Giana H. Davidson

Long-term survival of adult trauma patients

CONTEXT Inpatient trauma case fatality rates may provide an incomplete assessment for overall trauma care effectiveness. To date, there have been few large studies evaluating long-term mortality in trauma patients and identifying predictors that increase risk for death following hospital discharge. OBJECTIVES To determine the long-term mortality of patients following trauma admission and to evaluate survivorship in relationship with discharge disposition. DESIGN, SETTING, AND PATIENTS Retrospective cohort study of 124,421 injured adult patients during January 1995 to December 2008 using the Washington State Trauma Registry linked to death certificate data. MAIN OUTCOME MEASURES Kaplan-Meier and Cox proportional hazards models were used to evaluate long-term mortality following hospital admission for trauma. RESULTS Of the 124,421 trauma patients, 7243 died before hospital discharge and 21,045 died following hospital discharge. Cumulative mortality at 3 years postinjury was 16% (95% confidence interval [CI], 15.8%-16.2%) compared with the expected population cumulative mortality of 5.9% (95% CI, 5.9%-5.9%). In-hospital mortality improved during the 14-year study period from 8% (n = 362) to 4.9% (n = 600), whereas long-term cumulative mortality increased from 4.7% (95% CI, 4.1%-5.4%) to 7.4% (95% CI, 6.8%-8.1%). After adjustments for confounders, patients who were older and those who were discharged to a skilled nursing facility had the highest risk of death. The adjusted hazard ratios (HRs) for death after discharge to a skilled nursing facility compared with that after discharge home were 1.41 (95% CI, 0.72-2.76) for patients aged 18 to 30 years, 1.92 (95% CI, 1.36-2.73) for patients aged 31 to 45 years, 2.02 (95% CI, 1.39-2.93) for patients aged 46 to 55 years, 1.93 (95% CI, 1.40-2.64) for patients aged 56 to 65 years, 1.49 (95% CI, 1.14-1.94) for patients aged 66 to 75 years, 1.54 (95% CI, 1.27-1.87) for patients aged 76 to 80 years, and 1.38 (95% CI, 1.09-1.74) for patients older than 80 years. Other significant predictors of mortality after discharge included maximum head injury score on Abbreviated Injury Score scale (HR, 1.20; 95% CI, 1.13-1.26), Injury Severity Score (HR, 0.98; 95% CI, 0.97-0.98), Functional Independence Measure (HR, 0.89; 95% CI, 0.88-0.91), mechanism of injury being a fall (HR, 1.43; 95% CI, 1.30-1.58), and having Medicare (HR, 1.28; 95% CI, 1.15-1.43) or other government insurance (HR, 1.65; 95% CI, 1.47-1.85). CONCLUSIONS Among adults admitted for trauma in Washington State, 3-year cumulative mortality was 16% despite a decline in in-hospital deaths. Discharge to a skilled nursing facility at any age following trauma admission was associated with a higher risk of subsequent mortality.

Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management

Study objective Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics‐first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics‐first, including outpatient management, with appendectomy. Methods Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics‐first‐treated participants older than 13 years could be discharged after greater than or equal to 6‐hour emergency department (ED) observation with next‐day follow‐up. Outcomes included 1‐month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics‐first appendectomy rate. Results Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics‐first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/&mgr;L (range 6,200 to 23,100/&mgr;L), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic‐treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics‐first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics‐first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics‐first‐treated participants had less pain and disability. During median 12‐month follow‐up, 2 of 15 antibiotics‐first‐treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. Conclusion A multicenter US trial comparing antibiotics‐first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.

Validation of prehospital trauma triage criteria for motor vehicle collisions

BACKGROUND Triage of an injured patient to an appropriate trauma center can have an impact on morbidity and mortality. We sought to validate the 2012 national field triage guidelines for motor vehicle crashes. METHODS This is a retrospective cross-sectional study using the National Automotive Sampling System Crashworthiness Data System. Vehicle damage criteria proposed as prehospital triage guidelines were correlated with injury severity. RESULTS There were 85,761 individuals representing 29,397,234 occupants in car crashes from 2003 to 2008. Of the patients, 3.8% met physiologic Step 1 criteria with a mean Injury Severity Score (ISS) of 9.1 (95% confidence interval [CI], −3.1 to 20.9); Step 1 had a positive predictive value (PPV) of 20.8% (95% CI, 20.1–21.4%) for severe injury (ISS > 15). Of the patients, 0.43% met anatomic Step 2 criteria alone, with a mean ISS of 18.1 (95% CI, 16.4–19.8) and a PPV of 48.5% (95% CI, 46.8–50.1%). Step 3 criteria include injury mechanism; 3.7% of the patients met one of these criteria alone with a mean ISS of 5.1 (95% CI, 4.4–5.8) and a PPV of 9.7% (95% CI, 9.3–10.2%). Patients who met only Step 3 criteria were examined to determine crash characteristics that predict severe injury. Intrusion of greater than 12 inches had a PPV of 10.4% (95% CI, 9.5–11.3); steering wheel collapse had a PPV of 25.7% (95% CI, 23.0–28.4%). Older patients (age > 55 years) who met Step 3 mechanism criteria had higher predictive values for injury for nearly all crash characteristics. CONCLUSION Injury mechanism criteria alone predict significant injury in a substantial proportion of patients who did not meet the physiologic or anatomic criteria. Vehicular crash data could improve the ability of emergency medical service providers to triage injured occupants. Consideration of transport to a trauma center should be given for elderly patients and drivers with steering wheel collapse. LEVEL OF EVIDENCE Epidemiologic study, level III.

Outcomes of Patients Discharged to Skilled Nursing Facilities After Acute Care Hospitalizations.

Objectives:To evaluate previously independent older patients discharged to skilled nursing facilities (SNFs) and identify risk factors for failure to return home and death and development of a predictive tool to determine likelihood of adverse outcome. Background:Little is known about the likelihood of return to home, and higher than expected mortality rates in SNFs have recently been described, which may represent an opportunity for quality improvement. Methods:Retrospective cohort of older hospitalized patients discharged to SNFs during 2007 to 2009 in 5 states using Centers for Medicare & Medicaid Services linked minimum data set data from SNFs. We assessed mortality, hospital readmission, discharge to home, and logistic regression models for predicting risk of each outcome. Results:Of 416,997 patients, 3.8% died during the initial SNF stay, 28.6% required readmission, and 60.5% were ultimately discharged home. Readmission to a hospital was the strongest predictor of death in the years after SNF admission (unadjusted hazard ratio, 28.2; 95% confidence interval, 27.2–29.3; P < 0.001). Among all patients discharged to SNFs, 7.8% eventually died in an SNF and overall 1-year mortality was 26.1%. Risk factors associated with mortality and failure to return home were increasing age, male sex, increasing comorbidities, decreased cognitive function, decreased functional status, parenteral nutrition, and pressure ulcers. Conclusions:A large proportion of older patients discharging to SNFs never return home. A better understanding of the natural history of patients sent to SNFs after hospitalization and risk factors for failure to return to home, readmission, and death should help identify opportunities for interventions to improved outcome.

Temporal trends in surgical intervention for severe traumatic brain injury caused by extra-axial hemorrhage, 1995 to 2012

BACKGROUND Surgical intervention for severe traumatic brain injury (TBI) caused by extra-axial hemorrhage has declined in recent decades. The effect of this change on patient outcomes is unknown. OBJECTIVE To determine the change over time in surgical intervention in this population and to assess changes in patient outcomes. METHODS In this retrospective cohort study, the Washington State Trauma Registry was queried from 1995 to 2012 for patients with extra-axial hemorrhage and head Abbreviated Injury Scale score of 3 to 5. Data were linked to the state-wide death registry to analyze long-term mortality. The primary outcome was inpatient mortality. Secondary outcomes included 6- and 12-month mortality and modified Functional Independence Measure at discharge. Multivariable analyses were completed for all outcomes. RESULTS A total of 22974 patients met inclusion criteria. Over the study period, surgical intervention for severe TBI declined from 36% to 7%. There was a decline in case fatality from 22% to 12%. In 2012, the relative risk of inpatient mortality was 23% lower compared with 1995 (adjusted mortality risk ratio, 0.77; 95% confidence interval, 0.63-0.94). Changes in 6- and 12-month adjusted mortality and modified Functional Independence Measure were not statistically significant. CONCLUSION The decline in surgical intervention for severe TBI caused by extra-axial hemorrhage in Washington State was ubiquitous across regional, demographic, and injury characteristic strata. There was concurrently a reduction in inpatient mortality in this population. Functional status and long-term mortality, however, have remained the same. Future studies are needed to better identify modifiable risk factors for improvement in functional status and long-term mortality in this population.

Research considerations in the evaluation of minimally invasive pancreatic resection (MIPR)

The IHPBA/AHPBA-sponsored 2016 minimally invasive pancreatic resection (MIPR) conference held on April 20th, 2016 included a session designed to evaluate what would be the most appropriate scientific contribution to help define the increasing role of MIPR internationally. Participants in the conference reviewed the assessment of numerous pertinent scientific designs including randomized controlled trial (RCT), pragmatic international RCT, registry-RCT, non-RCT with propensity matching, and various types of clinical registries including those aiming to create a quality improvement data system or a learning health care system. The strengths and weaknesses of each of these designs, the status of trials which are currently recruiting patients, and pragmatic considerations were evaluated. A recommendation was made to establish a clinical registry to collect data prospectively from around the world to assess current practices and provide a framework for future studies in MIPR.

Engaging Stakeholders in Surgical Research: The Design of a Pragmatic Clinical Trial to Study Management of Acute Appendicitis

Discussion | The participation of a multidisciplinary stakeholder team provided unique perspectives that helped improve recruitment and retention rates in the RCT. Implementation of stakeholder recommendations on how to explain the purpose of the trial to eligible participants in the urgent emergency care setting significantly improved enrollment. The implementation of stakeholder recommendations for maximizing patient follow-up also significantly improved retention rates. We believe that our success in achieving these goals stems in part from involving stakeholders throughout the entirety of the project, building strong ongoing relationships, fostering open communication, and appreciating all opinions. This study demonstrates the potential value and effect of involving patients, families, and other health care stakeholders in the design and performance of surgical trials.

Use of Computed Tomography to Determine Perforation in Patients With Acute Appendicitis

PURPOSE Urgent appendectomy has long been the standard of care for acute appendicitis. Six randomized trials have demonstrated that antibiotics can safely treat appendicitis, but approximately 1 in 4 of these patients eventually requires appendectomy. Overall treatment success may be limited by complex disease including perforation. Patients׳ success on antibiotic therapy may depend on preoperative identification of complex disease on imaging. However, the effectiveness of computed tomography (CT) in differentiating complex disease including perforated from nonperforated appendicitis remains to be determined. The purpose of this study was to assess the preoperative diagnostic accuracy of CT in determining appendiceal perforation in patients operated for acute appendicitis. METHODS We performed a retrospective review of pathology and radiology reports from consecutive patients who presented to the emergency department with suspicion for acute appendicitis between January 2012 and May 2015. CT scans were re-reviewed by abdominal imaging fellowship-trained radiologists using standardized criteria, and the radiologists were blinded to pathology and surgical findings. Radiologists specifically noted presence or absence of periappendiceal gas, abscess, appendicolith, fat stranding, and bowel wall thickening. The overall radiologic impression as well as these specific imaging findings was compared to results of pathology and operative reports. Pathology reports were considered the standard for diagnostic accuracy. RESULTS Eighty-nine patients (65% male, average age of 34 years) presenting with right lower quadrant pain underwent CT imaging and prompt appendectomy. Final pathology reported perforation in 48% (n = 43) of cases. Radiologic diagnosis of perforation was reported in 9% (n = 8), correctly identifying perforation in 37.5% (n = 3), and incorrectly reporting perforation in 62.5% of nonperforated cases per pathology. Radiology missed 93% (n = 40) of perforations postoperatively diagnosed by pathology. There was no secondary finding (fat stranding, diameter >13mm, abscess, cecal wall thickening, periappendiceal gas, simple fluid collection, appendicolith, and phlegmon) with a clinically reliable sensitivity or specificity to predict perforated appendicitis. Surgeon׳s report of perforation was consistent with the pathology report of perforation in only 28% of cases. CONCLUSIONS The usefulness of a CT for determining perforation in acute appendicitis is limited, and methods to improve precision in identifying patients with complicated appendicitis should be explored as this may help for improving risk prediction for failure of treatment with antibiotic therapy and help guide patients and providers in shared decision-making for treatment options.

Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment

Introduction Several European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%–15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy. Objectives The Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy. Methods/Analysis CODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm. Ethics and dissemination This trial was approved by the University of Washington’s Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals. Trial registration number NCT02800785.

Improving transitions of care across the spectrum of healthcare delivery: A multidisciplinary approach to understanding variability in outcomes across hospitals and skilled nursing facilities

INTRODUCTION Improving coordination during transitions of care from the hospital to Skilled Nursing Facilities (SNF)s is critical for improving healthcare quality. In 2014, we formed (Improving Nursing Facility Outcomes using Real-Time Metrics, INFORM) to improve transitions of care by identifying structural and process factors that lead to poor clinical outcomes and hospital readmission. METHODS Stakeholders from 10 SNFs and 4 hospitals collaborated to assess the current hospital and system-level challenges to safe transitions of care and identify targets for interventions. RESULTS The INFORM collaborative identified areas for improvement including improving accuracy and timeliness of discharge information, facilitating congruent medication reconciliation, and developing care plans to support functional improvement. DISCUSSION Hospital and SNF stakeholder engagement prioritized the challenges in patient transitions from inpatient to skilled nursing facility settings. Innovative solutions that address barriers to safe and effective transitions of care are critical to improving clinical outcomes, decreasing adverse events and avoiding readmission.