双臂血压差异与心血管疾病结局之间的关联：个体患者数据荟萃分析方案及预后算法的开发
Associations between interarm differences in blood pressure and cardiovascular disease outcomes: protocol for an individual patient data meta-analysis and development of a prognostic algorithm.
作者信息
Clark Christopher E, Boddy Kate, Warren Fiona C, Taylor Rod S, Aboyans Victor, Cloutier Lyne, McManus Richard J, Shore Angela C, Campbell John L
机构信息
Primary Care Research Group, Institute of Health Services Research, University of Exeter Medical School, Exeter, Devon, UK.
Patient and Public Involvement Team, PenCLAHRC, University of Exeter Medical School, Exeter, Devon, UK.
出版信息
BMJ Open. 2017 Jul 2;7(6):e016844. doi: 10.1136/bmjopen-2017-016844.
INTRODUCTION
Individual cohort studies in various populations and study-level meta-analyses have shown interarm differences (IAD) in blood pressure to be associated with increased cardiovascular and all-cause mortality. However, key questions remain, such as follows: (1) What is the additional contribution of IAD to prognostic risk estimation for cardiovascular and all-cause mortality? (2) What is the minimum cut-off value for IAD that defines elevated risk? (3) Is there a prognostic value of IAD and do different methods of IAD measurement impact on the prognostic value of IAD? We aim to address these questions by conducting an individual patient data (IPD) meta-analysis.
METHODS AND ANALYSIS
This study will identify prospective cohort studies that measured blood pressure in both arms during recruitment, and invite authors to contribute IPD datasets to this collaboration. All patient data received will be combined into a single dataset. Using one-stage meta-analysis, we will undertake multivariable time-to-event regression modelling, with the aim of developing a new prognostic model for cardiovascular risk estimation that includes IAD. We will explore variations in risk contribution of IAD across predefined population subgroups (eg, hypertensives, diabetics), establish the lower limit of IAD that is associated with additional cardiovascular risk and assess the impact of different methods of IAD measurement on risk prediction.
ETHICS AND DISSEMINATION
This study will not include any patient identifiable data. Included datasets will already have ethical approval and consent from their sponsors. Findings will be presented to international conferences and published in peer reviewed journals, and we have a comprehensive dissemination strategy in place with integrated patient and public involvement.
PROSPERO REGISTRATION NUMBER
CRD42015031227.
引言
在不同人群中开展的个体队列研究以及研究层面的荟萃分析均显示，双臂血压差异（IAD）与心血管疾病及全因死亡率升高相关。然而，一些关键问题依然存在，如下所示：（1）IAD对心血管疾病和全因死亡率预后风险评估的额外贡献是什么？（2）定义风险升高的IAD的最小临界值是多少？（3）IAD是否具有预后价值，不同的IAD测量方法是否会影响IAD的预后价值？我们旨在通过开展个体患者数据（IPD）荟萃分析来解决这些问题。
方法与分析
本研究将识别在招募期间测量双臂血压的前瞻性队列研究，并邀请作者为该合作贡献IPD数据集。所有收到的患者数据将合并为一个数据集。使用单阶段荟萃分析，我们将进行多变量事件发生时间回归建模，目的是开发一种新的用于心血管风险评估的预后模型，该模型纳入IAD。我们将探讨IAD在预定义人群亚组（如高血压患者、糖尿病患者）中风险贡献的差异，确定与额外心血管风险相关的IAD下限，并评估不同IAD测量方法对风险预测的影响。
伦理与传播
本研究将不包括任何可识别患者身份的数据。纳入的数据集已经获得其主办方的伦理批准和同意。研究结果将在国际会议上展示，并发表在同行评审期刊上，我们制定了全面的传播策略，纳入了患者和公众的参与。
PROSPERO注册号：CRD42015031227。
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