RESUMEN
IMPORTANCE: Feasibility of home urogenital microbiome specimen collection is unknown. OBJECTIVES: This study aimed to evaluate successful sample collection rates from home and clinical research centers. STUDY DESIGN: Adult women participants enrolled in a multicentered cohort study were recruited to an in-person research center evaluation, including self-collected urogenital samples. A nested feasibility substudy evaluated home biospecimen collection prior to the scheduled in-person evaluation using a home collection kit with written instructions, sample collection supplies, and a Peezy™ urine collection device. Participants self-collected samples at home and shipped them to a central laboratory 1 day prior to and the day of the in-person evaluation. We defined successful collection as receipt of at least one urine specimen that was visibly viable for sequencing. RESULTS: Of 156 participants invited to the feasibility substudy, 134 were enrolled and sent collection kits with 89% (119/134) returning at least 1 home urine specimen; the laboratory determined that 79% (106/134) of these urine samples were visually viable for analysis. The laboratory received self-collected urine from the research center visit in 97% (115/119); 76% (91/119) were visually viable for sequencing. Among 401 women who did not participate in the feasibility home collection substudy, 98% (394/401) self-collected urine at the research center with 80% (321/401) returned and visibly viable for sequencing. CONCLUSIONS: Home collection of urogenital microbiome samples for research is feasible, with comparable success to clinical research center collection. Sample size adjustment should plan for technical and logistical difficulties, regardless of specimen collection site.
RESUMEN
INTRODUCTION: Community engagement is increasingly recognized as a critical component of research, but few studies provide details on how to successfully incorporate community perspectives in urological research. This manuscript describes the community engagement strategy used by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS) to design RISE FOR HEALTH (RISE), a multicenter, population-based, prospective cohort study to promote bladder health. METHODS AND RESULTS: The PLUS Community Engagement Subcommittee, guided by a set of antiracist community engagement principles and practices, organized, implemented, and communicated findings for all RISE community engagement activities. Community engagement was conducted through a diverse network of community partners at PLUS clinical research centers called Rapid Assessment Partners (RAPs). Via online surveys (4), virtual discussion groups (14), and one-on-one interviews (12), RAPs provided input on RISE processes and materials, including in-person visit procedures, specimen collection instructions, survey data collection instruments, recruitment materials, the study website, and the study name. This process resulted in significant changes to these aspects of the study design with reciprocal benefits for the community partners. DISCUSSION: Meaningful community engagement improved the design and implementation of RISE. PLUS will continue to engage community partners to interpret the RISE study results, disseminate RISE findings, and inform other PLUS studies toward the development of interventions to promote bladder health. Future urological studies would also benefit from community participation in determining priority research questions to address.
