Recruitment Sites Research Articles

Health care professional recruitment of patients and family carers to palliative care randomised controlled trials: A qualitative multiple case study.

Trial participant recruitment is an interactional process between health care professionals, patients and carers. Little is known about how clinicians carry out this role in palliative care trials and the reasons why they do or do not recruit participants. To explore how clinicians recruit to palliative care trials, why they choose to implement particular recruitment strategies, and the factors that influence their choices. A qualitative multiple case study of three UK palliative care trials. Data collection included interviews and study documentation. Analysis involved developing and refining theoretical propositions, guided by the '6Ps' of the 'Social Marketing Mix Framework' as an a priori framework (identifying participants, product, price, place, promotion and working with partners). Framework Analysis guided within and then cross-case analysis. Study investigators and research staff (n = 3, 9, 7) from trial coordinating centres and recruitment sites (hospice and hospital). Cross-case analysis suggests the 'Social Marketing Mix Framework' is useful for understanding recruitment processes but wider contextual issues need to be incorporated. These include the 'emotional labour' of diagnosing dying and communicating palliative and end-of-life care to potential participants and how the recruitment process is influenced by the power relationships and hierarchies that exist among professional groups. These factors can lead to and support paternalistic practices. Those planning trials need to ensure that trial recruiters, depending on their experience and trial characteristics, have access to training and support to address the 'emotional labour' of recruitment. The type of training required requires further research.

Key considerations for conducting qualitative research with LGBTQ + youth

Qualitative research involving lesbian, gay, bisexual, transgender and queer (LGBTQ+) youth must be sensitive to their exposure to stressors resulting from heteronormativity, cisnormativity, homophobia, and transphobia. This scoping review was conducted to explore unique methodological strategies for conducting qualitative data collection with LGBTQ + youth and identify any themes on facilitators and barriers to effective qualitative research involving these populations. Using seven EBSCO databases and the website ResearchRabbit, 149 studies were found, of which 30 were included in this review. This review revealed several key considerations for planning and conducting qualitative research with these populations, including alignment between theoretical framework and methodological approach, recruitment sites and strategies, interviewer positionality in relation to participants, parental consent for minor participation and protection of minor participants who may not be “out” to parents or adult caregivers, the site and setting of qualitative interviews, and innovative methodologies. Additionally, this review allowed for reflections on study limitations beyond the conventional non-generalizability disclaimers often used in qualitative research, providing useful insights for researchers conducting qualitative research with LGBTQ + youth and young adults.

A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose: NalPORS

BackgroundWorldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide ‘community members’, who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions.MethodsA European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design.DiscussionThere are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact.Trial registrationClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021

Epidemiology of Motoric Cognitive Risk Syndrome in the Kerala Einstein Study: Protocol for a Prospective Cohort Study.

The southern India state of Kerala has among the highest proportion of older adults in its population in the country. An increase in chronic age-related diseases such as dementia is expected in the older Kerala population. Identifying older individuals early in the course of cognitive decline offers the best hope of introducing preventive measures early and planning management. However, the epidemiology and pathogenesis of predementia syndromes at the early stages of cognitive decline in older adults are not well established in India. The Kerala Einstein Study (KES) is a community-based cohort study that was established in 2008 and is based in the Kozhikode district in Kerala state. KES aims to establish risk factors and brain substrates of motoric cognitive risk syndrome (MCR), a predementia syndrome characterized by the presence of slow gait and subjective cognitive concerns in individuals without dementia or disability. This protocol describes the study design and procedures for this KES project. KES is proposing to enroll a sample of 1000 adults ≥60 years old from urban and rural areas in the Kozhikode district of Kerala state: 200 recruited in the previous phase of KES and 800 new participants to be recruited in this project. MCR is the cognitive phenotype of primary interest. The associations between previously established risk factors for dementia as well as novel risk factors (apathy and traumatic brain injury) and MCR will be examined in KES. Risk factor profiles for MCR will be compared between urban and rural residents as well as with individuals who meet the criteria for mild cognitive impairment (MCI). Cognitive and physical function, medical history and medications, sociodemographic characteristics, lifestyle patterns, and activities of daily living will be evaluated. Participants will also undergo magnetic resonance imaging and electrocardiogram investigations. Longitudinal follow-up is planned in a subset of participants as a prelude to future longitudinal studies. KES (2R01AG039330-07) was funded by the US National Institutes of Health in September 2019 and received approval from the Indian Medical Council of Research to start the study in June 2021. We had recruited 433 new participants from urban and rural sites in Kozhikode as of May 2023: 41.1% (178/433) women, 67.7% (293/433) rural residents, and 13.4% (58/433) MCR cases. Enrollment is actively ongoing at all the KES recruitment sites. KES will provide new insights into risk factors and brain substrates associated with MCR in India and will help guide future development of regionally specific preventive interventions for dementia. DERR1-10.2196/49933.

Methods for estimating insulin resistance from untargeted metabolomics data

ContextInsulin resistance is associated with multiple complex diseases; however, precise measures of insulin resistance are invasive, expensive, and time-consuming.ObjectiveDevelop estimation models for measures of insulin resistance, including insulin sensitivity index (SI) and homeostatic model assessment of insulin resistance (HOMA-IR) from metabolomics data.DesignInsulin Resistance Atherosclerosis Family Study (IRASFS).SettingCommunity based.ParticipantsMexican Americans (MA) and African Americans (AA).Main outcomeEstimation models for measures of insulin resistance, i.e. SI and HOMA-IR.ResultsLeast Absolute Shrinkage and Selection Operator (LASSO) and Elastic Net regression were used to build insulin resistance estimation models from 1274 metabolites combined with clinical data, e.g. age, sex, body mass index (BMI). Metabolite data were transformed using three approaches, i.e. inverse normal transformation, standardization, and Box Cox transformation. The analysis was performed in one MA recruitment site (San Luis Valley, Colorado (SLV); N = 450) and tested in another MA recruitment site (San Antonio, Texas (SA); N = 473). In addition, the two MA recruitment sites were combined and estimation models tested in the AA recruitment sample (Los Angeles, California; N = 495). Estimated and empiric SI were correlated in the SA (r2 = 0.77) and AA (r2 = 0.74) testing datasets. Further, estimated and empiric SI were consistently associated with BMI, low-density lipoprotein cholesterol (LDL), and triglycerides. We applied similar approaches to estimate HOMA-IR with similar results.ConclusionsWe have developed a method for estimating insulin resistance with metabolomics data that has the potential for application to a wide range of biomedical studies and conditions.

Kidney Biopsy Utility: Patient and Clinician Perspectives from the Kidney Precision Medicine Project

Limited data exist on patient perspectives of the implications of kidney biopsies. We explored patients' perspectives alongside those of clinicians to better understand how kidney biopsies affect patients' viewpoints and the clinical utility of biopsies. Prospective Cohort Study. Patient participants and clinicians in the Kidney Precision Medicine Project, a prospective cohort study of patients who undergo a research protocol biopsy, at 9 recruitment sites across the United States. Surveys were completed at enrollment before biopsy and additional timepoints after biopsy (participants: 28 days, 6 months; clinicians: 2 weeks). Kappa statistics assessed prebiopsy etiology concordance between clinicians and participants. Participant perspectives after biopsy were analyzed using a thematic approach. Clinician ratings of clinical management value were compared to prebiopsy ratings with Wilcoxon matched-pairs signed-rank tests and paired t tests. A total of 167 participants undergoing biopsy (124 participants with chronic kidney disease [CKD], 43 participants with acute kidney injury [AKI]) and 58 clinicians were included in this study. CKD participants and clinicians had low etiology concordance for the 2 leading causes of CKD: diabetes (k=0.358) and hypertension (k=0.081). At 28 days postbiopsy, 46 (84%) participants reported that the biopsy affected their understanding of their diagnosis, and 21 (38%) participants reported that the results of the biopsy affected their medications. Participants also shared biopsy impressions in free-text responses, including impacts on lifestyle and concurrent condition management. The biopsy positively shifted clinician perceptions of the procedure's clinical management benefits, while perceptions of prognostic value decreased and diagnostic ratings remained unchanged. Our study did not have demographic data of clinicians and could not provide insight into postbiopsy experiences for participants who did not respond to follow-up surveys. Participant perspectives of the personal implications of kidney biopsy can be integrated into shared decision-making between clinicians and patients. Enhanced biopsy reports and interactions between nephrologists and pathologists could augment the management and prognostic value of kidney biopsies. The utility of kidney biopsy is debated among clinicians, and patients' perspectives are even less explored. To address these gaps, we synthesized perspectives from clinicians and patient participants of the Kidney Precision Medicine Project (KPMP). Both before and after biopsy, clinicians were surveyed on how the procedure affected their clinical management, diagnosis, and prognosis. After biopsy, participants shared how the procedure affected their diagnosis, medication, and lifestyle changes. Clinicians and patients shared an appreciation for the biopsy's impact on medical management but diverged in their takeaways on diagnosis and prognosis. These findings highlight the need for greater collaboration between patients and clinicians, particularly as they navigate shared decision-making when considering kidney biopsy.

A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial

BackgroundSelf-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm.MethodsThis was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016).ResultsWe screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (− 3.6 (− 4.9, − 2.4)), depression (− 7.1 (− 8.7, − 5.4)), hopelessness (− 2.6 (− 3.4, − 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention.ConclusionsSuicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.

Armed Citizens on the Border: How Guns Fuel Anti-Immigration Politics in America

Abstract To make a nation on stolen land using enslaved labor, the early American state relied on gun and immigration policy to create a well-armed white settler population. This legacy continues to animate modern conservativism, which is staked on supporting gun-friendly and anti-immigrant policies. Despite this history and ongoing political reality, however, the sociology of migration has largely ignored the relationship between firearms and immigration politics. To explore this relationship, the current study draws on 20 months of ethnographic data from the U.S.-Mexico border. I show how contemporary American gun culture bolsters anti-immigrant organizations through two mechanisms. First, gun shows and shooting ranges are important sites of recruitment among anti-immigrant groups. Second, the thrill of handling firearms mitigates the monotony of everyday anti-immigrant activism, while also easing the disenchantment that participants may otherwise feel about the effectiveness of their actions in bringing about long-term change. The article concludes by urging scholars of American politics to be mindful of the legacies of settler-colonialism and to take seriously the reinforcing effects of guns on nativist politics.

365-OR: A Machine-Learning Approach to Estimate Insulin Resistance from Untargeted Metabolomics Data

Insulin resistance (IR) is constantly invoked as a contributor to numerous common diseases, e.g. diabetes, cardiovascular disease and Alzheimer’s disease; however, with the exception of a narrow segment of diabetes-related studies, IR is infrequently measured and rarely measured well. Our goal was to develop IR estimation models for the dynamic measure of insulin sensitivity (SI) and the basal measure of homeostatic model assessment of IR (HOMAIR) from metabolomics data combined with minimal clinical data, e.g. age, sex, BMI. Least Absolute Shrinkage and Selection Operator (LASSO) and Elastic Net regression were used to build estimation models using 1274 metabolites, prioritized by trait associations and collected in the Insulin Resistance Atherosclerosis Family Study (IRASFS). Three metabolite transformations were implemented (inverse normal transformation, standardization, and Box Cox transformation) to account for distributional differences and tested to optimize estimation. The analysis was performed in one Mexican American (MA) recruitment site (San Luis Valley, CO (SLV), N=450) and tested in another MA recruitment site (San Antonio, TX (SA), N=473). In addition, the two MA recruitment sites were combined and estimation models tested in the African American recruitment site (AA; Los Angeles, California, N=495) to assess generalizability. Estimated SI was correlated with empiric SI in the SA (r2=0.77) and AA (r2=0.74) testing datasets. Further, we tested estimated SI for association with BMI, low-density lipoprotein cholesterol and triglycerides with results consistent with those observed for empiric SI. The same framework was used to estimate HOMAIR, and yielded similar results. In summary, we have developed methods for estimating multiple measures of IR from a single blood sample. This approach will greatly expand our ability to provide meaningful insight into the role of IR in disease, supporting the potential for application to a wide-range of biomedical studies. Disclosure N.Allred: None. D.W.Bowden: None. F.Hsu: None. S.Chen: None. M.Ng: None. M.O.Goodarzi: Advisory Panel; Nestlé Health Science, Other Relationship; Nestlé Health Science. J.I.Rotter: None. L.E.Wagenknecht: None. M.Bancks: None. R.N.Bergman: Consultant; Lilly, ReCor Medical, Inc., Research Support; AstraZeneca. Funding National Institutes of Health (DK118062)

COVID-19 host genetic risk study conducted at community pharmacies: Implications for public health, research and pharmacists’ scope of practice

Community pharmacists serve a large, diverse population of patients, resulting in the potential to utilize community pharmacies as recruitment sites for clinical research. Beyond traditional roles as one of the most accessible health care professionals in the US healthcare system, pharmacists have played a major role in the response to the COVID-19 pandemic, administering hundreds of thousands of vaccines and tests. However, less emphasis is placed on the ability to leverage community pharmacies as research-focused partners for clinical studies. In this study, we demonstrate the feasibility and workflow of recruiting study participants from community pharmacies and confirm genetic markers of COVID-19 susceptibility. Specific genetic markers include those associated with COVID-19 infection risk (ACE2, TMEM27, and RAVER1), difficulty breathing (NOTCH4), and hospitalization (OAS3). In addition, collaboration with a clinical laboratory allowed for a more seamless consenting process without substantial training needs or workflow disruption at the community pharmacy site. The COVID-19 pandemic has demonstrated that the expansion of pharmacists’ scope of practice is a key factor in managing the population health crisis; this study demonstrates that pharmacies can also advance clinical research studies by serving as sites for patient recruitment from a large, diverse, and ambulatory study population.

Learned lessons from a US-wide outreach program to broaden enrollment to the PROMISE Registry, a prostate cancer genetic registry.

10628 Background: Updates to NCCN genetic testing recommendations and approved PARPi treatments for prostate cancer (PCa) patients (pts) have clarified the need for genetic registries to identify pts for novel treatments and understand real-world effects of targeted therapies. PROMISE (NCT04995198) is a US prospective genetic registry that has deployed an outreach program to broaden enrollment beyond the usual approach of academic medical centers as recruitment sites. PROMISE aims to create a PCa genetic registry by enrolling and screening 5,000 PCa pts via germline testing to identify 500 for long-term follow-up with germline mutations in genes of interest. Methods: The outreach program was initiated in May 2021 alongside enrollment. The program aims to supplement ongoing recruitment at 23 institutions by broadening enrollment to include populations and areas not served by academic medical centers. Direct-to-pt outreach was prioritized via partnerships with PCa advocacy organizations with groups and geographic areas with high prevalence of PCa. Online activities include webinars, interviews, podcasts, articles, partner email blasts, and newsletters. In-person activities include tabling and presentation at patient- and provider-facing conferences, and tabling at pt walks. Letters were sent introducing PROMISE through the Maryland Cancer Registry to individuals with PCa. A dedicated team including marketing, partnerships and engagement, and website SEO specialists support the program. Funding for the outreach program is provided by the study funder, Advancing Clinical Trials (ACT). Results: As of January 2023, study accrual is 54% ahead of initial projections. 2,178 have been enrolled and 219 are eligible for long-term follow-up across 48 states, with most enrollment occurring on the east and west coasts. Race/ethnicity distribution is as follows: American Indian or Alaska Native 0.4%, Asian 2.0%, Black 3.9%, Hispanic 1.8%, Native Hawaiian or Pacific Islander 0.1%, White 76.4%, unknown 0.4%, and no response provided 16.3%. Conclusions: Traditional recruitment efforts by academic medical centers, when supplemented with direct-to-pt outreach yields increased enrollment. Effective components include 1) partnerships with PCa advocacy organizations, 2) communication from PIs, Investigators, and other medical professionals via webinars and interviews with clinically relevant topics and Q&A, and 3) varied methods of outreach. While the program has led to high accrual, distribution of enrolled participants supports findings from other genetic and genomic registries indicating that increasing diversity continues to be a challenge. Moving forward, we will continue to work with outreach partners to find well-targeted, efficient ways to reach PCa patients with attention to increasing participant diversity. Clinical trial information: NCT04995198 .

Cryo-EM structure of the Saccharomyces cerevisiae Rpd3L histone deacetylase complex

The Rpd3L histone deacetylase (HDAC) complex is an ancient 12-subunit complex conserved in a broad range of eukaryotes that performs localized deacetylation at or near sites of recruitment by DNA-bound factors. Here we describe the cryo-EM structure of this prototypical HDAC complex that is characterized by as many as seven subunits performing scaffolding roles for the tight integration of the only catalytic subunit, Rpd3. The principal scaffolding protein, Sin3, along with Rpd3 and the histone chaperone, Ume1, are present in two copies, with each copy organized into separate lobes of an asymmetric dimeric molecular assembly. The active site of one Rpd3 is completely occluded by a leucine side chain of Rxt2, while the tips of the two lobes and the more peripherally associated subunits exhibit varying levels of flexibility and positional disorder. The structure reveals unexpected structural homology/analogy between unrelated subunits in the fungal and mammalian complexes and provides a foundation for deeper interrogations of structure, biology, and mechanism of these complexes, as well as for the discovery of HDAC complex-specific inhibitors.

Effects of Corporate Social Responsibility on Online Recruitment Processes in the Vietnamese Food and Beverage Industry

This paper examines the effect of CSR perceptions on online recruitment practices and outcomes in the Vietnamese food and beverage sector. Semi-structured interviews were conducted with seventeen participants, including CEOs, HR (human resource) staff and store managers. The results show that CSR perception varies and is exemplified through employee-related activities, ethical products, environment, philanthropy, and international standards. The study is novel in establishing that, despite high unemployment in developing economies, CSR communication in online recruitment sites impacts job applicants’ choice of company. While the strategic potency of CSR has been established, this study brings to light its critical significance for human resources processes, particularly online recruitment, in an emerging economy context. The study has considerable implications for practitioners and researchers, suggesting the necessity to strategically manage the interface between CSR and online recruitment.

Improving the performance of supply chains in clinical trials with delays: an optimization approach to determining the number of recruitment sites

Improving the performance of supply chains in clinical trials with delays: an optimization approach to determining the number of recruitment sites

Redistribution of the chromatin remodeler Brg1 directs smooth muscle-derived adventitial progenitor-to-myofibroblast differentiation and vascular fibrosis.

Vascular smooth muscle-derived Sca1+ adventitial progenitor (AdvSca1-SM) cells are tissue-resident, multipotent stem cells that contribute to progression of vascular remodeling and fibrosis. Upon acute vascular injury, AdvSca1-SM cells differentiate into myofibroblasts and are embedded in perivascular collagen and the extracellular matrix. While the phenotypic properties of AdvSca1-SM-derived myofibroblasts have been defined, the underlying epigenetic regulators driving the AdvSca1-SM-to-myofibroblast transition are unclear. We show that the chromatin remodeler Smarca4/Brg1 facilitates AdvSca1-SM myofibroblast differentiation. Brg1 mRNA and protein were upregulated in AdvSca1-SM cells after acute vascular injury, and pharmacological inhibition of Brg1 by the small molecule PFI-3 attenuated perivascular fibrosis and adventitial expansion. TGF-β1 stimulation of AdvSca1-SM cells in vitro reduced expression of stemness genes while inducing expression of myofibroblast genes that was associated with enhanced contractility; PFI blocked TGF-β1-induced phenotypic transition. Similarly, genetic knockdown of Brg1 in vivo reduced adventitial remodeling and fibrosis and reversed AdvSca1-SM-to-myofibroblast transition in vitro. Mechanistically, TGF-β1 promoted redistribution of Brg1 from distal intergenic sites of stemness genes and recruitment to promoter regions of myofibroblast-related genes, which was blocked by PFI-3. These data provide insight into epigenetic regulation of resident vascular progenitor cell differentiation and support that manipulating the AdvSca1-SM phenotype will provide antifibrotic clinical benefits.

Smartphone Integration of Artificial Intelligence for Automated Plagiocephaly Diagnosis.

A prospective validation study was conducted at a large tertiary care center with two recruitment sites: (1) newborn nursery, (2) pediatric craniofacial surgery clinic. Eligible children were aged 0-12 months with no history of hydrocephalus, intracranial tumors, intracranial hemorrhage, intracranial hardware, or prior craniofacial surgery. Successful artificial intelligence diagnosis required identification of the presence and severity of positional plagiocephaly. A total of 89 infants were prospectively enrolled from the craniofacial surgery clinic (n = 25, 17 male infants [68%], eight female infants [32%], mean age 8.44 months) and newborn nursery (n = 64, 29 male infants [45%], 25 female infants [39%], mean age 0 months). The model obtained a diagnostic accuracy of 85.39% compared with a standard clinical examination with a disease prevalence of 48%. Sensitivity was 87.50% [95% CI, 75.94-98.42] with a specificity of 83.67% [95% CI, 72.35-94.99]. Precision was 81.40%, while likelihood ratios (positive and negative) were 5.36 and 0.15, respectively. The F1-score was 84.34%. The smartphone-based artificial intelligence algorithm accurately diagnosed positional plagiocephaly in a clinical environment. This technology may provide value by helping guide specialist consultation and enabling longitudinal quantitative monitoring of cranial shape.

Early markers of neurodevelopmental disorders based on general movements for very preterm infants: study protocol for a multicentre prospective cohort study in a clinical setting in China

IntroductionVery preterm (VPT) infants may experience varying degrees of neurodevelopmental challenges. Lack of early markers for neurodevelopmental disorders may delay referral to early interventions. The detailed General Movements Assessment (GMA)...

Investigating the Comparative Effectiveness of Place-Based and Scatter-Site Permanent Supportive Housing for People Experiencing Homelessness During the COVID-19 Pandemic: Protocols for a Mixed Methods, Prospective Longitudinal Study.

Permanent supportive housing (PSH) is an evidence-based practice to address homelessness that is implemented using 2 distinct approaches. The first approach is place-based PSH (PB-PSH), or single-site housing placement, in which an entire building with on-site services is designated for people experiencing homelessness. The second approach is scatter-site PSH (SS-PSH), which uses apartments rented from a private landlord while providing mobile case management services. This paper describes the protocols for a mixed methods comparative effectiveness study of 2 distinct approaches to implementing PSH and the patient-centered quality of life, health care use, and health behaviors that reduce COVID-19 risk. People experiencing homelessness who are placed in either PB-PSH or SS-PSH completed 6 monthly surveys after move-in using smartphones provided by the study team. A subsample of participants completed 3 qualitative interviews at baseline, 3 months, and 6 months that included photo elicitation interviewing. Two stakeholder advisory groups, including one featuring people with lived experience of homelessness, helped guide study decisions and interpretations of findings. Study recruitment was supposed to occur over 6 months starting in January 2021 but was extended due to delays in recruitment. These delays included COVID-19 delays (eg, recruitment sites shut down due to outbreaks and study team members testing positive) and delays that may have been indirectly related to the COVID-19 pandemic, including high staff turnover or recruitment sites having competing priorities. In end-July 2022, in total, 641 people experiencing homelessness had been referred from 26 partnering recruitment sites, and 563 people experiencing homelessness had enrolled in the study and completed a baseline demographic survey. Of the 563 participants in the study, 452 had recently moved into the housing when they enrolled, with 272 placed in PB-PSH and 180 placed in SS-PSH. Another 111 participants were approved but are still waiting for housing placement. To date, 49 participants have been lost to follow-up, and 12% of phones (70 of the initial 563 distributed) were reported lost by participants. Recruitment during the pandemic, while successful, was challenging given that in-person contact was not permitted at times either by program sites or the research institutions during COVID-19 surges and high community transmission, which particularly affected homelessness programs in Los Angeles County. To overcome recruitment challenges, flexible strategies were used, which included extending the recruitment period and the distribution of cell phones with paid data plans. Given current recruitment numbers and retention rates that are over 90%, the study will be able to address a gap in the literature by considering the comparative effectiveness of PB-PSH versus SS-PSH on patient-centered quality of life, health care use, and health behaviors that reduce COVID-19 risk, which can influence future public health approaches to homelessness and infectious diseases. ClinicalTrials.gov NCT04769349; https://clinicaltrials.gov/ct2/show/NCT04769349. DERR1-10.2196/46782.

Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis

This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

Abstract 4201: Associations of pre-diagnostic serum liver enzymes levels with lung cancer risk: results from the Southern Community Cohort Study

Abstract Introduction: Lung cancer is the leading cause of cancer death in the United States (U.S.). Lung cancer disproportionately affects African Americans (AAs) more than other racial/ethnic groups. Previous studies have linked liver diseases to lung cancer risk; however, few studies have evaluated the associations of circulating liver enzyme levels with lung cancer risk. In this study, we evaluated the associations of the serum alanine transaminase (ALT) and alkaline phosphatase (ALP) levels with the risk of subsequently developing lung cancer. Methods: We conducted a nested case-control study within the Southern Community Cohort Study, a well-conducted prospective cohort study in the southern U.S. mainly consisting of low-income AAs and European Americans (EAs). We included 552 incident lung cancer cases and 1,039 controls individually matched on age, sex, recruitment sites, and date of blood draw. Baseline serum levels of ALT and ALP were measured using the Beckman Coulter clinical chemistry analyzer. Conditional logistic regression and generalized estimating models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) after adjusting for age, education, household income, body mass index (BMI), smoking status, pack-years, alcohol consumption, physical activity levels, history of chronic obstructive pulmonary disease, hypertension, and diabetes. Results: Higher serum levels of ALT were associated with a lower overall risk of lung cancer. Compared with the lowest tertile, participants in the second and third tertiles had OR (95% CI) of 0.74 (0.48-1.14) and 0.47 (0.28-0.78) (Ptrend &amp;lt; 0.01). The inverse association was observed in both AAs and EAs. However, the inverse associations between serum ALT levels and lung cancer risk were more evident among men [ORT3 vs T1 = 0.36 (0.18-0.70)], current smokers [ORT3 vs T1 =0.65 (0.47-0.90)], participants with lower BMI [ORT3 vs T1=0.55 (0.38-0.79)], or lower physical activity [ORT3 vs T1 = 0.55 (0.37-0.83)]. Stratified analyses by time interval between blood collection and lung cancer diagnosis showed that the inverse associations were observed in both those diagnosed within [ORT3 vs T1 =0.48 (0.23-1.00)] and after [ORT3 vs T1 = 0.36 (0.19-0.69)] a median follow up time of 3 years. The serum ALT level was not associated with overall lung cancer; however, higher serum ALP levels were significantly associated with increased lung cancer risk among AA men [ORT3 vs T1 = 1.98 (1.18-3.34)]. Conclusion: Our results indicate that in a predominantly low-income AA and EA population, serum ALT levels may be related to a lower risk of lung cancer. Further studies are warranted to confirm our findings and elucidate the potential underlying mechanisms of the associations. Citation Format: Shuai Xu, Hui Cai, Jie Wu, Hyung-Suk Yoon, Regina Courtney, Xiao-Ou Shu, William J. Blot, Wei Zheng, Qiuyin Cai. Associations of pre-diagnostic serum liver enzymes levels with lung cancer risk: results from the Southern Community Cohort Study. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4201.