Student mental health during Summer 2022 research experiences for undergraduates (REUs): Mentorship, remote engagement, and COVID-19.

Objective: We examined how mentorship, remote participation, and COVID-19 challenges were associated with the mental health of college students participating in summer research programs. Participants: Participants were students participating in 78 National Science Foundation (NSF) Research Experiences for Undergraduate (REU) Sites during Summer 2022 (n = 516 students). Methods: We used multivariable generalized estimating equations that account for clustering by REU Site. Results: Students with more competent mentors had reduced depression severity. Students who spent ≥25% of their time doing remote research or ≥25% of their time in remote meetings and workshops had greater depression severity. Remote research was also associated with anxiety severity. Having a COVID-19 challenge that impacted students' research experience was associated with increases in depression and anxiety severity. Conclusions: Results suggest potential interventions: implement strategies to boost mentor competency and scaffold a support system into summer research programs to enhance student wellbeing. Additional research on remote engagement is needed.

Best Practices and Recommendations for Research Using Virtual Real-Time Data Collection: Protocol for Virtual Data Collection Studies.

BACKGROUND: The COVID-19 pandemic and the subsequent need for social distancing required the immediate pivoting of research modalities. Research that had previously been conducted in person had to pivot to remote data collection. Researchers had to develop data collection protocols that could be conducted remotely with limited or no evidence to guide the process. Therefore, the use of web-based platforms to conduct real-time research visits surged despite the lack of evidence backing these novel approaches. OBJECTIVE: This paper aims to review the remote or virtual research protocols that have been used in the past 10 years, gather existing best practices, and propose recommendations for continuing to use virtual real-time methods when appropriate. METHODS: Articles (n=22) published from 2013 to June 2023 were reviewed and analyzed to understand how researchers conducted virtual research that implemented real-time protocols. "Real-time" was defined as data collection with a participant through a live medium where a participant and research staff could talk to each other back and forth in the moment. We excluded studies for the following reasons: (1) studies that collected participant or patient measures for the sole purpose of engaging in a clinical encounter; (2) studies that solely conducted qualitative interview data collection; (3) studies that conducted virtual data collection such as surveys or self-report measures that had no interaction with research staff; (4) studies that described research interventions but did not involve the collection of data through a web-based platform; (5) studies that were reviews or not original research; (6) studies that described research protocols and did not include actual data collection; and (7) studies that did not collect data in real time, focused on telehealth or telemedicine, and were exclusively intended for medical and not research purposes. RESULTS: Findings from studies conducted both before and during the COVID-19 pandemic suggest that many types of data can be collected virtually in real time. Results and best practice recommendations from the current protocol review will be used in the design and implementation of a substudy to provide more evidence for virtual real-time data collection over the next year. CONCLUSIONS: Our findings suggest that virtual real-time visits are doable across a range of participant populations and can answer a range of research questions. Recommended best practices for virtual real-time data collection include (1) providing adequate equipment for real-time data collection, (2) creating protocols and materials for research staff to facilitate or guide participants through data collection, (3) piloting data collection, (4) iteratively accepting feedback, and (5) providing instructions in multiple forms. The implementation of these best practices and recommendations for future research are further discussed in the paper. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53790.

Field based research in the era of the pandemic in resource limited settings: challenges and lessons for the future.

The coronavirus pandemic that began in December 2019, has had an unprecedented impact on the global economy, health systems and infrastructure, in addition to being responsible for significant mortality and morbidity worldwide. The "new normal" has brought along, unforeseen challenges for the scientific community, owing to obstructions in conducting field-based research in lieu of minimizing exposure through in-person contact. This has had greater ramifications for the LMICs, adding to the already existing concerns. As a response to COVID-19 related movement restrictions, public health researchers across countries had to switch to remote data collections methods. However, impediments like lack of awareness and skepticism among participants, dependence on paper-based prescriptions, dearth of digitized patient records, gaps in connectivity, reliance on smart phones, concerns with participant privacy at home and greater loss to follow-up act as hurdles to carrying out a research study virtually, especially in resource-limited settings. Promoting health literacy through science communication, ensuring digitization of health records in hospitals, and employing measures to encourage research participation among the general public are some steps to tackle barriers to remote research in the long term. COVID-19 may not be a health emergency anymore, but we are not immune to future pandemics. A more holistic approach to research by turning obstacles into opportunities will not just ensure a more comprehensive public health response in the coming time, but also bolster the existing infrastructure for a stronger healthcare system for countries.

From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

Background/Objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials. Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes. This approach not only avoids spreading COVID-19 but it also can support inclusion of participants in more diverse socioeconomic circumstances and in rural settings. Results: Our team developed and deployed a decentralized trial platform to support patient engagement and adverse event reporting. Clinicians, engineers, and informaticians on our research team developed a Clinical-Trial-in-a-Box tool to optimally collect and analyze data from multiple decentralized platforms. Conclusion: Applying the decentralized model in Long COVID, using digital health technology and personal devices integrated with our telehealth platform, we share the lessons learned from our work, along with challenges and future possibilities.

Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2.

The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT's are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment.

"In general people aren't excited about the vaccine ": Frontline perspectives on COVID-19 vaccine hesitancy across Syria.

COVID-19 vaccine hesitancy is a new phenomenon in Syria, about which relatively little is known. We aimed to explore this, drawing from 37 semi-structured interviews with frontline health-workers and service-users across Syria's major military areas-of-control. We found COVID-19 vaccine hesitancy was common and increasing among service-users and less common, but still present, among health-workers in all areas. Interrelated reasons included pragmatic fears of novel vaccine risks, unreliable information, and conflict-related hesitancies as a form of resistance or reasserting some perceived control, particularly outside Al-Assad government-controlled areas. Vaccine hesitancy has thus become a socio-political issue, requiring macro-level responses, across Syria.

Researching with Qualitative Methodologies in the Time of Coronavirus: Clues and Challenges.

In late 2020 and the first semester of 2021, in Santiago de Chile, five women researchers who work with qualitative methodologies, based on their reflections on how the context of the COVID-19 pandemic has impacted on their doctoral research or their role as thesis advisors, conducted a reflective exploration of the conditions and challenges for qualitative research amid a global crisis. In this context, they convene once per week to explore how other researchers conduct and document their research processes, based on a purposive and thorough bibliographic exploration of qualitative studies on the pandemic and remote methods published in qualitative research journals. During these meetings, they reflect on and analyze the impacts and challenges of research in today's world, identifying possibilities and challenges in the methodological and ethical domains. Thus, they organize the present paper around two axes: one on the effects of the pandemic on academic and research practices, in general terms, and another on the specific methodological challenges facing qualitative research during the pandemic. These challenges are largely caused by difficulties in accessing and recruiting participants; the conditions of participation, influenced by vulnerabilities or barriers that constitute factors of inequality; the data production strategies and methodologies used in virtual contexts; ethical considerations; and the effects of the pandemic context on quality and rigor criteria. The article concludes with reflections and questions on the meanings, underlying logic, and practices of qualitative research, which are interrogated and re-signified in light of the COVID-19 pandemic while also illuminating research in post-pandemic settings.

Preferences of NIA Alzheimer's Disease Research Center participants regarding remote assessment during the COVID-19 pandemic.

Introduction: During the COVID-19 pandemic, in-person research study visits were moved to an online format using a variety of communication platforms (e.g., Webex and Zoom). Increased technology use among older adults allowed for greater insight regarding the remote research study visit format. Methods: A survey developed by the National Alzheimer's Coordinating Center (NACC) was distributed among 12 Alzheimer's Disease Research Centers (ADRCs). The COVID-19 Technology Accessibility Survey aimed to understand preferences of older adults regarding their research study visits and how they accessed the internet. Results: Among 12 ADRCs, 2070 responses were received (mean age: 72.8 years [standard deviation (SD) = 10.4], mean education: 16.6 years [SD = 2.6], race/ethnicity: 85% White/non-Hispanic). Among respondents, those with some form of cognitive impairment were more likely to prefer remote research study visits (mild cognitive impairment [MCI] vs. normal [odds ratio (OR) = 1.40, P = 0.02] and dementia vs. normal [OR = 1.48, P < 0.01]). Respondents with cognitive impairment were also less likely to have interest in smartphone use during at-home study visits (MCI vs. normal [OR = 0.71, P = 0.02] and dementia vs. normal [OR = 0.63, P < 0.001]). Results were similar regarding tablet use (MCI vs. normal [OR = 0.73, P = 0.04] and dementia vs. normal [OR = 0.72, P = 0.01]). Geographical location was analyzed in terms of the percentage of respondents in each region who preferred remote research study visits: West, 51%; Midwest, 34%; South, 41%; and Northeast, 57% (P < 0.0001). Discussion: Results from the study suggest that there is a growing interest in the remote research study visit format. Further studies will allow for greater understanding and development of this research format.

SPECTRa: An Online Tool for Simulating Prehospital Patient Care.

OBJECTIVES: To (1) develop a simulation software environment to conduct prehospital research during the COVID-19 pandemic on paramedics' teamwork and use of mobile computing devices, and (2) establish its feasibility for use as a research and training tool. BACKGROUND: Simulation-based research and training for prehospital environments has typically used live simulation, with highly realistic equipment and technology-enhanced manikins. However, such simulations are expensive, difficult to replicate, and require facilitators and participants to be at the same location. Although virtual simulation tools exist for prehospital care, it is unclear how best to use them for research and training. METHODS: We present SPECTRa-Simulated Prehospital Emergency Care for Team Research-an online simulated prehospital environment that lets participants care concurrently for single or multiple patients remotely. Patient scenarios are designed using Laerdal's SimDesigner. SPECTRa records data about scenario states and participants' virtual interaction with the simulated patients. SPECTRa's supporting environment records participants' verbal communication and their visual and physical interactions with their interface and devices using Zoom conferencing and audiovisual recording. We discuss a pilot research implementation to assess SPECTRa's feasibility. RESULTS: SPECTRa allows researchers to systematically test small-team interaction in single- or multipatient care scenarios and assess the impact of mobile devices on participants' assessment and care of patients. SPECTRa also supports pedagogical features that could allow prehospital educators to provide individual trainees or teams with online simulation training and evaluation. CONCLUSIONS: SPECTRa, an online tool for simulating prehospital patient care, shows potential for remote healthcare research and training.

Research outside the laboratory: Longitudinal at-home neurostimulation.

The use of noninvasive transcranial electrical stimulation (tES) has rapidly increased over the past two decades. Yet, tES continues to be largely implemented in laboratory and rehabilitation settings, thereby limiting accessibility to the broader population. We have previously demonstrated that transcranial alternating current stimulation (tACS) in the theta (4-7 Hz) band improves cognitive control, such as multitasking, in younger adults following a single tACS session, as well as in older adults following three tACS sessions. Here, the goal was to extend our in-lab results by (1) assessing the feasibility for at-home tACS and (2) evaluating whether five tACS sessions may yield continuing improvements in multitasking ability in young adults. Participants (aged 18 - 34 years) received bilateral prefrontal tACS while engaged in an adaptive multitasking training over five consecutive days in their home settings. Participants were randomly assigned to receive either 20-minutes of theta or delta tACS during daily multitasking training. Prior to and on the day immediately following five days of tACS, we assessed performance on single task, multitask, and sustained attention ability with analyses of variance statistics. 92.1% of participants were able to self-administer tACS at home without researcher assistance. However, we observed that both theta and delta tACS groups exhibited improvements in both single and multitask performance. Compared to previously collected data, five days of theta tACS was comparable to one day of theta tACS. However, theta tACS has continued benefits in older, but not younger adults as evidenced by previous research. Both groups similarly improved in sustained attention. These results demonstrate that laboratory paradigms utilizing neurostimulation can be effectively deployed in a home environment without direct support from research personnel. Moreover, these results suggest that while theta tACS may facilitate multitasking improvements over one session, multiple sessions of theta tACS results in diminishing returns in young adults. Additional research will be required to confirm if delta activity plays an important role in multitasking ability.

The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic.

The COVID-19 pandemic has necessitated a rapid shift to web-based or blended design models for both ongoing and future clinical research activities. Research conducted virtually not only has the potential to increase the patient-centeredness of clinical research but may also further widen existing disparities in research participation among underrepresented individuals. In this viewpoint, we discuss practical strategies for quantitative and qualitative remote research data collection based on previous literature and our own ongoing clinical research to overcome challenges presented by the shift to remote data collection. We aim to contribute to and catalyze the dissemination of best practices related to remote data collection methodologies to address the opportunities presented by this shift and develop strategies for inclusive research.

Video-Based Remote Administration of Cognitive Assessments and Interventions: a Comparison with In-Lab Administration.

While remote data collection is not a new concept, the quality and psychometric properties of data collected remotely often remain unclear. Most remote data collection is done via online survey tools or web-conferencing applications (i.e., Skype or Zoom) and largely involves questionnaires, interviews, or other self-report data. Little research has been done on the collection of cognitive assessments and interventions via web-conferencing that requires multiple sessions with or without the assistance of an experimenter. The present paper discusses limitations and challenges of studies administered remotely, and outlines methods used to overcome such challenges while effectively collecting cognitive performance data remotely via Zoom. We further discuss relative recruitment, retention rates, compliance, and performance findings between in-lab and remotely administered cognitive assessment and intervention studies, as well as limitations to remote data collection. We found that while it was necessary to recruit more participants in remote studies to reach enrollment goals, compliance and performance were largely comparable between in-lab and remotely administered studies, illustrating the opportunities of conducting this type of experimental research remotely with adequate fidelity.

A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting.

OBJECTIVE: Patients who die by suicide are often seen in primary care settings in the weeks leading to their death. There has been little study of brief interventions to prevent suicide in these settings. METHOD: We conducted a virtual, pilot, randomized controlled trial of a brief suicide prevention strategy called Veterans Affairs Brief Intervention and Contact Program (VA BIC) in patients who presented to a primary care mental health walk-in clinic for a new mental health intake appointment and were at risk for suicide. Our primary aim was to assess feasibility. We measured our ability to recruit 20 patients. We measured the proportion of enrolled patients who completed all study assessments. We assessed adherence among patients assigned to VA BIC. RESULTS: Twenty patients were enrolled and 95% (N = 19) completed all study assessments. Among the 10 patients assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10) completed ≥70% of the required interventions visits. CONCLUSION: It is feasible to conduct a virtual trial of VA BIC in an integrated care setting. Future research should clarify the role of VA BIC as a suicide prevention strategy in integrated care settings using an adequately powered design. CLINICAL TRIAL REGISTRATION: NCT04054947.

A catalyst for change: Developing a collaborative reflexive ethnographic approach to research with hospital doctors during the COVID-19 pandemic.

The understanding of what ethnography looks like, and its purpose, is continuously evolving. COVID-19 posed a significant challenge to ethnographers, particularly those working in health-related research. Researchers have developed alternative forms of ethnography to overcome some of these challenges; we developed the Mobile Instant Messaging Ethnography (MIME) adaptation to ethnography in 2021 to overcome restrictions to our own research with hospital doctors. However, for ethnographic innovations to make a substantial contribution to methodology, they should not simply be borne of necessity, but of a dedicated drive to expand paradigms of research, to empower participant groups and to produce change - in local systems, in participant-collaborators and in researchers and the research process itself. In this paper, we reflect on our experiences using MIME, involving collaborative remote observation and reflection with 28 hospital doctors in Ireland from June to December 2021. After reviewing literature on ethnography in COVID-19 and general epistemological developments in ethnography, we detail the MIME approach and illustrate how MIME presents an evolution of the ethnographic approach, not only practically but in terms of its reflexive shift, its connected and co-creative foundations, and its ability to drive change in research approaches, participant life-worlds and real-world improvement.

A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond.

BACKGROUND: Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or "Remote Trial Delivery". The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery. METHODS: The NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams. RESULTS: The patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies. CONCLUSIONS: The rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers.

Remote Research Methods: Considerations for Work With Children.

The growing shift to online research provides numerous potential opportunities, including greater sample diversity and more efficient data collection. While online methods and recruitment platforms have gained popularity in research with adults, there is relatively little guidance on best practices for how to conduct remote research with children. The current review discusses how to conduct remote behavioral research with children and adolescents using moderated (i.e., real-time interactions between the experimenter and child) and unmoderated (i.e., independent completion of study without experimenter interaction) methods. We examine considerations regarding sample diversity and provide recommendations on implementing remote research with children, including discussions about remote software, study design, and data quality. These recommendations can promote the use of remote research amongst developmental psychologists by contributing to our knowledge of effective online research practices and helping to build standardized guidelines when working with children.

Parent-Infant Interaction Tasks Adapted for Remote Testing: Strengths, Challenges, and Recommendations.

The closure of in-person laboratories and decreased safety of face-to-face interactions resulting from the COVID-19 pandemic jeopardized the ability of many developmental researchers to continue data collection during this time. Disruptions in data collection are particularly damaging to longitudinal studies, in which the testing of different age groups occurs on a continuous basis, and data loss at one time point can have cascading effects across subsequent time points and threaten the viability of the study. In an effort to continue collecting data for a longitudinal study on emotion development started in-person pre-pandemic, we adapted two parent-infant interaction tasks (free-play task and toy removal task) for a remote testing framework. Our procedure for pivoting these tasks to a supervised, remote online testing framework is outlined and the associated strengths and challenges of testing in this format (e.g., feasibility and implementation, testing environment and task setup validity, and accessibility, recruitment, and diversity) are critically evaluated. Considerations for applying this framework to other behavioral tasks are discussed and recommendations are provided.

Perspectives on the Future Development of Mobile Applications for Dermatology Clinical Research.

The COVID-19 pandemic significantly impacted clinical research in dermatology and practices around the country transitioned to teledermatology amid physical distancing requirements. Despite their growing use in teledermatology and clinical care, dermatology applications have not been studied extensively in the research space. The use of mobile applications has the potential to improve the experience of study subjects and physicians and increase the pool of individuals willing to participate in research beyond the pandemic. We discuss the various pros and cons of mobile apps, as well as the necessary components they require to successfully conduct research.

Developing Digital Tools for Remote Clinical Research: How to Evaluate the Validity and Practicality of Active Assessments in Field Settings.

The ability of remote research tools to collect granular, high-frequency data on symptoms and digital biomarkers is an important strength because it circumvents many limitations of traditional clinical trials and improves the ability to capture clinically relevant data. This approach allows researchers to capture more robust baselines and derive novel phenotypes for improved precision in diagnosis and accuracy in outcomes. The process for developing these tools however is complex because data need to be collected at a frequency that is meaningful but not burdensome for the participant or patient. Furthermore, traditional techniques, which rely on fixed conditions to validate assessments, may be inappropriate for validating tools that are designed to capture data under flexible conditions. This paper discusses the process for determining whether a digital assessment is suitable for remote research and offers suggestions on how to validate these novel tools.