Electronic Data Capture Tools Research Articles

Melanoma immunotherapy longitudinal database: A comprehensive approach to capture oncological and toxicity data.

e23314 Background: Evaluating immunotherapy approaches is consistently performed in melanoma, a forefront cancer in immunotherapy responsiveness. Although immune checkpoint inhibitors (ICIs) showed the highest significant survival benefits in melanoma, 50% of patients experience recurrence/refractory disease, and ~59% develop grade 3/4 immune-related adverse events (irAEs). Thus, understanding the disease's natural history, exploring biomarkers of response/toxicity, and identifying the efficacy/safety of immunotherapy using real-world data is warranted. Methods: We established a centralized pro-/retrospective database on Research Electronic Data Capture (REDCap), encompassing patients' demographics/comorbidities, disease risk factors, clinicopathological parameters, genomic/immune profiling, treatment modalities, tumor outcomes, irAEs, and patients’ reported outcomes (PROs). Additionally, to streamline data collection and minimize the required time, effort, and cost for manual retrieval, we developed an automated pathway for data capture using MD Anderson Cancer Center (MDACC) electronic data capture (EDC) tools which pull clinical data from EPIC. Data quality will be validated by comparing it to manually retrieved data from an ongoing study of melanoma patients treated with ICIs in the adjuvant setting (NCT04990726). Results: A total of 4074 immunotherapy-treated melanoma patients were identified. We automatically captured demographics and laboratory values at predefined time points from REDCap, along with PROs using validated electronic self-reported questionnaires already built in REDCap. We also automatically captured family history, comorbidities, pathology data, and cancer treatments from the Data Management Initiative (DMI) validated software that automatically captures data from 12 various institutional sources that complement each other, including Radiation Oncology Database, the Biospecimen Information Management System,...etc. Moreover, genomic data were automatically pulled from the Molecular and Clinical Data Integration Platform for 1850 patients. Automated capture of tumor response and irAEs according to the Response Evaluation Criteria in Solid Tumors 1.1. and Common Terminology Criteria for Adverse Events version-5, respectively are currently ongoing and will be presented. Conclusions: Integrating EDC tools demonstrated accurate real-time data capture and minimized the manual retrieval burden. Our immunotherapy-treated melanoma patients’ cohort provides a comprehensive and a valuable resource for exploring the safety signals and efficacy of various immunotherapeutic approaches beyond clinical trials.

Implementation of nurse administered propofol sedation for same-day discharge pulsed field ablation of atrial fibrillation is safe and has excellent patient reviews

Abstract Background In June 2022, we introduced Pulsed Field Ablation (PFA) for de novo pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Simultaneously, deep sedation with propofol undertaken by trained nurses from the cath lab was introduced. Purpose To evaluate feasibility, safety and patient reported experience for same-day discharge AF ablations performed with PFA on propofol sedation. Methods Patients with an ASA physical status classification of 1 or 2 referred for de novo AF ablation were planned for PFA in propofol sedation. Three nurses with previous experience from the intensive care unit planned and undertook the sedation. In addition, two nurses were trained locally. The initial 200 consecutive patients were included in the observational cohort study after signing consent to participate in follow-up after the procedure. Study data were collected and managed using REDCap electronic data capture tools. In addition to procedure related data, patient-reported quality measures were acquired 30 days after the procedure by an internet based questionnaire including scaling and open questions. Results 96% of the procedures were successfully completed using only propofol while 4% were scheduled for general anesthesia, mainly because of sleep apnea and high BMI. The average procedure time for the first 100 procedures was 57 min (95% CI, 54.1-62.9) and 45 min (95% CI, 42.6-47.4) for the following 100 procedures. Acute PVI was achieved during all procedures. No sedation related adverse effects were observed. One patient experienced pericardial tamponade requiring prolonged hospitalization. 87% were discharged on the same day as planned while 12% remained hospitalized one additional day for reassurance and social reasons. 93% (186/200) completed the questionnaire. 56% of patient only responded "very little" or "not at all" to all questions about adverse symptoms during and after the procedure. For each specific symptom, 80 to 95 % were only experienced "very little" or "not at all" (Fig 1). In general, patients felt safe about the preparation for and handling of the sedation (Fig 2). Conclusions Nurse administered deep sedation with propofol, provides excellent pain relief for PFA procedures, facilitates an efficient workflow and can safely be implemented and administered by nurses from the cath lab. Propofol sedation constitutes an important alternative to general anesthesia that is not widely available.Figure 1Figure 2

A global analysis of the use of immunoglobulin, shortages in supply, and mitigating measures: A survey of hospital providers (a BEST Collaborative study).

Immunoglobulin (IG) therapy is widely used to treat primary and secondary immune deficiencies and as immunomodulatory agent for various disorders. There is great concern that shortages of IG may rise, potentially affecting medical treatment options. An international survey was developed to study how intravenous immunoglobulins (IVIGs) are used and managed within hospitals in case of shortages. Study data were collected and managed using REDCap electronic data capture tools hosted by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The survey was directed to hospital pharmacists and blood bank transfusion professionals and disseminated through members of the BEST Collaborative network. Survey respondents from institutions in the USA, Canada, Europe, Japan, and Australia (n = 13) confirmed that the primary specialties utilizing IG are neurology, hematology, and immunology. More than 60% of respondents reported IG supply shortages, but mitigation strategies were not well developed. As IG is the leading driver in plasma demand, more studies are needed to understand current and future demand for IG from the clinical perspective. Necessity lies in establishing clinical guidance to address shortages.

Basis for a One Health Approach—Inventory of Routine Data Collections on Zoonotic Diseases in Lower Saxony, Germany

Two-thirds of human infectious diseases are zoonotic diseases and routine data collections exist for each sector (human, veterinary, environmental). However, these operate separately and the collected data are not integrated across sectors. Publicly available information on these routine data collections in terms of metadata and the information collected is sparse. The aim was to create an inventory of routine data collections in the Federal State of Lower Saxony, Germany. A systematic screening of existing routine data collections from the human and veterinary sectors on zoonotic infectious diseases was carried out on the basis of expert interviews. A standardised template was used to collect relevant metadata on data collections and pathogens they contain. The template was transferred to Research Electronic Data Capture tools. We recorded metadata for 19 veterinary, 16 human and 2 other data collections, and for 69 different zoonotic pathogens. The frequencies of a selection of metadata were analysed descriptively. The data collections, which served different purposes, differed, e.g., in underlying population and sampling strategy, export format and access to the original data. We identified challenges for integrated analyses of data from different collections, which need to be addressed to develop a One Health monitoring and surveillance system.

Mental Health Effects of the COVID-19 Pandemic on Aging Lesbian, Gay, Bisexual, Transgender, and Queer Populations.

The COVID-19 pandemic affected numerous subpopulations of people in unique ways. This study evaluated the impact of the COVID-19 pandemic on the mental health status of Broward County's aging lesbian, gay, bisexual, transgender, and queer (LGBTQ) seniors and identified strengths, weaknesses, and opportunities for interventions to enhance positive mental health outcomes. The study was performed from April 2021 through July 2021. Online surveys measuring anxiety, depression, social support, and resilience were delivered by email to 47 residents of Wilton Manors, Florida. Study data were collected and collated using research electronic data capture tools with bivariate analysis using the Mann-Whitney test and generalized linear regression. Bivariate analysis showed that males scored significantly higher on the social interactions subscale of the Duke Social Support Index, indicating greater social support, yet there was not a significant difference with sexual orientation or living situation. Multivariate analysis revealed differences for several dependent variables including anxiety and depression reporting being lower in LGBTQ individuals. This study provides important insight into specific mental health challenges faced by Broward County's LGBTQ seniors, which can be applied to other LGBTQ populations across the globe. Using the results, targeted interventions can be developed to help improve mental health outcomes during periods of isolation for all individuals.

Midwives’ perceptions of enablers and barriers to pertussis and influenza vaccination in pregnancy and information sharing

Background: Vaccination in pregnancy against influenza and pertussis protects the pregnant woman/person and their infant against severe disease. Aotearoa New Zealand has a lower uptake of vaccination in pregnancy than some other countries, despite this immunisation being publicly funded. Coverage is also inequitable, with Māori, Pacific people, and people from high deprivation areas less likely to be vaccinated. Many barriers exist to vaccinations in pregnancy, e.g., access barriers and lack of knowledge about vaccination. Discussions about recommended vaccines with healthcare professionals, particularly midwives, may have a positive impact on vaccine decision-making. Aim: This study aimed to investigate midwives’ perceptions of enablers and barriers with discussions about vaccinations in pregnancy, barriers to vaccination in pregnancy, and influences on vaccine decision-making in pregnancy. The study also aimed to gather midwives’ insights into what might improve vaccination uptake. Method: A structured questionnaire was developed containing a mix of closed and open-ended questions. The questionnaire was sent out to 3002 midwives registered in Aotearoa New Zealand in October 2021, using REDCap electronic data capture tools. Simple descriptive statistics were undertaken on the quantitative data. The answers to the open-ended questions were analysed using a direct, qualitative content analysis approach. Findings: Fifty-one midwives’ responses were included in the analysis (1.8% response rate). Almost all reported sufficient knowledge of vaccinations in pregnancy but had varying levels of confidence when discussing them. The most common enablers to conversations were good relationships, easy communication, and having the time and resources available. Respondents perceived that barriers to conversations were negative preconceptions, communication difficulties and lack of time. Lack of awareness, cost to access services and competing priorities for time were also thought to reduce the likelihood of vaccination in pregnancy. To improve vaccine uptake, respondents identified the need for accessible and suitable vaccination venues, appropriate information and the support of all healthcare professionals involved in maternal healthcare. Conclusion: Midwives surveyed understand the importance of vaccination in pregnancy but there may be lack of confidence, time or resources to effectively engage in discussions. A trusting relationship is important but this can be affected by disengagement or late presentation to healthcare services. Resources to counter pre-existing negative ideas and support communication would help midwives to provide useful information about vaccination. Furthermore, respect and cultural understanding of hapū Māori and their needs will positively support their ability to make informed decisions.

Addressing Chronic Anemia in Sickle Cell Disease: Characterizing Erythropoiesis-Stimulating Agent (ESA) Utilization and Practice Patterns Among Providers

Background: Chronic anemia exerts profound impacts on the morbidity, mortality, and quality of life in individuals with sickle cell disease (SCD), but therapeutic options are limited. Erythropoietin-stimulating agents (ESAs) are the standard of care for managing anemia in chronic kidney disease (CKD). However, their utilization in SCD remains ad hoc, with limited literature and no guidelines supporting the use of ESAs in SCD. To address this knowledge gap, we present preliminary findings from a survey designed to evaluate provider practices and identify factors influencing the use of ESAs in SCD. Methods: We conducted a cross-sectional web-based survey from March-July 2023 among providers taking care of patients with SCD in the United States (US) and internationally. Survey items were developed to assess provider demographic characteristics, practice environments, and provider practices around ESA use in SCD. The data was collected and managed using REDCap electronic data capture tools hosted at the University of Pittsburgh. Descriptive statistics were used to report the data. Results: The survey has been completed by 33 providers as of a cut date of July 23, 2023. Most providers were hematologists who practiced in an academic setting (23/33, 69.7%), with an equal gender distribution (Table 1). The number of patients with SCD seen annually varied, with 101-300 patients being the most common cohort size (13/33, 39.4%). In the 12 months prior to survey completion, 15/33 (45.5%) providers treated at least 1 patient with SCD with ESAs, usually outpatient (Table 2). Commonly reported barriers to outpatient ESA therapy included lack of insurance approval/coverage or cost concerns, lack of provider experience, and patient tolerability/adherence or inability to perform self-injections. Fewer respondents reported no barriers to prescribing ESAs in the outpatient setting, compared to in the acute/inpatient setting (18.2% vs. 48.5%). The most commonly reported indications for starting ESAs in the outpatient setting were chronic anemia from end-stage renal disease or CKD, reduction of blood transfusion requirement, and chronic anemia in patients refractory to approved therapies. Less commonly reported indications include severe or symptomatic anemia alone and chronic anemia in the setting of cardiopulmonary disease. Respondents reported several contraindications to starting ESAs, including a history of venous thromboembolism (VTE), malignancy, stroke, coronary artery disease, hypertension, and frequent vaso-occlusive crises. Respondents also expressed concerns about the cost/insurance coverage, efficacy, safety, patient burden, and appropriate dosing of ESAs in patients with SCD. Only 18/33 (54.5%) respondents reported ever treating outpatients with SCD with ESAs; nearly all of them used 1 st generation ESAs, and a majority used 2 nd generation ESAs. For 1 st generation ESAs, the most common starting dose was 3500-7000 units (U) (50-100 U/kg; 22.2%) or 7001-14000 U (101-200 U/kg; 22.2 %). Once weekly was the most common dosing interval (50%), followed by three times a week (TIW; 27.8%) and twice a week (16.7%). The maximum dose used was 56001-70000 U (801-1000 U/kg) TIW. For 2 nd generation ESAs, the most common starting dose was 141-210 mcg (2.1-3.0 mcg/kg) (22.2%), and administration often occurred once every 2 weeks (44.4%) or weekly (27.8%). The maximum dose used was 211-315 mcg (3.1-4.5 mcg/kg) weekly. Outpatient ESAs were most often initiated for hemoglobin (Hb) < 6 g/dL (8/18, 44.4%), and Hb > 9 g/dL was the most common treatment target (6/18, 33.3%). ESAs were often combined with hydroxyurea, voxelotor, and simple transfusions (Table 2). Conclusion: These preliminary survey results show considerable variability in how ESAs are currently being used in people with SCD. These variations in clinical practice highlight both significant ambiguity about what works in this setting and the need for further research into the optimal use of ESAs for the management of chronic anemia in SCD (ongoing clinical trial: ACHiEvE-SCD, NCT05451940). Future directions include evaluating differences in practice patterns among adult vs. pediatric and US-based vs. non-US-based providers.

Understanding inpatient mortality and 30-day mortality at a comprehensive cancer center.

59 Background: Inpatient mortality quality metric for hospital settings. We sought to review instances of inpatient mortality as part of continuing quality improvement (QI) in our pursuit of the Triple Aim of Health care to improve individual and population health, while reducing unnecessary physical harm, psychological harm, and costs. Methods: An interdisciplinary institutional mortality review committee (MRC) was assembled to review all instances of inpatient mortality or 30-day hospital mortality (hospital mortalities). Individual team members reviewed pertinent clinical information, and appropriate instances were discussed during monthly meetings. The purpose is to review the details of the hospitalization and make determinations if any learning opportunities or process improvements were present. Study data were collected and managed using REDCap electronic data capture tools. Approval from the IRB was obtained to conduct this retrospective analysis. Results: Between January 2022 and April 2023, a total of 430 instances of hospital mortalities were identified and reviewed. Of the 421 patients for which data was available, 294 deaths were classified as “Anticipated” while 127 were classified as “Unanticipated”. Out of the 421 patients, 189 (44.9%) were classified as having an improvement opportunity. There was no association between anticipated vs unanticipated death and opportunity for improvement χ2,(1, n=421) =0, p=.998. However, we noted a significant inverse association with prior goals of care conversation and learning opportunity χ2,(3, n=421) =77.2, p<0.001. During the period of this initiative, we have noted an upward trend in the percentage of patients who had a GOC conversation from 83% to 96%. Improvement opportunities and hospital mortalities related to hospital acquired infections, direct surgical complications, and misdiagnosis were rare. Conclusions: Regarding hospital mortality, opportunities for improvement were largely centered around goals of care conversations and advanced care planning. There is a suggestion that MRC may have contributed to the increase in documented Goals of Care conversations. We believe that an MRC can contribute towards a cultural shift to promote Advanced Care Planning. Initiatives to improve goals of care conservations early in a patient’s disease course may have the potential to reduce inpatient mortality and reduce the physical, psychological, and financial toll of disease.

Prevalence of Objective Voice Measurement Use in Laryngology Practices in the United States.

The aim of this study was to assess the prevalence of use of objective voice measurements (OVM), instrumentation, and factors that may impact OVM outcomes, such as setting and implementation to clarify current practice. Doing so should clarify the impact of OVM research on patient care. A 12-question, one-time anonymous survey using the Research Electronic Data Capture tool was distributed during January 2023 to laryngologists in the United States identified through membership in The Voice Foundation (TVF) or previous participation in a TVF symposium. A total of 101 responses to 418 emails yielded a response rate of 24.2%. Seventeen point eight percentage (N=18) were in private practice, 63.4% (N=64) were in academic settings, and 18.8% (N=19) were classified as mixed private and academic. Common OVMs used were fundamental frequency 95.12% (N=78), maximum phonation time 90.24% (N=74), noise-to-harmonic ratio 71.95% (N=59), jitter 71.95% (N=59), and shimmer 70.73% (N=58). Common equipment and software used Pentax Multi-Dimensional Voice Program 42.68% (N=35), Pentax Computerized Speech Lab Model 4500B 37.80% (N=31), and Pentax Visi-Pitch, Model 3950C 23.17% (N=19), PRAAT 21.95% (N=18), OperaVOX 4.88% (N=4), VoceVista 3.66% (N=3). Fifty one point two percentage (N=42) stated that they used OVMs with the majority of their patients, most commonly for the assessment of treatment effectiveness (84.1%, N=69), documentation (78.0%, N=64), research (70.7%, N=58), and/or diagnosis (61.0%, N=50). Ninety point two percentage (N=74) stated that OVMs were used during initial evaluation of patients. This study estimates of the prevalence of OVM use among laryngologists in the United States. There appears to be sufficient consistency among laryngology centers to permit comparison of results between centers, although additional research is needed. Future OVM research should compare measurements and equipment commonly used by laryngologists to define further the generalizability of results.

SAT444 Perceptions Of Endocrine Clinicians On Climate Change And Health

Abstract Disclosure: S. Steinmetz-Wood: None. K. Loomba: None. J. Hitt: None. A. Kennedy: None. M.P. Gilbert: Consulting Fee; Self; Novo Nordisk. K. Barrett: None. Introduction: Effects of climate change and pollution on the endocrine system are increasingly recognized, such as from EDCs, particulate matter, and the impact of malnutrition and unhealthy lifestyle practices. The Endocrine Society set a goal to increase awareness of the impact of climate change on endocrine health. Assessing perspectives is key in building climate change awareness, knowledge, preventative action and advocacy among health professionals. There are no existing surveys evaluating perceptions of endocrine clinicians on climate change. We aimed to 1) evaluate climate change awareness/knowledge among endocrine clinicians, 2) evaluate the motivation of endocrine clinicians to incorporate climate change concepts into practice, and 3) demonstrate the need for climate change curricula in endocrine training. Methods: We designed an online questionnaire including questions from existing surveys to healthcare professionals about climate change and endocrine-specific questions. The survey was shared to the endocrine community through social media and email. Study data were collected 9/20/2022 - 11/06/2022 and managed using REDCap electronic data capture tools. Results: There were a total of 164 responses; 98% were physicians, of which 31% were program directors (PD) and 28.66% were fellows. The median age was 41 and 91% are employed in the US. The majority (95%) think that climate change is happening, and 52% are very worried about climate change. Responses were variable regarding knowledge level on climate change and health (6.7% very, 40% moderately, 35% modestly, and 17.7% not at all) and concern of effects on patient health (12.8% a great deal, 36% a moderate amount, 26% only a little, 8% not at all, 17% don’t know). The top 3 endocrine climate-health concerns were reduced exercise from motorized transport, malnutrition from food prices, and disruptions to healthcare services during weather events. The majority of respondents agree teaching about climate change and health impacts should be integrated into medical education (72.8% strongly agree or agree) and 82.7% of the PDs and fellows indicated their program does not cover this topic. The majority feel motivated to take action in their personal or professional life for climate change (68.88% strongly agree or agree). The 3 resources perceived most helpful were CME, patient education materials, and policy statements. Conclusion: The majority of endocrine clinicians surveyed are aware and worried about climate change, with varying levels of knowledge and concern about climate change and its health effects. Most respondents agree teaching about climate change and health effects should be integrated into medical education and most feel motivated to take action in some way for climate change. The results also reflect an untapped interest for a curriculum on climate change and endocrine health in fellowship programs and in CME. Presentation: Saturday, June 17, 2023

A prospective preconception cohort study of the association between Mycoplasma genitalium and fecundability in Kenyan women trying to conceive.

Is Mycoplasma genitalium-infection associated with reduced fecundability? Preconception M. genitalium-infection was associated with 27% lower fecundability though confidence intervals were wide, and the association between M. genitalium and fecundability may be dependent on concurrent bacterial vaginosis (BV). M. genitalium has been associated with cervicitis, pelvic inflammatory disease, infertility, and preterm birth, but the extent to which M. genitalium is causally related to adverse reproductive sequelae in women is debated. Kenyan women enrolled in a prospective preconception cohort provided vaginal fluid specimens and underwent monthly pregnancy testing. Stored samples from 407 women who had been trying to conceive for ≤6 months were tested for M. genitalium using a nucleic acid amplification test. Data on first day of last menstrual period, sexual behavior, pregnancy status, and vaginal specimens were collected at monthly preconception visits. The association between M. genitalium detected at the visit prior to each pregnancy test and fecundability was estimated using discrete time proportional probabilities models. Secondary analyses explored the influence of concurrent BV on the association between M. genitalium and fecundability. The 407 participants experienced 1220 menstrual cycles and 213 pregnancies. The prevalence of M. genitalium at enrollment was 7.7%. After adjustment for age, frequency of condomless sex in the last 4 weeks, and study site, M. genitalium was associated with a 27% lower fecundability, but confidence intervals were wide (adjusted fecundability ratio (aFR) 0.73, 95% CI 0.44, 1.23). In secondary analyses, when compared to cycles without M. genitalium or BV at the visit prior, women with both M. genitalium and BV at the visit prior had a 51% lower fecundability (aFR = 0.49, 95% CI 0.22, 1.09) whereas there was no association of M. genitalium alone (aFR = 0.98 (95% CI 0.54, 1.76)), and a smaller reduction in fecundability for women with BV only (aFR = 0.80 (95% CI 0.60, 1.07)). Results should be interpreted cautiously given the relatively low prevalence of M. genitalium and wide confidence intervals. In this cohort of Kenyan women trying to conceive, the association between M. genitalium and fecundability was influenced by concurrent BV status, suggesting there may be a synergistic effect of M. genitalium and BV on fecundability. This work was supported by a National Institutes of Health grant (NICHD R01 HD087346-RSM). R.S.M. received additional support for mentoring (NICHD K24 HD88229). E.M.L. was supported by pre- and post-doctoral fellowships (NIAID T32 AI07140, NICHD F32 HD100202). Data collection and management were completed using REDCap electronic data capture tools hosted at the University of Washington's Institute of Translational Health Science supported by grants from NCATS/NIH (UL1 TR002319). The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. R.S.M. receives research funding, paid to the University of Washington, from Hologic Corporation and consulting fees from Lupin Pharmaceuticals. L.E.M. receives research funding and material for research studies, paid to the University of Washington, from Hologic Corporation and Nabriva Therapeutics, travel support from Hologic, and consulting fees from Health Advances. E.M.L.'s contributions to this study primarily occurred while affiliated with the University of Washington; at the time of submission, E.M.L. was an employee of and holds stock or stock grants for AbbVie, Inc. The other authors have no conflicts of interest. N/A.

Already current practice? A snapshot survey on doxycycline use for prevention of sexually transmitted infections in parts of the German MSM community

PurposeRecent studies point toward a potential benefit of doxycycline use for post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) to prevent sexually transmitted infections (STIs). Although prescribing doxycycline in a prophylactic intention is not generally recommended yet, we noticed an increasing number of inquiries from individuals within the LGBTQ community for doxycycline prescriptions.MethodsWe conducted an anonymous online survey to evaluate the current extent of doxycycline use for PEP or PrEP within the LGBTQ community using REDCap electronic data capture tools. Participants gained access to the online survey through a QR code on posters in the premises of our STI outpatient department and at LGBTQ community-related events in the south-western region of Germany. Additional access was provided by a direct link shared on social media profiles for men having sex with men (MSM), transgender, and queers.Results96 of 99 responses were eligible for analysis. Twenty-two participants (23%) indicated to have already used doxycycline for PEP and six participants (6%) used doxycycline for PrEP. The majority of participants used pills left over from previous doxycycline treatment. Forty percent of indicated modes of access were without a regular prescription, e.g., by provision from acquaintances (with or without healthcare profession) or by ordering online.ConclusionOur study shows that the concept of doxycycline use for prevention of STIs is already well known and applied in the LGBTQ community. Further analysis, especially modeling studies, are needed to evaluate strategies aiming to reduce doxycycline intake (PEP/PrEP versus repeated targeted therapies) and improve sexual health outcomes within the community.

2065. Increasing the HIV screening rates in Rural Syringes Service Programs

Abstract Background The Kentucky Income Reinvestment Program (KIRP) is a statewide reinvestment of income generated by the Ryan White HIV/AIDS Program (RWHAP) Kentucky AIDS Drug Assistance Program, which provides comprehensive early intervention services targeting those at the highest risk for HIV infection. The objective of this study was to compare the HIV screening rates in persons who inject drugs (PWID) at Syringe Service Programs (SSP) supported by KIRP versus SSPs not supported by KIRP in Kentucky Methods A cross-sectional study was conducted on 54 SSPs. We compared the HIV screening rates in the first quarter of 2020, 2021, and 2022. Fisher's exact test compared the HIV screening rates between the KIRP supported SSPs (KSSP) versus Non-KIRP supported SSPs (NKSSP). Study data were collected and managed using REDCap electronic data capture tools hosted at Kentucky Department for Public Health. The statistical analyses were performed with Stata 17 (College Station, TX: Stata Corp LLC). Results The analysis included data of 21,072 PWID who attended the SSPs utilizing the REDCap electronic data capture tool during the study timeframe. In the first quarter of 2022, a total of 1,607/4795 (33.5%) PWID were screened for HIV at KSSP vs 12/482 (2.5%) at NKSSP (p=< 0.001). The difference in the screening rates has increased over the years since the KIRP began in 2019 (Figure 1). Conclusion The HIV screening rate in PWID has increased significantly in the SSPs supported by KIRP through RWHAP program income early intervention funds. This increase has occurred mainly in rural counties where people who inject drugs remain a significant population at risk for new HIV infections. Disclosures All Authors: No reported disclosures.

1246. Prevalence of Hepatitis C Antibodies (Ab) in people at risk for HIV infection in Kentucky

Abstract Background The Kentucky Income Reinvestment Program (KIRP) provides comprehensive early intervention services targeting those at the highest risk for HIV infection. The objective of this study was to evaluate the prevalence of Hepatitis C Antibodies (HCV Ab) in people at risk for HIV infections in Kentucky. Methods A cross-sectional study was conducted using the KIRP Outreach database, including data from people at risk for HIV infections from January 2021 to March 2022. A screening tool was used to identify the people at risk. A Point-of-Care rapid test was used for the detection of HCV Ab. We compared the frequency of HCV Ab in People who inject drugs (PWID) versus people who denied the use of injected drugs. Study data were collected and managed using REDCap electronic data capture tools hosted at the University of Kentucky. Logistic Regression was performed, and the OR was reported. The statistical analyses were performed with Stata 17 (College Station, TX: Stata Corp LLC). Results The analysis included data of 8,225 people tested for Hepatitis C concomitant to screening for HIV; of them, 4,203 (51.1%) were female, and the median age was 41 years old (Range: 17 – 76). No previous test for HCV Ab detection was reported in 3,966 (48.2%). A total of 1,180 (14.3%) tests were positive. HIV infection was detected in 14 (0.2%) people; of them 3 (21.5%) were in people with detectable HCV Ab. The prevalence of HCV Ab in PWID was 36.6%, and the prevalence in people who denied the use of injected drugs was 5.0% (p< 0.001). Most people with detectable HCV Ab (68.0%) were younger than 45. After being adjusted by age, HCV Ab was strongly associated with PWID (OR: 9.3; 95% CI 7.9 – 11.0; p< 0.001). Conclusion The prevalence of the Hepatitis C virus in Kentucky remains higher, mainly in PWID; it was not associated with age. HCV/HIV Coinfection was identified in more than 20% of the Clients. Efforts to continue screening both HIV and HCV infections in PWID are necessary. Disclosures All Authors: No reported disclosures.

Does Fitzpatrick Score Predict Flap Loss? Microsurgical Breast Reconstruction Outcomes of Varying Skin Color.

This is a retrospective study conducted on patients who underwent any type of autologous flap breast reconstruction performed by the two senior authors at an academic center between January 2010 and December 2021. The sole primary outcome variable was flap loss. Patient skin tone was assessed using the Fitzpatrick scale on clinical photographs of patients. A total of 1115 pateints underwent autologous flap breast reconstruction, of which only 56 met both exclusion and inclusion criteria with 58 individual breasts being included in the final study population. The most common race of subjects was White (n = 33; 56.9%) while the most common Fitzpatrick score skin tone was type II (n = 22; 37.9%). The Cochran-Armitage test of trend showed a statistically significant linear trend, P = 0.006, with darker Fitzpatrick score skin tones associated with a higher proportion of flap loss in patients who had vascular compromise. A logistic regression showed that none of the predictor variables were significant. Patients with darker Fitzpatrick skin tones were associated with flap loss after vascular compromise. To prevent flap loss in patients who have darker Fitzpatrick score skin tones, more aggressive flap monitoring should be taken into consideration in the immediate postoperative setting.

Collaborating toward equity in Pennsylvania: The Age-Friendly Care, PA project.

To collaboratively implement the age-friendly health systems framework, known as the 4Ms: What Matters, Medication, Mentation, and Mobility, at The Primary Health Network (PHN), a federally qualified health center. Data were collected from PHN electronic medical records (EMRs) for individuals over age 65 from December 30, 2019 to December 24, 2021 and from Project ECHO© attendance and evaluation surveys. The telementoring educational program, Project ECHO©, was used to engage PHN health care professionals working in rural areas of Pennsylvania to incorporate the 4Ms into their practice starting with the annual wellness visit (AWV). Project ECHO© was launched at three primary care sites. After 18 months, it was then disseminated to an additional 18 sites creating pilot and comparison groups. Outcomes included codesigned patient process metrics using EMR data and project ECHO© participant data. EMR data were generated by system reports created by PHN's quality assurance program manager. Project ECHO© data were collected and managed using REDCap electronic data capture tools. Outcomes were aggregated, analyzed for trends over time, and compared between groups. All nine process outcomes increased from baseline to follow-up at the three initial sites, ranging from 4% to 43% g. At year two, the three initial sites had higher rates on AWVs (pilot 24%, comparison 12%; p < 0.0001), Advance Care Planning (New on file, pilot 8%, comparison 2%; Discussed with patient, pilot 18%, comparison 13%; Patient declined, pilot 0%, comparison 0%; p=0.0001), Dementia Screening (pilot 24%, comparison 12%; p < 0.0001), Fall Risk Management (pilot 43%, comparison 10%; p < 0.0001), and Mobility Goal (pilot 19%, comparison 9%; p < 0.0001); and lower rates on High-Risk Medication Elimination (pilot 54%, comparison, 63%, p < 0.02). Access to high-quality geriatric care for rural older adults can be improved by increasing health care professionals' knowledge of the 4Ms, beginning with its incorporation into the AWV.

The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases

ObjectiveThe present manuscript aims to describe an international, electronic-based, user-friendly and interoperable patient registry for monogenic autoinflammatory diseases (mAIDs), developed in the contest of the Autoinflammatory Diseases Alliance (AIDA) Network.MethodsThis is an electronic platform, based on the Research Electronic Data Capture (REDCap) tool, used for real-world data collection of demographics, clinical, laboratory, instrumental and socioeconomic data of mAIDs patients. The instrument has flexibility, may change over time based on new scientific acquisitions, and communicate potentially with other similar registries; security, data quality and data governance are corner stones of the platform.ResultsAIDA project will share knowledge and expertise on mAIDs. Since its start, 118 centers from 24 countries and 4 continents have joined the AIDA project. Fifty-nine centers have already obtained the approval from their local Ethics Committees. Currently, the platform counts 337 users (122 Principal Investigators, 210 Site Investigators, 2 Lead Investigators, and 3 data managers). The Registry collects baseline and follow-up data using 3,748 fields organized into 21 instruments, which include demographics, patient history, symptoms, trigger/risk factors, therapies, and healthcare information for mAIDs patients.ConclusionsThe AIDA mAIDs Registry, acts both as a research tool for future collaborative real-life studies on mAIDs and as a service to connect all the figures called to participate. On this basis, the registry is expected to play a pivotal role in generating new scientific evidence on this group of rare diseases, substantially improving the management of patients, and optimizing the impact on the healthcare system. NCT 05200715 available at https://clinicaltrials.gov.

Health professional students at the University of Illinois Chicago (HOLISTIC) Cohort Study: A protocol.

ObjectivesThe objectives of the HOLISTIC Cohort Study are to establish a prospective cohort study covering a period of three years that characterizes the health of students within and across health professional education programs at the University of Illinois Chicago (UIC) during the coronavirus disease 2019 (COVID-19) pandemic, implement an interprofessional student research team, and generate a meaningful dataset that is used to inform initiatives that improve student health. This report describes the protocol of the HOLISTIC Cohort Study, including survey development, recruitment strategy, and data management and analysis.MethodsAn interprofessional student research team has been organized with the goal of providing continuous assessment of study design and implementation across the seven health science colleges (applied health sciences, dentistry, medicine, nursing, pharmacy, public health, and social work) at the University of Illinois Chicago in Chicago, IL. To be eligible to participate in the HOLISTIC Cohort Study, students are required to be 1) age 18 years or older; 2) enrolled full- or part-time in one or more of UIC’s seven health science colleges; and 3) enrolled in a program that prepares its graduates to enter a healthcare profession. The study protocol includes a series of three recruitment waves (Spring 2021 [April 14, 2021, to May 5, 2021; completed], Spring 2022, Spring 2023). In the first recruitment wave, eligible students were sent an invitation via electronic mail (e-mail) to complete an online survey. The online survey was based on the U.S. Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System 2019 survey and the 2014 World Health Organization Report of the Strategic Advisory Group of Experts Working Group Vaccine Hesitancy Scale. Electronic informed consent and study data are collected and managed using Research Electronic Data Capture (REDCap) tools. This study utilizes convenience sampling from all seven health science colleges at UIC with a target recruitment total of 2,000 participants.Discussion and future directionsA total of 555 students across all seven health science colleges (10.8% of 5,118 students who were invited; 27.6% of target sample size) enrolled in the cohort during the first recruitment wave. The pilot data establishes the feasibility of the study during the COVID-19 pandemic. Adaptations to overcome barriers to study implementation, including the use of remote, rather than in-person, study meetings, staff training, and participant recruitment are discussed. For the second and third waves of recruitment, the student research team will seek institutional review board (IRB) approval to implement additional enrollment strategies that are tailored to each health science college, such as online newsletters, virtual townhalls, flyers on bulletin boards near classrooms tailored to each health science college.

State of use of Electronic Data Capture (EDC) tools in randomized controlled trials in India

ObjectivesElectronic data capture (EDC) tools can improve data quality gathered in clinical trials and may be more cost-effective. However, limited data is available on the adoption of EDC tools in randomized controlled trials (RCT) conducted in India. The objective of the current study was to determine the EDC adoption rate in RCTs in India. MethodsWe invited investigators of registered RCTs in India to an online survey. The questionnaire included questions on the use of EDC and features available. An EDC sophistication level (range 1 - 6) was computed. Respondents were also asked about barriers to the implementation of EDC. The EDC adoption rate (EAR) was defined as the proportion of clinical trials where EDC with a sophistication level of 2 or more was used. Multivariable logistic regression was used to identify factors that predicted EDC adoption. Results321 responses were received for 400 unique trials (participation rate of 21%), with an EAR of 27.5% (95% confidence intervals : 23.4% to 32.1%, n = 110). The number of sites influenced EDC adoption (odds ratio : 1.26, 95% CI : 1.12 - 1.47, p = 0.001) on multivariable analysis. EAR did not increase over time. The key barriers identified for not using an EDC were lack of technical support (170, 63.0%) and software cost (132, 48.9%). ConclusionsThe survey shows a low EAR in randomized trials registered in India. The barriers identified in the survey would need systematic solutions to improve the EAR in the future.

Development and implementation of the AIDA International Registry for patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis syndrome.

ObjectiveAim of this paper is to illustrate the methodology, design, and development of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to patients with the Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome.MethodsThis is a physician-driven, non-population- and electronic-based registry proposed to gather real-world demographics, clinical, laboratory, instrumental and socioeconomic data from PFAPA patients. Data recruitment is realized through the on-line Research Electronic Data Capture (REDCap) tool. This registry is thought to collect standardized information for clinical research leading to solid real-life evidence. The international scope and the flexibility of the registry will facilitate the realization of cutting-edge study projects through the constant updating of variables and the possible merging and transfer of data between current and future PFAPA registries.ResultsA total of 112 centers have already been involved from 23 countries and 4 continents starting from August 24th, 2021, to April 6th, 2022. In total 56/112 have already obtained the formal approval from their local Ethics Committees. The platform counts 321 users (113 principal investigators, 203 site investigators, two lead investigators, and three data managers). The registry collects retrospective and prospective data using 3,856 fields organized into 25 instruments, including PFAPA patient's demographics, medical histories, symptoms, triggers/risk factors, therapies, and impact on the healthcare systems.ConclusionsThe development of the AIDA International Registry for PFAPA patients will enable the on-line collection of standardized data prompting real-life studies through the connection of worldwide groups of physicians and researchers. This project can be found on https://clinicaltrials.gov NCT 05200715.