Covariate-constrained randomization in cluster randomized 2x2 factorial trials: Application to a diabetes prevention study.

Background: Cluster randomized trials (CRTs) are randomized trials where randomization takes place at an administrative level (e.g., hospitals, clinics, or schools) rather than at the individual level. When the number of available clusters is small, researchers may not be able to rely on simple randomization to achieve balance on cluster-level covariates across treatment conditions. If these cluster-level covariates are predictive of the outcome, covariate imbalance may distort treatment effects, threaten internal validity, lead to a loss of power, and increase the variability of treatment effects. Covariate-constrained randomization (CR) is a randomization strategy designed to reduce the risk of imbalance in cluster-level covariates when performing a CRT. Existing methods for CR have been developed and evaluated for two- and multi-arm CRTs but not for factorial CRTs. Methods: Motivated by the BEGIN study-a CRT for weight loss among patients with pre-diabetes-we develop methods for performing CR in 2x2 factorial cluster randomized trials. We apply our methods to the BEGIN study and use simulation to assess the performance of CR versus simple randomization for estimating treatment effects by varying the number of clusters, the degree to which clusters are associated with the outcome, the distribution of cluster level covariates, and analysis strategies. Results: Compared to simple randomization of clusters, CR in the factorial setting is effective at achieving balance across cluster-level covariates between treatment conditions and provides more precise inferences. When cluster-level covariates are included in the analyses model, CR also results in greater power to detect treatment effects, but power is low compared to unadjusted analyses when the number of clusters is small. Conclusions: CR should be used instead of simple randomization when performing factorial CRTs to avoid highly imbalanced designs and to obtain more precise inferences. Except when there are a small number of clusters, cluster-level covariates should be included in the analysis model to increase power and maintain coverage and Type 1 error rates at their nominal levels.

Psychotropic Medication Use and Polypharmacy Among Children and Adolescents Initiating Intensive Behavioral Therapy for Severe Challenging Behavior.

OBJECTIVE: To evaluate the prevalence, trends, and factors associated with psychotropic medication use and polypharmacy among children and adolescents initiating intensive behavioral therapy for severe challenging behavior over a 10-year period. STUDY DESIGN: In this retrospective observational study, we examined data from caregiver interviews and patient medical records on the number and types of psychotropic medications prescribed to patients initiating intensive behavioral therapy between January 1, 2013, and December 31, 2022. Trends in medication use and polypharmacy across the 10-year period were analyzed using regression analysis, while differences in demographics and clinical factors for patients with use and polypharmacy were analyzed using nonparametric statistical analysis with odds ratios presented for significant factors. RESULTS: Data from all 302 pediatric patients initiating intensive behavioral therapy across the 10-year period were analyzed. Among all patients and all years, 83.8% were taking at least 1 psychotropic medication and 68.2% experienced polypharmacy. There were no changes in the prevalence of use, mean number of medications taken, or polypharmacy across the 10-year period. Patients diagnosed with attention-deficit/hyperactivity disorder or anxiety disorder, as well as those exhibiting self-injurious behavior had higher use of psychotropic medication and polypharmacy and were taking more medications overall. CONCLUSIONS: Psychotropic medication use and polypharmacy were extremely high for children and adolescents with severe challenging behavior, but use and polypharmacy did not change over the 10-year period of data collection. Further research is needed to establish the generality of these findings to other regions of the US.

Mand Modality Preference Assessments among High- and Low-Tech Options for Individuals with Intellectual and Developmental Disabilities: A Systematic Review.

The extant literature demonstrates that individuals with intellectual and developmental disabilities (IDD) exhibit preferences among communication modalities when multiple modalities are available and produce reinforcement on identical reinforcement schedules. High- and low-tech communication options, such as voice output devices and picture cards, are commonly recommended for individuals with limited vocal communication skills. In this study, we conducted a systematic literature review of research studies that implemented mand modality preference assessments (MMPAs) that included both a high- and low-tech communication option with individuals with IDD. We identified 27 studies meeting our inclusion criteria and summarized the participant demographics, MMPA design and procedural variations, and MMPA outcomes. The results suggested that high-tech communication options were generally more preferred over low-tech options. However, there was a high degree of variability in how the studies were conducted and conclusions were reached. We discuss some of the current research gaps and the implications for clinical practice.

Use of hare bone for the manufacture of a Clovis bead.

A tubular bone bead dating to ~ 12,940 BP was recovered from a hearth-centered activity area at the La Prele Mammoth site in Converse County, Wyoming, USA. This is the oldest known bead from the Western Hemisphere. To determine the taxonomic origin of the bead, we extracted collagen for zooarchaeology by mass spectrometry (ZooMS). We also used micro-CT scanning for morphological analysis to determine likely skeletal elements used for its production. We conclude that the bead was made from a metapodial or proximal phalanx of a hare (Lepus sp.). This find represents the first secure evidence for the use of hares during the Clovis period. While the use of hare bone for the manufacture of beads was a common practice in western North America during the Holocene, its origins can now be traced back to at least the terminal Pleistocene.

A comparative effectiveness trial of functional behavioral assessment methods.

Clinicians report primarily using functional behavioral assessment (FBA) methods that do not include functional analyses. However, studies examining the correspondence between functional analyses and other types of FBAs have produced inconsistent results. In addition, although functional analyses are considered the gold standard, their contribution toward successful treatment compared with other FBA methods remains unclear. This comparative effectiveness study, conducted with 57 young children with autism spectrum disorder, evaluated the results of FBAs that did (n = 26) and did not (n = 31) include a functional analysis. Results of FBAs with and without functional analyses showed modest correspondence. All participants who completed functional communication training achieved successful outcomes regardless of the type of FBA conducted.

Association Between ICD-10 Codes for Social Needs and Subsequent Emergency and Inpatient Use.

BACKGROUND: International Classification of Diseases, 10th revision Z codes capture social needs related to health care encounters and may identify elevated risk of acute care use. OBJECTIVES: To examine associations between Z code assignment and subsequent acute care use and explore associations between social need category and acute care use. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Adults continuously enrolled in a commercial or Medicare Advantage plan for ≥15 months (12-month baseline, 3-48 month follow-up). OUTCOMES: All-cause emergency department (ED) visits and inpatient admissions during study follow-up. RESULTS: There were 352,280 patients with any assigned Z codes and 704,560 sampled controls with no Z codes. Among patients with commercial plans, Z code assignment was associated with a 26% higher rate of ED visits [adjusted incidence rate ratio (aIRR) 1.26, 95% CI: 1.25-1.27] and 42% higher rate of inpatient admissions (aIRR 1.42, 95% CI: 1.39-1.44) during follow-up. Among patients with Medicare Advantage plans, Z code assignment was associated with 42% (aIRR 1.42, 95% CI: 1.40-1.43) and 28% (aIRR 1.28, 95% CI: 1.26-1.30) higher rates of ED visits and inpatient admissions, respectively. Within the Z code group, relative to community/social codes, socioeconomic Z codes were associated with higher rates of inpatient admissions (commercial: aIRR 1.10, 95% CI: 1.06-1.14; Medicare Advantage: aIRR 1.24, 95% CI 1.20-1.27), and environmental Z codes were associated with lower rates of both primary outcomes. CONCLUSIONS: Z code assignment was independently associated with higher subsequent emergency and inpatient utilization. Findings suggest Z codes' potential utility for risk prediction and efforts targeting avoidable utilization.

Clinical performance and health equity implications of the American Diabetes Association's 2023 screening recommendation for prediabetes and diabetes.

Introduction: The American Diabetes Association (ADA) recommends screening for prediabetes and diabetes (dysglycemia) starting at age 35, or younger than 35 years among adults with overweight or obesity and other risk factors. Diabetes risk differs by sex, race, and ethnicity, but performance of the recommendation in these sociodemographic subgroups is unknown. Methods: Nationally representative data from the National Health and Nutrition Examination Surveys (2015-March 2020) were analyzed from 5,287 nonpregnant US adults without diagnosed diabetes. Screening eligibility was based on age, measured body mass index, and the presence of diabetes risk factors. Dysglycemia was defined by fasting plasma glucose ≥100mg/dL (≥5.6 mmol/L) or haemoglobin A1c ≥5.7% (≥39mmol/mol). The sensitivity, specificity, and predictive values of the ADA screening criteria were examined by sex, race, and ethnicity. Results: An estimated 83.1% (95% CI=81.2-84.7) of US adults were eligible for screening according to the 2023 ADA recommendation. Overall, ADA's screening criteria exhibited high sensitivity [95.0% (95% CI=92.7-96.6)] and low specificity [27.1% (95% CI=24.5-29.9)], which did not differ by race or ethnicity. Sensitivity was higher among women [97.8% (95% CI=96.6-98.6)] than men [92.4% (95% CI=88.3-95.1)]. Racial and ethnic differences in sensitivity and specificity among men were statistically significant (P=0.04 and P=0.02, respectively). Among women, guideline performance did not differ by race and ethnicity. Discussion: The ADA screening criteria exhibited high sensitivity for all groups and was marginally higher in women than men. Racial and ethnic differences in guideline performance among men were small and unlikely to have a significant impact on health equity. Future research could examine adoption of this recommendation in practice and examine its effects on treatment and clinical outcomes by sex, race, and ethnicity.

Screening for Prediabetes and Diabetes in a National Network of Federally Qualified Health Centers: An Observational Study.

BACKGROUND: In 2021, the U.S. Preventive Services Task Force (USPSTF) recommended screening for prediabetes and diabetes among adults aged 35-70 years with overweight or obesity. Studying dysglycemia screening in federally qualified health centers (FQHCs) that serve vulnerable patient populations is needed to understand health equity implications of this recommendation. OBJECTIVE: To investigate screening practices among FQHC patients who would be eligible according to the 2021 USPSTF recommendation. DESIGN: Retrospective cohort study analyzing electronic health records from a national network of 282 FQHC sites. PARTICIPANTS: We included 183,329 patients without prior evidence of prediabetes or diabetes, who had ≥ 1 office visit from 2018-2020. MAIN MEASURES: Screening eligibility was based on age and measured body mass index (BMI). The primary outcome, screening completion, was ascertained using hemoglobin A1c or fasting plasma glucose results from 2018-2020. KEY RESULTS: Among 89,543 patients who would be eligible according to the 2021 USPSTF recommendation, 53,263 (59.5%) were screened. Those who completed screening had higher BMI values than patients who did not (33.0 ± 6.7 kg/m2 vs. 31.9 ± 6.2 kg/m2, p < 0.001). Adults aged 50-64 years had greater odds of screening completion relative to younger patients (OR 1.13, 95% CI: 1.10-1.17). Patients from racial and ethnic minority groups, as well as those without health insurance, were more likely to complete screening than White patients and insured patients, respectively. Clinical risk factors for diabetes were also associated with dysglycemia screening. Among patients who completed screening, 23,588 (44.3%) had values consistent with prediabetes or diabetes. CONCLUSIONS: Over half of FQHC patients who would be eligible according to the 2021 USPSTF recommendation were screened. Screening completion was higher among middle-aged patients, those with greater BMI values, as well as vulnerable groups with a high risk of developing diabetes. Future research should examine adoption of the 2021 USPSTF screening recommendation and its impact on health equity.

Trends in Cardiovascular Health Counseling Among Postpartum Individuals.

Importance: Poor prepregnancy cardiovascular health (CVH) and adverse pregnancy outcomes (APOs) are key risk factors for subsequent cardiovascular disease (CVD) in birthing adults. The postpartum visit offers an opportunity to promote CVH among at-risk individuals. Objective: To determine prevalence, predictors, and trends in self-reported CVH counseling during the postpartum visit. Design, Setting, and Participants: Serial, cross-sectional analysis of data from 2016-2020 from the Pregnancy Risk Assessment Monitoring System (PRAMS), a nationally representative, population-based survey. The primary analysis included individuals who attended a postpartum visit 4 to 6 weeks after delivery with available data on receipt of CVH counseling, self-reported prepregnancy CVD risk factors (obesity, diabetes, and hypertension), and APOs (gestational diabetes, hypertensive disorders of pregnancy, and preterm birth) (N = 167 705 [weighted N = 8 714 459]). Exposures: Total number of CVD risk factors (0, 1, or ≥2 prepregnancy risk factors or APOs). Main Outcomes and Measures: Annual, age-adjusted prevalence of self-reported postpartum CVH counseling per 100 individuals, defined as receipt of counseling for healthy eating, exercise, and losing weight gained during pregnancy, was calculated overall and by number of CVD risk factors. Average annual percent change (APC) assessed trends in CVH counseling from 2016 through 2020. Data were pooled to calculate rate ratios (RRs) for counseling that compared individuals with and without CVD risk factors after adjustment for age, education, postpartum insurance, and delivery year. Results: From 2016 through 2020, prevalence of self-reported postpartum CVH counseling declined from 56.2 to 52.8 per 100 individuals among those with no CVD risk factors (APC, -1.4% [95% CI, -1.8% to -1.0%/y]), from 58.5 to 57.3 per 100 individuals among those with 1 risk factor (APC, -0.7% [95% CI, -1.3% to -0.1%/y]), and from 61.9 to 59.8 per 100 individuals among those with 2 or more risk factors (APC, -0.8% [95% CI, -1.3% to -0.3%/y]). Reporting receipt of counseling was modestly higher among individuals with 1 risk factor (RR, 1.05 [95% CI, 1.04 to 1.07]) and with 2 or more risk factors (RR, 1.11 [95% CI, 1.09 to 1.13]) compared with those who had no risk factors. Conclusions and Relevance: Approximately 60% of individuals with CVD risk factors or APOs reported receiving CVH counseling at their postpartum visit. Prevalence of reporting CVH counseling decreased modestly over 5 years.

Menu Calorie Label Use and Diet Quality: a Cross-Sectional Study.

INTRODUCTION: Menu calorie labeling has been implemented in food service businesses to promote healthy food choices; however, evidence is limited on whether label use is associated with healthier dietary intake. This study examined the association between menu calorie label use and diet quality and whether it varied by weight status. METHODS: Adults in the National Health and Nutrition Examination Survey 2017-2018 who visited restaurants were included. Menu calorie label use was categorized as did not notice labels, noticed labels, and used labels. Diet quality was measured using the Healthy Eating Index 2015 (maximum score 100) by two 24-hour diet recalls. The association between menu calorie label use and diet quality was examined using multiple linear regression and tested for effect modification by weight status. Data were collected during 2017-2018 and analyzed during 2022-2023. RESULTS: Of 3,312 participants (representing 195,167,928 U.S. adults), 43% did not notice labels, 30% noticed labels, and 27% used labels. Using labels was associated with 4.0 points (95% CI 2.2, 5.8) higher Healthy Eating Index 2015 scores than not noticing labels. Healthy Eating Index 2015 scores in those using labels were higher for adults with normal BMI (3.4 points; 95% CI=0.2, 6.7), overweight (6.5 points; 95% CI=3.6, 9.5), and obesity (3.0 points; 95% CI=1.0, 5.1) (p-interaction=0.0004) than those who did not notice labels. CONCLUSIONS: Using menu calorie labels was associated with modestly healthier diet quality than not noticing labels, regardless of weight status. This suggests that providing caloric information may help some adults with food decisions.

Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes.

BACKGROUND: Among 96 million U.S. adults with prediabetes, adoption of evidence-based treatment to prevent diabetes remains low. Primary care represents an essential venue for preventing diabetes, yet providers in this setting have limited time to address prevention. This highlights the need for low-touch interventions that promote diabetes prevention and are not delivered by primary care providers. Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not been definitively studied for managing prediabetes. METHODS: The Behavioral Nudges for Diabetes Prevention (BEGIN) trial is a pragmatic, cluster randomized trial testing the effectiveness of text messaging about diabetes prevention and a prediabetes decision aid. These interventions are being studied in 8 primary care clinics using a 2 × 2 factorial design, in which pairs of clinics are randomized in a 1:1:1:1 ratio to receive usual care, text messaging alone, prediabetes decision aid alone, or both interventions. A total of 656 patients are recruited to participate, receive the study interventions, and contribute data at baseline and 12 months. The primary outcome is 12-month weight change, and the secondary outcome is adoption of evidence-based treatment to prevent diabetes. Change in hemoglobin A1c is an exploratory outcome that will be assessed among participants with available values. CONCLUSION: Findings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care, where patients are diagnosed with prediabetes and there is little prior research. TRIAL REGISTRY: NCT04869917.

Screening for Prediabetes and Diabetes: Clinical Performance and Implications for Health Equity.

INTRODUCTION: In 2021, the U.S. Preventive Services Task Force (USPSTF) recommended prediabetes and diabetes screening for asymptomatic adults aged 35-70 years with overweight/obesity, lowering the age from 40 years in its 2015 recommendation. The USPSTF suggested considering earlier screening in racial and ethnic groups with high diabetes risk at younger ages or lower BMI. This study examined the clinical performance of these USPSTF screening recommendations as well as alternative age and BMI cutoffs in the U.S. adult population overall, and separately by race and ethnicity. METHODS: Nationally representative data were collected from 3,243 nonpregnant adults without diagnosed diabetes in January 2017-March 2020 and analyzed from 2021 to 2022. Screening eligibility was based on age and measured BMI. Collectively, prediabetes and undiagnosed diabetes were defined by fasting plasma glucose ≥100 mg/dL or hemoglobin A1c ≥5.7%. The sensitivity, specificity, and predictive values of alternate screening criteria were examined overall, and by race and ethnicity. RESULTS: The 2021 criteria exhibited marginally higher sensitivity (58.6%, 95% CI=55.5, 61.6 vs 52.9%, 95% CI=49.7, 56.0) and lower specificity (69.3%, 95% CI=65.7, 72.2 vs 76.4%, 95% CI=73.3, 79.2) than the 2015 criteria overall, and within each racial and ethnic group. Screening at lower age and BMI thresholds resulted in even greater sensitivity and lower specificity, especially among Hispanic, non-Hispanic Black, and Asian adults. Screening all adults aged 35-70 years regardless of BMI yielded the most equitable performance across all racial and ethnic groups. CONCLUSIONS: The 2021 USPSTF screening criteria will identify more adults with prediabetes and diabetes in all racial and ethnic groups than the 2015 criteria. Screening all adults aged 35-70 years exhibited even higher sensitivity and performed most similarly by race and ethnicity, which may further improve early detection of prediabetes and diabetes in diverse populations.

Lower-Intensity Interventions for Prediabetes: A Systematic Review.

INTRODUCTION: Systematic reviews of interventions for diabetes prevention have focused on lifestyle interventions, including the Diabetes Prevention Program (DPP) and translations of the DPP. However, nationally, few people with prediabetes have joined or completed a DPP, with one cited barrier being committing to a yearlong program. This study was a systematic review to evaluate the effectiveness of lower-intensity lifestyle interventions for prediabetes on weight change, glycemia, and health behaviors. METHODS: English-language studies from PubMed, Embase, PsycINFO, and CINAHL from 2000 to February 23, 2022 were searched for RCTs of nonpregnant adults with prediabetes and elevated BMI and lower-intensity interventions (defined as ≤12 months and <14 sessions over 6 months). Two reviewers independently identified 11 trials, assessed study quality (using Cochrane risk-of-bias tool), and extracted data serially. A qualitative synthesis was conducted by outcome. RESULTS: Only 1 of 11 trials of lower-intensity interventions was of high quality (>80% follow-up rate and low risk of bias). This 6-month study compared an app with standardized dietary advice, showing a 3-kg greater body weight reduction and 0.2% greater reduction of HbA1c. DISCUSSION: The evidence on lower-intensity lifestyle interventions for diabetes prevention is limited by the small number and methodologic weaknesses of previous trials, and future research is needed in this area. Given the low uptake of and retention in evidence-based high-intensity programs, future work is needed to investigate the effectiveness of novel lower-intensity interventions offered with established DPP content of varying duration and intensity.

Using fNIRS to evaluate ADHD medication effects on neuronal activity: A systematic literature review.

Background: Functional near infrared spectroscopy (fNIRS) is a relatively non-invasive and inexpensive functional neuroimaging technique that has shown promise as a method for understanding the differences in neuronal activity associated with various neurodevelopmental conditions, including ADHD. Additionally, fNIRS has been suggested as a possible tool to understand the impact of psychotropic medications on brain activity in individuals with ADHD, but this approach is still in its infancy. Objective: The purpose of this systematic literature review was to synthesize the extant research literature on the use of fNIRS to assess the effects of ADHD medications on brain activity in children and adolescents with ADHD. Methods: A literature search following Preferred Reporting Items for Systematic Literature Reviews and Meta-Analyses (PRISMA) guidelines was conducted for peer-reviewed articles related to ADHD, medication, and fNIRS in PsychInfo, Scopus, and PubMed electronic databases. Results: The search yielded 23 published studies meeting inclusion criteria. There was a high degree of heterogeneity in terms of the research methodology and procedures, which is explained in part by the distinct goals and approaches of the studies reviewed. However, there was also relative consistency in outcomes among a select group of studies that demonstrated a similar research focus. Conclusion: Although fNIRS has great potential to further our understanding of the effects of ADHD medications on the neuronal activity of children and adolescents with ADHD, the current research base is still relatively small and there are limitations and methodological inconsistencies that should be addressed in future studies.

Impact of changes in diabetes screening guidelines on testing eligibility and potential yield among adults without diagnosed diabetes in the United States.

AIMS: Recent USPSTF and ADA guidelines expanded criteria of whom to test to identify prediabetes and diabetes. We described which Americans are eligible and report receiving glucose testing by USPSTF 2015 and 2021 as well as ADA 2003 and 2022 recommendations, and performance of each guideline. METHODS: We analyzed cross-sectional data from 6,007 non-pregnant U.S. adults without diagnosed diabetes in the 2013-2018 National Health and Nutrition Examination Surveys. We reported proportions of adults who met each guideline's criteria for glucose testing and reported receiving glucose testing in the past three years, overall and by key population subgroups,. Defining prediabetes (FPG 100-125 mg/dL and/or HbA1c 5.7-6.4 %) or previously undiagnosed diabetes (FPG ≥ 126 mg/dL and/or HbA1c ≥ 6.5 %), we assessed sensitivity and specificity. RESULTS: During 2013-2018, 76.7 million, 90.4 million, 157.7 million, and 169.5 million US adults met eligibility for glucose testing by USPSTF 2015, 2021, and ADA 2003 and 2022 guidelines, respectively. On average, 52 % of adults reported receiving glucose testing within the past 3 years. Likelihood of receiving glucose testing was lower among younger adults, men, Hispanic adults, those with less than high school completion, those living in poverty, and those without health insurance or a usual place of care than their respective counterparts. ADA recommendations were most sensitive (range: 91.0 % to 100.0 %) and least specific (range: 18.3 % to 35.3 %); USPSTF recommendations exhibited lower sensitivity (51.9 % to 66.6 %), but higher specificity (56.6 % to 74.5 %). CONCLUSIONS: An additional 12-14 million US adults are eligible for diabetes screening. USPSTF 2021 criteria provide balanced sensitivity and specificity while ADA 2022 criteria maximize sensitivity. Glucose testing does not align with guidelines and disparities remain.

Examining How Social Risk Factors Are Integrated Into Clinical Settings Using Existing Data: A Scoping Review.

PURPOSE: Integrating social care into clinical care requires substantial resources. Use of existing data through a geographic information system (GIS) has the potential to support efficient and effective integration of social care into clinical settings. We conducted a scoping literature review characterizing its use in primary care settings to identify and address social risk factors. METHODS: In December 2018, we searched 2 databases and extracted structured data for eligible articles that (1) described the use of GIS in clinical settings to identify and/or intervene on social risks, (2) were published between December 2013 and December 2018, and (3) were based in the United States. Additional studies were identified by examining references. RESULTS: Of the 5,574 articles included for review, 18 met study eligibility criteria: 14 (78%) were descriptive studies, 3 (17%) tested an intervention, and 1 (6%) was a theoretical report. All studies used GIS to identify social risks (increase awareness); 3 studies (17%) described interventions to address social risks, primarily by identifying relevant community resources and aligning clinical services to patients' needs. CONCLUSIONS: Most studies describe associations between GIS and population health outcomes; however, there is a paucity of literature regarding GIS use to identify and address social risk factors in clinical settings. GIS technology may assist health systems seeking to address population health outcomes through alignment and advocacy; its current application in clinical care delivery is infrequent and largely limited to referring patients to local community resources.

A Retrospective Analysis of Therapists' Coaching Behavior When Directing Parents to Conduct Behavioral Assessments and Treatments Via Telehealth.

Research on the delivery of behavioral assessment and treatment via telehealth has focused largely on child outcomes and parent procedural fidelity. By contrast, the behavior of the therapists coaching parents to conduct assessment and treatment has garnered little research consideration. In this study, we conducted a retrospective analysis of behavior therapists' coaching behaviors when directing parents to conduct functional analysis (FA) and functional communication training (FCT) with their young children with autism via telehealth. Coaching behaviors for five experienced behavior therapists across seven parent-child dyads were scored using a combination of standardized and novel behavior codes. Therapists displayed more social engagement behaviors than any other type of behavior throughout the study, and rates of antecedent and consequence behaviors shifted across the FA and FCT phases. Results are discussed in relation to therapists' goals during behavioral assessment and treatment and the implications for training behavioral therapists to coach parents via telehealth.

Doubled-Up Households, Self-Management Behaviors, Diabetes Preventive Care Services, and Hospital Use in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) 2015-2020.

OBJECTIVE: We investigated associations of living in a doubled-up household (i.e., adults living with adult children, other related adults, or other unrelated adults) with diabetes self-management behaviors, occurrence of diabetes preventive care services, and hospital use by Hispanic/Latino adults with diabetes. RESEARCH DESIGN AND METHODS: We analyzed data from the second clinical visit (2014-2017) through subsequent annual follow-up interviews completed through January 2020 of all participants with diabetes in the Hispanic Community Health Study/Study of Latinos. Multivariable regression was used to test associations between doubled-up status with diabetes self-management behaviors (i.e., checking blood glucose level, checking feet for sores), diabetes preventive care services done by a doctor (i.e., dilated-eye examination, feet checked, hemoglobin A1c measured, urine analysis for kidney function), and hospital use (i.e., emergency department [ED] visits and hospitalizations). RESULTS: Hispanic/Latino adults living doubled up were less likely to have their urine checked by a doctor for kidney disease compared with adults not in doubled-up households. Doubled-up status was not associated with diabetes self-management behaviors. Adults living doubled up in a household with other related adults had a 33% increased risk of ED visits compared with adults living doubled up in a household with adult children. CONCLUSIONS: Health care settings where Hispanic/Latino adults with diabetes receive trusted care should add housing characteristics such as doubled-up status to social-needs screening to identify residents in need of connecting with housing or social services and more targeted diabetes management services.

Treatment modification after initiating second-line medication for type 2 diabetes.

OBJECTIVES: To describe changes in antidiabetic medication (ADM) use and characteristics associated with changes in ADM use after initiation of noninsulin second-line therapy. STUDY DESIGN: Retrospective cohort study. METHODS: This study analyzed private health plan claims for adults with type 2 diabetes who initiated 1 of 5 index ADM classes: sulfonylureas, dipeptidyl peptidase 4 inhibitors (DPP4is), sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or thiazolidinediones. Analyses evaluated 3 treatment modification outcomes-discontinuation, switching, and intensification-over 12-month follow-up. RESULTS: Of 82,624 included adults, nearly two-thirds (63.6%) experienced any treatment modification. Discontinuation was the most common modification (38.6%), especially among patients prescribed GLP-1 RAs (50.3%). Switching occurred in 5.2% of patients and intensification in 19.8%. In adjusted analysis, compared with patients prescribed sulfonylureas, discontinuation risk was 7% higher (HR, 1.07; 95% CI, 1.04-1.10) among patients prescribed DPP4is and 28% higher (HR, 1.28; 95% CI, 1.23-1.33) among patients prescribed GLP-1 RAs. Compared with sulfonylureas, all other index ADM classes had higher risks of switching and lower risks of intensification. Younger age group and female sex were both associated with higher risks of all modifications. Compared with index ADM prescription by a family medicine or internal medicine physician, index prescription by an endocrinologist was associated with both lower discontinuation risk and higher intensification risk. CONCLUSIONS: Most patients experienced a treatment modification within 1 year. Results highlight the need for new prescribing approaches and patient supports that can maximize medication adherence and reduce health system waste.

Effects of a Low-Carbohydrate Dietary Intervention on Hemoglobin A1c: A Randomized Clinical Trial.

Importance: Low-carbohydrate diets decrease hemoglobin A1c (HbA1c) among patients with type 2 diabetes at least as much as low-fat diets. However, evidence on the effects of low-carbohydrate diets on HbA1c among individuals with HbA1c in the range of prediabetes to diabetes not treated by diabetes medications is limited. Objective: To study the effect of a behavioral intervention promoting a low-carbohydrate diet compared with usual diet on 6-month changes in HbA1c among individuals with elevated untreated HbA1c. Design, Setting, and Participants: This 6-month randomized clinical trial with 2 parallel groups was conducted from September 2018 to June 2021 at an academic medical center in New Orleans, Louisiana. Laboratory analysts were blinded to assignment. Participants were aged 40 to 70 years with untreated HbA1c of 6.0% to 6.9% (42-52 mmol/mol). Data analysis was performed from November 2021 to September 2022. Interventions: Participants were randomized to a low-carbohydrate diet intervention (target <40 net grams of carbohydrates during the first 3 months; <60 net grams for months 3 to 6) or usual diet. The low-carbohydrate diet group received dietary counseling. Main Outcomes and Measures: Six-month change in HbA1c was the primary outcome. Outcomes were measured at 0, 3, and 6 months. Results: Of 2722 prescreened participants, 962 underwent screening, and 150 were enrolled (mean [SD] age, 58.9 [7.9] years; 108 women [72%]; 88 Black participants [59%]) and randomized to either the low-carbohydrate diet intervention (75 participants) or usual diet (75 participants) group. Six-month data were collected on 142 participants (95%). Mean (SD) HbA1c was 6.16% (0.30%) at baseline. Compared with the usual diet group, the low-carbohydrate diet intervention group had significantly greater 6-month reductions in HbA1c (net difference, -0.23%; 95% CI, -0.32% to -0.14%; P < .001), fasting plasma glucose (-10.3 mg/dL; 95% CI, -15.6 to -4.9 mg/dL; P < .001), and body weight (-5.9 kg; 95% CI, -7.4 to -4.4 kg; P < .001). Conclusions and Relevance: In this randomized clinical trial, a low-carbohydrate dietary intervention led to improvements in glycemia in individuals with elevated HbA1c not taking glucose-lowering medication, but the study was unable to evaluate its effects independently of weight loss. This diet, if sustained, might be a useful dietary approach for preventing and treating type 2 diabetes, but more research is needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03675360.