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Self-collected
vaginal swabs were acceptable and reliable for the laboratory
diagnosis of candidiasis and bacterial vaginosis.
The reliability of a
structured examination protocol and self administered vaginal swabs: a
pilot study of gynecological outpatients in Goa, India.
Tanksale VS, Sahasrabhojanee M, Patel V,
Nevrekar P, Menezes S, Mabey D.
Sexually
Transmitted Infections 2003;79:251-253
Summary:
Question
What are the reliability of a standardized protocol for recording vaginal
examination data and the acceptability and reliability of self-collected
vaginal swabs compared to clinician-collected swabs for the detection of
candidiasis and bacterial vaginosis (BV) in woman attending an outpatient
clinic in Goa, India?
Design
This pilot study describes the blinded evaluation of 1) the reliability of
a standardized vaginal examination record as measured by the agreement
between two gynecologists' independent findings, and 2) the acceptability
and reliability of self-collected vaginal swabs compared to
clinician-collected swabs for the laboratory detection of candidiasis and
BV in women with and without vaginal discharge.
Participants
Seventy-five women between 18 and 45 years old (mean age = 33.2 years)
attending the gynecological outpatient clinic of Goa Medical College, Goa,
India, were tested. Pregnant and postnatal women were excluded.
Seventy-seven percent, 25%, 49%, 19%, and 15% of women complained of
vaginal discharge, vaginal itching, lower abdominal pain, dyspareunia, and
dysuria, respectively.
Description of Tests and Diagnostic
Standard
Each woman was examined independently by two gynecologists who recorded
their findings separately using a standardized recording protocol based on
criteria set out in recently developed guidelines. The clinical findings
to be recorded were listed by "condition" for which a
"definition and rationale", and "guidelines for recording
observations" were provided. Observations were required for an
external examination, the color, amount, and odor of any vaginal
discharge, the color and amount of endocervical discharge, and other
signs. During her first examination, each woman was directed to insert a
swab into the vagina and roll the specimen onto a clean glass slide to
prepare a smear. A second swab was collected and a smear prepared by the
clinician. The vaginal smears were Gram stained and examined for the
presence of yeast cells and scored for BV organisms according to the
Nugent method.
Main Outcome Measures
The inter-rater reliability of items on the examination record and the
interslide reliability for laboratory identification of candida or BV were
determined using the κ statistic.
Main Results
Vaginal discharge was observed by the two gynecologists in 68% and 73% of
the women, respectively. Candida was detected in 29% and BV in 3% of women
by both sets of slides. The agreement between the two clinical
examinations for selected items, and between the patient and
clinician-collected Gram stained slides for detection of candida and BV
are shown in the table. The ? value ranged from 0.49 to 1 for all clinical
findings except pallor on external examination (κ = 0.33). Sixty
percent of women preferred swabs collected by gynecologists, 29% preferred
self-collected swabs, and 11% thought both methods were equally
acceptable.
Authors' Conclusions
The structured clinical examination
guidelines had moderate to high inter-rater reliability. The laboratory
diagnosis of candidiasis and BV revealed high concordance when comparing
specimens collected by the patient and the clinician. Self-collected swabs
are a useful way of obtaining vaginal specimens from women who do not wish
to undergo a gynecologic examination.
Source of funding: Wellcome Trust
Career Development Fellowship to VP.
For correspondence: Vikram Patel,
Sangath Society, Alto Parvorim, Goa 403521, India. E-mail address: vikpat@goatelecom.com.
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