Behavioral Health Screening in Military Cystic Fibrosis Centers: A Survey.

INTRODUCTION: Cystic fibrosis (CF) is the most common life-threatening genetic illness in the United States. People with CF as well as their caregivers are up to three times more likely to report experiencing symptoms of depression and anxiety than those without CF. In 2016, the Cystic Fibrosis Foundation and the European Cystic Fibrosis Society came together to form the International Committee on Mental Health in CF and released guidelines outlining behavioral health (BH) screening recommendations for patients with CF and at least one primary caregiver. This study sought to characterize the role of BH care in routine CF treatment within the DoD health care system and identify potential opportunities for improvement. The resultant brief report is intended to elucidate and present identified areas of improvement as well as to inform further research projects in this field. MATERIALS AND METHODS: A representative sample of program leaders (8 of 12; five program directors and three nurse coordinators) from all six affiliate CF centers in the DoD completed a 23-item web-based survey. This study sought to identify the following: (1) What tools are DoD affiliate CF centers using to screen patients with CF and their caregiver(s) for psychological distress and how often does screening take place? (2) What is the composition of the DoD's CF BH teams by specialty and to what degree are BH personnel available to support the needs of CF patients? (3) How comfortable are program directors and nurse coordinators in screening patients with CF and their caregiver(s) for indicators of psychological distress? (4) How familiar are CF BH teams with the use of the U.S. Military's Behavioral Health Data Portal (BHDP)? This descriptive study was approved by the Human Use Committee at the Tripler Army Medical Center. RESULTS: The results of this study indicated that 80% of the DoD affiliate CF centers are screening patients with CF who are 12 years and older and at least one caregiver at least annually for depression and anxiety with the Patient Health Questionnaire depression module and generalized anxiety disorder screening tool, respectively. Reported screening tools for suicidality were not standardized across centers. All respondents indicated that there is a designated social worker in their CF clinic team. Three-quarters of respondents reported that their social worker is physically present in CF clinics 75%-100% of the time. Other types of BH team members varied by clinic. Program directors and nurse coordinators on average indicated feeling "somewhat comfortable" in screening patients with CF for depression, anxiety, and suicidality. Eighty percent of program directors reported being "not so comfortable" in screening caregivers for depression, anxiety, and suicidality, with nurse coordinators on average reporting feeling "somewhat comfortable." Eighty percent of affiliate CF centers indicated that they are unaware of, are not utilizing, or do not have access to the BHDP to screen and record BH data for patients with CF or their caregiver(s). CONCLUSIONS: This study characterized routine CF BH care at DoD affiliate CF centers. Areas for improvement include the standardized use of screening tools for suicidality, increased provider comfort with screening, and streamlined recording and tracking of this data using the BHDP. Limitations of this study include inherent self-report bias, specifically social desirability bias. Steps toward suggested improvements and further utilization of the BHDP may improve BH care for patients with CF and their caregiver(s) in addition to facilitating future research.

Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD.

BACKGROUND: Cancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Program (NCORP), to compare outcomes of primary prophylactic colony stimulating factor (PP-CSF) use for an intervention of automated PP-CSF standing orders to usual care. The introduction of new methods for study implementation created challenges and opportunities for learning that can inform the design and approach of future CCD interventions. METHODS: The order entry system intervention was administered at the site level; sites were affiliated NCORP practices that shared the same chemotherapy order system. 32 sites without existing guideline-based PP-CSF standing orders were randomized to the intervention (n = 24) or to usual care (n = 8). Sites assigned to the intervention participated in tailored training, phone calls and onboarding activities administered by research team staff and were provided with additional funding and external IT support to help them make protocol required changes to their order entry systems. RESULTS: The average length of time for intervention sites to complete reconfiguration of their order sets following randomization was 7.2 months. 14 of 24 of intervention sites met their individual patient recruitment target of 99 patients enrolled per site. CONCLUSIONS: In this paper we share seven recommendations based on lessons learned from implementation of the S1415CD intervention at NCORP community oncology practices representing diverse geographies and patient populations across the U. S. It is our hope these recommendations can be used to guide future implementation of CCD interventions in both research and community settings. TRIAL REGISTRATION: NCT02728596 , registered April 5, 2016.

Blood Lead Levels in U.S. Women of Childbearing Age, 1976-2016.

BACKGROUND: Lead can adversely affect maternal and child health across a wide range of exposures; developing fetuses and breastfeeding infants may be particularly vulnerable. We describe the distribution of blood lead levels (BLLs) in U.S. women of childbearing age and associations with sociodemographic, reproductive, smoking, and housing characteristics over a 40-y period. METHODS: Data from the National Health and Nutrition Examination Survey (NHANES) II, NHANES III Phase I and Phase II, and 1999-2016 continuous NHANES were used to describe the distribution of BLLs (given in micrograms per deciliter; 1µg/dL=0.0483µmol/L) in U.S. women 15-49 years of age between 1976 and 2016. For all women with valid BLLs (n=22,408), geometric mean (GM) BLLs and estimated prevalence of BLLs ≥5µg/dL were calculated overall and by selected demographic characteristics. For NHANES II, estimated prevalence of BLLs ≥10 and ≥20µg/dL were also calculated. RESULTS: The most recent GM BLLs (2007-2010 and 2011-2016, respectively) were 0.81µg/dL [95% confidence interval (CI): 0.79, 0.84] and 0.61µg/dL (95% CI: 0.59, 0.64). In comparison, GM BLLs in earlier periods (1976-1980, 1988-1991, and 1991-1994) were 10.37µg/dL (95% CI: 9.95, 10.79), 1.85µg/dL (95% CI: 1.75, 1.94), and 1.53µg/dL (95% CI: 1.45, 1.60), respectively. In 2011-2016, 0.7% of women of childbearing age had BLLs ≥5µg/dL, and higher BLLs were associated with older age, other race/ethnicity, birthplace outside the United States, four or more live births, exposure to secondhand tobacco smoke, and ever pregnant or not currently pregnant. DISCUSSION: Lead exposure in U.S. women of childbearing age is generally low and has substantially decreased over this 40-y period. However, based on these estimates, there are still at least 500,000 U.S. women being exposed to lead at levels that may harm developing fetuses or breastfeeding infants. Identifying high-risk women who are or intend to become pregnant remains an important public health issue. https://doi.org/10.1289/EHP5925.

The Epidemiology of Benign Prostatic Hyperplasia Associated with Lower Urinary Tract Symptoms: Prevalence and Incident Rates.

This article assesses the reported prevalence and incidence rates for benign prostatic hyperplasia and lower urinary tract symptoms (BPH/LUTS) by age, symptom severity, and race/ethnicity. BPH/LUTS prevalence and incidence rates increase with increasing age and vary by symptom severity. The BPH/LUTS relationship is complex due to several factors. This contributes to the range of reported estimates and difficulties in drawing epidemiologic comparisons. Cultural, psychosocial, economic, and/or disease awareness and diagnosis factors may influence medical care access, symptom reporting and help-seeking behaviors among men with BPH/LUTS. However, these factors and their epidemiologic association with BPH/LUTS have not been thoroughly investigated.

Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment.

OBJECTIVE: To analyse the proportion of men taking tadalafil 5 mg once daily who experience a combined improvement in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: The data from men aged ≥45 years randomized to tadalafil 5 mg once daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analysed (N = 927). A novel classification of 'combined responders' to ED and LUTS/BPH treatment was defined, based on published criteria for men who showed improvement in both International Index of Erectile Function - Erectile Function domain (IIEF-EF) score and total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Unadjusted and adjusted logistic regressions provided odds ratios with 95% confidence intervals comparing combined responders with all others (partial and non-responders). RESULTS: Among men randomized to tadalafil 5 mg, 40.5% were combined responders (n = 189). Among placebo randomized men, 18.3% were combined responders (n = 84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were aged ≤65 years, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity and psychoactive medication use were significantly associated with responder status (P ≤ 0.05). Tadalafil-treated men had 2.8 times significantly increased adjusted odds of being combined responders vs non-responders (P < 0.001). For each unit decrease in baseline IIEF-EF or alcoholic drink consumption per week there was a 4% significant increase in the adjusted odds of being a combined responder to tadalafil therapy. CONCLUSIONS: This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH after treatment with tadalafil 5 mg once daily vs placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups after various types of treatment intervention (e.g. surgical vs pharmacotherapy vs non-pharmacological intervention).

The Co-occurring Syndrome-Coexisting Erectile Dysfunction and Benign Prostatic Hyperplasia and Their Clinical Correlates in Aging Men: Results From the National Health and Nutrition Examination Survey.

OBJECTIVE: To establish a descriptive profile of men with coexistent erectile dysfunction (ED) and/or benign prostatic hyperplasia (BPH), ED only or BPH only compared to those with neither condition and to identify the determinants of coexisting disease. MATERIALS AND METHODS: Self-report and/or medication use measures defining ED and BPH were assessed in men aged ≥40 years (N = 2142) between 2001 and 2004 using the National Health and Nutrition Examination Surveys. Descriptive analyses examined the ED and/or BPH covariate distribution. Logistic regressions calculated odds ratios (ORs, 95% confidence interval) comparing men with ED and/or BPH, BPH only, or ED only to men with neither condition. RESULTS: Of 393 men with BPH, 57.8% had coexistent ED, confirming the moderately strong co-occurrence of the conditions (P <.0001). Coexisting ED and/or BPH occurred in 10.6% of participants, whereas 24.4% and 7.7% reported ED and BPH. After age 60, the odds of reporting ED, BPH, or ED/BPH vs neither almost tripled per decade of increasing age, corresponding to prevalence increases. The unadjusted odds of ED and/or BPH vs no disease increased 1.3 times per prostate-specific antigen unit (ng/mL) increase and 1.1 times per C-reactive protein unit (mg/dL) increase. Other predisposing factors for ED and/or BPH included higher body mass index (OR = 2.5), increased antidiabetic (OR = 2.9) or proton pump inhibitor use (OR = 2.3), increased healthcare visits (≥4; OR = 3.5), and more frequent urinary voiding difficulties (OR = 9.7). CONCLUSION: Co-occurring ED and/or BPH is evident in ~10% of men ≥40 years old and is associated with significant clinical correlates. Clinicians need to pay greater attention to this clinically important syndrome in aging men.

Mitochondrial DNA in residual leukemia cells in cerebrospinal fluid in children with acute lymphoblastic leukemia.

UNLABELLED: This feasibility study was designed to assess the ability to measure mitochondrial DNA (mtDNA) in cerebrospinal fluid (CSF) cells that contributed to minimal disease/persistent or residual disease (MD/PRD) from children with acute lymphoblastic leukemia (ALL). Increase in mtDNA copies in cancer cells has been suggested to play a role in MD/PRD. CSF as well as blood specimens from 6 children were assayed for MD/PRD and mtDNA copy numbers by quantitative real-time polymerase chain reaction. Of 7 MD/PRD-positive specimens, 6 had increased mtDNA copy numbers; while 11 MD/PRD-negative specimens had no increase in mtDNA copy numbers, p < 0.003. This is the first proof-of-concept study to measure mtDNA copy numbers in MD/PRD-positive CSF specimens from children with ALL. Increase of mtDNA copy numbers in MD/PRD childhood ALL cells and its significance as a mechanism for recurrence requires further investigation. KEYWORDS: Minimal residual disease; Acute lymphoblastic leukemia; Central nervous system; Cerebrospinal fluid; Mitochondria.