Effect of home-based resistance training on chemotherapy relative dose intensity and tolerability in colon cancer: The FORCE randomized control trial.

BACKGROUND: Many patients with colon cancer cannot fully adhere to postoperative chemotherapy due to dose-limiting toxicities, resulting in lower relative dose intensity (RDI) and potentially compromising overall survival. This study examined whether home-based resistance training (RT) during adjuvant chemotherapy improves RDI and patient-reported toxicities versus usual care (UC) in colon cancer patients. METHODS: Multicenter, randomized control trial (RCT) conducted at community and academic practices. Enrollment of patients receiving postoperative chemotherapy for colon cancer occurred between February 23, 2018, and September 29, 2021; final follow-up was March 21, 2022. Participants were randomized to RT (n = 90) or UC (n = 91) for the duration of chemotherapy. Participants in the RT group engaged in twice weekly home-based progressive RT. At the end of the study, UC was given an online exercise program. RESULTS: Among 181 randomized patients (mean age, 55.2 [SD, 12.8] years, 95 [52.5%] were men), there were no differences in the mean RDI among those in RT (79% [SD, 19%]) and those in UC (82% [SD, 19%]); (mean difference -0.04 [95% confidence interval (CI), -0.09 to 0.02]). Assignment to RT did not significantly reduce the number of moderate/severe symptoms per week across follow-up (relative rate: 0.94 [95% CI, 0.72-1.22]). Additionally, time since randomization did not significantly modify the effect of RT on the overall number of symptoms (p = .06). CONCLUSIONS: Among patients with colon cancer, these results do not support home-based RT as an adjunct to chemotherapy specifically to improve planned treatment intensity.

Survival analysis under imperfect record linkage using historic census data.

BACKGROUND: Advancements in linking publicly available census records with vital and administrative records have enabled novel investigations in epidemiology and social history. However, in the absence of unique identifiers, the linkage of the records may be uncertain or only be successful for a subset of the census cohort, resulting in missing data. For survival analysis, differential ascertainment of event times can impact inference on risk associations and median survival. METHODS: We modify some existing approaches that are commonly used to handle missing survival times to accommodate this imperfect linkage situation including complete case analysis, censoring, weighting, and several multiple imputation methods. We then conduct simulation studies to compare the performance of the proposed approaches in estimating the associations of a risk factor or exposure in terms of hazard ratio (HR) and median survival times in the presence of missing survival times. The effects of different missing data mechanisms and exposure-survival associations on their performance are also explored. The approaches are applied to a historic cohort of residents in Ambler, PA, established using the 1930 US census, from which only 2,440 out of 4,514 individuals (54%) had death records retrievable from publicly available data sources and death certificates. Using this cohort, we examine the effects of occupational and paraoccupational asbestos exposure on survival and disparities in mortality by race and gender. RESULTS: We show that imputation based on conditional survival results in less bias and greater efficiency relative to a complete case analysis when estimating log-hazard ratios and median survival times. When the approaches are applied to the Ambler cohort, we find a significant association between occupational exposure and mortality, particularly among black individuals and males, but not between paraoccupational exposure and mortality. DISCUSSION: This investigation illustrates the strengths and weaknesses of different imputation methods for missing survival times due to imperfect linkage of the administrative or registry data. The performance of the methods may depend on the missingness process as well as the parameter being estimated and models of interest, and such factors should be considered when choosing the methods to address the missing event times.

Association of early hypotension in pediatric sepsis with development of new or persistent acute kidney injury.

OBJECTIVE: To determine how hypotension in the first 48 h of sepsis management impacts acute kidney injury (AKI) development and persistence. STUDY DESIGN: Retrospective study of patients > 1 month to < 20 years old with sepsis in a pediatric ICU between November 2012 and January 2015 (n = 217). All systolic blood pressure (SBP) data documented within 48 h after sepsis recognition were collected and converted to percentiles for age, sex, and height. Time below SBP percentiles and below pediatric advanced life support (PALS) targets was calculated by summing elapsed time under SBP thresholds during the first 48 h. The primary outcome was new or persistent AKI, defined as stage 2 or 3 AKI present between sepsis day 3-7 using Kidney Disease: Improving Global Outcomes creatinine definitions. Secondary outcomes included AKI-free days (days alive and free of AKI) and time to kidney recovery. RESULTS: Fifty of 217 sepsis patients (23%) had new or persistent AKI. Patients with AKI spent a median of 35 min under the first SBP percentile, versus 4 min in those without AKI. After adjustment for potential confounders, the odds of AKI increased by 9% with each doubling of minutes spent under this threshold (p = 0.03). Time under the first SBP percentile was also associated with fewer AKI-free days (p = 0.02). Time spent under PALS targets was not associated with AKI. CONCLUSIONS: The duration of severe systolic hypotension in the first 48 h of pediatric sepsis management is associated with AKI incidence and duration when defined by age, sex, and height norms, but not by PALS definitions. Graphical abstract.

Development of a Clinical Prediction Model for Central Line-Associated Bloodstream Infection in Children Presenting to the Emergency Department.

OBJECTIVE: The majority of the children with a central line who present to the emergency department with fever or other signs of bacteremia do not have a central line-associated bloodstream infection (CLABSI). Our objective was to develop a clinical prediction model for CLABSI among this group of children in order to ultimately limit unnecessary hospital admissions and antibiotic use. METHODS: We performed a nested case-control study of children with a central line who presented to the emergency department of an urban, tertiary care children's hospital between January 2010 and March 2015 and were evaluated for CLABSI with a blood culture. RESULTS: The final multivariable model developed to predict CLABSI consisted of 12 factors: age younger than 5 years, black race, use of total parenteral nutrition, tunneled central venous catheter, double-lumen catheter, absence of other bacterial infection, absence of viral upper respiratory tract infection symptoms, diarrhea, emergency department temperature greater than 39.5°C, fever prior to presentation, neutropenia, and spring/summer season. The clinical prediction score had good discrimination for CLABSI with a c-statistic of 0.81 (confidence interval, 0.77-0.85). A cut point less than 6 was associated with a sensitivity of 98.5% and a negative predictive value of 99.2% for CLABSI. CONCLUSIONS: We were able to identify risk factors and develop a clinical prediction model for CLABSI in children presenting to the emergency department. Once validated in future study, this clinical prediction model could be used to assess the need for hospitalization and/or antibiotics among this group of patients.

Ecological Momentary Assessment of Factors Associated with Water Intake among Adolescents with Kidney Stone Disease.

PURPOSE: Maintaining high water intake decreases kidney stone recurrence but is difficult to do. Strategies to reduce stone recurrence among adolescents are lacking. We conducted an ecological momentary assessment study to identify factors associated with water intake in adolescents with nephrolithiasis. MATERIALS AND METHODS: The study population consisted of 15 female and 10 male patients 12 to 18 years old with at least 1 prior kidney stone. For 7 days participants used "smart" bottles to self-monitor water intake and received questionnaires randomly 4 times daily, which were completed in real time on mobile devices. The questionnaires ascertained awareness of water intake volume, awareness of water intake goals, perceived need to drink, access to water, alternative beverage consumption and attitudes toward bathrooms. Linear mixed effects models were fit to estimate the association between momentary responses and daily water intake. RESULTS: During 175 person-days 595 assessments (85%) were completed. Median daily water intake was 1,304 ml (IQR 848-1,832) and 20% of participants met their intake goal for 4 days or more. Unawareness of water intake volume was associated with drinking 690 ml less water per day (p = 0.04). A strong self-perceived need to drink more was associated with drinking 1,954 ml less water each day compared to no self-perceived need to drink more (p <0.01). Unawareness of intake goals was weakly associated with drinking 1,129 ml less water each day (p = 0.1). Access to water, alternative beverage consumption and bathroom aversion were not associated with water intake. CONCLUSIONS: Unawareness of water volume consumed and low responsiveness to perceived need to drink more were associated with low water intake. Interventions that help adolescents recognize when and identify how to increase water intake may be effective in decreasing stone recurrence.

Urology Consultation and Emergency Department Revisits for Children with Urinary Stone Disease.

PURPOSE: We determined the association between urology consultation and emergency department revisits for children with urinary stones. MATERIALS AND METHODS: This retrospective cohort study included patients 18 years old or younger who presented to an emergency department in South Carolina with a urinary stone from 1997 to 2015. The primary exposure was urology consultation during the index emergency department visit. The primary outcome was a stone related emergency department revisit occurring within 180 days of discharge from an index emergency department visit. Secondary outcomes included computerized tomography use, inpatient admission and emergent surgery. RESULTS: Of 5,642 index emergency department visits for acute urinary stones 11% resulted in at least 1 stone related emergency department revisit within 180 days. Of revisits 59% occurred within 30 days of discharge and 39% were due to pain. The odds of emergency department revisit were highest within the first 48 hours of discharge home (OR 22.6, 95% CI 18.0 to 28.5) and rapidly decreased thereafter. Urology consultation was associated with a 37% lower adjusted odds of emergency department revisit (OR 0.63, 95% CI 0.44 to 0.90) and 68% lower odds of computerized tomography use across all emergency department visits (OR 0.32, 95% CI 0.15 to 0.69). Among patients who revisited the emergency department the frequency of pain complaints was 27% in those with a urological consultation at the index visit and 39% in those without. CONCLUSIONS: Urology consultation was associated with decreased emergency department revisits and computerized tomography use in pediatric patients with urinary stones. Future studies should identify patients who benefit most from urology consultation and ascertain processes of care that decrease emergency department revisits among high risk patients.

Risk factors and inpatient outcomes associated with acute kidney injury at pediatric severe sepsis presentation.

BACKGROUND: Little data exist on acute kidney injury (AKI) risk factors in pediatric sepsis. We identified risk factors and inpatient outcomes associated with AKI at sepsis recognition in children with severe sepsis. METHODS: Retrospective, cross-sectional study with inpatient outcome description of 315 patients > 1 month to < 20 years old with severe sepsis in a pediatric intensive care unit over 3 years. Exposures included demographics, vitals, and laboratory data. The primary outcome was kidney disease: Improving Global Outcomes creatinine-defined AKI within 24 h of sepsis recognition. Factors associated with AKI and AKI severity were identified using multivariable Poisson and multinomial logistic regression, respectively. RESULTS: AKI was present in 42% (133/315) of severe sepsis patients, and 26% (83/315) had severe (stage 2/3) AKI. In multivariable-adjusted analysis, hematologic/immunologic comorbidities, malignancies, chronic kidney disease (CKD), abdominal infection, admission illness severity, and minimum systolic blood pressure (SBP) ≤ 5th percentile for age and sex within 24 h of sepsis recognition were associated with AKI. Factors associated with mild AKI were CKD and abdominal infection, while factors associated with severe AKI were younger age, hematologic/immunologic comorbidities, malignancy, abdominal infection, and minimum SBP ≤ 5th percentile. Patients with AKI had increased hospital mortality (17 vs. 8%, P = 0.02) and length of stay [median 20 (IQR 10-47) vs. 16 days (IQR 7-37), P = 0.03]. CONCLUSIONS: In pediatric severe sepsis, AKI is associated with age, comorbidities, infection characteristics, and hypotension. Future evaluation of risk factors for AKI progression during sepsis is warranted to minimize AKI progression in this high-risk population.

Electronic health record (EHR) based postmarketing surveillance of adverse events associated with pediatric off-label medication use: A case study of short-acting beta-2 agonists and arrhythmias.

PURPOSE: Use electronic health record (EHR) data to (1) estimate the risk of arrhythmia associated with inhaled short-acting beta-2 agonists (SABA) in pediatric patients and (2) determine whether risk varied by on-label versus off-label prescribing. METHODS: Retrospective cohort study of 335 041 children ≤18 years using EHR primary care data from 2 pediatric health systems (2011-2013). A series of monthly pseudotrials were created, using propensity score methodology to balance baseline characteristics between SABA-exposed (identified by prescription) and SABA-unexposed children. Association between SABA and subsequent arrhythmia for each health system was estimated through pooled logistic regression with separate estimates for children initiating under and over 4 years old (off-label and on-label, respectively). RESULTS: Eleven percent of the cohort received a SABA prescription, 57% occurred under the age of 4 years (off-label). During the follow-up period, there were 283 first arrhythmia events, most commonly atrial tachyarrhythmias and premature ventricular/atrial contractions. In 1 health system, adjusted risk for arrhythmia was increased among exposed children (OR 1.89, 95% CI 1.31-2.73) without evidence of interaction between label status and risk. The absolute adjusted rate difference was 3.6/10 000 person-years of SABA exposure. The association between SABA exposure and arrhythmias was less strong in the second system (OR 1.26, 95% CI 0.30-5.33). CONCLUSION: Using EHR data, we could estimate the risk of a rare event associated with medication use and determine difference in risk related to on-label versus off-label status. These findings support the value of EHR-based data for postmarketing drug studies in the pediatric population.

Assessment of the combination of temperature and relative humidity on kidney stone presentations.

Temperature and relative humidity have opposing effects on evaporative water loss, the likely mediator of the temperature-dependence of nephrolithiasis. However, prior studies considered only dry-bulb temperatures when estimating the temperature-dependence of nephrolithiasis. We used distributed lag non-linear models and repeated 10-fold cross-validation to determine the daily temperature metric and corresponding adjustment for relative humidity that most accurately predicted kidney stone presentations during hot and cold periods in South Carolina from 1997 to 2015. We examined three metrics for wet-bulb temperatures and heat index, both of which measure the combination of temperature and humidity, and for dry-bulb temperatures: (1) daytime mean temperature; (2) 24-h mean temperature; and (3) most extreme 24-h temperature. For models using dry-bulb temperatures, we considered four treatments of relative humidity. Among 188,531 patients who presented with kidney stones, 24-h wet bulb temperature best predicted kidney stone presentation during summer. Mean cross-validated residuals were generally lower in summer for wet-bulb temperatures and heat index than the corresponding dry-bulb temperature metric, regardless of type of adjustment for relative humidity. Those dry-bulb models that additionally adjusted for relative humidity had higher mean residuals than other temperature metrics. The relative risk of kidney stone presentations at the 99th percentile of each temperature metric compared to the respective median temperature in summer months differed by temperature metric and relative humidity adjustment, and ranged from an excess risk of 8-14%. All metrics performed similarly in winter. The combination of temperature and relative humidity determine the risk of kidney stone presentations, particularly during periods of high heat and humidity. These results suggest that metrics that measure moist heat stress should be used to estimate the temperature-dependence of kidney stone presentations, but that the particular metric is relatively unimportant.

Dietary Zinc and Incident Calcium Kidney Stones in Adolescence.

PURPOSE: We determined the association between dietary zinc intake and incident calcium kidney stones in adolescents. We also examined the relationship between dietary zinc intake and urinary zinc excretion between cases and controls. MATERIALS AND METHODS: We conducted a nested case-control study within a large pediatric health care system. Three 24-hour dietary recalls and spot urine chemistry analyses were obtained for 30 participants 12 to 18 years old with a first idiopathic calcium based kidney stone and 30 healthy controls matched for age, sex, race and month of enrollment. Conditional logistic regression models were used to estimate the association between daily zinc intake and incident calcium kidney stones, adjusting for dietary phytate, protein, calcium, sodium and oxalate. Multivariable linear regression was used to estimate the association between dietary and urine zinc, adjusting for urine creatinine and dietary phytate and calcium. RESULTS: Cases had lower daily zinc intake (8.1 mg) than controls (10 mg, p = 0.029). Daily zinc intake of boys and girls with calcium stones was 2 mg and 1.2 mg less, respectively, than the daily intake recommended by the Institute of Medicine. Odds of incident stones were reduced by 13% for every 1 mg increase in daily zinc intake (OR 0.87, 95% CI 0.75-0.99). There was an estimated 4.5 µg/dl increase in urine zinc for every 1 mg increase in dietary zinc (p = 0.009), with weak evidence of a smaller increase in urine zinc in cases than in controls (interaction p = 0.08). CONCLUSIONS: Decreased dietary zinc intake was independently associated with incident calcium nephrolithiasis in this population of adolescents.

Topologically dissociable patterns of development of the human cerebral cortex.

Over 90 years ago, anatomists noted the cortex is thinner in sulci than gyri, suggesting that development may occur on a fine scale driven by local topology. However, studies of brain development in youth have focused on describing how cortical thickness varies over large-scale functional and anatomic regions. How the relationship between thickness and local sulcal topology arises in development is still not well understood. Here, we investigated the spatial relationships between cortical thickness, folding, and underlying white matter organization to elucidate the influence of local topology on human brain development. Our approach included using both T1-weighted imaging and diffusion tensor imaging (DTI) in a cross-sectional sample of 932 youths ages 8-21 studied as part of the Philadelphia Neurodevelopmental Cohort. Principal components analysis revealed separable development-related processes of regionally specific nonlinear cortical thickening (from ages 8-14) and widespread linear cortical thinning that have dissociable relationships with cortical topology. Whereas cortical thinning was most prominent in the depths of the sulci, early cortical thickening was present on the gyri. Furthermore, decline in mean diffusivity calculated from DTI in underlying white matter was correlated with cortical thinning, suggesting that cortical thinning is spatially associated with white matter development. Spatial permutation tests were used to assess the significance of these relationships. Together, these data demonstrate that cortical remodeling during youth occurs on a local topological scale and is associated with changes in white matter beneath the cortical surface.

Differential Child Maltreatment Risk Across Deployment Periods of US Army Soldiers.

OBJECTIVES: We described the risk for maltreatment among toddlers of US Army soldiers over different deployment cycles to develop a systematic response within the US Army to provide families appropriate supports. METHODS: We conducted a person-time analysis of substantiated maltreatment reports and medical diagnoses among children of 112,325 deployed US Army soldiers between 2001 and 2007. RESULTS: Risk of maltreatment was elevated after deployment for children of soldiers deployed once but not for children of soldiers deployed twice. During the 6 months after deployment, children of soldiers deployed once had 4.43 substantiated maltreatment reports and 4.96 medical diagnoses per 10,000 child-months. The highest maltreatment rate among children of soldiers deployed twice occurred during the second deployment for substantiated maltreatment (4.83 episodes per 10,000 child-months) and before the first deployment for medical diagnoses of maltreatment (3.78 episodes per 10,000 child-months). CONCLUSIONS: We confirmed an elevated risk for child maltreatment during deployment but also found a previously unidentified high-risk period during the 6 months following deployment, indicating elevated stress within families of deployed and returning soldiers. These findings can inform efforts by the military to initiate and standardize support and preparation to families during periods of elevated risk.

Adoption of a Portal for the Primary Care Management of Pediatric Asthma: A Mixed-Methods Implementation Study.

BACKGROUND: Patient portals may improve communication between families of children with asthma and their primary care providers and improve outcomes. However, the feasibility of using portals to collect patient-reported outcomes from families and the barriers and facilitators of portal implementation across diverse pediatric primary care settings have not been established. OBJECTIVE: We evaluated the feasibility of using a patient portal for pediatric asthma in primary care, its impact on management, and barriers and facilitators of implementation success. METHODS: We conducted a mixed-methods implementation study in 20 practices (11 states). Using the portal, parents of children with asthma aged 6-12 years completed monthly surveys to communicate treatment concerns, treatment goals, symptom control, medication use, and side effects. We used logistic regression to evaluate the association of portal use with child characteristics and changes to asthma management. Ten clinician focus groups and 22 semistructured parent interviews explored barriers and facilitators of use in the context of an evidence-based implementation framework. RESULTS: We invited 9133 families to enroll and 237 (2.59%) used the portal (range by practice, 0.6%-13.6%). Children of parents or guardians who used the portal were significantly more likely than nonusers to be aged 6-9 years (vs 10-12, P=.02), have mild or moderate/severe persistent asthma (P=.009 and P=.04), have a prescription of a controller medication (P<.001), and have private insurance (P=.002). Portal users with uncontrolled asthma had significantly more medication changes and primary care asthma visits after using the portal relative to the year earlier (increases of 14% and 16%, respectively). Qualitative results revealed the importance of practice organization (coordinated workflows) as well as family (asthma severity) and innovation (facilitated communication and ease of use) characteristics for implementation success. CONCLUSIONS: Although use was associated with higher treatment engagement, our results suggest that achieving widespread portal adoption is unlikely in the short term. Implementation efforts should include workflow redesign and prioritize enrollment of symptomatic children. CLINICALTRIAL: Clinicaltrials.gov NCT01966068; https://clinicaltrials.gov/ct2/show/NCT01966068 (Archived by WebCite at http://www.webcitation.org/6i9iSQkm3).

Propensity Score Methods for Analyzing Observational Data Like Randomized Experiments: Challenges and Solutions for Rare Outcomes and Exposures.

Randomized controlled trials are the "gold standard" for estimating the causal effects of treatments. However, it is often not feasible to conduct such a trial because of ethical concerns or budgetary constraints. We expand upon an approach to the analysis of observational data sets that mimics a sequence of randomized studies by implementing propensity score models within each trial to achieve covariate balance, using weighting and matching. The methods are illustrated using data from a safety study of the relationship between second-generation antipsychotics and type 2 diabetes (outcome) in Medicaid-insured children aged 10-18 years across the United States from 2003 to 2007. Challenges in this data set include a rare outcome, a rare exposure, substantial and important differences between exposure groups, and a very large sample size.

The thrombospondin-1 receptor CD36 is an important mediator of ovarian angiogenesis and folliculogenesis.

BACKGROUND: Ovarian angiogenesis is a complex process that is regulated by a balance between pro- and anti-angiogenic factors. Physiological processes within the ovary, such as folliculogenesis, ovulation, and luteal formation are dependent upon adequate vascularization and anything that disrupts normal angiogenic processes may result in ovarian dysfunction, and possibly infertility. The objective of this study was to evaluate the role of the thrombospondin-1 (TSP-1) receptor CD36 in mediating ovarian angiogenesis and regulating ovarian function. METHODS: The role of CD36 was evaluated in granulosa cells in vitro and ovarian morphology and protein expression were determined in wild type and CD36 null mice. RESULTS: In vitro, CD36 inhibition increased granulosa cell proliferation and decreased apoptosis. Granulosa cells in which CD36 was knocked down also exhibited an increase in expression of survival and angiogenic proteins. Ovaries from CD36 null mice were hypervascularized, with increased expression of pro-angiogenic vascular endothelial growth factor (VEGF) and its receptor VEGFR-2. Ovaries from CD36 null mice contained an increase in the numbers of pre-ovulatory follicles and decreased numbers of corpora lutea. CD36 null mice also had fewer number of offspring compared to wild type controls. CONCLUSIONS: The results from this study demonstrate that CD36 is integral to the regulation of ovarian angiogenesis by TSP-1 and the expression of these family members may be useful in the control of ovarian vascular disorders.

Elevated lead (Pb) in urban European starling (Sturnus vulgaris) feathers is not correlated to physiology or behavior.

Urbanization is rapidly changing the environment and creating new challenges in the lives of animals across the globe. Anthropogenic contaminants-like heavy metals-can persist within the environment for prolonged periods of time and present a widespread problem for those living near contaminated areas. Lead (Pb) was a commonly used heavy metal that continues to threaten the health of all organisms despite being phased out, especially in urban areas where historical use was more common. In this study, a common urban-adapter, the European starling (Sturnus vulgaris), was trapped to explore whether feather Pb burden is greater in birds from urban habitats than rural habitats, as well as whether Pb burdens were correlated with behavior, physiology, and feather development. Across four sites (two rural and two urban), soil Pb concentrations were measured and 197 free-living starlings were captured to measure feather Pb concentrations. Using linear mixed models, this study found that urban starling nestlings had elevated feather Pb burdens compared to rural nestlings. In contrast, there was no correlation between Pb and urbanization in adult birds whose exposure to Pb may reflect a larger spatial range compared to nestlings. For both nestlings and adults, feather Pb was uncorrelated to corticosterone, testosterone, aggressive behavior, or feather growth rates. These findings suggest that starlings may be a useful biomonitoring tool to detect Pb in the local environment, however, the age and spatial range of birds is a critical consideration in applying this tool. Further work is needed to understand the intricate relationship between heavy metals, behavior, morphological development, and physiology in free-living organisms.

Bayesian inference for two-phase studies with categorical covariates.

In this article, we consider two-phase sampling in the situation in which all covariates are categorical. Two-phase designs are appealing from an efficiency perspective since they allow sampling to be concentrated in informative cells. A number of likelihood-based methods have been developed for the analysis of two-phase data, but we describe a Bayesian approach which has previously been unavailable. The methods are first compared with existing approaches via a simulation study, and are then applied to data collected on Wilms tumor. The benefits of a Bayesian approach include relaxation of the reliance on asymptotic inference, particularly in sparse data situations, and the potential to model data with complex dependencies, for example, via the introduction of random effects. The sparse data situation is illustrated via a simulated example.

Comparative effectiveness of safety planning intervention with instrumental support calls (ISC) versus safety planning intervention with two-way text message caring contacts (CC) in adolescents and adults screening positive for suicide risk in emergency departments and primary care clinics: Protocol for a pragmatic randomized controlled trial.

BACKGROUND: Suicide is a leading cause of death in adolescents and adults in the US. Follow-up support delivered when patients return home after an emergency department (ED) or primary care encounter can significantly reduce suicidal ideation and attempts. Two follow-up models to augment usual care including the Safety Planning Intervention have high efficacy: Instrumental Support Calls (ISC) and Caring Contacts (CC) two-way text messages, but they have never been compared to assess which works best. This protocol for the Suicide Prevention Among Recipients of Care (SPARC) Trial aims to determine which model is most effective for adolescents and adults with suicide risk. METHODS: The SPARC Trial is a pragmatic randomized controlled trial comparing the effectiveness of ISC versus CC. The sample includes 720 adolescents (12-17 years) and 790 adults (18+ years) who screen positive for suicide risk during an ED or primary care encounter. All participants receive usual care and are randomized 1:1 to ISC or CC. The state suicide hotline delivers both follow-up interventions. The trial is single-masked, with participants unaware of the alternative treatment, and is stratified by adolescents/adults. The primary outcome is suicidal ideation and behavior, measured using the Columbia Suicide Severity Rating Scale (C-SSRS) screener at 6 months. Secondary outcomes include C-SSRS at 12 months, and loneliness, return to crisis care for suicidality, and utilization of outpatient mental health services at 6 and 12 months. DISCUSSION: Directly comparing ISC and CC will determine which follow-up intervention is most effective for suicide prevention in adolescents and adults.

Recruitment strategies and design considerations in a trial of resistance training to prevent dose-limiting toxicities in colon cancer patients undergoing chemotherapy.

Low muscle is associated with an increased risk of chemotherapy-related dose limiting toxicities (DLT) in cancer patients. Resistance training (RT) improves muscle mass; however, the effects of RT on preventing DLTs and dose reductions in colon cancer patients has not been investigated. FOcus on Reducing dose-limiting toxicities in Colon cancer with resistance Exercise (FORCE) is a multicenter, randomized clinical trial examining the effects of RT on relative dose intensity (RDI; primary outcome) and moderate and severe chemotoxicities (primary outcome) in non-metastatic colon cancer patients receiving adjuvant chemotherapy. Patients (N = 180) will be recruited from Kaiser Permanente Northern California, Dana-Farber Cancer Institute, and Penn State Cancer Institute. This paper describes recruitment strategies and design considerations. Patients will be randomized in equal numbers to RT intervention or control. Patients have baseline and post completion of chemotherapy visits where information on anthropometry, physical function, body composition, quality of life, physical activity and dietary behaviors, and inflammatory blood markers will be collected. Patient-reported outcomes of chemotherapy side effects will be collected around the time of chemotherapy throughout the duration of the trial. Intervention participants will be prescribed a progressive RT program consisting of 4-6 visits with a certified exercise trainer, delivered either in-person or remotely by video conference, and will be asked to engage twice weekly in-home training sessions. Control patients at the end of the study receive a consult with a FORCE exercise trainer, an online exercise RT training program and a set of resistance bands. Results of this trial will provide information on the benefit of resistance exercise as a treatment to increase RDI.

Spatial clustering of myelodysplastic syndromes (MDS) in the Seattle-Puget Sound region of Washington State.

OBJECTIVES: Incidence of myelodysplastic syndromes (MDS) has been described in the United States since its inclusion in the Surveillance, Epidemiology, and End Results program in 2001, and the Seattle-Puget Sound region of Washington State has among the highest rates of the registries. In this investigation, we described small-scale incidence patterns of MDS within the Seattle-Puget Sound region from 2002 to 2006 and identified potential spatial clusters to inform planning of future studies of MDS etiology. METHODS: We used a spatial disease mapping model to estimate smoothed relative risks for each census tract and to describe the spatial component of variability in the incidence rates. We also used two methods to describe the location of potential MDS clusters: the approach of Besag and Newell and the Kulldorff spatial scan statistic. RESULTS: Our findings from all three approaches indicated the most likely areas of increased MDS incidence were located on Whidbey Island in Island County. CONCLUSION: Interpretation is limited because our data are based on the residential location of the MDS case only at the time of diagnosis. Nevertheless, inclusion of identified cluster regions in future population-based research and investigation of individual-level exposures could shed light on environmental risk factors for MDS.