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The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization

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Harvard

Nordon, C, Karcher, H, Groenwold, RHH, Ankarfeldt, MZ, Pichler, F, Chevrou-Severac, H, Rossignol, M, Abbe, A, Abenhaim, L & GetReal consortium 2016, 'The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization', Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, bind 19, nr. 1, s. 75-81. https://doi.org/10.1016/j.jval.2015.09.2938

APA

Nordon, C., Karcher, H., Groenwold, R. H. H., Ankarfeldt, M. Z., Pichler, F., Chevrou-Severac, H., Rossignol, M., Abbe, A., Abenhaim, L., & GetReal consortium (2016). The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 19(1), 75-81. https://doi.org/10.1016/j.jval.2015.09.2938

CBE

MLA

Vancouver

Author

Nordon, Clementine ; Karcher, Helene ; Groenwold, Rolf H H ; Ankarfeldt, Mikkel Zöllner ; Pichler, Franz ; Chevrou-Severac, Helene ; Rossignol, Michel ; Abbe, Adeline ; Abenhaim, Lucien ; GetReal consortium. / The "Efficacy-Effectiveness Gap" : Historical Background and Current Conceptualization. I: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2016 ; Bind 19, Nr. 1. s. 75-81.

Bibtex

@article{68722a02ad1247638f59b227642deab5,
title = "The {"}Efficacy-Effectiveness Gap{"}: Historical Background and Current Conceptualization",
abstract = "BACKGROUND: The concept of the {"}efficacy-effectiveness gap{"} (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.OBJECTIVES: The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG.METHODS: A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different {"}paradigms{"} was performed by simple inductive analysis of the documents' content.RESULTS: The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors.CONCLUSIONS: The third paradigm provides an opportunity to look beyond any dichotomy between {"}standardized{"} versus {"}real-life{"} characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness.",
keywords = "Clinical Trials as Topic, Drug Therapy, Health Knowledge, Attitudes, Practice, Humans, Product Surveillance, Postmarketing, Treatment Outcome, Journal Article, Research Support, Non-U.S. Gov't",
author = "Clementine Nordon and Helene Karcher and Groenwold, {Rolf H H} and Ankarfeldt, {Mikkel Z{\"o}llner} and Franz Pichler and Helene Chevrou-Severac and Michel Rossignol and Adeline Abbe and Lucien Abenhaim and {GetReal consortium}",
note = "Copyright {\textcopyright} 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.",
year = "2016",
month = jan,
doi = "10.1016/j.jval.2015.09.2938",
language = "English",
volume = "19",
pages = "75--81",
journal = "Value in Health",
issn = "1098-3015",
publisher = "Wiley-Blackwell Publishing, Inc",
number = "1",

}

RIS

TY - JOUR

T1 - The "Efficacy-Effectiveness Gap"

T2 - Historical Background and Current Conceptualization

AU - Nordon, Clementine

AU - Karcher, Helene

AU - Groenwold, Rolf H H

AU - Ankarfeldt, Mikkel Zöllner

AU - Pichler, Franz

AU - Chevrou-Severac, Helene

AU - Rossignol, Michel

AU - Abbe, Adeline

AU - Abenhaim, Lucien

AU - GetReal consortium

N1 - Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

PY - 2016/1

Y1 - 2016/1

N2 - BACKGROUND: The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.OBJECTIVES: The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG.METHODS: A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different "paradigms" was performed by simple inductive analysis of the documents' content.RESULTS: The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors.CONCLUSIONS: The third paradigm provides an opportunity to look beyond any dichotomy between "standardized" versus "real-life" characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness.

AB - BACKGROUND: The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions.OBJECTIVES: The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG.METHODS: A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different "paradigms" was performed by simple inductive analysis of the documents' content.RESULTS: The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors.CONCLUSIONS: The third paradigm provides an opportunity to look beyond any dichotomy between "standardized" versus "real-life" characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness.

KW - Clinical Trials as Topic

KW - Drug Therapy

KW - Health Knowledge, Attitudes, Practice

KW - Humans

KW - Product Surveillance, Postmarketing

KW - Treatment Outcome

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.jval.2015.09.2938

DO - 10.1016/j.jval.2015.09.2938

M3 - Journal article

C2 - 26797239

VL - 19

SP - 75

EP - 81

JO - Value in Health

JF - Value in Health

SN - 1098-3015

IS - 1

ER -

ID: 49778694