Use of community-based reference ranges to estimate the prevalence of polycystic ovary syndrome by the recognised diagnostic criteria, a cross-sectional study

Study question

Does the application of recommended modifications to the traditional diagnostic criteria for polycystic ovary syndrome (PCOS) improve the certainty of diagnosis of PCOS in non-healthcare-seeking women?

Summary answer

Despite application of the most stringent definitions of the elements used to diagnose PCOS in a non-healthcare seeking community-based sample, the risk of healthy women being classified as having pathology remains.

What is known already

There is heterogeneity in prevalence estimates for PCOS due, in part, to lack of standardisation of the elements comprising the recognised National Institutes of Health (NIH), Rotterdam and Androgen Excess Society (AE-PCOS) diagnostic criteria. The AE-PCOS Society proposed refinements to the definitions of biochemical androgen excess and polycystic ovary morphology (PCOM) that can now be incorporated into these sets of diagnostic criteria to estimate PCOS prevalence.

Study design, size, duration

An Australian cross-sectional study of 168 non-healthcare-seeking women.

Participants/materials, setting, methods

The 168 included women were aged 18-39 years, euthyroid and normoprolactinemic, not recently pregnant, breast feeding or using systemic hormones. Each provided menstrual history and assessment of the modified Ferriman-Gallwey score (mFG), had measurement of sex steroids by liquid chromatography, tandem mass spectrometry, and a pelvic ultrasound. The presence of PCOS was determined using modified (m) NIH, Rotterdam and AE-PCOS criteria according to AE-PCOS Society recommendations.

Main results and the role of chance

Overall, 10.1% of the included participants met the mNIH PCOS criteria, which requires the presence of menstrual dysfunction, while 18.5% met the mRotterdam and 17.5% the AE-PCOS criteria, with the latter requiring hyperandrogenism. Eight of 27 participants with menstrual dysfunction, 10 of 31 women with PCOM, and 39 of 68 women with hyperandrogenism had no other feature of PCOS. Of the 19 participants with hyperandrogenemia, 10 met the mNIH criteria (52.5%) and 14 met both the mRotterdam and AE-PCOS criteria (78.9%). Women who had the combination of hyperandrogenism and PCOM explained the greatest discrepancy between the mNIH and the other criteria.

Limitations, reasons for caution

Clinical androgenisation relied on participant self-assessment, which has been shown to be valid when compared with clinician assessment.

Wider implications of the findings

Despite applying more stringent cut-offs for serum androgens, the mFG scale and the ovarian follicle count, these criteria remain arbitrary. Accordingly, healthy women maybe captured by these criteria, and misidentified as having PCOS, while women with the condition may be missed. Consequently, PCOS remains a diagnosis to be made with care.