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      Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making

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          Abstract

          Purpose

          Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making.

          Methods

          The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus‐building iterative process for the topics and framing of recommendations.

          Results

          The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making.

          Conclusion

          The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

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          Most cited references 38

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          An Agenda for Purely Confirmatory Research.

          The veracity of substantive research claims hinges on the way experimental data are collected and analyzed. In this article, we discuss an uncomfortable fact that threatens the core of psychology's academic enterprise: almost without exception, psychologists do not commit themselves to a method of data analysis before they see the actual data. It then becomes tempting to fine tune the analysis to the data in order to obtain a desired result-a procedure that invalidates the interpretation of the common statistical tests. The extent of the fine tuning varies widely across experiments and experimenters but is almost impossible for reviewers and readers to gauge. To remedy the situation, we propose that researchers preregister their studies and indicate in advance the analyses they intend to conduct. Only these analyses deserve the label "confirmatory," and only for these analyses are the common statistical tests valid. Other analyses can be carried out but these should be labeled "exploratory." We illustrate our proposal with a confirmatory replication attempt of a study on extrasensory perception.
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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement

              Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.
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                Author and article information

                Contributors
                mlberger301@gmail.com
                Journal
                Pharmacoepidemiol Drug Saf
                Pharmacoepidemiol Drug Saf
                10.1002/(ISSN)1099-1557
                PDS
                Pharmacoepidemiology and Drug Safety
                John Wiley and Sons Inc. (Hoboken )
                1053-8569
                1099-1557
                15 September 2017
                September 2017
                : 26
                : 9 ( doiID: 10.1002/pds.v26.9 )
                : 1033-1039
                Affiliations
                [ 1 ] New York City NY USA
                [ 2 ] Patient‐Centered Outcomes Research Institute Washington DC USA
                [ 3 ] International Society for Pharmacoeconomics and Outcomes Research Lawrenceville NJ USA
                [ 4 ] University of Utah Salt Lake City UT USA
                [ 5 ] European Medicines Agency London UK
                [ 6 ] Zorginstituut Nederland and University of Utrecht Utrecht The Netherlands
                [ 7 ] Columbia University New York City NY USA
                [ 8 ] Brigham and Women's Hospital Harvard Medical School Boston MA USA
                [ 9 ] Bocconi University Milan Italy
                [ 10 ] Premera Blue Cross Mountlake Terrace WA USA
                [ 11 ] University of Maryland Baltimore MD USA
                Author notes
                [* ] Correspondence

                M. L. Berger, New York, NY, USA.

                Email: mlberger301@ 123456gmail.com

                Article
                PDS4297 PDS-17-0311.R1
                10.1002/pds.4297
                5639372
                28913966
                © 2017 The Authors. Pharmacoepidemiology & Drug Safety published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Figures: 1, Tables: 0, Pages: 7, Words: 3938
                Product
                Categories
                Original Report
                Original Reports
                Custom metadata
                2.0
                pds4297
                September 2017
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.2.1 mode:remove_FC converted:13.10.2017

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