In-person Screening Research Articles

Assessing Adherence to Posttraumatic Stress Disorder Screening in Young Stroke Survivors.

Background: Over 795 000 US people per year experience a stroke, and 10% are younger than 50 years. After a stroke, posttraumatic stress disorder (PTSD) affects 10% to 30% of those patients and may compromise a survivor's secondary prevention compliance. At an inner-city clinic in Maryland where up to 300 young adult stroke survivors are followed, zero patients were screened for PTSD. A quality improvement project was implemented to screen for PTSD in a young adult stroke survivor clinic and to provide them with psychotherapy referrals and follow-up. Methods: Over 15 weeks in the fall of 2023, all patients presenting to the young adult stroke survivor clinic were screened for PTSD using the Posttraumatic Stress Disorder Checklist-5 validated screening tool. Providers and medical staff were all educated on the tool before implementation. Results: During the 15-week implementation period, 72 patients presented to the clinic. Posttraumatic stress disorder screening was completed for 88.9% (64/72). Of those, 32.8% (21/64) completed the Posttraumatic Stress Disorder Checklist-5 via the electronic health record, and 67.2% (43/64) completed it by in-person screening. Of the 64 patients screened, 12 patients screened positive for PTSD (18.8%, 12/64). Among those screening positive, 75% (9/12) were given a referral for psychotherapy. Conclusions: Literature reports that PTSD compromises stroke survivors' ability to optimize their health after a stroke. Screening identifies those experiencing symptoms of PTSD, providing an opportunity for referral and treatment. Results show that routine care of young stroke survivors can effectively include screening for PTSD.

The reliability and validity of in-person and remote behavioural screening tools for people with amyotrophic lateral sclerosis

ObjectiveThis study aimed to assess the psychometric properties of and relationships between total scores on different screening tools assessing behavioural change for people with amyotrophic lateral sclerosis (ALS), and whether administering the screens as online questionnaires (rather than on paper, in-person) influences total scores. MethodsThe behavioural component of the Edinburgh Cognitive and Behavioural ALS Screen (ECASb); the behavioural component of the ALS Cognitive Behavioural Screen (ALS-CBSb), the ALS-Frontotemporal Dementia Questionnaire (ALS-FTD-Q), the Beaumont Behavioural Inventory (BBI), and the Motor Neuron Disease Behavioural Instrument (MiND-B) were administered to 35 informants on paper. Online questionnaire versions of the behavioural screens were administered to 49 informants.Forward stepwise linear regressions were conducted to assess whether scores on behavioural screens were predicted by scores on the other behavioural screens and to assess whether total scores were predicted by the mode of administration (paper or online) of the screens. ResultsBehavioural screening tools, except the ECASb, had good internal consistency but mixed item-total correlations. All regression models assessing whether behavioural screen scores predict other behavioural screen scores were significant. The BBI performed best and the ECASb performed worst in terms of their predictive relationships with other screening tools. The administration mode of the questionnaires did not significantly affect total scores. ConclusionsThe psychometric properties of the scales varied. The scales predicted each other's scores, supporting convergent validity. Online and paper versions performed similarly, and demographics did not predict scores.

Comparison of targeted web-based advertising versus traditional methods for recruiting older adults into clinical trials.

Recruiting older adults into clinical trials can be particularly challenging. Our objective was to determine if targeted web-based advertising is an effective recruitment strategy. We compared the recruitment rates of traditional and targeted web-based methods for three representative clinical trials involving older adults. All studies utilized traditional recruitment methods initially, but shifted toward primarily targeted web-based advertising after experiencing slow recruitment rates. We found that web-based advertising reached more individuals compared to traditional methods. Compared to traditional methods, web-based methods also had at least twice the rate of expressed interest, completion of telephone and in-person screening, eligibility, and enrollment. Additionally, the proportion of individuals excluded after the telephone screening did not differ according to whether targeted web-based advertising (STAMINA: 51%; Berries and Steps: 62%; ISTIM: 20%) or traditional methods (STAMINA: 48%; Berries and Steps: 69%; ISTIM: 23%) were used within each study. Those recruited using web-based advertisements tended to be younger compared to traditional methods, but were similar in racial distribution and education. Targeted web-based advertisements may be more effective in recruiting older adults for clinical trials at a faster rate than traditional recruitment methods, but need further evaluation of compatible study designs, potential population bias, and cost-effectiveness.

Predictors of Participation in a Perinatal Text Message Screening Protocol for Maternal Depression and Anxiety: Prospective Cohort Study.

Universal screening for depression and anxiety in pregnancy has been recommended by several leading medical organizations, but the implementation of such screening protocols may overburden health care systems lacking relevant resources. Text message screening may provide a low-cost, accessible alternative to in-person screening assessments. However, it is critical to understand who is likely to participate in text message-based screening protocols before such approaches can be implemented at the population level. This study aimed to examine sources of selection bias in a texting-based screening protocol that assessed symptoms of depression and anxiety across pregnancy and into the postpartum period. Participants from the Montreal Antenatal Well-Being Study (n=1130) provided detailed sociodemographic information and completed questionnaires assessing symptoms of depression (Edinburgh Postnatal Depression Scale [EPDS]) and anxiety (State component of the State-Trait Anxiety Inventory [STAI-S]) at baseline between 8 and 20 weeks of gestation (mean 14.5, SD 3.8 weeks of gestation). Brief screening questionnaires, more suitable for delivery via text message, assessing depression (Whooley Questions) and anxiety symptoms (Generalized Anxiety Disorder 2-Item questionnaire) were also collected at baseline and then via text message at 14-day intervals. Two-tailed t tests and Fisher tests were used to identify maternal characteristics that differed between participants who responded to the text message screening questions and those who did not. Hurdle regression models were used to test if individuals with a greater burden of depression and anxiety at baseline responded to fewer text messages across the study period. Participants who responded to the text messages (n=933) were more likely than nonrespondents (n=114) to self-identify as White (587/907, 64.7% vs 39/96, 40.6%; P<.001), report higher educational attainment (postgraduate: 268/909, 29.5% vs 15/94, 16%; P=.005), and report higher income levels (CAD $150,000 [a currency exchange rate of CAD $1=US $0.76 is applicable] or more: 176/832, 21.2% vs 10/84, 11.9%; P<.001). There were no significant differences in symptoms of depression and anxiety between the 2 groups at baseline or postpartum. However, baseline depression (EPDS) or anxiety (STAI-S) symptoms did predict the total number of text message time points answered by participants, corresponding to a decrease of 1% (eβ=0.99; P<.001) and 0.3% (eβ=0.997; P<.001) in the number of text message time points answered per point increase in EPDS or STAI-S score, respectively. Findings from this study highlight the feasibility of text message-based screening protocols with high participation rates. However, our findings also highlight how screening and service delivery via digital technology could exacerbate disparities in mental health between certain patient groups.

Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study.

Major depressive disorder (MDD) is common worldwide and can be highly disabling. People with MDD face many barriers to treatment and may not experience full symptom relief even when treated. Therefore, new treatment modalities are needed for MDD. Digital therapeutics (DTx) may provide people with MDD an additional treatment option. This study aimed to describe a phase 3 remote, multicenter, randomized, masked, sham-controlled trial evaluating the efficacy of a smartphone app-based DTx (CT-152) in adult participants diagnosed with MDD, used as an adjunct to antidepressant therapy (ADT). Participants aged 22-64 years with a current primary diagnosis of MDD and an inadequate response to ADT were included. Participants were randomized 1:1 to CT-152 or a sham DTx. CT-152 is a smartphone app-based DTx that delivers a cognitive-emotional and behavioral therapeutic intervention. The core components of CT-152 are the Emotional Faces Memory Task exercises, brief lessons to learn and apply key therapeutic skills, and SMS text messaging to reinforce lessons and encourage engagement with the app. The sham DTx is a digital working memory exercise with emotionally neutral stimuli designed to match CT-152 for time and attention. Participants took part in the trial for up to 13 weeks. The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect. Sites and participants had the option of an in-person or remote screening visit; the remaining trial visits were remote. Efficacy was evaluated using the Montgomery-Åsberg Depression Rating Scale, the Generalized Anxiety Disorder-7, Clinical Global Impression-Severity scale, the Patient Health Questionnaire-9, and the World Health Organization Disability Assessment Schedule 2.0. The durability of the effect was evaluated with the Montgomery-Åsberg Depression Rating Scale and Generalized Anxiety Disorder-7 scale. Adverse events were also assessed. Satisfaction, measured by the Participant and Healthcare Professional Satisfaction Scales, and health status, measured by the EQ-5D-5L, were summarized using descriptive statistics. This study was initiated in February 2021 and had a primary completion date in October 2022. This represents the methodological design for the first evaluation of CT-152 as an adjunct to ADT. This study protocol is methodologically robust and incorporates many aspects of conventional pivotal pharmaceutical phase 3 trial design, such as randomization and safety end points. Novel considerations included the use of a sham comparator, masking considerations for visible app content, and outcome measures relevant to DTx. The rigor of this methodology will provide a more comprehensive understanding of the effectiveness of CT-152. ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285. RR1-10.2196/56960.

Feasibility of caregiver diabetes distress screening in routine clinical care of youth with type 1 diabetes.

Caregiver diabetes distress (DD) consists of feeling overwhelmed, sad, and/or concerned; one-third of parents of youth with type 1 diabetes (T1D) report severe distress up to 4 years after T1D diagnosis. PAID-PR (Problem Areas in Diabetes Survey-Parent Revised) assesses DD primarily in research settings; however, less is known about its clinical utility. We aimed to identify the feasibility of implementing PAID-PR screening at a diverse, academic US paediatric diabetes center during routine clinic follow-up visits through quality improvement methodologies. The PAID-PR was intended to be offered in English to caregivers at all paediatric T1D appointments, by the front desk during appointment check-in, or through REDCap prior to telehealth appointments or at local sites to all eligible caregivers. Adult psychosocial resources were provided to all, regardless of score. Forms were scored after appointments; scores ≥80 were referred to Diabetes Psychology providers for follow-up. A total of 391 caregivers completed the PAID-PR, though only half of eligible caregivers received it in person. Response rates were highest in person (90%), compared to REDCap (25%). In total, 27% (n = 107) scored ≥56 (DD). Of those with DD, 21% (n = 23) scored ≥80 and were referred to psychology. Demographics are reported in Table1. PAID-PR score was positively correlated to A1c (p = 0.038) and inversely to child age (p = 0.014). Clinic caregiver DD screening was implemented with higher response rates in person; however, expanding in-person screening to all eligible caregivers is necessary. Furthermore, since the PAID-PR was in English, some caregivers with DD were likely missed. Future directions include screening in additional languages.

Detecting and Predicting Cognitive Decline in Individuals with Traumatic Brain Injury: A Longitudinal Telephone-Based Study.

Traumatic brain injuries (TBIs) can lead to long-lasting cognitive impairments, and some survivors experience cognitive decline post-recovery. Early detection of decline is important for care planning, and understanding risk factors for decline can elucidate targets for prevention. While neuropsychological testing is the gold standard approach to characterizing cognitive function, there is a need for brief, scalable tools that are capable of detecting clinically significant changes in post-TBI cognition. This study examines whether a clinically significant change can be detected using the Brief Test of Adult Cognition by Telephone (BTACT) in a sample of individuals with chronic TBI and investigates whether potentially modifiable factors are associated with cognitive decline. Ninety participants aged 40 or older with complicated mild-to-severe TBI participated in two telephone-based study visits ∼1 year apart. Demographic, head trauma exposure, comorbid medical conditions, physical, and psychosocial functioning data were collected via self-report. The BTACT, a brief measure of global cognitive function, was used to assess cognitive performance across six domains. A reliable change index for quantifying clinically significant changes in BTACT performance was calculated. Results revealed cognitive decline in 10-27% of participants across various cognitive domains. More specifically, only depressive symptoms, including depressed affect and anhedonia, were significantly associated with cognitive decline after correcting for multiple comparisons using false discovery rate (FDR). Other factors such as the number of blows to the head, male gender, dyspnea, increased anxiety symptoms, seizures, illicit drug use, and fewer cardiovascular comorbidities should be considered hypothesis generating. Importantly, age was not a significant predictor of cognitive decline, which challenges the assumption that cognitive decline is solely related to the natural aging process. It suggests that there are unique factors associated with TBI that impact cognitive function, and these factors can affect individuals across the lifespan. The BTACT is a brief and sensitive tool for identifying clinically meaningful changes in cognitive function over a relatively brief period (i.e., 1 year) in a sample of individuals in the chronic stages of TBI (i.e., x̄ = 6.7 years post-TBI). Thus, the BTACT may be useful in surveillance efforts aimed at understanding and detecting decline, particularly in situations where in-person cognitive screening is impractical or unfeasible. We also identified potentially modifiable targets for the prevention of post-TBI cognitive decline. These findings can offer insights into treatment goals and preventive strategies for individuals at risk for cognitive decline, as well as help to facilitate early identification efforts.

Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening

Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion. To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy. This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023. Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person. Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications. Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing. The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.

Listening to Black Pregnant and Postpartum People: Using Technology to Enhance Equity in Screening and Treatment of Perinatal Mental Health and Substance Use Disorders.

Perinatal mood and anxiety disorders (PMADs), perinatal substance use disorders (PSUDs), and intimate partner violence (IPV) are leading causes of pregnancy-related deaths in the United States. Screening and referral for PMADs, PSUDs and IPV is recommended, however, racial disparities are prominent: Black pregnant and postpartum people (PPP) are less likely to be screened and attend treatment compared to White PPP. We conducted qualitative interviews to better understand the experience of Black PPP who used a text/phone-based screening and referral program for PMADs/PSUDs and IPV-Listening to Women and Pregnant and Postpartum People (LTWP). We previously demonstrated that LTWP led to a significant reduction in racial disparities compared to in-person screening and referral, and through the current study, sought to identify facilitators of PMAD/PSUD symptom endorsement and treatment attendance. Semi-structured interviews were conducted with 68 Black PPP who were or had been pregnant within the last 24 months, and who either had or did not have a PMAD or PSUD. Participants were enrolled in LTWP and provided feedback on their experience. Using a grounded theory approach, four themes emerged: usability, comfort, necessity, and recommendations. Ease of use, brevity, convenience, and comfort in discussing mental health and substance use via text were highlighted. Need for a program like LTWP in Black communities was discussed, given the reduction in perceived judgement and access to trusted information and resources for PMADs/PSUDs, which may lessen stigma. These qualitative findings illuminate how technology-based adaptations to behavioral health screening and referral can reduce perceived negative judgment and facilitate identification and referral to treatment, thereby more adequately meeting needs of Black PPP.

Abstract P117: Trial Recruitment Advertisement Modalities and Demographics of Participants: Implications for Equitable Representation in Clinical Trials

Background: Convenience and cost are major determinants of which strategies are used to recruit clinical trial participants. However, little is known about the impacts of recruitment strategy on representation of people from diverse backgrounds. Objective: Using the high-throughput recruitment drives of two trials, we assessed whether referral source was associated with demographic and social characteristics of people who inquired about the trials or participated in screening. Methods: The GoFresh studies (NCT05121337 &amp; NCT05393232) are two randomized trials testing the impact of a home-delivered DASH-patterned grocery intervention on blood pressures of Black adults residing in urban food deserts, with or without treated hypertension (HTN). Both share a common recruitment drive, incentive plan, and study design. Principal recruitment strategies were: mailed brochure to patients, advertising on public transit (bus or subway), or word-of-mouth referral. In prescreening, participants provide their age, HTN treatment status, and how they heard about the trial. Those eligible proceed to in-person screening, where they are asked about biologic sex, ethnicity, birthplace, car ownership, insurance status, education, employment, marital status, home ownership, income, and number of dependents. Results: Of 1,601 people who submitted a prescreening inquiry, 602 (38%) completed screening. At prescreening, people responding via public transit were younger (mean [SD] 36 [13]; overall 46 [16]) and fewer had treated HTN (18%; overall 35%). At screening, there were significant differences by referral source in sex, car ownership, employment, marital status, and home ownership ( Table ). Other factors did not differ (ethnicity, birthplace, insurance status, education, income, and dependents). Conclusion: Demographics and social characteristics of clinical trial participants differed by advertising modality. Trials intending to recruit diverse populations would benefit from multimodal forms of outreach.

APOE Genotype Disclosure Influences Decisions About Future Planning but not Adoption of Healthy Lifestyle Changes in Cognitively Unimpaired Individuals.

Studies have shown apolipoprotein E (APOE) genotype disclosure to be safe and well-tolerated in cognitively unimpaired (CU) older adults. This study aimed to examine the effect of the disclosure process on decisions about future directives and health behaviors in community-dwelling CU older adults from the Butler Alzheimer's Prevention Registry (BAPR). CU APOE E4 non-carriers (n = 106) and carriers (n = 80) aged 58-78 completed in-person psychological readiness screening to undergo APOE disclosure. Follow-up assessments were completed online 3days, 6weeks, and 6months post-disclosure. The primary outcomes were future directives, dietary habits, and physical activity scores. Disclosure was associated with decision making on future directives in E4 carriers (t = 3.59, P = .01) at 6months compared to baseline, but not non-carriers. Family history of memory impairment, SCD endorsement, and education consistently predicted scores on future directives. A significant interaction between E4+ and SCD endorsement on future directive scores was noted (OR = 163.06, 9.5-2,799.8). E4 + carrier status was associated with physical activity (W = 60,148, P = .005) but not dietary habits scores. Our findings indicate that disclosure led to a change in future directives but not protective health behaviors, specifically in E4 carriers. Future work will explore whether pairing disclosure with education about the role of lifestyle factors in AD risk and providing guidelines on making risk-lowering lifestyle modifications as an intervention approach leads to positive change.

Predictors of engagement in screening for a hepatitis C virus (HCV) treatment trial in a rural Appalachian community.

An HCV treatment trial was initiated in September 2019 to address the opioid/hepatitis C virus (HCV) syndemic in rural Kentucky. The focus of the current analysis is on participation in diagnostic screening for the trial. Initial eligibility (≥18 years of age, county resident) was established by phone followed by in-person HCV viremia testing. 900 rural residents met the inclusion criteria and comprised the analytic sample. Generalized linear models were specified to estimate the relative risk of non-attendance at the in-person visit determining HCV eligibility. Approximately one-quarter (22.1%) of scheduled participants were no-shows. People who inject drugs were no more likely than people not injecting drugs to be a no-show; however, participants ≤35 years of age were significantly less likely to attend. While the median time between phone screening and scheduled in-person screening was only 2 days, each additional day increased the odds of no-show by 3% (95% confidence interval: 2%-3%). Finally, unknown HCV status predicted no-show even after adjustment for age, gender, days between screenings and injection status. We found that drug injection did not predict no-show, further justifying expanded access to HCV treatment among people who inject drugs. Those 35 years and younger were more likely to no-show, suggesting that younger individuals may require targeted strategies for increasing testing and treatment uptake. Finally, streamlining the treatment cascade may also improve outcomes, as participants in the current study were more likely to attend if there were fewer days between phone screening and scheduled in-person screening.

In-person versus electronic screening for social risks among carers of pediatric inpatients: A mixed methods randomized trial

We aimed to compare disclosure of social risks according to self-report on an iPad versus face-to-face questions from a health professional and to explore carers’ experiences of screening. This two-arm, parallel group, randomized trial was conducted from January 19, 2021, to December 17, 2021, in a public hospital pediatric ward serving a disadvantaged area of an Australian capital city. Carers of children aged ≤ 5 years admitted to the Children’s Ward were eligible. The primary outcome was disclosure of social risks. The screener included nine items on food security, household utilities, transport, employment, personal and neighborhood safety, social support, housing and homelessness. Disclosure of social risks was similar between the self-completion (n = 193) and assisted-completion (n = 193) groups for all 9 items, ranging 4.1% higher for worrying about money for food (95% CI − 11.4, 3.1%) among the assisted-completion group, to 5.7% (−1.6, 13.0%) higher for unemployment among the self-completion group. In qualitative interviews, participants were positive about screening for social risks in the hospital ward setting and the majority indicated a preference for self-completion. Conclusion: Differences in the disclosure of social risks according to self- versus assisted-completion were small, suggesting that either method could be used. Most carers expressed a preference for self- completion, which is therefore recommended as the ideal mode for such data collection for Australian pediatric inpatient settings. Trial registration: Australia New Zealand Clinical Trial Registry (www.anzctry.org.au; #ACTRN12620001326987; date of registration 8 December 2020).What is Known:• Most evidence on screening of social risks in pediatric inpatient settings is from the USA.• Little is known about disclosure of social risks in countries with universal health care and social welfare.What is New:• Disclosure of social risks was similar for electronic compared with face-to-face screening.• Carers preferred electronic completion over face-to-face completion.

Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III)

BackgroundRecruitment of participants is the greatest risk to completion of most clinical trials, with 20–40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous system (CNS) therapies such as intervention for chronic stroke. The PISCES III trial was an invasive trial of stereotactically guided intracerebral injection of CTX0E03, a fetal derived neural stem cell line, in patients with chronic disability due to ischemic stroke. We report on the experience using a novel hybrid recruitment approach of a patient-facing portal to self-identify and perform an initial screen for general trial eligibility (tier 1), followed by phone screening and medical records review (tier 2) prior to a final in-person visit to confirm eligibility and consent.MethodsTwo tiers of screening were established: an initial screen of general eligibility using a patient-facing web portal (tier 1), followed by a more detailed screen that included phone survey and medical record review (tier 2). If potential participants passed the tier 2 screen, they were referred directly to visit 1 at a study site, where final in-person screening and consent were performed. Rates of screening were tracked during the period of trial recruitment and sources of referrals were noted.ResultsThe approach to screening and recruitment resulted in 6125 tier 1 screens, leading to 1121 referrals to tier 2. The tier 2 screening resulted in 224 medical record requests and identification of 86 qualifying participants for referral to sites. The study attained a viable recruitment rate of 6 enrolled per month prior to being disrupted by COVID 19.ConclusionsA tiered approach to eligibility screening using a hybrid of web-based portals to self-identify and screen for general eligibility followed by a more detailed phone and medical record review allowed the study to use fewer sites and reduce cost. Despite the difficult and narrow population of patients suffering moderate chronic disability from stroke, this strategy produced a viable recruitment rate for this invasive study of intracranially injected neural stem cells.Trial registrationClinicalTrials.gov Identifier: NCT03629275

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep in Individuals With Insomnia Symptoms: Protocol for a Double-Blind Randomized Controlled Trial.

Cortical hyperarousal and ruminative thinking are common aspects of insomnia that have been linked with greater connectivity in the default mode network (DMN). Therefore, disrupting network activity within the DMN may reduce cortical and cognitive hyperarousal and facilitate better sleep. This trial aims to establish a novel, noninvasive method for treating insomnia through disruption of the DMN with repetitive transcranial magnetic stimulation, specifically with continuous theta burst stimulation (cTBS). This double-blind, pilot randomized controlled trial will assess the efficacy of repetitive transcranial magnetic stimulation as a novel, nonpharmacological approach to improve sleep through disruption of the DMN prior to sleep onset for individuals with insomnia. Primary outcome measures will include assessing changes in DMN functional connectivity before and after stimulation. A total of 20 participants between the ages of 18 to 50 years with reported sleep disturbances will be recruited as a part of the study. Participants will then conduct an in-person screening and follow-on enrollment visit. Eligible participants then conduct at-home actigraphic collection until their first in-residence overnight study visit. In a double-blind, counterbalanced, crossover study design, participants will receive a 40-second stimulation to the left inferior parietal lobule of the DMN during 2 separate overnight in-residence visits. Participants are randomized to the order in which they receive the active stimulation and sham stimulation. Study participants will undergo a prestimulation functional magnetic resonance imaging scan and a poststimulation functional magnetic resonance imaging scan prior to sleep for each overnight study visit. Sleep outcomes will be measured using clinical polysomnography. After their first in-residence study visit, participants conduct another at-home actigraphic collection before returning for their second in-residence overnight study visit. Our study was funded in September 2020 by the Department of Defense (W81XWH2010173). We completed the enrollment of our target study population in the October 2022 and are currently working on neuroimaging processing and analysis. We aim to publish the results of our study by 2024. Primary neuroimaging outcome measures will be tested using independent components analysis, seed-to-voxel analyses, and region of interest to region of interest analyses. A repeated measures analysis of covariance (ANCOVA) will be used to assess the effects of active and sham stimulation on sleep variables. Additionally, we will correlate changes in functional connectivity to polysomnography-graded sleep. The presently proposed cTBS protocol is aimed at establishing the initial research outcomes of the effects of a single burst of cTBS on disrupting the network connectivity of the DMN to improve sleep. If effective, future work could determine the most effective stimulation sites and administration schedules to optimize this potential intervention for sleep problems. ClinicalTrials.gov NCT04953559; https://clinicaltrials.gov/ct2/show/NCT04953559. DERR1-10.2196/51212.

Effects of remote ear-nose-and-throat specialist assessment screening on self-reported hearing aid benefit and satisfaction

Objective To explore the impact of remote versus in-person ear-nose-and-throat (ENT) specialist screening before hearing treatment on self-reported hearing aid (HA) benefit and satisfaction among adult first-time HA users. Design Participants were randomised to either remote or in-person ENT assessment before treatment initiation. Hearing ability, hearing quality, and treatment satisfaction were assessed pre- and post-HA treatment using the SSQ12, IOI-HA, and selected items from the 2021 Danish national Patient-Reported Experience Measures. Average daily HA usage was also recorded. Study sample 751 adult potential first-time HA users with self-reported hearing impairment were included; 501 participants were remotely assessed in private or public audiological clinics, and 250 control group participants were assessed in-person by private ENT specialists. Of the 658 participants who completed the entire trial, 454 received HAs. Results No significant post-treatment HA benefit differences were found between groups. Remotely assessed HA recipients in private clinics expressed slightly higher staff and waiting time satisfaction. Participants with normal hearing and mild/moderate hearing loss reported higher pre-treatment hearing ability and quality. No significant difference in average daily HA usage was observed between groups. Conclusions Findings suggest that remote screening does not compromise patient-reported HA benefit and satisfaction when compared to in-person screening.

Screening for HPV-Related Oropharyngeal Cancer in Gay and Bisexual Men: Acceptability and Predicting Possible Use of "Oral Selfies" by Smartphone as a Secondary Prevention Approach.

Oropharyngeal cancers (OPCa) caused by HPV have emerged as one of the leading causes of malignancies caused by HPV infection. They are also significantly more likely to occur in males and in people with a history of oral sex with multiple partners. Gay and bisexual men are disproportionately affected by HPV-positive oropharyngeal cancers. We studied 1699 gay and bisexual men on 2 major dating sites in the US to assess their knowledge about HPV-related OPCa, attitudes toward screening for it, beliefs about oropharyngeal cancer screening based on the Health Belief Model, and attitudes toward possible screening approaches for OPCa. Knowledge on a 12-item scale was low, with a median of 5 items correct: 72% knew of the benefits of HPV vaccination. Significant predictors of needing OPCa screening included perception of risk for OPCa, seeing it as severe, having lower barriers, fewer reasons to avoid screening, higher knowledge, and being HPV vaccinated were significant predictors, explaining half the total variance. Most participants would accept routine, virtual/online doctor or dental appointments, and over half would accept an in-person screening. Nearly two-thirds stated that they would accept getting checked for OPCa if they could do self-screening at home, and half were prepared to use an online screening tool or app, where they could take an "oral selfie" and send it to a healthcare provider for examination. One-third stated that they would trust the results of a home screening completed by themselves and posted to a website equally as cancer screening completed online by a healthcare provider. Data indicate that despite low OPCA knowledge levels, the risk of HPV-associated OPCa was known. Being at personal risk and having knowledge of disease severity had 70% of the sample thinking about, or preparing to get, screening. Self-screening by a smartphone "oral selfie" transmitted to a screening website was acceptable to many gay and bisexual men, and online screening by a doctor or dentist was acceptable to most. OPCa screening in this population using electronic technology, together with the increasing incidence of HPV-associated OPCa in gay and bisexual men, brings together an opportunity to detect OPCa early.

Prevalence of glaucomatous-appearing discs in patients undergoing artificial intelligence screening for diabetic retinopathy

PurposeTo determine the prevalence of optic disc changes suspicious for glaucoma (OCSG) which may be overlooked by artificial intelligence-based diabetic retinopathy (DR) screening systems in place of in-person dilated screening exams. MethodsThis was a retrospective cross-sectional study. High-resolution images were retrieved for 677 consecutive automated DR screening exams performed in adult patients. These were reviewed by two blinded readers for evidence of OCSG, which included increased vertical cup-to-disc ratio (VCDR), beta-zone peripapillary atrophy, optic disc hemorrhage, vessel bayoneting, rim thinning, and/or central vessel nasalization. The prevalence of OCSG was reported and compared between subjects designated as referable versus non-referable for DR. ResultsIn total, 823 eyes of 413 subjects were included. The total OCSG prevalence was 4.8% to 20.6%, with no statistically significant difference between patients designated referable versus non-referable on artificial intelligence-based DR screening. The combined classification reliability of the image readers was moderate to substantial compared to a glaucoma specialist. ConclusionsOCSG were detected in 4.8% to 20.6% of adult diabetic patients who underwent AI-based DR screening in our cohort. This represents a significant prevalence of optic disc findings which, if detected on manual screening, would have prompted referral for a glaucoma workup. Such findings illustrate the need for artificial intelligence-based screening platforms which cover multiple high-prevalence ophthalmic conditions. Replacing manual dilated screening exams with systems optimized for a single disease may increase the risk of missing comorbid ocular disease.

Dementia and electronic health record phenotypes: a scoping review of available phenotypes and opportunities for future research.

We performed a scoping review of algorithms using electronic health record (EHR) data to identify patients with Alzheimer's disease and related dementias (ADRD), to advance their use in research and clinical care. Starting with a previous scoping review of EHR phenotypes, we performed a cumulative update (April 2020 through March 1, 2023) using Pubmed, PheKB, and expert review with exclusive focus on ADRD identification. We included algorithms using EHR data alone or in combination with non-EHR data and characterized whether they identified patients at high risk of or with a current diagnosis of ADRD. For our cumulative focused update, we reviewed 271 titles meeting our search criteria, 49 abstracts, and 26 full text papers. We identified 8 articles from the original systematic review, 8 from our new search, and 4 recommended by an expert. We identified 20 papers describing 19 unique EHR phenotypes for ADRD: 7 algorithms identifying patients with diagnosed dementia and 12 algorithms identifying patients at high risk of dementia that prioritize sensitivity over specificity. Reference standards range from only using other EHR data to in-person cognitive screening. A variety of EHR-based phenotypes are available for use in identifying populations with or at high-risk of developing ADRD. This review provides comparative detail to aid in choosing the best algorithm for research, clinical care, and population health projects based on the use case and available data. Future research may further improve the design and use of algorithms by considering EHR data provenance.

Examining the Role of Telemedicine in Diabetic Retinopathy.

With the increasing prevalence of diabetic retinopathy (DR), screening is of the utmost importance to prevent vision loss for patients and reduce financial costs for the healthcare system. Unfortunately, it appears that the capacity of optometrists and ophthalmologists to adequately perform in-person screenings of DR will be insufficient within the coming years. Telemedicine offers the opportunity to expand access to screening while reducing the economic and temporal burden associated with current in-person protocols. The present literature review summarizes the latest developments in telemedicine for DR screening, considerations for stakeholders, barriers to implementation, and future directions in this area. As the role of telemedicine in DR screening continues to expand, further work will be necessary to continually optimize practices and improve long-term patient outcomes.