Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial.

BACKGROUND: The current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue. METHODS: This randomised, parallel, phase 3 trial was conducted in 29 oncology outpatient clinics associated with the UPMC Hillman Cancer Center in the USA. Patients (aged ≥21 years) with any cancer type and clinical levels of depression, pain, or fatigue (or all of these) were eligible. Eligible family caregivers were aged 21 years or older and providing care to a patient diagnosed with cancer who consented for this study. Patients were randomly assigned (1:1) to stepped collaborative care or standard of care using a central, permuted block design (sizes of 2, 4, and 6) stratified by sex and prognostic status. The biostatistician, oncologists, and outcome assessors were masked to treatment assignment. Stepped collaborative care was once-weekly cognitive behavioural therapy for 50-60 min from a care coordinator via telemedicine (eg, telephone or videoconferencing). Pharmacotherapy for symptoms might be initiated or changed if recommended by the treatment team or preferred by the patient. Standard of care was screening and referral to a health-care provider for treatment of symptoms. The primary outcome was health-related quality of life in patients at 6 months. Maintenance of the treatment benefits was assessed at 12 months. Participants included in the primary analysis were per intention to treat, which included patients missing one or both follow-up assessments. This trial was registered with ClinicalTrials.gov (NCT02939755). FINDINGS: Between Dec 5, 2016, and April 8, 2021, 459 patients and 190 family caregivers were enrolled. 222 patients were assigned to standard of care and 237 to stepped collaborative care. Of 459 patients, 201 (44%) were male and 258 (56%) were female. Patients in the stepped collaborative care group had a greater 0-6-month improvement in health-related quality of life than patients in the standard-of-care group (p=0·013, effect size 0·09). Health-related quality of life was maintained for the stepped collaborative care group (p=0·74, effect size 0·01). Patients in the stepped collaborative care group had greater 0-6-month improvements than the standard-of-care group in emotional (p=0·012), functional (p=0·042), and physical (p=0·033) wellbeing. No adverse events were reported by patients in either group and deaths were considered unrelated to the study. INTERPRETATION: An integrated screening and novel stepped collaborative care intervention, compared with the current standard of care, is recommended to improve health-related quality of life. The findings of this study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide, improving outcomes for patients diagnosed with cancer. FUNDING: US National Cancer Institute.

A virtual, group-based mindfulness intervention for midlife and older women with low libido lowers sexual distress in a randomized controlled pilot study.

BACKGROUND: Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM: We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS: Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES: We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS: Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS: Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS: This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION: A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.

Impact of adherence to procalcitonin antibiotic prescribing guideline recommendations for low procalcitonin levels on antibiotic use.

BACKGROUND: The Procalcitonin Antibiotic Consensus Trial (ProACT) found provision of a procalcitonin antibiotic prescribing guideline to hospital-based clinicians did not reduce antibiotic use. Possible reasons include clinician reluctance to follow the guideline, with an observed 64.8% adherence rate. In this study we sought to determine the threshold adherence rate for reduction in antibiotic use, and to explore opportunities to increase adherence. METHODS: This study is a retrospective analysis of ProACT data. ProACT randomized 1656 patients presenting to 14 U.S. hospitals with suspected lower respiratory tract infection to usual care or provision of procalcitonin assay results and an antibiotic prescribing guideline to the treating clinicians. We simulated varying adherence to guideline recommendations for low procalcitonin levels and determined which threshold adherence rate could have resulted in rejection of the null hypothesis of no difference between groups at alpha = 0.05. We also performed sensitivity analyses within specific clinical settings and grouped patients initially prescribed antibiotics despite low procalcitonin into low, medium, and high risk of illness severity or bacterial infection. RESULTS: Our primary outcome was number of antibiotic-days by day 30 using an intention-to-treat approach and a null hypothesis of no difference in antibiotic use. We determined that an 84% adherence rate in the hospital setting (emergency department and inpatient) for low procalcitonin could have allowed rejection of the null hypothesis (3.7 vs 4.3 antibiotic-days, p = 0.048). The threshold adherence rate was 76% for continued guideline adherence after discharge. Even 100% adherence in the emergency department alone failed to reduce antibiotic-days. Of the 218 patients prescribed antibiotics in the emergency department despite low procalcitonin, 153 (70.2%) were categorized as low or medium risk. CONCLUSIONS: High adherence in the hospital setting to a procalcitonin antibiotic prescribing guideline is necessary to reduce antibiotic use in suspected lower respiratory tract infection. Continued guideline adherence after discharge and withholding of antibiotics in low and medium risk patients with low procalcitonin may offer impactful potential opportunities for antibiotic reduction. Trial registration Procalcitonin Antibiotic Consensus Trial (ProACT), ClinicalTrials.gov Identifier: NCT02130986. First posted May 6, 2014.

Parent-Reported Use of Pediatric Primary Care Telemedicine: Survey Study.

BACKGROUND: Telemedicine delivered from primary care practices became widely available for children during the COVID-19 pandemic. OBJECTIVE: Focusing on children with a usual source of care, we aimed to examine factors associated with use of primary care telemedicine. METHODS: In February 2022, we surveyed parents of children aged ≤17 years on the AmeriSpeak panel, a probability-based panel of representative US households, about their children's telemedicine use. We first compared sociodemographic factors among respondents who did and did not report a usual source of care for their children. Among those reporting a usual source of care, we used Rao-Scott F tests to examine factors associated with parent-reported use versus nonuse of primary care telemedicine for their children. RESULTS: Of 1206 respondents, 1054 reported a usual source of care for their children. Of these respondents, 301 of 1054 (weighted percentage 28%) reported primary care telemedicine visits for their children. Factors associated with primary care telemedicine use versus nonuse included having a child with a chronic medical condition (87/301, weighted percentage 27% vs 113/753, 15%, respectively; P=.002), metropolitan residence (262/301, weighted percentage 88% vs 598/753, 78%, respectively; P=.004), greater internet connectivity concerns (60/301, weighted percentage 24% vs 116/753, 16%, respectively; P=.05), and greater health literacy (285/301, weighted percentage 96% vs 693/753, 91%, respectively; P=.005). CONCLUSIONS: In a national sample of respondents with a usual source of care for their children, approximately one-quarter reported use of primary care telemedicine for their children as of 2022. Equitable access to primary care telemedicine may be enhanced by promoting access to primary care, sustaining payment for primary care telemedicine, addressing barriers in nonmetropolitan practices, and designing for lower health-literacy populations.

Patient and Family Factors Associated with Use of Telemedicine Visits for Pediatric Acute Respiratory Tract Infections, 2018-2019.

Background: Pediatric acute respiratory tract infections (ARTIs) were a common reason for commercial direct-to-consumer (DTC) telemedicine use before the COVID-19 pandemic, but the factors associated with this use are unknown. Objective: To identify child and family factors associated with use of commercial DTC telemedicine for ARTIs in 2018-2019. Methods: We performed a retrospective cohort analysis of claims data from the Optum Clinformatics® Data Mart Database. Among children with ARTI visits, we fitted logit models to examine child and family characteristics associated with DTC telemedicine use. Results: Of 660,725 children with ARTI visits, 12,944 (2.0%) had ≥1 commercial DTC telemedicine encounter. The odds of DTC telemedicine use were higher for children with age ≥12 years, lower parent educational attainment, higher household income, white non-Hispanic race/ethnicity, and residency in the West South Central census division. Conclusion: In 2018-2019, commercial DTC telemedicine use varied with child age, child race/ethnicity parent educational attainment, household income, and geography.

Prevalence and risk factors for hepatocellular carcinoma in individuals with haemophilia in the era of direct-acting antiviral agents: A national inpatient sample study.

BACKGROUND: Hepatocellular carcinoma (HCC) is a major complication of chronic hepatitis C virus (HCV) infection. Among haemophilic (H) men, HCV is the leading cause of liver disease. Direct-acting antiviral agents (DAA) reduce HCV viral load, but impact on HCC is unknown. METHODS: This was a retrospective study of adult H and nonhaemophilic (NH) male discharges, with and without HCC, identified by ICD-10 codes in the National Inpatient Sample (NIS) database, 2016-2018, with DAA availability. Analyses included discharge-level weights to reflect national estimates. Categorical variables were assessed by Rao-Scott chi-square and continuous variables by weighted simple linear regression. HCC correlates were determined by weighted multivariable logistic regression. RESULTS: Among 7,674,969 adult male discharges, 3730 H (.04%) were identified in 2016-2018, of whom 10.06% had HCV and 1.07% had HCC, significantly higher than NH (1.22% and .27%, respectively) all P < .001. Annual HCC rates were similar during the 3-year period (2016-2018) in H and NH. Among H, HCC is associated with older age and higher rates of HCV, HBV, NASH, end-stage liver disease, and Charlson comorbidity (CCI), each P < .001. Among HCC, H were younger and more likely HIV+, each P < .001, but less likely alcoholic (P = .018) or hyperlipidaemic (P = .008) compared to NH. In multivariable regression, risk factors for HCC among H included NASH (OR 21.6), HCV (OR 3.96), CCI (OR1.54), all P < .001, while HIV and hyperlipidaemia were protective. CONCLUSION: From 2016 to 2018, HCC rates did not change significantly in haemophilia discharges. NASH, HCV, and CCI are significant risks for HCC in haemophilia during the DAA-era.

Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1).

BACKGROUND: Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). OBJECTIVE: To evaluate the effect of SEP-1 on treatment patterns and patient outcomes. DESIGN: Longitudinal study of hospitals using repeated cross-sectional cohorts of patients. SETTING: 11 hospitals within an integrated health system. PATIENTS: 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department. INTERVENTION: Onset of the SEP-1 reporting requirement in October 2015. MEASUREMENTS: Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors. RESULTS: Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home. LIMITATION: Data are from a single health system. CONCLUSION: Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Trends and impact on cold ischemia time and clinical outcomes using virtual crossmatch for deceased donor kidney transplantation in the United States.

For assessing human leukocyte antigen compatibility in deceased donor kidney transplantation, virtual crossmatch is used as an alternative to physical crossmatch and has potential to reduce cold ischemia time. The 2014 United States kidney allocation system prioritized highly sensitized candidates but led to increased shipping of kidneys. Using data from the Scientific Registry of Transplant Recipients, we evaluated changes in virtual crossmatch use with the new allocation policy and the impact of virtual crossmatch use on cold ischemia time and transplant outcomes. This was a retrospective cohort study of adult deceased donor kidney recipients in the United States (2011-2018) transplanted with either 9,632 virtual or 71,839 physical crossmatches. Before allocation change, only 9% of transplants were performed relying on a virtual crossmatch. After the 2014 allocation change, this increased by 2.4%/year so that 18% transplants in 2018 were performed with just a virtual crossmatch. There was significant variation in virtual crossmatch use among transplant regions (range 0.7-36%) and higher use was noted among large volume centers. Compared to physical crossmatches, virtual crossmatches were significantly associated with shorter cold ischemia times (mean 15.0 vs 16.5 hours) and similar death-censored graft loss and mortality (both hazard ratios HR 0.99) at a median follow-up of 2.9 years. Thus, our results show that virtual crossmatch is an attractive strategy for shortening cold ischemia time without negatively impacting transplant outcomes. Hence, strategies to optimize use and reduce practice variation may allow for maximizing benefits from virtual crossmatch.

Large reduction in opioid prescribing by a multipronged behavioral intervention after major urologic surgery.

BACKGROUND: Surgeons play a pivotal role in combating the opioid crisis that currently grips the United States. Changing surgeon behavior is difficult, and the degree to which behavioral science can steer surgeons toward decreased opioid prescribing is unclear. METHODS: This was a single-institution, single-arm, pre- and postintervention study examining the prescribing of opioids by urologists for adult patients undergoing prostatectomy or nephrectomy. The primary outcome was the quantity of opioids prescribed in oral morphine equivalents (OMEs) after hospital discharge. The primary exposure was a multipronged behavioral intervention designed to decrease opioid prescribing. The intervention had 3 components: 1) formal education, 2) individual audit feedback, and 3) peer comparison performance feedback. There were 3 phases to the study: a pre-intervention phase, an intervention phase, and a washout phase. RESULTS: Three hundred eighty-two patients underwent prostatectomy, and 306 patients underwent nephrectomy. The median OMEs decreased from 195 to 19 in the prostatectomy patients and from 200 to 0 in the nephrectomy patients (P < .05 for both). The median OMEs prescribed did not increase during the washout phase. Prostatectomy patients discharged with opioids had higher levels of anxiety than patients discharged without opioids (P < .05). Otherwise, prostatectomy and nephrectomy patients discharged with and without opioids did not differ in their perception of postoperative pain management, activity levels, psychiatric symptoms, or somatic symptoms (P > .05 for all). CONCLUSIONS: Implementing a multipronged behavioral intervention significantly reduced opioid prescribing for patients undergoing prostatectomy or nephrectomy without compromising patient-reported outcomes.

Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection.

BACKGROUND: The effect of procalcitonin-guided use of antibiotics on treatment for suspected lower respiratory tract infection is unclear. METHODS: In 14 U.S. hospitals with high adherence to quality measures for the treatment of pneumonia, we provided guidance for clinicians about national clinical practice recommendations for the treatment of lower respiratory tract infections and the interpretation of procalcitonin assays. We then randomly assigned patients who presented to the emergency department with a suspected lower respiratory tract infection and for whom the treating physician was uncertain whether antibiotic therapy was indicated to one of two groups: the procalcitonin group, in which the treating clinicians were provided with real-time initial (and serial, if the patient was hospitalized) procalcitonin assay results and an antibiotic use guideline with graded recommendations based on four tiers of procalcitonin levels, or the usual-care group. We hypothesized that within 30 days after enrollment the total antibiotic-days would be lower - and the percentage of patients with adverse outcomes would not be more than 4.5 percentage points higher - in the procalcitonin group than in the usual-care group. RESULTS: A total of 1656 patients were included in the final analysis cohort (826 randomly assigned to the procalcitonin group and 830 to the usual-care group), of whom 782 (47.2%) were hospitalized and 984 (59.4%) received antibiotics within 30 days. The treating clinician received procalcitonin assay results for 792 of 826 patients (95.9%) in the procalcitonin group (median time from sample collection to assay result, 77 minutes) and for 18 of 830 patients (2.2%) in the usual-care group. In both groups, the procalcitonin-level tier was associated with the decision to prescribe antibiotics in the emergency department. There was no significant difference between the procalcitonin group and the usual-care group in antibiotic-days (mean, 4.2 and 4.3 days, respectively; difference, -0.05 day; 95% confidence interval [CI], -0.6 to 0.5; P=0.87) or the proportion of patients with adverse outcomes (11.7% [96 patients] and 13.1% [109 patients]; difference, -1.5 percentage points; 95% CI, -4.6 to 1.7; P<0.001 for noninferiority) within 30 days. CONCLUSIONS: The provision of procalcitonin assay results, along with instructions on their interpretation, to emergency department and hospital-based clinicians did not result in less use of antibiotics than did usual care among patients with suspected lower respiratory tract infection. (Funded by the National Institute of General Medical Sciences; ProACT ClinicalTrials.gov number, NCT02130986 .).

Factor VIII concentrate dosing with lean body mass, ideal body weight and total body weight in overweight and obesity: A randomized, controlled, open-label, 3 × 3 crossover trial.

INTRODUCTION: Obesity alters the pharmacokinetic (PK) properties of drugs making it difficult to determine the appropriate dose when administering weight-based medications. Alternative descriptors of body weight, such as lean body mass (LBM) and ideal body weight (IBW), are sometimes used in these situations. METHODS: We performed a single-centre, randomized, controlled, open-label, 3 × 3 crossover trial to determine whether recombinant factor VIII (rFVIII) dosing based on LBM and IBW achieves a targeted FVIII recovery with better precision than based on total body weight (TBW) in overweight and obese, adult males with haemophilia A. Participants were randomized to 1 of 6 possible FVIII concentrate dosing sequence scenarios (TBW, LBM and IBW). Recombinant FVIII was administered on 3 separate weeks following a washout period of at least 72 hours. RESULTS: A total of 19 participants were randomized and completed the study. FVIII recovery was lower at 30 minutes post-rFVIII infusion in LBM vs TBW and IBW vs TBW-based dosing, mean difference -0.38 (95% CI: -0.56, -0.20) and -0.28 (95% CI: -0.47, -0.10) IU/dL per IU/kg, respectively. In LBM vs TBW and IBW vs TBW-based dosing, there was a non-significant increase in the proportion of participants with a targeted FVIII recovery of 2.00 ± 0.20 IU/dl per IU/kg, OR = 1.93 (95% CI: 0.44, 8.55) and OR = 3.65 (0.80, 16.72), respectively. DISCUSSION: Based on our study's findings, overweight and obese patients with haemophilia A may benefit from an individualized PK analysis using LBM and IBW to determine the most accurate, and potentially cost-effective, method of achieving targeted FVIII recovery.

Economic Analysis of Mandated Protocolized Sepsis Care in New York Hospitals.

OBJECTIVES: Initial evidence suggests that state-level regulatory mandates for sepsis quality improvement are associated with decreased sepsis mortality. However, sepsis mandates require financial investments on the part of hospitals and may lead to increased spending. We evaluated the effects of the 2013 New York State sepsis regulations on the costs of care for patients hospitalized with sepsis. DESIGN: Retrospective cohort study using state discharge data from the U.S. Healthcare Costs and Utilization Project and a comparative interrupted time series analytic approach. Costs were calculated from admission-level charge data using hospital-specific cost-to-charge ratios. SETTING: General, short stay, acute care hospitals in New York, and four control states: Florida, Massachusetts, Maryland, and New Jersey. PATIENTS: All patients hospitalized with sepsis between January 1, 2011, and September 30, 2015. INTERVENTIONS: The 2013 New York mandate that all hospitals develop and implement protocols for sepsis identification and treatment, educate staff, and report performance data to the state. MEASUREMENTS AND MAIN RESULTS: The analysis included 1,026,664 admissions in 520 hospitals. Mean unadjusted costs per hospitalization in New York State were $42,036 ± $60,940 in the pre-regulation period and $39,719 ± $59,063 in the post-regulation period, compared with $34,642 ± $52,403 pre-regulation and $31,414 ± $48,155 post-regulation in control states. In the comparative interrupted time series analysis, the regulations were not associated with a significant difference in risk-adjusted mean cost per hospitalization (p = 0.12) or risk-adjusted mean cost per hospital day (p = 0.44). For example, in the 10th quarter after implementation of the regulations, risk-adjusted mean cost per hospitalization was $3,627 (95% CI, -$681 to $7,934) more than expected in New York State relative to control states. CONCLUSIONS: Mandated protocolized sepsis care was not associated with significant changes in hospital costs in patients hospitalized with sepsis in New York State.

Clinical Trials in Urology: Predictors of Successes and Failures.

PURPOSE: Clinical trials serve as a critical source of information to guide evidence-based practices in urology. Conversely, trials that are abandoned consume significant resources and results are underreported in the literature. MATERIALS AND METHODS: ClinicalTrials.gov was queried for urology trials from 2006 to 2016. Trials were screened by 2 screeners for applicability to urology and disputes were resolved by a third independent reviewer. Overall 1,340 trials met final inclusion criteria (722 successful trials, 618 failed trials). Univariable analysis used Fisher's exact, chi-squared and Wilcoxon rank sum tests. Trial characteristics, including AUA (American Urological Association) section, phase, subspecialty, intervention type, source of funding and randomization were examined for association with failure using multivariable logistic regression. RESULTS: Trial failure is associated with oncology subspecialty (adjusted odds ratio 2.25, 95% CI 1.60-3.18), infertility/andrology subspecialty (AOR 4.99, CI 1.60-17.61), device trials (AOR 1.64, CI 1.00-2.70) and combination funding by industry/government/grants (AOR 3.13, CI 2.21-4.48). Clinical trials in AUA sections were less likely to fail than international and multisectional trials. Among trials that failed, poor accrual was the primary reason for trial failure, comprising 41% of all failures. Other reasons for failure include inadequate budget (9%), sponsor cancellation (7%), poor interim results (7%) and toxicity (3%). CONCLUSIONS: Despite their significance, many urological trials fail prematurely due to poor accrual. Complex features inherent to oncology, andrology/infertility, devices and multisectional trials pose significant barriers to success.

The Influence of Stereotactic Body Radiation Therapy Adoption on Prostate Cancer Treatment Patterns.

PURPOSE: To our knowledge it is unknown whether stereotactic body radiation therapy of prostate cancer is a substitute for other radiation treatments or surgery, or for expanding the pool of patients who undergo treatment instead of active surveillance. MATERIALS AND METHODS: Using SEER (Surveillance, Epidemiology, and End Results)-Medicare we identified men diagnosed with prostate cancer between 2007 and 2011. We developed physician-hospital networks by identifying the treating physician of each patient based on the primary treatment received and subsequently assigning each physician to a hospital. We examined the relative distribution of prostate cancer treatments stratified by whether stereotactic body radiation therapy was performed in a network by fitting logistic regression models with robust SEs to account for patient clustering in networks. RESULTS: We identified 344 physician-hospital networks, including 30 (8.7%) and 314 (91.3%) in which stereotactic body radiation therapy was and was not performed, respectively. Networks in which that therapy was and was not done did not differ with time in the performance of robotic and radical prostatectomy, and active surveillance (all p >0.05). The relationship with intensity modulated radiation therapy did not show any consistent temporal pattern. In networks in which it was performed less intensity modulated radiation therapy was initially done but there were similar rates in later years. Brachytherapy trends differed among networks in which stereotactic body radiation therapy was vs was not performed with a lower brachytherapy rate in networks in which stereotactic body radiation therapy was done (p=0.03). CONCLUSIONS: Surgery and active surveillance rates did not differ in networks in which stereotactic body radiation therapy was vs was not performed but when that therapy was done there was a lower brachytherapy rate. Stereotactic body radiation therapy may represent more of an alternative to brachytherapy than to active surveillance.

Validation of an Electronic Pediatric Index of Mortality 2 Score in a Mixed Quaternary PICU.

OBJECTIVE: To assess the validity of an electronic version of the Pediatric Index of Mortality 2 score. DESIGN: Retrospective observational study. SETTING: Pediatric and cardiac ICUs at a quaternary medical center. PATIENTS: Patients more than 60 days old admitted to the PICU or cardiac ICU between January 1, 2010, and December 31, 2014. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: After adapting the Pediatric Index of Mortality 2 score into a version applicable to retrospective electronic health record data, it was validated in a mixed-ICU cohort. A manually ascertained Pediatric Index of Mortality 2 score was directly compared with the electronically derived electronic version of the Pediatric Index of Mortality 2 score in 100 randomly selected patients with good agreement between score components with nine out of 11 components having an intraclass correlation coefficient or Cohen κ greater than or equal to 0.6. In assessing the electronic version of the Pediatric Index of Mortality 2 score in the entire cohort of 12,582 patient encounters, it had good discrimination with area under the receiver operating curve of 0.89, appropriate calibration with no significant difference between observed and expected deaths, and excellent predictive ability with a Brier score of 0.0135. CONCLUSIONS: The Pediatric Index of Mortality 2 score can be adapted to utilize retrospective electronic health record data with acceptable discrimination, calibration and accuracy a large mixed-ICU cohort.

Increasing use of positron emission tomography among medicare beneficiaries undergoing radical cystectomy.

OBJECTIVE: To examine factors associated with PET scan use in the pre-operative evaluation of patients diagnosed with bladder cancer. METHODS: Using SEER-Medicare data, we identified bladder cancer patients who underwent radical cystectomy from 2006 to 2011 (n = 4,138). The primary outcome was PET scan use within 6 months before surgery. To examine predictors of PET scan use, we fit a mixed logit model with health service area as a random effect to account for patients nested within health service areas. We also calculated the adjusted probability of use over time and examined variation among the highest volume surgeons. RESULTS: Among the 4,138 patients, 406 (10%) received a pre-operative PET scan. The adjusted probability of a patient undergoing a PET scan increased from 0.04 in 2004 to 0.10 in 2011 (p < .001). Among the 78 highest volume surgeons, there was significant variation in PET scan use (p < .001). Patients with non-urothelial histology, measurement of alkaline phosphatase levels, and receipt of neoadjuvant chemotherapy were more likely to receive PET scan (all p < .05). CONCLUSION: Use of PET prior to radical cystectomy doubled over a 5-year period, suggesting its increased use in patients with muscle-invasive bladder cancer, particularly those with high-risk disease. Whether its use is warranted and improves patient outcomes is not clear and requires further studies.

Incidence and risk factors for hepatocellular cancer in individuals with haemophilia: A National Inpatient Sample Study.

INTRODUCTION: Among haemophilic (H) men, hepatitis C virus (HCV) is the leading cause of liver disease and mortality, but demographics and risks of hepatocellular carcinoma (HCC) in H are not well known. METHODS: Adult discharges in H and non-haemophilic (NH) men, with and without HCC were identified in the National Inpatient Sample (NIS) between 1998 and 2014, using ICD-9 codes. Analyses included NIS-provided discharge-level weights to reflect national estimates. Categorical variables were assessed by Rao-Scott chi-square and continuous variables by weighted simple linear regression. HCC predictors were determined by weighted multivariable logistic regression. RESULTS: Of 18 098 H, 144 (0.79%) had HCC between 1998 and 2014. Adjusted rates of HCC increased 3.0-fold in H vs 1.7-fold in NH (P = 0.484). Among HCV+, HCC rates adjusted for HIV, increased 2.2-fold in H vs 1.7-fold in NH (P = 0.740), while among HIV+, HCC increased 1.4-fold in H vs 0.2-fold in NH (P = 0.448). Among those with HCC, H were older than NH (P < 0.001), Caucasian (P = 0.006), platelet transfusion recipients (P < 0.001), with greater comorbidity (P < 0.001) and mortality (P < 0.006). H with HCC also had greater rates of HCV and HIV (each P < 0.001), lower rates of alcoholism and hyperlipidemia (each P < 0.001), and similar rates of HBV (P = 0.866), smoking (P = 0.507) and obesity (P = 0.502). In multivariable logistic regression, HCV was a strong predictor for HCC in haemophilia, (OR: 15.42, 95% CI: 8.75-27.16). DISCUSSION: Haemophilic men have increasing rates of HCC, similar to men without haemophilia. HCV is the major predictor of HCC in haemophilia. Future trends in HCC will depend on the impact of newer HCV antiviral therapy.

Palliative care use amongst patients with bladder cancer.

OBJECTIVES: To describe the rate and determinants of palliative care use amongst Medicare beneficiaries with bladder cancer and encourage a national dialogue on improving coordinated urological, oncological, and palliative care in patients with genitourinary malignancies. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients diagnosed with muscle-invasive bladder cancer (MIBC) between 2008 and 2013. Our primary outcome was receipt of palliative care, defined as the presence of a claim submitted by a Hospice and Palliative Medicine subspecialist. We examined determinants of palliative care use using logistic regression analysis. RESULTS: Over the study period, 7303 patients were diagnosed with MIBC and 262 (3.6%) received palliative care. Of 2185 patients with advanced bladder cancer, defined as either T4, N+ , or M+ disease, 90 (4.1%) received palliative care. Most patients that received palliative care (>80%, >210/262) did so within 24 months of diagnosis. On multivariable analysis, patients receiving palliative care were more likely to be younger, female, have greater comorbidity, live in the central USA, and have undergone radical cystectomy as opposed to a bladder-sparing approach. The adjusted probability of receiving palliative care did not significantly change over time. CONCLUSIONS: Palliative care provides a host of benefits for patients with cancer, including improved spirituality, decrease in disease-specific symptoms, and better functional status. However, despite strong evidence for incorporating palliative care into standard oncological care, use in patients with bladder cancer is low at 4%. This study provides a conservative baseline estimate of current palliative care use and should serve as a foundation to further investigate physician-, patient-, and system-level barriers to this care.

Waterpipe tobacco use in college and non-college young adults in the USA.

BACKGROUND: Waterpipe tobacco smoking (WTS or 'hookah') is common among adolescents and college students in the USA. However, there has not yet been a large-scale, nationally representative study independently examining WTS among young adults who are not in college. OBJECTIVE: This study sought to examine associations between attitudes, normative beliefs, certain socio-demographic factors and current WTS among young adults not in college and compare them to young adults in college. METHODS: A total of 3131 US adults ages 18-30 completed an online survey about WTS behaviour, attitudes, normative beliefs and relevant socio-demographic factors. Multivariable logistic regression was used to examine independent associations between these variables and current WTS stratified by student status. RESULTS: Ever WTS was reported by 29% of young adults not in college and by 35% of those in college, and current use rates were 3 and 7%, respectively. Multivariable models demonstrated that positive attitudes and perceived peer acceptability of WTS were significantly associated with increased current WTS for both young adults not in college [adjusted odds ratio (AOR) = 2.72; 95% CI: 2.00-3.71 and AOR = 2.02; 95% CI: 1.50-2.71, respectively] and young adults in college (AOR = 3.37; 95% CI: 2.48-4.58 and AOR = 2.05; 95% CI: 1.49-2.83, respectively). The magnitude of these associations was not significantly different when comparing individuals in college and not in college. CONCLUSIONS: Among young adults, WTS is common in non-college-based populations as well as in college-based populations. Therefore, prevention programming should extend to all young adults, not only to those in college.

Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis.

Importance: Beginning in 2013, New York State implemented regulations mandating that hospitals implement evidence-based protocols for sepsis management, as well as report data on protocol adherence and clinical outcomes to the state government. The association between these mandates and sepsis outcomes is unknown. Objective: To evaluate the association between New York State sepsis regulations and the outcomes of patients hospitalized with sepsis. Design, Setting, and Participants: Retrospective cohort study of adult patients hospitalized with sepsis in New York State and in 4 control states (Florida, Maryland, Massachusetts, and New Jersey) using all-payer hospital discharge data (January 1, 2011-September 30, 2015) and a comparative interrupted time series analytic approach. Exposures: Hospitalization for sepsis before (January 1, 2011-March 31, 2013) vs after (April 1, 2013-September 30, 2015) implementation of the 2013 New York State sepsis regulations. Main Outcomes and Measures: The primary outcome was 30-day in-hospital mortality. Secondary outcomes were intensive care unit admission rates, central venous catheter use, Clostridium difficile infection rates, and hospital length of stay. Results: The final analysis included 1 012 410 sepsis admissions to 509 hospitals. The mean age was 69.5 years (SD, 16.4 years) and 47.9% were female. In New York State and in the control states, 139 019 and 289 225 patients, respectively, were admitted before implementation of the sepsis regulations and 186 767 and 397 399 patients, respectively, were admitted after implementation of the sepsis regulations. Unadjusted 30-day in-hospital mortality was 26.3% in New York State and 22.0% in the control states before the regulations, and was 22.0% in New York State and 19.1% in the control states after the regulations. Adjusting for patient and hospital characteristics as well as preregulation temporal trends and season, mortality after implementation of the regulations decreased significantly in New York State relative to the control states (P = .02 for the joint test of the comparative interrupted time series estimates). For example, by the 10th quarter after implementation of the regulations, adjusted absolute mortality was 3.2% (95% CI, 1.0% to 5.4%) lower than expected in New York State relative to the control states (P = .004). The regulations were associated with no significant differences in intensive care unit admission rates (P = .09) (10th quarter adjusted difference, 2.8% [95% CI, -1.7% to 7.2%], P = .22), a significant relative decrease in hospital length of stay (P = .04) (10th quarter adjusted difference, 0.50 days [95% CI, -0.47 to 1.47 days], P = .31), a significant relative decrease in the C difficile infection rate (P < .001) (10th quarter adjusted difference, -1.8% [95% CI, -2.6% to -1.0%], P < .001), and a significant relative increase in central venous catheter use (P = .02) (10th quarter adjusted difference, 4.8% [95% CI, 2.3% to 7.4%], P < .001). Conclusions and Relevance: In New York State, mandated protocolized sepsis care was associated with a greater decrease in sepsis mortality compared with sepsis mortality in control states that did not implement sepsis regulations. Because baseline mortality rates differed between New York and comparison states, it is uncertain whether these findings are generalizable to other states.