Table 1.
Study design and basic demographics.
| First author and year | Participants | |||
|---|---|---|---|---|
| Inclusion criteria | Exclusion criteria | N | Mean or median age (SD; range) | |
| Xiao et al.49 * | Had breast lesions clearly visualized by ultrasound; Underwent biopsy and had pathological results; provided informed consent. | Patients who were pregnant or lactating; patients who had breast biopsy or were undergoing neoadjuvant chemotherapy or radiotherapy. | 389 | 46.86 (13.03; 19–84) |
| Zhang et al.50 * | NR | Pathological results were neither benign nor malignant; Patients with BI-RADS 1 or 2 and abnormal mammography results; patients who were diagnosed with Paget’s disease but had no masses in the breasts. | 2062 | NR |
| Zhou et al.51 * | Images were scanned under the same MR protocol; The lesion had complete pathology results; Imaging reports had definite BI-RADS category diagnosed; Lesions were a) solitary in one breast or b) in both breasts with the same BI-RADS and pathological results. | Normal or typical background parenchyma enhancement in bilateral breasts was eliminated. | 1537 | 47.5 (11.8; NR) |
| Agnes et al.52 | NR | NR | NR | NR |
| Tanaka et al.53 * | women with breast masses who were referred for further examination after their initial screening examination of breast cancer and then underwent ultrasonography and pathological examination. | Typical cysts; mass lesions ≥ 4.5 cm diameter | NR | NR |
| Becker et al.35 | Patients with postsurgical scars, initially indeterminate, or malignant lesions with histological diagnoses or 2 years follow up. | Patients with normal breast ultrasound, and all patients with lesions classified as clearly benign, except for patients with prior breast-conserving surgical treatment. | 632 | 53 (15; 15–91) |
| Kyono et al.54 | Women recalled after routine breast screening between ages of 47–73 or women with a family history of breast cancer attending annual screening between ages of 40–49. | NR | 2000 | NR (NR; 47–73) |
| Qi et al.55 * | NR | NR | 2047 | NR |
| Salim et al.56 * | Women aged 40–74 years who were diagnosed as having breast cancer, who had a complete screening examination prior to diagnosis, had no prior breast cancer, did not have implants. | With a cancer diagnosis that had ≥ 12 months between the examination and diagnosis date. | 8805 | 54.5 (16.1; 40–74) |
| Zhang et al.57 | NR | NR | 121 | NR |
| Wang et al.58 | NR | NR | 263 | 51.4 (9.8; 28–76) |
| Li et al.59 | NR | NR | 124 | NR |
| Mckinney et al.60 | NR | Cases without follow-up were excluded from the test set. | 28953 | NR |
| Shen et al.61 | NR | NR | 1249 | NR |
| Suh et al.62 * | 18 years or older and not having a history of previous breast surgery. | Subjects without medical records or pathological confirmation for a suspicious breast lesion, missing mammograms, or having poor-quality mammograms. | 1501 | 48.9 (11.1; NR) |
| O’Connell et al.63 | Adult females or males recommended for ultrasound-guided breast lesion biopsy or ultrasound follow-up with at least one suspicious lesion; age ≥ 18 years. | Unable to read and understand English at the University of Rochester; patients with diagnosis of breast cancer in the same quadrant; unwilling to undergo study procedures and informed consent. | 299 | 52.3 (NR; NR) |
| Ruiz et al.64 | Women presenting for screening with no symptoms or concerns. | Women with implants and/or a history of breast cancer. | 240 | 62 (53–66; 39–89) |
| Adachi et al.65 * | Patients who underwent DCE breast MRI; patients who were diagnosed with benign or malignant lesions by pathology or a follow-up examination at more than one year. | Patients who were treated with breast surgery, hormonal therapy, chemotherapy, or radiation therapy; age ≤ 20 years. | 371 | NR |
| Samala et al.66 | NR | NR | 2242 | 51.7 (NR; 24–82) |
| Schaffter et al.67 | NR | NR | 153588 | 56.1 (NR; NR) |
| Kim et al.68 * | NR | NR | 172230 | 50.3 (10; NR) |
| Wang et al.69 | All nodules of patients were newly discovered and untreated; patients had undertaken ABUS scan; definite pathological benign and malignant; the image quality of ABUS examination was good enough to show the entire margin of the lesion, no matter distinct or indistinct. | Non-nodular breast disease; ABUS artifact was obvious and the poor images quality; ABUS was not available; patients received chemotherapy, radiation therapy or surgical local resection before ABUS scan. | 264 | 54.31 (9.68; 37–75) |
| Yu et al.70 | Pathological results clearly; at least 2D mode US images available, but preferably CDFI and PW mode images. Without blurred images or color overflow. | A foreign-body in the breast; other metastatic tumors or co-infection with HIV; measurement markers, arrows, or puncture needles within the image; | 3623 | 42.5 (NR; 11–95) |
| Sasaki et al.71 * | Patients undergone bilateral mammography; patients in whom ultrasonography had established the presence or absence of a lesion; patients in whom a lesion, if present, had been diagnosed as being benign or malignant by cytology or histology; normal patients in whom ultrasonography had revealed no lesion and who had been followed up for at least 1 year. | NR | 310 | 50 (NR; 20–93) |
| Zhang et al.72 | NR | NR | 2620 | NR |
| Bao et al.73 * | Aged 20–65 years participated in the program. | NR | 703103 | NR (NR; 20–65) |
| Holmström et al.74 * | Nonpregnant aged between 18-64 years, confirmed HIV positivity, and signed informed consent. | NR | 740 | 41.8 (10.3; 18–64) |
| Cho et al.75 * | Age ≥18 years, not pregnant, had no history of cervical surgery, and had Pap test results. All lesions were pathologically confirmed by conization biopsy, and normal were defined as those with normal Pap test results. | NR | 791 | NR (NR; 18–94) |
| Bao et al.76 * | Aged 25–64 years; samples were processed with liquid-based method. done with HPV testing, and diagnosed by colposcopy-directed biopsy. | NR | 2145 | 38.4 (6.7; 25–46) |
| Hu et al.77 * | NR | No image, multiple colpo sessions, inadequate histology. | 9406 | 35 (NR;18–94) |
| Hunt et al.78 * | Abnormal cervical screening test, age ≥18 years, intact uterine cervix, not pregnant, no known allergy to the fluorescent dye used for HRME imaging, does not belong to an indigenous Brazilian population; | unable to provide informed consent; prior treatment history; pregnant; other clinical considerations. | 1486 | 40 (12.1; NR) |
| Wentzensen et al.79 * | Women aged ≥18 years referred to colposcopy. | NR | 4253 | NR |
| Xue et al.39 * | Aged 24-65 years with indications for the need for colposcopy imaging and biopsy, and those who were pathologically confirmed. | Empty or invalid images, low quality, unsatisfactory images, information loss. | 19435 | NR (NR; 24–65) |
| Yu et al.80 * | NR | NR | 679 | NR |
| Yuan et al.40 * | NR | Without complete clinical and pathological information; without biopsies; pathologically diagnosed as invasive cervical cancer or glandular intraepithelial lesions; poor-quality colposcopy images. | 22330 | NR (NR; 20–66) |
DCE dynamic contrast enhanced, NR not reported, MRI magnetic resonance imaging, BI-RADS breast imaging reporting and data system, MR magnetic resonance, ABUS automated breast ultrasound, CDFI color doppler flow imaging, PW pulsed wave, HIV human immunodeficiency virus, HRME high-resolution microendoscopy, DS dual stained.
*20 studies included in the meta-analysis.