OBJECTIVE: To assess the minimal clinically important difference (MCID) for the Ocular Surface Disease Index (OSDI; Allergan Inc, Irvine, California, holds the copyright), a 12-item patient-reported outcome questionnaire designed to quantify ocular disability due to dry eye disease. METHODS: Study data were collected within the Restasis Review of Efficacy and Safety vs Tears in the Relief of Dry Eye (RESTORE), an observational registry. A clinician global impression (CGI) and a subject global assessment (SGA) served as anchors to estimate the MCID for the overall OSDI score (range, 0-100). The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. RESTORE patients were included if they completed the OSDI at the baseline visit and at a follow-up visit and had a global change rating (SGA or CGI). RESULTS: Three hundred ten patients were included (82.3% white and 81.6% female [mean age, 57.8 years]). The CGI and SGA correlated with the OSDI score change for all OSDI categories except the normal category. The MCID ranged from 7.0 to 9.9 for all OSDI categories. The MCID ranged from 4.5 to 7.3 for mild or moderate disease and from 7.3 to 13.4 for severe disease. CONCLUSIONS: Using observational data, we estimated the MCIDs for different baseline OSDI categories of dry eye disease. These results will assist clinicians and researchers when interpreting OSDI score changes.
OBJECTIVE: To assess the minimal clinically important difference (MCID) for the Ocular Surface Disease Index (OSDI; Allergan Inc, Irvine, California, holds the copyright), a 12-item patient-reported outcome questionnaire designed to quantify ocular disability due to dry eye disease. METHODS: Study data were collected within the Restasis Review of Efficacy and Safety vs Tears in the Relief of Dry Eye (RESTORE), an observational registry. A clinician global impression (CGI) and a subject global assessment (SGA) served as anchors to estimate the MCID for the overall OSDI score (range, 0-100). The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. RESTORE patients were included if they completed the OSDI at the baseline visit and at a follow-up visit and had a global change rating (SGA or CGI). RESULTS: Three hundred ten patients were included (82.3% white and 81.6% female [mean age, 57.8 years]). The CGI and SGA correlated with the OSDI score change for all OSDI categories except the normal category. The MCID ranged from 7.0 to 9.9 for all OSDI categories. The MCID ranged from 4.5 to 7.3 for mild or moderate disease and from 7.3 to 13.4 for severe disease. CONCLUSIONS: Using observational data, we estimated the MCIDs for different baseline OSDI categories of dry eye disease. These results will assist clinicians and researchers when interpreting OSDI score changes.
Authors: Penny A Asbell; Maureen G Maguire; Ellen Peskin; Vatinee Y Bunya; Eric J Kuklinski Journal: Contemp Clin Trials Date: 2018-06-06 Impact factor: 2.226
Authors: Penny A Asbell; Maureen G Maguire; Maxwell Pistilli; Gui-shuang Ying; Loretta B Szczotka-Flynn; David R Hardten; Meng C Lin; Roni M Shtein Journal: N Engl J Med Date: 2018-04-13 Impact factor: 91.245
Authors: Alan Tomlinson; Anthony J Bron; Donald R Korb; Shiro Amano; Jerry R Paugh; E Ian Pearce; Richard Yee; Norihiko Yokoi; Reiko Arita; Murat Dogru Journal: Invest Ophthalmol Vis Sci Date: 2011-03-30 Impact factor: 4.799
Authors: Yoshihiro Inamoto; Nuria Valdés-Sanz; Yoko Ogawa; Monica Alves; Luigi Berchicci; John Galvin; Hildegard Greinix; Gregory A Hale; Biljana Horn; Debra Kelly; Hien Liu; Scott Rowley; Helene Schoemans; Ami Shah; Maria Teresa Lupo Stanghellini; Vaibhav Agrawal; Ibrahim Ahmed; Asim Ali; Neel Bhatt; Michael Byrne; Saurabh Chhabra; Zachariah DeFilipp; Kristina Fahnehjelm; Nosha Farhadfar; Erich Horn; Catherine Lee; Sunita Nathan; Olaf Penack; Pinki Prasad; Seth Rotz; Alicia Rovó; Jean Yared; Steven Pavletic; Grzegorz W Basak; Minoo Battiwalla; Rafael Duarte; Bipin N Savani; Mary E D Flowers; Bronwen E Shaw; Igor Petriček Journal: Biol Blood Marrow Transplant Date: 2018-11-24 Impact factor: 5.742