Nevin Manimala

Zhonghua Yi Xue Za Zhi. 2021 Aug 24;101(32):2544-2551. doi: 10.3760/cma.j.cn112137-20201229-03502.

ABSTRACT

Objective: To evaluate the cost-effectiveness of anti-tumor associated antigen autoantibody (TAAb) for hepatocellular carcinoma (HCC) screening in cirrhosis population with chronic hepatitis B (CHB). Methods: A simulated cohort of 40-year-old patients with CHB cirrhosis was established with a sample size of 10 000. Using TAAb screening alone or TAAb and AFP screening in parallel (TAAb + AFP) as the research strategy, and liver ultrasound and AFP screening in parallel (liver ultrasound + AFP) as the control strategy, the decision analysis Markov model was constructed and the model validity was evaluated. The 6-month cycle was simulated using TreeAge Pro 2020 software. Cost and quality-adjusted life years (QALY) were calculated. Incremental cost-effectiveness ratio (ICER) was used to compare the two strategies, and sensitivity analysis was used to evaluate the uncertainty of results. Results: The Markov model had a total of 11 outcomes, of which 7 were natural outcomes and 4 wereclinical intervention outcomes, and the goodness of fit was 0.969. The lifetime screening cost of TAAb+AFP strategy for HCC screening was 249 612 yuan/case, and the QALY per capita was 7.704 years. Compared with liver ultrasound +AFP strategy (247 805 yuan/case), the total health cost increased by 1 807 yuan/case, and the QALY obtained was 0.014. The ICER was 127 635 yuan /QALY. When the TAAb screening fee was higher than 889.552 yuan, or the discount rate was higher than 0.068, or the antiviral treatment compliance was lower than 45.1%, ICER > 212 676 yuan /QALY. When the single TAAb screening fee was 400-600 yuan, the TAAB+AFP strategy had cost effective value. When the willingness to pay was 70 892, 141 784 and 212 676 yuan /QALY, the probability of cost-effectiveness of TAAb+AFP strategy was 70.6%, 75.3% and 77.8%, respectively. Conclusion: It is cost-effective to use TAAb+AFP for early screening of liver cancer in Chinese population with CHB cirrhosis.

PMID:34407581 | DOI:10.3760/cma.j.cn112137-20201229-03502

Zhonghua Yi Xue Za Zhi. 2021 Aug 24;101(32):2531-2536. doi: 10.3760/cma.j.cn112137-20201210-03324.

ABSTRACT

Objective: To evaluate the effectiveness and safety of functional axillary dissection based on lymphatic drainage (FUND) in decreasing breast cancer-related lymphedema (BCRL) events. Methods: A total of 168 eligible patients in Zhongnan Hospital of Wuhan University from July 2018 to February 2019 were randomly assigned to the FUND group or axillary lymph node dissection (ALND) group using random number table generated by SPSS. In the FUND group, methylene blue (MB) was adopted to reveal the sentinel lymph node (SLN) for all patients; 0.1 ml MB was injected into the SLNs before resection to reveal the efferent lymphatic channels and subsequent-echelon lymph node. The blue-stained lymphatic channels were mapped by bluntly dissecting along the lymphatic drainage channels from the breast to the axilla. Then, the SLNs were removed and pathologically analyzed by immediate frozen sectioning (FS); if the SLNs were positive, the blue-stained bALNs in breast lymphatic level (BLL) Ⅱ were removed and sent for immediate FS; if the blue-stained ALNs in BLL Ⅱ were confirmed negative, the tissues in BLL Ⅱ were removed’en bloc’. Clinicopathologic information for all the patients in the two groups were collected. The fixed-point circumference volume measurement method and the Norman questionnaire scoring method were used to evaluate the arm lymphedema between the two groups. Clinicopathological characteristics, incidences of arm lymphedema, locoregional recurrence, and distant metastasis between the two groups were compared. Results: The mean age were (50.3±8.0) in the FUND group and (51.1±9.0) in the ALND group. Seventy-four cases (88.1%) in the FUND group successfully underwent FUND surgery, and patients whose breast lymphatics failed to be stained blue underwent standard ALND. There was no statistically significant difference in terms of age, BMI, histological types, surgical approaches and adjunct therapy between the FUND group (n=74) and ALND group (n=84) (P>0.05). The average operation time of the FUND group and the stand ALND group were (169±15) and (123±12) min respectively (range: 145-198, 103-146 min) (P<0.001), and the number of lymph nodes removed [M (Q₁, Q₃)] were 8.3 (6, 15) and 12.9 (7, 18) (P=0.019). The cumulative BCRL rate, within a median follow-up of 24 months and 23 months respectively for FUND and ALND group, were 10.8% (8/74) vs 23.8% (20/84) (P=0.033) measured by fixed-point circumference volume measurement method, and was 12.2% (9/74) vs 27.4% (23/84) by Norman questionnaire (P=0.018). There were no local regional recurrence events during the follow-up period between the two groups. Conclusion: For breast cancer patients with clinically node-positive axilla or positive SLN, FUND based on lymphatic drainage was a less radical axillary surgery, with which eliminating the risk of BCRL might be achieved.

PMID:34407579 | DOI:10.3760/cma.j.cn112137-20201210-03324

Zhonghua Yi Xue Za Zhi. 2021 Aug 24;101(32):2514-2518. doi: 10.3760/cma.j.cn112137-20210223-00466.

ABSTRACT

Objective: To evaluate the association of meibomian gland dysfunction (MGD) and body mass index (BMI) in Chinese adults. Methods: A total of 2 419 patients were retrospectively recruited between May and October 2013 from 33 ocular surface disease clinic in China. There were 780 males (32.2%) and 1 639 females (67.8%), aged 18-89 (46±16) years. BMI value of each patient was respectively calculated, and the patients were divided into underweight, normal weight, overweight and obesity groups accordingly. Meibomian gland-related examinations were performed in right eyes. Results: The number of the patients in four groups were 196, 1 556, 567 and 100, respectively. Compared with normal weight group, the rates of moderate to severe MGD (59.1%, 71.0% vs 49.9%) in overweight group and obesity group were higher, and the differences were statistically significant (both P<0.05). The scores of change in eyelid margin, meibomian gland dropout and meibum expressibility were significantly higher in overweight group and obesity group, compared with normal weight group (all P<0.05). Additionally, after stratified by age, all the above-mentioned three scores of obese patients were significantly higher than those of non-obese patients in young adult group. Multivariate logistic regression analysis showed that moderate to severe MGD was correlated with overweight (OR=2.19, 95%CI: 1.06-4.50, P=0.033) and obesity (OR=3.70, 95%CI: 2.57-5.04, P=0.008). Conclusion: Moderate to severe MGD significantly correlates with high BMI in Chinese adults.

PMID:34407576 | DOI:10.3760/cma.j.cn112137-20210223-00466

Zhonghua Yi Xue Za Zhi. 2021 Aug 24;101(32):2508-2513. doi: 10.3760/cma.j.cn112137-20210228-00508.

ABSTRACT

Objective: To evaluate the clinical efficacy of dietary supplement Licofor in the treatment of dry eye associated with meibomian gland dysfunction (MGD). Methods: This was a prospective, randomized controlled clinical trial. Sixty patients [25 males, 35 females, aged (42±13) years] who had dry eye associated with MGD were recruited in Xiangya Hospital of Central South University from December 2018 to October 2019. The patients were equally divided into two groups: 30 cases (60 eyes) in the experimental group and 30 cases (60 eyes) in the control group. All subjects were treated with eye hot compress, artificial tears and antibiotic ointment. After that, the experimental group and control group were received dietary supplementary Licofor or placebo daily for 12 weeks. The symptoms and signs of dry eye, morphology and function of meibomian gland, and inflammatory response were assessed at the beginning, 4^th, 8^th and 12^th week of treatment. Results: After 12 weeks of treatment, statistically significant improvements in ocular surface disease index (OSDI) scores, tear break-up time (TBUT), corneal fluorescein staining (CFS), the morphology of eyelid margin, meibomian gland orifice, meibomian gland expressibility, meibum quality, and periglandular inflammatory cell density were determined in both groups (all P<0.05). In the Licofor group, the improvement of OSDI scores [16.7 (12.5, 20.8) vs 20.8 (18.8, 22.9), P<0.001], the morphology of eyelid margin, meibomian gland orifice and periglandular inflammatory cell density [443 (318, 513) vs 553 (415, 676)/mm², P=0.002] were more significant (all P<0.05). Conclusion: The combined treatment of licofor and conventional treatment can significantly improve symptoms of dry eye, the morphology of eyelid margin, meibomian gland orifice, meibum quality, and eyelid inflammation response of dry eye associated with MGD.

PMID:34407575 | DOI:10.3760/cma.j.cn112137-20210228-00508

Appl Clin Inform. 2021 Aug;12(4):778-787. doi: 10.1055/s-0041-1733908. Epub 2021 Aug 18.

ABSTRACT

BACKGROUND: Suicide risk prediction models have been developed by using information from patients’ electronic health records (EHR), but the time elapsed between model development and health system implementation is often substantial. Temporal changes in health systems and EHR coding practices necessitate the evaluation of such models in more contemporary data.

OBJECTIVES: A set of published suicide risk prediction models developed by using EHR data from 2009 to 2015 across seven health systems reported c-statistics of 0.85 for suicide attempt and 0.83 to 0.86 for suicide death. Our objective was to evaluate these models’ performance with contemporary data (2014-2017) from these systems.

METHODS: We evaluated performance using mental health visits (6,832,439 to mental health specialty providers and 3,987,078 to general medical providers) from 2014 to 2017 made by 1,799,765 patients aged 13+ across the health systems. No visits in our evaluation were used in the previous model development. Outcomes were suicide attempt (health system records) and suicide death (state death certificates) within 90 days following a visit. We assessed calibration and computed c-statistics with 95% confidence intervals (CI) and cut-point specific estimates of sensitivity, specificity, and positive/negative predictive value.

RESULTS: Models were well calibrated; 46% of suicide attempts and 35% of suicide deaths in the mental health specialty sample were preceded by a visit (within 90 days) with a risk score in the top 5%. In the general medical sample, 53% of attempts and 35% of deaths were preceded by such a visit. Among these two samples, respectively, c-statistics were 0.862 (95% CI: 0.860-0.864) and 0.864 (95% CI: 0.860-0.869) for suicide attempt, and 0.806 (95% CI: 0.790-0.822) and 0.804 (95% CI: 0.782-0.829) for suicide death.

CONCLUSION: Performance of the risk prediction models in this contemporary sample was similar to historical estimates for suicide attempt but modestly lower for suicide death. These published models can inform clinical practice and patient care today.

PMID:34407559 | DOI:10.1055/s-0041-1733908

Fetal Diagn Ther. 2021 Aug 18:1-9. doi: 10.1159/000515251. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to determine if customized fetal growth charts developed excluding obese and underweight mothers (CC(18.5-25)) are better than customized curves (CC) at identifying pregnancies at risk of perinatal morbidity.

MATERIAL AND METHODS: Data from 20,331 infants were used to construct CC and from 11,604 for CC(18.5-25), after excluding the cases with abnormal maternal BMI. The 2 models were applied to 27,507 newborns and the perinatal outcomes were compared between large for gestational age (LGA) or small for gestational age (SGA) according to each model. Logistic regression was used to calculate the OR of outcomes by the group, with gestational age (GA) as covariable. The confidence intervals of pH were calculated by analysis of covariance.

RESULTS: The rate of cesarean and cephalopelvic disproportion (CPD) were higher in LGAonly by CC(18.5-25) than in LGAonly by CC. In SGAonly by CC(18.5-25), neonatal intensive care unit (NICU) and perinatal mortality rates were higher than in SGAonly by CC. Adverse outcomes rate was higher in LGAonly by CC(18.5-25) than in LGAonly by CC (21.6%; OR = 1.61, [1.34-193]) vs. (13.5%; OR = 0.84, [0.66-1.07]), and in SGA only by CC(18.5-25) than in SGAonly by CC (9.6%; OR = 1.62, [1.25-2.10] vs. 6.3%; OR = 1.18, [0.85-1.66]).

CONCLUSION: The use of CC(18.5-25) allows a more accurate identification of LGA and SGA infants at risk of perinatal morbidity than conventional CC. This benefit increase and decrease, respectively, with GA.

PMID:34407539 | DOI:10.1159/000515251

J Breath Res. 2021 Aug 18. doi: 10.1088/1752-7163/ac1ea5. Online ahead of print.

ABSTRACT

BACKGROUND: During the ongoing COVID-19 pandemic, face masks are among the most common and practical control measures used globally in reducing the risk of infection and disease transmission. Although several studies have investigated the efficacy of various face masks and respirators in preventing infection, the results have been inconsistent. Therefore, we performed a systematic review and network meta-analysis (NMA) of the randomized-controlled trials to assess the actual efficacy of face masks in preventing respiratory infections.

METHODS: We searched nine electronic databases up to July 2020 to find potential articles. We accepted trials reporting the protective efficacy of face masks against respiratory infections, of which the primary endpoint was the presence of respiratory infections. We used the ROB-2 Cochrane tool to grade the trial quality. We initially registered the protocol for this study in PROSPERO (CRD42020178516).

RESULTS: Sixteen randomized-controlled trials (RCTs) involving 17048 individuals were included for NMA. Overall, evidence was weak, lacking statistical power due to the small number of participants, and there was substantial inconsistency in our findings. In comparison to those without face masks, participants with fit-tested N95 respirators were likely to have lesser infection risk (RR 0.67, 95% CI 0.38 to 1.19, P-score 0.80), followed by those with non-fit-tested N95 and non-fit-tested FFP2 respirators that shared the similar risk, (RR 0.73, 95% CI 0.12 to 4.36, P-score 0.63) and (RR 0.80, 95% CI 0.38 to 1.71, P-score 0.63), respectively. Next, participants who donned face masks with and without hand hygiene practices showed modest risk improvement alike (RR 0.89, 95% CI 0.67 to 1.17, P-score 0.55) and (RR 0.92, 95% CI 0.70 to 1.22, P-score 0.51). Otherwise, participants donning double-layered cloth masks were prone to infection (RR 4.80, 95% CI 1.42 to 16.27, P-score 0.01). Eleven out of 16 RCTs that underwent a pairwise meta-analysis revealed a substantially lower infection risk in those donning medical face masks (MFMs) than those without face masks (RR 0.83 95% CI 0.71 to 0.96).

CONCLUSION: Given the body of evidence through a systematic review and meta-analyses, our findings supported the protective benefits of MFMs in reducing respiratory transmissions, and the universal mask-wearing should be applied-especially during the COVID-19 pandemic. More clinical data is required to conclude the efficiency of cloth masks; in the short term, users should not use cloth face masks in the outbreak hot spots and places where social distancing is impossible.

PMID:34407516 | DOI:10.1088/1752-7163/ac1ea5

Breast. 2021 Aug 11;59:351-357. doi: 10.1016/j.breast.2021.08.004. Online ahead of print.

ABSTRACT

PURPOSE: Incomplete response to neoadjuvant chemotherapy (NACT) in triple negative breast cancer (TNBC) patients is correlated to high risk of relapse. This study aimed to evaluate the role of adjuvant chemotherapy in TNBC with residual tumor after NACT.

METHODS: We retrospectively reviewed the outcome of patients with TNBC with residual tumor at surgery after a neoadjuvant treatment, followed by either adjuvant chemotherapy or observation. Primary endpoints were Disease Free Survival (DFS) and Overall Survival (OS).

RESULTS: Between January 2000 and December 2016, 223 patients with early TNBC operated at the European Institute of Oncology were eligible. A total of 83.4 % of patients received adjuvant chemotherapy after surgery. 90 patients received standard dose infusional regimens, while 96 patients (51.6 %) received oral metronomic chemotherapy. Adjusting the analysis by surgical stage and Ki67 value there was a benefit for DFS and OS in favor of the group that received postoperative chemotherapy (DFS-HR 0.58 p = 0.04; OS-HR 0.54, p = 0.02). At a subgroup analysis according to the different adjuvant treatments received, a benefit for metronomic chemotherapy versus no chemotherapy both for DFS (HR 0.46, p = 0.008) and OS (HR 0.45, p = 0.009) was reported.

CONCLUSION: Our retrospective analysis in a large cohort of TNBC patients with residual disease after NACT confirms the benefit of adding a postoperative treatment to reduce risk of relapse and death. Based on these results, we suggest that the adjuvant therapy based on metronomic cyclophosphamide and methotrexate deserves further investigation in this patients population.

PMID:34407499 | DOI:10.1016/j.breast.2021.08.004

Am J Med Sci. 2021 Aug 15:S0002-9629(21)00281-0. doi: 10.1016/j.amjms.2021.06.018. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of the study was to assess the epidemiology, risk factors and outcomes of native vertebral osteomyelitis (NVO) in patients with Staphylococcus aureus bacteremia (SAB).

METHODS: A retrospective institutional review was conducted at Mayo Clinic, Minnesota. Patients aged ≥ 18 years with SAB who developed NVO from January 1, 2006 to December 31, 2020 were included and 3-month follow-up data were abstracted. Data pertaining to patient demographics, risk factors and outcomes were recorded using REDCap. A 1:2 nested case-control analysis was performed, and controls were matched according to age, sex and year of SAB diagnosis.

RESULTS: A total of 103 patients had NVO. A majority (60.2%) of patients was male, with a median age of 62.0 years. Thirty-one (30.1%) cases were caused by methicillin-resistant S. aureus (MRSA). The lumbar spine was most commonly (57.6%) and the most commonly reported comorbid conditions included diabetes mellitus (36.9%) and coronary artery disease (27.2%). Mortality at three-month follow-up was 18.6%. Nested case-control analysis revealed that injection drug use (IDU) and tobacco consumption were significant risk factors associated with NVO, while chronic hemodialysis and chronic liver disease (CLD) were associated with a decreased risk of NVO.

CONCLUSIONS: Atherosclerotic vascular disease was prominent in our contemporary cohort with NVO in the setting of SAB. Diabetes mellitus, tobacco consumption, older age and male sex likely contributed to this profile. Because IDU was associated with NVO, an increased number of cases should be anticipated among patients with IDU given the ongoing opioid epidemic in the United States.

PMID:34407419 | DOI:10.1016/j.amjms.2021.06.018

Cell Rep. 2021 Aug 17;36(7):109560. doi: 10.1016/j.celrep.2021.109560.

ABSTRACT

We assess the degree of phenotypic variation in a cohort of 24-month-old male C57BL/6 mice. Because murine studies often use small sample sizes, if the commonly relied upon assumption of a normal distribution of residuals is not met, it may inflate type I error rates. In this study, 3-20 mice are resampled from the empirical distributions of 376 mice to create plasmodes, an approach for computing type I error rates and power for commonly used statistical tests without assuming a normal distribution of residuals. While all of the phenotypic and metabolic variables studied show considerable variability, the number of animals required to achieve adequate power is markedly different depending on the statistical test being performed. Overall, this work provides an analysis with which researchers can make informed decisions about the sample size required to achieve statistical power from specific measurements without a priori assumptions of a theoretical distribution.

PMID:34407413 | DOI:10.1016/j.celrep.2021.109560