PMID- 20065224
OWN - NLM
STAT- MEDLINE
DCOM- 20100127
LR  - 20220408
IS  - 1538-3601 (Electronic)
IS  - 0003-9950 (Linking)
VI  - 128
IP  - 1
DP  - 2010 Jan
TI  - Minimal clinically important difference for the ocular surface disease index.
PG  - 94-101
LID - 10.1001/archophthalmol.2009.356 [doi]
AB  - 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.
FAU - Miller, Kimberly L
AU  - Miller KL
AD  - ICON Clinical Research, 188 Embarcadero, Ste 200, San Francisco, CA 94105, USA. 
      Kimberly.Miller@iconplc.com
FAU - Walt, John G
AU  - Walt JG
FAU - Mink, David R
AU  - Mink DR
FAU - Satram-Hoang, Sacha
AU  - Satram-Hoang S
FAU - Wilson, Steven E
AU  - Wilson SE
FAU - Perry, Henry D
AU  - Perry HD
FAU - Asbell, Penny A
AU  - Asbell PA
FAU - Pflugfelder, Stephen C
AU  - Pflugfelder SC
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arch Ophthalmol
JT  - Archives of ophthalmology (Chicago, Ill. : 1960)
JID - 7706534
RN  - 0 (Emulsions)
RN  - 0 (Ophthalmic Solutions)
RN  - 83HN0GTJ6D (Cyclosporine)
SB  - IM
MH  - Comorbidity
MH  - Cyclosporine/administration & dosage
MH  - *Diagnostic Techniques, Ophthalmological
MH  - *Disability Evaluation
MH  - Dry Eye Syndromes/*diagnosis/drug therapy
MH  - Emulsions
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/administration & dosage
MH  - *Severity of Illness Index
MH  - *Surveys and Questionnaires
EDAT- 2010/01/13 06:00
MHDA- 2010/01/28 06:00
CRDT- 2010/01/13 06:00
PHST- 2010/01/13 06:00 [entrez]
PHST- 2010/01/13 06:00 [pubmed]
PHST- 2010/01/28 06:00 [medline]
AID - 128/1/94 [pii]
AID - 10.1001/archophthalmol.2009.356 [doi]
PST - ppublish
SO  - Arch Ophthalmol. 2010 Jan;128(1):94-101. doi: 10.1001/archophthalmol.2009.356.