Annex Improving national sexually transmitted infections surveillance in Pacific Island countries and territories Consensus document on sexually transmitted infections case definitions and minimum data set Prepared by the Sexually Transmitted Infections Working Group for the Pacific including WHO UNFPA SPC UNICEF OSSHHM CDC PRHP 8 May 2008 BACKGROUND As shown by a number of studies, including the recent second-generation surveillance studies, there is a high prevalence of sexually transmitted infections (STIs) in the Pacific region. Developing a programme that will effectively address this situation will depend on how STI data from the region are collected and analysed. One of the goals of the Pacific Regional Strategy on HIV Implementation Plan (2004–2008) is to enhance national-level routine surveillance systems for HIV and other STIs. One of the identified barriers to achieving this goal is the lack of regionally appropriate case definitions and a minimum data set for STIs that would allow the collection of high-quality, comparable data across the region. Adopting a consistent approach to definitions and reporting STI cases will enable more accurate and consistent data for monitoring trends in STI incidence and prevalence over time. To ensure that national and regional programmes seriously address the high prevalence of STIs, the Sexually Transmitted Infections Working Group for the Pacific (STIWGP) was established in late 2006. The STIWGP is a technical working group comprised of representatives from the Secretariat of the Pacific Community (SPC), World Health Organization (WHO), United Nations Population Fund (UNFPA), Centers for Disease Control and Prevention (CDC), United Nations Children’s Fund (UNICEF), Pacific Regional HIV/AIDS Project (PRHP) and Oceania Society for Sexual Health and HIV Medicine (OSSHHM). The following recommendations are made by a consensus of representatives from the STIWGP. This document has adapted the WHO ‘Guidelines for Sexually Transmitted Infections Surveillance’ (1999).1 Case definitions from WHO1 and CDC2, such as that for syphilis, have been simplified to enable use of more practical and consistent definitions in Pacific small island countries and territories. This document would be useful for public health staff, STI program managers, laboratory and clinical staff. Part A provides recommendations for STI case definitions, presented according to whether they are defined by laboratory tests or clinical presentation. Part B provides recommendations for a minimum data set for STI surveillance. 1 2. 2 See www.who.int/hiv/pub/me/en/GuidelinesforSTISurveillance1999_English.pdf See www.cdc.gov/std/stats/app-casedef.htm PART A: CASE DEFINITIONS Case definitions based on laboratory (aetiologic) diagnosis Gonorrhoea case definition a) Demonstration of Neisseria gonorrhoeae in a clinical specimen by a DNA probe or PCR test OR b) Culture of gram-negative, oxidase-positive diplococci (presumptive Neisseria gonorrhoeae) from a clinical specimen OR c) Observation of gram-negative intracellular diplococci on microscopy from an eye or a male urogenital swab Note: For assessment of antimicrobial susceptibility, culture is required. Gonococcal antibiotic sensitivity surveillance Total number of isolates tested over a specified period of time, e.g. 1 year Number and percentage of isolates resistant to x antibiotic during time period Number and percentage of isolates resistant to y antibiotic during time period. (Repeated for each antibiotic tested) Chlamydia case definition Positive DNA probe or PCR test or antigen detection test for Chlamydia trachomatis Trichomonas case definition a) Presence of motile (moving) trichomonads by microscopy of a wet mount (saline microscopy) of genital swabs from women OR b) Presence of trichomonads detected by cervical (Pap) smears 3 Syphilis case definition (where history of testing and treatment is unknown) Note: The definitions for syphilis are for surveillance purposes only and are not intended to replace clinical management protocols or guide management. Treponemal tests refer to any treponemal (specific) tests, including TPHA, TPPA, FTA and EIA, and rapid treponemal tests, such as Determine TP. VDRL is a non-specific test that is no longer used in the region; however, the terminology is often used to refer to RPR. The use of the correct terminology to describe syphilis tests should be encouraged. Early syphilis* Reactive treponemal test AND Reactive RPR with a titre equal to or greater than 1:8 * If a painless genital ulcer is present, classify as early syphilis regardless of RPR titre. Late syphilis and syphilis of unknown duration Reactive treponemal test AND Non-reactive or reactive RPR with a titre less than 1:8 Note: Testing can be done in either order. Syphilis case definition (where history of testing and treatment is known) Early syphilis a) New infection (sero-conversion) within the previous 2 years Reactive treponemal test (with either a reactive or non-reactive RPR) AND Documented previously non-reactive treponemal test within the previous 2 years with no history of treatment b) New infection acquired within the previous 2 years 2 titre (fourfold) increase in the RPR titre within the previous 2 years AND Reactive treponemal test Note: Testing can be done in either order. Late syphilis Evidence of syphilis not acquired within the previous 2 years: Reactive treponemal test AND Reactive or non-reactive RPR AND No history of treatment Note: Testing can be done in either order. 4 Congenital syphilis case definition Presumptive a) An infant whose mother had untreated or inadequately treated* syphilis at delivery Confirmed b) The infant or child has a reactive treponemal test AND any of the following: qq evidence of congenital syphilis on physical examination qq long bone x-rays compatible with congenital syphilis qq an elevated CSF (cerebrospinal fluid) cell count or protein (without other cause) qq a positive IgM antibody test in blood or CSF c) Stillbirth (foetal death): qq a foetal death that occurs at >20 weeks OR qq a foetal death in which the foetus weighs >500g when the mother had untreated or inadequately treated* syphilis at delivery * Inadequately treated is defined as: - Non-penicillin treatment OR - Incomplete penicillin treatment course OR - Penicillin treatment completed within 30 days of delivery Case definitions based on clinical syndromes Male urethral discharge AND/OR dysuria syndrome Urethral discharge and/or dysuria in men Genital ulcer syndrome Non-vesicular Ulcer on penis, scrotum or ano-rectum in men or on labia, vagina or ano-rectum in women. (This syndrome can be caused by syphilis, chancroid, lymphogranuloma venereum, granuloma inguinale or genital herpes.) Vesicular (blisters) Genital or anal vesicles (blisters) in men or women. (This syndrome is typically caused by genital HSV infection.) Opthalmia neonatorum Conjunctivitis with discharge in a newborn within 4 weeks of delivery 5 Vaginal discharge syndrome and lower abdominal pain in women syndrome Vaginal discharge syndrome and lower abdominal pain in women syndrome have NOT BEEN INCLUDED, as they are poor predictors of STI among women. WHO’s STI surveillance guidelines do not recommend reporting these syndromes for STI surveillance as they are not reliable for assessment of STI incidence or prevalence; therefore, this consensus document has not included them. Health services may wish to collect data on these syndromes for their own health service planning needs. Definitions are available at: www.who.int/hiv/pub/me/en/GuidelinesforSTISurveillance1999_English.pdf PART B: MINIMUM DATA SET Operational aspects Depending on individual circumstances, for routine STI surveillance Pacific Island countries and territories may rely solely on laboratory (aetiologic)-based surveillance, solely on clinical syndrome-based surveillance, or on a mixture of the two. In order for high-quality surveillance data to be collected at a country level, certain information should be available on each individual being tested (laboratory- or aetiologic-based reporting) or diagnosed (clinical syndrome-based reporting). This minimum information is listed on the next page. For laboratory (aetiologic)-based reporting, ideally a computerised database would be established for the recording of the information. In the long term, such a computerised system could also replace laboratory log books. For reporting of clinical syndromes, it is anticipated that tally sheets would be used at clinical facilities (see sample in this document). For specified time periods the information is summarised into country data for local interpretation and regional reporting. It is recommended that reporting be monthly for country data and three-monthly for regional data. Reporting would be done either via running a report on a computerised database or manually tabulating the data using tally sheets or laboratory log books. The information required for these summary data sets is presented on pages 9-10. 6
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