Search

Aim: To propose a framework for consistently applying the 2018 periodontal status classification scheme to epidemiological surveys (Application of the 2018 periodontal status Classification to Epidemiological Survey data, ACES). Proposed Framework: We specified data requirements and workflows for either completed or planned epidemiological surveys, utilizing commonly collected measures of periodontal status (clinical attachment levels [CAL], probing depths, bleeding on probing), as well as additional necessary variables for the implementation of the 2018 periodontal status classification (tooth loss due to periodontitis and complexity factors). Following detailed instructions and flowcharts, survey participants are classified as having periodontal health, gingivitis or periodontitis. Rates of edentulism must also be reported. In cases of periodontitis, instructions on how to compute the stage and extent are provided. Assessment of grade can be derived from CAL measurements (or from radiographic alveolar bone loss data) in relation to root length and the participant's age. Conclusions: ACES is a framework to be used in epidemiological studies of periodontal status that (i) have been completed, and in which stage and grade according to the 2018 classification are inferred retroactively, or (ii) are being planned. Consistent use of the proposed comprehensive approach will facilitate the comparability of periodontitis prevalence estimates across studies. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Orofacial Orthopedics/Fortschritte der Kieferorthopadie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Orofacial Orthopedics/Fortschritte der Kieferorthopadie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Orofacial Orthopedics/Fortschritte der Kieferorthopadie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Orofacial Orthopedics/Fortschritte der Kieferorthopadie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objectives: To systematically review the prevalence of bacteraemia, triggered by dental intervention and home oral hygiene practices, in children. The network meta‐analysis (NMA) quantitatively compared the risk of bacteraemia triggered by dental extractions and home and professional cleaning procedures. Materials and Methods: Clinical trials with the outcome "bacteraemia in children" were searched. The NMA was performed using the frequentist weighted least‐squares approach comparing the odds ratios (OR) of different interventions. Results: Among 11 of 13 studies, dental treatment was performed under general anaesthesia. In 2,381 patients, bacteraemia occurred in 38.7%–56% patients following single‐tooth extractions, in 22%–46% after manual toothbrushing (MTB), and in 26%–78% after power toothbrushing (PTB). When MTB was set as the reference (OR 1), rubber cup polishing showed a slightly higher risk (OR 1.26) of bacteraemia. PTB presented a higher risk (OR 1.79–2.27) than with single‐tooth extractions (OR 1.55) but lower than that with multiple extractions (OR 2.55). Conclusion: Daily use of MTB and routine professional cleaning were associated with the lowest risk of developing bacteraemia in children with gingivitis, almost as much as with a single‐tooth extractions. Improved plaque control with PTB increased the risk of bacteraemia. There is limited evidence on gingivitis‐free and systemically‐diseased children. [ABSTRACT FROM AUTHOR]

Introduction: Selective serotonin and norepinephrine reuptake inhibitors (SNRI) are among the most prescribed antidepressants, and dose escalation is a frequently applied strategy after non-response to an initially prescribed dose. Objective: This meta-analysis aimed to find evidence of a dose-response relationship or to the contrary in direct comparisons of different SNRI doses in patients with major depressive disorder. Methods: A systematic literature search for RCTs comparing at least two doses of SNRIs was carried out in CENTRAL, PubMed, PsycINFO, and EMBASE. Doses were classified as high, medium, and low according to manufacturers' product monographs and analyses at the level of SNRIs as a group and for single substances, accompanied by sensitivity network meta-analyses (Prospero CRD42018081031). Results: From 2,070 studies screened, we included 26 studies with a total of 10,242 patients. Comparisons of medium versus low and high versus medium doses resulted in clinically and statistically non-significant standardized mean differences of –0.06 (–0.16 to 0.04) and –0.06 (–0.16 to 0.03) in favor of higher doses. In the analyses of single substances, no statistically significant results emerged, and many contrasts yielded very small effect sizes. Dropouts due to side effects tended to be more frequent with higher doses. Heterogeneity was low. Network meta-analyses of direct comparisons supported the findings, as did a risk of bias analysis. Conclusion: Based on the lack of positive evidence for a dose-response relationship in SNRIs as a group and in single SNRIs, we recommend prescribing medium doses. In case of insufficient response, we do not recommend increasing the dose of SNRIs. [ABSTRACT FROM AUTHOR]

Purpose: Esophageal perforation is associated with high morbidity and mortality. In addition to surgical treatment, endoscopic endoluminal stent placement and endoscopic vacuum therapy (EVT) are established methods in the management of this emergency condition. Although health-related quality of life (HRQoL) is becoming a major issue in the evaluation of any therapeutic intervention, not much is known about HRQoL, particularly in the long-term follow-up of patients treated for non-neoplastic esophageal perforation with different treatment strategies. The aim of this study was to evaluate patients' outcome after non-neoplastic esophageal perforation with focus on HRQoL in the long-term follow-up. Methods: Patients treated for non-neoplastic esophageal perforation at the University Hospital Cologne from January 2003 to December 2014 were included. Primary outcome and management of esophageal perforation were documented. Long-term quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI), the Health-Related Quality of Life Index (HRQL) for patients with gastroesophageal reflux disease (GERD), and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires for general and esophageal specific QoL (QLQ-C30 and QLQ-OES18). Results: Fifty-eight patients were included in the study. Based on primary treatment, patients were divided into an endoscopic (n = 27; 46.6%), surgical (n = 20; 34.5%), and a conservative group (n = 11; 19%). Short- and long-term outcome and quality of life were compared. HRQoL was measured after a median follow-up of 49 months. HRQoL was generally reduced in patients with non-neoplastic esophageal perforation. Endoscopically treated patients showed the highest GIQLI overall score and highest EORTC general health status, followed by the conservative and the surgical group. Conclusion: HRQoL in patients with non-neoplastic esophageal perforation is reduced even in the long-term follow-up. Temporary stent or EVT is effective and provides a good alternative to surgery, not only in the short-term but also in the long-term follow-up. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: Baroreflex activation therapy (BAT) has been shown to lower blood pressure in patients with resistant hypertension. The purpose of this study was to analyze whether this translates into a reduction of more relevant clinical endpoints. Methods: Patients with resistant hypertension were treated with the second-generation BAT system. Records on hospitalization (dates of admission and discharge, main diagnosis) were obtained from medical insurance companies. Results: Records on hospitalization were available for a period of 1 year before BAT in two patients and 2 years in 22 patients. The total number of hospitalizations per patient was 3.3 ± 3.5/year before BAT and 2.2 ± 2.7/year after BAT (p = 0.03). Hospitalizations related to hypertension were significantly decreased from 1.5 ± 1.6/year before BAT to 0.5 ± 0.9/year after BAT (p < 0.01). The cumulative duration of hypertension-related hospital stays was significantly reduced from 8.0 ± 8.7 days/year before BAT to 1.8 ± 4.8 days/year after BAT (p < 0.01). Office cuff blood pressure was 183 ± 27 mmHg over 102 ± 17 mmHg under 6.6 ± 2.0 antihypertensive drugs before BAT and 157 ± 32 mmHg over 91 ± 20 mmHg (both p < 0.01) under 5.9 ± 1.9 antihypertensive drugs (p = 0.09 for number of drugs) at latest follow-up. Daytime ambulatory blood pressure was 164 ± 21 mmHg over 91 ± 14 mmHg before BAT and 153 ± 21 mmHg (p = 0.03) over 89 ± 15 mmHg (p = 0.56) at latest follow-up. Heart rate was 75 ± 16 bpm before BAT and 72 ± 12 bpm at latest follow-up (p = 0.35). Conclusions: Rate and duration of hypertension-related hospitalizations in patients with severe resistant hypertension were lowered after BAT. Whether the response is mediated through improvements in blood pressure control requires further studies. [ABSTRACT FROM AUTHOR]

Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial. [ABSTRACT FROM AUTHOR]

Objective: Scleroderma renal crisis (SRC) is a severe life-threatening manifestation in patients with systemic sclerosis (SSc). However, the knowledge about risk factors for SRC is limited. We determined here the frequency of SRC and identified risk factors for the prediction of SRC.Methods: Based on regular followup data from the German Network for Systemic Scleroderma, we used univariate and multivariate generalized estimating equations to analyze the association between clinical variables, SSc subsets, therapy [i.e., angiotensin-converting enzyme inhibitors (ACEi), corticosteroids], and the occurrence of SRC.Results: Data of 2873 patients with 10,425 visits were available for analysis with a mean number of registry visits of 3.6 ± 2.8 and a mean time of followup of 3.6 ± 3.8 years. In total, 70 patients developed SRC (70/2873, 2.4%). Of these patients, 57.1% (40/70) were diagnosed with diffuse cutaneous SSc, 31.4% (22/70) with limited cutaneous SSc, and 11.4% (8/70) with SSc-overlap syndromes. Predictive independent factors with the highest probability for SRC were positive anti-RNA polymerase antibodies (RNAP), a history of proteinuria prior to SRC onset, diminished DLCO, and a history of hypertension. Interestingly, positive antitopoisomerase autoantibodies did not predict a higher risk for SRC. Further, patients with SRC were significantly more frequently treated with ACEi and corticosteroids without being independently associated with SRC.Conclusion: In this cohort, SRC has become a rare complication. By far the highest risk for SRC was associated with the detection of anti-RNAP and proteinuria. [ABSTRACT FROM AUTHOR]

Introduction: The determination of the electrolytes sodium and potassium is essential in critical care. In daily clinical practice, both the blood gas analyzer (ABG) and the laboratory autoanalyzer (AA) are generally applied. However, there is still uncertainty regarding the convergence of the prementioned assays, and data about the comparability dependent on the pH value are still lacking.Materials and Methods: One hundred samples from intensive care unit patients with a range in pH values between 7.20 and 7.49 were evaluated in this retrospective cohort study. All patients suffered an infarct-related cardiogenic shock and were intubated and not under therapeutical hypothermia at the time of blood collection. We used scatter plots to compare different distributions of sodium and potassium values between the methods. Comparability of the analyses was assessed using the Bland-Altmann approach, and intraclass correlations (ICC) as estimates of interrater reliability were calculated.Results: The mean potassium level measured on ABG was 4.33 mmol/L (SD 0.48 mmol/L), and the value obtained using the AA was 4.40 mmol/L (SD 0.55 mmol/L). A Bland-Altman comparison for total potassium measurements revealed that the limits of agreement were small (-0.241 to 0.391 mmol/L). Total ICC displayed a very good correlation of 0.949. For sodium, we found average values of 140 mmol/L (SD 5.20 mmol/L) in the AA and 140 mmol/L (SD 5.80 mmol/L) in the ABG assessment. Contrarily, the Bland-Altman comparison for sodium displayed that the 95% limits of agreement were very wide (-5.99 to 6.59 mmol/L) for total measurements as well as in every pH subgroup. Total ICC only reached a value of 0.830.Conclusion: Data from our single-center study indicate that urgent and vital decisions based on potassium measurements can be made by trusting the value obtained on the ABG machine irrespective of pH values. [ABSTRACT FROM AUTHOR]

Aim: Psychological interventions, such as cognitive behavioural therapy (CBT) and supportive counselling (SC), are used to treat people with schizophrenia and people at clinical high risk (CHR) of psychosis. However, little information is available on predictors of treatment response. This study aims to identify such predictors of psychological interventions in CHR. Methods: A total of 128 help‐seeking CHR outpatients were randomized into two groups—integrated psychological intervention (IPI), including CBT, and SC—for 12 months. Multiple regression analysis was used to identify demographic, symptomatic and functional variables that predict improvement in positive (PANSS Positive), negative (PANSS Negative) and basic symptoms (Basic symptom total score) and improvement in functioning (GAF) at 1‐year follow up. Results: In the merged group (IPI + SC), people who lived independently, were younger and presented with higher baseline functioning showed more improvement in symptomatic outcomes at follow up. Negative symptoms at baseline predicted less improvement in positive and basic symptoms. Being married or cohabiting and living in the primary family were found to correlate with good functioning at 1‐year follow up. Conclusions: Younger CHR individuals and those who are functioning well may particularly benefit from early intervention. Treatment might need to be modified for low‐functioning CHR and those who already display higher scores of negative symptoms. Registration number: NCT00204087 [ABSTRACT FROM AUTHOR]

For nasal application of neurotrophins and mesenchymal stem cells, successful delivery to the brain and therapeutic effects are known from experimental data in animals. Human breast milk contains neurotrophins and stem cells, but gavage tube feeding in preterm infants bypasses the naso-oropharynx. This is a first exploration on additional nasal breast milk and neuromorphological outcome after severe neonatal brain injury. We present a retrospective summary of 31 very low birth weight preterm infants with intraventricular hemorrhage °3/4 from one third-level neonatal center. All were breast milk fed. Sixteen infants additionally received nasal drops of fresh breast milk daily with informed parental consent for at least 28 days. Cerebral ultrasound courses were reviewed by a pediatric radiologist blinded to the intervention. The main outcome measure was severity of porencephalic defects before discharge. Clinical covariates were comparable in both groups. With nasal breast milk, a trend to a lower incidence for severe porencephalic defects (21% vs. 58%) was detected. Incidences were lower for progressive ventricular dilatation (71% vs. 91%) and surgery for posthemorrhagic hydrocephalus (50% vs. 67%).Conclusion: The hypothesis is generated that early intranasal application of breast milk could have a beneficial effect on neurodevelopment in preterm infants. Controlled investigation is needed. What is Known:• Successful delivery to the brain and therapeutic effects are known for nasal application of neurotrophins and mesenchymal stem cells from experimental data in animal studies.• Human breast milk contains neurotrophins and stem cells, but gavage tube feeding in preterm infants bypasses the naso-oropharynx. What is New:• This is the first report on additional nasal breast milk application in very low birth weight preterm infants with severe brain injury observing a trend for less severe porencephalic defects.• The hypothesis is generated that nasal breast milk might exert neuroprotective effects in preterm infants. [ABSTRACT FROM AUTHOR]

Background This study evaluates whether preoperative statin therapy improves clinical outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndrome (ACS). Methods A total of 1,151 patients undergoing CABG for ACS were prospectively entered into the North-Rhine-Westphalia surgical myocardial infarction registry and subdivided into two groups according to their preoperative statin status (statin naive vs. statin group). A logistic regression model was employed to analyze the impact of a statin therapy and dose for the endpoints in-hospital mortality and major adverse cardiac events (MACE). Results Demographics, pre- and intraoperative data of the statin-naive group (n = 208; 18%) and statin-treated group (n = 943, 82%) did not differ. In-hospital mortality (12.6 vs. 6.3%, p = 0.002) and MACE rates (22.1 vs. 9.7%, p < 0.001) were significantly higher in statin naive when compared with statin-treated patients with ACS, respectively. Mevalonic acid revealed that both low- and high-dose statin treatment was associated to a reduction in in-hospital mortality and MACE, without a dose-dependent statin effect. Conclusion Statin therapy in patients with ACS undergoing CABG reduces in a dose-independent manner in-hospital mortality and MACE. [ABSTRACT FROM AUTHOR]

Copyright of Wiener Medizinische Wochenschrift is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: Hyponatremia is a common electrolyte abnormality seen in hospitalized patients. It may cause a variety of symptoms and is associated with longer hospitalizations and higher mortality. However, to date, only little is known about the extent of hyponatremia in patients with incurable diseases and whether it is associated with physical symptoms in this patient group. This study aims to describe the prevalence of hyponatremia, associated symptoms, and symptom intensity in inpatients with hyponatremia receiving specialist palliative care (SPC).Methods: This is a retrospective study. Demographic and clinical data as well as symptoms, scored symptom intensity, and laboratory values were collected. All inpatients of a large German University Hospital receiving SPC in 2013 with documented sodium values were included.Results: In 2013, 789 inpatients received SPC of which 710 had documented sodium values. The prevalence of hyponatremia was 38.7% (275/710). A mild degree showed 220 (31,0%), 44 (6.2%) had a moderate, and 11 (1.6%) a severe form. Hyponatremia patients experienced significantly more symptoms than normonatremic patients (mean = 7.71 vs 6.63; p < 0.001). Breathlessness, depressiveness, nausea, vomiting, poor appetite, constipation, and weakness were significantly more frequent in patients with hyponatremia. Furthermore, hyponatremia severity was associated with higher symptom intensity (mean = 13.29 vs 11.28; p < 0.001).Conclusions: More than one third of all SPC patients showed a hyponatremia, and the hyponatremia grade was associated with symptom burden and symptom intensity. A prospective analysis is needed to further examine this association and the possible influence of hyponatremia correction on symptom burden reduction. [ABSTRACT FROM AUTHOR]

Background: Estimating the quantitative effect of transcatheter mitral valve repair on functional parameters and quality of life is important for individual treatment decision-making. Methods: We combined data from a prospective monocentric cohort study ( N = 215) with data from a systematic literature review (PubMed search term 'mitraclip', till 30.04.2016) on patients undergoing MitraClip with at least mortality after discharge reported as an outcome. Effects on functional parameters were reported as range of mean change. Results: 36 observational studies and 1 randomized controlled trial were identified. Due to substantial heterogeneity of effect estimates ( I -heterogeneity >75%) and inadequate quality of studies with a lack of comparison group in 97.4% and lack of an independent assessment of outcomes in 86.8%, no pooled estimates were calculated. All studies reported improvements of mean New York Heart Association (NYHA) class (0.5-1.9 classes), Short-Form (SF)-12/36 scores (4.4-9.2 for physical component score, 2.6-8.9 for mental component score), 6-min walk distance [(6MWD) 2-336 m] and Minnesota Living with Heart failure questionnaire (MLWHFQ) score (−7 to −18 points), with improvements regarded as clinically relevant in 20 of 29 studies for NYHA class, in all of 7 studies for SF12/36, in 9 of 15 studies for 6MWD and in all of 8 studies for MLWHFQ. Conclusion: MitraClip therapy provides improvements in physical capacity, physical and mental functioning and disease-specific quality of life in the majority of patients. However, more comparative and high-quality studies are required for understanding the heterogeneity of results, which is crucial for optimal patient selection. [ABSTRACT FROM AUTHOR]

Regularly reported patient surveys are an important dimension of hospital quality management. This study investigates whether providing hospital staff with interim feedback on patient survey results following a best practices workshop can help hospitals improve patient centeredness. Standardized surveys with consecutive patient samples were administered in accredited breast cancer center (BCC) hospitals in one German state (18 million inhabitants), over a 6-month period, in 2012. Two studies were conducted by applying a combination of regression point displacement (RPD) and interrupted time series (ITS) designs. In Study 1, 2 of the 27 hospitals that had previously participated in a best practices workshop to discuss patient-centeredness issues were randomly chosen and were provided interim feedback of patient survey results and workshop minutes. In Study 2, 4 randomly chosen hospitals of 32 that had not participated in the workshop also received interim feedback but no workshop minutes. Control hospitals in both studies neither received feedback nor workshop minutes. The impact of interim feedback was evaluated by applying graphical assessments and multiple regression analyses. Both graphical assessments (locally weighted scatterplot smoothing (LOESS) lines, RPD plots) suggested an effect of interim feedback. Multiple regression results did not unambiguously support these findings. The suggested design approach may prove particularly useful to assess effects in pilot studies, when resources are not available to conduct a randomized study or when its conduct is contingent on initial, positive evidence. [ABSTRACT FROM AUTHOR]

Copyright of Der Onkologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims: The impact of type of first medical contact (FMC) in the setting of a guideline conform metropolitan ST-elevation myocardial infarction (STEMI) network providing obligatory primary percutaneous coronary intervention (PCI) is unclear. Methods and Results: 3,312 patients were prospectively included between 2006 and 2012 into a registry accompanying the “Cologne Infarction Model” STEMI network, with 68.4% primarily presenting to emergency medical service (EMS), 17.6% to non-PCI-capable hospitals, and 14.0% to PCI-capable hospitals. Median contact-to-balloon time differed significantly by FMC with 89 minutes (IQR 72–115) for EMS, 107 minutes (IQR 85–148) for non-PCI- and 65 minutes (IQR 48–91) for PCI-capable hospitals (p < 0.001). TIMI-flow grade III and in-hospital mortality were 75.7% and 10.4% in EMS, 70.3% and 8.6% in non-PCI capable hospital and 84.4% and 5.6% in PCI-capable hospital presenters, respectively (p both < 0.01). The association of FMC with in-hospital mortality was not significant after adjustment for baseline characteristics, but risk of TIMI-flow grade < III remained significantly increased in patients presenting to non-PCI capable hospitals. Conclusion: Despite differences in treatment delay by type of FMC in-hospital mortality did not differ significantly. The increased risk of TIMI-flow grade < III in patients presenting to non PCI-capable hospitals needs further study. [ABSTRACT FROM AUTHOR]

Aim: Treatment-outcome associations often differ substantially between observational studies (OSs) and randomized controlled trials (RCTs). We investigate causes, focusing on radiotherapy (RT) effects in early breast cancer treatment, to better understand each study type's merits. Methods and materials: We systematically analyzed three potential causes, by comparing data from a large OS with results from two previously published meta-analyses of RCTs: differences in patient populations combined with heterogeneous treatment effects, non-random treatment decisions in OSs, and differences in therapy administration. Results: RT-survival associations were considerably stronger in our OS than in the RCTs, e.g., a hazard rate for overall survival after breast-conserving therapy of 0.57 in the OS vs 0.90 in the RCTs. The first proposed reason has limited relevance: patient populations differed considerably, but effect heterogeneity between patient groups was limited. The second reason does explain part of the difference: in the OS treatment decisions (being nonrandomized) and prospects differed with patient characteristics. Notably, patients with early recurrences or mortality are generally excluded from RCTs. Their inclusion in OSs leads to stronger treatment-outcome associations. Conclusion: RCTs and OSs each have their own merits. While RCTs have their undisputed benefits, results from OSs that indicate that RT effects in early breast cancer are even stronger than those reported in RCTs should not be ignored. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma. Methods: A systematic literature search for phase III randomized controlled trials (RCTs) comparing first-line chemotherapies approved in Germany and recommended by guidelines at the time of study design was conducted. Random-effects meta-analysis (MA) was used for direct and the Bucher method for adjusted indirect treatment comparison. Results: One RCT comparing melphalan and prednisone plus bortezomib (VMP) vs. melphalan and prednisone (MP) and six RCTs comparing MP plus thalidomide (MPT) vs. MP were analysed. For MPT vs. MP, an individual patient data (IPD) MA was used for sensitivity analyses. VMP and MPT were superior to MP regarding efficacy endpoints (VMP vs. MP, overall survival (OS): hazard ratio (HR) 0.70, 95 % confidence interval (CI) 0.57-0.86; progression-free survival (PFS): HR 0.56, 0.39-0.79; complete response (CR), risk-ratio (RR) for non-response: 0.70, 0.65-0.75; MPT vs. MP, OS: HR 0.83, 0.66-1.03; PFS: HR 0.67, 0.56-0.81; CR, RR for non-response 0.92, 0.88-0.95); but had a higher risk of developing any grade 3-4 adverse events (AEs) (VMP vs. MP: RR 1.13, 1.06-1.20; MPT vs. MP: RR 2.06, 1.43-2.98). The indirect comparison of VMP vs. MPT via MP showed a statistically not significant advantage for VMP regarding survival outcomes (OS: HR 0.85, 0.63-1.14; PFS: HR 0.83, 0.56-1.23) and a significant advantage regarding CR (RR for non-response 0.76, 0.70-0.83) and AEs (RR 0.55, 0.38-0.80). Treatment comparisons using results of IPD MA yielded similar effect sizes. Conclusions: VMP and MPT seem more effective than MP, VMP was superior to MPT regarding response criteria and AEs. Our results may best be confirmed by a head-to-head trial of VMP vs. MPT. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Shared decision making (SDM) is considered a gold standard for the cooperation of doctor and patient. SDM improves patients' overall satisfaction and their confidence in decisions that have been taken. The extent to which it might also positively affect patient-relevant, disease-related endpoints is a matter of debate. Methods: We systematically searched the PubMed database and the Cochrane Library for publications on controlled intervention studies of SDM. The quality of the intervention and the risk of bias in each publication were assessed on the basis of pre-defined inclusion and exclusion criteria. The effects of SDM on patient-relevant, disease-related endpoints were compared, and effect sizes were calculated. Results: We identified 22 trials that differed widely regarding the patient populations studied, the types of intervention performed, and the mode of implementation of SDM. In ten articles, 57% of the endpoints that were considered relevant were significantly improved by the SDM intervention compared to the control group. The median effect size (Cohen's d) was 0.53 (0.14-1.49). In 12 trials, outcomes did not differ between the two groups. In all 22 studies identified, 39% of the relevant outcomes were significantly improved compared with the control groups. Conclusion: The trials performed to date to addressing the effect of SDM on patient-relevant, disease-related endpoints are insufficient in both quantity and quality. Although just under half of the trials reviewed here indicated a positive effect, no final conclusion can be drawn. A consensus-based standardization of both SDM-promoting measures and appropriate clinical studies are needed. [ABSTRACT FROM AUTHOR]

Background Systemic sclerosis (SSc)-overlap syndromes are a very heterogeneous and remarkable subgroup of SSc-patients, who present at least two connective tissue diseases (CTD) at the same time, usually with a specific autoantibody status. Objectives To determine whether patients, classified as overlap syndromes, show a disease course different from patients with limited SSc (lcSSc) or diffuse cutaneous SSc (dcSSc). Methods The data of 3240 prospectively included patients, registered in the database of the German Network for Systemic Scleroderma and followed between 2003 and 2013, were analysed. Results Among 3240 registered patients, 10% were diagnosed as SSc-overlap syndrome. Of these, 82.5% were female. SSc-overlap patients had a mean age of 48 ±1.2 years and carried significantly more often 'other antibodies' (68.0%; p<0.0001), including anti-U1RNP, -PmScl, -Ro, -La, as well as anti-Jo-1 and -Ku antibodies. These patients developed musculoskeletal involvement earlier and more frequently (62.5%) than patients diagnosed as lcSSc (32.2%) or dcSSc (43.3%) (p<0.0001). The onset of lung fibrosis and heart involvement in SSc-overlap patients was significantly earlier than in patients with lcSSc and occurred later than in patients with dcSSc. Oesophagus, kidney and PH progression was similar to lcSSc patients, whereas dcSSc patients had a significantly earlier onset. Conclusions These data support the concept that SSc-overlap syndromes should be regarded as a separate SSc subset, distinct from lcSSc and dcSSc, due to a different progression of the disease, different proportional distribution of specific autoantibodies, and of different organ involvement. [ABSTRACT FROM AUTHOR]

Background: Anemia is a major cause of morbidity in cancer. Erythropoiesis stimulating agents (ESA) are a mainstay of treatment, although some patients lack response for unknown reasons. Recently, ESA dosing recommendations have changed and iron is increasingly used as an adjunct. Due to these changes, potential laboratory predictors of response were re-evaluated. Methods: This was a multi-center, observational study in cancer outpatients developing anemia under standard chemotherapy without absolute iron deficiency. For up to 12 weeks, laboratory data was collected while patients were treated with darbepoetin α (DA) either alone or along with intravenous iron. Baseline erythropoietin (Epo), changes in soluble transferrin receptor (sTfR) and in hemoglobin (Hb) early after treatment initiation were re-evaluated as response predictors, based on logistic regression models. Results: Overall, 279 patients (mean age 66.1 years, 59.5% female) entered the study; 171 (61%) received at least one iron dose along with DA. Response and its predictability hardly increased through adjunct iron, although baseline ferritin <100 mg/L resulted in a 10 times higher probability of response to the combination than to ESA alone. Baseline Epo had low predictive value, regardless of tumor type or use of adjunct iron, although it varied with sex and age. If criteria for all three - Epo, sTfR, and Hb - were met, probability of preventing transfusions was 97%, dropping to 44%, if all three failed. Conclusions: Changes in ESA treatment recommendations had no impact on the predictability of response. Best prediction is still based on the immediacy of Hb increase. [ABSTRACT FROM AUTHOR]

Exposure to radiofrequency (RF) electromagnetic fields (EMF) is continuously increasing worldwide. Yet, conflicting results of a possible genotoxic effect of RF EMF continue to be discussed. In the present study, a possible genotoxic effect of RF EMF (GSM, 1,800 MHz) in human lymphocytes was investigated by a collaboration of six independent institutes (institutes a, b, c, d, e, h). Peripheral blood of 20 healthy, nonsmoking volunteers of two age groups (10 volunteers 16-20 years old and 10 volunteers 50-65 years old) was taken, stimulated and intermittently exposed to three specific absorption rates (SARs) of RF EMF (0.2 W/kg, 2 W/kg, 10 W/kg) and sham for 28 h (institute a). The exposures were performed in a setup with strictly controlled conditions of temperature and dose, and randomly and automatically determined waveguide SARs, which were designed and periodically maintained by ITIS (institute h). Four genotoxicity tests with different end points were conducted (institute a): chromosome aberration test (five types of structural aberrations), micronucleus test, sister chromatid exchange test and the alkaline comet assay (Olive tail moment and % DNA). To demonstrate the validity of the study, positive controls were implemented. The genotoxicity end points were evaluated independently by three laboratories blind to SAR information (institute c = laboratory 1; institute d = laboratory 2; institute e = laboratory 3). Statistical analysis was carried out by institute b. Methods of primary statistical analysis and rules to adjust for multiple testing were specified in a statistical analysis plan based on a data review before unblinding. A linear trend test based on a linear mixed model was used for outcomes of comet assay and exact permutation test for linear trend for all other outcomes. It was ascertained that only outcomes with a significant SAR trend found by at least two of three analyzing laboratories indicated a substantiated suspicion of an exposure effect. On the basis of these specifications, none of the nine end points tested for SAR trend showed a significant and reproducible exposure effect. Highly significant differences between sham exposures and positive controls were detected by each analyzing laboratory, thus validating the study. In conclusion, the results show no evidence of a genotoxic effect induced by RF EMF (GSM, 1,800 MHz). [ABSTRACT FROM AUTHOR]

Background: Thrombotic microangiopathies (TMA) in adults such as thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are life-threatening disorders if untreated. Clinical presentation is highly variable and prognostic factors for clinical course and outcome are not well established. Methods: We performed a retrospective observational study of 62 patients with TMA, 22 males and 40 females aged 16 to 76 years, treated with plasma exchange at one center to identify clinical risk factors for the development of renal insufficiency. Results: On admission, 39 of 62 patients (63%) had acute renal failure (ARF) with 32 patients (52%) requiring dialysis treatment. High systolic arterial pressure (SAP, p = 0.009) or mean arterial pressure (MAP, p = 0.027) on admission was associated with acute renal failure. Patients with SAP>140 mmHg on admission had a sevenfold increased risk of severe kidney disease (OR 7.464, CI 2.097-26.565)> MAP.100 mmHg indicated a fourfold increased risk for acute renal failure (OR 4.261, CI 1.400-12.972). High SAP, diastolic arterial pressure (DAP), and MAP on admission were also independent risk factors for persistent renal insufficiency with the strongest correlation for high MAP. Moreover, a high C-reactive protein (CRP) level on admission correlated with renal failure in the course of the disease (p = 0.003). At discharge, renal function in 11 of 39 patients (28%) had fully recovered, 14 patients (23%) remained on dialysis, and 14 patients (23%) had non-dialysisdependent chronic kidney disease. Seven patients (11%) died. We identified an older age as risk factor for death. Conclusions: High blood pressure as well as high CRP serum levels on admission are associated with renal insufficiency in TMA. High blood pressure on admission is also a strong predictor of sustained renal insufficiency. Thus, adult TMA patients with high blood pressure may require special attention to prevent persistent renal failure. [ABSTRACT FROM AUTHOR]

Background and Aims: This study investigated the long-term clinical course of patients with Schatzki rings, who were treated by single bougie dilation. Furthermore, it analyzed possible predictors for the time of recurrence.Patients and Methods: A total of 133 patients (100 males, 33 females) with a mean age of 57 ± 14.6 years who were treated by single dilation with the use of Maloney bougies without the aid of fluoroscopy were prospectively registered and followed-up for a mean duration of 58.3 months (range 12-240 months). Duration of remission was evaluated by Kaplan-Meier estimates with regard to recurrence. Log-rank test was performed to analyze possible predictors for the time to second dilation (recurrence).Results: No complications occurred and all patients were symptom-free at the first follow-up examination 4 weeks after dilation. However, later on, 73 patients required a second dilation. The estimate remission rates were 63.8% (95% CI: 55.6-72.0%) after 2 years, 44.3% (95% CI: 35.4-53.4%) after 5 years, and 39.9% (95% CI: 30.5-49.3%) after 10 years. Neither the initial morphological findings, nor age or gender determined the need for repeated dilation. Only patients treated with a large bougie diameter (≥52 F) seemed to have a tendency for a longer time until symptomatic recurrence.Conclusions: Single dilation of symptomatic Schatzki rings is a safe and effective therapy. However, more than half of the patients will need a second treatment. Recurrences are unrelated to initial morphological findings, age, or gender. Only the treatment with a large bougie diameter (≥52 F) showed a tendency for a longer time of remission. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to show differences between breast cancer patients ≤35 and >35 years with regard to tumor characteristics and to present the patient-relevant outcomes overall survival (OAS) and recurrence-free survival (RFS). Methods: We analyzed data from 119 women aged 35 years or younger with breast cancer and compared multiple parameters against breast cancer patients between 36 and 55 ( n = 1,097), all pre-menopausal. Data were adjusted for tumor characteristics and therapy. Results: There was no statistically significant difference in tumor size, axillary lymph node involvement, and histological subtypes. On the contrary, grading lymphovascular invasion and receptor negativity showed statistically significant differences. Unadjusted hazard ratio are 2.11 (1.32–3.39) (OAS) and 1.92 (1.35–2.73) (RFS). Multi-adjusted hazard ratio are 2.97 (1.70–5.18) (OAS) and 2.11 (1.42–3.13) (RFS). Conclusions: In conclusion, young breast cancer patients still have a poor prognosis. Even after adjustment of the data, OAS and RFS showed a worse prognosis. Normal prognostic factors like tumor size, axillary lymph node involvement, and grading can therefore be not the explanation for the more aggressive disease progress within early onset breast cancer patients. [ABSTRACT FROM AUTHOR]

J Oral Pathol Med (2010) : 786-792 Vascular endothelial growth factor (VEGF) plays an important role in promoting angiogenesis and is overexpressed in several malignancies. Polymorphisms of the VEGF gene can alter VEGF protein expression, which may be biologically significant and account for heterogeneity in disease risk and outcome. The aim of this case-control study was to evaluate potential associations between single nucleotide polymorphisms (SNP) of the VEGF gene with susceptibility of oral squamous cell carcinoma (OSCC). Five VEGF SNP (−1154 G/A, +405 G/C, +936 C/T, −2578 C/A and −460 C/T) were determined in peripheral blood isolated from 80 patients with OSCC and from 40 age- and gender-matched healthy volunteers (RT-PCR). The +936 T allele and the −2578 C/A SNP were expressed significantly more often in the OSCC-group ( P = 0.002; P < 0.0001) where three associations between two SNPs (+936 and +405, −2578 and −1154, −460 and −2578) were found. Our findings provide support that +936 T allele and −2578 C/A SNP of the VEGF gene alone or in combination with other SNP are associated with OSCC. The SNPs may be used as biomarker for the development of specialized anti-VEGF drugs. Further studies must confirm the value of preoperative genetic analysis for prognosis. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an article by S. Schrodi et al published in the journal.

For nasal application of neurotrophins and mesenchymal stem cells, successful delivery to the brain and therapeutic effects are known from experimental data in animals. Human breast milk contains neurotrophins and stem cells, but gavage tube feeding in preterm infants bypasses the naso-oropharynx. This is a first exploration on additional nasal breast milk and neuromorphological outcome after severe neonatal brain injury. We present a retrospective summary of 31 very low birth weight preterm infants with intraventricular hemorrhage °3/4 from one third-level neonatal center. All were breast milk fed. Sixteen infants additionally received nasal drops of fresh breast milk daily with informed parental consent for at least 28 days. Cerebral ultrasound courses were reviewed by a pediatric radiologist blinded to the intervention. The main outcome measure was severity of porencephalic defects before discharge. Clinical covariates were comparable in both groups. With nasal breast milk, a trend to a lower incidence for severe porencephalic defects (21% vs. 58%) was detected. Incidences were lower for progressive ventricular dilatation (71% vs. 91%) and surgery for posthemorrhagic hydrocephalus (50% vs. 67%).Conclusion: The hypothesis is generated that early intranasal application of breast milk could have a beneficial effect on neurodevelopment in preterm infants. Controlled investigation is needed. What is Known: • Successful delivery to the brain and therapeutic effects are known for nasal application of neurotrophins and mesenchymal stem cells from experimental data in animal studies. • Human breast milk contains neurotrophins and stem cells, but gavage tube feeding in preterm infants bypasses the naso-oropharynx. What is New: • This is the first report on additional nasal breast milk application in very low birth weight preterm infants with severe brain injury observing a trend for less severe porencephalic defects. • The hypothesis is generated that nasal breast milk might exert neuroprotective effects in preterm infants. [ABSTRACT FROM AUTHOR]

Background: Analgosedation is a cornerstone therapy for mechanically ventilated patients in intensive care units (ICU). To avoid inadequate sedation and its complications, monitoring of analgosedation is of great importance. The aim of this study was to investigate whether monitoring of analgosedative drug concentrations (midazolam and sufentanil) might be beneficial to optimize analgosedation and whether drug serum concentrations correlate with the results of subjective (Richmond Agitation-Sedation Scale [RASS]/Ramsay Sedation Scale) and objective (bispectral (BIS) index) monitoring procedures. Methods: Forty-nine intubated, ventilated, and analgosedated critically ill patients treated in ICU were clinically evaluated concerning the depth of sedation using RASS Score, Ramsay Score, and BIS index twice a day. Serum concentrations of midazolam and sufentanil were determined in blood samples drawn at the same time. Clinical and laboratory data were statistically analyzed for correlations using the Spearman’s rank correlation coefficient rho (ρ). Results: Average age of the population was 57.8 ± 16.0 years, 61% of the patients were males. Most frequent causes for ICU treatments were sepsis (22%), pneumonia (22%), or a combination of both (25%). Serum concentrations of midazolam correlated weakly with RASS (ρ = − 0.467) and Ramsay Scores (ρ = 0.476). Serum concentrations of sufentanil correlated weakly with RASS (ρ = − 0.312) and Ramsay Scores (ρ = 0.295). Correlations between BIS index and serum concentrations of midazolam (ρ = − 0.252) and sufentanil (ρ = − 0.166) were low. Conclusion: Correlations between drug serum concentrations and clinical or neurophysiological monitoring procedures were weak. This might be due to intersubject variability, polypharmacy with drug-drug interactions, and complex metabolism, which can be altered in critically ill patients. Therapeutic drug monitoring is not beneficial to determine depth of sedation in ICU patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES The aim of this retrospective study was to assess pre- and intraoperative factors leading to neurological complications and early death following repair of acute type A aortic dissection (ATAAD). METHODS There were 122 patients (85 male, age: 58.6 ± 12.5 years) with ATAAD, treated consecutively from August 2003 to August 2010. Pre- and intraoperative variables were analysed using a logistic regression model in order to identify risk factors for temporary neurological dysfunction (TND) and adverse outcome (AO), defined as stroke and 30-day mortality. RESULTS The 30-day mortality rate was 16.4%. Forty-one patients (33.6%) suffered transient neurological dysfunction and 20 (16.4%) had a postoperative stroke. Mean hypothermic circulatory arrest (HCA) temperature was 24 ± 4°C. Selective cerebral perfusion (SCP) was performed in 99 (82%) patients, with a mean SCP flow rate of 10.3 ml/kg/min. The duration of lower body ischaemia (LBI) was 36 ± 27 min, of HCA 8.7 ± 15.5 min and of SCP 34 ± 28 min, respectively. Male gender [odds ratio (OR): 3.30, 95% confidence interval (CI): 1.15–9.47], diabetes (OR: 3.95, 95% CI: 1.18–13.24), compromised consciousness (OR: 6.65, 95% CI: 1.41–31.48) and manifest arterial atherosclerosis (OR: 6.68, 95% CI: 1.31–34.09) were detected as risk factors for TND, whereas a high body mass index (OR: 1.14, 95% CI: 1.01–1.3), a preoperative malperfusion syndrome (OR: 2.28, 95% CI: 0.84–6.18) and left ventricular ejection fraction <50% (OR: 3.84, 95% CI: 1.41–10.43) were detected as independent predictors for an AO. A dissection entry localized in the aortic arch or the descending aorta independently increased the risk for a postoperative stroke. A prolonged LBI increased the risk for AO (OR: 1.02, 95% CI: 1.00–1.04), whereas femoral cannulation showed a trend to an increased stroke incidence (OR: 4.2, 95% CI: 0.8–21.3). CONCLUSIONS Regardless of standardized neuroprotective techniques, treatment of ATAAD remains a high-risk operation. Preoperatively, the presence of a reduced ejection fraction, a malperfusion syndrome or a high body mass index may increase the perioperative risk for an adverse outcome. A dissection ‘entry’ localized in the aortic arch or the descending aorta may increase the risk for postoperative stroke. Intraoperatively, cannulation of the femoral artery and extension of the LBI time over 45 min should be avoided. Especially in patients with manifest preoperative cerebral and/or end-organ malperfusion, the cannulation modality as well as the entire neuroprotective management should be chosen individually, respecting its limitations. [ABSTRACT FROM PUBLISHER]