P-545 Efficacy, safety and acceptability of a vaginal tampon for the collection of biospecimen samples: a systematic review and meta-analysis

Abstract

Abstract Study question Are self-collected vaginal tampons, as a biospecimen collection tool, comparable to current gold-standard methods in their efficacy, safety and acceptability? Summary answer Tampon efficacy for detection of gynaecological abnormalities was comparable to that of gold-standard methods in addition to being widely accepted with minimal reported adverse effects. What is known already Women’s services have poor attendance. Fear and embarrassment surrounding gynaecological health remain prevalent. Numerous long term sequalae can result from lack of gynaecological care include pelvic inflammatory disease, infertility and malignancy. Self-collection vaginal tampon samples have the potential to increase screening and diagnosis rates for multiple gynaecological conditions. Although the menstrual tampon as a biospecimen collection device has been demonstrated to be able to identify various gynaecological abnormalities, currently, possibly due to its novelty and lack of information on validity, they are not routinely used. Study design, size, duration Systematic review was conducted following PRISMA guidelines and prospectively registered with PROSPERO (CRD42022374857). A primary search through online databases was conducted, identifying 151 studies. Following this, title and abstract screening, full-text review and forward and backward citation searching were conducted in respective order, leading to a total of 92 studies for analysis. Participants/materials, setting, methods PubMed, MEDLINE, Cochrane Library, Scopus, and Web of Science were searched for eligible studies. All primary studies reporting the acceptability, efficacy or safety of vaginal tampons as a biospecimen collection device in comparison to other conventional methods of collection were included. Data was stratified based on which quantitative and/or qualitative variables were reported, baseline characteristics, and the abnormality being screened for. The Modified Newcastle Ottawa scale was used to assess risk of bias. Main results and the role of chance This systematic search identified 92 eligible studies, exploring HIV, HPV, HSV, Chlamydia trachomatis, Neisseria gonorrhoeae, cervical cancer, endometrial cancer, bacterial vaginosis, Candida albicans, Actinomyces israelii, Gardnerella vaginalis, Atopobium vaginae, and Trichomonas vaginalis. Menstrual tampons were compared to both clinician and self-collected samples including an endocervical swab, cervical brushing, cervicovaginal lavage, various tissue biopsies and urine samples. Detection of most gynaecological abnormalities did not profoundly vary between tampon collection versus gold-standard method. Self- collected tampon specimens were widely accepted with factors including lower pain scores, a greater willingness to use, convenient accessibility (especially in developing areas), and avoidance of embarrassment being reported. Very few papers reported adverse side effects and in those that did, vaginal tampon collection methods were regarded as less traumatic with a decreased likelihood of bleeding as compared to other methods including cervical swabs. Limitations, reasons for caution The effect of tampon sampling prior to other specimen collection methods could contribute to results that favoured tampon collection. A biopsy was not performed in some studies, leading to an unknown true disease status. Wider implications of the findings The use of menstrual tampons in clinical practice may help overcome barriers to accessing healthcare and participation in screening, necessary for preventing avoidable gynaecological conditions and their associated long-term complications. Further research is required to explore the optimisation of tampon specimen collection, including transportation and storage requirements. Trial registration number Not applicable