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You are here: HomePublic Comments and NominationsOpportunity for Public CommentDraft Research Plan : Draft Research Plan

Draft Research Plan

Draft Research Plan for Impaired Visual Acuity and Glaucoma in Adults: Screening

This opportunity for public comment expires on March 11, 2020 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Draft: Proposed Analytic Frameworks

Screening for Impaired Visual Acuity

The analytic framework depicts the relationship between the Key Questions for the systematic review within the context of the populations, interventions, outcomes, and harms of screening for and treatment of impaired visual acuity. The far left of the framework describes the target population as asymptomatic adults age 65 years and older without known vision impairment. To the right of the population is a line representing the diagnostic accuracy of screening leading to the diagnosis of impaired visual acuity (Key Question 3) and instruments for identifying patients at higher risk of impaired visual acuity (Key Question 4). An additional arrow indicates potential harms of screening (Key Question 2). A subsequent line and area of the framework leads from the diagnosis to outcomes from treatment (Key Questions 5 and 6), specifically improved visual acuity, morbidity, mortality, vision-related quality of life, functional status, and cognition. An additional arrow indicates potential harms of treatment (Key Question 7). An overarching arrow leading from the initial screening population to the outcomes represents the direct effects of screening on outcomes (Key Question 1).

Note: Subpopulations of interest include those defined by age, sex, race/ethnicity, setting (e.g., rural or urban), and functional and cognitive status.
*“Asymptomatic” persons are defined as those without known impaired visual acuity (based on current corrected vision) who have not sought care for evaluation of vision problems.
Conditions of interest include impaired visual acuity due to uncorrected refractive errors, cataracts, and age-related macular degeneration.

Abbreviation: KQ = key question.

Screening for Glaucoma

The analytic framework depicts the relationship between the Key Questions for the systematic review within the context of the populations, interventions, outcomes, and harms of screening for and treatment of glaucoma. The far left of the framework describes the target population as asymptomatic adults without known open-angle glaucoma. To the right of the population is a line representing the diagnostic accuracy of screening leading to the diagnosis of open-angle glaucoma (Key Question 4) and instruments for identifying patients at higher risk of open-angle glaucoma (Key Question 5). An additional arrow indicates potential harms of screening (Key Question 2). A subsequent line and area of the framework leads from the open-angle glaucoma diagnosis to outcomes from treatment (Key Questions 6, 8, and 10), including the intermediate outcomes of intraocular pressure, optic nerve assessment, and visual field assemment, and the health outcomes of reduced visual impairment and improved patient-reported outcomes. An additional arrow indicates potential harms of treatment (Key Questions 7, 9, and 11). An overarching arrow leading from the initial screening population to the outcomes represents the direct effects of screening (Key Question 1) and referral to an eye health provider (Key Question 3) on outcomes.

Note: Subpopulations of interest include those defined by age, sex, race/ethnicity, and setting (e.g., rural or urban).
*Includes open-angle glaucoma suspects.

Abbreviation: KQ = key question.

Draft: Proposed Key Questions to Be Systematically Reviewed

Screening for Impaired Visual Acuity

  1. What are the effects of vision screening in asymptomatic older adults vs. no screening on visual acuity, morbidity or mortality, general or vision-related quality of life, functional status, or cognition?
  2. What are the harms of vision screening in asymptomatic older adults vs. no screening?
  3. What is the diagnostic accuracy of screening for impaired visual acuity due to uncorrected refractive error, cataracts, or age-related macular degeneration?
  4. What is the accuracy of instruments for identifying patients at higher risk of impaired visual acuity due to uncorrected refractive error, cataracts, or age-related macular degeneration?
  5. What are the effects of treatment of wet or dry age-related macular degeneration vs. placebo or no treatment on visual acuity, morbidity, mortality, general or vision-related quality of life, functional status, or cognition?
  6. What are the effects of treatment of wet age-related macular degeneration with aflibercept or brolucizumab-dbll vs. other vascular endothelial growth factor inhibitors on visual acuity, morbidity, mortality, general or vision-related quality of life, functional status, or cognition?
  7. What are the harms of treatment of early impaired visual acuity due to wet or dry age-related macular degeneration?

Screening for Glaucoma

  1. What are the effects of screening for open-angle glaucoma vs. no screening on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  2. What are the harms of screening for open-angle glaucoma vs. no screening?
  3. What are the effects of referral to an eye health provider vs. no referral on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  4. What is the accuracy of screening for diagnosis of open-angle glaucoma?
  5. What is the accuracy of instruments for identifying patients at higher risk of open-angle glaucoma?
  6. What are the effects of medical therapies for open-angle glaucoma vs. placebo or no therapy on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  7. What are the harms of medical therapies for open-angle glaucoma vs. placebo or no therapy?
  8. What are the effects of medical therapies newly approved by the U.S. Food and Drug Administration (FDA) (latanoprostene bunod and netarsudil) vs. older medical therapies on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  9. What are the harms of newly FDA-approved medical therapies vs. older medical therapies?
  10. What are the effects of treatment of open-angle glaucoma with laser trabeculoplasty vs. no trabeculoplasty or medical therapy on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  11. What are the harms of treatment of open-angle glaucoma with laser trabeculoplasty vs. no trabeculoplasty or medical therapy?

Draft: Proposed Contextual Question

Screening for Glaucoma

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the association between changes in intraocular pressure, visual field loss, visual acuity, or optic nerve damage following treatment of open-angle glaucoma and improvement in visual impairment, quality of life, or function, and what is the association between changes in intraocular pressure and visual field loss?

Draft: Proposed Research Approach

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

Screening for Impaired Visual Acuity

  Included Excluded
Populations KQs 1–4: Asymptomatic adults age ≥65 years without known impaired visual acuity (based on current corrected vision) who have not sought care for evaluation of vision problems

KQs 5–7: Asymptomatic adults with vision impairment (current corrected visual acuity worse than 20/40 but better than 20/200) due to uncorrected refractive errors (myopia, hyperopia, astigmatism, or presbyopia), age-related macular degeneration, or cataracts

KQs 1–4: Adults with known impaired visual acuity based on current corrected vision or those who have sought care for evaluation of vision problems

KQs 5–7: Adults with visual acuity worse than 20/200 or other causes of vision loss

Interventions KQs 1, 2: Vision screening performed in primary care or community-based settings, including multicomponent screening with a distinct vision screening component

KQ 3, 4: Vision screening tests performed in primary care or community-based settings; questions or questionnaires for impaired visual acuity

KQs 5–7: For treatment of wet age-related macular degeneration, vascular endothelial growth factor inhibitors (ranibizumab, pegaptanib, aflibercept, brolucizumab-dbll, and bevacizumab); for treatment of dry age-related macular degeneration, vitamins and antioxidants

KQs 1, 2: Vision screening tests performed in eye specialty settings

KQ 3, 4: Diagnostic tests for vision screening performed in eye specialty settings (including funduscopic examination performed by an eye professional and specialized diagnostic testing)

KQs 5–7: Laser photocoagulation, photodynamic therapy, and treatment of uncorrected refractive error and cataracts

Outcomes KQs 1, 2, 5–7: Visual acuity; vision-related quality of life; functional capacity, including ability to drive and driving outcomes; other measures of morbidity; mortality; cognition; harms, including falls and fractures; and other treatment-related harms

KQ 3, 4: Sensitivity; specificity; positive and negative predictive values, areas under the receiver operating curve; and other measures of diagnostic test accuracy

KQs 1, 2, 5–7: Reading speed and other tests of vision function
Study designs KQs 1, 2: RCTs and controlled observational studies comparing vision screening to no screening, delayed screening, or usual care (i.e., targeted screening)

KQ 3, 4: Studies evaluating diagnostic accuracy of a screening question or diagnostic test compared to a reference standard

KQs 5–7: RCTs comparing treatment with no treatment (including sham injection); controlled observational studies will be included if evidence on harms from RCTs trials is insufficient

 
Language English  
Settings Settings applicable to the United States that are primary care–relevant  

Abbreviations: KQ = key question; RCTs = randomized, controlled trials.

Screening for Glaucoma

  Included Excluded
Definitions of disease Primary open-angle glaucoma: Glaucoma defined by presence of glaucomatous optic disc changes and retinal nerve fiber layer changes, with or without associated visual field changes or elevated intraocular pressure

Glaucoma suspect: Patients do not meet criteria for glaucoma but have a consistently elevated intraocular pressure, a suspicious appearance of the optic nerve, or visual field abnormalities consistent with glaucoma

 
Populations KQs 1–5: Asymptomatic adults age ≥40 years without visual symptoms

KQs 6–11: Adults with screen-detected, asymptomatic, or early primary open-angle glaucoma

KQs 1–5: Patients with visual symptoms, case-control studies of patients known to have open-angle glaucoma and normal controls

KQs 6–11: Patients with open-angle glaucoma and severe visual field or visual deficits; patients with narrow-angle glaucoma, secondary glaucoma, juvenile glaucoma, or other glaucoma

Interventions KQs 1, 2, 4, 5: Screening with a comprehensive eye examination (as defined in the studies) by an eye health provider; screening tests performed in primary care or applicable to primary care; and instruments for identifying persons at increased risk of open-angle glaucoma

KQ 3: Referral to an eye specialist

KQs 6–11: Treatment with:

  • First-line medical therapies (prostaglandin analogues, beta blockers, alpha2 agonists, and carbonic anhydrase inhibitors)
  • Selective laser trabeculoplasty
  • Latanoprostene bunod
  • Netarsudil
KQs 6–11: Second-line medical therapies, surgery, non-FDA–approved therapies, therapies not commonly used as first-line therapy in U.S. practice
Comparisons KQs 1, 2: No screening

KQ 3: No referral

KQs 4, 5: Reference standard for open-angle glaucoma (as defined in the studies)

KQs 6–11: Placebo, no therapy, or first-line medical therapies (i.e., selective laser trabeculoplasty, latanoprostene bunod, and netarsudil)

Comparisons involving second-line medical therapies or surgery
Outcomes KQs 1–3, 6–11: Intraocular pressure, visual field loss, visual acuity, optic nerve damage, visual impairment (defined as visual acuity <20/70 or <20/100), quality of life, function, and harms (e.g., eye irritation, corneal abrasion, infection, anterior synechiae, or cataracts)

KQs 4, 5: Measures of diagnostic accuracy

Other (not listed) outcomes
Setting Studies conducted in high-income countries applicable to U.S. practice; includes studies performed in primary care (including use of telemedicine) and specialty settings  
Study Design RCTs of screening and treatment; cohort studies for harms of treatment if RCTs not available; studies of diagnostic accuracy; and high-quality systematic reviews Case series, case reports, and case-control studies
Study Quality Fair- or good-quality studies Poor-quality studies

Abbreviations: FDA = U.S. Food and Drug Administration; KQ = key question; RCT = randomized controlled trial; U.S. = United States.

Current as of: February 2020

Internet Citation: Draft Research Plan: Impaired Visual Acuity and Glaucoma in Adults: Screening. U.S. Preventive Services Task Force. February 2020.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/vision-in-adults-screening

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