Figure - available via license: Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Content may be subject to copyright.
Source publication
To better understand and overcome difficulties with recruitment of adolescents with type 2 diabetes into clinical trials at three United States institutions, we reviewed recruitment and retention strategies in clinical trials of youth with various chronic conditions. We explored whether similar strategies might be applicable to pediatric patients w...
Similar publications
Background
Although the initiation of injection drug use has been well characterized among at-risk youth, factors that support or impede cessation of injection drug use have received less attention. We sought to identify socioeconomic factors associated with cessation of injection drug use among street-involved youth. Methods
From September 2005 to...
Children born to mothers who were younger than average at their first childbirth are at increased risk for future persistent delinquent behaviour, but explanations for this remain unclear.
Our aim was to identify possible family and parenting variables that may help explain this relationship. We hypothesised that parental stress, large number of ch...
Objective:
To estimate the prevalence of and risk factors for cardiovascular autonomic neuropathy (CAN) in adolescents and young adults with type 1 and type 2 diabetes enrolled in the SEARCH for Diabetes in Youth Study.
Methods:
The study included 1646 subjects with type 1 diabetes (age 18 ± 4 years, diabetes duration 8 ± 2 years, HbA1c 9.1 ± 1....
The Digital Divide is an important issue with serious consequences, both for the individuals affected and society. With 90% of youths in urban areas using the Internet, there is a myth that the Digital Divide no longer exists amongst urban youths. Based on a random survey of 1639 youths, this study analyses the possibility of a digital divide along...
Antisocial behavior (AB), including aggression, violence, and theft, is thought be underpinned by abnormal functioning in networks of the brain critical to emotion processing, behavioral control, and reward-related learning. To better understand the abnormal functioning of these networks, research has begun to investigate the structural connections...
Citations
... For example, it is challenging to recruit a large number of cancer patients for usability evaluation (Sygna et al., 2015;Jacobs et al., 2019;Mudaranthakam et al., 2022). The same is true for patients with mental health Liu et al., 2018), diabetes (Nguyen et al., 2014;Kanuch et al., 2016), disability, ageing and well-being problems (Van der Geest, 2006). Further key challenges include patient availability, comfortability, capability, well-being, awareness, social, cultural and ethical issues (De Bleecker and Okoroji, 2018;Kadam et al., 2016). ...
Abstract
Context:
Digital Health (DH) is widely considered essential for sustainable future healthcare systems. Software quality, particularly usability, is crucial for the success and adoption of most DH products. However, concerns about the effectiveness and efficiency of usability evaluation of DH products have been raised.
Objective:
This article aims to analyse the prevalence and application contexts of usability evaluation methods in DH and to highlight potential issues related to their effectiveness and efficiency.
Method:
A systematic literature review of usability evaluation studies, published by (academic) practitioners between 2016 and April 2023, was conducted. 610 primary articles were identified and analysed, utilising five major scientific databases.
Results:
Our findings show a preference for inquiry (85%) and testing (63%) methods, with inspection used less frequently (17%). The published studies employed methods like questionnaires (75%); notably the SUS (49%), semi-structured interviews (25%), and heuristic evaluations (73%), with percentages based on their group. Data collection mainly involved the use of participant feedback (45%), audio/video recordings (44%), and system logs (20%), with both qualitative and quantitative data analyses prevalent in studies. However, several usability characteristics such as accessibility, memorability, and operability were found to be largely overlooked, and automation tools or platforms were not widely used. Among the systems evaluated were mHealth applications (70%), telehealth platforms (36%), health information technology (HIT) solutions (29%), personalized medicine (Per. Med.) (17%), wearable devices (12%), and digital therapeutics (DTx) interventions (6%), with the participation of general users, patients, healthcare providers, and informal caregivers varying based on the health condition studied. Furthermore, insights and experiences gathered from 24 articles underscored the importance of a mixed-method approach in usability evaluations, the limitations of traditional methods, the necessity for sector-specific customisation, and the potential benefits of remote usability studies. Moreover, while eye-tracking emerged as a promising evaluation technique, careful execution and interpretation are crucial to avoid data misinterpretation.
Conclusion:
The study’s findings showed that employing a combination of inquiry and testing-based methods is prevalent for evaluating DH platforms. Despite an array of DH systems, method distribution remained consistent across platforms and targeted user groups. The study also underlines the importance of involving target user groups in the process. Potentially affected cognitive abilities of participants and potential user groups of interest have to be taken into account when choosing evaluation methods, and methods might therefore need to be tailored. Complementary inspection methods might be particularly useful when recruiting representative participants is difficult. Several potential paths for future research are outlined, such as exploring novel technologies like artificial intelligence, for improved automation tool support in the usability evaluation process.
... Further, among US smartphone owners, young adults, those with no college education, and those with lower income levels are most likely to use their mobile phone as their main source to access the internet [13]. At the same time, studies show that youth from diverse racial/ethnic, sexual orientation, gender identity, and low-income backgrounds are often underrepresented in research [14][15][16]. Thus, using these technologies can potentially expand youth participation, increase the diversity of participants [8,17,18], and reach youth from historically under-resourced communities [18]. ...
Background:
Online surveys can align with youth's increased use of the internet and can be a mechanism for expanding youth participation in research. This is particularly important during the coronavirus disease 2019 (COVID-19) pandemic, when in-person interactions are limited. However, the advantages and drawbacks of online systems used for research need to be carefully considered before utilizing such methodologies.
Aim:
To describe and discuss the strengths and limitations of an online system developed to recruit adolescent girls for a sexual health research study and conduct a three-month follow up survey.
Methods:
This methodology paper examines the use of an online system to recruit and follow participants three months after their medical visit to evaluate a mobile sexual and reproductive health application, Health-E You/Salud iTuTM, for adolescent girls attending school-based health centers (SBHCs) across the United States. SBHC staff gave adolescent girls a web link to an online eligibility and consent survey. Participants were then asked to complete two online surveys (baseline and 3-month follow-up). Surveys, reminders, and incentives to complete them were distributed through short message service (SMS) text messages. Upon completing each survey, participants were also sent an email with a link to an electronic gift card as a thank-you for their participation. Barriers to implementing this system were discussed with clinicians and staff at each participating SBHC.
Results:
This online recruitment and retention system enabled participant recruitment at 26 different SBHCs in seven states across the United States. Between September 2021 and June 2022, 415 adolescent girls were screened using the Qualtrics online survey platform, and 182 were eligible to participate. Of those eligible, 78.0% (n = 142) completed the baseline survey. Participants were racially, geographically, and linguistically diverse. Most of the participants (89.4%) were non-White, and 40.8% spoke Spanish. A total of 62.0% (n = 88) completed the 3-month follow-up survey. Limitations of this system included reliance on internet access (via Wi-Fi or cell service), which was not universally available or reliable. In addition, an individual unrelated to the study obtained the survey link, filled out multiple surveys, and received multiple gift cards before the research team discovered and stopped this activity. As a result, additional security protocols were instituted.
Conclusion:
Online systems for health research can increase the reach and diversity of study participants, reduce costs for research personnel time and travel, allow for continued study operation when in-person visits are limited (such as during the COVID-19 pandemic), and connect youth with research using technology. However, there are challenges and limitations to online systems, which include limited internet access, intermittent internet connection, data security concerns, and the potential for fraudulent users. These challenges should be considered prior to using online systems for research.
... The recruitment of young people with DM2 for clinical trials is relatively recent and has presented limited success. 13,14 Indeed, a major challenge for academics and the pharmaceutical industry is to achieve a safe and effective dose in paediatric patients. 15 Physiologically based pharmacokinetic (PBPK) models are a valuable approach for integrating known physiological changes that alter drug disposition in children with drug-specific parameters in an untested scenario. ...
Aims
To develop paediatric physiologically based pharmacokinetic modelling (PBPK) models of semaglutide to estimate the pharmacokinetic profile for subcutaneous injections in children and adolescents with healthy and obese body weights.
Methods
Pharmacokinetic modelling and simulations of semaglutide subcutaneous injections were performed using the Transdermal Compartmental Absorption & Transit model implemented in GastroPlus v.9.5 modules. A PBPK model of semaglutide was developed and verified in the adult population, by comparing the simulated plasma exposure with the observed data, and further scaled to the paediatric populations with normal and obese body weight.
Results
The semaglutide PBPK model was successfully developed in adults and scaled to the paediatric population. Our paediatric PBPK simulations indicated a significant increase in maximum plasma concentrations for the 10–14 years' paediatric population with healthy body weights, which was higher than the observed values in adults at the reference dose. Since gastrointestinal adverse events are related to increased semaglutide concentrations, peak concentrations outside the target range may represent a safety risk for this paediatric age group. Besides, paediatric PBPK models indicated that body weight was inversely related to semaglutide maximum plasma concentration, corroborating the consensus on the influence of body weight on semaglutide PK in adults.
Conclusion
Paediatric PBPK was successfully achieved using a top‐down approach and drug‐related parameters. The development of unprecedented PBPK models will support paediatric clinical therapy for applying aid‐safe dosing regimens for the paediatric population in diabetes treatment.
... An important part of co-design is ensuring all aspects of involvement are age appropriate. Children are likely to be less tolerant of unpleasant, time consuming, or poorly designed aspects of research participation [73,77,78]. Researchers should consider whether blood sampling is sufficiently minimised to ensure adequate cooperation from children and make sure that study materials, such as assent forms, use language accessible to the relevant age group [79]. ...
This is an exciting time for research and novel drug development in cystic fibrosis. However, rarely has the adage, “Children are not just little adults” been more relevant. This article is divided into two main sections. In the first, we explore why it is important to involve children in research. We discuss the potential benefits of understanding a disease and its treatment in children, and we highlight that children have the same legal and ethical right to evidence-based therapy as adults. Additionally, we discuss why extrapolation from adults may be inappropriate, for example, medication pharmacokinetics may be different in children, and there may be unpredictable adverse effects. In the second part, we discuss how to involve children and their families in research. We outline the importance and the complexities of selecting appropriate outcome measures, and we discuss the role co-design may have in improving the involvement of children. We highlight the importance of appropriate staffing and resourcing, and we outline some of the common challenges and possible solutions, including practical tips on obtaining consent/assent in children and adolescents. We conclude that it is unethical to simply rely on extrapolation from adult studies because research in young children is challenging and that research should be seen as a normal part of the paediatric therapeutic journey.
... The qualitative results gave potential reasons for this, such as the perceived need to give back to healthcare and research. Moreover, previous studies have showed that the recruitment of adolescents with chronic conditions to research studies is a challenge (165). A further explanation for this may be differences in brain development and that consequence thinking is not fully developed (63,64). ...
Transition programs have been developed for adolescents with chronic conditions and evaluated through randomized controlled trials. However, knowledge is lacking on what barriers and facilitators to implementation exist, how change is created, and the cost-effectiveness of these programs. The overall aim of this thesis was to perform a process evaluation and health economic analysis of the STEPSTONES transition program for adolescents with congenital heart disease in transition to adulthood and transfer to adult care. The methods used in this thesis were process evaluations (Studies I – III) and a health economic evaluation (Study IV). Mixed methods were used to design, collect, and analyze data according to the methodological guidance for process evaluation of complex interventions by Moore et al (2015). The findings showed that the transition program was implemented with high fidelity, although some components were more difficult to implement. Factors affecting the implementation process were the participants’ and healthcare professionals’ responsiveness and willingness to engage in the program, organizational factors, recruitment and retention, and the parents’ process of achieving balance between becoming a support system and managing their own information and support needs. Key change mechanisms were the opportunity to meet a transition coordinator trained in person-centered care and adolescent-friendly communication, the creation of a safe space that was built on confidentiality, a learning process starting from the adolescents’ needs, and goal setting beyond the heart defect. The health economic evaluations showed that the intervention group had higher costs due to receiving the transition program. No differences in health outcomes with the EQ-5D were observed in this study. The conclusion is that the transition program was largely implemented as it was intended. Implications from these findings are that transition programs have prerequisites for implementation but tailoring to other conditions and contexts needs to be taken into consideration. Knowledge is needed on the longitudinal impact of transition programs to provide decision makers with evidence on the future benefits of transition programs for adolescents with chronic conditions.
... A majority of common struggles are time demands, unstable living conditions, comprehension, and communication issues such as language barriers. However, data shows that the most successful components of recruiting minors are establishing trust, creative advertising, and monetary incentives [3]. ...
... Technology-based incentives and online advertising primarily on social media platforms have also proven to be effective. Trust building is interesting when concerning pediatric and adolescent recruitment because the site staff not only has to gain the trust of the potential subject, but also the trust and confidence of the parents or guardians [3]. ...
It is evident that both recruitment and retention play critical roles in clinical trials. Recruitment and retention models are beginning to be analyzed worldwide in an effort to assess how to conduct studies more efficiently, all the while, allowing researchers to provide sound and ethical data to help advance medicine through clinical studies. Sponsors and sites have recognized that clinical trial enrollment must become more diverse and inclusive. In this review, we address the important topics of recruitment and retention in clinical trials. Specifically, the obstacles in regard to recruiting vulnerable populations.
Methodologies to improve both the understanding of the study population
and community engagement are outlined. In particular, newer strategies
such as use of social media and more reliable strategies such as trust and relationship
building are described in detail. A strong focus on recruitment is
becoming widely recognized as being of such importance that consideration
is given to this key component even during initial protocol development. Attention
to recruitment and retention in the strategic planning process of clinical
trials can mitigate enrollment issues that clinical researchers are experiencing.
... Although most studies offered technological or financial incentives, ethical issues have been raised with respect to use in research involving children/youth [57]. Importantly, incentives are not a "magic bullet" [58] with the study offering the largest (US$100) terminated after 2 years with only 10 participants recruited [43]. ...
People with younger-onset type 2 diabetes (YOT2D, diagnosis before 40 years of age) are at higher risk of morbidity and premature mortality compared with their similar-age type 1 diabetes and later-onset type 2 diabetes peers. Despite recommendations for targeted, behavioural, and psychosocial approaches to optimising health outcomes, there are few such interventions for this group. Furthermore, evaluations of health behaviour change interventions targeting this priority population have proven challenging to complete. Despite this, there is little guidance for future behavioural programme developers. The aims of this paper are to synthesise lessons learned and recommendations from published evaluations of YOT2D-focused health behaviour change interventions, and illustrate challenges and solutions using case studies from our own experience. A rapid review of the literature identified 11 trials of behavioural interventions for YOT2D (5 randomised controlled trials, 6 pre/post studies). We sourced related needs assessment and development papers to describe the life course of each programme. We identified two development and two evaluation-related themes impacting successful trial execution. Development recommendations include ensuring appropriate adaptation of existing interventions to the unique challenges and characteristics of the target group, use of theory or theoretical frameworks throughout, and involvement of the priority population and key stakeholders from inception. Evaluation recommendations include planning for meaningful evaluation and development of age-appropriate Core Outcomes Sets. Future programme developers would benefit from closer attention to intervention development guidelines and a focus on supporting those with YOT2D to achieve behaviour change and diabetes self-management goals, ahead of change to biomedical outcomes.
... Because it is often conducted within hospitals and other healthcare institutions, qualitative health services researchers can face additional challenges regarding participant recruitment (Broyles et al., 2011). As we found, ethical concerns and legal restrictions surrounding confidentiality meant that potential participants had to be invited to participate directly by their care providers, limiting the possible recruitment strategies open to researchers who are outside patients' circles of care (Nguyen et al., 2014;Sullivan-Bolyai et al., 2007). Studies that focus on exploring patient experience with a specific medical program have a restricted patient pool from which to recruit (James et al., 2014;Poole & Peyton, 2013) and a limited number of providers and clinic staff to help recruit participants (Ellard-Grey et al., 2015). ...
Adequate participant recruitment is critical for any qualitative research project. Our research team experienced numerous difficulties when attempting to recruit young adults with type 1 diabetes to discuss their transition from pediatric to adult-focused care. Using our experience as a case study, we identify the activities involved in four phases of participant recruitment: (1) development of a recruitment plan, (2) implementation, (3) participant engagement post-data collection, and (4) post-recruitment assessment. We present a new definition of participant recruitment which better captures the range of activities involved. We discuss aspects impacting recruitment in our case: the influence of other stakeholders, the dynamic nature of recruitment, recruitment of specific populations, and the challenges of recruiting within a healthcare environment. Finally, we identify and consider four factors that impact participant recruitment: communication, participant interest/value, participant trust in the research project, and participant availability and consider potential strategies for overcoming barriers related to each factor. In the end, our case underscores the centrality and potential fluidity of participant recruitment within qualitative research.
... There are several factors that may interfere with recruiting pediatric T2D samples. In general, regardless of the medical condition, pediatric samples tend to be more difficult to recruit and retain than adult samples [31,32]. For diabetes in particular, the low prevalence of T2D in children (i.e., 0.46 per 1000 children aged 10-19 years in the US [1]) further limits the number of potential subjects for trials. ...
IntroductionIn recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to evaluate new therapies in children with T2D.MethodsA targeted review of peer-reviewed literature and trials registered on www.clinicaltrials.gov was conducted in January 2021 to identify pharmaceutical interventional studies in youth with T2D. Information regarding enrollment data, study design elements, subjects’ baseline characteristics, and key treatment outcomes was documented.ResultsAmong the 16 clinical studies included in this review, only five appeared to meet projected enrollment targets in < 4 years. Although three other studies met recruitment targets, two took approximately 5 years to complete and the third took nearly 10 years.Conclusions
Despite legislation requiring evaluation of pharmaceutical treatments in pediatric populations, surprisingly few interventional studies have been conducted in children with T2D. This review highlights that recruitment challenges may be impeding the conduct and completion of interventional studies. Consequently, few pharmaceutical treatments have been proven to be effective and approved for children with T2D. Metformin and liraglutide remain the only non-insulin treatments formally approved in the US for use in this population. More clinical research is needed to support regulatory decision-making as well as treatment decisions for children with T2D in clinical settings. Sponsors and investigators will need to implement strategies for improving trial enrollment as well as work with regulatory agencies to develop novel study designs that may require fewer patients.
... Considering the COVID-19 pandemic, a sufficient number of Canadian children of both sexes were still recruited in a timely manner before research activities were put on hold. Challenges in recruiting children with obesity, specifically those with metabolic abnormalities, are well-documented in several pediatric studies [87,88]. Although we did not enroll children without obesity as controls (i.e., case-control design), our results provide evidence of distinct taxonomic and functional profiles of the gut microbiome across HOMA-IR tertiles even in the presence of obesity. ...
The gut microbiome is hypothesized to play a crucial role in the development of obesity and insulin resistance (IR); the pathways linking the microbiome to IR in pediatrics have yet to be precisely characterized. We aimed to determine the relationship between the gut microbiome composition and metabolic functions and IR in children with obesity. In a cross-sectional study, fecal samples from children with obesity (10-16 years old) were collected for taxonomical and functional analysis of the fecal microbiome using shotgun metagenomics. The homeostatic model assessment for insulin resistance (HOMA-IR) was determined using fasting glucose and insulin. Associations between HOMA-IR and α-diversity measures as well as metabolic pathways were evaluated using Spearman correlations; relationships between HOMA-IR and β-diversity were assessed by permutational multivariate analysis of variance. Twenty-one children (nine males; median: age = 12.0 years; BMI z-score = 2.9; HOMA-IR = 3.6) completed the study. HOMA-IR was significantly associated with measures of α-diversity but not with β-diversity. Children with higher HOMA-IR exhibited lower overall species richness, Firmicutes species richness, and overall Proteobacteria species Shannon diversity. Furthermore, HOMA-IR was inversely correlated with the abundance of pathways related to the biosynthesis of lipopolysaccharides, amino acids, and short-chain fatty acids, whereas positive correlations between HOMA-IR and the peptidoglycan biosynthesis pathways were observed. In conclusion, insulin resistance was associated with decreased microbial α-diversity measures and abundance of genes related to the metabolic pathways. Our study provides a framework for understanding the microbial alterations in pediatric obesity.
