Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.

Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The digital site-less approach employed in the "Test Us At Home" study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.

Overcoming the challenges of recruiting and interviewing patients following critical illness.

BACKGROUND: The strict restrictions implemented in England during the COVID-19 pandemic meant it was no longer possible to recruit or interview participants in person. However, virtual recruitment and interviews are not without their challenges, particularly when exploring sensitive topics. AIM: To discuss how to overcome some of the challenges involved in recruiting and interviewing participants who have been critically ill with COVID-19. DISCUSSION: An exploratory, descriptive study was conducted involving interviews with 20 people who had been critically ill with COVID-19 and had been discharged from two community-based healthcare settings in London, England. Participants were interviewed at home after being discharged from hospital after at least one month. The sensitivity of the research topic meant strategies for recruiting and interviewing needed to be adapted, including involving patient experience facilitators, using virtual interviews, managing the distress of participants and self-care for the researchers. CONCLUSION: The adaptations used in this study can be used in research involving people who have been critically ill. IMPLICATIONS FOR PRACTICE: Researchers can explore innovative ways to recruit participants using hospital or community staff who are not usually involved in research. Virtual interviews require additional skills, such as building rapport with participants, so may require additional training. A distress protocol for participants should always be considered when discussing sensitive topics. Self-care and debrief strategies for interviewers are also critical.

Collaborative development of an innovative virtual research recruitment strategy through an academic/clinical partnership.

PURPOSE: Recruitment for research studies is the crucial first step and often the most challenging one. A major shift in recruitment methods for research was necessitated by the onset of the COVID-19 pandemic. Our goal is to describe lessons learned and the success rate of virtual research recruitment compared with other research recruitment strategies employed by our Academic/Clinical Partnership research team. METHODS: A descriptive design was employed to assess the success of in-person, mailed introductory letters with follow-up telephone calls and virtual recruitment strategies. The potential participants (N = 144) were parents caring for technology-dependent children (e.g., mechanical ventilation, feeding tubes) at home. To meet recruitment goals the Academic/Clinical Partnership research team (academic project team, hospital-based research nurses) collaboratively developed creative recruitment strategies and a framework to assess recruitment strategy success; percentage who agreed to be contacted by the academic partner, total time for recruitment visit, efficiency, and adherence to ethical recruitment principles. RESULTS: Virtual recruitment via telehealth visits was highly successful meeting all recruitment strategy benchmarks. Importantly, 91.7 % of potential participants that were approached agreed to be contacted for enrollment in a time efficient manner while adhering to ethical recruitment principles. Best practices and lessons learned were identified. CONCLUSIONS: The transition to virtual study recruitment due to the pandemic was an innovative and successful strategy. An Academic/Clinical Partnership research team benefits both partners: (1) enhances study recruitment by increasing research capacity at the clinical site; and (2) provides mentoring by nurse scientists to facilitate nurse research scholar knowledge and skills.

Engaging nurses in patient recruitment to research trials in the emergency department.

Research is essential for the implementation of evidence-based practice and can lead to improvements and innovations in care delivery. Although ultimately beneficial for patients and staff, the data collection involved in research often presents challenges, particularly in the emergency department (ED) setting. This article describes the challenges of undertaking a feasibility trial in a city centre ED. The target research population were adult patients who presented to the ED with an issue related to opioid misuse, for example opioid overdose, injection site wounds and/or abscess, or injury sustained during opioid intoxication. Challenges experienced during this trial included a demanding work environment, ED attendees not being suitable for recruitment into research, and suspension of the trial during the coronavirus disease 2019 (COVID-19) pandemic. The author details the strategies introduced to ensure effective patient recruitment to the trial, including nurse secondment onto the research team, offering incentives, raising awareness of the trial among ED staff and implementing flexible training. These strategies continued to be effective after a period of suspension due to the COVID-19 pandemic.

The impact of COVID-19 on doctoral research: adapting to the challenges and the opportunities of disruption.

BACKGROUND: The author is a professional doctorate student and full-time nurse in an education role in a UK NHS Trust. COVID-19 caused a major disruption to her research, which focused on nursing workforce development in primary care. She received ethical approval for the research in February 2020 and had just begun to collect data as the country entered its first period of lockdown and all activity not related directly to COVID-19 was sidelined. AIM: To share the author's reflections on this experience and make recommendations that may help others whose research is disrupted. DISCUSSION: The author had not considered in her plans the disruption that would be caused by COVID-19, but she adapted her study's design to minimise some of its effects and also discovered some new opportunities. CONCLUSION: Nurse researchers whose studies are disrupted can adapt to overcome the challenges and try to find new opportunities. IMPLICATIONS FOR PRACTICE: The author hopes that sharing her reflections will encourage other nurse researchers who face unexpected disruptions to their research.

Comparison of Communication Channels for Large-Scale Type 2 Diabetes Risk Screening and Intervention Recruitment: Empirical Study.

BACKGROUND: Clinical trials have shown that type 2 diabetes (T2D) is preventable through lifestyle interventions targeting high-risk people. Nevertheless, large-scale implementation of risk identification followed by preventive interventions has proven to be challenging. Specifically, recruitment of participants into preventive interventions is an important but often overlooked part of the intervention. OBJECTIVE: This study aims to compare the reach and yield of different communication channels to engage people at increased risk of T2D to fill in a digital screening questionnaire, with emphasis on reaching those at most risk. The participants expressing their willingness to participate is the final step in the risk screening test, and we aim to determine which channels had the most participants reach this step. METHODS: We established a stepwise web-based T2D risk screening tool with automated feedback according to the T2D risk level and, for those who were eligible, an invitation to participate in the StopDia prevention intervention study conducted in a primary health care setting. The risk estimate was based on the Finnish Diabetes Risk Score; history of repeatedly measured high blood glucose concentration; or, among women, previous gestational diabetes. We used several channels to invite people to the StopDia web-based screening tool, and respondents were classified into 11 categories based on the channel through which they reported having learned about StopDia. The demographics of respondents reached via different communication channels were compared using variance analysis. Logistic regression was used to study the respondents' likelihood of progressing through risk screening steps. RESULTS: A total of 33,399 persons started filling the StopDia screening tool. Of these, 86.13% (28,768/33,399) completed the test and named at least one communication channel as the source of information about StopDia. Altogether, 26,167 persons filled in sufficient information to obtain risk estimates. Of them, 53.22% (13,925/26,167) were at increased risk, 30.06% (7866/26,167) were men, and 39.77% (10,136/25,485) had low or middle education levels. Most frequently mentioned channels were workplace (n=6817), social media or the internet (n=6712), and newspapers (n=4784). The proportion of individuals at increased risk was highest among those reached via community pharmacies (415/608, 68.3%) and health care (1631/2535, 64.33%). The communication channel reaching the largest percentage of interested and eligible men (1353/3979, 34%) was relatives or friends. Health care (578/1069, 54.07%) and radio or television (225/487, 46.2%) accounted for the largest proportion of people with lower education. CONCLUSIONS: Communication channels reaching a large number of people, such as social media and newspapers, were the most effective channels for identifying at-risk people. Personalized approaches increased the engagement of men and less-educated people. Community pharmacies and health care services reached people with a particularly high T2D risk. Thus, communication and recruitment channels should be selected and modified based on the intended target group. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6574-y.

Lessons learned recruiting a diverse sample of rural study participants during the COVID-19 pandemic.

Residents of rural areas have been a hard-to-reach population for researchers. Geographical isolation and lower population density in rural areas can make it particularly challenging to identify eligible individuals and recruit them for research studies. If the study is about a stigmatizing topic, such as opioid overdose, recruitment can be even more difficult due to confidentiality concerns and distrust of outside researchers. This paper shares lessons learned, both successes and failures, for recruiting a diverse sample of rural participants for a multi-state research study about naloxone, an opioid overdose reversal agent. In addition, because our recruitment spanned the period before and after the COVID-19 pandemic in the U.S., we share lessons learned regarding the transition to all remote recruitment and data collection. We utilized various recruitment strategies including rural community pharmacy referrals, community outreach, participant referrals, mass emails, and social media with varying degrees of success. Among these modalities, pharmacist referrals and community outreach produced the highest number of participants. The trust and rapport that pharmacists have with rural community members eased their concerns about working with unknown researchers from outside their communities and facilitated study team members' ability to contact those individuals. Even with the limited in-person options during the pandemic, we reached our recruitment targets by employing multiple recruitment strategies with digital flyers and emails. We also report on the importance of establishing trust and maintaining honest communication with potential participants as well as how to account for regional characteristics to identify the most effective recruitment methods for a particular rural area. Our suggested strategies and recommendations may benefit researchers who plan to recruit underrepresented minority groups in rural communities and other historically hard-to-reach populations for future studies.

How nurses can support the inclusion in research of older people who lack capacity to consent.

Research is important because it underpins evidence-based care. However, people who lack capacity to consent are often excluded from research, due partly to ethical concerns and practical challenges, and partly to a lack of awareness among professionals of the legal framework that supports their inclusion. The COVID-19 pandemic, which has extensively affected care home residents, has reinforced the importance of including older people with cognitive impairment in research. Nurses who care for older people with impaired cognition have an important role in ensuring these people have the opportunity to contribute to and benefit from research. This article discusses some of the challenges associated with the inclusion in research of older people who lack capacity to consent, including the involvement of relatives and friends in decision-making. The article describes the findings of recent research and shares resources with the aim of supporting nurses to ensure that older people in their care who lack capacity can participate in research.