随机对照试验 CardioCare MV 的统计分析计划，该试验旨在研究一种新型综合护理概念（NICC）用于患有慢性心血管疾病的患者。

Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease.

机构信息

StatSol, Moenring 2, 23560, Lübeck, Germany.

School of Mathematics, Statistics and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa.

出版信息

Trials. 2020 Feb 3;21(1):131. doi: 10.1186/s13063-020-4052-6.

DOI:10.1186/s13063-020-4052-6

PMID:32014033

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6998105/

Abstract

BACKGROUND

Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertension, we have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a care center, including a call center, an integrated care network including inpatient and outpatient care providers and guideline therapy for patients (Schmidt et al. 2018 Trials 19:120). Here, we describe challenges and solutions in patient recruitment and provide the statistical analysis plan.

METHODS

The study CardioCare MV is a prospective, randomized, controlled, parallel-group, open-label, bi-center trial with two groups for comparing NICC with standard of care (SoC). Because of issues with patient enrollment we adapted the study plan after consultation with the Ethics Committee and the funding agency. We altered the analysis strategy for the primary endpoints, which led to a change in the required sample size. We also changed the access points to patients from inpatient hospitals specialized in the treatment of patients with cardiovascular disease to specialized practices.

RESULTS

Recruitment of patients started on 1 December 2017, and first patient in was on 4 December 2017. Recruitment was completed on 15 August 2019 as planned according to the amended study plan. The follow-up period will end in August 2020. A total of 964 patients was enrolled into the trial. The statistical analysis plan was finalized prior to last patient in. Results will be available by the end of 2020.

DISCUSSION

The trial will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a round-the-clock call center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. The trial will guide additional research to disentangle the effects of this complex intervention.

TRIAL REGISTRATION

DRKS, ID: DRKS00013124. Registered on 5 October 2017 ClinicalTrials.gov, ID: NCT03317951. Registered on 17 October 2017.

摘要

背景

心血管疾病是全球范围内主要的死亡原因，也是医疗保健系统的主要经济负担。对于心力衰竭、心房颤动或治疗抵抗性高血压的患者，我们开发了一种新的综合护理概念（NICC），它结合了远程医疗和护理中心的强化支持，包括呼叫中心、包括住院和门诊提供者的综合护理网络以及为患者提供的指南治疗（Schmidt 等人，2018 年试验 19：120）。在这里，我们描述了患者招募中的挑战和解决方案，并提供了统计分析计划。

方法

研究 CardioCare MV 是一项前瞻性、随机、对照、平行组、开放标签、双中心试验，有两组比较 NICC 与标准护理（SoC）。由于患者入组问题，我们在与伦理委员会和资助机构协商后修改了研究计划。我们改变了主要终点的分析策略，这导致所需样本量发生变化。我们还改变了从专门治疗心血管疾病患者的住院医院到专门实践的患者的入组途径。

结果

患者招募于 2017 年 12 月 1 日开始，第一位患者于 2017 年 12 月 4 日入组。根据修订后的研究计划，招募于 2019 年 8 月 15 日按计划完成。随访期将于 2020 年 8 月结束。共有 964 名患者入组试验。在最后一名患者入组之前，统计分析计划已最终确定。结果将于 2020 年底公布。