The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution: Protocol for a Randomized Controlled Trial.

BACKGROUND: The use of naloxone, an opioid antagonist, is a critical component of the US response to fatal opioid-involved overdoses. The importance and utility of naloxone in preventing fatal overdoses have been widely declaimed by medical associations and government officials and are supported by strong research evidence. Still, there are gaps in the current US national strategy because many opioid-involved overdose fatalities have no evidence of naloxone administration. Improving the likelihood that naloxone will be used to prevent fatal overdoses is predicated on facilitating an environment wherein naloxone is available near each overdose and can be accessed by someone who is willing and able to use it. How to accomplish this on a national scale has been unclear. However, there exists a national network of >1 million cardiopulmonary resuscitation (CPR) layperson responders and 4800 emergency responder agencies linked through a mobile phone app called PulsePoint Respond. PulsePoint responders certify that they are trained to administer CPR and are willing to respond to possible cardiac events in public. When such an event occurs near their mobile phone's location, they receive an alert to respond. These motivated citizens are ideally positioned to carry naloxone and reverse overdoses that occur in public. OBJECTIVE: This randomized controlled trial will examine the feasibility of recruiting first responder agencies and layperson CPR responders who already use PulsePoint to obtain overdose education and carry naloxone. METHODS: This will be a 3-arm parallel-group randomized controlled trial. We will randomly select 180 first responder agencies from the population of agencies contracting with the PulsePoint Foundation. The 3 study arms will include a standard recruitment arm, a misperception-correction recruitment arm, and a control arm (1:1:1 allocation, with random allocation stratified by zip code designation [rural or nonrural]). We will study agency recruitment and, among the agencies we successfully recruit, responder certification of receiving overdose and naloxone education, carrying naloxone, or both. Hypothesis 1 contrasts agency recruitment success between arms 1 and 2, and hypothesis 2 contrasts the ratios of layperson certification across all 3 arms. The primary analyses will be a logistic regression comparing the recruitment rates among the arms, adjusting for rural or nonrural zip code designation. RESULTS: This study was reviewed by the Indiana University Institutional Review Board (20218 and 20219). This project was funded beginning September 14, 2023, by the National Institute on Drug Abuse. CONCLUSIONS: The hypotheses in this study will test whether a specific type of messaging is particularly effective in recruiting agencies and layperson responders. Although we hypothesize that arm 2 will outperform the other arms, our intention is to use the best-performing approach in the next phase of this study if any of our approaches demonstrates feasibility. TRIAL REGISTRATION: OSF Registries osf.io/egn3z; https://osf.io/egn3z. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57280.

Design and conduct of a randomized controlled feeding trial in a residential setting with mitigation for COVID-19.

BACKGROUND: Evaluating effects of different macronutrient diets in randomized trials requires well defined infrastructure and rigorous methods to ensure intervention fidelity and adherence. METHODS: This controlled feeding study comprised two phases. During a Run-in phase (14-15 weeks), study participants (18-50 years, BMI, ≥27 kg/m2) consumed a very-low-carbohydrate (VLC) diet, with home delivery of prepared meals, at an energy level to promote 15 ± 3% weight loss. During a Residential phase (13 weeks), participants resided at a conference center. They received a eucaloric VLC diet for three weeks and then were randomized to isocaloric test diets for 10 weeks: VLC (5% energy from carbohydrate, 77% from fat), high-carbohydrate (HC)-Starch (57%, 25%; including 20% energy from refined grains), or HC-Sugar (57%, 25%; including 20% sugar). Outcomes included measures of body composition and energy expenditure, chronic disease risk factors, and variables pertaining to physiological mechanisms. Six cores provided infrastructure for implementing standardized protocols: Recruitment, Diet and Meal Production, Participant Support, Assessments, Regulatory Affairs and Data Management, and Statistics. The first participants were enrolled in May 2018. Participants residing at the conference center at the start of the COVID-19 pandemic completed the study, with each core implementing mitigation plans. RESULTS: Before early shutdown, 77 participants were randomized, and 70 completed the trial (65% of planned completion). Process measures indicated integrity to protocols for weighing menu items, within narrow tolerance limits, and participant adherence, assessed by direct observation and continuous glucose monitoring. CONCLUSION: Available data will inform future research, albeit with less statistical power than originally planned.

Assessing the acceptability and feasibility of remote spirometric monitoring for rural patients with interstitial lung disease: a multimethod approach.

INTRODUCTION: Interstitial lung disease encompasses a group of rare lung conditions causing inflammation and scarring of lung tissue. The typical method of monitoring disease activity is through pulmonary function tests performed in a hospital setting. However, accessing care can be difficult for rural patients due to numerous barriers. This study assesses the feasibility and acceptability of home spirometry telemonitoring using MIR-Spirometers and the patientMpower home-monitoring platform for rural patients with interstitial lung disease. METHODS: Unblinded, uncontrolled, prospective, multiple-methods study of the feasibility and utility of remote monitoring of 20 rural subjects with interstitial lung disease. Study assessments include adherence to twice weekly spirometry for 3 months in addition to mMRC dyspnea and EQ-5D-5L health-related quality of life questionnaires with each spirometry maneuver. Upon completion, subjects were encouraged to complete an 11-question satisfaction survey and participate in semi-structured qualitative interviews to further explore expectations and perceptions of rural patients to telehealth and remote patient monitoring. RESULTS: 19 subjects completed the 3-month study period. Adherence to twice weekly spirometry was mean 53% ± 38%, with participants on average performing 2.26 ± 1.69 maneuvers per week. The median (Range) number of maneuvers per week was 2.0 (0.0, 7.0). The majority of participants responded favorably to the patient satisfaction survey questions. Themes regarding barriers to access included: lack of local specialty care, distance to center with expertise, and time, distance, and high cost associated with travel. Remote monitoring was well perceived amongst subjects as a way to improve access and overcome barriers. CONCLUSIONS: Remote spirometry monitoring through web-based telehealth is acceptable and feasible for rural patients. Perceived benefits include overcoming access barriers like time, distance, and travel costs. However, cost, reimbursement, and internet access must be addressed before implementing it widely. Future studies are needed to ensure long-term feasibility and to compare outcomes with usual care.

Organizational Network Analysis of SAMHSA's Technology Transfer Center (TTC) Network.

Technology transfer centers (TTCs) facilitate the movement of evidence-based practices in behavioral healthcare from theory to practice. One of the largest such networks is the Substance Abuse and Mental Health Services Administration's (SAMHSA) TTC Network. This brief report shares findings from an organizational network analysis (ONA) of the network conducted as part of an external evaluation. For non-supervisory TTCs (n = 36) across three focus areas (addiction, prevention, and mental health), the authors computed network density, harmonic closeness, and non-null dyadic reciprocity for five types of interactions (e.g., "collaborated in workgroups"), then, for each interaction type, used Welch's T-test to compare mean harmonic closeness of standalone TTC grantees versus multiple-TTC grantees. ONA identified potentially isolated regional TTCs as well as mismatches between some centers' desired scope and their network centrality and enabled investigation of broader questions around behavioral health support systems. The approach appears useful for evaluating TTCs and similar support networks.

Comment on Marsigliante et al. Effects on Children's Physical and Mental Well-Being of a Physical-Activity-Based School Intervention Program: A Randomized Study. Int. J. Environ. Res. Public Health 2023, 20, 1927.

We conducted a critical review of the article "Effects on Children's Physical and Mental Well-Being of a Physical-Activity-Based School Intervention Program: A Randomized Study", published in the International Journal of Environmental Research and Public Health in 2023 as part of the Special Issue "Psychomotricity and Physical Education in School Health". We identified multiple mistakes in the statistical analyses applied. First, the authors claim to have found a statistically significant association between the proposed intervention and change in body composition (body mass index (BMI) percentiles, relative fat mass, and BMI classes) by way of exhibiting differences in nominal significance between the pre- and post-intervention changes within the control and intervention groups, instead of exhibiting a significant difference between groups. Furthermore, the analysis described fails to account for clustering and nesting in the data. The reporting of the statistical methods and results include multiple elements that are variously incorrect, incoherent, or impossible. Revised statistical analyses are proposed which can render the study's methods valid and its results substantiated, whereas the current methods and results are invalid and unsubstantiated, respectively.

Factors Associated with Cancer Prevention/Risk Reduction Behaviors among Latinos.

Improving understanding of behaviors that increase or reduce cancer risk for different Hispanic groups is a public health priority; such knowledge is sparse in new gateway immigration locations such as Indiana. The aims of this study were to: 1) describe cancer beliefs and cancer preventive/risk reduction behaviors (physical activity, tobacco, and alcohol use) among Hispanic adults; 2) examine differences in cancer beliefs and preventive behaviors by country/territory of birth, socioeconomic status, and area of residence (urban vs. rural); and 3) determine predictors of engagement in cancer prevention and risk reduction behaviors in this population. A cross-sectional online survey targeted adult Indiana residents who identified as Latino, Hispanic, or Spanish recruited using Facebook-targeted advertising. Complete survey data from 1520 respondents were analyzed using descriptive, unadjusted, and adjusted models. The majority of respondents believed they were unlikely to get cancer but held many other fatalistic beliefs about cancer. Only 35.6% of respondents had received the HPV vaccine, 37.6% reported they were currently smoking cigarettes, and 64% reported occasional or frequent drinking of alcohol. Respondents spent an average of 3.55 days per week engaged in moderate exercise. Differences were observed by country/territory of birth, income, and education but not by rural residence status. Predictors of cancer risk/risk reduction behaviors were identified. The Hispanic population in Indiana is diverse and effective interventions for cancer prevention should be culturally targeted based on country/territory of birth and individually tailored based on cancer-related beliefs.

Unreliable Findings Due to Miscalculations and Errors. Comment on Nally et al. The Effectiveness of School-Based Interventions on Obesity-Related Behaviours in Primary School Children: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Children 2021, 8, 489.

Nally et al. [...].

Corrected analysis of "the effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial" that accounts for clustering and nesting verifies conclusions.

In this correspondence, we explain the reasoning for invalidity of the analysis choices by Kolberg et al., and provide the results produced using correct statistical procedures for their study design. Reassuringly, we could verify the original conclusions. That is, results of the corrected statistical models are similar to the results of the original analysis. Regardless of the magnitude of difference that corrected statistical methods make, results and conclusions that are derived from invalid methods are unsubstantiated. By verifying the results, we allow the readers to be assured that the published conclusions in the study by Kolberg et al. now rest on a sound evidential basis.

Students' COVID-19 vaccine behaviors, intentions, and beliefs at a US Native American-Serving Nontribal Institution (NASNTI).

OBJECTIVE: Multiple national and international studies of college student COVID-19 vaccination have been recently published, providing important descriptive information and a conceptual basis to inform future decisions about infectious disease prevention in higher education settings. Yet almost no research has examined Native American-Serving Nontribal Institutions (NASNTIs), which occupy a unique space in US higher education in terms of structure and students served. To address that gap, this report describes results from a two-wave cross-sectional survey administered at a NASNTI in Durango, Colorado, as part of a larger study of COVID-19 campus response. Surveys were administered prior to (wave one) and following (wave two) statewide availability of the COVID-19 vaccine for ages 16+. Comparisons between waves used Cramer's V and Mann-Whitney U tests. RESULTS: A total of 283 students responded to wave one, and 186 responded to wave two. Notable results included a self-reported COVID-19 vaccination rate (40.1%) at wave one that far exceeded parallel national rates. Injunctive and disjunctive normative beliefs were also less supportive of vaccination among the unvaccinated at wave two compared to wave one. Findings from this study should be considered in the context of all available evidence and not used to make inferences in isolation.

Using Normative Language When Describing Scientific Findings: Randomized Controlled Trial of Effects on Trust and Credibility.

BACKGROUND: Scientists often make cognitive claims (eg, the results of their work) and normative claims (eg, what should be done based on those results). Yet, these types of statements contain very different information and implications. This randomized controlled trial sought to characterize the granular effects of using normative language in science communication. OBJECTIVE: Our study examined whether viewing a social media post containing scientific claims about face masks for COVID-19 using both normative and cognitive language (intervention arm) would reduce perceptions of trust and credibility in science and scientists compared with an identical post using only cognitive language (control arm). We also examined whether effects were mediated by political orientation. METHODS: This was a 2-arm, parallel group, randomized controlled trial. We aimed to recruit 1500 US adults (age 18+) from the Prolific platform who were representative of the US population census by cross sections of age, race/ethnicity, and gender. Participants were randomly assigned to view 1 of 2 images of a social media post about face masks to prevent COVID-19. The control image described the results of a real study (cognitive language), and the intervention image was identical, but also included recommendations from the same study about what people should do based on the results (normative language). Primary outcomes were trust in science and scientists (21-item scale) and 4 individual items related to trust and credibility; 9 additional covariates (eg, sociodemographics, political orientation) were measured and included in analyses. RESULTS: From September 4, 2022, to September 6, 2022, 1526 individuals completed the study. For the sample as a whole (eg, without interaction terms), there was no evidence that a single exposure to normative language affected perceptions of trust or credibility in science or scientists. When including the interaction term (study arm × political orientation), there was some evidence of differential effects, such that individuals with liberal political orientation were more likely to trust scientific information from the social media post's author if the post included normative language, and political conservatives were more likely to trust scientific information from the post's author if the post included only cognitive language (ß=0.05, 95% CI 0.00 to 0.10; P=.04). CONCLUSIONS: This study does not support the authors' original hypotheses that single exposures to normative language can reduce perceptions of trust or credibility in science or scientists for all people. However, the secondary preregistered analyses indicate the possibility that political orientation may differentially mediate the effect of normative and cognitive language from scientists on people's perceptions. We do not submit this paper as definitive evidence thereof but do believe that there is sufficient evidence to support additional research into this topic, which may have implications for effective scientific communication. TRIAL REGISTRATION: OSF Registries osf.io/kb3yh; https://osf.io/kb3yh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/41747.

High-Speed Videoendoscopic and Acoustic Characteristics of Inspiratory Phonation.

PURPOSE: Given the importance of inspiratory phonation for assessment of vocal fold structure, the aim of this investigation was to evaluate and describe the vocal fold vibratory characteristics of inspiratory phonation using high-speed videoendoscopy in healthy volunteers. The study also examined the empirical relationship between cepstral peak prominence (CPP) and glottal area waveform measurements derived from simultaneous high-speed videoendoscopy and audio recordings. METHOD: Vocally healthy adults (33 women, 28 men) volunteered for this investigation and completed high-speed videoendoscopic assessment of vocal fold function for two trials of an expiratory/inspiratory phonation task at normal pitch and normal loudness. Twelve glottal area waveform measures and acoustic CPP values were extracted for analyses. RESULTS: Inspiratory phonation resulted in shorter closing time, longer duration of the opening phase, and faster closing phase velocity compared to expiratory phonation. Sex differences were elucidated. CPP changes for inspiratory phonation were predicted by changes in the glottal area index and waveform symmetry index, whereas changes in CPP during expiratory phonation were predicted by changes in asymmetry quotient, glottal area index, and amplitude periodicity. CONCLUSIONS: Vocal fold vibratory differences were identified for inspiratory phonation when compared to expiratory phonation, the latter of which has been studied more extensively. This investigation provides important basic inspiratory phonation data to better understand laryngeal physiology in vivo and provides a basic model from which to further study inspiratory phonation in a larger population representing a broader age range. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.22223812.