The reliability of a structured examination protocol and self administered vaginal swabs: a pilot study of gynaecological outpatients in Goa, India

Abstract

Objectives: Low participation rates for gynaecological examination and low reliability of clinical reporting of gynaecological examination findings are problems in community studies of gynaecological morbidity in India. This pilot study aimed to describe the reliability of a new examination protocol for recording the findings of gynaecological examination and the reliability and acceptability of the use of self administered vaginal swabs for the diagnosis of reproductive tract infections. Method: 75 women attending a gynaecology outpatient clinic were purposively sampled. Each woman was examined by two gynaecologists independently who recorded findings on the new examination protocol. Two swabs were collected from each woman, one by the gynaecologist and one by the woman. Swabs were smeared on separate slides which were stained and read for bacterial vaginosis and candidiasis by laboratory technicians blind to the mode of collection of the slides. Results: The study showed a high inter-rater reliability for most of the items of the examination protocol. The interslide agreement for the diagnosis of the two RTIs was high. One third of women preferred the self administered swab. Conclusions:The examination protocol is a reliable method of recording gynaecological examination findings, and self administered swabs a useful way of obtaining vaginal specimens from women who did not wish to undergo gynaecological examinations in studies in the Indian setting. V aginal discharge is one of the commonest complaints in women in south Asia.1 2 There is poor concordance between self reported symptoms and laboratory confirmed reproductive tract infections (RTIs) limiting the usefulness of the syndromic approach to the management of RTIs.3 4 Many studies on gynaecological symptoms have suffered from low participation rates as a result of women's reluctance to undergo gynaecological examinations and the unreliability of gynaecological examination reports. This pilot study aimed to evaluate the reliability of a new examination protocol for vaginal examination 5 and to evaluate the acceptability and reliability of self administered vaginal swabs for the collection of vaginal specimens for the detection of candidiasis and bacterial vaginosis. The study was a pilot investigation aimed to guide the methodology of community studies of the aetiology of vaginal discharge where the use of self administered swabs could improve participation rates.This study aimed (1) to evaluate the inter-rater reliability of a new examination protocol for recording the findings of gynaecological examination; (2) to evaluate the acceptability of the use of self administered swabs versus gynaecologist administered swabs; and (3) to estimate the reliability of detection of RTIs (candidiasis and bacterial vaginosis) of such swabs by comparing the diagnostic yield of self administered and gynaecologist administered swabs. METHOD Setting and sampleWomen between 18-45 years of age attending the gynaecological outpatients department of Goa Medical College, were...

Reliability of self-collected versus provider-collected vaginal swabs for the diagnosis of bacterial vaginosis

“…Our study shows that when compared with the provider-collected smear, the ability of the self-collected smear to diagnose BV had a sensitivity of 70%, specificity of 97%, positive predictive value of 93% and negative predictive value of 83% comparable with earlier reports. 15 However, the low Kappa value obtained in our study comparing these two techniques could be because of the predominantly illiterate population our hospital caters to, because earlier studies, 11 which have reported high agreement between the two sets of specimens with a Kappa value of 0.98, had only 25% of their study population as illiterate. The ability of the self-collected smear to diagnose candidiasis had a sensitivity of 75%, specificity of 91.5%, positive predictive value of only 60% and a negative predictive value of 95.5% when compared with provider-collected smears.…”

“…Although there have been reports of their use in Africa and in developed countries 12,16,17 , to the best of our knowledge, there is only one report of their use in India. 11 Also, our results suggest that it would be preferable if a microbiologist rather than a gynaecologist evaluates a Gram-stained smear for the diagnosis of BV and candidiasis to reach a correct interpretation and start appropriate treatment.…”

The burden and determinants of HIV and sexually transmitted infections in a population-based sample of female sex workers in Goa, India

“…Biological samples were collected using self-administered vaginal swabs, previously validated in Goa,21 and dried-blood spots (DBS). For women who refused to take a vaginal swab, first-void urine samples were collected to test for gonococcal and chlamydial infection.…”

The burden and determinants of reproductive tract infections in India: a population based study of women in Goa, India

“…The study employed a semi-structured interview, which was a composite of questions eliciting data on different aspects of the participant's personal and health history, derived from a number of sources. [9][10][11] The composite interview was piloted with 100 women attending gynaecological outpatient clinics in two hospitals. For participants who consented to a gynaecological examination, two high vaginal (for polymerase chain reaction) and two vaginal swabs (for smears and culture) were collected.…”

“…The use of self administered swabs had been piloted in Goa, and was shown to be a reliable method of collection of vaginal specimens for the diagnosis of endogenous infections. 10 The data were organised in the following manner for the analyses.…”