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1.
Cancers (Basel) ; 13(5)2021 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-33801374

RESUMO

We aimed to investigate patients with gastric/gastro-esophageal adenocarcinomas for sex- and age-specific differences regarding overall survival (OS) and response to neoadjuvant chemotherapy (CTx) under consideration of tumor specific molecular subtypes. Overall, 717 patients were analyzed, including 426 patients treated with and 291 treated without neoadjuvant CTx. Microsatellite instability (MSI) and Epstein-Barr virus positivity (EBV+) were determined previously. Females demonstrated a significantly increased OS (p = 0.035), particularly in the subgroup treated with CTx (p = 0.054). No significant differences regarding age were found. In the molecular subgroups, no sex-related differences were observed in the non-CTx group. However in the CTx group, females with MSI-high (H) tumors showed the best OS (p = 0.043), followed by the male MSI-H (p = 0.198) and female MSS (p = 0.114) compared to the male MSS group as reference. The interaction between sex and MSI in this patient group was noticeable (p = 0.053) and was included as a relevant factor in multivariable analyses. In conclusion, our results show an effect of sex on OS in gastric/gastro-esophageal cancer specifically for patients treated with neoadjuvant CTx. The superior survival of women with MSI-H tumors after neoadjuvant CTx implies that combined consideration of these factors could contribute to an individualized treatment of the patients.

2.
JAMA Cardiol ; 2021 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-33787834

RESUMO

Importance: The assessment of new antithrombotic agents with a favorable safety profile is clinically relevant. Objective: To test the efficacy and safety of revacept, a novel, lesion-directed antithrombotic drug, acting as a competitive antagonist to platelet glycoprotein VI. Design, Setting, and Participants: A phase 2 randomized clinical trial; patients were enrolled from 9 centers in Germany from November 20, 2017, to February 27, 2020; follow-up ended on March 27, 2020. The study included patients with stable ischemic heart disease (SIHD) undergoing elective percutaneous coronary intervention (PCI). Interventions: Single intravenous infusion of revacept, 160 mg, revacept, 80 mg, or placebo prior to the start of PCI on top of standard antithrombotic therapy. Main Outcomes and Measures: The primary end point was the composite of death or myocardial injury, defined as an increase in high-sensitivity cardiac troponin to at least 5 times the upper limit of normal within 48 hours from randomization. The safety end point was bleeding type 2 to 5 according to the Bleeding Academic Research Consortium criteria at 30 days. Results: Of 334 participants (median age, 67.4 years; interquartile range, 60-75.1 years; 253 men [75.7%]; and 330 White participants [98.8%]), 120 were allocated to receive the 160-mg dose of revacept, 121 were allocated to receive the 80-mg dose, and 93 received placebo. The primary end point showed no significant differences between the revacept and placebo groups: 24.4%, 25.0%, and 23.3% in the revacept, 160 mg, revacept, 80 mg, and placebo groups, respectively (P = .98). The high dose of revacept was associated with a small but significant reduction of high-concentration collagen-induced platelet aggregation, with a median 26.5 AU × min (interquartile range, 0.5-62.2 AU × min) in the revacept, 160 mg, group; 43.5 AU × min (interquartile range, 22.8-99.5 AU × min) in the revacept, 80 mg, group; and 41.0 AU × min (interquartile range, 31.2-101.0 AU × min) in the placebo group (P = .02), while adenosine 5'-diphosphate-induced aggregation was not affected. Revacept did not increase Bleeding Academic Research Consortium type 2 or higher bleeding at 30 days compared with placebo: 5.0%, 5.9%, and 8.6% in the revacept, 160 mg, revacept, 80 mg, and placebo groups, respectively (P = .36). Conclusions and Relevance: Revacept did not reduce myocardial injury in patients with stable ischemic heart disease undergoing percutaneous coronary intervention. There were few bleeding events and no significant differences between treatment arms. Trial Registration: ClinicalTrials.gov Identifier: NCT03312855.

3.
Cardiovasc Res ; 2021 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-33576412

RESUMO

AIMS: Dynamic retinal vessel analysis (DVA) provides a noninvasive way to asses microvascular function in patients and potentially to improve predictions of individual cardiovascular (CV) risk. The aim of our study was to use untargeted machine learning on DVA in order to improve CV mortality prediction and to identify corresponding response alterations. METHODS AND RESULTS: We adopted a workflow consisting of noise reduction and extraction of independent components within DVA signals. Predictor performance was assessed in survival random forest models. Applying our technique to the prediction of all-cause mortality in a cohort of 214 hemodialysis patients resulted in the selection of a component which was highly correlated to maximal venous dilation following flicker stimulation (vMax), a previously identified predictor, confirming the validity of our approach. When fitting for CV mortality as the outcome of interest, a combination of three components derived from the arterial signal resulted in a marked improvement in predictive performance. Clustering analysis suggested that these independent components identified groups of patients with substantially higher CV mortality. CONCLUSIONS: Our results provide a machine learning workflow to improve the predictive performance of DVA and identify groups of hemodialysis patients at high risk of CV mortality. Our approach may also prove to be promising for DVA signal analysis in other CV disease states. TRANSLATIONAL PERSPECTIVE: DVA is a noninvasive technique which can help to assess microvascular dysfunction, one of the driving factors of CV disease. This study demonstrates a machine learning method which improves DVA interpretation for the estimation of CV risk in hemodialysis patients. Similar techniques can help doctors to identify high risk patients for timely therapeutic interventions and to monitor the effects of these interventions.

4.
BMJ Open ; 11(2): e045420, 2021 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-33579773

RESUMO

INTRODUCTION: The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off >50 ppb (parts per billion) is suitable for diagnosing asthma (sensitivity 35%, specificity 95%); (2) If the clinical symptoms 'allergic rhinitis' and 'wheezing' are present, asthma can be diagnosed at FeNO >33 ppb with a positive predictive value (PPV) >70% and (3) A FeNO >33 ppb can predict responsiveness to inhaled corticosteroid (ICS) with a PPV >70%. METHODS AND ANALYSIS: A prospective diagnostic study will be conducted in three practices of pneumologists in Germany. 300 patients suspected of suffering from asthma will be included. As an index test, patients perform FeNO measurement with the device NIOX VERO. As reference a test, patients are examined with whole bodyplethysmography and BP, if necessary. After 3 months, patients with an asthma diagnosis will be examined again to verify the diagnosis and evaluate ICS responsiveness. Patients who did not receive an asthma diagnosis at the initial examination will be phoned after 3 months and asked about persistent respiratory symptoms to exclude false negative findings. As a primary target, sensitivity and specificity of FeNO >50 ppb will be determined. As a secondary target the PPV for asthma at FeNO >33 ppb, when the symptoms 'allergic rhinitis' and 'wheezing' are present, will be calculated. Regarding ICS responsiveness, the PPV of FeNO >33 ppb will be determined. ETHICS AND DISSEMINATION: The study was approved by the Ethical Committee of the Technical University of Munich (Reference number 122/20 S). The major results will be published in peer-reviewed academic journals and disseminated through conferences. TRIAL REGISTRATION NUMBER: DRKS00021125.

5.
Med Decis Making ; 41(3): 329-339, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33629614

RESUMO

OBJECTIVE: Dealing with uncertainty is a core competence for physicians. To evaluate the impact of an educational intervention on family medicine residents' (FMRs') intention to request diagnostic tests and their attitudes toward uncertainty. METHODS: Nonrandomized controlled trial. Intervention group (IG) FMRs participated in interactive "dealing with uncertainty" seminars comprising statistical lessons and diagnostic reasoning. Control group (CG) FMRs participated in seminars without in-depth diagnostic lessons. FMRs completed the Dealing with Uncertainty Questionnaire (DUQ), comprising the Diagnostic Action and Diagnostic Reasoning scales. The Physicians' Reaction to Uncertainty (PRU) questionnaire, comprising 4 scales (Anxiety Due to Uncertainty, Concern about Bad Outcomes, Reluctance to Disclose Uncertainty to Patients, and Reluctance to Disclose Mistakes to Physicians) was also completed. Follow-up was performed 3 months later. Differences were calculated with repeated-measures analysis of variance. RESULTS: In total, 107 FMRs of the IG and 102 FMRs of the CG participated at baseline and follow-up. The mean (SD) Diagnostic Action scale score decreased from 24.0 (4.8) to 22.9 (5.1) in the IG and increased in the CG from 23.7 (5.4) to 24.1 (5.4), showing significant group difference (P = 0.006). The Diagnostic Reasoning scale increased significantly (P = 0.025) without a significant group difference (P = 0.616), from 19.2 (2.6) to 19.7 (2.4) in the IG and from 18.1 (3.3) to 18.8 (3.2) in the CG. The PRU scale Anxiety Due to Uncertainty decreased significantly (P = 0.029) without a significant group difference (P = 0.116), from 20.5 (4.8) to 18.5 (5.5) in the IG and from 19.9 (5.5) to 19.0 (6.0) in the CG. CONCLUSION: The structured seminar reduced self-rated diagnostic test requisition. The change in Anxiety Due to Uncertainty and Diagnostic Reasoning might be due to an unspecific accompanying effect of the extra-occupational seminars for residents.

6.
Clin Trials ; : 1740774520984866, 2021 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-33478253

RESUMO

BACKGROUND: Subgroup analyses are frequently used to assess heterogeneity of treatment effects in randomised clinical trials. Inconsistent, improper and incomplete implementation, reporting and interpretation have been identified as ongoing challenges. Further, subgroup analyses were frequently criticised because of unreliable or potentially misleading results. More recently, recommendations and guidelines have been provided to improve the reporting of data in this regard. METHODS: This systematic review was based on a literature search within the digital archives of three selected medical journals, The New England Journal of Medicine, The Lancet and Circulation. We reviewed articles of randomised clinical trials in the domain of cardiovascular disease which were published in 2015 and 2016. We screened and evaluated the selected articles for the mode of implementation and reporting of subgroup analyses. RESULTS: We were able to identify a total of 130 eligible publications of randomised clinical trials. In 89/130 (68%) articles, results of at least one subgroup analysis were presented. This was dependent on the considered journal (p < 0.001), the number of included patients (p < 0.001) and the lack of statistical significance of a trial's primary analysis (p < 0.001). The number of reported subgroup analyses ranged from 1 to 101 (median = 13). We were able to comprehend the specification time of reported subgroup analyses for 71/89 (80%) articles, with 55/89 (62%) articles presenting exclusively pre-specified analyses. This information was not always traceable on the basis of provided trial protocols and often did not include the pre-definition of cut-off values for the categorization of subgroups. The use of interaction tests was reported in 84/89 (94%) articles, with 36/89 (40%) articles reporting heterogeneity of the treatment effect for at least one primary or secondary trial outcome. Subgroup analyses were reported more frequently for larger randomised clinical trials, and if primary analyses did not reach statistical significance. Information about the implementation of subgroup analyses was reported most consistently for articles from The New England Journal of Medicine, since it was also traceable on the basis of provided trial protocols. We were able to comprehend whether subgroup analyses were pre-specified in a majority of the reviewed publications. Even though results of multiple subgroup analyses were reported for most published trials, a corresponding adjustment for multiple testing was rarely considered. CONCLUSION: Compared to previous reviews in this context, we observed improvements in the reporting of subgroup analyses of cardiovascular randomised clinical trials. Nonetheless, critical shortcomings, such as inconsistent reporting of the implementation and insufficient pre-specification, persist.

8.
Europace ; 2020 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-33276379

RESUMO

AIMS: Present society is constantly ageing and elderly frequently suffer from conditions that are difficult and/or costly to treat if detected late. Effective screening of the elderly is therefore needed so that those requiring detailed clinical work-up are identified early. We present a prospective validation of a screening strategy based on a Polyscore of seven predominantly autonomic, non-invasive risk markers. METHODS AND RESULTS: Within a population-based survey in Germany (INVADE study), participants aged ≥60 years were enrolled between August 2013 and February 2015. Seven prospectively defined Polyscore components were obtained during 30-min continuous recordings of electrocardiogram, blood pressure, and respiration. Out of 1956 subjects, 168 were excluded due to atrial fibrillation, implanted pacemaker, or unsuitable recordings. All-cause mortality over a median 4-year follow-up was prospectively defined as the primary endpoint. The Polyscore divided the investigated population (n = 1788, median age: 72 years, females: 58%) into three predefined groups with low (n = 1405, 78.6%), intermediate (n = 326, 18.2%), and high risk (n = 57, 3.2%). During the follow-up, 82 (4.6%) participants died. Mortality in the Polyscore-defined risk groups was 3.4%, 7.4%, and 17.5%, respectively (P < 0.0001). The Polyscore-based mortality prediction was independent of Framingham score, diabetes, chronic kidney disease, and major stroke and/or myocardial infarction history. It was particularly effective in those aged <75 years (n = 1145). CONCLUSION: The Polyscore-based mortality risk assessment from short-term non-invasive recordings is effective in the elderly general population, especially those aged 60-74 years. Implementation of a comprehensive Polyscore screening of this age group is proposed to advance preventive medical care.

9.
J Am Coll Cardiol ; 76(21): 2436-2446, 2020 Nov 24.
Artigo em Inglês | MEDLINE | ID: mdl-33213722

RESUMO

BACKGROUND: Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI). OBJECTIVES: This study sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management. METHODS: This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5. RESULTS: The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio [HR]: 1.41; 95% confidence interval [CI]: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month. CONCLUSIONS: In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800).

10.
JACC Cardiovasc Interv ; 13(19): 2238-2247, 2020 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-33032712

RESUMO

OBJECTIVES: The aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned. BACKGROUND: The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown. METHODS: This pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12 months after randomization). RESULTS: The primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p = 0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p < 0.001). There was a significant treatment arm-by-diabetic status interaction (pint = 0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500). CONCLUSIONS: DM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).

11.
J Clin Epidemiol ; 129: 86-96, 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33038543

RESUMO

OBJECTIVES: The objective of the study is to determine the impact of changing reference standards (RS), namely spirometry vs. whole-body plethysmography (WBP), on estimation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) and clinical signs and symptoms (CSS) as index tests regarding asthma diagnosis. STUDY DESIGN AND SETTING: This was a diagnostic study conducted in 393 patients attending a private practice of pneumologists with complaints suspicious of asthma. First, the index tests were compared with the diagnostic results of spirometry in terms of forced expiratory volume in the first second (FEV1) responsiveness. Second, the index tests were compared with the results of WBP in terms of specific airway resistance and FEV1 responsiveness. Areas under the curve (AUC) were compared with a generalized estimating equation approach based on binary logistic regression. RESULTS: FeNO values and CSS 'wheezing' and 'allergic rhinitis' showed higher specificities (P < 0.001) and sensitivities (not significant) when evaluated with WBP; also, Youden indices increased in these CSS (P < 0.05). AUC of FeNO in combination with 'wheezing' and 'allergic rhinitis' when WBP was used as RS (AUC = 0.724; 95% confidence interval 0.672 to 0.776) was higher compared with spirometry as RS (AUC = 0.654; 95% confidence interval 0.585 to 0.722) (P < 0.001). CONCLUSION: In case of asthma, superior RS led to more favorable assessment of index tests. FeNO measurement might have been underestimated in some previous studies.

12.
Circulation ; 2020 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-33115278

RESUMO

Background: Data on the comparative efficacy and safety of ticagrelor versus prasugrel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) are limited. We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head comparison in STEMI patients undergoing primary PCI. Methods: In this pre-specified subgroup analysis, we included 1653 patients with STEMI randomized to receive ticagrelor or prasugrel in the setting of the ISAR REACT-5 trial. The primary endpoint was the incidence of death, myocardial infarction or stroke at 1 year after randomization. The secondary endpoint was the incidence of bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding at 1 year after randomization. Results: The primary endpoint occurred in 83 patients (10.1%) in the ticagrelor group and in 64 patients (7.9%) in the prasugrel group (hazard ratio [HR]=1.31; 95% confidence interval [CI] 0.95-1.82; P=0.10). One-year incidence of all-cause death (4.9% vs. 4.7%; P=0.83), stroke (1.3% vs. 1.0%; P=0.46) and definite stent thrombosis (1.8% vs. 1.0%; P=0.15) did not differ significantly in patients assigned to ticagrelor or prasugrel. One-year incidence of myocardial infarction (5.3% vs. 2.8%; HR=1.95 [1.18-3.23], P=0.010) was higher with ticagrelor than with prasugrel. BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (HR=1.22 [0.80-1.87]; P=0.36). Conclusions: In patients with STEMI undergoing primary PCI, there was no significant difference in the primary endpoint between prasugrel and ticagrelor. Ticagrelor was associated with a significant increase in the risk for recurrent myocardial infarction. Clinical Trial Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT01944800.

13.
EuroIntervention ; 2020 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-32894230

RESUMO

AIMS: First, to assess the relation between neointimal pattern and clinical outcomes following in-stent restenosis (ISR) treatment; second, to explore a potential interaction between neointimal pattern and treatment modality relative to clinical outcomes. METHODS AND RESULTS: Based on the distribution of non-homogeneous quadrants, patients undergoing optical coherence tomography (OCT) prior to drug-eluting stent (DES) or drug-coated balloon (DCB) treatment of ISR, were categorized in low and high inhomogeneity groups (100 and 97 patients respectively). There were no significant differences in terms of MACE (P=0.939) or TLR (P=0.732). The exploratory analysis showed a significant interaction between neointimal pattern and treatment modality regarding MACE (P int =0.006) and TLR (P int =0.022). DES showed a significant advantage over DCB in the high [MACE: HR 0.26 (0.10-0.65), P=0.004; TLR: HR 0.28 (0.11-0.69), P=0.006], but not in the low inhomogeneity group (MACE: P=0.917; TLR: P=0.797). CONCLUSIONS: In patients with ISR treated with DCB or DES, there were no significant differences in terms of MACE or TLR between low and high inhomogeneity groups. A significant interaction was observed between treatment modality and neointimal pattern with an advantage of DES over DCB in the high and no difference in the low inhomogeneity group. This warrants confirmation from prospective dedicated studies.

14.
Breast Care (Basel) ; 15(4): 380-385, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32982648

RESUMO

Background: Complementary and alternative medicine (CAM) use is common among cancer patients. Data indicated that CAM use correlates with younger age, higher education levels, higher income, and less physician consultations. However, non-CAM use and predictors for non-CAM use are less clear among breast and gynecological cancer patients. Objectives: The purpose of this study was to determine the prevalence of non-CAM use and to investigate factors that might influence non-CAM use. Methods: The survey was conducted in breast cancer patients from January to May 2013 and in gynecological cancer patients from January to May 2014 with 2 pseudoanonymous questionnaires: one for CAM users (109 questions) and one for non-CAM users (85 questions). The survey was conducted via a telephone interview with 333 patients. Eligible participants were women with breast cancer (n = 285) and gynecological cancer (n = 291) who had undergone surgery at the Department of Gynecology and Obstetrics at the Technical University Munich, Germany, in the years 2012 (breast cancer) and 2011-2013 (gynecological cancer). Descriptive statistics were generated to determine patterns of non-CAM use. Univariable analysis was used to detect patient characteristics associated with noninterest in the different CAM therapies. Results: A total of 333 of 576 patients participated in the survey (58%). Fifty-eight percent (n = 192/333) were diagnosed with breast cancer and 42% (n = 141/333) with gynecological cancer. The overall prevalence of non-CAM use was 42% (n = 139/333). Eighty-one percent (n = 112/139) of the non-CAM users stated to have received no recommendation for CAM use, although 53% (n = 73/139) would have liked to receive information from their physician. As reasons for the nonuse of CAM therapies, 76% (n = 106/139) nonusers declared that they did not believe CAM use was necessary since the conventional therapy was considered sufficient, 44% (n = 61/139) reported a lack of information, 31% (n = 43/139) a fear of fraud, and 22% (n = 31/139) a fear of interactions and side effects of CAM. Sixty-eight percent (n = 95/139) of the patients stated that they would resort to CAM if the disease progressed while only 27% (n = 37/139) would still not use any CAM with progression of disease. Five percent (7/139) did not give any information regarding possible future CAM use with disease progression. Seventy-three percent (n = 102/139) would both welcome more physicians with qualifications in complementary medicine and supported an integration of CAM into our health care system. Furthermore, statistically significant correlations between patients' sociodemographic characteristics and their nonuse of complementary therapies were identified. Conclusions: Our data demonstrate a high overall interest in CAM even in non-CAM users. Health care professionals should be aware of this in order to be able to better address patients' needs. It is necessary to explore the use of CAM with cancer patients, educate them about potentially beneficial therapies even in the light of the limited available evidence, and work towards an integrated model of health care. Therefore, we implemented a counseling service as an outpatient program (ZIGG) for integrative medicine concepts and evidence-based complementary treatments to discuss integrative health approaches proactively with cancer patients in our cancer center in 2013.

15.
Arch Gynecol Obstet ; 302(6): 1461-1467, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32902674

RESUMO

PURPOSE: Prospectively collected outcome data of patients (pts) whose adjuvant systemic therapy recommendation was based on the clinico-molecular test EndoPredict® (EP) are presented. METHODS: Pts with ER-positive, HER2-negative early breast cancer with 0-3 positive lymph nodes were enrolled. The EP was carried out on all tumor samples. Pts were evaluated for treatment compliance, local recurrence, distant metastases and overall survival. Censored time-to-event outcomes were analysed by Cox proportional hazards models. Additional estimates of the event-free-survival were calculated by the Kaplan-Meier method. Hypothesis testing was conducted on two-sided exploratory 5% significance levels. RESULTS: 373 consecutive pts were enrolled. EP classified 238 pts (63.8%) as low risk and 135 pts (36.2%) as high risk. Median follow-up was 41.6 months. Risk for disease recurrence or death in EPclin high-risk patients was twofold higher in comparison with EPclin low-risk patients (hazard ratio (HR) 2.05 (95% CI 0.85-4.96; p = 0.110). Patients with EPclin high risk were at significant higher risk of distant metastases than patients with EPclin low risk (HR 5.18; 95% CI 1.04-25.74; p = 0.0443). EPclin high-risk patients who actually underwent adjuvant CTX had a 3-year-DFS of 96.3% (95% CI 92.2-100) in contrast to EPclin high-risk patients without CTX (3-year-DFS: 91.5% (95% CI 82.7-100%); HR 0.32; 95% CI 0.10-1.05; p = 0.061). CONCLUSION: These first prospective outcome results show that EP, in clinical routine, is a valid clinico-molecular test, to predict DFS and to guide decision of adjuvant CTX use in ER-positive, HER2-negative early breast cancer pts with 0-3 positive lymph nodes. Adjuvant CTX seems to be beneficial for EPclin high-risk patients.

16.
Eur J Med Res ; 25(1): 33, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32799924

RESUMO

BACKGROUND: Safe diagnosis of periprosthetic joint infection (PJI) is of utmost importance for successful exchange arthroplasty. However, current diagnostic tools show insufficient accuracy in the clinically common and challenging chronic low-grade infections. To close this diagnostic gap, reliable (bio)markers display the most promising candidates. Antimicrobial peptides (AMPs) are part of the innate immune response towards microbial growth. Recently we could show significant intraarticular levels of human cathelicidin LL-37 and ß-defensin-3 (HBD-3) with high diagnostic accuracy in PJI synovial fluid. Consequently, these promising biomarkers were evaluated in PJI synovial membrane and synoviocytes, which may significantly facilitate histological diagnosis of PJI to improve outcome of septic joint replacement. METHODS: In this prospective single-center controlled clinical study (diagnostic level II), consecutive patients with total hip (THR) and knee (TKR) replacements were included undergoing primary arthroplasty (n = 8), surgical revision due to aseptic loosening (n = 9) and septic arthroplasty with coagulase-negative staphylococci (n = 8) according to the criteria of the Musculoskeletal Infection Society (MSIS). Semiquantitative immunohistochemical (IHC) analysis of LL-37, HBD-3 and HBD-2 in synovial membrane and isolated synoviocytes based on Total Allred Score (TS) and Immunoreactive Remmele and Stegner score (IRS) was performed. For statistical analysis, SPSS 26.0/R3.6.3 (p < 0.05) was used. RESULTS: The AMPs LL-37 and HBD-3 were significantly elevated (up to 20×) in synovial membranes from PJI compared to aseptic loosening or primary arthroplasty. The area under the curve (AUC) in a receiver operating characteristic curve analysis was equal to 1.0 for both scores revealing excellent diagnostic accuracy. Isolated synoviocytes as cellular AMP source showed comparable results with a significant LL-37/HBD-3-increase up to 3 × in PJI. In contrast, local HBD-2 levels were negligible (p > 0.23) upon PJI with a lower diagnostic accuracy (AUC = 0.65) in analogy to our previous findings with synovial fluid. CONCLUSIONS: Our results implicate AMPs as promising and specific biomarkers for the histological diagnosis of PJI.

18.
J Craniomaxillofac Surg ; 48(9): 859-867, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32792109

RESUMO

BACKGROUND: Bone volume changes following vascularized bone flaps and possible confounding factors over time are described in the literature with some controversy. The purpose of this study was to evaluate the bone volume behavior of two frequently used free flaps. MATERIALS AND METHODS: Computed tomography (CT) scans were examined with regard to bone volume using the software program ITK-SNAP for all patients who required mandibular reconstruction with a free fibula flap (FFF, conventionally vs assisted by computer-aided design/computer-aided manufacturing (CAD/CAM)) or iliac crest flap (DCIA) following mandibular resection because of benign or malign processes, between August 2010 and August 2015. Clinical data, complication rates, and CT scans were analyzed retrospectively. Additionally, complication rates (microvascular revision, flap loss, postoperative fistula or dehiscence, and postoperative bone exposure) were compared within early (≤30 days), late (31st-100th day), and overall (≤100th day) postoperative time intervals. RESULTS: 113 cases, comprizing 89 FFF and 24 DCIA cases, were included. FFF showed superior bone volume behavior over the DCIA flap. Multivariable regression models assessed the relationships between the following and bone volume behavior: interval between operation and CT scan (p < 0.683), age (p = 0.004), gender (p = 0.006), BMI (p = 0.400), adjuvant radiation therapy (p = 0.334), reconstruction with DCIA flap (p < 0.0001), number of segments (p = 0.02), and incidence of dental implant insertion (p = 0.45). CONCLUSIONS: The bone volume of FFFs remains stable. DCIA flaps show a higher bone volume reduction, but the postoperative course might be associated with fewer complications. Time interval between operation and CT scan, age, gender, reconstruction with DCIA flap, and number of fibula segments contributed significantly to bone volume behavior.


Assuntos
Retalhos de Tecido Biológico/cirurgia , Reconstrução Mandibular , Procedimentos Cirúrgicos Reconstrutivos , Transplante Ósseo , Fíbula/cirurgia , Humanos , Mandíbula/cirurgia , Estudos Retrospectivos
19.
Cancers (Basel) ; 12(6)2020 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-32630478

RESUMO

We investigated the prognostic and predictive impact of p53 expression for gastric cancer (GC) patients treated without or with preoperative chemotherapy (CTx) and its relationship with specific molecular GC subtypes. Specimens from 694 GC patients (562 surgical resection specimens without or after CTx, 132 biopsies before CTx) were analyzed by p53 immunohistochemistry. High (H) and low (L) microsatellite instability (MSI) and Epstein-Barr virus positivity were determined previously. Our results show that aberrant p53 expression was a negative prognostic factor in uni- and multivariable analysis in the resection specimens cohort (each p < 0.01). Subgroup analysis showed the strongest prognostic effect for patients with distally located tumors or no CTx treatment. In the biopsy cohort before CTx, p53 did not predict response or survival. p53 expression was significantly different among the molecular subtypes in surgical resection and bioptic specimens with strong association of altered p53 with MSI-L. Patients with MSI-H and aberrant p53 showed the worst survival in the biopsy cohort. In conclusion, the prognostic impact of p53 in GC differs according to tumor localization and CTx. Altered p53 is characteristic for MSI-L, and the p53 status in biopsies before CTx delineates MSI-H subtypes with inverse prognostic impact.

20.
Ann Intern Med ; 173(6): 436-444, 2020 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-32687741

RESUMO

BACKGROUND: The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown. OBJECTIVE: To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800). DESIGN: Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial. SETTING: 23 centers in Germany and Italy. PATIENTS: 3997 patients with ACS planned for invasive management. INTERVENTION: Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group). MEASUREMENTS: The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months. RESULTS: In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; P for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2). LIMITATION: The study is a subgroup analysis. CONCLUSION: In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding. PRIMARY FUNDING SOURCE: German Center for Cardiovascular Research and Deutsches Herzzentrum München.

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