A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research.

BACKGROUND: Traditional medical research infrastructures relying on the Centers of Excellence (CoE) model (an infrastructure or shared facility providing high standards of research excellence and resources to advance scientific knowledge) are often limited by geographic reach regarding patient accessibility, presenting challenges for study recruitment and accrual. Thus, the development of novel, patient-centered (PC) strategies (e.g., the use of online technologies) to support recruitment and streamline study procedures are necessary. This research focused on an implementation evaluation of a design innovation with implementation outcomes as communicated by study staff and patients for CoE and PC approaches for a randomized controlled trial (RCT) for patients with vasculitis. METHODS: In-depth qualitative interviews were conducted with 32 individuals (17 study team members, 15 patients). Transcripts were coded using the Consolidated Framework for Implementation Research (CFIR). RESULTS: The following CFIR elements emerged: characteristics of the intervention, inner setting, characteristics of individuals, and process. From the staff perspective, the communication of the PC approach was a major challenge, but should have been used as an opportunity to identify one "point person" in charge of all communicative elements among the study team. Study staff from both arms were highly supportive of the PC approach and saw its promise, particularly regarding online consent procedures. Patients reported high self-efficacy in reference to the PC approach and utilization of online technologies. Local physicians were integral for making patients feel comfortable about participation in research studies. CONCLUSIONS: The complexity of replicating the interpersonal nature of the CoE model in the virtual setting is substantial, meaning the PC approach should be viewed as a hybrid strategy that integrates online and face-to-face practices. TRIAL REGISTRATIONS: 1) Name: The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach (TAPIR). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01940094 . Date of registration: September 10, 2013. 2) Name: The Assessment of Prednisone In Remission Trial - Patient Centric Approach (TAPIR). TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT01933724 . Date of registration: September 2, 2013.

Low-dose aspirin, maternal cardiometabolic health, and offspring respiratory health 9 to 14 years after delivery: Findings from the EAGeR Follow-up Study.

BACKGROUND: Accumulating evidence shows that peri-conceptional and in-utero exposures have lifetime health impacts for mothers and their offspring. OBJECTIVES: We conducted a Follow-Up Study of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with two objectives. First, we determined if women who enrolled at the Utah site (N = 1001) of the EAGeR trial (2007-2011, N = 1228) could successfully be contacted and agree to complete an online questionnaire on their reproductive, cardio-metabolic, and offspring respiratory health 9-14 years after original enrollment. Second, we evaluated if maternal exposure to low-dose aspirin (LDA) during pregnancy was associated with maternal cardio-metabolic health and offspring respiratory health. METHODS: The original EAGeR study population included women, 18-40 years of age, who had 1-2 prior pregnancy losses, and who were trying to become pregnant. At follow-up (2020-2021), participants from the Utah cohort completed a 13-item online questionnaire on reproductive and cardio-metabolic health, and those who had a live birth during EAGeR additionally completed a 7-item questionnaire on the index child's respiratory health. Primary maternal outcomes included hypertension and hypercholesterolemia; primary offspring outcomes included wheezing and asthma. RESULTS: Sixty-eight percent (n = 678) of participants enrolled in the follow-up study, with 10% and 15% reporting maternal hypertension and hypercholesterolemia, respectively; and 18% and 10% reporting offspring wheezing and asthma. We found no association between maternal LDA exposure and hypertension (risk difference [RD] -0.001, 95% confidence interval [CI] -0.05, 0.04) or hypercholesterolemia (RD -0.01, 95% CI -0.06, 0.05) at 9-14 years follow-up. Maternal LDA exposure was not associated with offspring wheezing (RD -0.002, 95% CI -0.08, 0.08) or asthma (RD 0.13, 95% CI 0.11, 0.37) at follow-up. Findings remained robust after considering potential confounding and selection bias. CONCLUSIONS: We observed no association between LDA exposure during pregnancy and maternal cardiometabolic or offspring respiratory health.

Recruitment and Enrollment of Low-income, Minority Residents of Urban Public Housing into Research.

Research participation among vulnerable populations is often limited by the same socioeconomic factors that contribute to poor health. Identifying best practices for inclusion is critical to addressing health disparities. Urban public housing communities bear a disproportionate burden of chronic disease and may represent an opportunity to directly engage historically vulnerable populations in research designed to ultimately reduce that burden. We used mixed-method data to analyze recruitment effectiveness among a random sample of households (N = 380) across two public housing developments in Boston, MA who were approached for participation in a pre-COVID oral health study. Quantitative data from detailed recruitment tracking methods was analyzed to assess the relative efficiency of the methods employed. Field journals of study staff were qualitatively analyzed to identify community-specific recruitment barriers and facilitators. The participation rate among randomly sampled households was 28.6% (N = 131), with participation from primarily Hispanic (59.5%) or Black (26%) residents. Door-to-door knocking with response yielded the highest participation (44.8%), followed by responses to informational study flyers (31%). Primary barriers to enrollment included references to unemployment and employment variations, shift work, childcare responsibilities, time demands, and managing multiple appointments and social services. This study finds active, door-to-door knocking and return visits resolved barriers to participation, and reduced safety concerns and historic distrust. It's time to consider how best to adapt effective pre-COVID recruitment practices for utilization under current and future exposure conditions as effective recruitment of populations such as urban public housing residents into research is only becoming more important.

Monitoring and modifying recruitment and retention strategies for an ongoing randomised clinical trial with venous leg ulcer patients: Overcoming barriers to participation.

Venous leg ulcers (VLUs) are open skin lesions of the lower legs arising in areas affected by venous hypertension that are associated with substantial morbidity. Clinical trials testing innovative approaches to improve healing outcomes are critically needed because standard therapies are often ineffective. However, patients with VLUs frequently have multiple physical, emotional and socioeconomic challenges that can negatively impact their decision to enrol in a clinical trial. To benefit clinical researchers and ultimately the community of patients with chronic wounds, this paper describes the monitoring and modification of recruitment strategies in an ongoing clinical trial testing effects of omega-3 fatty acid oral supplementation on VLU healing in ageing adults (n = 208). Multiple modifications over time in this study have targeted participation barriers identified through data monitoring and include expanding inclusion criteria, adding recruitment sites, enhancing communication methods, and meeting patients' transportation needs. Recruitment activities from January 2019 to June 2022 have resulted in 57 participants (mean age: 63.7 years). Overall, the recruitment rate is 42.5% of patients contacted during face-to-face visits. Overcoming barriers to participation is key to helping patients with VLUs interested in research enrol in clinical trials aiming to improve healing outcomes in this vulnerable population.

Barriers to recruitment into emergency department-initiated palliative care: a sub-study of a multi-site, randomized controlled trial.

BACKGROUND: Emergency department (ED) visits among older adults are common near the end of life. Palliative care has been shown to reduce ED visits and to increase quality of life among patients, but recruitment into these programs is often challenging. This descriptive analysis explores the barriers to enrolling seriously ill patients scheduled for discharge from the ED into palliative care research. METHODS: This descriptive sub-study aims to assess the reasons why patients with advanced illness scheduled for discharge home from 11 EDs across the United States decline to participate in Emergency Medicine Palliative Care Access (EMPallA), a Phase IV randomized controlled trial (RCT) comparing two modes of palliative care delivery. Our aim was to understand why patients decline to enroll to improve future recruitment rates and expand care for patients discharged home from the ED. Research coordinators documented reasons that patients declined to enroll in the larger EMPallA trial; reasons for refusing participation were independently analyzed by two researchers to identify overarching themes. RESULTS: Enrollment rate across all sites was 45%; of the 504 eligible patients who declined participation, 47% (n = 237) declined for reasons related to illness severity. 28% of refusals (n = 143) were related to the mode of palliative care delivery, while 24% (n = 123) were due to misconceptions or stigma related to palliative care. Less commonly, patients refused due to general research barriers (16.5%), family/caregiver barriers (11.7%), and physician-related barriers (< 1%). CONCLUSIONS: Patients with advanced illnesses presenting to the ED often refuse to participate in palliative care research due to the severity of their illness, the mode of care delivery, and misconceptions about palliative care. In contrast with other studies, our study found minimal physician gatekeeping, which may be the result of both changing attitudes toward palliative care and the nature of the ED setting. Robust training programs are crucial to overcome these misconceptions and to educate patients and providers about the role of palliative care. Future palliative care programs and study designs should recognize the burden this vulnerable population endures and consider alternative modes of care delivery in an effort to increase participation and enrollment. CLINICAL TRIALS REGISTRATION: NCT03325985 , October 30, 2017.

The challenges of PICU research: Lessons learned from a minimal-risk study with PICU parents.

Research conducted in pediatric intensive care units (PICUs) with families is essential to advancing evidenced-based practice and improving patient outcomes in this unique setting. However, several ethical, logistical, and methodological challenges have been cited in the literature as having a significant effect on the development of PICU research. Investigators at a large midwestern health care center encountered several challenges during the course of a minimal-risk, survey-based study with parents of PICU patients. This manuscript aims to highlight the challenges faced by the research team, which included challenges related to the environment of the PICU, the patients' length of stay, the health status of the patient, and the etiology of the patient's admission, as well as share the actions that the research team took to address these challenges.

Reasons for and associated characteristics with early study termination: Analysis of ClinicalTrials.gov data on pregnancy topics.

BACKGROUND: Prematurely terminated studies are unlikely to provide data for evidence-based practice. There has been no systematic review on premature study termination on pregnancy-related research. PURPOSE: This study investigated the reasons why studies on pregnancy topics are terminated and the associated characteristics with early termination. METHODS: A total of 3,623 studies (332 terminated and 3,291 completed) were retrieved from ClinicalTrials.gov registry. Reasons for termination were grouped into four categories, including accrual difficulty, research operation issues, data-related recommendations, and external factors. Study characteristics were statistically compared between terminated and completed studies. FINDINGS: Accrual difficulty (44.6%) and research operation issues (21.4%) were most frequently cited reasons for termination. Study design characteristics of intervention, randomization, masking, treatment and drug trial, and low funding from federal agencies were significantly associated with early termination. DISCUSSION: Population tailored subject recruitment strategies, scientifically sound research protocols, and well-planned research operations may mitigate premature study termination.

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.

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.

The CAN-DO-IT Model: a Process for Developing and Refining Online Recruitment in HIV/AIDS and Sexual Health Research.

PURPOSE OF REVIEW: HIV/AIDS and sexual health research has increasingly relied on online recruitment in recent years. However, as potential online recruitment avenues (e.g., dating and sexual networking applications, websites, social media) have proliferated, navigating this process has become increasingly complex. This paper presents a practical model to guide researchers through online recruitment irrespective of platform. RECENT FINDINGS: The CAN-DO-IT model reflects 7 iterative steps based on work by the authors and other investigators: conceptualize scope of recruitment campaign, acquire necessary expertise, navigate online platforms, develop advertisements, optimize recruitment-to-enrollment workflow, implement advertising campaign, and track performance of campaigns and respond accordingly. Online recruitment can accelerate HIV/AIDS research, yet relatively limited guidance exists to facilitate this process across platforms. The CAN-DO-IT model presents one approach to demystify online recruitment and reduce enrollment barriers.

Effectiveness of Social Media Approaches to Recruiting Young Adult Cigarillo Smokers: Cross-Sectional Study.

BACKGROUND: The prevalence of social media use among youth and young adults suggests it is an appropriate platform for study recruitment from this population. Previous studies have examined the use of social media for recruitment, but few have compared platforms, and none, to our knowledge, have attempted to recruit cigarillo users. OBJECTIVE: The purpose of this study was to examine the effectiveness of different social media platforms and advertisement images for recruiting cigarillo users aged 14-28 years to complete a cigarillo use survey. METHODS: We obtained objective data for advertisement impressions for a 39-week social media recruitment campaign. Advertisements were targeted to users based on their age, geography, and interests. Effectiveness was defined as the percentage of approved surveys per advertising impression. Chi-square tests were performed to compare the effectiveness of different advertisement images and platforms. RESULTS: Valid survey completers (n=1089) were predominately older (25-28 years old, n=839, 77%). Of the 1089 survey completers, 568 (52%) identified as male, 335 (31%) as African American, and 196 (18%) as Hispanic. Advertisements delivered via Facebook/Instagram were more effective than Twitter; 311/1,027,738 (0.03%) vs 661/2,998,715 (0.02%); χ21=21.45, N=4,026,453); P<.001. Across platforms, ads featuring exclusively an image of cigarillos were more effective (397/682,994, 0.06%) than ads with images of individuals smoking (254/1,308,675, 0.02%), individuals not smoking (239/1,393,134, .02%), and groups not smoking (82/641,650, 0.01%); χ23133.73, N=4,026,453; P<.001. CONCLUSIONS: The campaign was effective in recruiting a diverse sample representative of relevant racial/ethnic categories. Advertisements on Facebook were more effective than Twitter. Advertisements that featured an image of a cigarillo were consistently the most effective and should be considered by others recruiting cigarillo users via social media.

Predictors of Response Outcomes for Research Recruitment Through a Central Cancer Registry: Evidence From 17 Recruitment Efforts for Population-Based Studies.

When recruiting research participants through central cancer registries, high response fractions help ensure population-based representation. We conducted multivariable mixed-effects logistic regression to identify case and study characteristics associated with making contact with and obtaining cooperation of Utah cancer cases using data from 17 unique recruitment efforts undertaken by the Utah Cancer Registry (2007-2016) on behalf of the following studies: A Population-Based Childhood Cancer Survivors Cohort Study in Utah, Comparative Effectiveness Analysis of Surgery and Radiation for Prostate Cancer (CEASAR Study), Costs and Benefits of Follow-up Care for Adolescent and Young Adult Cancers, Study of Exome Sequencing for Head and Neck Cancer Susceptibility Genes, Genetic Epidemiology of Chronic Lymphocytic Leukemia, Impact of Remote Familial Colorectal Cancer Risk Assessment and Counseling (Family CARE Project), Massively Parallel Sequencing for Familial Colon Cancer Genes, Medullary Thyroid Carcinoma (MTC) Surveillance Study, Osteosarcoma Surveillance Study, Prostate Cancer Outcomes Study, Risk Education and Assessment for Cancer Heredity Project (REACH Project), Study of Shared Genomic Segment Analysis and Tumor Subtyping in High-Risk Breast-Cancer Gene Pedigrees, Study of Shared Genomic Segment Analysis for Localizing Multiple Myeloma Genes. Characteristics associated with lower odds of contact included Hispanic ethnicity (odds ratio (OR) = 0.34, 95% confidence interval (CI): 0.27, 0.41), nonwhite race (OR = 0.46, 95% CI: 0.35, 0.60), and younger age at contact. Years since diagnosis was inversely associated with making contact. Nonwhite race and age ≥60 years had lower odds of cooperation. Study features with lower odds of cooperation included longitudinal design (OR = 0.50, 95% CI: 0.41, 0.61) and study brochures (OR = 0.70, 95% CI: 0.54, 0.90). Increased odds of cooperation were associated with including a questionnaire (OR = 3.19, 95% CI: 1.54, 6.59), postage stamps (OR = 1.60, 95% CI: 1.21, 2.12), and incentives (OR = 1.62, 95% CI: 1.02, 2.57). Among cases not responding after the first contact, odds of eventual response were lower when >10 days elapsed before subsequent contact (OR = 0.71, 95% CI: 0.59, 0.85). Obtaining high response is challenging, but study features identified in this analysis support better results when recruiting through central cancer registries.

How different online recruitment methods impact on recruitment rates for the web-based coortesnaweb project: a randomised trial.

BACKGROUND: The number of web-based E-epidemiologic studies using online recruitment methods is increasing. However, the optimal online recruitment method in terms of maximizing recruitment rates is still unknown. Our aim was to compare the recruitment rates of three online recruitment methods and to describe how these rates differ according to individual's socioeconomic and demographic factors. METHODS: A total of 2394 members of the 1993 Pelotas birth cohort that provided an e-mail address, a Facebook name, and a WhatsApp number during a face-to-face follow-up were randomly allocated to be recruited by e-mail, Facebook or WhatsApp (798 individuals per method). This was a parallel randomised trial applying a block randomisation (block size = 3). Between January and February 2018, we sent messages inviting them to register into the web-based coortesnaweb platform. Recruitment rates were calculated for each method, and stratified according to the individual's socioeconomic and demographic characteristics. We also analysed absolute and relative inequalities on recruitment according to schooling and socioeconomic position. RESULTS: Out of the 2394 individuals analysed, 642 registered into the platform. The overall recruitment rate was 26.8%. Recruitment rates for women were almost 10 percentage points higher compared to men. Facebook was the most effective recruitment method, as 30.6% of those invited through the social network were recruited. Recruitment rates of e-mail and WhatsApp were similar (recruitment rate = 24.9%). E-mail and Facebook were the most effective recruitment methods to invite highly educated and wealthier individuals. However, sending e-mails to recruit individuals also reflected in the highest inequalities according to schooling and socioeconomic position. In contrast, the lowest inequalities according to socioeconomic position were observed using Facebook. CONCLUSIONS: Facebook was the most effective online recruitment method, also achieving the most equitable sample in terms of schooling and socioeconomic position. The effectiveness of online recruitment methods depends on the characteristics of the sample. It is important to know the profile of the target sample in order to decide which online recruitment method to use. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, identifier: RBR-3dv7gc , retrospectively registered in 10 April 2018.

Patient perspectives on use of electronic health records for research recruitment.

BACKGROUND: EHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. Even so, stakeholders in the process must still contend with the practical and ethical challenges associated with research recruitment. Patient perspectives on these matters are particularly important given that the success of research recruitment depends on patients' willingness to participate. METHODS: We conducted 15 focus groups (n = 110 participants) in four counties in diverse regions of the southeastern US: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. Based on a hypothetical study of a behavioral intervention for type 2 diabetes, we asked about the acceptability and appropriateness of direct investigator versus physician-mediated contact with patients for research recruitment, and whether patients should be asked to opt in or opt out of further contact in response to recruitment letters. RESULTS: For initial contact, nearly all participants said it would be acceptable for researchers to contact patients directly and three-fourths said that it would be acceptable for researchers to contact patients through their physicians. When we asked which would be most appropriate, a substantial majority chose direct contact. Themes that arose in the discussion included trust and transparency, decision-making power, the effect on research, and the effect on patient care. For response expectations, the vast majority of participants said both opt-in and opt-out would be acceptable-typically finding neither especially problematic and noting that both afford patients the opportunity to make their own decisions. CONCLUSIONS: External validity relies heavily on researchers' success enrolling eligible patients and failure to reach accrual targets is a costly and common barrier to advancing scientific knowledge. Our results suggest that patients recognize multiple advantages and disadvantages of different research recruitment strategies and place value on the implications not just for themselves, but also for researchers and healthcare providers. Our findings, including rich qualitative detail, contribute to the body of empirical and ethical literature on improving research recruitment and suggest specific ways forward as well as important areas for future research.

Using Paid and Free Facebook Methods to Recruit Australian Parents to an Online Survey: An Evaluation.

BACKGROUND: The prevalence of social media makes it a potential alternative to traditional offline methods of recruiting and engaging participants in health research. Despite burgeoning use and interest, few studies have rigorously evaluated its effectiveness and feasibility in terms of recruitment rates and costs, sample representativeness, and retention. OBJECTIVE: This study aimed to determine the feasibility of using Facebook to recruit employed Australian parents to an online survey about managing work and family demands, specifically to examine (1) recruitment rates and costs; (2) sample representativeness, compared with a population-based cohort of parents; and (3) retention, including demographic and health characteristics of parents who returned to complete a follow-up survey 6 weeks later. METHODS: Recruitment was conducted using 20 paid Facebook advertising campaigns, supplemented with free advertising approaches such as posts on relevant Facebook pages and requests for professional networks to circulate the survey link via Facebook. Recruitment rates and costs were evaluated using the Checklist for Reporting Results of Internet E-Surveys, including view rate, participation rate, completion rate, cost per consent, and cost per completer. Sample representativeness was evaluated by comparing demographic and outcome variables with a comparable sample from the Longitudinal Study of Australian Children including educational attainment, marital status, country of birth, neighborhood disadvantage, work-family conflict, and psychological distress. Retention was evaluated by comparing the number and demographic characteristics of participants at recruitment and at 6-week follow-up. RESULTS: Recruitment strategies together resulted in 6653 clicks on the survey link, from which 5378 parents consented to participate and 4665 (86.74%) completed the survey. Of those who completed the survey, 85.94% (4009/4665) agreed to be recontacted, with 57.79% (2317/4009) completing the follow-up survey (ie, 43.08% [2317/5378] of parents who consented to the initial survey). Paid Facebook advertising recruited nearly 75% of the sample at Aus $2.32 per completed survey (Aus $7969 spent, 3440 surveys completed). Compared with a population-based sample, participants at baseline were more likely to be university educated (P<.001), experience greater work-family conflict (P<.001) and psychological distress (P<.001), and were less likely to be born outside Australia (P<.001) or live in a disadvantaged neighborhood (P<.001). CONCLUSIONS: Facebook provided a feasible, rapid method to recruit a large national sample of parents for health research. However, some sample biases were observed and should be considered when recruiting participants via Facebook. Retention of participants at 6- to 8-week follow-up was less than half the initial sample; this may reflect limited ongoing participant engagement for those recruited through social media, compared with face-to-face.

The Search for Consumers of Web-Based Raw DNA Interpretation Services: Using Social Media to Target Hard-to-Reach Populations.

BACKGROUND: In recent years, there has been a proliferation of third-party Web-based services available to consumers to interpret raw DNA from direct-to-consumer genetic testing companies. Little is known about who uses these services and the downstream health implications. Identifying this hard-to-reach population of consumers for research raised questions about the most effective recruitment methods to undertake. Past studies have found that Web-based social media survey distribution can be cost-effective for targeting hard-to-reach populations, yet comparative efficacy information across platforms is limited. OBJECTIVE: The aim of this study was to identify the most effective Web-based strategies to identify and recruit the target population of direct-to-consumer genetic testing users who also made use of third-party interpretation services to analyze their raw genetic data. Web-based survey recruitment methods varying by social media platform and advertising method were compared in terms of cost-effectiveness and demographics of survey respondents. METHODS: A total of 5 Web-based survey distribution conditions were examined: 4 paid advertising services and 1 unpaid service. For the paid services, a 2x2 quasi-experimental design compared social media platforms (Facebook vs Twitter) and advertising tracking metrics (by click vs by conversion). The fifth unpaid comparison method consisted of study postings on the social media platform, Reddit, without any paid advertising. Links to identical Web-based versions of the study questionnaire were posted for 10 to 14 days for each of the distribution conditions, which allowed tracking the number of respondents that entered and completed the questionnaire by distribution condition. RESULTS: In total, 438 individuals were recruited to the study through all conditions. A nearly equivalent number of participants were recruited from paid campaigns on Facebook (n=159) and Twitter (n=167), with a smaller sample recruited on Reddit (n=112). Significantly more participants were recruited through conversion-tracking (n=222) than through click-tracking campaigns (n=104; Z=6.5, P<.001). Response rates were found to be partially driven by organic sharing of recruitment materials among social media users. Conversion tracking was more cost-effective than click tracking across paid social media platforms. Significant differences in terms of gender and age distributions were noted between the platforms and between the tracking metrics. CONCLUSIONS: Web-based recruitment methods were effective at recruiting participants from a hard-to-reach population in a short time frame. There were significant differences in the effectiveness of various paid advertising techniques. Recruitment through Web-based communities also appeared to perform adequately, yet it may be limited by the number of users accessible in open community groups. Future research should evaluate the impact of organic sharing of recruitment materials because this appeared to play a substantial role in the observed effectiveness of different methods.

Using Facebook Advertising to Recruit Representative Samples: Feasibility Assessment of a Cross-Sectional Survey.

BACKGROUND: Facebook has shown promise as an economical means of recruiting participants for health research. However, few studies have evaluated this recruitment method in Canada, fewer still targeting older adults, and, to our knowledge, none specifically in Newfoundland and Labrador (NL). OBJECTIVE: This study aimed to assess Facebook advertising as an economical means of recruiting a representative sample of adults aged 35 to 74 years in NL for a cross-sectional health survey. METHODS: Facebook advertising was used to recruit for a Web-based survey on cancer awareness and prevention during April and May 2018; during recruitment, additional advertisements were targeted to increase representation of demographics that we identified as being underrepresented in our sample. Sociodemographic and health characteristics of the study sample were compared with distributions of the underlying population to determine representativeness. Cramer V indicates the magnitude of the difference between the sample and population distributions, interpreted as small (Cramer V=0.10), medium (0.30), and large (0.50). Sample characteristics were considered representative if there was no statistically significant difference in distributions (chi-square P>.01) or if the difference was small (V≤0.10), and practically representative if 0.10

Challenges in recruiting African-American women for a breast cancer genetics study.

BACKGROUND: African-American women, especially in the southern United States, are underrepresented in cancer genetics research. A study was designed to address this issue by investigating the germline mutation rate in African-American women in Arkansas with a personal and/or family history of breast cancer. Women were tested for these mutations using a large panel of breast cancer susceptibility genes. In this analysis, we discuss the challenges encountered in recruiting African-American women from an existing biorepository to participate in this study. METHODS: We attempted to contact 965 African-American women with a personal and/or family history of breast cancer who participated in Spit for the Cure (SFTC) between 2007 and 2013 and provided consent to be recontacted. The SFTC participants were invited by telephone and email to participate in the genetic study. Enrollment required completion of a phone interview to obtain a family and medical history and return of a signed consent form. RESULTS: Among eligible SFTC participants, 39.6% (382/965) were able to be contacted with the phone numbers and email addresses they provided. Of these, 174 (45.5%) completed a phone interview and returned a signed consent form. Others were not able to be contacted (n = 583), declined to participate (n = 57), did not keep phone interview appointments (n = 82), completed the phone interview but never returned a signed consent (n = 54), were deceased (n = 13), or were too confused to consent to participate (n = 2). CONCLUSIONS: Recruiting African-American women into our breast cancer genetics study proved challenging primarily due to difficulty establishing contact with potential participants. Given their prior participation in breast cancer research, we anticipated that this would be a highly motivated population. Indeed, when we were able to contact SFTC participants, only 14.9% declined to participate in our study. Innovative communication, retention, and recruitment strategies are needed in future studies to address the recruitment challenges we faced.

Using Facebook for Large-Scale Online Randomized Clinical Trial Recruitment: Effective Advertising Strategies.

Targeted Facebook advertising can be an effective strategy to recruit participants for a large-scale online study. Facebook advertising is useful for reaching people in a wide geographic area, matching a specific demographic profile. It can also target people who would be unlikely to search for the information and would thus not be accessible via Google AdWords. It is especially useful when it is desirable not to raise awareness of the study in a demographic group that would be ineligible for the study. This paper describes the use of Facebook advertising to recruit and enroll 1145 women over a 15-month period for a randomized clinical trial to teach support skills to female partners of male smokeless tobacco users. This tutorial shares our study team's experiences, lessons learned, and recommendations to help researchers design Facebook advertising campaigns. Topics covered include designing the study infrastructure to optimize recruitment and enrollment tracking, creating a Facebook presence via a fan page, designing ads that attract potential participants while meeting Facebook's strict requirements, and planning and managing an advertising campaign that accommodates the rapid rate of diminishing returns for each ad.

Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study.

BACKGROUND: The target sample size for clinical trials often necessitates a multicenter (center of excellence, CoE) approach with associated added complexity, cost, and regulatory requirements. Alternative recruitment strategies need to be tested against this standard model. OBJECTIVES: The aim of our study was to test whether a Web-based direct recruitment approach (patient-centric, PC) using social marketing strategies provides a viable option to the CoE recruitment method. METHODS: PC recruitment and Web-based informed consent was compared with CoE recruitment for a randomized controlled trial (RCT) of continuing versus stopping low-dose prednisone for maintenance of remission of patients with granulomatosis with polyangiitis (GPA). RESULTS: The PC approach was not as successful as the CoE approach. Enrollment of those confirmed eligible by their physician was 10 of 13 (77%) and 49 of 51 (96%) in the PC and CoE arms, respectively (P=.05). The two approaches were not significantly different in terms of eligibility with 34% of potential participants in the CoE found to be ineligible as compared with 22% in the PC arm (P=.11) nor in provider acceptance, 22% versus 26% (P=.78). There was no difference in the understanding of the trial as reflected in the knowledge surveys of individuals in the PC and CoE arms. CONCLUSIONS: PC recruitment was substantially less successful than that achieved by the CoE approach. However, the PC approach was good at confirming eligibility and was as acceptable to providers and as understandable to patients as the CoE approach. The PC approach should be evaluated in other clinical settings to get a better sense of its potential.