HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
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DOI：
10.1002/pds.5507
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发表时间：
2023-01
影响因子：
2.6
通讯作者：
中科院分区：
文献类型：
--
作者：
关键研究参数沟通的模糊性限制了真实世界证据（RWE）研究在医疗决策中的效用。需要就数据来源、设计、分析和实施进行明确沟通。这将有助于独立数据的再现性、重复性和潜在偏倚来源的评估。国际药物流行病学学会（ISPE）和国际药物经济学和结局研究学会（ISPOR）召集了一个联合工作组，包括来自主要国际利益相关者的代表，为RWE研究创建一个统一的方案模板，以评估治疗效果并为决策提供信息。该模板建立在现有的提高透明度的努力基础上，并结合了最近关于实现RWE研究再现性所需的详细程度的见解。总体原则是在数据、设计、分析和实施方面达到足够的清晰度，以实现3个主要目标。第一，帮助研究者彻底考虑，然后记录他们对定义因果问题的关键研究参数（例如目标被估量）的选择和理由，第二，通过使审查者能够容易地评估与这些选择相关的偏倚的可能性来促进决策，第三，促进重现性。认识到这一统一模板的影响依赖于采用，我们概述了一项计划，在未来两年与主要国际利益攸关方一起引入和试点该模板。哈珀（HARmonized Protocol Template to Enhance Reproductivity）通过共同的文本、表格和视觉结构，帮助创建对预期科学决策的共同理解。该模板提供了一套明确和可重复的RWE研究方案的核心建议，旨在作为整个研究过程的支柱，从制定有效的研究方案到注册，再到实施和报告这些实施决策。关键研究参数沟通的模糊性限制了真实世界证据（RWE）研究在医疗决策中的效用。国际药物流行病学学会（ISPE）和国际药物经济学和结局研究学会（ISPOR）召集了一个联合工作组，为RWE研究创建一个统一的方案模板。该模板建立在现有的努力，以提高透明度，并纳入了最新的见解，所需的详细程度，使研究的重现性。首要原则是达到足够的清晰度，以实现3个主要目标。第一，帮助研究者彻底考虑，然后记录他们对定义因果问题的关键研究参数的选择和理由，第二，通过使审查者能够容易地评估与这些选择相关的偏倚的可能性来促进决策，第三，促进再现性。哈珀（HARmonized Protocol Template to Enhance Reproductivity）通过共同的文本、表格和视觉结构，帮助创建对预期科学决策的共同理解。该模板提供了一套明确和可重复的RWE研究方案的核心建议，旨在作为整个研究过程的支柱，从制定有效的研究方案到注册，再到实施和报告这些实施决策。
Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias. The International Society for Pharmacoepidemiology (ISPE) and International Society of Pharmacoeconomics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The overarching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g. target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. Recognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years. The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions. Ambiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. The International Society for Pharmacoepidemiology (ISPE) and International Society of Pharmacoeconomics and Outcomes Research (ISPOR) convened a joint task force to create a harmonized protocol template for RWE studies. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable study reproducibility. The overarching principle was to reach for sufficient clarity to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question, two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.
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影响因子：
2.6
作者：
Berger, Marc L.;Sox, Harold;Daniel Mullins, C.
通讯作者：
Daniel Mullins, C.
DOI：
10.18553/jmcp.2016.22.10.1107
发表时间：
2016-10-01
影响因子：
2.1
作者：
Dreyer, Nancy A.;Bryant, Allison;Velentgas, Priscilla
通讯作者：
Velentgas, Priscilla
影响因子：
37.8
作者：
Franklin JM;Patorno E;Desai RJ;Glynn RJ;Martin D;Quinto K;Pawar A;Bessette LG;Lee H;Garry EM;Gautam N;Schneeweiss S
通讯作者：
Schneeweiss S
影响因子：
6.7
作者：
Cocoros, Noelle M.;Arlett, Peter;Toh, Sengwee
通讯作者：
Toh, Sengwee
影响因子：
4.5
作者：
Berger, Marc L.;Martin, Bradley C.;Crown, William
通讯作者：
Crown, William