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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Date
2022
Authors
Wang, S.V.
Pottegård, A.
Crown, W.
Arlett, P.
Ashcroft, D.M.
Benchimol, E.I.
Berger, M.L.
Crane, G.
Goettsch, W.
Hua, W.
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Journal article
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Value in Health, 2022; 25(10):1663-1672
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Abstract
<h4>Objectives</h4>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.<h4>Methods</h4>The International Society for Pharmacoepidemiology (ISPE) and ISPOR-The Professional Society for Health Economics 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 over-arching 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.<h4>Strategies to disseminate and facilitate use</h4>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.<h4>Conclusion</h4>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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Data source: Supplementary data, https://doi.org/10.1016/j.jval.2022.09.001
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Copyright 2022 the Author(s). Elsevier Ltd and International Society for Pharmacoeconomics and Outcomes Research, Inc. and Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. This article is published under the Creative Commons CC-BY license.