Scientific Review Committee Research Articles

Predicting the Transition From Depression to Suicidal Ideation Using Facebook Data Among Indian-Bangladeshi Individuals: Protocol for a Cohort Study.

Suicide stands as a global public health concern with a pronounced impact, especially in low- and middle-income countries, where it remains largely unnoticed as a significant health concern, leading to delays in diagnosis and intervention. South Asia, in particular, has seen limited development in this area of research, and applying existing models from other regions is challenging due to cost constraints and the region's distinct linguistics and behavior. Social media analysis, notably on platforms such as Facebook (Meta Platforms Inc), offers the potential for detecting major depressive disorder and aiding individuals at risk of suicidal ideation. This study primarily focuses on India and Bangladesh, both South Asian countries. It aims to construct a predictive model for suicidal ideation by incorporating unique, unexplored features along with masked content from both public and private Facebook profiles. Moreover, the research aims to fill the existing research gap by addressing the distinct challenges posed by South Asia's unique behavioral patterns, socioeconomic conditions, and linguistic nuances. Ultimately, this research strives to enhance suicide prevention efforts in the region by offering a cost-effective solution. This quantitative research study will gather data through a web-based platform. Initially, participants will be asked a few demographic questions and to complete the 9-item Patient Health Questionnaire assessment. Eligible participants who provide consent will receive an email requesting them to upload a ZIP file of their Facebook data. The study will begin by determining whether Facebook is the primary application for the participants based on their active hours and Facebook use duration. Subsequently, the predictive model will incorporate a wide range of previously unexplored variables, including anonymous postings, and textual analysis features, such as captions, biographic information, group membership, preferred pages, interactions with advertisement content, and search history. The model will also analyze the use of emojis and the types of games participants engage with on Facebook. The study obtained approval from the scientific review committee on October 2, 2023, and subsequently received institutional review committee ethical clearance on December 8, 2023. Our system is anticipated to automatically detect posts related to depression by analyzing the text and use pattern of the individual with the best accuracy possible. Ultimately, our research aims to have practical utility in identifying individuals who may be at risk of depression or in need of mental health support. This initiative aims to enhance engagement in suicidal ideation medical care in South Asia to improve health outcomes. It is set to be the first study to consider predicting participants' primary social application use before analyzing their content to forecast behavior and mental states. The study holds the potential to revolutionize strategies and offer insights for scalable, accessible interventions while maintaining quality through comprehensive Facebook feature analysis. DERR1-10.2196/55511.

Abstract C174: Examining cervical cancer screening rates among women living with HIV in Kajiado County, Kenya

Abstract Background: Kenyan women are disproportionately affected by HIV than their male counterparts, with a prevalence 5.5% compared to men whose prevalence is 2.9%. Women living with HIV (WLHIV) are more susceptible to cancer, in particular HPV-related cancers due to their immune-compromised status. In response, Kenyan Health Ministry recommends that women living with HIV (WLWH) be screened for cervical cancer annually by either visual inspection with acetic acid (VIA) or visual inspection with Lugol’s iodine (VILI), cytology and testing for HPV once every two years. Objective: Examining the rate of cervical cancer screening among women living with HIV (WLWH) in Kajiado County in 2022. Methodology: The electronic health information system was used to abstract data for WLWH in Kajiado county with 57 antiretroviral (ART) facilities. However, our analysis accessed data from 38 facilities whose data is captured in the health information system. Authorized health care workers from the County were requested to abstract redacted data from the health information system. No personal identifiers were collected from the system as away of protecting the privacy of individuals and abiding with the Kenya’s data protection law. Authorization to access the county was obtained from the county’s department of health while ethical approval was obtained from Mount Kenya University’s Institutional Scientific and Ethics Review Committee. Results: In 2022, a total of 16,827 people living with HIV were enrolled for care at the 38 ART selected sites. 11,785 (70%) were women with an age range of 15 to 49 years. A total of 3342 WLWH, representing 28.36% of the target population, were screened by using VIA. Of those screened, 3240 (97%) tested negative, 78 (2.3%) had positive results while 24 (0.7%) had suspicious lesions. Conclusion: Our analysis shows low reach of cervical cancer screening with only 28.36% of the targeted women being screened in 2022. The only available testing method (VIA) is less robust as compared to cytology and HPV testing. Thus, cervical cancer screening is underutilized, and importantly the available screening suffers fromWe also found a gap in reporting of HPV testing in the county. We thus recommend implementation science with community engagement examining the barriers to cervical cancer screening and HPV testing as well as timely reporting from multistakeholder e.g., system, provider, patient, family and advocate perspectives. This multisectoral health system-services approach will better inform research, practice and policy for effective HPV-related cancer prevention and control to reduce cancer-related morbidity and mortality among WLWH,. Citation Format: Caren Kamau, MS, Alice Njoroge,MS, Francis Makokha,PhD, Kimlin Ashing,PhD. Examining cervical cancer screening rates among women living with HIV in Kajiado County, Kenya [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr C174.

Assessment of antimicrobial stewardship programmes and antibiotic use among children admitted to two hospitals in Sierra Leone: a cross-sectional study

IntroductionAntimicrobial resistance (AMR) is a global public health concern and irrational use of antibiotics in hospitals is a key driver of AMR. Even though it is not preventable, antimicrobial stewardship (AMS) programmes will reduce or slow it down. Research evidence from Sierra Leone has demonstrated the high use of antibiotics in hospitals, but no study has assessed hospital AMS programmes and antibiotic use specifically among children. We conducted the first-ever study to assess the AMS programmes and antibiotics use in two tertiary hospitals in Sierra Leone.MethodsThis was a hospital-based cross-sectional survey using the World Health Organization (WHO) point prevalence survey (PPS) methodology. Data was collected from the medical records of eligible patients at the Ola During Children’s Hospital (ODCH) and Makeni Regional Hospital (MRH) using the WHO PPS hospital questionnaire; and required data collection forms. The prescribed antibiotics were classified according to the WHO Access, Watch, and Reserve (AWaRe) classification. Ethics approval was obtained from the Sierra Leone Ethics and Scientific Review Committee. Statistical analysis was conducted using the SPSS version 22.ResultsBoth ODCH and MRH did not have the required AMS infrastructure; policy and practice; and monitoring and feedback mechanisms to ensure rational antibiotic prescribing. Of the 150 patients included in the survey, 116 (77.3%) were admitted at ODCH and 34 (22.7%) to MRH, 77 (51.3%) were males and 73 (48.7%) were females. The mean age was 2 years (SD=3.5). The overall prevalence of antibiotic use was 84.7% (95% CI: 77.9% – 90.0%) and 77 (83.8%) of the children aged less than one year received an antibiotic. The proportion of males that received antibiotics was higher than that of females. Most (58, 47.2 %) of the patients received at least two antibiotics. The top five antibiotics prescribed were gentamycin (100, 27.4%), ceftriaxone (76, 20.3%), ampicillin (71, 19.5%), metronidazole (44, 12.1%), and cefotaxime (31, 8.5%). Community-acquired infections were the primary diagnoses for antibiotic prescription.ConclusionThe non-existence of AMS programmes might have contributed to the high use of antibiotics at ODCH and MRH. This has the potential to increase antibiotic selection pressure and in turn the AMR burden in the country. There is need to establish hospital AMS teams and train health workers on the rational use of antibiotics.

STUDY OF RELATIONSHIP OF DAILY FETAL MOVEMENT COUNT, AMNIOTIC FLUID INDEX, COLOUR DOPPLER WITH PERINATAL OUTCOME

Background: In 2015 there were 2.6 million stillbirths globally, with more than 7178 deaths a day. Because more than 75% fetal death occur before the onset of labor and IUGR constitutes 5% of perinatal morbidity and mortality, it would be essential to extend the principle of intrapartum fetal heart rate monitoring to the antepartum period in an effort to prevent these fetal deaths and morbidity. Here comes the importance of Antepartum Fetal Surveillance (AFS). Antepartum Fetal Surveillance (AFS) is the assessment of fetal wellbeing in utero before the onset of labour. The main aim of antepartum fetal surveillance is to reduce perinatal mortality and morbidity and to avoid fetal death. Methods It is Prospective study conducted in Department of Obstetrics and Gynaecology, M.G.M. Medical College and M.Y. Hospital, Indore (M.P.) during the period from April 2015 to March 2016. The study has been started after the approval of topic by ethical and scientific review committee of MGM MEDICAL College, Indore. Results All the three seen to have significant correlation with perinatal outcome. Conclusion: In our study, all the three indices when abnormal were significantly associated with poor perinatal outcome. DFMC seen to be highly sensitive with more than half of the still births reporting with chief complaint of loss of fetal movements. So it can be considered as the earliest marker of fetal wellbeing with Color Doppler being highly specific predictor for early detection of IUGR.

Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria

BackgroundHigh-quality contraceptive counselling can accelerate global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of interventions designed to...

Abstract PO3-02-02: A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study

Abstract TIPS SABCS 2023 A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study Background: Clinical trials have been an invaluable tool in providing improvements in the discovery, treatment, and quality of life for various diseases and disorders including breast cancer, which impacts millions of people each year. The MammaPrint 70-gene assay along with BluePrint 80-gene subtype analysis are tools to provide such improvements in treatment planning. Historically, patient trial populations have not been racially diverse. Current efforts are focused on improving diversity and inclusion to promote efficacy and health equity across all races/ethnicities. Given recent publications supporting the ability of MammaPrint and BluePrint to identify genomic differences in outcomes of black women with breast cancer, the ongoing multi-center FLEX trial (NCT03053193) has proven to be an unparalleled source for improvement in breast cancer care. With a target of 30,000 enrolled patients, the collaborative research network within FLEX will use MammaPrint, BluePrint, full transcriptome, and clinical data to explore clinical and genomic differences in (sub)populations of interest to promote and advance precision medicine for patients with early-stage breast cancer. Methods: FLEX is the first of its kind to link clinical data with full transcriptome data. It is a prospective, observational trial that enrolls patients who are ≥ 18 years old with histologically proven stage I-III breast cancer with up to 3 positive lymph nodes. Patient eligibility for study enrollment include standard of care MammaPrint testing with or without BluePrint and consent to clinically annotated full transcriptome data collection. The study’s infrastructure facilitates the generation of hypotheses for targeted sub-studies that are important for breast cancer management. The FLEX network fosters collaboration with 99 active sites, including Canada, Greece, and Israel. All proposed substudies are vetted and approved by both internal and external research and scientific review committees. Since launching in April 2017, 13,547 patients have been enrolled including those who have been historically underrepresented in trials (Black n =1032; Latin n= 373; AAPI n =276), 43 investigator initiated sub-studies have been approved and are in progress on a varied number of approaches like MammaPrint/Blueprint clinical utilities, racial disparities, neoadjuvant treatment planning in ER+, and or HER2+ breast cancer with 31 abstracts accepted in national and international congresses. Five ongoing sub-studies within FLEX address differences in underlying biology and treatment response/management among Black, Latina, and Asian American patients with early-stage breast cancer. These studies provide a broader understanding of how differential gene expression patterns, identified with MammaPrint and BluePrint, are unique to racial/ethnic groups and can impact treatment outcomes. Overall, the FLEX study strives to use MammaPrint, BluePrint, and newly developed immune signature, ImPrint, along with full transcriptome data to improve precision medicine in early-stage breast cancer. Citation Format: JJ Alberty-Oller, Lee Riley, Laila Samiian, Sarah Thayer, Olexiy Aseyev, Karen Tedesco, Victoria Poillucci, William Audeh, Danijela Jelovac, Joyce O'Shaughnessy. A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-02-02.

Exercise oncology clinical trials during treatments: a commentary to address the safety concerns of human subjects regulatory reviewers and committees.

Exercise oncology clinical trials contribute to the advancement of our scientific knowledge and to the safety and care of patients diagnosed with cancer. Nevertheless, regulatory reviewers and committees may not be familiar with the well-documented long-term health benefits and safety of the regular practice of physical activity. Moreover, they may not see how the benefits outweigh the risks in the context where patients diagnosed with cancer are typically seen as vulnerable. Therefore, we would like to provide a purpose-built overview of exercise oncology clinical trials for members involved in institutional review committees, including the Scientific Review Committee (SRC), the Institutional Review Board (IRB), and the Data Safety Monitoring Committee (DSMC) to facilitate a greater understanding of the safety and benefits of physical activity during cancer treatments. Communication is key to improve the success of exercise oncology clinical trials, which are vital for patients diagnosed with cancer.

Assessment and treatment of compulsive sexual behavior disorder: a sexual medicine perspective.

The addition of compulsive sexual behavior disorder (CSBD) into the ICD-11 chapter on mental, behavioral, or neurodevelopmental disorders has greatly stimulated research and controversy around compulsive sexual behavior, or what has been termed "hypersexual disorder," "sexual addiction," "porn addiction," "sexual compulsivity," and "out-of-control sexual behavior." To identify where concerns exist from the perspective of sexual medicine and what can be done to resolve them. A scientific review committee convened by the International Society for Sexual Medicine reviewed pertinent literature and discussed clinical research and experience related to CSBD diagnoses and misdiagnoses, pathologizing nonheteronormative sexual behavior, basic research on potential underlying causes of CSBD, its relationship to paraphilic disorder, and its potential sexual health consequences. The panel used a modified Delphi method to reach consensus on these issues. CSBD was differentiated from other sexual activity on the basis of the ICD-11 diagnostic criteria, and issues regarding sexual medicine and sexual health were identified. Concerns were raised about self-labeling processes, attitudes hostile to sexual pleasure, pathologizing of nonheteronormative sexual behavior and high sexual desire, mixing of normative attitudes with clinical distress, and the belief that masturbation and pornography use represent "unhealthy" sexual behavior. A guide to CSBD case formulation and care/treatment recommendations was proposed. Clinical sexologic and sexual medicine expertise for the diagnosis and treatment of CSBD in the psychiatric-psychotherapeutic context is imperative to differentiate and understand the determinants and impact of CSBD and related "out-of-control sexual behaviors" on mental and sexual well-being, to detect forensically relevant and nonrelevant forms, and to refine best practices in care and treatment. Evidence-based, sexual medicine-informed therapies should be offered to achieve a positive and respectful approach to sexuality and the possibility of having pleasurable and safe sexual experiences.

Abstract 821: Uptake of cervical cancer screening services by women living with HIV in Kajiado County Kenya

Abstract Background: This project is an African Caribbean Cancer Consortium (AC3) facilitated study: Women living with HIV (WLHIV) are more susceptible to cancer due to their immune-compromised status. The Kenya Ministry of Health recommends that women diagnosed with HIV should be screened for cervical cancer annually by either visual inspection with acetic acid (VIA) or visual inspection with Lugol’s iodine (VILI), cytology and testing for HPV once every two years. Objective: We determined the uptake of cervical cancer screening and HPV testing by women living with HIV (WLHIV) in Kajiado County in 2022. Methodology: The electronic health information system was used to abstract data for WLHIV in Kajiado county. Kajiado county has 57 antiretroviral (ART) facilities. However, our analysis accessed data from 38 facilities whose data is captured in the health information system. Authorized health care workers from the county were requested to abstract redacted data from the health information system. No personal identifiers were collected from the system as a means of protecting the privacy of individuals and abiding with the Kenya’s data protection law. Authorization to access the county was obtained from the county’s department of health while ethical approval was obtained from Mount Kenya University’s Institutional Scientific and Ethics Review Committee. Results: A total of 16,827 people living with HIV were enrolled for care at the 38 ART selected sites in 2022. Out on the total population that was enrolled for care, 11,785 (70%) were women with an age range of 15 to 49 years. A total of 3342 WLHIV, representing 28.36% of the target population, were screened by using visual inspection with acetic acid (VIA). Data for other methods of screening and HPV testing was not available in the health information systems. Of those screened, 3240 (97%) tested negative, 78 (2.3%) had positive results while 24 (0.7%) had suspicious lesions. Conclusion: Our analysis shows low uptake of cervical cancer screening services with only 28.36% of the targeted women being screened in 2022. The only available testing method (VIA) is less robust as compared to cytology and HPV testing. We also found a gap in reporting of HPV testing in the county. We thus recommend implementation science research examining the systemic barriers to HPV testing and reporting to better inform best practice HPV-related cancer prevention and control policy and practice to reduce cancer-related morbidity and mortality among WLHIV. Citation Format: Caren Kamau, Alice Njoroge, Francis Makokha, Kimlin T. Ashing. Uptake of cervical cancer screening services by women living with HIV in Kajiado County Kenya [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 821.

Preventive analgesia with oral tramadol and pregabalin for post-operative pain in breast surgical patients

Background & objective: Preventive analgesia is implied before the actual surgical insult occurs and it is aimed to reduce the neuro-humoral changes associated with surgical induced pain. Different methods have been used by the anesthesiologists for this purpose. We studied the effect of pre-emptive oral tramadol 50 mg and pregabalin 100 mg on post-operative pain, the requirement of rescue analgesics and the stay in post-anesthesia care unit (PACU) in breast cancer surgery patients. Methodology: A randomized double blinded, placebo-controlled trial, was conducted in the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore (Pakistan) after ethical approval by the hospital Scientific Review Committee and Institutional Review Board. Atotal of 30 patients, undergoing breast cancer surgery, were enrolled and randomly divided into two groups. Group A (study group) patients were given tramadol 50 mg and pregabalin 100 mg orally, and Group B (control group) received two soda mint tablets orally 30 min prior to induction of anesthesia. Standard monitoring was done and routine general anesthesia was administered with intubation. After recovery, Visual Analog Scale (VAS) scores and time to rescue analgesia, total morphine consumption, were recorded. Data was analyzed using SPSS v.20. P < 0.05 was considered significant. Results: The mean ages in Group A and B were 36.67 ± 9.50 y and 41.80 ± 12.43 y (P = 0.236). The differences in intra-operative morphine and rescue morphine use in both groups were not significant (P = 0.139 and 0.293, The rescue analgesic use and VAS scores in PACU were significantly different in both groups (P = 0.005 and P = 0.022, respectively). Total PACU stay in Group A was 79.33 ± 26.31 min and in Group B was 96.67 ± 34.98 min (P = 0.281). Tramadol use in the ward was not statistically equivalent (P = 0.300). Mean post-operative rescue morphine was 0.2 ± 0.775 mg/kg in control group as compared to placebo group was 1.4 ± 1.682 mg/kg, which was statistically significant (P = 0.02). VAS scores in PACU in both groups showed statistically differences, e.g., 1.33 ± 1.1 vs 2.70 ± 1.60 (P = 0.01). PACU stay time was also higher in the control group. Conclusion: The use of pre-emptive analgesia with oral tramadol 50 mg and pregabalin 100 mg 30 min before the surgery can reduce the requirement of peri operative opioid use, achieve better pain control and early recovery. Abbreviations: BMI- Basal Metabolic Rate; PACU- Post-Anesthesia Care Unit; PONV- Postoperative Nausea and Vomiting; VAS- Visual Analog Scale Key words: Analgesia, Preventive; Cancer Surgery; Opioids; Post-Anesthesia Care Unit; Pregabalin; Tramadol Citation: Usman A, Mehdi SR, Khan AA. Preventive analgesia with oral tramadol and pregabalin for post-operative pain in breast surgical patients. Anaesth. pain intensive care 2024;28(1):81−84; DOI: 10.35975/apic.v28i1.2374 Received: November 17, 2021; Reviewed: September 24, 2022; Accepted: July 06, 2023

Women in Health and their Economic, Equity and Livelihood statuses during Emergency Preparedness and Response (WHEELER) protocol: a mixed methods study in Kenya

IntroductionKenya reported its first COVID-19 case on 13 March 2020. Pandemic-driven health system changes followed and unforeseen societal, economic and health effects reported. This protocol aims to describe the methods...

Learning from experience - Radiology ancillary review of prospective research studies involving imaging

This report describes the operational process of a big academic children's hospital's Radiology Scientific Review Committee, with a focus on its role in integrating radiology services into pediatric clinical research. We define the step-by-step workflow used to assess research proposals involving imaging and share insights from the past three years of data collection. Trends in modalities, radiologist involvement, and interpretation possibilities are outlined in the data. This systematic methodology provides essential resource allocation concepts and promotes high-quality pediatric clinical research.

Protocol in a Day: An Educational Institutional Workshop for Protocol Development

The Protocol-in-a-Day (PIAD) workshop was developed to support junior faculty and residents with clinical trial protocol design, with the main goal of providing initial feedback during development to reduce time for review and approval from institutional oversight committees. Our objectives are to mentor and educate participants and to evaluate the time to institutional approval by oversight committees. PIAD provided concurrent educational feedback on 6 key elements of trial design. These included: (1) regulatory aspects; (2) institutional scientific review committee (SRC) and institutional review board (IRB); (3) clinical research and data coordination (including nursing); (4) statistics; (5) correlatives including imaging, biospecimens, and health services research/patient-reported outcomes; and (6) operations. The average number of days from submission to IRB approval or study activation for PIAD protocols was compared to other protocols submitted between January 2018 - January 2022 within the Division of Radiation Oncology. Participants were also given a 15-question survey to assess their perspective of the impact of the workshop. A total of 25 protocols went through the PIAD workshop between January 2018-January 2022. Of the 25 protocols, 7 (28%) were excluded from this study due to not being submitted possibly after participants benefited from education on the limitations of their design. Eighteen protocols were included in our final analyses. These protocols included phase II (n = 11), phase 1 (n = 5), and phase III (n = 2). At the time of this report, all protocols (n = 18) have received IRB approval and have been activated. Protocol elements that could impact study activation included protocols requiring investigational new drug (IND) approval (n = 8) and multicenter studies (n = 1). Analyzing the time of submission to request for activation showed a decrease in time for protocols that went through PIAD vs those that did not [PIAD protocols, 254 days vs All other protocols, 262 days]. Likewise, those who attended PIAD had a lower average time from submission to IRB Approval [ PIAD protocols, 40 days vs All other protocols, 59 days]. All participants (100%) of the PIAD workshop responded that the educational program "improved the overall quality of the study design." The most commonly cited changes were protocol language (n = 17), statistics (n = 15), consent language (n = 8), and study design (n = 8). Aspects participants identified as the most educational included mentorship from regulatory, clinical research finance, and IRB review. PIAD from participant surveys provided high educational value in the areas of improving trial quality, language and statistical design. When analyzing the average time, from 'submission to IRB initial approval' and 'submission to activation', PIAD protocols had a shorter time for approval, and thus suggests PIAD is effective in improving the overall design of protocols.

E22 Experiences among parents caring for children with juvenile idiopathic arthritis at a tertiary referral hospital in Kenya

Abstract Background Juvenile idiopathic arthritis (JIA) is a highly morbid disease associated with significant rates of preventable permanent damage. The burden and distribution of JIA in African countries vary compared with data across the globe. High-income countries have shown a higher prevalence of JIA compared with low-income countries. Recent studies done in Zambia and Nigeria demonstrated contrasting results in the distributions of the subtypes of JIA within the African continent and those seen in Western countries. Most of these studies were quantitative in nature, looking at health related quality of life within this cohort of patients. Studies done looking at the parental experiences in caring for children for JIA have been reported in high income countries. No studies have been reported within our region to assess the impact of JIA has on parents/guardians caring for children suffering from JIA. Studies from high income countries have shown negative impacts on the social, emotional and financial well-being of guardians caring for children with JIA. We aim to look at impact JIA has on guardians caring for children affected within our context. A few studies in high income countries reported that parental experiences and perceptions play a big role in the long term wellbeing of the child. It still remains unknown the impact JIA might have within our population. Methods This will be a phenomenological type of qualitative study design. 18 potential participants (below 16 years) with a confirmed diagnosis of JIA will be purposively selected from the Kenya pediatric rheumatology registry database (KAPRI). Guardians of patients who meet the inclusion criteria will be scheduled for an introductory meeting on specific days of the week in line with their pediatric rheumatology appointment and in the presence of the primary investigator and the rheumatology consultant. Parental experiences will have been conceptualized using four major indicators: social experience, financial experiences, psychological experience, and medical and treatment-related experiences which impact their overall quality of life. These four concepts have been operationalized using various indicators which were retrieved from literature. The interview guide questionnaire was informed by the conceptual framework which was developed from extensive literature review findings on lived experiences of patients with various health conditions. The concepts in the framework will also serve as the pre-determined themes guiding the deductive thematic data analysis. We shall carry out a deductive thematic data analysis. Hence pre-determined themes extracted from the conceptual framework which was developed from extensive literature review findings on lived experiences of patients will be used in analyzing the data. At the same time, any other new emerging themes will be considered. The transcribed data will be analyzed using the Max for Qualitative Data Analysis (MAXQDA) software program version 2022. Results This project is in its preliminary data collection phase and enrolment of participants is ongoing at the Aga khan University Hospital Nairobi after approval by the Institutional Scientific and Ethical Review Committee (ISERC). Conclusions The results in this study will open avenues for further bigger studies to help promote patient centered care. The results in this study will depict the impact of JIA within our context, as studies done outside of Africa cannot be extrapolated because of the differences in social, economic, and cultural standards and capabilities of practice. Currently, the paucity of data from Africa makes it difficult to predict the burden and impact that JIA pauses on families. This study being a qualitative design, will give an in-depth view on the impact the disease has on the families compared with quantitative studies looking at the quality of life which scarce and despite their values, have limitations such as the inability to include social and cultural aspects and emotional aspects of children's lives and their families and the meaning of life.

Investigational drugs services pharmacists education and workflow structure.

169 Background: Per NIH U.S. National Library of Medicine, 428,103 research studies are registered globally as of September 19th, 2022. Each institution must assess its institutional readiness as the complexity and volume of clinical trial increases. Institutional readiness helps assess the capacity of an institution to adopt new technologies and policies to accept, activate, and adjust research despite the complexity of the clinical trial. Clinical research pharmacists help improve the safety and quality of the research by reviewing the scientific literature and medication-related information to develop protocols and evaluate clinical trial feasibility as part of the scientific review committee while performing supportive pharmaceutical review of the protocol, preparation, storage, dispensing, and consulting clinical coordinators and sponsors on the logistics of the trial. Investigational drug service (IDS) also oversees institutional compliance with Good Clinical Practices (GCPs) and Good Manufacturing Practices (GMPs), FDA regulations, and laws. Lack of training for pharmacists, poor safety and quality control, lack of resources, and unstandardized approach to the management of investigational drug products can lead to discrepancy, delay in care, and ultimately, harm to the patient. This study will address the deficiency of institutional readiness to conduct clinical trials with investigational agents and introduce policies and procedures needed to be followed by pharmacists or pharmacy technicians to conduct research. Methods: To explore the challenges in clinical trials and compare work efficiency, work productivity, and growth in the investigational drug service (IDS) pharmacy. This study is conducted at a single-health system compromised of 7 satellite investigational pharmacy from June 2021 to August 2022. Interventions include Epic/Beacon training, CITI training, annual compounding competencies, protocol and procedure development, and Vestigo implementation. Data for inclusion was identified from (where Dr. Ayoubi got data from) were extracted and analyzed. Results: 71% decrease in # of protocols on the priority list to amend protocols. Informatics pharmacists build 190 protocols in one year. Revenue has doubled in one year. Productivity increased as time to verify is reduced by 9.43 minutes to verify an order and time to dispense is reduced by 31.3 min. Number of clinical trials designated to each pharmacist increased from 3-4 to 20 productions per month. Number of investigational drugs ordered increased by 89 last year. Conclusions: Education and Training remain one of the main set back to clinical trials growth, and proper training and education are the pillars to conducting clinical trials in a safe manner and promote growth.

1162-P: Promoting Career Development of Physicians Engaged in Type 1 Diabetes (T1D) Research—The New DiabDocs Multicenter National K12 Program

Background: Given low rates of physicians entering diabetes research, NIH recently funded a multi-center National K12 “DiabDocs” Program to train and support physician-scientists for productive academic careers in T1D. Specific aims for the program include: 1) Expand the geographical access to diabetes K12 programs in the US, 2) Create a diverse nationwide cohort of promising physician-scientists through shared programmatic training experiences, 3) Develop a national mentor community, 4) Ensure consistency and effectiveness of mentoring, including focused attention on diversity, equity and inclusion. Methods: DiabDocs program administration is comprised of 2 Program Directors, an Executive Leadership Committee, a National Advisory Committee and Scientific Review Committee. Recruitment for the first cohort of program Scholars began in August 2022. Candidates self-nominated with a Letter of Intent (LOI). Eligible Scholars were then invited to submit a full application and attend a program retreat. Of the 12 LOIs received from 12 different institutions, 10 candidates were invited to submit a full application and attend the program retreat. At the retreat, 19 reviewers from 16 different institutions participated in diversity training, conducted interviews, and gathered as a study section to discuss applications. Results: Ultimately 4 scholars were selected: 2 with pediatric endocrinology and 2 with adult endocrinology backgrounds. Three scholars are women, and 1 scholar self-identifies as from a group underrepresented in medicine (25%). The next application cycle is planned for Jan-March 2023. Conclusions: The DiabDocs program will address the critical shortage of trained physician-scientists focused on T1D. We anticipate that the planned program training combined with existing research infrastructures will engage a talented and diverse pool of scholars and accelerate their career trajectories. Disclosure K.D.Dasani: None. L.Dimeglio: Advisory Panel; Merck & Co., Inc., Consultant; Abata Therapeutics, Vertex Pharmaceuticals Incorporated. F.K.Bishop: None. S.Golden: Advisory Panel; Abbott Diabetes, Medtronic. L.M.Laffel: Advisory Panel; Medtronic, Lilly Diabetes, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Roche Diagnostics, Provention Bio, Inc., Consultant; Dexcom, Inc., Janssen Pharmaceuticals, Inc., Medscape. R.G.Mirmira: None. A.Steck: None. W.V.Tamborlane: None. S.M.Willi: Advisory Panel; Boehringer Ingelheim International GmbH, Medtronic. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K12DK133995)

Amref Alternative Rites of Passage (ARP) model for female genital mutilation/cutting, teenage pregnancies, and child, early and forced marriages in Kenya: a stepped-wedge cluster randomised controlled trial protocol

Background The Amref Alternative Rites of Passage (ARP) model was initiated in 2009. To date, about 20,000 girls have been supported by their communities to denounce female genital mutilation/cutting (FGM/C) and graduate into ‘maturity’ through ARP. While this intervention has been implemented for decades, there is limited evidence of its effectiveness in ending FGM/C. In order to ascertain the effectiveness of this intervention, Amref has developed a digital tracking tool to follow up on girls who have and haven’t gone through the ARP. The key research question is: what effect does ARP have on incidences of FGM/C, teenage pregnancy and child, early and forced marriages among adolescent girls and young women? Methods The study will adopt a stepped-wedge cluster randomised controlled trial design to assess the effectiveness of the ARP model on the incidence of FGM/C; teenage pregnancy; child, early and forced marriage; and educational attainment. We selected one cluster in Kajiado County where recent ARPs have been conducted as the intervention site at the beginning of the study and 3 wards/clusters in Narok County as control sites. Approximately 604 girls aged 10-18 years who reside in selected sites/clusters in Kajiado and Narok counties will be recruited and followed up for 3 years post-exposure. Quantitative data analysis will be conducted at bivariate and multivariate levels. Content/thematic analysis approach will be used to analyse qualitative data. Ethics and dissemination The study obtained ethical approval from the Amref Ethics and Scientific Review Committee (AMREF-ESRC P1051-2021). The findings of this study will be shared with local, national and regional stakeholders working in ending FGM/C, teenage pregnancy, and child, early and forced marriages. Registration – Pan-African Clinical Trials Registry (PACTR202208731662190).

FLEX, a real-world evidence full transcriptome study of 30,000 patients with early-stage breast cancer.

TPS621 Background: Clinical trials have been an invaluable tool in providing improvements in the discovery, treatment, and quality of life for various diseases and disorders including breast cancer, which impacts millions of people each year. Historically, patient trial populations have not been racially diverse due to several factors such as bias, healthcare distrust, access, and eligibility criteria. However, current efforts are focused on improving diversity and inclusion to promote efficacy and health equity across all races/ethnicities. The ongoing, multi-center FLEX trial (NCT03053193), which pairs clinical data and full transcriptome expression data, seeks to enroll 30,000 patients to accelerate real world research. Due to the size of the database, it is also expected to capture patients typically underrepresented in clinical trials. Methods: FLEX is the first of its kind, prospective, observational trial that enrolls patients who are ≥ 18 years old with histologically proven stage I-III breast cancer with up to 3 positive lymph nodes. Patient eligibility for study enrollment include standard of care MammaPrint testing with or without BluePrint and consent to clinically annotated full transcriptome data collection. The study infrastructure facilitates the generation of hypotheses for targeted sub-studies. The FLEX network fosters collaboration with 114 sites, including one site in Greece and Israel, encouraging participating investigators to initiate sub-studies that can address research questions that are important for breast cancer management. All proposed sub-studies are vetted and approved by Research and Scientific Review Committees. Since launching in April 2017, 12,569 patients have been enrolled including those who have been historically underrepresented in trials (African American n= 1025; Latin n= 341; Asian n=156). Forty-two investigator initiated sub-studies have been approved and are in progress, with 40 abstracts accepted in national and international congresses. Five ongoing sub-studies within FLEX address differences in underlying biology and treatment response/management among African American, Latina, and Asian American patients with early-stage breast cancer. These studies provide a broader understanding of how differential gene expression patterns unique to racial/ethnic groups can impact treatment outcomes. With the large FLEX database, enrollment and sub-studies are extended to other racial/ethnic groups that are underrepresented in clinical trials, but not limited to specific groups. Overall, the FLEX study strives to use full transcriptome data to improve precision medicine in early-stage breast cancer. Clinical trial information: NCT03053193 .

A Suicide-Specific Diagnosis – The Case For

A Suicide-Specific Diagnosis – The Case For

Abstract OT2-05-01: FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols

Abstract FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols BACKGROUND: Genomic signatures, such as the 70-gene MammaPrint, provide additional prognostic information for early-stage breast cancer (EBC), such as tumor metastatic potential, and expand the available information clinicians and patients require for shared treatment decision making beyond the standard clinicopathologic factors. EBC tumors are further stratified into clinically actionable subtypes by molecular assays such as the 80-gene molecular profiling assay BluePrint, improving pathological complete response rates (pCR) and outcomes as evidenced by a number of recent trials. The ongoing FLEX Study (NCT03053193) is designed to expand the genomic information available for EBC cases, and to increase the speed of data generation for rare and underserved research areas. To date, FLEX is the largest international multicenter real-world evidence (RWE) EBC registry, with more than 10,000 patients enrolled in fewer than five years since opening. FLEX pairs full genome data with more than 800 clinical data points collected over 10 years of follow up to provide the most comprehensive big data database available for early-stage breast cancer. The FLEX enrollment has a goal of a minimum of 30,000 patients within 10 years. METHODS: The FLEX study is a multicenter, prospective, observational trial for patients ≥18 years old with histologically proven stage I-III invasive breast cancer that is node negative or positive (up to three nodes) who receive MammaPrint, with or without BluePrint as standard of care management. Patients consent to the collection of clinically annotated full transcriptome data. Additionally, this study protocol allows physicians to investigate targeted populations or clinical trial investigator-initiated studies (IIS) upon approval by a peer-driven Scientific Review Committee. As patients enrolled in the FLEX study meet all eligibility criteria for inclusion no additional consent is required. The FLEX enrollment has already surpassed 1/3 of set target goal. As of April 2022, the trial has surpassed 10,000 patients enrolled at nearly 100 trial sites across the US and Europe, Middle East and Africa (EMEA). To date, there have been 36 publications in international scientific congresses with 39 FLEX IIS and in progress. With over 250 active and collaborating physicians leveraging the shared infrastructure, the IIS have enabled the ability to address disparities in treatment to underrepresented populations, rare subtypes, age, and patient centered specific topics. Current and future questions investigated via this platform will continue to strive to improve outcomes for early-stage breast cancer patients. Citation Format: Alejandra Perez, Hannah Linden, Nathalie Johnson, Sami Diab, Chirag Jani, Chelsea D. Gawryletz, Richard Fine, Laura Lawson, Megan Baker, Victoria Poillucci, Lisa E. Blumencranz, William Audeh. FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-05-01.