P. Pancheri, R. Delle Chiaie, G. Boissard - Vol. 6, Marzo 2000, num.1
Testo Immagini Bibliografia Summary Riassunto Indice
Studio di Inter-rater reliability
sui punteggi ham-d tra gli sperimentatori degli studi multicentrici mc-3 ed
mc-4 per la valutazione dell’efficacia e della tollerabilità della same
nel trattamento della depressione maggiore
Interrater reliability of HAM-D scores among investigators of the MC-3
and MC-4 multicenter efficacy and safety studies of sulfoadenosylmethionine
in the treatment of major depression
Background
The final stages of drug evaluation currently imply the use of multicenter studies. These studies need that data collected from many centers be pooled and analysed together; hence, to avoid heterogeneity in patient assessment, that could significantly affect the validity of these data, a preliminary interrater reliability study should precede multicenter trials. Two ongoing multicenter studies of sulfoadenosyl methionine (SAMe) were recently undertaken to assess its efficacy and safety in the treatment of major depression, the first (MC-3) comparing oral SAMe vs. oral imipramine, is carriedout in 18 centers, while the second (MC-4) compares intramuscular (i.m.) SAMe vs. oral imipramine and is conducted in 26 centers. For both studies, the principal efficacy measure adopted is the 21-item Hamilton Depression Rating Scale (HAM-D) scores at end-point.
Aim and Method
To assess interrater reliability of raters participating in the MC-3 and MC-4 trials, all investigators of the centers involved in these trials rated on the HAM-D the depression of the same 10 major depressive patients whose interviews were videotyped, after viewing the videocassettes. Analyses were carried out on both total HAM-D scores and on scores on every single item.
Results
Indexes (R) obtained on total HAM-D scores were 0.76 for MC-3 and 0.80 for MC-4; R for the combined MC-3 and MC-4 rater samples was 0.79. The calculation of interrater correlation coefficient (K) of single items allowed to identify the areas of major diagnostic concordance among raters, i.e., items 3 (suicide), 4 (early insomnia), 5 (mid-night insomnia), 12 (gastrointestinal symptoms), 16 (weight loss), 17 (insight), 18 (daily variations).
Conclusions
Interrater reliability obtained for both multicenter studies of SAMe vs. imipramine in major depression are satisfactory and similar to what is found in literature for the 21-item version of the HAM-D.