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Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II.
Value Health. 2009 Nov-Dec; 12(8):1053-61.VH

Abstract

OBJECTIVES

The goal of comparative effectiveness analysis is to examine the relationship between two variables, treatment, or exposure and effectiveness or outcome. Unlike data obtained through randomized controlled trials, researchers face greater challenges with causal inference with observational studies. Recognizing these challenges, a task force was formed to develop a guidance document on methodological approaches to addresses these biases.

METHODS

The task force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This report, the second of three reported in this issue of the Journal, discusses the inherent biases when using secondary data sources for comparative effectiveness analysis and provides methodological recommendations to help mitigate these biases.

RESULTS

The task force report provides recommendations and tools for researchers to mitigate threats to validity from bias and confounding in measurement of exposure and outcome. Recommendations on design of study included: the need for data analysis plan with causal diagrams; detailed attention to classification bias in definition of exposure and clinical outcome; careful and appropriate use of restriction; extreme care to identify and control for confounding factors, including time-dependent confounding.

CONCLUSIONS

Design of nonrandomized studies of comparative effectiveness face several daunting issues, including measurement of exposure and outcome challenged by misclassification and confounding. Use of causal diagrams and restriction are two techniques that can improve the theoretical basis for analyzing treatment effects in study populations of more homogeneity, with reduced loss of generalizability.

Authors+Show Affiliations

Express Scripts, St. Louis, MO, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

19744292

Citation

Cox, Emily, et al. "Good Research Practices for Comparative Effectiveness Research: Approaches to Mitigate Bias and Confounding in the Design of Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II." Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research, vol. 12, no. 8, 2009, pp. 1053-61.
Cox E, Martin BC, Van Staa T, et al. Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II. Value Health. 2009;12(8):1053-61.
Cox, E., Martin, B. C., Van Staa, T., Garbe, E., Siebert, U., & Johnson, M. L. (2009). Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II. Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research, 12(8), 1053-61. https://doi.org/10.1111/j.1524-4733.2009.00601.x
Cox E, et al. Good Research Practices for Comparative Effectiveness Research: Approaches to Mitigate Bias and Confounding in the Design of Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II. Value Health. 2009 Nov-Dec;12(8):1053-61. PubMed PMID: 19744292.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report--Part II. AU - Cox,Emily, AU - Martin,Bradley C, AU - Van Staa,Tjeerd, AU - Garbe,Edeltraut, AU - Siebert,Uwe, AU - Johnson,Michael L, Y1 - 2009/09/10/ PY - 2009/9/12/entrez PY - 2009/9/12/pubmed PY - 2010/9/21/medline SP - 1053 EP - 61 JF - Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research JO - Value Health VL - 12 IS - 8 N2 - OBJECTIVES: The goal of comparative effectiveness analysis is to examine the relationship between two variables, treatment, or exposure and effectiveness or outcome. Unlike data obtained through randomized controlled trials, researchers face greater challenges with causal inference with observational studies. Recognizing these challenges, a task force was formed to develop a guidance document on methodological approaches to addresses these biases. METHODS: The task force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This report, the second of three reported in this issue of the Journal, discusses the inherent biases when using secondary data sources for comparative effectiveness analysis and provides methodological recommendations to help mitigate these biases. RESULTS: The task force report provides recommendations and tools for researchers to mitigate threats to validity from bias and confounding in measurement of exposure and outcome. Recommendations on design of study included: the need for data analysis plan with causal diagrams; detailed attention to classification bias in definition of exposure and clinical outcome; careful and appropriate use of restriction; extreme care to identify and control for confounding factors, including time-dependent confounding. CONCLUSIONS: Design of nonrandomized studies of comparative effectiveness face several daunting issues, including measurement of exposure and outcome challenged by misclassification and confounding. Use of causal diagrams and restriction are two techniques that can improve the theoretical basis for analyzing treatment effects in study populations of more homogeneity, with reduced loss of generalizability. SN - 1524-4733 UR - https://www.unboundmedicine.com/medline/citation/19744292/Good_research_practices_for_comparative_effectiveness_research:_approaches_to_mitigate_bias_and_confounding_in_the_design_of_nonrandomized_studies_of_treatment_effects_using_secondary_data_sources:_the_International_Society_for_Pharmacoeconomics_and_Outcomes_Research_Good_Research_Practices_for_Retrospective_Database_Analysis_Task_Force_Report__Part_II_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1098-3015(10)60309-9 DB - PRIME DP - Unbound Medicine ER -