core outcomes

Study: We need standardization of dry eye assessment protocols

Contact Lens and Anterior Eye recently published a report attempting to summarize findings for Sjogrens syndrome patients at six different sites. Symptoms (89.4% of patients) and corneal staining (78% of patients) were the most common findings, but their conclusion highlighted "a great deal of inconsistency in dry eye protocols among offices". It's hard to figure out what is best when everyone does it differently! This comment comes in the context of Sjogrens but is true across the board in dry eye.

This problem is exactly what Drs Wang and Craig are talking when they use terms like "methodological heterogeneity" in their beautiful commentary titled "Core Outcome Sets for Clinical Trials in Dry Eye Disease" which accompanied our study "Research Questions and Outcomes Prioritized by Patients With Dry Eye" in JAMA Ophthalmology earlier this month. 

The problem of heterogeneity - from apples and oranges to quince and dragon fruit - is a common observation in dry eye studies as well as throughout TFOS DEWS II's reports and it serves to underscore the crucial importance of the work by epidemiologist Ian Saldanha and colleagues towards the establishment of core outcome sets for clinical trials in dry eye disease.

Cont Lens Anterior Eye. 2018 Aug 18. pii: S1367-0484(18)30044-4. doi: 10.1016/j.clae.2018.08.006. [Epub ahead of print]
Sjogren's syndrome in optometric practices in North America.
Caffery B, Harthan J, Srinivasan S, Acs M, Barnett M, Edmonds C, Johnson-Tong L, Maharaj R, Pemberton B, Papinski D.


Abstract
PURPOSE:
To describe the presentation of dry eye in Sjogren's syndrome (SS) in optometric practices, to report on the methodology used in dry eye monitoring and to explore the level of corneal staining versus age and time of disease.

METHODS:
Records of SS patients were reviewed in 6 optometric sites. A standardized abstraction tool was developed to collect data from the records including: health history, medications and symptoms and signs of dry eye. The methods of testing symptoms and signs of dry eye were recorded. Variables were recorded at each site and collated at the University of Waterloo. The first visit after January 1, 2000 was selected for description in this paper.

RESULTS:
123 charts were included. The average time since diagnosis was 7.2 years ±5.1 years. Symptoms of dryness were present in 110/123 = 89.4% of charts. Corneal fluorescein staining was present in 96/123 = 78% of charts. MGD was present in 52% of charts. There were significant differences in the protocols and grading systems used in these 6 sites. Corneal staining levels did not change with greater age or length of disease.

CONCLUSION:
These 123 SS patients presented with a large variation in their symptoms and signs. Symptoms of dryness and corneal fluorescein staining were the most commonly recorded presentations. There was a great deal of inconsistency in dry eye protocols among offices. Future prospective research with standardized testing will contribute to our understanding of the best dry eye protocols for SS patients.