Final Research Plan

Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication

February 08, 2018

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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Panel 1

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.

The draft Research Plan was available for comment from December 7, 2017 until January 10, 2018 at 5:00 p.m., ET.

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 gonococcal ophthalmia neonatorum and associated 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 the prevention of gonococcal ophthalmia neonatorum and associated blindness?
  2. What are the harms of ocular prophylaxis for the prevention of 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 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.

  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, or blindness

KQ 2: Harms of ocular prophylaxis

 Cost-effectiveness or cost-related outcomes
Setting Any birth setting No exclusions
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 not categorized as “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.

A draft Research Plan was posted for public comment on the USPSTF Web site from December 7, 2017 to January 10, 2018. Some comments suggested more consistency in the use of terms presented in the Analytic Framework and KQs, and the USPSTF implemented these suggestions. Other comments suggested further specificity for the inclusion and exclusion criteria. Because of the dearth of literature on this topic, the USPSTF made no changes that would further limit the scope of the review. Suggested details such as timing of administration will be abstracted if new literature is found or will otherwise be included in the Introduction of the evidence review. Comments also suggested including an additional contextual question to examine whether increased risk of gonococcal infection among women of childbearing age increases the benefit of providing ocular prophylaxis for gonococcal ophthalmia neonatorum. The USPSTF did not add this suggested contextual question to the Research Plan, but incidence rates will be addressed in the Introduction of the evidence review.