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close this bookSexually Transmitted Diseases (STD) Syndromic Management (AIDSCAP/FHI, 1997, 54 p.)
close this folderSTD SYNDROMIC MANAGEMENT
View the document(introduction...)
View the documentDefinition
View the documentTheoretical Foundation
View the documentAdvantages and Disadvantages
View the documentCost-Effectiveness

(introduction...)

STD SYNDROMIC MANAGEMENT

Definition

The syndromic approach is an answer to many of the obstacles to efficient STD case management in developing countries. It is based on identifying a syndrome, a group of symptoms (what the patient feels or has noticed) and easily recognized signs (what the clinician finds on examination) associated with a number of well-defined etiologies (the specific organisms causing disease). Once a syndrome has been identified, treatment can be provided for the majority of the organisms responsible for that syndrome.

The syndromic approach allows health care workers to make a diagnosis without sophisticated laboratory tests. Several STD syndromes can be managed easily and rapidly using clinical flowcharts for diagnosis and treatment. A clinical flowchart (also known as an algorithm or a decision tree) depicts a path of diagnostic reasoning. It is a logical, step-by-step, standardized guide to medical decision making. The World Health Organization recommends national STD control programs incorporate diagnostic and therapeutic flowcharts into their STD management guidelines.10

The syndromic approach is an answer to many of the obstacles to efficient STD case management in developing countries. The World Health Organization recommends national STD control programs incorporate diagnostic and therapeutic flowcharts into their STD management guidelines.10

The syndromic approach to STD case management provides health workers in low-resource settings with practical tools to improve the diagnostic and treatment process. Based upon what is known about the prevalence of specific STDs in a given health care setting (including drug resistant stains), case management protocols are developed using common symptoms of STDs (urethral discharge, genital ulcer, vaginal discharge, lower abdominal pain, scrotal swelling) as the starting point and the patient management decision as the end point. As with all good STD management approaches, syndromic STD management also directs health workers to educate clients about STD prevention practices and partner notification.

Theoretical Foundation

STD syndromic management relies on clinical syndromes (for instance, vaginal discharge, genital ulcer, or urethral discharge) and, in some cases, assessments of an individual patient's risk for STD infection to make presumptive diagnoses of selected STDs. In many areas where definitive diagnostic tests generally are not available and/or where use of the tests and consequent treatment delays are not practical, syndromic diagnosis may offer a feasible approach to the management of STDs in men and women.

A fundamental goal of STD control programs is early detection and treatment of disease, preferably at the point of first encounter between the patient and the health system. In many countries, STD patients are seen more often in private facilities (private physicians, clinics, or pharmacies) and primary health care settings than in specialized STD clinics. Therefore, an effective and efficient public health program needs a tool that is rapid, inexpensive, simple, accurate, and can be implemented on a large scale by health providers with diverse levels of expertise and training.

Etiologic diagnosis of most STDs can be difficult, particularly in women. While simple diagnostic tests are being investigated, the range of existing laboratory tests appropriate for low-resource settings is limited. Both gonococcal and chlamydial infections in women currently have to be diagnosed through culture techniques that are expensive and technically demanding or through antigen/genomic detection (available tests are expensive and not always appropriate in low-resource settings). Gonococcal infections in men can be diagnosed through microscopy, assuming a microscope and trained microscopist are available. RPR/VDRL and TRUST tests can be used to screen for syphilis but require serum or plasma.

Even in settings with access to reliable laboratory facilities, the delays inherent in reporting test results hinder the timely treatment of STD cases. Referral of cases, even in a well-structured health system, remains problematic in practice due to constraints in time, resources, and social barriers. Delays in treatment can undermine the confidence a patient has in health providers; STD patients expect a health worker to make a prompt and reasonably accurate diagnosis. Furthermore, delays in treatment result in loss of follow up to a significant proportion of clients.

Flowcharts standardize clinical decision making. This standardization makes STD reports from different health facilities comparable; simplifies STD data collection and analysis; facilitates supervision of health care workers; ensures STD patients receive the same treatment for a given condition in every health facility; and delays the development of antimicrobial resistance of sexually transmitted microorganisms.

It is generally agreed that the use of appropriate syndromic diagnosis protocols in well-managed, adequately monitored facilities with ready access to therapeutic drugs would be a considerable improvement over how STDs currently are managed in many settings. The small proportion of patients who have access to STD services in many developing countries are often diagnosed according to a given provider's "best guess" as to the cause of specific symptoms and treated with available drugs that may or may not be appropriate. Experience has shown that even highly skilled STD specialists will misdiagnose or miss concurrent infections in a significant proportion of cases when making diagnoses on the basis of their own clinical experience.13,14

Flowcharts, on the other hand, rationalize and standardize clinical decision making. Their use can also standardize diagnosis, treatment and referral. Such standardization makes STD reports from different health facilities comparable; simplifies STD data collection and analysis, which in turn facilitates surveillance and planning (e.g., the purchase of drugs and other supplies); facilitates supervision of health care workers since the approach is the same in every health facility; ensures STD patients receive the same treatment for a given condition in every health facility, thereby enhancing confidence in health services; and delays the development of antimicrobial resistance of sexually transmitted microorganisms.

Advantages and Disadvantages

Advantages and Disadvantages of Syndromic Management

Advantages

Disadvantages

- can be implemented on a large scale
- rapid and simple
- high sensitivity in most cases
- lab tests not necessary
- cost effective
- clinicians at any level and expertise can succeed with this approach
- simplifies data collection and surveillance

- tends to over treat due to decreased specificity
- vaginal discharge algorithm does not perform well in low prevalence settings
- management of cervical infection is problematic
- ignores asymptomatic cases
- may overuse expensive drugs
- notifying sexual contacts without proof of infection in the index case is difficult

Advantages

Syndromic management is expedited, patient-centered care that can be implemented on a large scale. It is rapid and convenient for both patient and health care provider. As treatment can be provided at the first visit, there is usually no need for return visits, no risk for further disease spread, and less risk for complications and sequelae. Syndromic management allows health care workers to make a diagnosis without sophisticated laboratory tests, and it is theoretically more cost effective than the etiologic or clinical diagnosis. It requires minimum training and can be used by a broad range of health care workers as the flowcharts are simple and easy to follow. The syndromic approach simplifies and standardizes STD data collection and analysis that in turn facilitates surveillance and planning.

Disadvantages

There are some remaining concerns regarding syndromic case management. It can result in a certain proportion of female patients with vaginal discharge being over treated since the symptoms of cervical infection are not specific. This is especially true in low prevalence settings, such as in primary health centers where few STDs are seen. The syndromic approach also ignores asymptomatic cases, which are most common in women and make up over half of all STDs. As the name suggests, STD syndromic management is based on symptoms or signs and is not applied to asymptomatic populations unless they are sexual contacts to a syndromically diagnosed case. Additionally, it can result in the overuse of some drugs that may be expensive and difficult to obtain. Although by using single dose treatments, the chance of antibiotic resistance developing due to syndromic management would be rare.

While the syndromic approach has proven to be the best case management for genital ulcers and urethral discharge in men, the case management of women with vaginal discharge remains very difficult. The most common cause of vaginal discharge is vaginitis (i.e., bacterial vaginosis, candidiasis, or trichomoniasis), but the most serious cause, public health wise, is cervical infection. It is, therefore, recommended to incorporate a risk assessment for cervical infection in the flowchart. A risk assessment is a series of behavioral and demographic markers that, if present, increase a woman's probability of having an STD, independent of her symptoms or signs. This approach has been successfully evaluated in various settings.

Although contacting sexual partners of index STD cases for treatment should be an essential component of any STD control program, doing so based on an STD syndrome is delicate. For men with a urethral discharge or men or women with a genital ulcer, it would be rare for these syndromes not to be caused by an STD, and partner referral is straight forward. However, for women with vaginal discharge, the accuracy of the model is less exact, resulting in women without a real STD notifying their sexual partners about an STD. This obviously could have severe domestic and social consequences.

Cost-Effectiveness

A recent theoretical analysis calculated that the cost per patient managed through syndromic diagnosis could be four times less than through clinical diagnosis (using the clinician's "best guess") and seven times less than etiologic diagnosis (using laboratory tests). Considering direct costs only, the cost per patient cured by syndromic management was estimated to be two to three times less than clinical diagnosis and three to four times less than etiologic diagnosis.15

The cost-effectiveness of a flowchart can be calculated in many different ways, but only the cost per patient will be discussed here. A relative estimate of these costs can be made without sophisticated calculation.

The cost per patient C is the cost incurred by the health structure in applying a flowchart to one patient. It is the sum of all the costs of diagnosis and treatment divided by the total number of patients for whom the flowchart is used.

Or:

C = (Pd × Diagnosis) + (Pt × Treatment)

Wherein P is a proportion, Pd is the proportion of patients who will undergo diagnosis (examinations, tests) and Pt is the proportion of patients who will be treated.

The following is a typical example of how to compare the cost-effectiveness of two different flowcharts. This same method can be used to compare a flow chart with an etiological approach to STD management.

For example, consider 200 men attending a health center seeking treatment for urethral discharge. Upon clinical examination, 180 of these men had urethral discharge. Of the 180 men with urethral discharge, 140 had a positive Gram stain.

According to flowchart A (not shown), treatment for gonorrhea and chlamydial infection is given to all patients with clinically confirmed urethral discharge. According to flowchart B (not shown), a Gram stain is performed. If intracellular gram-negative diplococci (IGND) are seen on the Gram stain, treatment will be given for both infections. If no IGND are seen, the patient will be treated only for chlamydial infection. The question is which of the two flowcharts is the cheapest.

The prices used in this exercise were: U.S. $0.10 for a physical examination (gloves, disinfectant), U.S. $0.30 for a Gram stain, U.S. $0.50 for Chlamydia infection treatment (doxycycline, seven days) and U.S. $2.50 for a treatment for gonorrhea (norfloxacin, one dose).

The cost per patient applying flowchart A would be:

C = (200/200 × U.S. $0.10) + (180/200 × U.S. $3.00) = U.S. $2.80

The cost per patient applying flowchart B would be:

C = (200/200 × U.S. $0.10) +

(180/200 × U.S. $0.30) +

(140/200 × U.S. $3.00) +

(40/200 × U.S. $0.50)

= U.S. $2.57


Long-term costs will be determined in part by the cost of complications and sequelae, such as urethral stricture, chronic pain, extra-uterine pregnancies and infertility. These complications can be minimized by prompt and effective treatment. If a flowchart has a low sensitivity, missed or incorrectly treated infections will result. Treatment failure is also associated with the resistance pattern of the antibiotic used. Thus, the higher the sensitivity of the flowchart and the more effective the treatment, the lower the long-term costs will be. A balance must be reached between immediate costs, as reflected in the example above, and long-term costs.

Long-term costs also depend on days lost from work by STD patients and the number of additional people infected by someone with an STD, including secondary HIV infections. These long-term costs are very difficult to estimate.