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1.
Obstet Gynecol ; 139(4): 561-570, 2022 04 01.
Article in English | MEDLINE | ID: mdl-35271530

ABSTRACT

OBJECTIVE: To evaluate noninferiority of virtual transvaginal ultrasonography compared with in-clinic ultrasonography for ovarian reserve assessment. METHODS: We conducted a single-site, head-to-head crossover trial. Participants performed self-administered virtual transvaginal ultrasonography at home, guided by a remote-certified ultrasound technologist, then underwent transvaginal ultrasonography in-clinic with another ultrasound technologist. Participants were women in the greater Boston area interested in evaluating ovarian reserve and recruited through social media, health care referrals, and professional networks. The uterus and ovaries were captured in sagittal and transverse views. These randomized recordings were reviewed by two or three independent, blinded reproductive endocrinologists. The primary outcome was noninferiority of the rate of clinical quality imaging produced at home compared with in clinic. Sample size was selected for greater than 90% power, given the 18% noninferiority margin. Secondary outcomes included antral follicle count equivalency and net promoter score superiority. RESULTS: Fifty-six women were enrolled from December 2020 to May 2021. Participants varied in age (19-35 years), BMI (19.5-33.9), and occupation. Ninety-six percent of virtual and 98% of in-clinic images met "clinical quality." The difference of -2.4% (97.5% CI lower bound -5.5%) was within the noninferiority margin (18%). Antral follicle counts were equivalent across settings, with a difference in follicles (0.23, 95% CI -0.36 to 0.82) within the equivalence margin (2.65). Virtual examinations had superior net promoter scores (58.1 points, 97.5% CI of difference 37.3-79.0, P<.01), indicating greater satisfaction with the virtual experience. CONCLUSION: Virtual transvaginal ultrasonography remotely guided by an ultrasonography technologist is noninferior to in-clinic transvaginal ultrasonography for producing clinical quality images and is equivalent for estimating antral follicle count. Virtual transvaginal ultrasonography had superior patient satisfaction and has potential to significantly expand patient access to fertility care. FUNDING SOURCE: This study was sponsored by Turtle Health. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04687189.


Subject(s)
Ovarian Reserve , Boston , Female , Humans , Male , Ovarian Follicle/diagnostic imaging , Ovary/diagnostic imaging , Ultrasonography
2.
Radiology ; 237(2): 385-94, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16170016

ABSTRACT

PURPOSE: To retrospectively determine the frequency and spectrum of findings and recommendations reported with whole-body computed tomographic (CT) screening at a community screening center. MATERIALS AND METHODS: This HIPAA-compliant study received institutional review board approval, with waiver of informed consent. The radiologic reports of 1192 consecutive patients who underwent whole-body CT screening of the chest, abdomen, and pelvis at an outpatient imaging center from January to June 2000 were reviewed. Scans were obtained with electron-beam CT without oral or intravenous contrast material. Reported imaging findings and recommendations were retrospectively tabulated and assigned scores. Descriptive statistics were used (means, standard deviations, and percentages); comparisons between subgroups were performed with univariate analysis of variance and chi(2) or Fisher exact tests. RESULTS: Screening was performed in 1192 patients (mean age, 54 years). Sixty-five percent (774 of 1192) were men and 35% (418 of 1192) were women. Nine hundred three (76%) of 1192 patients were self referred, and 1030 (86%) of 1192 subjects had at least one abnormal finding described in the whole-body CT screening report. There were a total of 3361 findings, with a mean of 2.8 per patient. Findings were described most frequently in the spine (1065 [32%] of 3361), abdominal blood vessels (561 [17%] of 3361), lungs (461 [14%] of 3361), kidneys (353 [11%] of 3361), and liver (183 [5%] of 3361). Four hundred forty-five (37%) patients received at least one recommendation for further evaluation. The most common recommendations were for additional imaging of the lungs or the kidneys. CONCLUSION: With whole-body CT screening, findings were detected in a large number of subjects, and most findings were benign by description and required no further evaluation. Thirty-seven percent of patients had findings that elicited recommendations for additional evaluation, but further research is required to determine the clinical importance of these findings and the effect on patient care.


Subject(s)
Mass Screening , Tomography, X-Ray Computed/methods , Adult , Aged , Analysis of Variance , Chi-Square Distribution , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Retrospective Studies
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