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This study introduces a special series on validity studies of the Cognition Battery (CB) from the U.S. National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) (Gershon, Wagster et al., 2013) in an adult sample. This first study in the series describes the sample, each of the seven instruments in the NIHTB-CB briefly, and the general approach to data analysis. Data are provided on test–retest reliability and practice effects, and raw scores (mean, standard deviation, range) are presented for each instrument and the gold standard instruments used to measure construct validity. Accompanying papers provide details on each instrument, including information about instrument development, psychometric properties, age and education effects on performance, and convergent and discriminant construct validity. One study in the series is devoted to a factor analysis of the NIHTB-CB in adults and another describes the psychometric properties of three composite scores derived from the individual measures representing fluid and crystallized abilities and their combination. The NIHTB-CB is designed to provide a brief, comprehensive, common set of measures to allow comparisons among disparate studies and to improve scientific communication. (JINS, 2014, 20, 1–12)

Financial hardship (including financial stress, financial strain, asset depletion, and financial toxicity) is a highly relevant construct among the 6.9 million people living with Alzheimer's disease and related dementias (ADRD) in the United States and their family networks. This scoping review will identify existing measures and approaches for capturing financial strain among these families. This scoping review will be reported in accordance with PRISMA-ScR guidelines. Searches will be conducted in Embase (Embase.com), Medline (Ovid), CINAHLComplete (EbscoHost), AgeLine (EbscoHost), APA PsycInfo (EbscoHost), Scopus, and Web of Science Core Collection databases to identify tools, measures, or approaches for measuring self-reported financial hardship among family members of people living with ADRD. Data elements from both the National Health and Aging Trends Study and the associated National Study of Caregiving will also be considered. Two independent raters will screen the search results and discrepancies with be resolved by a third rater. Extraction will include the use of artificial intelligence-based software and verification by an independent human rater; any changes that are made to the AI-generated extraction will be reviewed by a second independent rater. A frequency analysis will be conducted to analyze the data, and a summary of the psychometric properties of each of the identified measures will be presented. The findings from this review will be disseminated through peer-reviewed publications and conference presentations. Ultimately, this work will inform the development of a new patient-reported outcome measurement system designed to provide a comprehensive assessment of the different aspects of financial hardship for families of people living with ADRD. In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P), the following protocol was registered via https://osf.io on March 14, 2025 (registration DOI: https://doi.org/10.17605/OSF.IO/J26KT).

Objectives:Minimal hepatic encephalopathy (HE) is common, characterized by deficits in reaction time and executive function, and strongly associated with disability and mortality. Point-of-care diagnostics performed without specialized skills or equipment are now available, albeit with limited data regarding their generalizability.Methods:We systematically reviewed MEDLINE, EMBASE, Cochrane Library, and Scopus for diagnostic studies of MHE using broad search terms including HE and minimal, covert, or the names of published diagnostic modalities. We included tests that provide results during clinical visits without requiring neuropsychologists to administer and/or special equipment. These include the Inhibitory Control Test (ICT, n=16), EncephalApp Stroop (n=3), an algorithm based on the Sickness Impact Profile (n=2), and the Animal Naming Test (ANT, n=1).Results:The populations enrolled in the included study were highly selected, excluding patients with recent (6-months) alcohol or psychoactive medications use. Cutoffs for MHE for each test varied widely. For the ICT, the optimal cutoffs for MHE varied by 300%, whereas healthy control performance varied >400%. The optimal cutoffs for the EncephalApp also varied (by 50%). The gold standards for MHE varied substantially between studies, and clinical outcomes were never used to develop test cutoffs. Data comparing the performance of each modality are lacking. Longitudinal data are limited but suggest that good performance on the ICT, EncephalApp or ANT is associated with reduced risk of developing overt HE.Conclusion:The point-of-care tests for MHE are promising tools. However, additional longitudinal studies are needed in clinically representative populations of at-risk patients with cutoffs validated based on the development of clinical outcomes.

Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit ® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit ® , provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration : ClinicalTrial.gov NCT04570930 ; https://clinicaltrials.gov/ct2/show/NCT04570930 .

Background Ureteral stents are placed by urologists to ensure ureteral patency in the postoperative period following ureteroscopy to treat kidney stones, with the goal to reduce complications. However, ureteral stents themselves cause pain and urinary symptoms in many patients that can lead to morbidity. Professional society guidelines support stent omission after uncomplicated ureteroscopy, which represents most cases. Despite this, ureteral stents are utilized in more than 80% of all ureteroscopy procedures. One reason for guideline discordance is the low level of evidence supporting stent omission recommendations. Studies are inconclusive on whether stents increase pain and complications. A recent Cochrane review concluded higher quality and large trials are needed to inform decision-making. Furthermore, there is a lack of studies evaluating health-related quality of life (HRQOL), patient-reported outcomes (PROs), and unplanned healthcare utilization. Another factor is that prospective clinical trials are hindered by patient reluctance to be randomized to either stent placement or omission. The outcomes of patients who decline randomization have been ignored in trials, limiting the generalizability of the evidence. Methods Through collaboration with patient partners, we developed a pragmatic multi-center combined randomized and observational cohort study in a quality improvement collaborative. Patients will be prospectively enrolled into a randomized cohort in which assignment to ureteral stent omission (vs. placement) is determined in the operating room using a web-based randomization platform. Patients who decline randomization are invited to take part in an observational (real-world) cohort in which the determination of stent use is at the discretion of the urologist. Patients in both cohorts will complete preoperative and postoperative assessments of PROs including pain, urinary symptoms, interference with usual activities, time taken off work or school, and treatment satisfaction. Unplanned healthcare utilization within 30 days postoperatively will be assessed by review of the electronic health record. Severe adverse events will be recorded. A subgroup of patients and urologists will also participate in qualitative semi-structured interviews focusing on knowledge, preferences, and practice patterns regarding ureteral stenting. Interview transcripts will be thematically analyzed. Discussion This study is designed to evaluate the HRQOL and 30-day healthcare utilization of patients undergoing ureteral stent omission compared to stent placement following uncomplicated ureteroscopic treatment of upper urinary tract stones. Additionally, patient and urologist opinions and preferences related to ureteral stenting will be explored through qualitative interviews, with the aim of identifying key barriers and facilitators of practice change related to stenting practices. Trial registration ClinicalTrials.gov, NCT05866081. Registered on 19 May 2023.

Aims This study aims to improve the interpretability and clinical utility of the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) by identifying distinct financial toxicity classes in adults with diabetes. Methods Data included a sample of 600 adults with Type 1 or Type 2 diabetes and high A1c. Latent Class Analysis was used to identify subgroups of patients based on COST-FACIT score patterns. Results We identified 3 financial toxicity classes (high, medium and low) with strong indicators of membership classification. Multiple indicators of financial stress, maladaptive cost-coping behaviors, more comorbidities, more prescribed medications, more diabetes distress, more depressive symptoms, closer to the federal poverty level, female, having lower educational attainment and being single were all significant predictors of high financial toxicity class membership. A score of 26 on the COST-FACIT was the strongest threshold for sorting high vs. medium/low financial toxicity, with a positive predictive value (PPV) of 76% and negative predictive value (NPV) of 93%. Conclusion The COST-FACIT can be used to reliably identify people with diabetes that have high financial toxicity. Integrating this new cut-score into clinical practice may help clinical teams identify people in need of additional support due to financial toxicity.

Consumer-grade wearables allow researchers to capture a representative picture of human behavior in the real world over extended periods. However, maintaining users' engagement remains a challenge and can lead to a decrease in compliance (eg, wear time in the context of wearable sensors) over time (eg, \"wearables' abandonment\"). In this work, we analyzed datasets from diverse populations (eg, caregivers for various health issues, college students, and pediatric oncology patients) to quantify the impact that wear time requirements can have on study results. We found evidence that emphasizes the need to account for participants' wear time in the analysis of consumer-grade wearables data. In Aim 1, we demonstrate the sensitivity of parameter estimates to different data processing methods with respect to wear time. In Aim 2, we demonstrate that not all research questions necessitate the same wear time requirements; some parameter estimates are not sensitive to wear time. We analyzed 3 Fitbit datasets comprising 6 different clinical and healthy population samples. For Aim 1, we analyzed the sensitivity of average daily step count and average daily heart rate at the population sample and individual levels to different methods of defining \"valid\" days using wear time. For Aim 2, we evaluated whether some research questions can be answered with data from lower compliance population samples. We explored (1) the estimation of the average daily step count and (2) the estimation of the average heart rate while walking. For Aim 1, we found that the changes in the population sample average daily step count could reach 2000 steps for different methods of analysis and were dependent on the wear time compliance of the sample. As expected, population samples with a low daily wear time (less than 15 hours of wear time per day) showed the most sensitivity to changes in methods of analysis. On the individual level, we observed that around 15% of individuals had a difference in step count higher than 1000 steps for 4 of the 6 population samples analyzed when using different data processing methods. Those individual differences were higher than 3000 steps for close to 5% of individuals across all population samples. Average daily heart rate appeared to be robust to changes in wear time. For Aim 2, we found that, for 5 population samples out of 6, around 11% of individuals had enough data for the estimation of average heart rate while walking but not for the estimation of their average daily step count. We leveraged datasets from diverse populations to demonstrate the direct relationship between parameter estimates from consumer-grade wearable devices and participants' wear time. Our findings highlighted the importance of a thorough analysis of wear time when processing data from consumer-grade wearables to ensure the relevance and reliability of the associated findings.

Importance Although pathological demand avoidance (PDA; also known as “extreme” or “persistent” demand avoidance and persistent drive for autonomy) was first described in 1980 as a distinct behavioral profile among a subgroup of children with autism spectrum disorder, there is limited scientific evidence to support children with PDA or their parents/guardians. Objective To establish the feasibility and acceptability of the Paradigm Shift Program®, a 12‐week educational and training program for parents and guardians of children with PDA. Methods Seventy‐six parents/guardians of children with PDA were enrolled in the study. Prior to the start of the program, the parents/guardians completed a baseline assessment (demographic questions, program expectations, and several patient‐reported outcomes [PROs] and proxy measures). At the end of the program, parents/guardians repeated the PROs and proxy measures, and completed a feasibility and acceptability questionnaire and anchor items. Results A total of 71 parents/guardians completed the pre‐program assessment, and 60 (85%) completed the end‐of‐program assessment. Among those with both assessments, program acceptability was high, and parents/guardians were generally satisfied with the different program elements (level of agreement >70% for agreed or strongly agreed). Parents/guardians reported significant improvement in health‐related quality of life (HRQOL) in 10 of the 13 PROs (all P < 0.05). Parent/guardian proxy reports also indicated significant improvements in demand characteristics (P < 0.05), as well as a trend for significant improvement in conduct problems (P = 0.08), total difficulties (P = 0.05), and externalizing behavior (P = 0.05), in their child with PDA. Interpretation The paradigm shift program was both feasible and acceptable. Furthermore, there was evidence that this program improved the HRQOL of parents/guardians as well as the behavior of children with PDA. The Paradigm Shift Program, a comprehensive training program for parents of neurodivergent children with pathological demand avoidance (PDA), was feasible and acceptable, and there were significant improvements in parents’ well‐being following program completion. As the first examination of a parent‐focused intervention for PDA, results suggest a promising alternative to traditional programs.

Compliance rates for mobile health (mHealth) studies that involve intensive study designs are highly variable. Both person- and study-specific factors likely contribute to this variability. We were interested in understanding the impact that care partner characteristics and demographics have on study engagement, given that engagement is critical to the success of mHealth interventions. The primary objective of this report was to analyze the overall and component-specific completion and compliance rates for an intensive 6-month mHealth intervention (CareQOL app) designed to promote self-awareness and self-care among care partners of individuals with traumatic brain injury. This randomized controlled trial was designed to test the CareQOL app, an mHealth app designed to promote care partner self-awareness (through self-monitoring) and self-care (through personalized self-care push notifications). The study design consisted of a baseline assessment, a 6-month home-monitoring period that included 3 daily ecological momentary assessment (EMA) questions, monthly patient-reported outcome (PRO) surveys, continuous activity and sleep monitoring using a Fitbit, and 2 follow-up PRO surveys at 3 and 6 months posthome monitoring. Three participants withdrew prior to the initiation of the home-monitoring period, resulting in a final analytical sample size of 254. All participants had access to a self-monitoring dashboard (CareQOL app) that included graphical displays of the daily survey scores, as well as daily steps and sleep data from the Fitbit. Overall compliance for the different aspects of the study was high. On average, the full-sample daily EMA PRO completion rate was 84% (SD 19%), Fitbit-based step count compliance was 90% (SD 21%), and Fitbit-based sleep duration compliance was 75% (SD 32%); there was no difference between the study arms for daily EMA PROs and Fitbit compliance rates. Completion rates for monthly and follow-up PRO surveys were even higher, with average end-of-month completion rates ranging from 97% to 100%, and follow-up completion rates of 95% for both time points. Again, these rates did not differ by study arm. The data were represented by 3 engagement groups: high-compliance-all data; high-compliance-PROs and steps only; and moderate PRO compliance-low Fitbit compliance. Group membership was predicted by both race (P<.001) and relationship to the care recipient (P=.001), but not by the other person-specific variables. The compliance rates for this intensive study design are consistent, but at the high end, with what has been reported previously in the literature for studies with shorter time durations. Except for race and relationship to the care recipient, person-specific factors did not appear to be significantly associated with the engagement group. As such, we anticipate that the high compliance rates observed in this study are likely due to several study-specific design elements that were used to encourage study engagement.

Background Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. Methods One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. Results Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time ( p  < 0.001). When the PROMIS measures were compared to the patients’ global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. Conclusion This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure.