[fr] La médecine factuelle fait souvent appel à la comparaison de deux interventions thérapeutiques dans des essais
cliniques contrôlés avec la démonstration d’une supériorité
(par rapport à un placebo ou un comparateur actif) ou au
moins d’une non-infériorité (par rapport à un comparateur
actif) en ce qui concerne un critère de jugement primaire
décidé a priori (survenue d’un événement clinique majeur,
par exemple). La différence dans la survenue d’un événement
entre les deux interventions thérapeutiques testées peut être
analysée, sur le plan statistique, par la réduction du risque
absolu, la réduction du risque relatif, le hasard ratio ou encore
l’odds ratio (rapport de cotes). Cet article discute les nuances,
parfois importantes, concernant la signification de ces diffé-
rents indices et analyse les précautions à prendre et les pièges
à éviter dans leur interprétation et leur utilisation. Le clinicien
est, en effet, de plus en plus souvent confronté aux résultats
d’études cliniques, mais est généralement peu informé quant
aux subtilités des analyses présentées [en] Evidence-based medicine often requires the
comparison of two therapeutic interventions in controlled clinical trials with the demonstration of a superiority (versus a
placebo or an active comparator) or at least a non-inferiority
(versus an active reference) concerning a primary endpoint
that has been defined a priori (occurrence of a major clinical
event, for instance). The difference in the occurrence of such
an event between two treatments may be statistically analyzed
by absolute risk reduction, relative risk reduction, hazard
ratio or odds ratio. The present article discusses the nuances,
sometimes of importance, concerning the significance of these
various indices and analyses the cautions to be taken and the
pitfalls to be avoided in their interpretation and use in practice. The clinician is, indeed, increasingly confronted to results
of clinical trials, but is generally poorly informed regarding
the nuances of these various statistical analyses.
Disciplines :
Human health sciences: Multidisciplinary, general & others
Author, co-author :
SCHEEN, André ; Centre Hospitalier Universitaire de Liège - CHU > Diabétologie,nutrition, maladies métaboliques
ERNEST, Philippe ; Centre Hospitalier Universitaire de Liège - CHU > Diabétologie,nutrition, maladies métaboliques
JANDRAIN, Bernard ; Centre Hospitalier Universitaire de Liège - CHU > Diabétologie,nutrition, maladies métaboliques
Language :
French
Title :
Comment j’explore …Une différence de risque de survenue d’un événement dans les études cliniques
Publication date :
November 2012
Journal title :
Revue Médicale de Liège
ISSN :
0370-629X
eISSN :
2566-1566
Publisher :
Université de Liège. Revue Médicale de Liège, Liège, Belgium
Scheen AJ.- Evidence-based medicine. Apport des essais cliniques contrôlés. Rev Med Liège, 2000, 55, 216-219.
Scheen AJ.- La mesure de l'efficacité thérapeutique, étape essentielle dans la médecine factuelle. Rev Med Liège, 2000, 55, 206-210.
Laupacis A, Sackett DL, Roberts RS.- An assessment of clinically useful measures of the consequences of treatment. N Eng J Med, 1988, 318, 1728-1733.
Collins R, MacMahon.- Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet, 2001, 357, 373-380. (Pubitemid 32128549)
Scheen AJ.- Comment j'explore ... les critères de jugement dans les essais cliniques : réflexion à propos d'études récentes de prévention cardio-vasculaire. Rev Med Liège, 2006, 61, 260-266. (Pubitemid 43873002)
Piérard GE, Scheen AJ.- Innover par l'EBM. Glossaire initiatique aux recherches cliniques. Rev Med Liège, 2005, 60, 190-194.
Replogle WH, Johnson WD.- Interpretation of absolute measures of disease risk in comparative research. Fam Med, 2007, 39, 432-435. (Pubitemid 46871364)
Rodondi N, Cornuz J.- Lecture d'articles médicaux: quelques pièges à éviter. Rev Med Suisse, 2007, 3, 2718-2723. (Pubitemid 350254085)
Bergmann JF, Chassany O.- Lire un compte rendu d'essai clinique. Rev Prat, 2000, 50, 838-845. (Pubitemid 30243532)
Morabia A.- Risque relatif et odds ratio. Rev Mal Resp, 2003, 20, 757-759.
Bucher HC, Weinbacher M, Gyr K.- Influence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ, 1994, 309, 761-764. (Pubitemid 24291634)
Spruance SL, Reid JE, Grace M, Samore M.- Hazard ratio in clinical trials. Antimicrob Agents Chemother, 2004, 48, 2787-2792.
Lee ET, Go OT.- Survival analysis in public health research. Annu Rev Public Health, 1997, 18, 105-134. (Pubitemid 27194066)
Cook RJ, Sackett DL.- The number needed to treat: a clinically useful measure of treatment effect. BMJ, 1995, 310, 452-454. Erratum in : BMJ, 1995, 310, 1056.
Hutton JL.- Number needed to treat and number needed to harm are not the best way to report and assess the results of randomised clinical trials. Br J Haematol, 2009, 146, 27-30.
Stang A, Poole C, Bender R.- Common problems related to the use of number needed to treat. J Clin Epidemiol, 2010, 63, 820-825.
Norman GR, Streiner DL.- Do CIs give you confidence? Chest, 2012, 141, 17-19.
Detsky AS, Sackett DL.- When was a "negative" clinical trial big enough? How many patients you needed depends on what you found. Arch Intern Med, 1985, 145, 709-712. (Pubitemid 15077939)
Mélot C.- Que signifie puissance d'une étude ? Comment la calculer ? Comment calculer le nombre de sujets nécessaires ? Rev Mal Respir, 2003, 20, 602-603. (Pubitemid 37214555)
Scheen AJ.- Comment j'explore ... les secrets d'une méta-analyse. Rev Med Liège, 2003, 58, 41-46. (Pubitemid 36188357)
Similar publications
Sorry the service is unavailable at the moment. Please try again later.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.