Journal articles: 'Deferred time assessment'

1

Mulla, Faruq Ibrahimbhai, and Kailash Sukhram Inaniya. "Assessment of donor return following temporary deferral in camp as well as in-house donors) in a blood bank attached to tertiary care hospital." International Journal of Research in Medical Sciences 5, no. 5 (April 26, 2017): 1846. http://dx.doi.org/10.18203/2320-6012.ijrms20171584.

Full text

Abstract:

Background: In India, about 60% of donation is through voluntary blood donors. However, about one third already motivated blood donors are deferred due to stringent screening criteria, either temporarily or permanently. The temporarily deferred donors could be a good source of blood donation after deferral period. The objective of this study was to know the main causes of pre-donation deferral in potentially healthy prospective blood donors, to investigate impact of deferral on donation pattern and to evaluate impact of post deferral counseling on donation pattern.Methods: The present study is carried out in A. D. Gorwala blood bank in Anand, Gujarat from April 2014 to September 2015. All donors screened as per the guideline and deferred donors are categorized as temporary and permanently deferred donors. A Comparison group of healthy eligible donors who donate blood at ADGBB is also studied to determine impact of deferral on donation pattern. From temporarily deferred donors, reason for deferral is considered. At the time of deferral, donors properly counseled, clearly informed about the reason of deferral and corrective actions are taken. As per reason of deferral, time duration for recalling the donor is defined. Based on this, donor is called back to donate again for up to six month’s period after expiration of deferral period.Results: Total 12.57% donors were deferred temporarily. Significant female preponderance was observed (58.7% vs 8.90%). Low hemoglobin (60.9%) was the most common reason of temporary deferral followed by abnormal BP and medicine ingestion. Total 378 donors were responded back out of 953 of deferred donors compare to 645 in non-deferred group. Middle age, male, repeat donors, in-house donors, high education, high socio-economic status, shorter duration of deferral appears to significantly predict donor return. In the evaluation of reasons of the re-deferral, Low hemoglobin was the prime reason. Unfavourable location, lack of time and change in job/college are major barrier to donor return. Total 39.60% response observed after post deferral counseling in present study compared to 11.20% in year 2013-2014.Conclusions: Efforts to increase the hemoglobin will improve the donor retention and overall blood safety can be increased. Temporary deferral has negative impact on donor return and duration of response after expiration of deferral, both in first time and repeat donors. Interventions to increase return behavior need to be better targeted at specific donor groups and it should be developed according to major barriers to donor return prevalent in particular region mainly through more effective communication with donors. Education, motivation, post deferral counseling.

APA, Harvard, Vancouver, ISO, and other styles

2

Greffin, Klara, Holger Muehlan, Samuel Tomczyk, Ariane Suemnig, Silke Schmidt, and Andreas Greinacher. "In the Mood for a Blood Donation? Pilot Study about Momentary Mood, Satisfaction, and Return Behavior in Deferred First-Time Donors." Transfusion Medicine and Hemotherapy 48, no. 4 (2021): 220–27. http://dx.doi.org/10.1159/000514016.

Full text

Abstract:

Introduction: To maintain a sufficient donor pool, deferred first-time donors (FTD) should be motivated to return for blood donation. This pilot study investigates how deferral affects momentary mood, satisfaction with the donation process, and subsequent return behavior to examine their potential for motivating (deferred) FTD. Methods: All of the subjects (n = 96) completed a first questionnaire (A1) before pre-donation assessment. Deferred FTD (n = 22) were asked to complete a second questionnaire (A2) immediately after deferral, while non-deferred FTD (n = 74) filled in the second questionnaire (A3) after blood donation. The impact of deferral, momentary mood, and satisfaction with the donation process on return behavior within 12 months was tested by calculating two path analyses, controlling for sex and age. Results: Mood (p < 0.001) and satisfaction with social aspects of the donation process (p = 0.01) were decreased after deferral. Deferred FTD were less likely than non-deferred FTD to return to the blood donation center within 12 months (60.8 vs. 36.4%; p = 0.043). However, path analyses revealed that deferral effects on mood and satisfaction were not connected to return behavior. Instead, age had a significant influence on return behavior (p < 0.05) such that, overall, non-returning FTD were older than returning FTD, regardless of their deferral status. Conclusion: Our findings suggest that mood and satisfaction with the donation process are directly affected by deferral but not clearly responsible for low return rates. It seems promising to embed these variables in established health behavior models in further studies to increase the return rates of deferred FTD.

APA, Harvard, Vancouver, ISO, and other styles

3

Siragusa, Sergio, Alessandra Malato, Antonino Giarratano, Francesco Falaschi, Fernando Porro, Maria Cristina Buonanno, Elena Maggi, Raffaela Anastasio, Lucio Lo Coco, and Guglielmo Mariani. "Objective Assessment of Pulmonary Embolism Can Be Deferred without Increased Risk." Blood 106, no. 11 (November 16, 2005): 1628. http://dx.doi.org/10.1182/blood.v106.11.1628.1628.

Full text

Abstract:

Abstract Background. Management of patients with suspected Pulmonary Embolism (PE) is problematic if diagnostic imaging is not available. Pretest Clinical Probability (PCP) and D-dimer (D-d) assessment were shown to be useful to identify those high risk patients for whom empirical, protective anticoagulation is indicated (Siragusa S et al. Arch Intern Med2004;164:2477–82). Objective of the study. In consecutive patients with suspected PE, we evaluated whether PCP and D-d assessment, together with the use of low molecular weight heparins (LMWHs), allow objective appraisal of PE to be deferred for up to 72 hours. Methods. In case of deferment of diagnostic imaging for PE, patients identified at high-risk (those with high PCP and those with moderate PCP and a positive D-d), received a protective full-dose treatment of LMWH; the remaining patients were discharged without anticoagulants. All patients were scheduled to undergo objective tests for PE (ventilation/perfusion lung scanning or computed tomography lung scan) within 72 hours from the index visit (figure). Standard antithrombotic therapy was then administered when diagnostic tests confirmed Venous ThromboEmbolism (VTE). Results. 336 patients with suspected PE were included in this study. The prevalence of VTE was 6.1% (95% CI 2.7–9.3) in the “low-risk group” and 50.4% (95% CI 41.7–59.1) in the “high-risk group”. In total, VTE was confirmed in 76 (22.6%) of 336 patients (95% CI 18.2–27). Patients’ characteristics, median time for deferral test and for LMWH administration are listed in table 1. Events at the short-term (72 hours) and long-term follow-up are listed in table 2. None of the patients had major bleeding events during the follow-ups. Conclusions. When objective diagnostic assessment of PE is not immediately available, management of symptomatic PE patients can prove highly unsatisfactory. This study demonstrates that a simple and reproducible approach allows a safe deferral of diagnostic imaging for PE for up to 72 hours. patients’ characteristics Baseline features Low risk group (n. 211) High-risk group (n. 125) p value n.s.: not significant Age in years (range) 59.3 (22–91) 60.3 (23–91) n.s. Sex (F/M) 98/113 59/66 n.s. Time since onset of symptoms (days) 1.7 1.5 n.s. Co-morbidity and 16 (7.5) 25 (19.2) 0.03 Median time of deferral test (hours) 49.5 42.5 n.s. Median time of protective anticoagulation (hours) not applicable 35.5 not applicable Outcome of Short- and Long-term FU Categories of patients (n) Events at the short-term FU Events at the long -term FU* FU indicates follow-up; CI indicates Confidence Intervals. *This refers to patients in whom Pulmonary Embolism has been previously ruled out (n. 260). “Low-risk group” (211) 0 (0%) [95% CI 1.4] 0 (0%) [95% CI 1.4] “High-risk group” (125) 1 (0.8%) [95% CI 2.3] 3 (2.4%) [95% CI 3.2] Patients clinically suspected of PE without immediate availability of diagnostic tests Patients clinically suspected of PE without immediate availability of diagnostic tests

APA, Harvard, Vancouver, ISO, and other styles

4

Gohel, Manjit S., Francine Heatley, Xinxue Liu, Andrew Bradbury, Richard Bulbulia, Nicky Cullum, David M. Epstein, et al. "Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT." Health Technology Assessment 23, no. 24 (May 2019): 1–96. http://dx.doi.org/10.3310/hta23240.

Full text

Abstract:

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.

APA, Harvard, Vancouver, ISO, and other styles

5

Lee, Byeong-Ryul. "A Comparative Assessment on the Real-Time Gross System in America." Korea International Trade Research Institute 18, no. 3 (June 30, 2022): 81–93. http://dx.doi.org/10.16980/jitc.18.3.202206.81.

Full text

Abstract:

Purpose The aim of this study is to compare the real-time gross system in America. Comparative analysis of precedent research, features and operational polices between Fedwire and FedNow was performed for research purposes. Design/Methodology/Approach The paper is organized as follows. In Section , the necessity and purpose of research this paper is outlined. In Section , outlines previous research in domestic and foreign literature and the development process the real-time gross system in America. Section contains a comparative explain of the operational polices ofthe central bank. payment liquidity, services resilience and payment reserves. Section contains a comparative analysis competitiveness evaluation including fees, legal stability, services accessibility, account methods and feedback between Fedwire and FedNow. Section summarizes and suggests that the payment system have more efficience, accuracy, and security with the remaining conclusions. Findings Fedwire Funds Service is a real-time gross settlement system that enables participants to initiate fund transfers that are immediate, final, and irrevocable once processed. The Fedwire Funds Service business day begins at 9:00 p.m. eastern time (ET) on the preceding calendar day and ends at 7:00 p.m. ET, Monday through Friday, excluding designated holidays. The FedNow Service will be designed to maintain uninterrupted 24x7x365 processing with security features to support payment integrity and data security. The service will have a 24-hour business day each day of the week, including weekends and holidays.Write the Findings of you research here. Research Implications In this paper, I would like to suggest the necessity of converting Korea’s current deferred-netting system to the real-time gross system.

APA, Harvard, Vancouver, ISO, and other styles

6

Gilmore, Natalie, Daniel Mirman, and Swathi Kiran. "Young Adults With Acquired Brain Injury Show Longitudinal Improvements in Cognition After Intensive Cognitive Rehabilitation." Journal of Speech, Language, and Hearing Research 65, no. 4 (April 4, 2022): 1494–520. http://dx.doi.org/10.1044/2021_jslhr-21-00324.

Full text

Abstract:

Purpose: The aim of this study was to assess the effect of an intensive cognitive and communication rehabilitation (ICCR) program on language and other cognitive performance in young adults with acquired brain injury (ABI). Method: Thirty young adults with chronic ABI participated in this study. Treatment participants ( n = 22) attended ICCR 6 hours/day, 4 days/week for at least one 12-week semester. Deferred treatment/usual care control participants ( n = 14) were evaluated before and after at least one 12-week semester. Pre- and postsemester standardized cognitive assessment items were assigned to subdomains. Between-groups and within-group generalized linear mixed-effects models assessed the effect of time point on overall item accuracy and differences by item subdomain. Subdomain analyses were adjusted for multiple comparisons. Results: Between-groups analyses revealed that treatment participants improved significantly faster over time than deferred treatment/usual care participants in overall item accuracy and specifically on items in the verbal expression subdomain. Investigating the three-way interaction between time point, group, and etiology revealed that the overall effects of the treatment were similar for individuals with nontraumatic and traumatic brain injuries. The treatment group showed an overall effect of treatment and significant gains over time in the verbal expression, written expression, memory, and problem solving subdomains. The control group did not significantly improve over time on overall item accuracy and showed significant subdomain-level gains in auditory comprehension, which did not survive correction. Conclusions: Sustaining an ABI in young adulthood can significantly disrupt key developmental milestones, such as attending college and launching a career. This study provides strong evidence that integrating impairment-based retraining of language and other cognitive skills with “real-world” application in academically focused activities promotes gains in underlying cognitive processes that are important for academic success as measured by standardized assessment items. These findings may prompt a revision to the current continuum of rehabilitative care for young adults with ABI. Supplemental Material: https://doi.org/10.23641/asha.19320068

APA, Harvard, Vancouver, ISO, and other styles

7

Ostashchenko, T. V., and I. N. Dubina. "ASSESSMENT OF REGIONAL INTELLECTUAL CAPITAL AND ITS CORRELATION WITH THE LEVEL OF ECONOMIC DEVELOPMENT OF THE ALTAI REGION AND THE SIBERIAN FEDERAL DISTRICT." Economics Profession Business, no. 4 (December 10, 2020): 98–107. http://dx.doi.org/10.14258/epb2019106.

Full text

Abstract:

The article discusses and comparatively analyses the dynamics of the level of intellectual capital and indicators of economic development of the Altai Region and the regions of the Siberian Federal District based on the author’s approach to the assessment of intellectual capital as a factor of economic development. A decrease in the competitiveness of the Altai Region in the field of education, research and development, innovation activity across the Russian Federation and the Siberian Federal District was found. Criteria of the effective transformation of regional intellectual potential into regional intellectual capital and regional innovation activity, as well as criteria of the effective use of intellectual capital as a factor of regional economic development are proposed. The deferred (time lag) effects of the impact of intellectual capital on the economic development of the regions of the Siberian Federal District are evaluated.

APA, Harvard, Vancouver, ISO, and other styles

8

Hill, Arleen, John Bevington, Rachel Davidson, Stephanie Chang, Ronald Eguchi, Beverley Adams, Susan Brink, et al. "Community-Scale Damage, Disruption, and Early Recovery in the 2010 Haiti Earthquake." Earthquake Spectra 27, no. 1_suppl1 (October 2011): 431–46. http://dx.doi.org/10.1193/1.3624964.

Full text

Abstract:

This study seeks to assess the levels of community-scale building damage and socioeconomic disruption following the January 2010 Haiti earthquake. Damage and disruption were analyzed for pre-event, post-event, and early recovery time periods in seven Haitian communities—three inside and four outside Port-au-Prince. Damage datasets from the Global Earth Observation-Catastrophe Assessment Network (GEO-CAN) postdisaster assessment were combined with analyses of fine-resolution satellite and aerial imagery to quantify building damage and recovery status, and were verified with field data. Disruption was assessed using community-level data obtained from interviews conducted in May 2010 with community leaders, NGOs, and government utility providers. The data pertain to 11 sectors, including shelter, livelihoods, and social networks. The findings document severe disruption and uneven restoration four months after the earthquake. Disruption showed little correlation with physical damage. Observations suggest that the impacts of the earthquake must be understood in the context of chronic disruption, and many consequences of the earthquake are merely deferred during recovery.

APA, Harvard, Vancouver, ISO, and other styles

9

Shetty, Kishore, and Vinay Vaidyanathan. "Intracranial and Orbital Complications of Sinusitis: A Case Series and Review of Literature." An International Journal Clinical Rhinology 4, no. 2 (2011): 87–92. http://dx.doi.org/10.5005/jp-journals-10013-1080.

Full text

Abstract:

ABSTRACT Complications of paranasal sinus infection most often involve the orbit and periorbita. Because of widespread use of antibiotics, intracranial extension of paranasal sinusitis is rarely seen today. Nevertheless, the clinician must be aware of the potential of these complications, as late recognition of this condition and delay in treatment can increase morbidity and mortality rates. An interesting case series of sinusitis with orbital and intracranial complication is presented, which was radiologically evaluated, and was managed by endoscopic sinus surgery with drainage of subdural empyema by appropriate neurosurgical technique. The radiological tools played a very important role in both assessment and timing of surgical intervention. Unparallel role of radiological investigations cannot be overemphasized. The key to successful treatment is aggressive management and the timing for surgical intervention should not be deferred. The patients made full recovery at the time of discharge.

APA, Harvard, Vancouver, ISO, and other styles

10

Tamindžić, Gordana, Maja Ignjatov, Dragana Milošević, Zorica Nikolić, Aleksandra Nastasić, Dušica Jovičić, and Jasna Savić. "Assessment of quality and viability of primed maize seed." Ratarstvo i povrtarstvo 57, no. 3 (2020): 87–92. http://dx.doi.org/10.5937/ratpov57-26575.

Full text

Abstract:

Good crop establishment is essential for achieving high yield and constraints to good establishment include untimely sowing and low seed quality combined with various adverse growing conditions after sowing. Seed priming is a pre-sowing technique used for the improvement of germination, reduction of the time from sowing to emergence and improvement of emergence uniformity. Various seed priming techniques, such as hydropriming and priming with zinc, are used nowadays to improve crop establishment. The importance of seed priming with zinc for better germination, improved stand establishment, and higher maize yield are well documented. However, there is still a lack of results on the effects of seed priming with water and zinc on seed quality and viability, given that maize seed can be kept in storage for many years without a significant reduction in germination. The study was aimed to evaluate the effects of seed priming with water and Zn on the quality and viability of the maize seed. In order to evaluate the response of four maize hybrids to priming with water (hydropriming) and 4 mM zinc sulphate, primed seeds were subjected to laboratory tests, namely to the germination test, the cold test, and the accelerated aging test. Both priming treatments increased the seed quality, but the beneficial effect of Zn-priming maintained to a larger extent than hydropriming in cold-treated and aged seeds. The negative effects of hydropriming on the viability o f the aged seed of hybrid NS 4023 imply a possible limitation to deferred sowing of primed maize seed.

APA, Harvard, Vancouver, ISO, and other styles

11

Crabtree, Aaron, and John J. Maher. "The Influence of Differences in Taxable Income and Book Income on the Bond Credit Market." Journal of the American Taxation Association 31, no. 1 (March 1, 2009): 75–99. http://dx.doi.org/10.2308/jata.2009.31.1.75.

Full text

Abstract:

ABSTRACT: We examine the importance of information pertaining to the relationship between taxable income and reported book income to bond rating analysts. Specifically, using a relatively large sample of new bond issues over an extended period of time, we examine information related to deferred taxes as well as the overall tax-to-book position in the assessment of a firm's default risk. Our results are consistent with the existence of a U-shaped relationship, with firms falling in the extreme upper or lower quintiles of their industry-year group receiving lower bond ratings than firms that are nearer to their industry average. Additional analyses suggest this effect is partially diminished for firms identified as highly effective tax planners. Finally, examination of investors' bond yields provides further corroborating evidence with respect to the importance and treatment of the information provided by the firm's overall tax-to-book position.

APA, Harvard, Vancouver, ISO, and other styles

12

Ettinger, Russell E., Theodore A. Kung, Natalie Wombacher, Mary Berger, M. Haskell Newman, Steven R. Buchman, and Steven J. Kasten. "Timing of Furlow Palatoplasty for Patients With Submucous Cleft Palate." Cleft Palate-Craniofacial Journal 55, no. 3 (December 14, 2017): 430–36. http://dx.doi.org/10.1177/1055665617726989.

Full text

Abstract:

Background: Submucous cleft palate (SMCP) is the most common form of cleft involving the posterior palate, resulting in variable degrees of velar dysfunction and speech disturbance. Although early surgical intervention is indicated for patients with true cleft palate, the indications for palatoplasty and timing of surgical intervention for patients with SMCP remain controversial. Methods: Twenty-nine patients with SMCP were retrospectively reviewed. Patients treated with Furlow palatoplasty were dichotomized based on patient age at the time of surgical correction into early speech development and late speech development. Primary outcome measures included standardized assessments of hypernasal resonance and quantitative pre- and postoperative nasometry scores. Patients managed nonoperatively were included for comparison of early and late speech outcomes. Results: Both early and late groups demonstrated improvement in qualitative assessment of hypernasal resonance following Furlow palatoplasty. Early and late groups also had significant improvement in pre- to postoperative nasometry scores from 7.4 to 2.3 SD from norm ( P = .01) and 6.0 to 3.6 SD from norm ( P = .02), respectively. There was no difference in postoperative nasometry scores between early and late groups, 2.3 and 3.6 SD ( P = .12). Conclusion: Furlow palatoplasty significantly improves the degree of hypernasality in patients with SMCP based on pre- and postoperative nasometry scores and on qualitative assessment of hypernasality. There were no differences in speech outcomes based on early compared with late operative intervention. Therefore, early palatal repair is not obligatory for optimal speech outcomes in children with SMCP and palatoplasty should be deferred until the emergence of overt velopharyngeal insufficiency.

APA, Harvard, Vancouver, ISO, and other styles

13

Campbell, Philip, Tongted Das, David Kipp, Patricia A. Walker, Jenny Muirhead, Sharon Avery, Sushrut S. Patil, et al. "Incidence and Kinetics Of Full Donor Chimerism and The Impact Of Minimal Residual Disease Status Following Outpatient Non-Myeloablative Allogeneic Stem Cell Transplantation For Myeloma." Blood 122, no. 21 (November 15, 2013): 2129. http://dx.doi.org/10.1182/blood.v122.21.2129.2129.

Full text

Abstract:

Abstract Background Chimerism analysis is routinely performed following allogeneic haemopoietic stem cell transplantation (allo HSCT) as a means of monitoring donor engraftment and relapse risk, although its role in the management of allografted myeloma patients is controversial. Multiparameter flow cytometry (MFC) assessment of minimal residual disease has been demonstrated to predict outcome following myeloblative autologous stem cell transplantation (ASCT) in multiple myeloma (MM). Relapse and disease progression is the principle cause of allograft failure and the detection of minimal residual disease (MRD) following tandem autologous/non-myeloablative(NMA) allo HSCT may potentially identify patients at risk of early relapse and provide a platform for early post-allograft therapy designed to further cytoreduce or enhance alloreactive T cell function and graft versus myeloma effect. Aim To evaluate the impact of MRD assessment performed at 3 months post-allo HSCT on PFS and OS and document the incidence and kinetics of full donor chimerism (FDC) in a cohort of myeloma patients undergoing tandem ASCT/outpatient non-myeloablative (NMA) allogeneic HSCT for MM. Methods Retrospective analysis of 33 MM patients referred to our centre for tandem ASCT/outpatient NMA HSCT between May 2008 and December 2012. Patients were transplanted as part of their front line management (upfront) (n=18) if they had one or more high risk disease features (poor prognosis cytogenetics/FISH abnormalities, elevated LDH, stage III disease or less than a PR following a novel agent-containing induction regimen) or as a ‘deferred’ procedure (n=15), if relapsing/progressing after an initial ASCT and maintenance/consolidation. Allo HSCT was undertaken as an ambulatory procedure and conditioned with oral fludarabine 48mg/m2 on days -4 to -2 and 2Gy TBI on day 0 followed by donor stem cell infusion, with a target CD34 dose of 2 x 106/kg and T cell dose of 3 x 108/kg. Sequential peripheral blood monitoring of CD3+ and CD33+ donor-specific chimerism was performed on days 30, 60, 90, 180 and 365 following allo HSCT. Bone marrow samples were collected for MRD analysis using MFC incorporating a CD56/CD19/CD45 panel following CD38/CD138 gating on plasma cells. MRD assessment was performed every 3 months during the first 12 months, 6 monthly during the second year and annually thereafter. Results The median age for the entire cohort (M 19, F 14) was 52 years (range 39-65) and the analysis performed after a median follow up of 719 days (50-1733). All patients were transplanted using matched sibling (20/33) or unrelated donors (13/33). Non-relapse mortality was 0% at 1 year and 6% overall. At the time of analysis, 26 (79%) patients were alive including 15 (45%) in CR. The median PFS for all patients was 2.8 years and although the median OS for the entire cohort has not been reached, the estimated probability of overall survival at 4 years is 67% (95% CI: 38-85%). 29/33 (88%) patients had MRD assessments performed at least once post-allo HSCT and 4 patients progressed within 3 months prior to MRD evaluation. At the first 3 month assessment, 11/29 (38%) were MRD +, 12/29 (41%) were MRD – , results were unavailable in 3/29 (10.5%) and 3 (10.5%) patients had morphological evidence of disease. Patients achieving MRD negativity at 3 months had superior PFS in comparison to those who remained MRD positive (median 2.81 years v 1.02 years; p=0.01) but this has yet to translate into an OS advantage. The MRD + patients transplanted as a deferred procedure (n=6) had a median PFS of less than 6 months (0.47 years), suggesting this subset of patients have a particularly poor outcome, although overall numbers are insufficient to directly compare outcome according to MRD status and transplant timing. 30 (91%) patients achieved FDC (16 and 14 in the upfront and deferred groups respectively) with 2 patients not assessed. The median time to FDC for the entire cohort was 180 days (range 30-730) and there was no significant difference according to transplant timing or relationship between FDC and MRD status, GVHD, PFS or PS. Conclusion The majority of patients undergoing outpatient-based tandem ASCT/NMA allo HSCT for myeloma achieve FDC. MRD status as assessed by MFC at 3 months post-allo HSCT appears to predict PFS and may be a useful early trigger for additional post-allograft therapy, particularly in patients with high risk disease or those transplanted later in their disease course. Disclosures: Spencer: Celgene: Honoraria, Membership on an entity’s Board of Directors or advisory committees.

APA, Harvard, Vancouver, ISO, and other styles

14

Lee, Christine M., Michelle Moh, Peggy S. Sullivan, and Neda A. Moatamed. "An Unusual Adenomatoid Tumor of Fimbria with Pronounced Psammoma Bodies in a BRCA Positive Patient as a Pitfall for Carcinoma on Frozen Section." Case Reports in Pathology 2018 (November 21, 2018): 1–5. http://dx.doi.org/10.1155/2018/8148147.

Full text

Abstract:

Background. BRCA gene mutations significantly increase the risk of breast and ovarian cancers where the lifetime risk of the ovarian cancer is about 40%. Therefore, many women with such mutations undergo prophylactic bilateral mastectomy and salpingo-oophorectomy. About 5-6% of these individuals display occult carcinomas in tubo-ovarian locations of which over 85% are tubal in origin. The objective of this case study was to emphasize emergence of benign lesions mimicking cancer under these circumstances. Case Report. We present a case with positive BRCA1 mutation who underwent the prophylactic procedure where a small mass was identified in her fallopian tube. Our initial encounter with this tumor was during intraoperative consultation. The tumor was associated with extensive psammoma bodies arranged in closely packed small tubules, mimicking serous carcinoma. Frozen section limitations including artifact, time constraint, and lack of ancillary studies as well as the clinical history further complicated our diagnostic assessment, which was deferred. A diagnosis of adenomatoid tumor was rendered on permanent sections. Conclusion. It is important to be familiar with this morphologic presentation of adenomatoid tumor as it is a pitfall for carcinoma, particularly on frozen section, and inaccurate diagnosis could lead to further unnecessary extensive procedures.

APA, Harvard, Vancouver, ISO, and other styles

15

Коробейникова, Екатерина, and Ekaterina Korobeinikova. "THE ANALYSIS OF CLIENTS IN THE CONTROL SYSTEM OF RECEIVABLES." Bulletin of Kemerovo State University. Series: Political, Sociological and Economic sciences 2017, no. 3 (September 25, 2017): 49–54. http://dx.doi.org/10.21603/2500-3372-2017-3-49-54.

Full text

Abstract:

The article presents a system of accounts of receivable management, including the methodology for its analysis in terms of customer base. The study was conducted with the purpose of optimization of client work within the accounts receivable management, improving the speed and quality of managerial decisions. Deferred payment in the sale of products (works, services) is considered as the basis of trustful and lasting relationships with clients, as it determines the attractiveness of the transaction, contributes to the preservation and expansion of client base. In the management of accounts legal, organizational and economic aspects can be distinguished. System analysis of receivables includes such areas as the analysis of the dynamics and structure of receivables, speed and time of its circulation, the analysis in the context of the debtors ‘ businesses and the analysis of the customer base, performance assessment of the sales divisions, the level of risk of non-payment, delinquency of payment. The developed method of structural-group analysis of customers-debtors, built on a modiﬁcation of the RFM analysis. The method of analysis of the clients-debtors allows them to rank in status, according to which transaction terms have to be adjusted.

APA, Harvard, Vancouver, ISO, and other styles

16

Alcock, Susan, Divjeet Batoo, Sudharsana Rao Ande, Rob Grierson, Marco Essig, Douglas Martin, Anurag Trivedi, et al. "Early diagnosis of mortality using admission CT perfusion in severe traumatic brain injury patients (ACT-TBI): protocol for a prospective cohort study." BMJ Open 11, no. 6 (June 2021): e047305. http://dx.doi.org/10.1136/bmjopen-2020-047305.

Full text

Abstract:

IntroductionSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI.Methods and analysisThe Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients.Ethics and disseminationThis study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study.Trial registration numberNCT04318665

APA, Harvard, Vancouver, ISO, and other styles

17

O’Sullivan, Jane, Jack Collins, David Cooper, Ana Magdalina, Frances Meehan, Lachmann Kumar, John Quinlan, Donal O’Connor, and Gerry Fitzpatrick. "Optimisation of perioperative investigations among elective orthopaedic patients in a Dublin-based teaching hospital." Journal of Perioperative Practice 29, no. 9 (December 19, 2018): 291–99. http://dx.doi.org/10.1177/1750458918813254.

Full text

Abstract:

Background The current National Institute for Health and Care Excellence guidelines, in accordance with the Association of Anaesthetists of Great Britain and Ireland guidelines, recommend the following haematological investigations for all patients undergoing major elective surgery: full blood count, renal profile and coagulation screen if clinically indicated. However, the guidelines fail to specify a time-interval for which normal blood results remain valid. Currently all patients in Ireland undergoing substantial elective surgery requiring general or regional anaesthetic have a preoperative assessment prior to the surgery. Patients have phlebotomy performed as part of this assessment. Patients admitted for elective surgery often have these bloods repeated on the morning of surgery. Objectives To determine if blood investigations taken over a one-year period prior to surgery can be used as a baseline for clinically stable patients undergoing elective surgery. Study design and methods All consecutive day of surgery admission patients >18 years of age undergoing elective orthopaedic surgery in Tallaght Hospital between 1 December 2014 and 1 December 2015 were identified using hospital records. Their blood results in the one-year period prior to surgery were compared to the blood results on the morning of surgery, using a McNemar’s test. A further clinical analysis was performed. Results There was no statistically significant change between blood results from three months prior to the surgery and the morning of surgery (P < 0.05). Furthermore, the blood results remained largely unchanged in the one year prior to surgery. No patient had the operation deferred due to aberrant blood results, following previously normal results prior to surgery. The potential cost-saving of omitting bloods is enormous. Conclusions There appears to be neither a statistical nor clinical benefit to repeating blood tests on the morning of surgery, following normal bloods <3 months in a clinically stable individual.

APA, Harvard, Vancouver, ISO, and other styles

18

Bayerlein, Leopold, and Omar Al Farooque. "Influence of a mandatory IFRS adoption on accounting practice." Asian Review of Accounting 20, no. 2 (July 13, 2012): 93–118. http://dx.doi.org/10.1108/13217341211242169.

Full text

Abstract:

PurposeThe purpose of this paper is to evaluate the changes of accounting policy choices and the harmonisation of accounting practices for two important financial reporting items within and between three IFRS adopting countries. Furthermore, it aims to address methodological shortcomings in the prior harmonisation literature through the introduction of two newly developed significance assessment methodologies.Design/methodology/approachThe influence of the mandatory IFRS adoption in Australia (AUS), Hong Kong (HK) and the UK on deferred taxation (DT) and goodwill (GW) accounting practices as well as the within and between country harmonisation of accounting practices is investigated through an event type study. These investigations are conducted using a McNemar test with Bowker extension as well as the Split C‐Index with a newly developed bootstrapping significance testing methodology.FindingsThis study demonstrates that the mandatory IFRS adoption in the analysed countries is linked to a significant harmonisation of DT and GW accounting practices between AUS, HK and the UK. Furthermore, the increase of adequate accounting policy information in the financial reporting documents of UK firms over the period of this study is identified as an important harmonisation accelerator.Originality/valueThis study adds to the prior literature due to its focus on the mandatory IFRS adoption within the analysed countries. Furthermore, the introduction of two newly developed methodologies to evaluate the significance of accounting policy choice changes and harmonisation over time addresses an important methodological shortcoming in the prior literature.

APA, Harvard, Vancouver, ISO, and other styles

19

Euden, Joanne, Emma Thomas-Jones, Stephen Aston, Lucy Brookes-Howell, Julie Carman, Enitan Carrol, Stephanie Gilbert, et al. "PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label, randomised controlled trial." BMJ Open 12, no. 6 (June 2022): e063424. http://dx.doi.org/10.1136/bmjopen-2022-063424.

Full text

Abstract:

IntroductionSepsis is a common, potentially life-threatening complication of infection. The optimal treatment for sepsis includes prompt antibiotics and intravenous fluids, facilitated by its early and accurate recognition. Currently, clinicians identify and assess severity of suspected sepsis using validated clinical scoring systems. In England, the National Early Warning Score 2 (NEWS2) has been mandated across all National Health Service (NHS) trusts and ambulance organisations. Like many clinical scoring systems, NEWS2 should not be used without clinical judgement to determine either the level of acuity or a diagnosis. Despite this, there is a tendency to overemphasise the score in isolation in patients with suspected infection, leading to the overprescription of antibiotics and potentially treatment-related complications and rising antimicrobial resistance. The biomarker procalcitonin (PCT) has been shown to be useful in specific circumstances to support appropriate antibiotics prescribing by identifying bacterial infection. PCT is not routinely used in the care of undifferentiated patients presenting to emergency departments (EDs), and the evidence base of its optimal usage is poor. The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.Methods and analysisPRONTO is a parallel two-arm open-label individually RCT set in up to 20 NHS EDs in the UK with a target sample size of 7676 participants. Participants will be randomised in a ratio of 1:1 to standard clinical management based on NEWS2 scoring or standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment. We will compare whether the addition of PCT measurement to NEWS2 scoring can lead to a reduction in intravenous antibiotic initiation in ED patients managed as suspected sepsis, with at least no increase in 28-day mortality compared with NEWS2 scoring alone (in conjunction with local standard care pathways). PRONTO has two coprimary endpoints: initiation of intravenous antibiotics at 3 hours (superiority comparison) and 28-day mortality (non-inferiority comparison). The study has an internal pilot phase and group-sequential stopping rules for effectiveness and futility/safety, as well as a qualitative substudy and a health economic evaluation.Ethics and disseminationThe trial protocol was approved by the Health Research Authority (HRA) and NHS Research Ethics Committee (Wales REC 2, reference 20/WA/0058). In England and Wales, the law allows the use of deferred consent in approved research situations (including ED studies) where the time dependent nature of intervention would not allow true informed consent to be obtained. PRONTO has approval for a deferred consent process to be used. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences.Trial registration numberISRCTN54006056.

APA, Harvard, Vancouver, ISO, and other styles

20

Wintzek, Patrick, Shawki Alsayed Ali, Markus Zdrallek, Julian Monscheidt, Ben Gemsjäger, and Adam Slupinski. "Development of Planning and Operation Guidelines for Strategic Grid Planning of Urban Low-Voltage Grids with a New Supply Task." Electricity 2, no. 4 (December 16, 2021): 614–52. http://dx.doi.org/10.3390/electricity2040035.

Full text

Abstract:

In contrast to rural distribution grids, which are mostly “feed-in oriented” in terms of electrical power, urban distribution grids are “load oriented”, as the number of customer connections and density of loads in urban areas is significantly higher than in rural areas. Taking into account the progressive electrification of the transport and heating sector, it is necessary to assess the required grid optimization or expansion measures from a conventional, as well as an innovative point of view. This is necessary in order to be able to contain the enormous investment volumes needed for transforming the energy system and aligning the infrastructures to their future requirements in time. Therefore, this article first explains the methodological approach of allocating scenarios of the development of electric mobility and heat pumps to analyzed grids. The article continues with describing which power values need to be applied and which conventional and innovative planning measures are available for avoiding voltage band violations and equipment overloads within the framework of strategic grid planning. Subsequently, the results of grid planning studies are outlined and evaluated with an assessment model that evaluates capital as well as operational costs. On this basis, planning and operation guidelines for urban low-voltage grids are derived. The main result is that low-voltage grids can accommodate charging infrastructure for electric mobility, as well as heat pumps to a certain degree. In addition, it is concluded that conventional planning measures are not completely avoidable, but can be partially avoided or deferred through dynamic load management.

APA, Harvard, Vancouver, ISO, and other styles

21

Tan, Vanessa, Gregory Ang, Kim Huat Goh, Adrian Yeow, Gamaliel Tan, and Cynthia Chen. "IMPACT OF COVID-19 MOVEMENT CONTROL ON OLDER ADULTS’ HEALTHCARE UTILIZATION." Innovation in Aging 6, Supplement_1 (November 1, 2022): 314–15. http://dx.doi.org/10.1093/geroni/igac059.1244.

Full text

Abstract:

Abstract Singapore was one of the first countries affected by COVID-19. Measures to contain the spread of COVID-19 include raising the Disease Outbreak Response System Condition (DORSCON) risk assessment to Orange and instituting a movement control order, termed as the Circuit Breaker. These measures have caused significant disruption in primary care and chronic disease management. As the first point of contact in testing suspected cases, primary care providers shifted their focus from non-COVID-19 services. Using an interrupted time series analysis, we examine the associations of DORSON Orange and Circuit Breaker on acute and chronic primary care visits among older adults aged above 50. We found significant reductions in both acute and chronic primary care visits immediately following DORSCON Orange and Circuit Breaker. DORSCON Orange was associated with a drop of 231 mean acute and chronic daily visits (95% CI -356 to -106). Circuit Breaker was associated with a further drop of 268 mean daily visits (95% CI -426 to -111). These reductions were also observed for acute and chronic visits separately. Routine chronic care appointments were deferred or cancelled to reduce the risk of transmission as patients with underlying medical conditions were at higher risk of developing severe complications. Delayed access to primary care can have profound health implications, especially for older adults. Ensuring accessibility to primary care is a key priority in maintaining population health. Understanding the impact of COVID-19 tightening measures on older adults’ primary care utilisation will be useful for future public health planning.

APA, Harvard, Vancouver, ISO, and other styles

22

Horning, SJ, N. Galili, M. Cleary, and J. Sklar. "Detection of non-Hodgkin's lymphoma in the peripheral blood by analysis of antigen receptor gene rearrangements: results of a prospective study." Blood 75, no. 5 (March 1, 1990): 1139–45. http://dx.doi.org/10.1182/blood.v75.5.1139.1139.

Full text

Abstract:

Abstract Analysis of immunoglobulin (Ig) and T-cell receptor gene rearrangements, using Southern blot hybridization, has been applied to peripheral blood lymphocytes (PBL) in 335 samples from patients with non-Hodgkin's lymphoma. The incidence of circulating lymphoma cells detected by gene rearrangement analyses is related to the histologic subtype, clinical stage of disease, and clinical status. Among 104 patients studied at diagnosis, the incidence of positive analyses was 34% in low-grade lymphoma and only 8% in intermediate-grade lymphoma. Clonal Ig gene rearrangements were detected nearly universally in the small lymphocytic histologic subtype. PBL studies were related to the initial stage of disease: positive studies were seen in 35% of patients with stage IV disease, 29% of patients with stage III disease, and 12% of patients with stages I-II disease. The incidence of PBL rearrangements at the time of disease recurrence in 32 patients requiring cytoreductive therapy was 48%, somewhat greater than at initial diagnosis. A group of patients with low-grade lymphoma, who had treatment deferred after diagnosis or recurrence, was also studied; the incidence of PBL rearrangements was 38% in this population. Among 157 patients clinically free of disease, DNA analyses of the PBL were positive in only 10%. Subsequent relapse of disease in 26 patients was antedated by PBL rearrangement in only one patient. Clonal rearrangements detected in 15 patients have been followed by recurrence of clinical disease in only one patient over a median of 24 months from the time of analysis. The lack of detectable rearrangements in the peripheral blood in the majority of patients may be due to methodology or the biology of the disease. These issues may be further addressed with alternative methods for assessment of minimal disease. However, rigorous testing of any new molecular tool requires an adequate patient population in which disease status is closely monitored over a sufficient period of time.

APA, Harvard, Vancouver, ISO, and other styles

23

Horning, SJ, N. Galili, M. Cleary, and J. Sklar. "Detection of non-Hodgkin's lymphoma in the peripheral blood by analysis of antigen receptor gene rearrangements: results of a prospective study." Blood 75, no. 5 (March 1, 1990): 1139–45. http://dx.doi.org/10.1182/blood.v75.5.1139.bloodjournal7551139.

Full text

Abstract:

Analysis of immunoglobulin (Ig) and T-cell receptor gene rearrangements, using Southern blot hybridization, has been applied to peripheral blood lymphocytes (PBL) in 335 samples from patients with non-Hodgkin's lymphoma. The incidence of circulating lymphoma cells detected by gene rearrangement analyses is related to the histologic subtype, clinical stage of disease, and clinical status. Among 104 patients studied at diagnosis, the incidence of positive analyses was 34% in low-grade lymphoma and only 8% in intermediate-grade lymphoma. Clonal Ig gene rearrangements were detected nearly universally in the small lymphocytic histologic subtype. PBL studies were related to the initial stage of disease: positive studies were seen in 35% of patients with stage IV disease, 29% of patients with stage III disease, and 12% of patients with stages I-II disease. The incidence of PBL rearrangements at the time of disease recurrence in 32 patients requiring cytoreductive therapy was 48%, somewhat greater than at initial diagnosis. A group of patients with low-grade lymphoma, who had treatment deferred after diagnosis or recurrence, was also studied; the incidence of PBL rearrangements was 38% in this population. Among 157 patients clinically free of disease, DNA analyses of the PBL were positive in only 10%. Subsequent relapse of disease in 26 patients was antedated by PBL rearrangement in only one patient. Clonal rearrangements detected in 15 patients have been followed by recurrence of clinical disease in only one patient over a median of 24 months from the time of analysis. The lack of detectable rearrangements in the peripheral blood in the majority of patients may be due to methodology or the biology of the disease. These issues may be further addressed with alternative methods for assessment of minimal disease. However, rigorous testing of any new molecular tool requires an adequate patient population in which disease status is closely monitored over a sufficient period of time.

APA, Harvard, Vancouver, ISO, and other styles

24

Kajka, Natalia. "The influence of metacognitive training on the improvement of working memory in children with ADHD." Current Problems of Psychiatry 20, no. 3 (September 1, 2019): 217–27. http://dx.doi.org/10.2478/cpp-2019-0015.

Full text

Abstract:

Abstract The purpose of the study is to check whether the memory will be strengthened after three months of metacognitive training using such mnemonic techniques as Mind Maps and Sketchnoting in children diagnosed with ADHD. According to the most recent, the Fifth Edition of The Diagnostic and Statistical Manual of Mental Disorders, working memory plays a key role both in the symptoms of ADHD and in secondary problems such as: learning disorders, professional or social difficulties. Method: 45 schoolchildren took part in the experimental study (M=1,42; SD = 10,41;). .Each child had a diagnosed psychomotor overexcitability and attention disorders. The participants were randomly qualified into three groups: the first group was tested for the effect of Mind Maps; the second group, for the effect of Sketchnoting while the third group was assigned the role of a control group. All of the groups were administered The Deferred Naming Test before and after the training. This assessment method belongs to the PU-1 Set of Diagnostic Tests. Results: The working memory improved in each of the three groups. The smallest number of errors were made by the children in the group with Mind Maps, while the biggest number of errors were made by the children in the control group. Conclusion: Mind Maps can be an important complement to other forms of therapeutic treatment for children with ADHD diagnosis. Regular use of this tool in education or therapy strengthens the memory. The improvement of this executive function can be substantial in learning to write and read (memorization of the correct shapes of letters), remembering and recalling from memory the rules agreed with the child or better time orientation.

APA, Harvard, Vancouver, ISO, and other styles

25

Desidera, S., G. Chauvin, M. Bonavita, S. Messina, H. LeCoroller, T. Schmidt, R. Gratton, et al. "The SPHERE infrared survey for exoplanets (SHINE)." Astronomy & Astrophysics 651 (July 2021): A70. http://dx.doi.org/10.1051/0004-6361/202038806.

Full text

Abstract:

Context. Large surveys with new-generation high-contrast imaging instruments are needed to derive the frequency and properties of exoplanet populations with separations from ~5 to 300 au. A careful assessment of the stellar properties is crucial for a proper understanding of when, where, and how frequently planets form, and how they evolve. The sensitivity of detection limits to stellar age makes this a key parameter for direct imaging surveys. Aims. We describe the SpHere INfrared survey for Exoplanets (SHINE), the largest direct imaging planet-search campaign initiated at the VLT in 2015 in the context of the SPHERE Guaranteed Time Observations of the SPHERE consortium. In this first paper we present the selection and the properties of the complete sample of stars surveyed with SHINE, focusing on the targets observed during the first phase of the survey (from February 2015 to February 2017). This early sample composed of 150 stars is used to perform a preliminary statistical analysis of the SHINE data, deferred to two companion papers presenting the survey performance, main discoveries, and the preliminary statistical constraints set by SHINE. Methods. Based on a large database collecting the stellar properties of all young nearby stars in the solar vicinity (including kinematics, membership to moving groups, isochrones, lithium abundance, rotation, and activity), we selected the original sample of 800 stars that were ranked in order of priority according to their sensitivity for planet detection in direct imaging with SPHERE. The properties of the stars that are part of the early statistical sample wererevisited, including for instance measurements from the Gaia Data Release 2. Rotation periods were derived for the vast majority of the late-type objects exploiting TESS light curves and dedicated photometric observations. Results. The properties of individual targets and of the sample as a whole are presented.

APA, Harvard, Vancouver, ISO, and other styles

26

Royle, Pamela, Hema Mistry, Peter Auguste, Deepson Shyangdan, Karoline Freeman, Noemi Lois, and Norman Waugh. "Pan-retinal photocoagulation and other forms of laser treatment and drug therapies for non-proliferative diabetic retinopathy: systematic review and economic evaluation." Health Technology Assessment 19, no. 51 (July 2015): 1–248. http://dx.doi.org/10.3310/hta19510.

Full text

Abstract:

BackgroundDiabetic retinopathy is an important cause of visual loss. Laser photocoagulation preserves vision in diabetic retinopathy but is currently used at the stage of proliferative diabetic retinopathy (PDR).ObjectivesThe primary aim was to assess the clinical effectiveness and cost-effectiveness of pan-retinal photocoagulation (PRP) given at the non-proliferative stage of diabetic retinopathy (NPDR) compared with waiting until the high-risk PDR (HR-PDR) stage was reached. There have been recent advances in laser photocoagulation techniques, and in the use of laser treatments combined with anti-vascular endothelial growth factor (VEGF) drugs or injected steroids. Our secondary questions were: (1) If PRP were to be used in NPDR, which form of laser treatment should be used? and (2) Is adjuvant therapy with intravitreal drugs clinically effective and cost-effective in PRP?Eligibility criteriaRandomised controlled trials (RCTs) for efficacy but other designs also used.Data sourcesMEDLINE and EMBASE to February 2014, Web of Science.Review methodsSystematic review and economic modelling.ResultsThe Early Treatment Diabetic Retinopathy Study (ETDRS), published in 1991, was the only trial designed to determine the best time to initiate PRP. It randomised one eye of 3711 patients with mild-to-severe NPDR or early PDR to early photocoagulation, and the other to deferral of PRP until HR-PDR developed. The risk of severe visual loss after 5 years for eyes assigned to PRP for NPDR or early PDR compared with deferral of PRP was reduced by 23% (relative risk 0.77, 99% confidence interval 0.56 to 1.06). However, the ETDRS did not provide results separately for NPDR and early PDR. In economic modelling, the base case found that early PRP could be more effective and less costly than deferred PRP. Sensitivity analyses gave similar results, with early PRP continuing to dominate or having low incremental cost-effectiveness ratio. However, there are substantial uncertainties. For our secondary aims we found 12 trials of lasers in DR, with 982 patients in total, ranging from 40 to 150. Most were in PDR but five included some patients with severe NPDR. Three compared multi-spot pattern lasers against argon laser. RCTs comparing laser applied in a lighter manner (less-intensive burns) with conventional methods (more intense burns) reported little difference in efficacy but fewer adverse effects. One RCT suggested that selective laser treatment targeting only ischaemic areas was effective. Observational studies showed that the most important adverse effect of PRP was macular oedema (MO), which can cause visual impairment, usually temporary. Ten trials of laser and anti-VEGF or steroid drug combinations were consistent in reporting a reduction in risk of PRP-induced MO.LimitationThe current evidence is insufficient to recommend PRP for severe NPDR.ConclusionsThere is, as yet, no convincing evidence that modern laser systems are more effective than the argon laser used in ETDRS, but they appear to have fewer adverse effects. We recommend a trial of PRP for severe NPDR and early PDR compared with deferring PRP till the HR-PDR stage. The trial would use modern laser technologies, and investigate the value adjuvant prophylactic anti-VEGF or steroid drugs.Study registrationThis study is registered as PROSPERO CRD42013005408.FundingThe National Institute for Health Research Health Technology Assessment programme.

APA, Harvard, Vancouver, ISO, and other styles

27

Schweighofer, Carmen D., Florence Cymbalista, Carolin Müller, Raymonde Busch, Raphael Porcher, Petra Langerbeins, Bruno Cazin, et al. "Early Versus Deferred Treatment With Combined Fludarabine, Cyclophosphamide and Rituximab (FCR) Improves Event-Free Survival In Patients With High-Risk Binet Stage A Chronic Lymphocytic Leukemia – First Results Of a Randomized German-French Cooperative Phase III Trial." Blood 122, no. 21 (November 15, 2013): 524. http://dx.doi.org/10.1182/blood.v122.21.524.524.

Full text

Abstract:

Abstract Introduction Patients with asymptomatic early Rai or Binet stage chronic lymphocytic leukemia (CLL) do not benefit from mono-chemotherapy. Therefore, clinical observation without treatment (watch&wait; W&W) has been the gold standard for the management of these patients. Chemoimmunotherapy with FCR improves the outcome of patients with advanced CLL, but its efficacy in early stage disease has not been investigated. Several clinical and biological variables identify those patients who have a high risk of an aggressive disease course and who might benefit from early interventions. Consequently, this trial was conducted to test the value of FCR treatment in patients with early stage, high-risk CLL. Methods This report represents the endpoint and safety analysis of a randomized German-French cooperative phase III trial comparing the efficacy of early versus deferred FCR therapy in treatment-naïve Binet stage A CLL patients with a high risk of disease progression. Risk assessment was performed using 4 prognostic markers: Lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, an unmutated immunoglobulin heavy chain variable region gene (IGHV) status, and presence of unfavorable cytogenetics (del11q, del17p, trisomy 12) by fluorescence-in-situ hybridization. Presence of at least 2 versus less than 2 of these factors defined “high-risk” versus “low-risk” CLL. High-risk CLL patients were further randomized to receive either 6 cycles FCR (HR-FCR) or to be followed by a W&W strategy (HR-W&W). Patients with low-risk CLL were observed only (LR-W&W). Results Between 2005 and 2010, a total of 824 patients was enrolled, 423 patients in 69 centers of the German CLL Study Group and 401 patients in 25 centers of the French Cooperative Group on CLL. The diagnosis of CLL needed to be established no longer than 12 months prior to enrollment and patients were required to present with previously untreated stage Binet A CLL at the time of inclusion. Overall, 800 patients (97.1%) were stratified, 201 of them categorized as high-risk CLL (25.1%). There was no significant difference between high-risk patients from the two study groups regarding common baseline characteristics (e.g., age, sex, comorbidity, immunophenotype) and the distribution of risk factors used for stratification. 100 out of 201 high-risk patients were randomized to receive FCR therapy (HR-FCR), while 101 patients were allocated to the HR-W&W arm. 18 out of 100 patients (18%) withdrew consent for FCR therapy before treatment was started. 71 (86.6%) of 82 treated patients completed ≥4 cycles. The most common of 228 CTC grade III/IV adverse events reported within 12 months after treatment initiation were hematotoxicity (73.2% of patients) and infections (19.5% of patients). Three patients (3.7%) developed fatal CTC grade V infections (2 septic bacteremias, 1 of them with pulmonary aspergillosis; 1 encephalitis). Out of 79 patients available for response assessment until month 12 after treatment start, 76 showed a complete or partial remission (ORR 96.2%), 2 patients had stable disease (2.5%) and 1 patient had progressed (1.3%). After a median follow up of 46 months (range 0-88 months), HR-FCR patients demonstrated a significantly improved event-free survival (EFS) compared to HR-W&W patients (median EFS not reached versus 24.5 months, respectively, P<0.0001, Fig. 1). Overall survival was not significantly different between HR-FCR and HR-W&W with 181 high-risk patients (90%) being alive at last follow up. Both, HR-FCR and HR-W&W patients exhibited a significant shorter event-free and overall survival than LR-W&W patients, demonstrating an efficient prognostic segregation of patients by the risk assessment used for this trial (analysis based on the German LR-W&W cohort only, complete German-French LR-W&W data will be presented at the meeting). Conclusion This is the first randomized phase III trial investigating the efficacy of FCR chemoimmunotherapy in early stage CLL. So far, the study has revealed two major results: 1. A combination of clinical and biological factors can be used to identify early stage CLL patients who experience a rapid disease progression with unfavorable outcome, 2. FCR chemoimmunotherapy substantially improves event-free survival in early stage high-risk CLL. Disclosures: Langerbeins: Roche: travel grants Other. Cazin:roche: meeting invitation Other, Membership on an entity’s Board of Directors or advisory committees; GSK: meeting invitation, meeting invitation Other, Membership on an entity’s Board of Directors or advisory committees. Fischer:Mundipharma: Travel grants, Travel grants Other; Roche: Travel grants Other. Stilgenbauer:Roche: Consultancy, Research Funding, Travel grants Other; Mundipharma: Consultancy, Research Funding. Leblond:Roche : Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau; Janssen: Honoraria, Membership on an entity’s Board of Directors or advisory committees; Mundipharma: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau. Hallek:F. Hoffmann-La Roche: Consultancy, Honoraria, Research Funding.

APA, Harvard, Vancouver, ISO, and other styles

28

Soumerai, Jacob D., Kurt S. Bantilan, Ai Ni, Connie Batlevi, Anna Alperovich, Katy Smith, Zhitao Ying, et al. "Intervention Versus Observation: What Is the Appropriate Endpoint? Assessment of Endpoints in Patients with Advanced Stage Follicular Lymphoma Who Are Initially Observed." Blood 128, no. 22 (December 2, 2016): 1777. http://dx.doi.org/10.1182/blood.v128.22.1777.1777.

Full text

Abstract:

Abstract BACKGROUND: Treatment may be safely deferred in asymptomatic patients with advanced stage, low tumor burden follicular lymphoma (FL) until onset of symptoms or organ failure without compromising overall survival (OS). A randomized trial comparing immediate rituximab vs. observation in this setting reported a Time to New Treatment benefit without a corresponding OS benefit (Ardeshna et al, Lancet Oncol 2014). This is a comparison of Time to 1st Treatment (TT1T, observation arm) vs. Time to 2nd Treatment (TT2T, rituximab arm) and thus biased to immediate intervention. TT2T might be a less biased primary endpoint for trials evaluating immediate intervention vs. observation. Time to Treatment n (TT(n)T) is a function of cumulative time spent from diagnosis in periods of observation, treatment, and remission, and TT(n)T approaches OS as n approaches the maximum number of therapies received, thus we also hypothesize that TT2T might be a surrogate for OS. We have therefore performed a comprehensive evaluation of standard endpoints (TT1T, OS, and EFS12), described TT2T as a novel endpoint for trials evaluating intervention vs. observation in asymptomatic patients with advanced stage, low tumor burden FL, and aimed to determine if TT2T is a reliable surrogate for OS. METHODS: We identified 246 consecutive patients at our institution, diagnosed from 1998 to 2007 with advanced stage, low tumor burden follicular lymphoma grade 1-3A, for whom physician intention at diagnosis was observation. Median time to event was calculated using the Kaplan-Meier method for each event: TT1T, TT2T, and OS. Modified Kendall's tau was used to assess the correlation between TT1T, TT2T, and OS, accounting for censoring in these quantities. Tests of modified Kendall's tau against 0 (i.e. no correlation) were performed. EFS12 was defined as non-death event within 12 months of initiation of first treatment, and median OS for EFS12 analysis was calculated from end of first treatment. Of 69 patients who received chemoimmunotherapy as first therapy following initial observation, the log-rank test was used to compare survival distributions by EFS12. RESULTS: Of 246 patients with advanced stage, follicular lymphoma grade 1-3A for whom physician intention at diagnosis was observation, there was a slight female predominance (1.16:1), 34.6% were above age 60 with a median age of 56.1 years (range 25-88), and 11.8% (29/246) developed histologic transformation prior to 1st/2nd therapy, including 7.7% (19/246) prior to 1st treatment. At a median follow-up of 10.9 years: median TT1T was 43.5 months (3.5-217.4+, 179 events), median TT2T was 151.8 months (range 5.2-219.6+, 101 events), and median OS was not reached (range 5.2-219.6+, 48 events). The modified Kendall's tau measuring correlation between TT1T and OS was 0.012 (p = 0.537), and was 0.078 (p < 0.001) between TT2T and OS, suggesting that TT2T is strongly correlated with OS while TT1T is not. Failure to achieve EFS12 was observed in 10.3% (7/68) and associated with inferior OS (p=0.001). Of 7 patients who failed to achieve EFS12, 3 had histologic transformation. CONCLUSIONS: TT2T is a preferred primary endpoint for clinical trials evaluating intervention vs. observation. In patients with advanced stage, low tumor burden FL who are initially observed, the median time from diagnosis to 2nd treatment is 12.7 years. Future trials evaluating the role of immediate therapy in low tumor burden FL might restrict eligibility to high risk patients expected to have inferior TT2T. Efforts are ongoing to develop biomarkers (e.g. m7-FLIPI) that identify a population enriched with high risk patients. Our data also suggest that TT2T might be a better surrogate for OS than TT1T, and analyses are ongoing to validate this finding. Figure 1 Figure 1. Disclosures Hamlin: Molecular Templates: Research Funding; Seattle Genetics: Research Funding; Portola: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Research Funding; Xencor: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Horwitz:Spectrum: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy; Huya: Consultancy; Infinity: Consultancy, Research Funding; Kyowa Hakka Kirin: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Celgene: Consultancy; ADCT Therapeutics: Research Funding. Palomba:Pharmacyclics: Consultancy. Moskowitz:Merck: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding. Noy:Pharmacyclics, LLC, an AbbVie Company: Other: travel, accommodations, expenses, Research Funding. Kumar:Celgene: Research Funding; Pharmacyclics: Research Funding; Adaptive Biotechnologies: Research Funding; Seattle Genetics: Research Funding; Celgene: Honoraria, Other: Scientific Advisory Board. Zelenetz:Amgen: Consultancy; Takeda Pharma: Consultancy; Novartis: Consultancy; Nanostring Tech: Consultancy; Portola Pharmaceuticals: Consultancy; Adaptive Biotechnology: Consultancy; Bristol Myers: Research Funding; Boehringer Ingelheim: Other: DMC Membership; Janssen: Consultancy, Research Funding; Hospira: Consultancy; Celgene: Consultancy; Gilead: Consultancy, Research Funding; GSK: Consultancy, Research Funding; Genentech/Roche: Consultancy, Research Funding.

APA, Harvard, Vancouver, ISO, and other styles

29

Cocca, Carolina, and Michele Mincolelli. "Effects of endotracheal suctioning on respiratory parameters in Pediatric Intensive Care Unit: a prospective observational study." infermieristica journal 1, no. 1 (June 29, 2022): 30–35. http://dx.doi.org/10.36253/if-1658.

Full text

Abstract:

Introduction The endotracheal suctioning is an invasive practice performed in critical care units that allows removal of the pulmonary secretions in intubated patients. During this procedure, patients are exposed to potential risks that health professionals, should prevent or minimize. At date is a shortage of published studies on the frequency of endotracheal suction in pediatric critically ill patients. It is supposed that the endotracheal suction does not affect significantly the assessment of short-term respiratory parameters and therefore may be deferred by the clinical condition of the patient. Methods The study carried out from 1 January to 30 September 2016 in mechanically ventilated pediatric patients at pediatric intensive care unit of Salesi children’s Hospital of Ancona. The study involved the collection of two venous blood samples taken from a central venous catheter: the first blood gas analysis was performed on each patient 1 minute before endotracheal aspiration and after a time interval of about 30 minutes from the endotracheal suctioning a second sample from the same vascular access device. Mean and percentages were calculated for qualitative variables, mean and standard deviation were calculated for quantitative parameters. For inferential purposes, to evaluate the effects of endotracheal aspiration on respiratory parameters detected by blood gas analysis, the student T test was performed for paired data with a 95% confidence interval. Results A total of 40 patients were recruited, of which 14 were females (35%) and 26 were males (65%). The results were as follows: For pH, the mean of the difference in values is .0065 [95% CI -0.0067 - 0.0197]. According to T test for paired data, a p=.3256 was obtained. From the inferential point of view, this difference is not considered statistically significant. For the pO2 the mean of the difference in values is .03 [95% CI-1.62 -1.67]. According to T tests for paired data, a p =.9756 was obtained. For the pCO2, the mean of the difference in values is -1.88 [95% CI -3.81 - 0.06] with a p value = .0577. Discussion Our findings highlighted no statistically significant differences between pre and post endotracheal aspiration values of pH, pO2 and pCO2. This suggests that the aspiration has beneficial effects on the pulmonary mechanics. Therefore, it is declared that the reduction of the frequency of endotracheal aspiration pediatric cause a reduction of the related infectious risks, reducing costs and respiratory nosocomial infections leading to reduced length of hospital stay.

APA, Harvard, Vancouver, ISO, and other styles

30

Gilbert, Robert B., Larry W. Lake, Christopher J. Jablonowski, James W. Jennings, and Emilio Nunez. "A Procedure for Assessing the Value of Oilfield Sensors." SPE Reservoir Evaluation & Engineering 12, no. 04 (July 30, 2009): 618–29. http://dx.doi.org/10.2118/109628-pa.

Full text

Abstract:

Summary Spurred by improvements in reliability, cost, and accuracy, sensors offer a means of increasing expected ultimate hydrocarbon recovery in producing assets as well as in planned and prospective projects. Ultimate hydrocarbon recoveries larger than those currently achieved are possible, especially when sensors are used with advanced recovery methods. However, it is often unclear if the incremental recovery justifies the cost of installing the sensors. This paper proposes a method for estimating incremental values attributable to real-time sensors and provides a demonstration of the method for several production technologies and reservoir settings. The method offers a transparent and practical means of making value of information (VOI) computations to be implemented readily by project teams. An additional benefit of this method is that the process of specifying the inputs to the analysis facilitates a systematic discussion of strengths and weaknesses, and builds consensus regarding assumptions. The method is applied to four scenarios developed by a panel of industry experts to represent generic, but yet realistic reservoirs. The results for these scenarios indicate the value of sensors depends on the market price for product and the type of reservoir and production technology. The greatest absolute economic value for the use of sensors is obtained for a deepwater reservoir, while the greatest economic value per equivalent barrel of oil produced is obtained for a mature onshore reservoir. These expected economic values are intended to be compared to the cost required to implement the sensors to assess whether or not there is an expected net benefit. Introduction Formal methods of valuing information (sometimes called monetizing information) have existed in the research and professional literature for many years. Most publications on VOI have appeared in financial, economic, operations research, or decision analysis journals (Roberts and Weitzman 1981); little has appeared in engineering publications, especially petroleum engineering publications. Recently, a review of VOI in the oil and gas industry was presented by Bratvold et al. (2007). VOI methods are simple at the highest conceptual level: the values for courses of action with and without sensors are estimated and compared. The difference between the expected values with and without sensors is the expected value of the sensors and therefore represents the maximum willingness to pay (WTP) for the sensors. If the WTP for the sensors is greater than the cost of installation (e.g., sensor cost, installation costs, and deferred production) and operation of the sensors, their installation is expected to provide a net benefit. VOI assessments have the following components:They account for uncertainty in the outcome of decisions. The existence of uncertainty is the reason the valuation is based on expected values.They capture the ability of the sensors to change a decision. Typical decisions are an optimization of the current technology, immediate changes in technology, or the nature and timing of future technology changes.They allow for the sensors to change the monetary outcome of a course of action even when a decision is not changed by the information. This paper proposes a method for VOI assessment of real-time sensors and demonstrates the method for four different combinations of hydrocarbon recovery technologies and reservoir settings:CO2 injection in mature oil reservoirs,steam-assisted gravity drainage in heavy oil reservoirs,hydraulic fracturing in tight gas reservoirs, andwaterflooding in deepwater sandstone reservoirs. Drawing on industry experts, significant effort was made to make the cases as realistic as possible so the results can be used to inform the development of project- and corporate-level plans regarding the use of sensors. But, because of project and portfolio idiosyncrasies, the results are not to be viewed as definitive or totally generalizable.

APA, Harvard, Vancouver, ISO, and other styles

31

Harron, Katie, Quen Mok, Kerry Dwan, Colin H. Ridyard, Tracy Moitt, Michael Millar, Padmanabhan Ramnarayan, et al. "CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children." Health Technology Assessment 20, no. 18 (March 2016): 1–220. http://dx.doi.org/10.3310/hta20180.

Full text

Abstract:

BackgroundImpregnated central venous catheters (CVCs) are recommended for adults to reduce bloodstream infection (BSI) but not for children.ObjectiveTo determine the effectiveness of impregnated compared with standard CVCs for reducing BSI in children admitted for intensive care.DesignMulticentre randomised controlled trial, cost-effectiveness analysis from a NHS perspective and a generalisability analysis and cost impact analysis.Setting14 English paediatric intensive care units (PICUs) in England.ParticipantsChildren aged < 16 years admitted to a PICU and expected to require a CVC for ≥ 3 days.InterventionsHeparin-bonded, antibiotic-impregnated (rifampicin and minocycline) or standard polyurethane CVCs, allocated randomly (1 : 1 : 1). The intervention was blinded to all but inserting clinicians.Main outcome measureTime to first BSI sampled between 48 hours after randomisation and 48 hours after CVC removal. The following data were used in the trial: trial case report forms; hospital administrative data for 6 months pre and post randomisation; and national-linked PICU audit and laboratory data.ResultsIn total, 1859 children were randomised, of whom 501 were randomised prospectively and 1358 were randomised as an emergency; of these, 984 subsequently provided deferred consent for follow-up. Clinical effectiveness – BSIs occurred in 3.59% (18/502) of children randomised to standard CVCs, 1.44% (7/486) of children randomised to antibiotic CVCs and 3.42% (17/497) of children randomised to heparin CVCs. Primary analyses comparing impregnated (antibiotic and heparin CVCs) with standard CVCs showed no effect of impregnated CVCs [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.37 to 1.34]. Secondary analyses showed that antibiotic CVCs were superior to standard CVCs (HR 0.43, 95% CI 0.20 to 0.96) but heparin CVCs were not (HR 1.04, 95% CI 0.53 to 2.03). Time to thrombosis, mortality by 30 days and minocycline/rifampicin resistance did not differ by CVC. Cost-effectiveness – heparin CVCs were not clinically effective and therefore were not cost-effective. The incremental cost of antibiotic CVCs compared with standard CVCs over a 6-month time horizon was £1160 (95% CI –£4743 to £6962), with an incremental cost-effectiveness ratio of £54,057 per BSI avoided. There was considerable uncertainty in costs: antibiotic CVCs had a probability of 0.35 of being dominant. Based on index hospital stay costs only, antibiotic CVCs were associated with a saving of £97,543 per BSI averted. The estimated value of health-care resources associated with each BSI was £10,975 (95% CI –£2801 to £24,751). Generalisability and cost-impact – the baseline risk of BSI in 2012 for PICUs in England was 4.58 (95% CI 4.42 to 4.74) per 1000 bed-days. An estimated 232 BSIs could have been averted in 2012 using antibiotic CVCs. The additional cost of purchasing antibiotic CVCs for all children who require them (£36 per CVC) would be less than the value of resources associated with managing BSIs in PICUs with standard BSI rates of > 1.2 per 1000 CVC-days.ConclusionsThe primary outcome did not differ between impregnated and standard CVCs. However, antibiotic-impregnated CVCs significantly reduced the risk of BSI compared with standard and heparin CVCs. Adoption of antibiotic-impregnated CVCs could be beneficial even for PICUs with low BSI rates, although uncertainty remains whether or not they represent value for money to the NHS. Limitations – inserting clinicians were not blinded to allocation and a lower than expected event rate meant that there was limited power for head-to-head comparisons of each type of impregnation. Future work – adoption of impregnated CVCs in PICUs should be considered and could be monitored through linkage of electronic health-care data and clinical data on CVC use with laboratory surveillance data on BSI.Trial registrationClinicalTrials.gov NCT01029717.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 18. See the NIHR Journals Library website for further project information.

APA, Harvard, Vancouver, ISO, and other styles

32

Clutter, Courtney, and Morgan Jordan. "A Grave Initial Presentation of Graves’ Disease in a Patient With Moyamoya." Journal of the Endocrine Society 5, Supplement_1 (May 1, 2021): A913. http://dx.doi.org/10.1210/jendso/bvab048.1864.

Full text

Abstract:

Abstract Background: Moyamoya syndrome is chronic stenoocclusive disease involving the intracranial internal carotid arteries and their proximal branches along with an associated condition, such as hyperthyroidism1. The concurrence of moyamoya and Graves’ disease is rare. Ischemic stroke in moyamoya syndrome is postulated to be precipitated by thyrotoxicosis-induced hemodynamic instability. Clinical Case: A 63-year old Korean female with history of moyamoya disease with two prior ischemic strokes, hypertension and type 2 diabetes mellitus presented to the ER with 6 hours of left leg weakness and involuntary arm movements. A code stroke was activated and neurologic examination was notable for left leg paresis and left arm stereotypy. CT head showed loss of gray-white matter differentiation in the right frontal lobe concerning for acute ischemia. CT angiography of the head and neck noted diffuse stenosis of intracerebral vasculature and significant stenosis of the cavernous and supraclinoid portions of the internal carotid arteries. MRI brain later confirmed an acute infarct in the right ACA distribution. Neuroimaging incidentally showed a multinodular goiter with a 1.7 cm right thyroid nodule. Subsequently TSH was obtained and resulted as <0.030 mcIU/mL (0.27-5.00 mcIU/mL) with a reflex FT4 of >7.00 ng/dL (0.6-1.8 ng/dL). A review of her prior TFTs showed biochemical euthyroidism. Due to iodinated contrast administration on admission, RAIU scan was deferred. Thyroid ultrasound showed multinodular goiter with diffuse increased vascularity and multiple TI-RADS 4 and 5 nodules bilaterally. On further questioning, the patient reported tachycardia, diarrhea, weight loss and decreased appetite prior to hospitalization. A diagnosis of Graves’ disease was confirmed with TSI of 70.7 IU/L (0.00-0.55 IU/L). She was started on methimazole 20 mg twice daily and propranolol 20 mg q6h. FT4 downtrend from >7.00 to 3.3 ng/dL at time of discharge. Following four weeks of methimazole 20 mg daily, FT4 normalized to 1.70 ng/dL. The patient chose to continue antithyroidal drug therapy for treatment of Graves’ disease. Conclusion: Thyroid function assessment should be considered when evaluating a patient with moyamoya and acute ischemic stroke. If moyamoya syndrome associated with Graves’ disease is identified, treatment should be aimed at maintenance of euthyroidism. Reference: 1. Scott RM, Smith ER. Moyamoya disease and moyamoya syndrome. N Engl J Med. 2009 Mar 19;360(12):1226-37. Disclaimer: The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government.

APA, Harvard, Vancouver, ISO, and other styles

33

Yator, Obadia, Lincoln I. Khasakhala, Grace John-Stewart, and Manasi Kumar. "Acceptability and Feasibility of Group Interpersonal Therapy (IPT-G) for Depressed HIV+ Postpartum Adolescents Delivered by Community Health Workers: A Protocol Paper." Clinical Medicine Insights: Psychiatry 11 (January 2020): 117955732095122. http://dx.doi.org/10.1177/1179557320951222.

Full text

Abstract:

Introduction: Postpartum depression affects mothers at 4 to 6 weeks after delivery. Adolescent pregnancy can lead the expectant girl to drop out of school, receive poor obstetric care, and family support. Adolescent mothers are prone to severe postpartum depression as compared to older women. Early sexual initiation increases the risk of unintended pregnancies and potentially increases HIV exposure. WHO recommends Group interpersonal psychotherapy (IPT-G) as an evidence-based intervention for use in both primary care and community settings. We will assess the acceptability and feasibility of community health workers (CHWs), delivering IPT-G among postpartum adolescents (PPA) living with HIV. Method: This is a pilot feasibility study testing CHWs’ delivery of IPT-G to postpartum adolescents and young women living with HIV who will be attending the prevention of mother-to-child HIV transmission (PMTCT) clinics in 2 primary care health centers. Young women aged 15 to 24 years and 6 to 12 weeks postpartum will be eligible for participation. Our study is a two-arm intervention implementation study with one receiving group IPT and another one treatment-as-usual (TAU). We intend to treat the TAU group so that we will offer IPT-G post-intervention. There will be 2 groups running in the 2 facilities. Depression will be assessed using the Edinburgh postnatal depression scale (EPDS); those with EPDS >10 become eligible for the intervention. Besides, HIV-related stigma would be screened using HIV/AIDS Stigma Instrument (HASI–P), and social functioning rated using the World Health Organization’s Disability Assessment Schedule 2.0 (WHODAS 2.0). CHWs will deliver IPT-G for 8 sessions (1 session per week). The intervention group will receive immediate IPT-G, and the wait-list control group will receive deferred IPT-G as part of our intent to treat the group. Primary outcome measure and analysis: Descriptive statistics will be used to compare changes in depressive symptoms, HIV-related stigma, and social functioning between baseline and 8 weeks, and between 16 weeks and 24 weeks. The changes will be explored along with the differences between intervention and treatment as usual groups reporting effect sizes (Cohen’s d). Longitudinal continuous outcome variables across the time points will be analyzed using the Generalized Linear Model. For qualitative data, any emerging themes from KIIs and FGDs will be identified: framework matrixes, queries, and cross-tabulations will be used to analyze and interpret the data in view of assessing acceptability and feasibility of IPT-G. Ethics and dissemination The Kenyatta National Hospital-University of Nairobi approved this study of Nairobi Ethics and Research Committee (Approval No. P97/02/2018). The findings will be published in peer-reviewed journals and also shared with Kenya’s National AIDS Control Council.

APA, Harvard, Vancouver, ISO, and other styles

34

Murugaveni, S., B. Priyalakshmi, and K. Vijayan. "Energy Efficient Routing and Peer to Peer Trust Assessment for Increasing the Network Life Time in Delay Tolerant Networks." International Journal of Engineering & Technology 7, no. 3.12 (July 20, 2018): 726. http://dx.doi.org/10.14419/ijet.v7i3.12.16464.

Full text

Abstract:

In military network environments is resource-constrained arrange conditions, where end-to-end network is not ensured because of successive deferral, an efficient solution is required for trustful and energy efficient routing. Proposed work, provenance trust based routing is combined with energy efficient route to opt for a high network lifetime. Proposed scheme is designed for peer-to-peer trust assessment and maximize the delivery of correct messages received by destination nodes while minimizing message delay and communication cost Provenance alludes to the historical backdrop of responsibility for esteemed data. Proposed scheme avoids malicious node using provenance model and achieves good network lifetime using energy efficient routing strategy. Node’s trust is calculated dynamically in response to changes in the environmental and node conditions.

APA, Harvard, Vancouver, ISO, and other styles

35

Ruan, Jia, Peter Martin, Bijal D. Shah, Stephen J. Schuster, Sonali M. Smith, Richard R. Furman, Paul Christos, et al. "Combination Biologic Therapy Without Chemotherapy As Initial Treatment For Mantle Cell Lymphoma: Multi-Center Phase II Study Of Lenalidomide Plus Rituximab." Blood 122, no. 21 (November 15, 2013): 247. http://dx.doi.org/10.1182/blood.v122.21.247.247.

Full text

Abstract:

Abstract Background Initial treatment for mantle cell lymphoma (MCL) is not standardized. Current conventional upfront chemoimmunotherapies are generally not curative and can be deferred in some patients. This presents an opportunity to evaluate novel therapeutic approaches in the first line setting. Lenalidomide, an immunomodulatory compound which targets both the tumor cells directly and the tumor microenvironment, has shown clinical efficacy either alone or in combination with rituximab in relapsed MCL. We report findings of the first study of a chemotherapy-free approach as initial treatment for MCL, using lenalidomide and rituximab as a combination biologic doublet. Methods The study protocol includes both an induction phase and a maintenance phase. During the induction phase, lenalidomide is administered at 20 mg daily on days 1-21 of a 28-day cycle for a total of 12 cycles, with dose escalation to 25 mg daily if tolerated. Standard dose rituximab is administered weekly x 4 during cycle 1, then once every other cycle, for a total of 9 doses. During the maintenance phase which starts with cycle 13, lenalidomide is administered at 15 mg daily on days 1-21 of a 28-day cycle, with rituximab maintenance once every other cycle until progression of disease. The primary objective was to evaluate overall response rate (ORR). Secondary objectives included safety analysis, progression-free survival, overall survival, and QOL assessment. Based on a Simon two-stage design comparing an ORR of ≥60% with treatment to an unacceptable ORR of ≤40% (alpha=10%, power=80%), 15 or more overall responses out of 28 enrolled patients were required to declare the treatment effective and worthy of further testing. Results From 7/2011 to 2/2013, 31 subjects with previously untreated MCL were enrolled at 4 centers, and the study met its accrual. At study entry, median age was 65 years (range 42-86), and the M:F ratio was 3:1. All patients had stage III/IV disease, 12 (39%) had elevated LDH, and 27 (87%) had bone marrow involvement. MIPI scores were evenly distributed between low-, intermediate-, and high-risk (36%, 32%, and 32% respectively). Ki67 index was <30% in 23 (74%) subjects. Treatment was generally well tolerated with expected side effects. Grade 3-4 hematologic toxicities included neutropenia (39%), thrombocytopenia (13%) and anemia (7%). Grade 3-4 non-hematologic toxicities included rash (23%), tumor flare (7%) and serum sickness associated with rituximab (7%). Grade 1-2 infections included URI (29%), UTI (10%), pneumonia (10%) and sinusitis (7%). One incidence each of DVT and PE were observed and resolved with treatment. As of July 2013 at a median follow-up of 12 months (range 5-23 months), 27 (87%) patients remain on study without evidence of disease progression, including 18 who have completed induction and now in the maintenance phase. Four patients went off study – one withdrew consent, two had progression of disease, and one could not tolerate tumor flare associated side effects. Thirty patients are evaluable for efficacy with at least one response assessment. The preliminary ORR for evaluable patients is 77% (95% CI = 57% to 89%) with 40% CR/CRu (95% CI = 23% to 59%), and may further improve with additional follow-up on continued treatment. Median time to objective response was 2.8 months, with CR typically confirmed between 6-12 months. Four patients (13%) have stable disease with ongoing clinical benefit at 5+, 6+, 12+ and 13+ months. Median progression-free survival and duration of response have not been reached. Neither MIPI score nor Ki67 index correlated with response. All patients have maintained or improved quality of life parameters during treatment by FACT-Lym analysis. Conclusions This study provides the first demonstration that a chemotherapy-free, combination biologic approach is feasible as initial therapy for mantle cell lymphoma. Lenalidomide up to 25 mg daily given 21 out of 28 days can be safely combined with rituximab as frontline therapy for MCL. Preliminary efficacy data on response rates are encouraging. More precise assessment of response rate and durability will require more follow-up with additional subjects. However, these data justify further evaluation of the lenalidomide + rituximab regimen both alone and as a platform for the integration of novel agents in combination approaches in MCL both in the upfront and relapsed settings. Disclosures: Ruan: Celgene: Consultancy, Research Funding, Speakers Bureau. Off Label Use: Lenalidomide in the frontline treatment of mantle cell lymphoma. Martin:Seattle Genetics: Consultancy, Speakers Bureau; Millennium: Research Funding; Genentech: Speakers Bureau; Celgene: Consultancy, Research Funding; Teva: Consultancy, Research Funding. Shah:Celgene: Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau. Schuster:Celgene: Research Funding. Smith:Micromet: Consultancy; Seattle Genetics: Consultancy; Celgene: Consultancy; Allos: Consultancy; Genentech: Consultancy; Onyx: Consultancy. Furman:Celgene: Research Funding. Coleman:Celgene: Consultancy. Leonard:Celgene: Consultancy; Genentech: Consultancy.

APA, Harvard, Vancouver, ISO, and other styles

36

Duncan, Luke Mangaliso, Chiara D’Egidio Kotze, and Neville Pillay. "Long-Term Spatial Restriction Generates Deferred Limited Space Use in a Zoo-Housed Chimpanzee Group." Animals 12, no. 17 (August 27, 2022): 2207. http://dx.doi.org/10.3390/ani12172207.

Full text

Abstract:

Background: Appropriate space is considered paramount for good captive animal welfare. There has been a concerted effort by captive institutions, particularly zoos, to provide captive animals with relatively large, naturalistic enclosures which havehad demonstrated welfare benefits for animals. However, post-occupancy assessments of these enclosures tend to focus on short-term welfare-centredbehavioural effects or human perceptions of the enclosures and their effects and seldom consider spaceuse. We examined the space use of a group of eight captive chimpanzees 5 years after large-scale enclosure modification at the Johannesburg Zoo, South Africa. Methods: Instantaneous scan sampling was used to record behaviour and location of each chimpanzee at 5 min intervals in the new enclosure. From these 6.8 h of data, space-use patterns and subgroup (two or more chimpanzees within 10 m of each other) spacing were considered relative to local environmental variables, social conditions and the location and size of the previous smaller enclosures in which they had been kept. Results: Space use was heterogeneous, with some enclosure zones being used more than others, and 97.5% of subgroups restricted their spacing to the dimensions of the previous housing (10 m × 10 m). Conclusions: This pattern was not explained by individual behaviour, time of day, location, available space, weather, temperature or shade availability, inter-individual spacing or subgroup composition. We suggest the learned helplessness phenomenon may explain these observations and discuss the implications for both animal welfare and endangered species conservation.Regardless of the mechanism, we suggest that such effects could be avoided through the provision of large enclosures for captive animals.

APA, Harvard, Vancouver, ISO, and other styles

37

Brennan, David J., J. P. Armstrong, Maya Kesler, Tsegaye Bekele, Nathan J. Lachowsky, Daniel Grace, Trevor A. Hart, Rusty Souleymanov, and Barry D. Adam. "Willingness and eligibility to donate blood under 12-month and 3-month deferral policies among gay, bisexual, and other men who have sex with men in Ontario, Canada." PLOS Global Public Health 3, no. 1 (January 6, 2023): e0001380. http://dx.doi.org/10.1371/journal.pgph.0001380.

Full text

Abstract:

In Canada, gay, bisexual and other men who have sex with men (GBMSM) are a population that are willing to donate blood, if eligible, but have a history of ineligibility and deferrals due to concerns that their blood poses an increased risk of HIV entering the blood supply. Our objective was to examine the proportion of GBMSM who are willing and eligible to donate under the 12-month deferral policy (implemented in 2016) and the 3-month deferral policy (implemented in 2019). Data for this study comes from the #iCruise study, a mixed cohort study designed to examine sexual health outreach experiences through online services and mobile apps among GBMSM in Ontario. A total of 910 participants were recruited between July 2017 and January 2018. Eligibility criteria include identify as male (cisgender or transgender); at least 14 years old; having had sex with a man in the previous year or identifying as sexually/romantically attracted to other men or identifying as gay, bisexual, queer or two-spirit; and living or working in Ontario or having visited Ontario four or more times in the past year. Participants completed a baseline and a follow-up questionnaire. A subset of #iCruise participants (n = 447) further completed this questionnaire. Willingness and eligibility to donate blood were assessed under 12-month and 3-month deferral policies. Of the 447 GBMSM surveyed, 309 (69.1%) reported a general interest in donating blood. 109 (24.4%) GBMSM were willing, 75 (16.7%) were eligible, and 24 (5.4%) were both willing and eligible to donate blood under the 12-month deferral policy. Under the 3-month deferral policy, willingness and eligibility to donate blood increased significantly to 42.3% and 29.3%, respectively. The percent of GBMSM who were both willing and eligible to donate blood also increased significantly to 12.3% under the 3-month deferral policy. The increase in willingness to donate blood varied by age, ethnicity, and geographic residence of participants whereas the increase in eligibility to donate blood varied by education level of participants. Under the 3-month deferral policy, GBMSM who were 50 years or older, identified as bisexual or other, had a lower education level, and who were not ‘out’ to others were more likely to be eligible to donate. GBMSM who reported a general interest in donating blood were more likely to be willing to donate blood under both deferral policies. The most common reason for not being interested in donating blood was the MSM deferral policy itself; many participants interpreted the policy as discriminatory for ‘singling out’ GBMSM or self-assed themselves as ineligible. Among study participants, both willingness and eligibility to donate blood was significantly higher under the 3-month deferral policy. The results suggest that a time-based reduction to a 3-month deferral policy is impactful but limited. Future research should measure GBMSM’s willingness and eligibility under the individual risk-based assessment (to be implemented in 2022).

APA, Harvard, Vancouver, ISO, and other styles

38

Vidal Amaral, João Ricardo, Rommel Thiago Jucá Ramos, Fabrício Almeida Araújo, Rodrigo Bentes Kato, Flávia Figueira Aburjaile, Siomar de Castro Soares, Aristóteles Góes-Neto, et al. "Bacteriocin Producing Streptococcus agalactiae Strains Isolated from Bovine Mastitis in Brazil." Microorganisms 10, no. 3 (March 9, 2022): 588. http://dx.doi.org/10.3390/microorganisms10030588.

Full text

Abstract:

Antibiotic resistance is one of the biggest health challenges of our time. We are now facing a post-antibiotic era in which microbial infections, currently treatable, could become fatal. In this scenario, antimicrobial peptides such as bacteriocins represent an alternative solution to traditional antibiotics because they are produced by many organisms and can inhibit bacteria, fungi, and/or viruses. Herein, we assessed the antimicrobial activity and biotechnological potential of 54 Streptococcus agalactiae strains isolated from bovine mastitis. Deferred plate antagonism assays revealed an inhibition spectrum focused on species of the genus Streptococcus—namely, S. pyogenes, S. agalactiae, S. porcinus, and S. uberis. Three genomes were successfully sequenced, allowing for their taxonomic confirmation via a multilocus sequence analysis (MLSA). Virulence potential and antibiotic resistance assessments showed that strain LGMAI_St_08 is slightly more pathogenic than the others. Moreover, the mreA gene was identified in the three strains. This gene is associated with resistance against erythromycin, azithromycin, and spiramycin. Assessments for secondary metabolites and antimicrobial peptides detected the bacteriocin zoocin A. Finally, comparative genomics evidenced high similarity among the genomes, with more significant similarity between the LGMAI_St_11 and LGMAI_St_14 strains. Thus, the current study shows promising antimicrobial and biotechnological potential for the Streptococcus agalactiae strains.

APA, Harvard, Vancouver, ISO, and other styles

39

Vachhani, Pankit, Jonathan A. Abbas, Evelyn M. Flahavan, Esprit Ma, Tao Xu, Huan Jin, Melissa Montez, et al. "Real World Treatment Patterns and Outcomes of Venetoclax (Ven) and Hypomethylating Agents (HMA) in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) in the United States." Blood 138, Supplement 1 (November 5, 2021): 2290. http://dx.doi.org/10.1182/blood-2021-147851.

Full text

Abstract:

Abstract Background: Ven+HMA is now a standard treatment (Tx) for newly diagnosed (ND) AML in patients (pts) aged ≥75 years (y), or with comorbidities precluding intensive chemotherapy. The Phase 3 VIALE-A trial demonstrated clinical benefit and longer overall survival (OS) for Ven+azacitidine (Aza) vs Aza alone; however, frequent Ven dose modifications (mods) occurred due to cytopenias (DiNardo et al. NEJM 2020). We describe real world (RW) Tx practices and outcomes in ND AML pts treated with Ven+HMA in the US. Methods: This retrospective cohort study used the Flatiron Health electronic health record (EHR)-derived, nationwide, de-identified database. Pts aged ≥18 y with ND AML, initiating Ven+HMA Tx ≤30 days (d) from diagnosis, from Jun 1, 2018 to Jan 31, 2020, were included (i.e., prior to VIALE-A data availability, reflecting early experience). Ven Tx data and Tx mods (Ven dose and Tx schedule changes [in-cycle interruptions, cycle delays, schedule per cycle changes]) were abstracted from the EHR, including frequency of and reasons (where documented) for Tx mods and discontinuations (d/c). Timing of bone marrow (BM) biopsy and response to Tx were measured. BM response was defined as ≤5% blasts by BM biopsy. RW complete response/complete response with partial hematologic recovery (rwCR/CRh) was defined as ≤5% BM blasts, with platelet count >50 × 10 9/L and absolute neutrophil count >0.5 × 10 9/L, within 14 d of BM biopsy. Tx mods post-rwCR/CRh are described. Median Ven+HMA Tx duration, and OS from start of Ven Tx to d/c, death, or censoring at the last EHR activity before data cutoff (Aug 31, 2020) were examined by Kaplan-Meier analyses. Time-varying survival analyses assessed the effect of Ven Tx mods on Tx duration and OS. Results: A total of 169 eligible pts treated with Ven+HMA were included. Median age at diagnosis was 77 y, 27% of pts had an ECOG performance status ≥2, 44% had secondary AML, and the overall majority (85%) were treated in community practice. European LeukemiaNet (ELN) classification was 13% favorable, 22% intermediate, 39% adverse, and 26% unknown. By Day 7 of Tx (after ramp-up), Ven dose was 400 mg in 49% of pts, 300 mg in 3%, 200 mg in 20%, and ≤100 mg in 20%. Dose was not recorded in 8% of pts. Of 72 pts with doses <400 mg, 19 (26%) had concomitant Tx with CYP3A4 inhibitors documented in the EHR. In total, 56/169 (33%) pts had Ven dose changes in the subsequent Tx cycles, with toxicity (38%) or drug-drug interaction (25%) the most common reasons. Tx schedule changes were common and noted in 101 (60%) pts; primarily due to toxicity (78% of pts). Median time to first Tx schedule change was 33 d (95% confidence interval [CI] 28-52), at approx. 1-2 Tx cycles. At 7.2 months (mo; range 0.6-24.8) median follow-up, median Tx duration was 5.2 mo (95% CI 4.0-7.7) and median OS (mOS) was 8.4 mo (95% CI 7.2-11.1). Of the 95 pts with BM data during follow-up, 51 (54%) had their first biopsy by Day 28 (±14) of Tx (proxy for BM around Tx Cycle 1), with the majority of pts (41/51; 80%) achieving a BM response at that time. Of the 82% (78/95) of pts who had a BM response at any time, 47% (45/95) had a rwCR/CRh. Three of 95 (3%) pts with documented BM biopsy had early mortality (≤60 d of starting first-line Tx) vs 14/74 (19%) pts without documented BM biopsy. Tx mods post-rwCR/CRh occurred in 25/45 (56%) pts; dose holds occurred in 7/25 pts, cycle delays in 8/25, Tx schedule changes in 6/25, dose changes and d/c in ≤4/25. Within the entire cohort, time-varying adjusted analyses showed that, compared with pts with no Tx schedule changes, those with Tx schedule changes had a longer median Tx duration (4.2 vs 6.0 mo, respectively; non-significant) and longer mOS (7.2 vs 10.0 mo, respectively; p=0.02; Figure). Conclusions: This study reflects early RW experience with Ven+HMA Tx in a predominantly community setting, ahead of Phase 3 VIALE-A data availability. Around half of pts started on full-dose Ven, suggesting that azole prophylaxis was either deferred or not received in many pts, although not all pts on lower doses had documented CYP3A4 inhibitor Tx. Only half of pts had a documented BM biopsy at approx. Cycle 1, but a high response rate was observed in evaluated pts. While the RW cohort reported here had a shorter follow-up time and mOS than reported in clinical trials, pts with Tx schedule mods had longer OS vs those without. These observations highlight, among other points, the importance of appropriate Ven management, including early BM assessment, to optimize pts' outcomes. Figure 1 Figure 1. Disclosures Vachhani: CTI BioPharma Corp: Consultancy; O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham: Current Employment; Abbvie: Consultancy; Agios: Consultancy; Pfizer: Consultancy; Incyte: Consultancy, Speakers Bureau; Jazz Pharmaceuticals: Consultancy; Novartis: Consultancy; Astellas Pharma: Speakers Bureau; Seattle Genetics: Research Funding; Blueprint Medicines: Consultancy. Abbas: Tennessee Oncology: Current Employment; Jazz: Consultancy, Speakers Bureau; TG: Consultancy, Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; Incyte: Speakers Bureau; Amgen: Speakers Bureau; Takeda: Speakers Bureau. Flahavan: Roche Products Ltd. UK: Current Employment; Roche: Current equity holder in publicly-traded company. Ma: Genentech, Inc.: Current Employment, Other: May hold equity. Xu: F. Hoffmann-La Roche AG: Current Employment. Jin: Roche: Current equity holder in publicly-traded company; Genentech Inc: Current Employment. Montez: Genentech, Inc: Current Employment, Other: May hold equity. Huang: Genentech: Current Employment; University of Washington: Ended employment in the past 24 months. Gershon: Genentech: Current Employment; F. Hoffmann-La Roche Ltd: Current holder of stock options in a privately-held company. Ku: Genentech: Current Employment, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; Roche: Current Employment, Current equity holder in publicly-traded company, Other: TRAVEL, ACCOMMODATIONS, EXPENSES. Flores: Genentech: Current Employment; Roche: Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company, Divested equity in a private or publicly-traded company in the past 24 months. Onishi: Genentech: Current Employment; Roche: Current Employment, Current equity holder in publicly-traded company. Bui: Abbvie: Current Employment, Other: May hold equity.

APA, Harvard, Vancouver, ISO, and other styles

40

Kalisch, Brett, and David Pearce. "Shuts, turns and roundabouts." APPEA Journal 62, no. 2 (May 13, 2022): S29—S33. http://dx.doi.org/10.1071/aj21198.

Full text

Abstract:

The outcomes of operational shutdowns and maintenance events, ‘Shuts and Turns’, can significantly affect a company’s performance and reputation. These are typically highly complex operations that demand significant resources and must deliver results. Shuts and Turns are expensive activities, not only in terms of the direct cost of labour plant and materials but also the production deferral. Leading operators recognise that they also pose significant risk to future production which is why significant time and effort goes into robust management framework. Safety performance is paramount, with schedule adherence also key. Operators spend considerable time planning to ensure successful Shuts and Turns have: an established management framework; effective scope management; thorough front-end loading; robust controls and change management; an assessment of the risks of emerging work; efficient resource planning; and rigorous safety and QA/QC processes. This paper provides: an overview of the different types of Shuts and Turns used by Australian operators; the benefits of a robust shutdown governance approach; an overview of key success areas; importance of lessons learned; and a detailed case study based on our work with a major downstream facility. The paper will appeal to oil and gas operators, major contractors and service providers.

APA, Harvard, Vancouver, ISO, and other styles

41

Tejada-Tayabas, Luz María, Liseth Amell Salcedo, and Joel Monárrez Espino. "Medical therapeutic itineraries of women with breast cancer diagnosis affiliated to the People's Health Insurance in San Luis Potosí, central Mexico." Cadernos de Saúde Pública 31, no. 1 (January 2015): 60–70. http://dx.doi.org/10.1590/0102-311x00009114.

Full text

Abstract:

This study aims to describe the medical itineraries followed by breast cancer women affiliated to the People's Health Insurance in San Luis Potosí, central Mexico. We used an ethnographic approach based on oral histories of 12 women diagnosed with breast cancer in the year prior to the first meeting. Two face-to-face sessions per participant lasting 60 minutes each were conducted followed by a telephone interview. Content and diachronic analyses were used. Three main itineraries were identified: (1) diagnostic process, (2) final diagnosis to treatment, and (3) cancer control and relapse. Findings suggested that infrastructure and human resources to adequately screen and timely diagnose breast cancer were scant and insufficiently trained, respectively. Deferral of medical assessment was related with lack of information about breast cancer consequences, with women being afraid of a positive result, and with economic constraints. The current screening program needs to be redesigned to prevent diagnostic delays, as these seem to explain the high frequency of advanced stages reported at the time of diagnosis.

APA, Harvard, Vancouver, ISO, and other styles

42

Plimack, Elizabeth R., Cheryl Nemec, Paul Elson, Cristina Suarez, Tanya B. Dorff, James M. G. Larkin, Cecilia McAleer, Isaac Nuñez, Rosalie Anne Fisher, and Brian I. Rini. "An observational study of metastatic renal cell carcinoma patients prior to initiation of initial systemic therapy." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): TPS4679. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps4679.

Full text

Abstract:

TPS4679 Background: The biology of metastatic RCC is extremely diverse, including a subpopulation of patients with indolent growth of metastases. Because of the acute and chronic toxicity and assumed non-curative nature of current systemic targeted therapy, a select subset of patients may be better served with initial surveillance. Such an approach may allow for deferral of systemic therapy to minimize overall treatment-related toxicity burden while maintaining treatment benefit. Methods: A prospective phase II trial is being conducted to characterize the clinical course of patients with mRCC who defer initial systemic treatment. Appropriate patients are selected by the treating physician based on an observed indolent growth pattern. As such, there is a 12 month window allowed between the first diagnosis of metastatic disease and study entry. Patients must be treatment-naïve, asymptomatic, with histologically confirmed mRCC and clinically-evident, measurable disease to be eligible. Radiographic assessment is performed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months. The primary objective is to characterize the clinical outcome of patients on observation in terms of time to RECIST defined disease progression and time to initiation of systemic treatment. Secondary endpoints include measurement of disease-related symptoms and depression/anxiety using standardized questionnaires (FKSI-DRS and HADS), as well as correlative endpoints analyzing the immune response over time for which blood is being collected for immune assays (TH1/TH2 phenotype, Tregs). Pts remain on study until initiation of systemic therapy due to radiographic disease progression, development of disease-related symptoms, withdraw of consent or clinical change that renders the patient unacceptable for further observation. Local therapy (e.g. surgery, radiation) during the observation period is permitted. Currently, 29 patients have been accrued at 5 collaborating sites. The target accrual of 50 pts provides adequate power for the primary descriptive endpoint as well as 80% power to detect changes from baseline for the correlate endpoints based on a two-sided Wilcoxon signed rank test.

APA, Harvard, Vancouver, ISO, and other styles

43

Stoliarchuk, Yaroslava, Denys Ilnytskyy, and Glib Turolev. "GLOBAL BUSINESS NETWORK: OFF-SHORE MODEL’S DIVERSIFICATION AND IMPACT." Economics & Education 5, no. 2 (April 25, 2020): 20–29. http://dx.doi.org/10.30525/2500-946x/2020-2-3.

Full text

Abstract:

Modern literature lacks systematization and assessment of impact of network of international corporations and their off-shore models on development of national economies in post-industrial times. There is variety of tools besides well-known multinational corporate accounting policies and strategies of MNCs that provide mechanism for the management of transaction costs in reporting period, thus reducing the amount of taxable profit due to application of the method of accelerated depreciation and channels of tax deferrals, which allow to reduce corporate tax payments owing to the objective reduction of real purchasing power of money over time. The purpose of the article is to propose in-depth systematization of balanced pros and cons for further development of national FDI policies aimed at network of MNCs. The paper utilizes a compound methodology of review and systematization to calculate overall impact of offshoring that exceeds 1% of global GDP. While modern financial and economic activities of MNC’s distinguish both internal and external offshoring, the paper focuses upon endogenous one. The key attention is on dominant ones – tax inversion phenomenon is known as base erosion and profit shifting, tax planning strategies, international debt shifting, models of tax treaty shopping, tax deferral, tax hybrids, strategic transfer pricing tools. In business and financial management MNCs resort to the development of extremely complex network structures of parent and subsidiary companies in order to increase international competitive advantages. MNCs make special efforts to recruit staff capable of effectively performing key functions in the field of corporate offshoring. We find huge regional asymmetries in MNCs impact on development of national economies. On one hand, a number of highly profitable corporations pay almost zero tax in favour of their countries of registration; on the other, MNCs create jobs, markets, volumes and asymmetries of geographical structure of differences in the value of goods and services supplied through international trade between developing and developed countries due to enormous scale of business offshoring.

APA, Harvard, Vancouver, ISO, and other styles

44

McDaneld, Patrick, Devlin Smith, and Frank Tverdek. "438. Dalbavancin Clinical Experience at an NCI Designated Cancer Center." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S217—S218. http://dx.doi.org/10.1093/ofid/ofz360.511.

Full text

Abstract:

Abstract Background Dalbavancin (DAL) is a long-acting lipoglycopeptide, which allows for up to 2 weeks of therapy from a single dose. Outside of its FDA-approved indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI), there is a growing interest in the utilization of DAL for other indications, including catheter-related bloodstream infection (CRBSI). The long-acting formulation potentially facilitates patient discharge or admission deferral without the need for daily outpatient parenteral antimicrobial therapy (OPAT). However, there is limited experience reporting DAL utilization in an oncology population. The objective of this study was to report our experience with DAL in an oncology patient population at a National Cancer Institute (NCI) Designated Cancer Center. Methods We conducted a retrospective review of all patients receiving DAL therapy in June 2016–June 2017. The primary outcome was a clinical success at 30 days (complete/partial resolution of symptoms without readmission for a same/similar infection), with secondary outcomes including readmission rate, acute kidney injury (AKI) incidence (Acute Kidney Injury Network [AKIN] criteria) and additional antimicrobial use within 30 days. Results We identified 76 unique subjects, with 77 unique infectious episodes, receiving 78 DAL doses. The majority of the subjects were male (57%), the median age was 61 years old, 55% had a solid tumor type and most were treated for ABSSSI (86%). Doses were administered inpatient 76% of the time and most patients received 1500 mg (90%). The most common pathogen isolated was Staphylococcus aureus (19%). Patients frequently received additional methicillin-resistant Staphylococcus aureus active oral antibiotics (39%). Clinical success was reported in 78% of infections. Potential DAL-related AKI was identified in 4 subjects (5%). Conclusion We reported on the use of DAL in a variety of oncology patients at a major cancer center. Clinical success was often achieved in ABSSSI with a single DAL dose and nephrotoxicity was infrequently encountered. Limitations include the frequent use of additional, potentially active antimicrobials and difficulty in assessment of clinical success and AKI in patients after discharge. Disclosures All authors: No reported disclosures.

APA, Harvard, Vancouver, ISO, and other styles

45

Elgar-Reyes, Charina Melinda C., and Patrick Joseph A. Pardo. "Relapsing Polychondritis." Philippine Journal of Otolaryngology-Head and Neck Surgery 24, no. 1 (June 15, 2009): 32–34. http://dx.doi.org/10.32412/pjohns.v24i1.713.

Full text

Abstract:

Relapsing Polychondritis is an autoimmune disease that can present with a variety of non-specific symptoms involving the ears, nose, throat, head and neck. Although uncommon, we should be aware of this disease entity, and should include it as a differential diagnosis in patients who complain of difficulty breathing. It is also prudent that we never forget to look at the larger picture beyond specific symptoms to understand and explain a patient’s condition. CASE An 18 year old female was admitted at the Pediatric emergency room (PER) due to recurrent, non-productive cough associated with occasional difficulty of breathing. One year prior to this admission, the patient complained of on and off cough, with no other associated symptoms. There was no improvement with antibiotics she was given at a local clinic, and the cough spontaneously resolved only to recur. Along with the recurrent cough, she eventually experienced difficulty of breathing and found herself in and out of the hospital, treated for bronchial asthma or pulmonary tuberculosis. Due to the symptoms’ recurring and worsening nature, the family consulted at our institution, where she was referred to the ORL service for further evaluation. On examination, she exhibited hoarseness, occasional stridor and difficulty of breathing. She also had a characteristic saddle nose deformity. Flexible nasolaryngotracheoscopy revealed a smooth extraluminal bulge extending from the area of the subglottis up to the second tracheal ring, at the 4 to 7 o’clock position of the neck. A neck soft tissue lateral (STL) film showed widening of the prevertebral soft tissue spaces with irregular calcifications at the level of C4 to C6 pushing the trachea anteriorly, causing narrowing of the tracheal air column (Fig. 1). CT scans revealed a homogenous, ill-defined mass, posterolateral to the trachea, pushing the trachea anteriorly (Fig. 2). A CT-guided aspiration biopsy (CT-GAB) was deferred by the radiologist who opined that the biopsy would be technically difficult since the mass was small and adjacent to the vessels. Prophylactic tracheostomy and open biopsy were recommended, but no consent was given by the family, and they opted to go home. 4 months after, the patient returned to the PER with difficulty of breathing. She was also noted to have bilateral auricular perichondritis and ocular redness which were described by the mother as usually associated with her episodes of dyspnea. An emergent tracheostomy and suspension laryngoscopy were performed, revealing marked enlargement of the cricoid and arytenoid cartilages. Both appeared to be heavily calcified. The thyroid cartilage was thinned out and was laterally splayed. On tracheoscopy, a smooth, mucosal swelling and smooth tracheal rings with concentric narrowing were seen. An open biopsy revealed an extraluminal hard, gritty mass adherent to the thyroid cartilage, posteriorly extending from the thyroid notch to the first tracheal ring. Biopsy specimens measuring approximately 1.5 x 1.5 cm aggregate diameter were sent for histopathology which revealed fragments of mature hyaline cartilage and lamellar bone with fragments of fibrocartilaginous tissue of chronic non-specific inflammation. With the history of recurrent cough and dyspnea; saddle-nose deformity; binaural perichondritis; ocular redness/inflammation, and histologic finding of cartilage inflammation, an assessment of relapsing polychondritis was made. She was referred to the Rheumatology service for further evaluation. and started on steroids, with note of improvement of her symptoms. DISCUSSION Relapsing polychondritis is a rare, autoimmune condition. It is characterized by recurrent inflammation leading to destruction of cartilage and other connective tissues. The ear, nose and tracheobronchial cartilage are most commonly affected.1 Males and females are affected equally with an average age at diagnosis of 51 years old. Only a few cases of relapsing polychondritis have been reported in children.2 It is believed that autoantibodies to cartilage components, specifically to collagen type II, cause inflammatory infiltration and cellular mechanisms involving lysosomal enzyme release and eventually result in the destruction of the cartilage due to the following mechanisms: excessive release of proteolytic enzymes by chondrocytes, down-regulation of collagen synthesis, and autoimmune reactions against cartilage intercellular matrix components.3 Histopathologic studies reveal cartilage destruction with loss of basophilic staining and islands of lymphocytic infiltration. Subsequently, fragmentation of cartilage occurs with replacement by fibrous tissue. 4 Relapsing polychondritis most often manifests as swelling and erythema of the ear (88%) and arthralgias (81%). Repeated auricular inflammation, scarring and retraction may cause the appearance of “cauliflower ears.” Ocular inflammation manifests in almost 60% of patients.5,2 Relapsing polychondritis may also result in dermatologic, cardiac, renal and neurologic manifestations. Respiratory involvement is the most common cause of death.6 Chondritis may affect the external nares, nasal septal turbinates, eustachian tubes, epiglottis, larynx, thyroid, cricoid, arytenoid, trachea, and bronchi. Nasal chondritis involves the distal part of the nasal septum and may lead to a saddle nose deformity. Laryngotracheal involvement may initially manifest as recurrent cough. Hoarseness, dyspnea, anterior neck pain, stridor, and wheezing may also be observed. The obstruction is due to edema, vocal cord palsy, and fixed subglottic or bronchial stenoses. This may suddenly exacerbate to dynamic airway collapse necessitating the need for tracheostomy.1,5 Life-threatening respiratory involvement is more common in females with a 2.6:1 ratio.4 Due to the wide-spectrum of signs and symptoms and their non-specificity, a diagnosis of relapsing polychondritis is often only attained a few years after the first manifestation of the disease and after repeated consults with various specialists. The time from onset of initial symptoms to diagnosis varies from 8 months to 13 years.4 McAdam, et al,7 proposed diagnostic criteria based on the most common clinical features of relapsing polychondritis. This was further modified by Damiani and Levine8 (See Table 1). Our patient presented with five of McAdam’s signs namely: recurrent chondritis of both ears, chondritis of nasal cartilages, chondritis of the laryngotracheal cartilage, and ocular inflammation. Hence, a diagnosis of relapsing polychondritis was established. There is no specific laboratory exam for relapsing polychondritis. However, normocytic, normochromic anemia, mild leukocytosis, thrombocytosis, hypergammaglobulinemia and elevated ESR are often observed.6,9 Our patient manifested with normocytic, hypochromic anemia, mild leukocytosis and with thrombocytosis. Bronchoscopy is an indispensable tool in establishing the exact site, nature and severity of airway involvement. It may show an inflammation of the tracheobronchial tree with narrowing or collapse of the airways. Bronchoscopy must be done with caution as it may cause dyspnea, airway collapse, hypoxia, asphyxia and death.4 Bronchoscopy in this patient revealed an inflamed and edematous epiglottis with progressive concentric narrowing of the tracheal space. A computed tomography (CT) scan can show deformity or circumferential thickening of the cricoid or tracheal cartilage, edema, and fibrosis or ossification of the soft tissues.6 The course of relapsing polychondritis may vary from immediate death to a relatively benign and painless course for several years. The prognosis is based on the degree of respiratory and cardiovascular involvement.2 Corticosteroids are the mainstay of treatment in relapsing polychondritis. This is due to their anti-inflammatory and anti-chondrolytic properties. Non-steroidal anti-inflammatory drugs, dapsone and colchicines may be used for mild cases. Immunosuppressive therapy in the form of cyclophosphamide, azathioprine and cyclosporine is used for severe cases.2,5 Our patient was initially treated with hydrocortisone 100 mg IV every 12 hours and was later shifted to prednisone 40 mg per day. Her disease was sufficiently controlled with this medication. Tracheostomy, as was performed in our patient, may be necessary when there is respiratory distress and subglottic involvement. Other possible adjuncts to medical therapy include continuous positive airway pressure for symptomatic relief, and metallic stent placement.5,10

APA, Harvard, Vancouver, ISO, and other styles

46

Artanian, Veronica, Valeria E. Rac, Heather J. Ross, and Emily Seto. "Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 9, no. 10 (October 13, 2020): e19705. http://dx.doi.org/10.2196/19705.

Full text

Abstract:

Background Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication. Objective The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect the implementation and effectiveness of the intervention. Methods A mixed methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses data from a smartphone-based telemonitoring system with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semistructured interviews with a purposive sample of clinicians and patients. Results Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to be completed by the winter of 2021. Conclusions This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring and its impact on patient health outcomes. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups. Trial Registration ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513 International Registered Report Identifier (IRRID) DERR1-10.2196/19705

APA, Harvard, Vancouver, ISO, and other styles

47

Groener, Albrecht, Martin Groschup, and Wolfram Schäfer. "Efficient Reduction of Prions by the Manufacturing Process of a VWF/FVIII Product." Blood 112, no. 11 (November 16, 2008): 995. http://dx.doi.org/10.1182/blood.v112.11.995.995.

Full text

Abstract:

Abstract Variant Creutzfeldt-Jakob disease (vCJD) is a fatal neurodegenerative disease acquired through infection with prions which cause bovine spongiform encephalopathy (BSE) by consumption of beef products from infected cattle. Presumptive transfusion transmitted cases of vCJD have been reported in the UK increasing the concern that medicinal products manufactured from plasma might also pose a risk of vCJD transmission. Therefore, investigational studies were performed to assess the prion reduction capacity of the manufacturing process of a VWF/FVIII product (Haemate® P / Humate-P®). In these studies hamster brain derived prion material in the form of a microsomal preparation were used to spike plasma product intermediates. As the purification process of a desired plasma protein may impact the physico-chemical form of the spiked prion protein, the addition of reduction factors from single step studies possibly might not reflect the true prion reduction of the full process; in particular where the spike material is heterogeneous, one fraction, i.e. gross aggregates of prion material could be preferentially removed by one step and the same subfraction by a subsequent step. Therefore, we employed a combined step study approach and not a single spike step approach to address that issue of the impact of heterogeneous spike fractions regarding the overall reduction factor. The manufacturing process of the VWF/FVIII product was divided in two parts which were studied independently twice: Pooled plasma donations (4,500 ml) were spiked and processed covering cryoprecipitation, Al(OH)3 adsorption and subsequent precipitations by glycine and NaCl. The second part of the VWF/FVIII manufacturing process was studied starting with spiked dissolved NaCl precipitate (154 ml) and processed further by pasteurization, second NaCl precipitation, dialysis, ultracentrifugation and sterile filtration. The prion spiked starting material and product intermediate were processed according to the manufacturing conditions based on a valid down-scale model. The prion reduction factors were determined as the difference of the prion load in the spiked starting materials and in the respective final samples using a biochemical assay (Conformation-Dependent Immunoassay (CDI)) or a bioassay in hamsters for quantification of PrPSc (dose dependent incubation period measurement). The results of these investigational studies for the two prion quantification methods are shown below PrionReduction Factors [log10] demonstrated by Manufacturing steps biochemical methods (CDI) bioassay (incubation time) Cryo precipitation / Al(OH)3adsorption / Glycine precipitation 3.2 ± 0.1 2.8 ± 0.3 Pasteurization / NaCl precipitation / Dialysis / Ultracentrifugation / Sterile filtration 2.9 ± 0.2 3.1 ± 0.1 Filling / Lyophilization n.d. n.d. Overall Prion Reduction Factor 6.1 ± 0.2 5.9 ± 0.3 These results demonstrate (i) comparable prion reduction factors quantified either by biochemical methods or by a bioassay and (ii) an appropriate overall prion reduction capacity of the manufacturing process of Haemate® P / Humate-P®. Based on complementary safety procedures, i.e., collection of plasma by stringent donor selection due to geographic donor deferral policy and the overall prion reduction factor of approximately 6 log10, which clearly exceeds a potential prion load in the manufacturing pool, a risk assessment results in an extremely remote risk of prion transmission by the VWF / FVIII product Haemate® P / Humate-P®.

APA, Harvard, Vancouver, ISO, and other styles

48

Bergenheim, Sara J., Marte Saupstad, Nina Pistoljevic, Anders Nyboe Andersen, Julie Lyng Forman, Kristine Løssl, and Anja Pinborg. "Immediate versus postponed frozen embryo transfer after IVF/ICSI: a systematic review and meta-analysis." Human Reproduction Update 27, no. 4 (February 16, 2021): 623–42. http://dx.doi.org/10.1093/humupd/dmab002.

Full text

Abstract:

Abstract BACKGROUND In Europe, the number of frozen embryo transfer (FET) cycles is steadily increasing, now accounting for more than 190 000 cycles per year. It is standard clinical practice to postpone FET for at least one menstrual cycle following a failed fresh transfer or after a freeze-all cycle. The purpose of this practice is to minimise the possible residual negative effect of ovarian stimulation on the resumption of a normal ovulatory cycle and receptivity of the endometrium. Although elective deferral of FET may unnecessarily delay time to pregnancy, immediate FET may be inefficient in a clinical setting, following an increased risk of irregular ovulatory cycles and the presence of functional cysts, increasing the risk of cycle cancellation. OBJECTIVE AND RATIONALE This review explores the impact of timing of FET in the first cycle (immediate FET) versus the second or subsequent cycle (postponed FET) following a failed fresh transfer or a freeze-all cycle on live birth rate (LBR). Secondary endpoints were implantation, pregnancy and clinical pregnancy rates (CPR) as well as miscarriage rate (MR). SEARCH METHODS We searched PubMed (MEDLINE) and EMBASE databases for MeSH and Emtree terms, as well as text words related to timing of FET, up to March 2020, in English language. There were no limitations regarding year of publication or duration of follow-up. Inclusion criteria were subfertile women aged 18-46 years with any indication for treatment with IVF/ICSI. Studies on oocyte donation were excluded. All original studies were included, except for case reports, study protocols and abstracts only. Covidence, a Cochrane-tool, was used for sorting and screening of literature. Risk of bias was assessed using the Robins-I tool and the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation framework. OUTCOMES Out of 4124 search results, 15 studies were included in the review. Studies reporting adjusted odds ratios (aOR) for LBR, CPR and MR were included in meta-analyses. All studies (n = 15) were retrospective cohort studies involving a total of 6,304 immediate FET cycles and 13,851 postponed FET cycles including 8,019 matched controls. Twelve studies of very low to moderate quality reported no difference in LBR with immediate versus postponed FET. Two studies of moderate quality reported a statistically significant increase in LBR with immediate FET and one small study of very low quality reported better LBR with postponed FET. Trends in rates of secondary outcomes followed trends in LBR regarding timing of FET. The meta-analyses showed a significant advantage of immediate FET (n =2,076) compared to postponed FET (n =3,833), with a pooled aOR of 1.20 (95% CI 1.01–1.44) for LBR and a pooled aOR of 1.22 (95% CI 1.07–1.39) for CPR. WIDER IMPLICATIONS The results of this review indicate a slightly higher LBR and CPR in immediate versus postponed FET. Thus, the standard clinical practice of postponing FET for at least one menstrual cycle following a failed fresh transfer or a freeze-all cycle may not be best clinical practice. However, as only retrospective cohort studies were assessed, the presence of selection bias is apparent, and the quality of evidence thus seems low. Randomised controlled trials including data on cancellation rates and reasons for cancellation are highly needed to provide high-grade evidence regarding clinical practice and patient counselling.

APA, Harvard, Vancouver, ISO, and other styles

49

Bal, Susan, Saurabh Chhabra, Natalie S. Callander, Eva Medvedova, Bhagirathbhai Dholaria, Rebecca W. Silbermann, Kelly N. Godby, et al. "Biologic Basis of the Impact of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma Treated with Quadruplet Therapy." Blood 138, Supplement 1 (November 5, 2021): 483. http://dx.doi.org/10.1182/blood-2021-145533.

Full text

Abstract:

Abstract Background Unprecedented depth of response is observed with quadruplet combinations in newly diagnosed multiple myeloma (NDMM). The incremental benefit of autologous hematopoietic cell transplantation (AHCT) in this setting has not be described and can be appraised with the serial assessment of minimal residual disease (MRD). Here we describe the impact of AHCT on MM burden assessed by next generation sequencing (NGS) for patients enrolled in the MASTER trial. Methods MASTER is a prospective, multi-center clinical trial utilizing daratumumab, carfilzomib, lenalidomide and dexamethasone (Dara-KRd) induction, AHCT (Melphalan conditioning), followed by MRD response-adapted Dara-KRd consolidation with planned enrichment for patients with high-risk chromosome abnormalities (HRCA). MRD assessment is performed by NGS (ClonoSEQ® platform) upon completion of induction therapy with 4 cycles of Dara-KRd, 60-80 days after AHCT and after each 4 cycle-block of consolidation, where applicable. Patients with confirmed MRD negativity (MRD<10 -5 in two consecutive time points) enter treatment free observation and active surveillance of MRD resurgence ("MRD-SURE"). The primary endpoint of the study is negativity utilizing IMWG criteria (MRD<10 −5). Achievement of MRD <10 −6 is an exploratory endpoint. Patients are categorized as having 0, 1, 2+ HRCA [gain 1q, t(4;14), t(14;16), t(14;20), del(17p)]. We describe changes in MRD burden with AHCT and explore patient and disease features influencing magnitude of MRD reduction with AHCT. Results Between 3/2018 and 9/2020, 123 participants were accrued. Of those, 118 were MRD evaluable and 109 have NGS-MRD post-induction and post AHCT and are included in this analysis. The median age is 61 y (35-79) and 18% are 70 or older. Twenty-four percent of patients are non-white, 20% have ECOG 2, 19% high LDH, and 19% R-ISS3. Forty seven (43%) have 0 HRCA, 41 (38%) have 1 HRCA, and 21 (19%) with 2+ HRCA (ultra-HR MM). Forty percent achieved MRD negativity after four cycles of Dara-KRd induction, increasing to 69% after AHCT. Twenty-six percent patients were MRD<10 -6 post induction, increasing to 51% post-AHCT (Table). Of the 65 patients (60%) who remained MRD positive post-induction, 54 (83%) had a reduction in MRD burden with AHCT (figure). The median reduction in MRD with auto-HCT was 1.10 log 10 (range -1.26 to 3.41). Patients with HRCAs had a greater reduction in MRD burden (P=0.02). For patients with 0, 1 and 2+ HRCA, median reduction was 0.91 log 10 (range -0.75 to 2.14), 1.26 log 10 (range -0.21to 3.26) and 1.34 log 10 (range -1.28 to 3.41),respectively. More than 1 log 10 reduction in MRD was seen in 56.0% of patients, 43%, 74% and 71% of patients with 0, 1 and 2+ HRCA respectively. Greater than 2 log reductions in MRD was seen in 20% of patients, 11%, 17% and 43% of patients with 0, 1 and 2 HRCA, respectively. In multivariable analysis that included age, stage, performance status and treatment response post induction, the presence of HRCA was the only factor associated with greater than 1 log 10 reduction in MRD burden with AHCT (OR 3.6, 95% CI 1.27-10.2, P=0.016). Conclusions An ultrasensitive quantitative MRD assay using NGS demonstrates the incremental benefit of AHCT in the context of highly efficacious quadruplet induction. The greatest impact is afforded to the highest risk disease subset elucidating the biologic underpinnings of the impact of AHCT in MM. At this time, AHCT should remain an integral part of therapy for fit, NDMM patients, particularly those with the high-risk disease and those who remain MRD positive after induction. Future studies exploring AHCT deferral in NDMM should be focused on patients who are MRD negative post optimal induction. Figure 1 Figure 1. Disclosures Chhabra: GSK: Honoraria. Dholaria: Angiocrine: Research Funding; MEI: Research Funding; Pfizer: Research Funding; Jazz: Speakers Bureau; Takeda: Research Funding; Poseida: Research Funding; Janssen: Research Funding; Celgene: Speakers Bureau. Silbermann: Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding. Giri: PackHealth: Research Funding; CareVive: Honoraria, Research Funding. Hari: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Millenium: Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive Biotech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Karyopharm: Consultancy; Celgene-BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau. Costa: Karyopharm: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria.

APA, Harvard, Vancouver, ISO, and other styles

50

Fanale, Michelle A., Chao-Ming Lai, Sue A. Rimes, Mildred M. Ramirez, Fredrick B. Hagemeister, Nathan H. Fowler, Anas Younes, et al. "Positive Maternal-Fetal Outcomes with Treatment of Lymphoma During Pregnancy: UT MD Anderson Cancer Center Prospective Experience." Blood 120, no. 21 (November 16, 2012): 3670. http://dx.doi.org/10.1182/blood.v120.21.3670.3670.

Full text

Abstract:

Abstract Abstract 3670 Background: Diagnosis of cancer during pregnancy is emotionally stressful for the patient and her family and presents challenges for the medical team including how to best minimize risk of adverse fetal events while still ensuring the best disease outcome for the woman. Cancer is diagnosed during 0.1% of pregnancies with lymphoma being the 4th most common cancer effecting 1 in 6000 pregnancies (Brenner, B et al, The Lancet, 2012 & Pereg, D et al, Haematologica, 2007). This prevalence is anticipated to grow given the shift towards increasing average age at time of pregnancy. The overall rarity of this presentation and the variance of the histological diagnoses have prevented the conduction of large prospective clinical trials, and thus no stringent management algorithms exist. Methods: From 2005 women with a diagnosis of lymphoma during pregnancy were consented and enrolled into this IRB-approved prospective database trial. Patients received multidisciplinary care including counseling and co-management with our maternal-fetal medicine and reproductive medicine collaborators. Results: A total of 19 patients (pts) were consented with full treatment (tx) and fetal outcome data available for 16. The median age of the women was 30 (20–38) years with a slightly lower median age for the classical Hodgkin lymphoma (HL) pts of 28.5 (20–35) years. Ten pts had HL (6 early stage [ES], 2 advanced stage [AS], 2 relapsed), while the remaining 9 had NHL (3 [2 ES, 1 AS] diffuse large B-cell lymphoma [DLBCL], 1 ES anaplastic lymphoma kinase [ALK]-positive LBCL, 1 primary CNS DLBCL, 1 AS follicular lymphoma [FL] with transformation to DLBCL, 1 ES FL, 1 AS MALT, and 1 ALK+ anaplastic LCL). Fifteen pts had diagnoses made of initial or relapsed disease during pregnancy at a median of 18 (3–34) weeks (wks) gestation with 33% during 1st trimester, 54% during 2nd trimester, and 13% during 3rd trimester. Four pts with chronic oligomenorrhea with baseline negative serum pregnancy tests became pregnant while on tx (ABVD, rituximab plus gemcitabine, R-CHOP, and maintenance rituximab) with fetal loss in all 4 with spontaneous abortions from wk 8 to 26 and an elective abortion at wk 6. Four pts of the 15 pts deferred start of tx until after delivery (ES HL and ES primary mediastinal DLBCL pts, a relapsed HL pt, and a ES FL grade 3B pt diagnosed respectively at wks gestation of 31, 34, 14, and 27) and the 3 pts for whom outcome data is available have durable complete remissions (CRs) at a median of 25 (5–52) months (mos) of follow-up with babies born at a median of 35 (31–37) wks at a median birth weight of 2381 (1814–3004) grams with 75% being above the 50% weight percentile. Ten pts started tx while pregnant (80% during 2nd/3rd trimester) at a median of 18 (11–29) wks (ABVD/AVD in 5, R-CHOP/AVD in 1, R-CHOP in 2, HCVAD in 1, and DeAngelis regimen in 1) with all but 1 pt having MRIs and ultrasounds for staging. Seven of these pts delivered babies at a median of 37 (33–39) weeks with 57% delivered at term, a median birth weight of 2948 (2494–3061) grams with 50% being above the 50% weight percentile, and no fetal malformations. At a median of 20.5 (8–53) mos of follow-up 60% of the pts who received tx while pregnant are free of progression while 2 HL pts (1 ES HL pt 22 months after delivery) died from disease progression and 2 pts are on active treatment for relapsed disease (HL and ALK+ LBCL). Three pts experienced fetal loss including a AS HL pt with SVC syndrome necessitating intubation with prolonged ICU care (spontaneous abortion at 23 wks), a AS HL pt who started ABVD at 14 wks of gestation (stillbirth of twins at 26 wks), and the pt with CNS DLBCL who initiated the DeAngelis regimen with high dose methotrexate at 13 wks (elective abortion at 19 wks). Conclusions: Given the rarity of the diagnosis of lymphoma during pregnancy our series to our knowledge represents one of the largest single center prospective clinical studies. Our data highlight that ABVD, R-CHOP, and HCVAD can be given with excellent outcomes for pt and fetus at a preferred start of 2nd trimester or later, although 1 pt with symptomatic HL did start ABVD early at 11 wks of gestation with preservation of positive outcomes. These findings also emphasize the importance of co-management through all the steps of treatment with a maternal-fetal medicine colleague. Furthermore, we show the need to counsel oligomenorrheic pts on the risk of still becoming pregnant and perform assessments to rule-out pregnancy beyond the baseline pre-tx visit. Disclosures: Fanale: Millennium: Research Funding; MedImmune: Research Funding; Novartis: Honoraria, Research Funding, Travel Expenses, Travel Expenses Other; Genentech: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding, Travel Expenses, Travel Expenses Other; Seattle Genetics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Travel Expenses Other; Onyx: Research Funding; Allos: Membership on an entity's Board of Directors or advisory committees. Lai:Celgene: Membership on an entity's Board of Directors or advisory committees. Younes:Seattle Genetics, Inc.: Consultancy, Research Funding; Millennium: Honoraria; Novartis: Honoraria, Research Funding; Celgene: Honoraria; Affimed: Research Funding; Gilead: Research Funding; Johnson & Johnson: Research Funding.

APA, Harvard, Vancouver, ISO, and other styles

Journal articles on the topic 'Deferred time assessment'

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles