Web applications aid clinical trial recruitment. Cancer discovery The websites Ask Dory and My Cancer Genome won a government-sponsored contest for providing details on clinical trials and genetic mutations for cancer patients, clinicians, and researchers. 10.1158/2159-8290.CD-NB2012-004
    GeneMatch: A novel recruitment registry using at-home APOE genotyping to enhance referrals to Alzheimer's prevention studies. Langbaum Jessica B,Karlawish Jason,Roberts J Scott,Wood Elisabeth M,Bradbury Angela,High Nellie,Walsh Trisha L,Gordon David,Aggarwal Raj,Davis Peter,Stowell Carter,Trisko Lane,Langlois Carolyn M,Reiman Eric M,Tariot Pierre N Alzheimer's & dementia : the journal of the Alzheimer's Association INTRODUCTION:Recruitment for Alzheimer's disease (AD) prevention research studies is challenging because of lack of awareness among cognitively healthy adults coupled with the high screen fail rate due to participants not having a genetic risk factor or biomarker evidence of the disease. Participant recruitment registries offer one solution for efficiently and effectively identifying, characterizing, and connecting potential eligible volunteers to studies. METHODS:Individuals aged 55-75 years who live in the United States and self-report not having a diagnosis of cognitive impairment such as MCI or dementia are eligible to join GeneMatch. Participants enroll online and are provided a cheek swab kit for DNA extraction and apolipoprotein E (APOE) genotyping. Participants are not told their APOE results, although the results may be used in part to help match participants to AD prevention studies. RESULTS:As of August 2018, 75,351 participants had joined GeneMatch. Nearly 30% of participants have one APOE4 allele, and approximately 3% have two APOE4 alleles. The percentages of APOE4 heterozygotes and homozygotes are inversely associated with age (P < .001). DISCUSSION:GeneMatch, the first trial-independent research enrollment program designed to recruit and refer cognitively healthy adults to AD prevention studies based in part on APOE test results, provides a novel mechanism to accelerate prescreening and enrollment for AD prevention trials. 10.1016/j.jalz.2018.12.007
    Strategies for recruitment and retention of participants in clinical trials. Probstfield Jeffrey L,Frye Robert L JAMA 10.1001/jama.2011.1544
    Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches. Elliott Daisy,Husbands Samantha,Hamdy Freddie C,Holmberg Lars,Donovan Jenny L European urology CONTEXT:The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. OBJECTIVE:This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. EVIDENCE ACQUISITION:A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. EVIDENCE SYNTHESIS:The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. CONCLUSIONS:Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. PATIENT SUMMARY:Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process. 10.1016/j.eururo.2017.04.036
    Statistical models to predict recruitment in clinical trials were rarely used by statisticians in UK and European networks. Gkioni Efstathia,Dodd Susanna,Rius Roser,Gamble Carrol Journal of clinical epidemiology OBJECTIVE:Identify the current practice for recruitment prediction and monitoring within clinical trials. STUDY DESIGN AND SETTING:Chief investigators (CIs) were surveyed to identify data sources and adjustments made to support recruitment prediction. Statisticians were surveyed to determine methods and adjustments used when predicting and monitoring recruitment. Participants were identified from the National Institute for Health Research recently funded studies, the UK Clinical Research Collaboration registered Clinical Trial Units network or by the European Clinical Research Infrastructure Network. RESULTS:A total of 51 CIs (UK = 32, ECRIN = 19) and 104 statisticians (UK = 51, ECRIN = 53) were contacted. Response rates varied (CIs UK = 53% ECRIN = 32%; statisticians UK = 98% ECRIN = 36%). Multiple data sources are used to support recruitment rates, most commonly audit data from multiple sites. Variation in individual site recruitment rates are frequently incorporated, but staggered site openings were featured more commonly among UK respondents. Simple prediction methods are preferred to rarely used statistical models. Lack of familiarity with statistical methods are barriers to their use with evidence needed to justify the time required to support their implementation. CONCLUSION:Simplistic methods will continue as the mainstay of prediction; however, generation of evidence supporting the benefits of complex statistical models should promote their implementations. Multiple data sources to support recruitment prediction are being used, and further work on the quality of these data is needed. Pressure to be optimistic about recruitment rates for the trial to be attractive to funders was felt by a sizable minority. 10.1016/j.jclinepi.2020.03.012
    Rare lung disease research: strategies for improving identification and recruitment of research participants. Gupta Samir,Bayoumi Ahmed M,Faughnan Marie E Chest Research in rare lung diseases faces methodologic limitations by virtue of the small number of participants available to be studied. We explored several strategies that may improve researchers' ability to identify and recruit research participants with rare lung diseases. We provide an overview of strategies based on available evidence, previously used approaches, and reasoning. First, disease detection is generally poor and may be improved through strategies targeted at primary care practitioners or directly at patients, thus increasing the pool of patients available for research studies. Next, standardization of case definitions in rare lung diseases is often lacking, hindering research recruitment efforts because of confusion over appropriate recruitment criteria. Expert consensus statements can enhance both clinical care and research recruitment by standardizing definitions. Finally, recruitment strategies using rare lung disease registries, clinical research networks, novel Internet-based direct patient recruitment approaches, and patient organizations may facilitate recruitment of patients with rare lung diseases. In summary, although several strategies for improving the identification and recruitment of research participants with rare lung diseases have been proposed, published examples are few. Objective measurement and reporting of novel recruitment methods and collaboration among researchers facing the same limitations across various rare lung diseases are required. Advancements in this area are vital to the design and performance of much-needed robust clinical studies across the spectrum of rare lung diseases. 10.1378/chest.11-1094
    Electronic medical record-based cohort selection and direct-to-patient, targeted recruitment: early efficacy and lessons learned. Miller Hailey N,Gleason Kelly T,Juraschek Stephen P,Plante Timothy B,Lewis-Land Cassie,Woods Bonnie,Appel Lawrence J,Ford Daniel E,Dennison Himmelfarb Cheryl R Journal of the American Medical Informatics Association : JAMIA OBJECTIVE:The study sought to characterize institution-wide participation in secure messaging (SM) at a large academic health network, describe our experience with electronic medical record (EMR)-based cohort selection, and discuss the potential roles of SM for research recruitment. MATERIALS AND METHODS:Study teams defined eligibility criteria to create a computable phenotype, structured EMR data, to identify and recruit participants. Patients with SM accounts matching this phenotype received recruitment messages. We compared demographic characteristics across SM users and the overall health system. We also tabulated SM activation and use, characteristics of individual studies, and efficacy of the recruitment methods. RESULTS:Of the 1 308 820 patients in the health network, 40% had active SM accounts. SM users had a greater proportion of white and non-Hispanic patients than nonactive SM users id. Among the studies included (n = 13), 77% recruited participants with a specific disease or condition. All studies used demographic criteria for their phenotype, while 46% (n = 6) used demographic, disease, and healthcare utilization criteria. The average SM response rate was 2.9%, with higher rates among condition-specific (3.4%) vs general health (1.4%) studies. Those studies with a more inclusive comprehensive phenotype had a higher response rate. DISCUSSION:Target population and EMR queries (computable phenotypes) affect recruitment efficacy and should be considered when designing an EMR-based recruitment strategy. CONCLUSIONS:SM guided by EMR-based cohort selection is a promising approach to identify and enroll research participants. Efforts to increase the number of active SM users and response rate should be implemented to enhance the effectiveness of this recruitment strategy. 10.1093/jamia/ocz168
    Use of electronic recruitment methods in a clinical trial of adults with gout. Miller Hailey N,Charleston Jeanne,Wu Beiwen,Gleason Kelly,White Karen,Dennison Himmelfarb Cheryl R,Ford Daniel E,Plante Timothy B,Gelber Allan C,Appel Lawrence J,Miller Edgar R,Juraschek Stephen P Clinical trials (London, England) BACKGROUND/AIMS:Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods. METHODS:We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method. RESULTS:Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans. CONCLUSION:An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials. 10.1177/1740774520956969
    A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1). Palac Hannah L,Alam Nameyeh,Kaiser Susan M,Ciolino Jody D,Lattie Emily G,Mohr David C Journal of medical Internet research BACKGROUND:The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants. OBJECTIVE:This paper describes a "do-it-yourself" recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials. METHODS:This work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system. RESULTS:We describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants. CONCLUSIONS:Using tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures. 10.2196/11049
    The Role of Social Media in Enhancing Clinical Trial Recruitment: Scoping Review. Darmawan Ida,Bakker Caitlin,Brockman Tabetha A,Patten Christi A,Eder Milton Journal of medical Internet research BACKGROUND:Recruiting participants into clinical trials continues to be a challenge, which can result in study delay or termination. Recent studies have used social media to enhance recruitment outcomes. An assessment of the literature on the use of social media for this purpose is required. OBJECTIVE:This study aims to answer the following questions: (1) How is the use of social media, in combination with traditional approaches to enhance clinical trial recruitment and enrollment, represented in the literature? and (2) Do the data on recruitment and enrollment outcomes presented in the literature allow for comparison across studies? METHODS:We conducted a comprehensive literature search across 7 platforms to identify clinical trials that combined social media and traditional methods to recruit patients. Study and participant characteristics, recruitment methods, and recruitment outcomes were evaluated and compared. RESULTS:We identified 2371 titles and abstracts through our systematic search. Of these, we assessed 95 full papers and determined that 33 studies met the inclusion criteria. A total of 17 studies reported enrollment outcomes, of which 9 achieved or exceeded their enrollment target. The proportion of participants enrolled from social media in these studies ranged from 0% to 49%. Across all 33 studies, the proportion of participants recruited and enrolled from social media varied greatly. A total of 9 studies reported higher enrollment rates from social media than any other methods, and 4 studies reported the lowest cost per enrolled participant from social media. CONCLUSIONS:While the assessment of the use of social media to improve clinical trial participation is hindered by reporting inconsistencies, preliminary data suggest that social media can increase participation and reduce per-participant cost. The adoption of consistent standards for reporting recruitment and enrollment outcomes is required to advance our understanding and use of social media to support clinical trial success. 10.2196/22810
    Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials. Niranjan Soumya J,Martin Michelle Y,Fouad Mona N,Vickers Selwyn M,Wenzel Jennifer A,Cook Elise D,Konety Badrinath R,Durant Raegan W Cancer BACKGROUND:In recent years, extensive attention has been paid to the possibility that bias among health care professionals contributes to health disparities. In its 2003 report, the Institute of Medicine concluded that bias against racial minorities may affect communication or care offered. However, to the authors' knowledge, the role of bias within the context of recruitment of racial and ethnic minorities to cancer clinical trials has not been explored to date. Therefore, the authors assessed the experiences of clinical and research personnel related to factors influencing the recruitment of racial and ethnic minorities for cancer clinical trials. METHODS:A total of 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: 1) cancer center leaders; 2) principal investigators; 3) referring clinicians; and 4) research staff. Data analysis was conducted using a content analysis approach to generate themes from the transcribed interviews. RESULTS:Five prominent themes emerged: 1) recruitment interactions with potential minority participants were perceived to be challenging; 2) potential minority participants were not perceived to be ideal study candidates; 3) a combination of clinic-level barriers and negative perceptions of minority study participants led to providers withholding clinical trial opportunities from potential minority participants; 4) when clinical trial recruitment practices were tailored to minority patients, addressing research misconceptions to build trust was a common strategy; 5) for some respondents, race was perceived as irrelevant when screening and recruiting potential minority participants for clinical trials. CONCLUSIONS:Not only did some respondents view racial and ethnic minorities as less promising participants, some respondents reported withholding trial opportunities from minorities based on these perceptions. Some providers endorsed using tailored recruitment strategies whereas others eschewed race as a factor in trial recruitment. The presence of bias and stereotyping among clinical and research professionals recruiting for cancer clinical trials should be considered when designing interventions to increase minority enrollment. 10.1002/cncr.32755
    Recruitment strategies in randomised controlled trials of men aged 50 years and older: a systematic review. Bracken Karen,Askie Lisa,Keech Anthony C,Hague Wendy,Wittert Gary BMJ open OBJECTIVES:To identify and review evaluations of strategies to recruit men aged 50 years and over to randomised controlled trials (RCTs). DESIGN:Systematic review and narrative synthesis. DATA SOURCES:MEDLINE, EMBASE, CINAHL and ORRCA databases were searched to 1 December 2017. ELIGIBILITY CRITERIA:Studies using quantitative methods to evaluate recruitment strategies to RCTs of men aged 50 years and older. DATA EXTRACTION AND SYNTHESIS:A single reviewer extracted data (for each strategy, number of participants approached, screened and randomised, and cost). Study quality was assessed using National Heart, Lung and Blood Institute Quality Assessment Tools and considered study design, description of interventions, description and measurement of outcomes, completeness of outcome reporting, performance of statistical testing and consideration of confounders. Recruitment strategies were categorised by the recruitment stage they addressed. RESULTS:Sixteen studies (n >14 000) were included: one good quality, ten fair quality and five poor quality. Studies evaluated strategies to identify prospective participants, and to improve the processes for assessing participant eligibility, providing participant information and seeking consent. In good and fair quality studies, the most effective strategies for identifying participants were referral from an affiliated health service provider (two studies), mass mailing (five studies) and media coverage (two studies). Community outreach activities such as displaying posters and attending local community events were not effective (two studies). Trial-specific training of site recruitment staff, developed using qualitative analysis of recruitment visits (two studies), and provision of study information to prospective participants at a multidisciplinary, group information session (one study) both improved recruitment. CONCLUSION:Improved engagement of men aged 50 years and older in RCTs is needed. A gender-sensitised approach to RCT recruitment may help to address this need. We have identified several promising recruitment strategies that merit further evaluation. PROSPERO REGISTRATION NUMBER:CRD42017060301. 10.1136/bmjopen-2018-025580
    Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions. Watson Noreen L,Mull Kristin E,Heffner Jaimee L,McClure Jennifer B,Bricker Jonathan B Journal of medical Internet research BACKGROUND:Despite having many advantages, online eHealth trials are not without challenges-notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies. OBJECTIVE:To address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions. METHODS:To ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification. RESULTS:We randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source. CONCLUSIONS:Continuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials. TRIAL REGISTRATION:ClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO). 10.2196/10351
    We could be heroes: ethical issues with the pre-recruitment of research participants. Hunter David Journal of medical ethics Pre-recruitment is the practice of recruiting potential participants to a list of potential research volunteers in general rather than to a specific research project. This is a relatively common practice in commercial medical research as it reduces the time and hence costs of recruitment and makes it possible to be more efficient by recruiting participants who may be useful for a variety of different pieces of research. It focuses on present practices in the UK although the conclusions and suggestions should be read more widely than this, applying in any situation where pre-recruitment is used as a recruitment tool for clinical trials and beyond. Current pre-recruitment practices in the UK clash significantly with what are seen as best practices and ethical guidance with regard to recruiting participants to individual trials, and insofar as this undermines these practices should be reformed. 10.1136/medethics-2014-102639
    Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. Brøgger-Mikkelsen Mette,Ali Zarqa,Zibert John R,Andersen Anders Daniel,Thomsen Simon Francis Journal of medical Internet research BACKGROUND:Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. OBJECTIVE:This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. METHODS:Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. RESULTS:In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). CONCLUSIONS:Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate. 10.2196/22179
    Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. Benoit-Piau Justine,Dumoulin Chantale,Carroll Marie-Soleil,Mayrand Marie-Hélène,Bergeron Sophie,Khalifé Samir,Waddell Guy,Morin Mélanie, The journal of sexual medicine BACKGROUND:Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment. AIM:To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods. METHODS:The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics. MAIN OUTCOME MEASURES:The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method. RESULTS:The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60). CLINICAL IMPLICATIONS:Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates. STRENGTH & LIMITATIONS:Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size. CONCLUSION:The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311. 10.1016/j.jsxm.2020.04.005
    Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis. Fletcher Jane M,Saunders-Smith Terry,Manns Braden J,Tsuyuki Ross,Hemmelgarn Brenda R,Tonelli Marcello,Campbell David J T BMC medical research methodology BACKGROUND:Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. METHODS:Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. RESULTS:Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. CONCLUSIONS:We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. TRIAL REGISTRATION:Trial Registration Number: NCT02579655 - initially registered Oct 19, 2015. 10.1186/s12874-020-01140-6
    Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children: a systematic review. Robinson Louise,Adair Pauline,Coffey Margaret,Harris Rebecca,Burnside Girvan Trials BACKGROUND:Randomised controlled trials (RCTs) are recommended as the 'gold standard' in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. AIM:To identify predictors of recruitment and retention in RCTs involving children. METHODS:A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0-12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. RESULTS:Twenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child's illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. CONCLUSION:Parent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention. 10.1186/s13063-016-1415-0
    Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience. Aroda Vanita R,Sheehan Patricia R,Vickery Ellen M,Staten Myrlene A,LeBlanc Erin S,Phillips Lawrence S,Brodsky Irwin G,Chadha Chhavi,Chatterjee Ranee,Ouellette Miranda G,Desouza Cyrus,Pittas Anastassios G, Clinical trials (London, England) AIMS:To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods. METHODS:Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods. RESULTS:In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level. CONCLUSION:Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments. 10.1177/1740774519839062
    Recruitment and retention of the participants in clinical trials: Challenges and solutions. Chaudhari Nayan,Ravi Renju,Gogtay Nithya J,Thatte Urmila M Perspectives in clinical research Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2 billion for the process. Delay in investigator-initiated studies can cause financial loss to grant providers (either public or private) and investigator's reputation may also be at stake. Participant recruitment and retention are two major bottlenecks in conducting clinical trials and contribute vastly to the delays. They are essential for both scientific validity of the clinical study and economic reasons. Thus, issues in recruitment and retention should be addressed and minimized. A proper recruitment and retention plan incorporating adequate communication between all stakeholders will eventually avoid the delays in drug development and make treatments available to the consumer at an earlier date and at a more affordable price. Awareness of challenges and reviewing strategies that can optimise recruitment and retention will facilitate drug development. The article gives a first-person perspective on challenges and proposed solutions from an experienced clinical study centre in a tertiary care hospital. 10.4103/picr.PICR_206_19
    A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Identification of Efficient and Cost-Effective Methods for Decision Making (Part 2). Lattie Emily G,Kaiser Susan M,Alam Nameyeh,Tomasino Kathryn N,Sargent Elizabeth,Rubanovich Caryn Kseniya,Palac Hannah L,Mohr David C Journal of medical Internet research BACKGROUND:The ability to successfully recruit participants for electronic health (eHealth) clinical trials is largely dependent on the use of efficient and effective recruitment strategies. Determining which types of recruitment strategies to use presents a challenge for many researchers. OBJECTIVE:The aim of this study was to present an analysis of the time-efficiency and cost-effectiveness of recruitment strategies for eHealth clinical trials, and it describes a framework for cost-effective trial recruitment. METHODS:Participants were recruited for one of 5 eHealth trials of interventions for common mental health conditions. A multipronged recruitment approach was used, including digital (eg, social media and Craigslist), research registry-based, print (eg, flyers and posters on public transportation), clinic-based (eg, a general internal medicine clinic within an academic medical center and a large nonprofit health care organization), a market research recruitment firm, and traditional media strategies (eg, newspaper and television coverage in response to press releases). The time costs and fees for each recruitment method were calculated, and the participant yield on recruitment costs was calculated by dividing the number of enrolled participants by the total cost for each method. RESULTS:A total of 777 participants were enrolled across all trials. Digital recruitment strategies yielded the largest number of participants across the 5 clinical trials and represented 34.0% (264/777) of the total enrolled participants. Registry-based recruitment strategies were in second place by enrolling 28.0% (217/777) of the total enrolled participants across trials. Research registry-based recruitment had a relatively high conversion rate from potential participants who contacted our center for being screened to be enrolled, and it was also the most cost-effective for enrolling participants in this set of clinical trials with a total cost per person enrolled at US $8.99. CONCLUSIONS:On the basis of these results, a framework is proposed for participant recruitment. To make decisions on initiating and maintaining different types of recruitment strategies, the resources available and requirements of the research study (or studies) need to be carefully examined. 10.2196/11050
    Evaluation of Different Recruitment Methods: Longitudinal, Web-Based, Pan-European Physical Activity Through Sustainable Transport Approaches (PASTA) Project. Gaupp-Berghausen Mailin,Raser Elisabeth,Anaya-Boig Esther,Avila-Palencia Ione,de Nazelle Audrey,Dons Evi,Franzen Helen,Gerike Regine,Götschi Thomas,Iacorossi Francesco,Hössinger Reinhard,Nieuwenhuijsen Mark,Rojas-Rueda David,Sanchez Julian,Smeds Emilia,Deforth Manja,Standaert Arnout,Stigell Erik,Cole-Hunter Tom,Int Panis Luc Journal of medical Internet research BACKGROUND:Sufficient sample size and minimal sample bias are core requirements for empirical data analyses. Combining opportunistic recruitment with a Web-based survey and data-collection platform yields new benefits over traditional recruitment approaches. OBJECTIVE:This paper aims to report the success of different recruitment methods and obtain data on participants' characteristics, participation behavior, recruitment rates, and representativeness of the sample. METHODS:A longitudinal, Web-based survey was implemented as part of the European PASTA (Physical Activity through Sustainable Transport Approaches) project, between November 2014 and December 2016. During this period, participants were recruited from 7 European cities on a rolling basis. A standardized guide on recruitment strategy was developed for all cities, to reach a sufficient number of adult participants. To make use of the strengths and minimize weakness, a combination of different opportunistic recruitment methods was applied. In addition, the random sampling approach was applied in the city of Örebro. To reduce the attrition rate and improve real-time monitoring, the Web-based platform featured a participant's and a researchers' user interface and dashboard. RESULTS:Overall, 10,691 participants were recruited; most people found out about the survey through their workplace or employer (2300/10691, 21.51%), outreach promotion (2219/10691, 20.76%), and social media (1859/10691, 17.39%). The average number of questionnaires filled in per participant varied significantly between the cities (P<.001), with the highest number in Zurich (11.0, SE 0.33) and the lowest in Örebro (4.8, SE 0.17). Collaboration with local organizations, the use of Facebook and mailing lists, and direct street recruitment were the most effective approaches in reaching a high share of participants (P<.001). Considering the invested working hours, Facebook was one of the most time-efficient methods. Compared with the cities' census data, the composition of study participants was broadly representative in terms of gender distribution; however, the study included younger and better-educated participants. CONCLUSIONS:We observed that offering a mixed recruitment approach was highly effective in achieving a high participation rate. The highest attrition rate and the lowest average number of questionnaires filled in per participant were observed in Örebro, which also recruited participants through random sampling. These findings suggest that people who are more interested in the topic are more willing to participate and stay in a survey than those who are selected randomly and may not have a strong connection to the research topic. Although direct face-to-face contacts were very effective with respect to the number of recruited participants, recruiting people through social media was not only effective but also very time efficient. The collected data are based on one of the largest recruited longitudinal samples with a common recruitment strategy in different European cities. 10.2196/11492
    Ethics and Privacy Implications of Using the Internet and Social Media to Recruit Participants for Health Research: A Privacy-by-Design Framework for Online Recruitment. Bender Jacqueline Lorene,Cyr Alaina B,Arbuckle Luk,Ferris Lorraine E Journal of medical Internet research BACKGROUND:The Internet and social media offer promising ways to improve the reach, efficiency, and effectiveness of recruitment efforts at a reasonable cost, but raise unique ethical dilemmas. We describe how we used social media to recruit cancer patients and family caregivers for a research study, the ethical issues we encountered, and the strategies we developed to address them. OBJECTIVE:Drawing on the principles of Privacy by Design (PbD), a globally recognized standard for privacy protection, we aimed to develop a PbD framework for online health research recruitment. METHODS:We proposed a focus group study on the dietary behaviors of cancer patients and their families, and the role of Web-based dietary self-management tools. Using an established blog on our hospital website, we proposed publishing a recruitment post and sharing the link on our Twitter and Facebook pages. The Research Ethics Board (REB) raised concern about the privacy risks associated with our recruitment strategy; by clicking on a recruitment post, an individual could inadvertently disclose personal health information to third-party companies engaged in tracking online behavior. The REB asked us to revise our social media recruitment strategy with the following questions in mind: (1) How will you inform users about the potential for privacy breaches and their implications? and (2) How will you protect users from privacy breaches or inadvertently sharing potentially identifying information about themselves? RESULTS:Ethical guidelines recommend a proportionate approach to ethics assessment, which advocates for risk mitigation strategies that are proportional to the magnitude and probability of risks. We revised our social media recruitment strategy to inform users about privacy risks and to protect their privacy, while at the same time meeting our recruitment objectives. We provide a critical reflection of the perceived privacy risks associated with our social media recruitment strategy and the appropriateness of the risk mitigation strategies that we employed by assessing their alignment with PbD and by discussing the following: (1) What are the potential risks and who is at risk? (2) Is cancer considered "sensitive" personal information? (3) What is the probability of online disclosure of a cancer diagnosis in everyday life? and (4) What are the public's expectations for privacy online and their views about online tracking, profiling, and targeting? We conclude with a PbD framework for online health research recruitment. CONCLUSIONS:Researchers, REBs, ethicists, students, and potential study participants are often unaware of the privacy risks of social media research recruitment and there is no official guidance. Our PbD framework for online health research recruitment is a resource for these wide audiences. 10.2196/jmir.7029
    A novel use of a statewide telecolposcopy network for recruitment of participants in a Phase I clinical trial of a human papillomavirus therapeutic vaccine. Stratton Shawna L,Spencer Horace J,Greenfield William W,Low Gordon,Hitt Wilbur C,Quick Charles M,Jeffus Susanne K,Blackmon Victoria,Nakagawa Mayumi Clinical trials (London, England) BACKGROUND:Historically, recruitment and retention of young women in intervention-based clinical trials have been challenging. In August 2012, enrollment for a clinical trial testing of an investigational human papillomavirus therapeutic vaccine called PepCan was opened at our institution. This study was an open-label, single-arm, single-institution, dose-escalation Phase I clinical trial. Women with recent Papanicolaou smear results showing high-grade squamous intraepithelial lesions or results that could not rule out high-grade squamous intraepithelial lesion were eligible to enroll. Patients with biopsy-confirmed high-grade squamous intraepithelial lesion were also eligible. Colposcopy was performed at the screening visit, and participants became eligible for vaccination when the diagnosis of high-grade squamous intraepithelial lesion was confirmed with biopsy and other inclusion criteria were met. The aim of this study was to identify strategies and factors effective in recruitment and retention of study participants. METHODS:Potential vaccine candidates were recruited through direct advertisement as well as referrals, including referrals through the Arkansas telecolposcopy network. The network is a federally funded program, administered by physicians and advanced practice nurses. The network telemedically links rural health sites and allows physician-guided colposcopy and biopsies to be conducted by advanced practice nurses. A variety of strategies were employed to assure good retention, including face-to-face contact with the study coordinator at the time of consent and most of study visits; frequent contact using text messaging, phone calls, and e-mails; and creation of a private Facebook page to improve communication among research staff and study participants. A questionnaire, inquiring about motivation for joining the study, occupation, education, household income, number of children, and number of sexual partners, was administered at the screening visit with the intent of identifying factor(s) associated with recruitment and retention. RESULTS:A total of 37 participants were enrolled between September 2012 and March 2014. The largest proportion of participants (46%) was enrolled from the telecolposcopy network. Others were enrolled through outside institutions (43%), in-house referrals (8%), or direct advertisement (3%). Most participants were motivated to join the study to take care of their health issues. Only two participants joined the Facebook private page. Of the 24 participants who qualified for vaccination, only 1 terminated early due to an unanticipated move. CONCLUSION:The availability of a large number of potential participants from the telecolposcopy network increased recruitment to this clinical trial by 85% over other traditional means of recruitment. The telecolposcopy network is not only a means of providing a gynecological service to women who otherwise would forego care but also a novel and valuable resource in recruiting participants for a clinical trial. 10.1177/1740774514566333
    Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study. Plante Timothy B,Gleason Kelly T,Miller Hailey N,Charleston Jeanne,McArthur Kristen,Himmelfarb Cheryl Dennison,Lazo Mariana,Ford Daniel E,Miller Edgar R,Appel Lawrence J,Juraschek Stephen P, Clinical trials (London, England) BACKGROUND/AIM:Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content. METHODS:The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health-sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content. RESULTS:Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%;  = 0.005). CONCLUSION:Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants. 10.1177/1740774519873657
    Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. Walters Stephen J,Bonacho Dos Anjos Henriques-Cadby Inês,Bortolami Oscar,Flight Laura,Hind Daniel,Jacques Richard M,Knox Christopher,Nadin Ben,Rothwell Joanne,Surtees Michael,Julious Steven A BMJ open BACKGROUND:Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. OBJECTIVES:To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. DATA SOURCES AND STUDY SELECTION:HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. DATA EXTRACTION:Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. MAIN OUTCOME MEASURES:Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). RESULTS:This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43-2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79-97%). CONCLUSIONS:There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. 10.1136/bmjopen-2016-015276
    Recruiting participants to an Internet-based eating disorder prevention trial: Impact of the recruitment strategy on symptom severity and program utilization. Vollert Bianka,von Bloh Paula,Eiterich Nadine,Beintner Ina,Hütter Kristian,Taylor Craig Barr,Jacobi Corinna The International journal of eating disorders OBJECTIVE:Using data from a randomized controlled trial, we examined two different strategies to recruit participants for an indicated preventive intervention (StudentBodies-AN) for women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy. METHOD:We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment). We compared symptom severity and program utilization between the two groups. RESULTS:A total of 4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54) were randomized to the intervention. We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face. Also, participants recruited through media were more likely to log onto the program (χ = 5.06; p = .029) and accessed more of the intervention. DISCUSSION:Recruitment through media seems both more feasible and suitable to reach individuals in need of indicative prevention, and should be part of a multimodal recruitment package. Future studies should be explicitly designed to investigate the impact of recruitment modality on reach and effectiveness including cost-effectiveness analyses. 10.1002/eat.23250
    Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map. Frampton Geoff K,Shepherd Jonathan,Pickett Karen,Griffiths Gareth,Wyatt Jeremy C Trials BACKGROUND:Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, but an overview of this research area is lacking. We aimed to systematically map the characteristics of digital recruitment and retention tools for RCTs, and the features of the comparative studies that have evaluated the effectiveness of these tools during the past 10 years. METHODS:We searched Medline, Embase, other databases, the Internet, and relevant web sites in July 2018 to identify comparative studies of digital tools for recruiting and/or retaining participants in health RCTs. Two reviewers independently screened references against protocol-specified eligibility criteria. Included studies were coded by one reviewer with 20% checked by a second reviewer, using pre-defined keywords to describe characteristics of the studies, populations and digital tools evaluated. RESULTS:We identified 9163 potentially relevant references, of which 104 articles reporting 105 comparative studies were included in the systematic map. The number of published studies on digital tools has doubled in the past decade, but most studies evaluated digital tools for recruitment rather than retention. The key health areas investigated were health promotion, cancers, circulatory system diseases and mental health. Few studies focussed on minority or under-served populations, and most studies were observational. The most frequently-studied digital tools were social media, Internet sites, email and tv/radio for recruitment; and email and text-messaging for retention. One quarter of the studies measured efficiency (cost per recruited or retained participant) but few studies have evaluated people's attitudes towards the use of digital tools. CONCLUSIONS:This systematic map highlights a number of evidence gaps and may help stakeholders to identify and prioritise further research needs. In particular, there is a need for rigorous research on the efficiency of the digital tools and their impact on RCT participants and investigators, perhaps as studies-within-a-trial (SWAT) research. There is also a need for research into how digital tools may improve participant retention in RCTs which is currently underrepresented relative to recruitment research. REGISTRATION:Not registered; based on a pre-specified protocol, peer-reviewed by the project's Advisory Board. 10.1186/s13063-020-04358-3
    Use of Rideshare Services to Increase Participant Recruitment and Retention in Research: Participant Perspectives. Leavens Eleanor Ladd Schneider,Stevens Elise Marie,Brett Emma Irene,Molina Neil,Leffingwell Thad Ryan,Wagener Theodore Lee Journal of medical Internet research BACKGROUND:Recruitment and retention of participants are important factors in empirical studies. Methods that increase recruitment and retention can reduce costs and burden on researchers related to the need for over-recruitment because of attrition. Rideshare services such as Uber and Lyft are a potential means for decreasing this burden. OBJECTIVE:This study aimed to understand the role rideshare utilization plays in participant recruitment and retention in research trials. METHODS:Data are presented for a study (N=42) in which rideshare services were utilized for participant transportation to and from study visits during a 2-session, in-laboratory research study. RESULTS:Retention at visit 2 was greater than 95% (42/44) in the initial study. In a follow-up survey of the participants from the original trial, participants (N=32) reported that the rideshare service was an important reason they returned for all study visits. Participants reported whether they would prefer differing levels of additional monetary compensation or a ride from a rideshare service. When the additional compensation was less than US $15, participants reported a preference for the rideshare service. CONCLUSIONS:Rideshare services may represent a relatively low cost means for increasing study retention. Specifically, findings indicate that rideshare services may not be crucial for initial participant recruitment but for their retention in multi-visit studies. 10.2196/11166