At-home transvaginal pelvic ultrasonography may meet clinical standards for gynecologic imaging in selected premenopausal women, with diagnostic-quality examinations achieved in most participants and higher satisfaction than recalled in-clinic ultrasonography.
Researchers conducted the prospective, interventional, single-group SELF-GYN1 trial between July 2022 and July 2023 among premenopausal women aged 22 to 50 years recruited from 10 US states and Washington, DC. A total of 265 women enrolled, and 263 completed at-home transvaginal ultrasonography examinations. Participants performed the scans while receiving real-time verbal guidance from trained remote sonographers, and physicians blinded to the imaging setting independently evaluated image quality. The coprimary outcomes were diagnostic image quality and participant satisfaction, measured by net promoter score, while secondary outcomes included participant discomfort, sonographer experience, and adverse events.
Diagnostic-quality images were obtained in 253 of 263 examinations (96%). Imaging findings interpreted as gynecologic abnormalities were reported in 69 participants (26%), including uterine fibroids, complex ovarian cysts, endometrial polyps, and malpositioned intrauterine devices. Elevated body mass index (BMI) was the factor most commonly associated with nondiagnostic image quality.
Participants reported greater satisfaction with the at-home experience than with recalled in-clinic ultrasonography, with net promoter scores of 59 vs 25, respectively. In a blinded image review that included at-home and previously acquired in-clinic images, interpreting physicians correctly identified the imaging setting in 331 of 589 assessments (56%). Interpretation of this finding was limited because only 63 assessments involved in-clinic images. No adverse events were reported, and only a small proportion of respondents reported mild pain or discomfort following the examination. Sonographers also reported greater job satisfaction and substantially less work-related discomfort when remotely guiding examinations than when performing conventional in-clinic scans.
The researchers said the findings suggest that remotely guided at-home ultrasonography could potentially reduce barriers to gynecologic imaging while lessening the physical demands associated with conventional sonography. They also noted that elevated BMI and, in one participant, height of less than 4 ft 6 in were associated with lower image quality.
The study had several limitations. Its nonrandomized, single-group design did not include a concurrent in-clinic comparison group or a clinical reference standard for establishing diagnostic accuracy. Recruitment through online advertising, social media, professional networks, and physician referral may have favored participants with higher health literacy. Satisfaction comparisons relied on recalled prior in-clinic examinations, and only 181 of 263 participants (69%) completed the 3-day postexamination questionnaire. Many participants with abnormalities identified on at-home imaging did not undergo confirmatory clinical follow-up, preventing assessment of false-positive rates and sensitivity. The investigators also noted that equipment costs and specialized sonographer training could limit broader implementation.
Overall, the findings suggest that remotely guided at-home transvaginal ultrasonography may be a feasible option for selected premenopausal women, although additional studies are needed to evaluate implementation, diagnostic performance in broader populations, and long-term clinical use.
“These findings represent an innovative and clinically accurate solution to expansion of at-home care that aims to decrease barriers to care, both individual and systemic,” wrote lead study author Alessandra J. Ainsworth, MD, of Mayo Clinic, Rochester, Minnesota, and colleagues.
Disclosures: The study was funded by Turtle Health. Dr. Ainsworth reported holding a financial interest in Turtle Health during the study. Drs. Sacha, Vitek, Martini, and Brown reported receiving personal fees from Turtle Health during the study; Dr. Vitek also reported receiving personal fees from Siemens Diagnostics outside the submitted work. Turtle Health participated in the study design, conduct, analysis, manuscript review, and decision to submit the manuscript for publication. No other disclosures were reported.
Source: JAMA Network Open
