Participant Recruitment Research Articles

Engagement in rapid public health research among young people from underserved communities: maximising opportunities and overcoming barriers

BackgroundInclusion in public health research of young people from low-income households and those from minority ethnic groups remains low. It is recognised that there is a need to change the way in which research is conducted so that it becomes more inclusive. The aim of this work was to identify novel and innovative ways to maximise recruitment and inclusion of diverse participants when doing co-production within very short time frames for emergency responses.MethodWe conducted interviews with young people from low-income and minority ethnic backgrounds, and members or leaders of groups or organisations supporting or representing young people from underserved communities.ResultsA total of 42 participants took part in an interview. This included 30 young people from low income or minority ethnic backgrounds and 12 community leaders/service providers. Of the 30 young people, 26 participants identified as female and 12 participants identified as being from a minority ethnic background. Participants discussed a number of interrelated barriers to research involvement and identified ways in which barriers may be reduced. Prejudice and discrimination experienced by young people from underserved communities has led to substantial mistrust of educational and governmental establishments. Rigid and unfamiliar research practices further limit the involvement of young people. Four themes were identified as ways of supporting involvement, including: making opportunities available for young people, adaptations to research governance, understanding and acknowledging challenges faced by young people, and ensuring reciprocal benefits.ConclusionThis research explored barriers to engagement in rapid public health co-production. Working with communities to co-produce rapid recruitment and research procedures to suit the needs and the context in which young people live is necessary.

Recruitment and retention of pediatric participants for pandemic preparedness research: Experience from the PREMISE EV-D68 Pilot Study

Recruitment and retention are challenges for prospective pediatric cohort studies, particularly those involving serial venipunctures. We investigated factors underlying enrollment and retention in the Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology (PREMISE) Enterovirus D68 (EV-D68) Pilot Study, a multicenter prospective longitudinal cohort study assessing the utility of immunologic surveillance for pandemic preparedness. This study enrolls children ≤10 years for two blood draws, pre- and post-EV-D68 season, separated by 6–18 months. Overall, 174 children were enrolled in Cohort 1 of the study and 120 (69 %) of children completed the study, with follow-up blood samples obtained from 101 (58 %) of participants. Families were primarily motivated to participate by a desire to help other children, advance science, and better prepare for the next pandemic. Adding research blood draws to clinically indicated blood draws improved enrollment, and multiple study touch points facilitated retention. These findings can be applied to improve recruitment and retention in future pandemic preparedness efforts and longitudinal pediatric cohort studies.

Ameliorating Racial Disparities in HIV Prevention via a Nurse-Led, AI-Enhanced Program for Pre-Exposure Prophylaxis Utilization Among Black Cisgender Women: Protocol for a Mixed Methods Study.

HIV pre-exposure prophylaxis (PrEP) is a critical biomedical strategy to prevent HIV transmission among cisgender women. Despite its proven effectiveness, Black cisgender women remain significantly underrepresented throughout the PrEP care continuum, facing barriers such as limited access to care, medical mistrust, and intersectional racial or HIV stigma. Addressing these disparities is vital to improving HIV prevention outcomes within this community. On the other hand, nurse practitioners (NPs) play a pivotal role in PrEP utilization but are underrepresented due to a lack of awareness, a lack of human resources, and insufficient support. Equipped with the rapid evolution of artificial intelligence (AI) and advanced large language models, chatbots effectively facilitate health care communication and linkage to care in various domains, including HIV prevention and PrEP care. Our study harnesses NPs' holistic care capabilities and the power of AI through natural language processing algorithms, providing targeted, patient-centered facilitation for PrEP care. Our overarching goal is to create a nurse-led, stakeholder-inclusive, and AI-powered program to facilitate PrEP utilization among Black cisgender women, ultimately enhancing HIV prevention efforts in this vulnerable group in 3 phases. This project aims to mitigate health disparities and advance innovative, technology-based solutions. The study uses a mixed methods design involving semistructured interviews with key stakeholders, including 50 PrEP-eligible Black women, 10 NPs, and a community advisory board representing various socioeconomic backgrounds. The AI-powered chatbot is developed using HumanX technology and SmartBot360's Health Insurance Portability and Accountability Act-compliant framework to ensure data privacy and security. The study spans 18 months and consists of 3 phases: exploration, development, and evaluation. As of May 2024, the institutional review board protocol for phase 1 has been approved. We plan to start recruitment for Black cisgender women and NPs in September 2024, with the aim to collect information to understand their preferences regarding chatbot development. While institutional review board approval for phases 2 and 3 is still in progress, we have made significant strides in networking for participant recruitment. We plan to conduct data collection soon, and further updates on the recruitment and data collection progress will be provided as the study advances. The AI-powered chatbot offers a novel approach to improving PrEP care utilization among Black cisgender women, with opportunities to reduce barriers to care and facilitate a stigma-free environment. However, challenges remain regarding health equity and the digital divide, emphasizing the need for culturally competent design and robust data privacy protocols. The implications of this study extend beyond PrEP care, presenting a scalable model that can address broader health disparities. PRR1-10.2196/59975.

Preventing Cognitive Decline in Older Latino Adults With HIV Through a Culturally Tailored Health Promotion Intervention: Protocol for a Single-Arm Pilot Trial.

Older Latino adults with HIV are at increased risk for mild cognitive impairment and earlier onset of aging-related cognitive decline. Improvements in cognitive functioning and cognitive outcomes are possible among people with HIV who adopt health promotion behaviors. However, health promotion interventions for older Latino adults with HIV have not been extensively used or widely recognized as viable treatment options. Happy Older Latinos are Active (HOLA) is a multicomponent, health promotion intervention that is uniquely tailored for older Latino adults with HIV. This study aims to (1) determine the feasibility and acceptability of an adapted version of HOLA aimed at improving cognitive functioning among older Latino adults with HIV; (2) explore whether HOLA will produce changes in cognitive functioning; (3) explore whether HOLA will produce changes in activity, psychosocial functioning, or biomarkers of cognition; and (4) explore whether changes in activity, psychosocial functioning or cognitive biomarkers correlate with changes in cognition, while accounting for genetic risk for dementia. A single-arm pilot trial with 30 Latino (aged 50 years and older) men and women with HIV was conducted to assess feasibility, acceptability, and preliminary effects on cognition. Participants were assessed at 2 time points (baseline and postintervention) on measures of neurocognitive and psychosocial functioning. In addition, blood samples were collected to determine biomarkers of cognition at baseline and postintervention. Successful recruitment was defined as meeting 100% of the targeted sample (N=30), with 20% (n=6) or less of eligible participants refusing to participate. Adequate retention was defined as 85% (n=25) or more of participants completing the postintervention assessment and acceptability was defined as 80% (n=38) or more of sessions attended by participants. Participant recruitment began on February 22, 2022, and was completed on August 15, 2022. The last study visit took place on February 20, 2023. Data analysis is currently ongoing. Encouraging findings from this exploratory study may provide a blueprint for scaling up the HOLA intervention to a larger cohort of older Latino adults with HIV who may be currently experiencing or are at risk for HIV-related cognitive challenges. ClinicalTrials.gov NCT04791709; https://clinicaltrials.gov/study/NCT04791709. DERR1-10.2196/55507.

Clinical efficacy of two vertical soft tissue augmentation techniques for peri-implant crestal bone level stability: A randomized clinical trial.

This study aimed to compare the efficacy of two techniques-acellular dermal matrix (ADM) grafting and tenting technique (TT)-for soft tissue height (STH) augmentation simultaneous to implant placement to minimize peri-implant crestal bone level (CBL) changes. Forty patients with a healed single mandibular posterior edentulous site with a thin soft tissue phenotype were enrolled. Twenty patients received simultaneously to implant placement ADM grafting, while the others received submerged healing abutment (TT). Clinical peri-implant soft tissue height and radiographic CBL changes were measured at restoration delivery and 1-year follow-up. Both techniques effectively increased soft tissue thickness, resulting in a final average STH of 3.4 ± 0.5 mm after augmentation. On average, soft tissue increased by 1.6 ± 0.5 mm in group ADM and by 1.8 ± 0.4 mm in group TT after augmentation. In Group ADM, mesial CBL decreased from 0.4 ± 0.3 mm to 0.1 ± 0.2 mm, and distal CBL decreased from 0.5 ± 0.3 mm to 0.2 ± 0.3 mm over 1 year. In Group TT, mesial CBL remained stable at 0.3 ± 0.2 mm, while distal CBL reduced slightly from 0.5 ± 0.5 mm to 0.3 ± 0.2 mm. Both groups showed minimal changes in CBL, indicating great stability (pmesial = 0.003, pdistal = 0.004). TT was particularly effective in preventing mesial bone loss (pmesial = 0.019). The mesial CBL changes significantly differed between groups (p = 0.019), and not significantly at distal sites (p = 0.944). Neither treatment exhibited significant bone remodeling below the implant shoulder. This study suggests that both techniques were successful in STH augmentation, and they may effectively reduce peri-implant crestal bone level changes, with TT being slightly superior. TT was more prone to post-surgical complications. This RCT was not registered before participant recruitment and randomization.

Development and Evaluation of a Web-Based Platform for Personalized Educational and Professional Assistance for Dementia Caregivers: Proposal for a Mixed Methods Study.

Alzheimer disease (AD) and AD-related dementia are prevalent concerns for aging populations. With a growing older adult population living in the United States, the number of people living with dementia is expected to grow, posing significant challenges for informal caregivers. The mental and physical burdens associated with caregiving highlight the importance of developing novel and effective resources to support caregivers. However, technology solutions designed to address their needs often face low adoption rates due to usability issues and a lack of contextual relevance. This study focuses on developing a web-based platform providing financial and legal planning information and education for dementia caregivers and evaluating the platform's usability and adoptability. The goal of this project is to create a web-based platform that connects caregivers with personalized and easily accessible resources. This project involves industrial, academic, and community partners and focuses on two primary aims: (1) developing a digital platform using a Dementia Care Personalization Algorithm and assessing feasibility in a pilot group of caregivers, and (2) evaluating the acceptability and usability of the digital platform across different racial or ethnic populations. This work will aid in the development of technology-based interventions to reduce caregiver burden. The phase I study follows an iterative Design Thinking approach, involving at least 25 dementia caregivers as a user feedback panel to assess the platform's functionality, aesthetics, information, and overall quality using the adapted Mobile Application Rating Scale. Phase II is a usability study with 300 dementia caregivers in Texas (100 African American, 100 Hispanic or Latinx, and 100 non-Hispanic White). Participants will use the digital platform for about 4 weeks and evaluate its usefulness and ease of use through the Technology Acceptance Survey. The study received funding from the National Institute on Aging on September 3, 2021. Ethical approval for phase I was obtained from the Texas A&M University Institutional Review Board on December 8, 2021, with data collection starting on January 1, 2022, and concluding on May 31, 2022. Phase I results were published on September 5, 2023, and April 17, 2024, respectively. On June 21, 2023, ethical approval for human subjects for phase II was granted, and participant recruitment began on July 1, 2023. Upon completing these aims, we expect to deliver a widely accessible digital platform tailored to assist dementia caregivers with financial and legal challenges by connecting them to personalized, contextually relevant information and resources in Texas. If successful, we plan to work with caregiving organizations to scale and sustain the platform, addressing the needs of the growing population living with dementia. DERR1-10.2196/64127.

The Sri Lanka Mother and Newborn Growth (S-MaNGro) Cohort: Protocol of a Nationwide Prospective Study.

Perinatal cohort studies with a prospective longitudinal design are critical for determining the effects of early-life exposures on offspring's health outcomes. The Sri Lanka Mother and Newborn Growth cohort study aims to investigate the impact of maternal nutritional and psychosocial factors on newborns' birth weight in the Sri Lankan context. This paper presents the methodology of participant recruitment, follow-ups, an overview of measurements, and planned data analyses. This study included a nationally representative sample of Sri Lankan pregnant women recruited in their first trimester of pregnancy. Follow-up assessments were conducted once during the second and third trimesters of pregnancy and after the baby's birth, prospectively tracking the women's dietary intake, mental health, hemoglobin concentrations, and gestational weight gain data. Once the participants delivered their babies, the data on gestational age, sex of the newborn, birth weight, length and occipitofrontal circumference at birth, and mode of delivery were collected. Between August 2022 and August 2023, we recruited 2000 first-trimester pregnant women to the cohort and continued to follow up with them until the baby's birth. The response rates were 90.4%, 81.4%, and 75.2% in the first, second, and third follow-ups. We plan to analyze the data in July 2024. We expect this study to provide valuable insights into various early-life exposures affecting neonatal birth weight. The study's findings will serve as a valuable information resource for a broader scientific community, enabling the development of effective policies to prevent low-birth-weight deliveries in low-resource settings.

Biomarkers of sleep-wake disturbance as predictors of cognitive decline and accelerated disease progression.

In older adults, where sleep disturbances and cognitive impairment are common, mounting evidence suggests a potential connection between sleep and cognitive function, highlighting the significance of utilizing sleep as a biomarker for early detection of cognitive impairment to improve clinical outcomes in a noninvasive, cost-effective manner. This review describes the relationship between sleep and cognitive function in older adults, encompassing both subjective and objective measures of sleep quality, duration, architecture, and sleep-disordered breathing. The authors consider the directionality of the associations observed in prospective and cross-sectional studies, exploring whether sleep disturbances precede cognitive decline or vice versa. Furthermore, they discuss the potential bidirectional relationships between sleep and Alzheimer's disease (AD) risks in older adults while also examining the neurodegenerative pathways of this relationship. Routine sleep monitoring in primary care settings has the potential to bolster early detection and treatment of sleep disturbance, and by extension, reduce the risk of dementia. Improving sleep assessment tools, such as wearables, provide scalable alternatives to traditional methods like polysomnography, potentially enabling widespread monitoring of sleep characteristics. Standardized measurement and inclusive participant recruitment are needed to enhance generalizability, while longitudinal studies are essential to understand the interaction between sleep and AD pathology.

Experiences in Recruitment for Hispanic, Non-Hispanic Black, and Other Non-White Cancer Survivors Through Community Outreach and Other Targeted Approaches

ObjectivesRecruitment of racial/ethnic underserved populations in oncology research is essential to address health disparities. This article presents strategies and lessons learned from community outreach and other approaches for recruiting non-Hispanic Black, Hispanic, and other non-White survivors of cancer into a pilot study that investigated biopsychosocial determinants of health behaviors. MethodsWe critically examined the participant recruitment approaches to explore challenges and successful strategies and develop recommendations for future studies. Direct recruitment strategies included engaging with research staff members’ personal community contacts/liaisons and participating in community outreach events (eg, farmers’ markets, block parties, library events, cancer awareness events). Indirect recruitment strategies included posting and distribution of study flyers in community centers (eg, LIVESTRONG® at the YMCA, churches, libraries), online platforms (eg, FORCE, Survivor Journey website), and invitation letters sent to individuals identified as eligible through a single state cancer registry. ResultsBetween April 2022 and May 2023, among the 64 individuals recruited, 36 were non-Hispanic Black, 25 were Hispanic, and three were American Indian/Alaska Native people. The use of a state cancer registry (64.1%), snowballing/word of mouth (7.8%), and advertisement through an established cancer support organization (ie, FORCE) website (7.8%) were the most effective strategies in this study. ConclusionRecruitment of non-Hispanic Black, Hispanic, and other non-White people into biobehavioral studies through community-engaged research is challenging and requires long-term commitment and engagement with partners from target communities and affiliated organizations. Implication for Nursing PracticeRegistries and community outreach events can build trust for successful enrollment. Using multiple strategies can provide the best opportunities to reach diverse populations and enroll them in cancer-related research studies.

Factorial randomised controlled trial to examine the potential effect of a text message-based intervention on reducing adolescent susceptibility to e-cigarette use: a study protocol

IntroductionAdolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite...

Examining the Complexities of Conducting Randomized Controlled Trials in Child Welfare Settings

ABSTRACT Background Randomized controlled trials (RCTs) are considered the gold standard for assessing the effectiveness of interventions. At the same time, it is challenging to evaluate interventions using experimental designs in child welfare settings. Objective This study explores the facilitators and challenges faced when carrying out a pilot RCT of a home-visitation intervention, Family Partner, that was implemented within Norwegian child welfare services. Method This study draws on 29 qualitative in-depth interviews and four focus group interviews that were carried out with child welfare workers, managers and stakeholders. Results Results revealed one facilitator and four challenges with carrying out RCTs in child welfare settings: The main facilitator was the staff’s belief in the intervention, while the challenges were 1) ethical concerns in participant recruitment and information sharing, 2) resource management challenges in randomization, 3) emotional strains in response to randomization, and 4) contamination between the intervention and control participants. Conclusion While we present possible solutions to the challenges, our results also highlight the importance of careful planning, preparation, piloting, and using mixed method research approaches when conducting RCTs within child welfare services.

Sustainable Lifestyle Among Office Workers (the SOFIA Study): Protocol for a Cluster Randomized Controlled Trial.

Society is facing multiple challenges, including lifestyle- and age-related diseases of major public health relevance, and this is of particular importance when the general population, as well as the workforce, is getting older. In addition, we are facing global climate change due to extensive emissions of greenhouse gases and negative environmental effects. A lifestyle that promotes healthy life choices as well as climate and environmentally friendly decisions is considered a sustainable lifestyle. This study aims to evaluate if providing information about a sustainable lifestyle encourages individuals to adopt more nutritious dietary habits and increase physical activity, as compared to receiving information solely centered around health-related recommendations for dietary intake and physical activity by the Nordic Nutrition Recommendations and the World Health Organization. Novel features of this study include the use of the workplace as an arena for health promotion, particularly among office workers-a group known to be often sedentary at work and making up 60% of all employees in Sweden. The SustainableOfficeIntervention (SOFIA) study is a 2-arm, participant-blinded, cluster randomized controlled trial that includes a multilevel sustainable lifestyle arm (intervention arm, n=19) and a healthy lifestyle arm (control arm, n=14). The eligibility criteria were being aged 18-65 years and doing office work ≥20 hours per week. Both intervention arms are embedded in the theoretically based behavioral change wheel method. The intervention study runs for approximately 8 weeks and contains 6 workshops. The study focuses on individual behavior change as well as environmental and policy features at an organizational level to facilitate or hinder a sustainable lifestyle at work. Through implementing a citizen science methodology within the trial, the participants (citizen scientists) collect data using the Stanford Our Voice Discovery Tool app and are involved in analyzing the data, formulating a list of potential actions to bring about feasible changes in the workplace. Participant recruitment and data collection began in August 2022. As of June 2024, a total of 37 participants have been recruited. The results of the pilot phase are expected to be published in 2024 or 2025. Given the ongoing climate change, negative environmental effects, and the global epidemic of metabolic diseases, a sustainable lifestyle among office workers holds important potential to help in counteracting this trend. Thus, there is an urgent unmet need to test the impact of a sustainable lifestyle on food intake, physical activity, and environmental and climate impacts in a worksite-based randomized controlled trial. This study protocol responds to a societal need by addressing multilevel aspects, including individual behavior changes as well as environmental and organizational changes of importance for the successful implementation of sustainable lifestyle habits in an office setting. DERR1-10.2196/57777.

The Spider: a visual, multisystemic symptom impact questionnaire for people with hypermobility-related disorders—validation in adults

IntroductionHypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) are often accompanied by varied and complex multisystemic comorbid symptoms/conditions. The Spider questionnaire was developed to evaluate the presence and impact of eight common multisystemic comorbidities. Thirty-one questions across eight symptom domains assess neuromusculoskeletal, pain, fatigue, cardiac dysautonomia, urogenital, gastrointestinal, anxiety, and depression symptoms. This study aimed to evaluate the Spider’s construct validity in adults.MethodA cross-sectional observational study was conducted over four stages. Three international patient charities aided recruitment of participants through social media and website advertisements. Adults aged 18 to 65 years, with and without HSD/hEDS, were invited to participate. Validated, frequently used comparator questionnaires were used to establish convergent validity of Spider symptom domains. A control group was recruited for known-group validity analysis. Participants answered each Spider domain and the corresponding comparator questionnaire via surveys hosted by REDCap. Anonymous data were analysed using SPSS. Convergent validity was assessed through Spearman’s correlational analysis and known-group validity through Mann–Whitney U analysis.ResultsA total of 11,151 participants were recruited across the four stages. Statistically significant, moderate-to-strong correlations were found between all Spider domains and their comparators (p < 0.001, r = 0.63 to 0.80). Known-group validity analysis showed statistically significant differences (p < 0.001) between the hypermobile and control groups in all eight domains.ConclusionsConvergent and known-group validity of the Spider was established with adults. These results suggest the Spider can measure the presence and impact of multisystemic comorbid symptoms/conditions in adults with HSD/hEDS, providing a tool which guides multidisciplinary management.Key Points• The Spider questionnaire is a novel tool assessing the presence and impact of the multisystemic comorbid symptoms/conditions associated with HSD/hEDS.• Convergent and known-group validity of the Spider questionnaire was established in adults aged 18 to 65.• This tool provides a quick and easy method to visualise the symptom profile of those with HSD/hEDS to guide symptom management.

Evaluation of a Musculoskeletal Digital Assessment Routing Tool (DART): Crossover Noninferiority Randomized Pilot Trial.

Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on patients and increasing demand for health care use. Triage directing patients to appropriate level intervention improving health outcomes and efficiency has been prioritized. We developed a musculoskeletal digital assessment routing tool (DART) mobile health (mHealth) system, which requires evaluation prior to implementation. Such innovations are rarely rigorously tested in clinical trials-considered the gold standard for evaluating safety and efficacy. This pilot study is a precursor to a trial assessing DART performance with a physiotherapist-led triage assessment. The study aims to evaluate trial design, assess procedures, and collect exploratory data to establish the feasibility of delivering an adequately powered, definitive randomized trial, assessing DART safety and efficacy in an NHS primary care setting. A crossover, noninferiority pilot trial using an integrated knowledge translation approach within a National Health Service England primary care setting. Participants were patients seeking assessment for a musculoskeletal condition, completing a DART assessment and the history-taking element of a face-to-face physiotherapist-led triage in a randomized order. The primary outcome was agreement between DART and physiotherapist triage recommendation. Data allowed analysis of participant recruitment and retention, randomization, blinding, study burden, and potential barriers to intervention delivery. Participant satisfaction was measured using the System Usability Scale. Over 8 weeks, 129 patients were invited to participate. Of these, 92% (119/129) proceeded to eligibility assessment, with 60% (78/129) meeting the inclusion criteria and being randomized into each intervention arm (39/39). There were no dropouts and data were analyzed for all 78 participants. Agreement between physiotherapist and DART across all participants and all primary triage outcomes was 41% (32/78; 95% CI 22-45), intraclass correlation coefficient 0.37 (95% CI 0.16-0.55), indicating that the reliability of DART was poor to moderate. Feedback from the clinical service team led to an adjusted analysis yielding of 78% (61/78; 95% CI 47-78) and an intraclass correlation coefficient of 0.57 (95% CI 0.40-0.70). Participant satisfaction was measured quantitively using amalgamated System Usability Scale scores (n=78; mean score 84.0; 90% CI +2.94 to -2.94), equating to an "excellent" system. There were no study incidents, and the trial burden was acceptable. Physiotherapist-DART agreement of 78%, with no adverse triage decisions and high patient satisfaction, was sufficient to conclude DART had the potential to improve the musculoskeletal pathway. Study validity was enhanced by the recruitment of real-world patients and using an integrated knowledge translation approach. Completion of a context-specific consensus process is recommended to provide definitive definitions of safety criteria, range of appropriateness, noninferiority margin, and sample size. This pilot demonstrated an adequately powered definitive trial is feasible, which would provide evidence of DART safety and efficacy, ultimately informing potential for DART implementation. ClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029. RR2-10.2196/31541.

Rationale and design of a randomized placebo-controlled nutritional trial embracing a citizen science approach

Modulation of the gut microbiota through specific dietary interventions shows potential for maintenance and optimization of health. A dietary fiber diet and fermented foods diet appear to alter the gut microbiota, but evidence is limited. Therefore, we designed the Gut Health Enhancement by Eating Favorable Food study, a 21-week randomized controlled trial studying effects of dietary fibers and fermented foods on gut microbiota diversity and composition, while also stimulating dietary behavior changes through a citizen science (CS) approach. We hypothesized that a high-fermented food diet would increase microbial diversity, whereas a high-dietary fiber diet would stimulate the growth of specific fiber-degrading bacteria. The following elements of CS were adopted: education on the gut microbiota, tailored dietary intervention, remote data collection by participants, sharing of personal gut microbiota outcomes with participants, and vlogs by participants for dissemination of results. Here we describe the study protocol and report the flow of participants, baseline characteristics, and compliance rates. Completed in March 2024, the trial included 147 healthy adults randomized to a high-dietary fiber intervention, high-fermented food intervention, or control group. Each group received an additional study product after 2 weeks: dried chicory root, a fermented beverage, or maltodextrin (placebo). A 3-month follow-up assessed the participants’ ability to sustain dietary changes. The recruitment of participants was successful, reflected by 1448 applications. The compliance with the dietary guidelines and study products was >90%. This study shows that including elements of CS in an randomized controlled trial is feasible and may help recruitment and compliance.

Social marketing and the challenges of participant recruitment.

Recruitment of research participants often has not obtained a desired sample size, thereby becoming a major problem inhibiting investigators' ability to adequately test the specified hypotheses. Social marketing with its four Ps, originally developed by the business world to sell products and adapted for public health initiatives, is proposed as a dynamic comprehensive conceptual framework to apply marketing principles and practices to enhance participant recruitment. Applying a social marketing approach to research recruitment would require initial investigation to understand the motivations of the target audience in regard to research participation, and continued research throughout the main project to adapt the recruitment efforts as limitations arise. Additional funding would be needed for successful social marketing research recruitment programs to be systematically implemented and evaluated as part of research projects. In this paper, we define social marketing concepts, briefly review the available literature supporting social marketing applied to recruitment for research studies, and consider ethical issues that may arise when using a social marketing approach.

What Is Qualitative Research? An Overview and Guidelines

This guide explains the focus, rigor, and relevance of qualitative research, highlighting its role in dissecting complex social phenomena and providing in-depth, human-centered insights. The guide also examines the rationale for employing qualitative methods, underscoring their critical importance. An exploration of the methodology’s strengths, such as its ability to offer contextual depth and holistic perspectives, is juxtaposed against challenges like constrained generalizability and potential researcher bias, accompanied by practical mitigation strategies. Covering a spectrum of qualitative approaches, including grounded theory, phenomenology, ethnography, action research, and general inquiry, the guide sheds light on diverse data collection and analysis techniques. Noteworthily, the guide underscores the crucial aspect of trustworthiness in qualitative research, detailing methods to establish credibility, dependability, confirmability, and transferability. The integration of technologies like recording and transcribing tools with data analysis software and the growing influence of artificial intelligence, machine learning, and deep learning are also explored. Concluding with a discussion on ethical considerations, from participant recruitment to data stewardship, this guide serves as an essential resource that offers insightful, actionable guidance for conducting effective and impactful qualitative research.

Randomised, double-blind, placebo-controlled study evaluating the effect of allopurinol on the risk of cardiovascular events in patients with high and very high cardiovascular risk, including the presence of long-COVID-19 syndrome: the ALL-VASCOR study protocol

IntroductionNumerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The randomised, double-blind, placebo-controlled study evaluating the effect of allopurinol on the risk of...

Tailored approach to participant recruitment and retention to maximize health equity in pediatric cancer research

BackgroundLack of diversity in participants throughout the research process limits the generalizability of findings and may contribute to health disparities. There are unique challenges to recruitment of families to pediatric cancer research studies, especially for those from disadvantaged backgrounds. Thus, there is a need to evaluate the most effective recruitment and retention strategies to optimize equitable recruitment of diverse participants.MethodsThe present study adapted and implemented methods outlined previously in the literature. These previous efforts were developed to address barriers to pediatric research, behavioral health intervention research and research with Black adolescents. Recruitment and retention strategies are described across four different time points: pre-approach, initial connection, building connection and follow-up. Eligible families of children with a pediatric cancer diagnosis were approached during a routine oncology visit. Once consented, enrollment and retention rates over three timepoints of data collection were recorded and evaluated.ResultsResults indicated high rates of enrollment (86%) and retention (95%) for eligible participants. There were no trends in heightened attrition for any specific subgroup.ConclusionsThe findings of this study are promising and suggest these recruitment and retention strategies may be useful in recruiting individuals from disadvantaged backgrounds.

Effectiveness of a Mobile Phone Messaging-Based Message Framing Intervention for Improving Maternal Health Service Uptake and Newborn Care Practice in Rural Jimma Zone, Ethiopia: Protocol for a Cluster Randomized Controlled Trial.

Ethiopia has high rates of maternal and neonatal mortality. In 2019 and 2020, the maternal and newborn mortality rates were estimated at 412 per 1,000,000 births and 30 per 10,000 births, respectively. While mobile health interventions to improve maternal and neonatal health management have shown promising results, there are still insufficient scientific studies to assess the effectiveness of mobile phone messaging-based message framing for maternal and newborn health. This research aims to examine the effectiveness of mobile phone messaging-based message framing for improving the use of maternal and newborn health services in the Jimma Zone, Ethiopia. A 3-arm cluster-randomized trial design was used to evaluate the effects of mobile phone-based intervention on maternal and newborn health service usage. The trial arms were (1) gain-framed messages (2) loss-framed messages, and (3) usual care. A total of 21 health posts were randomized, and 588 pregnant women who had a gestational age of 16-20 weeks, irrespective of their antenatal care status, were randomly assigned to the trial arms. The intervention consisted of a series of messages dispatched from the date of enrolment until 6-8 months. The control group received existing care without messages. The primary outcomes were maternal health service usage and newborn care practice, while knowledge, attitude, self-efficacy, iron supplementation, and neonatal and maternal morbidity were secondary outcomes. The outcomes will be analyzed using a generalized linear mixed model and the findings will be reported according to the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement for randomized controlled trials. Recruitment of participants was conducted and the baseline survey was administered in March 2023. The intervention was rolled out from May 2023 till December 2023. The end-line assessment was conducted in February 2024. This trial was carried out to understand how mobile phone-based messaging can improve maternal and newborn health service usage. It provides evidence for policy guidelines around mobile health strategies to improve maternal and newborn health. Pan African Clinical Trials Registry PACTR202201753436676; https://tinyurl.com/ykhnpc49. DERR1-10.2196/52395.