9 results
506 Examining Participant Representation in Atopic Dermatitis Clinical Trials from 2011-2022
- Part of
- Eunjoo Pacifici, Kaye Karen Manrique, Araksi L Terteryan, Emily Lai
-
- Journal:
- Journal of Clinical and Translational Science / Volume 8 / Issue s1 / April 2024
- Published online by Cambridge University Press:
- 03 April 2024, p. 150
-
- Article
-
- You have access Access
- Open access
- Export citation
-
OBJECTIVES/GOALS: This study seeks to comprehensively evaluate the extent to which participants in clinical trials (CT) for Atopic Dermatitis (AD) accurately mirror the demographics and characteristics of the broader AD-affected populations. We will achieve this objective by analyzing data from AD CTs spanning the years 2011 to 2022. METHODS/STUDY POPULATION: We examined completed trials for 10 FDA approved treatments for AD, utilizing data sourced fromclinicaltrials.gov [http://clinicaltrials.gov]. In light of the increased number of AD clinical trials over the past decade, we tailored our search parameters to encampass all trials related to approved treatments from 2011-2022. To assess the characteristics of the participant population in these trials, information including inclusion and exclusion criteria, age, location, sex, and disease severity were collected for each trial. Furthermore, race and ethnicity data were also extracted and analyzed. Additionally, comparisons were drawn between trials completed before and after April 2017, when the FDA began requiring that researchers publish race and ethnicity data toclinicaltrials.gov [http://clinicaltrials.gov]. RESULTS/ANTICIPATED RESULTS: Across 67 CTs examined, 45% of trials were restricted to adult patients, 28% were restricted to pediatric patients, and 27% included both. 77% of CTs occurred in urban settings and 23% occurred in rural settings according to the The Economic Research Service definition. 36% of CTs included mild-to-moderate AD patients, and 64% of CTs included moderate-to-severe AD patients. Race distribution of CTs revealed 67% White, 14% Black/African American, 16% Asian, and 3% others. 13% of participants identified as Hispanic or Latino. With further analysis, we will determine whether there is a difference in ethnic distribution between trials completed before and after April 2017, when the FDA started requiring race/ethnicity data to be submitted. DISCUSSION/SIGNIFICANCE: The findings highlight a significant concern in AD CTs: the insufficient representation of Black and Asian populations. The findings emphasize the need for a more inclusive selection process that accurately reflects the diversity of patients. Failing to do so could undermine the assessment of treatment effectiveness in such populations.
56 Chronic Musculoskeletal Pain, Biobehavioral and Psychosocial Resilience Index, and Brain Age Gap
- Udell Holmes III, Jared Tanner, Brittany Addison, Kenia Rangel, Angela M Mickle, Cynthia S Garvan, Emily J Bartley, Amber K Brooks, Lai Song, Roland Staud, Burel Goodin, Roger B Fillingim, Catherine C Price, Kimberly T Sibille
-
- Journal:
- Journal of the International Neuropsychological Society / Volume 29 / Issue s1 / November 2023
- Published online by Cambridge University Press:
- 21 December 2023, p. 465
-
- Article
-
- You have access Access
- Export citation
-
Objective:
Chronic musculoskeletal pain is associated with neurobiological, physiological, and cellular measures. Importantly, we have previously demonstrated that a biobehavioral and psychosocial resilience index appears to have a protective relationship on the same biomarkers. Less is known regarding the relationships between chronic musculoskeletal pain, protective factors, and brain aging. This study investigates the relationships between clinical pain, a resilience index, and brain age. We hypothesized that higher reported chronic pain would correlate with older appearing brains, and the resilience index will attenuate the strength of the relationship between chronic pain and brain age.
Participants and Methods:Participants were drawn from an ongoing observational multisite study and included adults with chronic pain who also reported knee pain (N = 135; age = 58.3 ± 8.1; 64% female; 49% non-Hispanic Black, 51% non-Hispanic White; education Mdn = some college; income level Mdn = $30,000 - $40,000; MoCA M = 24.27 ± 3.49). Measures included the Graded Chronic Pain Scale (GCPS), characteristic pain intensity (CPI) and disability, total pain body sites; and a cognitive screening (MoCA). The resilience index consisted of validated biobehavioral (e.g., smoking, waist/hip ratio, and active coping) and psychosocial measures (e.g., optimism, positive affect, negative affect, perceived stress, and social support). T1-weighted MRI data were obtained. Surface area metrics were calculated in FreeSurfer using the Human Connectome Project's multi-modal cortical parcellation scheme. We calculated brain age in R using previously validated and trained machine learning models. Chronological age was subtracted from predicted brain age to generate a brain age gap (BAG). With higher scores of BAG indicating predicated age is older than chronological age. Three parallel hierarchical regression models (each containing one of three pain measures) with three blocks were performed to assess the relationships between chronic pain and the resilience index in relation to BAG, adjusting for covariates. For each model, Block 1 entered the covariates, Block 2 entered a pain score, and Block 3 entered the resilience index.
Results:GCPS CPI (R2 change = .033, p = .027) and GCPS disability (R2 change = 0.038, p = 0.017) significantly predicted BAG beyond the effects of the covariates, but total pain sites (p = 0.865) did not. The resilience index was negatively correlated and a significant predictor of BAG in all three models (p < .05). With the resilience index added in Block 3, both GCPS CPI (p = .067) and GCPS disability (p = .066) measures were no longer significant in their respective models. Additionally, higher education/income (p = 0.016) and study site (p = 0.031) were also significant predictors of BAG.
Conclusions:In this sample, higher reported chronic pain correlated with older appearing brains, and higher resilience attenuated this relationship. The biobehavioral and psychosocial resilience index was associated with younger appearing brains. While our data is cross-sectional, findings are encouraging that interventions targeting both chronic pain and biobehavioral and psychosocial factors (e.g., coping strategies, positive and negative affect, smoking, and social support) might buffer brain aging. Future directions include assessing if chronic pain and resilience factors can predict brain aging over time.
Tecovirimat use among patients with monkeypox (mpox) in Alameda County, California, June–October 2022
- Megan Ouyang, Munira Shemsu, Rachel Marusinec, April Pena, Kavita Trivedi, Eileen Dunne, Emily Yette, Nicholas Moss, Paul Bayard, Magdalen Edmunds, Sunny Lai, Mychi Nguyen, Sumanth Rajagopal, Sally Slome, Michele Tang, George Ayala, Amit Chitnis
-
- Journal:
- Antimicrobial Stewardship & Healthcare Epidemiology / Volume 3 / Issue S2 / June 2023
- Published online by Cambridge University Press:
- 29 September 2023, p. s105
-
- Article
-
- You have access Access
- Open access
- Export citation
-
Background: Tecovirimat (TPOXX) is an antiviral drug only available via an Expanded Access Program (EAP) investigational new drug protocol and is recommended for treatment of select patients with monkeypox (mpox) infection. Alameda County Public Health Department prioritizes health equity but does not have a dedicated public health clinic. Therefore, we partnered closely with local healthcare providers that serve communities disproportionally impacted by mpox to ensure there was access to TPOXX. Using data collected during the outbreak we assessed whether populations in Alameda County most affected by mpox received treatment. Methods: We describe Alameda County patients with confirmed or probable mpox who received TPOXX during June–October 2022. Data were collected from case investigation interviews with patients and state-wide reportable disease database(s), which included demographic, clinical, and behavioral information. Confidence intervals (CIs) were calculated using the exact method for Poisson counts. We compared characteristics of mpox patients who received and did not receive TPOXX using the Pearson χ2 or Fisher exact test. P < .05 was considered significant. Results: Mpox case rates in Alameda County were highest among Black or African-American residents (35.6 per 100,000, 95% CI, 26.7–46.4) and Hispanic or Latinx residents (25.2, 95% CI, 20.2–31.0) compared to Asian residents (3.9, 95% CI, 2.3–6.1) and white residents (10.4, 95% CI, 7.7–13.9) residents. Among 242 mpox patients, 69 patients (28.5%) received TPOXX. The distribution of demographic and clinical characteristics among patients who received TPOXX was not significantly different than among those who did not, including residents aged 31–40 years (36.2% vs 34.7%), Black or African-American residents (20% vs 26.3%), Hispanic or Latinx residents (38.5% vs 41%), male residents (89.9% vs 95.3%), gay, lesbian, or same-gender loving residents (67.2% vs 67.4%) in the city of Oakland (63.2% vs 61.5%), or residents with human immunodeficiency virus infection (43.5% vs 36.6%). Conclusions: During the Alameda County mpox outbreak, nearly one-third of patients received TPOXX. Demographic and clinical characteristics were similar among TPOXX recipients and nonrecipients. A proactive approach to obtaining TPOXX in Alameda County and strong relationships with local providers may have allowed for treatment to be accessible to mpox patients. Regular review of outbreak data can inform public health activities, ensure health equity, and help refine local response efforts.
Disclosures: None
98 Forging a New (Digital) Path: Designing a Strategic Pilot to Engage and Educate the Public about Clinical Research on Social Media
- Part of
- Nicki Karimipour, Suail Fabros, Andrea Diaz, Gordon Wimpress, Emily Lai
-
- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue s1 / April 2023
- Published online by Cambridge University Press:
- 24 April 2023, p. 28
-
- Article
-
- You have access Access
- Open access
- Export citation
-
OBJECTIVES/GOALS: To conceptualize, implement and evaluate a three-pronged social media plan with goals to: 1) disseminate information about the Southern California CTSI and its activities on multiple platforms; 2) educate the public about clinical research participation; 3) use storytelling methods to spread awareness about research careers. METHODS/STUDY POPULATION: We will start by creating a logic model to identify activities, outputs, short, medium and long-term outcomes of this social media innovation project, using CTSI and community stakeholder input (focus groups). This model will guide the creation of a comprehensive strategic social media plan that includes an editorial calendar for each platform, storyboarding and an operationalized narrative strategy, as well as KPIs relating to areas like reach, engagement, conversion, and sentiment. Collecting/analyzing these metrics will yield information about how the public feels about clinical research and will assist us in refining our content strategy. After completing formative research, we will create accounts on Instagram, TikTok, LinkedIn and Meta to complement our existing Twitter presence. RESULTS/ANTICIPATED RESULTS: We hope to identify which types of content lead to greater engagement and more positive sentiment on each platform, which will help us iteratively refine our content strategy. Examples of content type can include: imparting research-related information, debunking myths, providing career information, etc. Through this process we will also gain knowledge about what methods are more appealing to our users, such as narrative storytelling. Visually, we anticipate learning about what types of multimedia content works best as a mechanism to disseminate information about clinical research (e.g. video, photo, audio, or a combination). DISCUSSION/SIGNIFICANCE: In a post-pandemic world of dis- and misinformation, it is more important than ever to disseminate trusted, vetted information about clinical research in novel and engaging ways. Through this initiative we will gather information, metrics and key lessons learned to present back to CTSA hubs to inform their short and long-term social media strategies.
Processing of social and monetary rewards in autism spectrum disorders
- Sarah Baumeister, Carolin Moessnang, Nico Bast, Sarah Hohmann, Pascal Aggensteiner, Anna Kaiser, Julian Tillmann, David Goyard, Tony Charman, Sara Ambrosino, Simon Baron-Cohen, Christian Beckmann, Sven Bölte, Thomas Bourgeron, Annika Rausch, Daisy Crawley, Flavio Dell'Acqua, Guillaume Dumas, Sarah Durston, Christine Ecker, Dorothea L. Floris, Vincent Frouin, Hannah Hayward, Rosemary Holt, Mark H. Johnson, Emily J. H. Jones, Meng-Chuan Lai, Michael V. Lombardo, Luke Mason, Bethany Oakley, Marianne Oldehinkel, Antonio M. Persico, Antonia San José Cáceres, Thomas Wolfers, Eva Loth, Declan G. M. Murphy, Jan K. Buitelaar, Heike Tost, Andreas Meyer-Lindenberg, Tobias Banaschewski, Daniel Brandeis, the EU-AIMS LEAP Group
-
- Journal:
- The British Journal of Psychiatry / Volume 222 / Issue 3 / March 2023
- Published online by Cambridge University Press:
- 26 January 2023, pp. 100-111
- Print publication:
- March 2023
-
- Article
-
- You have access Access
- Open access
- HTML
- Export citation
-
Background
Reward processing has been proposed to underpin the atypical social feature of autism spectrum disorder (ASD). However, previous neuroimaging studies have yielded inconsistent results regarding the specificity of atypicalities for social reward processing in ASD.
AimsUtilising a large sample, we aimed to assess reward processing in response to reward type (social, monetary) and reward phase (anticipation, delivery) in ASD.
MethodFunctional magnetic resonance imaging during social and monetary reward anticipation and delivery was performed in 212 individuals with ASD (7.6–30.6 years of age) and 181 typically developing participants (7.6–30.8 years of age).
ResultsAcross social and monetary reward anticipation, whole-brain analyses showed hypoactivation of the right ventral striatum in participants with ASD compared with typically developing participants. Further, region of interest analysis across both reward types yielded ASD-related hypoactivation in both the left and right ventral striatum. Across delivery of social and monetary reward, hyperactivation of the ventral striatum in individuals with ASD did not survive correction for multiple comparisons. Dimensional analyses of autism and attention-deficit hyperactivity disorder (ADHD) scores were not significant. In categorical analyses, post hoc comparisons showed that ASD effects were most pronounced in participants with ASD without co-occurring ADHD.
ConclusionsOur results do not support current theories linking atypical social interaction in ASD to specific alterations in social reward processing. Instead, they point towards a generalised hypoactivity of ventral striatum in ASD during anticipation of both social and monetary rewards. We suggest this indicates attenuated reward seeking in ASD independent of social content and that elevated ADHD symptoms may attenuate altered reward seeking in ASD.
Population-Level Burden of Delayed or In Vitro Discordant Empiric Antibiotics Among Bacteremic Patients at US Hospitals
- Sameer Kadri, Yi Ling Lai, Sarah Warner, Jeffrey R. Strich, Ahmed Babiker, Emily Ricotta, John P. Dekker, Tara Palmore, Chanu Rhee, Michael Klompas, David Hooper, John H. Powers, Robert L. Danner, Jennifer Adjemian
-
- Journal:
- Infection Control & Hospital Epidemiology / Volume 41 / Issue S1 / October 2020
- Published online by Cambridge University Press:
- 02 November 2020, pp. s44-s45
- Print publication:
- October 2020
-
- Article
-
- You have access Access
- Export citation
-
Background: Delayed or in vitro inactive empiric antibiotic therapy may be detrimental to survival in patients with bloodstream infections (BSIs). Understanding the landscape of delayed or discordant empiric antibiotic therapy (DDEAT) across different patient, pathogen, and hospital types, as well as by their baseline resistance milieu, may enable providers, antimicrobial stewardship programs, and policy makers to optimize empiric prescribing. Methods: Inpatients with clinically suspected serious infection (based on sampling of blood cultures and receiving systemic antibiotic therapy on the same or next day) found to have BSI were identified in the Cerner Healthfacts EHR database. Patients were considered to have received DDEAT when, on culture sampling day, they received either no antibiotic(s) or none that displayed in vitro activity against the pathogenic bloodstream isolate. Antibiotic-resistant phenotypes were defined by in vitro resistance to taxon-specific prototype antibiotics (eg, methicillin/oxacillin resistance in S. aureus) and were used to estimate baseline resistance prevalence encountered by the hospital. The probability of DDEAT was examined by bacterial taxon, by time of BSI onset, and by presence versus absence of antibiotic-resistance phenotypes, sepsis or septic shock, hospital type, and baseline resistance. Results: Of 26,036 assessable patients with a BSI at 131 US hospitals between 2005 and 2014, 14,658 (56%) had sepsis, 3,623 (14%) had septic shock, 5,084 (20%) had antibiotic-resistant phenotypes, and 8,593 (33%) received DDEAT. Also, 4,428 (52%) recipients of DDEAT received no antibiotics on culture sampling day, whereas the remaining 4,165 (48%) received in vitro discordant therapy. DDEAT occurred most often in S. maltophilia (87%) and E. faecium (80%) BSIs; however, 75% of DDEAT cases and 76% of deaths among recipients of DDEAT collectively occurred among patients with S. aureus and Enterobacteriales BSIs. For every 8 bacteremic patients presenting with septic shock, 1 patient did not receive any antibiotics on culture day (Fig. 1A). Patients with BSIs of hospital (vs community) onset were twice as likely to receive no antibiotics on culture day, whereas those with bloodstream pathogens displaying antibiotic-resistant (vs susceptible) phenotypes were 3 times as likely to receive in vitro discordant therapy (Fig. 1B). The median proportion of DDEAT ranged between 25% (14, 37%) in eight <300-bed teaching hospitals in the lowest baseline resistance quartile and 40% (31, 50%) at five ≥300-bed teaching hospitals in the third baseline resistance quartile (Fig. 2). Conclusions: Delayed or in vitro discordant empiric antibiotic therapy is common among patients with BSI in US hospitals regardless of hospital size, teaching status, or local resistance patterns. Prompt empiric antibiotic therapy in septic shock and hospital-onset BSI needs more support. Reliable detection of S. aureus and Enterobacteriales bloodstream pathogens and their resistance patterns earlier with rapid point-of-care diagnostics may mitigate the population-level impact of DDEAT in BSI.
Funding: This study was funded in part by the National Institutes of Health Clinical Center, National Institutes of Allergy and Infectious Diseases, National Cancer Institute (NCI contract no. HHSN261200800001E) and the Agency for Healthcare Research and Quality.
Disclosures: None
Sustainability of treatment effect of a 3-year early intervention programme for first-episode psychosis
- Wing Chung Chang, Vivian Wing Yan Kwong, Emily Sin Kei Lau, Hon Cheong So, Corine Sau Man Wong, Gloria Hoi Kei Chan, Olivia Tsz Ting Jim, Christy Lai Ming Hui, Sherry Kit Wa Chan, Edwin Ho Ming Lee, Eric Yu Hai Chen
-
- Journal:
- The British Journal of Psychiatry / Volume 211 / Issue 1 / July 2017
- Published online by Cambridge University Press:
- 02 January 2018, pp. 37-44
- Print publication:
- July 2017
-
- Article
-
- You have access Access
- HTML
- Export citation
-
Background
Evidence indicates that the positive effects of 2-year early intervention services for psychosis are not maintained after service withdrawal. Optimal duration of early intervention in sustaining initial improved outcomes remains to be determined.
AimsTo examine the sustainability of the positive effects of an extended, 3-year, early intervention programme for patients with first-episode psychosis (FEP) after transition to standard care.
MethodA total of 160 patients, who had received a 2-year early intervention programme for FEP, were enrolled to a 12-month randomised-controlled trial (ClinicalTrials.gov: NCT01202357) comparing a 1-year extension of the early intervention (3-year specialised treatment) with step-down care (2-year specialised treatment). Participants were followed up and reassessed 2 and 3 years after inclusion to the trial.
ResultsThere were no significant differences between the treatment groups in outcomes on functioning, symptom severity and service use during the post-trial follow-up period.
ConclusionsThe therapeutic benefits achieved by the extended, 3-year early intervention were not sustainable after termination of the specialised service.
Optimal duration of an early intervention programme for first-episode psychosis: randomised controlled trial
- Wing Chung Chang, Gloria Hoi Kei Chan, Olivia Tsz Ting Jim, Emily Sin Kei Lau, Christy Lai Ming Hui, Sherry Kit Wa Chan, Edwin Ho Ming Lee, Eric Yu Hai Chen
-
- Journal:
- The British Journal of Psychiatry / Volume 206 / Issue 6 / June 2015
- Published online by Cambridge University Press:
- 02 January 2018, pp. 492-500
- Print publication:
- June 2015
-
- Article
-
- You have access Access
- HTML
- Export citation
-
Background
Numerous early intervention services targeting young people with psychosis have been established, based on the premise that reducing treatment delay and providing intensive treatment in the initial phase of psychosis can improve long-term outcome.
AimsTo establish the effect of extending a specialised early intervention treatment for first-episode psychosis by 1 year.
MethodA randomised, single-blind controlled trial (NCT01202357) compared a 1-year extension of specialised early intervention with step-down care in patients who had all received a 2-year intensive early intervention programme for first-episode psychosis.
ResultsPatients receiving an additional year of specialised intervention had better outcomes in functioning, negative and depressive symptoms and treatment default rate than those managed by step-down psychiatric care.
ConclusionsExtending the period of specialised early intervention is clinically desirable but may not be feasible in lower-income countries.
Contributors
-
- By Zachary W. Adams, Margarita Alegría, Atalay Alem, Jordi Alonso, Victor Aparicio, Rifat Atun, Florence Baingana, Emily Baron, Marco Bertelli, Dinesh Bhugra, Sanchita Biswas, José Miguel Caldas de Almeida, Edwin Cameron, Somnath Chatterji, Erminia Colucci, Janice L. Cooper, Carla Kmett Danielson, Diego De Leo, Mary-Jo DelVecchio Good, Marten W. de Vries, Maureen S. Durkin, Xiangming Fang, Julia W. Felton, Sally Field, Andrea Fiorillo, Lance Gable, Teddy Gafna, Sandro Galea, Patrick Gatonga, Sofia Halperin-Goldstein, Yanling He, Grace A. Herbert, Sabrina Hermosilla, Simone Honikman, Takashi Izutsu, Ruwan M. Jayatunge, Janis H. Jenkins, Rachel Jenkins, Lynne Jones, Jayanthi Karunaratne, Ronald C. Kessler, Rob Keukens, Lincoln I. Khasakhala, Hanna Kienzler, Sarah Kippen Wood, M. Thomas Kishore, Robert Kohn, Natasja Koitzsch Jensen, Sheri Lapatin, Anna Lessios, Isabel Louro Bernal, Feijun Luo, Laura MacPherson, Matthew J. Maenner, Anne W. Mbwayo, David McDaid, Ingrid Meintjes, Victoria N. Mutiso, David M. Ndetei, Samuel O. Okpaku, Lijing Ouyang, Ramachandran Padmavati, Clare Pain, Duncan Pedersen, Jordan Pfau, Felipe Picon, Rodney D. Presley, Reima Pryor, Shoba Raja, Thara Rangaswamy, Jorge Rodriguez, Diana Rose, Moosa Salie, Norman Sartorius, Ester Shapiro, Manuela Silva, Daya Somasundaram, Katherine Sorsdahl, Dan J. Stein, Deborah M. Stone, Heather Stuart, Athula Sumathipala, Hema Tharoor, Rita Thom, Lay San Too, Atsuro Tsutsumi, Chris Underhill, Anne Valentine, Claire van der Westhuizen, Thandi van Heyningen, Robert van Voren, Inka Weissbecker, Gail Wyatt
- Edited by Samuel O. Okpaku
-
- Book:
- Essentials of Global Mental Health
- Published online:
- 05 March 2014
- Print publication:
- 27 February 2014, pp x-xiv
-
- Chapter
- Export citation