Participant retention in follow-up studies of intensive care unit survivors - A scoping review.

OBJECTIVE: To synthesize participant retention data and related reporting in studies evaluating post-hospital outcomes of survivors of critical illness after an intensive care unit (ICU) stay. REVIEW METHOD USED: A synthesis of literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. DATA SOURCES: PubMed, EMBASE, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Controlled Trials Registry. Hand searched reference lists and personal files of relevant narrative and systematic review articles. REVIEW METHODS: Articles were screened by pairs of independent reviewers. Similarly, data were abstracted by pairs of data collectors, with conflicts resolved by consensus or by a third reviewer. RESULTS: We included 243 publications, from 225 unique studies of 87,602 participants. Participant retention could not be calculated for any time-points in 13% of studies nor in 22% of all follow-up time-points. Retention ranged from 18-100%. When compared to follow-up before 1-month, retention at each later timepoint was not significantly different. Age and sex were not associated with retention and more recent studies had decreased retention (odds ratio: 0.94 [95% confidence interval: 0.92-0.96; p < 0.001]). Reporting of retention-related study methodology was inconsistent. CONCLUSION: Retention rate could not be calculated for 22% of study follow-up time-points, with retention at the remaining time-points generally being high (≥85%), but with high variability (18% - 100%). ICU survivorship research could be improved via: (i) more detailed guidance on reporting participant retention, and (ii) use of existing resources and best practices to facilitate better study design and to improve participant retention to preserve statistical power and reduce selection bias.

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials.

BACKGROUND/AIMS: High follow-up is critical in randomized clinical trials. We developed novel approaches to modify in-person visits and complete follow-up during COVID-19. Since these strategies are broadly applicable to circumstances wherein follow-up is difficult, they may help in contingency planning. The objective of this article is to develop and evaluate new approaches to replace detailed, in-person study visits for two trials focused on preventing diabetic foot complications. METHODS: A quasi-experimental pre-post design compared approaches for follow-up during COVID-19 to approaches pre-COVID-19. Study subjects were outpatients at two Veterans Affairs Medical Centers. Following a research "hold," research resumed in February 2021 for Self-monitoring, Thermometry and Educating Patients for Ulcer Prevention (STEP UP) (n = 241), which focused on preventing recurrent foot ulcers, and in April 2021 for Preventing Amputation by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT) (n = 406), which focused on preventing pre-ulcerative and ulcerative lesions. To complete data collection, we shortened visits, focused on primary and secondary outcomes, and conducted virtual visits when appropriate. For STEP UP, we created a 20-min assessment process that could be administered by phone. Since PATRIOT required plantar photographs to assess foot lesions, we conducted short face-to-face visits. We explored differences and assessed proportion completing visit, visit completion/100 person-months and compared COVID-19 to pre- COVID-19 using unadjusted risk ratios, incidence rate ratios, all with associated 95% confidence intervals (CIs). Finally, we report time-to-visit curves. RESULTS: In both studies, participants whose follow-up concluded pre- COVID-19 seemed older than those whose follow-up concluded during COVID-19 (PATRIOT: 68.0 (67.2, 68.9) versus 65.2 years (61.9, 68.5); STEP UP: 67.5 (66.2, 68.9) versus 65.3 (63.3, 67.3)). For STEP UP, we completed 91 visits pre- COVID-19 (37.8% (31.6%, 44.2%)) and 63 visits during COVID-19 (78.8% (68.2%, 87.1%)). This was over 1309 person-months pre-COVID-19, and over 208.8 person-months during COVID-19; the visit completion rate/100 person-months were: pre-COVID-19 7.0 (5.6, 8.5), COVID-19 30.2 (23.2, 38.6); risk ratio: 2.1 (1.7, 2.5); and incidence rate ratio 4.3 (3.1, 5.9). Similarly, for PATRIOT, we completed 316 visits pre-COVID-19 (77.8% (73.5%, 81.8%)) and 27 assessments during COVID-19 (84.4% (67.2%, 94.7%)). This was over 1192.7 person-months pre-COVID-19 and 39.3 person-months during COVID-19. The visit completion rate/100 person-months in PATRIOT were: pre-COVID-19 2.7 (2.4, 3.0), COVID-19 6.9 (4.5, 10); risk ratio 1.1 (0.9, 1.3); incidence rate ratio 2.6 (1.8, 3.8). For both studies, the follow-up curves began separating at < 2 months. CONCLUSIONS: We achieved higher completion rates during COVID-19 compared to pre-COVID-19 by modifying visits and focusing on primary and secondary outcomes. These strategies prevent excessive missing data, support more valid conclusions, and improve efficiency. They may provide important alternative strategies to achieving higher follow-up in randomized clinical trials.

Establishing Requirements for Technology to Support Clinical Trial Retention: Systematic Scoping Review and Analysis Using Self-determination Theory.

BACKGROUND: Retaining participants in clinical trials is an established challenge. Currently, the industry is moving to a technology-mediated, decentralized model for running trials. The shift presents an opportunity for technology design to aid the participant experience and promote retention; however, there are many open questions regarding how this can be best supported. We advocate the adoption of a stronger theoretical position to improve the quality of design decisions for clinical trial technology to promote participant engagement. OBJECTIVE: This study aimed to identify and analyze the types of retention strategies used in published clinical trials that successfully retain participants. METHODS: A systematic scoping review was carried out on 6 electronic databases for articles published from 1990 to September 2020, namely CINAHL, The Cochrane Library, EBSCO, Embase, PsycINFO, and PubMed, using the concepts "retention," "strategy," "clinal trial," and "clinical research." This was followed by an analysis of the included articles through the lens of self-determination theory, an evidence-based theory of human motivation. RESULTS: A total of 26 articles were included in this review. The motivational strategies identified in the clinical trials in our sample were categorized into 8 themes: autonomy; competence; relatedness; controlled motivation; branding, communication material, and marketing literature; contact, tracking, and scheduling methods and data collection; convenience to contribute to data collection; and organizational competence. The trials used a wide range of motivational strategies. Notably, the trials often relied on controlled motivation interventions and underused strategies to support intrinsic motivation. Moreover, traditional clinical trials relied heavily on human interaction and "relatedness" to support motivation and retention, which may cause problems in the move to technology-led decentralized trials. We found inconsistency in the data-reporting methods and that motivational theory-based approaches were not evident in strategy design. CONCLUSIONS: This study offers direction and a framework to guide digital technology design decisions for future decentralized clinical trials to enhance participant retention during clinical trials. This research defines previous clinical trial retention strategies in terms of participant motivation, identifies motivational strategies, and offers a rationale for selecting strategies that will improve retention. It emphasizes the benefits of using theoretical frameworks to analyze strategic approaches and aid decision-making to improve the quality of technology design decisions.

Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention.

BACKGROUND: Ensuring protocol visit compliance and maintaining high participant retention remain critical elements of clinical trials. In the HVTN 702 HIV vaccine trial, Setshaba Research Centre in Soshanguve, Tshwane, South Africa, experienced challenges in communicating with participants to remind them about their study visits. In order to improve participants adhering to their study visits, and study retention, we aimed to identify challenges in mobile communication, and to establish preferences in communication methods and interest in receiving study information via cellphones. METHODS: We conducted a paper-based survey among HVTN 702 HIV vaccine trial participants at Setshaba Research Centre. The survey comprised of dichotomous and scale questions and was completed voluntarily and anonymously. The questions included those on their primary form of communication (calling, SMS and WhatsApp), the best time of day for the site to communicate with them, whether they were interested in receiving regular general study information updates via their cellular phone, how often they changed their cellular phones and/or network, whether they experienced any challenges with their cellular phones and what these challenges were, if any. All participants scheduled to visit the clinic from February to May 2019 were invited to participate. Thus, 90 of 380 (24%) participants enrolled by May 2019 were surveyed. RESULTS: The majority (68%) of participants were 26-35 years old and almost three-quarters (73%) were female. Almost all participants (99%) had a personal cellphone. Half of the participants experienced some challenge related to cellphones, these being poor network signal at home (12%), battery running flat frequently (11%), sharing their phone (9%), lack of data (9%), challenges with use of applications (6%) and their cellphones being unreliable (3%). Annually, 20% of participants made a single or multiple network changes. Communication preferences were calls by site staff (80%), SMS (16%) and WhatsApp (3%). Most preferred to be contacted in the morning (49%) or afternoon (31%). Site contact was rated as 'very helpful' (87%), and 97% were interested in receiving regular general study information updates via their cellphone. CONCLUSION: Despite participants owning cellphones, there are still technical challenges, for example, network signals, battery-charging and applications. The majority of participants preferred being called rather than communicating by text messages or WhatsApp. Future studies need to include addressing participant challenges in maintaining contact and training of participants on use of cellphone applications to optimise communication. Noting the preferred time of day for participants to be called might improve the likelihood of making contact with them. The willingness to receive updates will aid in keeping participant interest high and enhance retention.

Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2).

BACKGROUND: Addressing recruitment and retention challenges in trials is a key priority for methods research, but navigating the literature is difficult and time-consuming. In 2016, ORRCA (www.orrca.org.uk) launched a free, searchable database of recruitment research that has been widely accessed and used to support the update of systematic reviews and the selection of recruitment strategies for clinical trials. ORRCA2 aims to create a similar database to map the growing volume and importance of retention research. METHODS: Searches of Medline (Ovid), CINAHL, PsycINFO, Scopus, Web of Science Core Collection and the Cochrane Library, restricted to English language and publications up to the end of 2017. Hand searches of key systematic reviews were undertaken and randomised evaluations of recruitment interventions within the ORRCA database on 1 October 2020 were also reviewed for any secondary retention outcomes. Records were screened by title and abstract before obtaining the full text of potentially relevant articles. Studies reporting or evaluating strategies, methods and study designs to improve retention within healthcare research were eligible. Case reports describing retention challenges or successes and studies evaluating participant reported reasons for withdrawal or losses were also included. Studies assessing adherence to treatments, attendance at appointments outside of research and statistical analysis methods for missing data were excluded. Eligible articles were categorised into one of the following evidence types: randomised evaluations, non-randomised evaluations, application of retention strategies without evaluation and observations of factors affecting retention. Articles were also mapped against a retention domain framework. Additional data were extracted on research outcomes, methods and host study context. RESULTS: Of the 72,904 abstracts screened, 4,364 full texts were obtained, and 1,167 articles were eligible. Of these, 165 (14%) were randomised evaluations, 99 (8%) non-randomised evaluations, 319 (27%) strategies without evaluation and 584 (50%) observations of factors affecting retention. Eighty-four percent (n = 979) of studies assessed the numbers of participants retained, 27% (n = 317) assessed demographic differences between retained and lost participants, while only 4% (n = 44) assessed the cost of retention strategies. The most frequently reported domains within the 165 studies categorised as 'randomised evaluations of retention strategies' were participant monetary incentives (32%), participant reminders and prompts (30%), questionnaire design (30%) and data collection location and method (26%). CONCLUSION: ORRCA2 builds on the success of ORRCA extending the database to organise the growing volume of retention research. Less than 15% of articles were randomised evaluations of retention strategies. Mapping of the literature highlights several areas for future research such as the role of research sites, clinical staff and study design in enhancing retention. Future studies should also include cost-benefit analysis of retention strategies.

Improving retention of community-recruited participants in HIV prevention research through Saturday household visits; findings from the HPTN 071 (PopART) study in South Africa.

BACKGROUND: Identifying successful strategies to improve participant retention in longitudinal studies remains a challenge. In this study we evaluated whether non-traditional fieldworker shifts (after hours during the week and weekends) enhanced participant retention when compared to retention during traditional weekday shifts in the HPTN 071 (PopART) population cohort (PC). METHODS: HPTN 071 (PopART) PC participants were recruited and followed up in their homes on an annual basis by research fieldworkers over a 3-4 year period. The average number of successful follow-up visits, where a PC participant was found and retained in the study, was calculated for each of 3 visit schedules (early weekday shift, late weekday shift, and Saturday shift), and standardized to account for variation in fieldwork shift duration. We used one-way univariate analysis of variance (ANOVA) to describe differences in mean-successful visits and 95% confidence intervals between the shift types. RESULTS: Data on 16 651 successful visits were included. Successful visit rates were higher when conducting Saturday visits (14.0; 95% CI: 11.3-16.6) compared to both regular (4.5; 95% CI: 3.7-5.3) and late weekday shifts (5.3; 95% CI: 4.7-5.8) overall and in all subgroup analyses (P<0.001). The successful visit rate was higher amongst women than men were during all shift types (3.2 vs. 1.3, p<0.001). Successful visit rates by shift type did not differ significantly by age, over time, by PC round or by community triplet. CONCLUSION: The number of people living with HIV continues to increase annually. High quality evidence from longitudinal studies remains critical for evaluating HIV prevention and treatment strategies. This study showed a significant benefit on participant retention through introduction of Saturday shifts for home visits and these data can make an important contribution to the emerging body of evidence for improving retention in longitudinal research. TRIAL REGISTRATION: PopART was approved by the Stellenbosch University Health Research Ethics Committees (N12/11/074), London School of Hygiene and Tropical Medicine (6326) ethics committee and the Division of AIDS (DAIDS) (Protocol ID 11865). PopART was registered with ClinicalTrials.gov (registration number NCT01900977 ).

Qualitative perceptions of and preferences for the research process among patients with eating disorders.

OBJECTIVE: Low participation and retention rates are persistent problems in eating disorder (ED) research. In order to improve the research process, this study used a qualitative approach to examine factors promoting and limiting research study participation among patients with EDs, and their preferences during research. METHOD: Five 90-min focus groups were conducted with adult women (N = 29) enrolled at a residential ED treatment facility. Facilitators asked a series of open-ended questions about participants' experiences, opinions, and preferences with regard to ED treatment research. Transcript analysis identified themes using a consensual qualitative research approach. RESULTS: It was revealed that preventing others' suffering, improving ED treatment, and having low participant burden were major themes facilitating research participation. Major barriers to research participation included concern that research interferes with self-care/recovery, burdensome nature of study design, and demeanor of the researchers/institutions involved with the study. Patients believed that the format of research assessments could be improved by better assessing the nuances of ED behaviors, examining non-ED outcomes, and including more open-ended questions. Patients anticipated that challenges in recovery, feelings of guilt, and logistical barriers could interfere with their ability to complete follow-up research assessments. DISCUSSION: Factors related to the recruitment process, assessment format, follow-up methods, and communication throughout the research process may need to be addressed to increase participation and retention rates. Findings indicate that recruitment strategies should include emphasizing the broader impact of the research and increasing sensitivity to the nature of patients with EDs experiences.

Use of Online or Paper Surveys by Australian Women: Longitudinal Study of Users, Devices, and Cohort Retention.

BACKGROUND: There is increasing use of online surveys to improve data quality and timeliness and reduce costs. While there have been numerous cross-sectional studies comparing responses to online or paper surveys, there is little research from a longitudinal perspective. OBJECTIVE: In the context of the well-established Australian Longitudinal Study on Women's Health, we examined the patterns of responses to online or paper surveys across the first two waves of the study in which both modes were offered. We compared the following: differences between women born between 1946 and 1951 and between 1973 and 1978; types of device used for online completion; sociodemographic, behavioral, and health characteristics of women who responded online or using mailed paper surveys; and associations between mode of completion in the first survey and participation and mode of completion in the second survey. METHODS: Participants in this study, who had responded to regular mailed surveys since 1996, were offered a choice of completing surveys using paper questionnaires or Web-based electronic questionnaires starting in 2012. Two groups of women were involved: an older cohort born between 1946 and 1951 aged in their 60s and a younger cohort born between 1973 and 1978 aged in their 30s when the online surveys were first introduced. We compared women who responded online on both occasions, women who responded online at the first survey and used the paper version of the second survey, women who changed from paper to online, and those who used paper for both surveys. RESULTS: Of the 9663 women in their 60s who responded to one or both surveys, more than 50% preferred paper surveys (5290/9663, 54.74%, on the first survey and 5373/8621, 62.32%, on the second survey). If they chose the online version, most used computers. In contrast, of the 8628 women in their 30s, 56.04% (4835/8628) chose the online version at the first survey. While most favored computers to phones or tablets, many did try these alternatives on the subsequent survey. Many women who completed the survey online the first time preferred the paper version on the subsequent survey. In fact, for women in their 60s, the number who went from online to paper (1151/3851, 29.89%) exceeded the number who went from paper to online (734/5290, 13.88%). The online option was more likely to be chosen by better educated and healthier women. In both cohorts, women who completed paper surveys were more likely than online completers to become nonrespondents on the next survey. Due to the large sample size, almost all differences were statistically significant, with P<.001. CONCLUSIONS: Despite the cost-saving advantages of online compared to paper surveys, paper surveys are likely to appeal to a different population of potential respondents with different sociodemographic, behavioral, and health characteristics and greater likelihood of attrition from the study. Not offering a paper version is therefore likely to induce bias in the distribution of responses unless weighting for respondent characteristics (relative to the target population) is employed. Therefore, if mixed mode (paper or online) options are feasible, they are highly likely to produce more representative results than if only the less costly online option is offered.

Principles of Precision Prevention Science for Improving Recruitment and Retention of Participants.

Precision medicine and precision public health focus on identifying and providing the right intervention to the right population at the right time. Expanding on the concept, precision prevention science could allow the field to examine prevention programs to identify ways to make them more efficient and effective at scale, including addressing issues related to engagement and retention of participants. Research to date on engagement and retention has often focused on demographics and risk factors. The current paper proposes using McCurdy and Daro (Family Relations, 50, 113-121, 2001) model that posits a complex mixture of individual, provider, program, and community-level factors synergistically affect enrollment, engagement, and retention. The paper concludes recommending the use of research-practice partnerships and innovative, rapid cycle methods to design and improve prevention programs related to participant engagement and retention at scale.

Women's experiences of participating in a prospective, longitudinal postpartum depression study: insights for perinatal mental health researchers.

Barriers to recruitment for research on mental illness include participant distrust of researchers and social stigma. Though these issues may be acutely important in perinatal mental health research, they remain unexplored in this context. In order to inform strategies to more fully engage women in perinatal mental health research, we explored the motivations and experiences of women with a history of major depressive disorder who participated in a prospective longitudinal research study on postpartum depression (PPD). Sixteen women with a history of depression who had either completed or recently made a decision about participation in a longitudinal research study about PPD were interviewed by telephone. Qualitative, semi-structured interviews explored participants' decision-making about, and experiences of, participation. Interviews were audio-recorded, transcribed, and qualitatively analyzed using elements of grounded theory methodology. Follow-up interviews were conducted with four participants to refine and clarify preliminary results. Foundational elements necessary for women to consider participating in PPD research included personal acceptance of illness and trust in the research team/institution. Other main motivators included perceived personal relevance, anticipated benefits (including access to support/resources, learning opportunities, and improved self-worth), altruism, and accessible study procedures. Our data suggest that participating in perinatal mental health research may help women make meaning of their mental illness experience and is perceived as providing support. The findings-particularly around the importance of participant-researcher rapport and accessibility of study design-may inform strategies that improve participation rates, decrease attrition, and maximize participant benefits in perinatal mental health research.

Postal contact with participating children and its impact on response rate: Japan Environment and Children's Pilot Study.

BACKGROUND: Communication with participating children and its effect on participation outcome is one of the most important but untouched issues in birth cohort studies. The purpose of this study was to assess the effect of postal communication with the participating preschool children on the response rate to postal questionnaires. METHODS: One hundred and five mother-preschool child pairs from the Japan Environment and Children's Study (JECS) pilot cohort were included. During the 6 month study period, letters addressed to the children were enclosed with our biannual questionnaires, and the response rate transition was observed. Additionally, the participants were allocated to two groups. One of these was sent the letter with the individual name of the child at the top, and the other without it. The response rates of the two groups were compared using chi-squared test. Parents' impressions of the letters and the changes in their motivation to complete the questionnaires were surveyed using an evaluation form. RESULTS: The overall response rate was 83.8%, which was lower than the previous survey period. Response rate was not significantly different between the two letter types. The duration before questionnaire return was not changed. Despite their favorable impression based on parent evaluation, the letters were not associated with the parents' motivation to respond. CONCLUSION: Letters to participating preschool children had no effect on response rate, but the long-term impact of its favorability still remains to be evaluated. A similar trial at later ages may be more effective.

Cultural Connections: the Key to Retention of Black, Latina, and Arab Women in the Kin Keeper(SM) Cancer Prevention Intervention Studies.

Diverse racial and ethnic populations must be included in research studies in order to address health disparities. Retaining hard-to-reach populations including poor, underserved, and racial/ethnic groups in longitudinal studies can be quite difficult. Using innovative retention strategies that address culture and community are imperative. The objective of this report is to identify and describe strategies for successful retention rates among a unique group of hard-to-reach racial/ethnic participants. We analyzed the follow-up rates in two different cohorts using the Kin Keeper(SM) study design. The aim of Study A was to examine the capability of the Kin Keeper(SM) education to increase health literacy in breast and cervical cancer. The primary aim of Study B was to measure changes in breast and cervical cancer screening after receiving the Kin Keeper(SM) education. Retention rates were analyzed and compared over 12 months for both cohorts. We found good retention rates for both cohorts with each having a unique set of differences. The overall follow-up rate was 82 % for Study A and 88 % for Study B with demographic differences between the studies reported herein. Despite changing cultural, community, and geopolitical factors, we were able to maintain consistent participation for each study. We attribute high retention rates to trusted cultural connections and the flexibility to adjust retention strategies.

The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial.

BACKGROUND: REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality. In this analysis we describe a comprehensive multidimensional methodology for evaluating CRS performance. METHODS: The REPRIEVE Data Coordinating and Clinical Coordinating Centers developed a robust system for evaluation of and communication with CRSs, designed to identify potential issues and obstacles to performance, provide real-time technical support, and make recommendations for process improvements to facilitate efficient trial execution. We describe these systems and evaluate their impact on participant retention, data management, and specimen management from 2019 to 2022, corresponding to the period from end of recruitment to present. This evaluation was based on pre-defined metrics, regular reviews, and bidirectional communication. RESULTS: Participant retention, data management, and specimen management all remained steady over the three-year period, although metrics varied by country of enrollment. Targeted messaging relating to certain performance metrics was effective. CONCLUSION: Site performance is vital to ensure trial integrity and achievement of key trial goals. This analysis demonstrates that utilization of a comprehensive approach allows for a thorough evaluation of CRS performance, facilitates data and specimen management, and enhances participant retention. Our approach may serve as a guidepost for maximizing future large-scale clinical trials' operational success and scientific rigor. CLINICALTRIALS: gov Identifier: NCT02344290.

The RIC COVID-19 Recruitment & Retention Toolkit: A community-informed resource of recruitment tools and strategies for clinical trial investigators.

The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable resources to help research teams increase awareness of clinical trials and opportunities to participate; produce culturally sensitive and engaging recruitment materials; improve consent and return of results processes; and enhance recruitment of individuals from populations disproportionately impacted by COVID-19. This resource, the "RIC COVID-19 Recruitment and Retention Toolkit," is available free online. We describe the toolkit and the community feedback used to author and curate this resource.

Recruitment and retention of emerging adults in lifestyle interventions: Findings from the REACH trial.

OBJECTIVE: Emerging adulthood (EA) is a critical time to promote cardiometabolic health, but EAs are underrepresented in lifestyle intervention trials. Knowledge gaps exist regarding how best to recruit and retain sociodemographically diverse EAs. Our goal was to begin to address these gaps using data from the Richmond Emerging Adults Choosing Health (REACH) Trial. METHODS: REACH was a comparative efficacy trial for EAs, age 18-25, with a body mass index of 25-45 kg/m2. Enrollment goals were: N = 381, ≥40% underrepresented race/ethnicity, ≥30% men, ≥85% retention at 6 months. We translated formative work into a recruitment and retention plan, examined yield for recruitment and retention overall, and by gender and race/ethnicity, as well as cost data. Descriptive statistics and chi square tests were used. RESULTS: Enrollment benchmarks were met overall (N = 382) and for participants from underrepresented race/ethnic backgrounds (58.0%), but not men (17.3%). The most common recruitment sources were email (26.9%), radio (22.2%), and online radio (15.4%); this pattern largely held true across gender and race/ethnic groups, though word of mouth and participant referral together accounted for nearly a quarter of enrolled men. Costs averaged $155 per randomized participant. Retention was 89% at 3-months, 84% at 6-months (primary endpoint) and 80% at 12-months (follow-up), with no significant differences by gender or race/ethnicity (all p's > 0.05). Retention did not differ by recruitment method (p = .69). CONCLUSIONS: Grounding our approach in formative data and embracing participants as partners in research contributed to the recruitment and retention of sociodemographically diverse EAs. Additional efforts are needed to enroll EA men.

Feasibility of Digital Memory Assessments in an Unsupervised and Remote Study Setting.

Sensitive and frequent digital remote memory assessments via mobile devices hold the promise to facilitate the detection of cognitive impairment and decline. However, in order to be successful at scale, cognitive tests need to be applicable in unsupervised settings and confounding factors need to be understood. This study explored the feasibility of completely unsupervised digital cognitive assessments using three novel memory tasks in a Citizen Science project across Germany. To that end, the study aimed to identify factors associated with stronger participant retention, to examine test-retest reliability and the extent of practice effects, as well as to investigate the influence of uncontrolled settings such as time of day, delay between sessions or screen size on memory performance. A total of 1,407 adults (aged 18-89) participated in the study for up to 12 weeks, completing weekly memory tasks in addition to short questionnaires regarding sleep duration, subjective cognitive complaints as well as cold symptoms. Participation across memory tasks was pseudorandomized such that individuals were assigned to one of three memory paradigms resulting in three otherwise identical sub-studies. One hundred thirty-eight participants contributed to two of the three paradigms. Critically, for each memory task 12 independent parallel test sets were used to minimize effects of repeated testing. First, we observed a mean participant retention time of 44 days, or 4 active test sessions, and 77.5% compliance to the study protocol in an unsupervised setting with no contact between participants and study personnel, payment or feedback. We identified subject-level factors that contributed to higher retention times. Second, we found minor practice effects associated with repeated cognitive testing, and reveal evidence for acceptable-to-good retest reliability of mobile testing. Third, we show that memory performance assessed through repeated digital assessments was strongly associated with age in all paradigms, and individuals with subjectively reported cognitive decline presented lower mnemonic discrimination accuracy compared to non-complaining participants. Finally, we identified design-related factors that need to be incorporated in future studies such as the time delay between test sessions. Our results demonstrate the feasibility of fully unsupervised digital remote memory assessments and identify critical factors to account for in future studies.

Recruitment and retention for chronic pain clinical trials: a narrative review.

Opioid misuse is at a crisis level. In response to this epidemic, the National Institutes of Health has funded $945 million in research through the Helping to End Addiction Long-term (HEAL) Pain Management Initiative, including funding to the Vanderbilt Recruitment Innovation Center (RIC) to strategize methods to catalyze participant recruitment. The RIC, recognizing the challenges presented to clinical researchers in recruiting individuals experiencing pain, conducted a review of evidence in the literature on successful participant recruitment methods for chronic pain trials, in preparation for supporting the HEAL Pain trials. Study design as it affects recruitment was reviewed, with issues such as sufficient sample size, impact of placebo, pain symptom instability, and cohort characterization being identified as problems. Potential solutions found in the literature include targeted electronic health record phenotyping, use of alternative study designs, and greater clinician education and involvement. For retention, the literature reports successful strategies that include maintaining a supportive staff, allowing virtual study visits, and providing treatment flexibility within the trial. Community input on study design to identify potential obstacles to recruitment and retention was found to help investigators avoid pitfalls and enhance trust, especially when recruiting underrepresented minority populations. Our report concludes with a description of generalizable resources the RIC has developed or adapted to enhance recruitment and retention in the HEAL Pain studies. These resources include, among others, a Recruitment and Retention Plan Template, a Competing Trials Tool, and MyCap, a mobile research application that interfaces with Research Electronic Data Capture (REDCap).

Recruitment and Retention in Remote Research: Learnings From a Large, Decentralized Real-world Study.

BACKGROUND: Smartphones are increasingly used in health research. They provide a continuous connection between participants and researchers to monitor long-term health trajectories of large populations at a fraction of the cost of traditional research studies. However, despite the potential of using smartphones in remote research, there is an urgent need to develop effective strategies to reach, recruit, and retain the target populations in a representative and equitable manner. OBJECTIVE: We aimed to investigate the impact of combining different recruitment and incentive distribution approaches used in remote research on cohort characteristics and long-term retention. The real-world factors significantly impacting active and passive data collection were also evaluated. METHODS: We conducted a secondary data analysis of participant recruitment and retention using data from a large remote observation study aimed at understanding real-world factors linked to cold, influenza, and the impact of traumatic brain injury on daily functioning. We conducted recruitment in 2 phases between March 15, 2020, and January 4, 2022. Over 10,000 smartphone owners in the United States were recruited to provide 12 weeks of daily surveys and smartphone-based passive-sensing data. Using multivariate statistics, we investigated the potential impact of different recruitment and incentive distribution approaches on cohort characteristics. Survival analysis was used to assess the effects of sociodemographic characteristics on participant retention across the 2 recruitment phases. Associations between passive data-sharing patterns and demographic characteristics of the cohort were evaluated using logistic regression. RESULTS: We analyzed over 330,000 days of engagement data collected from 10,000 participants. Our key findings are as follows: first, the overall characteristics of participants recruited using digital advertisements on social media and news media differed significantly from those of participants recruited using crowdsourcing platforms (Prolific and Amazon Mechanical Turk; P<.001). Second, participant retention in the study varied significantly across study phases, recruitment sources, and socioeconomic and demographic factors (P<.001). Third, notable differences in passive data collection were associated with device type (Android vs iOS) and participants' sociodemographic characteristics. Black or African American participants were significantly less likely to share passive sensor data streams than non-Hispanic White participants (odds ratio 0.44-0.49, 95% CI 0.35-0.61; P<.001). Fourth, participants were more likely to adhere to baseline surveys if the surveys were administered immediately after enrollment. Fifth, technical glitches could significantly impact real-world data collection in remote settings, which can severely impact generation of reliable evidence. CONCLUSIONS: Our findings highlight several factors, such as recruitment platforms, incentive distribution frequency, the timing of baseline surveys, device heterogeneity, and technical glitches in data collection infrastructure, that could impact remote long-term data collection. Combined together, these empirical findings could help inform best practices for monitoring anomalies during real-world data collection and for recruiting and retaining target populations in a representative and equitable manner.

Where Have They Gone? Recruiting and Retaining Older Rural Research Participants.

ISSUE: Rural-dwelling elderly have been shown to suffer from health disparities when compared to the general population. Research involving these individuals is important, and to have meaningful results, sample sizes must be adequate. Recruiting and retaining these individuals pose significant challenges. CONTEXT: Nurse researchers in the rural northwestern United States conducted a 4-part educational intervention aimed at increasing general and complementary and alternative health care literacy of older rural dwellers. Significant challenges were faced in both recruiting and retaining participants over the 6-month study period. Despite careful planning and community selection, the team had to double the number of communities in which they carried out the project to meet recruitment goals. Retention was also a challenge. Of 127 participants initially enrolled in the study, only 52 remained to the end. LESSONS LEARNED: Challenges of recruiting and retaining are complex and compounded when the target population is rural, older and the study is longitudinal. Recruitment challenges included reaching older adults, offering a compelling program, and offering it in an acceptable format at a convenient time and place. A variety of outreach activities were conducted including in-person presentations, advertising or public interest stories in local newspapers or radio stations, and flyers on bulletin boards in restaurants, clinics, churches, community centers, and libraries. A project champion, an individual well known and connected within the community and committed to the success of the proposed study, is a major asset. Retention strategies included developing relationships with the participants and maintaining contact with them over the course of the study through such mechanisms as appointment cards, e-mail or regular mail, telephone reminders, and thank you cards. Oversampling was important as factors beyond the control of the researcher occurred; for example, illness, death, family crises, unexpected relocations, and weather events that prevented travel to scheduled research events.

The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention.

Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC's goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.