Mild hyponatremia has traditionally been considered benign, but it may be associated with gait and attention deficits and an increased risk of falls that may result in fracture. A retrospective study ...was conducted to quantify the association of hyponatremia with fracture occurrence and to examine whether this relationship is independent of osteoporosis.
This study analyzed 1408 consecutive female patients who underwent bone mineral density measurement (Lunar IDXA) between September 1, 2006 and April 11, 2007 and who had available laboratory data. Self reported fracture occurrence was confirmed by radiology report or attendance at a fracture clinic. The significance and independence of the association of hyponatremia with fracture was quantified using logistic regression.
The mean (SD) serum sodium (Na(+)) was 140.6 (3.0) mmol/L; 59 (4.2%) had Na(+) < 135 mmol/L. Forty-five percent of subjects were osteoporotic and 18% had a prior fracture. Hyponatremia was present in 8.7% of those with versus 3.2% of those without a confirmed fracture (P < 0.001). On multivariate logistic regression analysis controlling for age, T-score, chronic kidney disease stage, osteoporotic risk factors (amenorrhea, family history, regular steroid use, smoking history, alcohol use, history of liver disease, and low-calcium diet), and osteoporosis treatments (calcium and vitamin D supplements, antiresorptives, and hormonal replacement therapy), Na(+) < 135 versus Na(+) >or= 135 mmol/L remained significantly and independently associated with fracture occurrence (P < 0.01).
Mild hyponatremia may be a readily identifiable and potentially modifiable risk factor for fracture.
There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, ...and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.
Several lines of evidence point to kidney disease as an important complication of human immunodeficiency virus infection. here, Gupta et al present some guidelines that address the clinical issues ...involved in both adults and children with HIV-related renal diseases and are written for those providing inpatient and outpatient care for theses patients and for the patients themselves.
Immune complex deposits in ANCA-associated crescentic glomerulonephritis: A study of 126 cases.
Necrotizing and crescentic glomerulonephritis related to antineutrophil cytoplasmic autoantibodies ...(ANCA) is typically referred to as “pauci-immune”; however, it is not unusual for renal biopsies in such cases to exhibit some immune complex deposition within glomeruli on immunofluorescence and/or electron microscopic study. The composition and intraglomerular localization of such deposits in ANCA-glomerulonephritis has not been widely studied, and their potential pathologic and clinical significance is not clear, although a possible synergistic effect between immune complexes and ANCA in producing more severe glomerulonephritis is suggested by some human and animal studies.
Electron micrographs from 126 renal biopsies showing necrotizing/crescentic glomerulonephritis characterized by positive ANCA serology C-ANCA, anti-proteinase 3 (anti-PR3), or anti-myeloperoxidase (MPO) or necrotizing arteritis in the absence of known ANCA results were examined for the presence, quantity, and location of electron-dense deposits. The presence or absence of such deposits was correlated with histologic findings (fraction of glomeruli with crescents and segmental necrotizing lesions, mesangial and endocapillary hypercellularity), immunofluorescence findings, and clinical data, including serum creatinine and 24-hour urine protein levels at the time of biopsy.
Sixty-eight (54%) of these biopsies showed glomerular immune complex deposits on electron microscopy; 87% of the latter also showed positive immunofluorescence findings for at least one immunoglobulin or complement component, although staining was relatively mild in most instances (≤2+ on a 0 to 4+ scale in all but eight cases). Nearly half of biopsies negative for deposits by electron microscopy also showed positive immunofluorescence findings, though even more so than in cases with deposits on electron microscopy the intensity of immunofluorescence staining in these biopsies was typically very weak (trace or trace to 1+ in most cases, none >2+). Hypercellularity within the glomerular tuft was seen in 50% of biopsies with deposits on electron microscopy but only 14% of those without deposits; in each group this was usually mild and mesangial. Notably, the presence of deposits on electron microscopy was associated with a higher median level of proteinuria (3.2 versus 1.3g/24hours, P < 0.0001) and a higher median percentage of glomeruli with crescents (62.5% versus 44.0%, P = 0.06).
Immune complex deposits were found on electron microscopy in just over half of renal biopsies with crescentic glomerulonephritis associated with positive ANCA serology and/or necrotizing arteritis. Clinical correlations suggest that these immune complex deposits may somehow potentiate the effect of ANCA in producing glomerulonephritis.
Ivacaftor produces significant clinical benefit in patients with cystic fibrosis (CF) with the G551D mutation. Prevalence of this mutation at the Cork CF Centre is 23%. This study assessed the impact ...of cystic fibrosis transmembrane conductance regulator modulation on multiple modalities of patient assessment.
Thirty-three patients with the G551D mutation were assessed at baseline and prospectively every 3 months for 1 year after initiation of ivacaftor. Change in ultra-low-dose chest CT scans, blood inflammatory mediators, and the sputum microbiome were assessed.
Significant improvements in FEV
, BMI, and sweat chloride levels were observed post-ivacaftor treatment. Improvement in ultra-low-dose CT imaging scores were observed after treatment, with significant mean reductions in total Bhalla score (P < .01), peribronchial thickening (P = .035), and extent of mucous plugging (P < .001). Reductions in circulating inflammatory markers, including interleukin (IL)-1β, IL-6, and IL-8 were demonstrated. There was a 30% reduction in the relative abundance of Pseudomonas species and an increase in the relative abundance of bacteria associated with more stable community structures. Posttreatment community richness increased significantly (P = .03).
Early and sustained improvements on ultra-low-dose CT scores suggest it may be a useful method of evaluating treatment response. It paralleled improvement in symptoms, circulating inflammatory markers, and changes in the lung microbiota.
Attention! A good bedside test for delirium? O'Regan, Niamh A; Ryan, Daniel J; Boland, Eve ...
Journal of neurology, neurosurgery and psychiatry,
10/2014, Letnik:
85, Številka:
10
Journal Article
Recenzirano
Odprti dostop
Routine delirium screening could improve delirium detection, but it remains unclear as to which screening tool is most suitable. We tested the diagnostic accuracy of the following screening methods ...(either individually or in combination) in the detection of delirium: MOTYB (months of the year backwards); SSF (Spatial Span Forwards); evidence of subjective or objective 'confusion'.
We performed a cross-sectional study of general hospital adult inpatients in a large tertiary referral hospital. Screening tests were performed by junior medical trainees. Subsequently, two independent formal delirium assessments were performed: first, the Confusion Assessment Method (CAM) followed by the Delirium Rating Scale-Revised 98 (DRS-R98). DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) criteria were used to assign delirium diagnosis. Sensitivity and specificity ratios with 95% CIs were calculated for each screening method.
265 patients were included. The most precise screening method overall was achieved by simultaneously performing MOTYB and assessing for subjective/objective confusion (sensitivity 93.8%, 95% CI 82.8 to 98.6; specificity 84.7%, 95% CI 79.2 to 89.2). In older patients, MOTYB alone was most accurate, whereas in younger patients, a simultaneous combination of SSF (cut-off 4) with either MOTYB or assessment of subjective/objective confusion was best. In every case, addition of the CAM as a second-line screening step to improve specificity resulted in considerable loss in sensitivity.
Our results suggest that simple attention tests may be useful in delirium screening. MOTYB used alone was the most accurate screening test in older people.
Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. ...Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry.
We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis.
Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management.
Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.
Abstract Context The international cohort of hemodialysis patients is aging and increasing in number. Nephrologists have a therapeutic relationship with their patients that may span decades. Often ...overlooked components of chronic disease management include symptom control and assessment of health-related quality of life (HRQoL). Objectives This study describes the symptom profile of a large cohort of patients with end-stage renal disease on hemodialysis in England and Ireland and evaluates how symptom burden and other factors influence quality-of-life scores. Methods A prospective cross-sectional observational study of hemodialysis patients was conducted in Ireland and England during 2011 and 2012. Two validated clinical tools were used to determine HRQoL and symptom burden. Demographic and clinical data were examined, and regression analysis was used to determine associations with HRQoL scores. Results A total of 893 patients on hemodialysis (mean SD age 64 16 years) had a high symptom burden and poor HRQoL compared with population norms. Specifically, 64% of patients reported pain (95% confidence interval 61%–67%) and 79% reported weakness (95% confidence interval 75%–81%). A total of 43 percent of patients reported between six and 10 symptoms in the week preceding the survey. HRQoL was significantly and independently associated with poor mobility and pain and remained significant after adjusting for variations in clinical characteristics. Being listed on a transplant wait-list register was positively associated with HRQoL. Conclusion These findings illustrate the high symptom burden and poor HRQoL of the hemodialysis population. Emphasis during clinical reviews on pain assessment and on assessing mobility plus interventions, such as pain management and physiotherapy/occupational therapy, are practical ways for renal teams to help improve patients' quality of life.
Arteriovenous fistulae (AVF) have advantages over arteriovenous grafts (AVG) and central venous catheters (CVC), but whether AVF are associated independently with better survival is unclear. Recent ...studies showing such a survival benefit did not include early access experience or account for changes in access type over time and did not include data on some important confounders. Reported here are survival rates stratified by the type of access in use up to 3 yr after initiation of hemodialysis among 616 incident patients who were enrolled in the Choices for Healthy Outcomes in Caring for ESRD (CHOICE) Study. A total of 1084 accesses (185 AVF, 296 AVG, 603 CVC) were used for a total of 1381 person-years. At initiation, 409 (66%) patients were using a CVC, 122 (20%) were using an AVG, and 85 (14%) were using an AVF. After 6 mo, 34% were using a CVC, 40% were using an AVG, and 26% were using an AVF. Annual mortality rates were 11.7% for AVF, 14.2% for AVG, and 16.1% for CVC. Adjusted relative hazards (RH) of death compared with AVF were 1.5 (95% confidence interval, 1.0 to 2.2) for CVC and 1.2 (0.8 to 1.8) for AVG. The increased hazards associated with CVC, as compared with AVF, were stronger in men (n = 334; RH = 2.0; P = 0.01) than women (n = 282; RH = 1.0 for CVC; P = 0.92). These results strongly support existing clinical practice guidelines and suggest that the use of venous catheters should be minimized to reduce the frequency of access complications and to improve patient survival, especially among male hemodialysis patients.
•CFTR modulation with ivacaftor significantly improves clinical outcomes for PWCF.•Only modest changes in overall microbial community composition are observed following one year of ivacaftor ...treatment.•However, there was a shift towards a bacterial ecology associated with less severe CF lung disease with an increased microbial richness and diversity.•Furthermore, a significant correlation was observed between richness and diversity and lower levels of circulating markers of inflammation.
Treatment with Ivacaftor provides a significant clinical benefit in people with cystic fibrosis (PWCF) with the class III G551D-CFTR mutation. This study determined the effect of CFTR modulation with ivacaftor on the lung microbiota in PWCF.
Using both extended-culture and culture-independent molecular methods, we analysed the lower airway microbiota of 14 PWCF, prior to commencing ivacaftor treatment and at the last available visit within the following year. We determined total bacterial and Pseudomonas aeruginosa densities by both culture and qPCR, assessed ecological parameters and community structure and compared these with biomarkers of inflammation and clinical outcomes.
Significant improvement in FEV1, BMI, sweat chloride and levels of circulating inflammatory biomarkers were observed POST-ivacaftor treatment. Extended-culture demonstrated a higher density of strict anaerobic bacteria (p = 0.024), richness (p = 1.59*10−4) and diversity (p = 0.003) POST-treatment. No significant difference in fold change was observed by qPCR for either total bacterial 16S rRNA copy number or P. aeruginosa density for oprL copy number with treatment. Culture-independent (MiSeq) analysis revealed a significant increase in richness (p = 0.03) and a trend towards increased diversity (p = 0.07). Moreover, improvement in lung function, richness and diversity displayed an inverse correlation with the main markers of inflammation (p < 0.05).
Following treatment with ivacaftor, significant improvements in clinical parameters were seen. Despite modest changes in overall microbial community composition, there was a shift towards a bacterial ecology associated with less severe CF lung disease. Furthermore, a significant correlation was observed between richness and diversity and levels of circulating inflammatory markers.
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