Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory.

Objective: Most pragmatic trials follow the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria. The criteria specify unobtrusive measurement of participants' protocol adherence and practitioners' intervention fidelity but suggest no special monitoring strategies to assure trial integrity. We present experience with adherence/fidelity monitoring in the Pain Management Collaboratory (PMC) and provide recommendations for their monitoring in pragmatic trials to preserve inferences of treatment comparisons.

Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual.

Background: Veterans transitioning to civilian life often have chronic pain from service-related musculoskeletal disorders (MSD) with higher risk for substance misuse. Many seek VA (Department of Veterans Affairs) compensation for MSD. Use of Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT-PM) by VA Post-9/11 Military2VA (M2VA) case managers presents an opportunity to engage these veterans in VA pain care and address substance misuse.

Asynchronous education improves emergency medical services clinician confidence and knowledge in caring for patients near the end-of-life.

Objective: To evaluate the impact of a nationally available continuing education online curriculum on Emergency Medical Services (EMS) clinician confidence and knowledge in caring for end-of-life (EOL) patients.

Methods: This is a prospective observational study of EMS clinicians (emergency medical technicians [EMTs], advanced EMTs [AEMTs], and paramedics). EMS clinicians and physicians with both EMS and palliative care expertise developed two 20-min modules regarding: (1) communication skills (including death notification) and (2) hospice knowledge.

Clinician-caregiver informant discrepancy is associated with sex, diagnosis age, and intervention use among autistic children.

In some cases, a clinician's perceptions of a child's autism-related behaviors are not the same as the child's caregiver's perceptions. Identifying how these discrepancies relate to the characteristics of the child is critical for ensuring that diagnosis procedures are unbiased and suitable for all children. This study examined whether discrepancies between clinician and caregiver reports of autism features related to the child's sex at birth.

Integrated Stepped Alcohol Treatment With Contingency Management for Unhealthy Alcohol Use Among People With HIV: A Randomized Controlled Trial.

Background: We examined the impact of integrated stepped alcohol treatment with contingency management (ISAT + CM) on alcohol abstinence among people with HIV (PWH) and unhealthy alcohol use.

Methods: In this multisite 24-week trial, we randomized PWH reporting untreated unhealthy alcohol use and with phosphatidylethanol (PEth) >20 ng/mL to receive ISAT+CM or treatment as usual (TAU). Intervention : Step 1 : Social worker-delivered CM; Step 2 : Addiction physician management plus motivational enhancement therapy.

Spatiotemporal Eye Movement Dynamics Reveal Altered Face Prioritization in Early Visual Processing Among Autistic Children.

Background: Reduced social attention-looking at faces-is one of the most common manifestations of social difficulty in autism that is central to social development. Although reduced social attention is well characterized in autism, qualitative differences in how social attention unfolds across time remains unknown.

Methods: We used a computational modeling (i.

"SafetyNet": Evaluation of a Recovery Coach and Paramedic Intervention Following Naloxone Resuscitation From an Opioid Overdose.

Objective: Emergency department (ED)-initiated buprenorphine has proven efficacy, but many patients are reluctant to begin this treatment. This study evaluated SafetyNet, a program using a 2-person, recovery coach and paramedic (RCP) intervention postoverdose to reduce subsequent opioid overdose, engage patients in medications for opioid use disorder (MOUD), and reduce illicit drug use.

Methods: We conducted a prospective nonrandomized study in individuals who experienced opioid overdoses, received naloxone, but subsequently declined buprenorphine initiation in the ED.

Vigorous Exercise in Patients With Congenital Long QT Syndrome: Results of the Prospective, Observational, Multinational LIVE-LQTS Study.

Background: Whether vigorous exercise increases risk of ventricular arrhythmias for individuals diagnosed and treated for congenital long QT syndrome (LQTS) remains unknown.

Methods: The National Institutes of Health-funded LIVE-LQTS study (Lifestyle and Exercise in the Long QT Syndrome) prospectively enrolled individuals 8 to 60 years of age with phenotypic and/or genotypic LQTS from 37 sites in 5 countries from May 2015 to February 2019. Participants (or parents) answered physical activity and clinical events surveys every 6 months for 3 years with follow-up completed in February 2022.

Modeling of drinking and driving behaviors among adolescents and young adults in the United States: Complexities and Intervention outcomes.

Alcohol-impaired driving is a formidable public health problem in the United States, claiming the lives of 37 individuals daily in alcohol-related crashes. Alcohol-impaired driving is affected by a multitude of interconnected factors, coupled with long delays between stakeholders' actions and their impacts, which not only complicate policy-making but also increase the likelihood of unintended consequences. We developed a system dynamics simulation model of drinking and driving behaviors among adolescents and young adults.

Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal.

Importance: Buprenorphine is an effective yet underused treatment for opioid use disorder (OUD).

Objective: To evaluate the feasibility (acceptability, tolerability, and safety) of 7-day injectable extended-release buprenorphine in patients with minimal to mild opioid withdrawal.

Design, Setting, And Participants: This nonrandomized trial comprising 4 emergency departments in the Northeast, mid-Atlantic, and Pacific geographic areas of the US included adults aged 18 years or older with moderate to severe OUD and Clinical Opiate Withdrawal Scale (COWS) scores less than 8 (minimal to mild), in which scores range from 0 to 7, with higher scores indicating increasing withdrawal.

Parsing evoked and induced gamma response differences in Autism: A visual evoked potential study.

Objective: Electroencephalography (EEG) measures of visual evoked potentials (VEPs) provide a targeted approach for investigating neural circuit dynamics. This study separately analyses phase-locked (evoked) and non-phase-locked (induced) gamma responses within the VEP to comprehensively investigate circuit differences in autism.

Methods: We analyzed VEP data from 237 autistic and 114 typically developing (TD) children aged 6-11, collected through the Autism Biomarkers Consortium for Clinical Trials (ABC-CT).

Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial.

Introduction: There is uncertainty about whether criminal legal involvement (CLI) impacts the effectiveness of medications for opioid use disorder (MOUD). We aimed to determine whether CLI modifies the association between buprenorphine-naloxone (BUP-NX) vs. extended-release naltrexone (XR-NTX) and MOUD treatment outcomes.

Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol.

Introduction: The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis.

The dementia care study (D-CARE): Recruitment strategies and demographic characteristics of participants in a pragmatic randomized trial of dementia care.

Introduction: Pragmatic research studies that include diverse dyads of persons living with dementia (PLWD) and their family caregivers are rare.

Methods: Community-dwelling dyads were recruited for a pragmatic clinical trial evaluating three approaches to dementia care. Four clinical trial sites used shared and site-specific recruitment strategies to enroll health system patients.

An Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes.

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3-12 months. This reinforces the concept of tobacco outcomes as a dichotomous state-one is, or is not, abstinent.

Opioid prescription and risk of atrial fibrillation in younger veterans.

Background: Opioids may play a part in the development of atrial fibrillation (AF). Understanding the relationship between opioid exposure and AF can help providers better assess the risk and benefits of prescribing opioids.

Objective: To assess the incidence of AF as a function of prescribed opioids and opioid type.

Facilitation and Preferred Models for Delivering Substance Use Disorder Treatment in HIV Clinics: Results From a Multisite Randomized Trial.

Background: Integrated addiction treatment in HIV clinics is associated with improved outcomes, yet it is offered inconsistently and with variable models of care. We sought to evaluate the impact of Implementation Facilitation ("Facilitation") on clinician and staff preference for provision of addiction treatment in HIV clinics with on-site resources (all trained or designated on-site specialist) versus outside resources (outside specialist or refer out).

Methods: From July 2017 to July 2020, surveys assessed clinician and staff preferences for addiction treatment models during control (ie, baseline), intervention, evaluation, and maintenance phases in 4 HIV clinics in the Northeast United States.

The Selective Social Attention task in children with autism spectrum disorder: Results from the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) feasibility study.

The Selective Social Attention (SSA) task is a brief eye-tracking task involving experimental conditions varying along socio-communicative axes. Traditionally the SSA has been used to probe socially-specific attentional patterns in infants and toddlers who develop autism spectrum disorder (ASD). This current work extends these findings to preschool and school-age children.

URINE TOXICOLOGY PROFILES OF EMERGENCY DEPARTMENT PATIENTS WITH UNTREATED OPIOID USE DISORDER: A MULTI-SITE VIEW.

Background: Opioid overdose deaths in 2021 were the highest ever, driven by fentanyl and polysubstance use.

Objective: The aim of the study was to characterize drug use, assessed by urine drug screens (UDSs), in patients with untreated opioid use disorder (OUD) presenting to 28 emergency departments (EDs) nationally and by region.

Methods: We analyzed UDSs from patients enrolled in the CTN-0099 ED-INNOVATION (Emergency Department-Initiated Buprenorphine Validation) trial between July 12, 2020 and March 9, 2022.

Perspectives on contingency management for alcohol use and alcohol-associated conditions among people in care with HIV.

Background: Contingency management (CM) is an evidence-based approach for reducing alcohol use; however, its implementation into routine HIV primary care-based settings has been limited. We evaluated perspectives on implementing CM to address unhealthy alcohol use and associated conditions for people with HIV in primary care settings.

Methods: From May 2021 to August 2021, we conducted two focus groups with staff involved in delivering the intervention (n = 5 Social Workers and n = 4 Research Coordinators) and individual interviews (n = 13) with a subset of participants involved in the multi-site Financial Incentives, Randomization, and Stepped Treatment (FIRST) trial.

Effect of a Home Health and Safety Intervention on Emergency Department Use in the Frail Elderly: A Prospective Observational Study.

Introduction: Geriatric patients are often frail and may lose independence through a variety of mechanisms including cognitive decline, reduced mobility, and falls. Our goal was to measure the effect of a multidisciplinary home health program that assessed frailty and safety and then coordinated ongoing delivery of community resources on short-term, all-cause emergency department (ED) utilization across three study arms that attempted to stratify frailty by fall risk.

Methods: Subjects became eligible for this prospective observational study via one of three pathways: 1) by visiting the ED after a fall (2,757 patients); 2) by self-identifying as at risk for falling (2,787); or 3) by calling 9-1-1 for a "lift assist" after falling and being unable to get up (121).