Comparative effectiveness research: what to do when experts disagree about risks

Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research....
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Gespeichert in:

Autor*in:	Lie, Reidar K. [verfasserIn] Chan, Francis K.L. Grady, Christine Ng, Vincent H. Wendler, David

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Standard of care Research ethics Risk judgments Research ethics review Equipoise

Anmerkung:	© The Author(s). 2017

Übergeordnetes Werk:	Enthalten in: BMC medical ethics - London : BioMed Central, 2000, 18(2017), 1 vom: 19. Juni
Übergeordnetes Werk:	volume:18 ; year:2017 ; number:1 ; day:19 ; month:06

Links:	Volltext

DOI / URN:	10.1186/s12910-017-0202-0

Katalog-ID:	SPR028198344

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520			\|a Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation.
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allfields	10.1186/s12910-017-0202-0 doi (DE-627)SPR028198344 (SPR)s12910-017-0202-0-e DE-627 ger DE-627 rakwb eng Lie, Reidar K. verfasserin (orcid)0000-0002-5734-5777 aut Comparative effectiveness research: what to do when experts disagree about risks 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. Standard of care (dpeaa)DE-He213 Research ethics (dpeaa)DE-He213 Risk judgments (dpeaa)DE-He213 Research ethics review (dpeaa)DE-He213 Equipoise (dpeaa)DE-He213 Chan, Francis K.L. aut Grady, Christine aut Ng, Vincent H. aut Wendler, David aut Enthalten in BMC medical ethics London : BioMed Central, 2000 18(2017), 1 vom: 19. Juni (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:18 year:2017 number:1 day:19 month:06 https://dx.doi.org/10.1186/s12910-017-0202-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 19 06
spelling	10.1186/s12910-017-0202-0 doi (DE-627)SPR028198344 (SPR)s12910-017-0202-0-e DE-627 ger DE-627 rakwb eng Lie, Reidar K. verfasserin (orcid)0000-0002-5734-5777 aut Comparative effectiveness research: what to do when experts disagree about risks 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. Standard of care (dpeaa)DE-He213 Research ethics (dpeaa)DE-He213 Risk judgments (dpeaa)DE-He213 Research ethics review (dpeaa)DE-He213 Equipoise (dpeaa)DE-He213 Chan, Francis K.L. aut Grady, Christine aut Ng, Vincent H. aut Wendler, David aut Enthalten in BMC medical ethics London : BioMed Central, 2000 18(2017), 1 vom: 19. Juni (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:18 year:2017 number:1 day:19 month:06 https://dx.doi.org/10.1186/s12910-017-0202-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 19 06
allfields_unstemmed	10.1186/s12910-017-0202-0 doi (DE-627)SPR028198344 (SPR)s12910-017-0202-0-e DE-627 ger DE-627 rakwb eng Lie, Reidar K. verfasserin (orcid)0000-0002-5734-5777 aut Comparative effectiveness research: what to do when experts disagree about risks 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. Standard of care (dpeaa)DE-He213 Research ethics (dpeaa)DE-He213 Risk judgments (dpeaa)DE-He213 Research ethics review (dpeaa)DE-He213 Equipoise (dpeaa)DE-He213 Chan, Francis K.L. aut Grady, Christine aut Ng, Vincent H. aut Wendler, David aut Enthalten in BMC medical ethics London : BioMed Central, 2000 18(2017), 1 vom: 19. Juni (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:18 year:2017 number:1 day:19 month:06 https://dx.doi.org/10.1186/s12910-017-0202-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 19 06
allfieldsGer	10.1186/s12910-017-0202-0 doi (DE-627)SPR028198344 (SPR)s12910-017-0202-0-e DE-627 ger DE-627 rakwb eng Lie, Reidar K. verfasserin (orcid)0000-0002-5734-5777 aut Comparative effectiveness research: what to do when experts disagree about risks 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. Standard of care (dpeaa)DE-He213 Research ethics (dpeaa)DE-He213 Risk judgments (dpeaa)DE-He213 Research ethics review (dpeaa)DE-He213 Equipoise (dpeaa)DE-He213 Chan, Francis K.L. aut Grady, Christine aut Ng, Vincent H. aut Wendler, David aut Enthalten in BMC medical ethics London : BioMed Central, 2000 18(2017), 1 vom: 19. Juni (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:18 year:2017 number:1 day:19 month:06 https://dx.doi.org/10.1186/s12910-017-0202-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 19 06
allfieldsSound	10.1186/s12910-017-0202-0 doi (DE-627)SPR028198344 (SPR)s12910-017-0202-0-e DE-627 ger DE-627 rakwb eng Lie, Reidar K. verfasserin (orcid)0000-0002-5734-5777 aut Comparative effectiveness research: what to do when experts disagree about risks 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. Standard of care (dpeaa)DE-He213 Research ethics (dpeaa)DE-He213 Risk judgments (dpeaa)DE-He213 Research ethics review (dpeaa)DE-He213 Equipoise (dpeaa)DE-He213 Chan, Francis K.L. aut Grady, Christine aut Ng, Vincent H. aut Wendler, David aut Enthalten in BMC medical ethics London : BioMed Central, 2000 18(2017), 1 vom: 19. Juni (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:18 year:2017 number:1 day:19 month:06 https://dx.doi.org/10.1186/s12910-017-0202-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 19 06
language	English
source	Enthalten in BMC medical ethics 18(2017), 1 vom: 19. Juni volume:18 year:2017 number:1 day:19 month:06
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title	Comparative effectiveness research: what to do when experts disagree about risks
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title_sort	comparative effectiveness research: what to do when experts disagree about risks
title_auth	Comparative effectiveness research: what to do when experts disagree about risks
abstract	Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. © The Author(s). 2017
abstractGer	Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. © The Author(s). 2017
abstract_unstemmed	Background Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. Main text We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative(s). We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. © The Author(s). 2017
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