Is the writing on the wall? The relationship between the number of disease-modifying anti-inflammatory bowel disease drugs used and the risk of surgical resection.

BACKGROUND: Disease-modifying anti-inflammatory bowel disease drugs (DMAIDs) revolutionized the management of ulcerative colitis (UC). This study assessed the relationship between the number and timing of drugs used to treat UC and the risk of colectomy and postoperative complications. METHODS: This was a retrospective review of adult patients with UC treated with disease-modifying drugs between 2005 and 2020 in the MarketScan database. Landmark and time-varying regression analyses were used to analyze risk of surgical resection. Multivariable Cox regression analysis was used to determine risk of postoperative complications, emergency room visits, and readmissions. RESULTS: A total of 12,193 patients with UC and treated with disease-modifying drugs were identified. With a median follow-up time of 1.7 years, 23.8% used >1 drug, and 8.3% of patients required surgical resection. In landmark analyses, using 2 and ≥3 drugs before the landmark date was associated with higher incidence of surgery for each landmark than 1 drug. Multivariable Cox regression showed hazard ratio (95% CIs) of 4.22 (3.59-4.97), 11.7 (9.01-15.3), and 22.9 (15.0-34.9) for using 2, 3, and ≥4 drugs, respectively, compared with using 1 DMAID. That risk was constant overtime. The number of drugs used preoperatively was not associated with an increased postoperative risk of any complication, emergency room visits, or readmission. CONCLUSION: The use of multiple disease-modifying drugs in UC is associated with an increased risk of surgical resection with each additional drug. This provides important prognostic data and highlights the importance of patient counseling with minimal concern regarding risk of postoperative morbidity for additional drugs.

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.

Re-Analyses of 8 Historical Trials in Cardiovascular Medicine Assessing Multimorbidity Burden and Its Association with Treatment Response.

OBJECTIVE: The purpose of this study was to examine the multimorbidity burden of clinical trial participants and assess its association with treatment response. METHODS: We conducted a reanalysis of patient level data. There were 29,954 participants from 8 clinical trials containing 11 comparisons between an intervention and control condition. Patients were classified by Charlson Comorbidity Index (CCI) score. The primary outcomes were the primary study endpoints as originally specified for each trial. A Cox model that included the CCI score groups, the randomized group, and their interaction, was used to compare the primary outcome between randomized groups. The interaction term between randomized group and comorbidity index allowed the treatment effect to differ by level of comorbidity index and comprised the primary effect of interest. Hazard ratios and risk differences were reported for all comparisons. RESULTS: The mean CCI scores of trial populations ranged from 2.1 to 3.9 points, and the percentage of patients with scores ≥5 from 3% to 39%. Tests of interaction terms in models yielded P values ≤ .10 for 4/11 comparisons and ≤ .05 for 2/11 comparisons. In 3 additional comparisons, potentially important treatment variation on an absolute scale was observed despite interaction tests with P values > .10 on the relative scale. CONCLUSIONS: These trials were mainly composed of patient populations with CCI scores ≤4. Despite this, biologically plausible treatment interactions were commonly suggested. These results are hypothesis generating; confirmation of results would require larger studies or studies targeted specifically toward patients with higher levels of multimorbidity.

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.

Efficacy of Systemic Bevacizumab for Recurrent Respiratory Papillomatosis with Pulmonary Involvement.

OBJECTIVES: Pulmonary papillomatosis is a rare but severe manifestation of recurrent respiratory papillomatosis (RRP). Efficacy data of systemic bevacizumab for pulmonary RRP are limited. This study's objective was to characterize disease response of pulmonary RRP to systemic bevacizumab. METHODS: A retrospective review was performed to identify patients with pulmonary RRP seen at three medical institutions. Clinical symptoms, CT findings, and disease response were compared before and after initiation of systemic bevacizumab therapy. Disease response was categorized as complete response, partial response, stabilization, or progression for each subsite involved by papilloma. RESULTS: Of the 12 pulmonary RRP patients treated with systemic bevacizumab, 4 (33.3%) were male, and 11 (91.7%) were juvenile-onset RRP patients. All presented with laryngeal, tracheal, and pulmonary RRP. The median (range) age at first bevacizumab infusion was 48.1 (19.5-70.2) years. Progression to pulmonary malignancy was identified in 3 (25.0%) patients, 2 before initiation of and 1 after complete cessation of bevacizumab therapy. Clinical symptoms such as dyspnea (75.0% vs. 25.0%; p = 0.01) and dysphagia and/or odynophagia (33.3 vs. 0.0%; p = 0.03) were significantly decreased following bevacizumab therapy. Compared with pre-treatment baseline, 9 (75.0%) patients experienced a stable-to-partial response in the lungs to systemic bevacizumab, and 10 (83.3%) experienced partial-to-complete responses in the larynx and trachea. CONCLUSION: Systemic bevacizumab is effective in stabilizing progression in even the most severe cases of RRP, with both a dramatic reduction in laryngeal and tracheal disease as well as a stable-to-partial response of pulmonary involvement in a majority of patients. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:577-581, 2024.

Lessons Learned from an Academic Partnership to Review Pennsylvania Network for Student Assistance Services' Annual Survey.

INTRODUCTION: Pennsylvania's Student Assistance Program (SAP) began in the mid-1980s to address student barriers to academic success. SAP teams, groups of trained school and community professionals, review referrals, and connect students to services. State leadership conducts an annual SAP team survey, but capacity to evaluate data and affect change is limited. In 2020, leadership partnered with [institution name] to collaboratively review the survey data. METHODS: Frequencies and percentages were calculated. Open responses were coded. Logistic regression models evaluated the association between SAP team size, team meeting frequency, and team maintenance. RESULTS: The 2019 to 2020 survey had 1003 respondents. Median number of SAP team members was 8 (range 1-21). The majority (54%) indicated their SAP team met once per week/cycle for 30 to 90+ minutes. Larger teams met more often. Annual team maintenance occurred for 38% of teams, and was more common for larger teams. SAP team members identified mental health (68%), trauma (44%), and parent engagement (36%) as top training needs. CONCLUSIONS: An academic partnership successfully provided the capacity to review SAP survey responses, and informed evidenced-based discussion of best practice guidelines and realignment of staff professional development opportunities.

Cooking with the Community: Addressing Food Insecurity Through Equipment Provision and Professional Instruction.

Introduction: Food insecurity is a common problem with many associated negative downstream health impacts. Despite government sponsored and private supports, many individuals struggle with making healthy, nutritious meals. Penn State's Cooking with the Community program was constructed with the objective of providing cooking equipment and instructions to increase knowledge of healthy cooking techniques and consumption of under-utilized food pantry ingredients. Methods: Four cooking demonstrations were held over an 8-month study period in 2021 designed to educate participants on under-utilized and seasonally available ingredients. Each demonstration was professionally led by a chef who taught cooking skills and the use of different equipment, which were subsequently gifted to the participants. Participants were surveyed before and after each demonstration to assess cooking perceptions and comfort using Likert scales. Final analysis was completed in 2022 using mixed effects models to analyze changes between pre- and post-demonstration. Results: There were 34 total participants. Statistically significant improvements were seen in confidence in cooking (mean increase=0.5; SD=0.2; p=0.031; 95% CI=0.1, 1.0), preparation of a simple recipe (mean increase=0.6; SD=0.2; p=0.013; 95% CI=0.1, 1.0), and cooking new foods (mean increase=0.6; SD=0.3; p=0.026; 95% CI=0.1, 1.1). Conclusions: Cooking with the Community provides valuable information on how cooking confidence may be boosted within vulnerable populations by providing cooking equipment and professional instructions on its use.

Newborn weight nomograms in selected low and middle-income countries.

Growth impairment is common in low- and middle-income countries (LMIC) and may begin during early infancy, increasing morbidity and mortality. To ensure healthy infant growth, healthcare providers in high-income countries (HIC) track newborn weight change using tools developed and validated in HIC. To understand the utility of these tools for LMIC, we conducted a secondary analysis to compare weight trajectories in the first 5 days of life among newborns born in our LMIC cohort to an existing HIC newborn weight tool designed to track early weight change. Between April 2019 and March 2020, a convenience sample of 741 singleton healthy breastfeeding newborns who weighed ≥ 2000 g at birth were enrolled at selected health facilities in Guinea-Bissau, Nepal, Pakistan, and Uganda. Using a standardized protocol, newborn weights were obtained within 6 h of birth and at 1, 2, 3, 4, and 5 days, and nomograms depicting newborn weight change were generated. The trajectories of early newborn weight change in our cohort were largely similar to published norms derived from HIC infants, with the exceptions that initial newborn weight loss in Guinea-Bissau was more pronounced than HIC norms and newborn weight gain following weight nadir was more pronounced in Guinea-Bissau, Pakistan, and Uganda than HIC norms. These data demonstrate that HIC newborn weight change tools may have utility in LMIC settings.

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial.

BACKGROUND: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. METHODS: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11-14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. DISCUSSION: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers. TRIAL REGISTRATION: ClinicalTrials.govNCT04587167. Registered on October 14, 2020.

Pilot Study of Inclined Position and Infant Gastroesophageal Reflux Indicators.

To reduce gastroesophageal reflux, infants are commonly placed in an inclined position. We sought to observe the extent to which infants exhibit (1) oxygen desaturation and bradycardia in supine and inclined positions and (2) signs and symptoms of post-feed regurgitation in these positions. Study Design: Healthy infants aged 1-5 months with gastroesophageal reflux disease (GERD) (N = 25) and controls (N = 10) were enrolled into one post-feed observation. Infants were monitored in a prototype reclining device for consecutive 15-minute periods in supine position with head elevations of 0°, 10°, 18°, and 28° in random order. Continuous pulse oximetry assessed hypoxia (O2 saturation <94%) and bradycardia (heart rate <100). Regurgitation episodes and other symptoms were recorded. Mothers assessed comfort using an ordinal scale. Incident rate ratios were estimated using Poisson or negative binomial regression models. Results: Among infants with GERD, in each position, most had no episodes of hypoxia, bradycardia, or regurgitation. Overall, 17 (68%) infants had 80 episodes of hypoxia (median 20 seconds duration), 13 (54%) had 33 episodes of bradycardia (median 22 seconds duration), and 15 (60%) had 28 episodes of regurgitation. For all 3 outcomes, incident rate ratios were not significantly different between positions, and no differences were discovered for observed symptoms or infant comfort. Conclusions: Brief episodes of hypoxia and bradycardia as well as observed regurgitation are common for infants with GERD placed in the supine position after a feed with no differences in outcomes at various degrees of head elevation. These data may be used to power future, larger, and longer evaluations. ClinicalTrials.gov Identifier: NCT04542239.

Differing prevalence of microcephaly and macrocephaly in male and female fetuses.

Objective: To compare the proportion of female and male fetuses classified as microcephalic (head circumference [HC] < 3rd percentile) and macrocephalic (>97th percentile) by commonly used sex-neutral growth curves. Methods: For fetuses evaluated at a single center, we retrospectively determined the percentile of the first fetal HC measurement between 16 and 0/7 and 21-6/7 weeks using the Hadlock, Intergrowth-21st, and NICHD growth curves. The association between sex and the likelihood of being classified as microcephalic or macrocephalic was evaluated with logistic regression. Results: Female fetuses (n = 3,006) were more likely than male fetuses (n = 3,186) to be classified as microcephalic using the Hadlock (0.4% male, 1.4% female; odds ratio female vs. male 3.7, 95% CI [1.9, 7.0], p < 0.001), Intergrowth-21st (0.5% male, 1.6% female; odds ratio female vs. male 3.4, 95% CI [1.9, 6.1], p < 0.001), and NICHD (0.3% male, 1.6% female; odds ratio female vs. male 5.6, 95% CI [2.7, 11.5], p < 0.001) curves. Male fetuses were more likely than female fetuses to be classified as macrocephalic using the Intergrowth-21st (6.0% male, 1.5% female; odds ratio male vs. female 4.3, 95% CI [3.1, 6.0], p < 0.001) and NICHD (4.7% male, 1.0% female; odds ratio male vs. female 5.1, 95% CI [3.4, 7.6], p < 0.001) curves. Very low proportions of fetuses were classified as macrocephalic using the Hadlock curves (0.2% male, < 0.1% female; odds ratio male vs. female 6.6, 95% CI [0.8, 52.6]). Conclusion: Female fetuses were more likely to be classified as microcephalic, and male fetuses were more likely to be classified as macrocephalic. Sex-specific fetal head circumference growth curves could improve interpretation of fetal head circumference measurements, potentially decreasing over- and under-diagnosis of microcephaly and macrocephaly based on sex, therefore improving guidance for clinical decisions. Additionally, the overall prevalence of atypical head size varied using three growth curves, with the NICHD and Intergrowth-21st curves fitting our population better than the Hadlock curves. The choice of fetal head circumference growth curves may substantially impact clinical care.

Effects of COVID-19 pandemic on pediatric weight: A retrospective chart review.

The COVID-19 pandemic forced United States school closures in March 2020. Students moved to online learning, fostering a sedentary lifestyle. As the pandemic heightened population disparities, the impact on weight gain may also be unequally distributed. This study aimed to evaluate changes in body mass index (BMI) z-scores and weight percentiles of pediatric patients during the pandemic and associated demographics to identify those at risk for weight gain. Methods included a retrospective chart review of patients 5-18 years-old with a well-visit in the three years 2018, 2019 and 2020; first identified with a well-visit in August-September of 2020. BMI z-scores and weight percentiles were analyzed using a correlated errors regression model appropriate for longitudinal data. This longitudinal approach was used to model outcomes by patient demographics. Interaction terms with time were evaluated for each variable. Of 728 patients, mean age was 9.7 years (2018); 47 % female, 70 % white, and 23 % publicly insured. BMI z-score did not increase significantly from 2018-2019 versus 2019-2020. Weight percentile demonstrated a slight trajectory increase over these same time points. Publicly insured patients demonstrated significantly greater increase in BMI z-score versus privately insured patients (p = 0.009). Mean differences between groups increased from 0.26 in 2018 (95 % CI [0.07, 0.45]) to 0.42 in 2020 (95 % CI [0.23, 0.61]). Results were similar for weight percentile. Publicly insured pediatric patients experienced significant increase in BMI-z score and weight percentile, but over time this trajectory remained constant. The results support targeting at risk subgroups in addressing long-term impacts of the pandemic.

Evaluation of Income and Food Insecurity as Risk Factors for Failure to Thrive: An Analysis of National Survey Data.

Limited data exist regarding the relationship between socioeconomic risk factors and failure to thrive (FTT). Using data from the National Health and Nutrition Examination Survey (NHANES) from years 1999 to 2014, we sought to determine whether there was a higher prevalence of underweight (<5th percentile weight-for-age [WFA], weight-for-length [WFL], or body mass index-for-age [BFA]), and, therefore, likely a higher risk of FTT, in US children <3 years with low household income or food insecurity compared with children without these factors. Among 7356 evaluated children, there were no significant differences in the prevalence of underweight by adjusted household income quintile, food security, household Women, Infants, and Children (WIC) status, or federal poverty income ratio. These findings do not support a link between low income or food security and underweight in children and, therefore, do not provide support for an association between low income or food security and FTT.

A Collaborative Analysis of Trends in Referrals to the Pennsylvania Student Assistance Program from 2013 to 2018.

BACKGROUND: The Student Assistance Program (SAP) is mandated kindergarten to 12th grade in Pennsylvania schools to address barriers to student academic success. Following student referral, SAP teams use a systematic process to inform recommendations for school or community-based services. To evaluate program outcomes, a review of student SAP referral trends over a 5-year period was undertaken. METHODS: The Pennsylvania Network for Student Assistance Services (PNSAS), the state leadership providing oversight of SAP, partnered with Penn State College of Medicine in a retrospective analysis of student referral data from 2013 to 2018. Public school enrollment demographics were used for comparison. Frequencies and percentages were calculated. RESULTS: Referrals (total n = 352,640) increased by 24% over the 5 years; demographics 55% male, 69% non-Hispanic white, 16% non-Hispanic black, and 10% Hispanic. Referrals were most commonly for behavioral concerns (31%). Discontinued referrals (39%) were primarily for parent refusal/no permission. Trends included rising minority and elementary referrals over the study period. CONCLUSIONS: SAP referral demographics were consistent with state public school enrollment race/ethnicity breakdown suggesting lack of systematic bias. The proportion of behavioral referrals was consistent with rising youth behavioral health needs. PNSAS must consider strategies to support rising referral numbers and trends.

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..

Feasibility of Large-Scale Implementation of an Electronic Patient-Reported Outcome Remote Monitoring System for Patients on Active Treatment at a Community Cancer Center.

PURPOSE: The use of digital symptom monitoring with patient-reported outcomes (PROs) has been shown to improve patient outcomes. The evidence of benefit has been largely derived from research studies. The feasibility of adopting this technology in the real-world setting is unknown. METHODS: We report on the clinical implementation of a proprietary electronic patient-reported outcome (ePRO)-based digital symptom monitoring platform at the Highlands Oncology Group practice, a large community oncology practice. We present here our experience with patient enrollment, engagement, and retention; reasons for discontinued use; proportion of reports generating alerts and containing severe symptoms; and the responses to alerts including nursing telephone consultations and urgent office visits. RESULTS: Over an approximately 17-month period, 923 patients were successfully enrolled. Patients enrolled from June 20, 2020, through November 30, 2021, with follow-up through February 28, 2022. Retention rates at 3, 6, 9, and 12 months were 94%, 88%, 73%, and 67%, respectively, with greater retention at 12 months in patients age 65 years or older. Few patients discontinued use for reasons related to the platform (n = 47; 5%). Of the 25,311 ePRO reports submitted, 49% (n = 12,334) exceeded the predefined alert thresholds and 8% (n = 1,920) included severe symptoms. The nursing team responded within 24 hours by telephone to 31.2% (n = 3,910) of all reports with alerts. Of reports with severe symptoms, 72.7% (n = 1,395) received a call. Only 6.4% (n = 249) of phone calls required an office evaluation within 72 hours of the report. CONCLUSION: This single-center experience indicates that an ePRO-based digital symptom monitoring platform can be effectively implemented at a large scale with a high level of long-term patient engagement. Most reports could be effectively resolved by nurses, and physician intervention was infrequently required.

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.

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.

Relationships between erectile dysfunction, prostate cancer treatment type and inflatable penile prosthesis implantation.

PURPOSE: The prevalence of erectile dysfunction (ED) and the utilization of inflatable penile prosthesis (IPP) among prostate cancer patients are understudied. The aim of the study was to examine the relationships between ED, prostate cancer treatment type and IPP implantation in a national cohort. MATERIALS AND METHODS: We identified a retrospective cohort of Surveillance, Epidemiology, and End Results (SEER)-Medicare patients diagnosed with locoregional prostate cancer between 2006 and 2011 and treated with surgery or radiation. Chi-square tests were used to detect significant differences in ED rates as well as use of IPP among the subset with ED. Multivariable logistic regression was used to examine factors associated with the use of IPP. RESULTS: Among 31,233 patients in our cohort, 10,334 (33.1%) received prostatectomy and 20,899 (66.9%) received radiation. ED within 5 years was significantly more common in the prostatectomy group relative to those the radiation group (65.3% vs. 33.8%, p<0.001). In the subset of 13,812 patients with ED, the radiation group had greater median time to ED diagnosis compared to the prostatectomy group (346 vs. 133 days, p<0.001). IPP implantation was more frequent for prostatectomy patients than for radiation patients (3.6% vs. 1.4%, p<0.001). Cancer treatment type, race, and marital status were significantly associated with IPP utilization. CONCLUSIONS: ED is highly prevalent among prostate cancer patients, and IPP implantation is be underutilized. ED rates, time to ED diagnosis and utilization of IPP differed significantly by prostate cancer treatment type.

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.