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- Title
Time to generalization and prediction of survival in patients with amyotrophic lateral sclerosis: a retrospective observational study.
- Authors
Tortelli, R.; Copetti, M.; Panza, F.; Fontana, A.; Cortese, R.; Capozzo, R.; Introna, A.; D'Errico, E.; Zoccolella, S.; Arcuti, S.; Seripa, D.; Simone, I. L.; Logroscino, G.
- Abstract
Background and purpose A strong association between time to generalization ( TTG), considered as the time of spreading of the clinical signs from spinal or bulbar localization to both, and survival was recently identified in patients with amyotrophic lateral sclerosis ( ALS). Thus, TTG may be used as an early to intermediate end-point in survival studies. The aim of the present study was to test TTG as a predictor of survival in ALS. Methods This was an observational retrospective study of ALS patients from a tertiary referral centre over a 5-year follow-up period. Results In 212 ALS patients, TTG was associated with time to death/tracheostomy [R 0.62, 95% confidence interval ( CI) 0.53-0.70; P < 0.001]. In a time-to-event analysis, longer TTG resulted in lower risk to reach a composite outcome (death or tracheostomy) both in univariate [hazard ratio ( HR) 0.98, 95% CI 0.97-0.99] and multivariate Cox analyses ( HR 0.98, 95% CI 0.96-0.99). TTG predicted death/tracheostomy at 4 years ( C-statistic 0.58; 95% CI 0.53-0.63) and at 5 years ( C-statistic 0.58; 95% CI 0.53-0.62). Conclusions Based on the present results from a large clinical cohort, TTG may be used as a new early to intermediate end-point to describe the ALS natural history. TTG may be potentially useful as a new primary outcome measure for clinical trials.
- Subjects
SURVIVAL; AMYOTROPHIC lateral sclerosis; TRACHEOTOMY; CLINICAL trials; DEATH; PATIENTS
- Publication
European Journal of Neurology, 2016, Vol 23, Issue 6, p1117
- ISSN
1351-5101
- Publication type
Article
- DOI
10.1111/ene.12994