The Australian living guidelines for the clinical care of people with COVID-19: What worked, what didn't and why, a mixed methods process evaluation.

INTRODUCTION: The Australian National COVID-19 Clinical Evidence Taskforce is producing living, evidence-based, national guidelines for treatment of people with COVID-19 which are updated each week. To continually improve the process and outputs of the Taskforce, and inform future living guideline development, we undertook a concurrent process evaluation examining Taskforce activities and experience of team members and stakeholders during the first 5 months of the project. METHODS: The mixed-methods process evaluation consisted of activity and progress audits, an online survey of all Taskforce participants; and semi-structured interviews with key contributors. Data were collected through five, prospective 4-weekly timepoints (beginning first week of May 2020) and three, fortnightly retrospective timepoints (March 23, April 6 and 20). We collected and analysed quantitative and qualitative data. RESULTS: An updated version of the guidelines was successfully published every week during the process evaluation. The Taskforce formed in March 2020, with a nominal start date of March 23. The first version of the guideline was published two weeks later and included 10 recommendations. By August 24, in the final round of the process evaluation, the team of 11 staff, working with seven guideline panels and over 200 health decision-makers, had developed 66 recommendations addressing 58 topics. The Taskforce website had received over 200,000 page views. Satisfaction with the work of the Taskforce remained very high (>90% extremely or somewhat satisfied) throughout. Several key strengths, challenges and methods questions for the work of the Taskforce were identified. CONCLUSIONS: In just over 5 months of activity, the National COVID-19 Clinical Evidence Taskforce published 20 weekly updates to the evidence-based national treatment guidelines for COVID-19. This process evaluation identified several factors that enabled this achievement (e.g. an extant skill base in evidence review and convening), along with challenges that needed to be overcome (e.g. managing workloads, structure and governance) and methods questions (pace of updating, and thresholds for inclusion of evidence) which may be useful considerations for other living guidelines projects. An impact evaluation is also being conducted separately to examine awareness, acceptance and use of the guidelines.

Hospital Volumes of Inpatient Pediatric Surgery in the United States.

BACKGROUND: Perioperative outcomes of children depend on the skill and expertise in managing pediatric patients, as well as integration of surgical, anesthesiology, and medical teams. We compared the types of pediatric patients and inpatient surgical procedures performed in low- versus higher-volume hospitals throughout the United States. METHODS: Retrospective analysis of 323,258 hospitalizations with an operation for children age 0 to 17 years in 2857 hospitals included in the Agency for Healthcare Research and Quality (AHRQ) Kids' Inpatient Database (KID) 2016. Hospitals were categorized by their volume of annual inpatient surgical procedures. Specific surgeries were distinguished with the AHRQ Clinical Classification System. We assessed complex chronic conditions (CCCs) using Feudtner and Colleagues' system. RESULTS: The median annual volume of pediatric inpatient surgeries across US hospitals was 8 (interquartile range [IQR], 3-29). The median volume of inpatient surgeries for children with a CCC was 4 (IQR, 1-13). Low-volume hospitals performed significantly fewer types of surgeries (median 2 vs 131 types of surgeries in hospitals with 1-24 vs ≥2000 volumes). Appendectomy and fixation of bone fracture were among the most common surgeries in low-volume hospitals. As the volume of surgical procedures increased from 1 to 24 to ≥2000, the percentage of older children ages 11 to 17 years decreased (70.9%-32.0% [P < .001]) and the percentage of children with a CCC increased (11.2%-60.0% [P < .001]). CONCLUSIONS: Thousands of US hospitals performed inpatient surgeries on few pediatric patients, including those with CCCs who have the highest risk of perioperative morbidity and mortality. Evaluation of perioperative decision making, workflows, and pediatric clinicians in low- and higher-volume hospitals is warranted.

The impact of COVID-19 pandemic on aortic valve surgical service: a single centre experience.

BACKGROUND: The coronavirus-disease 2019 (COVID-19) pandemic imposed an unprecedented burden on the provision of cardiac surgical services. The reallocation of workforce and resources necessitated the postponement of elective operations in this cohort of high-risk patients. We investigated the impact of this outbreak on the aortic valve surgery activity at a single two-site centre in the United Kingdom. METHODS: Data were extracted from the local surgical database, including the demographics, clinical characteristics, and outcomes of patients operated on from March 2020 to May 2020 with only one of the two sites resuming operative activity and compared with the respective 2019 period. A similar comparison was conducted with the period between June 2020 and August 2020, when operative activity was restored at both institutional sites. The experience of centres world-wide was invoked to assess the efficiency of our services. RESULTS: There was an initial 38.2% reduction in the total number of operations with a 70% reduction in elective cases, compared with a 159% increase in urgent and emergency operations. The attendant surgical risk was significantly higher [median Euroscore II was 2.7 [1.9-5.2] in 2020 versus 2.1 [0.9-3.7] in 2019 (p = 0.005)] but neither 30-day survival nor freedom from major post-operative complications (re-sternotomy for bleeding/tamponade, transient ischemic attack/stroke, renal replacement therapy) was compromised (p > 0.05 for all comparisons). Recommencement of activity at both institutional sites conferred a surgical volume within 17% of the pre-COVID-19 era. CONCLUSIONS: Our institution managed to offer a considerable volume of aortic valve surgical activity over the first COVID-19 outbreak to a cohort of higher-risk patients, without compromising post-operative outcomes. A backlog of elective cases is expected to develop, the accommodation of which after surgical activity normalisation will be crucial to monitor.

Review of Irish patients meeting ST elevation criteria during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has seen the introduction of important public health measures to minimise the spread of the virus. We aim to identify the impact government restrictions and hospital-based infection control procedures on ST elevation myocardial infarction (STEMI) care during the COVID-19 pandemic. METHODS: Patients meeting ST elevation criteria and undergoing primary percutaneous coronary intervention from 27 March 2020, the day initial national lockdown measures were announced in Ireland, were included in the study. Patients presenting after the lockdown period, from 18 May to 31 June 2020, were also examined. Time from symptom onset to first medical contact (FMC), transfer time and time of wire cross was noted. Additionally, patient characteristics, left ventricular ejection fraction, mortality and biochemical parameters were documented. Outcomes and characteristics were compared against a control group of patients meeting ST elevation criteria during the month of January. RESULTS: A total of 42 patients presented with STEMI during the lockdown period. A significant increase in total ischaemic time (TIT) was noted versus controls (8.81 hours (±16.4) vs 2.99 hours (±1.39), p=0.03), with increases driven largely by delays in seeking FMC (7.13 hours (±16.4) vs 1.98 hours (±1.46), p=0.049). TIT remained significantly elevated during the postlockdown period (6.1 hours (±5.3), p=0.05), however, an improvement in patient delays was seen versus the control group (3.99 hours (±4.5), p=0.06). There was no difference seen in transfer times and door to wire cross time during lockdown, however, a significant increase in transfer times was seen postlockdown versus controls (1.81 hours (±1.0) vs 1.1 hours (±0.87), p=0.004). CONCLUSION: A significant increase in TIT was seen during the lockdown period driven mainly by patient factors highlighting the significance of public health messages on public perception. Additionally, a significant delay in transfer times to our centre was seen postlockdown.

Association Between Patient Survival and Clinician Variability in Treatment Rates for Aortic Valve Stenosis.

Background Patients with symptomatic severe aortic stenosis (ssAS) have a high mortality risk and compromised quality of life. Surgical/transcatheter aortic valve replacement (AVR) is a Class I recommendation, but it is unclear if this recommendation is uniformly applied. We determined the impact of managing cardiologists on the likelihood of ssAS treatment. Methods and Results Using natural language processing of Optum electronic health records, we identified 26 438 patients with newly diagnosed ssAS (2011-2016). Multilevel, multivariable Fine-Gray competing risk models clustered by cardiologists were used to determine the impact of cardiologists on the likelihood of 1-year AVR treatment. Within 1 year of diagnosis, 35.6% of patients with ssAS received an AVR; however, rates varied widely among managing cardiologists (0%, lowest quartile; 100%, highest quartile [median, 29.6%; 25th-75th percentiles, 13.3%-47.0%]). The odds of receiving AVR varied >2-fold depending on the cardiologist (median odds ratio for AVR, 2.25; 95% CI, 2.14-2.36). Compared with patients with ssAS of cardiologists with the highest treatment rates, those treated by cardiologists with the lowest AVR rates experienced significantly higher 1-year mortality (lowest quartile, adjusted hazard ratio, 1.22, 95% CI, 1.13-1.33). Conclusions Overall AVR rates for ssAS were low, highlighting a potential challenge for ssAS management in the United States. Cardiologist AVR use varied substantially; patients treated by cardiologists with lower AVR rates had higher mortality rates than those treated by cardiologists with higher AVR rates.

Association Between 2010 Medicare Reform and Inpatient Rehabilitation Access in People With Intracerebral Hemorrhage.

Background Evidence suggests intracerebral hemorrhage survivors have earlier recovery compared with ischemic stroke survivors. The Centers for Medicare and Medicaid Services prospective payment system instituted documentation rules for inpatient rehabilitation facilities (IRFs) in 2010, with the goal of optimizing patient selection. We investigated whether these requirements limited IRF and increased skilled nursing facility (SNF) use compared with home discharge. Methods and Results Intracerebral hemorrhage discharges to IRF, SNF, or home were estimated using GWTG (Get With The Guidelines) Stroke registry data between January 1, 2008, and December 31, 2015 (n=265 444). Binary hierarchical models determined associations between the 2010 Rule and discharge setting; subgroup analyses evaluated age, geographic region, and hospital type. From January 1, 2008, to December 31, 2009, 45.5% of patients with intracerebral hemorrhage had home discharge, 22.2% went to SNF, and 32.3% went to IRF. After January 1, 2010, there was a 1.06% absolute increase in home discharge, a 0.46% increase in SNF, and a 1.52% decline in IRF. The adjusted odds of IRF versus home discharge decreased 3% after 2010 (adjusted odds ratio [aOR], 0.97; 95% CI, 0.95-1.00). Lower odds of IRF versus home discharge were observed in people aged <65 years (aOR, 0.92; 95% CI, 0.89-0.96), Western states (aOR, 0.89; 95% CI, 0.84-0.95), and nonteaching hospitals (aOR, 0.90; 95% CI, 0.86-0.95). Adjusted odds of SNF versus home discharge increased 14% after 2010 (aOR, 1.14; 95% CI, 1.11-1.18); there were significant associations in all age groups, the Northeast, the South, the Midwest, and teaching hospitals. Conclusions The Centers for Medicare and Medicaid Services 2010 IRF prospective payment system Rule resulted in fewer discharges to IRF and more discharges to SNF in patients with intracerebral hemorrhage. Health policy changes potentially affect access to intensive postacute rehabilitation.

Surgeon experience versus volume differentially affects lower extremity bypass outcomes in contemporary practice.

BACKGROUND: Calls for minimum case thresholds to guide surgeon credentialing paradigms are increasing in contemporary practice. To date, the volume-outcome relationship and the role of surgeon experience as a proxy for quality have remained primarily focused on nonvascular extirpative surgery and aneurysm repair. However, it is unclear whether these data can be rightly extrapolated to predict lower extremity bypass (LEB) outcomes. Thus, the purpose of the present study was to examine whether the annualized case volume vs surgeon experience is more consequential in predicting for successful LEB reconstruction. METHODS: A total of 25,852 procedures with sufficient 1-year follow-up data from the Society for Vascular Surgery Vascular Quality Initiative infrainguinal bypass registry (2003-2019) were reviewed for chronic limb threatening ischemia among patients undergoing infrageniculate reconstruction. The procedures were categorized according to surgeon years of practice experience at surgery (ie, 0-5, 6-10, 11-15, >15 years) and the number of LEB procedures performed by the surgeon during the year of surgery (volume quartiles: 1-8, 9-14, 15-21, and >21). Mixed effects logistic and Cox regression models were used to assess the effects of experience, volume, and their interaction on outcomes. RESULTS: Increasing practice experience was more significantly associated with a reduction of in-hospital complications (odds ratio, 0.97; 95% confidence interval [CI], 0.96-0.99; P = .002) and the risk of major adverse limb events (odds ratio, 0.94; 95% CI, 0.92-0.97; P < .0001) compared with the volume. Increasing experience and volume were both associated with increased freedom from thrombosis (hazard ratio, 0.95; 95% CI, 0.93-0.98; P = .001). In contrast, neither experience nor volume had any significant association with early mortality. However, a higher volume was associated with diminished long-term survival (hazard ratio, 1.04; 95% CI, 1.0-1.1; P = .01). The most experienced surgeons (>15 years' experience) were significantly more likely to perform LEB for rest pain (P < .0001). No significant differences were found in the bypass rates among patients with tissue loss. The most experienced and highest volume surgeons were more likely to use an autogenous and/or composite conduit, in situ reconstruction, and/or pedal targets (P < .05). Similarly, more experienced and higher volume surgeons had less blood loss and shorter procedure times (P < .0001). Overall, the most experienced surgeons (>15 years' experience) were significantly more likely to have a higher volume with a diminished risk for all LEB outcomes. CONCLUSIONS: Surgeon experience appears to have the most important role in predicting for overall LEB performance with improved in-hospital outcomes and major adverse limb events. The more experienced surgeons performed more complex reconstructions with fewer complications. These findings have significant clinical and educational implications as our most experienced surgeons approach retirement. Mentorship strategies to facilitate ongoing technical development among less experienced surgeons are imperative to sustain optimal limb salvage outcomes and have significant ramifications regarding expectations for regulatory and credentialing paradigms.

Avoidable Acute Care Use for Vaccine-Preventable Illnesses Among Medicaid Beneficiaries With Lupus.

OBJECTIVE: Nearly 25% of patients with systemic lupus erythematosus (SLE) are hospitalized yearly, often for outcomes that may have been avoided if patients had received sustained outpatient care. We examined acute care use for vaccine-preventable illnesses to determine sociodemographic contributors and modifiable predictors. METHODS: Using US Medicaid claims from 29 states (2000-2010), we identified adults (18-65 years) with prevalent SLE and 12 months of enrollment prior to the first SLE code (index date) to identify baseline data. We defined acute care use for vaccine-preventable illnesses as emergency department (ED) or hospital discharge diagnoses for influenza, pneumococcal disease, meningococcal disease, herpes zoster, high-grade cervical dysplasia/cervical cancer, and hepatitis B after the index date. We estimated the incidence rate of vaccine-preventable illnesses and used Cox regression to assess risk (with hazard ratios and 95% confidence intervals) by sociodemographic factors and health care utilization, adjusting for vaccinations, comorbidities, and medications. RESULTS: Among 45,654 Medicaid beneficiaries with SLE, <10% had billing claims for vaccinations. There were 1,290 patients with ≥1 ED visit or hospitalization for a vaccine-preventable illness (6.6 per 1,000 person-years); 93% of events occurred in unvaccinated patients. Patients who were Black compared to White had 22% higher risk. Greater outpatient visits were associated with lower risk. CONCLUSION: Medicaid beneficiaries with SLE who are not vaccinated are at risk for potentially avoidable acute care use for vaccine-preventable illnesses. Racial disparities were noted, with a higher risk among Black patients compared to White patients. Greater outpatient use was associated with reduced risk, suggesting that access to ambulatory care may reduce avoidable acute care use.

Patient Characteristics and Outcomes Associated with Decline in Stroke Volumes During the Early COVID-19 Pandemic.

BACKGROUND AND PURPOSE: Delayed evaluation of stroke may contribute to COVID-19 pandemic-related morbidity and mortality. This study evaluated patient characteristics, process measures and outcomes associated with the decline in stroke presentation during the early pandemic. METHODS: Volumes of stroke presentations, intravenous thrombolytic administrations, and mechanical thrombectomies from 52 hospitals from January 1-June 30, 2020 were analyzed with piecewise linear regression and linear spline models. Univariate analysis compared pandemic (case) and pre-pandemic (control) groups defined in relation to the nadir of daily strokes during the study period. Significantly different patient characteristics were further evaluated with logistic regression, and significantly different process measures and outcomes were re-analyzed after propensity score matching. RESULTS: Analysis of 7,389 patients found daily stroke volumes decreased 0.91/day from March 12-26 (p < 0.0001), reaching a nadir 35.0% less than expected, and increased 0.15 strokes/day from March 27-June 23, 2020 (p < 0.0001). Intravenous thrombolytic administrations decreased 3.3/week from February 19-March 31 (p = 0.0023), reaching a nadir 33.4% less than expected, and increased 1.4 administrations/week from April 1-June 23 (p < 0.0001). Mechanical thrombectomy volumes decreased by 1.5/week from February 19-March 31, 2020 (p = 0.0039), reaching a nadir 11.3% less than expected. The pandemic group was more likely to ambulate independently at baseline (p = 0.02, OR = 1.60, 95% CI = 1.08-2.42), and less likely to present with mild stroke symptoms (NIH Stroke Scale ≤ 5; p = 0.04, OR = 1.01, 95% CI = 1.00-1.02). Process measures and outcomes of each group did not differ, including door-to-needle time, door-to-puncture time, and successful mechanical thrombectomy rate. CONCLUSION: Stroke presentations and acute interventions decreased during the early COVID-19 pandemic, at least in part due to patients with lower baseline functional status and milder symptoms not seeking medical care. Public health messaging and initiatives should target these populations.

Evaluation of Factors Associated with, and Outcomes for Patients with Nonhome Discharge Destinations Following Carotid Endarterectomy.

INTRODUCTION: Following a carotid endarterectomy (CEA) procedure, patients are discharged to their homes or other locations than home such as an acute care facility or skilled nursing facility based on their functional status and level of medical attention needed. Decision-making for discharge destination following a CEA to home or nonhome locations is important due to the differences in survival and postoperative complications. While primary outcomes such as mortality and occurrence of stroke following CEA have been extensively studied, there is a paucity of information characterizing outcomes of discharge destination and the factors associated. The purpose of this study was to explore the factors associated with discharge to nonhome destinations after CEA, and outcomes after discharge. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, we identified patients who underwent CEA from 2011 to 2018. Patients were divided into two groups based on their discharge destination (home versus nonhome). Univariate and multivariate analysis were performed for preoperative and intraoperative factors associated with different discharge destinations. Postoperative complications associated with discharge to nonhome destinations were analyzed and mortality after discharge from hospital was compared between the 2 groups. RESULTS: A total of 25,094 patients met the criteria for inclusion in the study, of which 39% were females and 61% were males; median age was 71 years. Twenty four thousand one hundred twenty-five patients (93.13%) were discharged to home (Group I) and 1,779 (6.87%) were discharged to nonhome destinations (Group II). Following preoperative and intraoperative factors were associated with discharge to nonhome locations: older age, diabetes mellitus, functional independent status, transfer from other hospitals, symptomatic status, need for preoperative blood transfusions, severe ipsilateral carotid stenosis, elective CEA, need for intraoperative shunt and general anesthesia (all P< 0.05). Following postoperative complications had statistically significant association with discharge to nonhome destinations: postoperative blood transfusion, pneumonia, unplanned intubation, longer than 48 hours on ventilator, development of stroke, myocardial infarction, deep vein thrombosis, and sepsis (all P< 0.05). Mortality after discharge from hospital was 0.39% (n = 100). Mortality among those who were discharged to home was 0.29% vs. 1.63% for those who were discharged to nonhome locations (P< 0.05). CONCLUSIONS: Majority of the patients after CEA are discharged back to their homes. This study identifies the factors which predispose patients discharged to locations, other than home. Patients who are not discharged home have higher mortality as compared to those who are discharged to their homes.

Age-Related Disparities in the Quality of Stroke Care and Outcomes in Rehabilitation Hospitals: The Australian National Audit.

INTRODUCTION: Stroke affects all ages. Despite increased incidence in those <65 years, little is known about age-based differences in inpatient rehabilitation management and outcomes. OBJECTIVES: To investigate management and outcomes, comparing younger (<65 years) and older (≥65 years) patients with stroke, who received inpatient rehabilitation. METHODS: Multicentre, cross-sectional study using data from Australian hospitals who participated in the Stroke Foundation national stroke rehabilitation audit (2016-2018). Chi-square tests compared characteristics and care by age. Multivariable regression models were used to compare outcomes by age (e.g. length of stay). Models were adjusted for sex, stroke type and severity factors. RESULTS: 7,165 audited cases from 127 hospitals; 23% <65 years (66% male; 72% ischaemic stroke). When compared to older patients, younger patients were more likely male (66% vs 52%); identify as Aboriginal or Torres Strait Islander (6% vs 1%); be less disabled on admission; receive psychology (46% vs 34%) input, and community reintegration support, including return to work (OR 1.47, 95% CI 1.03, 2.11), sexuality (OR 1.60, 95% CI 1.39, 1.84) and self-management (OR 1.39, 95% CI 1.23, 1.57) advice. Following adjustment, younger patients had longer lengths of stay (coeff 3.54, 95% CI 2.27, 4.81); were more likely to be independent on discharge (aOR 1.96, 95% CI 1.68, 2.28); be discharged to previous residences (aOR 1.64, 95% CI 1.41, 1.91) and receive community rehabilitation (aOR: 2.27, 95% CI 1.91, 2.70). CONCLUSIONS: Age-related differences exist in characteristics, management and outcomes for inpatients with stroke accessing rehabilitation in Australia.

Impact of the COVID-19 Pandemic on Acute Stroke Care, Time Metrics, Outcomes, and Racial Disparities in a Southeast Michigan Health System.

BACKGROUND: COVID-19 has impacted acute stroke care with several reports showing worldwide drops in stroke caseload during the pandemic. We studied the impact of COVID-19 on acute stroke care in our health system serving Southeast Michigan as we rolled out a policy to limit admissions and transfers. METHODS: in this retrospective study conducted at two stroke centers, we included consecutive patients presenting to the ED for whom a stroke alert was activated during the period extending from 3/20/20 to 5/20/20 and a similar period in 2019. We compared demographics, time metrics, and discharge outcomes between the two groups. RESULTS: of 385 patients presented to the ED during the two time periods, 58% were African American. There was a significant decrease in the number of stroke patients presenting to the ED and admitted to the hospital between the two periods (p <0.001). In 2020, patients had higher presenting NIHSS (median: 2 vs 5, p = 0.012), discharge NIHSS (median: 2 vs 3, p = 0.004), and longer times from LKW to ED arrival (4.8 vs 9.4 h, p = 0.031) and stroke team activation (median: 10 vs 15 min, p = 0.006). In 2020, stroke mimics rates were lower among African Americans. There were fewer hospitalizations (p <0.001), and transfers from outside facilities (p = 0.015). CONCLUSION: a trend toward faster stroke care in the ED was observed during the pandemic along with dramatically reduced numbers of ED visits, hospitalizations and stroke mimics. Delayed ED presentations and higher stroke severity characterized the African American population, highlighting deepening of racial disparities during the pandemic.

Impact of COVID-19 on vascular patients worldwide: analysis of the COVIDSurg data.

BACKGROUND: The COVIDSurg collaborative was an international multicenter prospective analysis of perioperative data from 235 hospitals in 24 countries. It found that perioperative COVID-19 infection was associated with a mortality rate of 24%. At the same time, the COVER study demonstrated similarly high perioperative mortality rates in vascular surgical patients undergoing vascular interventions even without COVID-19, likely associated with the high burden of comorbidity associated with vascular patients. This is a vascular subgroup analysis of the COVIDSurg cohort. METHODS: All patients with a suspected or confirmed diagnosis of COVID-19 in the 7 days prior to, or in the 30 days following a vascular procedure were included. The primary outcome was 30-day mortality. Secondary outcomes were pulmonary complications (adult respiratory distress syndrome, pulmonary embolism, pneumonia and respiratory failure). Logistic regression was undertaken for dichotomous outcomes. RESULTS: Overall, 602 patients were included in this subgroup analysis, of which 88.4% were emergencies. The most common operations performed were for vascular-related dialysis access procedures (20.1%, N.=121). The combined 30-day mortality rate was 27.2%. Composite secondary pulmonary outcomes occurred in half of the vascular patients (N.=275, 45.7%). CONCLUSIONS: Mortality following vascular surgery in COVID positive patients was significantly higher than levels reported pre-pandemic, and similar to that seen in other specialties in the COVIDSurg cohort. Initiatives and surgical pathways that ensure vascular patients are protected from exposure to COVID-19 in the peri-operative period are vital to protect against excess mortality.

Trends in Comorbidities and Complications Among Patients Undergoing Hip Fracture Repair.

BACKGROUND: Hip fracture patients represent various perioperative challenges related to their significant comorbidity burden and the high incidence of morbidity and mortality. As population trend data remain rare, we aimed to investigate nationwide trends in the United States in patient demographics and outcomes in patients after hip fracture repair surgery. METHODS: After Institutional Review Board (IRB) approval (IRB#2012-050), data covering hip fracture repair surgeries were extracted from the Premier Healthcare Database (2006-2016). Patient demographics, comorbidities, and complications, as well as anesthesia and surgical details, were analyzed over time. Cochran-Armitage trend tests and simple linear regression assessed significance of (linear) trends. RESULTS: Among N = 507,274 hip fracture cases, we observed significant increases in the incidence in preexisting comorbid conditions, particularly the proportion of patients with >3 comorbid conditions (33.9% to 43.4%, respectively; P < .0001). The greatest increase for individual comorbidities was seen for sleep apnea, drug abuse, weight loss, and obesity. Regarding complications, increased rates over time were seen for acute renal failure (from 6.9 to 11.1 per 1000 inpatient days; P < .0001), while significant decreasing trends for mortality, pneumonia, hemorrhage/hematoma, and acute myocardial infarction were recorded. In addition, decreasing trends were observed for the use of neuraxial anesthesia either used as sole anesthetic or combined with general anesthesia (7.3% to 3.6% and 6.3% to 3.4%, respectively; P < .0001). Significantly more patients (31.9% vs 41.3%; P < .0001) were operated on in small rather than medium- and large-sized hospitals. CONCLUSIONS: From 2006 to 2016, the overall comorbidity burden increased among patients undergoing hip fracture repair surgery. Throughout this same time period, incidence of postoperative complications either remained constant or declined with the only significant increase observed in acute renal failure. Moreover, use of regional anesthesia decreased over time. This more comorbid patient population represents an increasing burden on the health care system; however, existing preventative measures appear to be effective in minimizing complication rates. Although, given the proposed benefits of regional anesthesia, decreased utilization may be of concern.

Association between coronary artery bypass graft center volume and year-to-year outcome variability: New York and California statewide analysis.

OBJECTIVE: We evaluated whether volume-based, rather than time-based, annual reporting of center outcomes for coronary artery bypass grafting may improve inference of quality, assuming that large center-level year-to-year outcome variability is related to statistical noise. METHODS: We analyzed 2012 to 2016 data on isolated coronary artery bypass grafting using statewide outcome reports from New York and California. Annual changes in center-level observed-to-expected mortality ratio represented stability of year-to-year outcomes. Cubic spline fit related the annual observed-to-expected ratio change and center volume. Volume above the inflection point of the spline curve indicated centers with low year-to-year change in outcome. We compared observed-to-expected ratio changes between centers below and above the volume threshold and observed-to-expected ratio changes between consecutive annual and biennial measurements. RESULTS: There were 155 centers with median annual volume of 89 (interquartile range, 55-160) for isolated coronary artery bypass grafting. The inflection point of observed-to-expected ratio variability was observed at 111 cases/year. Median year-to-year observed-to-expected ratio change for centers performing less than 111 cases (62 centers) was greater at 0.83 (0.26-1.59) compared with centers performing 111 cases or more (93 centers) at 0.49 (022-0.87) (P < .001). By aggregating the outcome over 2 years, centers above the 111-case threshold increased from 93 centers (60%) to 118 centers (76%), but the median observed-to-expected change for all centers was similar between annual aggregates at 0.70 (0.26-1.22) compared with observed-to-expected change between biennial aggregates at 0.54 (0.23-1.02) (P = .095). CONCLUSIONS: Center-level, risk-adjusted coronary artery bypass grafting mortality varies significantly from one year to the next. Reporting outcomes by specific case volume may complement annual reports.

Association between surgeon case volume and years of practice experience with open abdominal aortic aneurysm repair outcomes.

BACKGROUND: Widespread adoption of endovascular aneurysm repair has led to a consequential decline in the use of open aneurysm repair (OAR). This evolution has had significant ramifications on vascular surgery training paradigms and contemporary practice patterns among established surgeons. Despite being the subject of previous analyses, the surgical volume-outcome relationship has remained a focus of controversy. At present, little is known about the complex interaction of case volume and surgeon experience with patient selection, procedural characteristics, and postoperative complications of OAR. The purpose of the present analysis was to examine the association between surgeon annual case volume and years of practice experience with OAR. METHODS: All infrarenal OARs (n = 11,900; elective, 70%; nonelective, 30%) included in the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2019 were examined. Surgeon experience was defined as years in practice after training. The experience level at repair was categorized chronologically (≤5 years, n = 1667; 6-10 years, n = 1887; 11-15 years, n = 1806; ≥16 years, n = 6540). The annual case volume was determined by the number of OARs performed by the surgeon annually (median, five cases). Logistic regression was used to perform risk adjustment of the outcomes across surgeon experience and volume (five or fewer vs more than five cases annually) strata for in-hospital major complications and 30-day and 1-year mortality. RESULTS: Practice experience had no association with unadjusted mortality (30-day death: elective, P = .2; nonelective, P = .3; 1-year death: elective, P = .2; nonelective, P = .2). However, more experienced surgeons had fewer complications after elective OAR (25% with ≥16 years vs 29% with ≤5 years; P = .004). A significant linear correlation was identified between increasing surgeon experience and performance of a greater proportion of elective OAR (P-trend < .0001). Risk adjustment (area under the curve, 0.776) revealed that low-volume (five or fewer cases annually) surgeons had inferior outcomes compared with high-volume surgeons across the experience strata for all presentations. In addition, high-volume, early career surgeons (≤5 years' experience) had outcomes similar to those of older, low-volume surgeons (P > .1 for all pairwise comparisons). Early career surgeons (≤5 years) had operated on a greater proportion of elective patients with American Society of Anesthesiologists class ≥4 (35% vs 30% [≥16 years' experience]; P = .0003) and larger abdominal aortic aneurysm diameters (mean, 62 vs 59 mm [≥16 years' experience]; P < .0001) compared with all other experience categories. Similarly, the use of a suprarenal cross-clamp occurred more frequently (26% vs 22% [≥16 years' experience]; P = .0009) but the total procedure time, estimated blood loss, and renal and/or visceral ischemia times were all greater for less experienced surgeons (P-trend < .0001). CONCLUSIONS: Annual case volume appeared to be more significantly associated with OAR outcomes compared with the cumulative years of practice experience. To ensure optimal OAR outcomes, mentorship strategies for "on-boarding" early career, as well as established, low-volume, aortic aneurysm repair surgeons should be considered. These findings have potential implications for widespread initiatives surrounding regulatory oversight and credentialing paradigms.

National Trends in Utilization and Outcome of Endovascular Thrombectomy for Acute Ischemic Stroke in Elderly.

OBJECTIVE: Octogenarians were excluded and/or underrepresented in the major endovascular thrombectomy (EVT) randomized controlled trials, but continue to make up a growing proportion of stroke patients. To evaluate real-world trends in utilization and outcome of EVT in patients ≥80 years in a large nationally representative database. METHODS: Using the Nationwide Inpatient Sample (2014-2016), we identified patients admitted to United States hospitals with acute ischemic stroke (AIS) who also underwent EVT. The primary endpoint was good outcome (discharge to home/acute rehabilitation center). Poor outcome (discharge to skilled nursing facility or hospice and in-hospital mortality), intracerebral hemorrhage and in-hospital mortality were secondary outcome measures. RESULTS: In 376,956 patients with AIS, 6,230(1.54%) underwent EVT. 1,547(24.83%) were ≥80. The rate of EVT in AIS patients ≥80 more than doubled from 0.83%(n = 317) in 2014 to 1.83%(n = 695) in 2016. The rate of good outcome in patients ≥80 was 9%, significantly lower than younger patients (26%, p<0.001). In-hospital mortality was 19% in patients ≥80 compared to 13% in the younger cohort (p < 0.001). There was no difference in the rate of hemorrhagic transformation between octogenarians and younger patients (18.52% vs 17.01%, p=0.19). In patients ≥80 years of age, decreasing baseline comorbidity burden independently predicted good outcome (OR 0.258, 95% CI [0.674- 0.935]). CONCLUSIONS: A two-fold increase in the utilization of EVT in patients ≥80 years of age was seen from 2014 to 2016. While the comparative rate of good outcome is significantly lower in this age group, elderly patients with fewer comorbidities demonstrated better outcomes after EVT.

Developing a core outcome set for future infertility research: an international consensus development study.

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative: 1023.

Number of Patients with Ischemic Stroke did not Decline in a Regional Stroke Unit After the Implementation of Mechanical Thrombectomy.

OBJECTIVES: Since the implementation of mechanical thrombectomy (MT) in 2015 for patients with ischemic stroke and large-vessel occlusion, the question arose as to whether patients should be primarily admitted to the nearest regional stroke unit (SU) for prompt intravenous thrombolysis (IVT) or to a more distant supraregional SU performing MT, to avoid secondary-transfer delays in MT. Although an evidence-based answer is still lacking, a discrepant discussion with potential consequences for the regional flow of stroke patients arose. We aimed to assess if MT implementation was associated with the number and characteristics of patients with stroke/transient ischemic attack (TIA) admitted to a regional SU not offering endovascular treatment. MATERIALS AND METHODS: Patients with acute stroke/TIA treated at the Klinikum Main-Spessart Lohr, Germany, in 2013/2014 or 2017/2018 were included in this retrospective study. Data were derived from the clinical information system and mandatory stroke quality assessment. We assessed the catchment area using a region-based approach. For each region, the number of patients treated in our hospital, including data regarding clinical severity, demographic characteristics, and changes over time, were analyzed. RESULTS: The number of patients with acute stroke/TIA increased from 890 (2013/2014) to 1016 (2017/2018). Aggregated demographic and clinical data of the whole catchment area showed no differences between 2013/2014 and 2017/2018 (P > 0.05) besides duration of hospitalization (P < 0.01), IVT rate (P < 0.01), and secondary transfer for MT. A region-based analysis revealed an increase in younger and more severely affected patients admitted from the periphery of the catchment area between 2013/2014 and 2017/2018. CONCLUSION: Despite the implementation of MT in the supraregional SUs around our regional SU (not offering MT), more patients with stroke/TIA were admitted to our hospital, especially younger and more severely affected patients, from the border regions of the catchment area.