Interval estimation for operating characteristic of continuous biomarkers with controlled sensitivity or specificity.

The receiver operating characteristic (ROC) curve provides a comprehensive performance assessment of a continuous biomarker over the full threshold spectrum. Nevertheless, a medical test often dictates to operate at a certain high level of sensitivity or specificity. A diagnostic accuracy metric directly targeting the clinical utility is specificity at the controlled sensitivity level, or vice versa. While the empirical point estimation is readily adopted in practice, the nonparametric interval estimation is challenged by the fact that the variance involves density functions due to estimated threshold. In addition, even with a fixed threshold, many standard confidence intervals including the Wald interval for binomial proportion could have erratic behaviors. In this article, we are motivated by the superior performance of the score interval for binomial proportion and propose a novel extension for the biomarker problem. Meanwhile, we develop exact bootstrap and establish consistency of the bootstrap variance estimator. Both single-biomarker evaluation and two-biomarker comparison are investigated. Extensive simulation studies were conducted, demonstrating competitive performance of our proposals. An illustration with aggressive prostate cancer diagnosis is provided.

The Impact of COVID-19 on Laboratory Test Utilization at a Pediatric Medical Center.

BACKGROUND: The epidemiology and clinical manifestation of coronavirus disease 2019 (COVID-19) in the pediatric population is different from the adult population. The purpose of this study is to identify effects of the COVID-19 pandemic on laboratory test utilization in a pediatric hospital. METHODS: We performed retrospective analysis on test utilization data from Ann & Robert H. Lurie Children's Hospital of Chicago, an academic pediatric medical center. Data between two 100-day periods prior to (prepandemic) and during the pandemic (mid-pandemic) were analyzed to evaluate changes in test volume, lab utilization, and test positivity rate. We also evaluated these metrics based on in- vs outpatient testing and performed modeling to determine what variables significantly impact the test positivity rate. RESULTS: During the pandemic period, there was an expected surge in COVID-19 testing, while over 84% of lab tests studied decreased in ordering volume. The average number of tests ordered per patient was not significantly different during the pandemic for any of the laboratories (adjusted P value > 0.05). Thirty-three studied tests showed significant change in positivity rate during the pandemic. Linear modeling revealed test volume and inpatient status as the key variables associated with change in test positivity rate. CONCLUSIONS: Excluding severe acute respiratory syndrome coronavirus 2 tests, the COVID-19 pandemic has generally led to decreased test ordering volume and laboratory utilization. However, at this pediatric hospital, the average number of tests performed per patient and test positivity rates were comparable between pre- and mid-pandemic periods. These results suggest that, overall, clinical test utilization at this site remained consistent during the pandemic.

A Quality Improvement Initiative to Increase Central Line Maintenance Bundle Compliance through Nursing-led Rounds.

INTRODUCTION: Improvements in maintenance bundle compliance around central line-associated bloodstream infections (CLABSIs) lack standardization. The objective was to implement a formalized nursing-led rounding process, Rounds for Influence, with a goal of 12 rounds/wk on each inpatient unit and Ambulatory Infusion Center, achieving > 90% maintenance bundle compliance. METHODS: Nurses served as peer "influencers" to perform rounds. The CLABSI prevention team created three comprehensive rounding tools (line access, dressing change/port needle insertion, and cap change) on a digital platform. The team designed these tools to assess clinical competence for maintenance bundle components and implemented nine plan-do-study-act cycles throughout the study period. RESULTS: Influencers completed 191 rounds after the first month of implementation, resulting in a 264.2% increase from the baseline of 52.5 rounds per month. Over the 2.5 years postimplementation, rounds resulted in 7836 total observations. Maintenance bundle compliance decreased from 86.9% (centerline value from November 2017 to September 2018) to 40.8% after the first month of implementation. Compliance increased iteratively (two separate centerline shifts) to a current centerline value of 87.1%. The CLABSI 12-month cumulative standardized infection ratio (SIR) was 0.9 in November 2017 and dropped to 0.53 in June 2021. CONCLUSION: Implementing a formalized nursing-led rounding process led to increased maintenance bundle compliance, decreased CLABSI SIR, and is an integral part of nursing practice. Given this success, there is interest from other hospital-acquired condition improvement teams in applying this rounding practice to their improvement work.

Challenge of balancing duration of stay and readmissions in children's operation.

BACKGROUND: Surgeons balance competing interests of minimizing duration of stay with readmissions. Complications that occur early after discharge often result in readmissions. This study examines the relationship between duration of stay, timing of complications, and readmission risk. METHODS: Cases from the 2012-2014 National Surgical Quality Improvement Project-Pediatric were organized into 30 procedural groups. Procedures where duration of stay approximated the median day of complication were identified. A theoretical model was applied to minimize readmissions by extending duration of stay. RESULTS: From 30 procedure groups, 3 were identified where duration of stay approximated median day of compilations: complicated appendectomy, antireflux operation, and abdominal operation without bowel resection. The complicated appendectomy readmission rate drops from 12.2% to 8.2%, increasing duration of stay from 3 to 8 days at the cost of 16,428 additional hospital days among 4,740 patients (3.5 days/patient). Readmission optimization tapers after duration of stay of 8 days. Similar findings were observed for antireflux operation and abdominal operation without bowel resection with readmission optimization at duration of stay of 5 days (2.6 days/patient) and 7 days (5.3 days/patient), respectively. CONCLUSION: Our theoretical model aimed at balancing readmissions by extending duration of stay to capture early complications results in a substantial increase in hospital days illustrating the conflict between competing quality metrics and limited resources.

Perioperative Visual Loss in Spine Fusion Surgery: Ischemic Optic Neuropathy in the United States from 1998 to 2012 in the Nationwide Inpatient Sample.

BACKGROUND: Perioperative ischemic optic neuropathy (ION) causes visual loss in spinal fusion. Previous case-control studies are limited by study size and lack of a random sample. The purpose of this study was to study trends in ION incidence in spinal fusion and risk factors in a large nationwide administrative hospital database. METHODS: In the Nationwide Inpatient Sample for 1998 to 2012, procedure codes for posterior thoracic, lumbar, or sacral spine fusion and diagnostic codes for ION were identified. ION was studied over five 3-yr periods (1998 to 2000, 2001 to 2003, 2004 to 2006, 2007 to 2009, and 2010 to 2012). National estimates were obtained using trend weights in a statistical survey procedure. Univariate and Poisson logistic regression assessed trends and risk factors. RESULTS: The nationally estimated volume of thoracic, lumbar, and sacral spinal fusion from 1998 to 2012 was 2,511,073. ION was estimated to develop in 257 patients (1.02/10,000). The incidence rate ratio (IRR) for ION significantly decreased between 1998 and 2012 (IRR, 0.72 per 3 yr; 95% CI, 0.58 to 0.88; P = 0.002). There was no significant change in the incidence of retinal artery occlusion. Factors significantly associated with ION were age (IRR, 1.24 per 10 yr of age; 95% CI, 1.05 to 1.45; P = 0.009), transfusion (IRR, 2.72; 95% CI, 1.38 to 5.37; P = 0.004), and obesity (IRR, 2.49; 95% CI, 1.09 to 5.66; P = 0.030). Female sex was protective (IRR, 0.30; 95% CI, 0.16 to 0.56; P = 0.0002). CONCLUSIONS: Perioperative ION in spinal fusion significantly decreased from 1998 to 2012 by about 2.7-fold. Aging, male sex, transfusion, and obesity significantly increased the risk.

Corneal abrasion in hysterectomy and prostatectomy: role of laparoscopic and robotic assistance.

BACKGROUND: Radical prostatectomy (RP) is most commonly performed laparoscopically with a robot (robotic-assisted laparoscopic radical prostatectomy, R/PROST). Hysterectomy, which may be open hysterectomy (O/HYST) or laparoscopic hysterectomy (L/HYST), has been increasingly frequently done via robot (R/HYST). Small case series suggest increased corneal abrasions (CAs) with less invasive techniques. METHODS: The authors identified RP (166,942), O/HYST (583,298), or L/HYST (216,890) discharges with CA in the Nationwide Inpatient Sample (2000-2011). For 2009-2011, they determined odds ratios (ORs) and 95% confidence intervals (CIs) for CA, in R/PROST, non-R/PROST, L/HYST, O/HYST, and R/HYST. Uni- and multivariate models studied CA risk depending on surgical procedure, age, race, year, chronic illness, and malignancy. RESULTS: In 2000-2011, 0.18% RP, 0.13% L/HYST, and 0.03% O/HYST sustained CA. Compared with 17,554 non-R/PROSTs (34 abrasions, 0.19%) in 2009-2011, OR was not significantly higher in 28,521 R/PROSTs (99, 0.35%; OR 1.508; CI 0.987 to 2.302; P < 0.057). CA significantly increased in L/HYST (70/51,323; 0.136%) versus O/HYST (70/191,199; 0.037%; OR 3.821; CI 2.594 to 5.630; P < 0.0001), further increasing in R/HYST (63/21, 213; 0.297%; OR 6.505; CI 4.323 to 9.788; P < 0.0001). For hysterectomy, risk of CA increased with age (OR 1.020; CI 1.007 to 1.034; P < 0.003) and number of chronic conditions (OR 1.139; CI 1.065 to 1.219; P < 0.0001). CA risk was likewise elevated in R/HYST with number of chronic conditions. Being African American significantly decreased CA risk in R/PROST and in R/HYST or L/HYST. CONCLUSIONS: L/HYST increased CA nearly four-fold, and R/HYST approximately 6.5-fold versus O/HYST. Identifiable preoperative factors are associated with either increased risk (age, chronic conditions) or decreased risk (race).