Research Coordinators Research Articles

81 Family Perceptions of TRaC-K (Telehealth Rounding and Consultation for Kids) a Novel Inpatient Tertiary Regional Virtual Health Collaborative

Abstract Background Telehealth Rounding and Consultation for Kids (TRaC-K) is an innovative virtual tertiary-regional collaborative care service for regional pediatric inpatients launched in Southern Alberta in August 2020. TRaC-K uses a mobile audiovisual platform to connect regional and tertiary pediatricians and multidisciplinary clinicians caring for admitted children from Southeastern Alberta. The mobile cart also enables children and families to participate in TRaC-K sessions at the bedside. The TRaC-K model is being evaluated during a 1 year pilot between the Alberta Children’s Hospital (ACH) and the Medicine Hat Regional Hospital (MHRH). Objectives As part of the evaluation of the TRaC-K model, we aimed to explore family perceptions of their experience participating in one or more TRaC-K sessions. Design/Methods Family perceptions of receiving care using the TRaC-K model were explored using qualitative analysis of family interviews. Semi-structured interviews were conducted with consenting families who had participated in one or more TRaC-K sessions while their child was admitted at ACH or MHRH. Interviews were conducted via ZOOM or telephone by a research coordinator experienced in qualitative interviews. A short questionnaire of participant information was completed. A series of questions were asked in addition to clarifying questions. Interviews were recorded, transcribed and the NVivo 12 Pro qualitative data analysis software was used for coding. Inductive thematic analysis was completed by two research team members and three transcriptions were coded by both and compared to ensure alignment in coding methodology. There were 15 transcriptions in total. Themes and subthemes were shared with the research team to validate the assignment of quotes to themes and further organize the themes and subthemes. Results Of the 85 TRaC-K sessions during the one year pilot, 36 sessions included at least one family member participant. Of the family members participating in a TRaC-K session, 15 families completed an interview with contributions from one or more parents/guardians. Thematic analysis identified five themes and several subthemes. Themes included: 1. family centered care, 2. access to care closer to home with a subtheme of ease of transition, 3. enhances quality of care with a subtheme of assessment, 4. communication tool with subthemes of real time, technology, facilitates collaboration and shared decision making, and 5. increases family confidence. Conclusion TRaC-K, a tertiary-regional inpatient virtual health model, was perceived by families to be beneficial to their child’s care and their own experience with inpatient care. Families were able to identify many facets of their experience with this novel model of care. To enhance family centered care for families from outside large urban centers whose children require inpatient admission, virtual health models like TRaC-K that enable tertiary-regional clinician collaboration and family participation should be spread to other pediatric inpatient populations.

An exploration of individual, job, and organizational characteristics associated with district research leaders' knowledge brokering work

The role of district research leaders (DRLs) in central offices has emerged as a strategy for improving the creation, flow, and use of research knowledge in decision-making. However, there is limited information about the responsibilities, opportunities, and challenges inherent in these roles. This exploratory qualitative study features document analysis to examine the individual backgrounds, job demands, and organizational contexts of DRLs. The result of this study suggest that multiple pathways to the DRL role exist, but few include formal training in knowledge brokering. Further findings suggest that DRL jobs are complex and entail diverse tasks, but share a focus on research leadership and coordination, identifying and obtaining relevant research information, and facilitating evidence-informed change. Moreover, organizational contexts varied in supportiveness for knowledge brokering work. Overall, there was limited evidence of alignment across individual, job, and organizational characteristics, signaling an opportunity to better define and support those in DRL roles.

Communication in the research process

Introduction. During the COVID-19 pandemic, our research and development team at the Croatian Academic and Research Network (CARNET) studied the implementation of distance learning, and here we present our methodological approach which is focused on communication supported by digital technologies. Our method combines quantitative and qualitative approach, the first by means of an online questionnaire on a large sample of respondents consisting of 535 principals, 5,619 teachers and 20,717 parents (26,871 in total). The qualitative part was carried out with eleven participants: five teachers, three principals, and three pedagogues, who kept reflective diaries (logs, journals) about what they were doing and why (Turner, 2020) and participated in communities of practice (Wenger, 1998) and individual interviews. The objectives of the qualitative research were to:▸ gain insight into the practices of using technology in distance learning,▸ provide support to teachers, principals, and pedagogues to study their own practice and give recommendations for further possible distance learning.Their testimonies describe each situation without the intervention of external researchers and provide researchers with insight into the actual practices of educators – participants / researchers (Meth, 2003). Communication as a prerequisite and result of a qualitative approach Throughout the writing phase of the research diaries, the coordinator closely collaborated with researchers who shared their experiences via weekly online meetings, e-mail, telephone. We also held 13 focus groups with the researchers. Communication of all involved was a prerequisite but also the result of the research. Due to its importance, we determined a communication strategy and selected the most efficient communication channels in advance, so that they did not require additional mastering of communication tools for video conferencing. Likewise, the pace and time of the meeting was measured so as not to further burden the researchers, who were primarily focused on writing diaries. This qualitative research resulted in more than 220 pages of diary entries and established two communities of practitioners – one consisting of pedagogues and principals and the other of teachers, who were meeting separately every two weeks. In addition, the research included dozens of hours of individual interviews.Conclusion. Qualitative action research is based on communication between researchers, and if it is designed that way, between researchers and the research coordinator. In an online environment, communication needs to be planned and rely on the digital tool that will be used and on the dynamics of interactions.

Job satisfaction and symptoms of depression, anxiety, stress, and burnout: A survey of Australian and New Zealand intensive care research coordinators

IntroductionIntensive care unit clinical research is often implemented by specialised research coordinators (RCs). Clinical research activity within Australian and New Zealand intensive care units has escalated, particularly during the COVID-19 pandemic. Growth of the intensive care RC workforce to match research demand is poorly understood. AimThe aim of this study was to repeat an Intensive Care Research Coordinator Interest Group workforce survey conducted in 2004 and 2009 to describe the current workforce and role satisfaction and also to determine reported symptoms of depression, anxiety, stress, and burnout in Australian and New Zealand intensive care RCs. MethodsIn April 2021, an online anonymised survey was distributed to intensive care RCs to complete demographic and workforce questions, the McCloskey/Mueller Satisfaction Scale, the Depression Anxiety Stress Scales-21, and the Maslach Burnout Inventory–Human Services Survey for Medical Personnel. ResultsOf 128 Intensive Care Research Coordinator Interest Group eligible members, 98 (77%) completed the survey. Respondents were mainly women (91%), the median age was 47 years, 37% have a postgraduate qualification, and a third have over 10 years of RCC experience (31%). Half do not have permanent employment (52%). The mean Depression Anxiety Stress Scales-21 scores were within the normal range, and respondents reported symptoms of depression (21 [21%]), anxiety (23 [23%]), and stress (26 [27%]). Nearly half of the respondents (44%) exhibited an early symptom of burnout by reporting problematic experiences of work. The overall role satisfaction score was 3.5/5 (neutral; neither satisfied nor dissatisfied). ConclusionsIntensive care RCs are an experienced group of professionals with limited satisfaction in the role. One-fifth of the ICU RCs experienced depression, anxiety, or stress symptoms, with close to half reporting signs of burnout. These results highlight the need to address areas of concern to ensure retention of this specialised intensive care workforce.

Exploring the construction of clinical trial research unionsin China

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Underrepresented minority clinical trial participation: Perspectives of the research care team and patients.

93 Background: Clinical trials (CT) are important treatment options for patients with cancer, yet enrollment rates among underrepresented minority (URM) patients remain suboptimal. Oncology care teams need to assess barriers and facilitators of CT participation and identify practices and resources to better support patients. As part of a larger mixed-methods project, we elicited perspectives on improving URM CT enrollment from oncology research care teams and patients. Methods: We conducted four 60-minute focus groups with 12 oncology physicians, 12 research nurses, and nine clinical research coordinators, and semi-structured interviews with nine URM CT patients at a large academic medical center between January and December 2021. Results: Thematic analysis of the focus groups and interviews identified multiple barriers and potential resources and supports at the patient, healthcare team, institutional, and trial design levels. Barriers included difficulty ensuring patient understanding and informed consent, especially among patients with low health literacy and limited-English proficiency, complex logistical and financial demands of CT participation for patients, and the lack of multidisciplinary oncology care team collaboration. Collectively, these barriers undermined communication, trust, and the quality of patients’ relationships with the care team, all affecting CT participation. Suggested resources and practices included proactive needs assessments for all patients with early engagement of social workers, providing a liaison or navigator for each patient, services and support to reduce patient out of pocket costs, expansion of non-English materials availability and increased used of interpreters, increased training and diversity for all care team roles, and simplifying CT requirements by streamlining informed consent documents, eliminating unnecessary CT-related appointments, and broadening eligibility criteria. Conclusions: Findings suggest that changes in clinical trial design, care team coordination, and early assessment and monitoring of patients’ needs and experiences may help reduce access barriers and increase enrollment of URM patients into cancer CTs.

Near-term climate risks and sunlight reflection modification: a roadmap approach for physical sciences research

Current impacts and escalating risks of climate change require strong and decisive action to reduce greenhouse gas (GHG) emissions. They also highlight the urgency of research to enhance safety for human and natural systems, especially for those most vulnerable. This is reflected in two recent US National Academies of Science, Engineering, and Medicine studies that recommended a national focus on advancing our understanding of how to manage urgent current and future climate risks, and the study of approaches for increasing the reflection of sunlight from the atmosphere to reduce global warming, a process referred to as sunlight reflection modification (SRM). Here, we build on these recommendations by proposing a roadmap approach for the planning, coordination, and delivery of research to support a robust scientific assessment of SRM to reduce near-term climate risks in a defined timeframe. This approach is designed to support the evaluation of SRM as a possible rapid, temporary, additive measure to reduce catastrophic impacts from anthropogenic climate change, not as a substitute for aggressive GHG mitigation. Assessing SRM is proposed to be undertaken in the context of climate hazard risks through 2050, weighing the impacts associated with likely climate change trajectories against scenarios of possible SRM implementations. Provided that research is undertaken openly and that scientific resources are made widely available, the transparency of the process and the evidence generated would contribute to the democratization of information, participation by diverse stakeholders, more informed decision-making, and better opportunities for all people to weigh SRM options against climate change risks.

ANDRONET: A new European network to boost research coordination, education and public awareness in andrology.

ANDRONET: A new European network to boost research coordination, education and public awareness in andrology.

182 A qualitative needs assessment of people with cystic fibrosis and research coordinators to inform future clinical trials incorporating home spirometry as an endpoint

182 A qualitative needs assessment of people with cystic fibrosis and research coordinators to inform future clinical trials incorporating home spirometry as an endpoint

Determining the speed dependent source level of a snowmobile traveling on sea-ice

As part of the Sustainable Nunatsiavut Futures project, a field experiment to determine the acoustic properties and underwater radiated sound level of a snowmobile was designed and executed. The fieldwork consists of lowering acoustic recorders under the sea ice and driving a snowmobile with a known position and velocity to evaluate its speed-dependent source level. This experiment is the first step toward collaborative Dalhousie and community research on underwater sound as it relates to the marine habitat, human use of the ocean, and sea-ice in Nunatsiavut. Due to COVID-19, the planning stages were coordinated virtually, and the fieldwork in Nunatsiavut was conducted by local Inuit Research Coordinators (IRCs), while a twin Dalhousie-led experiment was conducted in Caraquet, New Brunswick. A single hydrophone sensor was used in Nunatsiavut, and a vertical array of hydrophones was used in Caraquet to obtain underwater sound data from a moving snowmobile. Skidoo specifications for each site were recorded as well as sea-ice thickness, temperature, salinity, and sound-speed data were collected. Spectrograms of skidoos traveling at different speeds were computed. Comparisons between received levels at different velocities, sites, and ranges are shown, and the impact of sea ice and snowmobile specifications on received levels are discussed.

Improving participation of under-represented minorities in breast cancer therapeutic trials in a safety-net system.

90 Background: Racial and ethnic minorities remain under-represented in cancer clinical trials. Strategies to improve access and participation of diverse populations in clinical trials is therefore a key step to improve outcomes and eliminate disparities. Methods: Parkland Health (PH) is the safety-net system for Dallas County, Texas, and is affiliated with the UT Southwestern/Harold C. Simmons Comprehensive Cancer Center (SCCC). Trial operations at PH is mainly supported by a dedicated team of SCCC research coordinators. Interventions employed to increase minority access and accruals were focused on optimizing the portfolio, increasing provider awareness, and enhanced screening. A bilingual research patient navigator was also added to the research team to improve patient education and engagement. Transportation and childcare assistance are routinely provided for patients at PH. Accrual data for 2021, compared to 2017-2020, is presented here. Results: The majority (73%) of breast cancer patients at PH are uninsured and 88% belong to racial/ethnic minorities (57% Hispanics, 31% Blacks). Of the 15 therapeutic breast cancer trials open at SCCC in 2021, 12 (80%) were open at PH. The PH breast cancer trial portfolio included 4 cooperative group, 5 industry-sponsored (ISTs), and 3 investigator-initiated studies (IITs). Four trials were in metastatic setting and 8 were in curative intent setting. Four trials required a genomic biomarker. Forty-three patients were enrolled in therapeutic trials at PH in 2021. This represents 10.3% (43/418) of new cases during the same time period. Thirty-two were enrolled in cooperative group studies, 10 in IITs, and 1 in ISTs. The majority (93%) of the trial participants belonged to under-represented minorities. Number of trial participants in 2021 increased by 48% compared to the best year in the past 5 years (29 patients enrolled in 2018). Conclusions: Collaboration between academic institutions and safety-net systems presents a unique opportunity to provide clinical trial options to under-represented minorities. In this setting, interventions to improve trial portfolio, provider awareness, screening process, and patient education, as well as addition of a patient research navigator resulted in a significant increase in the number of minority participants in breast cancer trials at our safety-net hospital.

Forming scientific-methodical principles of satellite agroecological monitoring in Ukraine

The article presents the historical aspects of developing remote agroecological monitoring. It is shown that in the process of improving satellite sensors, opening access to foreign satellite data, the possibilities and effectiveness of using the results of remote sensing in scientific and environmental protection activities, in the production of safe agricultural products have expanded. The stages of forming scientific and technical program of satellite agro-ecological monitoring «Agrokosmos», the main fundamentals, tasks and results of this research direction are analyzed. The effectiveness of satellite information for determining the structure of agrolandscapes and land use systems, climate change, its impact on the condition of crops and their moisture supply, productivity of grain crops is shown. Methodical approaches to identifying and mapping manifestations of desertification processes, erosive degradation of agricultural land and associated negative trends are considered. It is noted that modern satellite information is an important tool not only for improving the agroecological monitoring system, but also for developing and implementing measures to achieve a neutral level of soil degradation, prevent the development of desertification processes, and adapt to climate change. It has been proven that the satellite agroecological monitoring system needs improvement in terms of more detailed classification of individual elements of agrolandscapes, as well as improvement of algorithms and image processing methods to expand the possibilities of timely using these data to provide management recommendations and prompt adjustment of agricultural technologies. The main directions of further development of the «Agrokosmos» program are presented. An important issue remains the strengthening of the coordination of research works with the scientific institutions of the National Academy of Sciences, the State Space Agency, the development of cooperation with foreign partners within the framework of international projects. The urgent task of improving the information potential of the use of Earth remote sensing data is the creation of a national network of sub-satellite terrestrial agricultural test sites. The effective use of satellite data in management, production and scientific activities in agriculture requires creating an interdepartmental informative and analytical center «Agrokosmos» within the framework of the National Academy of Sciences and the Ministry of Agricultural Policy and Food.

Vocational teacher training in Russia at the present stage: Conceptual aspect

Introduction. The features of vocational teacher education (the system of vocational teacher training), its understanding and management complexity, dynamics of modern changes, and needs of educational practice call for conceptual visualisation of its present-day state. The paper presents the authors’ vision of this phenomena based on the ideas of humanisation, continuity, and democratisation of vocational teacher training system. The authors put forward some principles developing these ideas and outline the conditions for their implementation.Aim. The current research aims to present the conceptual foundations of vocational teacher training in a systematic way, providing its complete explanation and facilitating its designing amid socio-economic and socio-pedagogical changes.Methodology and research methods. The research is conducted in the context of humanistic educational paradigm, which seems to be the most advantageous for achieving the goal set, based on systemic, activity-shaped personality, integrative, and managerial-and-technological approaches, as well as theoretical and methodological analysis of the scientific sources concerning the object under study.The research is based on the nearly 100-year experience of training teaching staff for educational organisations of vocational training, the results of pedagogical research on the training problems, analysis of the history and current state of Russian vocational teacher training and relevant foreign experience, the results of experiments on introducing state educational standards and designing the vocational teacher training content.Results and scientific novelty. The conceptual foundations of vocational teacher training are represented in the unity of three components. The first component represents the general methodology, which reveals its history (development stages), role and place in the social, economic and educational system of the country. The second component determines the development prospects of vocational teacher training, which include the following aspects: its purpose, consisting in creating and maintaining conditions necessary for effective and high-quality training of teachers for the system of professional education and vocational training; conditions necessary for the development of a personality capable of self-implementation in vocational education; objectives including the formation of a versatile, socially functional, and continuously developing personality, ready for effective vocational and professional training; the guiding ideas of humanisation, democratisation and continuity of vocational education and training, as well as the conceptual principles of humanitarisation, fundamentalisation, action orientation, self-organisation of educational activities, public administration, correspondence of the content of continuous vocational teacher training stages to the main stages of personality development, continuity of training curricula, diversity of educational institutions, and the deployment of an advanced vocational teacher training system. The third component outlines the expected state indicated by the necessary conditions for the implementation of conceptual principles of vocational teacher training and concerning the selection of teaching content, building the structure of the system of vocational teacher training system supported with relevant management tools.Practical significance. The information presented in the article can contribute to the development of vocational teacher training programmes; serve as a methodological basis when forming the topics of fundamental, applied research and development on vocational teacher training, as well as for the organisation and coordination of relevant research and the implementation of the practical results obtained. The research results can also be taken into account in adapting different approaches to this type of education and in defining further development policies. There are reasons to believe that such a view on vocational teacher training complements the experience gained by other authors, and in turn, can be developed in further research.

Improving capacity to conduct observational studies in Australian and New Zealand ICUs

To the Editor: The Australian and New Zealand intensive care community is world renowned for conducting high quality intensive care unit (ICU) research. However, research capacity in Australia and New Zealand appears to have peaked due to increased research coordinator workload, competition for funding, and relative shortfalls of funded studies.

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses.

Background: The COVID-19 pandemic has accelerated adoption of remote consulting in healthcare. Despite opportunities posed by telemedicine, most hypertension services in Europe have suspended ambulatory blood pressure monitoring (ABPM). Methods: We examined the process and performance of remotely delivered ABPM using two methodologies: firstly, a Failure Modes and Effects Analysis (FMEA) and secondly, a quantitative analysis comparing ABPM data from a subgroup of 65 participants of the Screening for Hypertension in the INpatient Environment (SHINE) diagnostic accuracy study. The FMEA was performed over seven sessions from February to March 2021, with a multidisciplinary team comprising a patient representative, a research coordinator with technical expertise and four research clinicians. Results: The FMEA identified a single high-risk step in the remote ABPM process. This was cleaning of monitoring equipment in the context of the COVID-19 pandemic, unrelated to the remote setting. A total of 14 participants were scheduled for face-to-face ABPM appointments, before the UK March 2020 COVID-19 lockdown; 62 were scheduled for remote ABPM appointments since emergence of the COVID-19 pandemic between November 2020 and August 2021. A total of 65 (88%) participants completed ABPMs; all obtained sufficient successful measurements for interpretation. For the 10 participants who completed face-to-face ABPM, there were 402 attempted ABPM measurements and 361 (89%) were successful. For the 55 participants who completed remote ABPM, there were 2516 attempted measurements and 2214 (88%) were successful. There was no significant difference in the mean per-participant error rate between face-to-face (0.100, SD 0.009) and remote (0.143, SD 0.132) cohorts (95% CI for the difference -0.125 to 0.045 and two-tailed P-value 0.353). Conclusions: We have demonstrated that ABPM can be safely and appropriately provided in the community remotely and without face-to-face contact, using video technology for remote fitting appointments, alongside courier services for delivery of equipment to participants.

Diversity among research coordinators in a pediatric emergency medicine research collaborative network.

We conducted a survey study of clinical research coordinators (CRCs) at the member institutions of the Pediatric Emergency Care Applied Research Network, to determine the demographic and linguistic characteristics of CRCs around the network, and any perceived impact of those characteristics on their duties. A total of 53/74 CRCs completed the survey. Most respondents identified as "female," "white," and "not Hispanic/Latino." Most respondents felt that their race/ethnicity and their ability to speak a language other than English would positively impact recruitment. Four female respondents felt that their gender hindered their recruitment efforts and their sense of belonging within the research team.

Successful recruitment of monolingual Spanish speaking Latinos to university phase II and III outpatient COVID-19 clinical treatment trials in Northern California

Through a public County/University partnership, we employed a Spanish/English bilingual research coordinator to increase awareness of newly available treatments with FDA Emergency Use Authorization and clinical trial opportunities for Latino outpatients with mild to moderate COVID-19. Out of the 550 San Mateo County outpatients with COVID-19 referred to Stanford University between July 2020 and April 2022, 9.5% elected to receive monoclonal antibody EUA treatment. COVID-19 treatment trial enrollment of County patients, 5% of those recruited, was commensurate with non-County populations enrollment. Recruitment models such as ours have the potential to increase US Latino populations' recruitment in outpatient COVID-19 treatment trials and contribute to decreasing COVID-19 health disparities.

P28. Complication rates following adult spinal deformity surgery: the category of complication dictates timing

<h3>BACKGROUND CONTEXT</h3> Adult spinal deformity (ASD) is a complex pathology associated with high complication rates. Although complication rates have been previously reported, the interplay between timing and type of complications has not been fully analyzed. <h3>PURPOSE</h3> Provide benchmarks for the rates of complications by type and timing. <h3>STUDY DESIGN/SETTING</h3> Prospective multicenter database. <h3>PATIENT SAMPLE</h3> Operatively treated ASD patients with 2-year follow-up. <h3>OUTCOME MEASURES</h3> Rates of medical complications (cardiac, GI, infection, pulmonary, renal) and surgical complications (implant-related, operative, neurologic, radiographic) within 2 years postsurgery <h3>METHODS</h3> In the context of a prospective multicenter ASD database, standardized forms were used to collect data on surgery-related complications. Onsite research coordinators and central auditing helped ensure data capture completeness. Inclusion criteria were age >18 years, ASD and minimum 2-year follow-up. Date and type of complication were collected and classified into three severity groups (minor, major, major leading to reoperation). Only complications occurring before the 2-year visit were retained for analysis. <h3>RESULTS</h3> A total of 997 out of 1,260 patients eligible for 2-year follow-up (79.1%) were captured. The mean age at the time of surgery was 60.4yo±14.3, 76.3% were female and 50.5% had a history of previous spine surgery. The vast majority of patients (98.9%) had treatment including a posterior procedure, 57.9% had decompression, 71.2% had at least one osteotomy, and 18.1% had a 3-column osteotomy. Interbody fusion (IBF) was used in 64.0%: 48.7% posterior (TLIF or PLIF), 38.3% anterior (ALIF) and 23.2% lateral (LLIF). The mean ASD surgical invasiveness index was 88.8±36.1; 66.3% of the patients were admitted postop to the ICU, with a median overall length of hospital stay of 7 days (IQR 5 to 9). The overall complication rate was 67.4% (N=672). A total of 247 patients (24.8%) experienced at least one complication the day of surgery (including intraoperatively), 359 (36.0%) between POD1 and 6-weeks postoperatively, 271 (27.2%) between 6 weeks and 1-year postoperatively, and finally 162 (16.3%) between 1- and 2-years postoperatively. Using Kaplan-Meier survival analysis, the rate of remaining complication-free was estimated at 70.9% by POD1, 59.0% by POD7, 51.4% by 30 days, 47.4% by 3 months, and 33.6% by 2-years postoperatively. Breakdown by severity of remaining complication-free revealed the following rates for minor | major | reop: by POD1=87.3% | 90.1% | 97.4%; by POD7=78.4% | 86.8% | 95.8%; by 3 months=71.6% | 81.0% | 86.7%; by 6 months = 70.3% | 80.1% | 86.7%; and by 2-years postop=64.5% | 75.1% | 77.0%. Stratification by type of complication demonstrated that most of the medical complications occurred within the first 60 days. Surgical complications followed two types of behavior: operative, wound and infection occurred early (within 60 days), while implant-related and radiographic complications happened at a constant rate over the 2-year period. Neurologic complications had a high occurrence with the first 60 days, followed by a continuous increase up to the 2-year visit. <h3>CONCLUSIONS</h3> Only one-third of ASD patients remained complication-free 2-years postoperatively. Two patients out of ten had a complication requiring a reoperation/revision. Estimation of timing and type of complication associated with surgical treatment is crucial when counseling patients and planning treatment cost-effectiveness. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Retinal microvasculature and risk of spontaneous abortion in multiethnic Southeast Asian women

To better understand the underlying pathogenesis of spontaneous abortion that affects 10%-20% of recognized pregnancies. We used retinal imaging to study the role of systemic microvasculature and the risk of spontaneous abortion. A prospective multiethnic preconception cohort study conducted in Singapore. Hospital-based. A total of 1,032 Southeast Asian women who intended to conceive naturally were screened at study entry, among which 480 women spontaneously conceived within the 12-month observation period. After excluding 24 women who were lost to follow-up, we calculated the spontaneous abortion rate among 456 women. Further, we included 379 women for the final association analysis because 63 women did not undergo preconception retinal imaging examination and 14 had other types of pregnancy loss instead of spontaneous abortion. Trained photographers performed retinal examination using a 45-degree nonmydriatic retinal camera at study entry during the preconception screening. Using a semiautomated, computer-based program, we assessed quantitative retinal microvascular measurements, including caliber, fractal dimension, curvature tortuosity, and branching angle. Clinical research coordinators collected information on sociodemographic status, menstrual characteristics, and lifestyle, and assessed blood pressure and anthropometry at study entry. We performed a modified Poisson regression model to estimate the relative risk (RR) and 95% confidence interval (CI) for each retinal microvascular feature and its association with spontaneous abortion after adjusting for major confounders such as maternal prepregnancy, body mass index, and previous pregnancy loss history. We reported a spontaneous abortion rate of 13.4% (61 out of 456). Among all retinal microvascular features, retinal arteriolar caliber, retinal arteriolar, and venular curvature tortuosity were associated with a high risk of incident spontaneous abortion. In the regression model, per SD increase in retinal curvature tortuosity was associated with a 25%-34% increased risk of incident spontaneous abortion (arteriolar: unadjusted RR, 1.29 [95% CI, 1.06-1.56] and adjusted RR, 1.26 [1.04-1.53]; venule: unadjusted RR, 1.30 [1.08-1.55] and adjusted RR, 1.34 [1.09-1.64]). Our prospective cohort observed an increased risk of spontaneous abortion among Asian women with more tortuous retinal vessels assessed during the preconception phase. Our results indicate a role of vascular inflammatory and oxidative stress in the pathogenesis of spontaneous abortion. ClinicalTrials.gov, NCT03531658.

臨床研究コーディネーターが治験における被験者ケアにおいて抱える課題の抽出：フォーカスグループインタビュー法を用いた研究

臨床研究コーディネーターが治験における被験者ケアにおいて抱える課題の抽出：フォーカスグループインタビュー法を用いた研究