Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

Lê, Jimmy T.; Viswanathan, S; Tarver, Michelle E.; Eydelman, Malvina B.; Li, Tianjing

doi:10.1001/jamaophthalmol.2016.2101

Cited by 18 publications

(13 citation statements)

References 8 publications

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“…FDA has encouraged and, more recently, issued guidance on patient-reported outcomes and patient preference information to accompany traditional study findings relating to safety and effectiveness endpoints as part of medical device submissions [5,6]. Patient input can be incorporated into the development, evaluation, and labeling of medical products [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices

Lê

Cui

et al. 2019

Eye

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Background Many therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies. Objectives To summarize the progress to date. Methods Questionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods. Results Questionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day." Conclusions Patients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices.

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Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices

Lê

Cui

et al. 2019

Eye

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“…While most patients with OAG exhibit elevated intraocular pressure (IOP) upon repeated measurement, IOP is not a direct measure of structural or functional glaucomatous optic neuropathy and not all patients with glaucoma present with elevated IOP (AAO 2015; Le 2016; Medeiros 2015). Nevertheless, because IOP is the only known modifiable risk factor, treatment for OAG has focused predominantly on lowering IOP to slow disease progression and decrease the rate of visual field loss (Li 2016; Quigley 2007).…”

Section: Introductionmentioning

confidence: 99%

Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma

Gazzard

Bunce

et al. 2016

Cochrane Database of Systematic Reviews

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This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective is to assess the comparative effectiveness and safety of ab interno trabecular bypass surgery with iStent or iStent inject for OAG in comparison to conventional medical, laser, or surgical treatment. A secondary objective is to examine the effectiveness and safety of iStent or iStent Inject surgery in people who have concomitant phacoemulsification.

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“…Our findings on outcomes must be explored further to ensure that they make sense as stated to clinicians and are important to patients. 39 For example, the use of visual loss and visual acuity as a single outcome may be problematic. The terms visual loss or vision loss can be too vague and interpreted inconsistently, that is, they may include loss of vision function perceived by a patient based on visual acuity in both eyes or loss of vision or loss of visual acuity in 1 eye.…”

Section: Discussionmentioning

confidence: 99%

Setting Priorities for Diabetic Retinopathy Clinical Research and Identifying Evidence Gaps

Lê

Hutfless²,

et al. 2017

Ophthalmology Retina

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Purpose Prioritizing comparative effectiveness research may contribute to obtaining answers that clinicians perceive they need and may minimize research that could be considered wasteful. Our objective was to identify evidence gaps and set priorities for new systematic reviews and randomized controlled trials for managing diabetic retinopathy (DR), including diabetic macular edema (DME). Design Cross-sectional study. Participants Diabetic Retinopathy Clinical Research Network (DRCR.net) investigators. Methods We provided recommendations from the American Academy of Ophthalmology’s 2012 Preferred Practice Patterns for Diabetic Retinopathy as 91 answerable clinical research questions about intervention effectiveness to 410 DRCR.net investigators to rate each question’s importance from 0 (not important) to 10 (very important) using a 2-round Delphi survey and to suggest additional questions. We considered questions as high priority if at least 75% of respondents to both rounds assigned an importance rating of 5 or more in round 2. We also extracted outcome measures relevant to DR and asked respondents to identify those that must be measured in all studies. We mapped Cochrane reviews published up to March 2016 to high-priority clinical research questions. Main Outcome Measure Ranking of importance of each clinical question. Results Thirty-two individuals completed rounds 1 and 2 and suggested 15 questions. Among the final list of 106 clinical research questions, 22 questions met our definition of high priority: 9 of 22 concerned the effectiveness of anti-VEGF therapy, and 13 of 22 focused on how often patients should be followed up (re-examination) and treatment effectiveness in patients with specific characteristics (e.g., DME). Outcomes that 75% or more of respondents marked as “must be measured in all studies” included visual acuity and visual loss, death of participants, and intraocular pressure. Only 1 prioritized question was associated with conclusive evidence from a Cochrane systematic review. Conclusions A limited response rate among DRCR.net members identified 22 comparative effectiveness research questions as high priority for the management of DR, including DME, but few were associated with Cochrane reviews. These results support the need of systematic reviews and randomized controlled trials to address evidence gaps.

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Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

Cited by 18 publications

References 8 publications

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices

Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma

Setting Priorities for Diabetic Retinopathy Clinical Research and Identifying Evidence Gaps

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