scholarly journals Comparison of clinical data based on limits of agreement

2012 ◽  
Vol 49 (1) ◽  
pp. 45-56 ◽  
Author(s):  
Luís M. Grilo ◽  
Helena L. Grilo

Summary Two different medical measurement methods, which usually do not produce exactly the same results, are used to analyse the serum levels of folic acid in a blood sample. We assess the (dis)agreement of the available data in order to replace the old method (the reference method, which involves a lot of human intervention) with the new one (which uses mostly machines), without causing problems in clinical interpretation. The 95% limits of agreement are estimated, before and after a logarithmic transformation, and an appropriate use of regression and a nonparametric approach are also considered. The application of these different statistical techniques is very useful and easily interpreted by medical researchers, but the results obtained do not provide confidence that the new method can be used in place of the old one for clinical purposes.

2019 ◽  
Vol 49 (1/2019) ◽  

Background and aims: Overweight and obese patients who undergo bariatric surgery require a rigorous clinical and paraclinical assessment both before and after the surgery at 3, 6, and 12 months.The present study aims the assessment of serum leptin levels and insulin resistance status in compliant bariatric patients to scheduled medical laboratory assessment at 6 months after surgery. Material and Method: The study included 109 eligible patients selected for bariatric surgery, 48 of whom attended the scheduled visit at 6 months after the surgery. Laboratory assessing regarded the insulin resistance by determining before meal the serum levels of leptin, glucose and insulin, as well as HOMA 1 and HOMA 2 indexes. Results: Patients who underwent bariatric treatment experienced a significant decrease in insulin resistance status. A higher percentage in the preoperative group was recorded in women, feature which was also recorded in the postoperative group that attended the scheduled visit at 6 months after surgery. Age is also an important factor that significantly influences the behavioral adherence to postoperative visits. Conclusions: Insulin resistance status improved significantly in 6 months after bariatric surgery among the fully compliant patients. The percentage of attendance at scheduled visits is higher among women, and decreases with age. Keywords: obesity surgery, leptin resistance, insulin resistance, HOMA index, compliance


2020 ◽  
pp. 19-29
Author(s):  
Patricia Diaz Ortega ◽  
Manuel García Manero

Introduction: Symptomatic uterine fibroids can cause symptoms that can be disabling. There are many treatments, including ulipristal acetate, whose role in reducing symptoms and decreasing the size of the fibroid is well known. With this preliminary study, we also try to evaluate the correlation between myoma vascularization measured by ultrasound (Power Doppler 2D) and serum VEGF levels, before and after treatment with ulipristal acetate; in patients diagnosed with symptomatic uterine fibroids. Materials and Methods: A preliminary, prospective observational pilot study was designed. Twenty-four premenopausal women, diagnosed with symptomatic uterine fibroids, were included and all of them completed the study. Four cycles of ulipristal acetate were administered according to the dose and indications specified in the data sheet. In order to assess the influence of this treatment on the angiogenesis process of the fibroids, measurements of VEGF serum levels were made and their vascularization was assessed by means of 2D power doppler ultrasound; at the beginning and the end of treatment. In addition, several determinations of the same parameters were made throughout the successive visits. Endpoints were defined as the decrease in VEGF levels from previous levels, the decrease in myoma vascularization on ultrasound, and the reduction in myoma size. Result: 24 patients who met the inclusion criteria were enrolled (n=24). The average size of myomas was reduced from 45,08 ? 24,02mm to 29?16,96mm after treatment. The average VEGF serum level significantly decreased after the first treatment cycle (from 147,17 ? 153,51 pg/ml to 102,04 ? 186,08pg/ml). Vascularization of myomas after treatment with ulipristal acetate was analyzed, and a significantly decrease was achieved in 83,3% of cases. Conclusion: There is a correlation between myoma vascularization and treatment with Ulipristal acetate. SPRMs may provide effective treatment for women with symptomatic fibroids by two ways: supports selective progesterone receptor modulators and reduced angiogenesis. Keywords: Angiogenesis; Ulipristal Acetate; Uterine fibroids; VEGF


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Giulia Brigante ◽  
Giorgia Spaggiari ◽  
Barbara Rossi ◽  
Antonio Granata ◽  
Manuela Simoni ◽  
...  

AbstractTrying to manage the dramatic coronavirus disease 2019 (COVID-19) infection spread, many countries imposed national lockdown, radically changing the routinely life of humans worldwide. We hypothesized that both the pandemic per se and the consequent socio-psychological sequelae could constitute stressors for Italian population, potentially affecting the endocrine system. This study was designed to describe the effect of lockdown-related stress on the hypothalamic-pituitary-thyroid (HPT) axis in a cohort of young men. A prospective, observational clinical trial was carried out, including patients attending the male infertility outpatient clinic before and after the national lockdown for COVID-19 pandemic. The study provided a baseline visit performed before and a follow-up visit after the lockdown in 2020. During the follow-up visit, hormonal measurements, lifestyle habits and work management were recorded. Thirty-one male subjects were enrolled (mean age: 31.6 ± 6.0 years). TSH significantly decreased after lockdown (p = 0.015), whereas no significant changes were observed in the testosterone, luteinising hormone, follicle-stimulating hormone, estradiol and prolactin serum levels. No patient showed TSH serum levels above or below reference ranges, neither before nor after lockdown. Interestingly, TSH variation after lockdown was dependent on the working habit change during lockdown (p = 0.042). We described for the first time a TSH reduction after a stressful event in a prospective way, evaluating the HPT axis in the same population, before and after the national lockdown. This result reinforces the possible interconnection between psychological consequences of a stressful event and the endocrine regulation.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Meysam Yousefi ◽  
Sara Rajaie ◽  
Vahideh Keyvani ◽  
Somayeh Bolandi ◽  
Malihe Hasanzadeh ◽  
...  

AbstractCirculating tumor cells (CTCs) have recently been considered as new prognostic and diagnostic markers for various human cancers; however, their significance in epithelial ovarian cancer (EOC) remains to be elucidated. In this study, using quantitative real-time PCR, we evaluated the expression of EPCAM, MUC1, CEA, HE4 and CA125 mRNAs, as putative markers of CTCs, in the blood of 51 EOC patients before and/or after adjuvant chemotherapy. Our results demonstrated that, before chemotherapy, the expression of EPCAM, MUC1, CEA and HE4 mRNAs were correlated to each other. CEA expression was correlated with tumor stage (r = 0.594, p = 0.000) before chemotherapy, whereas its expression after chemotherapy was correlated with serum levels of CA125 antigen (r = 0.658, p = 0.000). HE4 mRNA showed the highest sensitivity both before and after chemotherapy (82.98% and 85.19%, respectively) and the persistence of this marker after chemotherapy was associated with advanced disease stage. The expression of CA125 mRNA had negative correlation with the other markers and with tumor stage and therapy response (evaluated by the measurement of serum CA125 antigen). Collectively, our results indicated a better clinical significance of tumor-specific markers (CEA and HE4 mRNAs) compared to epithelial-specific markers (EPCAM and MUC1 mRNAs).


2021 ◽  
Vol 11 (4) ◽  
pp. 1710
Author(s):  
Jinwook Lee ◽  
Hyo-Sun Kim ◽  
Donik Ku ◽  
Jihun Lim ◽  
Minkyu Jung ◽  
...  

Membrane-based vacuum dehumidification technology is currently being actively studied. In most studies, the performance of the membrane-based systems is evaluated under the assumption that the membrane can achieve ideal separation, which results in ideal coefficient of performance (COP) values. However, the performance factors for membranes vary depending on the experimental conditions and measurement methods. Therefore, relevant values can only be calculated if the data are measured in an environment close to that of the application conditions. The cup measurement method is a simple method to measure the permeability, however, there are limitations regarding adding variables during the experiment. To overcome these limitations, a new experimental device was constructed that combines pressurized cell with the cup method. Using the device, the performance of polyethylene-amide-bonded dense membranes was evaluated under conditions where absolute pressure differentials occurred before and after the membrane, such as in air conditioner dehumidification systems.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1323.2-1324
Author(s):  
K. Sato ◽  
S. Mamada ◽  
C. Hayashi ◽  
T. Nagashima ◽  
S. Minota

Background:Biologic disease modifying anti-rheumatic drugs (DMARDs) have demonstrated that proinflammatory cytokines such as interleukin (IL-) 6 and tumor necrosis factor (TNF) play important roles in the pathogenesis of rheumatoid arthritis (RA). Other cytokines, such as type I interferons (IFNs), are also implicated in its pathogenesis (ref 1). However, the complete picture of the cytokine network involved in RA remains to be elucidated.Objectives:By quantifying sets of cytokines in the serum of RA patients before and after treatment with various biologic DMARDs, we sought to determine the effects of drugs on (A) type I IFNs, (B) soluble IL-6 receptors, and (C) other cytokines.Methods:52 patients with RA were treated with various biologic DMARDs (tocilizumab (TOC): 16, abatacept (ABT): 15, and TNF inhibitors (TNFi): 21). Serum samples were obtained (1) before, (2) approximately 4 weeks after (3) and approximately 12 weeks after the initiation of treatment. A suspension bead-array system was used for analysis; Bio-Plex Human Cytokine 17-plex Assay kits and Express Custom Panels (Bio-Rad), including IFN-β, IFN-α2, soluble IL-6 receptor α (sIL6Rα) and gp130 were used.Results:(1) As expected, the disease activity score 28-joiny count (DAS28) using the erythrocyte sedimentation rate (ESR) significantly decreased in all three groups (TOC, ABT and TNFi) by 12 weeks.(2) IFN-α2 was barely detected in the serum samples. IFN-β seemed to increase slightly in the ABT group, but the increase was not statistically significant.(3) The levels of sIL6Rα did not change substantially. Those of gp130 decreased slightly but significantly in the TOC group by 12 weeks.(4) The levels of IL-6 decreased significantly in the ABT group by 12 weeks. Those in the TNFi group decreased significantly at 4 weeks but not 12 weeks (Fig. 1A).(5) The levels of IL-7 decreased significantly only in the TOC group (Fig. 1B).Conclusion:(1) The biologic DMARDs tested in this study did not significantly affect the serum levels of type I IFNs in this study.(2) The decrease in gp130 in the TOC group may imply that gp130 is induced by IL-6, although whether this level of decrease has physiological significance is open to question.(3) Serum IL-6 was significantly decreased in the TNFi group at 4 weeks but not 12 weeks. TNF has been reported to induce IL-6 (ref 2), but negative feedback loop(s) may be present. Such a feedback system might make the discontinuation of TNFi difficult, even if patients are in remission.(4) IL-7 may be a target of IL-6. A higher level of IL-7 has been reported to be present in the joints of RA patients compared with osteoarthrosis and it is a cytokine implicated in the differentiation of osteoclasts (ref 3). This may partly explain the effect of TOC on preventing bone erosion in RA.References:[1]Ann Rheum Dis. 2007; 66: 1008–14[2]Rheumatology 2007; 46: 920-6[3]Rheumatology 2008; 47: 753-9Acknowledgments:We thank all the members of the Division of Rheumatology and Clinical Immunology, Department of Medicine, Jichi Medical University. We are also grateful to the patients involved in this study.Disclosure of Interests:Kojiro Sato Grant/research support from: Abbie, Pfizer, Chugai, Astellas, Mitsubishi-Tanabe, Ono, Takeda, Sachiko Mamada: None declared, Chiyomi Hayashi: None declared, Takao Nagashima: None declared, Seiji Minota: None declared


Author(s):  
Mohammad Reza. Shiran ◽  
Davar Amani ◽  
Abolghasem Ajami ◽  
Mahshad Jalalpourroodsari ◽  
Maghsoud Khalizadeh ◽  
...  

Abstract Objectives Breast cancer is a common malignant tumor in women with limited treatment options and multiple side effects. Today, the anti-cancer properties of natural compounds have attracted widespread attention from researchers worldwide. Methods In this study, we treated 4T1 tumor-bearing Balb/c mice with intraperitoneal injection of Auraptene, paraffin oil, and saline as two control groups. Body weight and tumor volume were measured before and after treatment. Hematoxylin and eosin (H & E) staining and immunohistochemistry of Ki-67 were used as markers of proliferation. In addition, ELISA assays were performed to assess serum IFN-γ and IL-4 levels. Results There was no significant change in body weight in all animal groups before and after treatment. 10 days after the last treatment, Auraptene showed its anti-cancer effect, which was confirmed by the smaller tumor volume and H & E staining. In addition, Ki-67 expression levels were significantly reduced in tumor samples from the Auraptene-treated group compared to the paraffin oil and saline-treated groups. In addition, in tumor-bearing and normal mice receiving Auraptene treatment, IL-4 serum production levels were reduced, while serum levels of IFN-γ were significantly up-regulated in tumor-bearing mice after Auraptene treatment. Conclusions In the case of inhibition of tumor volume and Ki-67 proliferation markers, Auraptene can effectively inhibit tumor growth in breast cancer animal models. In addition, it might increases Th1 and CD8 + T cell responses after reducing IL-4 serum levels and IFN-γ upregulation, respectively. However, further research is needed to clarify its mechanism of action.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Juan Lu ◽  
Chun-lei Chen ◽  
Jian-di Jin ◽  
Jun Chen ◽  
Cheng-bo Yu

Abstract Background Serum levels of procalcitonin (PCT) are considered a useful biomarker for the diagnosis of bacterial infection or inflammation. There are few reports of high PCT levels in end-stage liver disease regardless of bacterial infection. Here, we present a case of extremely high PCT levels (> 100 ng/mL) in a patient with severe cirrhosis combined with hepatic carcinoma. Case presentation A 65-year-old man developed end-stage cirrhosis with hepatic carcinoma. Radiographic imaging showed a massive hepatocellular carcinoma with multiple loci lack of indications of resection. Hence, transcatheter hepatic arterial chemoembolization was performed three times over a period of 4 months. Before and after interventional therapies, the biochemistry laboratory results were only slightly abnormal except for persistently high PCT concentrations (> 100 ng/mL), irrespective of the evidence for bacterial infection or sepsis. Conclusions This case suggests that continuously high levels of PCT (> 100 ng/mL) may be present in advanced liver disease, particularly in complex situations such as decompensated cirrhosis and liver cancer, in the absence of severe infection or sepsis. This knowledge could expand the significance of PCT in liver disease.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Junya Kusumoto ◽  
Atsushi Uda ◽  
Takeshi Kimura ◽  
Shungo Furudoi ◽  
Ryosuke Yoshii ◽  
...  

Abstract Background In Japan, oral third-generation cephalosporins with broad-spectrum activity are commonly prescribed in the practices of dentistry and oral surgery. However, there are few reports on the appropriate use of antibiotics in the field of oral surgery. This study aimed to evaluate the appropriateness of antibiotic use before and after an educational intervention in the Department of Oral and Maxillofacial Surgery, Kobe University Hospital. Methods The use of oral antibiotics was investigated among inpatients and outpatients before and after an educational intervention conducted by the antimicrobial stewardship team. Additionally, the frequency of surgical site infection after the surgical removal of an impacted third mandibular molar under general anesthesia and the prevalence of adverse effects of the prescribed antibiotics were comparatively evaluated between 2013 and 2018. Results After the educational intervention, a remarkable reduction was noted in the prescription of oral third-generation cephalosporins, but increased use of penicillins was noted among outpatients. There was reduced use of macrolides and quinolones in outpatients. Although a similar trend was seen for inpatients, the use of quinolones increased in this population. Despite the change in the pattern of antibiotic prescription, inpatients who underwent mandibular third molar extraction between 2013 and 2018 did not show a significant increase in the prevalence of surgical site infections (6.2% vs. 1.8%, p = .336) and adverse effects of drugs (2.1% vs. 0%, p = .466). Conclusions This study suggests that the judicious use of oral antibiotics is possible through conscious and habitual practice of appropriate antibiotic use. However, further investigation is required to develop measures for appropriate use of oral antibiotics.


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