Birnbaum Adam I, Gombosev Adrijana, Grant-Freeman Zion T, Hoang Dan, Gillen Daniel L, Grill Joshua D
Department of Statistics, University of California, Irvine, Bren Hall 2019, Irvine, CA, 92697-1250, USA.
Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA.
BMC Med Res Methodol. 2025 Jul 31;25(1):181. doi: 10.1186/s12874-025-02640-z.
Despite their potential as tools for improving the efficiency of accrual in clinical research, few analyses have assessed the effectiveness of recruitment registries. We investigated referrals to clinical research studies from the University of California, Irvine Consent-to-Contact registry, a local online recruitment registry in Orange County, CA. Our analyses sought to quantify the total number of referrals and the proportion of referrals leading to subsequent enrollment in a clinical research study. Key secondary objectives were to investigate the relationship with referral outcomes for registrant research attitudes and the participant burden of the contacting study.
We categorized referral outcomes as: (i) unable to reach, (ii) declined to participate, (iii) phone screened but ineligible, (iv) consented but ineligible, or (v) consented and enrolled. We assessed the overall effectiveness of the registry using the observed distribution of referral outcomes. We investigated the marginal relationship between referral outcome and the participant burden of the contacting study using distributions of referral outcomes conditional on participant burden. We used a binary logistic linear mixed effects model to investigate relationships between registrant characteristics and the odds of a referral leading to participant consent.
Overall, the registry made 6,314 resolved referrals of 3,843 unique registrants to 57 unique research studies. 1,642 (26%) of these referrals were successful, leading to enrollment. Among referrals to interview studies, registrant research attitudes as measured by the research attitudes questionnaire were not associated with the odds of successful first referral (odds ratio per 5 points: 1.00, 95% CI: (0.79, 1.28), p = 0.98). Registrant research attitudes were positively associated with the odds of a successful first referral in non-invasive longitudinal studies (odds ratio per 5 points on the research attitudes questionnaire: 1.17, 95% CI: (1.03-1.32), p = 0.02). The observed relationship was stronger, though not significant in invasive and interventional research (odds ratio: 1.22, 95% CI: (0.99-1.49), p = 0.06).
Our results emphasize the potential effectiveness of recruitment registries and of the research attitudes questionnaire to predict referral outcomes to higher burden clinical research.
尽管招募登记处有潜力成为提高临床研究入组效率的工具，但很少有分析评估其有效性。我们调查了来自加利福尼亚大学欧文分校同意接触登记处（加利福尼亚州奥兰治县的一个本地在线招募登记处）向临床研究的转诊情况。我们的分析旨在量化转诊总数以及转诊后进入临床研究的比例。关键的次要目标是研究登记参与者的研究态度和接触研究的参与者负担与转诊结果之间的关系。
我们将转诊结果分为：（i）无法联系到，（ii）拒绝参与，（iii）电话筛选但不符合条件，（iv）同意但不符合条件，或（v）同意并入组。我们使用观察到的转诊结果分布来评估登记处的总体有效性。我们使用以参与者负担为条件的转诊结果分布来研究转诊结果与接触研究的参与者负担之间的边际关系。我们使用二元逻辑线性混合效应模型来研究登记参与者特征与转诊导致参与者同意的几率之间的关系。
总体而言，该登记处对3843名独特的登记参与者进行了6314次已解决的转诊，涉及57项独特的研究。其中1642次（26%）转诊成功，导致入组。在转诊到访谈研究的情况中，通过研究态度问卷衡量的登记参与者研究态度与首次转诊成功的几率无关（每5分的优势比：1.00，95%置信区间：(0.79, 1.28)，p = 0.98）。在非侵入性纵向研究中，登记参与者研究态度与首次转诊成功的几率呈正相关（研究态度问卷每5分的优势比：1.17，95%置信区间：(1.03 - 1.32)，p = 0.02）。在侵入性和干预性研究中观察到的关系更强，尽管不显著（优势比：1.22，95%置信区间：(0.99 - 1.49)，p = 0.06）。
我们的结果强调了招募登记处和研究态度问卷在预测向更高负担临床研究的转诊结果方面的潜在有效性。
