• United States Preventive Services Task Force. Screening for syphilis infection: recommendation statement. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2004 Jul. 8 p. [18 references]

This is the current release of the guideline.

This version updates a previously published guideline: U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore (MD): Williams & Wilkins; 1996. Chapter 26, Screening for syphilis. p. 287-92.

Syphilis

Prevention
Screening

Family Practice
Internal Medicine
Obstetrics and Gynecology
Pediatrics

Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians

• To summarize the U.S. Preventive Services Task Force recommendations on screening for syphilis and the supporting scientific evidence
• To update the 1996 recommendations contained in the Guide to Clinical Preventive Services, Second Edition

• Persons at increased risk for syphilis infection seen in primary care settings
• All pregnant women seen in primary care settings

Screening for syphilis using nontreponemal tests, such as the Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagin (RPR), followed by a confirmatory fluorescent treponemal antibody absorbed (FTA-ABS) or Treponema pallidum particle agglutination (TP-PA)

• Key Question 1: Is there new direct evidence that screening for syphilis reduces morbidity or mortality, the prevalence of congenital syphilis in neonates, or disease transmission?
• Key Question 2: Can high-risk groups and individuals be reliably identified?
• Key Question 3: Is there new information on screening tests and methods?
• Key Question 4: What are the harms and costs of screening?
• Key Question 5: Is there new information on the effectiveness of treatment?
• Key Question 6: What are the harms and costs of treatment?

Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Note from the National Guideline Clearinghouse (NGC): A targeted review of the literature was prepared by the Oregon Evidence-based Practice Center (EPC) for the Agency for Healthcare Research and Quality (AHRQ) for use by the U.S. Preventive Services Task Force (USPSTF) (see the "Companion Documents" field).

Search Strategy

MEDLINE® was searched from 1996 to September 2003 (see Appendix 1 in the companion document). References cited by expert reviewers were also included. Captured titles and/or abstracts were downloaded and imported into the EndNote program to create a library. Titles and/or abstracts were dual-reviewed for inclusion or exclusion. Full-text articles were retrieved and reviewed using specific inclusion and exclusion criteria (see Appendix 2 in the evidence review).

Five hundred and twenty-seven abstracts and titles were identified from the MEDLINE search; 89 full-text articles were retrieved for additional review: 71 from the MEDLINE search and 18 from experts and reference lists. In addition, a systematic review of antenatal screening in the United Kingdom was reviewed for this update.

Weighting According to a Rating Scheme (Scheme Given)

The U.S. Preventive Services Task Force (USPSTF) grades the quality of the overall evidence for a service on a 3-point scale (good, fair, poor):

Good

Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes.

Fair

Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes.

Poor

Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.

Systematic Review

Not stated

Balance Sheets
Expert Consensus

When the overall quality of the evidence is judged to be good or fair, the U.S. Preventive Services Task Force (USPSTF) proceeds to consider the magnitude of net benefit to be expected from implementation of the preventive service. Determining net benefit requires assessing both the magnitude of benefits and the magnitude of harms and weighing the two.

The USPSTF classifies benefits, harms, and net benefits on a 4-point scale: "substantial," "moderate," "small," and "zero/negative."

"Outcomes tables" (similar to "balance sheets") are the USPSTF's standard resource for estimating the magnitude of benefit. These tables, prepared by the topic teams for use at USPSTF meetings, compare the condition specific outcomes expected for a hypothetical primary care population with and without use of the preventive service. These comparisons may be extended to consider only people of specified age or risk groups or other aspects of implementation. Thus, outcomes tables allow the USPSTF to examine directly how the preventive service affects benefits for various groups.

When evidence on harms is available, the topic teams assess its quality in a manner like that for benefits and include adverse events in the outcomes tables. When few harms data are available, the USPSTF does not assume that harms are small or nonexistent. It recognizes a responsibility to consider which harms are likely and judge their potential frequency and the severity that might ensue from implementing the service. It uses whatever evidence exists to construct a general confidence interval on the 4-point scale (e.g., substantial, moderate, small, and zero/negative).

Value judgments are involved in using the information in an outcomes table to rate either benefits or harms on the USPSTF's 4-point scale. Value judgments are also needed to weigh benefits against harms to arrive a rating of net benefit.

In making its determinations of net benefit, the USPSTF strives to consider what it believes are the general values of most people. It does this with greater confidence for certain outcomes (e.g., death) about which there is little disagreement about undesirability, but it recognizes that the degree of risk people are willing to accept to avert other outcomes (e.g., cataracts) can vary considerably. When the USPSTF perceives that preferences among individuals vary greatly, and that these variations are sufficient to make trade-off of benefits and harms a "close-call," then it will often assign a C recommendation (see the "Recommendation Rating Scheme" field). This recommendation indicates the decision is likely to be sensitive to individual patient preferences.

The USPSTF uses its assessment of the evidence and magnitude of net benefit to make recommendations. The general principles the USPSTF follows in making recommendations are outlined in Table 5 of the companion document cited below. The USPSTF liaisons on the topic team compose the first drafts of the recommendations and rationale statements, which the full panel then reviews and edits. Recommendations are based on formal voting procedures that include explicit rules for determining the views of the majority.

From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM, Atkins D. Current methods of the U.S. Preventive Services Task Force: a review of the process. Methods Work Group, Third U.S. Preventive Services Task Force. Am J Prev Med 2001 Apr;20(3S):21-35.

The USPSTF grades its recommendations according to one of 5 classifications (A, B, C, D, I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms):

A

The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms.

B

The USPSTF recommends that clinicians provide [the service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms.

C

The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation.

D

The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits.

I

The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that [the service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined.

Seven cost studies done in different countries support continued universal testing during pregnancy. In a study done in the United Kingdom, universal prenatal screening of pregnant women was about as cost-effective as targeted screening programs.

Comparison with Guidelines from Other Groups
External Peer Review
Internal Peer Review

Peer Review. Before the U.S. Preventive Services Task Force (USPSTF) makes its final determinations about recommendations on a given preventive service, the Evidence-based Practice Center and the Agency for Healthcare Research and Quality send a draft systematic evidence review to 4 to 6 external experts and to federal agencies and professional and disease-based health organizations with interests in the topic. They ask the experts to examine the review critically for accuracy and completeness and to respond to a series of specific questions about the document. After assembling these external review comments and documenting the proposed response to key comments, the topic team presents this information to the Task Force in memo form. In this way, the Task Force can consider these external comments and a final version of the systematic review before it votes on its recommendations about the service. Draft recommendations are then circulated for comment from reviewers representing professional societies, voluntary organizations and Federal agencies. These comments are discussed before the whole USPSTF before final recommendations are confirmed.

Recommendation of Others. Recommendations for screening for syphilis from the following groups were discussed: Centers for Disease Control and Prevention, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists.

The U.S. Preventive Services Task Force (USPSTF) grades its recommendations (A, B, C, D, or I) and the quality of the overall evidence for a service (good, fair, poor). The definitions of these grades can be found at the end of the "Major Recommendations" field.

• The USPSTF strongly recommends that clinicians screen persons at increased risk for syphilis infection. A recommendation.

Although the USPSTF found no new direct evidence that screening for syphilis infection leads to improved health outcomes in persons at increased risk (see "Clinical Considerations"), there is adequate evidence that screening tests can accurately detect syphilis infection and that antibiotics can cure syphilis. Screening may result in potential harms (such as clinical evaluation of false-positive results, unnecessary anxiety to the patient, and harms of antibiotic use). The USPSTF concludes that the benefits of screening persons at increased risk for syphilis infection substantially outweigh the potential harms.

• The USPSTF strongly recommends that clinicians screen all pregnant women for syphilis infection. A recommendation.

The USPSTF found observational evidence that the universal screening of pregnant women decreases the proportion of infants with clinical manifestations of syphilis infection and those with positive serologies. The USPSTF concludes that the benefits of screening all pregnant women for syphilis infection substantially outweigh potential harms.

• The USPSTF recommends against routine screening of asymptomatic persons who are not at increased risk for syphilis infection. D recommendation.

Given the low incidence of syphilis infection in the general population and the consequent low yield of such screening, the USPSTF concludes that potential harms of screening (i.e., opportunity cost, false-positive tests, and labeling) in a low-incident population outweigh the benefits.

Clinical Considerations

• Populations at increased risk for syphilis infection (as determined by incident rates) include men who have sex with men and engage in high-risk sexual behavior, commercial sex workers, persons who exchange sex for drugs, and those in adult correctional facilities. There is no evidence to support an optimal screening frequency in this population. Clinicians should consider the characteristics of the communities they serve in determining appropriate screening strategies. Prevalence of syphilis infection varies widely among communities and patient populations. For example, the prevalence of syphilis infection differs by region (the prevalence of infection is higher in the southern U.S. and in some metropolitan areas than it is in the U.S. as a whole) and by ethnicity (the prevalence of syphilis infection is higher in Hispanic and African American populations than it is in the white population).
• Persons diagnosed with other sexually transmitted diseases (STDs) (i.e., chlamydia, gonorrhea, genital herpes simplex, human papilloma virus, and human immunodeficiency virus [HIV]) may be more likely than others to engage in high-risk behavior, placing them at increased risk for syphilis; however, there is no evidence that supports the routine screening of individuals diagnosed with other STDs for syphilis infection. Clinicians should use clinical judgment to individualize screening for syphilis infection based on local prevalence and other risk factors (see above).
• Nontreponemal tests commonly used for initial screening are the Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagin (RPR), followed by a confirmatory fluorescent treponemal antibody absorbed (FTA-ABS) or Treponema pallidum particle agglutination (TP-PA). The optimal screening interval in average- and high-risk persons has not been determined.
• All pregnant women should be tested at their first prenatal visit. For women in high-risk groups, repeat serologic testing may be necessary in the third trimester and at delivery. Follow-up serologic tests should be obtained to document decline initially after treatment. These follow-up tests should be performed using the same nontreponemal test initially used to document infections (e.g., VDRL or RPR) to ensure comparability.

Definitions:

Strength of Recommendations

The USPSTF grades its recommendations according to one of 5 classifications (A, B, C, D, I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms):

A

The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms.

B

The USPSTF recommends that clinicians provide [the service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms.

C

The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation.

D

The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits.

I

The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that [the service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined.

Strength of Evidence

The USPSTF grades the quality of the overall evidence for a service on a 3-point scale (good, fair, poor):

Good

Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes.

Fair

Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes.

Poor

Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.

None provided

The type of evidence supporting the recommendations is identified in the "Major Recommendations" field.

• Although the USPSTF found no new direct evidence that screening for syphilis infection leads to improved health outcomes in persons at increased risk (see "Clinical Considerations" in the "Major Recommendations" field), there is adequate evidence that screening tests can accurately detect syphilis infection and that antibiotics can cure syphilis. Screening may result in potential harms (such as clinical evaluation of false-positive results, unnecessary anxiety to the patient, and harms of antibiotic use). The USPSTF concludes that the benefits of screening persons at increased risk for syphilis infection substantially outweigh the potential harms.
• The USPSTF found observational evidence that the universal screening of pregnant women decreases the proportion of infants with clinical manifestations of syphilis infection and those with positive serologies. The USPSTF concludes that the benefits of screening all pregnant women for syphilis infection substantially outweigh potential harms.

No studies have directly looked at the harms of screening or treatment. Potential harms of screening may include opportunity costs to the clinician and patient (time, resources, etc.) and false-positive results, which may lead to stress, labeling, and further work-up. Harms of treatment include adverse drug-related effects, including anaphylaxis from penicillin allergy and the Jarisch-Herxheimer reaction (febrile reaction with headache, myalgia, and other symptoms) that may occur within the first 24 hours after any therapy for syphilis.

Recommendations made by the U.S. Preventive Services Task Force 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.

Staying Healthy

Effectiveness
Patient-centeredness

• United States Preventive Services Task Force. Screening for syphilis infection: recommendation statement. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2004 Jul. 8 p. [18 references]

Not applicable: The guideline was not adapted from another source.

1996 (revised 2004 Jul 27)

United States Preventive Services Task Force - Independent Expert Panel

The U.S. Preventive Services Task Force (USPSTF) is a federally-appointed panel of independent experts. Conclusions of the U.S. Preventive Services Task Force do not necessarily reflect policy of the U.S. Department of Health and Human Services (DHHS) or its agencies.

United States Government

U.S. Preventive Services Task Force (USPSTF)

The U.S. Preventive Services Task Force has an explicit policy concerning conflict of interest. All members and evidence-based practice center (EPC) staff disclose at each meeting if they have an important financial conflict for each topic being discussed. Task Force members and EPC staff with conflicts can participate in discussions about evidence, but members abstain from voting on recommendations about the topic in question.

From: Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow, CD, Teutsch SM, Atkins D. Current methods of the U.S. Preventive Services Task Force: a review of the process. Methods Work Group, Third U.S. Preventive Services Task Force. Am J Prev Med 2001 Apr;20(3S):21-35.

This is the current release of the guideline.

This version updates a previously published guideline: U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore (MD): Williams & Wilkins; 1996. Chapter 26, Screening for syphilis. p. 287-92.

This summary was completed by ECRI on July 20, 2004.