Opioid and Non-Opioid Pharmacotherapy Use for Pain Management Among Privately Insured Pediatric Patients With Cancer in the United States.

BACKGROUND: This study examined the trends and patterns of opioid and non-opioid pharmacotherapy use among a large national sample of privately insured pediatric patients with cancer in the United States. MATERIALS AND METHODS: We identified pediatric (aged < 21) patients diagnosed with central nervous system (CNS), lymphoma, gonadal, leukemia, or bone cancer from MarketScan data 2005-2019. We examined the proportion of patients who filled a prescription for the following 5 types of pharmacotherapy: opioid, anticonvulsant, non-steroidal anti-inflammatory drug (NSAID), antidepressant, and muscle relaxant during active cancer treatment. We assessed the trends and patterns in pharmacotherapy using multivariable logistic regressions. RESULTS: Among 4174 patients included, 2979 (71%) had an opioid prescription; 746 (18%), 384 (9%), 202 (5%), and 169 (4%) had anticonvulsant, NSAID, antidepressant and muscle relaxant prescriptions, respectively. Multivariable logistic regression showed a nonlinear trend in the use of opioids among pediatric patients with cancer over time such that use slightly increased until 2012 (OR of 1.40 [95% CI, 1.12-1.73] for 2012 vs. 2006) but then decreased thereafter (OR of 0.51 [0.37-0.68] for 2018 vs. 2012). The use of anticonvulsants, NSAIDs, and muscle relaxants increased significantly linearly over time (all P < .005). CONCLUSION: There has been a downward trend in the use of opioids in recent years among pediatric patients with cancer and an upward trend in the use of non-opioid pharmacotherapy for pain management potentially as an alternative to opioids.

Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC.

BACKGROUND: Despite promising outcomes of treatment with anti-programmed cell death (PD)-1/PD-ligand (L)1 agents in combination with platinum-doublet chemotherapy (PDC) in the first-line setting, a significant unmet medical need remains in patients with PD-L1-unselected non-small cell lung cancer (NSCLC). METHODS: This multicenter, open-label, phase 1b study comprising dose-confirmation and dose-expansion parts investigated the combination of spartalizumab and various PDC regimens, with or without canakinumab, in treatment-naïve patients with PD-L1-unselected, metastatic NSCLC. The primary objectives were to determine maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of spartalizumab, with or without canakinumab, in combination with PDC in the dose-confirmation part and antitumor activity of spartalizumab in the dose-expansion part. RESULTS: The MTD/RDE of spartalizumab was 300 mg every 3 weeks (Q3W) when administered with either gemcitabine (1250 mg/m2)/cisplatin (75 mg/m2) (group A; no dose-limiting toxicities [DLTs]), pemetrexed (500 mg/m2)/cisplatin (group B; 2 DLTs: grade 2 posterior reversible encephalopathy syndrome and grade 4 hyponatremia), or paclitaxel (200 mg/m2)/carboplatin area under the curve 6 min*mg/mL (group C; 1 DLT: grade 4 neutropenic colitis). The RDE of canakinumab combined with spartalizumab and pemetrexed/cisplatin (group E; no DLTs) was 200 mg Q3W (no dose-expansion part was initiated). No new safety signals were identified. In groups A, B, C, and E, the overall response rates were 57.6%, 55.3%, 51.5%, and 57.1%, respectively. Group B compared with other groups had the longest median progression-free survival (10.4 months vs. 6.2-7.5 months), overall survival (29.7 months vs. 16.1-21.0 months), and duration of response (30.1 months vs. 6.0-8.2 months). CONCLUSIONS: The combination of spartalizumab and PDC, with or without canakinumab, was well tolerated across treatment groups. The antitumor activity across treatment groups was comparable with that of pembrolizumab and pemetrexed combination. Canakinumab did not appear to improve the antitumor activity when combined with spartalizumab, pemetrexed and cisplatin. TRIAL REGISTRATION: The trial was registered in Clinicaltrials.gov with identifier no. NCT03064854. Date of Registration: 06 February 2017.

Stories to Prevent Cancer: A Pilot Study Using Cancer Survivor Narratives to Increase Human Papillomavirus Vaccine Intentions.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates are lower than other recommended adolescent vaccines. Cancer survivor narratives are used to promote cancer prevention and control, but little is known about their impact on adolescent HPV vaccination. OBJECTIVE: This pilot study explored the feasibility and effects of a video education intervention using a cancer survivor narrative to improve parents' attitudes toward and intentions to get the HPV vaccine. METHODS: This study utilized a one-group design; participants completed a pre-intervention survey, watched the video before attending their sons' wellness visits, and completed a post-intervention survey within one week of their appointment. Using the narrative persuasion framework, we developed a 4-minute video of a local HPV-related cancer survivor to promote the HPV vaccine as cancer prevention. We recruited 37 participants between June and October 2020. Participants were parents of males ages 9-17 who had not yet initiated HPV vaccination. RESULTS: After the video, more parents agreed that HPV vaccination is safe (pre: 66% vs. post: 82%; P = .045) and that their child's chances of getting HPV-related cancer in the future are high (pre: 24% vs. post: 46%; P = .014). Overall, 91% of parents felt the cancer survivor story helped them understand the risks of HPV cancers, and 52% said the story influenced their decision to start HPV vaccination for their child. CONCLUSIONS: Our findings suggest that cancer survivor narratives influence parents' vaccine opinions and understanding of their child's risk of HPV infection, leading to increased parental intent to get the HPV vaccine for their adolescent males.

Early Transient Hypoglycemia and Test Performance in At-Risk Newborns.

OBJECTIVE: This study aimed to evaluate if early (within the first 3 hours after birth) transient neonatal hypoglycemia (TNH) is associated with poor academic performance in infants at-risk for hypoglycemia. STUDY DESIGN: This was a retrospective cohort study of at risk-infants (late preterm infants, small and large for gestational age infants, and infants of diabetic mothers [IDMs]) who were born in 1998 and 1999 at the University of Arkansas for Medical Sciences and had ≥1 recorded glucose concentration. The outcome measure was proficiency on 4th grade literacy and mathematics achievement tests. Three glucose concentration cutoffs for defining hypoglycemia (<35, <40, and <45 mg/dL) were investigated. Logistic regression models were developed to examine the association between early TNH and achievement test proficiency based on perinatal factors. RESULTS: Among 726 infants, 472 had one, 233 had two, and 21 had three risk factor(s). Early TNH (glucose concentration <35, <40, and <45 mg/dL) was observed in 6.3, 11.6, and 20.5% of the study cohort, respectively. Irrespective of the cutoff used, the frequency of early TNH (number of patients with early TNH in a risk category divided by the total number of patients in that category) was significantly greater among infants with multiple risk factors. After controlling for perinatal factors, early TNH (cutoffs <35 and <40 mg/dL) was significantly associated with decreased probability of proficiency in literacy but not mathematics. Despite that early TNH was more common in IDMs and infants with three risk factors, the category or number of risk factors did not impact academic proficiency. CONCLUSION: Early TNH (<35 and <40 mg/dL) was associated with lower adjusted probability of proficiency on 4th grade literacy achievement tests in at-risk infants. The impact of early TNH on academic performance was similar irrespective of category or number of risk factors. KEY POINTS: · Transient hypoglycemia was associated with lower proficiency on 4th grade tests in at-risk infants.. · The category of risk factors among at-risk infants did not impact 4th grade academic proficiency.. · The number of risk factors among at-risk infants did not impact 4th grade academic proficiency..

Adolescent Suicide Risk Screening: A Secondary Analysis of the SHIELD Randomized Clinical Trial.

OBJECTIVE: To evaluate the effectiveness of adolescent suicide risk screening to increase initiation of mental health services via a secondary analysis using data from the SHIELD (Screening in High Schools to Identify, Evaluate and Lower Depression) randomized clinical trial, which evaluated school-based screening for major depressive disorder (MDD). STUDY DESIGN: Students in 14 Pennsylvania high schools were randomized by grade to either the usual school practice of targeted referral for behavior raising a concern for suicide risk or universal screening using the Patient Health Questionnaire-9 (PHQ-9), with any response >0 to item 9 regarding suicide risk considered positive. Students identified in either arm were referred to the Student Assistance Program (SAP), which is mandated in all Pennsylvania schools. The SAP determined follow-up. Study groups were compared using mixed-effects logistic regression. RESULTS: The participants comprised 12 909 students, with 6473 (50.1%) randomized to universal screening. The study group was 46% female and 43% Hispanic or non-Hispanic Black. Adolescents in the universal screening arm had 7.1-fold greater odds (95% CI, 5.7-8.8) of being identified as at risk for suicide, 7.8-fold greater odds (95% CI, 4.6-13.1) of follow-up needs, and 4.0-fold greater odds (95% CI, 2.0-7.9) of initiating mental health treatment. CONCLUSIONS: Although the PHQ-9 is a MDD screening tool, its use in universal screening increased identification and treatment initiation for adolescents at risk for suicide. This confirms the value of universal screening and suggests that a suicide-specific risk assessment would have even greater impact on treatment initiation for identified youth. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03716869.

Longitudinal analysis of symptoms in the Ehlers-Danlos syndromes.

Our study extends a cross-sectional dataset on the Ehlers-Danlos syndromes (EDS) assembled by the National Institute on Aging (NIA), under a protocol entitled Clinical and Molecular Manifestations of Heritable Disorders of Connective Tissue. We were successful in contacting 171 of the original 252 participants with EDS. Our study cohort included 91 participants who completed at least one of the following surveys: Brief Pain Inventory (BPI), Pittsburgh Sleep Quality Index (PSQI), Multidimensional Fatigue Inventory (MFI-20), and Short Form (SF-36) Health Survey, at both baseline and follow-up. Follow-up surveys occurred a median of 11.6 years after the baseline survey. We used mixed effects linear regression models to examine the change in scores for multiple indices reported by participants. There were small mean changes reflected in our estimates for the EDS population as a whole. There was wide heterogeneity between reported individual experiences, with some participants markedly improved and some dramatically worse. Men had a greater increase in mean pain severity over time than women. This is the first study to report a decade of longitudinal data in EDS.

Are Routine Chest Radiographs After Chest Tube Removal in Thoracic Surgery Patients Necessary?

INTRODUCTION: The routine use of chest x-ray (CXR) to evaluate the pleural space after chest tube removal is a common practice driven primarily by surgeon preference and institutional protocol. The results of these postpull CXRs frequently lead to additional interventions that serve only to increase health care costs and resource utilization. We investigated the utility of these postpull CXRs in thoracic surgery patients and assessed their effectiveness in predicting the need for tube replacement. METHODS: Single-institution retrospective study comprising thoracic surgery patients requiring postoperative chest tube drainage over a 3-y period. Demographics and surgical characteristics, including surgical approach, procedure, and procedure type, were recorded. Outcomes included postpull CXR findings, interventions resulting from radiographic abnormalities, and the additional health resource utilization incurred by obtaining these studies on asymptomatic patients. RESULTS: The study included 433 patients. Postpull CXRs were performed in 87.1% of patients, with 33.2% demonstrating an abnormality compared with the prior study. Among these, 65.7% resulted only in repeat imaging and 25.7% resulted in discharge delay. Overall, a total of 13 patients (3%) required chest tube replacement, three during the index hospitalization and the other 10 requiring readmission. Among those requiring chest tube replacement, 75% had normal postpull imaging, and all were symptomatic. CONCLUSIONS: Recurrent pneumothorax after chest tube removal requiring immediate tube reinsertion is relatively rare and does not occur in the absence of symptoms. Our study suggests that routine postpull CXRs have limited clinical utility and can be safely omitted in asymptomatic patients with appropriate clinical observation.

Utilization and costs of epidermal growth factor receptor mutation testing and targeted therapy in Medicare patients with metastatic lung adenocarcinoma.

BACKGROUND: Guidelines in 2013 and 2014 recommended Epidermal Growth Factor Receptor (EGFR) testing for metastatic lung adenocarcinoma patients as the efficacy of targeted therapies depends on the mutations. However, adherence to these guidelines and the corresponding costs have not been well-studied. METHODS: We identified 2362 patients at least 65 years old newly diagnosed with metastatic lung adenocarcinoma from January 2013 to December 2015 using the SEER-Medicare database. We examined the utilization patterns of EGFR testing and targeted therapies including erlotinib and afatinib. We further examined the costs of both EGFR testing and targeted therapy in terms of Medicare costs and patient out-of-pocket (OOP) costs. RESULTS: The EGFR testing rate increased from 38% in 2013 to 51% and 49% in 2014 and 2015 respectively. The testing rate was 54% among the 394 patients who received erlotinib, and 52% among the 42 patients who received afatinib. The median Medicare and OOP costs for testing were $1483 and $293. In contrast, the costs for targeted therapy were substantially higher with median 30-day costs at $6114 and $240 for erlotinib and $6239 and $471 for afatinib. CONCLUSION: This population-based study suggests that testing guidelines improved the use of EGFR testing, although there was still a large proportion of patients receiving targeted therapy without testing. The costs of targeted therapy were substantially higher than the testing costs, highlighting the need to improve adherence to testing guidelines in order to improve clinical outcomes while reducing the economic burden for both Medicare and patients.

Newborn weight change and predictors of underweight in the neonatal period in Guinea-Bissau, Nepal, Pakistan and Uganda.

In low- and middle-income countries (LMIC), growth impairment is common; however, the trajectory of growth over the course of the first month has not been well characterised. To describe newborn growth trajectory and predictors of growth impairment, we assessed growth frequently over the first 30 days among infants born ≥2000 g in Guinea-Bissau, Nepal, Pakistan and Uganda. In this cohort of 741 infants, the mean birth weight was 3036 ± 424 g. For 721 (98%) infants, weight loss occurred for a median of 2 days (interquartile range, 1-4) following birth until weight nadir was reached 5.9 ± 4.3% below birth weight. At 30 days of age, the mean weight was 3934 ± 592 g. The prevalence of being underweight at 30 days ranged from 5% in Uganda to 31% in Pakistan. Of those underweight at 30 days of age, 56 (59%) had not been low birth weight (LBW), and 48 (50%) had reached weight nadir subsequent to 4 days of age. Male sex (relative risk [RR] 2.73 [1.58, 3.57]), LBW (RR 6.41 [4.67, 8.81]), maternal primiparity (1.74 [1.20, 2.51]) and reaching weight nadir subsequent to 4 days of age (RR 5.03 [3.46, 7.31]) were highly predictive of being underweight at 30 days of age. In this LMIC cohort, country of birth, male sex, LBW and maternal primiparity increased the risk of impaired growth, as did the modifiable factor of delayed initiation of growth. Interventions tailored to infants with modifiable risk factors could reduce the burden of growth impairment in LMIC.

Point-of-Care Testing Improves Lead Screening Rates at 1- and 2-Year Well Visits.

OBJECTIVE: To increase blood lead level screening rates in children at 12- and 24-month well visits through provider education and the implementation of a point-of-care (POC) lead screening program in 4 primary care practice offices located in and neighbored by counties with ≥5% prevalence of blood lead levels ≥5 µg/dL. STUDY DESIGN: Baseline data were collected July 2017 to June 2018. All providers received education on screening recommendations and local prevalence of elevated blood lead levels in July 2018. POC testing began June 2019 at 1 of the 4 practice sites. Screening rates were measured by electronic medical record abstraction. Rates were plotted monthly on statistical process control charts during implementation and analyzed using logistic regression under an interrupted time series approach for program evaluation. RESULTS: There was a small but significant increase in screening following provider education (OR 1.04 per month, 95% CI 1.02-1.07). POC testing was associated with a substantial immediate increase (OR 4.17, 95% CI 2.45-7.09) and a substantial continued increase (OR 1.34 per month, 95% CI 1.17-1.54) in screening at the site that implemented POC. CONCLUSIONS: POC testing substantially increases blood lead level screening rates at 12- and 24-month well visits and may be beneficial in other primary care settings.

The association between state-based provisional attendance periods and adolescent middle school-entry vaccination coverage.

The rise of vaccine-preventable disease outbreaks calls for a deeper understanding of the impact of policy on school-entry vaccine compliance. Provisional attendance policies vary by state but permit under-vaccinated students a limited period to attend school while receiving their immunizations. The primary objective of this study was to clarify the relationship between annual immunization coverage and state provisional policies for a single-dose of school-entry-required adolescent vaccinations: tetanus, diphtheria, pertussis (Tdap), meningococcal conjugate (MCV4), and human papillomavirus (HPV). From June 22, 2020 to August 20, 2020, the Immunization Action Coalition and state-level Department of Health (DOH) webpages were reviewed with email confirmation with a DOH representative to determine provisional period policy. Vaccination coverage for Tdap, MCV4, and HPV were obtained from the Center for Disease Control's National Immunization Survey. Overall, 49 states and D.C. legally mandate exclusion of vaccine noncompliant adolescents, and the majority of jurisdictions assign responsibility for exclusion to local school officials (84%). Complete provisional period data was obtained for 46/51 jurisdictions. The effect of provisional period length categorized as 0 days (18 jurisdictions, 35.3%), 1 to 30 days (18 jurisdictions, 35.3%), 31+ days (10 jurisdictions, 19.6%), and "unclear" (5 jurisdictions with incomplete data, 9.8%) had no significant association with annual adolescent vaccination coverage for Tdap (p = 0.82), MCV4 (p = 0.08), and HPV (p = 0.76). Provisional policies may not increase vaccination coverage as anticipated. Unintended consequences, such as increased nonmedical exemptions and increased demands on clinical providers, are additional factors to consider.

Correction to: Improving infant sleep safety via electronic health record communication: a randomized controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Improving infant sleep safety via electronic health record communication: a randomized controlled trial.

BACKGROUND: With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines. METHODS: One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher's Exact test to assess group differences in guideline adherence at 2 months. RESULTS: One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25-52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface. CONCLUSIONS: Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices. TRIAL REGISTRATION: Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None.

One-Year Postpartum Mental Health Outcomes of Mothers of Infants with Neonatal Abstinence Syndrome.

INTRODUCTION: Women with substance use disorders have high incidences of psychiatric and mood disorders, which may affect their ability to cope with an infant with neonatal abstinence syndrome (NAS), particularly one with a protracted NICU course, exacerbating symptoms of mental health disorders. We examined the incidence of mental health diagnoses in the first 12 postpartum months in mothers of an NAS infant compared to mothers of an infant without NAS. METHODS: In this retrospective, cohort study, data were extracted from MarketScan® database (2005-2013). NAS newborns were identified using ICD-9 codes. Each mother of an NAS newborn was matched to a mother of a newborn without NAS on age at delivery, birth year, gestational age, NICU stay and maternal mental health diagnoses in the 9 months prior to delivery. Primary outcomes were claims for major depression, postpartum depression, anxiety, adjustment reaction, post-traumatic stress disorder, and suicidal ideation. RESULTS: 338 mother-infant pairs met all inclusion/exclusion criteria and were matched 1-to-1 with controls. 245 (73%) of the NAS infants had a NICU admission. Median length of stay for these infants was 10 days compared to 3 days for infants with no NICU admission (p < 0.001). Mothers of NAS infants were more likely to have claims for major depression (33% vs. 15%, p < 0.01), postpartum depression (7% vs. 3%, p = 0.04), and anxiety (27% vs. 13%, p < 0.01). CONCLUSION: Mothers of infants with NAS have a higher incidence of mental health diagnoses in the first 12 months postpartum compared to mothers of infants without NAS.

Trends in the Treatment of Bell's Palsy.

The aim of the study is to: (1) evaluate national trends in care of facial paralysis, namely Bell's palsy, patients to identify the types of treatments patients are receiving and treatment gaps and (2) identify if newer, more complex surgical therapies published in the literature are being employed. Data were collected from the MarketScan Commercial Claims and Encounters Database by Truven Health. From the database, all inpatient and outpatient claims with International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes for facial paralysis/dysfunction between 2005 and 2013 were extracted. Trends in medical and surgical management were evaluated specifically cataloging the use of steroids, antivirals, botulinum toxin, surgical and rehabilitation service current procedural terminology codes. A total of 42,866 of patients with a formal diagnosis of Bell's palsy were identified with 39,292 (92%) adults and 3,754 (8%) children (< 18 years old), respectively. Steroids were provided to 50.1% of children and 59.8% of adults and antivirals were prescribed to 26.2 and 39.4% of the children and adults, respectively. Within the first 2 years after diagnosis, 0.5% of children and 0.9% of adults received surgery, 0.1% of children and 0.8% of adults received botulinum toxin treatments, and 10.9% of children and 21.5% of adults received rehabilitation services. Despite the limitations of a claims database study, results showing trends in care of facial paralysis are still nonsurgical with many patients receiving no treatment at all. Although limited literature has shown an increase in the use of pharmacotherapy as well as techniques including physiotherapy, chemodenervation, and various surgical therapies, these interventions may be underutilized.

Use of prescription opioid and other drugs among a cohort of persons with Ehlers-Danlos syndrome: A retrospective study.

Against the backdrop of increased opioid prescribing in the United States and the associated high rate of side effects, dependence, and addiction, our study examined how opioids and other medications are being used among persons with Ehlers-Danlos syndrome (EDS). EDS is a set of heritable connective tissue disorders with high symptom burden, including chronic pain. Prescription medication use among persons with EDS was compared to a cohort of matched controls using 10 years of administrative claims data from a large database of privately insured patients (2005-2014). Our dataset included 4,294 persons with EDS, ages 5-62 years old. In both adults and children, we found that the percentage of persons with a prescription drug claim was higher in the EDS cohort for all prescription drug classes examined. Among children, opioid use was double in the EDS cohort compared to the control group (27.5% vs. 13.5%); in adults, it was nearly double in EDS patients (62% vs. 34.1%). Among persons who were prescribed opioids, those with EDS had higher cumulative dosages over a 2-year time period versus controls. Our study aids in understanding opioid and prescription drug use patterns in a vulnerable population with high symptom burden and chronic pain that is often severe.

Determinants of treatment in patients with stage IV renal cell carcinoma.

BACKGROUND: Advances in systemic targeted therapies afford treatment opportunities in patients with metastatic renal cell carcinoma (RCC). Elderly patients with metastatic RCC present a subpopulation for consideration owing to competing causes of mortality and benefits seen with new therapeutic agents. We investigate treatment patterns for elderly patients with stage IV RCC and determine factors associated with not receiving treatment. METHODS: The Surveillance Epidemiology and End Results (SEER) Medicare linked data set contained 949 stage IV RCC patients over age 65 diagnosed between 2007 and 2011. Treatment approach was modeled using multinomial logistic regression. Landmark analysis at 6 months accounted for early death as a potential explanation for no treatment. RESULTS: Of the 949 patients with stage IV RCC, 26.2% received surgery and 34.1% received systemic therapy within 6 months of diagnosis. Among our entire cohort, over half (51.2%) had no evidence of receiving surgery or systemic therapy. Among the 447 patients who survived at least 6 months, 26.6% did not receive treatment during this time. Older patients and those with a higher Charlson Comorbidity Index (CCI) had lower odds of being treated with surgery, systemic therapy, or both. Conversely, married patients had higher odds of receiving these therapies. These associations were largely sustained in the 6-month landmark analyses. CONCLUSIONS: Elderly patients with metastatic RCC present a unique subpopulation for consideration owing to competing causes of mortality. Many elderly patients with stage IV RCC did not receive surgery or systemic therapy up to 6 months from diagnosis. Several clinical and demographic factors were associated with this observation. Further investigation is needed to understand the rationale underlying the underutilization of systemic therapy in elderly patients.

Depression Rates After Facial Paralysis.

INTRODUCTION: Facial paralysis (FP) has many functional consequences with a large impact on daily life. Although an association with FP and depression has been observed and described in the literature, there are currently no large-scale studies to further validate this correlation. Our goal was to determine whether patients with FP become depressed at a higher rate compared with matched controls. METHODS: We performed a retrospective cohort study using MarketScan Commercial Claims and Encounters Database by Truven Health. From the database, all inpatient and outpatient claims with International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for FP and depression between 2005 and 2013 were extracted. Patients younger than 18 years were categorized as children and those 18 years or older as adults. Patients were subcategorized as having a history of depression if a diagnosis of depression preceding a diagnosis of FP was noted. We matched each patient to a control in the MarketScan database based on age, sex, and state of residence. We compared rates of depression between these patients and matched controls using conditional logistic regression. The method of Kaplan and Meier was used to estimate cumulative incidence curves of depression by each group. RESULTS: Approximately 57,941 patients were identified with International Classification of Diseases, Ninth Revision, codes for FP. Among children and adult patients without a diagnosis of depression before the index date for FP, 6.4% (285) and 9.7% (4733), respectively, had a diagnosis of depression within 2 years of the diagnosis of FP. Matched controls showed depression rates within 2 years of 3.9% for children (P < 0.001) and 6.1% for adults (P < 0.001). CONCLUSIONS: The present study adds to the current body of knowledge on FP and depression given its large sample size and analysis of adult and pediatric populations over 2 years. Indeed, we found that depression rates were significantly increased in both adults and children as compared with matched controls. Our results suggest a need for long-term depression screening in patients with FP.

Truven Health Analytics MarketScan Databases for Clinical Research in Colon and Rectal Surgery.

The MarketScan databases are a family of administrative claims databases that contain data on inpatient and outpatient claims, outpatient prescription claims, clinical utilization records, and healthcare expenditures. The three main databases available for use are each composed of a convenience sample for one of the following patient populations: (1) patients with employer-based health insurance from contributing employers, (2) Medicare beneficiaries who possess supplemental insurance paid by their employers, and (3) patients with Medicaid in one of eleven participating states. Eleven supplemental databases are available, which are utilized to overcome the limited clinical data available in the core MarketScan databases. There are several limitations to this database, primarily related to the fact that individuals or their family members within two of the core databases mandatorily possess some form of employer-based health insurance, which prevents the dataset from being nationally representative. Nonetheless, this database provides detailed and rigorously maintained claims data to identify healthcare utilization patterns among this cohort of patients.

Pregnancy after a melanoma diagnosis in women in the United States.

BACKGROUND: Melanoma is the third most common cancer in women aged 18-39 years. Medical literature recommends that women wait for at least 2 years before becoming pregnant, yet few studies have examined pregnancy after melanoma. Our aims were to investigate the pregnancy rate after a melanoma diagnosis and the relationship between melanoma treatment and subsequent pregnancy. METHODS: We studied women with a melanoma diagnosis in the Truven Health MarketScan database. Women with a melanoma diagnosis were matched 1:1 to women with no melanoma diagnosis to compare pregnancy rates between groups. For women with melanoma, Cox models were fitted for rates of pregnancy overall, pregnancy if postsurgical treatment was received, and for treatment after pregnancy. RESULTS: The sample included 11,801 women aged 18-40 years with melanoma, who were not pregnant on the index date. These women had a higher rate of pregnancy within 2 years compared to matched controls (15.8% versus 13.6%, P < 0.001). For 0-9 months after diagnosis, women who received postsurgical treatment had a 74% lower probability of becoming pregnant (hazard ratio = 0.26, P = 0.003). Rates of treatment received after pregnancy were not significantly different (hazard ratio = 0.68, P = 0.23). CONCLUSIONS: Our study is the largest review of postmelanoma pregnancy in the United States. After a melanoma diagnosis, women had a slightly higher rate of pregnancy than matched controls, indicating that women are not delaying pregnancy. However, women who received advanced treatment for melanoma had a lower rate of pregnancy than untreated women. Women who became pregnant after a melanoma diagnosis did not have an increased risk of requiring subsequent treatment for melanoma.