Research Coordinators Research Articles

간호대학생을 위한 팀프로젝트기반 임상시험연구 교육의 효과

Objectives Project-based learning engages students in practical activities related to course contents and has been demonstrated to improve academic performance. Nurses play a particularly important role in promoting clinical trial research as a new professional workforce. An entry-leveled educational course was developed to learn the future professional workforce roles in clinical trial research for nursing students. This study evaluated the effectiveness of a clinical trial research course on the importance and performance of the clinical research coordinators' role, students' recognized achievement, and cooperative self-efficacy.
 Methods Five professional clinical coordinators and two nursing professors developed the four projects on the clinical research processes and roles based on Good Clinical Practice guidelines. Thirteen junior students divided into 4 small groups completed a new project-based clinical research course composed of 8 sessions of clinical field work, discussion, reflection, portfolio, and presentation from September to October 2022. Students responded questionnaires on the importance-performance clinical trial nurses' roles, recognized achievement, and cooperative self-efficacy, and reported the reflective journal on the class. The students' class evaluation data was retrieved and analyzed using importance-performance analysis (IPA) and Wilcoxon signed rank test.
 Results Compared to baseline scores, protocol assessment (z=-2.59, p=.010), protocol planning (z=-1.96, p=.050), and subject recruitment (z=-2.16, p=.031) increased among the 8-section of clinical trial coordinator's roles. Additionally professional role recognition increased after the class (z=-2.25, p=.025). IPA analysis exhibited that nursing students recognized the 8-section clinical trial nurses' roles as more important and more performing. The mean score of nursing students' recognized achievement was high (4.96 points out of 5 points), and cooperative self-efficacy was high (4.37 points out of 5 points) after completing a clinical trial research course.
 Conclusions An entry-leveled educational course on the clinical trial research using project-based learning may expand the possibility of a new professional career for nursing students.

Use of an Advance Chart Preparation Process Improves Overall Care in Pediatric Patients with Sickle Cell Disease

Background: Clinics have mostly used pre-clinic chart reviews to increase efficiency of patient appointments and typically only include the provider the day the patient is seen in the clinic. Additionally, these pre-clinic chart reviews tend to focus only on the biomedical needs of the patients and do not often account for the patients' needs relating to social determinants of health (SDoH). Objective: To improve clinical care consistent with national guidelines and enhance comprehensive care coordination for patients with sickle cell disease (SCD) through an advanced chart preparation process incorporating multi-disciplinary team members (Community Health Worker, Research Coordinators, Nurses, and Medical Providers). Methods: Scheduled chart-prep meetings (CPMs) are held approximately 2 weeks before SCD clinic, and are routinely attended by the SCD team spanning multiple disciplines: community health worker (CHW), research coordinators (RC), nurses, and providers. If additional personnel, such as palliative care, counseling, exercise physiology, dietitian, etc., are needed for CPMs, they are invited in advance to the meeting. In preparation for the CPM, a nurse care coordinator conducts a chart review of each scheduled patient to complete a standardized guided chart prep sheet (Fig. 1). During CPMs, the chart prep sheet is used to discuss each patient to ensure all standard of care guidelines are met along with quality improvement objectives. The guided sheet also addresses personalized medical needs for the individual patient, social needs, school/career plans, transition, subspecialty referrals, and screening for eligibility to participate in open QI and research projects. The CPMs assure optimal completion of the following pre-appointment activities: (1) order placement, (2) acquiring external patient data relevant to the upcoming visit, (3) coordinating other same-day testing/appointments, and (4) accommodating social needs (i.e., transportation). After closing any care gaps, the CPM sheet is incorporated into the clinic appointment flow for brief provider review immediately prior to seeing the patient and to assure completion of all needed assessments. Results: CPMs have improved a variety of patient care metrics, making patient appointments more efficient, comprehensive, and patient-focused, and improving pre and post-appointment coordination of care. The advanced chart preparation process increases efficiency for patients, families, and providers. One example has been the increase of annual TCD completion rates from 50% to 93%, largely accomplished by coordinating TCD and clinic appointments, especially for patients living hours from the clinic. Combining other services and appointments on the same appointment day minimizes transportation needs and maximizes completed referral appointments. Incorporating a patient immunization database into CPMs has improved immunization completion rates significantly, more than doubling the rates for some (Men A from 11% to 93%, Men B from 15% to 83%) (Fig. 2). Overall, the CPMs: 1) maximize quality time with patients, 2) assure discussion of non-medical (interpersonal, school, etc.) issues, 3) encourage patient and family medical education opportunities, 4) emphasize attention to each patient's individual SDoH needs, 5) increase successful care coordination, 6) enhance collaboration among members of the SCD care team, 7) provide ongoing focus on QI initiatives, and 8) facilitate patient enrollment in open clinical studies and research trials. Conclusions: Our multidisciplinary SCD care team found that CPMs result in more efficient, effective, and comprehensive patient- and family-centered care while promoting care collaboration by team members. They promoted adherence to guidelines, as evidenced by significant increases in TCD (up 43%) and immunization rates (average improvement 36%, with biggest improvements 82% and 68%, shown above). In addition, the time put into appointment preparation has allowed us to use more clinic time to develop trusting relationships with the patients and families we serve. Furthermore, this process has facilitated patient participation in QI efforts, new databases, and clinical trials. Such chart prep meetings are easily adaptable to a variety of clinical care teams and health delivery settings.

Establishing a Sociodemographic Data Banking Study in Patients with Hematologic Disorders - a Feasibility Assessment

Introduction Social determinants of health (SDOH) play a critical role in patient-related health outcomes. Several small-scale studies among patients with sickle cell disease have demonstrated an association between adverse SDOH and inferior health outcomes-with subsequent calls for SDOH-targeted interventions to improve outcomes. Few studies have investigated the impact of SDOH in other hematologic disorders. Systematic collection of modifiable SDOH data (e.g. transportation, food, utility, and housing insecurity) among patients with non-malignant hematologic disorders is essential to identify populations at risk for disparate outcomes and concurrently inform the design of interventions to mitigate health inequities. Objective To determine the feasibility of establishing a clinically annotated sociodemographic data banking protocol for patients establishing care in the hematology clinic of a tertiary academic pediatric center in the United States. Methods A single-center, prospective, sociodemographic banking study at Dana-Farber / Boston Children's Cancer and Blood Disorders Center opened to accrual in non-malignant hematology in October 2022. Subjects <18 years old within 6 months of a new non-malignant hematologic diagnosis establishing care within the outpatient hematology clinic were considered eligible for the study. The research team (a physician, a research coordinator, and an intern) screened weekly hematology clinic lists to identify eligible patients beginning first with a single disease group (sickle cell disease) and subsequently expanding to include other disease groups (immune thrombocytopenia, thrombosis, iron deficiency anemia) as study support allowed. Patients were approached sequentially, in-person while at a scheduled clinic visit. Parents who consented to the study completed a single time-point survey at study enrollment asking questions about their home environment. Paper/pencil or REDCap surveys available in English and Spanish were self-completed or read aloud by study personnel in any language with an appropriate interpreter. At the time of consent, parents/guardians signed a HIPAA release allowing the study team to track the course of disease-targeted therapy received and associated treatment responses. Survey domains include demographics, household material hardship, household income, social support, resilience, anxiety/depression, and experiences of discrimination. Data were banked for future research studies with appropriate IRB approval. Results A total of 65 eligible patients with a new hematologic diagnosis of sickle cell disease, immune thrombocytopenia, thrombosis, or iron deficiency anemia were approached and offered an opportunity to participate, with 43 (66%) consenting to participation. Among the 22 who declined participation, 10 (46%) declined contact with all research study teams, 6 (27%) transferred care to a satellite clinic, and 6 (27%) declined participation following study introduction. Among consenting participants, 31 (72%) have completed the baseline survey, including n=28 in English and n=3 in Spanish. A total of n=9 surveys are pending and n=3 surveys are considered missing (>8 weeks since consent with survey not yet completed) data. Conclusion Systematic collection of SDOH data for research purposes in the context of a sociodemographic data banking study is feasible in a large, tertiary-care outpatient hematology clinic based on high participant willingness to enroll and complete surveys and successful implementation in four hematologic disease groups. This study will expand to include all hematologic disease groups by late 2023. This protocol has already been implemented successfully among pediatric oncology patients with de novo or relapsed/refractory cancers and those receiving cellular therapy, and is being expanded to 2 additional US institutions. Expanding this protocol to other care centers across the United States will provide essential data to advance health equity research in pediatric hematology/oncology.

A rendészettudomány művelésének és fejlesztésének nemzetközi lehetőségei

Aim: This paper, as a kind of simplified follow-up to an earlier study on international law enforcement research cooperation published in the first issue of Belügyi Szemle in 2011, attempts to take stock of the most important institutions that can be identified today for the support of research on law enforcement, albeit only in an exemplary manner.Methodology: Based partly on personal experience, the study describes and illustrates the institutional options available for improving law enforcement. It recalls a working group meeting convened by INTERPOL in 2010 and the main findings of the study that was carried out on that occasion.Findings: In particular, INTERPOL can be a useful catalyst for the coordination of police research and the practical application of scientific results in the fields of criminal law enforcement, criminology and international cooperation in criminal matters. Other voluntary institutions (e.g. AEPC) could provide a regular forum for sharing the results of research in police academics across continental boundaries.Value: The value of the study is to draw attention to the institutions that can be major catalysts for the cultivation and development of police science.

Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial

Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis. This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged ≥18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed. Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0·0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6·1 percentage points [95% CI -16·5 to 4·5]; p=0·22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16·1 percentage points [-37·4 to 7·0]; p=0·17), nor procedure-related adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13·4 percentage points [-30·8 to 5·0]; p=0·14). In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. None.

SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery

BackgroundMood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial.MethodsThis is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not.The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH.DiscussionOur trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.

Abstract 328: Identification of In-Hospital Cardiac Arrest Using Administrative Billing Codes

Introduction: In-hospital cardiac arrest (IHCA) is experienced by approximately 200,000 patients annually in the US. While individual care teams can readily identify IHCA at the bedside, subsequent event identification for research or quality improvement (QI) purposes is challenging and often relies on the use of administrative billing codes. Prior research has shown that the use of administrative codes from International Classification of Diseases-9 (ICD-9) was both insensitive and nonspecific for identification of IHCA events. However, the performance of this approach using updated ICD-10 codes has not been established. Hypothesis: ICD-10 codes can be used to identify IHCAs in a QI database of IHCA events with high sensitivity. Methods: We performed a retrospective cohort study of all adult IHCA patients ( > 18 years old) at the Hospital of the University of Pennsylvania from 06/2018-03/2022. True IHCA events were confirmed by a research coordinator and a physician through detailed encounter-level chart review of clinical records. We searched for four individual ICD-10 diagnostic codes: ICD I46.2 - cardiac arrest due to underlying cardiac condition; ICD I46.8 - cardiac arrest due to other underlying condition; ICD I46.9 - cardiac arrest, unspecified; and ICD I49.01 - ventricular fibrillation. ICD-identified IHCA was defined as the presence of any of these codes from a hospital stay but not present on hospital arrival. Results: Of 466 patients with a confirmed IHCA event contained within the QI database, the median age was 65 (54-73), 43% (199/466) were female, and 69% (323/466) had sustained return of spontaneous circulation (ROSC) at the end of their code. The use of billing codes identified 318 patients as having IHCA, corresponding to a sensitivity of 68%. The most used ICD-10 code in this cohort was ICD I46.9 (141/466, 30%). Conclusions: The use of ICD-10 codes has a low sensitivity for identification of IHCA events. These findings are consistent with previously published work using older ICD iterations and suggests significant limitations with using administrative codes to identify IHCA events. Novel approaches (e.g., natural language processing and machine learning algorithms) to identify IHCA may facilitate more accurate research and QI efforts.

Feasibility of implementing an intervention to reduce burden of adjuvant therapy for older women with low-risk breast cancer.

445 Background: In patients ≥70 with early stage (pT1, c/p N0), hormone-receptor positive/ HER2 negative breast cancer, there is an opportunity to reduce adjuvant treatment burden through short-course radiotherapy (RT) approaches and/or endocrine therapy (ET) monotherapy. However, practices may vary in approach to treatment, necessitating differences in approach to interventions designed to tailor decision-making. Methods: Site needs assessment and semi-structured stakeholder interviews at 6 Minority Underserved NCORP sites was conducted, including 3 radiation oncologists (RO), 2 medical oncologists (MO), 1 research coordinator, and 2 breast surgeons (BS). Participant responses were manually recorded and used to construct structural and workflow maps for the possible patient care pathways across the 6 sites. Baseline information on ET and RT use was collected. A planned multi-level intervention that includes patient questionnaires (including a mortality risk calculator) to inform tailored decision-making, and education on guideline-concordant, lower burden options was introduced and dominant themes for barriers and facilitators of the intervention were abstracted. Results: Patients followed multiple pathways and received care at more than one site. The 6 sites span urban, suburban, and rural areas with variable presence of provider types (RO, MO, BS), research support, and RT technology. At baseline, patient reported data, geriatric assessments, mortality risk calculators, and decision aid tools were not routinely used. About 85% of eligible patients receive both ET and moderately hypofractionated whole breast RT; the only commonly used form of partial breast RT is intra-operative. Themes were physician acceptability of the intervention, multidisciplinary care, and physician willingness to offer lower burden treatment options. Physician acceptability subthemes included high baseline guideline knowledge, interest in mortality risk calculator use, need for support to interpret and incorporate patient questionnaire data, and variable physician research engagement. Multidisciplinary care facilitators were multi-campus tumor boards and strong research support staff; barriers were variable insurance across providers and surgeon-driven care plan expectations. Lower burden care subthemes included support for ET for almost all patients; barriers to RT omission were concern about ET non-adherence and to short-course RT were lack of data and toxicity concerns in patients with larger body habitus/resultant RT dose inhomogeneity. Conclusions: Results demonstrated multiple barriers and facilitators of interventions targeting lower burden treatment options for low-risk early-stage breast cancer and identified physician education about interpretation/use of patient-reported data and mortality risk assessments as key to successful study design.

What about Model Data? Best Practices for Preservation and Replicability

Abstract It has become common for researchers to make their data publicly available to meet the data management and accessibility requirements of funding agencies and scientific publishers. However, many researchers face the challenge of determining what data to preserve and share and where to preserve and share those data. This can be especially challenging for those who run dynamical models, which can produce complex, voluminous data outputs, and have not considered what outputs may need to be preserved and shared as part of the project design. This manuscript presents findings from the NSF EarthCube Research Coordination Network project titled “What About Model Data? Best Practices for Preservation and Replicability” (https://modeldatarcn.github.io/). These findings suggest that if the primary goal of sharing data are to communicate knowledge, most simulation-based research projects only need to preserve and share selected model outputs along with the full simulation experiment workflow. One major result of this project has been the development of a rubric, designed to provide guidance for making decisions on what simulation output needs to be preserved and shared in trusted community repositories to achieve the goal of knowledge communication. This rubric, along with use cases for selected projects, provide scientists with guidance on data accessibility requirements in the planning process of research, allowing for more thoughtful development of data management plans and funding requests. Additionally, this rubric can be referred to by publishers for what is expected in terms of data accessibility for publication.

Pilot implementation study of a default genetic referral process for patients with young-onset colorectal cancer.

429 Background: Young-onset colorectal cancer (yCRC) diagnosed under age 50 is increasing at alarming rates, with >75% of young-onset cases occurring in patients between 40-49 years old. Although national guidelines recommend germline genetic risk evaluations for all patients with yCRC, multiple studies have shown suboptimal rates of guideline-recommended genetic evaluations. Methods: We conducted a pilot implementation study of a default genetic referral process for patients diagnosed with CRC between ages 40-49 from 1/2019-4/2022 at five hospitals in an academic health system. Patients previously referred to genetics were analyzed as a historical comparator cohort. In the intervention cohort, a research coordinator notified patients and their oncologists of their eligibility for a default genetic referral via an electronic patient portal message or telephone call, after which all patients who did not opt out within two weeks were referred for genetic counseling, testing, and result disclosure as per usual care. The primary outcome was feasibility, defined as a ≥60% referral rate; secondary outcomes included the proportion of genetic referrals that were scheduled, completed, and resulted in testing within three months of referral. Semi-structured exit interviews were conducted with a subset of patients and oncologists to assess attitudes toward the default genetic referral process. Results: We identified 128 patients with yCRC; 75 (59%) had previously been referred to genetics and were assigned to the historical cohort. There were no significant differences in sex, race, or ethnicity between the historical and intervention cohorts. All 10 patients with mismatch repair deficient tumors had previously been referred to genetics. Of the 53 patients in the intervention cohort, 49 (92%) were referred to genetics after one oncologist opted out on behalf of an international patient due to financial concerns and three patients requested to discuss with their oncologist before being referred. Of the patients who were referred, 38 (78%) were scheduled, 22 (45%) completed genetic counseling, and 13 (27%) underwent testing within three months of referral. Reasons for failing to complete the germline genetic risk evaluation process included lack of interest, competing priorities, communication/scheduling challenges, and failure to return saliva-based genetic testing kits. In exit interviews with 10 patients who completed testing and 10 oncologists, participants reported finding the default genetic referral process to be acceptable and feasible to implement. Conclusions: A default genetic referral process is feasible and results in a high referral rate for patients with yCRC, but subsequent scheduling, evaluation, and testing rates remain suboptimal. Multilevel implementation strategies are needed to address the patient, clinician, and system barriers identified in this study. Clinical trial information: NCT05018156 .

4.C. Round table: The role of EU bodies and European Health Union policies, and implications for the Pandemic Treaty

Abstract As the CoViD-19 pandemic unfolded, policy- and decision-makers within and beyond European borders became acutely aware of the urgent need to revisit policies and cross-border collaboration to increase preparedness. CoViD-19 lessons, regional autonomy, the way EU bodies functioned at times of crisis but also at times of peace, and EU's role in global health were all considered. In 2022, a new EU body, the Health Emergency Preparedness and Response (HERA) Authority became operational “to prevent, detect, and rapidly respond to health emergencies, through intelligence gathering and building the necessary response capacities.” In March 2022, the Council of the EU adopted the decision to authorise the opening of negotiations for an international agreement on these topics, i.e., ‘The Pandemic Treaty’. Upon ratification, the treaty will become a legally binding instrument to determine coordination of public-private partnerships, towards discovery, and research and development (R&D) for vaccines, diagnostic and medicinal products. Negotiations started in the summer of 2022, with the Intergovernmental Negotiating Body (INB4) drafting the treaty in the WHO framework, the ‘Zero Draft’ presented in Nov 2022, progress to be reported to the World Health Assembly (WHA76) (May 2023), and a final draft agreement to be delivered in May 2024. In March 2023, HERA and the European Centre for Disease Prevention and Control (ECDC), and HERA and the European Medicines Agency (EMA) formalised agreements to clearly delineate working arrangements “to strengthen cooperation and to coordinate their work in support of health emergency preparedness and response in the area of medical countermeasures”. The increasing level of complexity, with rapid policy developments necessitates better understanding of the role of EU bodies and policies play, equipping public health professionals and of the tools to participate in these exchanges at national and cross-border levels, ultimately ensuring public health priorities and interests are served. This RT aims to provide an overview of recent developments for these bodies (HERA, EMA, ECDC), how they interact with WHO, and implications of the recently presented EU Global Health Strategy (EUGHS) (Nov 2022) and EU General Pharmaceutical Legislation (EUGPL) (Apr 2023). Panellists and Chairs include representatives to these bodies and legal experts to help elucidate key aspects. Brief interventions followed by discussion will explore: • The role of EU bodies in relation to the treaty • EU priorities, incl. regional autonomy, and related legislation, i.e., EUGPL and EUGHS • Key treaty articles and implications for European public health and global public health • The relevance of existing instruments, e.g., International Health Regulations, the Nagoya Protocol, the UN Biodiversity Convention • The guiding principles and rights in the Zero Draft Active audience interaction is envisioned via polls to prioritise topics and submit questions. Key messages • The global and European public health landscapes are rapidly being transformed. Comprehensive understanding of bodies and policies at interplay by public health professionals is key. • Current developments involve key deliberation and consultation steps at national, EU-wide and global levels. The public health community must be informed and engaged to safeguard public health. Speakers/Panelists Ricardo Mexia INSA - National Health Institute Doutor Ricardo Jorge, Lisbon, Portugal Debjani Muller HTAi, Edmonton, Canada Sujitha Subramanian UK Dimitra Lingri National Organization for Health Care Services Provision, Athens, Greece

Scholarly Curriculum at a Psychiatry Residency Program in Canada: 10-Year Outcomes.

For research in medicine to address needed interventions and produce outcomes relevant to patient care, it is important for physicians to gain hands-on experience in scientific methods during their training. However, the results of recent studies in the United States and Canada indicate low interest in research among residents. In 2011, involvement in a scholarly activity was made mandatory for all residents joining the Western University psychiatry residency program (WUPRP). A faculty member was appointed as a research coordinator who collaborated with research-intensive faculty members and prepared a list of potential projects suitable for resident involvement; organized monthly research meetings to support residents in initiating scholarly activities, monitor their progress, and address challenges; and developed competency-based research objectives, guidelines, and assessment tool. Data on all residents enrolled at WUPRP from 2011 to 2017 (the latter graduated in 2022 with completed scholarly requirements) were analyzed with respect to residents' participation in a scholarly project. A total of 54 residents were enrolled during this period. Fifty-two (96%) residents were involved in a scholarly project; of these 52, 38 (73%) completed their project. Of these 38, 32 (84%) had academic achievements, which include poster and oral presentations at a conference, publications, and prizes and awards. Of the 52 residents involved in a scholarly project, 14 (27%) residents could not complete their projects, though they still met scholarly activity requirements and 1 (2%) enrolled in the Western University Clinician Investigator Program with the goal of pursuing research as a career. There is a lack of data on how many WUPRP graduates from 2011 to 2017 are currently pursuing careers in research. The authors plan to perform longer and closer follow-up of residents to evaluate whether a scholarly curriculum makes an impact on residents' career choices.

Enabling successful science‐policy knowledge exchange between marine biodiversity research and management: An Australian case study

AbstractKnowledge exchange (KE) between research and decision‐making is increasingly demanded for tackling environmental challenges, yet there is still much to learn about how to enable that effectively. Here, we analyze a distributor of research funding (i.e., the Australian National Environmental Science Program Marine Biodiversity Hub (‘the hub’)) which actively coordinated KE between researchers and state‐ and Commonwealth Government end‐users. Through 30 in‐depth qualitative interviews with researchers, hub executives and end‐users we identify enablers of KE engagement, compare what researchers and decision‐makers found most important, and highlight what research programs and funding organizations can learn from this case study. Through an evolution of programs, the hub had a strong governance structure, co‐identified priority setting, and funding for emerging priorities. Additional enablers were a legacy of longstanding interpersonal working relationships, regular engagement, knowledge brokering roles, and the nationally trusted role of the hub. Researchers more so than end‐users found trust, the focus on clear end‐user needs as well as the hub's governance and progress‐monitoring key to success. End‐users more often indicated the early engagement, collaborative nature, and flexibility to adjust as important assets to effective interaction. Visions for future KE included better engagement of Traditional Owners, streamlining direct access to expertise, more accessible outputs, and earlier involvement of researchers in policy development. In sum, we find that time (e.g., pre‐story, early engagement) and boundary roles (e.g., knowledge brokering individuals, engaged research funders or coordinators) are key to success underlining that there are substantial components to KE success that can be nurtured and planned for.

Updates in SJS/TEN: collaboration, innovation, and community.

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a predominantly drug-induced disease, with a mortality rate of 15-20%, that engages the expertise of multiple disciplines: dermatology, allergy, immunology, clinical pharmacology, burn surgery, ophthalmology, urogynecology, and psychiatry. SJS/TEN has an incidence of 1-5/million persons per year in the United States, with even higher rates globally. One of the challenges of SJS/TEN has been developing the research infrastructure and coordination to answer questions capable of transforming clinical care and leading to improved patient outcomes. SJS/TEN 2021, the third research meeting of its kind, was held as a virtual meeting on August 28-29, 2021. The meeting brought together 428 international scientists, in addition to a community of 140 SJS/TEN survivors and family members. The goal of the meeting was to brainstorm strategies to support the continued growth of an international SJS/TEN research network, bridging science and the community. The community workshop section of the meeting focused on eight primary themes: mental health, eye care, SJS/TEN in children, non-drug induced SJS/TEN, long-term health complications, new advances in mechanisms and basic science, managing long-term scarring, considerations for skin of color, and COVID-19 vaccines. The meeting featured several important updates and identified areas of unmet research and clinical need that will be highlighted in this white paper.

118 Research coordination perceptions of a coached home spirometry protocol: ongoing experiences with the OUTREACH study

118 Research coordination perceptions of a coached home spirometry protocol: ongoing experiences with the OUTREACH study

A Technology-Informed Approach to Clinical Trial Equity

Despite efforts to increase participation of diverse communities in clinical trials, ethnic/racial minorities remain underrepresented. One such determinant may be lack of access to a comprehensive cancer center that conducts clinical research. Historically, our institution has had low accrual from rural regions further away from our cancer center, with Hispanic or Latino (HL) patients (pts) being especially underrepresented in our clinical research. In this study, we explored the impact of a clinical trial that allowed pts to receive chemotherapy (chemo) with their local oncologist. We hypothesize that allowing pts to receive chemo locally will lead to higher rates of enrollment from populations under-represented in clinical trials. We conducted a study for pts with rectal cancer to undergo short-course radiation followed by 4 months of chemo with the option to pursue watch and wait if pts achieve a clinical complete response. Radiation was administered at our institution while pts could receive standard-of-care chemo closer to home with their local oncologist. For pts who received chemo locally, the research coordinator and co-investigators held video visits with the pts prior to each chemo infusion to review adverse events (AE), labs, and chemo dosing. We compared demographic data of pts on this trial with that of pts enrolled across all adult therapeutic oncologic clinical trials over the same time period at our institution. Distance to our institution was calculated based on pts' primary residence zip code. Protocol compliance with AE reporting for pts who received chemo locally was assessed by chart review. Between May 2020 and January 2023, 24/35 enrolled pts completed both radiation and chemo on trial. 13/24 pts (54%) received chemo locally. Of the 24 pts, 16 were White (67%), 7 Asian (29%), 1 Native Hawaiian/ Pacific Islander (4%). Of all enrolled patients, 4 were HL (16.7%), compared to our institutional average of 16.5%. All enrolled HL pts received their chemo locally. The average distance traveled by non-HL pts from their home to our institution was 87.7 miles (range 5.1 - 308). In contrast, HL pts traveled an average of 147.8 miles (range 110 - 249), 68% further than their non-HL counterparts. There was 100% compliance with AE reporting among those pts who received their chemo locally. Although the percentage of HL participation in our study was consistent with our institutional average, all HL pts enrolled on the trial received treatment locally and lived substantially further from our institution than non-HL. By allowing pts to receive this part of treatment locally, we provided pts who live further away an opportunity to engage in clinical research without the associated financial and time toxicities related with traveling for treatment. By decentralizing clinical trials and leveraging telemedicine, we can promote the participation of under-represented groups in clinical trials.

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.

Characteristics of intellectual capital for the research process in some university centers of the colombian Caribbean

The characteristics of the intellectual capital model for the research process in Higher Education institutions of the City of Cartagena are described. Research with a quantitative, positivist, analytical approach, field designs, in a non-experimental, transversal or transactional way, descriptive type. The study population group is made up of vice-rectories of the research area, coordination's, headquarters or leaders of the research area, who are in charge of the management and viability of the research processes in 7 universities of Cartagena de Indias, survey, an instrument was used with alternatives of closed Likert-type answers, the Statistics of the data was Descriptive systematized in Microsoft Excel, SPSS and R.3.2.3. In general, the researchers of the different institutions state that they totally disagree with the fact that the intellectual capital of their institutions presents these characteristics. In general, HEIs do not comply with being an open and flexible model, but it is required to be more systematic, adaptive, dynamic and innovative.

B-138 Skewed Demographics of Patient Population Contributes to Selection Biases in Clinical Study Population

Abstract Background The racial, ethnic and sex compositions of a study population may impact the clinical performance of a biomarker. In a prospective clinical study to evaluate biomarkers for asthmatic and allergic conditions in a large medical center in the upper Midwest, a largely White-alone patient population was encountered. Using several outreach strategies, potential eligible patients were contacted to enroll in a biomarker clinical study and to provide blood specimens. The patient demographics between the eligible candidates and the enrolled participants were compared. The analysis was carried out to understand the likelihood of enrollment in different race, ethnicity, and sex groups; and to identify factors that contribute to selection biases in enrolled cohorts. Methods Patients with eligible asthma and allergic conditions were selected based on relevant diagnostic codes in their electronic medical records, verified by clinical research coordinator. In accordance with Institutional Review Board approval, eligible patients were contacted via their electronic healthcare portal or with a phone call. The study information was also posted in an internal classified ad as an additional outreach strategy. Interested participants were then contacted a second time to complete consent. Upon consent, participants were considered as “enrolled”. Demographics information including sex, race, ethnicity, and age were de-identified for comparison analysis. Results Among all eligible patients, a disproportionally low representation of Blacks, Asians, and Hispanics (“non-White” groups) was observed, relative to regional demographics (22.2% non-White groups, 2021 census) and higher asthma and allergy prevalence in the non-White groups. In eligible adult patients (>18 years old) with asthma, only 13.4% were from non-White racial and ethnic groups. In eligible pediatric asthma patients, a larger proportion at 24.1% were from American Indian, Asian, Black, or Hispanic groups. In patients with allergic conditions, 10.3% of the adult patients were from non-White only groups, compared to 21.9% in pediatric patients. Among all eligible patients, White-alone patients were more likely to enroll in the study compared to their counterparts from non-White groups, further skewing the racial and ethnic distribution in the enrolled cohorts. As a result, less than 10% of enrolled adult patients were from non-White background in both allergy and asthma cohorts. Among the enrolled pediatric asthma and allergy patients, 16.9% and 10.3% respectively were from non-White groups. We also identified sex and age dependent enrollment behavior across different study cohorts. In adult groups, there were more female eligible patients (allergy: 66.7% female; asthma: 66.7% female) than male patients. Female adult patients were significantly more likely to participate, thus constituting 79.6% and 75.8% of the enrolled allergy and asthma cohorts. In the pediatric groups, male patients represented a larger share of eligible patients (allergy: 58.6%; asthma 64.7%). Female pediatric patients were still more likely to participate in the study. Hence, male and female enrolled patients were closer to equal distribution (allergy: 50.0% male; asthma 59.7% male). Conclusion The non-even distribution of demographics in eligible patients contributed to biased distribution in enrolled patients. Existing outreach approaches were not effective in reversing enrollment rates in underrepresented racial and ethnic groups.

Research capacity, motivators and barriers to conducting research among healthcare providers in Tanzania’s public health system: a mixed methods study

BackgroundBuilding health research capacity in low- and middle-income countries is essential to achieving universal access to safe, high-quality healthcare. It can enable healthcare workers to conduct locally relevant research and apply findings to strengthen their health delivery systems. However, lack of funding, experience, know-how, and weak research infrastructures hinders their ability. Understanding research capacity, engagement, and contextual factors that either promote or obstruct research efforts by healthcare workers can inform national strategies aimed at building research capacity.MethodsWe used a convergent mixed-methods study design to understand research capacity and research engagement of healthcare workers in Tanzania’s public health system, including the barriers, motivators, and facilitators to conducting research. Our sample included 462 randomly selected healthcare workers from 45 facilities. We conducted surveys and interviews to capture data in five categories: (1) healthcare workers research capacity; (2) research engagement; (3) barriers, motivators, and facilitators; (4) interest in conducting research; and (5) institutional research capacity. We assessed quantitative and qualitative data using frequency and thematic analysis, respectively; we merged the data to identify recurring and unifying concepts.ResultsRespondents reported low experience and confidence in quantitative (34% and 28.7%, respectively) and qualitative research methods (34.5% and 19.6%, respectively). Less than half (44%) of healthcare workers engaged in research. Engagement in research was positively associated with: working at a District Hospital or above (p = 0.006), having a university degree or more (p = 0.007), and previous research experience (p = 0.001); it was negatively associated with female sex (p = 0.033). Barriers to conducting research included lack of research funding, time, skills, opportunities to practice, and research infrastructure. Motivators and facilitators included a desire to address health problems, professional development, and local and international collaborations. Almost all healthcare workers (92%) indicated interest in building their research capacity.ConclusionIndividual and institutional research capacity and engagement among healthcare workers in Tanzania is low, despite high interest for capacity building. We propose a fourfold pathway for building research capacity in Tanzania through (1) high-quality research training and mentorship; (2) strengthening research infrastructure, funding, and coordination; (3) implementing policies and strategies that stimulate engagement; and (4) strengthening local and international collaborations.