Abstract and Introduction
Abstract
Objective We evaluated agreement in diagnoses for bacterial vaginosis (BV), Trichomonas vaginalis (TV) and vulvovaginal candidiasis (VVC) between clinicians examining the patient and performing diagnostic tests versus a clinician with access only to the patient's history and diagnostic findings from self-obtained vaginal swabs (SOVS).
Design Women presenting with vaginal discharge to a sexually transmitted infections clinic provided SOVS for evaluation and completed the study and qualitative questionnaires. A clinician then obtained a history and performed speculum and bimanual examinations. Participants' history and diagnostic test results from SOVS were provided to a masked non-examining clinician who rendered independent diagnoses. Overall agreement in diagnoses and κ statistics was calculated.
Results The prevalence of infections among the 197 participants was 63.4% (BV), 19% (TV) and 14% (VVC). The per cent agreement between the examining and non-examining clinician for the diagnoses of BV was 68.5%, 90.9% for TV and 91.9% for VVC. Of the 105 women diagnosed with BV by the examining clinician, 34 (32%) were missed by the non-examining clinician. The non-examining clinician missed 13 (48%) of 27 women and 12 (34%) of 35 women treated for VVC and TV, respectively. Four women who all presented with abdominal pain were diagnosed with pelvic inflammatory disease.
Conclusions Tests from SOVS and history alone cannot be used to adequately diagnose BV, TV and VVC in women presenting with symptomatic vaginal discharge. Cost benefits from eliminating the speculum examination and using only tests from SOVS may be negated by long-term costs of mistreatment.
Introduction
Symptomatic vaginal discharge is a common gynaecological complaint. Current clinical practice includes a speculum examination (SE) for evaluating the discharge. The clinician inspects the external genitalia, vagina and cervix; assesses characteristics of the discharge; notes physical signs such as inflammation and lesions; and collects specimens for laboratory testing. Many clinicians also perform a bimanual examination. The SE requires time, supplies and a trained clinician. Additionally, discomfort of a pelvic exam may lead women to delay or avoid seeking care. Developing accurate approaches to diagnosing lower genital infections without a SE would be advantageous to both clinicians and patients.
Highly sensitive and specific nucleic acid amplification tests (NAATs) have been developed for the detection of Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV). NAATs are superior to conventional tests. Novel methods of obtaining and testing pelvic specimens have been developed and validated. Studies demonstrate the comparability of self-obtained vaginal swabs (SOVS) and provider obtained specimens. Patient-inserted tampons, first void urine collection, and self-obtained vaginal, introital, vulvar or perineal swabs have all performed better than provider obtained tests in the detection of CT, GC and TV. These tests could change the way clinicians diagnose abnormal vaginal discharge.
A previous study showed that elimination of SE in women presenting to a sexually transmitted infections (STI) clinic resulted in few missed serious diagnoses using NAATs to detect GC, CT and TV and standard serological tests for syphilis and HIV. The goal of this study was to determine if SE could be eliminated in the evaluation of vaginitis syndromes (bacterial vaginosis (BV), TV and vulvovaginal candidiasis (VVC)). Specifically, we aimed to assess the accuracy of history alone and SOVS in establishing the correct diagnosis in women presenting with symptomatic vaginal discharge. We also sought to determine if eliminating the SE would lead to significant missed diagnoses.