Final Research Plan
Chlamydia and Gonorrhea: Screening
June 15, 2013
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.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from March 7 until April 3, 2013 at 5:00 p.m., ET.
Asymptomatic, Sexually Active Men and Nonpregnant Women, Including Adolescents
[D] Select for Text Description.
I. Analytic Framework (Text Description)
This analytic framework is a diagram that depicts the events that asymptomatic, sexually active men and women, including adolescents, may experience during a screening for gonorrhea or chlamydia. During the screening, they may experience adverse events, they may be diagnosed with a gonococcal or chlamydia infection, and they may go through treatment. The treatment could lead to reduced complications of the gonococcal or chlamydial infection, and it may lead to reduced transmission or acquisition of disease.
Asymptomatic Pregnant Women
[D] Select for Text Description.
II. Analytic Framework (Text Description)
This analytic framework is a diagram that depicts the events that asymptomatic pregnant women may experience during a screening for gonorrhea or chlamydia. During the screening, they may experience adverse events, they may be diagnosed with a gonococcal or chlamydia infection, and they may go through treatment, which could lead to adverse effects. The treatment could lead to reduced complications of the gonococcal or chlamydial infection and to reduced adverse pregnancy outcomes. The treatment could also lead to reduced tramsmission of the infection to the newborn, and it may lead to reduced adverse infant outcomes.
Asymptomatic, Sexually Active Men and Nonpregnant Women, Including Adolescents
- How effective is screening for gonorrhea and chlamydia in reducing complications of infection and transmission or acquisition of disease, including gonorrhea, chlamydia, and HIV?
- How effective are different screening strategies in identifying persons with gonococcal and chlamydial infections? Strategies include selective screening of high-risk groups (e.g., younger populations, men who have sex with men), sampling from various anatomical sites, co-testing for concurrent sexually transmitted infections (STIs) such as HIV, and using different screening intervals.
- How accurate are screening tests in detecting gonococcal and chlamydial infections?
- What are the harms of screening for gonococcal and chlamydial infections (e.g., labeling, anxiety, false-positive results, false-negative results/reassurance)?
Asymptomatic Pregnant Women
- How effective is screening for gonococcal and chlamydial infections in reducing maternal complications, adverse pregnancy and infant outcomes, and transmission or acquisition of disease, including gonorrhea, chlamydia, and HIV?
- What are the harms of screening for gonococcal and chlamydial infections (e.g., labeling, anxiety, false-positive results, false-negative results/reassurance)?
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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).
| Category | Include | Exclude |
|---|---|---|
| Definition of Disease | Positive for chlamydia or gonorrhea on any test modality | |
| Population | Asymptomatic, pregnant and nonpregnant adults (ages ≥18 years) and adolescents (ages 13 to <18 years) | Symptomatic patients, children, persons with other STIs |
| Interventions |
Asymptomatic, sexually active men and nonpregnant women, including adolescents:
KQs 1, 4: Screening effectiveness KQs 2, 4: Screening strategies to detect infection, including selective screening of high-risk groups (e.g., younger populations, men who have sex with men), sampling from various anatomical sites (listed below), co-testing for concurrent STIs such as HIV, and using different screening intervals KQs 3, 4: Tests that detect chlamydia or gonorrhea in biological specimens from various anatomical sites: urine, endocervix, urethra, vagina, anus, pharynx Asymptomatic pregnant women: KQs 1, 2: Screening effectiveness |
|
| Comparators |
Asymptomatic, sexually active men and nonpregnant women, including adolescents:
KQs 1, 2, 4: No screening or alternate screening strategy or methods KQs 3, 4: Gold standard Asymptomatic pregnant women: KQs 1, 2: No screening or alternate screening strategy or methods |
No comparison |
| Outcomes |
Asymptomatic, sexually active men and nonpregnant women, including adolescents:
KQ 1: Reduction in:
KQ 2: Detection of infection KQ 3: Diagnostic accuracy KQ 4: Harms from screening (e.g., labeling, false-negative or false-positive results) Asymptomatic pregnant women: KQ 1: Reduction in:
KQ 2: Harms from screening (e.g., labeling, false-negative or false-positive results) |
Intermediate outcomes (outcomes that are not health outcomes, such as eradication of infection, laboratory studies) |
| Setting | Primary care settings and primary care–referable settings (e.g., correctional settings and community care, such as schools and STI clinics) | |
| Study Designs |
All KQs: Good-quality systematic reviews
Benefits: Randomized, controlled trials, controlled observational trials Harms: Randomized, controlled trials, controlled observational trials, uncontrolled observational trials |
Benefits: Uncontrolled observational trials, case reports
Harms: Small, uncontrolled observational trials, case studies |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from March 7 to April 3, 2013. In response to comments, the USPSTF clarified that the systematic review would address screening for both gonorrhea and chlamydia. The USPSTF added several explicit inclusion and exclusion criteria that had been implied in the draft Research Plan, including screening strategies, anatomical sites for testing, clinical outcomes in men, and inclusion of HIV as a concurrent STI. For the systematic review on screening in asymptomatic men, nonpregnant women, and adolescents, the target population was clarified as persons who are sexually active and reduced ectopic pregnancy was added as an outcome. For the systematic review on screening in pregnant women, reduced transmission and acquisition of disease were added as outcomes and reduced ectopic pregnancy was removed. Treatment harms will be discussed in the background section of the systematic review. Other comments addressed outcomes and interventions that are considered outside the scope of the USPSTF's focus on primary care and prevention.