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A clinical algorithm validated for high-risk women in Jamaica did not work well for management of RTIs in pregnant women.

Marginal validity of syndromic management for reproductive tract infections among pregnant women in Jamaica.
Hylton-Kong T, Brathwaite AR, Del Rosario GR, Kristensen S, Kamara P, Jolly PE, Hook III EW, Figueroa JP, Vermund SH.
Int J STD AIDS 2004;15:371-375.

 

Summary:

Question
How well does syndromic case management using a vaginal discharge algorithm previously evaluated among STD and family planning clinic attendees in Jamaica perform for diagnosis of RTIs among pregnant women in Jamaica?

Design
A vaginal discharge algorithm that had been evaluated among STD and family planning clinic attendees in Jamaica was validated for the diagnosis of RTIs in pregnant women in Jamaica by comparison with laboratory test results.  

Participants
Three hundred seventy-one pregnant women attending one of four prenatal care facilities in Jamaica were tested.  The women were attending for their first clinic visit for the current pregnancy and were past their first trimester.  The mean age was 23.7 years (range = 13 to 41 years).  Half were either married or in a steady relationship, 36.8% had a previous history of STD treatment.    

Description of Tests and Diagnostic Standard
Clinicians applied the WHO syndromic management algorithm for vaginal discharge and collected laboratory specimens.  Laboratory methods included: 1) pH of the vaginal fluid using pH paper (ColorpHast Indicator strips, EM science, Gibbstown, NJ) applied to the vaginal wall, 2) a “Whiff test” using swabs of the vaginal wall dipped into potassium hydroxide, 3) endocervical swabs for Gram stained smears and Thayer-Martin agar culture of N. gonorrhoeae, 4) endocervical swabs for C. trachomatis enzyme immunoassay (EIA, Clearview/Biostar), 5) swabs of the posterior fornix for T. vaginalis culture (InPouch TV test, Biomed Diagnostics, San Jose, CA), 6) swabs of vaginal fluid in saline for microscopy for clue cells, motile trichomonads, and yeast, 7) swabs of vaginal fluid for Gram stain for bacterial vaginosis (BV) according to the Nugent criteria, and 8) sera for syphilis serology (TRUST, New Horizons Diagnostics, Columbia, MD).  Sera reactive for syphilis were confirmed by the fluorescent treponemal antibody absorption assay.  Laboratory test results were used as a gold standard to assess diagnoses derived from the syndromic management algorithm.  

Main Outcome Measures
The validity of the syndromic case management was assessed by comparing the sensitivity, specificity, and positive predictive value (PPV) of each syndromic diagnosis versus the gold standard laboratory diagnosis.  

Main Results
Among 371 women tested, 8.1% presented with a complaint of vaginal discharge.  By laboratory test results, 3.6% had serological evidence of syphilis, 5.4% were positive for N. gonorrhoeae by culture, and 17.8% were positive for C. trachomatis by EIA.  Among a subset of 269 tested, 18% were positive for trichomonas by culture, 6.9% were positive for BV, and 30.5% were positive for yeast.  The sensitivity, specificity, and PPV for each syndromic diagnosis as determined by laboratory tests are shown in the table.  Using the algorithm for diagnosis, 68.1% of the women were over-treated for cervicitis, 79.8% for trichomoniasis, 93.1% for BV, and 64.2% for yeast.  The proportion for whom treatment was missed included 12.2% for cervicitis, 17.5% for trichomoniasis, 6.9% for BV, and 19.1% for yeast.  

Performance of syndromic case management for diagnosis of RTIs among 269 pregnant women in Jamaica

Diagnosis

Performance (%)

Sensitivity

Specificity

PPV

Cervicitis

66.7

62.8

31.9

Trichomoniasis

35.4

68.5

20.2

Bacterial vaginosis

11.1

88.8

6.9

Yeast

24.0

81.1

35.9

Authors’ Conclusions
The algorithm for vaginal discharge had poor diagnostic value among antenatal clinic attendees.  Syndromic diagnosis of RTIs in pregnant women using this algorithm was sub-optimal and should be considered a temporary solution until more simple and affordable diagnostic tests are available or until laboratory support can be upgraded at antenatal clinics.    

Source of funding:  The United States Agency for International Development support to the Gorgas Memorial Institute for Tropical and Preventive Medicine, Inc., a Minority International Research Training Grant from the Fogarty International Center, NIH, the John J. Sparkman Center for Interntional Public Health Education at the University of Alabama, and the Planning Institute of Jamaica by the Jamaican Ministry of Health.

For correspondence:  Sibylle Kristensen, School of Medicine, University of Alabama at Birmingham, BBRB 206H, 1530 3rd Avenue South, Birmingham, AL 35294-2170.  E-mail address: sibylle@uab.edu.  

   

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