Standardizing Quality Assessment of Observational Studies for Decision Making in Health Care

Brixner, Diana

doi:10.18553/jmcp.2009.15.3.275

Cited by 17 publications

(10 citation statements)

References 38 publications

(56 reference statements)

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“…4 Critics of such studies also worry that the RWE literature is biased because of "data dredging" (ie, conducting multiple analyses until one provides the hoped-for result) and selective publication (ie, journals' preference for publishing positive results). [5][6][7][8] As a first step toward addressing these concerns, the 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.…”

mentioning

confidence: 99%

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

Berger¹,

Sox

Willke³

et al. 2017

Value in Health

316

239

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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. KEYWORDScomparative effectiveness, decision making, guidelines, pharmacoepidemiology, real-world data, treatment effectivenessThis 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.

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confidence: 99%

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

Berger¹,

Sox

Willke³

et al. 2017

Value in Health

316

239

View full text Add to dashboard Cite

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“…5 ISPOR established a Real-World Data Task Force and conducted a series of round-table discussions. [6][7][8] The discussions on training and education focused on the use of a quality assessment tool for RWR studies. Similar to our findings, the workshop suggested a web-based model to accommodate an audience with varied knowledge levels.…”

Section: Discussionmentioning

confidence: 99%

Survey of Real-World Research Workforce, Training, and Education: Report from the DIA Real-World Outcomes Task Force

Gliklich

Glennie²,

Mattox

et al. 2012

Drug Information J

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The demand for real-world research (RWR) from many stakeholders has resulted in an increasing need for well-trained professionals who understand how to perform and evaluate RWR and to interpret the results of such data. The Drug Information Association (DIA) Real World Outcomes Task Force (RWOTF) developed a survey to explore North American workforce and training needs in RWR for DIA's constituencies. The primary goals of the project were to assess current and future capacity to perform and interpret real-world outcome studies and identify the educational needs and the potential role of DIA in the RWR arena. The survey confirmed that the use of RWR is growing, and identified key barriers to using RWR. Organizational needs for RWR are increasing and a well-trained workforce to perform or use RWR is critical. However, the current workforce is not considered sufficient and there appear to be significant gaps in available training programs. There are clear opportunities for organizations like DIA to help meet the demand for training and education.

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“…To reduce this risk, measurement of the unmet informational needs of managed care decision makers is essential to establish a base of evidence before "promoting the utilization of real-world data." 5 …”

Section: Our Continued Plea For Transparencymentioning

confidence: 99%

“…The body would "be formed as a consortium of experts giving access to a broad range of resources and expertise for an audit, review, or quality certification process." 5 We wonder how such a group would differ from the available pool of journal peer reviewers who, as experts in particular topic areas, are already tasked with screening the quality of research articles. Certainly, any consortium of experts would be faced with, and challenged by, the same lack of transparency in research reporting that has by now become infamous among journal peer reviewers, editors, and methodologists.…”

mentioning

confidence: 99%

“…A second key proposal advanced by the roundtable participants was a "process to achieve dissemination and acceptance of an assessment tool," essentially a public information campaign that would "increase public awareness of the need for quality assessment of observational evidence and subsequently, the acceptance of observational studies meeting defined quality standards to be used in the decision-making process." 5 The window of opportunity for public dissemination of this information appears to be open-but only by the slightest crack. Deficiencies in the research literature have been publicly acknowledged for about 15 years, and EQUATOR standards have been adopted by a wide variety of journals, including Annals of Internal Medicine, BMJ, JAMA, PLoS Medicine, the Journal of Clinical Epidemiology, and others.…”

mentioning

confidence: 99%

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Selling Real-World Health Care Research to Reluctant Buyers-Evidence-Based Education or Marketing a Defective Product?

Fairman¹,

Curtiss²

2009

JMCP

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Standardizing Quality Assessment of Observational Studies for Decision Making in Health Care

Cited by 17 publications

References 38 publications

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

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

Survey of Real-World Research Workforce, Training, and Education: Report from the DIA Real-World Outcomes Task Force

Selling Real-World Health Care Research to Reluctant Buyers-Evidence-Based Education or Marketing a Defective Product?

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