.7% vs 45.7%; P < .05) and ventilation use (22.5% vs 16.9%; P < .05). Adjusted comparisons showed higher rates of acute respiratory distress syndrome (1.7% vs .4%; P < .05) and death (8.1% vs 3.4%; P < .05). CONCLUSIONS: This multicenter study conducted during the early pandemic period revealed few trauma patients tested COVID-19 positive, suggesting relatively low exposure risk to care providers. COVID-19 positive status was associated with significantly higher mortality and specific morbidity. Further analysis is needed with consideration for care guidelines specific to COVID-19 positive trauma patients as the pandemic continues.

Bacteremia in Trauma: A Contemporary Analysis of Blood Culture Results and Outcomes in 158,884 Patients.

Background: Bacteremia is a potentially lethal complication. Limited research exists describing its incidence and associated outcomes in trauma patients. This descriptive study characterized the incidence, risk factors, and outcomes of bacteremia in trauma patients. Methods: This study used 2017-2020 system-wide Trauma Registry/Electronic Data Warehouse to select trauma activations aged ≥18 years. Blood culture information, including pathogen genera and species, was obtained from electronic laboratory records. Bacteremia positive was defined as two blood cultures within two hours of each other, growing the same organism; bacteremia negative as no growth, only one blood culture with growth, or growth of two different organisms. Bacteremia-positive and bacteremia-negative patients were compared with patients without blood cultures. Logistic regression compared blood culture results with outcomes, adjusting for age, gender, Injury Severity Score (ISS), and comorbidities. Results: Of 158,884 patients at 89 centers, 17,166 (10.8%) had blood cultures. Of those with blood cultures, 1214 were bacteremia positive (7.1%). Compared with no blood cultures, bacteremia-positive patients were more likely male, with higher ISS, and more comorbidities and intensive care unit use. Bacteremia-positive patients were more likely to die (adjusted odds ratio [aOR], 3.78; 95% confidence interval [CI], 3.17-4.51; p < 0.001) and have severe sepsis/septic shock (aOR, 114.91; 95% CI, 95.09-138.85; p < 0.001). Most common isolates were Staphylococcus epidermidis (14%), non-methicillin resistant Staphylococcus aureus (12%), and Escherichia coli (6%), with highest mortality associated with Pseudomonas aeruginosa (45%), Enterococcus faecalis (30%), and Escherichia coli (28%). Conclusions: Bacteremia in trauma is uncommon (<1%) but associated with increased resource use and poorer outcomes. Bacteremia, or suspicion thereof, identifies a high-risk population and justifies aggressive empiric intervention to maximize survival.

Design and analysis of umbrella trials: Where do we stand?

Background: The efficiencies that master protocol designs can bring to modern drug development have seen their increased utilization in oncology. Growing interest has also resulted in their consideration in non-oncology settings. Umbrella trials are one class of master protocol design that evaluates multiple targeted therapies in a single disease setting. Despite the existence of several reviews of master protocols, the statistical considerations of umbrella trials have received more limited attention. Methods: We conduct a systematic review of the literature on umbrella trials, examining both the statistical methods that are available for their design and analysis, and also their use in practice. We pay particular attention to considerations for umbrella designs applied outside of oncology. Findings: We identified 38 umbrella trials. To date, most umbrella trials have been conducted in early phase settings (73.7%, 28/38) and in oncology (92.1%, 35/38). The quality of statistical information available about conducted umbrella trials to date is poor; for example, it was impossible to ascertain how sample size was determined in the majority of trials (55.3%, 21/38). The literature on statistical methods for umbrella trials is currently sparse. Conclusions: Umbrella trials have potentially great utility to expedite drug development, including outside of oncology. However, to enable lessons to be effectively learned from early use of such designs, there is a need for higher-quality reporting of umbrella trials. Furthermore, if the potential of umbrella trials is to be realized, further methodological research is required.

UniStArt: A 12-Month Prospective Observational Study of Body Weight, Dietary Intake, and Physical Activity Levels in Australian First-Year University Students.

Background: Students in the United States gain weight significantly during their first year of university, however limited data are available for Australian students. Methods: This 12-month observational study was conducted to monitor monthly body weight and composition, as well as quarterly eating behaviours, dietary intake, physical activity, sedentary behaviours, and basal metabolic rate changes amongst first-year Australian university students. Participants were first-year university students over 18 years. Results: Twenty-two first-year university students (5 males and 17 females) completed the study. Female students gained weight significantly at two, three, and four-months (+0.9 kg; +1.5 kg; +1.1 kg, p < 0.05). Female waist circumference (2.5 cm increase at three-months, p = 0.012), and body fat also increased (+0.9%, p = 0.026 at three-months). Intakes of sugar, saturated fat (both >10% of total energy), and sodium exceeded recommended levels (>2000 mg) at 12-months. Greater sedentary behaviours were observed amongst male students throughout the study (p <0.05). Conclusions: Female students are at risk of unfavourable changes in body composition during the first year of university, while males are at risk of increased sedentary behaviours. High intakes of saturated fat, sugars, and sodium warrant future interventions in such a vulnerable group.

Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.

Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they have potential to bring benefit. One barrier to their more widespread use is a lack of understanding about how the choice to use an adaptive design, rather than a traditional design, affects resources (staff and non-staff) required to set-up, conduct and report a trial. The Costing Adaptive Trials project investigated this issue using quantitative and qualitative research amongst UK Clinical Trials Units. Here, we present guidance that is informed by our research, on considering the appropriate resourcing of adaptive trials. We outline a five-step process to estimate the resources required and provide an accompanying costing tool. The process involves understanding the tasks required to undertake a trial, and how the adaptive design affects them. We identify barriers in the publicly funded landscape and provide recommendations to trial funders that would address them. Although our guidance and recommendations are most relevant to UK non-commercial trials, many aspects are relevant more widely.

What Makes a Trauma Patient "Pediatric"? Survey of Providers' Admission Decision Making for Pediatric Trauma Patients.

BACKGROUND: Only a fraction of pediatric trauma patients are treated in pediatric-specific facilities, leaving the remaining to be seen in centers that must decide to admit the patient to a pediatric or adult unit. Thus, there may be inconsistencies in pediatric trauma admission practices among trauma centers. OBJECTIVE: Describe current practices in admission decision making for pediatric patients. METHODS: An email survey was distributed to members of three professional organizations: The American Association for the Surgery of Trauma, Society of Trauma Nurses, and Pediatric Trauma Society. The survey contained questions regarding pediatric age cutoffs, institutional placement decisions, and scenario-based assessments to determine mitigating placement factors. RESULTS: There were 313 survey responses representing freestanding children's hospitals (114, 36.4%); children's hospitals within general hospitals (107, 34.2%), and adult centers (not a children's hospital; 90, 28.8%). The mean age cutoff for pediatric admission was 16.6 years. The most reported cutoff ages were 18 years (77, 25.6%) and 15 years (76, 25.2%). The most common rationales for the age cutoffs were "institutional experience/tradition" (139, 44.4%) and "physician preference" (89, 28.4%). CONCLUSION: There was no single widely accepted age cutoff that distinguished pediatric from adult trauma patients for admission placement. There was significant variability between and within the types of facilities, with noted ambiguity in the definition of a "pediatric" patient. Thresholds appear to be based primarily on subjective criteria such as traditions or preferences rather than scientific data. Institutions should strive for objective, evidence-based policies for determining the appropriate placement of pediatric patients.

MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty - protocol for a double-blind, randomised controlled proof-of-concept trial.

INTRODUCTION: Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty. METHODS AND ANALYSIS: MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit. ETHICS AND DISSEMINATION: The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community. TRIAL REGISTRATION NUMBER: ISRCTN29932357.

Hyperglycemia in nondiabetic adult trauma patients is associated with worse outcomes than diabetic patients: An analysis of 95,764 patients.

BACKGROUND: The adverse impact of acute hyperglycemia is well documented but its specific effects on nondiabetic trauma patients are unclear. The purpose of this study was to analyze the differential impact of hyperglycemia on outcomes between diabetic and nondiabetic trauma inpatients. METHODS: Adults admitted 2018 to 2019 to 46 Level I/II trauma centers with two or more blood glucose tests were analyzed. Diabetes status was determined from International Classification of Diseases-10th Rev.-Clinical Modification, trauma registry, and/or hemoglobin A1c greater than 6.5. Patients with and without one or more hyperglycemic result >180 mg/dL were compared. Logistic regression examined the effects of hyperglycemia and diabetes on outcomes, adjusting for age, sex, Injury Severity Score, and body mass index. RESULTS: There were 95,764 patients: 54% male; mean age, 61 years; mean Injury Severity Score, 10; diabetic, 21%. Patients with hyperglycemia had higher mortality and worse outcomes compared with those without hyperglycemia. Nondiabetic hyperglycemic patients had the highest odds of mortality (diabetic: adjusted odds ratio, 3.11; 95% confidence interval, 2.8-3.5; nondiabetics: adjusted odds ratio, 7.5; 95% confidence interval, 6.8-8.4). Hyperglycemic nondiabetics experienced worse outcomes on every measure when compared with nonhyperglycemic nondiabetics, with higher rates of sepsis (1.1 vs. 0.1%, p < 0.001), more SSIs (1.0 vs. 0.1%, p < 0.001), longer mean hospital length of stay (11.4 vs. 5.0, p < 0.001), longer mean intensive care unit length of stay (8.5 vs. 4.0, p < 0.001), higher rates of intensive care unit use (68.6% vs. 35.1), and more ventilator use (42.4% vs. 7.3%). CONCLUSION: Hyperglycemia is associated with increased odds of mortality in both diabetic and nondiabetic patients. Hyperglycemia during hospitalization in nondiabetics was associated with the worst outcomes and represents a potential opportunity for intervention in this high-risk group. LEVEL OF EVIDENCE: Therapeutic/care management; Level III.

The public health burden of geriatric trauma: Analysis of 2,688,008 hospitalizations from Centers for Medicare and Medicaid Services inpatient claims.

BACKGROUND: Geriatric trauma care (GTC) represents an increasing proportion of injury care, but associated public health research on outcomes and expenditures is limited. The purpose of this study was to describe GTC characteristics, location, diagnoses, and expenditures. METHODS: Patients at short-term nonfederal hospitals, 65 years or older, with ≥1 injury International Classification of Diseases, Tenth Revision, were selected from 2016 to 2019 Centers for Medicare and Medicaid Services Inpatient Standard Analytical Files. Trauma center levels were linked to Inpatient Standard Analytical Files data via American Hospital Association Hospital ID and fuzzy string matching. Demographics, care location, diagnoses, and expenditures were compared across groups. RESULTS: A total of 2,688,008 hospitalizations (62% female; 90% White; 71% falls; mean Injury Severity Score, 6.5) from 3,286 hospitals were included, comprising 8.5% of all Medicare inpatient hospitalizations. Level I centers encompassed 7.2% of the institutions (n = 236) but 21.2% of hospitalizations, while nontrauma centers represented 58.5% of institutions (n = 1,923) and 37.7% of hospitalizations. Compared with nontrauma centers, patients at Level I centers had higher Elixhauser scores (9.0 vs. 8.8) and Injury Severity Score (7.4 vs. 6.0; p < 0.0001). The most frequent primary diagnosis at all centers was hip/femur fracture (28.3%), followed by traumatic brain injury (10.1%). Expenditures totaled $32.9 billion for trauma-related hospitalizations, or 9.1% of total Medicare hospitalization expenditures and approximately 1.1% of the annual Medicare budget. The overall mortality rate was 3.5%. CONCLUSION: Geriatric trauma care accounts for 8.5% of all inpatient GTC and a similar percentage of expenditures, the most common injury being hip/femur fractures. The largest proportion of GTC occurs at nontrauma centers, emphasizing their vital role in trauma care. Public health prevention programs and GTC guidelines should be implemented by all hospitals, not just trauma centers. Further research is required to determine the optimal role of trauma systems in GTC, establish data-driven triage guidelines, and define the impact of trauma centers and nontrauma centers on GTC mortality. LEVEL OF EVIDENCE: Therapeutic/care management, Level III.

Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.

BACKGROUND: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources are required to conduct a high-quality adaptive clinical trial, compared to a traditional fixed design. The Costing Adaptive Trials (CAT) project investigated which additional resources may be required to support adaptive trials. METHODS: We conducted a mock costing exercise amongst seven Clinical Trials Units (CTUs) in the UK. Five scenarios were developed, derived from funded clinical trials, where a non-adaptive version and an adaptive version were described. Each scenario represented a different type of adaptive design. CTU staff were asked to provide the costs and staff time they estimated would be needed to support the trial, categorised into specified areas (e.g. statistics, data management, trial management). This was calculated separately for the non-adaptive and adaptive version of the trial, allowing paired comparisons. Interviews with 10 CTU staff who had completed the costing exercise were conducted by qualitative researchers to explore reasons for similarities and differences. RESULTS: Estimated resources associated with conducting an adaptive trial were always (moderately) higher than for the non-adaptive equivalent. The median increase was between 2 and 4% for all scenarios, except for sample size re-estimation which was 26.5% (as the adaptive design could lead to a lengthened study period). The highest increase was for statistical staff, with lower increases for data management and trial management staff. The percentage increase in resources varied across different CTUs. The interviews identified possible explanations for differences, including (1) experience in adaptive trials, (2) the complexity of the non-adaptive and adaptive design, and (3) the extent of non-trial specific core infrastructure funding the CTU had. CONCLUSIONS: This work sheds light on additional resources required to adequately support a high-quality adaptive trial. The percentage increase in costs for supporting an adaptive trial was generally modest and should not be a barrier to adaptive designs being cost-effective to use in practice. Informed by the results of this research, guidance for investigators and funders will be developed on appropriately resourcing adaptive trials.

The Impact of Nursing on Trauma Patient Satisfaction: An Analysis of HCAHPS From 112,283 Patients.

BACKGROUND: Assessment of patient satisfaction is central to understanding and improving system performance with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) national standard survey. However, no large, multi-institutional study exists, which examines the role of nurses in trauma patient satisfaction. OBJECTIVE: To assess the impact of nurses on trauma patient satisfaction. METHODS: This retrospective, descriptive study of Level I-IV trauma centers in a multistate hospital system evaluated patients 18 years and older admitted with at least an overnight stay. Data were obtained electronically for patients discharged in 2018-2019 who returned an HCAHPS survey. Surveys were linked by an honest broker to demographic and injury data from the trauma registry, and then anonymized prior to analysis. Patients were categorized as "trauma" per the National Trauma Data Standard (NTDS) definition or as "medical" or "surgical" per the HCAHPS definition. RESULTS: Of 112,283 surveys from 89 trauma centers, "trauma" patients (n = 5,126) comprised 4.6%, "surgical" 39.0% (n = 43,763), and "medical" 56.5% (n = 63,394). Nurses had an overwhelming impact on "trauma" patient satisfaction, accounting for 63.9% (p < .001) of the variation (adjusted R2) in the overall score awarded the institution-larger than for "surgery" (59.6%; p < .001) or "medical" (58.4%; p < .001) patients. The most important individual domain contributor to the overall rating of a facility was "nursing communication." CONCLUSIONS: The magnitude of the effect of trauma nurses was noteworthy, with their communication ability being the single biggest driver of institutional ratings. These data provide insight for future performance benchmark development and emphasize the critical impact of trauma nurses on the trauma patient experience.

Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial.

OBJECTIVE: To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care. DESIGN: Economic evaluation within a randomised controlled trial. SETTING: Four National Health Service (NHS) centres in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust. PARTICIPANTS: 770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke. INTERVENTIONS: Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care. MAIN ECONOMIC OUTCOME MEASURES: Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves. RESULTS: At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis. CONCLUSIONS: The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered. TRIAL REGISTRATION NUMBER: ISRCTN69371850.

Redefining geriatric trauma: 55 is the new 65.

INTRODUCTION: As the prevalence of geriatric trauma patients has increased, protocols are being developed to address the unique requirements of this demographic. However, categorical definitions for geriatric patients vary, potentially creating confusion concerning which patients should be cared for according to geriatric-specific standards. The aim of this study was to identify data-driven cut points for mortality based on age to support implementation of age-driven guidelines. METHODS: Adults aged 18 to 100 years with blunt or penetrating injury were selected from 95 hospitals' trauma registries. Change point analysis techniques were used to detect inflection points in the proportion of deaths at each age. Based on these calculated points, patients were allocated into age groups, and their characteristics and outcomes were compared. Logistic regression was used to estimate risk-adjusted in-hospital mortality controlling for sex, race, Injury Severity Score, Glasgow Coma Scale, and number of comorbidities. RESULTS: A total of 255,099 patients were identified (female, 45.7%; mean age, 59.3 years; mean Injury Severity Score, 8.69; blunt injury, 92.6%). Statistically significant increases in mortality rate were noted at ages 55, 77, and 82 years. Compared with the referent group (age, <55 years), adjusted odds ratios (AORs) showed increases in mortality if age 55 to 76 years (AOR, 2.42), age 77 to 81 years (AOR, 4.70), or age 82 years or older (AOR, 6.43). National Trauma Data Standard-defined comorbidities significantly increased once age surpassed 55 years, as the rate more than doubled for each of the older age categories (p < 0.001). As age increased, each group was more likely to be female, have dementia, sustain a ground level fall, and be discharged to a skilled nursing facility (p < 0.001). CONCLUSION: This large multicenter analysis established a clinically and statistically significant increase in mortality at ages 55, 77, and 82 years. This research strongly suggests that trauma patients older than 55 years be considered for inclusion in geriatric trauma protocols. The other age inflection points identified (77 and 82 years) may also warrant additional specialized care considerations. LEVEL OF EVIDENCE: Epidemiological study, level III; Care management, level IV.

Analysing the Action Research Arm Test (ARAT): a cautionary tale from the RATULS trial.

Many studies of stroke rehabilitation use the Action Research Arm Test (ARAT) as an outcome, which measures upper limb function by scoring the ability to complete functional tasks. This report describes an issue encountered when analysing the ARAT subscales in a trial of upper limb therapies after stroke. The subscales of the ARAT at three months followed a 'U-shaped' distribution, and therefore, comparing means or medians was not appropriate. A simple alternative approach was chosen that dichotomised the subscales. When analysing the ARAT, the shape of the distributions must be checked in order to choose the most appropriate descriptive and inferential statistical techniques. In particular, if the data follows a 'U-shaped' distribution, a simple dichotomising or a more sophisticated approach is needed. These should also be considered for heavily skewed distributions, often arising from substantial floor or ceiling effects. Inappropriate analyses can lead to misleading conclusions.