Estimating treatment effect in randomized trial after control to treatment crossover using external controls.

In clinical trials, it is common to design a study that permits the administration of an experimental treatment to participants in the placebo or standard of care group post primary endpoint. This is often seen in the open-label extension phase of a phase III, pivotal study of the new medicine, where the focus is on assessing long-term safety and efficacy. With the availability of external controls, proper estimation and inference of long-term treatment effect during the open-label extension phase in the absence of placebo-controlled patients are now feasible. Within the framework of causal inference, we propose several difference-in-differences (DID) type methods and a synthetic control method (SCM) for the combination of randomized controlled trials and external controls. Our realistic simulation studies demonstrate the desirable performance of the proposed estimators in a variety of practical scenarios. In particular, DID methods outperform SCM and are the recommended methods of choice. An empirical application of the methods is demonstrated through a phase III clinical trial in rare disease.

Androgen receptor transcriptional activity is required for heregulin-1ß-mediated nuclear localization of the HER3/ErbB3 receptor tyrosine kinase.

Prostate cancer is initially regulated by the androgen receptor (AR), a ligand-activated, transcription factor, and is in a hormone-dependent state (hormone-sensitive prostate cancer (HSPC)), but eventually becomes androgen-refractory (castration-resistant prostate cancer (CRPC)) because of mechanisms that bypass the AR, including by activation of ErbB3, a member of the epidermal growth factor receptor family. ErbB3 is synthesized in the cytoplasm and transported to the plasma membrane for ligand binding and dimerization, where it regulates downstream signaling, but nuclear forms are reported. Here, we demonstrate in prostatectomy samples that ErbB3 nuclear localization is observed in malignant, but not benign prostate, and that cytoplasmic (but not nuclear) ErbB3 correlated positively with AR expression but negatively with AR transcriptional activity. In support of the latter, androgen depletion upregulated cytoplasmic, but not nuclear ErbB3, while in vivo studies showed that castration suppressed ErbB3 nuclear localization in HSPC, but not CRPC tumors. In vitro treatment with the ErbB3 ligand heregulin-1ß (HRG) induced ErbB3 nuclear localization, which was androgen-regulated in HSPC but not in CRPC. In turn, HRG upregulated AR transcriptional activity in CRPC but not in HSPC cells. Positive correlation between ErbB3 and AR expression was demonstrated in AR-null PC-3 cells where stable transfection of AR restored HRG-induced ErbB3 nuclear transport, while AR knockdown in LNCaP reduced cytoplasmic ErbB3. Mutations of ErbB3's kinase domain did not affect its localization but was responsible for cell viability in CRPC cells. Taken together, we conclude that AR expression regulated ErbB3 expression, its transcriptional activity suppressed ErbB3 nuclear translocation, and HRG binding to ErbB3 promoted it.

Obesity Risk Assessment for Spanish-Speaking Immigrant Families with Young Children in the United States: Reliability and Validity with Nutrient Values.

The purpose is to examine validity and reliability for an obesity risk assessment tool developed in Spanish for immigrant families with children, 3-5 years old using an 8-week cross-sectional design with data collected over 1 year at Head Start and Special Supplemental Nutrition Program for Women, Infants and Children [WIC]. Parent/child dyads (206) provided a child obesity risk assessment, three child modified 24 h dietary recalls, three child 36+ h activity logs and one parent food behavior checklist. Main outcome measures were convergent validity with nutrients, cup equivalents, and diet quality and three assessments of reliability that included item difficulty index, item discrimination index, and coefficient of variation. Validity was demonstrated for assessment tool, named Niños Sanos. Scales were significantly related to variables in direction hypothesized [p ≤ 0.05]: Healthy Eating Index, fruit/vegetable cup equivalents, folate, dairy cup equivalents, vitamins D, ß-carotene, fiber, saturated fat, sugar, time at screen/ sleep/physical activity and parent behaviors. Three measures of reliability were acceptable. The addition of nutrient values as an analytical validation approach adds strength and consistency to previously reported Niños Sanos validation results using children's blood biomarkers and body mass index. This tool can be used by health professionals as an assessment of obesity risk in several capacities: (1) screener for counseling in a clinic, (2) large survey, (3) guide for participant goal setting and tailoring interventions, and (4) evaluation.

Household Social Needs, Emotional Functioning, and Stress in Low-Income Latinx Children and their Mothers.

Latinx families may be particularly vulnerable to emotional dysfunction, due to higher rates of economic hardship and complex social influences in this population. Little is known about the impact of environmental stressors such as unmet social needs and maternal stress on the emotional health of Latinx children from low-income families. We conducted secondary analyses using survey and biomarker data from 432 Latinx children and mothers collected in a separate study. We used binomial and multinomial logistic regression to test if household social needs, or maternal perceived stress or hair cortisol concentration (HCC), predicted child measures of emotional functioning or child HCC, independent of relevant sociodemographic factors. Approximately 40% of children in the sample had symptoms consistent with emotional dysfunction, and over 37% of households reported five or more social needs. High perceived maternal stress predicted higher odds of child emotional dysfunction (OR = 2.15; 95% CI [1.14, 4.04]; p = 0.01), and high maternal HCC was positively associated with high child HCC (OR = 10.60; 95% CI [4.20, 26.74]; p < 0.01). Most individual household social needs, as well as the level of household social need, were not independently associated with child emotional dysfunction or child HCC. Our findings begin to define a framework for understanding emotional health, stress, and resilience when caring for Latinx children and mothers living with high levels of social need, and the need for integrated mental health and social needs screening and interventions in settings that serve this population.

A Cross-Sectional Study of the Characteristics Associated With Chronic Pain Documentation on the Problem List.

ABSTRACT: Chronic pain is often elusive because of its specific diagnosis and complex presentation, making it challenging for healthcare providers to develop safe and effective treatment plans. Experts recommend a multifaceted approach to managing chronic pain that requires interdisciplinary communication and coordination. Studies have found that patients with a complete problem list receive better follow-up care. This study aimed to determine the factors associated with chronic pain documentation in the problem list. This study included 126 clinics and 12,803 patients 18 years or older with a chronic pain diagnosis within 6 months before or during the study period. The findings revealed that 46.4% of the participants were older than 60 years, 68.3% were female, and 52.1% had chronic pain documented on their problem list. Chi-square tests revealed significant differences in demographics between those who did and did not have chronic pain documented on their problem list, with 55.2% of individuals younger than 60 years having chronic pain documented on their problem list, 55.0% of female patients, 60.3% of Black non-Hispanic people, and 64.8% of migraine sufferers. Logistic regression analysis revealed that age, sex, race/ethnicity, diagnosis type, and opioid prescriptions were significant predictors of chronic pain documentation on the problem list.

COVID-19 mitigation behaviors among English-Speaking Hmong Americans.

BACKGROUND: COVID-19 mitigation strategies such as masking, social distancing, avoiding group gatherings, and vaccination uptake are crucial interventions to preventing the spread of COVID-19. At present, COVID-19 data are aggregated and fail to identify subgroup variation in Asian American communities such as Hmong Americans. To understand the acceptance, adoption, and adherence to COVID-19 mitigation behaviors, an investigation of Hmong Americans' contextual and personal characteristics was conducted. METHODS: This study aims to describe COVID-19 mitigation behaviors among Hmong Americans and the contextual and personal characteristics that influence these behaviors. A cross-sectional online survey was conducted from April 8 till June 1, 2021, with Hmong Americans aged 18 and over. Descriptive statistics were used to summarize the overall characteristics and COVID-19 related behaviors of Hmong Americans. Chi-square and Fisher's Exact Test were computed to describe COVID-19 mitigation behaviors by gender and generational status (a marker of acculturation). RESULTS: The sample included 507 participants who completed the survey. A majority of the Hmong American participants in our study reported masking (449/505, 88.9%), social distancing (270/496, 55.3%), avoiding group gatherings (345/505, 68.3%), avoiding public spaces (366/506, 72.3%), and obtaining the COVID-19 vaccination (350/506, 69.2%) to stay safe from COVID-19. Women were more likely to socially distance (P = .005), and avoid family (P = .005), and social gatherings (P = .009) compared to men. Social influence patterns related to mitigation behaviors varied by sex. Men were more likely compared to women to be influenced by Hmong community leaders to participate in family and group gatherings (P = .026), masking (P = .029), social distancing (P = .022), and vaccination uptake (P = .037), whereas healthcare providers and government officials were social influencers for social distancing and masking for women. Patterns of social distancing and group gatherings were also influenced by generational status. CONCLUSION: Contextual and personal characteristics influence COVID-19 mitigation behaviors among English speaking Hmong Americans. These findings have implications for identifying and implementing culturally appropriate health messages, future public health interventions, policy development, and ongoing research with this population.

Social Needs and Acculturation as Predictors of Emotional Problems and Perceived Stress Among Latinx Mothers with Low Income.

Associations between household social needs, acculturation, and emotional health remain understudied, particularly among Latinx mothers. We analyzed baseline survey data from 455 Latinx mothers in a previous study. Using multinomial regression, we examined whether emotional problems and perceived stress were associated with household social needs and acculturation. Almost half the sample reported four or more household social needs. Social needs cumulatively and independently predicted increased odds of frequent emotional problems or perceived stress. Lower acculturation predicted lower odds of frequent emotional problems. There is increased risk for emotional problems and stress in low-income Latinx mothers who experience high social need. Integrated social service and mental health care models may be one way to improve health outcomes. More research is needed to understand how clinical settings can leverage unique cultural protective factors to address the social and emotional health needs of Latinx mothers.

A Least Absolute Shrinkage and Selection Operator-Derived Predictive Model for Postoperative Respiratory Failure in a Heterogeneous Adult Elective Surgery Patient Population.

BACKGROUND: Postoperative respiratory failure (PRF) is associated with increased hospital charges and worse patient outcomes. Reliable prediction models can help to guide postoperative planning to optimize care, to guide resource allocation, and to foster shared decision-making with patients. RESEARCH QUESTION: Can a predictive model be developed to accurately identify patients at high risk of PRF? STUDY DESIGN AND METHODS: In this single-site proof-of-concept study, we used structured query language to extract, transform, and load electronic health record data from 23,999 consecutive adult patients admitted for elective surgery (2014-2021). Our primary outcome was PRF, defined as mechanical ventilation after surgery of > 48 h. Predictors of interest included demographics, comorbidities, and intraoperative factors. We used logistic regression to build a predictive model and the least absolute shrinkage and selection operator procedure to select variables and to estimate model coefficients. We evaluated model performance using optimism-corrected area under the receiver operating curve and area under the precision-recall curve and calculated sensitivity, specificity, positive and negative predictive values, and Brier scores. RESULTS: Two hundred twenty-five patients (0.94%) demonstrated PRF. The 18-variable predictive model included: operations on the cardiovascular, nervous, digestive, urinary, or musculoskeletal system; surgical specialty orthopedic (nonspine); Medicare or Medicaid (as the primary payer); race unknown; American Society of Anesthesiologists class ≥ III; BMI of 30 to 34.9 kg/m2; anesthesia duration (per hour); net fluid at end of the operation (per liter); median intraoperative FIO2, end title CO2, heart rate, and tidal volume; and intraoperative vasopressor medications. The optimism-corrected area under the receiver operating curve was 0.835 (95% CI,0.808-0.862) and the area under the precision-recall curve was 0.156 (95% CI, 0.105-0.203). INTERPRETATION: This single-center proof-of-concept study demonstrated that a structured query language extract, transform, and load process, based on readily available patient and intraoperative variables, can be used to develop a prediction model for PRF. This PRF prediction model is scalable for multicenter research. Clinical applications include decision support to guide postoperative level of care admission and treatment decisions.

The Association Between Habitual Sleep Duration and Blood Pressure Control in United States (US) Adults with Hypertension.

Purpose: This study examined the relationship between habitual sleep duration and blood pressure (BP) control in adults with hypertension. Methods: This cross-sectional study used data of 5163 adults with hypertension obtained from the 2015-2018 National Health and Nutrition Examination Survey (NHANES). Multivariable logistic regression was used to analyze the association between habitual sleep duration and BP control. Habitual sleep duration was self-reported and defined as the amount of sleep usually obtained in a night or main sleep period during weekdays or workdays. It was categorized as <6, 6 - <7, 7-9, and >9 hours. BP control was defined as average systolic BP <130mmHg and diastolic BP <80mmHg. Results: Results from the fully adjusted models show that among all adults with hypertension, habitual sleep duration of <6 hours night/main sleep period was associated with reduced odds of BP control (OR = 0.53, 95% CI: 0ss.37-0.76, P = 0.001) when compared to 7-9 hours. In the subpopulation of adults who were on antihypertensive medication, those with a sleep duration of <6 hours had lower odds of BP control than those with a sleep duration of 7-9 hours (OR = 0.53, 95% CI: 0.36-0.77, P = 0.002). No significant differences were noted in all adults with hypertension and in the subpopulation of those on antihypertensive medication in BP control between the reference sleep duration group (7-9 hours) and the 6 - <7 or >9 hours groups. There were no significant differences across age groups or gender in the relationship between habitual sleep duration and BP control. Conclusion: Sleep duration of <6 hours is associated with reduced odds of hypertension control. These significant findings indicate that interventions to support adequate habitual sleep duration may be a promising addition to the current hypertension management guidelines.

Outcomes and risk factors for delayed-onset postoperative respiratory failure: a multi-center case-control study by the University of California Critical Care Research Collaborative (UC3RC).

BACKGROUND: Few interventions are known to reduce the incidence of respiratory failure that occurs following elective surgery (postoperative respiratory failure; PRF). We previously reported risk factors associated with PRF that occurs within the first 5 days after elective surgery (early PRF; E-PRF); however, PRF that occurs six or more days after elective surgery (late PRF; L-PRF) likely represents a different entity. We hypothesized that L-PRF would be associated with worse outcomes and different risk factors than E-PRF. METHODS: This was a retrospective matched case-control study of 59,073 consecutive adult patients admitted for elective non-cardiac and non-pulmonary surgical procedures at one of five University of California academic medical centers between October 2012 and September 2015. We identified patients with L-PRF, confirmed by surgeon and intensivist subject matter expert review, and matched them 1:1 to patients who did not develop PRF (No-PRF) based on hospital, age, and surgical procedure. We then analyzed risk factors and outcomes associated with L-PRF compared to E-PRF and No-PRF. RESULTS: Among 95 patients with L-PRF, 50.5% were female, 71.6% white, 27.4% Hispanic, and 53.7% Medicare recipients; the median age was 63 years (IQR 56, 70). Compared to 95 matched patients with No-PRF and 319 patients who developed E-PRF, L-PRF was associated with higher morbidity and mortality, longer hospital and intensive care unit length of stay, and increased costs. Compared to No-PRF, factors associated with L-PRF included: preexisiting neurologic disease (OR 4.36, 95% CI 1.81-10.46), anesthesia duration per hour (OR 1.22, 95% CI 1.04-1.44), and maximum intraoperative peak inspiratory pressure per cm H20 (OR 1.14, 95% CI 1.06-1.22). CONCLUSIONS: We identified that pre-existing neurologic disease, longer duration of anesthesia, and greater maximum intraoperative peak inspiratory pressures were associated with respiratory failure that developed six or more days after elective surgery in adult patients (L-PRF). Interventions targeting these factors may be worthy of future evaluation.

Factors associated with habitual sleep duration in US adults with hypertension: a cross-sectional study of the 2015-2018 National Health and Nutrition Examination Survey.

BACKGROUND: The relationship between inadequate sleep duration and hypertension risk has been established in the general population, but there is a gap in the literature on predictors of habitual sleep duration in adults with hypertension. This study examined factors associated with habitual sleep duration among adults with hypertension in the United States (US). METHODS: Data of 5660 adults with hypertension were obtained by combining the 2015-2018 cycles of the National Health and Nutrition Examination Survey (NHANES). Survey weighted multinomial logistic regression models were fit to examine factors associated with short (< 7 h) and long (> 9 h) sleep duration with adequate sleep duration (7-9 h) as the reference. RESULTS: The prevalence of self-reported adequate sleep duration was 65.7%, while short sleep duration was 23.6%, and long sleep duration 10.7%. Short sleep duration (compared to adequate sleep duration) was positively associated with history of seeking help for sleeping difficulties (relative risk ratio [RRR], 1.25; 95% confidence interval [CI], 1.02-1.53), Non-Hispanic Black race/ethnicity (RRR, 2.08; 95% CI, 1.61-2.67), working ≥45 h/week (RRR, 1.81; 95% CI, 1.32-2.48), and negatively associated with older age ≥ 65 years (RRR, 0.63; 95% CI, 0.45-0.91) and female gender (RRR, 0.70; 95% CI, 0.56-0.88). Long sleep duration was positively associated with female gender (RRR, 1.24; 95% CI, 1.001-1.54), chronic kidney disease (RRR, 1.48; 95% CI, 1.14-1.92), moderate depressive symptoms (RRR, 1.62; 95% CI, 1.08-2.44), moderately severe to severe depressive symptoms (RRR, 1.89; 95% CI, 1.05-3.43), being in retirement (RRR, 3.46; 95% CI, 2.18-5.49), and not working due to health reasons (RRR, 4.87; 95% CI, 2.89-8.22) or other reasons (RRR, 3.29; 95% CI, 1.84-5.88). CONCLUSION: This population-based study identified factors independently associated with habitual sleep duration in adults with hypertension. These included help-seeking for sleeping difficulty, gender, age, chronic kidney disease, depressive symptoms, race/ethnicity, and employment status. These findings can help in the development of tailored approaches for promoting adequate sleep duration in adults with hypertension.

Factors Associated With Cannabis Use During the Reproductive Cycle: A Retrospective Cross-Sectional Study of Women in States With Recreational and Medical Cannabis Legalization.

INTRODUCTION: Passage of cannabis laws may impact cannabis use and the use of other substances. The suggested association is of particular concern in pregnant women where exposure to substances can cause harm to both the pregnant woman and fetus. The present study contributes to the minimal literature on factors associated with cannabis use during the preconception, prenatal, and postpartum periods including state legalization status, concurrent use of tobacco and e-cigarettes and adequacy of prenatal care. METHODS: We conducted a cross-sectional analysis using combined survey data from the 2016-2018 Pregnancy Risk Assessment Monitoring System (PRAMS) collected from 36,391 women. Logistic regression was used to estimate the impact of state-legalization, adequacy of prenatal care, and other substance use on cannabis use during the preconception, prenatal, and post-partum periods. RESULTS: In the preconception model, residence in a recreationally legal state (OR: 2.37; 95% CI, 2.04-2.75) or medically legal state (OR:3.32; 95% CI, 2.90-3.80) compared to a non-legal state was associated with higher odds of cannabis use. In the prenatal model, residence in a recreationally legal state was associated with higher odds of cannabis use (OR: 1.51; 95% CI, 1.29-1.79) whereas there was no association with residence in a medically legal state. Tobacco use including e-cigarettes and moderate prenatal alcohol use were also significantly associated with cannabis use. CONCLUSION: Recreational cannabis legalization is associated with the use of cannabis prior to, during, and after pregnancy. Renewed clinical and policy efforts may be warranted to update prenatal substance use prevention programs, educational campaigns, and provider education as cannabis legalization evolves.

Feasibility of Colocating a Nutrition Education Program into a Medical Clinic Setting to Facilitate Pediatric Obesity Prevention.

PURPOSE: Within a medical clinic environment, pediatric obesity prevention education for families faces challenges. Existing long-term government-funded nutrition education programs have the expertise and staff to deliver. The purpose is to determine feasibility of colocating the Expanded Food and Nutrition Education Program (EFNEP) into a medical clinic setting to support pediatric obesity prevention. METHODS: Physicians from a large university teaching and research hospital (n = 73) and 4 small Medicaid-serving community clinics (n = 18) in the same geographic area in northern California were recruited and trained in the patient-referral protocol for a primary prevention intervention provided by EFNEP. The 8-week intervention deployed in the medical clinics, included general nutrition, physical activity and parenting topics anchored with guided goal setting and motivational modeling. Referral, enrollment, and attendance data were collected for 2 years. Parent and physician feasibility surveys, parent interviews and parent risk assessment tools were administered. Paired-sample t-test analysis was conducted. RESULTS: Twenty intervention series with parents of patients (n = 106) were conducted at 5 clinics. Physicians (n = 92) generated 686 referrals. Every 6 referrals generated 1 enrolled parent. Physicians (91%, n = 34) reported the intervention as useful to families. Parents (n = 82) reported improved child behaviors for sleep, screen time, physical activity, and food and beverage offerings (P < .0001) and at family mealtime (P < .001). Focus group interviews (n = 26) with 65 participants indicated that parents (97%) reacted positively to participating in the intervention with about a third indicating the classes were relevant to their needs. CONCLUSION: The intervention is a feasible strategy for the 5 medical clinics. Physicians referred and parents enrolled in the intervention with both physicians and parents indicating positive benefits. Feasibility is contingent upon physician awareness of the intervention and motivation to refer patients and additional EFNEP and clinic staff time to enroll and keep parents engaged.

Psychometric Properties of the Preparedness Assessment for the Transition Home After Stroke Instrument.

PURPOSE: The aim of this study was to evaluate psychometric properties of the Preparedness Assessment for the Transition Home After Stroke (PATH-s), a novel instrument to assess stroke caregiver commitment and capacity. The PATH-s instrument can be obtained at www.rehabnurse.org/pathtool. DESIGN: The design of this study is cross-sectional. METHODS: The PATH-s, the Preparedness for Caregiving Scale (PCS), the Patient Health Questionnaire, the Perceived Stress Scale, and the Global Health Scale were self-reported from a convenience sample of caregiver-stroke survivor dyads (n = 183) during inpatient rehabilitation. RESULTS: Exploratory factor analysis revealed eight factors underlying the PATH-s structure. The PATH-s Cronbach's alpha of .90 demonstrated criterion-related validity with the PCS (r = .79, p < .01). Both the PATH-s and the PCS were negatively correlated with the Patient Health Questionnaire (r = -.26 and -.27, respectively; p < .01) and the Perceived Stress Scale (r = -.12 and -.15, respectively; p > .05) and positively correlated with the Global Health Scale (r = -.46 and .46, respectively; p < .01), indicating convergent validity. CONCLUSIONS: The PATH-s demonstrates excellent internal consistency and satisfactory criterion-related and convergent validity. CLINICAL RELEVANCE: The PATH-s may be used to assess the risk/needs of caregivers over time.

Risk Factors Associated With Early Postoperative Respiratory Failure: A Matched Case-Control Study.

BACKGROUND: Postoperative respiratory failure is the most common serious postoperative pulmonary complication, yet little is known about factors that can reduce its incidence. We sought to elucidate modifiable factors associated with respiratory failure that developed within the first 5 d after an elective operation. MATERIALS AND METHODS: Matched case-control study of adults who had an operation at five academic medical centers between October 1, 2012 and September 30, 2015. Cases were identified using administrative data and confirmed via chart review by critical care clinicians. Controls were matched 1:1 to cases based on hospital, age, and surgical procedure. RESULTS: Our total sample (n = 638) was 56.4% female, 71.3% white, and had a median age of 62 y (interquartile range 51, 70). Factors associated with early postoperative respiratory failure included male gender (odds ratio [OR] 1.72, 95% confidence interval [CI] 1.12-2.63), American Society of Anesthesiologists class III or greater (OR 2.85, 95% CI 1.74-4.66), greater number of preexisting comorbidities (OR 1.14, 95% CI 1.004-1.30), increased operative duration (OR 1.14, 95% CI 1.06-1.22), increased intraoperative positive end-expiratory pressure (OR 1.23, 95% CI 1.13-1.35) and tidal volume (OR 1.13, 95% CI 1.004-1.27), and greater net fluid balance at 24 h (OR 1.17, 95% CI 1.07-1.28). CONCLUSIONS: We found greater intraoperative ventilator volume and pressure and 24-h fluid balance to be potentially modifiable factors associated with developing early postoperative respiratory failure. Further studies are warranted to independently verify these risk factors, explore their role in development of early postoperative respiratory failure, and potentially evaluate targeted interventions.

Obesity Risk Assessment Tool for Low-Income Spanish Speaking Immigrant Parents with Young Children: Validity with BMI and Biomarkers of Obesity.

Children of Hispanic origin bear a high risk of obesity. Child weight gain trajectories are influenced by the family environment, including parent feeding practices. Excessive body fat can result in unhealthful metabolic and lipid profiles and increased risk of metabolic diseases. The objective was to estimate criterion validity of an obesity risk assessment tool targeting Spanish-speaking families of Mexican origin using anthropometric measures and blood values of their young children. A cross-sectional study design with five data collection sessions was conducted over an eight-week period and involved 206 parent/child dyads recruited at Head Start and the Special Supplemental Nutrition Program for Women, Infants and Children in Northern California. Main outcome measures were criterion validity of Niños Sanos, a pediatric obesity risk assessment tool, using anthropometric measures and blood biomarkers. Niños Sanos scores were inversely related to child BMI-for-age percentiles (p = 0.02), waist-for-height ratios (p = 0.05) and inversely related to blood biomarkers for the metabolic index (p = 0.03) and lipid index (p = 0.05) and positively related to anti-inflammatory index (p = 0.047). Overall, children with higher Niños Sanos scores had more healthful lipid, metabolic and inflammatory profiles, as well as lower BMI-for-age percentiles and waist-to height ratios, providing evidence for the criterion validity of the tool. Niños Sanos can be used by child obesity researchers, by counselors and medical professionals during clinic visits as a screening tool and by educators as a tool to set goals for behavior change.

Obesity Risk Assessment Tool among 3-5 Year Olds: Validation with Biomarkers of Low-Grade Chronic Inflammation.

Background: Many families with young children practice nutrition, parenting, and lifestyle behaviors that set their children on trajectories for unhealthful weight gain. Potential adverse health effects of excessive body fat can result in the secretion of proinflammatory molecules and increased risk of inflammation and metabolic diseases. A pediatric obesity risk assessment tool named Healthy Kids (HK), demonstrated validity in a longitudinal study with child's measured BMI and 36-hour diet, screen, sleep, and activity logs. Our objective was to provide additional evidence of validity with low-income families with literacy issues using an inflammation index composed of four proinflammatory biomarkers. Methods: Parent/child pairs (n = 104) from Head Start and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provided HK, blood samples, and measured heights/weights. Select child inflammatory markers were discretized into two groups of HK scores. Data were analyzed with a mixed model adjusted for children's age and BMI. Results: A significant HK-time interaction effect was shown for the child inflammation index with two data collection points 1 year apart (pdid = 0.039). This index increased over 12 months in children with less healthful behaviors (p = 0.007), but not in children with more healthful profiles (p = 0.58). Conclusions: Children with less healthful HK scores had an elevated inflammation index indicating a low-grade chronic systemic inflammatory state. Taken together with our previously published findings, the HK tool has potential as a rapid and easy-to-administer assessment of the family environment and the child's obesity risk. HK can be useful for federal nutrition programs for evaluation, risk assessment, goal setting, and/or program planning in clinical and community environments.

Development of an Instrument to Assess Stroke Caregivers' Readiness for the Transition Home.

PURPOSE: The study purpose was to develop a measure to assess stroke caregivers' commitment and capacity to assume the caregiving role prior to discharge. DESIGN: Participants were caregivers of stroke survivors in an inpatient rehabilitation facility. METHODS: A sequential, multimethod approach, which included item generation from qualitative data, review of items by expert clinicians, cognitive interviews to determine response format (n = 22), and item clarity (n = 20), and an analysis of pilot data were utilized. FINDINGS: Cognitive interviewing provided information to improve item clarity. CONCLUSION: This instrument development approach resulted in the Preparedness Assessment for the Transition Home After Stroke (PATH-s), a 26-item self-report instrument. The PATH-s represents the domains of the Model of Caregiver Readiness, upon which the instrument was developed. CLINICAL RELEVANCE: The PATH-s, once further validated, may guide healthcare providers in the development of tailored care plans to address identified gaps and better prepare caregivers for the transition home.

Postoperative respiratory failure: An update on the validity of the Agency for Healthcare Research and Quality Patient Safety Indicator 11 in an era of clinical documentation improvement programs.

BACKGROUND: Administrative data can be used to identify cases of postoperative respiratory failure (PRF). We aimed to determine if recent changes to the Agency for Healthcare Research and Quality Patient Safety Indicator 11 (PSI 11) and adoption of clinical documentation improvement programs have improved the validity of PSI 11. We also analyzed reasons why PSI 11 was falsely triggered. STUDY DESIGN: Cross-sectional study of all eligible discharges using health record data from five academic medical centers between October 1, 2012 and September 30, 2015. RESULTS: Of 437 flagged records, 434 (99.3%) were accurately coded and 414 (94.7%) represented true clinical PRF. None of the false positive records involved respiratory failure present on admission. Most (78.3%) false positive records required airway protection but did not have respiratory failure. CONCLUSION: The validity of PSI 11 has improved with recent changes to the code criterion and adoption of clinical documentation improvement programs.

Extent of diagnostic inquiry among a population-based cohort of patients with cancer of unknown primary.

PURPOSE: Current cancer registry data cannot distinguish a justified cancer of unknown primary (CUP) diagnosis, where the patient received a complete diagnostic evaluation that was unable to identify the primary tumor, from potentially misclassified patients, documented as CUP but not based on a complete diagnostic evaluation. This misclassification may skew population-based cancer registry surveillance research used to frame and guide translational CUP research. We identified characteristics of patients who received justified vs. potentially misclassified CUP diagnoses in cancer registry data. METHODS: We developed a conceptual definition of a complete diagnostic evaluation from professional society-recommended guidelines. We translated this definition into procedure codes in the Medicare encounter data. We assessed age, gender, comorbidities, urban or rural residence, income, race, and tumor pathology by receipt of a complete diagnostic evaluation and palliative therapy among 10,575 elderly CUP patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset. We calculated odds ratios and adjusted probabilities using marginal standardization. RESULTS: Only 35% of elderly CUP patients identified in the cancer registry received a complete diagnostic evaluation. After adjustment for age and comorbidities, socioeconomic barriers to a complete diagnostic evaluation persisted: adjusted odds ratio and 95% confidence interval (AOR) for rural vs. urban 0.8(0.8,0.9) and for highest income vs. lowest income 1.2(1.1,1.4). Patients with vague or undocumented tumor pathology in SEER had 80% lower odds of receiving a complete diagnostic evaluation AOR(95%CI)=0.2(0.2,0.2). Although patients with a complete diagnostic evaluation were twice as likely to receive palliative therapy than those without a complete evaluation, AOR(95%CI)=2.0(1.7,2.3), they only had a 46.7% probability of receiving therapy, 95%CI=(44.4,49.1). CONCLUSION: Patients without a complete diagnostic evaluation are not limited to the frail and underserved. For accurate assessment of the CUP burden and disparities in utilization of diagnostic care, we recommend that the SEER definition of CUP include the extent of diagnostic inquiry.