Assessment of efficacy and safety of dose-dense doxorubicin and cyclophosphamide (ddAC) in combination with immunotherapy in early-stage triple-negative breast cancer.

PURPOSE: This study aimed to assess safety and efficacy of a modified KEYNOTE 522 protocol, which incorporated pembrolizumab every 6 weeks, allowing for concomitant dose-dense (14 day) doxorubicin and cyclophosphamide (ddAC). By optimizing this dosing, the intention of this modified protocol was to improve pathologic complete response (pCR) rates in a population associated with a poorer prognosis. METHODS: This was a retrospective, single-center, cohort study. Patients were included if they had early stage, triple-negative breast cancer, and received at least one dose of AC. The entire cohort received neoadjuvant chemotherapy including weekly carboplatin and paclitaxel with pembrolizumab every 3 weeks for 12 weeks (4 cycles). The group then received either ddAC with pembrolizumab 400 mg every 6 weeks, or AC with pembrolizumab 200 mg every 3 weeks. The primary objective was pCR rate at time of surgery. RESULTS: This study assessed outcomes in 25 patients over 34 months. The pCR rate in the pembrolizumab, AC 3-week cohort was 64.3% versus 81.8% in the ddAC and 6-week pembrolizumab group. No pembrolizumab-associated grade 3-4 adverse events occurred in the either cohort. Despite seeing an increased incidence of grade 3-4 toxicities in the ddAC arm, this did not result in additional chemotherapy delays or dose reductions. CONCLUSION: This study demonstrated tolerability and a potential for favorable outcomes with this patient population, making this modified KEYNOTE 522 protocol a reasonable treatment approach. Larger, prospective studies are warranted to assess the feasibility of this dosing and true optimization of patient outcomes given the small sample size of this study.

The cost of lung transplantation in the United States: How high is too high?

Objectives: To identify patient and process factors that contribute to the high cost of lung transplantation (LTx) in the perioperative period, which may allow transplant centers to evaluate situations in which transplantation is most cost-effective to inform judicious resource allocation, avoid futile care, and reduce costs. Methods: The MarketScan Research databases were used to identify 582 privately insured patients undergoing single or bilateral LTx between 2013 and 2019. The patients were subdivided into groups by disease etiology using the United Network of Organ Sharing classification system. Multivariable generalized linear models using a gamma distribution with a log link were fit to examine the associations between the etiology of lung disease and costs during the index admission, 3 months before admission, and 3 months after discharge. Results: Our results indicate that the index admission contributed the most to the total transplantation costs compared to the 3 months before admission and after discharge. The regression-adjusted mean index hospitalization cost was 35% higher for patients with pulmonary vascular disease compared to those with obstructive lung disease ($527,156 vs $389,055). The use of extracorporeal membrane oxygenation, mechanical ventilation, and surgical complications in the post-transplantation period were associated with higher costs during the index admission. Surprisingly, age ≥55 was associated with lower costs during the index admission. Conclusions: This analysis identifies pivotal factors influencing the high cost of LTx, emphasizing the significant impact of the index admission, particularly for patients with pulmonary vascular disease. These insights offer transplant centers an opportunity to enhance cost-effectiveness through judicious resource allocation and service bundling, ultimately reducing overall transplantation costs.

Demographics of focused ultrasound thalamotomy for essential tremor and trends in deep brain stimulation surgery after its introduction in the USA.

Background: Essential tremor (ET) is a movement disorder that affects 4%-5% of adults >65 years. For patients with medically refractory ET, neurosurgical interventions such as deep brain stimulation (DBS) and unilateral MR-guided focused ultrasound thalamotomy (MRgFUS) are available. In this retrospective cohort study, we examined the demographics of patients with ET who have received MRgFUS and evaluated trends in DBS usage in the USA after the introduction of MRgFUS in 2016. Methods: We used multiple databases to examine the demographics of patients who received DBS and MRgFUS, and trends in DBS. To assess the demographics, we queried the TriNetX database from 2003 to 2022 to identify patients diagnosed with ET and stratify them by DBS or MRgFUS treatment by using Current Procedural Terminology codes. Patient demographics were reported as frequencies and percentages. To examine the trends in DBS for ET, the yearly frequency of DBS procedures done for ET between 2012 and 2019 was extracted from the National Inpatient Sample (NIS) database, and breakpoint analysis was performed. Additionally, the yearly frequency of MRgFUS procedures for ET was obtained from Insightec Exlabate. Results: Most of the patients (88.69%) in the cohort extracted from TriNetX database self-identified as white, followed by black or African American (2.40%) and Asian (0.52%). A higher percentage of black patients received MRgFUS treatment than DBS (4.10% vs 1.88%). According to the NIS database, from 2012 to 2020, 13 525 patients received DBS for ET. Conclusion: This study provides an overview of the characteristics of patients who undergo DBS or MRgFUS. We found notable differences in sex and race among patients who underwent each treatment type. Additionally, until at least the beginning of 2020, the number of DBS procedures for ET was not negatively affected after the introduction of MRgFUS.

Nationwide Analysis of Risk Factors Related to Opioid Weaning Following Lumbar Decompression Surgery - A Retrospective Database Study.

BACKGROUND: Opioids are often prescribed for patients who eventually undergo lumbar decompression. Given the potential for opioid-related morbidity and mortality, postoperative weaning is often a goal of surgery. The purpose of this study was to examine the relationship between preoperative opioid use and postoperative complete opioid weaning among lumbar decompression patients. METHODS: We surveyed the IBM Marketscan Databases for patients who underwent lumbar decompression during 2008-2017, had >30 days of opioid use in the year preceding surgery, and consumed a daily average of >0 morphine milligram equivalents in the 3 months preceding surgery. We used multivariable logistic regression and marginal standardization to examine the association between preoperative opioid use duration, average daily dose, and their interactions with complete opioid weaning in the 10-12 months after surgery. RESULTS: Of the 11,114 patients who met inclusion criteria, most (54.7%, n = 6083) had a preoperative average daily dose of 1-20 morphine milligram equivalents. Postoperatively, 6144 patients (55.3%) remained on opioids. For patients with >180 days of preoperative use, the adjusted probability of weaning increased as the preoperative dose decreased. Obesity increased the likelihood of weaning, whereas older age, several comorbidities, female sex, and Medicaid decreased the odds of weaning. CONCLUSIONS: Patients who used opioids for longer preoperatively were less likely to completely wean following surgery. Among patients with >180 days of preoperative use, those with lower preoperative doses were more likely to wean. Weaning was also associated with several clinical and demographic factors. These findings may help shape expectations regarding opioid use following lumbar decompression.

Disparities in the treatment of movement disorders using deep brain stimulation.

OBJECTIVE: Deep brain stimulation (DBS) is a well-established treatment for Parkinson's disease (PD) and essential tremor (ET). Although the prevalence of PD and ET can vary by sex and race, little is known about the accessibility of neurosurgical treatments for these conditions. In this nationwide study, the authors aimed to characterize trends in the use of DBS for the treatment of PD and ET and to identify disparities in the neurosurgical treatment of these diseases based on ethnic, racial, sex, insurance, income, hospital, and geographic factors. METHODS: Using the dates January 1, 2012, to December 31, 2019, the authors queried the National Inpatient Sample database for all discharges with an ICD-9 or ICD-10 diagnosis of PD or ET. Among these discharges, the DBS rates were reported for each subgroup of race, ethnicity, and sex. To develop national estimates, all analyses were weighted. RESULTS: Among 2,517,639 discharges with PD, 29,820 (1.2%) received DBS, and among 652,935 discharges with ET, 11,885 (1.8%) received DBS. Amid the PD cases, Black patients (n = 405 [0.2%], OR 0.16, 95% CI 0.12-0.20) were less likely than White patients (n = 23,975 [1.2%]) to receive DBS treatment, as were Hispanic patients (n = 1965 [1.1%], OR 0.76, 95% CI 0.65-0.88), whereas Asian/Pacific Islander patients (n = 855 [1.5%]) did not statistically differ from White patients. Amid the ET cases, Black (n = 230 [0.8%], OR 0.39, 95% CI 0.27-0.56), Hispanic (n = 215 [1.0%], OR 0.39, 95% CI 0.28-0.55), and Asian/Pacific Islander (n = 55 [1.0%], OR 0.51, 95% CI 0.28-0.93) patients were less likely than White patients (n = 10,440 [1.9%]) to receive DBS. Females were less likely than males to receive DBS for PD (OR 0.69, p < 0.0001) or ET (OR 0.70, p < 0.0001). CONCLUSIONS: The authors describe significant racial and sex-based differences in the utilization of DBS for the treatment of PD and ET. Further research is required to ascertain the causes of these disparities, as well as any differences in access to specialty neurosurgical care and referral for neuromodulation approaches.

Healthcare resource utilization for chronic low back pain among high-utilizers.

BACKGROUND: Chronic low back pain is a leading cause of morbidity and is among the largest cost drivers for the healthcare system. Research on healthcare resource utilization of patients with low back pain who are not surgical candidates is limited, and few studies follow individuals who generate high healthcare costs over time. PURPOSE: This claims study aimed to identify patients with high-impact mechanical, chronic low back pain (CLBP), quantify their low back pain-related health resource utilization, and explore associated patient characteristics. We hypothesize that patients in the top quartile of healthcare resource utilization in the second year after initial diagnosis will continue to generate considerable back pain-related costs in subsequent years. STUDY DESIGN/SETTING: IBM MarketScan Research Databases from 2009-2019 were retrospectively analyzed. PATIENT SAMPLE: Adults in the United States with an initial diagnosis of low back pain between 2010 and 2014 who did not have cancer, spine surgery, recent pregnancy, or inflammatory spine conditions, were identified using the International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes. To ensure patients had chronic low back pain, it was required that individuals had additional claims with a low back pain diagnosis 6 to 12 and 12 to 24 months after initial diagnosis. OUTCOME MEASURES: Cost and utilization of inpatient visits, outpatient visits, emergency room visits, pharmacologic and nonpharmacologic treatment options and imaging for chronic low back pain. METHODS: Annual back pain-related costs and the use of pharmacologic and nonpharmacologic treatments for 5 years were analyzed. Logistic regression was utilized to identify factors associated with persistent high spending. RESULTS: Of 16,917 individuals who met the criteria for chronic low back pain, 4,229 met the criteria for having high healthcare utilization, defined as being in the top quartile of back pain-related costs in the 12 to 24 months after their initial diagnosis. The mean and median back pain-related cost in the first year after an initial diagnosis was $7,112 (SD $9,670) and $4,405 (Q1 $2,147, Q3 $8,461). Mean and median back pain related costs in the second year were $11,989 (SD $20,316) and $5,935 (Q1 $3,892, Q3 $10,678). Costs continued to be incurred in years 3 to 5 at a reduced rate. The cumulative mean cost for back pain over the 5 years following the initial diagnosis was $31,459 (SD $39,545). The majority of costs were from outpatient services. Almost a quarter of the high utilizers remained in the top quartile of back pain-related costs during years 3 to 5 after the initial diagnosis, and another 19% remained in the top quartile for 2 of the 3 subsequent years. For these two groups combined (42%), the 5-year cumulative mean cost for back pain was $43,818 (SD $48,270). Patient characteristics associated with a higher likelihood of remaining as high utilizers were diabetes, having a greater number of outpatient visits and pharmacologic prescriptions, and lower utilization of imaging services. CONCLUSION: This is one of the first studies to use an administrative claims database to identify high healthcare resource utilizers among a population of United States individuals with nonsurgical, chronic low back pain and follow their utilization over time. There was a population of individuals who continued to experience high costs 5 years beyond their initial diagnosis, and the majority of individuals continued to seek outpatient services. Further longitudinal claims research that incorporates symptom severity is needed to understand the economic implications of this condition.

Ratios of head circumference to ventricular size vary over time and predict eventual need for CSF diversion in intraventricular hemorrhage of prematurity.

PURPOSE: Intraventricular hemorrhage (IVH) of prematurity can lead to hydrocephalus, sometimes necessitating permanent cerebrospinal fluid (CSF) diversion. We sought to characterize the relationship between head circumference (HC) and ventricular size in IVH over time to evaluate the clinical utility of serial HC measurements as a metric in determining the need for CSF diversion. METHODS: We included preterm infants with IVH born between January 2000 and May 2020. Three measures of ventricular size were obtained: ventricular index (VI), Evan's ratio (ER), and frontal occipital head ratio (FOHR). The Pearson correlations (r) between the initial (at birth) paired measurements of HC and ventricular size were reported. Multivariable longitudinal regression models were fit to examine the HC:ventricle size ratio, adjusting for the age of the infant, IVH grade (I/II vs. III/IV), need for CSF diversion, and sex. RESULTS: A total of 639 patients with an average gestational age of 27.5 weeks were included. IVH grade I/II and grade III/IV patients had a positive correlation between initial HC and VI (r = 0.47, p < 0.001 and r = 0.48, p < 0.001, respectively). In our longitudinal models, patients with a low-grade IVH (I/II) had an HC:VI ratio 0.52 higher than those with a high-grade IVH (p-value < 0.001). Patients with low-grade IVH had an HC:ER ratio 12.94 higher than those with high-grade IVH (p-value < 0.001). Patients with low-grade IVH had a HC:FOHR ratio 12.91 higher than those with high-grade IVH (p-value < 0.001). Infants who did not require CSF diversion had an HC:VI ratio 0.47 higher than those who eventually did (p < 0.001). Infants without CSF diversion had an HC:ER ratio 16.53 higher than those who received CSF diversion (p < 0.001). Infants without CSF diversion had an HC:FOHR ratio 15.45 higher than those who received CSF diversion (95% CI (11.34, 19.56), p < 0.001). CONCLUSIONS: There is a significant difference in the ratio of HC:VI, HC:ER, and HC:FOHR size between patients with high-grade IVH and low-grade IVH. Likewise, there is a significant difference in HC:VI, HC:ER, and HC:FOHR between those who did and did not have CSF diversion. The routine assessments of both head circumference and ventricle size by ultrasound are important clinical tools in infants with IVH of prematurity.

At home adaptive dual target deep brain stimulation in Parkinson's disease with proportional control.

Continuous deep brain stimulation (cDBS) of the subthalamic nucleus (STN) or globus pallidus is an effective treatment for the motor symptoms of Parkinson's disease. The relative benefit of one region over the other is of great interest but cannot usually be compared in the same patient. Simultaneous DBS of both regions may synergistically increase the therapeutic benefit. Continuous DBS is limited by a lack of responsiveness to dynamic, fluctuating symptoms intrinsic to the disease. Adaptive DBS (aDBS) adjusts stimulation in response to biomarkers to improve efficacy, side effects, and efficiency. We combined bilateral DBS of both STN and globus pallidus (dual target DBS) in a prospective within-participant, clinical trial in six patients with Parkinson's disease (n = 6, 55-65 years, n = 2 females). Dual target cDBS was tested for Parkinson's disease symptom control annually over 2 years, measured by motor rating scales, on time without dyskinesia, and medication reduction. Random amplitude experiments probed system dynamics to estimate parameters for aDBS. We then implemented proportional-plus-integral aDBS using a novel distributed (off-implant) architecture. In the home setting, we collected tremor and dyskinesia scores as well as individualized ß and DBS amplitudes. Dual target cDBS reduced motor symptoms as measured by Unified Parkinson's Disease Rating Scale (UPDRS) to a greater degree than either region alone (P < 0.05, linear mixed model) in the cohort. The amplitude of ß-oscillations in the STN correlated to the speed of hand grasp movements for five of six participants (P < 0.05, Pearson correlation). Random amplitude experiments provided insight into temporal windowing to avoid stimulation artefacts and demonstrated a correlation between STN ß amplitude and DBS amplitude. Proportional plus integral control of aDBS reduced average power, while preserving UPDRS III scores in the clinic (P = 0.28, Wilcoxon signed rank), and tremor and dyskinesia scores during blinded testing at home (n = 3, P > 0.05, Wilcoxon ranked sum). In the home setting, DBS power reductions were slight but significant. Dual target cDBS may offer an improvement in treatment of motor symptoms of Parkinson's disease over DBS of either the STN or globus pallidus alone. When combined with proportional plus integral aDBS, stimulation power may be reduced, while preserving the increased benefit of dual target DBS.

Disparities in Access to Deep Brain Stimulation and Responsive Neurostimulation Approaches to Drug-Resistant Epilepsy.

BACKGROUND: Epilepsy affects 1% to 2% of the global population, and those who are resistant to medical treatment may be candidates for neuromodulation. In select populations, brain stimulation approaches including deep brain stimulation (DBS) and responsive neurostimulation (RNS) are used. Although studies have shown that patients from Black, Hispanic, lower income, and rural communities have less access to epilepsy care and have lower rates of epilepsy surgery, disparities in the use of brain stimulation for epilepsy treatment are currently not known. MATERIALS AND METHODS: We queried the US National Inpatient Sample data base from January 1, 2014 to December 31, 2019 for all patients discharged with an International Classification of Diseases (ICD) Ninth Revision or ICD Tenth Revision diagnosis of drug-resistant epilepsy. Among these patients discharged, the rates of brain stimulation treatment, including DBS and RNS, were reported in each subgroup of race, ethnicity, and insurance. To generate national estimates, all analyses were weighted. RESULTS: A total of 237,895 patients discharged with drug-resistant epilepsy were identified, of whom 4,925 (2.1%) received brain stimulation treatment for drug-resistant epilepsy. Black patients (n = 420, 0.9%, odds ratio [OR] = 0.51, 95% CI [0.40, 0.64]) were less likely to receive brain stimulation treatment than were White patients (n = 3300, 2.4%). There was no significant difference between Asian (n = 105, 2.3%, OR = 0.80, 95% CI [0.53, 1.33]) and Hispanic (n = 655, 2.6%, OR = 0.95, 95% CI [0.77, 1.17]) patients and White patients. No significant difference was observed between female (n = 2515, 2.1%, OR = 1.02, 95% CI [0.89, 1.17]) and male (n = 2410, 2.0%) patients either. Patients with Medicare (n = 1150, 1.2%, OR = 0.69, 95% CI [0.57, 0.84]) or Medicaid (n = 1150, 1.8%, OR = 0.52, 95% CI [0.44, 0.62]) were less likely to receive brain stimulation treatment than were those with private insurance as the primary payer (n = 2370, 3.9%). CONCLUSIONS: We discovered significant disparities in the use of brain stimulation treatments for drug-resistant epilepsy based on race and insurance status. More research will be required to determine the cause of these disparities.

Associations Between Management Pathway and Opioid Prescriptions for Patients Entering the Emergency Department With Neck and Back Pain.

Objective: To determine associations between post-emergency department (ED) management pathways and downstream opioid prescriptions in patients seeking care for incident neck and/or back pain. Patients and Methods: We identified patients seeking first-time ED care for neck and/or back pain from January 1, 2013, through November 6, 2017. We reported demographic characteristics and opioid prescriptions across management pathways using descriptive statistics and assessed the relative risk of any opioid prescription 12 months post-ED visit among 5 different post-ED management pathways using Poisson regression adjusted for patient demographic characteristics. Results: Within 12 months after the index ED visit, 58.0% (n=10,949) were prescribed an opioid, with most patients prescribed an opioid within the first week (average daily morphine milligram equivalents of 6.8 mg (SD 9.6 mg). The morphine milligram equivalents decreased to 0.7 mg (SD 8.2 mg) by week 4 and remained consistently less than 1 mg between week 4 and 12 months. Compared with the ED to primary care provider pathway, the relative risk of opioid prescription between 7 days and 12 months after the index ED visit was similar for the ED to physical therapy pathway, higher for both the ED to hospital admission or repeat ED visit pathway (30% increase; relative risk (RR), 1.3; 95% CI, 1.17-1.44) and the ED to specialist pathway (19% increase; RR, 1.19; 95% CI, 1.07-1.33), and lower in the ED with no follow-up visits pathway (41% decrease; RR, 0.59; 95% CI, 0.54-0.65). Conclusion: In general, more conservative care was associated with lower opioid prescription rates, and escalated care was associated with higher opioid prescription rates.

Utility of Routine Preoperative Urinalysis in the Prevention of Surgical Site Infections.

OBJECTIVE: Preoperative assessment is important for neurosurgical risk stratification, but the level of evidence for individual screening tests is low. In preoperative urinalysis (UA), testing may significantly increase costs and lead to inappropriate antibiotic treatment. We prospectively evaluated whether eliminating preoperative UA was noninferior to routine preoperative UA as measured by 30-day readmission for surgical site infection in adult elective neurosurgical procedures. METHODS: A single-institution prospective, pragmatic study of patients receiving elective neurosurgical procedures from 2018 to 2020 was conducted. Patients were allocated based on same-day versus preoperative admission status. Rates of preoperative UA and subsequent wound infection were measured along with detailed demographic, surgical, and laboratory data. RESULTS: The study included 879 patients. The most common types of surgery were cranial (54.7%), spine (17.4%), and stereotactic/functional (19.5%). No preoperative UA was performed in 315 patients, while 564 underwent UA. Of tested patients, 103 (18.3%) met criteria for suspected urinary tract infection, and 69 (12.2%) received subsequent antibiotic treatment. There were 14 patients readmitted within 30 days (7 without UA [2.2%] vs. 7 with UA [1.2%]) for subsequent wound infection with a risk difference of 0.98% (95% confidence interval -0.89% to 2.85%). The upper limit of the confidence interval exceeded the preselected noninferiority margin of 1%. CONCLUSIONS: In this prospective study of preoperative UA for elective neurosurgical procedures using a pragmatic, real-world design, risk of readmission due to surgical site infection was very low across the study cohort, suggesting a limited role of preoperative UA for elective neurosurgical procedures.

Lateral neck dissection surgeon volume and complications in head and neck endocrine malignancy.

Background: Increased surgeon volume is associated with decreased complications for many surgeries, including thyroidectomy. We sought to use two national databases to assess for associations between surgeon volume and complications in patients undergoing lateral neck dissection for thyroid or parathyroid malignancy. Methods: Lateral neck dissections for thyroid and parathyroid cancer from the Nationwide Inpatient Sample and State Inpatient Database were analyzed. The primary outcome was any inpatient complication common to thyroidectomy, parathyroidectomy, or lateral neck dissection. The principle independent variable was surgeon volume. Multivariable analysis was then performed on this retrospective cohort study. Results: The 1,094 Nationwide Inpatient Sample discharges had a 28% (305/1,094) complication rate. After adjustment, surgeons with volumes between 3-34 neck dissections/year demonstrated a surgeon volume-complication rate association [adjusted odds ratio: 1.03; 95% confidence interval (CI): 1.01-1.05]. The 1,235 State inpatient Database discharges had a 21% (258/1,235) overall complication rate, and no association between surgeon volume and complication rates (P=0.25). Conclusions: This retrospective review of 2,329 discharges for patients undergoing lateral neck dissection for thyroid or parathyroidectomy demonstrated somewhat conflicting results. The Nationwide Inpatient Sample demonstrated increasing complication rates for increasing surgeon volume among intermediate volume surgeons, while the State Inpatient Database demonstrated no surgeon volume-complication association. Given these disparate results, and further limitations with these databases, conclusions regarding surgical volume and clinical decision making based on these data should be assessed cautiously.

Electronic health record-based readmission risk model performance for patients undergoing outpatient parenteral antibiotic therapy (OPAT).

BACKGROUND: Outpatient Parenteral Antibiotic Therapy (OPAT) provides coordinated services to deliver parenteral antibiotics outside of the acute care setting. However, the reduction in monitoring and supervision may impact the risks of readmission to the hospital. While identifying those at greatest risk of hospital readmission through use of computer decision support systems could aid in its prevention, validation of such tools in this patient population is lacking. OBJECTIVE: The primary aim of this study is to determine the ability of the electronic health record-embedded EPIC Unplanned Readmission Model 1 to predict all-cause 30-day hospital unplanned readmissions in discharged patients receiving OPAT through the Duke University Heath System (DUHS) OPAT program. We then explored the impact of OPAT-specific variables on model performance. METHODS: This retrospective cohort study included patients ≥ 18 years of age discharged to home or skilled nursing facility between July 1, 2019 -February 1, 2020 with OPAT care initiated inpatient and coordinated by the DUHS OPAT program and with at least one Epic readmission score during the index hospitalization. Those with a planned duration of OPAT < 7 days, receiving OPAT administered in a long-term acute care facility (LTAC), or ongoing renal replacement therapy were excluded. The relationship between the primary outcome (unplanned readmission during 30-day post-index discharge) and Epic readmission scores during the index admission (discharge and maximum) was examined using multivariable logistic regression models adjusted for additional predictors. The performance of the models was assessed with the scaled Brier score for overall model performance, the area under the receiver operating characteristics curve (C-index) for discrimination ability, calibration plot for calibration, and Hosmer-Lemeshow goodness-of-fit test for model fit. RESULTS: The models incorporating maximum or discharge Epic readmission scores showed poor discrimination ability (C-index 0.51, 95% CI 0.45 to 0.58 for both models) in predicting 30-day unplanned readmission in the Duke OPAT cohort. Incorporating additional OPAT-specific variables did not improve the discrimination ability (C-index 0.55, 95% CI 0.49 to 0.62 for the max score; 0.56, 95% CI 0.49 to 0.62 for the discharge score). Although models for predicting 30-day unplanned OPAT-related readmission performed slightly better, discrimination ability was still poor (C-index 0.54, 95% CI 0.45 to 0.62 for both models). CONCLUSION: EPIC Unplanned Readmission Model 1 scores were not useful in predicting either all-cause or OPAT-related 30-day unplanned readmission in the DUHS OPAT cohort. Further research is required to assess other predictors that can distinguish patients with higher risks of 30-day unplanned readmission in the DUHS OPAT patients.

Conflict resolution styles and skills and variation among medical students.

BACKGROUND: Conflict is inevitable on healthcare teams, yet few professional school curricula teach or assess conflict resolution skills. Little is known about the variation in conflict resolution styles across medical students and how these styles might impact conflict resolution skills. METHODS: This is a prospective, single blinded, group randomized quasi experimental trial to assess the impact of knowing one's own conflict resolution style on conflict resolution skills in a simulated encounter. Graduating medical students completed a mandatory conflict resolution session with standardized patients acting as nurses during a transition to residency course. Coaches reviewed videotapes of the simulation, focusing on students' skills with negotiation and emotional intelligence. Retrospectively, we assessed the impact of the students knowing their conflict resolution style prior to simulation, student gender, race, and intended field of practice on conflict resolution skills as judged by coaches. RESULTS: One hundred and eight students completed the simulated conflict session. Sixty-seven students completed the TKI before the simulated patient (SP) encounter and 41 after. The most common conflict resolution style was accommodating (n = 40). Knowing one's conflict resolution style in advance of the simulation and one's identified race/ethnicity did not impact skill as assessed by faculty coaches. Students pursuing diagnosis-based specialties had higher negotiation (p = 0.04) and emotional quotient (p = 0.006) scores than those pursuing procedural specialties. Females had higher emotional quotient scores (p = 0.02). CONCLUSIONS: Conflict resolution styles vary among medical students. Male gender and future practice in a procedural specialty impacted conflict resolution skills but knowing conflict resolution style did not.

Short-Term Health Care Costs of High-Frequency Spinal Cord Stimulation for the Treatment of Postsurgical Persistent Spinal Pain Syndrome.

OBJECTIVE: High-frequency spinal cord stimulation (HF-SCS) is a treatment option for postsurgical persistent spinal pain syndrome (type 2 PSPS). We aimed to determine the health care costs associated with this therapy in a nationwide cohort. MATERIALS AND METHODS: IBM Marketscan® Research Databases were used to identify patients who underwent HF-SCS implantation from 2016 to 2019. Inclusion criteria included prior spine surgery or diagnoses of PSPS or postlaminectomy pain syndrome any time within the two years before implantation. Inpatient and outpatient service costs, medication costs, and out-of-pocket costs were collected six months before implantation (baseline) and one, three, and six months after implantation. The six-month explant rate was calculated. Costs were compared between baseline and six months after implant via Wilcoxon sign rank test. RESULTS: In total, 332 patients were included. At baseline, patients incurred median total costs of $15,393 (Q1: $9,266, Q3: $26,216), whereas the postimplant median total costs excluding device acquisition were $727 (Q1: $309, Q3: $1,765) at one month, $2,840 (Q1: $1,170, Q3: $6,026) at three months, and $6,380 (Q1: $2,805, Q3: $12,637) at six months. The average total cost was reduced from $21,410 (SD $21,230) from baseline to $14,312 (SD $25,687) at six months after implant for an average reduction of $7,237 (95% CI = $3212-$10,777, p < 0.001). The median device acquisition costs were $42,937 (Q1: $30,102, Q3: $65,880). The explant rate within six months was 3.4% (8/234). CONCLUSIONS: HF-SCS for PSPS was associated with significant decreases in total health care costs and offsets acquisition costs within 2.4 years. With the rising incidence of PSPS, it will be critical to use clinically effective and cost-efficient therapies for treatment.

Assessment of Health Care Costs and Total Baclofen Use Associated With Targeted Drug Delivery for Spasticity.

BACKGROUND: Chronic spasticity causes significant impairment and financial burden. Oral baclofen, the first-line therapy, can have intolerable, dose-dependent side effects. Targeted drug delivery (TDD) through intrathecal baclofen delivers smaller amounts of baclofen into the thecal sac via an implanted infusion system. However, the health care resource utilization of patients with spasticity receiving TDD has not been studied extensively. MATERIALS AND METHODS: Adult patients who received TDD for spasticity between 2009 and 2017 were identified using the IBM MarketScan® data bases. Patients' use of oral baclofen and health care costs were examined at baseline (one year before implantation) and three years after implantation. A multivariable regression model using the generalized estimating equations method and a log link function was used to compare postimplantation costs with those at baseline. RESULTS: The study identified 771 patients with TDD for medication analysis and 576 for cost analysis. At baseline, the median costs were $39,326 (interquartile range [IQR]: $19,526-$80,679), which increased to $75,728 (IQR: $44,199-$122,676) in year 1, decreased to $27,160 (IQR: $11,896-$62,427) in year 2, and increased slightly to $28,008 (IQR: $11,771-$61,885) in year 3. In multivariable analysis, the cost was 47% higher than at baseline (cost ratio [CR] 1.47, 95% CI: 1.32-1.63) in year 1 but was 25% lower (CR 0.75, 95% CI: 0.66-0.86) in year 2 and 32% lower (CR 0.68, 95% CI: 0.59-0.79) in year 3. Before implant, 58% of patients took oral baclofen, which decreased to 24% by year 3. The median daily baclofen dose decreased from 61.8 mg (IQR: 40-86.4) before TDD to 32.8 mg (IQR: 30-65.7) three years later. CONCLUSIONS: Our findings indicate that patients who undergo TDD use less oral baclofen, potentially reducing the risk of side effects. Although total health care costs increased immediately after TDD, most likely owing to device and implantation costs, they decreased below baseline after one year. The costs of TDD reach cost neutrality approximately three years after implant, indicating its potential for long-term cost savings.

MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial.

Kidney transplant (KT) recipients who are not actively engaged in their care and lack self-management skills have poor transplant outcomes, which are disproportionately observed among Black KT recipients. This pilot study aimed to determine whether the MyKidneyCoach app, an mHealth intervention that provides self-management monitoring and coaching, improved patient activation, engagement, and nutritional behaviors in a diverse KT population. Methods: This was a randomized, age-stratified, parallel-group, attention-control, pilot study in post-KT patients. Participants were randomized into the attention-control with access to MyKidneyCoach for education and self-management (n = 9) or the intervention with additional tailored nurse coaching (n = 7). Feasibility, acceptability, and clinical outcomes were assessed. Results: The acceptability of MyKidneyCoach by System Usability Scale was 67.5 (95% confidence interval [CI], 59.1-75.9). Completion rates based on actively using MyKidneyCoach were 81% (95% CI, 57%-93%) and study retention rate of 73%. Patient activation measure significantly increased overall by a mean of 11 points (95% CI, 3.2-18.8). Additionally, Black patients (n = 7) had higher nutrition self-efficacy scores of 80.5 (95% CI, 74.4-86.7) compared with 75.6 (95% CI, 71.1-80.1) in non-Black patients (n = 9) but lower patient activation measure scores of 69.3 (95% CI, 56.3-82.3) compared with 71.8 (95% CI, 62.5-81) in non-Black patients after 3 mo. Conclusions: MyKidneyCoach was easy to use and readily accepted with low attrition, and improvements were demonstrated in patient-reported outcomes. Both Black and non-Black participants using MyKidneyCoach showed improvement in self-management competencies; thus, this intervention may help reduce healthcare inequities in KT.

Disparities in Prostate Cancer Screening for Transgender Women: An Analysis of the MarketScan Database.

OBJECTIVE: To describe the prevalence of PSA screening amongst transgender women. A transgender individual is someone whose gender identity differs from their birth sex or the societal norms of that assigned sex. There are no formal guidelines regarding PSA screening in transgender women, even though they retain prostatic tissue throughout the gender-affirming process, and there is a lack of existing data to adequately inform clinical practice. METHODS: We identified a cohort of transgender women in the IBM MarketScan dataset using ICD codes. The patient...s eligibility for inclusion was determined on an annual basis for the years 2013-2019. For each year, we required continuous enrollment, 3 months of post-transgender diagnosis follow-up, and aged 40-80 without a prior diagnosis of prostate malignancy. This cohort was compared to cisgender men with similar eligibility criteria. The proportions of individuals undergoing PSA screening were compared using log-binomial regression. RESULTS: A group of 2957 transgender women met the inclusion criteria. We saw significantly lower PSA screening rates among transgender individuals for ages 40-54 and 55-69, but higher rates within the age group 70-80 (P.ß<.ß.001 for all). CONCLUSION: This is the first study evaluating PSA screening rates for insured transgender women. While the rates for screening in transgender women over the age of 70 are higher, the overall rate of screening for all other age groups lags below the general population in this dataset. Further investigation is necessary to provide equitable care for the transgender community.

Utility of a risk assessment model in predicting 30†day unplanned hospital readmission in adult patients receiving outpatient parenteral antimicrobial therapy.

Objectives: Outpatient parenteral antimicrobial therapy (OPAT) is associated with high hospital readmission rates. A 30 day unplanned readmission risk prediction model for OPAT patients has been developed in the UK. Given significant differences in patient mix and methods of OPAT delivery, we explored the model for its utility in Duke University Health System (DUHS) patients receiving OPAT. Methods: We analysed OPAT episodes of adult patients from two hospitals between 1 July 2019 and 1 February 2020. The discriminative ability of the model to predict 30 day unplanned all-cause and OPAT-related admission was examined. An updated model was created by logistic regression with the UK risk factors and additional risk factors, OPAT delivery in a skilled nursing facility, vancomycin use and IV drug abuse. Results: Compared with patients of the UK cohort, our study patients were of higher acuity, treated for more invasive infections, and received OPAT through different modes. The 30 day unplanned readmission rate in our cohort was 20% (94/470), with 59.5% (56/94) of those being OPAT-related. The original model was unable to discriminate for all-cause readmission with a C-statistic of 0.52 (95% CI 0.46-0.59) and for OPAT-related readmission with a C-statistic of 0.55 (95% CI 0.47-0.64). The updated model with additional risk factors did not have improved performance, with a C-statistic of 0.55 (95% CI 0.49-0.62). Conclusions: The UK 30 day unplanned hospital readmission model performed poorly in predicting readmission for the OPAT population at a US academic medical centre.

Medication Payments by Insurers and Patients for the Treatment of Metastatic Castrate-Resistant Prostate Cancer.

PURPOSE: The implications of high prices for cancer drugs on health care costs and patients' financial burdens are a growing concern. Patients with metastatic castrate-resistant prostate cancer (mCRPC) are often candidates for multiple first-line systemic therapies with similar impacts on life expectancy. However, little is known about the gross and out-of-pocket (OOP) payments associated with each of these drugs for patients with employer-sponsored health insurance. We therefore aimed to determine the gross and OOP payments of first-line drugs for mCRPC and how the payments vary across drugs. METHODS: This retrospective cohort study included 4,298 patients with prostate cancer who initiated therapy with one of six drugs approved for first-line treatment of mCRPC between July 1, 2013, and June 30, 2019. We compared gross and OOP payments during the 6 months after initiation of treatment for mCRPC using private payer claims data across patients using different first-line drugs. RESULTS: Gross payments varied across drugs. Over the 6 months after the index prescription, mean unadjusted gross drug payments were highest for patients receiving sipuleucel-T ($115,525 USD) and lowest for patients using docetaxel ($12,804 USD). OOP payments were lower than gross drug payments; mean 6-month OOP payments were highest for cabazitaxel ($1,044 USD) and lowest for docetaxel ($296 USD). There was a wide distribution of OOP payments within drug types. CONCLUSION: Drugs for mCRPC are expensive with large differences in payments by drug type. OOP payments among patients with employer-sponsored health insurance are much lower than gross drug payments, and they vary both across and within first-line drug types, with some patients making very high OOP payments. Although lowering drug prices would reduce pharmaceutical spending for patients with mCRPC, decreasing patient financial burden requires understanding an individual patient's benefit design.