Sl. Collins et al., Seeking a simple measure of analgesia for mega-trials: is a single global assessment good enough?, PAIN, 91(1-2), 2001, pp. 189-194
We sought to investigate the potential of using a simple global estimation
('How effective do you think the treatment was?') as a measure of efficacy
by comparing it with at least 50%maxTOTPAR (at least 50% of the maximum pos
sible pain relief) in acute pain studies. One hundred and fifty randomized,
double-blind trials included in Il systematic reviews of single dose, oral
analgesics for postoperative pain were used as a source of data. The relat
ionship between the proportion of patients reporting the top two or three v
alues on a five-point global scale and the proportion with at least 50%maxT
OTPAR was investigated. Twenty-six trials provided data on the proportion r
eporting the top two categories (very good or excellent) and 27 gave data o
n the top three categories (good, very good or excellent). The relationship
between the percentage of patients recording the top two categories on a f
ive-point global scale and the proportion with at least 50%maxTOTPAR was fa
ir (r(2) = 0.67). That for the top three categories was less good (r(2) = 0
.57). Similar numbers-needed-to-treat were calculated for aspirin 600/650 m
g and ibuprofen 400 mg using at least 50%maxTOTPAR and the top two categori
es, No real difference was seen in the correlation for standard wording com
pared to non-standard wording. Individual patient data were also used from
four randomized, placebo-controlled, double-blind trials in postoperative p
ain. The frequency distribution for %maxTOTPAR was plotted for patients rep
orting each of the five categories on the global scale. A global assessment
provides similar measures of analgesic efficacy as TOTPAR derived from hou
rly measurements, but the effects of adverse effects have yet to be underst
ood. (C) 2001 International Association for the Study of Pain. Published by
Elsevier Science B.V. All rights reserved.