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在美国最大的公立医院进行预筛选以增加肿瘤治疗试验的入组人数。

Prescreening to Increase Therapeutic Oncology Trial Enrollment at the Largest Public Hospital in the United States.

作者信息

Wu Jennifer, Yakubov Amin, Abdul-Hay Maher, Love Erica, Kroening Gianna, Cohen Deirdre, Spalink Christy, Joshi Ankeeta, Balar Arjun, Joseph Kathie-Ann, Ravenell Joseph, Mehnert Janice

机构信息

NYU Grossman School of Medicine, New York, NY.

出版信息

JCO Oncol Pract. 2022 Apr;18(4):e620-e625. doi: 10.1200/OP.21.00629. Epub 2021 Nov 8.

DOI:10.1200/OP.21.00629
PMID:34748371
Abstract

PURPOSE

The recruitment of underserved patients into therapeutic oncology trials is imperative. The National Institutes of Health mandates the inclusion of minorities in clinical research, although their participation remains under-represented. Institutions have used data mining to match patients to clinical trials. In a public health care system, such expensive tools are unavailable.

METHODS

The NYU Clinical Trials Office implemented a quality improvement program at Bellevue Hospital Cancer Center to increase therapeutic trial enrollment. Patients are screened through the electronic medical record, tumor board conferences, and the cancer registry. Our analysis evaluated two variables: number of patients identified and those enrolled into clinical trials.

RESULTS

Two years before the program, there were 31 patients enrolled. For a period of 24 months (July 2017 to July 2019), we identified 255 patients, of whom 143 (56.1%) were enrolled. Of those enrolled, 121 (84.6%) received treatment, and 22 (15%) were screen failures. Fifty-five (38.5%) were referred to NYU Perlmutter Cancer Center for therapy. Of the total enrollees, 64% were female, 56% were non-White, and overall median age was 55 years (range: 33-88 years). Our participants spoke 16 different languages, and 57% were non-English-speaking. We enrolled patients into eight different disease categories, with 38% recruited to breast cancer trials. Eighty-three percent of our patients reside in low-income areas, with 62% in both low-income and Health Professional Shortage Areas.

CONCLUSION

Prescreening at Bellevue has led to a 4.6-fold increase in patient enrollment to clinical trials. Future research into using prescreening programs at public institutions may improve access to clinical trials for underserved populations.

摘要

目的

将服务不足的患者纳入肿瘤治疗试验势在必行。美国国立卫生研究院要求在临床研究中纳入少数族裔,尽管他们的参与度仍然不足。一些机构已使用数据挖掘来为患者匹配临床试验。在公共医疗系统中,此类昂贵的工具无法使用。

方法

纽约大学临床试验办公室在贝尔维尤医院癌症中心实施了一项质量改进计划,以增加治疗试验的入组人数。通过电子病历、肿瘤病例讨论会和癌症登记处对患者进行筛查。我们的分析评估了两个变量:识别出的患者数量和纳入临床试验的患者数量。

结果

在该计划实施的两年前,有31名患者入组。在24个月(2017年7月至2019年7月)期间,我们识别出255名患者,其中143名(56.1%)入组。在入组的患者中,121名(84.6%)接受了治疗,22名(15%)筛查未通过。55名(38.5%)被转诊至纽约大学珀尔马特癌症中心接受治疗。在所有入组患者中,64%为女性,56%为非白人,总体中位年龄为55岁(范围:33 - 88岁)。我们的参与者说16种不同的语言,57%的人不讲英语。我们将患者纳入了八个不同的疾病类别,其中38%被招募到乳腺癌试验中。我们83%的患者居住在低收入地区,62%的患者既居住在低收入地区又居住在卫生专业人员短缺地区。

结论

在贝尔维尤医院进行的预筛查使临床试验的患者入组人数增加了4.6倍。未来对公共机构使用预筛查计划的研究可能会改善服务不足人群参与临床试验的机会。

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