Inadequate Dietary Education and Poor Adherence to a High Protein, Low Sodium Diet in Cirrhosis: Mixed Methods Approach.

BACKGROUND: Malnutrition in cirrhosis is associated with poor outcomes, leading to guidelines for a high protein, low sodium diet; however, there is no guidance regarding the implementation of diet education in clinical practice. METHODS: A mixed methods study enrolled 21 patients with cirrhosis and their caregivers. Semi-structured interviews on barriers and facilitators of dietary education and adherence were conducted. Demographic and clinical data were obtained, along with quantitative measures of dietary adherence, including 24-h food recall and spot urine sodium. Combined deductive and inductive coding was used to identify qualitative themes, along with a quantitative assessment of interviews. Quantitative data was reported using descriptive statistics with frequencies, mean and confidence intervals. RESULTS: Participants were mostly male (16/21) with a mean age 57.8 years (SE 2.8) and MELD-Na 9 (SE 1.2). 4 themes emerged: 1. More than 50% of participants and caregivers endorsed no or inadequate diet education 2. They reported mostly negative experiences with dietary adherence with largest impact on social life 3. Facilitators of adherence included the presence of household support and fear of complications of cirrhosis 4. Overwhelmingly desired non-generic handouts and information. Dietary adherence was poor with only one participant meeting protein and sodium requirements based on food recall. Four participants who adhered to < 2000 mg sodium had inadequate daily caloric intake. CONCLUSIONS: Dietary education is inadequate, and adherence to dietary recommendations is poor in patients with cirrhosis. Future studies should use these barriers and facilitators for intervention development.

Delayed Diagnostic Paracentesis Is Associated with Increased Preventable Healthcare Utilization in Disadvantaged Patient Populations with Advanced Liver Disease and Elevated INR.

BACKGROUND: Patients hospitalized with cirrhosis, ascites, and elevated INR often experience delays in timely diagnostic paracentesis. AIMS: Identify whether delays in diagnostic paracentesis were associated with adverse outcomes in a hospital system serving a large disadvantaged population. METHODS: Retrospective cohort analysis of patients admitted from January 2017 to October 2019 with cirrhosis, ascites, and INR ≥ 1.5 across a multi-hospital health system in central Texas. We examined demographic and clinical characteristics of patients with diagnostic paracentesis (1) ≤ 24 h; (2) > 24 h; (3) therapeutic only or no paracentesis. We used logistic regression to examine differences in clinical outcomes controlling for confounders. RESULTS: 479 patients met inclusion criteria. 30.0% (N = 143) were Latino, 6.7% (N = 32) African American, and 67.8% (N = 325) under or uninsured. 54.1% of patients received a diagnostic paracentesis ≤ 24 h of admission and 21.1% did not receive a diagnostic paracentesis during the hospitalization. Undergoing diagnostic paracentesis > 24 h of admission was associated with a 2.3 day increase in length of stay (95% CI 0.8-3.8), and OR 1.7 for an Emergency Room visit within 30 days of discharge (95% CI 1.1-2.7) compared to receiving a diagnostic paracentesis ≤ 24 h. Patients receiving diagnostic paracentesis in radiology were more likely to have a delay in procedure OR 5.8 (95% CI 2.8-8.6). CONCLUSION: Delayed diagnostic paracentesis is associated with increased preventable healthcare utilization compared with timely diagnostic paracentesis. Health systems should support efforts to ensure timely diagnostic paracentesis for patients with advanced liver disease, including performance at the bedside.

MELD-Na Accurately Predicts 6-Month Mortality in Patients With Decompensated Cirrhosis: Potential Trigger for Hospice Referral.

GOAL: The goal of this study was to determine the accuracy of Model of End-stage Liver Disease-Sodium (MELD-Na) in predicting 6-month mortality for patients listed for liver transplantation on the United Network of Organ Sharing (UNOS) waitlist. BACKGROUND: End-stage liver disease patients underutilize hospice services despite significant morbidity and mortality associated with advanced liver disease. A well-known barrier to hospice referral is clinician uncertainty in identifying patients with an expected survival of <6 months, a requirement for a referral. METHODS: Retrospective cross-sectional analysis was performed from UNOS data spanning February 27, 2002, to September 30, 2019. Inclusion criteria of patients aged 18 years and above, diagnosis of cirrhosis, liver transplant eligible, and listed in the UNOS database. Exclusion criteria included fulminant hepatic failure, prior history of liver transplantation, diagnosis of hepatocellular carcinoma, receipt of liver transplant in <180 days, or removal from waiting list <180 days for a reason other than death. MEASUREMENT: Mortality by 180 days. RESULTS: Of the 93,157 patients that met inclusion criteria, MELD-Na was calculated for all patients with sodium, total bilirubin, international normalized ratio, and creatinine available (N=79,611). The c -statistic with 95% confidence interval for MELD-Na for the predicted 6-month mortality was 0.83 (0.827-0.835). Mean MELD-Na of 28.2 was associated with ≤50% 6-month survival. CONCLUSION: MELD-Na is an objective, quick measure that can aid providers in identifying patients with increased 6-month mortality in time-constrained settings, and a score of 28 can trigger the discussion for hospice as a means of improving value-based health care.

Endovascular Thrombolysis or Thrombectomy for Cerebral Venous Thrombosis: Study of Nationwide Inpatient Sample 2004-2014.

BACKGROUND AND PURPOSE: 15% of cerebral venous thrombosis (CVT) patients have poor outcomes despite anticoagulation. Uncontrolled studies suggest that endovascular approaches may benefit such patients. In this study, we analyze Nationwide Inpatient Sample (NIS) data to evaluate the safety and efficacy of endovascular therapy (ET) versus medical management in CVT. We also examined the yearly trends of ET utilization in the United States. METHODS: International Classification of Diseases, Ninth Revision, Clinical Modification codes were utilized to identify CVT patients who received ET. To make the data nationally representative, weights were applied per NIS recommendations. Since ET was not randomly assigned to patients and was likely to be influenced by disease severity, propensity score weighting methods were utilized to correct for this treatment selection bias. Outcome variables included in-hospital mortality and discharge disposition. To determine if our primary outcomes were associated with ET, we used weighted multivariable logistic regression analyses. RESULTS: Of the 49,952 estimated CVT cases, 48,704 (97%) received medical management and 1248 (3%) received ET (mechanical thrombectomy [MT] alone, N = 269 [21%], MT ± thrombolysis, N = 297 [24%], and thrombolysis alone, N = 682 [55%]). Patients who received ET were older with more CVT associated complications including venous infarct, intracranial hemorrhage, coma, seizure, and cerebral edema. There was a significant yearly rise in the use of ET, with a trend favoring MT versus thrombolysis alone. ET was independently associated with an increased risk of death (odds ratio 1.96, 95% confidence interval 1.15-3.32). CONCLUSIONS: Patients receiving ET experienced higher mortality after adjusting for age and CVT associated complications. Large, well designed prospective randomized trials are warranted for further evaluation of the safety and efficacy of ETs.

Using Topic Modeling to Develop Multi-level Descriptions of Naturalistic Driving Data from Drivers with and without Sleep Apnea.

One challenge in using naturalistic driving data is producing a holistic analysis of these highly variable datasets. Typical analyses focus on isolated events, such as large g-force accelerations indicating a possible near-crash. Examining isolated events is ill-suited for identifying patterns in continuous activities such as maintaining vehicle control. We present an alternative approach that converts driving data into a text representation and uses topic modeling to identify patterns across the dataset. This approach enables the discovery of non-linear patterns, reduces the dimensionality of the data, and captures subtle variations in driver behavior. In this study topic models are used to concisely described patterns in trips from drivers with and without untreated obstructive sleep apnea (OSA). The analysis included 5000 trips (50 trips from 100 drivers; 66 drivers with OSA; 34 comparison drivers). Trips were treated as documents, and speed and acceleration data from the trips were converted to "driving words." The identified patterns, called topics, were determined based on regularities in the co-occurrence of the driving words within the trips. This representation was used in random forest models to predict the driver condition (i.e., OSA or comparison) for each trip. Models with 10, 15 and 20 topics had better accuracy in predicting the driver condition, with a maximum AUC of 0.73 for a model with 20 topics. Trips from drivers with OSA were more likely to be defined by topics for smaller lateral accelerations at low speeds. The results demonstrate topic modeling as a useful tool for extracting meaningful information from naturalistic driving datasets.

Attachment and Effortful Control in Toddlerhood Predict Academic Achievement Over a Decade Later.

A child's attachment to his or her caregiver is central to the child's development. However, current understanding of subtle, indirect, and complex long-term influences of attachment on various areas of functioning remains incomplete. Research has shown that (a) parent-child attachment influences the development of effortful control and that (b) effortful control influences academic success. The entire developmental cascade among these three constructs over many years, however, has rarely been examined. This article reports a multimethod, decade-long study that examined the influence of mother-child attachment and effortful control in toddlerhood on school achievement in early adolescence. Both attachment security and effortful control uniquely predicted academic achievement a decade later. Effortful control mediated the association between early attachment and school achievement during adolescence. This work suggests that attachment security triggers an adaptive cascade by promoting effortful control, a vital set of skills necessary for future academic success.

Mutually Responsive Orientation: A novel observational assessment of mother-child mealtime interactions.

Mother-child mealtime interactions during preschool years is an important but overlooked factor when evaluating the influence of parent-child relationships on child eating and weight. This paper describes the validation of the Mutually Responsive Orientation (MRO) coding system adapted for assessing parent-child interactions during food preparation and consumption situations. Home-based mealtimes of 94 mothers and their children (3.03 ± 0.75 years) were filmed at two time points, 12-months apart. Filmed dimensions of mutual mother-child responsiveness, shared positive affect, maternal control relating to food and child compliance were assessed. Objective BMI and maternal reports of parenting, feeding, child eating, diet and child temperament were also collected. Correlations, repeated measures ANOVAs and regressions were performed to examine the validity of MRO variables and their stability across both time points. Validation analysis showed the MRO coding system performed as expected: dyads with higher MRO scores expressed lower control/power assertion, lower child non-compliance, and greater committed compliance. The measure demonstrated sensitivity to specific contexts: maternal responsiveness, mother and child positive affect were higher during food consumption compared to food preparation. Coded dimensions were stable across time points, with the exception of decreases in maternal responsiveness in food consumption and child non-compliance in food preparation. MRO and maternal dimensions were correlated with maternally reported parenting and feeding measures. Maternal responsiveness (inversely) and child responsiveness (positively) were concurrently associated with child fussy eating, and child refusal was prospectively and inversely associated with child fussy eating. Findings suggest the adapted MRO coding system is a useful measure for examining observed parent-child mealtime interactions potentially implicated in preschoolers' eating and weight development.

Measuring listening effort: driving simulator versus simple dual-task paradigm.

OBJECTIVES: The dual-task paradigm has been widely used to measure listening effort. The primary objectives of the study were to (1) investigate the effect of hearing aid amplification and a hearing aid directional technology on listening effort measured by a complicated, more real world dual-task paradigm and (2) compare the results obtained with this paradigm to a simpler laboratory-style dual-task paradigm. DESIGN: The listening effort of adults with hearing impairment was measured using two dual-task paradigms, wherein participants performed a speech recognition task simultaneously with either a driving task in a simulator or a visual reaction-time task in a sound-treated booth. The speech materials and road noises for the speech recognition task were recorded in a van traveling on the highway in three hearing aid conditions: unaided, aided with omnidirectional processing (OMNI), and aided with directional processing (DIR). The change in the driving task or the visual reaction-time task performance across the conditions quantified the change in listening effort. RESULTS: Compared to the driving-only condition, driving performance declined significantly with the addition of the speech recognition task. Although the speech recognition score was higher in the OMNI and DIR conditions than in the unaided condition, driving performance was similar across these three conditions, suggesting that listening effort was not affected by amplification and directional processing. Results from the simple dual-task paradigm showed a similar trend: hearing aid technologies improved speech recognition performance, but did not affect performance in the visual reaction-time task (i.e., reduce listening effort). The correlation between listening effort measured using the driving paradigm and the visual reaction-time task paradigm was significant. The finding showing that our older (56 to 85 years old) participants' better speech recognition performance did not result in reduced listening effort was not consistent with literature that evaluated younger (approximately 20 years old), normal hearing adults. Because of this, a follow-up study was conducted. In the follow-up study, the visual reaction-time dual-task experiment using the same speech materials and road noises was repeated on younger adults with normal hearing. Contrary to findings with older participants, the results indicated that the directional technology significantly improved performance in both speech recognition and visual reaction-time tasks. CONCLUSIONS: Adding a speech listening task to driving undermined driving performance. Hearing aid technologies significantly improved speech recognition while driving, but did not significantly reduce listening effort. Listening effort measured by dual-task experiments using a simulated real-world driving task and a conventional laboratory-style task was generally consistent. For a given listening environment, the benefit of hearing aid technologies on listening effort measured from younger adults with normal hearing may not be fully translated to older listeners with hearing impairment.

The development of stranger fear in infancy and toddlerhood: normative development, individual differences, antecedents, and outcomes.

Despite implications that stranger fear is an important aspect of developing behavioral inhibition, a known risk factor for anxiety, normative and atypical developmental trajectories of stranger fear across infancy and toddlerhood remain understudied. We used a large, longitudinal data set (N = 1285) including multi-trait, multi-method assessments of temperament to examine the normative course of development for stranger fear and to explore the possibility that individual differences exist in trajectories of stranger fear development between 6 and 36 months of age. A latent class growth analysis suggested four different trajectories of stranger fear during this period. Stable, high levels of stranger fear over time were associated with poorer RSA suppression at 6 months of age. Rates of concordance in trajectory-based class membership for identical (monozygotic) and fraternal (dizygotic) twins, along with associations between atypical stranger fear development and greater anxiety-related maternal characteristics, suggested that individual differences in developmental trajectories of stranger fear may be heritable. Importantly, trajectories of stranger fear during infancy and toddlerhood were linked to individual differences in behavioral inhibition, with chronically high levels of stranger fear and sharp increases in stranger fear over time related to greater levels of inhibition than other developmental trajectories.

The Language of Driving: Advantages and Applications of Symbolic Data Reduction for Analysis of Naturalistic Driving Data.

Recent advances in onboard vehicle data recording devices have created an abundance of naturalistic driving data. The amount of data exceeds the resources available for analysis; this situation forces researchers to focus on analyses of critical events and to use simple heuristics to identify those events. Critical event analysis eliminates the context that can be critical in understanding driver behavior and can reduce the generalizability of the analysis. This work introduced a method of naturalistic driving data analysis that would allow researchers to examine entire data sets by reducing the sets by more than 90%. The method utilized a symbolic data reduction algorithm, symbolic aggregate approximation (SAX), which reduced time series data to a string of letters. SAX can be applied to any continuous measurement, and SAX output can be reintegrated into a data set to preserve categorical information. This work explored the application of SAX to speed and acceleration data from a naturalistic driving data set and demonstrated SAX's integration with other methods that could begin to tame the complexity of naturalistic data.

Consider hospice in end-stage liver disease prognostic scale to open discussions regarding six-month mortality.

Background and Aim: Hospice is underutilized in the management of patients with end-stage liver disease and may improve the patient experience at the end of life. This study aims to create a novel prognostic scale to accurately predict 6-month mortality to more comprehensively facilitate hospice referral. Methods: Sociodemographic, clinical, and laboratory variables associated with mortality from the United Network for Organ Sharing database were tested in univariate analysis followed by multivariate analyses with four predictor groups: Demographics, Diagnoses, Complexities, and Laboratory studies to develop the hospice in end-stage liver disease prognostic scale (HELP) scale (70% sample, N = 13 516) followed with replication in a 30% (N = 5792) internal validation sample. Results: Only the predictor groups of Complexities and Laboratory studies met the c-statistic threshold of 0.70 for inclusion in the multivariate analyses. Backward elimination in the final logistic regression and validated weighted transformation procedure resulted in: HELP scale = (functional status × 11) + (ascites × 3) + (SBP × 3) + (HE × 4) + (dialysis × 5) + (TIPS × -3) + (albumin × -3) + (MELD-Na ≥ 21 × 20). HELP scale had a strong predictive value for six-month mortality with Area under the Receiver Operating Curve (AUROC) 0.816 and replicated in the validation sample. Conclusion: HELP scale is a novel prognostic score utilizing the strength of model of end-stage liver disease-sodium (MELD-Na), along with clinical factors, for a more nuanced assessment of six-month mortality. This scale can provide an individualized approach in opening discussions of hospice referral and may be better accepted by patients and providers given its contextualization of important clinical factors.

Effect of a Layperson-Delivered Telephone Program for People With Depressive Symptoms.

OBJECTIVE: This study investigated whether a layperson-delivered telephone program focusing on empathy could improve depressive symptoms among adults. METHODS: Data for a subset of participants from a randomized controlled trial (July 6-September 24, 2020) were analyzed to assess the impact of a telephone program on mental health. Participants in this post hoc analysis had baseline depressive symptoms and were assessed for depression, anxiety, loneliness, and isolation. RESULTS: Of the 240 people in the original sample, 58 had depressive symptoms (i.e., baseline scores of ≥10 on the eight-item Patient Health Questionnaire [PHQ-8]); 56 of the 58 were reassessed 4 weeks later. Participants in the intervention arm had greater improvements in PHQ-8 scores (baseline mean±SD=13.0±2.6, postintervention mean=9.2±3.0; mean difference=3.8, 95% CI=2.9-4.7) than participants in the control arm (mean difference=1.3, 95% CI=0.1-2.5) (p=0.013). CONCLUSIONS: This telephone intervention, delivered by a lay workforce, holds promise for reducing the burden on the clinical care system.

Establishing a training plan and estimating inter-rater reliability across the multi-site Texas childhood trauma research network.

OBJECTIVE: Minimal guidance is available in the literature to develop protocols for training non-clinician raters to administer semi-structured psychiatric interviews in large, multi-site studies. Previous work has not produced standardized methods for maintaining rater quality control or estimating interrater reliability (IRR) in such studies. Our objective is to describe the multi-site Texas Childhood Trauma Research Network (TX-CTRN) rater training protocol and activities used to maintain rater calibration and evaluate protocol effectiveness. METHODS: Rater training utilized synchronous and asynchronous didactic learning modules, and certification involved critique of videotaped mock scale administration. Certified raters attended monthly review meetings and completed ongoing scoring exercises for quality assurance purposes. Training protocol effectiveness was evaluated using individual measure and pooled estimated IRRs for three key study measures (TESI-C, CAPS-CA-5, MINI-KID [Major Depressive Episodes - MDE & Posttraumatic Stress Disorder - PTSD modules]). A random selection of video-recorded administrations of these measures was evaluated by three certified raters to estimate agreement statistics, with jackknife (on the videos) used for confidence interval estimation. Kappa, weighted kappa and intraclass correlations were calculated for study measure ratings. RESULTS: IRR agreement across all measures was strong (TESI-C median kappa 0.79, lower 95% CB 0.66; CAPS-CA-5 median weighted kappa 0.71 (0.62), MINI-MDE median kappa 0.71 (0.62), MINI-PTSD median kappa 0.91 (0.9). The combined estimated ICC was ≥0.86 (lower CBs ≥0.69). CONCLUSIONS: The protocol developed by TX-CTRN may serve as a model for other multi-site studies that require comprehensive non-clinician rater training, quality assurance guidelines, and a system for assessing and estimating IRR.

Characterizing patterns of substance use in trauma exposed youth.

OBJECTIVE: Previous work investigating the impact of childhood trauma on substance use and co-occurring psychiatric disorders has primarily been conducted in adults or on specific trauma types. This limits understanding of traumas impact in childhood and how different types of traumas play a role. We sought to characterize substance use in a sample of trauma-exposed youth in the context of psychiatric comorbidities. METHOD: 1152 youth from the Texas Childhood Trauma Research Network (TX-CTRN) that were exposed to at least one trauma meeting DSM-5 Criterion A were assessed for current substance use and psychiatric diagnoses. Latent class analysis was used to identify patterns of substance use. To characterize these patterns, we examined if demographics, number of trauma types experienced, or childhood psychiatric disorders predicted class membership. RESULTS: We identified four primary patterns of substance use: Non-use (66.1%), predominantly alcohol use (19.7%), predominantly cannabis use (4.5%), and polysubstance use (9.7%). Compared to the non-users, polysubstance users tended to be older, Non-Hispanic White, have experienced more types of trauma. They were also more likely to have fulfilled diagnostic criteria for suicidality and ADHD. Comparisons among the substance using classes were more nuanced. CONCLUSION: The findings highlight the need for universal assessments of trauma, substance misuse, and mental health symptoms in youth as the presence or absence of their co-occurrence has implications for treatment.

Effect of Brief Produce Exposure and Unconstrained Grocery Gift Cards on Caregiver Influence on Diet of Elementary Age Children: A Randomized Clinical Trial.

Importance: Children's diets affect health trajectories but are difficult to influence, especially for resource-constrained families. Objective: To assess the effectiveness of providing 4 weeks of grocery gift cards and small produce boxes to caregivers on their ability to support healthy shifts in children's diets. Design, Setting, and Participants: This 2-group randomized clinical trial was conducted from May to July 2021, with 4 weeks of intervention and follow-up at 8 weeks. Resources were provided curbside at 3 schools, 3 housing sites, and 1 after-school site for use at home. Participants consisted of 1 index child ages 5 to 11 years with 1 index caregiver from 68 low-income families. Data were analyzed from July 2021 through March 2022. Interventions: During each week for 4 weeks, caregivers were offered 10-lb (4.5 kg) boxes of fruits and vegetables, $10.00 grocery gift cards, an additional $10.00 gift card over the last 3 weeks triggered by a task completion, and a 1-time choice of a $25.00 food preparation tool. Main Outcomes and Measures: Index child and caregiver diets were measured together over the phone at baseline, 4 weeks, and 8 weeks using the 2019 to 2020 Texas School Physical Activity and Nutrition (SPAN) tool, which measures the number of times food items were eaten over the prior day to report a SPAN Healthy Eating Index (SHEI) score and subscores for specific categories of foods (range, 0-57, with higher scores indicating a more healthful diet). Results: Among 68 children (mean [SD] age, 8.2 [1.7] years; 35 [51.5%] girls) and caregivers (mean [SD] age, 37.9 [7.9] years; 63 mothers [92.6%]) from primarily low-income families, 26 caregivers were Hispanic or Latino (38.2%), while 18 caregivers were Black (26.4%), 25 caregivers were White (36.7%), and 24 caregivers had more than 1 race (35.3%). Most families were below the federal poverty level (41 of 60 families that reported income [68.3%]). Per participating caregiver, a mean (SD) 2.7 [1.4] fruit and vegetable boxes and $42.35 ($25.46) worth of gift cards were picked up over 4 weeks. Mean (SE) child SPAN SHEI increased from 32.03 (0.62) times/d to 33.75 (0.69) times/d at 4 weeks (ie, postintervention) and 34.03 (0.69) times/d 4 weeks later (ie, at 8 weeks of follow-up). Mean (SE) child fruit and vegetable intake increased from 5.31 (0.47) times/d to 5.78 (0.51) times/d postintervention and 6.03 (0.51) times/d at follow-up. Children in the control group did not have improved diet (overall mean [SE] SHEI: 31.48 [0.58] times/d at baseline, 31.68 [0.54] times/d postintervention, and 31.81 [0.52] times/d at follow-up; mean [SE] fruit and vegetable intake: 5.21 [0.45] times/d at baseline, 4.77 [0.45] times/d postintervention, and 4.68 [0.41] times/d at follow-up). Compared with children in the control group, mean SHEI was increased for children in the intervention group by 2.07 times/d postintervention and 2.23 times/d at follow-up. Improvements as a function of program dose were statistically significant for child SHEI (P = .01) and fruit and vegetable intake (P = .03). No significant changes in caregiver diets were found. Conclusions and Relevance: This study found that easily accessed fruits and vegetables and unconstrained grocery store cards provided directly to caregivers over 4 weeks resulted in improvements in child diet, which were sustained over 4 additional weeks. Future work may investigate whether diet improvement from a brief intervention optimized for caregiver flexibility reflects a natural maximum or potential for greater improvements on extension. Trial Registration: ClinicalTrials.gov Identifier: NCT04827654.

Effect of Layperson-Delivered, Empathy-Focused Program of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 Pandemic: A Randomized Clinical Trial.

Importance: Loneliness is a risk factor for many clinical conditions, but there are few effective interventions deployable at scale. Objective: To determine whether a layperson-delivered, empathy-focused program of telephone calls could rapidly improve loneliness, depression, and anxiety in at-risk adults. Design, Setting, and Participants: From July 6 to September 24, 2020, we recruited and followed up 240 adults who were assigned to receive calls (intervention group) or no calls (control group) via block randomization. Loneliness, depression, and anxiety were measured using validated scales at enrollment and after 4 weeks. Intention-to-treat analyses were conducted. Meals on Wheels Central Texas (MOWCTX) clients received calls in their homes or wherever they might have been when the call was received. The study included MOWCTX clients who fit their service criteria, including being homebound and expressing a need for food. A total of 296 participants were screened, of whom 240 were randomized to intervention or control. Interventions: Sixteen callers, aged 17 to 23 years, were briefly trained in empathetic conversational techniques. Each called 6 to 9 participants over 4 weeks daily for the first 5 days, after which clients could choose to drop down to fewer calls but no less than 2 calls a week. Main Outcomes and Measures: Primary outcome was loneliness (3-item UCLA Loneliness Scale, range 3-9; and 6-item De Jong Giervald Loneliness [De Jong] Scale, range 0-6). Secondary outcomes were depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale), and self-rated health (Short Form Health Survey Questionnaire). Results: The 240 participants were aged 27 to 101 years, with 63% aged at least 65 years (n = 149 of 232), 56% living alone (n = 135 of 240), 79% women (n = 190 of 240), 39% Black or African American (n = 94 of 240), and 22% Hispanic or Latino (n = 52 of 240), and all reported at least 1 chronic condition. Of 240 participants enrolled, 13 were lost to follow-up in the intervention arm and 1 in the control arm. Postassessment differences between intervention and control after 4 weeks showed an improvement of 1.1 on the UCLA Loneliness Scale (95% CI, 0.5-1.7; P < .001; Cohen d of 0.48), and improvement of 0.32 on De Jong (95% CI, -0.20 to 0.81; P = .06; Cohen d, 0.17) for loneliness; an improvement of 1.5 on the Personal Health Questionnaire for Depression (95% CI, 0.22-2.7; P < .001; Cohen d, 0.31) for depression; and an improvement of 1.8 on the Generalized Anxiety Disorder scale (95% CI, 0.44 to 3.2; P < .001; Cohen d, 0.35) for anxiety. General physical health on the Short Form Health Questionnaire Survey showed no change, but mental health improved by 2.6 (95% CI, 0.81 to 4.4; P = .003; Cohen d of 0.46). Conclusions and Relevance: A layperson-delivered, empathy-oriented telephone call program reduced loneliness, depression, and anxiety compared with the control group and improved the general mental health of participants within 4 weeks. Future research can determine whether effects on depression and anxiety can be extended to maximize clinical relevance. Trial Registration: ClinicalTrials.gov Identifier: NCT04595708.

Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Decision aids can help inform appropriate selection of total knee replacement (TKR) for advanced knee osteoarthritis (OA). However, few decision aids combine patient education, preference assessment, and artificial intelligence (AI) using patient-reported outcome measurement data to generate personalized estimations of outcomes to augment shared decision-making (SDM). Objective: To assess the effect of an AI-enabled patient decision aid that includes education, preference assessment, and personalized outcome estimations (using patient-reported outcome measurements) on decision quality, patient experience, functional outcomes, and process-level outcomes among individuals with advanced knee OA considering TKR in comparison with education only. Design, Setting, and Participants: This randomized clinical trial at a single US academic orthopedic practice included 129 new adult patients presenting for OA-related knee pain from March 2019 to January 2020. Data were analyzed from April to May 2020. Intervention: Patients were randomized into a group that received a decision aid including patient education, preference assessment, and personalized outcome estimations (intervention group) or a group receiving educational material only (control group) alongside usual care. Main Outcomes and Measures: The primary outcome was decision quality, measured using the Knee OA Decision Quality Instrument (K-DQI). Secondary outcomes were collaborative decision-making (assessed using the CollaboRATE survey), patient satisfaction with consultation (using a numerical rating scale), Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) score, consultation time, TKR rate, and treatment concordance. Results: A total of 69 patients in the intervention group (46 [67%] women) and 60 patients in the control group (37 [62%] women) were included in the analysis. The intervention group showed better decisional quality (K-DQI mean difference, 20.0%; SE, 3.02; 95% CI, 14.2%-26.1%; P < .001), collaborative decision-making (CollaboRATE, 8 of 69 [12%] vs 28 of 60 [47%] patients below median; P < .001), satisfaction (numerical rating scale, 9 of 65 [14%] vs 19 of 58 [33%] patients below median; P = .01), and improved functional outcomes at 4 to 6 months (mean [SE] KOOS JR, 4.9 [2.24] points higher in intervention group; 95% CI, 0.8-9.0 points; P = .02). The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19). Conclusions and Relevance: In this randomized clinical trial, an AI-enabled decision aid significantly improved decision quality, level of SDM, satisfaction, and physical limitations without significantly impacting consultation times, TKR rates, or treatment concordance in patients with knee OA considering TKR. Decision aids using a personalized, data-driven approach can enhance SDM in the management of knee OA. Trial Registration: ClinicalTrials.gov Identifier: NCT03956004.

Association of admission clinical predictors and functional outcome in patients with Cerebral Venous and Dural Sinus Thrombosis.

OBJECTIVES: Cerebral venous sinus thrombosis (CVST) is a rare subtype of stroke that most commonly affects younger women. While most patients treated with anticoagulation therapy have good outcomes, a significant number go on to experience disability. The primary aim of this study was to identify objective, easily reproducible, clinical admission predictors of poor outcome at discharge in patients with CVST. PATIENTS AND METHODS: This was a retrospective cohort study of adult CVST patients admitted at our comprehensive stroke center between April 2004 and December 2017. The medical records of patients with a CVST discharge diagnosis code were reviewed for diagnosis confirmation and extraction of clinical and demographic admission data. Multivariable logistic regression was used to build predictive models of objective, standardized examination signs and adjusted for confounders. The primary endpoint was modified Rankin Scale score at discharge defined as good outcome (0-2) and poor outcome (3-6). Mortality was the secondary endpoint. RESULTS: A total of 176 CVST patients were identified. Most patients were white (91 %) and female (65 %). The median age was 40 years old. Headache was the most commonly reported symptom (74 %). Intracranial hemorrhage (ICH) was present in 27 % of patients, venous infarct occurred in 22 % of the patients, and 12 % had both. Age (OR = 1.03, 95 % CI 1.01-1.05), abnormal level of consciousness (OR = 4.38, 95 % CI 1.86-8.88), and focal motor deficits (OR = 3.49, 95 % CI 1.49-8.15) were found to be predictive of poor functional outcome. Pre-hospitalization infections (OR = 5.22, 95 % CI 1.51-18.07) and abnormal level of consciousness (OR = 9.22, 95 % CI 2.34-36.40) were significant predictors of mortality. The predictive effect remained significant after adjusting by median PTT level, presence of intracranial hemorrhage, and venous infarct. CONCLUSIONS: Age, abnormal level of consciousness, and focal motor deficits identified at admission are independently associated with poor outcome in CVST patients. These frequently prevalent, easily reproducible examination signs represent the first step to develop a clinical prediction tool toward stratifying CVST patients with poor prognosis at admission.

A developmental model of maternal and child contributions to disruptive conduct: the first six years.

BACKGROUND: The parent-child relationship is considered important for children's future conscience, and conscience is seen as protecting them from disruptive behavior problems, but specific mechanisms of this developmental process are rarely studied. METHODS: This multi-trait multi-method study examined, in a longitudinal design, paths linking early maternal responsiveness to the child with the child's future conscience and disruptive behavior in 102 mother-child dyads. We tested a conceptual model where maternal responsiveness to the child, observed at 7 and 15 months, engenders a responsive stance in the child, observed at 25 and 38 months; that stance, in turn, becomes enduring and generalized, promoting multiple aspects of the child's conscience, observed at 52 months. In turn, conscience serves as a protective factor from disruptive behavior problems, rated by mothers and fathers at 67 months. RESULTS: The postulated paths were examined using sequential regressions and mediation effects were tested using bootstrapping analyses. Child responsive stance at 25-38 months fully mediated the link between maternal responsiveness in infancy and conscience at 52 months, and conscience fully mediated the link between child responsive stance and future disruptive behavior at 67 months. CONCLUSIONS: Examination of developmental links among early maternal behavior, the child's responsive stance toward the mother, conscience, and disruptive behavior is a promising step toward elucidating mechanisms of children's adaptive and maladaptive trajectories.

Effects of Actigraphically Acquired Sleep Quality on Driving Outcomes in Obstructive Sleep Apnea Patients and Control Drivers: A Naturalistic Study.

We examined the effects of sleep quality on next day driving outcomes in a 3.5-month naturalistic driving study of 67 OSA and 47 matched control drivers. Sleep quality measures included total sleep time and sleep fragmentation from actigraphy. The driving outcomes included average speed, lateral control, longitudinal control, distraction, attention to driving- and non-driving related tasks. Sleep quality affected next day's driving performance differently for OSA and control drivers. Better sleep quality was associated with better lateral and longitudinal control during highway driving for control drivers. The reverse was true for OSA drivers. Similar effects were also seen in terms of distractions and attention to the driving task. These effects suggest improved sleep leads to greater risky driving and 'activation' among OSA drivers. Collectively, the findings suggest investment in long-term monitoring of sleep quality in commercial vehicle drivers both with and without sleep disorders may help manage safety risks.