Using early phase studies to advance intervention research: The science of behavior change.

This special issue showcases how investigators working in different areas of health behavior change are utilizing early phase studies to advance intervention development. Through the publication of design or protocol papers for currently funded Science of Behavior Change (SOBC) network projects, the special issue illustrates how investigative teams are implementing the experimental medicine approach to advance our understanding of the mechanisms of action that underlie behavior change interventions and, in turn, develop an evidence base that can inform future intervention design. Given that a goal of the experimental medicine approach is the accumulation of an evidence base regarding the links between intervention strategies and putative mechanisms of action, it is critical that this evidence base is readily accessible to investigators and practitioners. Therefore, each of the included articles describes how it is implementing the open-science approach within its study protocol to ensure rigor and reproducibility. Each article provides information about how to register an early phase experiment before study conduct and how to publicly deposit the data, metadata, and publications. The special issue includes 10 design and protocol articles and 2 commentaries on a diverse array of scientific areas and approaches to test mechanisms of action for health behavior change interventions. By disseminating how the National Institutes of Health SOBC Initiative has supported the conduct of early phase intervention studies implementing the experimental medicine and open science approaches, the special issue provides a substantive roadmap to other scientists for how to adopt these approaches. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area.

Importance: There is limited information describing the presenting characteristics and outcomes of US patients requiring hospitalization for coronavirus disease 2019 (COVID-19). Objective: To describe the clinical characteristics and outcomes of patients with COVID-19 hospitalized in a US health care system. Design, Setting, and Participants: Case series of patients with COVID-19 admitted to 12 hospitals in New York City, Long Island, and Westchester County, New York, within the Northwell Health system. The study included all sequentially hospitalized patients between March 1, 2020, and April 4, 2020, inclusive of these dates. Exposures: Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample among patients requiring admission. Main Outcomes and Measures: Clinical outcomes during hospitalization, such as invasive mechanical ventilation, kidney replacement therapy, and death. Demographics, baseline comorbidities, presenting vital signs, and test results were also collected. Results: A total of 5700 patients were included (median age, 63 years [interquartile range {IQR}, 52-75; range, 0-107 years]; 39.7% female). The most common comorbidities were hypertension (3026; 56.6%), obesity (1737; 41.7%), and diabetes (1808; 33.8%). At triage, 30.7% of patients were febrile, 17.3% had a respiratory rate greater than 24 breaths/min, and 27.8% received supplemental oxygen. The rate of respiratory virus co-infection was 2.1%. Outcomes were assessed for 2634 patients who were discharged or had died at the study end point. During hospitalization, 373 patients (14.2%) (median age, 68 years [IQR, 56-78]; 33.5% female) were treated in the intensive care unit care, 320 (12.2%) received invasive mechanical ventilation, 81 (3.2%) were treated with kidney replacement therapy, and 553 (21%) died. As of April 4, 2020, for patients requiring mechanical ventilation (n = 1151, 20.2%), 38 (3.3%) were discharged alive, 282 (24.5%) died, and 831 (72.2%) remained in hospital. The median postdischarge follow-up time was 4.4 days (IQR, 2.2-9.3). A total of 45 patients (2.2%) were readmitted during the study period. The median time to readmission was 3 days (IQR, 1.0-4.5) for readmitted patients. Among the 3066 patients who remained hospitalized at the final study follow-up date (median age, 65 years [IQR, 54-75]), the median follow-up at time of censoring was 4.5 days (IQR, 2.4-8.1). Conclusions and Relevance: This case series provides characteristics and early outcomes of sequentially hospitalized patients with confirmed COVID-19 in the New York City area.

A Systems-Level Approach to Improving Medication Adherence in Hypertensive Latinos: a Randomized Control Trial.

BACKGROUND: Despite numerous interventions targeting medication adherence in patients with uncontrolled hypertension, practice-based trials in Latino patients are scant. OBJECTIVE: To evaluate the effect of a systems-level adherence intervention, delivered by medical assistants (MAs), versus a comparison condition on medication adherence and blood pressure (BP) in 119 hypertensive Latino patients who were initially non-adherent to their antihypertensive medications. STUDY DESIGN: Randomized control trial. PARTICIPANTS: Patients (50% women; mean age, 61 years) were recruited from April 2013 to August 2015 in a community-based practice in New York. INTERVENTION: Systems-level approach that included an office system component built into the electronic health record and a provider support component consisting of nine MA-delivered health coaching sessions for improving medication adherence. The comparison group received the standard health coaching procedures followed at the clinic. MAIN OUTCOME MEASURES: The primary outcome was rate of medication adherence measured by an electronic monitoring device (EMD) across 6 months. The secondary outcomes were self-reported medication adherence measured by the eight-item Morisky Medication Adherence Scale (MMAS-8) and BP reduction from baseline to 6 months. KEY RESULTS: Adherence as measure by EMD worsened for both groups (p = 0.04) with no between-group difference (- 9.6% intervention and - 6.6% control, p = 0.66). While systolic BP improved in both groups, the difference between groups was not significant (- 6 mmHg in intervention vs. - 2.7 mmHg in control, p = 0.34). In contrast, the intervention group had a greater improvement in self-reported adherence (mean change 1.98 vs. 1.26, p = 0.03) when measured using the MMAS-8. CONCLUSIONS: Among Latinos with poorly controlled BP who were non-adherent to their antihypertensive medications, a systems-level intervention did not improve adherence as measured by EMD nor blood pressure. However, many patients reported challenges to using the EMD. Improvements in self-reported adherence suggest that this measure captures different aspects of adherence behavior than EMD. CLINICAL TRIAL REGISTRATION: NCT03560596.

Health behaviour change in cardiovascular disease prevention and management: meta-review of behaviour change techniques to affect self-regulation.

Self-regulation processes assume a major role in health behaviour theory and are postulated as important mechanisms of action in behavioural interventions to improve health prevention and management. The need to better understand mechanisms of behaviour change interventions for cardiovascular diseases (CVD) called for conducting a meta-review of meta-analyses for interventions targeting self-regulation processes. The protocol, preregistered on Open Science Framework (OSF), found 15 eligible meta-analyses, published between 2006 and August 2019, which quantitatively assessed the role of self-regulatory mechanisms and behaviour change techniques (BCTs). Quality of the meta-analyses varied widely according to AMSTAR-2 criteria. Several BCTs, assumed to engage self-regulatory mechanisms, were unevenly represented in CVD meta-analytic reviews. Self-monitoring, the most frequently studied self-regulatory BCT, seemed to improve health behaviour change and health outcomes but these results merit cautious interpretation. Findings for other self-regulatory BCTs were less promising. No studies in the CVD domain directly tested engagement of self-regulation processes. A general challenge for this area stems from reliance on post-hoc tests of the effects of BCTs in multiple-component interventions. Recent advances in BCT taxonomies and the experimental medicine approach to engaging self-regulation mechanisms, however, provide opportunities to improve CVD prevention and management behavioural interventions.

Sensitive Periods for Cerebellar-Mediated Autistic-like Behaviors.

Despite a prevalence exceeding 1%, mechanisms underlying autism spectrum disorders (ASDs) are poorly understood, and targeted therapies and guiding parameters are urgently needed. We recently demonstrated that cerebellar dysfunction is sufficient to generate autistic-like behaviors in a mouse model of tuberous sclerosis complex (TSC). Here, using the mechanistic target of rapamycin (mTOR)-specific inhibitor rapamycin, we define distinct sensitive periods for treatment of autistic-like behaviors with sensitive periods extending into adulthood for social behaviors. We identify cellular and electrophysiological parameters that may contribute to behavioral rescue, with rescue of Purkinje cell survival and excitability corresponding to social behavioral rescue. In addition, using anatomic and diffusion-based MRI, we identify structural changes in cerebellar domains implicated in ASD that correlate with sensitive periods of specific autism-like behaviors. These findings thus not only define treatment parameters into adulthood, but also support a mechanistic basis for the targeted rescue of autism-related behaviors.

Involvement of the oxytocin system in the nucleus accumbens in the regulation of juvenile social novelty-seeking behavior.

Exploration of novel environments, stimuli, and conspecifics is highly adaptive during the juvenile period, as individuals transition from immaturity to adulthood. We recently showed that juvenile rats prefer to interact with a novel individual over a familiar cage mate. However, the neural mechanisms underlying this juvenile social novelty-seeking behavior remain largely unknown. One potential candidate is the oxytocin (OXT) system, given its involvement in various motivated social behaviors. Here, we show that administration of the specific oxytocin receptor antagonist desGly-NH2,d(CH2)5-[Tyr(Me)2,Thr4]OVT reduces social novelty seeking-behavior in juvenile male rats when injected into the nucleus accumbens (10ng/0.5µl/side). The same drug dose was ineffective at altering social novelty-seeking behavior when administered into the lateral septum or basolateral amygdala. These results are the first to suggest the involvement of the OXT system in the nucleus accumbens in the regulation of juvenile social novelty-seeking behavior.

Development of the Healthcare Triggering Questionnaire in adult sexual abuse survivors.

OBJECTIVE: One in 4 women and 1 in 10 men in the United States are survivors of sexual abuse (SA). For these survivors, healthcare experiences may trigger memories, thoughts, feelings or sensations related to this past abuse. Such triggering can be associated with negative responses to healthcare (e.g., anxiety, avoidance). However, to date, no healthcare triggering assessment tool exists. Therefore, the study goal was to describe the prevalence of healthcare triggering, to develop a brief Healthcare Triggering Questionnaire (HTQ), and to examine its initial validity. METHOD: An initial pool of 117 items was developed based on previous research. Two-parameter logistic item response theory models were used to develop the scales. SA survivors [male (n = 233), female (n = 222)] and a comparison group of non-SA individuals [male (n = 114), female (n = 106)] were recruited through Amazon Mechanical Turk and completed the study anonymously online. RESULTS: Three 10-item scales were developed: (a) the HTQ-M for males; (b) the HTQ-F for females; and (c) the HTQ-U (unisex) for all respondents. The results supported the utility and initial validity of the gender-specific and unisex scales. CONCLUSIONS: The HTQ scales are a psychometrically sound approach to evaluating healthcare triggering experienced by adult sexual abuse survivors. The HTQ may be considered for use by researchers interested in studying healthcare triggering, healthcare retraumatization, and healthcare adherence. The HTQ may also be of use to clinicians interested in identifying trauma survivors who are more likely to experience triggering in healthcare settings. (PsycINFO Database Record