Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study.

Background: Members of vulnerable populations are underrepresented in Parkinson's disease (PD) research. A complex web of research barriers perpetuates this gap. Community-based research methods are one approach to addressing this issue.

Designing the Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease study.

Background: Population reflective research enrollment improves study generalizability and disease knowledge. Nevertheless, the proportion of underrepresented groups (URGs) in Parkinson's disease (PD) research remains low. Hence, the current manuscript describes the process of designing a study to analyze the effectiveness of strategies to overcome barriers to URG recruitment in PD research.

Characteristics and Outcomes of US Patients Hospitalized With COVID-19.

Background: Understanding COVID-19 epidemiology is crucial to clinical care and to clinical trial design and interpretation.

Objective: To describe characteristics, treatment, and outcomes among patients hospitalized with COVID-19 early in the pandemic.

Methods: A retrospective cohort study of consecutive adult patients with laboratory-confirmed, symptomatic SARS-CoV-2 infection admitted to 57 US hospitals from March 1 to April 1, 2020.

Results and Molecular Correlates from a Pilot Study of Neoadjuvant Induction FOLFIRINOX Followed by Chemoradiation and Surgery for Gastroesophageal Adenocarcinomas.

Purpose: We performed a NCI-sponsored, prospective study of neoadjuvant FOLFIRINOX followed by chemoradiation with carboplatin/paclitaxel followed by surgery in patients with locally advanced gastric or gastroesophageal cancer.

Patients And Methods: The primary objective was to determine completion rate of neoadjuvant FOLFIRINOX × 8 followed by chemoradiation. Secondary endpoints were toxicity and pathologic complete response (pCR) rate.

Assessment of a Contralateral Esophagus-Sparing Technique in Locally Advanced Lung Cancer Treated With High-Dose Chemoradiation: A Phase 1 Nonrandomized Clinical Trial.

Importance: Severe acute esophagitis occurs in up to 20% of patients with locally advanced lung cancer treated with chemoradiation therapy to at least 60 Gy once daily and represents a dose-limiting toxic event associated with poor outcomes.

Objective: To assess whether formalized sparing of the contralateral esophagus (CE) is associated with reduced risk of severe acute esophagitis.

Design, Setting, And Participants: This single-center phase 1 nonrandomized clinical trial assessing an empirical CE-sparing technique enrolled patients from July 2015 to January 2019.

Association of Race and Ethnicity with Sedation Management in Pediatric Intensive Care.

Racial disparities in pain management have been previously reported for children receiving emergency care. To determine whether patient race or ethnicity is associated with the broader goal of pain management and sedation among pediatric patients mechanically ventilated for acute respiratory failure. Planned secondary analysis of RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure).

Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.

Background: The benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.

Methods: We randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure [PEEP] of ≥8 cm of water) to a 48-hour continuous infusion of cisatracurium with concomitant deep sedation (intervention group) or to a usual-care approach without routine neuromuscular blockade and with lighter sedation targets (control group). The same mechanical-ventilation strategies were used in both groups, including a strategy involving a high PEEP.

Cross-domain correlates of cannabis use disorder severity among young adults.

Background: Correlates of cannabis use and dependence among young adults have been widely studied. However, it is not known which factors are most strongly associated with severity of cannabis use dependence (CUD) severity. Identification of the salient correlates of CUD severity will be of increasing clinical significance as use becomes more socially normative.

One Month of Cannabis Abstinence in Adolescents and Young Adults Is Associated With Improved Memory.

Objective: Associations between adolescent cannabis use and poor neurocognitive functioning have been reported from cross-sectional studies that cannot determine causality. Prospective designs can assess whether extended cannabis abstinence has a beneficial effect on cognition.

Methods: Eighty-eight adolescents and young adults (aged 16-25 years) who used cannabis regularly were recruited from the community and a local high school between July 2015 and December 2016.

Development of a Sexual Dysfunction Scale for Women With Inflammatory Bowel Disease.

Background: Women with inflammatory bowel disease (IBD) may have decreased sexual function. To understand how common this condition is in our female patients, we developed a new IBD-specific Female Sexual Dysfunction Scale (the IBD-FSDS).

Methods: We performed a prospective cross-sectional study of 454 female IBD patients ≥18 years of age attending 1 of 3 IBD clinics in the United States or Denmark.

Phase IIb Trial of an α7 Nicotinic Receptor Partial Agonist With and Without Nicotine Patch for Withdrawal-Associated Cognitive Deficits and Tobacco Abstinence.

Purpose/background: The objective of this study was to determine whether a novel α7 nicotinic acetylcholine receptor partial agonist improves cognition during nicotine withdrawal and improves abstinence rates. To do so, the effect of the α7 nicotinic acetylcholine receptor partial agonist, encenicline, on cognition and abstinence was evaluated when given as monotherapy and when combined with transdermal nicotine patch (nicotine replacement therapy [NRT]).

Methods: Adult daily smokers, n = 160, who were motivated to quit smoking completed cognitive testing at satiated baseline and after overnight abstinence and then were randomized to receive a 12-week trial of encenicline 1 mg twice daily or identical placebo the day of the overnight abstinent cognitive testing.

Sexual Dysfunction in Men With Inflammatory Bowel Disease: A New IBD-Specific Scale.

Background: Men with inflammatory bowel disease (IBD) may have increased sexual dysfunction. To measure the prevalence of sexual dysfunction in our male patients, we aimed to develop a new IBD-specific Male Sexual Dysfunction Scale (the IBD-MSDS).

Methods: We used a cross-sectional survey and enrolled male patients (N = 175) ≥18 years old who attended IBD clinics at 2 Boston hospitals.

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

Objective: To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial.

Study Design: We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent.