Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV.

Persons with serious mental illnesses are at increased risk for contracting and transmitting HIV and often have poor adherence to medication regimens. Determining the economic feasibility of different HIV adherence interventions among individuals with HIV and serious mental illness is important for program planners who must make resource allocation decisions. The goal of this study was to provide a methodology to estimate potential cost savings from an HIV medication adherence intervention program for a new study population, using data from prior published studies. The novelty of this approach is the way CD4 count data was used as a biological marker to estimate costs averted by greater adherence to anti-retroviral treatment. Our approach is meant to be used in other adherence intervention studies requiring cost modeling.

Allergy History and Immunotherapy Response in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

OBJECTIVE: This study examines the association between patient-reported allergy history and immune checkpoint inhibition (ICI) response in patients with recurrent or metastatic head and neck squamous cell carcinoma (RMHNSCC). STUDY DESIGN: Retrospective cohort study. SETTING: Academic tertiary care hospital. METHODS: Data were collected from the electronic medical records on baseline age, sex, allergy history, human papillomavirus status, T-stage, N-stage, smoking status, and survival for patients with and without an allergy history. The primary outcome was ICI response defined as complete or partial response by the RECIST criteria. Chi-square and logistic regression analyses were conducted to compare rates and odds of ICI response. Kaplan-Meier analyses were used to compare survival between groups. RESULTS: Our study included 52 patients with an allergy history and 36 patients without an allergy history. The groups were similar in age, sex, HPV status, smoking status, and T- and N-stage. Patients with an allergy history (17/52, 32.1%) had a greater ICI response rate than patients without allergy history (4/36, 11.1%) (P = .02). After adjusting for HPV, patients with allergies had 3.93 (1.19-13.00) times increased odds of ICI response compared to patients without allergies. The median progression-free survival was 6.0 and 4.2 months for patients with and without an allergy history respectively (log-rank, P = .04). The median overall survival was 25.0 and 11.1 months for patients with and without an allergy history respectively (log-rank, P = .002). CONCLUSION: Patient-reported allergy history was associated with ICI response in patients with RMHNSCC, underscoring the potential clinical utility of allergy history in estimating ICI response.

Lower mortality in magnet hospitals.

BACKGROUND: Although there is evidence that hospitals recognized for nursing excellence--Magnet hospitals--are successful in attracting and retaining nurses, it is uncertain whether Magnet recognition is associated with better patient outcomes than non-Magnets, and if so why. OBJECTIVES: To determine whether Magnet hospitals have lower risk-adjusted mortality and failure-to-rescue compared with non-Magnet hospitals, and to determine the most likely explanations. METHOD AND STUDY DESIGN: Analysis of linked patient, nurse, and hospital data on 56 Magnet and 508 non-Magnet hospitals. Logistic regression models were used to estimate differences in the odds of mortality and failure-to-rescue for surgical patients treated in Magnet versus non-Magnet hospitals, and to determine the extent to which differences in outcomes can be explained by nursing after accounting for patient and hospital differences. RESULTS: Magnet hospitals had significantly better work environments and higher proportions of nurses with bachelor's degrees and specialty certification. These nursing factors explained much of the Magnet hospital effect on patient outcomes. However, patients treated in Magnet hospitals had 14% lower odds of mortality (odds ratio 0.86; 95% confidence interval, 0.76-0.98; P=0.02) and 12% lower odds of failure-to-rescue (odds ratio 0.88; 95% confidence interval, 0.77-1.01; P=0.07) while controlling for nursing factors as well as hospital and patient differences. CONCLUSIONS: The lower mortality we find in Magnet hospitals is largely attributable to measured nursing characteristics but there is a mortality advantage above and beyond what we could measure. Magnet recognition identifies existing quality and stimulates further positive organizational behavior that improves patient outcomes.

Tumor Histological Grade and Immunotherapy Response in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

Importance: Tumor histological factors that predict immunotherapy response in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are not well defined. Objective: To investigate the association between tumor grade and immunotherapy response in patients with recurrent or metastatic mucosal HNSCC. Design, Setting, and Participants: In this retrospective cohort study, the medical records of 60 patients with recurrent or metastatic mucosal HNSCC treated with immune checkpoint inhibitors at Johns Hopkins Hospital between July 1, 2015, and January 22, 2020, were reviewed. Exposures: High-grade tumors (HGTs) vs low-grade tumors (LGTs) in recurrent or metastatic HNSCC. Main Outcomes and Measures: Patients were divided into 2 groups: those with LGTs (well differentiated and moderately differentiated) and those with HGTs (poorly differentiated). The main outcome was a clinically beneficial immunotherapy response, defined as complete response or partial response. Univariable and multivariable logistic regressions were conducted to calculate odds ratios for each variable's association with immunotherapy response. Survival differences were evaluated using Kaplan-Meier survival curves with multivariable Cox proportional hazards regression models. Results: The 60 patients (35 with HGTs and 25 with LGTs) had a mean (SD) age of 64.6 (8.88) years; 51 were male (85%); and 38 were current or former smokers (63%). The oropharynx was the most common primary tumor site both in patients with HGTs (22 of 35; 63%) and those with LGTs (12 of 25; 48%). Bivariate analysis showed the proportion of patients having a beneficial response to immunotherapy was greater for patients with HGTs (12 of 35; 34.3%) than those with LGTs (2 of 25, 8.0%) (difference, 26.3%; 95% CI, 7.3%-45.3%). Upon multivariable analysis, patients with HGTs had 5.35-fold increased odds (95% CI, 1.04-27.37) of having a clinically beneficial response to immunotherapy. Among patients with available tumor genomic profiling data, the mean tumor mutational burden was greater for patients with HGTs (mean [SD], 8.6 [5.4] mut/Mb; n = 8) than patients with LGTs (mean [SD], 3.6 [1.1] mut/Mb; n = 4) (difference = 5.0 mut/Mb; 95% CI -1.4 to 11.4 mut/Mb; Cohen d = 1.2). Conclusions and Relevance: In this cohort study, tumor grade was independently associated with immunotherapy response in patients with recurrent or metastatic mucosal HNSCC. These findings highlight the potential role of tumor grade in predicting immunotherapy response in mucosal HNSCC.

Using psychiatric symptomatology to assess risk for HIV infection in individuals with severe mental illness.

In this study, we use the Colorado Symptom Index, a measure of psychiatric symptomatology, to identify vulnerable subgroups within the severely mentally ill population at elevated risk for HIV infection. Baseline data on 228 HIV positive and 281 HIV negative participants from two clinical trials were used. With years to HIV diagnosis as our primary endpoint, Kaplan-Meier estimates were calculated to find a CSI cut-off score, and a Cox proportional hazards model was used to obtain relative risks of infection for the two CSI categories created by the cut point. We found that a CSI score ≥ 30 was associated with a 47% increased risk for HIV infection (P < 0.01). While this study establishes the foundation for using CSI scores to identify a vulnerable subgroup within the SMI community, further studies should develop effective approaches to mitigate psychiatric symptomatology in order to examine the impact on HIV transmission risky behaviors.

Paraneoplastic Hyperleukocytosis in Pancreatic Adenocarcinoma.

Background: Paraneoplastic hyperleukocytosis is a rare phenomenon observed in patients with adenocarcinomas and other malignancies. In this study, we present a case of paraneoplastic hyperleukocytosis in pancreatic adenocarcinoma secondary to excessive secretion of serum granulocyte colony-stimulating factor (G-CSF). Presentation: We report a 71-year-old Caucasian male who presented to our hospital with hyperleukocytosis in the setting of locally advanced pancreatic adenocarcinoma. The patient was recently diagnosed 4 months before presentation and received abraxane/gemcitabine in addition to palliative radiation therapy for continued gastrointestinal bleeding. During routine laboratory assessment, the patient was found to have a white blood cell (WBC) count of 153 K/UL (75% neutrophils and 14% bands). Bone marrow biopsy and cytology were negative for neoplastic features. Serum G-CSF levels returned markedly elevated, supporting the diagnosis of paraneoplastic hyperleukocytosis. Interestingly, the WBC count decreased significantly following each of two cycles of chemotherapy, further suggesting a paraneoplastic etiology of hyperleukocytosis. The patient did not receive any growth factor support at any point before or during treatment. Conclusion: In conclusion, the presence of hyperleukocytosis in cancer should raise clinical suspicion of a paraneoplastic phenomenon when other possible causes have been excluded. Hyperleukocytosis in this setting may correlate with progression of disease and lessen with treatment.

Effect of actionable somatic mutations on racial/ethnic disparities in head and neck cancer prognosis.

BACKGROUND: Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide and minorities have the worst survival. However, the molecular mechanisms underlying survival disparities have not been elucidated. METHODS: In a retrospective study, we assessed association between HNSCC early death (<2 years) and 208 somatic mutations of 10 cancer-related genes in 214 patients: 98 non-Hispanic whites (46%), 72 Hispanic whites (34%), and 44 African Americans (20%). RESULTS: Hispanic whites and African Americans had significantly higher mutation rates for EGFR, HRAS, KRAS, and TP53. HNSCC early death was significantly associated with 3+ mutations (odds ratio [OR] = 2.78, 95% confidence interval [CI] = 1.16, 6.69), NOTCH1 mutations in non-Hispanic whites (OR = 5.51; 95% CI = 1.22-24.83) and TP53 mutations in Hispanic whites (OR = 3.84; 95% CI = 1.08-13.68) in multivariable analysis adjusted for age, sex, tumor site, and tumor stage. CONCLUSION: We have provided the proof-of-principal data to link racial/ethnic-specific somatic mutations and HNSCC prognosis and pave the way for precision medicine to overcome HNSCC survival disparities. © 2016 Wiley Periodicals, Inc. Head Neck 38:1234-1241, 2016.

Changes in hospital nurse work environments and nurse job outcomes: an analysis of panel data.

BACKGROUND: One strategy proposed to alleviate nursing shortages is the promotion of organizational efforts that will improve nurse recruitment and retention. Cross-sectional studies have shown that the quality of the nurse work environment is associated with nurse outcomes related to retention, but there have been very few longitudinal studies undertaken to examine this relationship. OBJECTIVES: To demonstrate how rates of burnout, intention to leave, and job dissatisfaction changed in a panel of hospitals over time, and to explore whether these outcomes were associated with changes in nurse work environments. METHODS: A retrospective, two-stage panel design was chosen for this study. Survey data collected from large random samples of registered nurses employed in Pennsylvania hospitals in 1999 and 2006 were used to derive hospital-level rates of burnout, intention to leave current position, and job dissatisfaction, and to classify the quality of nurses' work environments at both points in time. A two-period difference model was used to estimate the dependence of changes in rates of nurse burnout, intention to leave, and job dissatisfaction on changes in nurse work environments between 1999 and 2006 in 137 hospitals, accounting for concurrent changes in nurse staffing levels. RESULTS: In general, nurse outcomes improved between 1999 and 2006, with fewer nurses reporting burnout, intention to leave, and job dissatisfaction in 2006 as compared to 1999. Our difference models showed that improvements in work environment had a strong negative association with changes in rates of burnout (ß=-6.42%, p<0.01) intention to leave (ß=-4.10%, p<0.01), and job dissatisfaction (ß=-8.00%, p<0.01). CONCLUSIONS: Improvements in nurse work environments over time are associated with lower rates of nurse burnout, intention to leave current position, and job dissatisfaction.

Nurse staffing, burnout, and health care-associated infection.

BACKGROUND: Each year, nearly 7 million hospitalized patients acquire infections while being treated for other conditions. Nurse staffing has been implicated in the spread of infection within hospitals, yet little evidence is available to explain this association. METHODS: We linked nurse survey data to the Pennsylvania Health Care Cost Containment Council report on hospital infections and the American Hospital Association Annual Survey. We examined urinary tract and surgical site infection, the most prevalent infections reported and those likely to be acquired on any unit within a hospital. Linear regression was used to estimate the effect of nurse and hospital characteristics on health care-associated infections. RESULTS: There was a significant association between patient-to-nurse ratio and urinary tract infection (0.86; P = .02) and surgical site infection (0.93; P = .04). In a multivariate model controlling for patient severity and nurse and hospital characteristics, only nurse burnout remained significantly associated with urinary tract infection (0.82; P = .03) and surgical site infection (1.56; P < .01) infection. Hospitals in which burnout was reduced by 30% had a total of 6,239 fewer infections, for an annual cost saving of up to $68 million. CONCLUSIONS: We provide a plausible explanation for the association between nurse staffing and health care-associated infections. Reducing burnout in registered nurses is a promising strategy to help control infections in acute care facilities.

A randomized trial of a nursing intervention for HIV disease management among persons with serious mental illness.

OBJECTIVE: The heightened risk of persons with serious mental illness to contract and transmit HIV is recognized as a public health problem. Persons with HIV and mental illness may be at risk for poor treatment adherence, development of treatment-resistant virus, and worse outcomes. The objective of this study was to test the effectiveness of a community-based advanced practice nurse (APN) intervention (PATH, Preventing AIDS Through Health) to promote adherence to HIV and psychiatric treatment regimens. METHODS: Community-dwelling HIV-positive participants with co-occurring serious mental illnesses (N=238) were recruited from community HIV provider agencies from 2004 to 2008 to participate in the randomized controlled trial. Participants in the intervention group (N=128) were assigned an APN who provided community-based care management at a minimum of one visit per week and coordinated clients' medical and mental health care for one year. Viral load and CD4 cell count were evaluated at baseline and 12 months. RESULTS: Longitudinal models for continuous log viral load showed that compared with the control group, the intervention group exhibited a significantly greater reduction in log viral load at 12 months (d=-.361 log 10 copies per milliliter, p<.001). Differences in CD4 counts from baseline to 12 months were not statistically significant. CONCLUSIONS: This project demonstrated the effectiveness of community-based APNs in delivering a tailored intervention to improve outcomes of individuals with HIV and co-occurring serious mental illnesses. Persons with these co-occurring conditions can be successfully treated; with appropriate supportive services, their viral loads can be reduced.