Draft Research Plan
Draft Research Plan for Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication
This opportunity for public comment expires on January 10, 2018 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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.
Draft: Proposed Contextual Question
The contextual question will not be systematically reviewed and is not shown in the Analytic Framework.
- 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?
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 (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.
|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)
|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.
Internet Citation: Draft Research Plan: Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication. U.S. Preventive Services Task Force. December 2017.