Development and Evaluation of a Machine Learning Model for the Early Identification of Patients at Risk for Sepsis.

Study Objective: The Third International Consensus Definitions (Sepsis-3) Task Force recommended the use of the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score to screen patients for sepsis outside of the ICU. However, subsequent studies raise concerns about the sensitivity of qSOFA as a screening tool. We aim to use machine learning to develop a new sepsis screening tool, the Risk of Sepsis (RoS) score, and compare it with a slate of benchmark sepsis-screening tools, including the Systemic Inflammatory Response Syndrome, Sequential Organ Failure Assessment (SOFA), qSOFA, Modified Early Warning Score, and National Early Warning Score.

Patient Reported Comparative Effectiveness of Contemporary Intensity Modulated Radiation Therapy Versus External Beam Radiation Therapy of the Mid 1990s for Localized Prostate Cancer.

Introduction: Little is known about differences in patient reported outcomes between contemporary external beam radiation therapy for localized prostate cancer that delivers higher doses of conformal radiation and older techniques. We examined sexual, urinary and bowel function between men undergoing contemporary intensity modulated radiation therapy vs those undergoing external beam radiation therapy in the mid 1990s.

Methods: Subjects were selected from 2 large population based prospective cohort studies.

Variation in the Diagnostic Evaluation among Persons with Hematuria: Influence of Gender, Race and Risk Factors for Bladder Cancer.

Purpose: We sought to determine whether race, gender and number of bladder cancer risk factors are significant predictors of hematuria evaluation.

Materials And Methods: We used self-reported data from SCCS (Southern Community Cohort Study) linked to Medicare claims data. Evaluation of subjects diagnosed with incident hematuria was considered complete if imaging and cystoscopy were performed within 180 days of diagnosis.

Association Between Radiation Therapy, Surgery, or Observation for Localized Prostate Cancer and Patient-Reported Outcomes After 3 Years.

Importance: Understanding the adverse effects of contemporary approaches to localized prostate cancer treatment could inform shared decision making.

Objective: To compare functional outcomes and adverse effects associated with radical prostatectomy, external beam radiation therapy (EBRT), and active surveillance.

Design, Setting, And Participants: Prospective, population-based, cohort study involving 2550 men (≤80 years) diagnosed in 2011-2012 with clinical stage cT1-2, localized prostate cancer, with prostate-specific antigen levels less than 50 ng/mL, and enrolled within 6 months of diagnosis.

The Influence of Psychosocial Constructs on the Adherence to Active Surveillance for Localized Prostate Cancer in a Prospective, Population-based Cohort.

Objective: To evaluate the influence of psychosocial factors such as prostate cancer (PCa) anxiety, social support, participation in medical decision-making (PDM), and educational level on patient decisions to discontinue PCa active surveillance (AS) in the absence of disease progression.

Methods: The Comparative Effectiveness Analysis of Surgery and Radiation study is a prospective, population-based cohort study of men with localized PCa diagnosed in 2011-2012. PCa anxiety, social support, PDM, educational level, and patient reasons for discontinuing AS were assessed through patient surveys.

Racial Variation in Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Results from the CEASAR Study.

Background: Relatively little is known about the relationship between race/ethnicity and patient-reported outcomes after contemporary treatments for localized prostate cancer.

Objective: To test the hypothesis that treatment-related changes in urinary, bowel, sexual, and hormonal function vary by race/ethnicity.

Design, Setting, And Participants: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study that enrolled 3708 men diagnosed with localized prostate cancer in 2011-2012.

Analysis of Risk of Recurrence by Subtype in ≤ 1-cm Breast Tumors.

Introduction: Triple negative breast cancer (TNBC) is an aggressive subtype of breast cancer with higher recurrence rates than other breast cancer subtypes. Increasing numbers of women are being diagnosed with early-stage breast cancer because of improvements in screening mammography. TNBC is known to be highly sensitive to chemotherapy; however, the benefit of adjuvant chemotherapy among women with ≤ 1-cm, lymph node-negative TNBC is unknown.

The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples.

Purpose: Robotic assisted radical prostatectomy has largely replaced open radical prostatectomy for the surgical management of prostate cancer despite conflicting evidence of superiority with respect to disease control or functional sequelae. Using population cohort data, in this study we examined sexual and urinary function in men undergoing open radical prostatectomy vs those undergoing robotic assisted radical prostatectomy.

Materials And Methods: Subjects surgically treated for prostate cancer were selected from 2 large population based prospective cohort studies, the Prostate Cancer Outcomes Study (enrolled 1994 to 1995) and the Comparative Effectiveness Analysis of Surgery and Radiation (enrolled 2011 to 2012).

Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia.

Background: There is a need for a survey instrument to measure arthralgia (joint pain) that has been psychometrically validated in the context of existing reference instruments. We developed the 16-item Patient-Reported Arthralgia Inventory (PRAI) to measure arthralgia severity in 16 joints, in the context of a longitudinal cohort study to assess aromatase inhibitor-associated arthralgia in breast cancer survivors and arthralgia in postmenopausal women without breast cancer. We sought to evaluate the reliability and validity of the PRAI instrument in these populations, as well as to examine the relationship of patient-reported morning stiffness and arthralgia.

Knowledge of diagnosis, treatment history, and risk of late effects among childhood cancer survivors and parents: The impact of a survivorship clinic.

Background: Childhood cancer survivors are at risk for treatment-related adverse health outcomes, known as late effects. Through matched and longitudinal cohorts, we assessed the impact of survivorship care on patient and parent knowledge of treatment history and associated health risks.

Procedure: Childhood cancer survivors were recruited from a single-institution survivorship clinic and matched with survivors receiving routine follow-up care (controls) on diagnosis, age, and time off therapy.

Gender, race, and variation in the evaluation of microscopic hematuria among Medicare beneficiaries.

Background: Female gender and black race are associated with delayed diagnosis and inferior survival in patients with bladder cancer.

Objective: We aimed to determine the association between gender, race, and evaluation of microscopic hematuria (an early sign of bladder cancer).

Design And Participants: This was a cohort study using a 5 % random sample of fee-for-service Medicare beneficiaries diagnosed with incident hematuria (International Classification of Diseases, Ninth Revision [ICD-9] code 599.

The Impact of Gender on Use of Pelvic Lymphadenectomy at the Time of Radical Cystectomy.

Introduction: Although women are less likely to be diagnosed with bladder cancer than men, they experience a disproportionally high rate of cancer specific mortality. Underuse of evidence-based processes of care may contribute to this mortality difference. We explored variation in the use of pelvic lymphadenectomy at the time of radical cystectomy between men and women, and determined if this was impacted by surgeon or hospital volume.

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials.

Background: Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size.

Purpose: We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods.

Results: For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables.

Should mesenteric tumor deposits be included in staging of well-differentiated small intestine neuroendocrine tumors?

Well-differentiated small intestine neuroendocrine tumors can give rise to mesenteric tumor deposits, which are not included in the current American Joint Committee on Cancer staging system for small intestine neuroendocrine tumors, and their impact on patient prognosis is unknown. Seventy-two small intestine neuroendocrine tumors resections were identified in our files with slides, reports, and follow-up data available. Cases were assessed for T-category and for the presence of mesenteric tumor deposits, lymph node metastases, lymphovascular invasion, and liver metastases.

Racial variation in the quality of surgical care for bladder cancer.

Background: Differences in quality of care may contribute to racial variation in outcomes of bladder cancer (BCa). Quality indicators in patients undergoing surgery for BCa include the use of high-volume surgeons and high-volume hospitals, and, when clinically indicated, receipt of pelvic lymphadenectomy, receipt of continent urinary diversion, and undergoing radical cystectomy instead of partial cystectomy. The authors compared these quality indicators as well as adverse perioperative outcomes in black patients and white patients with BCa.

Prevalence of 25-hydroxyvitamin D deficiency in child and adolescent patients undergoing hematopoietic cell transplantation compared to a healthy population.

Background: Pediatric patients undergoing allogeneic hematopoietic cell transplant (HCT) are at risk for low bone mineral density, which may due, in part, to low 25-hydroxyvitamin D levels.

Procedure: We compared the serum 25-hydroxyvitamin D status of 22 pediatric HCT patients with 100 healthy pediatric controls. We determined the prevalence of and risk factors for 25-hydroxyvitamin D insufficiency and deficiency.

Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort.

Background: More than 80,000 postmenopausal breast cancer patients in the United States each year are estimated to begin a 5-year course of aromatase inhibitors (AIs) to prevent recurrence. AI-related arthralgia (joint pain and/or stiffness) may contribute to nonadherence, but longitudinal data are needed on arthralgia risk factors, trajectories, and background in postmenopause. This study sought to describe 1-year arthralgia trajectories and baseline covariates among patients with AI and a postmenopausal comparison group.

Impact of evidence-based standardized assessment on the disability clinical interview for diagnosis of service-connected PTSD: a cluster-randomized trial.

Posttraumatic stress disorder (PTSD) is one of the fastest growing compensated medical conditions. The present study compared usual disability examiner practices for PTSD with a standardized assessment that incorporates evidence-based assessments. The design was a multicenter, cluster randomized, parallel-group study involving 33 clinical examiners and 384 veterans at 6 Veterans Affairs medical centers.

Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study): study protocol for a randomized controlled trial.

Background: Severe TBI, defined as a Glasgow Coma Scale ≤ 8, increases intracranial pressure and activates the sympathetic nervous system. Sympathetic hyperactivity after TBI manifests as catecholamine excess, hypertension, abnormal heart rate variability, and agitation, and is associated with poor neuropsychological outcome. Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow, brain edema, and agitation.

Anti-transforming growth factor ß antibody treatment rescues bone loss and prevents breast cancer metastasis to bone.

Breast cancer often metastasizes to bone causing osteolytic bone resorption which releases active TGFβ. Because TGFβ favors progression of breast cancer metastasis to bone, we hypothesized that treatment using anti-TGFβ antibody may reduce tumor burden and rescue tumor-associated bone loss in metastatic breast cancer. In this study we have tested the efficacy of an anti-TGFβ antibody 1D11 preventing breast cancer bone metastasis.

Management of cerebrospinal fluid leaks after vestibular schwannoma surgery.

Objective: To evaluate the incidence and treatment of cerebrospinal fluid (CSF) leaks after resection of vestibular schwannomas and to propose a treatment algorithm for their management.

Study Design: Retrospective chart review.

Setting: Tertiary referral center.

Variation in practices and attitudes of clinicians assessing PTSD-related disability among veterans.

One hundred thirty-eight Veterans Affairs mental health professionals completed a 128-item Posttraumatic Stress Disorder (PTSD) Practice Inventory that asked about their practices and attitudes related to disability assessment of PTSD. Results indicate strikingly wide variation in the attitudes and practices of clinicians conducting disability assessments for PTSD. In a high percentage of cases, these attitudes and practices conflict with best-practice guidelines.

Use of T2 signal intensity of cerebellar neoplasms in pediatric patients to guide preoperative staging of the neuraxis.

Object: The question of whether to obtain routine or selective preoperative imaging of the neuraxis in pediatric patients with cerebellar neoplasms remains a controversial topic. Staging of the neuraxis is generally considered beneficial in patients with neoplasms associated with an elevated risk of leptomeningeal dissemination (LD). When these studies are obtained preoperatively, there is a decrease in the number of false-positive images related to debris in the immediate postoperative period.

The effectiveness of baby books for providing pediatric anticipatory guidance to new mothers.

Objective: To assess whether embedding pediatric anticipatory guidance into books read to infants is an effective way to educate low-income, first-time mothers about injury-prevention and health-promotion practices.

Patients And Methods: Primiparous women (N = 168) were randomly assigned to 1 of 3 groups: an educational-book group; a noneducational-book group; or a no-book group. Knowledge of anticipatory-guidance topics regarding children from birth to 12 months of age (eg, injury prevention, parenting, nutrition) was assessed during the third trimester of pregnancy and again when infants were approximately 2, 4, 6, 9, 12, and 18 months of age.