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1.
Spine (Phila Pa 1976) ; 46(5): 285-293, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33534439

RESUMO

STUDY DESIGN: Multicenter double-blind randomized sham-controlled trial. OBJECTIVE: To assess the efficacy of radiofrequency (RF) denervation of the cervical facet joints in chronic cervical facet joint pain. SUMMARY OF BACKGROUND DATA: One randomized controlled trial showed efficacy of RF denervation in whiplash-associated disease. There are no randomized controlled trials on RF denervation in patients with chronic cervical facet joint pain. METHODS: Patients were randomized to receive RF denervation combined with bupivacaine (intervention group) or bupivacaine alone (control group). In the intervention group, an RF thermal lesion was made at the cervical medial branches after the injection of bupivacaine. The primary outcome was measured at 6 months and consisted of pain intensity, self-reported treatment effect, improvement on the Neck Disability Index, and the use of pain medication. Duration of effect was determined using telephone interviews. RESULTS: We included 76 patients. In the intervention group, 55.6% showed > 30% pain decrease versus 51.3% in the control group (P = 0.711); 50.0% reported success on the Patients' Global Impression of Change in the intervention group versus 41.0% (P = 0.435); the Neck Disability Index was 15.0 ±â€Š8.7 in the intervention group compared with 16.5 ±â€Š7.2 (P = 0.432), the need for pain medication did not differ significantly between groups (P = 0.461). The median time to end of treatment success for patients in the RF group was 42 months, compared with 12 months in the bupivacaine group (P = 0.014). CONCLUSIONS: We did not observe significant differences between RF denervation combined with injection of local anesthesia compared with local anesthesia only at 6 months follow-up. We found a difference in the long-term effect after 6 months follow-up in favor of the RF treatment.Level of Evidence: 2.

2.
Cancers (Basel) ; 13(4)2021 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-33578746

RESUMO

Glioblastoma (GBM) is the most malignant primary brain tumor for which no curative treatment options exist. Non-invasive qualitative (Visually Accessible Rembrandt Images (VASARI)) and quantitative (radiomics) imaging features to predict prognosis and clinically relevant markers for GBM patients are needed to guide clinicians. A retrospective analysis of GBM patients in two neuro-oncology centers was conducted. The multimodal Cox-regression model to predict overall survival (OS) was developed using clinical features with VASARI and radiomics features in isocitrate dehydrogenase (IDH)-wild type GBM. Predictive models for IDH-mutation, 06-methylguanine-DNA-methyltransferase (MGMT)-methylation and epidermal growth factor receptor (EGFR) amplification using imaging features were developed using machine learning. The performance of the prognostic model improved upon addition of clinical, VASARI and radiomics features, for which the combined model performed best. This could be reproduced after external validation (C-index 0.711 95% CI 0.64-0.78) and used to stratify Kaplan-Meijer curves in two survival groups (p-value < 0.001). The predictive models performed significantly in the external validation for EGFR amplification (area-under-the-curve (AUC) 0.707, 95% CI 0.582-8.25) and MGMT-methylation (AUC 0.667, 95% CI 0.522-0.82) but not for IDH-mutation (AUC 0.695, 95% CI 0.436-0.927). The integrated clinical and imaging prognostic model was shown to be robust and of potential clinical relevance. The prediction of molecular markers showed promising results in the training set but could not be validated after external validation in a clinically relevant manner. Overall, these results show the potential of combining clinical features with imaging features for prognostic and predictive models in GBM, but further optimization and larger prospective studies are warranted.

3.
EClinicalMedicine ; : 100652, 2020 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-33283178

RESUMO

Background: Many studies investigate the role of pharmacological treatments on disease course in Corona Virus Disease 2019 (COVID-19). Sex disparities in genetics, immunological responses, and hormonal mechanisms may underlie the substantially higher fatality rates reported in male COVID-19 patients. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. Therefore, in this scoping review, we investigated whether studies on pharmacological treatment in COVID-19 were performed based on a priori sex-specific design or post-hoc sex-specific analyses. Methods: We systematically searched PubMed, EMBASE, UpToDate, clinical trial.org, and MedRxiv for studies on pharmacological treatment for COVID-19 until June 6th, 2020. We included case series, randomized controlled trials, and observational studies in humans (≥18 years) investigating antiviral, antimalarial, and immune system modulating drugs. Data were collected on 1) the proportion of included females, 2) whether sex stratification was performed (a priori by design or post-hoc), and 3) whether effect modification by sex was investigated. Findings: 30 studies were eligible for inclusion, investigating remdesivir (n = 2), lopinavir/ritonavir (n = 5), favipiravir (n = 1), umifenovir (n = 1), hydroxychloroquine/chloroquine (n = 8), convalescent plasma (n = 6), interleukin-6 (IL-6) pathway inhibitors (n = 5), interleukin-1 (IL-1) pathway inhibitors (n = 1) and corticosteroids (n = 3). Only one study stratified its data based on sex in a post-hoc analysis, whereas none did a priori by design. None of the studies investigated effect modification by sex. A quarter of the studies included twice as many males as females. Interpretation: Analyses assessing potential interference of sex with (side-)effects of pharmacological therapy for COVID-19 are rarely reported. Considering sex differences in case-fatality rates and genetic, immunological, and hormonal mechanisms, studies should include sex-specific analyses in their design to optimise COVID-19 care. Funding: None.

4.
PLoS One ; 15(12): e0242603, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33259508

RESUMO

BACKGROUND: Providing high quality care is important and has gained more attention since the introduction of value-based healthcare. Value should be measured by outcomes achieved, relevant for patients. Patient-centeredness is one domain for quality improvement determined by the Institute of Medicine, aiming to deliver care responsive to the patient. The development and implementation of patient reported outcome- and experience measures can be used for this goal. Recently, we developed the Patient Reported Measure (PRM)-acute care, based on five relevant domains to evaluate and improve the quality of care in the Emergency Department (ED). OBJECTIVE: To validate the PRM-acute care, in order to evaluate and improve patient-centered care in the ED. METHODS: We performed a prospective questionnaire-based study. Patients ≥18 years presenting for internal medicine in the ED were eligible. The validity of the PRM-acute care was evaluated according to the COSMIN-criteria. We performed hypotheses testing to evaluate construct validity. The perceived quality of care was evaluated by statistical analysis. RESULTS: Face- and content validity was evaluated based on previously performed research and deemed good. Construct validity was supported by demonstrated differences between subgroups; patients with severe symptoms had a higher perceived quality of care. The correlation between overall satisfaction and the total mean score of the PRM-acute care (r = 0,447, p = 0.01) was significant. Overall, patients reported a mean perceived quality of care of 4.67/6.0. CONCLUSION: The PRM-acute care is a valid instrument to measure the perceived quality of care in an acute setting for internal medicine patients. Additionally, patients reported a good perceived quality of care in the ED with scores ranging from moderate to well for each of the relevant domains. Therefore, we believe that the PRM-acute care can be implemented in daily practice to evaluate the perceived quality of care and to improve the quality of acute care.

5.
Neuromodulation ; 2020 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-33340192

RESUMO

OBJECTIVES: Dorsal root ganglion stimulation (DRGS) is a promising neurostimulation modality in the treatment of painful polyneuropathy. The aim of this prospective pilot study was to investigate the effect of DRGS on pain intensity in patients with intractable painful polyneuropathy. MATERIALS AND METHODS: Nine patients with chronic, intractable painful polyneuropathy in the lower limbs were recruited. In each subject, between two and four DRGS leads were placed at the level of the L5 and S1 dorsal root ganglion. If trial stimulation was successful, a definitive implantable pulse generator (IPG) was implanted. Pain intensity was scored using an 11-point numeric rating scale (NRS) and reported as median and interquartile range (IQR), and compared to baseline values using the Wilcoxon signed-rank test. Additionally, patients' global impression of change (PGIC), pain extent, presence of neuropathic pain, physical functioning, quality of life, and mood were assessed. RESULTS: Eight out of nine patients had a successful trial phase, of which seven received an IPG. Daytime pain decreased from a median (IQR) NRS score of 7.0 (5.9-8.3) to 2.0 (1.0-3.5) and 3.0 (1.6-4.9) in the first week and at six months after implantation, respectively. Similar effects were observed for night time and peak pain scores. CONCLUSIONS: The results of this study suggest that DRGS significantly reduces both pain intensity and PGIC in patients with intractable painful polyneuropathy in the lower extremities. Large-scale clinical trials are needed to prove the efficacy of DRGS in intractable painful polyneuropathy.

6.
Eur J Surg Oncol ; 2020 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-33349525

RESUMO

BACKGROUND: Regional recurrence (RR), also known as lymph node recurrence, is an endpoint in several trials concerning reducing axillary treatment in cT1-2N0 breast cancer patients. The risk of RR may decrease with each subsequent event-free year, affecting the yield and consequently usefulness of long (er) follow-up. The aim of this study is to determine the risk of RR as a first event within five years after diagnosis in subtypes of breast cancer, conditional to being event-free for one, two, three and four years. METHODS: From the Netherlands Cancer Registry, cT1-2N0 breast cancer patients diagnosed from 2005 to 2008 were analyzed. Subgroup analysis was performed for pT1-2N+(sn) patients. RR risk was calculated with Kaplan-Meier analysis. Conditional RR (assuming x event-free years) was determined by selecting patients without an event at x years, and calculating the remaining risk for RR within five years after diagnosis. RESULTS: A total of 18,009 cT1-2N0 (all pN stages) breast cancer patients were included. RR occurred in 1.3% of cT1-2N0 and 1.5% of pT1-2N+(sn) patients. The risk of RR varied between subtypes; it was highest for triple negative tumors and lowest for ER + PR + Her2-and ER + Her2+ tumors. After event-free years, the risk of RR decreased subsequently in both groups and in all subtypes. After two event-free years, the risk of RR was 0.8%. CONCLUSION: The absolute yield of follow-up to detect RR beyond two years is low; for every 125 event-free patients, one RR can be expected until five years. This suggests that follow-up longer than two years is of limited value for detecting RR in both clinical and research setting.

7.
Plast Reconstr Surg ; 2020 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-33165291

RESUMO

BACKGROUND: The LTP flap, based on the tissue of the upper lateral thigh, is an excellent option for autologous breast reconstruction. The aim of this study was to introduce the technique to perform a nerve coaptation in LTP flap breast reconstruction and to analyze our results by comparing the sensory recovery of the reconstructed breast and donor site between innervated and noninnervated LTP flaps. METHODS: A prospective cohort study was conducted of patients who underwent an innervated or noninnervated LTP flap breast reconstruction between December 2014 and August 2018. Direct nerve coaptation was performed between a branch of the lateral femoral cutaneous nerve and the anterior cutaneous branch of the intercostal nerve. Sensory testing was done with Semmes-Weinstein monofilaments to assess the sensation of the native skin, flap skin and donor site during follow-up. RESULTS: In total, 24 patients with 37 innervated LTP flaps and 18 patients with 26 noninnervated LTP flaps were analyzed (median follow-up 17 and 15 months). Significantly lower mean monofilament values were found for the native skin (adjusted difference -0.83; p=0.011) and flap skin (adjusted difference -1.11; p<0.001) of the reconstructed breast in innervated compared to noninnervated flaps. For the donor site, no statistically significant differences were found between both groups. CONCLUSIONS: Nerve coaptation in LTP flap breast reconstruction resulted in a significantly better sensory recovery of the reconstructed breast compared to noninnervated flaps. The data also suggests that harvesting a sensory nerve branch does not compromise the sensory recovery of the upper lateral thigh.

8.
J Crit Care ; 62: 38-45, 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33246196

RESUMO

BACKGROUND: The majority of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are admitted to the Intensive Care Unit (ICU) for mechanical ventilation. The role of multi-organ failure during ICU admission as driver for outcome remains to be investigated yet. DESIGN AND SETTING: Prospective cohort of mechanically ventilated critically ill with SARS-CoV-2 infection. PARTICIPANTS AND METHODS: 94 participants of the MaastrICCht cohort (21% women) had a median length of stay of 16 days (maximum of 77). After division into survivors (n = 59) and non-survivors (n = 35), we analysed 1555 serial SOFA scores using linear mixed-effects models. RESULTS: Survivors improved one SOFA score point more per 5 days (95% CI: 4-8) than non-survivors. Adjustment for age, sex, and chronic lung, renal and liver disease, body-mass index, diabetes mellitus, cardiovascular risk factors, and Acute Physiology and Chronic Health Evaluation II score did not change this result. This association was stronger for women than men (P-interaction = 0.043). CONCLUSIONS: The decrease in SOFA score associated with survival suggests multi-organ failure involvement during mechanical ventilation in patients with SARS-CoV-2. Surviving women appeared to improve faster than surviving men. Serial SOFA scores may unravel an unfavourable trajectory and guide decisions in mechanically ventilated patients with SARS-CoV-2.

9.
TH Open ; 4(4): e365-e375, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33235946

RESUMO

Objective Severe cases of coronavirus disease 2019 (COVID-19) can require continuous renal replacement therapy (CRRT) and/or extracorporeal membrane oxygenation (ECMO). Unfractionated heparin (UFH) to prevent circuit clotting is mandatory but monitoring is complicated by (pseudo)-heparin resistance. In this observational study, we compared two different activated partial thromboplastin time (aPTT) assays and a chromogenic anti-Xa assay in COVID-19 patients on CRRT or ECMO in relation to their UFH dosages and acute phase reactants. Materials and Methods The aPTT (optical [aPTT-CS] and/or mechanical [aPTT-STA] clot detection methods were used), anti-Xa, factor VIII (FVIII), antithrombin III (ATIII), and fibrinogen were measured in 342 samples from 7 COVID-19 patients on CRRT or ECMO during their UFH treatment. Dosage of UFH was primarily based on the aPTT-CS with a heparin therapeutic range (HTR) of 50-80s. Associations between different variables were made using linear regression and Bland-Altman analysis. Results Dosage of UFH was above 35,000IU/24 hours in all patients. aPTT-CS and aPTT-STA were predominantly within the HTR. Anti-Xa was predominantly above the HTR (0.3-0.7 IU/mL) and ATIII concentration was >70% for all patients; mean FVIII and fibrinogen were 606% and 7.5 g/L, respectively. aPTT-CS correlated with aPTT-STA ( r 2 = 0.68) with a bias of 39.3%. Correlation between aPTT and anti-Xa was better for aPTT-CS (0.78 ≤ r 2 ≤ 0.94) than for aPTT-STA (0.34 ≤ r 2 ≤ 0.81). There was no general correlation between the aPTT-CS and ATIII, FVIII, fibrinogen, thrombocytes, C-reactive protein, or ferritin. Conclusion All included COVID-19 patients on CRRT or ECMO conformed to the definition of heparin resistance. A patient-specific association was found between aPTT and anti-Xa. This association could not be explained by FVIII or fibrinogen.

10.
Contemp Clin Trials ; 99: 106177, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33080380

RESUMO

BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.

11.
JMIR Med Educ ; 6(2): e17030, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33001034

RESUMO

BACKGROUND: Several publications on research into eHealth demonstrate promising results. Prior researchers indicated that the current generation of doctors is not trained to take advantage of eHealth in clinical practice. Therefore, training and education for everyone using eHealth are key factors to its successful implementation. We set out to review whether medical students feel prepared to take advantage of eHealth innovations in medicine. OBJECTIVE: Our objective was to evaluate whether medical students desire a dedicated eHealth curriculum during their medical studies. METHODS: A questionnaire assessing current education, the need for education about eHealth topics, and the didactical forms for teaching these topics was developed. Questionnaire items were scored on a scale from 1 (fully disagree with a topic) to 10 (fully agree with a topic). This questionnaire was distributed among 1468 medical students of Maastricht University in the Netherlands. R version 3.5.0 (The R Foundation) was used for all statistical procedures. RESULTS: A total of 303 students out of 1468, representing a response rate of 20.64%, replied to our questionnaire. The aggregate statement "I feel prepared to take advantage of the technological developments within the medical field" was scored at a mean value of 4.8 out of 10. Mean scores regarding the need for education about eHealth topics ranged from 6.4 to 7.3. Medical students did not favor creating their own health apps or mobile apps; the mean score was 4.9 for this topic. The most popular didactical option, with a mean score 7.2, was to remotely follow a real-life patient under the supervision of a doctor. CONCLUSIONS: To the best of our knowledge, this is the largest evaluation of students' opinions on eHealth training in a medical undergraduate curriculum. We found that medical students have positives attitudes toward incorporating eHealth into the medical curriculum.

12.
Invest Radiol ; 55(10): 666-672, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32898357

RESUMO

OBJECTIVES: The aim of the study was to reach homogeneous enhancement of the liver, irrespective of total body weight (TBW) or tube voltage. An easy-to-use rule of thumb, the 10-to-10 rule, which pairs a 10 kV reduction in tube voltage with a 10% decrease in contrast media (CM) dose, was evaluated. MATERIALS AND METHODS: A total of 256 patients scheduled for an abdominal CT in portal venous phase were randomly allocated to 1 of 4 groups. In group 1 (n = 64), a tube voltage of 120 kV and a TBW-adapted CM injection protocol was used: 0.521 g I/kg. In group 2 (n = 63), tube voltage was 90 kV and the TBW-adapted CM dosing factor remained 0.521 g I/kg. In group 3 (n = 63), tube voltage was reduced by 20 kV and CM dosing factor by 20% compared with group 1, in line with the 10-to-10 rule (100 kV; 0.417 g I/kg). In group 4 (n = 66), tube voltage was decreased by 30 kV paired with a 30% decrease in CM dosing factor compared with group 1, in line with the 10-to-10 rule (90 kV; 0.365 g I/kg). Objective image quality was evaluated by measuring attenuation in Hounsfield units (HU), signal-to-noise ratio, and contrast-to-noise ratio in the liver. Overall subjective image quality was assessed by 2 experienced readers by using a 5-point Likert scale. Two-sided P values below 0.05 were considered significant. RESULTS: Mean attenuation values in groups 1, 3, and 4 were comparable (118.2 ± 10.0, 117.6 ± 13.9, 117.3 ± 21.6 HU, respectively), whereas attenuation in group 2 (141.0 ± 18.2 HU) was significantly higher than all other groups (P < 0.01). No significant difference in attenuation was found between weight categories 80 kg or less and greater than 80 kg within the 4 groups (P ≥ 0.371). No significant differences in subjective image quality were found (P = 0.180). CONCLUSIONS: The proposed 10-to-10 rule is an easily reproducible method resulting in similar enhancement in portal venous CT of the liver throughout the patient population, irrespective of TBW or tube voltage.

13.
J Community Genet ; 2020 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-32880035

RESUMO

Individuals having a genetic predisposition to cancer and their partners face challenging decisions regarding their wish to have children. This study aimed to determine the effects of an online decision aid to support couples in making an informed decision regarding their reproductive options. A nationwide pretest-posttest study was conducted in the Netherlands among 131 participants between November 2016 and May 2018. Couples were eligible for participation if one partner had a pathogenic variant predisposing for an autosomal dominant hereditary cancer syndrome. Participants completed a questionnaire before use (T0), and at 3 months (T3) after use of the decision aid to assess the primary outcome measure informed decision-making, and the secondary outcome measures decisional conflict, knowledge, realistic expectations, level of deliberation, and decision self-efficacy. T0-T3 comparisons show an overall positive effect for all outcome measures (all ps < 0.05; knowledge (ES = - 1.05), decisional conflict (ES = 0.99), participants' decision self-efficacy (ES = -0.55), level of deliberation (ES = - 0.50), and realistic expectations (ES = - 0.44). Informed decision-making increased over time and 58.0% of the participants made an informed reproductive decision at T3. The online decision aid seems to be an appropriate tool to complement standard reproductive counseling to support our target group in making an informed reproductive decision. Use of the decision aid may lessen the negative psychological impact of decision-making on couples' daily life and wellbeing.

14.
Cancers (Basel) ; 12(9)2020 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-32971946

RESUMO

Adrenocortical carcinoma (ACC) has an incidence of about 1.0 per million per year. In general, survival of patients with ACC is limited. Predicting survival outcome at time of diagnosis is a clinical challenge. The aim of this study was to develop and internally validate a clinical prediction model for ACC-specific mortality. Data for this retrospective cohort study were obtained from the nine centers of the Dutch Adrenal Network (DAN). Patients who presented with ACC between 1 January 2004 and 31 October 2013 were included. We used multivariable Cox proportional hazards regression to compute the coefficients for the prediction model. Backward stepwise elimination was performed to derive a more parsimonious model. The performance of the initial prediction model was quantified by measures of model fit, discriminative ability, and calibration. We undertook an internal validation step to counteract the possible overfitting of our model. A total of 160 patients were included in the cohort. The median survival time was 35 months, and interquartile range (IQR) 50.7 months. The multivariable modeling yielded a prediction model that included age, modified European Network for the Study of Adrenal Tumors (mENSAT) stage, and radical resection. The c-statistic was 0.77 (95% Confidence Interval: 0.72, 0.81), indicating good predictive performance. We developed a clinical prediction model for ACC-specific mortality. ACC mortality can be estimated using a relatively simple clinical prediction model with good discriminative ability and calibration.

15.
J Am Heart Assoc ; 9(19): e015043, 2020 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-32924785

RESUMO

Background During uncomplicated pregnancy, left ventricular remodeling occurs in an eccentric way. In contrast, during preeclamptic gestation, the left ventricle hypertrophies concentrically, concurrent with loss in circulatory volume and increased blood pressure. Concentric cardiac structure persists in a substantial proportion of women and may be associated with pressure and volume load after preeclampsia. We hypothesize that low volume load, as indicated by plasma volume (PV) after preeclampsia and increased pressure load, is associated with remote concentric remodeling. Methods and Results In this longitudinal cohort study, we included 100 formerly preeclamptic women. Two visits were performed: at 0.8 years postpartum and at 4.8 years postpartum. During visit 1, we measured blood pressure and PV (I125 dilution technique, low PV ≤48 mL/kg lean body mass). During the second visit, we assessed cardiac geometry by cardiac ultrasound. Concentric remodeling was defined as relative wall thickness >0.42 and left ventricular mass index ≤95 g/m2. We adjusted multivariable analysis for primiparity, systolic blood pressure, PV mL/kg lean body mass, and antihypertensive medication at visit 1. Low PV is associated with remote concentric remodeling (odds ratio [OR], 4.37; 95% CI, 1.06-17.40; and adjusted OR, 4.67; 95% CI, 1.02-21.42). Arterial pressure load (systolic, diastolic, and mean arterial pressure) is also associated with development of concentric remodeling (OR, 1.15 [95% CI, 0.99-1.35]; OR, 1.24 [95% CI, 0.98-1.58]; and OR, 1.20 [95% CI, 0.98-1.47], respectively). Conclusions In former preeclamptic women, development toward left ventricular concentric remodeling is associated with low volume load and increased pressure load.

16.
Artigo em Inglês | MEDLINE | ID: mdl-32916262

RESUMO

CONTEXT: Certain treatments are potentially inappropriate when administered to nursing homes residents at the end of life and should be carefully considered. An international comparison of potentially inappropriate treatments allows insight into common issues and country-specific challenges of end-of-life care in nursing homes and helps direct health-care policy in this area. OBJECTIVES: To estimate the prevalence of potentially inappropriate treatments in the last week of life in nursing home residents and analyze the differences in prevalence between countries. METHODS: A cross-sectional study of deceased residents in nursing homes (2015) in six European countries: Belgium (Flanders), England, Finland, Italy, The Netherlands, and Poland. Potentially inappropriate treatments included enteral administration of nutrition, parental administration of nutrition, artificial fluids, resuscitation, artificial ventilation, blood transfusion, chemotherapy/radiotherapy, dialysis, surgery, antibiotics, statins, antidiabetics, new oral anticoagulants. Nurses were questioned about whether these treatments were administered in the last week of life. RESULTS: We included 1384 deceased residents from 322 nursing homes. In most countries, potentially inappropriate treatments were rarely used, with a maximum of 18.3% of residents receiving at least one treatment in Poland. Exceptions were antibiotics in all countries (between 11.3% in Belgium and 45% in Poland), artificial nutrition and hydration in Poland (54.3%) and Italy (41%) and antidiabetics in Poland (19.7%). CONCLUSION: Although the prevalence of potentially inappropriate treatments in the last week of life was generally low, antibiotics were frequently prescribed in all countries. In Poland and Italy, the prevalence of artificial administration of food/fluids in the last week of life was high, possibly reflecting country differences in legislation, care organization and culture, and the palliative care competences of staff.

17.
Cardiovasc Diabetol ; 19(1): 129, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32807203

RESUMO

BACKGROUND: Pericardial fat (PF) has been suggested to directly act on cardiomyocytes, leading to diastolic dysfunction. The aim of this study was to investigate whether a higher PF volume is associated with a lower diastolic function in healthy subjects. METHODS: 254 adults (40-70 years, BMI 18-35 kg/m2, normal left ventricular ejection fraction), with (a)typical chest pain (otherwise healthy) from the cardiology outpatient clinic were retrospectively included in this study. All patients underwent a coronary computed tomographic angiography for the measurement of pericardial fat volume, as well as a transthoracic echocardiography for the assessment of diastolic function parameters. To assess the independent association of PF and diastolic function parameters, multivariable linear regression analysis was performed. To maximize differences in PF volume, the group was divided in low (lowest quartile of both sexes) and high (highest quartile of both sexes) PF volume. Multivariable binary logistic analysis was used to study the associations within the groups between PF and diastolic function, adjusted for age, BMI, and sex. RESULTS: Significant associations for all four diastolic parameters with the PF volume were found after adjusting for BMI, age, and sex. In addition, subjects with high pericardial fat had a reduced left atrial volume index (p = 0.02), lower E/e (p < 0.01) and E/A (p = 0.01), reduced e' lateral (p < 0.01), reduced e' septal p = 0.03), compared to subjects with low pericardial fat. CONCLUSION: These findings confirm that pericardial fat volume, even in healthy subjects with normal cardiac function, is associated with diastolic function. Our results suggest that the mechanical effects of PF may limit the distensibility of the heart and thereby directly contribute to diastolic dysfunction. Trial registration NCT01671930.

18.
Clin Transl Gastroenterol ; 11(7): e00209, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32764210

RESUMO

INTRODUCTION: Gastrointestinal symptoms in irritable bowel syndrome (IBS) have been correlated with psychological factors using retrospective symptom assessment. However, real-time symptom assessment might reveal the interplay between abdominal and affective symptoms more reliably in a longitudinal perspective. The aim was to evaluate the association between stress and abdominal pain, using the Experience Sampling Method (ESM) as a real-time, repeated measurement method. METHODS: Thirty-seven patients with IBS (26 women; mean age 36.7 years) and 36 healthy controls (HC; 24 women; mean age 31.1 years) completed an electronic ESM during 7 consecutive days. Abdominal pain and stress were scored on an 11-point Numeric Rating Scale at a maximum of 10 random moments each day. RESULTS: Abdominal pain scores were 2.21 points higher in patients with IBS compared with those in HC (P < 0.001), whereas stress levels did not differ significantly (B: 0.250, P = 0.406). In IBS, a 1-point increase in stress was associated with, on average, 0.10 points increase in abdominal pain (P = 0.017). In HC, this was only 0.02 (P = 0.002). Stress levels at t = -1 were not a significant predictor for abdominal pain at t = 0 in both groups, and vice versa. DISCUSSION: Our results demonstrate a positive association between real-time stress and abdominal pain scores and indicate a difference in response to stress and not a difference in experienced stress per se. Furthermore, an in-the-moment rather than a longitudinal association is suggested. This study underlines the importance of considering the individual flow of daily life and supports the use of real-time measurement when interpreting potential influencers of abdominal symptoms in IBS.

19.
Breast Cancer Res Treat ; 184(1): 173-183, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32767202

RESUMO

PURPOSE: Lymphedema is a debilitating condition that significantly affects patient's quality of life (QoL). The aim of this study was to assess the long-term outcomes after lymphaticovenous anastomosis (LVA) for extremity lymphedema. METHODS: A single-center prospective study on upper and lower extremity lymphedema patients was performed. All LVA procedures were preceded by outpatient Indocyanine Green (ICG) lymphography. Quality of life measured by the Lymph-ICF was the primary outcome. Limb circumference, use of compression garments, and frequency of cellulitis episodes and manual lymphatic drainage (MLD) sessions were secondary outcomes. RESULTS: One hundred consecutive patients, predominantly experiencing upper extremity lymphedema following breast cancer (n = 85), underwent a total of 132 LVAs. During a mean follow-up of 25 months, mean Lymph-ICF score significantly decreased from 43.9 preoperative to 30.6 postoperative, representing significant QoL improvement. Decrease in upper and lower limb circumference was observed in 52% of patients with a mean decrease of 6%. Overall mean circumference was not significantly different. Percentage of patients that could reduce compression garments in the upper and lower extremity group was 65% and 40%, respectively. Number of cellulitis episodes per year and MLD sessions per week showed a mean decrease of respectively 0.6 and 0.8 in the upper extremity and 0.4 and 1.0 in the lower extremity group. CONCLUSIONS: LVA resulted in significant QoL improvement in upper and lower extremity lymphedema patients. Limb circumference did not significantly improve but good results concerning compression garments, cellulitis episodes, and MLD sessions were obtained. Additionally, a simple and patient-friendly method for outpatient ICG lymphography is presented.

20.
BMC Cancer ; 20(1): 735, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32767988

RESUMO

BACKGROUND: Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections. METHODS: This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits. DISCUSSION: To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage. TRIAL REGISTRATION: This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .

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