Understanding facilitators of research participation among adults with self-reported chronic pain - a survey examining hypothetical research participation.

BACKGROUND: An inability to successfully recruit participants into clinical research has consequences that negatively affect the conduct and reliability of research studies. Understanding facilitators of research participation, namely motives for participation and preferred research outcomes, may improve recruitment and retention of clinical trials related to chronic pain. The present study explored research participation facilitators among individuals with chronic pain and their association with demographic characteristics, pain-related characteristics, and factors related to future research engagement. METHODS: Individuals from Michigan who were 18 years or older and self-reported having chronic pain completed an online survey assessing motives for research participation and desired research outcomes. Analyses were conducted in three stages. First, we evaluated underlying factors of motives for participation and research outcome preferences using principal components analysis. Second, we classified individuals according to their patterns of facilitators using latent profile analysis. Finally, we evaluated differences between facilitator profiles in demographic characteristics, pain-related characteristics, and factors related to future research engagement using χ2 analyses and Kruskal-Wallis rank sum tests. RESULTS: Three components of motives for research participation were identified: social engagement/enjoyment; pain improvement/advancing science; and compensation. Three components of research outcome preferences were identified: co-occurring symptom reduction; behavior reduction modification; and pain and function improvement. Four potential patient-centered profiles utilizing these dimensions of facilitators were identified that had unique demographic characteristics, research participation willingness, and treatment interest. CONCLUSIONS: Our data provide a framework of motives and research outcome preferences that may inform recruitment and retention in chronic pain research. It also gives an indication of who may respond best to active or passive recruitment strategies that appeal to a given motive or preferred outcome. This information may be useful for improving recruitment and to monitor any potential biases in participant samples.

Engaging Black sexual minority women in breast cancer research: Lessons in community partnerships.

BACKGROUND: Black sexual minority women (BSMW) face significant breast cancer health inequities and are underrepresented in health research because of historical and present-day exclusion. However, there exists no peer-reviewed literature on best practices for the inclusion of BSMW in cancer research. "Our Breast Health: The Access Project" was a national primary data collection study in June 2018 through October 2019 that aimed to identify facilitators and barriers to breast cancer care among BSMW, and that successfully recruited the highest number of BSMW for any national breast cancer screening study at the time of its publication. METHODS: The present analysis highlights best practices for reaching BSMW by examining by how effective various recruitment sources were at recruiting BSMW. Recruitment partners were grouped into several categories: (1) cancer focused, (2) Black women or sexual minority women focused, (3) BSMW focused, (4) social media, and (5) other. Then logistic regression was used to estimate the odds that a particular recruitment source category could recruit BSMW compared with other categories. RESULTS: Partnerships with community-based organizations led by and intended for BSMW were the most successful at recruiting BSMW, demonstrating the importance of an intersectional approach to recruitment. Community-based organizations focused on BSMW specifically were 26 times more successful in recruiting BSMW to the study compared with recruiting Black women who were not sexual minorities (odds ratio, 26.43 [95% CI, 7.50-93.10]). CONCLUSIONS: Successful recruitment enables breast cancer research grounded in the perspectives of BSMW, which can generate key findings that have the potential to remedy longstanding health inequities for this population.

Nominal Versus Realized Costs of Recruiting and Retaining a National Sample of Sexual Minority Adolescents in the United States: Longitudinal Study.

BACKGROUND: Web-based recruitment for research studies is becoming increasingly popular and necessary. When compared with the traditional methods of recruitment, these methods may enable researchers to reach more diverse participants in less time. Social media use is highly prevalent among adolescents, and the unique context of social media may be particularly important for the recruitment of sexual minority young people who would not be captured by traditional methods. OBJECTIVE: This paper described the details of a national web-based study recruitment approach aimed at sexual minority adolescents across the United States, focusing on important details of this relatively novel approach, including cost, time efficiency, and retention outcomes. METHODS: This study recruited sexual minority adolescents aged 14-17 years living in the United States through targeted advertisements on Facebook, Instagram, and YouTube and through respondent-driven sampling (RDS). Potential participants completed eligibility screening surveys and were automatically directed to a baseline survey if they were eligible. After baseline survey completion, additional data checks were implemented, and the remaining participants were contacted for recruitment into a longitudinal study (surveys every 6 months for 3 years). RESULTS: Recruitment lasted 44 weeks, and 9843 participants accessed the initial screening survey, with 2732 (27.76%) meeting the eligibility criteria and completing the baseline survey. Of those, 2558 (93.63%) were determined to have provided nonfraudulent, usable study data and 1076 (39.39%) subsequently enrolled in the longitudinal study. Of the baseline sample, 79.05% (2022/2558) was recruited through Facebook and Instagram, 3.05% (78/2558) through YouTube, and 17.9% (458/2558) through RDS. The average cost of recruiting a participant into the study was US $12.98, but the recruitment cost varied by method or platform, with a realized cost of US $13 per participant on Facebook and Instagram, US $24 on YouTube, and US $10 through RDS. Participant differences (sex assigned at birth, race and ethnicity, sexual orientation, region, and urbanicity) were identified between platforms and methods both in terms of overall number of participants and cost per participant. Facebook and Instagram were the most time efficient (approximately 15 days to recruit 100 participants), whereas RDS was the least time efficient (approximately 70 days to recruit 100 participants). Participants recruited through YouTube were the most likely to be longitudinally retained, followed by Facebook and Instagram, and then RDS. CONCLUSIONS: Large differences exist in study recruitment cost and efficiency when using social media and RDS. Demographic, region, and urbanicity differences in recruitment methods highlight the need for attention to demographic diversity when planning and implementing recruitment across platforms. Finally, it is more cost-effective to retain than recruit samples, and this study provided evidence that with thorough screening and data quality practices, social media recruitment can result in diverse, highly involved study populations.

The PPD-ACT app in Canada: feasibility and a latent class analysis of participants with postpartum depression recruited to a psychiatric genetics study using a mobile application.

BACKGROUND: Postpartum depression (PPD) and postpartum psychosis (PPP) are linked to negative consequences for women and families. Virtual applications present a solution to the challenge of recruiting large samples for genetic PPD/PPP research. This study aimed to evaluate the feasibility of a protocol for enrolling Canadian women with PPD and PPP to a large international psychiatric genetics study using a mobile application (PPD-ACT), and identify clinically distinct subtypes of PPD in the recruited sample. METHODS: From April 2017-June 2019, Canadian women provided phenotypic data through the PPD-ACT app. Requests for a genetic sample were made from those with a current or past PPD episode based on an Edinburgh Postnatal Depression Scale (EPDS) score > 12 with onset in pregnancy or 0-3 months postpartum, and from those self-reporting lifetime PPP. Latent class analysis (LCA) was used to identify clinically distinct PPD subgroups based on participant responses to the EPDS scale. RESULTS: We identified 797 PPD cases, 404 of whom submitted DNA. There were 109 PPP cases, with 66 submitting DNA. PPD cases (86.7% White, mean 4.7 +/- 7.0 years since their episode) came from across Canadian provinces/territories. LCA identified two PPD classes clinically distinct by symptom severity: [1] moderate-severity (mean EPDS = 18.5+/- 2.5; 8.6% with suicidality), and [2] severe (mean EPDS = 24.5+/- 2.1; 52.8% with suicidality). CONCLUSIONS: A mobile application rapidly collected data from individuals with moderate and severe symptoms of PPD, an advantage for genetics where specificity is optimal, as well as from women with a history of PPP, supporting future work using this approach.

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.

Recruiting people facing social disadvantage: the experience of the Free Meds study.

BACKGROUND: Researching access to health services, and ways to improve equity, frequently requires researchers to recruit people facing social disadvantage. Recruitment can be challenging, and there is limited high quality evidence to guide researchers. This paper describes experiences of recruiting 1068 participants facing social disadvantage for a randomised controlled trial of prescription charges, and provides evidence on the advantages and disadvantages of recruitment methods. METHODS: Those living in areas of higher social deprivation, taking medicines for diabetes, taking anti-psychotic medicines, or with COPD were eligible to participate in the study. Several strategies were trialled to meet recruitment targets. We initially attempted to recruit participants in person, and then switched to a phone-based system, eventually utilising a market research company to deal with incoming calls. We used a range of strategies to publicise the study, including pamphlets in pharmacies and medical centres, media (especially local newspapers) and social media. RESULTS: Enrolling people on the phone was cheaper on average than recruiting in person, but as we refined our approach over time, the cost of the latter dropped significantly. In person recruitment had many advantages, such as enhancing our understanding of potential participants' concerns. Forty-nine percent of our participants are Maori, which we attribute to having Maori researchers on the team, recruiting in areas of high Maori population, team members' existing links with Maori health providers, and engaging and working with Maori providers. CONCLUSIONS: Recruiting people facing social disadvantage requires careful planning and flexible recruitment strategies. Support from organisations trusted by potential participants is essential. REGISTRATION: The Free Meds study is registered with the Australian and New Zealand Clinical Trials Registry ( ACTRN12618001486213 ).

Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research.

AIM: Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role. BACKGROUND: Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The 'caring-recruiting' dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction. DESIGN: This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The 'caring-recruiting' dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research. CONCLUSION: The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as 'hard to reach' was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues. RELEVANCE TO WORKFORCE DEVELOPMENT: This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.

Effectiveness of incentives and follow-up on increasing survey response rates and participation in field studies.

BACKGROUND: Questionnaires are valuable data collection instruments in public health research, and can serve to pre-screen respondents for suitability in future studies. Survey non-response leads to reduced effective sample sizes and can decrease representativeness of the study population, so high response rates are needed to minimize the risk of bias. Here we present results on the success of different postal questionnaire strategies at effecting response, and the effectiveness of these strategies at recruiting participants for a field study on the effects of aircraft noise on sleep. METHODS: In total, we mailed 17 rounds of 240 questionnaires (total n = 4080) to randomly selected households around Atlanta International Airport. Different mailing rounds were varied in the length of the questionnaire (11, 26 or 55 questions), survey incentive (gift card or $2 cash), number of follow-up waves (0, 2 or 3), incentive for participating in a 5-night in-home sleep study ($100, $150 or $200), and address personalization. RESULTS: We received completed questionnaires from 407 respondents (response rate 11.4%). Personalizing the address, enclosing a $2 cash incentive with the initial questionnaire mailing and repeated follow-up mailings were effective at increasing response rate. Despite the increased expense of these approaches in terms of each household mailed, the higher response rates meant that they were more cost-effective overall for obtaining an equivalent number of responses. Interest in participating in the field study decreased with age, but was unaffected by the mailing strategies or cash incentives for field study participation. The likelihood that a respondent would participate in the field study was unaffected by survey incentive, survey length, number of follow-up waves, field study incentive, age or sex. CONCLUSIONS: Pre-issued cash incentives and sending follow-up waves could maximize the representativeness and numbers of people from which to recruit, and may be an effective strategy for improving recruitment into field studies.

Recruiting Older African Americans to Brain Health and Aging Research Through Community Engagement: Lessons from the African-American Brain Health Initiative at Rutgers University-Newark.

The African-American Brain Health Initiative at Rutgers University-Newark is a university-community partnership combining community engagement, education and training, and brain health research. Partnering with community-based organizations, it promotes brain health literacy, Alzheimer's awareness, brain-healthy lifestyle choices, and participation in brain research for older African Americans in Greater Newark, New Jersey. Our approach to recruitment relies on building trust through long-term relationships; communicating health knowledge through trusted community leaders; recruiting subjects through targeted efforts; and cultivating research participants as ambassadors.

Comparison of Three Popular Methods for Recruiting Young Persons Who Inject Drugs for Interventional Studies.

Persons who inject drugs (PWID) are at risk for adverse health outcomes as a result of their drug use, and the resulting social stigma makes this a difficult population to reach for interventions aimed at reducing morbidity and mortality. During our study of adult PWID aged ≤40 years living in San Diego during 2009 and 2010, we compared three different sampling methods: respondent-driven sampling (RDS), venue-based sampling at one syringe exchange program (SEP), and street-based outreach. We compared demographic, socioeconomic, health, and behavioral factors and tested participants for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) and compared across the three methods. Overall, 561 (74.8%) of the targeted 750 PWID were enrolled. Venue-based convenience sampling enrolled 96% (242/250) of the targeted participants, followed closely by street-based outreach with 92% (232/250) recruited. While RDS yielded the fewest recruits, producing only 35% (87/250) of the expected participants, those recruited through RDS were more likely to be female, more racially diverse, and younger.

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies.

BACKGROUND: African-American and Latino patients are often difficult to recruit for asthma studies. This challenge is a barrier to improving asthma care and outcomes for these populations. OBJECTIVES: We sought to examine the recruitment experiences of 8 asthma comparative effectiveness studies that specifically targeted African-American and Latino patients, and identify the solutions they developed to improve recruitment. METHODS: Case report methodology was used to gather and evaluate information on study design, recruitment procedures and outcomes from study protocols and annual reports, and in-depth interviews with each research team. Data were analyzed for themes, commonalities, and differences. RESULTS: There were 4 domains of recruitment challenges: individual participant, institutional, research team, and study intervention. Participants had competing demands for time and some did not believe they had asthma. Institutional challenges included organizational policies governing monetary incentives and staff hiring. Research team challenges included ongoing training needs of recruitment staff, and intervention designs often were unappealing to participants because of inconveniences. Teams identified a host of strategies to address these challenges, most importantly engagement of patients and other stakeholders in study design and troubleshooting, and flexibility in data collection and intervention application to meet the varied needs of patients. CONCLUSIONS: Asthma researchers may have greater success with recruitment by addressing uncertainty among patients about asthma diagnosis, engaging stakeholders in all aspects of study design and implementation, and maximizing flexibility of study and intervention protocols. However, even with such efforts, engagement of African-American and Latino patients in asthma research may remain low. Greater investment in research on engaging these populations in asthma research may ultimately be needed to improve their asthma care and outcomes.

The ß-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial.

BACKGROUND: ß-Blocking agents reduce cardiovascular mortality in patients with heart disease, but their potential benefit in dialysis patients is unclear. We aimed to determine the feasibility of a randomized controlled trial (RCT). STUDY DESIGN: Pilot RCT. SETTING & PARTICIPANTS: Patients who received dialysis for 3 or more months and were 50 years or older (or ≥18 years with diabetes or cardiovascular disease) were recruited from 11 sites in Australia and New Zealand. We aimed to recruit 150 participants. INTERVENTION: After a 6-week run-in with the ß-blocker carvedilol, we randomly assigned participants to treatment with carvedilol or placebo for 12 months. OUTCOMES & MEASUREMENTS: The prespecified primary outcome was the proportion of participants who tolerated carvedilol, 6.25mg, twice daily during the run-in period. After randomization, we report participant withdrawal and the incidence of intradialytic hypotension (IDH). RESULTS: Of 1,443 patients screened, 354 were eligible, 91 consented, and 72 entered the run-in stage. 49 of 72 run-in participants (68%; 95% CI, 57%-79%) achieved the primary outcome. 5 of the 23 withdrawals from run-in were attributable to bradycardia or hypotension. After randomization, 10 of 26 allocated to carvedilol and 4 of 23 allocated to placebo withdrew. 4 participants randomly assigned to carvedilol withdrew because of bradycardia or hypotension. Overall, there were 4 IDH events per 100 hemodialysis sessions; in participants allocated to carvedilol versus placebo, respectively, there were 7 versus 2 IDH events per 100 hemodialysis sessions (P=0.1) in the 2 weeks immediately following a dose increase and 4 versus 3 IDH events per 100 hemodialysis sessions after no dose increase (P=0.7). LIMITATIONS: Unable to recruit planned sample size. CONCLUSIONS: Recruiting patients receiving dialysis to an RCT of ß-blocker versus placebo will prove challenging. Possible solutions include international collaboration and exploring novel trial designs such as a registry-based RCT.

Recruitment strategies at the Iowa site for parent/infant pairs in a longitudinal dental caries study.

BACKGROUND/AIMS: Recruitment of parent/infant pairs can be more difficult and challenging than recruitment of adult subjects alone as the parent has to consider themselves along with the infant to be study participants. In order to determine which recruitment methods most effectively resulted in accrual of subjects, recruitment efforts at the University of Iowa were evaluated, one of three clinical sites involved in a longitudinal prospective study of dental caries. METHODS: Enrollment goals were 300 parent/infant pairs within a year. Recruitment strategies included (1) a direct mailing to potential subjects who were University of Iowa Hospitals and Clinics patients and potentially met inclusion criteria; (2) face-to-face recruitment visits at medical offices; (3) provision of recruitment materials to staff at off-campus agencies and medical offices serving low-income individuals; (4) a campus-wide mass e-mail; (5) recruitment materials to daycare centers and neighborhood centers; and (6) recruitment at a children's museum. RESULTS: From these recruitment efforts, 515 potential participants expressed interest and were screened for this study and 348 (68%) were enrolled during an 11-month time period. The face-to-face strategy had the highest recruitment rate of 25%, followed by direct individual mailings at 9% and follow-up telephone calls at 7%. For the face-to-face strategy, the contact at the children's museum was most successful compared to the other office settings. The lowest rate of recruitment of 0.09% was attained with the mass e-mail. However, in terms of actual numbers recruited, the mass e-mail remained an important modality since it yielded 21 recruits and was much less time-intensive. CONCLUSION: An intensive, multi-pronged recruitment strategy proved successful in meeting enrollment goals and resulted in finishing the enrollment prior to the projected study deadline. Effective recruitment approaches are imperative for a study's success and each recruitment strategy needs to be budgeted and planned for in a study. Investigators may need to adapt their approach to attain the needed number of subjects. Planning needs to include the numbers needed to be approached to attain your recruitment goal, how you will recruit, who will be responsible, and the costs and time commitment for various strategies.

Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia.

BACKGROUND: Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials. The Silent Cerebral Infarct Multi-Center Clinical (SIT) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children. Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease (SCD) and silent cerebral infarct (SCI) in the SIT Trial after initial consent. PROCEDURE: Differences in socio-economic and demographic variables, family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent. Head of household educational level and family income were examined separately for US versus non-US sites. RESULTS: Of 1,176 children enrolled in the SIT Trial, 1,016 (86%) completed screening. Of 208 (20%) children with qualifying SCI on pre-randomization MRI, 196 (94%) were successfully randomized. There were no differences in socio-economic, demographic, or disease-related variables between children who were or were not randomized. Participants from non-US sites were more likely to be randomized (22% vs. 12%, P = 0.011); although, randomization by country was associated with neither head of household education nor family income. CONCLUSION: In the SIT Trial, acceptance of random allocation was not associated with socio-economic or demographic factors. Although these factors may represent barriers for some participants, they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation.

Recruitment of Row Crop Farmers into a Research Study to Assess Farm Hazards.

Farmers are at an elevated risk for injuries and are, therefore, highly sought after for research studies. However, their participation in research studies is low. We examine how characteristics of the farmer, farm location, and timing of recruitment contact impact the probability that farmers will engage and participate in a study of injuries and related farm hazards. Study data were obtained from the Farm Safety Study conducted at the University of Iowa between June 2019 and March 2020. We used recruitment data from participants enrolled using Farm Journal magazine subscription lists. Multinomial logistic regression was used for predictive modeling. Predictor variables included the time of day and the farm season in which phone contact for study recruitment was attempted, as well as the rurality of the farm. Two models were created to characterize screening and participation of farmers in the study. Farm season and time of day of the last recruitment call increased the likelihood of farmers being screened for study participation and completing the study. Specifically, contacting farmers during the growing season and during the daytime, regardless of farm rurality, resulted in higher probabilities of participation. Studies of agricultural injury may be more efficiently conducted, with higher participation responses, when circumstances of the recruitment call are considered. This work serves as a starting place for much-needed methodological research to identify factors that increase participation of farmers and farm workers in research studies.

Using social media to recruit research participants: a literature review.

BACKGROUND: It may be challenging for researchers to recruit enough participants to have a diverse and representative sample for their studies. Usual recruitment methods that were historically effective can be difficult to use because of high costs, time constraints and geographical limitations. Social media is a low-cost, time-saving alternative. AIM: To summarise the benefits and challenges of using social media for recruitment. DISCUSSION: This article provides an overview of social media. It considers the advantages of social media for recruitment, including its cost-effectiveness, accessibility, speed and potential exposure for researchers. It also discusses the challenges of using social media for recruitment, including ethical ambiguity, homogenous sampling and questionable validity of information gathered. CONCLUSION: Using social media for research saves time and reduces costs, increasing access to hard-to-reach populations and the reach of recruitment efforts. IMPLICATIONS FOR PRACTICE: Options for researchers wishing to use social media for study recruitment are outlined, as are strategies for managing some of the challenges involved in this recruitment method.

Best practices for recruitment in veterinary clinical trials.

A successful clinical trial requires participants, but many factors can impede effective study recruitment. To better recruit for quality veterinary clinical trials in client-owned animals that lead to improved evidence-based patient care and outcomes, there is a collective need to share and implement current best practices for recruitment strategies. These strategies should utilize a holistic view of recruitment, encompassing study design and logistics, representative participation, incentives, personnel resources, advertising, and participant retention. Although human clinical trial data and resources can provide guidance, effort also needs to be put into evaluating current practices and opportunities for process improvement that are specific to the conduct of veterinary clinical trials. Considering the power of pets as naturally occurring models of disease and as sentinels, improved conduct of veterinary clinical research has the potential to inform human health outcomes. Continued development of collaborations surrounding best practices and training opportunities in veterinary clinical research will improve the impact of veterinary clinical trials teams, while also promoting workforce development and alternate career paths for veterinary professionals.

Research staff's experiences of how the COVID-19 pandemic impacted recruitment for a paediatric network study.

PURPOSE: Since the COVID-19 pandemic, a paediatric network study with clinical sites across Canada suffered a reduction in participation. When research studies fail to meet enrolment targets, it can reduce the strength and validity of the results. This study explores research staff's experiences of how the COVID-19 pandemic impacted recruitment for a paediatric network study. METHODS: This study was conducted using a qualitative design. Focus group sessions were used to gain the perspective of research staff involved in recruitment and transcripts were analysed using Colaizzi's seven-step method of data analysis. RESULTS: Analysis revealed four major themes: (1) the COVID-19 pandemic had an impact on research activity; (2) families of children with medical complexity perform a risk-benefit assessment when deciding whether to take part in research; (3) a trusting relationship with clinicians is a key factor in research recruitment; and (4) research needs to be flexible in order to adapt to evolving contexts. CONCLUSION: This study identified both COVID-19 and non-COVID-19-related factors that impacted study recruitment for a paediatric network study. Understanding and addressing these challenges will mitigate the negative impacts on health outcomes that can occur when research studies fail to meet enrolment targets.

Research protocol and recruitment redesign of a study of pregnant women and their infants during the COVID-19 pandemic: Childhood Allergy and the NeOnatal Environment (CANOE).

Background: Recruitment for research studies is a challenging endeavor that was further complicated by the coronavirus disease 2019 pandemic. We launched a new multicenter birth cohort, Childhood Allergy and the NeOnatal Environment (CANOE), supported by the National Institutes of Health in January 2020 across 4 sites. Although the pandemic temporarily halted clinical research, we restructured the study and instituted novel recruitment methods that we hypothesized would enable brisk enrollment when research activities resumed. Objective: We sought to develop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic. Methods: Even though study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods such as clinician referrals, institutional social media, and telemedicine screening and consent procedures. Protocol changes included reducing the frequency of in-person visits, leveraging clinical care visits to collect biospecimens, expanded self-collection of samples at home, and making study materials available online. Results: Remote methods, including targeted social media posts, mailed letters, and email, combined with in-clinic recruitment with modifications for social distancing led to successful recruitment at all sites. Rates of consent have been similar across recruitment sites, with the highest rates of enrollment of mother-infant dyads realized by sites that implemented multiple recruitment strategies. Conclusions: Study procedures that prioritize health and safety measures such as social distancing, study participant convenience, and use diverse recruitment strategies enable successful enrollment of pregnant women and their newborns into clinical research while adhering to public health restrictions during a global pandemic.

Using the principles of practice development to address challenges in recruitment and data collection when face-to-face methods are unavailable.

BACKGROUND: Researchers conducting studies involving pregnant women often find recruitment challenging. The COVID-19 pandemic added further complexity to studies requiring face-to-face participation. AIM: To demonstrate how to maintain the principles of practice development (PD) when a study must switch from face-to-face to remote methods of collecting data. DISCUSSION: The number of participants in the authors' study increased when they moved from face-to-face to telephone engagement during the COVID-19 pandemic. They continued using PD principles when they changed method and the quality of the data they collected remained constant, even once lockdown restrictions were in place. CONCLUSION: PD principles can offer ways for nurse researchers to engage, collaborate with and reflect with people for research projects, including when constraints compete with participation. They can also assist researchers in optimising and maintaining recruitment and data collection when face-to-face research methods are impossible. IMPLICATIONS FOR PRACTICE: The telephone can be a valuable alternative medium for recruiting participants and collecting data when face-to-face methods are impossible to use. PD principles can be maintained and response rates and participation may even be greater when using it.