Analysis of Surgical Masks Adverse Effects on Facial Skin in Long Term Usage During COVID-19 Pandemic.

Objectives: During the coronavirus disease-2019 pandemic, masks have become mandatory for protection against the virus transmitted by breathing. This study examined the impact of surgical masks used daily on civilian facial skin. Materials and Methods: Moisture, elasticity, pore, melanin, acne, wrinkle, and sensitivity parameters of 83 volunteers were measured numerically using an API-100 skin analyzer and camera recordings. Numerical values were compared following the device's algorithm calibrated according to age, gender, and race. Finally, the obtained data were statistically evaluated and compared with the averages. Results: Pore, melanin, acne, and wrinkle parameters were higher without gender discrimination, whereas moisture and elasticity parameters were low. While a significant increase was observed in women for sensitivity, the increase was not statistically significant in men. Conclusion: The negative effects of long-term daily wearing of surgical masks on facial skin were statistically significant. Therefore, taking outdoor breaks during mask use, washing the face intermittently, using moisturizing and purifying cosmetic products, and anti-wrinkle effects have been proposed to reduce the possible defects.

Patient Survival With Extended Home Hemodialysis Compared to In-Center Conventional Hemodialysis.

Introduction: More frequent and/or longer hemodialysis (HD) has been associated with improvements in numerous clinical outcomes in patients on dialysis. Home HD (HHD), which allows more frequent and/or longer dialysis with lower cost and flexibility in treatment planning, is not widely used worldwide. Although, retrospective studies have indicated better survival with HHD, this issue remains controversial. In this multicenter study, we compared thrice-weekly extended HHD with in-center conventional HD (ICHD) in a large patient population with a long-term follow-up. Methods: We matched 349 patients starting HHD between 2010 and 2014 with 1047 concurrent patients on ICHD by using propensity scores. Patients were followed-up with from their respective baseline until September 30, 2018. The primary outcome was overall survival. Secondary outcomes were technique survival; hospitalization; and changes in clinical, laboratory, and medication parameters. Results: The mean duration of dialysis session was 418 ± 54 minutes in HHD and 242 ± 10 minutes in patients on ICHD. All-cause mortality rate was 3.76 and 6.27 per 100 patient-years in the HHD and the ICHD groups, respectively. In the intention-to-treat analysis, HHD was associated with a 40% lower risk for all-cause mortality than ICHD (hazard ratio [HR] = 0.60; 95% confidence interval [CI] 0.45 to 0.80; P < 0.001). In HHD, the 5-year technical survival was 86.5%. HHD treatment provided better phosphate and blood pressure (BP) control, improvements in nutrition and inflammation, and reduction in hospitalization days and medication requirement. Conclusion: These results indicate that extended HHD is associated with higher survival and better outcomes compared to ICHD.

Dabigatran for stroke prevention in real life in a sample of population from Turkey: D-SPIRIT registry.

OBJECTIVE: The D-SPIRIT registry is designed to investigate the safety and effectiveness of dabigatran etexilate in patients with atrial fibrillation in routine clinical practice. METHODS: D-SPIRIT is the first national, multicenter, prospective, observational, postmarketing registry that investigates the usage of dabigatran in real life. A total of 326 noveloral anticoagulant-eligible patients with atrial fibrillation who have been taking dabigatran etexilate therapy for stroke prevention at least 6 months from 9 different centers were enrolled into the registry. Patients were followed up for 2 years to evaluate the effectiveness and safety of the treatment. All adverse clinical events including bleeding, thromboembolic events, stroke, systemic embolism, transient ischemic attack, myocardial infarction, and all-cause death were recorded. RESULTS: The mean age was 71.1±9.6 years, and 57.4% of the study participants were female. The mean CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack [TIA], vascular disease, age 65-74 years, sex category) score was 3.4±1.6. The cumulative adverse clinical events rate was 6.30% per year. The rate for embolic events including TIA, ischemic stroke, and peripheral embolism was 1.26% per year. The rate for major bleeding was 2.20% per year, and the mortality rate was 0.94% per year. CONCLUSION: This registry obtained an important overview of the current safety and effectiveness of the dabigatran etexilate in Turkey. Our results indicate similar rates of thromboembolic and bleeding events with pivotal phase 3 trial and other real-life registries. However, rate of undertreatment usage of dabigatran etexilate in real life was found to be considerable.

Assessing the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease.

OBJECTIVE: The aim of this study was to determine the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease (LCPD). METHODS: A total of 47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study. The patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data were retrospectively collected. The arthrographies were performed immediately before the surgery under general anesthesia. The patients were staged according to the Catterall and Herring classifications and examined in terms of head-at-risk signs before the study. Four sets of patient files were established based on the aforementioned data, with each child in a randomized and blinded order. Ten consultant pediatric orthopedic surgeons randomly assessed the patient files on 4 separate occasions (Set 1 vs Set 2 and Set 3 vs Set 4), with a minimum time interval of 4 weeks. In the first and second sets, the demographic and clinical information, including the age, gender, hip ROM, and hip radiographs, were presented. In the third and fourth sets, hip arthrography was presented in addition to the data from Set 1 and Set 2. The observers were instructed to choose the best treatment options. The percent agreement (PA) and Gwet's AC1 statistics were used to establish a relative level of agreement among the observers. RESULTS: The mean intra-observer reliabilities ranged from fair to moderate after adding the hip arthrography data (Gwet's AC1 = 0.36 for Set 1 vs Set 2 and 0.42 for Set 3 vs Set 4). The mean PA was 56.6% (range = 29.8% to 78.7%) with a Gwet's AC1 value of 0.51 (range: 0.21 to 0.77) between Set 1 and Set 3 (moderate intra-observer reliability). The decision for the treatment strategy was changed in 43.4% of the patients. For inter-observer reliability, Gwet's AC1 was computed as 0.48 (moderate reliability). The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups. Thus, there is a negative correlation with the disease progression. CONCLUSION: Hip arthrography seems to have a significant role in the treatment decision making for children with LCPD, especially in the advanced stages of the disease. LEVEL OF EVIDENCE: Level IV, Therapeutic study.

The Effect of Clinical Knowledge and Surgical Experience on Treatment Choice in Legg-Calve-Perthes Disease: Intra-observer and Inter-observer Reliability Study.

AIM: The aim of this study was to evaluate standardized hip radiographs, arthographs, demographic characteristics, physical examination findings, and their effects on treatment choices in leg-calve-perthes disease (LCPD). Intraobserver and interobserver realibility between orthopaedic residents, orthopaedic surgeons, and paediatric orthopaedic surgeons were also investigated. MATERIALS AND METHODS: 47 LCPD patients were included this cross-sectional study. Six separate presentations including different variabilities (clinical findings, standard radiographs, and arthrographs) were evaluated by three different groups (residents, surgeons, paediatric orthopaedic surgeons) and were sent to the observers every other month by hiding patients' personal information. Seven different treatment modalities were introduced for the best treatment modality. Intraobserver and interobserver reliability in these three groups were examined. Percentage aggreement (PA) and intraclass correlation coefficients (ICC) tests were used for this purpose. RESULTS: Treatment PA rates between presentations were 29.5-53.6% in residents, 38.3-60.4% in surgeons, and 39.1-59.8% in pediatric orthopaedic surgeons. Conservative methods were mostly preferred as treatment modality in all groups; followed by proximal femoral osteotomies. Pediatric orthopaedic surgeons preferred safe dislocation and femur head and/or neck reconstruction surgery 5-18 times more than residents and orthopaedic surgeons. Intraobserver reliability of treatment modalities was higher among the paediatric orthopaedic surgeons; the results were fair-good (0.483-0.763). Among residents and orthopaedic surgeons, ICC values were poor to good, respectively (- 0.080 to 0.636 and 0.263-0.643). Interobserver reliability among three groups was meanly good. CONCLUSION: As surgical experience increases, both the compliance rates of the treatment modalities and the intra- and inter-group reliability are increased. Knowledge of the demographic data and clinical findings of patients besides hip radiographs or arthrographs increase treatment compliance in paediatric orthopaedic surgeons, however, cause changes in treatment modalities in residents. As surgical experience increases, more difficult surgeries such as safe dislocation and femoral head/neck reconstruction are preferred.

Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial.

BACKGROUND AND OBJECTIVES: A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair®, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair® in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease. METHODS: A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated. RESULTS: The mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). The FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each). CONCLUSIONS: Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair® in patients with chronic obstructive pulmonary disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03028701.

Critical review of European Medicines Agency (EMA) assessment report and related literature on domperidone.

European Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30 mg and treatment duration to 7 days. This paper presents a critical review of the scientific basis of the literatures having a role in the decision of EMA on domperidone with an approach based on statistical and epidemiological perspective. Although observational studies used by EMA were published, the EMA didn't use an algorithm including "randomized clinical trials" according to evidence-based medicine when presenting their results. In conclusion, the results obtained from published studies are controversial, especially for the bias. From these publications, it cannot be concluded that domperidone exposure definitely increases the risk of "sudden cardiac death", "death associated with ventricular arrhythmia" or "ventricular arrhythmia" The most concrete result of these studies is that the risk is higher with metoclopramide exposure compared to domperidone exposure.

Impact of body mass index on short-term and long-term survival in prevalent hemodialysis patients.

INTRODUCTION: Numerous studies showed that higher body mass index (BMI) is associated with better survival in hemodialysis (HD) patients. Most of them evaluated short-term mortality. It has been suggested that presence of inflammation may be a key modifier of relationship between BMI and mortality in incident HD patients. We examined whether presence of inflammation modifies the association between BMI and mortality in both short-term and long-term follow-up in a large group of prevalent HD patients. METHODS: A total of 3.252 HD patients from 41 HD centers were enrolled; the patients were divided into quartiles based on time-averaged BMI (Q1 < 21.5, Q2 21.5 to <24.3, Q3 24.3 to <27.4, Q4 ≥ 27.4 kg/m2 ). Inflammation status was defined as present (inflamed) (C-reactive protein (CRP) ≥1.0 mg/dL and/or serum albumin ≤3.5 g/dL) or absent (noninflamed). FINDINGS: During 7 years of follow-up 1386 patients (42.6%) died. Compared to noninflamed patients, inflamed patients in the lowest BMI quartile showed 5-fold increased risk for mortality in the short-term (95% confidence interval [CI] 2.82-9.22, P < 0.001) and 3-fold in the long-term (95%CI 2.42-4.27, P < 0.001) compared to the highest BMI quartile. Whereas, inflamed patients in the highest BMI quartile experienced 2-fold increased risk in short-term (95%CI 1.17-3.74, P = 0.01) and 1.68-fold increased risk in long-term (95%CI 1.30-2.18, P < 0.001) than in noninflamed patients. The protective effect of BMI for overall mortality was present in all age groups, in both genders, in patient with and without diabetes. BMI was not a mortality predictor in patients with HD duration more than 76 months at baseline. The protective effect of BMI was observed in all albumin tertiles. In patients in the lowest CRP tertile, BMI was not associated with mortality. DISCUSSION: Higher BMI is associated with lower short-term and long-term mortality risk, especially in patients with inflammation in a prevalent HD population.

Intra- and inter-observer reliability of Laredo classification system in Legg-Calvé-Perthes Disease.

The purpose of the current study was to investigate intra- and inter-observer reliability of arthrographic Laredo classification system in Perthes disease. Forty-seven patients were included in this cross-sectional descriptive study. Patients' age, gender, physical findings and hip arthrographs were collected from hospital medical records. Two different sets of power point slides were prepared in which the order of cases was randomized and blinded. Observers were divided into three groups according to their surgical experience (9 residents, 10 seniors, 10 pediatric orthopedists), and they assessed two times 1 month's intervals. Statistical analysis was performed by using the SPSS v21. Inter- and intra-observer reliabilities were calculated using intra-class correlation coefficient, weighted kappa and percentage agreement. Percentage agreement of Laredo classification was about 50% for all groups (residents, seniors and pediatric orthopedists); intra-observer reliabilities were excellent, excellent and fair, respectively. Inter-observer reliability of Laredo classification for each set was found to be excellent for all groups. Length of experience did not correlated significantly with the level of intra-observer agreement. As a conclusion, our results showed that Laredo's arthrographic classification system's intra-observer reliability is at least at a fair level and inter-observer reliability is at an excellent level. We believe that this classification system is valuable for an orthopedic surgeon who deals with the treatment of Perthes disease.

A meta-analysis on the cardiac safety profile of domperidone compared to metoclopramide.

BACKGROUND: This meta-analysis aimed to assess the cardiac safety profile of domperidone treatment for the risk of cardiovascular (CV) event and QT prolongation. METHODS: Data from nine studies involving 101,155 patients were used for the analysis of CV event risk, while data from eight studies involving 390 patients were used for the analysis of QT prolongation risk. RESULTS: Meta-analysis findings suggested a significant increase in CV risk under domperidone as compared to no treatment for domperidone doses of >30 mg/day (OR: 3.14, 95% CI, 1.191 to 8.304, p = 0.021), no significant increase in QT prolongation event rates with domperidone (3.54%, 95% CI, 1.73% to 7.10%) and a significantly lower CV risk for domperidone than for metoclopramide (OR: 0.63, 95% CI, 0.58 to 0.70, p < 0.001). CONCLUSIONS: The present meta-analysis indicates that domperidone treatment may not be associated with an overall CV event risk increase at doses ≤30 mg/day and does not result in QT prolongation.

Evaluation of the impact of warfarin time in therapeutic range on outcomes of patients with atrial fibrillation in Turkey: perspectives from the observational, prospective WATER Registry.

BACKGROUND: Warfarin is highly efficacious in reducing stroke risk in patients with atrial fibrillation (AF). However, its safety and efficacy in stroke prevention is markedly influenced by its time in therapeutic range (TTR). The quality of anticoagulant therapy varies considerably among countries. Representative data concerning the quality of anticoagulant therapy and its effects on clinical outcomes in Turkey are lacking. METHODS: Warfarin in Therapeutic Range (WATER) registry is a prospective, observational study which followed 572 AF patients (mean age 67.3 ± 12 years; females 60%; 71% non-valvular AF) treated with warfarin. RESULTS: At a median of 22-month follow-up, the mean TTR value was 42.3 ± 18% (median: 40%) for the whole population and lower in non-valvular AF su group than valvular AF subgroup (40.3 ± 18 vs. 46.9 ± 19, respectively, p < 0.001). Death, cardiac hospital-ization and minor bleeding rates were higher in the group with TTR value < 40% than the group with > 40% (3.4% vs. 5.9%; 28.6% vs. 35.4%; 36.5% vs. 41.7%, respectively, all of them p < 0.001). A correlation analysis showed a negative correlation between age and TTR value (r = -0.178, p < 0.001). Mean CHA2DS2VASc score was 3.63 ± 1.5 and mean HASBLED score was 2.38 ± 1.01 in the non-valvular AF group. A negative correlation was observed between TTR levels and CHA2DS2VASc score. CONCLUSIONS: WATER provides insight into the anticoagulation control status of AF patients in Turkey. The quality of anticoagulation was poor. Strategies should be undertaken by clinicians and patients to improve TTR. New oral anticoagulant agents may be perfect alternatives for non-valvular AF patients.