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Evaluating treatments in health care: The instability of a one-legged stool

BACKGROUND: Both scientists and the public routinely refer to randomized controlled trials (RCTs) as being the 'gold standard' of scientific evidence. Although there is no question that placebo-controlled RCTs play a significant role in the evaluation of new pharmaceutical treatments, espe...

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Autores principales: Kaplan, Bonnie J, Giesbrecht, Gerald, Shannon, Scott, McLeod, Kevin
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103483/
https://www.ncbi.nlm.nih.gov/pubmed/21569350
http://dx.doi.org/10.1186/1471-2288-11-65
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author Kaplan, Bonnie J
Giesbrecht, Gerald
Shannon, Scott
McLeod, Kevin
author_facet Kaplan, Bonnie J
Giesbrecht, Gerald
Shannon, Scott
McLeod, Kevin
author_sort Kaplan, Bonnie J
collection PubMed
description BACKGROUND: Both scientists and the public routinely refer to randomized controlled trials (RCTs) as being the 'gold standard' of scientific evidence. Although there is no question that placebo-controlled RCTs play a significant role in the evaluation of new pharmaceutical treatments, especially when it is important to rule out placebo effects, they have many inherent limitations which constrain their ability to inform medical decision making. The purpose of this paper is to raise questions about over-reliance on RCTs and to point out an additional perspective for evaluating healthcare evidence, as embodied in the Hill criteria. The arguments presented here are generally relevant to all areas of health care, though mental health applications provide the primary context for this essay. DISCUSSION: This article first traces the history of RCTs, and then evaluates five of their major limitations: they often lack external validity, they have the potential for increasing health risk in the general population, they are no less likely to overestimate treatment effects than many other methods, they make a relatively weak contribution to clinical practice, and they are excessively expensive (leading to several additional vulnerabilities in the quality of evidence produced). Next, the nine Hill criteria are presented and discussed as a richer approach to the evaluation of health care treatments. Reliance on these multi-faceted criteria requires more analytical thinking than simply examining RCT data, but will also enhance confidence in the evaluation of novel treatments. SUMMARY: Excessive reliance on RCTs tends to stifle funding of other types of research, and publication of other forms of evidence. We call upon our research and clinical colleagues to consider additional methods of evaluating data, such as the Hill criteria. Over-reliance on RCTs is similar to resting all of health care evidence on a one-legged stool.
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spelling pubmed-31034832011-05-28 Evaluating treatments in health care: The instability of a one-legged stool Kaplan, Bonnie J Giesbrecht, Gerald Shannon, Scott McLeod, Kevin BMC Med Res Methodol Debate BACKGROUND: Both scientists and the public routinely refer to randomized controlled trials (RCTs) as being the 'gold standard' of scientific evidence. Although there is no question that placebo-controlled RCTs play a significant role in the evaluation of new pharmaceutical treatments, especially when it is important to rule out placebo effects, they have many inherent limitations which constrain their ability to inform medical decision making. The purpose of this paper is to raise questions about over-reliance on RCTs and to point out an additional perspective for evaluating healthcare evidence, as embodied in the Hill criteria. The arguments presented here are generally relevant to all areas of health care, though mental health applications provide the primary context for this essay. DISCUSSION: This article first traces the history of RCTs, and then evaluates five of their major limitations: they often lack external validity, they have the potential for increasing health risk in the general population, they are no less likely to overestimate treatment effects than many other methods, they make a relatively weak contribution to clinical practice, and they are excessively expensive (leading to several additional vulnerabilities in the quality of evidence produced). Next, the nine Hill criteria are presented and discussed as a richer approach to the evaluation of health care treatments. Reliance on these multi-faceted criteria requires more analytical thinking than simply examining RCT data, but will also enhance confidence in the evaluation of novel treatments. SUMMARY: Excessive reliance on RCTs tends to stifle funding of other types of research, and publication of other forms of evidence. We call upon our research and clinical colleagues to consider additional methods of evaluating data, such as the Hill criteria. Over-reliance on RCTs is similar to resting all of health care evidence on a one-legged stool. BioMed Central 2011-05-11 /pmc/articles/PMC3103483/ /pubmed/21569350 http://dx.doi.org/10.1186/1471-2288-11-65 Text en Copyright ©2011 Kaplan et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Debate
Kaplan, Bonnie J
Giesbrecht, Gerald
Shannon, Scott
McLeod, Kevin
Evaluating treatments in health care: The instability of a one-legged stool
title Evaluating treatments in health care: The instability of a one-legged stool
title_full Evaluating treatments in health care: The instability of a one-legged stool
title_fullStr Evaluating treatments in health care: The instability of a one-legged stool
title_full_unstemmed Evaluating treatments in health care: The instability of a one-legged stool
title_short Evaluating treatments in health care: The instability of a one-legged stool
title_sort evaluating treatments in health care: the instability of a one-legged stool
topic Debate
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103483/
https://www.ncbi.nlm.nih.gov/pubmed/21569350
http://dx.doi.org/10.1186/1471-2288-11-65
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