Digital Breast Tomosynthesis Plus Ultrasound Versus Digital Mammography Plus Ultrasound for Screening Breast Cancer in Women With Dense Breasts.

OBJECTIVE: To compare the outcomes of digital breast tomosynthesis (DBT) screening combined with ultrasound (US) with those of digital mammography (DM) combined with US in women with dense breasts. MATERIALS AND METHODS: A retrospective database search identified consecutive asymptomatic women with dense breasts who underwent breast cancer screening with DBT or DM and whole-breast US simultaneously between June 2016 and July 2019. Women who underwent DBT + US (DBT cohort) and DM + US (DM cohort) were matched using 1:2 ratio according to mammographic density, age, menopausal status, hormone replacement therapy, and a family history of breast cancer. The cancer detection rate (CDR) per 1000 screening examinations, abnormal interpretation rate (AIR), sensitivity, and specificity were compared. RESULTS: A total of 863 women in the DBT cohort were matched with 1726 women in the DM cohort (median age, 53 years; interquartile range, 40-78 years) and 26 breast cancers (9 in the DBT cohort and 17 in the DM cohort) were identified. The DBT and DM cohorts showed comparable CDR (10.4 [9 of 863; 95% confidence interval {CI}: 4.8-19.7] vs. 9.8 [17 of 1726; 95% CI: 5.7-15.7] per 1000 examinations, respectively; P = 0.889). DBT cohort showed a higher AIR than the DM cohort (31.6% [273 of 863; 95% CI: 28.5%-34.9%] vs. 22.4% [387 of 1726; 95% CI: 20.5%-24.5%]; P < 0.001). The sensitivity for both cohorts was 100%. In women with negative findings on DBT or DM, supplemental US yielded similar CDRs in both DBT and DM cohorts (4.0 vs. 3.3 per 1000 examinations, respectively; P = 0.803) and higher AIR in the DBT cohort (24.8% [188 of 758; 95% CI: 21.8%-28.0%] vs. 16.9% [257 of 1516; 95% CI: 15.1%-18.9%; P < 0.001). CONCLUSION: DBT screening combined with US showed comparable CDR but lower specificity than DM screening combined with US in women with dense breasts.

9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): a multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea.

BACKGROUND: With the introduction of new anti-tuberculosis drugs, all-oral regimens with shorter treatment durations for multidrug-resistant tuberculosis have been anticipated. We aimed to investigate whether a new all-oral regimen was non-inferior to the conventional regimen including second-line anti-tuberculosis drugs for 20-24 months in the treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis. METHODS: In this multicentre, randomised, open-label phase 2/3 non-inferiority trial, we enrolled men and women aged 19-85 years with multidrug-resistant tuberculosis confirmed by phenotypic or genotypic drug susceptibility tests or rifampicin-resistant tuberculosis by genotypic tests at 12 participating hospitals throughout South Korea. Participants with fluoroquinolone-resistant multidrug-resistant tuberculosis were excluded. Participants were randomly assigned (1:1) to two groups using a block randomisation, stratified by the presence of diabetes and cavitation on baseline chest radiographs. The investigational group received delamanid, linezolid, levofloxacin, and pyrazinamide for 9 months, and the control group received a conventional 20-24-month regimen, according to the 2014 WHO guidelines. The primary outcome was the treatment success rate at 24 months after treatment initiation in the modified intention-to-treat population and the per-protocol population. Participants who were "cured" and "treatment completed" were defined as treatment success following the 2014 WHO guidelines. Non-inferiority was confirmed if the lower limit of a 97·5% one-sided CI of the difference between the groups was greater than -10%. Safety data were collected for 24 months in participants who received a predefined regimen at least once. This study is registered with ClinicalTrials.gov, NCT02619994. FINDINGS: Between March 4, 2016, and Sept 14, 2019, 214 participants were enrolled, 168 (78·5%) of whom were included in the modified intention-to-treat population. At 24 months after treatment initiation, 60 (70·6%) of 85 participants in the control group had treatment success, as did 54 (75·0%) of 72 participants in the shorter-regimen group (between-group difference 4·4% [97·5% one-sided CI -9·5% to ∞]), satisfying the predefined non-inferiority margin. No difference in safety outcomes was identified between the control group and the shorter-regimen group. INTERPRETATION: 9-month treatment with oral delamanid, linezolid, levofloxacin, and pyrazinamide could represent a new treatment option for participants with fluoroquinolone-sensitive multidrug-resistant tuberculosis. FUNDING: Korea Disease Control and Prevention Agency, South Korea.

Addition of Screening Breast US to Digital Mammography and Digital Breast Tomosynthesis for Breast Cancer Screening in Women at Average Risk.

Background Digital breast tomosynthesis (DBT) with or without digital mammography (DM) is the primary method of breast cancer screening. However, the sufficiency of DBT screening for women at average risk and the need for supplemental whole-breast US needs further investigation. Purpose To evaluate the added value of supplemental US screening following combined DM/DBT. Materials and Methods A retrospective database search identified consecutive asymptomatic women who underwent DM/DBT and radiologist-performed screening breast US simultaneously between March 2016 and December 2018. The cancer detection rate (CDR) per 1000 screening examinations, sensitivity, specificity, and abnormal interpretation rate of DM/DBT and DM/DBT combined with US were compared. Results A total of 1003 women (mean age, 56 years ± 8.6 [standard deviation]) were included. Among them, 12 cancers (mean invasive tumor size, 14 mm; range, 6-33 mm) were diagnosed. With DM/DBT and DM/DBT combined with US, the CDRs were 9.0 per 1000 screening examinations (nine of 1003 women; 95% CI: 4.1, 17) and 12 per 1000 screening examinations (12 of 1003 women; 95% CI: 6.2, 21), respectively, and the abnormal interpretation rates were 7.8% (78 of 1003 women; 95% CI: 6.2, 9.6) and 24% (243 of 1003 women; 95% CI: 22, 27). In women with negative findings at DM/DBT, supplementary US yielded a CDR of 3.2 per 1000 examinations (three of 925 women; 95% CI: 0.7, 9.4), sensitivity of 100% (three of three women; 95% CI: 29, 100), specificity of 82% (760 of 922 women; 95% CI: 80, 85), and abnormal interpretation rate of 18% (165 of 925 women; 95% CI: 15, 21). The three additional US-detected cancers were identified in women with dense breasts; no benefit was observed in women with nondense breasts. Conclusion The addition of breast US to digital mammography and digital breast tomosynthesis yielded an additional 0.7-9.4 cancers per 1000 women at average risk, with a substantial increase in the abnormal interpretation rate. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Rahbar in this issue.

The Long-term Reoperation Rate Following Surgery for Lumbar Stenosis: A Nationwide Sample Cohort Study With a 10-year Follow-up.

STUDY DESIGN: Retrospective cohort study of a nationwide sample database. OBJECTIVE: The objective of the present study was to compare the long-term incidence of reoperation for lumbar spinal stenosis (LSS) after anterior fusion, posterior fusion, and decompression. SUMMARY OF BACKGROUND DATA: Surgical treatment for LSS can be largely divided into 2 categories: decompression only and decompression with fusion. A previous nationwide study reported that fusion surgery was performed in 10% of patients with LSS, and the 10-year reoperation rate was approximately 17%. However, with the development of surgical techniques and changes in surgical trends, these results should be reassessed. METHODS: The National Health Insurance Service-National Sample Cohort of the Republic of Korea was utilized to establish a cohort of adult patients (N = 1400) who first underwent surgery for LSS during 2005 to 2007. Patients were followed for 8 to 10 years. Considering death before reoperation as a competing event, reoperation hazards were compared among surgical techniques using a Fine and Gray regression model after adjustment for sex, age, diabetes, osteoporosis, Charlson comorbidity index, severity of disability, type of medical coverage, and type of hospital. RESULTS: The overall cumulative incidence of reoperation was 6.2% at 2 years, 10.8% at 5 years, and 18.4% at 10 years. The cumulative incidence of reoperation was 20.6%, 12.6%, and 18.6% after anterior fusion, posterior fusion, and decompression, respectively, at 10 years postoperatively (P = 0.44). The first surgical technique did not affect the reoperation type (P = 0.27). Decompression was selected as the surgical technique for reoperation in 83.5% of patients after decompression, in 72.7% of patients after anterior fusion, and in 64.3% of patients after posterior fusion. CONCLUSION: The initial surgical technique did not affect reoperation during the 10-year follow-up period. Decompression was the most commonly used technique for reoperation. LEVEL OF EVIDENCE: 4.

Long-Term Effect of Diabetes on Reoperation After Lumbar Spinal Surgery: A Nationwide Population-Based Sample Cohort Study.

BACKGROUND: Diabetes mellitus (DM) is associated with poor postoperative outcomes and increased morbidity after surgeries. Some previous studies have addressed the close association between DM and those leading to reoperations, whereas others have rejected this theory. This study aimed to evaluate the long-term effect of DM on lumbar spinal surgery using data from a nationwide sample cohort. METHODS: A population-based cohort comprised one million people, which is a 2.1% representative sample of the Korean population. The present study included adult patients with lumbar degenerative diseases (e.g., lumbar spinal stenosis and spondylolisthesis), who underwent their first lumbar surgery in 2006. The cumulative incidence function for reoperation was calculated and multivariate analysis was performed to define correlation between reoperation and independent factors. RESULTS: A total of 2020 patients were enrolled and followed up for 10 years. Nondiabetic patients, patients with DM without complication (DwoC), and patients with DM with complication (DwC) accounted for 79.5%, 9.36%, and 11.14% of all patients, respectively. Reoperation incidence stratified by DM was 12.7% for nondiabetic patients, 22.2% for patients with DwoC, and 20.0% for patients with DwC in 10 years of follow-up. During the same period, death, a competing event of reoperation, occurred in 7.8% of nondiabetic patients, in 13.2% of patients with DwoC, and in 20.9% of patients with DwC. CONCLUSIONS: DM increased 1.65 times the overall cumulative incidences of reoperation after lumbar spinal surgeries for 10 years of follow-up. The reoperation incidence for DwC may be lower than that for DwoC because of a high incidence of death as a competing event of reoperation.

The Long-term Reoperation Rate Following Surgery for Lumbar Herniated Intervertebral Disc Disease: A Nationwide Sample Cohort Study With a 10-year Follow-up.

STUDY DESIGN: A retrospective cohort study of a nationwide sample database. OBJECTIVE: The objective of the present study was to compare the long-term incidence of reoperation for lumbar herniated intervertebral disc disease (HIVD) after major surgical techniques (open discectomy, OD; laminectomy; percutaneous endoscopic lumbar discectomy, PELD; fusion). SUMMARY OF BACKGROUND DATA: HIVD is a major spinal affliction; if the disease is intractable, surgery is recommended. Considering both the aging of patients and the chronicity of lumbar degenerative disease, the effect of surgical treatment for the lumbar spine should be durable for as long as possible. METHODS: The National Health Insurance Service-National Sample Cohort (NHIS-NSC) of Republic of Korea was utilized to establish a cohort of adult patients (N = 1856) who underwent first surgery for lumbar HIVD during 2005 to 2007. Patients were followed for 8 to 10 years. Considering death before reoperation as a competing event, reoperation hazards were compared among surgical techniques using the Fine and Gray regression model after adjustment for age, gender, Charlson comorbidity score, osteoporosis, diabetes, the severity of disability, insurance type, and hospital type. RESULTS: The overall cumulative incidences of reoperation were 4% at 1 year, 6% at 2 years, 8% at 3 years, 11% at 5 years, and 16% at 10 years. The cumulative incidences of reoperation were 16%, 14%, 16%, and 10% after OD, laminectomy, PELD, and fusion, respectively, at 10 years postoperation, with no difference among the surgical techniques. However, the distribution of reoperation types was significantly different according to the first surgical technique (P < 0.01). OD was selected as the reoperation surgical technique in 80% of patients after OD and in 81% of patients after PELD. CONCLUSION: The probability of reoperation did not differ among OD, laminectomy, PELD, and fusion during the 10-year follow-up period. However, OD was the most commonly used technique in reoperation. LEVEL OF EVIDENCE: 4.

Sagittal imbalance in patients with lumbar spinal stenosis and outcomes after simple decompression surgery.

BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is the most common lumbar degenerative disease, and sagittal imbalance is uncommon. Forward-bending posture, which is primarily caused by buckling of the ligamentum flavum, may be improved via simple decompression surgery. PURPOSE: The objectives of this study were to identify the risk factors for sagittal imbalance and to describe the outcomes of simple decompression surgery. STUDY DESIGN: This is a retrospective nested case-control study PATIENT SAMPLE: This was a retrospective study that included 83 consecutive patients (M:F=46:37; mean age, 68.5±7.7 years) who underwent decompression surgery and a minimum of 12 months of follow-up. OUTCOME MEASURES: The primary end point was normalization of sagittal imbalance after decompression surgery. METHODS: Sagittal imbalance was defined as a C7 sagittal vertical axis (SVA) ≥40 mm on a 36-inch-long lateral whole spine radiograph. Logistic regression analysis was used to identify the risk factors for sagittal imbalance. Bilateral decompression was performed via a unilateral approach with a tubular retractor. The SVA was measured on serial radiographs performed 1, 3, 6, and 12 months postoperatively. The prognostic factors for sagittal balance recovery were determined based on various clinical and radiological parameters. RESULTS: Sagittal imbalance was observed in 54% (45/83) of patients, and its risk factors were old age and a large mismatch between pelvic incidence and lumbar lordosis. The 1-year normalization rate was 73% after decompression surgery, and the median time to normalization was 1 to 3 months. Patients who did not experience SVA normalization exhibited low thoracic kyphosis (hazard ratio [HR], 1.04; 95% confidence interval [CI], 1.02-1.10) (p<.01) and spondylolisthesis (HR, 0.33; 95% CI, 0.17-0.61) before surgery. CONCLUSIONS: Sagittal imbalance was observed in more than 50% of LSS patients, but this imbalance was correctable via simple decompression surgery in 70% of patients.

Work productivity and activity impairment in gastroesophageal reflux disease in Korean full-time employees: a multicentre study.

INTRODUCTION: The costs of gastroesophageal reflux disease have not been assessed in Asia, even though the prevalence of gastroesophageal reflux disease is gradually increasing. We evaluated work presenteeism and absenteeism as indirect costs of gastroesophageal reflux disease in Korea. METHODS: This was a cross-sectional and multicentre study using patient-reported outcome instruments. A total of 1009 full-time employees who visited the gastrointestinal department for any reason (281 patients with gastroesophageal reflux disease and 728 controls) were included. Main outcomes were presenteeism and absenteeism measured as work productivity loss and monetary cost per week. RESULTS: Absenteeism and presenteeism were significantly higher in the gastroesophageal reflux disease than the control group (1.49% vs. 0.46%, P=0.0010; 34.13% vs. 9.23%, P<0.0001). Loss of work productivity was significantly greater in the gastroesophageal reflux disease than the control group (33.09% vs. 9.02%; P<0.0001). This loss of work productivity difference between the two groups represented an additional productivity loss of 11.7h/week in the gastroesophageal reflux disease group compared with the control group. Assuming average hourly wages of $14.12, the weekly burden of gastroesophageal reflux disease reached $165.07 per person. CONCLUSIONS: Gastroesophageal reflux disease was associated with substantial work productivity loss, mainly due to presenteeism rather than absenteeism, in Korean full-time employees.