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临床研究中青少年和年轻人的参与不足:COVID-19 期间随机临床试验的入组差异。

Undermining the Translational Potential of Clinical Research With Adolescents and Young Adults: Differential Enrollment in Randomized Clinical Trials During COVID-19.

机构信息

From the Department of International Health, Johns Hopkins School of Public Health.

Department of Pediatrics.

出版信息

Sex Transm Dis. 2024 Oct 1;51(10):681-685. doi: 10.1097/OLQ.0000000000001994. Epub 2024 May 1.


DOI:10.1097/OLQ.0000000000001994
PMID:38691409
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11392639/
Abstract

BACKGROUND: COVID-19 stay-at-home orders and research restrictions halted recruitment and follow-up of clinical research patients. Although clinical research has resumed, it is an open question whether research participation has returned to levels similar to those before COVID-19. METHODS: We used data from the TECH-PN (NCT No. NCT03828994) study, a single-center randomized controlled trial enrolling 13- to 25-year-olds with mild-moderate pelvic inflammatory disease (PID) receiving ambulatory care. We examined enrollment patterns before COVID-19 and during/after COVID-19 among those assessed for eligibility by estimating the average rate of recruitment visits for each period. We focused on this monthly rate by pandemic status, the length of stay (LOS) by pandemic status, as well as the relationship between the LOS and patient demographics. Descriptive analyses were conducted, including Student t test to compare rates between time periods and a χ2 test to compare the proportion refusing enrollment. RESULTS: The monthly enrollment rate during/after the pandemic was significantly lower than before COVID-19 (4.8 per month compared with 7.4 per month, P < 0.001). However, eligible participants' age, race, and insurance type were similar before and during/after the pandemic. Among eligible patients, LOS for receiving PID care was slightly increased, from a median of 5.4 to 6.4 hours ( P = 0.650), and the rate of refusal to participate among those eligible was similar (23% vs. 27%, P = 0.362). There were a similar number of ineligible patients because of inpatient admissions during both periods. CONCLUSION: COVID-19 pandemic restrictions negatively impacted recruitment into this randomized controlled trial. Enrollment differences may reflect ongoing perceptions of restrictions in care access or a hesitancy to use health services. More research is needed to stabilize access to ambulatory sexually transmitted infection/PID care and access to clinical trials.

摘要

背景:COVID-19 的居家令和研究限制暂停了临床研究患者的招募和随访。尽管临床研究已经恢复,但研究参与度是否已恢复到 COVID-19 之前的水平仍是一个悬而未决的问题。

方法:我们使用了来自 TECH-PN(NCT No. NCT03828994)研究的数据,这是一项在接受门诊治疗的 13 至 25 岁轻中度盆腔炎(PID)患者中进行的单中心随机对照试验。我们通过估计每个时期的平均招募就诊次数来检查 COVID-19 之前和期间/之后符合条件的患者的入组模式。我们根据大流行状态关注这个月的入组率、大流行状态下的留院时间(LOS)以及 LOS 与患者人口统计学特征之间的关系。进行了描述性分析,包括学生 t 检验比较不同时间段的入组率和卡方检验比较拒绝入组的比例。

结果:大流行期间/之后的每月入组率明显低于 COVID-19 之前(每月 4.8 次与每月 7.4 次相比,P<0.001)。然而,符合条件的参与者在年龄、种族和保险类型方面在大流行之前和期间/之后相似。在符合条件的患者中,接受 PID 治疗的 LOS 略有增加,从中位数 5.4 小时增加到 6.4 小时(P=0.650),而符合条件的参与者拒绝参与的比例相似(23%对 27%,P=0.362)。在这两个时期,因住院而导致的不合资格患者数量相似。

结论:COVID-19 大流行限制对这项随机对照试验的入组产生了负面影响。入组差异可能反映了对护理获取限制的持续看法,或对使用医疗服务的犹豫。需要进一步研究以稳定门诊性传播感染/PID 护理和临床试验的获取。

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本文引用的文献

[1]
Self-reported delays in care-seeking in West Africa during the first wave of the COVID-19 pandemic.

BMC Health Serv Res. 2023-7-22

[2]
Patient hesitancy in perioperative clinical trial enrollment during the COVID-19 pandemic.

PLoS One. 2023

[3]
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BMJ Glob Health. 2022-10

[4]
Health service utilisation during the COVID-19 pandemic in sub-Saharan Africa in 2020: a multicountry empirical assessment with a focus on maternal, newborn and child health services.

BMJ Glob Health. 2022-5

[5]
The Impact of COVID-19 on Routine Medical Care and Cancer Screening.

J Gen Intern Med. 2022-5

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BMJ Glob Health. 2021-12

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JAMA Netw Open. 2021-9-1

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The impact of the COVID-19 pandemic on Sexually Transmitted Infections surveillance data: incidence drop or artefact?

BMC Public Health. 2021-9-7

[9]
Sexual Behavior Change Among Gay and Bisexual Men During the First COVID-19 Pandemic Wave in the United States.

Sex Res Social Policy. 2023

[10]
Impact of the COVID-19 Pandemic on Cancer Clinical Trials.

Ann Surg Oncol. 2021-11

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