Understanding facilitators of research participation among adults with self-reported chronic pain - a survey examining hypothetical research participation.

BACKGROUND: An inability to successfully recruit participants into clinical research has consequences that negatively affect the conduct and reliability of research studies. Understanding facilitators of research participation, namely motives for participation and preferred research outcomes, may improve recruitment and retention of clinical trials related to chronic pain. The present study explored research participation facilitators among individuals with chronic pain and their association with demographic characteristics, pain-related characteristics, and factors related to future research engagement. METHODS: Individuals from Michigan who were 18 years or older and self-reported having chronic pain completed an online survey assessing motives for research participation and desired research outcomes. Analyses were conducted in three stages. First, we evaluated underlying factors of motives for participation and research outcome preferences using principal components analysis. Second, we classified individuals according to their patterns of facilitators using latent profile analysis. Finally, we evaluated differences between facilitator profiles in demographic characteristics, pain-related characteristics, and factors related to future research engagement using χ2 analyses and Kruskal-Wallis rank sum tests. RESULTS: Three components of motives for research participation were identified: social engagement/enjoyment; pain improvement/advancing science; and compensation. Three components of research outcome preferences were identified: co-occurring symptom reduction; behavior reduction modification; and pain and function improvement. Four potential patient-centered profiles utilizing these dimensions of facilitators were identified that had unique demographic characteristics, research participation willingness, and treatment interest. CONCLUSIONS: Our data provide a framework of motives and research outcome preferences that may inform recruitment and retention in chronic pain research. It also gives an indication of who may respond best to active or passive recruitment strategies that appeal to a given motive or preferred outcome. This information may be useful for improving recruitment and to monitor any potential biases in participant samples.

Motivations and demographic differences in pregnant individuals in the decision to participate in research.

PURPOSE: Although many patients agree to participate in research studies, many decline. The decision of whether or not to participate is especially complex in pregnant individuals as they may be concerned about both themselves and the fetus. We sought to understand patient reasoning for and demographic associations with participation in a trial surrounding the utility of epidural preservative-free morphine after successful vaginal delivery. METHODS: We conducted a survey-based study in which parturients were approached within 36 hr after delivery to complete a survey assessing reasons for why they participated or not in the original trial. The survey also included self-reported demographics. Survey responses were categorized as follows: active participation, passive participation, ambivalence, aversion, miscommunication, clinical difficulty, unwilling to receive placebo, and screening failures. RESULTS: The survey response rate was 47%. Having a bachelor's degree or higher was associated with participating in the study (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.07 to 3.64; P = 0.03). Race and ethnicity were not predictive of participation. Participants who self-identified as Black were more likely to select reasons of aversion for why they did not participate in the trial (OR, 2.6; 95% CI, 1.00 to 6.75; P = 0.05). Seventy-three percent of participants who self-identified as Black and declined to participate selected aversion, compared with 31% of those who self-identified as non-Black. Additionally, 71% of participants who self-identified as Hispanic and declined to participate selected aversion, compared with 32% of those who self-identified as non-Hispanic. CONCLUSIONS: These findings can help identify areas for improvement of participation of pregnant individuals in research studies. Demographic associations may influence participation and reasons for participation.

RéSUMé: OBJECTIF: Bien que bon nombre de patient·es acceptent de participer à des études de recherche, beaucoup déclinent. La décision de participer ou non est particulièrement complexe chez les personnes enceintes, car elles peuvent être inquiètes pour elles-mêmes et pour le fœtus. Nous avons cherché à comprendre le raisonnement des patient·es et les associations démographiques concernant la participation à une étude portant sur l'utilité de la morphine péridurale sans agent de conservation après un accouchement vaginal réussi. MéTHODE: Nous avons mené une étude basée sur des questionnaires dans laquelle les personnes parturientes ont été approchées dans les 36 heures suivant l'accouchement afin de compléter un questionnaire évaluant les raisons pour lesquelles elles avaient participé ou non à l'étude initiale. Le questionnaire comprenait également des données démographiques autodéclarées. Les réponses au questionnaire ont été classées comme suit : participation active, participation passive, ambivalence, aversion, mauvaise communication, difficulté clinique, refus de recevoir un placebo et échecs au dépistage. RéSULTATS: Le taux de réponse était de 47 %. Le fait d'avoir un baccalauréat ou plus était associé à la participation à l'étude (rapport de cotes [RC], 1,97; intervalle de confiance [IC] à 95 %, 1,07 à 3,64; P = 0,03). La race et l'origine ethnique n'étaient pas prédictives de la participation. Les participant·es qui se sont identifié·es comme Noir·es étaient plus susceptibles de choisir des raisons d'aversion pour expliquer leur non-participation à l'étude (RC, 2,6; IC 95 %, 1,00 à 6,75; P = 0,05). Soixante-treize pour cent des participant·es qui se sont identifié·es comme Noir·es et ont refusé de participer ont choisi l'aversion, comparativement à 31 % des personnes qui se sont identifié·es comme non Noir·es. De plus, 71 % des participant·es qui se sont identifié·es comme d'origine hispanique et ont refusé de participer ont choisi l'aversion, comparativement à 32 % des personnes qui se sont identifié·es comme non Hispaniques. CONCLUSION: Ces résultats peuvent aider à identifier les domaines dans lesquels la participation des personnes enceintes aux études de recherche peut être améliorée. Les associations démographiques peuvent influencer la participation et les raisons de la participation.

Community Trust, Attitudes and Preferences Related to Participation in Cancer Research in South Carolina.

African American adults have the highest mortality rate for most cancers in the United States, and meaningful, community-driven research is needed to inform optimal strategies for addressing these disparities. Unfortunately, research mistrust, often driven by historical inequities, is well-documented among African Americans.This study explored trust, attitudes, and preferences regarding participation in cancer research activities among primarily African American and other medically underserved communities in South Carolina from August 2020 to December 2021. Trust was measured using the Trust in Medical Researchers Scale (TMRS).The mean TMRS score for all study participants (N = 179) was 26.54 (SD 7.57) out of 48 (maximum possible score). Significant differences in mean values of the TMRS scores were only observed for gender (p = 0.0056) and race (p < 0.0001), with White participants and males reporting higher levels of trust in medical researchers. Overall, 52.5% of participants were somewhat likely or likely to volunteer to participate in a cancer research opportunity, with White participants (73.81%) being more likely to participate in cancer research compared to African American participants (45.74%) (p = 0.0054). Furthermore, participants were most willing to provide saliva (80.85%) and urine samples (80.85%), new blood samples (60.64%), stool samples (54.26%), medical records or laboratory results (52.13%) and least willing to allow left-over blood, tissue, or other fluids from medical procedures to be used for research (50%).These results provide evidence of the need for concerted programmatic efforts to build trust in cancer researchers, particularly among females and African American adults.

Biological and Medicinal Chemistry in Africa.

The young, fast-growing population of Africa means that harnessing the economic benefits of scientific research is critical to sustained and equitable growth in the continent. Moreover, the whole world would benefit from the added intellectual contribution that would come from nurturing African science. The high burden of neglected diseases in Africa makes chemical biology a particularly important field. In this editorial, the reconvergence of science conducted at the interface of chemistry and biology is placed in the context of African participation, its importance to global science and the unique blend of supporting and hindering factors that influence African scientific contributions. The new Biological and Medicinal Chemistry in Africa special collection showcases a broad spectrum of African chemical biology.

"What I wanted to do was build myself back up and prepare": qualitative findings from the PERCEPT trial of prehabilitation during autologous stem cell transplantation in myeloma.

BACKGROUND: The addition of qualitative methodology to randomised controlled trials evaluating complex interventions allows better understanding of contextualised factors and their potential influence on trial delivery and outcomes, as well as opportunities for feedback on trial participation to improve future trial protocols. This study explored the experiences of participation in cancer rehabilitation research during active cancer treatment. Participants were people living with haematological cancer myeloma, undergoing autologous stem cell transplantation (ASCT) recruited to the PERCEPT myeloma pilot trial. METHODS: A qualitative semi-structured interview study, embedded within a pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered before, during and after ASCT among people living with myeloma. Transcripts were analysed using reflexive thematic analysis. RESULTS: Interviews from 16 trial participants (n = 8 intervention group; n = 8 control group; mean age 61 years, 56% male) were analysed. Four main themes were identified: (1) "It's not just beneficial for me, it's for people after me as well"; (2) Disparities in experience of recovery - expectations, feeling prepared and support; (3) "What I wanted to do was build myself back up and prepare"; (4) Active ingredients - participants' experience of the trial intervention. Participants reported both altruistic and perceived personal gain as motivators for enrolling in the trial. Disappointment caused by allocation to control arm may have led to participants seeking exercise elsewhere, indicating possible contamination of control condition. Disparities in experience of recovery from transplant were evident with intervention participants reporting greater trajectory of recovery. CONCLUSIONS: The findings from this embedded qualitative study highlight numerous considerations required when designing pilot and efficacy trials of complex interventions. The addition of qualitative investigation offers greater understanding of motivations for participation, intervention mechanisms at play as well as effects of participation that may impact interpretation of quantitative outcomes. TRIAL REGISTRATION: Qualitative findings from a prospectively registered pilot trial (ISRCTN15875290), registered 13/02/2019.

Asynchronous online focus groups for research with people living with amyotrophic lateral sclerosis and family caregivers: usefulness, acceptability and lessons learned.

BACKGROUND: People with amyotrophic lateral sclerosis (ALS) face disability- and travel-related barriers to research participation. We investigate the usefulness and acceptability of asynchronous, online focus groups (AOFGs) for research involving people affected by ALS (patients and family caregivers) and outline lessons learned. METHODS: The ALS Talk Project, consisting of seven AOFGs and 100 participants affected by ALS, provided context for this investigation. Hosted on the secure itracks Board™ platform, participants interacted in a threaded web forum structure. Moderators posted weekly discussion questions and facilitated discussion. Data pertaining to methodology, participant interaction and experience, and moderator technique were analyzed using itracks and NVivo 12 analytics (quantitative) and conventional content analysis and the constant-comparative approach (qualitative). RESULTS: There was active engagement within groups, with post lengths averaging 111.48 words and a complex network of branching interactions between participants. One third of participant responses included individual reflections without further interaction. Participants affirmed their co-group members, offered practical advice, and discussed shared and differing perspectives. Moderators responded to all posts, indicating presence and probing answers. AOFGs facilitated qualitative and quantitative data-gathering and flexible response to unanticipated events. Although total participation fell below 50% after 10-12 weeks, participants valued interacting with peers in an inclusive, confidential forum. Participants used a variety of personal devices, browsers, and operating systems when interacting on the online platform. CONCLUSIONS: This methodological examination of AOFGs for patient-centred investigations involving people affected by ALS demonstrates their usefulness and acceptability, and advances knowledge of online research methodologies. Lessons learned include: early identification of research goals and participant needs is critical to selecting an AOFG platform; although duration longer than 10-12 weeks may be burdensome in this population, participants were positive about AOFGs; AOFGs offer real world flexibility enabling response to research challenges and opportunities; and, AOGFs can effectively foster safe spaces for sharing personal perspectives and discussing sensitive topics. With moderators playing an important role in fostering engagement, AOFGs facilitated rich data gathering and promoted reciprocity by fostering the exchange of ideas and interaction between peers. Findings may have implications for research involving other neurologically impaired and/or medically vulnerable populations.

At the intersection of trust and mistrust: A qualitative analysis of motivators and barriers to research participation at a safety-net hospital.

INTRODUCTION: The underrepresentation of Black, Indigenous, and People of Color (BIPOC) individuals in healthcare research limits generalizability and contributes to healthcare inequities. Existing barriers and attitudes toward research participation must be addressed to increase the representation of safety net and other underserved populations. METHODS: We conducted semi-structured qualitative interviews with patients at an urban safety net hospital, focusing on facilitators, barriers, motivators, and preferences for research participation. We conducted direct content analysis guided by an implementation framework and used rapid analysis methods to generate final themes. RESULTS: We completed 38 interviews and identified six major themes related to preferences for engagement in research participation: (1) wide variation in research recruitment preferences; (2) logistical complexity negatively impacts willingness to participate; (3) risk contributes to hesitation toward research participation; (4) personal/community benefit, interest in study topic, and compensation serve as motivators for research participation; (5) continued participation despite reported shortcomings of informed consent process; and (6) mistrust could be overcome by relationship or credibility of information sources. CONCLUSION: Despite barriers to participation in research studies among safety-net populations, there are also facilitators that can be implemented to increase knowledge and comprehension, ease of participation, and willingness to join research studies. Study teams should vary recruitment and participation methods to ensure equal access to research opportunities. PATIENT/PUBLIC CONTRIBUTION: Our analysis methods and study progress were presented to individuals within the Boston Medical Center healthcare system. Through this process community engagement specialists, clinical experts, research directors, and others with significant experience working with safety-net populations supported data interpretation and provided recommendations for action following the dissemination of data.

Qualitative analysis of stakeholder perspectives on engaging Latinx patients in kidney-related research.

BACKGROUND: Latinx individuals are disproportionally burdened by kidney diseases compared to non-Latinx White individuals and are underrepresented in kidney-related research. We aimed to describe stakeholder perspectives on Latinx patient engagement in kidney-related research. METHODS: We conducted a thematic analysis of two online moderated discussions and an interactive online survey with open-text responses involving participants (i.e. stakeholders), with personal and/or professional experiences with Latinx patients with kidney diseases and their families/caregivers. RESULTS: Among the eight stakeholders (Female:75%; Latinx ethnicity:88%), there were three physicians, one nurse, one patient with kidney disease who received a kidney transplant, one policy maker, one Doctor of Philosophy, and one executive director of a non-profit health organization. We identified five themes. The majority of themes and their respective subthemes (in parentheses) reflected barriers to engagement: Lack of personal relevance (unable to relate to research staff and marketing resources, and unclear benefit of research to self, family, and community); fear and vulnerability (immigration concerns, stigma with seeking care, skepticism of Western medicine); logistical and financial barriers (limited opportunities to enroll in clinical trials, out-of-pocket costs, transportation issues); and distrust and asymmetry of power (related to limited English proficiency or health literacy, and provider bias). The last theme centered on stimulating interest and establishing trust in the research process. CONCLUSIONS: To overcome barriers to engagement in kidney-related research and establish trust among potential Latinx research participants, stakeholders recommended employing cultural responsiveness and community-based strategies. These strategies can help identify local health priorities, enhance research recruitment and retention strategies, and establish partnerships that continue to elevate research endeavors aiming to enhance the health of Latinx individuals with kidney diseases.

Mexican Americans agree to participate in longitudinal clinical research more than non-Hispanic whites.

BACKGROUND: The National Institutes of Health has advocated for improved minority participation in clinical research, including clinical trials and observational epidemiologic studies since 1993. An understanding of Mexican Americans (MAs) participation in clinical research is important for tailoring recruitment strategies and enrollment techniques for MAs. However, contemporary data on MA participation in observational clinical stroke studies are rare. We examined differences between Mexican Americans (MAs) and non-Hispanic whites (NHWs) participation in a population-based stroke study. METHODS: We included 3,594 first ever stroke patients (57.7% MAs, 48.7% women, median [IQR] age 68 [58-79]) from the Brain Attack Surveillance in Corpus Christi Project, 2009-2020 in Texas, USA, who were approached and invited to participate in a structured baseline interview. We defined participation as completing a baseline interview by patient or proxy. We used log-binomial models adjusting for prespecified potential confounders to estimate prevalence ratios (PR) of participation comparing MAs with NHWs. We tested interactions of ethnicity with age or sex to examine potential effect modification in the ethnic differences in participation. We also included an interaction between year and ethnicity to examine ethnic-specific temporal trends in participation. RESULTS: Baseline participation was 77.0% in MAs and 64.2% in NHWs (Prevalence Ratio [PR] 1.20; 95% CI, 1.14-1.25). The ethnic difference remained after multivariable adjustment (1.17; 1.12-1.23), with no evidence of significant effect modification by age or sex (Pinteraction by age = 0.68, Pinteraction by sex = 0.83). Participation increased over time for both ethnic groups (Ptrend < 0.0001), but the differences in participation between MAs and NHWs remained significantly different throughout the 11-year time period. CONCLUSION: MAs were persistently more likely to participate in a population-based stroke study in a predominantly MA community despite limited outreach efforts towards MAs during study enrollment. This finding holds hope for future research studies to be inclusive of the MA population.

Planning ahead for research participation: survey of public and professional stakeholders' views about the acceptability and feasibility of advance research planning.

BACKGROUND: Anticipatory planning in the UK focuses on supporting people who anticipate periods of impaired capacity to express their wishes about future care through processes such as advance care planning. Other countries have extended anticipatory planning to include processes for people to prospectively express their preferences about research participation. Advance research planning (ARP) is thought to extend autonomy and ensure that 'proxy' decisions about research are based on their wishes and preferences. METHODS: A cross-sectional survey was conducted with two stakeholder groups (members of the public including people living with capacity-affecting conditions and family members; researchers and other professionals) who were recruited via research registries and other routes. Online questionnaires were used to capture the perspectives of the two groups. Responses were analysed using descriptive statistics and content analysis. RESULTS: A total of 327 participants (members of the public n = 277, professionals n = 50) completed the survey (November 2022 - March 2023). ARP was supported by 97% of public contributors and 94% of professionals. Participants thought that ARP should include the person's general wishes about research, specific types of studies, and who should make decisions on their behalf. They identified a number of challenges, including how ARP could take account of changes in individuals' preferences or circumstances whilst protecting their rights and interests. Implementation barriers included the potential time, complexity, and cost involved. These could be addressed by embedding ARP in existing anticipatory planning pathways and aligning it with other research enrolment activities. Relationships and trust played a key role, including underpinning who should support the delivery of ARP, how they are trained, and when it is undertaken. CONCLUSIONS: There were high levels of support for introducing ARP in the UK. Further research should explore practical barriers and stakeholder concerns and identify any unintended consequences. Future activities should include developing ARP interventions alongside training and other resources, and also focus on public awareness campaigns, and engaging policymakers and other stakeholders.

Factors Influencing Community Participation in Internet Interventions Compared With Research Trials: Observational Study in a Nationally Representative Adult Cohort.

BACKGROUND: Digital mental health (DMH) programs can be effective in treating and preventing mental health problems. However, community engagement with these programs can be poor. Understanding the barriers and enablers of DMH program use may assist in identifying ways to increase the uptake of these programs, which have the potential to provide broad-scale prevention and treatment in the community. OBJECTIVE: In this study, we aimed to identify and compare factors that may influence participation in DMH programs in practice and research trials, identify any respondent characteristics that are associated with these factors, and assess the relationship between intentions to use DMH programs and actual uptake. METHODS: Australian adults aged ≥18 years were recruited from market research panels to participate in the study. The sample was representative of the Australian adult population based on age, gender, and location. Participants completed a cross-sectional web-based survey assessing demographic characteristics, mental health symptom measures, attitudes and use of DMH programs in practice and in research studies, and the factors influencing their use in both settings. RESULTS: Across both research and practice, trust in the organization delivering the service or trial was the top-ranked factor influencing participation, followed by anonymity or privacy and adequate information. There was little variation in rankings across demographic groups, including intentions to use DMH programs or mental health status. Intentions to use DMH programs were a strong predictor of both current (odds ratio 2.50, 99% CI 1.41-4.43; P<.001) and past (odds ratio 2.98, 99% CI 1.71-5.19; P<.001) use behaviors. CONCLUSIONS: Efforts to increase the uptake of DMH programs or participation in research trials should focus on clearly communicating the following to users: the legitimacy of the organization delivering the program, security and use of participant data, and effectiveness of DMH programs.

Caregivers' perception of adults with Down syndrome willingness to participate in research.

BACKGROUND: Historically, individuals with Down syndrome have been excluded from clinical research. Our objective was to assess the degree of interest adults with Down syndrome have in participating in research from the perspective of the caregivers who care for them. METHODS: We conducted an online survey of N = 390 caregivers of adults with Down syndrome and asked about interest in research participation and demographics. RESULTS: Caregivers were mostly family members, older than 55 years, and White. Caregivers reported that the adult with Down syndrome that they cared for would be more comfortable participating in research that was physiological, such as research involving fit bits (70.2% would participate), exercise (63.3%) or diet apps (53.9%), whereas they would be less likely to participate in clinical trials involving more invasive procedures such as injections (10.9%) and laboratory exams like MRIs (32.0%). We found little difference by age or gender of the adult with Down syndrome or by caregiver education level. CONCLUSIONS: Our survey identified high interest for less invasive studies, illustrating acceptability of observational and lifestyle studies. More effort may be needed to understand fear and barriers to participation and to create tools and methods to increase interest in more invasive studies.

Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico-legal position.

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations.

Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai.

A complex network of ethico-legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements.

Ritual Abuse Survivors' Perspectives on Research Participation: An Exploratory Mixed Methods Online Study.

This exploratory study sought a deeper understanding of the perspectives of self-defined ritual abuse (RA) survivors, who had experienced sexual victimization, on participation in research. A mixed-methods qualitative design involving online survey and follow-up virtual interviews included 68 adults across eight countries. Content and thematic analysis of responses indicated that RA survivors were keen to be involved in a range of research activities to share their experience, knowledge, and support for other survivors. Having a voice, gaining knowledge, and feeling empowered were reported as advantages of participation, while concerns included exploitation, researcher ignorance, and emotional dysregulation caused by content discussed. To enable their engagement in the future research, RA survivors identified participative research designs, anonymity, and increased opportunities for inclusion in decision-making.

Health concerns and attitudes towards research participation in a community of rural Black Americans.

OBJECTIVES: Describe health concerns of Black Americans as they age and what influences their participation in aging and clinical research. METHODS: Fifty participants attended focus groups and completed questionnaires to identify barriers to research participation and attitudes toward dementia screening. Bivariate correlations explored associations between barriers to research participation and attitudes toward dementia screening. RESULTS: Cancer, hereditary conditions, vascular conditions, memory disorders, and psychological disorders were the greatest health concerns. Time demands, mistrust, lack of knowledge about potential research, and stigma were identified as barriers for research participation. Incentives, better understanding of how proposed research will benefit the community, lifestyle modification studies, active presence of principal researchers/clinicians, and community investment were identified as factors to improve participation. Questionnaires revealed mistrust and religious beliefs to be among the primary barriers. Attitudes toward dementia screening reflected perceived stigma, suffering, and subsequent loss of independence. Higher barriers to participation were associated with perceived stigma and loss of independence related to dementia screening. CONCLUSIONS: Successfully recruiting Black Americans for aging and clinical research remains a challenge. This study identifies barriers to participation and offers suggestions for planning and recruitment.

An updated assessment of 43,110 patients enrolled in the Childhood Cancer Research Network: A Children's Oncology Group report.

BACKGROUND: The Childhood Cancer Research Network (CCRN) was established by the Children's Oncology Group (COG) as a resource for epidemiologic studies of childhood cancer. The objective of this study was to evaluate the representativeness of CCRN and identify factors associated with enrollment. METHOD: The number of US childhood patients with cancer diagnosed <20 years of age enrolled in CCRN (2008-2015) was compared to expected counts, calculated from Surveillance, Epidemiology, and End Results incidence rates and US Census population estimates. Observed-to-expected ratios and corresponding 95% confidence intervals (CI) were estimated across sex, race, diagnosis age, calendar year, and cancer diagnosis groups. Multivariable linear regression models were generated to evaluate the association between open COG phase 3 therapeutic trials and CCRN enrollment rates. RESULT: The 43,110 cases enrolled in CCRN represented 36% of the expected childhood cancers diagnosed from 2008 to 2015 (N = 120,118). CCRN enrollment ratios [95% CI] were highest among males (0.38 [95% CI, 0.37-0.38]), non-Hispanics (0.35 [95% CI, 0.35-0.36]), and those diagnosed from 1 to 4 years of age (0.50 [95% CI, 0.50-51]). Enrollment ratios varied by diagnosis group, with leukemia, myeloproliferative diseases, myelodysplastic diseases (0.55 [95% CI, 0.54-0.55]), and renal tumors (0.55 [95% CI, 0.53-0.58]) having the highest enrollment. After adjusting for year of diagnosis and cancer diagnosis, there was a 3.1% [95% CI, 0.6-5.6%] increase in CCRN enrollment during windows of open COG therapeutic trials. CONCLUSIONS: Despite enrolling only 36% of newly diagnosed cases, CCRN remains a valuable resource for investigators conducting childhood cancer etiology and survivorship research. The results of this study may inform efforts to improve enrollment on current and future COG nontherapeutic registry protocols.

A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project.

An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit-such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)-requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

"Please help us with important research": A retrospective analysis examining the impact of research invitation and participation on subsequent blood donor behavior.

BACKGROUND: As over-communication can negatively impact consumer behavior, it is important to understand the impact of research communication on donors' future donation behavior. The aim of this study was to determine the effect of (i) being invited to participate in research, and (ii) participating in that research, on future donation behavior. STUDY DESIGN AND METHODS: A retrospective cohort analysis was conducted with 36,418 donors who were invited to participate in one of 17 research projects, and a matched control group of 36,252 non-invited donors. Poisson regression models were used to examine the associations between invitation or participation in the studies and the likelihood of creating an appointment to donate and attending an appointment at 1, 3, and 6 months. RESULTS: Donors were significantly more likely to create an appointment within 14 days of receiving an invitation compared to controls (RR: 1.91, 95% CI 1.81-2.02), and to return to donate at 1 (RR:1.18, 95% CI 1.13-1.24), 3 (RR:1.10, 95% CI 1.07-1.13) and 6 (RR:1.11, 95% CI 1.09-1.13) months compared to non-invited controls. Donors who participated in the research were more likely to return than control donors at all time points, while donors who were invited but did not participate were also likely to return more at 1 month (RR:1.06, 95% CI 1.00-1.11) and 6 months (RR:1.03, 95% CI 1.00-1.5) than non-invited controls. DISCUSSION: Our findings suggest that research participation is positively associated with future donor behavior and provides reassurance that contacting donors for research does not negatively impact blood collections.

Adolescent Health Series: Engagement with young people as partners in health research: Four case studies from Sub-Saharan Africa.

OBJECTIVES: Existing health services for young people (YP)(10-24 years), which are predominantly designed for but not with young people, often do not meet YP's needs. The 2018 Global Consensus Statement on meaningful adolescent and youth engagement affirms that YP have a fundamental right to actively and meaningfully engage in all matters that affect their lives. We present four case studies from three countries in sub-Saharan Africa as practical examples of the engagement of young people as partners in health research. We critically reflect on best practices to inform and guide the increasing adoption of collaborative approaches. METHODS: We developed a narrative summary of each case study through review of study documentation and discussions with research staff and young people. A youth engagement framework was used to describe partnership activities according to the following dimensions: purpose, process, positioning, perspective, power relations, place and protection. We reflected on innovative practices used, overall level of participation achieved and strategies to address ethical, logistical and/or financial barriers. RESULTS: In all case studies, we found evidence of engagement activities that aligned with the Global Consensus Statement on Meaningful Youth Engagement. However, access to participation was often uneven and despite efforts, marginalised young people continue to have insufficient opportunities to engage. Furthermore, although young people had some opportunity to influence the research methods, many of the key design decisions had been determined prior to their involvement. In our case studies, researchers had built in insufficient opportunities to evaluate the level and impact of youth engagement. CONCLUSIONS: We therefore recommend early involvement of young people in the research process so that they can contribute to setting the research agenda, the design of planned studies and thus increase the scope of their engagement from the beginning. Youth engagement activities need to be evaluated from the perspective of all stakeholders including young people themselves with a focus on opportunities to engage, the level of engagement achieved and impact of engagement. From the beginning, researchers should provide space for learning, and involve young people in encouraging critical reflection of what does not yet work, as well as what does, to enable improvements.