Net efficacy adjusted for risk: further developments.
BACKGROUND
'Net efficacy adjusted for risk' (NEAR) is a simple quantitative indicator integrating risk and benefit in one measure. NEAR considers that, in a clinical trial (CT), the drug with the best risk:benefit profile corresponds to that causing the greatest number of patients to respond favourably without suffering adverse drug reactions. This number is only exceptionally reported; thus, a NEAR estimate is obtained by calculating expected frequencies. NEAR is designed to compare two drugs and may be expressed as odds ratio or relative risk with their 95% CIs.


OBJECTIVE
To analyse the influence of using either intention-to-treat (ITT) or per-protocol (PP) populations in NEAR results. The use of NEAR as 'effect size' in performing meta-analyses is posed.


METHODS
By analyzing several examples, differences between NEAR calculated by considering either ITT or PP populations are presented. Likewise, an example of meta-analysis by using NEAR as effect size is shown.


CONCLUSIONS
NEAR results may be optimised by considering the type of population analysed, ITT or PP. Meta-analyses using NEAR as effect size provide new insights into CT results. Last, correcting certain deficits in adverse drug reactions reporting is required in CT risk assessment.
Boada
J
J
University of La Laguna, Tenerife, Spain. boadajuarez@gmail.com
Boada
C
C
Garcia
M M
MM
Rodriguez
C
C
Garcia
M
M
Fernandez
E
E
D000818:Animals; D004358:Drug Therapy / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015201:Meta-Analysis as Topic; D018570:Risk Assessment / Q000379:methods*