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BACKGROUND: The set-up, activation, and delivery of clinical trials is pivotal for the advancement of medical science, serving as the primary mechanism through which new therapeutic interventions are validated for clinical use. Despite their critical role, the execution of these trials is often encumbered by a multitude of challenges. The North West London Clinical Trials Alliance (The Alliance) was established to address these complexities. It aims to bridge the gap between emerging scientific research and its clinical application through strategic collaborations among healthcare and research entities, thereby enhancing the regional ecosystem for clinical trials. MAIN TEXT: This commentary aims to offer clarity on the fundamental insights that underlie The Alliance, providing a comprehensive understanding of its operational structure and the ecosystem it has fostered to optimise clinical trial delivery and revenue generation. The strategy employed by The Alliance centres on the cultivation of strategic partnerships across a broad spectrum of stakeholders. This approach addresses key operational challenges in clinical trial management, facilitating improvements in the development, setup, activation, and recruitment stages. Notably, The Alliance has reduced the average time to initiate trials to 19 days, compared to the standard 75 days typically observed for commercial setups in North West London. The effectiveness of The Alliance's framework was notably demonstrated during the COVID-19 pandemic, particularly with the expedited recruitment performance in the Janssen COVID-19 vaccine study conducted at Charing Cross Hospital. This instance highlighted the Alliance's capability to meet and exceed recruitment targets promptly while maintaining diversity within study cohorts. Additionally, The Alliance has effectively harnessed digital technology and infrastructure, enhancing its attractiveness to commercially funded studies and illustrating a sustainable model for clinical trial financing and execution. CONCLUSION: The North West London Clinical Trials Alliance represents a strategic response to the conventional challenges faced in clinical trial management, emphasising the importance of cross-sectoral collaboration and resource optimisation. Its efforts, particularly highlighted by its response to the COVID-19 pandemic, provide a case study in enhancing trial delivery and efficiency with significant implications for both regional and global clinical trials research communities.

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Introduction: The All of Us Research Program (Program) is an ongoing epidemiologic cohort study focused on collecting lifestyle, health, socioeconomic, environmental, and biological data from 1 million US-based participants. The Program has a focus on enrolling populations that are underrepresented in biomedical research (UBR). Federally Qualified Health Centers (FQHCs) are a key recruitment stream of UBR participants. The Program is digital by design where participants complete surveys via web-based platform. As many FQHC participants are not digitally ready, recruitment and retention is a challenge, requiring high-touch methods. However, high-touch methods ceased as an option in March 2020 when the Program paused in-person activities because of the pandemic. In January 2021, the Program introduced Computer Assisted Telephone Interviewing (CATI) to help participants complete surveys remotely. This paper aims to understand the association between digital readiness and mode of survey completion (CATI vs. web-based platform) by participants at FQHCs. Methods: This study included 2,089 participants who completed one or more surveys via CATI and/or web-based platform between January 28, 2021 (when CATI was introduced) and January 27, 2022 (1 year since CATI introduction). Results and discussion: Results show that among the 700 not-digitally ready participants, 51% used CATI; and of the 1,053 digitally ready participants, 30% used CATI for completing retention surveys. The remaining 336 participants had "Unknown/Missing" digital readiness of which, 34% used CATI. CATI allowed survey completion over the phone with a trained staff member who entered responses on the participant's behalf. Regardless of participants' digital readiness, median time to complete retention surveys was longer with CATI compared to web. CATI resulted in fewer skipped responses than the web-based platform highlighting better data completeness. These findings demonstrate the effectiveness of using CATI for improving response rates in online surveys, especially among populations that are digitally challenged. Analyses provide insights for NIH, healthcare providers, and researchers on the adoption of virtual tools for data collection, telehealth, telemedicine, or patient portals by digitally challenged groups even when in-person assistance continues to remain as an option. It also provides insights on the investment of staff time and support required for virtual administration of tools for health data collection.

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Background: There is no consensus on how to determine appropriate financial compensation for research recruitment. Selecting incentive amounts that are reasonable and respectful, without undue inducement, remains challenging. Previously, we demonstrated that incentive amount significantly impacts participants' willingness to complete various hypothetical research activities. Here we further explore this relationship in a mock decentralized study. Methods: Adult ResearchMatch volunteers were invited to join a prospective study where interested individuals were given an opportunity to view details for a study along with participation requirements, then offered a randomly generated compensation amount between $0 and $50 to enroll and participate. Individuals agreeing to participate were then asked to complete tasks using a remote mobile application (MyCap), for two weeks. Tasks included a weekly survey, a daily gratitude journal and daily phone tapping task. Results: Willingness to participate was 85% across all incentive levels but not significantly impacted by amount. Task completion appeared to increase as a function of compensation until a plateau at $25. While participants described the study as low burden and reported that compensation was moderately important to their decision to join, only 31% completed all study tasks. Conclusion: While offering compensation in this study did not have a strong effect on enrollment rate, this work provides insight into participant motivation when joining and participating in studies employing mobile applications.

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BACKGROUND: Digital screening and intervention tools have shown promise in the identification and reduction of substance use in health care settings. However, research in this area is impeded by challenges in integrating recruitment efforts into ongoing clinical workflows or staffing multiple study clinics with full-time research assistants, as well as by the underreporting of substance use. OBJECTIVE: The aim of the study is to evaluate pragmatic methods for facilitating study recruitment in health care settings by examining recruitment rates and participant characteristics using in-person-based versus flyer approaches. METHODS: This study compared recruitment rates at a Women's Health clinic in the Midwest under 2 different recruitment strategies: in person versus via a flyer with a QR code. We also examined the disclosure of substance use and risk screener positivity for the 2 strategies. We also obtained information about the current use of technology and willingness to use it for study participation. RESULTS: A greater percentage of patients recruited in person participated than those recruited via flyers (57/63, 91% vs 64/377, 17%). However, the final number recruited in each group was roughly equal (n=57 vs n=64). Additionally, participants recruited via flyers were more likely to screen positive for alcohol use risk on the Tolerance, Annoyed, Cut Down, Eye-Opener alcohol screen than those recruited at the clinic (24/64, 38% vs 11/57, 19%; χ21=4.9; P=.03). Participants recruited via flyers were also more likely to screen positive for drug use risk on the Wayne Indirect Drug Use Screener than those recruited at the clinic (20/64, 31% vs 9/57, 16%; χ21=4.0; P=.05). Furthermore, of the 121 pregnant women, 117 (96.7%) reported owning a smartphone, 111 (91.7%) had an SMS text message plan on their phone, and 94 (77.7%) reported being willing to receive SMS text messages or participate in a study if sent a link to their phone. CONCLUSIONS: The distribution of flyers with a QR code by medical staff appears to be an efficient and cost-effective method of recruitment that also facilitates disclosure while reducing the impact on clinic workflows. This method of recruitment can be useful for data collection at multiple locations and lead to larger samples across and between health systems. Participant recruitment via technology in perinatal health care appears to facilitate disclosure, particularly when participants can learn about the research and complete screening using their own device at a place and time convenient for them. Pregnant women in an urban Midwestern hospital had access to and were comfortable using technology.

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Objectives: Clinical trials studying Alzheimer's Disease (AD) face the challenge of recruiting participants with significant barriers to entering research studies. The objective of this study is to compare digital recruitment strategies' ability to recruit older adults with cognitive impairment (CI). Methods: Older adults with CI were recruited for a clinical trial studying vestibular therapy in reducing falls and improving balance and cognition in older adults with CI. Potential participants were recruited via two different digital recruitment methods, a direct messaging campaign using established patient records and a social media campaign. Potential participants then filled out surveys to determine eligibility for the study. Results: The direct messaging campaign contacted 3060 potential participants and the social media campaign resulted in 8265 instances of unique engagement. Of the number of people reached, the direct messaging campaign had a higher percentage of people who submitted the survey compared to the social media campaign (8.3% vs. 1.2%, p < 0.001). There was no significant difference in age, race, ethnicity, education, household income, and insurance status between the recruitment groups (p > 0.05). Direct messaging recruitment proved more cost-effective at $21.74 per eligible participant compared to the social media campaign at $859.58 per eligible participant. Conclusion: This study found that direct messaging recruitment using established patient records was more cost-effective compared to social media recruitment for this clinical trial. In this sample size, similar demographics were reached by both recruitment methods. Future studies should continue to explore the use of social media and alternative methods to recruit representative participant populations for ongoing AD research.

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We examine whether perceptual decision-making differs as a function of the time in the academic term and whether the participant is an undergraduate participating for course credit, a paid in-person participant, or a paid online participant recruited via Amazon Mechanical Turk. We use a mixture modeling approach within an evidence accumulation framework that separates stimulus-driven responses from contaminant responses, allowing us to distinguish between performance when a participant is engaged in the task and the consistency in this task focus. We first report a survey showing cognitive psychologists expect performance and response caution to be lower among undergraduate participants recruited at the end of the academic term compared to those recruited near the start, and highest among paid in-person participants. The findings from two experiments using common paradigms revealed very little evidence of time-of-semester effects among course credit participants on accuracy, response time, efficiency of information processing (when engaged in the task), caution, and non-decision time, or consistency in task focus. However, paid in-person participants did tend to be more accurate than the other two groups. Groups showed similar effects of speed/accuracy emphasis on response caution and of discrimination difficulty on information processing efficiency, but the effect of speed/accuracy emphasis on information processing efficiency was less consistent among groups. We conclude that online crowdsourcing platforms can provide quality perceptual decision-making data, but recommend that mixture modeling be used to adequately account for data generated by processes other than the psychological phenomena under investigation.

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BACKGROUND: Web-based participant recruitment registries can be useful tools for accelerating enrollment into studies, but existing Alzheimer's disease (AD)-focused recruitment registries have had limited success enrolling individuals from underrepresented racial and ethnic groups. Designing these registries to meet the needs of individuals from these communities, including designing mobile-first, may facilitate improvement in the enrollment of underrepresented groups. OBJECTIVES: Evaluate the usability of a prototype mobile-first participant recruitment registry for AD prevention studies; assess users' perceptions of and willingness to sign up for the registry. DESIGN AND SETTING: Quantitative usability testing and an online survey; online setting. PARTICIPANTS: We recruited 1,358 adults ages 45-75 who self-reported not having a diagnosis of mild cognitive impairment, AD, or other forms of dementia (Study 1: n=589, Study 2: n=769). Black/African American and Hispanic/Latino participants were specifically recruited, including those with lower health literacy. METHODS AND MEASUREMENTS: Study 1 measures the prototype's usability through observed task success rates, task completion times, and responses to the System Usability Scale. Study 2 uses an online survey to collect data on perceptions of and willingness to sign up for the mobile-first registry. RESULTS: Study 1 findings show the prototype mobile-first recruitment registry website demonstrates high usability and is equally usable for Black / African American, Hispanic/Latino, and White user groups. Survey results from Study 2 indicate that users from underrepresented communities understand the registry's purpose and content and express willingness to sign up for the registry on a mobile device. CONCLUSIONS: Designing mobile-first participant recruitment registries based on feedback from underrepresented communities may result in more sign-ups by individuals from minoritized communities.

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BACKGROUND: Alzheimer's disease (AD) disproportionately affects Black/African American and Hispanic/Latino adults, yet they are underrepresented in AD studies. Recruitment challenges for these populations limit generalizability of findings. OBJECTIVES: This study explores barriers and facilitators to signing up for an AD participant recruitment registry website intended to optimize recruitment of these adults. The registry is geared toward recruitment on smartphones and tablets (mobile devices), as research suggests that mobile-first approaches may be more successful within these populations. DESIGN: In 2020, we conducted four focus groups (n = 39) and an online survey (n = 1010) with Black/African American and Hispanic/Latino adults. The survey also included Whites as a comparison group. SETTING: Focus groups were in-person at research facilities in New Orleans, Louisiana, and Los Angeles, California. The online survey was distributed by a survey panel company to participants nationwide. PARTICIPANTS: Black/African American (n = 360), Hispanic/Latino (n = 359), or White (n = 330) individuals, 45-75 years old, who self-reported not having mild cognitive impairment (MCI), dementia, or AD. MEASUREMENTS: Barriers and facilitators explored in the focus groups and survey were related to health and AD (e.g., AD-related concerns and past participation/willingness to participate in health or AD studies); current use of mobile devices (e.g., comfort using devices and receptivity to the AD recruitment registry); and participant characteristics and beliefs (e.g., demographics, health literacy level, and trust in government and the scientific community). RESULTS: The focus groups and survey revealed similar findings. Participants commonly use mobile devices to go online and perform health-related activities. They were aware of AD, expressed concerns with developing it, and were willing to participate in AD-related studies (motivated by personal connection to AD, altruism, and compensation). When presented with the AD recruitment registry, most provided positive feedback (e.g., easy to use and informative) and shared an interest in joining. Barriers to joining the registry with a mobile device included complex or multistep enrollment processes, beliefs that studies are primarily for those with a specific disease, and confusion about how studies can prevent AD among those low-risk for AD. The focus groups also revealed that Black/African American participants expressed more hesitation than Hispanic/Latinos in joining the registry due to greater distrust in the government and scientific community. CONCLUSIONS: Recruiting more Black/African American and Hispanic/Latino participants into AD studies is vitally important. This mixed methods study suggests that adults in these underrepresented groups are motivated to prevent AD and willing to sign up for an AD participant recruitment registry using mobile devices. Most barriers to joining a registry can be addressed through slight modifications to the registry's design and functionality and by adding content. These findings can help enhance the appeal of joining AD recruitment registries to ultimately enroll more diverse, representative groups of participants and increase the generalizability of AD study findings.

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INTRODUCTION: People living rurally face health inequities fuelled by social exclusion, access to and awareness of health services, and poor transport links. In order to improve the acceptability, accessibility and applicability of health and care interventions, it is important that clinical trial participant populations include people living rurally. Identifying strategies that improve recruitment of rural participants to trials will support trialists, reduce research waste and contribute to alleviating health inequalities experienced by rural patients. The objective of the review is to quantify the effects of randomised evaluations of strategies to recruit rural participants to randomised controlled trials. METHODS: The following databases will be searched for relevant studies: Ovid MEDLINE, Embase, Cochrane Library, Web of Science All, EBSCO CINAHL, Proquest, ERIC, IngentaConnect, Web of Science SSCI and AHCI, and Scopus. Any randomised evaluation of a recruitment intervention aiming to improve recruitment of rural participants to a randomised trial will be included. We will not apply any restriction on publication date, language or journal. The primary, and only, outcome of our review will be the proportion of participants recruited to a randomised controlled trial. Two reviewers will independently screen abstracts and titles for eligible studies, and then full texts of relevant records will be reviewed by the same two reviewers. Where disagreements cannot be resolved through discussion, a third reviewer will adjudicate. RESULTS: We will assess the methodological quality of individual studies using the Cochrane risk of bias tool, and the GRADE approach will be applied to determine the certainty of the evidence within each comparison. CONCLUSION: This systematic review will quantify the effects of randomised evaluations of strategies to recruit rural participants to trials. Our findings will contribute to the evidence base to support trial teams to recruit a participant population that represents society as a whole, informing future research and playing a part to alleviate health inequalities between rural and urban populations.

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BACKGROUND: The COVID-19 pandemic triggered a rapid scale-up of telehealth services in Australia as a means to provide continued care through periods of physical restrictions. The factors that influence engagement in telehealth remain unclear. OBJECTIVE: The purpose of this study is to understand the experience of Australian people who engaged in a telehealth consultation during the pandemic period (2020-2021) and the demographic factors that influence engagement. METHODS: A web-based survey was distributed to Australians aged over 18 years that included 4 questions on frequency and type of clinical consultation, including with a general practitioner (GP), specialist, allied health, or nurse; 1 question on the experience of telehealth; and 2 questions on the quality of and satisfaction with telehealth. Statistical analysis included proportion of responses (of positive responses where a Likert scale was used) and regression analyses to determine the effect of demographic variables. RESULTS: Of the 1820 participants who completed the survey, 88.3% (1607/1820) had engaged in a health care consultation of some type in the previous 12 months, and 69.3% (1114/1607) of those had used telehealth. The most common type of consultation was with a GP (959/1114, 86.1%). Older people were more likely to have had a health care consultation but less likely to have had a telehealth consultation. There was no difference in use of telehealth between metropolitan and nonmetropolitan regions; however, people with a bachelor's degree or above were more likely to have used telehealth and to report a positive experience. A total of 87% (977/1114) of participants agreed or strongly agreed that they had received the information they required from their consultation, 71% (797/1114) agreed or strongly agreed that the outcome of their consultation was the same as it would have been face-to-face, 84% (931/1114) agreed or strongly agreed that the doctor or health care provider made them feel comfortable, 83% (924/1114) agreed or strongly agreed that the doctor or health care provider was equally as knowledgeable as providers they have seen in person; 57% (629/1114) of respondents reported that they would not have been able to access their health consultation if it were not for telehealth; 69% (765/1114) of respondents reported that they were satisfied with their telehealth consultation, and 60% (671/1114) reported that they would choose to continue to use telehealth in the future. CONCLUSIONS: There was a relatively high level of engagement with telehealth over the 12 months leading up to the study period, and the majority of participants reported a positive experience and satisfaction with their telehealth consultation. While there was no indication that remoteness influenced telehealth usage, there remains work to be done to improve access to older people and those with less than a bachelor's degree.

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BACKGROUND: Alzheimer's disease (AD) prevention trials require a large outreach and screening funnel to identify cognitively unimpaired adults who meet the study's inclusion criteria, such as certain clinical or demographic criteria, genetic risk factors, and/or biomarker evidence of the disease. OBJECTIVES: Describe tactics and strategies to identify and enroll cognitively unimpaired adults with one (heterozygotes [HT]) or two (homozygotes [HM]) copies of the APOE ε4 allele, a genetic risk factor for dementia due to AD, into the Alzheimer's Prevention Initiative (API) Generation Program, the largest and only prevention trials for late onset AD using this enrichment technique. DESIGN AND SETTING: The Generation Program was comprised of two global, randomized, double-blind, placebo-controlled, parallel group adaptive design with variable treatment duration clinical trials. Generation Study 1 randomized participants into one of two cohorts: Cohort 1 which evaluated CAD106 vs. placebo or Cohort 2 which evaluated umibecestat vs placebo. Generation Study 2 randomized participants into two doses of umibecestat vs. placebo. The Generation Program was terminated early in 2019, while enrollment was still occurring. PARTICIPANTS: Both Generation Study 1 and Generation Study 2 enrolled cognitively unimpaired APOE ε4 HMs aged 60-75; Generation Study 2 also enrolled APOE ε4 HTs ages 60-75 with elevated brain amyloid. METHODS AND MEASUREMENTS: Describe results of the centralized and localized outreach, recruitment, screening strategies and tactics as well as characteristics of sites successful at enrolling genetically eligible participants, with a particular focus on APOE ε4 HMs given the 2-3% prevalence of this genotype. RESULTS: At the time the trial program was terminated, 35,333 individuals had consented to the optional prescreening ICF1a/ICFA and provided a sample of DNA for APOE genotyping, 1,138 APOE ε4 HMs consented to screening for Generation Study 1 (ICF1b), and 1,626 APOE ε4 carriers were randomized into either Generation Study 1 or Generation Study 2. Genetic testing registries, partnerships with genetic testing/counseling companies, and the optional prescreening ICF1a/ICFA were the most successful strategies for identifying genetically eligible participants for screening. CONCLUSIONS: It is feasible to recruit, screen and randomize cognitively unimpaired APOE ε4 carriers, particularly APOE ε4 HMs for a global AD prevention trial. The Generation Program was on track to complete enrollment by end of 2019. Factors that were key to this success included: working with sites to develop customizable outreach, recruitment, and screening programs specific to their site needs, providing forums for sites to exchange best practices, and developing partnerships between the sponsor team and trial sites.

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Future efficacy testing of interventions to prevent HIV or other infections will require engagement of vulnerable populations. We characterized willingness to participate in a future HIV vaccine trial and barriers to participation among men who have sex with men in a 12-month German cohort study. Among 1015 participants at enrollment, 604 (60%) reported willingness, 60 (6%) were unwilling, 351 (35%) were unsure or refused to answer. Among those unwilling, the primary reason was fear of getting HIV. Among those willing, reasons included protection against HIV and furthering scientific knowledge. In a multivariable logistic regression model, higher odds of willingness to participate were seen among participants at the 12-month visit (aOR: 1.09, 95% CI: 1.04-1.15) and with prior knowledge of HIV vaccine research (aOR: 1.14, 95% CI: 1.06-1.23). Educating potential participants about vaccine research may facilitate recruitment and participation in future trials of HIV vaccine candidates and other prevention interventions.

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CONTEXT: Low recruitment rates in palliative care clinical trials amongst Black and rural individuals have been attributed to lack of trust and procedural barriers. Community engagement strategies have increased clinical trial participation of under-represented populations. OBJECTIVE: Describe a successful community-engaged recruitment strategy in an ongoing multi-site randomized clinical trial (RCT). STUDY DESIGN AND METHODS: Using community-based participatory research principles and input from a prior pilot study's community advisory group (CAG), we designed a novel recruitment strategy for Community Tele-Pal, a three-site, culturally based palliative care tele-consult RCT for Black and White seriously ill inpatients and their family caregivers. Local site CAGs helped design and implement a recruitment strategy in which a CAG member accompanied the study coordinators to introduce the study to eligible patients. Initially, CAG members could not accompany study coordinators in person due to pandemic restrictions. Hence, they created videos of themselves introducing the study, just as they would have done in person. We examined outcomes to date by the three recruitment methods and race. RESULTS: Of the 2879 patients screened, 228 were eligible and approached. Overall, the proportions of patients who consented 102 (44.7%) vs. not consented 126 (55.3%) were similar by race- White (consented= 75 [44.1%]) vs; Black (consented = 27 [46.6%]). Proportionally, consent rates favored CAG-involved methods: coordinator only- 47 approached and 13 (12.7%) consented vs. coordinator/CAG video-105 approached and 60 (58.8%) consented. CONCLUSION: A novel community-enhanced recruitment strategy demonstrated the potential to increase clinical trial participation from historically under-represented populations.

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BACKGROUND: Recruitment into clinical trials is a challenging process, with as many as 40% of studies failing to meet their target sample sizes. The principles of direct-to-consumer (DTC) advertising rely upon novel marketing strategies. The ability to reach expansive audiences in the web-based realm presents a unique opportunity for researchers to overcome various barriers to enrollment in clinical trials. Research has investigated the use of individual web-based platforms to aid in recruitment and accrual into trials; however, a gap in the literature exists, whereby multiple mass communication platforms have yet to be investigated across a range of clinical trials. OBJECTIVE: There is a need to better understand how individual factors combine to collectively influence trial recruitment. We aimed to test whether DTC recruitment of potentially eligible study participants via social media platforms (eg, Facebook [Meta Platforms Inc] and Twitter [Twitter Inc]) was an effective strategy or whether this acted as an enhancement to traditional (eg, email via contact registries) recruitment strategies through established clinical research sites. METHODS: This study tested multiple DTC web-based recruitment efforts (Facebook, Twitter, email, and patient advocacy group [PAG] involvement) across 6 national and international research studies from 5 rare disease consortia. Targeted social media messaging, social media management software, and individual study websites with prescreening questions were used in the Protocol for Increasing Accrual Using Social Media (PRISM). RESULTS: In total, 1465 PRISM website referrals occurred across all 6 studies. Organic (unpaid) Facebook posts (676/1465, 46.14%) and Rare Diseases Clinical Research Network patient contact registry emails (461/1465, 31.47%) represented the most successful forms of engagement. PRISM was successful in accumulating a 40.1% (136/339) lead generation (those who screened positive and consented to share their contact information to be contacted by a clinical site coordinator). Despite the large number of leads generated from PRISM recruitment efforts, the number of patients who were subsequently enrolled in studies was low. Across 6 studies, 3 participants were ultimately enrolled, meaning that 97.8% (133/136) of leads dropped off. CONCLUSIONS: The results indicate that although accrual results were low, this is consistent with previously documented challenges of studying populations with rare diseases. Targeted messaging integrated throughout the recruitment process (eg, referral, lead, and accrual) remains an area for further research. Key elements to consider include structuring the communicative workflow in such a way that PAG involvement is central to the process, with clinical site coordinators actively involved after an individual consents to share their contact information. Customized approaches are needed for each population and research study, with observational studies best suited for social media recruitment. As evidenced by lead generation, results suggest that web-based recruitment efforts, coupled with targeted messaging and PAG partnerships, have the potential to supplement clinical trial accrual.

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BACKGROUND: Health research using commercial data is increasing. The evidence on public acceptability and sociodemographic characteristics of individuals willing to share commercial data for health research is scarce. OBJECTIVE: This survey study investigates the willingness to share commercial data for health research in the United Kingdom with 3 different organizations (government, private, and academic institutions), 5 different data types (internet, shopping, wearable devices, smartphones, and social media), and 10 different invitation methods to recruit participants for research studies with a focus on sociodemographic characteristics and psychological predictors. METHODS: We conducted a web-based survey using quota sampling based on age distribution in the United Kingdom in July 2020 (N=1534). Chi-squared tests tested differences by sociodemographic characteristics, and adjusted ordered logistic regressions tested associations with trust, perceived importance of privacy, worry about data misuse and perceived risks, and perceived benefits of data sharing. The results are shown as percentages, adjusted odds ratios, and 95% CIs. RESULTS: Overall, 61.1% (937/1534) of participants were willing to share their data with the government and 61% (936/1534) of participants were willing to share their data with academic research institutions compared with 43.1% (661/1534) who were willing to share their data with private organizations. The willingness to share varied between specific types of data-51.8% (794/1534) for loyalty cards, 35.2% (540/1534) for internet search history, 32% (491/1534) for smartphone data, 31.8% (488/1534) for wearable device data, and 30.4% (467/1534) for social media data. Increasing age was consistently and negatively associated with all the outcomes. Trust was positively associated with willingness to share commercial data, whereas worry about data misuse and the perceived importance of privacy were negatively associated with willingness to share commercial data. The perceived risk of sharing data was positively associated with willingness to share when the participants considered all the specific data types but not with the organizations. The participants favored postal research invitations over digital research invitations. CONCLUSIONS: This UK-based survey study shows that willingness to share commercial data for health research varies; however, researchers should focus on effectively communicating their data practices to minimize concerns about data misuse and improve public trust in data science. The results of this study can be further used as a guide to consider methods to improve recruitment strategies in health-related research and to improve response rates and participant retention.

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Purpose: In this brief report, we highlight the challenges that we experienced while attempting to conduct primary data collection with intimate partner violence (IPV) survivors living in an IPV emergency shelter throughout the prolonged COVID-19 pandemic and our strategies to overcome them. Method: In the summer of 2021, we began collecting data on a study investigating maternal-child bonding while living in IPV emergency shelters. We proposed a 14-day electronic daily diary methodology with follow-up semi-structured interview. The purpose of the study was to understand what factors affect maternal-child bonding to support survivors' relationships with their children while living in an emergency shelter. Results: We encountered two global obstacles to study implementation: the Institutional Review Board (IRB) pausing in-person data collection and low IPV shelter utilization. In what we term methodological resilience, we engaged in innovative and flexible team work to overcome these barriers. Specific strategies centered on creating an entirely remote data collection process and expanding our geographic area and participant eligibility criteria. Conclusions: Implications for researchers include greater communication with IRB offices, planning for multi-state recruitment, triangulated recruitment methods, reminder texts for participants and incremental incentives to ensure continued engagement with the study.

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Persistent barriers exist to engage rural providers in research and training. Provider shortages exacerbate these challenges, leading to a scarcity of time and limiting motivation to participate in research. We present application of an innovative engagement model to increase rural primary care provider participation in research. Using our Community Engagement and Research Core, we demonstrate that fundamental principles of training and expertise, attention to efficiency and multitasking, and commitment to community are important for addressing provider recruitment barriers. We encourage other Clinical and Translational Science Centers to provide similar services to their local investigators to enhance provider engagement in research.

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Maintaining data quality on Amazon Mechanical Turk (MTurk) has always been a concern for researchers. These concerns have grown recently due to the bot crisis of 2018 and observations that past safeguards of data quality (e.g., approval ratings of 95%) no longer work. To address data quality concerns, CloudResearch, a third-party website that interfaces with MTurk, has assessed ~165,000 MTurkers and categorized them into those that provide high- (~100,000, Approved) and low- (~65,000, Blocked) quality data. Here, we examined the predictive validity of CloudResearch's vetting. In a pre-registered study, participants (N = 900) from the Approved and Blocked groups, along with a Standard MTurk sample (95% HIT acceptance ratio, 100+ completed HITs), completed an array of data-quality measures. Across several indices, Approved participants (i) identified the content of images more accurately, (ii) answered more reading comprehension questions correctly, (iii) responded to reversed coded items more consistently, (iv) passed a greater number of attention checks, (v) self-reported less cheating and actually left the survey window less often on easily Googleable questions, (vi) replicated classic psychology experimental effects more reliably, and (vii) answered AI-stumping questions more accurately than Blocked participants, who performed at chance on multiple outcomes. Data quality of the Standard sample was generally in between the Approved and Blocked groups. We discuss how MTurk's Approval Rating system is no longer an effective data-quality control, and we discuss the advantages afforded by using the Approved group for scientific studies on MTurk.

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OBJECTIVE: Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship between the proportion of SARS-CoV-2 investigational trial sites within each USA state with unsuccessful patient-participant recruitment and: (i) the proportion of cases required to reach state recruitment goals; (ii) state population based on data from the US Census; and, (iii) number of trial sites per state. RESULTS: Our study included 151 clinical trials. The proportion of trials with successful recruitment was 72.19% (109 of 151 trials). We did not find a significant relationship between unsuccessful patient-participant recruitment, state recruitment goals, state population or the number of trial sites per state in both our simple and multivariable regression analyses. Our results do not suggest that early in the COVID-19 pandemic, competition for patient-participants impeded successful recruitment in SARS-CoV-2 trials. This may reflect the unique circumstances of the first few months of the pandemic in the United States, in which the number and location of SARS-CoV-2 cases was sufficient to meet trial recruitment requirements, despite the large number of trials launched.

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Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers' intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner.

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