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Draft Research Plan

Draft Research Plan for Chlamydial and Gonococcal Infections: Screening

This opportunity for public comment expires on March 6, 2019 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 Framework

The analytic framework depicts the relationship between the populations, interventions, outcomes, and harms of screening for chlamydia and gonorrhea. The far left of the framework describes the target population as asymptomatic adolescents and adults, including those who are pregnant. To the right of the population is an arrow that represents chlamydia and gonorrhea screening, including screening strategies for populations at increased risk (key question 2) and test methods of anatomic sites (key question 3), that leads to the population with chlamydial and gonococcal infection. An arrow below key questions 2 and 3 represents harms or adverse effects of screening for chlamydia and gonorrhea (key question 4). To the right of the population with chlamydial and gonorrheal infection a dotted line arrow represents treatment and leads to the three clinical health outcomes, including reduced complications of chlamydial or gonococcal infection, reduced transmission or acquisition of disease, and reduced adverse maternal, fetal, or infant outcomes. The clinical health outcome of reduced transmission or acquisition of disease is an intermediate outcome, as noted by the rounded edges of the box. A dotted line arrow to the right of reduced transmission or acquisition of disease leads to reduced adverse maternal, fetal, or infant outcomes, depicting an association. Arrows with dotted lines acknowledge the relationship between infection and outcomes, but will not be directly addressed in this systematic review. An overarching arrow that extends from the screened population to the clinical health outcomes symbolizes the effectiveness of screening (key question 1).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. In sexually active, asymptomatic adolescents and adults, including those who are pregnant, what is the effectiveness of screening for chlamydial and gonococcal infections in reducing complications of infection and transmission or acquisition of disease, including gonorrhea, chlamydia, and HIV?
  2. What is the effectiveness of risk stratification methods or alternative screening strategies for identifying persons who are at increased risk for chlamydial and gonococcal infections (such as those who are younger, men who have sex with men)? Screening strategies include cotesting for concurrent sexually transmitted infections, including HIV, or using different screening intervals.
  3. What is the diagnostic accuracy of anatomic site–specific testing and self-collected swabs for identifying persons with chlamydial and gonococcal infections?
  4. What are the harms of screening for chlamydial and gonococcal infections (such as labeling, anxiety, false-positive results, false-negative results/reassurance, change in risk behaviors or risk perception)?

Draft: Proposed Contextual Question

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

  1. What is the effectiveness of partner management (such as traditional partner notification and management, expedited partner therapy) in reducing rates of reinfection or acquisition of chlamydial and gonococcal infections?

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).

  Included Excluded
Populations Asymptomatic adults (ages ≥18 years) and adolescents (ages 13 to <18 years); pregnant persons Patients with symptoms of chlamydial or gonococcal infections; patients with current or recent diagnosis of any sexually transmitted infection, including HIV; children (age <13 years); studies in which the majority of participants was comprised of HIV-infected persons or HIV-uninfected persons currently using pre-exposure prophylaxis
Interventions KQs 1, 4: Screening for chlamydial and gonococcal infections

KQ 2: Screening strategies to detect infection, including selective screening of high-risk groups (such as persons who are younger, men who have sex with men, persons with high-risk sexual behavior or high-risk sexual partners), cotesting for concurrent sexually transmitted infections, including HIV; and using different screening intervals

KQ 3: Test methods and approaches to detect chlamydial or gonococcal infections in biological specimens from various anatomical sites (urine, endocervix, urethra, vagina, anus, pharynx)

No intervention; no screening
Comparisons KQs 1, 2: Screening vs. no screening or alternate screening strategy or methods

KQ 3: Gold standard

No comparison
Outcomes KQ 1: Complications of infection (pelvic inflammatory disease, ectopic pregnancy, infertility, chronic pelvic pain, epididymitis, other clinical outcomes); disease transmission; reproductive, pregnancy-related, and perinatal outcomes

KQ 2: Accuracy of screening strategies

KQ 3: Diagnostic accuracy of anatomic site–specific testing; accuracy of self-collected specimens

KQ 4: Harms from screening (such as labeling, false-negative results, false-positive results, change in risk perception or risk behaviors)

Intermediate outcomes (outcomes that are not health outcomes, such as eradication of infection, laboratory studies)

 

Setting Primary care and primary care–referable settings (such as correctional settings and community care, such as schools and sexually transmitted infection clinics); emergency departments; military/college intake or entrance settings Other settings not relevant or referable to primary care
Study Design All KQs: Good-quality systematic reviews

Benefits: Randomized, controlled trials; controlled observational trials

Harms: Randomized, controlled trials; controlled observational trials; uncontrolled observational trials

Uncontrolled observational trials, case reports, small uncontrolled observational trials, and case studies
Study Quality Fair- and good-quality studies based on USPSTF criteria Poor-quality studies

Abbreviations: HIV = human immunodeficiency virus, KQ = key question, USPSTF = U.S. Preventive Services Task Force.

Current as of: February 2019

Internet Citation: Draft Research Plan: Chlamydial and Gonococcal Infections: Screening. U.S. Preventive Services Task Force. February 2019.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/chlamydial-and-gonococcal-infections-screening

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