Category: Statistics

Oral Health Prev Dent. 2021 Jan 7;19(1):301-309. doi: 10.3290/j.ohpd.b1453013.

ABSTRACT

PURPOSE: Grape-seed extract (GSE) contains polyphenols that readily adhere to proteins and modify the acquired enamel pellicle (AEP). The first step in biofilm formation is bacterial adhesion to the AEP-covered enamel. The aim of this in vitro study was to test whether AEP modification with GSE, fluoride (F-), or their combination (GSE+F-) modulates bacterial adhesion, biofilm metabolism and composition, or cariogenic demineralisation of the enamel.

MATERIALS AND METHODS: The study comprised 3 parts: 1) single-strain Streptococcus gordonii species, 2) a five-species biofilm model, or 3) biofilm (re-)formation using the five-species biofilm model after removal of initial biofilm with toothbrushing. Human whole-mouth stimulated saliva was used to form an AEP on human enamel specimens. The AEP was incubated in water (control), or modified with GSE, F-, or GSE+F-. Bacterial adhesion, biofilm diversity, metabolic activity, biofilm mass, and cariogenic demineralisation (surface hardness) of enamel were assessed after incubation in bacterial broths after 4 h or 22 h. Differences between groups were analysed with one-way ANOVA and post-hoc Bonferroni tests.

RESULTS: GSE and GSE+F- statistically significantly decreased single-strain S. gordonii adhesion, but had no relevant influence when the five-species biofilm model was used. In the biofilm (re-)formation model, GSE reduced bacterial adhesion compared to GSE+F-, while F- caused less cariogenic demineralisation than was found in the control group.

CONCLUSION: AEP modified with GSE retards S. gordonii adhesion, but it does not influence the formation, metabolism and composition of a cariogenic multi-species biofilm.

PMID:34057340 | DOI:10.3290/j.ohpd.b1453013

Oral Health Prev Dent. 2021 Jan 7;19(1):311-319. doi: 10.3290/j.ohpd.b1453071.

ABSTRACT

PURPOSE: To assess the impact of nonsurgical periodontal treatment, performed by undergraduate dental students, on oral health-related quality of life of patients with periodontitis.

MATERIALS AND METHODS: An observational, prospective, single-arm cohort study with pre‑post test involving 31 undergraduate dental students was performed. A complete periodontal examination was performed before and after receiving nonsurgical periodontal treatment. The main independent clinical variables assessed were the degree of periodontal inflammation and the number of teeth with periodontitis. Oral health-related quality of life was assessed before and after treatment through the Oral Impacts on Daily Performances (OIDP) questionnaire. The association between the extent of periodontal treatment (measured as number of treated teeth) and final OIDP score was assessed, adjusting for age, sex, and baseline OIDP, in a multiple regression model.

RESULTS: Thirty-four patients were enrolled and treated by the undergraduate students. The mean OIDP value (global absolute score), representing the severity and frequency of the impacts, decreased from 26.2 to 12 after treatment. The mean percentage of impact, representing the number dimensions affected by oral health (global percent score), was reduced from 13% to 6%. However, no association between the number of treated teeth and post-treatment OIDP score was observed after adjusting for age, sex, and baseline OIDP score.

CONCLUSION: Nonsurgical periodontal treatment performed by undergraduate dental students improved the oral health-related quality of life of periodontal patients, although no statistically significant association was found between the extent of periodontal treatment and the final OIDP score.

PMID:34057341 | DOI:10.3290/j.ohpd.b1453071

ESC Heart Fail. 2021 May 31. doi: 10.1002/ehf2.13451. Online ahead of print.

ABSTRACT

AIMS: To study clinical phenotype, prognosis for all-cause and cardiovascular (CV) mortality and predictive factors in patients with incident heart failure (HF) after aortic valvular intervention (AVI) for aortic stenosis (AS).

METHODS AND RESULTS: In this retrospective, observational study we included patients from the Swedish Heart Failure Registry (SwedeHF) recorded 2003-2016, with AS diagnosis and AVI before HF diagnosis. The AS diagnosis was established according to International Classification of Diseases 10th revision (ICD-10) codes, thus without information concerning clinical or echocardiographical data on the aortic valve disease. The patients were divided into two subgroups: left ventricular ejection fraction (LVEF) ≥ 50% (AS-HFpEF) and <50% (AS-HFrEF). We individually matched three controls with HF from the SwedeHF without AS (control group) for each patient. Baseline characteristics, co-morbidities, survival status and outcomes were obtained by linking the SwedeHF with two other Swedish registries. We used Kaplan-Meier curves to present time to all-cause mortality, cumulative incidence function for time to CV mortality and Cox proportional hazards model to evaluate the relative difference between AS-HFrEF and AS-HFpEF and AS-HF and controls. The crude all-cause mortality was 49.0%, CV mortality 27.9% in AS-HF patients, respectively 44.7% and 26.6% in matched controls. The adjusted risk for all-cause mortality and CV mortality was similar in HF, regardless of LVEF vs. controls. No significant difference in factors predicting higher all-cause mortality was observed in AS-HFrEF vs. AS-HFpEF, except for diabetes (only in AS-HFrEF), with statistically significant interaction predicting death between the two groups.

CONCLUSIONS: In this nationwide SwedeHF study, we characterized incident HF population after AVI. We found no significant differences in all-cause and CV mortality compared with general HF population. They had virtually the same predictors for mortality, regardless of LVEF.

PMID:34057321 | DOI:10.1002/ehf2.13451

Turk J Haematol. 2021 May 31. doi: 10.4274/tjh.galenos.2021.2021.0105. Online ahead of print.

ABSTRACT

OBJECTIVE: Although inhibition of complement system at different steps is a promising therapy modality in PNH (paroxysmal paroxysmal nocturnal hemoglobinuria) patients, allogeneic hematopoetic stem cell transplantation (HCT) is still the only curative therapy especially for patients with intractable hemolysis or bone marrow failure. The aim of this study is to evaluate the outcomes of allogeneic HCT in PNH patients with or without aplastic anemia ( PNH-AA).

MATERIAL AND METHODS: 35 PNH / PNH-AA patients who were treated with allegeneic HCT in ten transplantation centers in Turkey were retrospectively analyzed.

RESULTS: 16 (45.7 %) and 19 (54.3 %) patients were diagnosed as classical PNH and PNH / AA respectively. The median age of the patients was 32 ( 18-51) 2-year overall survival (OS) and GVHD-free, failure-free survival (GFFS) was 81.2 % and 78.1 % , respectively. 2 year OS in classical PNH and PNH /AA was 81.3 % and % 79.9 (p =0,87), respectively and 2 year GFFS in PNH and PNH/AA was 79% and 76% (0,977) without statistical significance. OS and GFFS rates did not differ between transplantations with matched sibling donor (MSD) and matched unrelated donor (MUD), neither.

CONCLUSION: Allo HCT with MSD or MUD is a good option in selected patients with classical PNH and PNH / AA. Especially, patients with debilitating and refractory hemolysis and patients with bone marrow failure might form the excellent group for allo – HCT.

PMID:34057336 | DOI:10.4274/tjh.galenos.2021.2021.0105

Arthritis Care Res (Hoboken). 2021 May 31. doi: 10.1002/acr.24720. Online ahead of print.

ABSTRACT

BACKGROUND: The Antiphospholipid Syndrome (APS) is an acquired coagulopathy associated with the presence of antiphospholipid antibodies. Whether ethnicity modulates APS clinical course is not known. The aim of our study was to assess the interplay ethnicity and APS in Israel.

METHODS: We retrospectively evaluated the ethnic distribution of APS patients from 3 medical centres in Israel compared to the general population. Ethnic groups were defined according to the Israeli bureau of statistics as Ashkenazi (European), former Union of Soviet Socialist Republics (USSR), North African, Asian (West Asia, Greece and Turkey), Israeli Arabs and others.

RESULTS: Our cohort included 382 patients. With the prevalence of Ashkenazi and Asian ethnicities were more pronounce (33% vs. 12.8% and 15.4% vs. 7.7% respectively; p<0.001), while Israeli Arabs were less represented (5.2% vs. 31.1%; p<0.001) relative to their part in the general population. Arab patients were younger at presentation (28±10y vs. 34±13y; p<0.001), more likely to present with venous thrombosis (50% vs. 35%; p=0.037) and to suffer from venous thrombotic recurrence (45% vs.16%; p<0.001) compared to other ethnicities. Mortality was higher among patients of Asian ethnic origin (8.8% vs. 1.1%; p=0.005), intriguingly this group suffered more often from cardiovascular risk factors (i.e. dyslipidaemia as well hypertension).

CONCLUSION: Ethnicity may affect the prevalence and/or natural course of APS which is less prevalent and differs clinically in Israeli Arabs patients while mortality was linked with Asian ethnicity.

PMID:34057315 | DOI:10.1002/acr.24720

Cancer Rep (Hoboken). 2021 May 31:e1461. doi: 10.1002/cnr2.1461. Online ahead of print.

ABSTRACT

BACKGROUND: Delays in care and increased risk for mental health diagnoses put individuals identifying as a sexual minority with cancer at risk for decreased quality of life.

AIM: To assess psychosocial health among sexual minority gynecologic cancer survivors, we compared self-reported quality of life and psychosocial measures between individuals diagnosed with gynecologic cancers identifying as lesbian/gay/bisexual (LGB) and heterosexual.

METHODS AND RESULTS: English-speaking adults with gynecologic cancers were invited to participate in an ongoing cohort survey study. Quality of life and psychosocial measures included the Functional Assessment of Cancer Therapy-General, Distress Thermometer (distress), Patient Health Questionnaire-8 (depression), General Anxiety Disorder-7 (anxiety), and Post-traumatic Stress Disorder Checklist for DSM-5 (post-traumatic stress disorder; PTSD). Measures were compared by self-reported sexual orientation (heterosexual vs. LGB) using descriptive statistics (frequencies and means) and linear and logistic regression models, adjusting for college education. Of 814 patients invited, 457 enrolled (56.1%) and 401 (92.6%) completed the survey and provided information on their sexuality. All but one self-identified as cisgender women and 22 (5.5%) as LGB. LGB participants were more likely to have completed college (68.2% vs. 40.1%, p = .009) but were otherwise similar across demographic and clinical characteristics. Quality of life and distress scores were similar between groups. LGB participants, compared to heterosexual, reported higher rates of depression (31.8% vs. 10.6%, adjusted odds ratio [OR] = 4.1 [95% confidence interval [CI]: 1.6-11.0], p = .004), anxiety (25.0% vs. 7.1%, adjusted OR = 5.4 [95% CI: 1.7-16.7], p= .004), and PTSD (13.6% vs. 3.5%, adjusted OR = 4.2 [95% CI: 1.1-16.3], p = .04).

CONCLUSION: LGB participants reported poorer emotional health following a gynecologic cancer diagnosis than heterosexual participants. Our data suggest this population may need additional resources and support during and after their cancer diagnosis. Future work is needed to identify additional risk factors and the underlying sources of these disparities in order to improve patient care and wellness in this population.

PMID:34057316 | DOI:10.1002/cnr2.1461

Cancer Med. 2021 May 31. doi: 10.1002/cam4.3976. Online ahead of print.

ABSTRACT

BACKGROUND: While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue.

METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m² , C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m² , C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony-stimulating factor (G-CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN).

RESULTS: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression-free survival and overall survival were 5.1 (95% CI, 3.2-6.5) and 8.2 months (95% CI, 6.0-14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0-6.9) and 11.9 months (95% CI, 7.4-15.9), respectively, in arm 2.

CONCLUSIONS: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G-CSF.

PMID:34057299 | DOI:10.1002/cam4.3976

J Ren Care. 2021 May 30. doi: 10.1111/jorc.12378. Online ahead of print.

ABSTRACT

BACKGROUND: Nutritional status and protein energy wasting (PEW) is prevalent in patients with nondialysis-dependent chronic kidney disease (CKD). The relationship between PEW and long-term development of clinically important outcomes remains to be examined.

OBJECTIVES: To investigate the relationships between PEW, as measured by Subjective Global Assessment (SGA 1-7), and progression to important clinical outcomes: mortality and/or kidney failure.

DESIGN: Prospective cohort design.

PARTICIPANTS: One hundred and thirty-nine participants were well-nourished and 37 moderately malnourished patients with CKD 3-5.

MEASUREMENTS: The outcomes were 2, 5, and 10-year progression to kidney failure (dialysis or transplant) or mortality, kidney failure alone, and mortality alone. SGA was determined by a registered renal dietitian. Food frequency questionnaires were used to assess dietary intake. Clinical and laboratory baseline characteristics were collected. Multivariable regression models and Cox models were created to examine the relationship between SGA and outcomes.

RESULTS: PEW was associated with the combined outcome of kidney failure or mortality at 2 (p = 0.003), 5 (p = 0.004), but not at 10 (p = 0.73) years. This relationship was primarily driven by the relationship between PEW and kidney failure. In Cox models, the relationship between PEW and kidney failure remained after adjusting for Kidney Failure Risk Equation scores. The multivariable modeling revealed that PEW remained a statistically significant predictor of the combined outcome and ESKD after adjustment for age, estimated glomerular filtration rate (eGFR), sex, albumin-to-creatinine ratio, diabetes, albumin, and protein intake.

CONCLUSIONS: PEW, determined by the SGA 1-7, is an important prognostic tool. Further research looking at clinically important outcomes are needed to implement nutritional interventions for nondialysis-dependent CKD patients.

PMID:34053197 | DOI:10.1111/jorc.12378

Int J Clin Pract. 2021 May 30:e14420. doi: 10.1111/ijcp.14420. Online ahead of print.

ABSTRACT

AIM: Esophageal squamous papilloma (ESP) is a rare tumoral lesion of the esophagus considered to have a benign course. Due to the fact that they are rare lesions, there are not many publications with large case series on ESPs in the literature. In this study, we aimed to investigate the clinical, endoscopic and histopathological characteristics of ESPs.

METHODS: Reports of upper gastrointestinal endoscopies performed in the endoscopy unit within the Division of Gastroenterology of a tertiary care hospital in the Southeastern Anatolia Region of Turkey in the last eight-year period were evaluated retrospectively. Patients who were determined to have esophageal polypoid lesions during the endoscopic procedure and were then diagnosed with esophageal squamous cell papilloma in the histopathological examination were included in the study.

RESULTS: Of 11541 patients who underwent upper gastrointestinal endoscopy, 51 were diagnosed with a total number of 55 ESPs (0.44%). In addition, 26 of these patients (51%) were female, and the mean age of the patients at the time of diagnosis was 42.2 years. The average size of the ESPs was 3.47 millimeters, and the most frequent location was the middle esophagus with 51%. No statistically significant relationship was found between the location of ESPs and gender, endoscopy indication, esophagitis, lower esophageal sphincter dysfunction, hiatal hernia, gastroesophageal reflux disease (GERD) and Helicobacter pylori positivity.

CONCLUSION: In this study with the largest case series ever reported from Turkey, it was determined that ESPs were seen in younger ages in Turkey and were also smaller in size, which is not in agreement with the literature data. Besides, this study, in which ESPs were most frequently detected in the middle esophagus, supports the view that GERD may not be the main factor in ESP etiology.

PMID:34053176 | DOI:10.1111/ijcp.14420

Eur J Heart Fail. 2021 May 30. doi: 10.1002/ejhf.2256. Online ahead of print.

ABSTRACT

BACKGROUND: Circulating troponin is an important measure of risk in patients with heart failure, but it has not been used to determine if disease severity influences the responses to drug treatments in randomized controlled trials.

METHODS: In the EMPEROR-Reduced trial, patients with class II-IV heart failure and a reduced ejection fraction were randomly assigned to placebo or empagliflozin 10 mg daily and followed for the occurrence of serious heart failure and renal events. High-sensitivity cardiac troponin T (hs-cTnT) was measured in 3636 patients (> 97%) at baseline, and patients were divided into four groups based on the degree of troponin elevation.

RESULTS: With increasing concentrations of hs-cTnT, patients were progressively more likely to have diabetes and atrial fibrillation, to have New York Heart Association class III-IV symptoms and been hospitalized for heart failure within the prior year, and to have elevated levels of natriuretic peptides and worse renal function (P-trend <0.0001 for all comparisons), but importantly, the troponin groups did not differ with respect to ejection fraction. A linear relationship was observed between the logarithm of hs-cTnT and the combined risk of cardiovascular death or hospitalization for heart failure (P = 0.0015). When treated with placebo, patients with the highest levels of hs-cTnT had risks of cardiovascular death and hospitalization for heart failure that were 3-5 fold greater than those with values in the normal range. Patients with higher levels of hs-cTnT were also more likely to experience worsening of renal function and serious adverse renal events and show the least improvement in health status (as measured by the Kansas City Cardiomyopathy questionnaire). When compared with placebo, empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure, regardless of the baseline level of hs-cTnT, whether the effects of treatment were analyzed as hazard ratios or absolute risk reductions (Graphical Abstract)..

CONCLUSIONS: Elevations in hs-cTnT reflect the clinical severity, stability and prognosis of patients with heart failure and a reduced ejection fraction, with biomarkers, comorbidities, clinical course and risks that are proportional to the magnitude of hs-cTnT elevation. Empagliflozin exerted favorable effects on heart failure and renal outcomes, regardless of the baseline concentration of hs-cTnT.

PMID:34053177 | DOI:10.1002/ejhf.2256