Category: Statistics

Zhonghua Wei Chang Wai Ke Za Zhi. 2021 May 25;24(5):433-439. doi: 10.3760/cma.j.cn.441530-20200505-00255.

ABSTRACT

Objective: At present, though the laparoscopic delta-shaped anastomosis and overlapping delta-shaped anastomosis have been gradually applied to complete laparoscopic radical resection of left hemicolon cancer, the comparative evaluation of their efficacy has not been mentioned in the published literatures. This study aims to explore the safety, feasibility and short-term efficacy of overlapping delta-shaped anastomosis (ODA) in totally laparoscopic left hemicolectomy. Methods: A retrospective cohort study was performed. The clinical and pathological data of patients who underwent totally laparoscopic left hemicolectomy at Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from May 2017 to October 2020 were retrospectively analyzed. The case inclusion criteria were as follows: (1) age of 18-75 years; (2) body mass index (BMI) of 18.5-30 kg/m(2); (3) descending colonic and proximal sigmoid colonic adenocarcinoma was confirmed by preoperative colonoscopy and pathology. The exclusion criteria: (1) multiple primary colorectal cancers; (2) uncontrolled or poorly controlled diabetes mellitus, immune system diseases, or hematological diseases; (3) severe intestinal obstruction; (4) left transverse colonic or splenic flexure colonic adenocarcinoma; (5) distant metastasis of liver, lung and other viscera determined by enhanced computed tomography in the chest, abdomen and pelvis. According to the above criteria, a total of 115 patients with left hemicolon cancer were enrolled. All the patients underwent totally laparoscopic left hemicolectomy. Patients who underwent laparoscopic traditional delta-shaped anastomosis were selected as the control group. Patients who underwent laparoscopic ODA were selected as the ODA group. Effects of these two laparoscopic reconstruction methods on postoperative recovery and perioperative complications were analyzed and compared. Results: A total of 60 patients were enrolled in the ODA group, including 32 males and 28 females, with mean age of (57.3±10.4) years and body mass index (BMI) of (25.0±3.1) kg/m(2). While mean 55 patients were enrolled in the control group, including 31 males and 24 females, with mean age of (56.7±9.9) years and BMI of (24.4±2.9) kg/m(2). There was no statistically significant differences between the two groups in gender, age, BMI, American Society of Anesthesiologist (ASA) classification, TNM staging, preoperative abdominal surgery history, neoadjuvant chemotherapy and nutritional status (levels of hemoglobin, lymphocyte count, prealbumin, and albumin) (all P>0.05). All the patients in both groups received R0 resection without conversion to open laparotomy or conversion to extra-abdominal anastomosis. The digestive tract reconstruction time of the ODA group was significantly shorter than that of the control group [(15.1±1.7) minutes vs. (15.9±2.4) minutes, t=-2.053, P=0.042]. There were no statistically significant differences in the total operation time, intraoperative blood loss, length of skin incision, tumor size, proximal and distal margins, harvested lymph nodes, postoperative first ambulatory time, and postoperative hospital stay (all P>0.05). However, the time to the first flatus and the first defecation in the ODA group was significantly shorter as compared to control group [(1.5±0.5) days vs. (1.7±0.5) days, t=-2.028, P=0.045; (3.1±0.6) days vs. (3.4±0.7) days, t=-2.095, P=0.039], indicating faster intestinal function recovery in patients with ODA. The morbidity of postoperative complication was 6.7% (4/60) in the ODA group and 7.3% (4/55) in the control group and no significant difference was found (χ(2)=0.016, P=0.898). Two cases of incision infection, 1 case of lung infection, and 1 case of intra-abdominal infection occurred in the ODA group, while 3 cases of lung infection and 1 case of intra-abdominal infection occurred in the control group. All these complications were resolved after conservative treatment, and no secondary operation was performed due to complications. Conclusion: Compared with the traditional delta-shaped anastomosis, ODA is associated with a faster recovery of postoperative intestinal function without increasing the morbidity of postoperative complications, and has the satisfactory short-term efficacy.

PMID:34000773 | DOI:10.3760/cma.j.cn.441530-20200505-00255

Zhonghua Wei Chang Wai Ke Za Zhi. 2021 May 25;24(5):403-412. doi: 10.3760/cma.j.cn.441530-20200111-00014.

ABSTRACT

Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.

PMID:34000769 | DOI:10.3760/cma.j.cn.441530-20200111-00014

Klin Monbl Augenheilkd. 2021 May 17. doi: 10.1055/a-1473-5897. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the association between serum vitamin B12/folate and retinal vein occlusion (RVO).

METHODS: A comprehensive search of the PubMed database was performed, which identified 271 abstracts to be screened. Ten studies met our inclusion criteria and a meta-analysis of these comparative case-control studies was performed on the mean ± standard deviation serum vitamin B12 and folate levels, without language restrictions. Nine studies with 720 patients with RVO and 613 controls were included in the meta-analysis for vitamin B12, and 10 studies with 784 patients with RVO and 677 controls in the meta-analysis for folate.

RESULTS: There was no statistically significant difference between patients with RVO and controls in serum vitamin B12 levels (mean difference: – 40.25 pg/mL, p = 0.28), either central RVO (mean difference: – 18.24 pg/mL, p = 0.71) or branch RVO (mean difference: – 23.56 pg/mL, p = 0.48). On the contrary, the plasma folate level was significantly lower in RVO patients than in controls (mean difference: – 1.34 ng/mL, p = 0.001), as well as in patients with CRVO compared to controls (mean difference: – 1.48 ng/mL, p = 0.006), but not in BRVO patients (mean difference: – 0.72 ng/mL, p = 0.11).

CONCLUSIONS: RVO is associated with low serum folate levels, but not with serum vitamin B12 levels.

PMID:34000749 | DOI:10.1055/a-1473-5897

Klin Monbl Augenheilkd. 2021 May 17. doi: 10.1055/a-1384-0737. Online ahead of print.

ABSTRACT

INTRODUCTION: Oxygen saturation in retinal vessels can be non-invasively measured by a new method. It is known that oxygen extraction is lowered in diabetic retinopathy. In the cross-sectional study presented here, it has been investigated whether diabetes-specific changes and typical accompanying diseases could influence the measurements in oximetry.

METHODS: During a time span of seven months, 237 diabetics were included who came to our clinic for an intravitreal injection, who met the inclusion criteria, who showed no exclusion criteria and gave written consent. 203 eyes of 203 patients were evaluated. The oxygen saturation (SO₂) was measured in digitally stored fundus images taken with a fundus camera (Zeiss 450 FF). In its illumination beam, a filter was inserted with two transmission maxima at 584 nm and 610 nm (bandwidth 10 nm). With the program “Oximetry” (Imedos Systems, Jena, Germany), the venous and the arterial SO₂ were measured. The values were stored in a spreadsheet. Diabetes related data, clinical parameters and accompanying diseases were documented in the predefined scheme.

RESULTS: In the whole patient sample, the venous oxygen saturation (vSO₂) was 69 ± 12%, the arterial saturation (aSO₂) 99 ± 5% and the arteriovenous difference 31 ± 9%. A statistically significant association could not be found between the measurement values of oximetry and age, duration of diabetes and HbA_1c (Kruskal-Wallis ANOVA: p > 0.05). The differences in oximetry values between units of analysis (UOA) e.g. hypertension and non units of analysis (NOA) were analysed. Descriptive testing showed significant differences in vSO₂% in the following units of analysis: allergies n = 47: UOA vs. NUOA: 64 vs. 69 (t test: p < 0.02); sartan therapy n = 46: UOA vs. NUOA: 64 vs. 70 (p = 0.003); state after intravitreal injections n = 144: 68 vs. 71 (p = 0.02). Oxygen extraction from the retinal capillaries was improved in patients who had injections with VEGF inhibitors. An improvement in oxygen extraction is also seen in patients with allergies and hypertension in comparison to those without these units of analysis.

CONCLUSION: The clinically observed improvement in the retinal state situation after intravitreal injections with VEGF inhibitors may be seen in association with the improved oxygen extraction. It seems reasonable to study whether a switch to sartans in the therapy of hypertension may improve retinal function.

PMID:34000750 | DOI:10.1055/a-1384-0737

Int J Epidemiol. 2021 May 17;50(2):685-693. doi: 10.1093/ije/dyaa259.

ABSTRACT

Statistical learning includes methods that extract knowledge from complex data. Statistical learning methods beyond generalized linear models, such as shrinkage methods or kernel smoothing methods, are being increasingly implemented in public health research and epidemiology because they can perform better in instances with complex or high-dimensional data-settings in which traditional statistical methods fail. These novel methods, however, often include random sampling which may induce variability in results. Best practices in data science can help to ensure robustness. As a case study, we included four statistical learning models that have been applied previously to analyze the relationship between environmental mixtures and health outcomes. We ran each model across 100 initializing values for random number generation, or ‘seeds’, and assessed variability in resulting estimation and inference. All methods exhibited some seed-dependent variability in results. The degree of variability differed across methods and exposure of interest. Any statistical learning method reliant on a random seed will exhibit some degree of seed sensitivity. We recommend that researchers repeat their analysis with various seeds as a sensitivity analysis when implementing these methods to enhance interpretability and robustness of results.

PMID:34000733 | DOI:10.1093/ije/dyaa259

Klin Monbl Augenheilkd. 2021 May 17. doi: 10.1055/a-1333-2723. Online ahead of print.

ABSTRACT

AIM: This retrospective investigated the impact of donor age, recipient age, donor endothelial cell density, vis-à-tergo, and additional intraoperative lens exchange (triple-procedure) on overall early and late phase postoperative endothelial cell density (ECD) following penetrating keratoplasty (PKP) in various diagnosis groups.

PATIENTS AND METHODS: In 590 cases with diagnosed keratoconus (KC), Fuchs dystrophy (FD) and herpes simplex virus infection (HSV) who underwent PKP or triple surgery, the ECD in cells/mm² was analysed, both preoperatively, with all-sutures-in (early postoperative stage), and after last suture removal. The factors were tested by Mann-Whitney U-test, correlation analysis and linear regression analysis.

OUTCOME: Correlation analysis demonstrated a weak negative correlation between the patient’s ECD and donor age (early postoperative stage: r = – 0.25, p < 0.001; after last suture removal: r = – 0.16; p = 0.003). Regression analysis revealed that donor age did not impact postoperative patient ECD. There was a weak negative correlation between postoperative ECD and recipient age (early postoperative stage: r = – 0.31, p < 0.001; after last suture removal: r = – 0.34, p < 0.001). Regression analysis confirmed the negative impact of recipient age on patient ECD (early postoperative stage: β = – 13.2, p = 0.001; after last suture removal: β = – 4.6, p < 0.001). Correlation analysis determined a weak positive correlation between postoperative ECD and donor endothelial cell density (early postoperative stage: r = 0.37, p < 0.001; after last suture removal: r = 0.32, p < 0.001). Regression analysis also determined that donor endothelial cell density had a positive impact on postoperative ECD following last suture removal (β = 0.4, p < 0.001). Vis-à-tergo and additional lens exchange (triple procedure) had no significant effect on postoperative ECD (p > 0.05). This was also confirmed by the results of the regression analysis after last suture removal.

CONCLUSION: Recipient age and donor endothelial cell density have a significant impact on postoperative ECD following PKP. Not all of the statistical tests proved donor age to be a significant influencing factor. Vis-à-tergo and additional lens exchange (triple procedure) had no significant effect on postoperative ECD following PKP.

PMID:34000746 | DOI:10.1055/a-1333-2723

Klin Monbl Augenheilkd. 2021 May 17. doi: 10.1055/a-1384-1020. Online ahead of print.

ABSTRACT

PURPOSE: Minimally invasive glaucoma surgery (MIGS), like Xen45 gel stents, is known as effective therapy in lowering intraocular pressure (IOP); however, fibrotic reactions are a common problem in postoperative management. It was the aim of this study to investigate the therapeutic success of Xen45 gel stents as a stand-alone technique (Xen) and combined with cataract surgery (XenPhaco), and with antimetabolites (mitomycin C, MMC) in open-angle glaucoma patients.

METHODS: Retrospective analysis was performed of 199 eyes of 177 glaucoma patients of the Department of Ophthalmology, University of Erlangen Nürnberg, and from the Erlangen Glaucoma Registry (NCT00494923; ISSN 2191-5008, CS-2011) who underwent implantation of a Xen45 gel stent. Therapeutic success was defined as IOP reduction of ≥ 20% on the same or less anti-glaucomatous medication after 12 months compared to preoperative and without any additional glaucoma-related surgery (except bleb needling). IOP reduction, reduction in local anti-glaucomatous eye drops, and intra- and postoperative complications were monitored.

RESULTS: Stand-alone Xen45 gel stent: therapeutic success was reached in 39% (-MMC) and 55% (+MMC). Failure rate was 61% (-MMC) and 45% (+MMC). XenPhaco: therapeutic success was achieved in 57% (-MMC) and 46% (+MMC). Failure rate was 43% (-MMC) and 54% (+MMC). Data were not different for group and subgroup analyses (p > 0.05).

CONCLUSIONS: The use of MMC seemed to increase the therapeutic success rate after stand-alone Xen45 gel stent implantation and combined with cataract surgery, yet statistical significant was not reached.

PMID:34000747 | DOI:10.1055/a-1384-1020

Diabetes Metab Syndr. 2021 May 8;15(3):1017-1022. doi: 10.1016/j.dsx.2021.05.006. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Understanding people’s attitudes towards Covid-19 vaccination is crucial to the successful implementation of a vaccination program. Hence this research study seeks to identify critical factors influencing Indian people’s attitudes and intentions to take up Covid-19 vaccinations.

METHODS: An online questionnaire was administered to a sample (n = 254) drawn from Indian population, to assess the impact of perceived benefits, risk perceptions, social media exposure, social norms, and trust associated with Covid-19 vaccines on people’s attitudes towards Covid-19 vaccines and their intentions to take up the Covid-19 vaccinations.

RESULTS: The findings showed that the perceived benefits, social norms, and trust correlated significantly with people’s attitudes towards Covid-19 vaccinations. In contrast, risk perceptions and social media exposure showed an insignificant influence on people’s attitudes towards Covid-19 vaccinations. Social norms, trust, and people’s attitudes towards the Covid-19 vaccinations are significantly correlated with their intentions to take up Covid-19 vaccinations. On the contrary, social media exposure was found to have an insignificant influence on people’s intentions to take up Covid-19 vaccinations.

CONCLUSION: Participants’ intentions to take up Covid-19 vaccinations was influenced mainly by their attitudes and perceptions of Covid-19 vaccines in general, which strongly confirms the importance of various dimensions (perceived benefits, trust, social norms) of Covid-19 vaccines in cultivating Covid-19 vaccination acceptance among participants’.

PMID:34000711 | DOI:10.1016/j.dsx.2021.05.006

Int Arch Allergy Immunol. 2021 May 17:1-7. doi: 10.1159/000513810. Online ahead of print.

ABSTRACT

INTRODUCTION: While there exists considerable evidence for efficacy of sublingual immunotherapy (SLIT), its impact on the improvement of nasal signs in allergic rhinitis (AR) patients remains quite unclear. In this study, the endoscopic examination and the modified Lund-Kennedy (MLK) scoring system were performed to describe and evaluate the therapeutic effect of SLIT.

METHODS: A total of 105 patients with AR induced by house dust mites were enrolled and treated with standardized Dermatophagoides farinae (D. farinae) drops for 1 year. The total nasal symptoms score (TNSS), total medication score (TMS), visual analog scale (VAS), and MLK scores were assessed at baseline and 6 and 12 months. The MLK score was also compared for its correlation with TNSS, TMS, and VAS.

RESULTS: The TNSS, TMS, and VAS scores statistically decreased after SLIT compared to baseline (all p < 0.05). After 12 months of treatment, the rates of well-controlled, partial controlled, and uncontrolled AR patients were 42, 49.5, and 8.5%, respectively. The nasal endoscopy findings showed significant improvement in nasal signs, which mainly included color change of turbinate mucosa, reduction of nasal secretions, and improvement of nasal edema. A significant decrease was observed in MLK scores, and there was a positive correlation between MLK and VAS scores.

CONCLUSIONS: In addition to commonly utilized subjective assessments (TMS, TNSS, and VAS), our results of endoscopic examination and the MLK scores consistently confirmed that SLIT is an effective therapeutic modality for AR patients. The MLK scores might be considered as an auxiliary tool to evaluate efficacy of SLIT in clinical practice and outcomes research.

PMID:34000723 | DOI:10.1159/000513810

Oncology. 2021 May 17:1-8. doi: 10.1159/000515280. Online ahead of print.

ABSTRACT

INTRODUCTION: This study compared clinical outcomes of 2nd- and 3rd-line regorafenib in patients with unresectable hepatocellular carcinoma.

METHODS: In this retrospective cohort study, 48 patients were treated with regorafenib for unresectable hepatocellular carcinoma. Thirty-five and 13 patients were initiated on 2nd- and 3rd-line therapy, respectively. We assessed the responses to and safety of the therapy.

RESULTS: There were no statistically significant differences in clinical characteristics at the start of 2nd- or 3rd-line regorafenib therapy. The overall response rate of 2nd- and 3rd-line regorafenib was 20 and 8%, respectively. The disease control rate was 57 and 54%, respectively. Median overall survival (mOS) from the start of 2nd-line regorafenib was 17.5 months. mOS from the start of 3rd-line regorafenib was not obtained. Median progression-free survival of 2nd- and 3rd-line regorafenib was 4.9 and 2.3 months, respectively. mOS from 1st-line therapy with tyrosine kinase inhibitor plus sorafenib-regorafenib-lenvatinib was 29.5 months; that with lenvatinib-sorafenib-regorafenib was not obtained. Patients on 3rd-line therapy tended to have better Child-Pugh scores and tumor factors at the start of 1st-line therapy than other patients.

CONCLUSION: Patients on 2nd- and 3rd-line regorafenib showed favorable responses. Good Child-Pugh scores and tumor factors may be associated with a better response rate and OS.

PMID:34000725 | DOI:10.1159/000515280