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应用成熟度模型促进 CAR-T 细胞治疗引入——START CAR-T 项目结果

英文原题:Use of a maturity model for facilitating the introduction of CAR T-cell therapy-Results of the START CAR-T project.

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Use of a maturity model for facilitating the introduction of CAR T-cell therapy-Results of the START CAR-T project.

PubMed 2022/01/08(内容时间) Glob Reg Health Technol Assess Q4 · IF 0.7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究概要

START CAR-T MM 似乎是一个有用且广泛适用的工具。它可能帮助中心优化 CAR-T 细胞治疗的许多方面,并改善患者获得这种新型治疗选择的机会。

研究思路结论见上方概要

嵌合抗原受体(CAR)T细胞疗法是治疗血液系统恶性肿瘤的新型免疫疗法。这些疗法在专业中心由多学科团队实施,需要仔细协调细胞疗法制造和使用所涉及的所有步骤。成熟度模型(MM)是一种用于评估各种活动有效性的工具。在医疗保健领域,它可以帮助临床医生逐步改进CAR-T 细胞疗法和其他复杂治疗的患者管理。

START CAR-T 项目旨在研究 MM 在 CAR-T 细胞治疗背景下的潜力。四家意大利诊所参与了专用 MM 的创建。在该 MM 开发和测试之后,其有效性和普适性通过提交给 18 家意大利中心的问卷得到了进一步检验。

START CAR-T MM 评估了临床中心的成熟度水平,重点关注组织、流程和数字化支持。针对每个领域,该模型定义了四个成熟度步骤,并指出了从基础状态发展到高级状态所需采取的行动。将 MM 应用于 18 个临床中心,描述了意大利中心在引入 CAR-T 细胞疗法方面的成熟度水平。

展开英文摘要原文

The START CAR-T project was initiated to investigate the potential of a MM in the setting of CAR T-cell therapy. Four Italian clinics participated in the creation of a dedicated MM. Following the development and test of this MM, its validity and generalizability were further tested with a questionnaire submitted to 18 Italian centers.

The START CAR-T MM assessed the maturity level of clinical sites, with a focus on organization, process, and digital support. For each area, the model defined four maturity steps, and indicated the actions required to evolve from a basic to an advanced status. The application of the MM to 18 clinical sites provided a description of the maturity level of Italian centers with regard to the introduction of CAR T-cell therapy.

The START CAR-T MM appears to be a useful and widely applicable tool. It may help centers optimize many aspects of CAR T-cell therapy and improve patient access to this novel treatment option.

论文信息

作者
Bramanti S、Carrabba MG、Di Rocco A、Fabris E、Gastaldi L、Locatelli P、Tisi MC
第一作者单位
BMT Unit, IRCCS Humanitas Research Hospital, Rozzano - Italy.Italy
通讯作者单位
Cell Therapy and Hematology, San Bortolo Hospital, Vicenza - Italy.Italy
期刊
Global & regional health technology assessment2022 Jan-Dec
原文标识
PubMed 36628303 · DOI 10.33393/grhta.2022.2340