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Research Questions and Outcomes Prioritized by Patients With Dry Eye.

ABSTRACT: Importance:Dry eye is a common ocular surface condition with significant influence on patient quality of life and societal economic burden. There is an urgent need to prioritize new research for dry eye. Objective:To identify and rank research questions and outcomes important to patients with dry eye. Design, Setting, and Participants:This study was conducted using the following 6 steps: (1) identifying research questions from a previous survey of clinicians who treat patients with dry eye; (2) identifying outcomes from existing research (systematic reviews and their cited clinical trials in the Cochrane Eyes and Vision US Satellite database of eyes and vision reviews, and National Eye Institute-funded clinical trials registered on ClinicalTrials.gov) as of June 13, 2017; (3) identifying a sample of patients with dry eye from the email subscribers to the online newsletter KeratoScoop; (4) and (5) conducting a 2-round Delphi survey of those patients online in November and December 2017, respectively; and (6) designating and ranking questions and outcomes as important. Main Outcomes and Measures:Importance assigned to research questions and outcomes for dry eye. A research question or outcome ranked by at least 75% of patients as 6 or higher on a scale of 0 to 10 was considered important. Results:Among the 420 patients from 15 countries who completed both rounds of the Delphi survey, most were 60 years of age or older (233 [56%]), female (348 [83%]), white (393 [94%]), and of non-Hispanic ethnicity (398 [95%]). Among the 12 questions that clinicians had previously prioritized, patients rated 8 as important. The top 3 questions pertained to effectiveness of patient education, environmental modifications, and topical anti-inflammatory eye drops for dry eye. Among the 109 outcomes identified in existing research on dry eye, patients rated 26 as important. Ten of these 26 were unpopular in existing research, with fewer than 10% of 158 studies reporting these outcomes. Of the 10 most important outcomes, 9 were associated with symptoms or quality of life. The 3 outcomes rated most important by patients were ocular burning or stinging, ocular discomfort, and ocular pain. Conclusions and Relevance:This study identified research questions and outcomes important to patients with dry eye. A considerable gap was noted between outcomes in existing research on dry eye and outcomes patients consider important. Future research on dry eye should consider addressing the important research questions and outcomes identified herein, taking into account the patient perspective.

SUBMITTER: Saldanha IJ

PROVIDER: S-EPMC6218931 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Research Questions and Outcomes Prioritized by Patients With Dry Eye.

Saldanha Ian J IJ Petris Rebecca R Han Genie G Dickersin Kay K Akpek Esen K EK

JAMA ophthalmology 20181001 10

<h4>Importance</h4>Dry eye is a common ocular surface condition with significant influence on patient quality of life and societal economic burden. There is an urgent need to prioritize new research for dry eye.<h4>Objective</h4>To identify and rank research questions and outcomes important to patients with dry eye.<h4>Design, setting, and participants</h4>This study was conducted using the following 6 steps: (1) identifying research questions from a previous survey of clinicians who treat patie ...[more]

PMID: 30128547

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Project description:BackgroundDry eye disease (DED), Meibomian gland dysfunction (MGD), and Sjögren's syndrome dry eye disease (SS-DED) are eye dryness conditions that show significant overlap in various symptoms of ocular discomfort. The aim of this study was to qualitatively explore the patient experience and evaluate content validity of the newly developed Dry Eye Disease Questionnaire (DED-Q).MethodsSemi-structured interviews were conducted with 61 US adults who reported experiencing ocular symptoms due to their physician-confirmed primary diagnosis of DED (n = 21), MGD (n = 20), or SS-DED (n = 20). The open-ended concept-elicitation phase was followed by cognitive debriefing (CD) of the DED-Q to evaluate participants' understanding and relevance of the instructions, items, response options, and recall periods. Interviews were also conducted with eight specialist healthcare professionals to assess clinical relevance of the concepts included. Verbatim interview transcripts were analyzed using thematic analysis in ATLAS.ti v8 software.ResultsA total of 29 symptoms and 14 impacts on quality of life were reported across participant interviews. Primary ocular symptoms reported included eye dryness (n = 61/61; 100%), eye irritation (n = 55/61; 90%), eye itch (n = 54/61; 89%), burning sensation (n = 52/61; 85%), and foreign body sensation (n = 51/61; 84%). The most impacted aspects of daily life were using digital screens (n = 46/61; 75%), driving (n = 45/61; 74%), working (n = 39/61; 64%), and reading (n = 37/61; 61%). CD findings showed most participants had good understanding of DED-Q items and confirmed most concepts were relevant to the lived experience of their condition. Aside from few minor changes to the items and examples to facilitate more accurate interpretation, the proposed instruction wording was modified for various symptom and impact modules to encourage participants to focus only on dry eye vision problems.ConclusionsThis research identified multiple prevalent symptoms and impacts of DED, MGD, and SS-DED, most of which were similar across the conditions. The DED-Q was confirmed to be a content-valid PRO measure suitable for use in clinical studies to assess the patient experience of DED, MGD, and SS-DED. Future work will focus on evaluating the psychometric properties of the DED-Q for use as an efficacy endpoint in clinical trials.

Project description:IntroductionSocial media listening (SML) is an approach to assess patient experience in different indications. This is the first study to report the results of using SML to understand patients' experiences of living with dry eye disease (DED).MethodsPublicly available, English-language social media content between December 2016 and August 2017 was searched employing pre-defined criteria using Social Studio®, an online aggregator-tool for posts from social media channels. Using natural language processing (NLP), posts were indexed using patient lexicon and disease-related keywords to derive a set of patient posts. NLP was used to identify relevance, followed by further manual evaluation and analysis to generate patient insights.ResultsIn all, 2279 possible patient records were identified following NLP, which were filtered for relevance to disease area by analysts, resulting in a total of 1192 posts which formed the basis of this study. Of these, 77% (n = 915) were from the USA. Symptoms, causes, diagnosis and treatments were the most commonly discussed themes. Most common symptoms mentioned were eye dryness (138/901), pain (114/901) and blurry vision (110/901). Pharmaceutical drugs (prescription and over-the-counter; 55%; 764/1393), followed by medical devices (20%; 280/1393), were mentioned as major options for managing symptoms. Of the pharmaceutical drugs, eye drops (33%; 158/476) and artificial tears (10%; 49/476) were the most common over-the-counter options reported, and Restasis® (22%; 103/476) and Xiidra® (6%; 27/476) were the most common prescription drugs. Patients voiced a significant impact of DED on their daily activities (4%; 9/224), work (23%; 51/224) and driving (12%; 26/224). Lack of DED specialists, standard diagnostic procedures, effective treatment options and need to increase awareness of DED among patients were identified as the key unmet needs.ConclusionsInsights revealed using SML strengthen our understanding about patient experiences and their unmet needs in DED. This study illustrates that an SML approach contributed effectively in generating patient insights, which can be utilised to inform early drug development process, market access strategies and stakeholder discussions.FundingNovartis Pharma AG, Basel, Switzerland. Plain language summary available for this article.

Project description:Knowledge about the variability of measurements using the TearLab Osmolarity System is necessary when evaluating the clinical utility of readings.To examine the variability of tear osmolarity measured by the TearLab Osmolarity System in patients with Sjögren syndrome (SS), patients with blepharitis, and control participants.Cross-sectional study at a tertiary care academic center from June 13, 2012, to March 21, 2013. Participants included 74 eyes of 37 patients from a volunteer sample (18 patients with SS, 11 patients with blepharitis, and 8 control participants) who were evaluated using the TearLab Osmolarity System, with 3 consecutive osmolarity measurements taken at 1-minute intervals in a session; 15 of these patients had the same measurements taken by the same examiner in 2 additional sessions on the same day (9 AM-10 AM, 12 PM-1 PM, or 3 PM-4 PM). Most patients with SS and patients with blepharitis were taking systemic or topical dry eye medications at the time of enrollment.Mean osmolarity and its variability calculated from a linear mixed model for each disease group that accounts for the variations attributable to different patients, eyes, and sessions and measurement error specific to each disease group.Mean tear osmolarity was 307 mOsm/L, 304 mOsm/L, and 301 mOsm/L in the SS, blepharitis, and control groups, respectively (P?=?.46). The error associated with repeated measurements within a session in the patients without dry eye (10.5 mOsm/L [95% CI, 9.0-12.4]) was significantly lower than in the patients with blepharitis (14.6 mOsm/L [95% CI, 12.5-17.5]; P?=?.006) and patients with SS (15.8 mOsm/L [95% CI, 14.2-17.8]; P?<?.001) but a difference in the error of repeated measurements between patients with blepharitis and patients with SS was not identified (P?=?.46).There was increased variability attributable to error in repeated measurements in patients with SS and patients with blepharitis compared with control participants. The high variability of TearLab osmolarity readings in all groups makes the clinical interpretation of measurements unclear.

Project description:To investigate corneal sensitivity to selective mechanical, chemical, and thermal stimulation and to evaluate their relation to dry eye symptoms in patients with keratoconus.Corneal sensitivity to mechanical, chemical, and thermal thresholds were determined using a gas esthesiometer in 19 patients with keratoconus (KC group) and in 20 age-matched healthy subjects (control group). Tear film dynamics was assessed by Schirmer I test and by the non-invasive tear film breakup time (NI-BUT). All eyes were examined with a rotating Scheimpflug camera to assess keratoconus severity.KC patients had significatly decreased tear secretion and significantly higher ocular surface disease index (OSDI) scores compared to controls (5.3±2.2 vs. 13.2±2.0 mm and 26.8±15.8 vs. 8.1±2.3; p<0.001). There was no significant difference in NI-BUT between the two groups (KC: 9.8±4.8 vs. control: 10.7±3.8; p>0.05). The mean threshold for selective mechanical (KC: 139.2±25.8 vs. control: 109.1±24.0 ml/min), chemical (KC: 39.4±3.9 vs. control: 35.2±1.9%CO2), heat (KC: 0.91±0.32 vs. control: 0.54±0.26 ?°C) and cold (KC: 1.28±0.27 vs. control: 0.98±0.25 ?°C) stimulation in the KC patients were significantly higher than in the control subjects (p<0.001, for all parameters). No correlation was found between age and mechanical, chemical, heat or cold thresholds in the patients with KC (p>0.05), whereas in the control subjects both mechanical (r = 0.52, p = 0.02), chemical (r = 0.47, p = 0.04), heat (r = 0.26, p = 0.04) and cold threshold (r = 0.40, p = 0.03) increased with age. In the KC group, neither corneal thickness nor tear flow, NI-BUT or OSDI correlated significantly with mechanical, chemical, heat or cold thresholds (p>0.05 for all variables).Corneal sensitivity to different types of stimuli is decreased in patients with keratoconus independently of age and disease severity. The reduction of the sensory input from corneal nerves may contribute to the onset of unpleasant sensations in these patients and might lead to the impaired tear film dynamics.

Project description:ObjectiveTo investigate the clinical effects of IRT5 probiotics in the environmental dry eye model.MethodsEight week old male C57BL/6 mice were randomly divided into two groups; control group (n = 16) received oral gavage of 300 μL phosphate-buffered saline (PBS) alone once daily, IRT5 group (n = 9) received oral gavage of 1 x 109 CFU IRT5 probiotics powder in 300 μL PBS once daily, both groups for 11 to 12 days. Simultaneously, all mice underwent dry eye induction. Tear secretion, corneal staining and conjunctival goblet cell density were evaluated. Quantative real-time polymerase chain reaction (RT-PCR) for inflammation-related markers was performed. 16S ribosomal RNA of fecal microbiome was analyzed and compositional difference, alpha and beta diversities were assessed.ResultsThere was no difference in NEI score but significant increase in tear secretion was observed in IRT5 group (p < 0.001). There was no significant difference in goblet cell density between groups. Quantative RT-PCR of cornea and conjunctiva revealed increased TNF-α expression in IRT5 group (p < 0.001) whereas other markers did not significantly differ from control. IRT5 group had significantly increased species diversity by Shannon index (p = 0.041). Beta diversity of genus by UniFrac principle coordinates analysis showed significant distance between groups (p = 0.001). Compositional differences between groups were observed and some were significantly associated with tear secretion. Multivariate linear regression analysis revealed Christensenellaceae (p = 0.009), Lactobacillus Helveticus group (p = 0.002) and PAC001797_s (p = 0.011) to strongly influence tear secretion.ConclusionIn experimental dry eye model, IRT5 probiotics treatment partially improves experimental dry eye by increasing tear secretion which was associated with and influenced by the change in intestinal microbiome. Also, intestinal microbiome may affect the lacrimal gland through a different mechanism other than regulating inflammation.

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Research Questions and Outcomes Prioritized by Patients With Dry Eye.

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Research Questions and Outcomes Prioritized by Patients With Dry Eye.

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