School of Medicine, Public Health Sciences, University of Virginia, Charlottesville, VA, United States.
School of Medicine, Family Medicine, University of Virginia, Charlottesville, VA, United States.
Front Public Health. 2024 May 9;12:1371768. doi: 10.3389/fpubh.2024.1371768. eCollection 2024.
Under-represented subgroups in biomarker research linked to behavioral health trials may impact the promise of precision health. This mixed methods study examines biorepository donations across an Appalachian sample enrolled in a sugary drink reduction intervention trial.
Participants enrolled in the behavioral trial were asked to join an optional biomarker study and were tracked for enrollment and biospecimen returns (stool and/or buccal sample). At 6 months, participants completed a summative interview on decision-making process, experiences collecting samples, and recommendations to encourage biospecimen donation. Return rates were analyzed across demographics (i.e., age, gender, race, education, income, health literacy status, and rurality status) using chi-squares. Qualitative data were content coded with differences compared by biomarker study enrollment and donation choices.
Of the 249 invited participants, 171 (61%) enrolled, and 63% ( = 157) returned buccal samples and 49% ( = 122) returned stool samples. Metro residing participants were significantly more likely (56%) to return stool samples compared to non-metro (39%) counterparts [ = 6.61; = 0.01]. Buccal sample return had a similar trend, 67 and 57%, respectively for metro vs. non-metro [ = 2.84; = 0.09]. An additional trend indicated that older (≥40 years) participants were more likely (55%) to donate stool samples than younger (43%) participants [ = 3.39; = 0.07]. No other demographics were significantly associated with biospecimen return. Qualitative data indicated that societal (66-81%) and personal (41-51%) benefits were the most reported reasons for deciding to donate one or both samples, whereas mistrust (3-11%) and negative perceptions of the collection process (44-71%) were cited the most by those who declined one or both samples. Clear instructions (60%) and simple collection kits (73%) were donation facilitators while challenges included difficult stool collection kits (16%) and inconveniently located FedEx centers (16%). Recommendations to encourage future biorepository donation were to clarify benefits to science and others (58%), provide commensurate incentives (25%), explain purpose (19%) and privacy protections (20%), and assure ease in sample collection (19%).
Study findings suggest the need for biomarker research awareness campaigns. Researchers planning for future biomarker studies in medically underserved regions, like Appalachia, may be able to apply findings to optimize enrollment.
在与行为健康试验相关的生物标志物研究中代表性不足的亚组可能会影响精准健康的前景。这项混合方法研究调查了在参加含糖饮料减少干预试验的阿巴拉契亚样本中进行的生物库捐赠情况。
参加行为试验的参与者被要求参加可选的生物标志物研究，并跟踪他们的入组和生物样本返回情况（粪便和/或口腔样本）。在 6 个月时，参与者完成了关于决策过程、样本采集经验和鼓励生物样本捐赠的建议的总结性访谈。使用卡方检验分析了人口统计学特征（年龄、性别、种族、教育程度、收入、健康素养状况和农村状况）的回归率。使用差异比较对生物标志物研究入组和捐赠选择的定性数据进行内容编码。
在 249 名受邀参与者中，171 名（61%）入组，63%（157 名）返回了口腔样本，49%（122 名）返回了粪便样本。居住在大都市的参与者明显更有可能（56%）返回粪便样本，而不是非大都市（39%）参与者[=6.61；=0.01]。口腔样本的返回也有类似的趋势，大都市和非大都市的分别为 67%和 57%[=2.84；=0.09]。另一个趋势表明，年龄较大（≥40 岁）的参与者比年龄较小（43 岁）的参与者更有可能（55%）捐赠粪便样本[=3.39；=0.07]。其他人口统计学特征与生物样本的回归均无显著相关性。定性数据表明，社会（66-81%）和个人（41-51%）利益是决定捐赠一个或两个样本的最主要原因，而不信任（3-11%）和对采集过程的负面看法（44-71%）是那些拒绝一个或两个样本的人最常提到的原因。明确的说明（60%）和简单的采集试剂盒（73%）是捐赠的促进因素，而困难的粪便采集试剂盒（16%）和不方便的联邦快递中心（16%）则是挑战。鼓励未来生物库捐赠的建议包括澄清对科学和他人的益处（58%）、提供相应的激励（25%）、解释目的（19%）和隐私保护（20%）以及确保样本采集的便利性（19%）。
研究结果表明需要开展生物标志物研究意识宣传活动。在阿巴拉契亚等医疗服务不足地区计划未来生物标志物研究的研究人员可能能够将这些发现应用于优化招募。
