January 2019

CORNEA

Research highlight
Focusing dry eye research with patient guidance


by Vanessa Caceres EyeWorld Contributing Writer

Study illuminates patient priorities

Research for dry eye often focuses on changes in disease based on signs as measured with clinical tests.
Yet a new study shines a spotlight on the importance of symptoms and quality of life, as prioritized by patients.
The study, “Research questions and outcomes prioritized by patients with dry eye,” identifies and ranks research questions and outcomes that are important to dry eye patients.1
Led by Ian Saldanha, MBBS, MPH, PhD, assistant professor, Center for Evidence Synthesis in Health, Department of Health Services, Policy, and Practice, and Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, researchers used a multi-step process that started with identifying 24 research questions that are important to clinicians when measuring dry eye study outcomes. Those results were previously published.2 For the current study, they focused on 12 of the 24 research questions that clinicians said were the most important.
Researchers then focused on outcomes used in previous dry eye research, identified via a literature review. “Across all 158 studies denoted as existing research for dry eye, … we identified 109 unique outcomes,” the authors wrote. “Among the 109 unique outcomes, we categorized 18 as popular and 91 as unpopular in existing research.”
Next, researchers surveyed the more than 13,700 subscribers of KeratoScoop, a weekly online newsletter created by fellow study author Rebecca Petris, founder of the Dry Eye Company, Poulsbo, Washington. The Dry Eye Company has an online information portal called Dry Eye Zone, and visitors to that site are typically the ones who subscribe to KeratoScoop. A web link for the study survey was sent to KeratoScoop subscribers. Those participating in the survey were asked to rate the importance of questions prioritized by clinicians and rate the importance of the popular outcomes.
The study also had a round two survey during which the results from round one were compiled, and patients were asked to rate each outcome again, taking into account their own response and the responses from their peers in round one.
Among the KeratoScoop subscribers, 622 patients completed round one of the survey and 420 completed round two. Focusing on round two survey responders, 56% were age 60 or older, 83% were female, and 94% were white. The majority live in the U.S. and Canada, although a total of 15 countries were represented among the respondents. More than two-thirds had been living with dry eye for 6 years or longer, with blepharitis as the most common underlying diagnosis (43%). However, 38% had received no underlying diagnosis.

Ranking the research questions

When evaluating the research questions, patients ranked 8 of 12 questions as important and 4 of the 12 as moderately important. The research questions that survey participants identified as important, in order of importance, were:
• Is patient education effective in treating patients with dry eye?
• Are environmental modifications effective in treating patients with dry eye?
• Are topical anti-inflammatory agents such as cyclosporine and corticosteroids effective in treating patients with dry eye?
• Are autologous serum tears effective in treating patients with dry eye?
• Are autologous serum drops effective in improving ocular irritation in patients with Sjögren’s syndrome or graft-versus-host disease and dry eye?
• Are autologous serum drops effective in improving ocular irritation, conjunctival and corneal dye staining in patients with Sjögren’s syndrome or graft-versus-host disease and dry eye?
• Are oral omega-3 fatty acids effective in patients with dry eye?
• Is a specific combination of treatments more effective than another combination in treating patients with dry eye?
The following questions were ranked as moderately important:
• Are systemic anti-inflammatory agents effective in patients with dry eye and systemic disease such as rheumatoid arthritis?
• Is a specific sequence of treatments more effective than another sequence in treating patients with dry eye?
• Are systemic immunosuppressive agents effective in patients with dry eye and systemic disease such as rheumatoid arthritis?
• Are systemic tetracyclines effective in patients with meibomianitis or rosacea and dry eye?
Researchers did not find any notable difference in the ranking by patient subgroups as defined by underlying diagnosis.
Round two of the survey, during which patients rated 28 outcomes, had similar results. “The 10 most important outcomes included 6 symptoms, 3 outcomes associated with quality of life, and 1 sign or clinical testing outcome,” the authors wrote. “The three most important outcomes were ocular burning or stinging, ocular discomfort, and ocular pain.” Some of the other important outcomes as ranked by patients were ocular dryness, visual acuity, impact of dry eye disease on daily life, vision-related quality of life, and patient’s acceptability or satisfaction with treatment.
Common tests used to assess dry eye, such as ocular surface staining, tear production or volume, and conjunctival staining ranked low in the study. The lowest-ranked outcomes among the 28 outcomes rated by patients were dryness of the mouth and salivary flow; however, as might be expected, those were rated as more important by patients with Sjögren’s syndrome.

Clinical, research implications

The focus on patient priorities for dry eye research questions and outcomes is overdue, said Ms. Petris, who is a patient advocate and a dry eye patient herself. “The disconnect between dry eye signs and symptoms has been widely acknowledged and talked about for a long time, but knowing the disconnect exists doesn’t seem to have helped steer the focus of either clinical care or research. My hope is that this study, where the patient’s voice has been documented so powerfully, could help change that in favor of patients,” she said.
“The extent of the disconnect between what patients value and what exists in dry eye research is surprising to us,” Dr. Saldanha said. “It is a problem that the field needs to urgently address so that we are identifying effective treatments based on demonstrated evidence of improvement in the things that matter the most to patients.”
“This study emphasizes the need to consider patients as partners in disease understanding and management,” said Lama Al-Aswad, MD, MPH, associate professor of ophthalmology, Columbia University Medical Center, New York.
Although the study focused on research outcomes, there are also potential implications in practice. “The study confirms the importance of listening to patients and understanding their symptoms and concerns. Treatment should be geared to the underlying cause and give a special focus to their symptoms and concerns,” Dr. Al-Aswad said.
Physicians treating dry eye should keep patient concerns in mind, Dr. Saldanha said. “Our paper can add information and context to the clinical signs that the practitioner observes,” he added.
Ms. Petris said that she urges dry eye patients to discuss with physicians how dry eye symptoms affect their life. For example, she encourages them to use the Ocular Surface Disease Index smartphone app to report their symptoms.
Although Chika Shigeyasu, MD, Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan, agreed that patient symptoms are necessary, physicians should strike a balance. “I do think the qualitative evaluation of dry eye by clinical tests is still important. I think a combination of tests should be performed, in addition to subjective symptoms in clinical practice,” Dr. Shigeyasu said. Dr. Shigeyasu recently led another study that measured quality of life among dry eye subgroups (see sidebar).
Dr. Saldanha is working with other researchers to identify core outcomes that should be a priority in future dry eye research, based on the 28 outcomes identified in the current study; they also recently published a commentary on this topic.3 “The objective is for those outcomes to then be considered a minimum or core set that all future research will measure. Then, if that objective is met and the core outcome sets are adhered to, we will have common yardsticks with which to evaluate and compare treatments,” he said.
“Researchers can use the 8 research questions identified by both clinicians and patients as important to guide future research,” Dr. Saldanha added.

References

1. Saldanha IJ, et al. Research questions and outcomes prioritized by patients with dry eye. JAMA Ophthalmol. 2018;136:1170–1179.
2. Saldanha IJ, et al. Gaps in current knowledge and priorities for future research in dry eye. Cornea. 2017;36:1584–1591.
3. Saldanha IJ, et al. Choosing core outcomes for use in clinical trials in ophthalmology: perspectives from three ophthalmology outcomes working groups. Ophthalmology. 2018. Article in press.
4. Shigeyasu C, et al. Qualify of life measures and health utility values among dry eye subgroups. Health Qual Life Outcomes. 2018;16:170.

Editors’ note: The sources have no financial interests related to their comments.

Contact information

Al-Aswad
: jr3674@cumc.columbia.edu
Petris: rebecca@dryeyecompany.com
Saldanha: ian_saldanha@brown.edu
Shigeyasu: shigeyasu@eye-center.org

Focusing dry eye research with patient guidance Focusing dry eye research with patient guidance
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