RTI International

Importance Understanding environmental risk factors for gestational diabetes (GD) is crucial for developing preventive strategies and improving pregnancy outcomes. Objective To examine the association of county-level radon exposure with GD risk in pregnant individuals. Design, Setting, and Participants This multicenter, population-based cohort study used data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b) cohort, which recruited nulliparous pregnant participants from 8 US clinical centers between October 2010 and September 2013. Participants who had pregestational diabetes or were missing data on GD or county-level radon measurements were excluded from the current study. Data were analyzed from September 2023 to January 2024. Exposures County-level radon data were created by the Lawrence Berkeley National Laboratory based on the Environmental Protection Agency’s short- and long-term indoor home radon assessments. Radon exposure was categorized into 3 groups: less than 1, 1 to less than 2, and 2 or more picocuries (pCi)/L (to convert to becquerels per cubic meter, multiply by 37). Because radon, smoking, and fine particulate matter air pollutants (PM 2.5 ) may share similar biological pathways, participants were categorized by joint classifications of radon level (<2 and ≥2 pCi/L) with smoking status (never smokers and ever smokers) and radon level with PM 2.5 level (above or below the median). Main Outcomes and Measures The main outcome was GD, identified based on glucose tolerance testing and information from medical record abstraction. Multiple logistic regression models were used to assess the association between radon exposure and GD. Results Among the 9107 participants, mean (SD) age was 27.0 (5.6) years; 3782 of 9101 (41.6%) had ever used tobacco. The mean (SD) county-level radon concentration was 1.6 (0.9) pCi/L, and 382 participants (4.2%) had GD recorded. After adjusting for potential confounders, individuals living in counties with the highest radon level (≥2 pCi/L) had higher odds of developing GD compared with those living in counties with the lowest radon level (<1 pCi/L) (odds ratio [OR], 1.37; 95% CI, 1.02-1.84); after additional adjustment for PM 2.5 , the OR was 1.36 (95% CI, 1.00-1.86). Elevated odds of GD were also observed in ever smokers living in counties with a higher (≥2 pCi/L) radon level (OR, 2.09; 95% CI, 1.41-3.11) and participants living in counties with higher radon and PM 2.5 levels (OR, 1.93; 95% CI, 1.31-2.83), though no statistically significant interactions were observed. Conclusions and Relevance This cohort study suggests that higher radon exposure is associated with greater odds of GD in nulliparous pregnant individuals. Further studies are needed to confirm the results and elucidate the underlying mechanisms, especially with individual-level residential radon exposure assessment.

Background Telehealth services can increase access to care by reducing barriers. Telephone-administered care, in particular, requires few resources and may be preferred by communities in areas that are systemically underserved. Understanding the effectiveness of audio-based care is important to combat the current mental health crisis and inform discussions related to reimbursement privileges. Objectives We compared the effectiveness of audio-based care to usual care for managing mental health and substance use disorders (MHSUD). Design We used systematic review methods to synthesize available evidence. Studies We searched for English-language articles reporting randomized controlled trials (RCTs) of adults diagnosed with MHSUD published since 2012. Outcomes We abstracted data on clinical outcomes, patient-reported health and quality of life, health care access and utilization, care quality and experience, and patient safety. Results We included 31 RCTs of participants diagnosed with depression, post-traumatic stress disorder (PTSD), other serious mental illness (SMI), anxiety, insomnia, or substance use disorder (SUD). Most of the evidence was for interventions targeting depression, PTSD, and SUD. The evidence demonstrates promise for: (1) replacing in-person care with audio care for depression, other SMI, and SUD (very low to moderate certainty of comparable effectiveness); and (2) adding audio care to monitor or treat depression, PTSD, anxiety, insomnia, and SUD (low to moderate certainty of evidence favoring audio care for clinical outcomes). Conclusions MHSUD can be managed with audio care in certain situations. However, more evidence is needed across conditions, and specifically for anxiety and other conditions for which no research was identified.

Background There is a lack of consensus on the effectiveness of audio-based care to manage chronic conditions. This knowledge gap has implications for health policy decisions and for health equity, as underserved populations are more likely to access care by telephone. Objectives We compared the effectiveness of audio-based care to usual care for managing chronic conditions (except diabetes). Design We used systematic review methods to synthesize available evidence. Studies We searched for English-language articles reporting on randomized controlled trials (RCTs) of adults diagnosed with a chronic condition published since 2012. Outcomes We abstracted data on clinical outcomes, patient-reported health and quality of life, health care access and utilization, care quality and experience, and patient safety. Results We included 40 RCTs evaluating audio-based care for a variety of chronic conditions, including cancer, heart failure, neurological disease, respiratory disease, musculoskeletal conditions, kidney disease, and others. There was significant heterogeneity across conditions and interventions. We generally found low to very low certainty of evidence of comparable effectiveness in the use of audio-based care to replace other care. Audio care as a supplement exhibited greater effectiveness in some outcomes, with generally low to very low certainty of evidence for most outcomes but moderate certainty for 2 groups of study outcomes. Conclusions More research is needed to identify the conditions, populations, and intervention design combinations that improve outcomes and to determine when audio-based care can effectively replace other synchronous care.

Objectives We compared the effectiveness of audio-based care, as a replacement or a supplement to usual care, for managing diabetes. Background Diabetes is a chronic condition afflicting many in the United States. The impact of audio-based care on the health of individuals with diabetes is unclear, particularly for those at risk for disparities—many of whom may only be able to access telehealth services through telephone. Methods We used systematic review methods to synthesize available evidence. We systematically searched for English-language articles from 2012 reporting randomized controlled trials of adults diagnosed with diabetes. We abstracted data on clinical outcomes (including A1c), patient-reported health and quality-of-life, health care access and utilization, care quality and experience, and patient safety. Results Evidence for replacing in-person care with audio care was limited (n = 2), with low certainty of evidence for greater and comparable effectiveness for A1c and harms, respectively. Supplemental audio care (n = 23) had a positive effect on A1c (pooled mean difference A1c −0.20%; n = 8763; 95% CI: −0.36% to −0.04%), with moderate certainty of evidence. Stratified results indicated that audio interventions supplementing usual care performed more favorably in individuals with A1c ≤ 9%; populations not at risk of disparities; interventions with at least monthly contact; and interventions using remote monitoring tools. Conclusions This evidence base reveals some promise for managing diabetes with audio-based care as a supplement to in-person care. Future studies could further investigate the effectiveness of audio-based care as a replacement and modify interventions to better serve individuals with poor glucose control and those at risk for disparities.

Prevalence of autism diagnosis has historically differed by demographic factors. Using data from 8224 participants drawn from the Environmental influences on Child Health Outcomes (ECHO) Program, we examined relationships between demographic factors and parent‐reported autism‐related traits as captured by the Social Responsiveness Scale (SRS; T score > 65) and compared these to relations with parent‐reported clinician diagnosis of ASD, in generalized linear mixed effects regression analyses. Results suggested lower odds of autism diagnosis, but not of SRS T > 65, for non‐Hispanic Black children (adjusted odds ratio [OR] = 0.76, 95% CI 0.55, 1.06) relative to non‐Hispanic White children. Higher maternal education was associated with reduced odds of both outcomes (OR = 0.73, 95% CI 0.51, 1.05 for ASD autism diagnosis and 0.4, 95% CI 0.29, 0.55 for SRS score). In addition, results suggested a lower likelihood of autism diagnosis but a higher likelihood of an SRS score > 65 in Black girls. Findings suggest lower diagnostic recognition of autism in non‐Hispanic Black children, despite a similar degree of SRS‐assessed autism‐related traits falling in the clinically elevated range. Further work is needed to address this disparity.

Analytical research relevant to cigar products is relatively limited compared to other tobacco product categories and very few standardized methods are in place. In recent years, scientific and regulatory interests in cigar testing have increased. Thus, there is a need for increased foundational knowledge in the product space. The objective of this work was to characterize cigars across a range of design features to understand relative magnitude of results and to evaluate analytical variability among and between three laboratories using their own practices and methodology. Commercial cigars across a broad range of design characteristics were evaluated for tobacco and smoke harmful or potentially harmful constituents (HPHCs) typically applied to cigarettes and smokeless tobacco products (i.e., FDA-Center for Tobacco Product’s abbreviated list). Design features such as size, manufacturing technique (machine vs. hand), and tipping (untipped, filtered, and mouthpiece designs) were included in the study matrix. For smoke analytes, a currently accepted regime for cigar smoking was employed. Cigars from the same lots were tested by three independent laboratories using their own methodologies to assess lab-to-lab differences across 5 physical parameter measures, 10 tobacco analytes, and 21 smoke analytes. Thus, the overall study was a randomized design with a two-factor arrangement: cigar type (with six levels) and laboratory (with three levels). Calculation of Lab Product Range (LPR) allowed for a comparison of magnitude in results across the product set. Data analysis included determination of relative variability (% RSD, Relative Standard Deviation) for replicate testing among the products. Lab Range (LR) was calculated to compare spread in results among the laboratories for each product. Low LR and similar LPR among the labs is an indicator of laboratory consistency. LPR results ranged from 45% for length to 445% for smoke ammonia. For example, tobacco weight, at approximately 260% LPR, ranged from 1 g/cigar to 18 g/cigar. Tobacco NNN, LPR 328%, ranged from 2000 ng/g to 27,000 ng/g. Replicate variability (% RSD) of physical characteristics, tobacco, and smoke analytes was much higher for the cigar products than previously reported for typical cigarette products. For example, tobacco weight % RSD was as high as 11%. Commercial factory-made cigarettes are typically reported at < 1% RSD. Lab Range was as low as < 1% for cigar length and as high as 247% for tobacco NNK. Smoke nicotine, one of the few analytes tested using standard methodology and subject to routine collaborative studies, had an LR as high as 73%. Tobacco BaP and carbonyls LR results were very inconsistent between labs. For example, acetaldehyde for Sample D was reported as 0.29, 0.81, and < 0.10 µg/g for Lab 1, Lab 2, and Lab 3, respectively. Cigars with a broad range of design features were shown to have relatively high variability, a wide magnitude in analyte levels and smoking characteristics, and in some cases quite distinct results from lab-to-lab. Some analytes, such as BaP and crotonaldehyde, were determined to be inadequate for characterization in cigar tobacco due to a lack of quantifiable results. Based on LR results, smoke ammonia and carbonyls were found to lack robust methodology. The results of this study support the need for increased standardization for smoking analyte methods and the use of reference products across studies to improve understanding of product differences and the contribution of analytical variability. Additionally, in the absence of foundational data, the results are cautionary regarding using isolated data sets for characterization via HPHC testing for cigars, especially hand rolled products.

Pneumococcal infections are a serious health issue associated with increased morbidity and mortality. This systematic review evaluated the efficacy, effectiveness, immunogenicity, and safety of the pneumococcal conjugate vaccine (PCV)15 compared to other pneumococcal vaccines or no vaccination in children and adults. We identified 20 randomized controlled trials (RCTs). A meta-analysis of six RCTs in infants showed that PCV15 was non-inferior compared with PCV13 for 12shared serotypes. Based on a meta-analysis of seven RCTs in adults, PCV15 was non-inferior toPCV13 for 13 shared serotypes. For the unique PCV15 serotypes, 22F and 33F, immune responses were higher in infants and adults vaccinated with PCV15 compared to those receiving PCV13.Regarding safety, meta-analyses indicated comparable risks of adverse events between PCV15 andPCV13 in infants. Adults receiving PCV15 had a slightly higher risk of adverse events, though serious events were similar between groups.

Recent Monte Carlo research (Lance, Woehr, & Meade, 2007) has questioned the primary analytical tool used toassess the construct-related validity of assessment center post-exercise dimension ratings (PEDRs) – aconfirmatory factor analysis of a multitrait-multimethod (MTMM) matrix. By utilizing a hybrid of Monte Carlodata generation and univariate generalizability theory, we examined three primary sources of variance (i.e.,persons, dimensions, and exercises) and their interactions in 23 previously published assessment center MTMMmatrices. Overall, the person, dimension, and person by dimension effects accounted for a combined 34.06% ofvariance in assessment center PEDRs (16.83%, 4.02%, and 13.21%, respectively). However, the largest singleeffect came from the person by exercise interaction (21.83%). Implications and suggestions for futureassessment center research and design are discussed.

Markov latent class analysis (MLCA) is a modeling technique for panel or longitudinal data that can be used to estimate the classification error rates (e.g., false positive and false negative rates for dichotomous items) for discrete outcomes with categorical predictors when gold-standard measurements are not available. Because panel surveys collect data at multiple time points, the grouping variables in the model may either be time varying or time invariant (static). Time varying grouping variables may be more correlated with either the latent construct or the measurement errors because they are measured simultaneously with the construct during the measurement process. However, they generate a large number of model parameters that can cause problems with data sparseness, model diagnostic validity, and model convergence. In this paper we investigate whether more parsimonious grouping variables that either summarize the variation of the time varying grouping variable or assume a structure that lacks memory of previous values of the grouping variables can be used instead, without sacrificing model fit or validity. We propose a simple diagnostic approach for comparing the validity of models that use time-invariant summary variables with their time-varying counterparts. To illustrate the methodology, this approach is applied to data from the National Crime Victimization Survey (NCVS) where greater parsimony and a reduction in data sparseness were achieved with no appreciable loss in model validity for the outcome variables considered. The approach is generalized for application to essentially any MLCA using time varying group variables and its advantages and disadvantages are discussed.

Community–clinical partnerships are an effective approach to connecting primary care with public health to increase disease prevention and screenings and reduce health inequities. We explore how the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) award recipients and clinic teams are using community–clinical linkages to deliver services to populations who are without access to health care and identify barriers, facilitators, and lessons that can be used to improve program implementation. We used purposive sampling to select nine state recipients of the NBCCEDP and a clinic partner for each recipient. The data collection was implemented through a multimodal approach using questionnaires, semistructured interviews, and focus groups. Partnerships between award recipients and clinic teams enhanced planning as clinics were able to optimize the use of electronic medical records to identify women who were not up to date with screening. Partnerships with community organizations, hospital systems, and academic institutions were important to increase community outreach and access to services. These partnerships offered a source of client referrals, a forum to deliver in-person education, a platform for joint dissemination activities to reach a wider audience, collaborations to provide transportation, and coverage for clinical services not available at NBCCEDP participating clinics. In conclusion, partnerships between various organizations are important to enhance planning, increase outreach, and improve access to cancer screening. Internal organizational and external support is important to identify appropriate partners, and technical assistance and training may be beneficial to maintain and optimize community partnerships to address health disparities.

Background Diabetes affects millions of people in the United States and poses significant health and economic challenges, but it can be prevented or managed through health behavior changes. Such changes might be aided by voice-activated personal assistants (VAPAs), which offer interactive and real-time assistance through features such as reminders, or obtaining health information. However, there are little data on interest and acceptability of integrating VAPAs into programs such as the National Diabetes Prevention Program (National DPP) or diabetes, self-management, education, and support (DSMES) services. Methods We conducted individual and small-group semi-structured interviews of National DPP and DSMES staff and program participants. We used rapid-turnaround qualitative thematic analysis to identify emerging themes using an adapted version of the Consolidated Framework for Implementation Research (CFIR). Results Nearly all program participants and staff had prior experience with VAPAs, but not in the context of these programs. Most program participants felt confident in their ability to use VAPAs but were concerned about their privacy and security. Program staff were optimistic about the feasibility of integrating VAPAs into existing programs given their ability to support healthy habit formation, but staff were less optimistic about using VAPAs to share health information. Program staff also felt that additional resources to support VAPA use would help ensure that VAPAs would not create an extra burden on staff and program participants. Implications Integrating VAPAs as a resource to enhance mobile applications already in use shows potential to support health behavior change. Future research should include how this technology could be further optimized to enhance utility.

Criminal legal systems are increasingly adopting actuarial pretrial assessments which use statistical formulas to estimate individuals’ probability of adhering to pretrial requirements and guide the conditions of their supervision. A large gap in the study of pretrial assessments is due to inattention to implementation of these assessments in real-world settings. We conducted qualitative research examining personnel and data resource factors that influenced adoption and implementation of one pretrial assessment, the Public Safety Assessment (PSA) in seven counties in the United States. Qualitative interviews with legal and community actors were conducted and supplemented with implementation process data to elucidate personnel and data capacity factors impacting PSA adoption and implementation. Findings suggest that generally, jurisdictions with existing pretrial services programs were more likely to adopt the PSA and to encounter fewer barriers to implementation due to personnel and data infrastructure. Implications for PSA adoption and implementation in future pretrial settings are discussed.

Introduction The clinical, research and advocacy communities for Rett syndrome are striving to achieve clinical trial readiness, including having fit-for-purpose clinical outcome assessments. This study aimed to (1) describe psychometric properties of clinical outcome assessment for Rett syndrome and (2) identify what is needed to ensure that fit-for-purpose clinical outcome assessments are available for clinical trials. Methods Clinical outcome assessments for the top 10 priority domains identified in the Voice of the Patient Report for Rett syndrome were compiled and available psychometric data were extracted. The clinical outcome assessments measured clinical severity, functional abilities, comorbidities and quality of life, and electrophysiological biomarkers. An international and multidisciplinary panel of 29 experts with clinical, research, psychometric, biostatistical, industry and lived experience was identified through International Rett Syndrome Foundation networks, to discuss validation of the clinical outcome assessments, gaps and next steps, during a workshop and in a follow-up questionnaire. The identified gaps and limitations were coded using inductive content analysis. Results Variable validation profiles across 26 clinical outcome assessments of clinical severity, functional abilities, and comorbidities were discussed. Reliability, validity, and responsiveness profiles were mostly incomplete; there were limited content validation data, particularly parent-informed relevance, comprehensiveness and comprehensibility of items; and no data on meaningful change or cross-cultural validity. The panel identified needs for standardised administration protocols and systematic validation programmes. Conclusion A pipeline of collaborative clinical outcome assessment development and validation research in Rett syndrome can now be designed, aiming to have fit-for-purpose measures that can evaluate meaningful change, to serve future clinical trials and clinical practice.

Prescription drugs may be indicated to treat more than one medical condition, and companies may promote more than one indication in the same direct-to-consumer (DTC) ad. This study examined how presenting multiple prescription drug indications in one DTC television ad affects consumers’ processing of drug information. We conducted two studies with adults diagnosed with diabetes (Study 1, N = 408) or rheumatoid arthritis (Study 2, N = 411). We randomly assigned participants to view one of three television ads: primary indication only (Study 1: diabetic peripheral neuropathy; Study 2: rheumatoid arthritis), primary plus a similar secondary indication (Study 1: fibromyalgia; Study 2: psoriatic arthritis), or primary plus a dissimilar secondary indication (Study 1: generalized anxiety disorder; Study 2: ulcerative colitis). Remembering and understanding the primary indication was not significantly affected by the presence of a secondary indication (similar or dissimilar). Higher health literacy participants remembered and understood secondary indications. Including a second indication in DTC television ads does not appear to have detrimental effects and can increase awareness of the second indication for some participants. Industry and regulators should continue to ensure DTC promotion is truthful and non-misleading, irrespective of the number of indications presented.

The life cycle greenhouse gas (GHG) emissions of biofuels depend on uncertain estimates of induced land use change (ILUC) and subsequent emissions from carbon stock changes. Demand for oilseed-based biofuels is associated with particularly complex market and supply chain dynamics, which must be considered. Using the global partial equilibrium model GLOBIOM, this study explores the uncertainty in market-mediated impacts and ILUC-related emissions from increasing demand for soybean biodiesel in the United States in the period 2020−2050. A one-at-a-time (OAT) analysis and a Monte Carlo (MC) analysis are performed to assess the sensitivity of modeled ILUC-GHG emissions intensities (gCO2e/MJ) to varying key economic and biophysical model parameters. Additionally, the influence of the approach on the simulation of future ILUC effects is explored using two alternative ILUC-GHG metrics: a comparative-static approach for 2030 and a recursive-dynamic approach using model outputs through 2050. We find that projected ILUC-GHG values largely vary based on which vegetable oils replace diverted soybean oil, market responses to coproducts, and the carbon content of land converted for agricultural use. These are all, in turn, subject to decision uncertainty through the choice of the modeling approach and the time horizon considered for each ILUC-GHG metric. Given the longer simulation period, ILUC-GHG emission uncertainty ranges increase under the recursive-dynamic approach (42.4 ± 25.9 gCO2e/MJ) compared to the comparative-static approach (40.8 ± 20.5 gCO2e/MJ). The combination of MC analysis with other techniques such as Bayesian Additive Regression Trees (BART) is powerful for understanding model behavior and clarifying the sensitivity of market responses, ILUC, and associated GHG emissions to specific model parameters when simulated with global economic models. The BART reveals that biophysical parameters generate more linear ILUC-GHG responses to changes in assumed parameter values while changes in economic parameters lead to more nonlinear ILUC-GHG results as multiple effects at the interplay of food, feed, and fuel uses overlap. The choice of the recursive-dynamic metric allows capturing the longer-term evolution of ILUC while generating additional uncertainties derived from the baseline definition.

Background Identifying contextual factors that might support or hinder implementation of evidence-based mental health interventions for youth in low- and middle- income countries may improve implementation success by increasing the alignment of intervention implementation with local needs and resources. This study engaged community partners in Sierra Leone to: (a) investigate barriers and facilitators to implementing a mental health intervention within Sierra Leone’s schools; (b) develop an implementation blueprint to address identified implementation barriers; (c) explore the feasibility of using the implementation blueprint methodology in Sierra Leone. Methods We recruited Ministry of Education Officials (n = 2), teachers (n = 15) and principals (n = 15) in Sierra Leone to participate in needs assessment qualitative interviews. We used a rapid qualitative analysis approach to analyze data. Three team members summarized transcripts based on domains aligned with the structured research questions, organized themes into a matrix, and identified and discussed key themes to arrive at consensus. We then reconvened community partners to discuss implementation strategies that could address identified barriers. Participants ranked barriers according to high/low feasibility and high/low importance and selected implementation strategies for the blueprint. Results Qualitative results revealed several implementation barriers: teacher/parent/student buy-in; teacher motivation; scheduling time; limited funding; waning interest; daily hardships outside of school. Strategies selected included: develop/distribute educational materials; conduct education meetings/outreach; identify and prepare champions; access new funding. Conclusions Engaging community partners to develop an implementation blueprint for integration of a mental health intervention within Sierra Leone’s schools was feasible and may increase implementation effectiveness.