患者在肾脏精准医学项目中对研究用肾脏活检协议的体验。

Participant Experience with Protocol Research Kidney Biopsies in the Kidney Precision Medicine Project.

机构信息

Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, Connecticut.

Division of Nephrology, School of Medicine, Johns Hopkins University, Baltimore, Maryland.

出版信息

Clin J Am Soc Nephrol. 2024 Feb 1;19(2):202-212. doi: 10.2215/CJN.0000000000000334. Epub 2023 Oct 23.

DOI:10.2215/CJN.0000000000000334

PMID:37871973

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10861112/

Abstract

BACKGROUND

Kidney biopsies are procedures commonly performed in clinical nephrology and are increasingly used in research. In this study, we aimed to evaluate the experiences of participants who underwent research kidney biopsies in the Kidney Precision Medicine Project (KPMP).

METHODS

KPMP research participants with AKI or CKD were enrolled at nine recruitment sites in the United States between September 2019 and January 2023. At 28 days postbiopsy, participants were invited to complete a survey to share their experiences, including motivation to participate in research, comprehension of informed consent, pain and anxiety during and after the biopsy procedure, overall satisfaction with KPMP participation, and effect of the study on their lives. The survey was developed in collaboration with the KPMP Community Engagement Committee and the Institute of Translational Health Sciences at the University of Washington.

RESULTS

One hundred and eleven participants completed the survey, 23 enrolled for AKI and 88 for CKD. The median age was 61 (interquartile range [IQR], 48-67) years, 43% were women, 28% were Black, and 18% were of Hispanic ethnicity. Survey respondents most commonly joined KPMP to help future patients (59%). The consent form was understood by 99%, and 97% recognized their important role in this study. Pain during the biopsy was reported by 50%, at a median level of 1 (IQR, 0-3) on a 0-10 scale. Anxiety during the biopsy was described by 64% at a median level of 3 (IQR, 1-5) on a 0-10 scale. More than half conveyed that KPMP participation had an effect on their diet, physical activity, and how they think about kidney disease.

CONCLUSIONS

KPMP survey respondents were most commonly motivated to participate in research protocol kidney biopsies by altruism, with excellent understanding of the informed consent process.

PODCAST

This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_11_20_CJN0000000000000334.mp3This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_11_20_Spanish_CJN00000000.mp3.

摘要

背景

肾脏活检是临床肾脏病学中常见的程序，并且在研究中越来越多地使用。在这项研究中，我们旨在评估参与肾脏精准医学计划（KPMP）研究性肾脏活检的参与者的经验。

方法

2019 年 9 月至 2023 年 1 月，在美国的九个招募地点招募了 AKI 或 CKD 的 KPMP 研究参与者。在活检后 28 天，邀请参与者完成一项调查，以分享他们的经验，包括参与研究的动机、对知情同意书的理解、活检过程中和之后的疼痛和焦虑、对 KPMP 参与的总体满意度，以及研究对他们生活的影响。该调查是与 KPMP 社区参与委员会和华盛顿大学转化健康科学研究所合作开发的。

结果

111 名参与者完成了调查，23 名参与者因 AKI 而参与，88 名参与者因 CKD 而参与。中位年龄为 61（四分位距[IQR]，48-67）岁，43%为女性，28%为黑人，18%为西班牙裔。调查受访者最常见的加入 KPMP 是为了帮助未来的患者（59%）。知情同意书被 99%的人理解，97%的人认识到他们在这项研究中的重要作用。50%的人报告活检时有疼痛，疼痛程度中位数为 1（IQR，0-3），在 0-10 刻度上。64%的人描述活检时焦虑，焦虑程度中位数为 3（IQR，1-5），在 0-10 刻度上。超过一半的人表示，KPMP 的参与对他们的饮食、体育活动和他们对肾脏疾病的看法产生了影响。