SIGNIFICANT CHANGE IN TESTS OF NEUROLOGICAL IMPAIRMENT IN PATIENTS WITH BRAIN-TUMORS

There is a need for valid objective tests of neurological improvement or deterioration to more accurately define response or progression in phase II studies of malignant glioma. The Edinburgh Functional Impairm ent Tests (EFIT) incorporate objective measures of upper and lower lim b function, memory and a rating scale for dysphasia. We examined the i ntra-observer repeatability of the (EFIT) 24 hours apart in 55 patient s with brain tumors and stable neurological disease and the inter-rate r repeatability in 33 patients in the perioperative period (54 dual as sessments). Intra-observer studies of the four subtests, failed to dem onstrate any learning effect and showed close agreement. Inter-rater s tudies were affected by a treatment effect (steroids) and identified s light inter-rater bias for the ten meter walk. Altman-Bland plots show ed that the level of agreement was less good in patients with more sev ere impairment. Correction for the severity of handicap was possible u sing a simple formulae: (timed tests: [rater 1 - rater 2]/[rater 1 + r ater 2], Williams Delayed Recall Test [WDRT] (rater 1 - 2/81). Using t his correction, all intra- and inter-rater variance of patients tested within 12 hours were < 0.2. A change of greater than or equal to 0.2 for the timed tests and WDRT, and a change in dysphasia score of 2 2, represent a significant change in impairment using the EFIT. The EFIT should be a useful addition in phase II studies where objectively reco rding response or time to progression is important.