Patients receiving cancer treatment who had an intermediate-to-high risk of venous thromboembolism were randomly assigned to apixaban or placebo for 6 months. VTE was noted in 4.2% of patients ...receiving apixaban and 10.2% of those receiving placebo, a significant difference. Major bleeding occurred in 3.5% of patients with apixaban and in 1.8% with placebo.
OBJECTIVE:Delirium is common during critical illness and associated with adverse outcomes. We compared characteristics and outcomes of delirious and nondelirious patients enrolled in a multicenter ...trial comparing protocolized sedation with protocolized sedation plus daily sedation interruption.
DESIGN:Randomized trial.
SETTING:Sixteen North American medical and surgical ICUs.
PATIENTS:Four hundred thirty critically ill, mechanically ventilated adults.
INTERVENTIONS:All patients had hourly titration of opioid and benzodiazepine infusions using a validated sedation scale. For patients in the interruption group, infusions were resumed, if indicated, at half of previous doses. Delirium screening occurred daily; positive screening was defined as an Intensive Care Delirium Screening Checklist score of 4 or more at any time.
MEASUREMENTS AND MAIN RESULTS:Delirium was diagnosed in 226 of 420 assessed patients (53.8%). Coma was identified in 32.7% of delirious compared with 22.7% of nondelirious patients (p = 0.03). The median time to onset of delirium was 3.5 days (interquartile range, 2–7), and the median duration of delirium was 2 days (interquartile range, 1–4). Delirious patients were more likely to be male (61.1% vs 46.6%; p = 0.005), have a surgical/trauma diagnosis (21.2% vs 11.0%; p = 0.030), and history of tobacco (31.5% vs 16.2%; p = 0.002) or alcohol use (34.6% vs 20.9%; p = 0.009). Patients with positive delirium screening had longer duration of ventilation (13 vs 7 d; p < 0.001), ICU stay (12 vs 8 d; p < 0.0001), and hospital stay (24 vs 15 d; p < 0.0001). Delirious patients were more likely to be physically restrained (86.3% vs 76.7%; p = 0.014) and undergo tracheostomy (34.6% vs 15.5%; p < 0.0001). Antecedent factors independently associated with delirium onset were restraint use (hazard ratio, 1.87; 95% CI, 1.33–2.63; p = 0.0003), antipsychotic administration (hazard ratio, 1.67; 95% CI, 1.005–2.767; p = 0.047), and midazolam dose (hazard ratio, 0.998; 95% CI, 0.997–1.0; p = 0.049). There was no difference in delirium prevalence or duration between the interruption and control groups.
CONCLUSION:In mechanically ventilated adults, delirium was common and associated with longer duration of ventilation and hospitalization. Physical restraint was most strongly associated with delirium.
We summarize published data on associations between cavernous neurovascular bundle preservation (nerve sparing) during prostatectomy and positive surgical margins, erectile function, urinary function ...and other patient reported outcomes.
A systematic literature search of MEDLINE®, Embase® and Cochrane Reviews databases was performed for interventional or observational studies published between 2000 and 2014. English language articles that compared clinical outcomes of patients undergoing nerve sparing and nonnerve sparing radical prostatectomy were included. Meta-analyses were performed to calculate pooled relative risk estimates for positive surgical margins, erectile dysfunction and urinary incontinence in nerve sparing and nonnerve sparing groups. Sensitivity analyses compared outcomes among unilateral and bilateral nerve sparing vs nonnerve sparing groups.
Of the 1,883 articles identified, 124 studies (73,448 patients) were included in the analysis. Nerve sparing did not increase the risk of positive surgical margins in patients with pT2 (RR 0.92, 95% CI 0.75–1.13) or pT3 disease (RR 0.83, 95% CI 0.71–0.96), potentially due to appropriate patient selection. The risk of incontinence was lower in nerve sparing cases (RR 0.75, 95% CI 0.65–0.85 and RR 0.61, 95% CI 0.44–0.84) at 3 and 12 months, respectively. The relative risk of erectile dysfunction with nerve sparing was 0.77 (95% CI 0.70–0.85) at 3 months and 0.53 (95% CI 0.39–0.71) at 12 months. Subgroup analyses of unilateral and bilateral nerve sparing approaches demonstrated similar results.
Among cohort studies nerve sparing was not associated with worse cancer outcomes. Nerve sparing is associated with better urinary and erectile function. These results should be interpreted with caution given the potential for selection bias and unadjusted confounding factors.
Reversible cerebral vasoconstriction syndrome (RCVS) is a syndrome of recurrent thunderclap headaches and reversible vasoconstriction of the cerebral arteries on neuroimaging within 3 months of ...onset. Initial non-contrast computed tomography (CT) can reveal abnormalities such as ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage (SAH) can be present in patients with RCVS and may delay diagnosis.
We conducted a systematic review and meta-analysis in accordance with the PRISMA guidelines. We aimed to estimate the prevalence of imaging abnormalities on initial non-contrast CT head in adult patients with RCVS.
We searched electronic databases including MEDLINE, EMBASE, and the Cochrane Register of Clinical Trials from inception to August 2, 2022. Eligible studies included articles reporting the prevalence of non-contrast CT abnormalities on initial neuroimaging in patients with RCVS, aged 18 and older. Case series, observational studies and clinical trials were included. Data was extracted directly from included papers using a standardized data charting form.
The search yielded 722 titles with duplicates removed. Twenty studies that included 379 patients with RCVS met inclusion criteria. We classified non-contrast CT abnormalities as either ischemic stroke, ICH, or SAH. We pooled prevalence data using a random effects model with the inverse-variance weighted method. The most common imaging finding was SAH with a pooled prevalence of 24% (95% CI:17%-33%), followed by ICH at 14% (95% CI:8%-22%), and ischemic stroke at 10% (95% CI:7%-14%). The pooled prevalence of any of these imaging abnormalities on initial non-contrast CT was 31% (95% CI:23%-40%). Risk of bias was moderate to very-high-risk for case-series and low-risk for observational studies.
Our review demonstrates that one-third of patients with RCVS will have an abnormality on initial non-contrast CT head, including either an ischemic stroke, ICH, or SAH. These findings highlight the diagnostic challenges of RCVS imaging and contribute to our understanding of this disease.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Venous thromboembolic disease (VTE) is a common complication among patients with cancer. Data reporting risk of VTE among patients receiving chemotherapy for recurrent cancer compared to those with ...newly diagnosed tumors is scarce. Furthermore, it is unclear if thromboprophylaxis is beneficial and safe in these specific patient populations. Post-hoc analysis of the AVERT trial which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The HRs for recurrent VTE and major bleeding episodes in patients with newly diagnosed and recurrent cancers were calculated using a Cox regression model controlling for age, gender, and center. Of the 563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively. Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR 0.45; 95% CI 0.27–0.76; p = 0.002) and a higher rate of major bleeding (HR 2.10; 95% CI 1.09–4.08; p = 0.028). In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR 0.26; 95% CI 0.13–0.53; p < 0.001) without an associated significantly increased risk of major bleeding (HR 1.82; 95% CI 0.36–9.15; p = 0.466). Patients with recurrent cancer seem to be at higher risk of recurrent VTE and major bleeding complications compared to those with newly diagnosed tumors. Apixaban appears to be safe and effective in these patient populations.
Summary Background Placenta-mediated pregnancy complications include pre-eclampsia, late pregnancy loss, placental abruption, and birth of a small-for-gestational-age (SGA) neonate. These ...complications are leading causes of maternal, fetal, and neonatal morbidity and mortality in high-income countries. Affected women are at high risk of recurrence in subsequent pregnancies; however, effective strategies to prevent recurrence are absent. Findings from our previous study-level meta-analysis suggested that low-molecular-weight heparin reduced the risk of recurrent placenta-mediated pregnancy complications. However, we identified significant heterogeneity in the results, possibly due to trial design or inclusion criteria. To identify which patients benefit from, and which outcomes are prevented by, low-molecular-weight heparin, we did an individual patient data meta-analysis. Methods We did a systematic review in May, 2013, which identified eight eligible randomised trials done between 2000 and 2013 of low-molecular-weight heparin to prevent recurrent placenta-mediated pregnancy complications. We excluded studies on the basis of the wrong population, the study being ongoing, inability to confirm eligibility of participants, intervention stopped too early, and no response from the principal investigator. We requested individual patient data from the study authors for eligible women (women pregnant at the time of the study with a history of previous pregnancy that had been complicated by one or more of the following: pre-eclampsia, placental abruption, birth of an SGA neonate <10th percentile, pregnancy loss after 16 weeks' gestation, or two losses after 12 weeks' gestation) and recoded, combined, and analysed the data for our meta-analysis. The primary outcome was a composite of early-onset (<34 weeks) or severe pre-eclampsia, birth of an SGA neonate (<5th percentile), late pregnancy loss (≥20 weeks' gestation), or placental abruption leading to delivery, assessed on an intention-to-treat basis. We assessed risk of bias with the Cochrane Risk of Bias tool. This study is registered with PROSPERO, number CRD42013006249. Findings We analysed data from 963 eligible women in eight trials: 480 randomly assigned to low-molecular-weight heparin and 483 randomly assigned to no low-molecular-weight heparin. Overall, the risk of bias was not substantial enough to affect decisions regarding trial inclusion. Participants were mostly white (795/905; 88%) with a mean age of 30·9 years (SD 5·0) and 403/963 (42%) had thrombophilia. In the primary analysis, low-molecular-weight heparin did not significantly reduce the risk of recurrent placenta-mediated pregnancy complications (low-molecular-weight heparin 62/444 14% versus no low-molecular-weight heparin 95/443 (22%) absolute difference −8%, 95% CI −17·3 to 1·4, p=0·09; relative risk 0·64, 95% CI 0·36–1·11, p=0·11). We noted significant heterogeneity between single-centre and multicentre trials. In subgroup analyses, low-molecular-weight heparin in multicentre trials reduced the primary outcome in women with previous abruption (p=0·006) but not in any of the other subgroups of previous complications. Interpretation Low-molecular-weight heparin does not seem to reduce the risk of recurrent placenta-mediated pregnancy complications in at-risk women. However, some decreases in event rates might have been too small for the power of our study to explore. Funding Canadian Institutes of Health Research.
Phthalates and bisphenol A (BPA) are high production volume and ubiquitous chemicals that are quickly metabolized in the body. Traditionally, studies have relied on single spot urine analyses to ...assess exposure; ignoring variability in concentrations throughout a day or over a longer period of time. We compared BPA and phthalate metabolite results from urine samples collected at five different time points. Participants (n=80) were asked to collect all voids in a 24 h period on a weekday and then again on a weekend before 20 weeks of pregnancy. During the second and third trimesters and in the postpartum period, single spot urines were collected. Variability over time in urinary concentrations was assessed using intraclass correlation coefficients (ICCs) and the sensitivity to correctly classify a single sample as high or low versus the geometric mean (GM) of all samples was calculated. We found low reproducibility and sensitivity of BPA and all phthalate metabolites throughout pregnancy and into the postpartum period but much higher reproducibility within a day. Time of day when the urine was collected was a significant predictor of specific gravity adjusted exposure levels. We concluded that, if the interest is in average exposures across pregnancy, maternal/fetal exposure estimation may be more accurate if multiple measurements, collected across the course of the entire pregnancy, rather than a single spot measure, are performed.
The necessity of routine preoperative esophagogastroduodenoscopy (EGD) before bariatric surgery is controversial. European guidelines recommend routine EGD while North American guidelines recommend a ...selective approach.
Perform a systematic review and meta-analysis to determine the proportion and scope of clinical findings discovered at preoperative EGD.
Academic hospital, Canada.
A search of MEDLINE, Embase, and Cochrane databases included MeSH terms "bariatric surgery," "endoscopy," and "preoperative." Inclusion criteria were any case series, cohort study, or clinical trial describing results of preoperative EGD for any bariatric surgery. Exclusion criteria were studies with<10 patients, patients<18 years of age, or revisional operations. Changes in surgical and medical management and proportions of pathologic findings were extracted and combined in a meta-analysis using the random effects model.
Initial search identified 532 citations. Forty-eight were included after full text review. Included studies comprised 12,261 patients with a mean (SD) age of 40.5 (1.3) years and body mass index of 46.3 (1.5) kg/m(2). The majority of patients (77.1%) were female. The proportion of EGDs resulting in a change in surgical management was 7.8%. After removing benign findings with controversial impact on management (hiatal hernia, gastritis, peptic ulcer), this was found to be .4%. Changes in medical management were seen in 27.5%, but after eliminating Helicobacter pylori eradication, this was found to be 2.5%.
Preoperative EGD in average-risk, asymptomatic bariatric surgery patients should be considered optional, as the proportion of EGDs that resulted in important changes in management was low.
To characterize the frequency and timing of complications following radical cystectomy in a cohort of patients treated at community and academic hospitals.
Radical cystectomy patients captured from ...NSQIP hospitals from January 1 2006 to December 31 2012 were included. Baseline information and complications were abstracted by study surgical clinical reviewers through a validated process of medical record review and direct patient contact. We determined the incidence and timing of each complication and calculated their associations with patient and operative characteristics.
2303 radical cystectomy patients met inclusion criteria. 1115 (48%) patients were over 70 years old and 1819 (79%) were male. Median hospital stay was 8 days (IQR 7-13 days). 1273 (55.3%) patients experienced at least 1 post-operative complication of which 191 (15.6%) occurred after hospital discharge. The most common complication was blood transfusion (n = 875; 38.0%), followed by infectious complications with 218 (9.5%) urinary tract infections, 193 (8.4%) surgical site infections, and 223 (9.7%) sepsis events. 73 (3.2%) patients had fascial dehiscence, 82 (4.0%) developed a deep vein thrombosis, and 67 (2.9%) died. Factors independently associated with the occurrence of any post-operative complication included: age, female gender, ASA class, pre-operative sepsis, COPD, low serum albumin concentration, pre-operative radiotherapy, pre-operative transfusion >4 units, and operative time >6 hours (all p<0.05).
Complications remain common following radical cystectomy and a considerable proportion occur after discharge from hospital. This study identifies risk factors for complications and quality improvement needs.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Rates of maternal mortality and morbidity in Africa remain unacceptably high, as many women deliver at home, without access to skilled birth attendants and life-saving medications. In rural Tanzania, ...women face significant barriers accessing health care facilities for their deliveries.
From January 2017 to February 2019 we conducted a multiple baseline (interrupted time series) trial within the four divisions of Rorya District, Tanzania. We collected baseline data, then sequentially introduced a complex intervention in each of the divisions, in randomized order, over 3 month intervals. We allowed for a 6 month transition period to avoid contamination between the pre- and post-intervention periods. The intervention included using community health workers to educate about safe delivery, distribution of birth kits with misoprostol, and a transport subsidy for women living a distance from the health care facility. The primary outcome was the health facility birth rate, while the secondary outcomes were the rates of antenatal and postpartum care and postpartum hemorrhage. Outcomes were analyzed using fixed effects segmented logistic regression, adjusting for age, marital status, education, and parity. Maternal and baby morbidity/mortality were analyzed descriptively.
We analyzed data from 9565 pregnant women (2634 before and 6913 after the intervention was implemented). Facility births increased from 1892 (71.8%) before to 5895 (85.1%) after implementation of the intervention. After accounting for the secular trend, the intervention was associated with an immediate increase in the odds of facility births (OR = 1.51, 95% CI 1.14 to 2.01, p = 0.0045) as well as a small gradual effect (OR = 1.03 per month, 95% CI 1.00 to 1.07, p = 0.0633). For the secondary outcomes, there were no statistically significant immediate changes associated with the intervention. Rates of maternal and baby morbidity/mortality were low and similar between the pre- and post-implementation periods.
Access to health care facilities can be improved through implementation of education of the population by community health workers about the importance of a health care facility birth, provision of birth kits with misoprostol to women in late pregnancy, and access to a transport subsidy for delivery for women living at a distance from the health facility.
NCT03024905 19/01/2017.
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