scholarly journals 944 Outliers: The Forgotten Patients

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
G McConaghie ◽  
D C Osei-Bordom ◽  
M Charan
Keyword(s):  
Adverse Events ◽  
Initial Assessment ◽  
Care Plans ◽  
Review Period ◽  
Number Of Patients

Abstract Aim It was recognized that surgical wards often have a large number of patients outlied to them. Unfortunately, it was also noted that they often were not regularly seen and so had no daily medical plan. Evidence shows outliers have: The aim was to develop a means of increasing outlier reviews, plans and awareness of outlier parent speciality. Method Medical outliers and outliers from other surgical specialties were included looking at how often care plans were updated and if the nurses knew who and how to contact the patient's named consultant/team. Brightly coloured posters were created to highlight the importance of a patient plan and how to escalate a request. Stickers were created for the notes to highlight outliers and their last plan and their named consultant/team. The effect of the interventions was tracked for just under 6 weeks. Results Initial assessment showed care plans were only updated twice a week and nurses were largely unsure who to contact for an individual outlier. With the increased awareness the nurses achieved three reviews a week with patient plans. Importantly, during the review period there were no adverse events, and the nurses reported increased confidence in who to approach. Patients were also discharged earlier and not moved to another ward. Conclusions The nurses were empowered, and the patients benefitted from more regular reviews and up to date plans, importantly resulting in fewer adverse events and quicker discharges.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

scholarly journals Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

2021 ◽  
Vol 18 (5) ◽  
pp. 2546
Author(s):  
Noriko Morioka ◽  
Masayo Kashiwagi
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Home Care ◽  
Process Of Care ◽  
Related Factors ◽  
Cross Sectional ◽  
Home Care Nursing ◽  
Number Of Patients ◽  
Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

scholarly journals Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study

2021 ◽  
Vol 10 (8) ◽  
pp. 1638
Author(s):  
Hirohito Minami ◽  
Shuntaro Mukai ◽  
Atsushi Sofuni ◽  
Takayoshi Tsuchiya ◽  
Kentaro Ishii ◽  
...  
Keyword(s):  
Bile Duct ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Significant Risk ◽  
Histopathological Analysis ◽  
Bile Duct Stones ◽  
Serious Adverse Events ◽  
Visualization System ◽  
Visual Impression ◽  
Number Of Patients

Although Spy DS (SpyGlass DS Direct Visualization System) is considered to be useful for the diagnosis of bile duct strictures and the treatment of bile duct stones, there is limited data to date validating its efficacy. We hence retrospectively evaluated the clinical outcomes of the use of Spy DS in a large number of patients. A total of 183 patients who underwent Spy DS-guided procedures for indeterminate bile duct strictures (n = 93) and bile duct stones (n = 90) were analyzed retrospectively. All patients (93/93) with bile duct strictures successfully underwent visual observation, and 95.7% (89/93) of these patients successfully underwent direct biopsy. The sensitivity, specificity, and overall accuracy were 94.7%, 83.3%, and 90.3%, respectively, for visual impression; 80.9%, 100%, and 89.2%, respectively, for histopathological analysis of a direct biopsy; and 96.5%, 91.7%, and 94.6%, respectively, for visual impression combined with biopsy. Successful visualization of the stones was achieved in 98.9% (89/90) of the patients, and complete stone removal was achieved in 92.2% (83/90) of the patients, with an average of 3.3 procedures. The adverse events rate was 17.5% (32/183; cholangitis in 15 patients, fever the following day in 25, pancreatitis in 1, hemorrhage in 1, and gastrointestinal perforation in 1). No administration of antibiotics before the procedure was found to be a statistically significant risk factor for the development of fever after the procedure (p < 0.01). Spy DS-guided procedures are effective for the diagnosis and treatment of bile duct lesions and can be performed with a low risk of serious adverse events.

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

scholarly journals PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Marcos Augusto Bastos Dias ◽  
◽  
Leandro De Oliveira ◽  
Arundhanthi Jeyabalan ◽  
Beth Payne ◽  
...  
Keyword(s):  
Knowledge Transfer ◽  
Adverse Events ◽  
Risk Stratification ◽  
Risk Reduction ◽  
Randomised Trial ◽  
Adverse Outcomes ◽  
Cluster Randomised Trial ◽  
Care Providers ◽  
Stepped Wedge ◽  
Number Of Patients

Abstract Background Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. Trial registration ClinicalTrials.gov: NCT03073317.

scholarly journals AB0864 DO CORTICOSTEROIDS AND HYALURONIC ACID INJECTIONS CAUSE INFECTIONS? A SYSTEMATIC REVIEW OF LITERATURE ON ADVERSE EFFECTS AND INFECTION RATES OF INTRA-ARTICULAR CORTICOSTEROID AND HYALURONIC ACID INJECTIONS IN PATIENTS WITH KNEE OSTEOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1739.2-1739
Author(s):  
C. Hatzantonis
Keyword(s):  
Systematic Review ◽  
Hyaluronic Acid ◽  
Adverse Effects ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Adverse Reactions ◽  
Infection Rates ◽  
Management Options ◽  
Cochrane Reviews ◽  
Number Of Patients

Background:Knee osteoarthritis has been a leading cause of chronic pain and disability in our increasingly aging population. Conservative management options of physiotherapy and oral analgesics offer some relief, but delivery of intra-articular injections such as corticosteroids or hyaluronic acid has increasingly become the mainstay of pain management of knee osteoarthritis. In a clinical setting, intra-articular injections offer a means to delay a total knee replacement. Despite the abundance of literature on corticosteroids and hyaluronic acid, there is no known percentage of infection rates or adverse effects that clinicians may use to inform patients prior to obtaining consent for the injection.Objectives:To determine a rate of adverse events and infection rates in patients undergoing intra-articular injections of corticosteroids or hyaluronic acid.Methods:A systematic review of current literature including studies involving patients ranging from 45 patients (Carmona L, 2018) to Cochrane reviews of 1767 patients (Campbell Kirk, 2015). From these studies, the number of patients, adverse reactions (i.e. pain, erythema) and serious adverse reactions (infections) were calculated.Results:Within our study, there was a large variation of numbers of adverse effects of hyaluronic acid and corticosteroids amongst studies, with percentages as variable as 0-9.3%. Corticosteroids demonstrated 11-26% reduction of adverse events compared to hyaluronic acid. However, confidence intervals were found to not be statistically significant.Conclusion:Intra-articular injections of corticosteroids and hyaluronic acid, although deemed clinically effective, continue to demonstrate variable rates of adverse effects and infection amongst patients with progressive knee osteoarthritis.Disclosure of Interests:None declared

Abstract 3446: Inpatient Code Stroke Protocol: A Quality Improvement and Knowledge Translation Strategy for a Challenging Scenario

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Jacqueline D Willems ◽  
Krsytyna Skrabka ◽  
Roseane Nisenbaum ◽  
Judith Barnaby ◽  
Pawel Kostyrko ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Acute Stroke ◽  
Robust Regression ◽  
Stroke Care ◽  
Initial Assessment ◽  
Stroke Severity ◽  
Care Hospital ◽  
Presenting Symptoms ◽  
Number Of Patients ◽  
Assessment And Treatment

Background: Stroke care faces a clinical challenge in treating inhospital strokes, which account for about 15% of all strokes. Prior studies showed an inequity in the assessment and treatment of inpatients who suffer a stroke versus out-of hospital. For example, inpatients have longer time to initial assessment, CT and are less likely (wait longer) to receive tissue plasminogen activator (t-PA). There is limited research evaluating the efficacy of inpatient code stroke protocols (ICSP) on access to and quality of hyper-acute stroke care. Objective: To evaluate the efficacy of the ICSP in a large tertiary care hospital. Methods: This prospective study evaluated a quality improvement strategy involving ICSP implementation at St Michael’s Hospital in 2009. The ICSP focuses on the identification of stroke symptoms and timely notification of most responsible physician, then leverages the Emergency Department code stroke process. A 3-month hospital-wide implementation period involved 60 min. education sessions with a minimum of 2 sessions per unit. Demographic factors, presenting symptoms, stroke severity, vascular risk factors as well as time of: symptoms onset, CT; and physician assessment were collected by chart abstraction after ethics approval. The primary outcomes was time from last seen normal (LSN) to CT scan. Secondary outcomes include time from LSN to initial assessment (IA), medical complications and number of patients receiving endovascular interventions or intravenous thrombolysis. The analysis was completed by comparing unadjusted and adjusted outcomes pre and post implementation of the ICSP. Descriptive statistics and robust regression was completed using SAS 9.0. Results: Overall, there were 245 inhospital strokes during the study period (152 pre and 93 post ICSP implementation). Mean age was 69.8 yrs, 60% were male. Most inpatient strokes occurred on cardiovascular services (42.9%). Main results summarized in table . There was no difference in the number of patients receiving thrombolysis or endovascular treatment. After adjustment for covariates, the ICS was associated with a significant reduction of 288 minutes (95%CI -566, -10) in time from LSN to CT. Similarly, there was significant reduction of 307 (95%CI -532, -82) in time from LSN to IA. Conclusions: Implementation of the ICSP resulted in improvements in the process indicators related to assessment and treatment of hyper-acute stroke. Similar quality improvement strategies can be implemented to ameliorate disparities between care for inpatients and outpatient presenting with an acute ischemic stroke.

scholarly journals 5α-Reductase Inhibitors for Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 70 (2) ◽  
Author(s):  
Jennifer E J Jun ◽  
Angus Kinkade ◽  
Anthony C H Tung ◽  
Aaron M Tejani
Keyword(s):  
Adverse Events ◽  
Latin American ◽  
Acute Urinary Retention ◽  
Health Sciences ◽  
Prostatic Hyperplasia ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Rétention Urinaire ◽  
Number Of Patients ◽  
Latin American And Caribbean

<p><strong>ABSTRACT</strong></p><p><strong>Background:</strong> Finasteride and dutasteride are competitive inhibitors of 5a-reductase enzymes and are commonly used to treat symptomatic benign prostatic hyperplasia (BPH).</p><p><strong>Objective:</strong> To compare the efficacy and safety of finasteride and dutasteride in terms of clinically important outcomes.</p><p><strong>Data Sources:</strong> A literature search was performed using the search terms “prostatic hyperplasia”, “prostatic hypertrophy”, “dutasteride”, “finasteride”, “quality of life”, “adverse drug reaction”, and “mortality”. The Embase, PubMed, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature databases were searched from inception to December 2015.</p><p><strong>Study Selection and Data Extraction:</strong> Randomized controlled trials, quasi-randomized trials, and systematic reviews comparing finasteride with dutasteride, either as monotherapy or in combination with a-blockers, for treatment of men with BPH were included. The outcomes of interest included need for prostate-related surgery, episodes of acute urinary retention, withdrawals due to adverse events, number of patients experiencing serious adverse events, mortality, and sexual dysfunction.</p><p><strong>Data Synthesis:</strong> Four studies involving a total of 1879 patients were included in the analysis. There were no significant differences in any of the clinically important outcomes examined: for prostate-related surgery, odds ratio (OR) 2.01 (95% confidence interval [CI] 0.18–22.24); for episodes of acute urinary retention, OR 1.47 (95% CI 0.68–3.19); for number of withdrawals due to adverse events, OR 1.10 (95% CI 0.68–1.75); for total number of patients experiencing adverse events, OR 0.94 (95% CI 0.78–1.14); for number of patients experiencing serious adverse events, OR 1.31 (95% CI 0.87–1.97); and for sexual dysfunction, OR 0.83 (95% CI 0.64–1.08).</p><p><strong>Conclusion:</strong> There is insufficient evidence to suggest that either finasteride or dutasteride offers an advantage in efficacy or safety over the other, in terms of clinically important outcomes.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte :</strong> Le finastéride et le dutastéride sont des inhibiteurs compétitifs de l’enzyme 5 alpha-réductase. Ils sont fréquemment employés comme traitement symptomatique de l’hyperplasie bénigne de la prostate (HBP).</p><p><strong>Objectif :</strong> Comparer l’efficacité et l’innocuité du finastéride et du dutastéride en ce qui concerne les résultats thérapeutiques cliniquement importants.</p><p><strong>Sources des données :</strong> Une recherche documentaire a été effectuée à l’aide des termes « hyperplasie de la prostate », « hypertrophie de la prostate », « dutastéride », « finastéride », « qualité de vie », « réaction indésirable aux médicaments » et « mortalité ». Les bases de données Embase, PubMed, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature et Latin American and Caribbean Health Sciences Literature ainsi que le Registre central Cochrane des essais comparatifs ont été interrogées pour la période allant de leur création à décembre 2015.</p><p><strong>Sélection des études et extraction des données :</strong> Les essais comparatifs à répartition aléatoire, les essais quasi-aléatoires et les analyses systématiques qui comparent le finastéride et le dutastéride, en monothérapie ou en association avec des a-bloquants, pour le traitement de la HBP chez l’homme, ont été retenus. Parmi les résultats d’intérêt, on comptait : la nécessité de recourir à une chirurgie de la prostate, les épisodes de rétention urinaire aiguë, les retraits de l’étude pour cause d’événements indésirables, le nombre total de patients ayant subi des événements indésirables graves, la mortalité et le dysfonctionnement sexuel.</p><p><strong>Synthèse des données :</strong> Quatre études comptant au total 1879 patients ont été retenues pour l’analyse. Aucune différence significative n’a été relevée en ce qui touche les résultats thérapeutiques cliniquement importants : la nécessité de recourir à une chirurgie de la prostate (risque relatif approché [RRA] de 2,01, intervalle de confiance [IC] à 95 % de 0,18 à 22,24), les épisodes de rétention urinaire aiguë (RRA de 1,47, IC à 95 % de 0,68 à 3,19), le nombre de retraits de l’étude pour cause d’événements indésirables (RRA de 1,10, IC à 95 % de 0,68 à 1,75), le nombre total de patients ayant subi des événements indésirables (RRA de 0,94, IC à 95 % de 0,78 à 1,14); le nombre de patients ayant subi des événements indésirables graves (RRA de 1,31, IC à 95 % de 0,87 à 1,97) et le dysfonctionnement sexuel (RRA de 0,83, IC à 95 % de 0,64 à 1,08).</p><p><strong>Conclusion :</strong> Il n’y a pas suffisamment de données probantes pour croire que le finastéride ou le dutastéride offrent, l’un par rapport à l’autre, un avantage quant à l’efficacité ou à l’innocuité, en ce qui concerne les résultats thérapeutiques cliniquement importants.</p>

scholarly journals Combined CTLA-4 and PD-L1 blockade in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer is associated with increased myeloid and neutrophil immune subsets in the bone microenvironment

2021 ◽  
Vol 9 (10) ◽  
pp. e002919
Author(s):  
Sumit K Subudhi ◽  
Bilal A Siddiqui ◽  
Ana M Aparicio ◽  
Shalini S Yadav ◽  
Sreyashi Basu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Immune Checkpoints ◽  
Castration Resistant Prostate Cancer ◽  
Bone Microenvironment ◽  
Castration Resistant ◽  
Number Of Patients ◽  
Measurable Disease

BackgroundImmune checkpoint therapy (ICT) has low response rates in patients with metastatic castration-resistant prostate cancer (mCRPC), in part due to few T cells in the tumor microenvironment (TME). Anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) promotes intratumoral T cell infiltration but induces upregulation of PD-1 and programmed death ligand-1 (PD-L1) within the prostate TME. Combined anti-CTLA-4 plus anti-PD-1 can partly overcome this adaptive resistance and was recently shown to augment responses in patients with mCRPC with measurable disease. Although bone is the most common site of metastasis in prostate cancer, patients with bone-predominant disease are frequently excluded from trials because they lack measurable disease, which limits assessment of disease progression and tissue sampling. We therefore designed this study to investigate combined ICT in mCRPC to bone.HypothesisCombined anti-CTLA-4 (tremelimumab) plus anti-PD-L1 (durvalumab) is safe and well tolerated in patients with chemotherapy-naïve mCRPC to bone.Patients and methodsIn this single-arm pilot study, men with chemotherapy-naïve mCRPC to bone received tremelimumab (75 mg intravenous) plus durvalumab (1500 mg intravenous) every 4 weeks (up to four doses), followed by durvalumab (1500 mg intravenous) maintenance every 4 weeks (up to nine doses). The primary endpoint was incidence of adverse events. Secondary endpoints included serum prostate-specific antigen (PSA), progression-free survival (PFS), radiographic PFS (rPFS), and maximal PSA decline.ResultsTwenty-six patients were treated between August 8, 2017 and March 28, 2019. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 11 patients (42%), with no grade 4 or 5 events. TRAEs leading to discontinuation occurred in three patients (12%). PSA decline ≥50% occurred in three patients (12%). Six patients (24%) achieved stable disease for >6 months. At a median follow-up of 43.6 months, median rPFS was 3.7 months (95% CI: 1.9 to 5.7), and median overall survival was 28.1 months (95% CI: 14.5 to 37.3). Post-treatment evaluation of the bone microenvironment revealed transcriptional upregulation in myeloid and neutrophil immune subset signatures and increased expression of inhibitory immune checkpoints.ConclusionsTremelimumab plus durvalumab was safe and well tolerated in patients with chemotherapy-naïve mCRPC to bone, with potential activity in a small number of patients as measured by rPFS. Combination of CTLA-4 and PD-L1 blockade with therapies targeting the myeloid compartment or other inhibitory immune receptors may be necessary to overcome mechanisms of resistance within prostate bone microenvironment.Trial registration numberNCT03204812.

The assessment of cognitive function in the elderly using videoconferencing

1998 ◽  
Vol 4 (1_suppl) ◽  
pp. 36-38 ◽  
Author(s):  
Chris Ball ◽  
Alison Puffett
Keyword(s):  
Cognitive Function ◽  
Inner City ◽  
The Elderly ◽  
Structured Interview ◽  
The Other ◽  
Initial Assessment ◽  
Face To Face ◽  
Number Of Patients ◽  
Old Age Psychiatry ◽  
Videoconferencing System

People over the age of 65 were recruited from an inner-city old-age psychiatry service. Subjects had a structured interview (the CAMCOG test) by videoconferencing, and also face to face, by an investigator blind to the results of the test in the other mode. Reassessments were carried out within one week of the initial assessment. Eleven subjects were initially enrolled in the study and eight completed both modes. The number of patients in this study is very small but the results suggest that the CAMCOG test can be used reliably over a videoconferencing system without major modification.

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