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Introduction
Gallbladder cancer (GBC) is an aggressive type of digestive system cancer with a dismal outcome. Given the lack of effective treatment options, the disease rapidly reoccurs and 5-year survival rate is
Introduction
Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.
Methods and analyses
This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.
Ethics and dissemination
Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.
Trial registration number
ISRCTN 10278811.
Objective
To assess the efficacy of inhaled ciclesonide in reducing the duration of oxygen therapy (an indicator of time to clinical improvement) among adults hospitalised with COVID-19.
Design
Multicentre, randomised, controlled, open-label trial.
Setting
9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021.
Participants
Adults hospitalised with COVID-19 and receiving oxygen therapy.
Intervention
Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care.
Main outcome measures
Primary outcome was duration of oxygen therapy, an indicator of time to clinical improvement. Key secondary outcome was a composite of invasive mechanical ventilation/death.
Results
Data from 98 participants were analysed (48 receiving ciclesonide and 50 receiving standard care; median (IQR) age, 59.5 (49–67) years; 67 (68%) men). Median (IQR) duration of oxygen therapy was 5.5 (3–9) days in the ciclesonide group and 4 (2–7) days in the standard care group (HR for termination of oxygen therapy 0.73 (95% CI 0.47 to 1.11), with the upper 95% CI being compatible with a 10% relative reduction in oxygen therapy duration, corresponding to a
Objective
Determine the prevalence, functional and structural alterations of primary open-angle glaucoma (POAG) in patients with obstructive sleep apnoea (OSA).
Design
Cross-sectional.
Setting
Tertiary hospital associated with specialised center in ophthalmologic images in Bogota, Colombia.
Participants
150 patients, for a sample of 300 eyes, 64 women (42.7%) and 84 men (57.3%) between 40 and 91 years old with a mean age of 66.8 (±12.1) years.
Interventions
Visual acuity, biomicroscopy, intraocular pressure, indirect gonioscopy and direct ophthalmoscopy. Patients classified as glaucoma suspects underwent automated perimetry (AP) and optical coherence tomography of the optic nerve
Outcome measure
The primary outcomes are the determination of prevalence of glaucoma suspects and POAG in patients with OSA. Secondary outcomes are the description of functional and structural alterations in computerised exams of patients with OSA.
Results
The prevalence of glaucoma suspect was 12.6%, and for POAG was 17.3%. No alterations in the appearance of the optic nerve was seen in 74.6%, focal or diffuse thinning of the neuroretinal rim (16.6%) was the most frequently finding, followed by asymmetry of the disc >0.2 mm (8.6%) (p=0.005). In the AP, 41% showed arcuate, nasal step and paracentral focal defects. The mean retinal nerve fiber layer (RNFL) was normal ( >80 µM) in 74% of the mild OSA group, 93.8% of the moderate group and 17.1% of the severe group. Similarly, normal (P5-90) ganglion cell complex (GCC) in 60%, 68% and 75%, respectively. Abnormal results in the mean RNFL was seen in 25.9%, 6.3% and 23.4% of the mild, moderate and severe groups, respectively. In the GCC, 39.7%, 33.3% and 25% of the patients in the aforementioned groups.
Conclusion
It was possible to determine the relationship between structural changes in the optic nerve and the severity of OSA. No relationship with any of the other studied variables was identified.
Falcaro M, Osborn D, Hayes J, et al. Time trends in access to smoking cessation support for people with depression or severe mental illness: a cohort study in English primary care. BMJ Open 2021;11:e048341. doi: 10.1136/bmjopen-2020-048341
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Annals of Internal Medicine, Ahead of Print.
Introduction
Roxadustat is a first-in-class oral therapy that treats chronic kidney disease (CKD) anaemia with the benefit of a novel mechanism of action that consistently corrects and maintains haemoglobin (Hb) across the spectrum of non-dialysis-dependent (NDD) CKD anaemia with an acceptable safety profile.
Methods and analysis
This is a randomised, control, open-label, multicentre trial. About 250 adult Chinese participants with stage 3–5 CKD NDD in approximately 30 centres will be enrolled, randomly assigned in a 1:1 ratio, to receive a 16-week treatment and 4-week follow-up. The interventions for study arm are
Objectives
To evaluate how women access and engage with different models of maternity care, whether specialist models improve access and engagement for women with social risk factors, and if so, how?
Design
Realist evaluation.
Setting
Two UK maternity service providers.
Participants
Women accessing maternity services in 2019 (n=1020).
Methods
Prospective observational cohort with multinomial regression analysis to compare measures of access and engagement between models and place of antenatal care. Realist informed, longitudinal interviews with women accessing specialist models of care were analysed to identify mechanisms.
Main outcome measures
Measures of access and engagement, healthcare-seeking experiences.
Results
The number of social risk factors women were experiencing increased with deprivation score, with the most deprived more likely to receive a specialist model that provided continuity of care. Women attending hospital-based antenatal care were more likely to access maternity care late (risk ratio (RR) 2.51, 95% CI 1.33 to 4.70), less likely to have the recommended number of antenatal appointments (RR 0.61, 95% CI 0.38 to 0.99) and more likely to have over 15 appointments (RR 4.90, 95% CI 2.50 to 9.61) compared with community-based care. Women accessing standard care (RR 0.02, 95% CI 0.00 to 0.11) and black women (RR 0.02, 95% CI 0.00 to 0.11) were less likely to have appointments with a known healthcare professional compared with the specialist model. Qualitative data revealed mechanisms for improved access and engagement including self-referral, relational continuity with a small team of midwives, flexibility and situating services within deprived community settings.
Conclusion
Inequalities in access and engagement with maternity care appears to have been mitigated by the community-based specialist model that provided continuity of care. The findings enabled the refinement of a realist programme theory to inform those developing maternity services in line with current policy.
Circulation, Volume 147, Issue 6, Page 465-468, February 7, 2023.
Objective
To evaluate the long-term outcomes of trabeculectomy (TE) surgery in a large cohort with a minimum follow-up of 3 years.
Design
Retrospective cohort study.
Setting
University Eye Hospital, Germany.
Participants
Three hundred and seventy-nine patients with open-angle glaucoma underwent TE with mitomycin C (MMC) between January 2013 and February 2017 with a minimal follow-up of 3 years. Eligible patients were identified via an electronic surgical case register.
Interventions
All patients had undergone TE with MMC following a set surgical protocol. To assess the influence of cataract surgery following TE, eyes which underwent cataract surgery at least 6 months after TE were matched 1:3 by sex and age to eyes who did not undergo cataract surgery during the follow-up period.
Main outcome measures
Primary outcome was the proportion of surgical success based on intraocular pressure (IOP), surgical complications, the need for revision surgery, loss of light perception and the need for additional pressure-lowering medication.
Results
The mean follow-up time was 6 (±0.8, IQR: 5.4–6.5) years. Seventy-three per cent of eyes achieved qualified surgical success at the last follow-up (IOP≥5 mm Hg and ≤18 mm Hg, without surgical complications or complete loss of vision) but necessitated additional medical therapy, complete surgical success with no additional medical therapy was achieved in 69% of eyes. There was no significant difference in the success probability between eyes that had undergone cataract surgery after TE and those that had not (p=0.45).
Conclusions
The results demonstrate a high and stable success rate of TE after a mean follow-up time of approximately 6 years, that is, not affected by later cataract surgery.
Objectives
Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important outcomes. We conducted a pilot trial to explore the feasibility of a large trial powered for clinically important outcomes.
Design
FLUID was a pragmatic pilot cluster randomised cross-over trial.
Setting
Four hospitals in the province of Ontario, Canada
Participants
All hospitalised adult and paediatric patients with an incident admission to the hospital over the course of each study period.
Interventions
A hospital wide policy/strategy which stocked either NS or RL throughout the hospital for 12 weeks before crossing over to the alternate fluid for the subsequent 12 weeks.
Primary and secondary outcome measures
The primary feasibility outcome was study fluid protocol adherence. Secondary feasibility outcomes included time to Research Ethics Board (REB) approval and trial initiation. Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes were analysed descriptively.
Results
Among 24 905 included patients, mean age 59.1 (SD 20.5); 13 977 (56.1%) were female and 21 150 (85.0%) had medical or surgical admitting diagnoses. Overall, 96 821 L were administered in the NS arm, and 78 348 L in the RL arm. Study fluid adherence to NS and RL was 93.7% (site range: 91.6%–98.0%) and 79.8% (site range: 72.5%–83.9%), respectively. Time to REB approval ranged from 2 to 48 days and readiness for trial initiation from 51 to 331 days. 5544 (22.3%) patients died or required hospital re-admission in the first 90 days.
Conclusions
The future large trial is feasible. Anticipating and addressing logistical challenges during the planning stages will be imperative.
Trial registration number
NCT02721485.
Stroke, Volume 54, Issue Suppl_1, Page A73-A73, February 1, 2023. Introduction:Ischemic stroke (IS) patients are frequently transferred between hospitals. Our objective was to determine whether patient insurance status contributes to variation in access to stroke center care among transferred patients with IS.Methods:We compiled California data on every nonfederal hospital admission from 2010-17 and used ICD-9, ICD-10, and DRG codes to identify IS patients transferred from an initial emergency department to another hospital. Transfers were categorized based on whether or not the patient was ultimately discharged from a stroke center hospital (primary or comprehensive). Patient insurance status was categorized as private, Medicare, Medicaid or self/uninsured. Clusters of closely connected hospitals via transfer frequency were identified using network science community detection methods. Within each cluster, we examined the degree of disparity in stroke center access by quantifying the difference between the insurance groups with the highest and lowest proportion of transfers discharged from a stroke center.Results:We identified 10,049 IS transfers during the study period (private 5,297 [53%]; Medicare 3,328 [33%]; Medicaid 904 [9%]; self/uninsured 520 [5%]). Stroke center access varied by patient insurance (overall 87%, private 89%, Medicare 87%, Medicaid 82%, self 72%). There were 14 clusters of closely connected hospitals via transfers. In the highest performing cluster, 100% of transferred patients in each insurance category were discharged from a stroke center (delta 0). The lowest performing cluster was also the largest (n=2,364 transfers); in this cluster 69% of transfers were discharged from a stroke center, ranging from 32% of self-pay transfers to 81% of privately insured transfers (highest delta among all clusters: 49%).Conclusions:These findings demonstrate that current care patterns differ by insurance status. Further research is needed to determine interventions to address this disparity.
Stroke, Volume 54, Issue Suppl_1, Page AHUP14-AHUP14, February 1, 2023. Background:Cerebral cavernous malformation is a common lesion affecting more than a million Americans, with potential severe sequelae. It is unclear how socioeconomic status (SES) and race influence access to specialized care, and the enrollment and adherence in clinical trials aimed at novel therapies for CCM.Methods:We analyzed a cohort of patients harboring CCM lesions screened for IRB approved research studies between 01/2010 -12/2021 at an accredited center of excellence for CCM, leading NIH funded clinical studies. Demographics, lesion location, history of hemorrhage, insurance type and area of deprivation index (ADI) were collected. Insurance type was categorized as commercial, Medicare/Medicaid, or out-of-pocket. The ADI ranking score was analyzed per decile with 1 (least disadvantaged) through 10 (most disadvantaged). Primary outcomes were clinical follow-up within a year from the 1stvisit for all CCM patients (excluding pregnancy), and enrollment/adherence among eligible subjects for first in disease NIH funded clinical trial [clinicaltrials.gov NCT02603328]. Statistical analysis (Chi2test; t-test) was applied to determine whether these differed in ADI groups, races or insurance type categories.Results:Despite the institution’s location in an area with majority African American population and lower SES, only 11.5% of subjects were African American, and the majority (52.8%) had a high SES (ADI 1-3). As expected, patients who had a symptomatic bleed were more likely to follow-up (p=0.01), and those with brainstem lesion were more likely to enroll and adhere in clinical trial (p=0.02). Correcting for these confounders, there was no difference in rates of clinical follow-up or enrollment/adherence among different ADI groups, races or insurance coverage.Conclusion:Access of disadvantaged patients and races to a center of excellence care and research remains limited despite geographic proximity to their community. Contrary to common belief, patients with poor SES and African Americans are as likely to follow-up and enroll/adhere in clinical trials, if provided access to specialized care. Mitigation efforts should target systemic causes of low access to specialized care among poor and African American patients.
Stroke, Volume 54, Issue Suppl_1, Page ATMP43-ATMP43, February 1, 2023. Introduction:Mechanical thrombectomy (MT) is a highly safe and effective standard of care for acute ischemic strokes with large vessel occlusion. However, timely access to MT is extremely limited on a global scale, with vast disparities in access between countries. MT2020+, a global non-profit initiative of SVIN, aimed to create a semi-quantitative global MT access barrier score (MTABS) to objectively measure the barriers impeding the implementation of treatment worldwide.Methods:Four independent investigators performed an in-depth systematic literature review using the peer review of electronic search strategies. Barriers to access were identified and categorized into 3 groups: information and diagnostic, physical, and financial. An international expert panel was created and scored each attribute using a modified Delphi process with the assistance of consultants from the University of Calgary W21C. A 1-9-point scale was used, with 1 being not at all important and 9 being extremely important. A meeting was held for the attributes that require deliberation. After an agreement, a list of attributes for access was elaborated. Next, a ranking of importance and individual weighting was done. We assigned a presence of or lack of an attribute a numerical value (1 for yes, 0 for no) and multiply by its weight to determine a final score.Results:After an initial screening of 2864 abstracts, 121 studies were included in the final systematic review. A total of 34 possible attributes that are barriers to access were identified. After the modified Delphi process, 26 individual attributes were selected. The MTABS was made with possible results from 0-62 points, with higher scores meaning higher barriers to access to MT.Conclusions:The global MTABS represents the first tool to quantify barriers to MT access worldwide. Its implementation will objectively measure the magnitude and identify key barriers to guide regional public health interventions to improve MT workflow and access.
Stroke, Volume 54, Issue Suppl_1, Page AWP153-AWP153, February 1, 2023. Introduction:Efficacy and safety of tirofiban in endovascular therapy among cardio-embolized ischemic stroke patients remains controversial. We aimed to assess effects of tirofiban before endovascular therapy in cardio-embolized stroke patients.Methods:This is a post hoc analysis of Endovascular Treatment With vs Without Tirofiban for Patients with Large Vessel Occlusion Stroke (RESCUE BT) trial. Before endovascular therapy, participants were randomized to tirofiban or placebo group in ratio of 1:1. Tirofiban was administrated as a bolus dose of 10 ug/kg, followed by continuous infusion of 0.15 ug/kg /min for up to 24-hour. We collected cardio-embolized stroke patients according to Trial of Org 10172 in Acute Stroke Treatment classification. The efficacy outcome was global disability at 90-day assed by modified Rankin Scale (mRS). The primary safety outcome was symptomatic intracranial hemorrhage (sICH) assessed by Heidelberg bleeding classification within 48-hour. Secondary safety outcome was any radiologic intracranial hemorrhage and death at 90-day.Results:406 cardio-embolized stroke patients were collected. Tirofiban did not correlated to favorable shift to lower 90-day mRS (adjusted odds ratio [aOR], 0.91; 95% CI, 0.64-1.3;P= 0.617). However, tirofiban subgroup had a significantly higher risk of sICH within 48-hour (aOR, 3.26; 95% CI, 1.4-7.57;P= 0.006) compared with placebo group. The aOR was 1.44 (95% CI, 0.94-2.19;P= 0.094) for any intracranial hemorrhage and1.48 (95% CI, 0.88-2.52;P= 0.143) for death at 90-day.Conclusions:Tirofiban increased symptomatic intracranial hemorrhage after endovascular therapy in cardio-embolized stroke patients.Figure 1. Outcomes of endovascular therapy in cardio-embolic stroke participants in tirofiban vs placebo group.
Stroke, Volume 54, Issue Suppl_1, Page AWP163-AWP163, February 1, 2023. Introduction:Few studies have investigated the tortuosity of great vessels only in the longitudinal direction during endovascular reperfusion therapy. This study evaluated the tortuosity of the great vessels in the perpendicular and longitudinal directions by using novel reference line and how it affects procedural difficulty.Methods:We retrospectively reviewed the medical records of 294 patients with large vessel occlusion. Features of the anatomy of the ipsilateral great vessels were investigated by preintervention CT angiography. The reference line used to evaluate tortuosity was defined as a line from the origin of each ipsilateral great vessel to the entrance of the external auditory canal (AE-line). Coronal and sagittal angles were calculated using the AE-line and the most curved point of each ipsilateral great vessel. The right side of the reference line was negative and the left side was positive, and similarly, the ventral side of the reference line was negative and the dorsal side of the reference line was positive. Patients were divided into three groups with a threshold of -20° and 20° based on sagittal and coronal angles on the both sides, and finally into nine groups. (Figure) Reference group was set to Group 5. Procedural difficulty was determined by whether or not the internal carotid artery could be accessed within 10 min.Results:On the left side, compared with the reference group, the odds ratio [OR] (95% confidence interval [CI]) for the procedural difficulty in the Group 9 was 9.020 (2.85-28.5; p
