Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors.
Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors.
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DOI：
10.1186/2046-4053-2-75
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发表时间：
2013-09-13
影响因子：
3.7
通讯作者：
Brug J
中科院分区：
文献类型：
--
作者：
Buffart LM;Kalter J;Chinapaw MJ;Heymans MW;Aaronson NK;Courneya KS;Jacobsen PB;Newton RU;Verdonck-de Leeuw IM;Brug J
改善癌症幸存者生活质量的有效干预措施至关重要。许多随机对照试验评估了身体活动或心理社会干预对癌症幸存者健康相关生活质量的影响，通常样本量较小，影响不大。更有针对性的干预措施可能会产生更大的效果。为了实现这种有针对性的干预，我们必须确定哪些干预措施目前适用于哪些患者，以及潜在的机制是什么（即身体活动和心理干预的调节者和调解者）。个体患者数据荟萃分析被描述为系统综述方法学的“金标准”。而不是从研究报告或作者那里提取汇总数据，直接从研究人员那里获得原始研究数据。个体患者数据荟萃分析允许对干预效应和此类效应的调节剂进行充分的统计分析。在这里，我们报告的基本原理和设计的预测最佳癌症康复和支持性护理（POLARIS）联盟。POLARIS的主要目的是：1）基于个体患者数据进行荟萃分析，以评价体力活动和心理社会干预对癌症幸存者健康相关生活质量的影响; 2）确定影响的重要人口统计学、临床、个人或干预相关调节因素;以及3）建立和验证临床预测模型，以识别干预成功的最相关预测因素。我们将邀请随机对照试验的研究人员加入POLARIS联盟，并分享他们的数据，用于解决拟议目标的汇总分析，这些试验旨在评估体力活动和/或心理社会干预对成年癌症幸存者健康相关生活质量的影响，并与等待名单，常规护理或注意力对照组进行比较。我们正在通过四个数据库中的文献检索确定合格的随机对照试验。到目前为止，我们已经确定了132个合格的和独特的试验。POLARIS联盟将进行第一次个体患者数据荟萃分析，以生成针对个体幸存者的特征、能力和偏好的体力活动和心理社会计划所必需的证据。PROSPERO：国际前瞻性系统综述注册中心，CRD 42013003805
Effective interventions to improve quality of life of cancer survivors are essential. Numerous randomized controlled trials have evaluated the effects of physical activity or psychosocial interventions on health-related quality of life of cancer survivors, with generally small sample sizes and modest effects. Better targeted interventions may result in larger effects. To realize such targeted interventions, we must determine which interventions that are presently available work for which patients, and what the underlying mechanisms are (that is, the moderators and mediators of physical activity and psychosocial interventions). Individual patient data meta-analysis has been described as the ‘gold standard’ of systematic review methodology. Instead of extracting aggregate data from study reports or from authors, the original research data are sought directly from the investigators. Individual patient data meta-analyses allow for adequate statistical analysis of intervention effects and moderators of such effects. Here, we report the rationale and design of the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) Consortium. The primary aim of POLARIS is 1) to conduct meta-analyses based on individual patient data to evaluate the effect of physical activity and psychosocial interventions on the health-related quality of life of cancer survivors; 2) to identify important demographic, clinical, personal, or intervention-related moderators of the effect; and 3) to build and validate clinical prediction models identifying the most relevant predictors of intervention success. We will invite investigators of randomized controlled trials that evaluate the effects of physical activity and/or psychosocial interventions on health-related quality of life compared with a wait-list, usual care or attention control group among adult cancer survivors to join the POLARIS consortium and share their data for use in pooled analyses that will address the proposed aims. We are in the process of identifying eligible randomized controlled trials through literature searches in four databases. To date, we have identified 132 eligible and unique trials. The POLARIS consortium will conduct the first individual patient data meta-analyses in order to generate evidence essential to targeting physical activity and psychosocial programs to the individual survivor’s characteristics, capabilities, and preferences. PROSPERO: International prospective register of systematic reviews, CRD42013003805