Draft Research Plan

Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication

December 07, 2017

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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Figure 1 is the analytic framework that depicts the two Key Questions to be addressed in the systematic review. The figure illustrates how ocular prophylaxis for gonococcal ophthalmia neonatorum may result in improved health outcomes, including reduced newborn conjunctivitis and blindness (Key Question 1). Additionally, the figure illustrates whether ocular prophylaxis for gonococcal ophthalmia neonatorum is associated with any harms (Key Question 2).

  1. What is the effectiveness of ocular prophylaxis for gonococcal ophthalmia neonatorum?
  2. What are the harms of ocular prophylaxis for gonococcal ophthalmia neonatorum?

The contextual question will not be systematically reviewed and is not shown in the Analytic Framework.

  1. What are the comparative effectiveness and harms of various agents used for ocular prophylaxis for gonococcal ophthalmia neonatorum? What is the availability of these agents in the United States?

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 (KQs). The Reaffirmation Evidence Update for this topic will be conducted using rapid synthesis procedures, as described in Section 4.7 of the USPSTF Procedure Manual.

Category Included Excluded
Populations Newborns Populations other than newborns
Interventions Ocular prophylaxis for gonococcal ophthalmia neonatorum Treatments other than ocular prophylaxis
Comparisons KQ 1: No treatment, placebo (randomized, controlled trials)

KQ 2: No treatment (randomized, controlled trials) or no comparator (observational studies)

 Comparative effectiveness*
Outcomes KQ 1: Incidence of gonococcal ophthalmia neonatorum, visual impairment

KQ 2: Harms of ocular prophylaxis

 Cost-effectiveness or cost-related outcomes
Setting Any birth setting None
Country Studies conducted in countries categorized as “high” or “very high” on the Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries categorized as less than “high” or “very high” on the Human Development Index
Study design KQ 1: Randomized, controlled trials; systematic reviews and meta-analyses

KQ 2: Randomized, controlled trials; systematic reviews and meta-analyses; cohort studies, case-control studies, and large case series (≥100 subjects)

 Narrative reviews, editorials, and case reports
Publication language English-language only Languages other than English
Study quality Fair- or good-quality studies Poor-quality studies

* Comparative effectiveness of treatments will be examined for a contextual question using a nonsystematic, targeted search.