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巴西透析中心的多中心研究:SARC-HD研究的招募与实施

Multicenter research in dialysis centers in Brazil: recruitment and implementation of the SARC-HD study.

作者信息

Duarte Marvery P, Nóbrega Otávio T, Vogt Barbara P, Vieira Fábio A, Mondini Dário R, Silva Maryanne Z C, Disessa Henrique S, Krug Rodrigo R, Sant'Helena Bruna R M, Bundchen Daiana C, Bohlke Maristela, Adamoli Angélica N, Uchida Marco C, Avesani Carla M, Reboredo Maycon M, Ribeiro Heitor S

机构信息

Universidade de Brasília, Faculdade de Ciências da Saúde, Brasília, DF, Brazil.

Universidade Federal de Uberlândia, Faculdade de Medicina, Programa de Pós-Graduação em Ciências da Saúde, Uberlândia, MG, Brazil.

出版信息

J Bras Nefrol. 2025 Jan-Mar;47(1):e20240009. doi: 10.1590/2175-8239-JBN-2024-0009en.

Abstract

INTRODUCTION

Multicenter research initiatives in Brazilian dialysis centers are scarce. We described the recruitment and implementation phases of the SARC-HD study, aimed at investigating sarcopenia and its impact on adverse clinical outcomes.

METHODS

The SARC-HD is a cohort study being conducted with patients on hemodialysis in Brazil. The recruitment phase was defined as the period from the invitation to the center until the start of patient enrollment, whereas the implementation phase lasted from then until the completion of enrollment and baseline data collection. Upon implementation, a structured questionnaire was distributed to collect feedback from principal investigators.

RESULTS

21 centers from three Brazilian regions consented to participate, with two dropping out. Ten principal investigators oversaw the 19 sites. Nine centers (47%) were funded entirely by health insurance companies. A total of 1525 patients were screened for eligibility and 1008 were enrolled, with a 66.1% recruitment rate. Recruitment and baseline data collection took 12 [interquartile range: 5-15] weeks. Qualitative content analysis identified barriers such as a lack of infrastructure and logistics for research. Facilitators included the management and organization of the steering committee. Data collection challenges were mainly reported with the subjective 7-point global assessment and the international physical activity questionnaire. The main challenge for the ongoing maintenance phase will be the lack of standardized information in electronic health records.

CONCLUSIONS

The recruitment and implementation phases of the multicenter SARC-HD study were feasible. Barriers and facilitators identified by principal investigators may help future multicenter initiatives to integrate research-related tasks into clinical routine, facilitating successful experiences.

摘要

引言

巴西透析中心的多中心研究项目较少。我们描述了SARC-HD研究的招募和实施阶段,该研究旨在调查肌肉减少症及其对不良临床结局的影响。

方法

SARC-HD是一项针对巴西血液透析患者的队列研究。招募阶段定义为从向中心发出邀请到开始患者入组的时间段,而实施阶段从那时起持续到入组完成和基线数据收集结束。在实施过程中,分发了一份结构化问卷以收集主要研究者的反馈。

结果

来自巴西三个地区的21个中心同意参与,其中两个退出。十位主要研究者负责这19个研究点。九个中心(47%)完全由保险公司资助。总共筛选了1525名患者的资格,1008名患者入组,招募率为66.1%。招募和基线数据收集耗时12周[四分位间距:5-15周]。定性内容分析确定了一些障碍,如缺乏研究基础设施和后勤保障。促进因素包括指导委员会的管理和组织。数据收集方面的挑战主要报告在主观的7分总体评估和国际体力活动问卷方面。正在进行的维持阶段的主要挑战将是电子健康记录中缺乏标准化信息。

结论

多中心SARC-HD研究的招募和实施阶段是可行的。主要研究者确定的障碍和促进因素可能有助于未来的多中心项目将与研究相关的任务融入临床常规,促成成功经验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dec1/11755877/f3cbf84a1aa5/2175-8239-jbn-47-1-e20240009-gf01.jpg

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