Extended reports
Clinical trials in rheumatoid arthritis: methodological
suggestions for assessing radiographs arising from the GRISAR* study
a Novartis Farma, Medical Department, Milan,
Italy , b Institute of Radiology, Catholic University,
Rome, Italy , c Department of Radiology, S Giovanni Rotondo, Italy
, d Department of
Radiology, Treviso, Italy , e Chair of Rheumatology, Pisa, Italy , f Rheumatic Disease Unit, Department of Internal
Medicine, Udine, Italy , g Institute of Medical Statistics and Biometry, Milan,
Italy
Correspondence to: R Ferrara, Novartis Farma SpA, Medical Department, SS 233, km 20.5, I-21040 Origgio(VA), Italy.
Accepted for publication 1 July 1997
OBJECTIVES
The three x ray
assessors of the GRISAR study (blinded to treatment) gave consensual
erosion and damage scores to the baseline and 12 month radiographs of
284 rheumatoid arthritis (RA) patients using three different methods:
single readings (blinded as to patient and chronological sequence of
the x rays), paired readings (blinded as to sequence), and
chronologically ordered paired readings. The aim was to evaluate which
of these reading procedures is the most appropriate for clinical trials.
METHODSThe progression of the scores obtained
using each procedure was compared by means of descriptive statistics,
principal components analysis, and intra-patient correlation
coefficients of pairs of methods. Bootstrap estimates of the variance
of the difference in the means of two equally sized random samples were
calculated to evaluate the power of the statistical analysis performed
to assess the possible treatment effect for both paired and
chronological reading methods.
RESULTS(a)The standard deviations of the paired
and chronological readings were similar, but that of the single
readings was higher. (b) The knowledge that two x rays were
of the same patient accounted for a sizeable proportion of the between
method variability. (c) Agreement was satisfactory between the paired
and chronological methods for both scores but, between them and the
single readings, it was modest for erosions and poor for damage. (d)
The bootstrap estimate of the variance of the difference was smaller
for the paired than the chronological method, possibly giving it
greater power to test treatment effect.
CONCLUSIONSThese results suggested that paired
readings were the most suitable for evaluating the progression of joint
damage in the GRISAR study.
* Gruppo Reumatologi Italiani Studio Artrite Reumatoide
© 1997 by Annals of the Rheumatic Diseases
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