Relationality and online interpersonal research: Ethical, methodological and pragmatic extensions

The availability, affordability and usability of communication technologies have created new ways to conduct interpersonal qualitative research. Access to digital communications remains uneven, but the online environment provides an alternative, and at times a potentially preferable, research space. As Covid-19 has interrupted and disrupted the dominant assumption that qualitative research must be conducted in person, this paper outlines possibilities and reservations of online interpersonal methods. Though the standard ethical considerations of qualitative research hold true, we argue that these are necessary, but often inadequate, in the contexts of conducting online synchronous interpersonal research. Through centring relational and reflexive practice, we consider the associated pragmatic, methodological and ethical domains from feminist and virtual–material positional perspectives. Unpacking the complexities and possibilities of researching digital environments, we present six guiding principles to inform ethically responsive, methodologically robust and pragmatically feasible approaches to conducting online interpersonal qualitative research.

Plasma expansion and renal perfusion in critical COVID-19 with AKI

Introduction: We have previously described decreased renal perfusion in acute kidney injury (AKI) due to critical COVID-19 [1]. The objective of this study was to compare the effects of plasma expansion with a standardized fluid bolus on renal perfusion in patients with AKI compared to similar patients without AKI. Method(s): A case control study design was used to investigate group differences before and after a standardized intervention. ICU-treated COVID-19 patients without underlying kidney disease were assigned to two groups based on KDIGO Creatinine criteria for AKI. Renal perfusion was assessed by magnetic resonance imaging using phase contrast and arterial spin labeling before and directly after plasma expansion with 7.5 ml/kg Ringer's Acetate (Baxter). Mean arterial pressure (MAP) was recorded before plasma infusion and compared with maximum value after. Data was analyzed with a mixed model repeated measures ANOVA for all kidneys using a random effect to account for research subjects. Result(s): Nine patients with AKI and eight without were included in the study. Patients in both groups were of similar mean age and weight, 66 (SD 8) years and 94 (SD 22) kg in AKI group and 64 (SD 15) years and 93 (SD 20) kg in patients without AKI. The response to plasma expansion was similar with increased MAP by 18 (CI 8-28) mmHg and 20 (CI 10-31) mmHg respectively (Table 1). Total renal perfusion and cortical perfusion was not significantly changed by plasma expansion, however there was a reduction of medullary perfusion in patients without AKI (Table 1). Conclusion(s): Plasma expansion with a standardized fluid bolus did not increase renal perfusion in critically ill patients with ARDS due to COVID-19.

Post covid 19 radiological changes in pediatric patients

Background: Introduction: Coronavirus disease (COVID-19) is a global problem. The COVID-19 pandemic has infected millions of people and the number of patients who have been exposed to postcovid implications are increased. Postcovid changes are more investigated in adults, although information is scarce in pediatric patients. Method(s): The aim of the study was to evaluate the radiological changes of respiratory system in peaditric patients after acute mild and severe covid infections. Research subjects: 259 pediatric patients (age: 10 months -18 years) recovered from Covid-19 and had a negative PCR test were examined. All patients underwent X-ray examinations. Patients were divided into 3 subgroups. Patients (46%) recovered from severe or moderate covid pneumonia and had non-respiratory symptoms upon arrival at the clinic: weakness, mild fatigue, drowsiness. Patients (28%) recovered from covid infection and had respiratory symptoms: cough, shortness of breath during exercise, respiratory failure;Patients (26%) with a fever upon entry to the hospital. The statitical analysis was done using SPSS 12.0 software. Result(s): Patients, whose had (69.9% ) the severe Covid pneumonia and postcovid respiratory symptoms (cough 78.4%), which was the cause of abnormal changes in the cardiovascular system were onserved in 48.6% of patients. Unlike other types of viral infections, the changes continue in the postcovid period. Severe course of the disease does not always mean detection of postcovid syndrome and vice versa. However, in case of mild disease the possibility development of various degrees of polyorgan damage was 26.9%. Conclusion(s): The radiological changes are manifested during 4th week from recovery and may last for a longer period of time, however the radiological changes do not always indicator a severity of the disease.

Using a Single Irb for Nih-Funded Multisite Trials

As clinical trials evolve, the oversight by Institutional Review Boards (IRBs) has also evolved to meet everexpanding needs for both efficiency and changing regulatory requirements in the protection of human subjects. The most significant regulatory change to occur was the change to the Revised Common Rule Research Provision (45 CFR 46.114(b)) that went into effect on 20 January 2020, requiring all cooperative research subject to the Common Rule to use a single Institutional Review Board (sIRB) to review the research. Since the Common Rule affects all federally funded research, clinical trialists performing multicenter trials using federal grants are now required to use an sIRB instead of individual IRBs at each research site in their trials. For those multicenter trialists, using an sIRB offers efficiencies in time and effort which can aid in bringing trial results to fruition both faster and at a lower cost while still providing protection to human subjects. While commercial sIRBs have been available for many years, sIRBs placed at academic institutions and health care systems are relatively new. They can offer the benefit of lower cost for trialists within an institution, and better overall trial management by having more frequent communication and discussion regarding trial issues as well as improved safety management through aggregate safety review. They can also offer increased speed of research review with cooperative planning between trialist and the sIRB representatives. This session will focus on the use of sIRBs from various perspectives to give the view from an academic sIRB, from end users of both an academic sIRB and a health system IRB, and guidance from a clinical regulatory specialist regarding maintaining a trial master file while using an sIRB. Mr. Jarrod Feld from the University of Iowa will present from his perspective as the External IRB Coordinator at the University of Iowa. Mr. Feld coordinates reliance and compliance for University of Iowa human research studies which use the University of Iowa Institutional Review Board as their sIRB, and studies where Iowa relies on another institutional IRB. Mr. Feld also provides guidance to investigators on using an sIRB. Using his experience, Mr. Feld will outline the nature of reliance agreements, discuss working with a range of local IRBs to develop understanding regarding the reliance program and outline best practices for using an sIRB, and discuss enhanced safety management oversight when using an sIRB for large multisite trial. Ms. Tina Neill-Hudson from the University of Iowa will present from her experience as the sIRB Liaison for both the Acute to Chronic Pain Signature (A2CPS) Consortium, an NIH (National Institutes of Health)- funded multisite observational trial, and the Fibromyalgia and TENS in Physical Therapy Study (FM TIPS) study, an NIH-funded embedded pragmatic clinical trial. Ms. Neill-Hudson works with relying sites on completing the necessary regulatory documents needed for reliance agreements and sIRB approval. Ms. Neill-Hudson will discuss the process for obtaining reliance for institutions who may or may not have local IRB oversight and provide examples of specific steps and procedures for obtaining sIRB approval in a timely manner. Ms. Neill-Hudson will speak to the importance of having an sIRB liaison on the study team and the use of SMART IRB. Ms. Catherine Gladden from MassGeneral Brigham will present on using an sIRB for multicenter NIHfunded trials. Ms. Gladden will discuss the use of a Consortium-level reliance agreement and role of the local IRBs. Ms. Gladden oversees the sIRB liaison team at the Coordinating Center for the NeuroNEXT Network and works with the sIRB and local IRBs to ensure local policies and requirements are followed while maintaining compliance with the sIRB and the NeuroNEXT reliance agreement. Ms. Gladden will be discussing best practices for using an sIRB in a multicenter trial and discuss the experience of using an sIRB in the safety management plan. Ms. Cynthia Diltz from the University of Iowa wi l present on the topic of managing a trial master file while using an sIRB. Ms. Diltz will speak on her experience with electronic trial master files versus hard copy master files, and in using commercial software for trial master file management. Using an electronic trial master file is a necessity in the scheme of using an sIRB to assist sponsors and individual clinical research sites to view Institutional Review Board documents in real time and to provide a single storage location for documentation of Institutional Review Board approvals and activities such as continuing review. This session is timely due to the change to the Common Rule mandating the use of an sIRB for all research subject to the Common Rule, which has the most significant impact on trialists at academic institutions and health care systems. In an era of the need for timely study results for use in addressing urgent public health policy concerns, using an sIRB is becoming a necessity. The speed with which clinical trials need to be managed by an IRB has accelerated during recent public health care crises, notably the COVID-19 pandemic. In addition, it is likely that there will be changes to local IRBs as the norm becomes using an sIRB for any research subject to the Common Rule. Investigators and clinical site staff will require education on the evolution of human subject's protection and research review happening at an sIRB instead of within their local IRBs, and assistance in understanding the process and planning for success will be crucial.

Unidos Hablemos de: Engaging Hispanic Patients in Patient Centered Outcomes Research and Clinical Effectiveness Research (PCOR/CER)

Rationale: Historically, Hispanics are underrepresented in research which reduces the generalizability of research findings. Patient engagement in research can support more relevant research through better alignment with patients' and clinicians' real-world needs and concerns. A virtual conference series for the Hispanic community was held to gain insights to better engage Hispanic patients in research. Methods: A Patient Advisory Group (PAG) comprised of Hispanic patients diagnosed with COVID-19 and/or asthma and a Faith-based leader developed a six-month virtual series (objectives, platform, theme, agendas, and identification of presenters), pre-and-post knowledge surveys, polling questions, and session evaluations. Based on the PAG feedback, messaging, promotion and handouts were offered in English and Spanish. Results: Between October 2021- March 2022, 2200 people attended over the 6 virtual sessions. Attendees identifying as Hispanic patients or caregivers increased by 6.7%, and 19% requested content in Spanish. Overall knowledge was gained for sessions 2-6. 66.4% of attendees agreed they would be willing to be a research subject in an asthma study, while 15.6% did not agree and 18% would if their doctor thought it was a good idea. When asked about willingness to be a patient partner/advisor for an asthma study, 77.6% agreed, while only 3.2% did not agree and the remaining 20% were either unsure or participation would depend on whether their doctor thought it was a good idea. Conclusions: This bilingual virtual series engaged patients/caregivers to learn about COVID-19 and asthma, and tools used to participate in research with the goal to increase representation of Hispanics in research.

A community-partnered approach for diversity in COVID-19 vaccine clinical trials.

Introduction: Communities of color have faced disproportionate morbidity and mortality from COVID-19, coupled with historical underrepresentation in US clinical trials, creating challenges for equitable participation in developing and testing a safe and effective COVID-19 vaccine. Methods: To increase diversity, including racial and ethnic representation, in local Los Angeles County NIH-sponsored Phase 3 SARS-CoV-2 vaccine clinical trials, we used deliberative community engagement approaches to form a Community Consultant Panel (CCP) that partnered with trial research teams. Thirteen members were recruited, including expertise from essential workers, community-based and faith-based organizations, or leaders from racial and ethnic minority communities. Results: Working closely with local investigators for the vaccine studies, the CCP provided critical insight on best practices for community trust building, clinical trial participation, and reliable information dissemination regarding COVID-19 vaccines. Modifying recruitment, outreach, and trial protocols led to majority-minority participants (55%-78%) in each of the three vaccine clinical trials. CCP's input led to cultural tailoring of recruitment materials, changes in recruitment messaging, and supportive services to improve trial accessibility and acceptability (transportation, protocols for cultural competency, and support linkages to care in case of an adverse event). Barriers to clinical trial participation unable to be resolved included childcare, requests for after-hours appointment availability, and mobile locations for trial visits. Conclusion: Using deliberative community engagement can provide critical and timely insight into the community-centered barriers to COVID-19 vaccine trial participation, including addressing social determinants of health, trust, clinical trial literacy, structural barriers, and identifying trusted messenger and reliable sources of information.

Effect of Covid-19 Pandemic on Levels of Empathy among Dental Students in Bhubaneswar- a Cross-Sectional Study

Objective: The purpose of this research was to examine how the Coronavirus epidemic has affected the compassion of dentistry students in Bhubaneswar. Materials and Equipment: In this study, undergraduate dental students in Bhubaneswar served as the research subjects for a cross-sectional analysis. Following informed permission, dental school students from two time periods (one before and one after the occurrence of Coronavirus in India) were given the authorized and pretested Toronto Sympathy Poll (TEQ) (Bhubaneswar). A five-point scale was used to indicate members' levels of comprehension. Using a one-way analysis of variance, we compared students' TEQ scores during their four years of dentistry school (investigation of difference). The results of the meetings were analyzed using Tukey's post hoc test. The Chi-square test was used to analyze data collected before and during the recent Coronavirus epidemic (importance level, p 0.05). Only 270 of the 300 dentistry students enrolled in the focus before Coronavirus reached its conclusion;the remaining 260 enrolled thereafter. Comparing results from the same group before and after exposure to the Coronavirus revealed striking discrepancies in the compassion ratings. More than eighty-five percent of individuals answered the survey. As a result of this study's findings, it is concluded that undergraduate dental students' mean empathy ratings increased after COVID-19, indicating a discernibly greater degree of empathy at that time. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Pandemic-Related Innovations in Oncology Nursing Research: Seeking the Positive: lthough COVID-19 was a major setback for completing and initiating projects, it ushered in a new era for investigators

The article focuses on the scientists across industry, academic and healthcare settings that were forced to halt their ongoing research studies because of isolation mandates associated with the management of contagion in the COVID-19 pandemic. Topics include examines for many scientists, this unprecedented stoppage continued for many months and not only disrupted preexisting studies but delayed the development of new work.

Research Subject Perceptions Regarding Infection Control Procedures to Reduce COVID-19

Introduction: The COVID pandemic has altered health care delivery, including clinical research, by introduction of measures to reduce COVID. How these measures affect clinical research participation is unclear. Objectives: The purpose of this survey was to document research volunteer's attitudes toward COVID infection control procedures. Methods: Our research program implemented the following: 1. Staff wore masks, disposable gowns, face shields and gloves when with subjects. 2. Subjects were asked if they tested positive or were experiencing COVID symptoms;upon entry their temperature was measured, and hand sanitizer used. 3. Disinfecting was expanded to all scanner room surfaces in contact with humans between each visit. 4. Only 1 subject was allowed in the research office at a time. Staff, when possible, remained > 6 feet away from other persons. As part of a study evaluating total body DXA, community dwelling volunteers completed a self-administered health care delivery preference survey from Dec 2020 to May 2021. A 5-point scale was used to capture responses to 10 questions (Table 1). Responses were tested using Chi Square with age and sex comparisons assessed by ANOVA. Results: Eighty-two adults (41F/41M) mean (SD) age 50.9 (18.3) yrs (range 18-79) without sex difference participated. Participants strongly agreed (84%;p < 0.001) they were more comfortable seeing effort to prevent COVID-19;72% agreed 1 subject, without a companion, should be seen, and 81% strongly agreed masks be required. Seeing staff clean visit space was important to 66%, more so among women (33%) than men (21% (p = 0.007)). Most subjects (83%) reported comfort having elective procedures and did not feel “unclean” or “diseased” (87%) by procedures. Some, 26%, preferred a non-hospital setting, 66% were neutral;those age 50+ (17%) preferred this more (p = 0.004) than younger subjects (5%). Finally, 91% preferred to have a brief test description before visit arrival. Conclusions: In this university-based study, most subjects favored masking, cleaning and limiting personal contact for research visits. Notably, no information regarding vaccination status was exchanged and the study began just as vaccines became available and ended just after all US citizens over age 16 were eligible for vaccination. Thus, it is unknown if vaccination status might alter research participation perception. However, people do prefer that steps are taken to reduce infection in research settings. It seems likely that this would be the case in clinical care settings.

The Analysis of Personal Protective Equipment Covid-19 in The Hospital Sallewangan, Maros Regency 2020

Purpose: to analyze of the use of Covid-19 Personal Protective Equipment on health workers at Salewangang Hospital, Maros Regency. Methods: The type of research used is the analytical survey method of research conducted without intervention to the research subject. Data collection regarding free and dependent variables was carried out online using Google Form and the results of Google Form data collection Results: Availability of personal protective equipment has a significant effect on the behavior of using personal protective equipment Covid-19, Knowledge of health workers has a significant effect on behavior of using personal protective equipment Covid-19, Attitudes of health workers have a significant effect on behavior of using personal protective equipment Covid-19 in health workers at the Salewangang Hospital, Maros Regency with a sig. 0.000 Conclusion: there is a relation between personal equipment on helath workers at the sallewangan hospital at maros regency.

Implementation and management of drug clinical trials during the period of COVID-19 epidemic

Objective: To explore the implementation and management measures of drug clinical trials during the period of COVID-19 epidemic, protect the safety and rights of subjects, ensure the smooth implementation of clinical trials, and provide reference and suggestions for the management work of clinical trial institutions. Methods: According to the requirements of COVID-19 epidemic prevention and control policies and the national guiding principles for drug clinical trial management, combining the experience of our hospital, we optimized the working process and proposed management measures in four aspects including project and personnel management, subject follow-up management, drug distribution management, and communication between all parties involved in clinical trials. Results and conclusions: During the period of COVID-19 epidemic, our hospital has taken a series of measures which ensured the smooth implementation of more than 200 drug clinical trials and protected the safety and rights of subjects and researchers.

Practical strategies for qualitative inquiry in a virtual world.

AIM: The aim of this article is to provide practical strategies for maintaining methodological rigour in executing a virtual qualitative study. Strategies are based on evidence from existing research about virtual qualitative methods and on the strategies used by the authors to convert a planned in-person qualitative, grounded theory study to an entirely virtual grounded theory study during the COVID-19 pandemic. The study began in-person in September 2019 and was converted to virtual in March 2020. Virtual data collection was completed in September 2020. DESIGN: This article provides a case exemplar of virtual adaptations made to a study underway when the pandemic rendered all in-person research impractical and potentially dangerous. DATA SOURCES: The strategies discussed are based on our own experiences and the supporting theoretical assumptions of qualitative research, specifically grounded theory methods. IMPLICATIONS FOR NURSING: Nursing scholars conducting qualitative inquiry may find these strategies helpful in continuing research activities during periods of limited access to the phenomena or persons of interest. Furthermore, these strategies allow nursing scholars to conduct rigorous, in-depth research without geographical limitations, providing greater possibilities for international collaborations and cross-institution research. CONCLUSION: Despite novel challenges, methodological adaptations that are carefully planned and purposeful allow qualitative and non-qualitative scholars to continue research activities in a fully virtual manner. IMPACT: This case exemplar and discussion provide practical strategies for qualitative scholars to consider while planning new studies or converting an in-person study to a virtual one. Despite the in-person nature of in-depth qualitative inquiry, a historic pandemic and a changing research environment require qualitative researchers to adapt to virtual methods while still conducting high quality, methodologically rigorous research. Qualitative scholars can use the strategies presented here to continue rigorous qualitative inquiry despite limited access to phenomena or persons.

Capturing COVID-19-Like Symptoms at Scale Using Banner Ads on an Online News Platform: Pilot Survey Study.

BACKGROUND: Identifying new COVID-19 cases is challenging. Not every suspected case undergoes testing, because testing kits and other equipment are limited in many parts of the world. Yet populations increasingly use the internet to manage both home and work life during the pandemic, giving researchers mediated connections to millions of people sheltering in place. OBJECTIVE: The goal of this study was to assess the feasibility of using an online news platform to recruit volunteers willing to report COVID-19-like symptoms and behaviors. METHODS: An online epidemiologic survey captured COVID-19-related symptoms and behaviors from individuals recruited through banner ads offered through Microsoft News. Respondents indicated whether they were experiencing symptoms, whether they received COVID-19 testing, and whether they traveled outside of their local area. RESULTS: A total of 87,322 respondents completed the survey across a 3-week span at the end of April 2020, with 54.3% of the responses from the United States and 32.0% from Japan. Of the total respondents, 19,631 (22.3%) reported at least one symptom associated with COVID-19. Nearly two-fifths of these respondents (39.1%) reported more than one COVID-19-like symptom. Individuals who reported being tested for COVID-19 were significantly more likely to report symptoms (47.7% vs 21.5%; P<.001). Symptom reporting rates positively correlated with per capita COVID-19 testing rates (R2=0.26; P<.001). Respondents were geographically diverse, with all states and most ZIP Codes represented. More than half of the respondents from both countries were older than 50 years of age. CONCLUSIONS: News platforms can be used to quickly recruit study participants, enabling collection of infectious disease symptoms at scale and with populations that are older than those found through social media platforms. Such platforms could enable epidemiologists and researchers to quickly assess trends in emerging infections potentially before at-risk populations present to clinics and hospitals for testing and/or treatment.

Facilitators, Challenges, and Messaging Strategies for Hispanic/Latino Populations Participating in Alzheimer's Disease and Related Dementias Clinical Research: A Literature Review.

Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) disproportionally affect Hispanic and Latino populations, yet Hispanics/Latinos are substantially underrepresented in AD/ADRD clinical research. Diverse inclusion in trials is an ethical and scientific imperative, as underrepresentation reduces the ability to generalize study findings and treatments across populations most affected by a disease. This paper presents findings from a narrative literature review (N = 210) of the current landscape of Hispanic/Latino participation in clinical research, including the challenges, facilitators, and communication channels to conduct culturally appropriate outreach efforts to increase awareness and participation of Hispanics/Latinos in AD/ADRD clinical research studies. Many challenges identified were systemic in nature: lack of culturally relevant resources; staffing that does not represent participants' cultures/language; eligibility criteria that disproportionately excludes Hispanics/Latinos; and too few studies available in Hispanic/Latino communities. The paper also details facilitators and messaging strategies to improve engagement and interest among Hispanics/Latinos in AD/ADRD research, starting with approaches that recognize and address the heterogeneity of the Hispanic/Latino ethnicity, and then, tailor outreach activities and programs to address their diverse needs and circumstances. The needs identified in this article represent longstanding failures to improve engagement and interest among Hispanics/Latinos in AD/ADRD research; we discuss how the field can move forward learning from the experiences of the COVID-19 pandemic.

SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Healthy Young Adults First.

In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (WHO) as an alternative to conventional approaches. In such trials, healthy volunteers are deliberately infected with the pathogen of interest, enabling scientists to study the infection process and facilitate further research on treatments or prophylactics, including vaccines. While human challenge trials would offer a collective benefit to society, minimizing the risks is always difficult. Ethical controversy thus inevitably surrounds these trials. Typically, healthy young adults are recruited to serve as the first candidate subjects for human challenge trials because they are generally considered to represent a low-risk population. Here, we present three reasons for doubt about this healthy-young-adults-first criterion and give justification for also recruiting healthy older adults (or not-young adults), meaning those over 30 years of age, to participate in such trials for SARS-CoV-2.