BLOG: Dissecting DREAM, part 1: Real-world dry eye care
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“If you can’t say something nice about someone, don’t say anything at all.” Every mom, ever.
DREAM was the topic of my January “The Dry Eye” column. In a footnote, I promised to dive more deeply into the minutiae of the study, a more granular evaluation than that which would be possible in a 1,200-word column. It should be obvious to anyone who read the column that I do not agree with the conclusion of the authors (fish oil does not improve DED symptoms) and that I feel that the study is flawed. Having said that, and because my Mom is still alive and occasionally reads my drivel, let me start this series of posts with something the DREAM designers got very right.
It is pretty messy in the real world of DED care. We can attribute at least some of this reality to the relative youth of the study and widespread treatment of DED, but we must also acknowledge that there are very vocal groups both within and outside eye care that still view all of DED as little more than a lifestyle inconvenience. One need only go back to the earliest statin trials in cardiology to find a similar situation in the study of a disease. Interventions were rapidly employed and abandoned, and in the real world, patients were often switched in and out and between different protocols.
So it is in present-day DED care.
Patients and doctors use a multitude of discrete treatment modalities. Some are prescription medications while others are OTC options that are often as not chosen by the patient. There are all kinds of newer, direct treatments available (eg, LipiFlow from Johnson & Johnson Vision and intense pulsed light), but not universally. Indeed, the malignant vicissitudes of the health insurance market means that not all prescription medications are available to all patients. The symptoms suffered by DED patients are so significant that there is a near constant flux in any individual treatment plan in an attempt to reduce their impact.
It is clear from both the statements of the DREAM authors and the study protocols that this was designed to be a “real-world” study that took all of the above into account. In this, I think DREAM was successful. When I look at the description of the participants and the various (non-study) treatments taken, it looks an awful lot like how our referral patients are being treated when they come in for a consultation. Changes in individual treatment programs during DREAM sound like every narrative we hear when our new patients recall their most recent year of treatment.
If you are a working physician, what you want to see is exactly this. So many studies seem to be the equivalent of counting angels on the head of a pin when what we really want to know is what happens when you have 100 of those pins stuck in your patient’s eyelid. Unless a study cohort is precisely the same as the patient sitting at your slit lamp, you can’t be sure that the results apply. Not that this keeps us from trying to do just that, of course. That’s why “real-world” studies are so important to us on the frontlines of health care.
As we work through DREAM’s shortcomings, we should all acknowledge that the authors attempted to give us something that looks like what we see in our lanes. Few studies do.
Disclosure: White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.