Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice

Background and Objectives In clinical trials, the relative risk or risk ratio (RR) is a mainstay of reporting of the effect magnitude for an intervention. The RR is the ratio of the probability of an outcome in an intervention group to its probability in a control group. Thus, the RR provides a meas...

وصف كامل

محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Suhail A., Doi (author)
مؤلفون آخرون: Furuya-Kanamori, Luis (author), Xu, Chang (author), Lin, Lifeng (author), Chivese, Tawanda (author), Thalib, Lukman (author)
التنسيق: article
منشور في: 2020
الموضوعات:
الوصول للمادة أونلاين:http://dx.doi.org/10.1016/j.jclinepi.2020.08.019
https://www.sciencedirect.com/science/article/pii/S0895435620311719?v=s5
http://hdl.handle.net/10576/16985
الوسوم: إضافة وسم
لا توجد وسوم, كن أول من يضع وسما على هذه التسجيلة!
_version_ 1857415085292519424
author Suhail A., Doi
author2 Furuya-Kanamori, Luis
Xu, Chang
Lin, Lifeng
Chivese, Tawanda
Thalib, Lukman
author2_role author
author
author
author
author
author_facet Suhail A., Doi
Furuya-Kanamori, Luis
Xu, Chang
Lin, Lifeng
Chivese, Tawanda
Thalib, Lukman
author_role author
dc.creator.none.fl_str_mv Suhail A., Doi
Furuya-Kanamori, Luis
Xu, Chang
Lin, Lifeng
Chivese, Tawanda
Thalib, Lukman
dc.date.none.fl_str_mv 2020-11-17T05:19:45Z
2020-11-07
dc.format.none.fl_str_mv application/pdf
dc.identifier.none.fl_str_mv http://dx.doi.org/10.1016/j.jclinepi.2020.08.019
: Doi SA, Furuya-Kanamori L, Xu C, Lin L, Chivese T, Thalib L, Questionableutility of the relative risk in clinical research: A call for change to practice, Journal of ClinicalEpidemiology (2020), doi:https://doi.org/10.1016/j.jclinepi.2020.08.019
08954356
https://www.sciencedirect.com/science/article/pii/S0895435620311719?v=s5
http://hdl.handle.net/10576/16985
dc.language.none.fl_str_mv en
dc.publisher.none.fl_str_mv Elsevier
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv binary effect measure
relative risk
odds ratio
risk difference
posterior probability
dc.title.none.fl_str_mv Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
dc.type.none.fl_str_mv Article
info:eu-repo/semantics/publishedVersion
info:eu-repo/semantics/article
description Background and Objectives In clinical trials, the relative risk or risk ratio (RR) is a mainstay of reporting of the effect magnitude for an intervention. The RR is the ratio of the probability of an outcome in an intervention group to its probability in a control group. Thus, the RR provides a measure of change in the likelihood of an event linked to a given intervention. This measure has been widely used because it is today considered a measure with “portability” across varying outcome prevalence, especially when the outcome is rare. It turns out, however, that there is a much more important problem with this ratio, and this paper aims to demonstrate this problem. Methods We used mathematical derivation to determine if the RR is a measure of effect magnitude alone (i.e., a larger absolute value always indicating a stronger effect) or not. We also used the same derivation to determine its relationship to the prevalence of an outcome. We confirm the derivation results with a follow-up analysis of 140,620 trials scraped from the Cochrane. Results We demonstrate that the RR varies for reasons other than the magnitude of the effect because it is a ratio of two posterior probabilities, both of which are dependent on baseline prevalence of an outcome. In addition, we demonstrate that the RR shifts toward its null value with increasing outcome prevalence. The shift toward the null happens regardless of the strength of the association between intervention and outcome. The odds ratio (OR), the other commonly used ratio, measures solely the effect magnitude and has no relationship to the prevalence of an outcome in a study nor does it overestimate the RR as is commonly thought. Conclusions The results demonstrate the need to (1) end the primary use of the RR in clinical trials and meta-analyses as its direct interpretation is not meaningful, (2) replace the RR by the OR, and (3) only use the postintervention risk recalculated from the OR for any expected level of baseline risk in absolute terms for purposes of interpretation such as the number needed to treat. These results will have far-reaching implications such as reducing misleading results from clinical trials and meta-analyses and ushering in a new era in the reporting of such trials or meta-analyses in practice.
eu_rights_str_mv openAccess
format article
id qu_ef2bf3c8a45266c9edf4607b1f6ba63d
identifier_str_mv : Doi SA, Furuya-Kanamori L, Xu C, Lin L, Chivese T, Thalib L, Questionableutility of the relative risk in clinical research: A call for change to practice, Journal of ClinicalEpidemiology (2020), doi:https://doi.org/10.1016/j.jclinepi.2020.08.019
08954356
language_invalid_str_mv en
network_acronym_str qu
network_name_str Qatar University repository
oai_identifier_str oai:qspace.qu.edu.qa:10576/16985
publishDate 2020
publisher.none.fl_str_mv Elsevier
repository.mail.fl_str_mv
repository.name.fl_str_mv
repository_id_str
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
spelling Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practiceSuhail A., DoiFuruya-Kanamori, LuisXu, ChangLin, LifengChivese, TawandaThalib, Lukmanbinary effect measurerelative riskodds ratiorisk differenceposterior probabilityBackground and Objectives In clinical trials, the relative risk or risk ratio (RR) is a mainstay of reporting of the effect magnitude for an intervention. The RR is the ratio of the probability of an outcome in an intervention group to its probability in a control group. Thus, the RR provides a measure of change in the likelihood of an event linked to a given intervention. This measure has been widely used because it is today considered a measure with “portability” across varying outcome prevalence, especially when the outcome is rare. It turns out, however, that there is a much more important problem with this ratio, and this paper aims to demonstrate this problem. Methods We used mathematical derivation to determine if the RR is a measure of effect magnitude alone (i.e., a larger absolute value always indicating a stronger effect) or not. We also used the same derivation to determine its relationship to the prevalence of an outcome. We confirm the derivation results with a follow-up analysis of 140,620 trials scraped from the Cochrane. Results We demonstrate that the RR varies for reasons other than the magnitude of the effect because it is a ratio of two posterior probabilities, both of which are dependent on baseline prevalence of an outcome. In addition, we demonstrate that the RR shifts toward its null value with increasing outcome prevalence. The shift toward the null happens regardless of the strength of the association between intervention and outcome. The odds ratio (OR), the other commonly used ratio, measures solely the effect magnitude and has no relationship to the prevalence of an outcome in a study nor does it overestimate the RR as is commonly thought. Conclusions The results demonstrate the need to (1) end the primary use of the RR in clinical trials and meta-analyses as its direct interpretation is not meaningful, (2) replace the RR by the OR, and (3) only use the postintervention risk recalculated from the OR for any expected level of baseline risk in absolute terms for purposes of interpretation such as the number needed to treat. These results will have far-reaching implications such as reducing misleading results from clinical trials and meta-analyses and ushering in a new era in the reporting of such trials or meta-analyses in practice.Elsevier2020-11-17T05:19:45Z2020-11-07Articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1016/j.jclinepi.2020.08.019: Doi SA, Furuya-Kanamori L, Xu C, Lin L, Chivese T, Thalib L, Questionableutility of the relative risk in clinical research: A call for change to practice, Journal of ClinicalEpidemiology (2020), doi:https://doi.org/10.1016/j.jclinepi.2020.08.01908954356https://www.sciencedirect.com/science/article/pii/S0895435620311719?v=s5http://hdl.handle.net/10576/16985enhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:qspace.qu.edu.qa:10576/169852024-07-23T11:23:09Z
spellingShingle Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
Suhail A., Doi
binary effect measure
relative risk
odds ratio
risk difference
posterior probability
status_str publishedVersion
title Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
title_full Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
title_fullStr Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
title_full_unstemmed Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
title_short Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
title_sort Controversy and Debate: Questionable utility of the relative risk in clinical research: Paper 1: A call for change to practice
topic binary effect measure
relative risk
odds ratio
risk difference
posterior probability
url http://dx.doi.org/10.1016/j.jclinepi.2020.08.019
https://www.sciencedirect.com/science/article/pii/S0895435620311719?v=s5
http://hdl.handle.net/10576/16985