Clinical Practice Guideline for Syndromic Management of Patients with Sexually Transmitted Infections and Other Genital Tract Infections – 2013
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Revista Colombiana de Obstetricia y Ginecología Vol. 64 No. 2 • Abril-Junio 2013 • (126-177) ARTÍCULO DE REVISIÓN CLINICAL PRACTICE GUIDELINE FOR SYNDROMIC MANAGEMENT OF PATIENTS WITH SEXUALLY TRANSMITTED INFECTIONS AND OTHER GENITAL TRACT INFECTIOns – 2013. Guía de práctica clínica para el manejo sindrómico de los pacientes con infecciones de transmisión sexual y otras infecciones del tracto genital – 2013 Syndromic management of STI and other GTI guideline development group Received: 10 June 2012 – Accepted: 11 June 2013 ABSTRACT Results: The “Clinical Practice Guidelines” we Objective: To reduce practice variability in reproduced, including recommendations and the management of genital tract and sexually- supporting evidence for prevention, diagnosis and transmitted infections (GTI/STI) and provide treatment in terms of effectiveness and safety, health care practitioners caring for GTI/STI and follow-up for cervicitis, urethritis, genital patients with the most recent evidence regarding ulcers, vaginal discharge, scrotal inflammation and the effectiveness and safety of primary, secondary inguinal buboes. and tertiary prevention interventions alongside Conclusions: The guideline’s core recommendation creating indicators for tracking the implementation concerns patient management using a single dose of the guidelines and their impact on public health. and expedited patient treatment regarding sexual Materials and methods: A multidisciplinary partners whenever possible. The guidelines must development team was set up consisting of be updated in three years. professionals in health care and patient repre- Key words: Clinical practice guidelines, sexually- sentatives. Relevant clinical questions were posed and transmitted infection, reproductive tract infection, a search was made of the national and international cervicitis, urethritis, vaginal discharge, genital ulcer. guideline data-bases. Existing guidelines were evaluated for quality and applicability. None of the PROPOSAL AND SCOPE guidelines met the criteria for adaptation, therefore The current guidelines are aimed at supporting it was decided to develop de novo guidelines. The clinicians/personnel providing health care for Pubmed, Ovid, Embase, Cochrane and Lilacs patients of both genders who may be susceptible databases were searched for systematic reviews to contracting/presenting sexually-transmitted and meta-analyses, clinical trials and observational infections (STI) and other genital tract infections studies. Tables of evidence and recommendations (GTI). Genital tract infections arising from medical/ were prepared using the GRADE approach based surgical procedures were not included. on informal and formal consensus methodology. Rev Colomb Obstet Ginecol 2012;63:126-177 CLINICAL PRACTICE GUIDELINE FOR SYNDROMIC MANAGEMENT OF PATIENTS WITH SEXUALLY TRANSMITTED INFECTIONS AND OTHER GENITAL TRACT INFECTIONS – 2013 127 Recommendations were made for primary, Diseases form an aging sexually-transmitted secondary and tertiary health care levels. The infections published in line with Colombian primary level would involve prevention, risk Ministry of Health Resolution 412 which proposed assessment, early detection, and initial management a syndromic approach to people suffering STI/GTI and reference action. Secondary and tertiary syndromes (1). levels would involve the management of STI/GTI complications as well as advice on preventing INTRODUCTION TO AND relapses or chronicity (secondary prevention). JUSTIFICATION FOR THE Managing specific conditions by sub-specialists GUIDELINES recommendations are not covered within the scope GTI are caused by microorganisms which are of these guidelines. normally present in the reproductive tract or The guidelines target the 14 to 74 year-old went it have been introduced for sexual contact population residing in Colombia, regardless of a or during medical-surgical procedures. They patient’s health insurance scheme or whether a affect both females and males (2, 3). GTI not patient actually has health insurance. sexually transmitted are more common in females, As well as reducing variability regarding particularly bacterial vaginosis (BV), a type of current practice in managing of GTI and STI, vaginal infection which is more common amongst these guidelines are aimed at supporting health reproductive aged females and which also represents care personnel attending GTI/STI patients using the commonest cause of vaginal discharge, followed the most recent evidence available regarding the by Candida albicans (4, 5). STI are caused by different effectiveness and safety of primary, secondary and organisms: bacteria such as Neisseria gonorrhoeae and tertiary prevention interventions. They also seek to Chlamydia trachomatis, protozoa such as Trichomonas cut the STI transmission chain, reduce the burden vaginalis and viruses such as herpes simplex virus (HSV), of disease associated with GTI/STI in Colombia and human immune deficiency virus (HIV) and human provide indicators for implementing such guidelines papilloma virus (HPV)(4). and for their impact on public health. GTI and STI frequently present with symptoms The syndromes accompanying genital tract such increased vaginal secretion, urethral secretion, conditions (the target for these guidelines) are the genital ulcers, pruritus, irritation, the presence of following: foetid odour or pelvic pain (6, 7). The signs and symptoms of infection have been grouped into 1. Cervical infection syndrome (females). the aforementioned clinical syndromes, following 2. Urethral discharge syndrome (males and females). the supposition that they are caused by groups of 3. Genital ulcer syndrome (males and females). specific organisms and that such grouping will lead 4. Vaginal discharge syndrome (females). to greater effectiveness in diagnosis and treatment. 5. Scrotal inflammation syndrome (males). This should ideally occur during a patient’s first 6. Inguinal bubo syndrome (males and females). contact with the health care services, especially when there is no access to laboratory services. The guidelines for managing pelvic inflammatory The World Health Organisation (WHO) has disease/disorder (PID) will be published separately recommended a syndromic management approach because it follows a different methodological to treating STI and GTI (8). adaptation (i.e. not de novo like the aforementioned The female syndromes proposed are vaginal syndromes). These clinical practice guidelines discharge syndrome, which includes vaginitis update the Guidelines for Attending Sexually-Transmitted caused by Candida sp, Trichomonas vaginalis and 128 Revista Colombiana de Obstetricia y Ginecología Vol. 64 No. 2 • 2013 bacterial vaginosis; the cervicitis syndrome mainly provide health care administrators and professionals caused by Neisseria gonorroheae, Chlamydia trachomatis throughout Colombia with unified, evidence based, and finally pelvic inflammatory disease (PID) cost-effective tool to help guide optimal care of syndrome caused by Neisseria gonorroheae, Chlamydia GTI/STI patients in all health care settings. trachomatis, mycoplasma (9) and anaerobic organisms gaining access to the upper genital tract (10). The MATERIALS AND METHODS scrotal inflammation syndrome caused by Neisseria The Guideline Development Group (GDG) consisted gonorroheae, Chlamydia trachomatis and gram-negative of experts in STI, clinical epidemiology, primary bacteria (9) are proposed in males. Syndromes attention, urologists, infectologists, gynaecologists, affecting both sexes include the genital ulcer psychologists, nurses, pharmacists, communicators syndrome caused by Treponema pallidum, Haemophilus and experts on the topics of public health and policy ducreyi, Chlamydia trachomatis serotypes 1, 2 and design. Patient’s representatives were also included 3, Klebsiella granulomatis and Herpes simplex virus, who gave their opinions during the different phases the inguinal bubo syndrome caused by Chlamydia involved in developing the guidelines. trachomatis and Haemophilus ducreyi and the urethral Once the clinical questions had been formulated, discharge syndrome caused by Neisseria gonorrhoeae, the GDG performed a systematic search of clinical Chlamydia trachomatis and Trichomonas vaginalis (9). practice guidelines (CPG) orientated towards STI represent one of the main causes of mor bi- identifying currently available national and inter- dity in developing countries and carries a significant national CPG. The systematic search for CPG burden, both socially and financially to the country’s was undertaken with the support of the Sexually health care system and its patients (11). A report trasmitted infections Cochrane review group at the dealing with STI in Colombia 1976-2000 concerned following sites: AHRQ-Clearing house, NHS, Guia itself almost exclusively with the HIV/AIDS Salud, Guidelines International Network, Scottish situation, reporting 406,722 years of potential life Intercollegiate Guidelines Network, National lost (YPLL) between 1991 and 1998 (12). The years Institute for Clinical Excellence, Australian of life lost and disability-adjusted life years (DALYs) National Health and Medical Research Council, due to STI (excluding HIV/AIDS) are secondary New Zealand Guidelines Group, World Health to the following complications: cancer (13), pelvic Organisation, Pan-American Health Organisation, inflammatory disease (PID), pregnancy, infertility, TRIP database, Medline via PubMed, Lilacs via BVS chronic pelvic pain, complications of pregnancy