Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment.

BACKGROUND: Recruiting to multi-site trials is challenging, particularly when striving to ensure the randomized sample is demographically representative of the larger disease-suffering population. While previous studies have reported disparities by race and ethnicity in enrollment and randomization, they have not typically investigated whether disparities exist in the recruitment process prior to consent. To identify participants most likely to be eligible for a trial, study sites frequently include a prescreening process, generally conducted by telephone, to conserve resources. Collection and analysis of such prescreening data across sites could provide valuable information to improve understanding of recruitment intervention effectiveness, including whether traditionally underrepresented participants are lost prior to screening. METHODS: We developed an infrastructure within the National Institute on Aging (NIA) Alzheimer's Clinical Trials Consortium (ACTC) to centrally collect a subset of prescreening variables. Prior to study-wide implementation in the AHEAD 3-45 study (NCT NCT04468659), an ongoing ACTC trial recruiting older cognitively unimpaired participants, we completed a vanguard phase with seven study sites. Variables collected included age, self-reported sex, self-reported race, self-reported ethnicity, self-reported education, self-reported occupation, zip code, recruitment source, prescreening eligibility status, reason for prescreen ineligibility, and the AHEAD 3-45 participant ID for those who continued to an in-person screening visit after study enrollment. RESULTS: Each of the sites was able to submit prescreening data. Vanguard sites provided prescreening data on a total of 1029 participants. The total number of prescreened participants varied widely among sites (range 3-611), with the differences driven mainly by the time to receive site approval for the main study. Key learnings instructed design/informatic/procedural changes prior to study-wide launch. CONCLUSION: Centralized capture of prescreening data in multi-site clinical trials is feasible. Identifying and quantifying the impact of central and site recruitment activities, prior to participants signing consent, has the potential to identify and address selection bias, instruct resource use, contribute to effective trial design, and accelerate trial enrollment timelines.

Including General Audiences in a Virtual Scientific Dementia Conference: Will They Get Anything From It?

BACKGROUND: Study participants, patients, and care partners are key stakeholders in research and have asked for greater inclusion in the dissemination of scientific learning. However, the participation of general audiences in scientific conferences dedicated to Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) is not widely supported or studied. OBJECTIVE: Our objectives were to evaluate the interest, level of engagement, and impact of including general audiences in a virtual dementia conference. METHODS: A diverse group of lay participants, identified via community-based health advocacy groups and research centers, were invited to attend the 2021 Alzheimer's Association International Conference (AAIC), with optional small-group discussions. Participants received complimentary access to all scientific sessions and were supported via navigation tips, recommended sessions, and a glossary of frequently used terms and acronyms. RESULTS: Lay participants demonstrated a high level of engagement, even among those that were research-naïve, attending virtual sessions for an average of 11.7 hours across the five days and recommending a variety of sessions to each other on topics extending from prevention of dementia to new therapies and care. Most participants said they would attend the conference again and rated the quality of interaction as high, while requesting more opportunities to engage directly with researchers. CONCLUSION: General audiences, in particular research participants, are advocating for greater participation in scientific conferences. This program can serve as a model to accomplish inclusion; thereby acknowledging their invaluable contribution to science.

Connectedness in the time of COVID-19: Reddit as a source of support for coping with suicidal thinking.

The COVID-19 pandemic is adversely impacting suicidality at a population level, with consequences resulting from a variety of pandemic-driven disruptions, including social activities and connectedness. This paper uses a single case study design to explore how members of the Reddit r/COVID19_support community create a sense of connectedness among those who have suicidal thoughts due to the pandemic. Data were gathered from posts to the r/COVID19_support subreddit forum from February 2020 through December 2020. The second step of Klonsky and May's (2015) Three-Step Theory (3ST) of suicide, connectedness as a key protective factor, was used as the theoretical framework. This study explored r/COVID19_support's constructed environment, users' dialogical interactions, and the four primary tenets of connectedness as proposed by Klonsky and May - Purpose and Meaning, Relationships, Religiosity, and Employment. Findings demonstrate a deep sense of connectedness for online community members. Relationships and Purpose and Meaning featured as the most salient sources of connectedness within this subreddit, whereas Religiosity was rarely discussed, and Employment was often spoken of in negative terms (i.e., creating mental distress, rather than facilitating connectedness). Contributors' responses offered various opportunities for connectedness both on- and off-line. Safe online spaces, such as r/COVID19_support, can serve as a protective factor amid suicidality, facilitating connectedness, and thereby helping to curtail suicidal thoughts from advancing to suicidal actions. This subreddit and similar online spaces can benefit specific populations who may otherwise find it challenging to access services or who wish to remain anonymous.

Reddit Users' Experiences of Suicidal Thoughts During the COVID-19 Pandemic: A Qualitative Analysis of r/Covid19_support Posts.

Background: The COVID-19 pandemic is having considerable impacts on population-level mental health, with research illustrating an increased prevalence in suicidal thoughts due to pandemic stressors. While the drivers of suicidal thoughts amid the pandemic are poorly understood, qualitative research holds great potential for expanding upon projections from pre-pandemic work and nuancing emerging epidemiological data. Despite calls for qualitative inquiry, there is a paucity of qualitative research examining experiences of suicidality related to COVID-19. The use of publicly available data from social media offers timely and pertinent information into ongoing pandemic-related mental health, including individual experiences of suicidal thoughts. Objective: To examine how Reddit users within the r/COVID19_support community describe their experiences of suicidal thoughts amid the COVID-19 pandemic. Methods: This study draws on online posts from within r/COVID19_support that describe users' suicidal thoughts during and related to the COVID-19 pandemic. Data were collected from creation of this subreddit on February 12, 2020 until December 31, 2020. A qualitative thematic analysis was conducted to generate themes reflecting users' experiences of suicidal thoughts. Results: A total of 83 posts from 57 users were included in the analysis. Posts described a range of users' lived and living experiences of suicidal thoughts related to the pandemic, including deterioration in mental health and complex emotions associated with suicidal thinking. Reddit users situated their experiences of suicidal thoughts within various pandemic stressors: social isolation, employment and finances, virus exposure and COVID-19 illness, uncertain timeline of the pandemic, news and social media, pre-existing mental health conditions, and lack of access to mental health resources. Some users described individual coping strategies and supports used in attempt to manage suicidal thoughts, however these were recognized as insufficient for addressing the multilevel stressors of the pandemic. Conclusions: Multiple and intersecting stressors have contributed to individuals' experiences of suicidal thoughts amid the COVID-19 pandemic, requiring thoughtful and complex public health responses. While ongoing challenges exist with self-disclosure of mental health challenges on social media, Reddit and other online platforms may offer a space for users to share suicidal thoughts and discuss potential coping strategies.

DNA buoyant density shifts during 15N-DNA stable isotope probing.

DNA-based stable isotope probing (SIP) is a novel technique for the identification of organisms actively assimilating isotopically labeled compounds. Herein, we define the limitations to using 15N-labeled substrates for SIP and propose modifications to compensate for these shortcomings. Changes in DNA buoyant density (BD) resulting from 15N incorporation were determined using cultures of disparate GC content (Escherichia coli and Micrococcus luteus). Incorporation of 15N into DNA increased BD by 0.015+/-0.002 g mL(-1) for E. coli and 0.013+/-0.002 g mL(-1) for M. luteus. The DNA BD shift was greatly increased (0.045 g mL(-1)) when dual isotope (13C plus 15N) labeling was employed. Despite the limited DNA BD shift following 15N enrichment, we found the use of gradient fractionation, followed by a comparison of T-RFLP profiles from fractions of labeled and control treatments, facilitated detection of enrichment in DNA samples from either cultures or soil.

Use of myocardial performance index in pediatric patients with idiopathic pulmonary arterial hypertension.

BACKGROUND: The myocardial performance index (MPI) correlates with clinical status in adults with idiopathic pulmonary arterial (PA) hypertension (IPAH). This pediatric study used MPI to assess response to bosentan therapy. METHODS: The study included 12 children with IPAH and 12 healthy control subjects. MPI was correlated with catheterization data at initiation of bosentan and at a median follow-up of 9 months. Therapy responders were defined by a greater than 20% decrease in mean PA pressure. RESULTS: Right ventricular MPI for patients with IPAH was 0.64 +/- 0.30 versus 0.28 +/- 0.03 in control subjects (P < .01). It had a strong correlation with mean PA pressure (R = 0.94; P < .001). Right ventricular MPI decreased significantly in responders (range 20%-44%, mean 25%) with a 5% increase in nonresponders. CONCLUSIONS: Right ventricular MPI in pediatric IPAH correlates with mean PA pressure and response to therapy. This study suggests that this noninvasive Doppler index may be useful to follow up children with IPAH, particularly when tricuspid regurgitation data are insufficient.

Hepatic dysfunction following the Fontan procedure.

OBJECTIVES: The Fontan procedure offers a palliation for the hemodynamic derangements associated with congenital heart lesions characterized by a single functional ventricle, but it causes a chronically elevated systemic venous pressure that may result in hepatic congestion. The objective of this study was to characterize hepatic function and its relationship to cardiac function in children who had undergone the Fontan procedure. METHODS: In a cross-sectional study of 11 children aged 38 months to 216 months (mean, 149 months), the authors evaluated indices of cardiac and hepatic function, including galactose clearance, Doppler hepatic ultrasonography, synthetic function, and markers of liver injury, at 9 months to 176 months (mean, 100 months) after children had undergone the Fontan procedure. RESULTS: The most common biochemical abnormality of hepatic function was a prolongation of the prothrombin time and a low factor V level. There was a trend toward progressive abnormality in prothrombin time with increasing interval since the Fontan procedure. Galactose elimination half-life and galactose elimination capacity were inversely correlated with the time after Fontan (R2= 0.65, P = 0.004). There was no relationship between cardiac functional measurements and liver function. CONCLUSIONS: Prothrombin time and galactose elimination half-life are abnormal in children who have undergone the Fontan procedure and may be useful markers of hepatic function in the longitudinal assessment of these patients.