Pragmatic Trial End Point Capture: Making Sure Makes the Difference

2021 ◽  
Author(s):  
Jens Sundbøll ◽  
Kasper Adelborg
Keyword(s):  
Pragmatic Trial ◽  
End Point ◽  
The Difference

The comparative effectiveness of direct oral anti-coagulants and low molecular weight heparins for prevention of recurrent venous thromboembolism in cancer: The CANVAS pragmatic randomized trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12020-12020
Author(s):  
Deborah Schrag ◽  
Hajime Uno ◽  
Rachel Pam Greenerger Rosovsky ◽  
Cynthia Rutherford ◽  
Kristen Marie Sanfilippo ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Comparative Effectiveness ◽  
Pragmatic Trial ◽  
Study Drug ◽  
Recurrent Venous Thromboembolism ◽  
The Us ◽  
Recurrent Vte ◽  
The Difference ◽  
To Receive

12020 Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWH for preventing recurrent VTE but have higher risk of bleeding. However, the balance of benefits and burdens remains uncertain. Objective: The CANVAS pragmatic trial compared recurrent VTE, bleeding and death in cancer patients following an initial VTE treated with either DOAC or LMWH therapy. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial, with randomized and preference cohorts. Between 12/16 and 4/20, 671 participants were randomized and followed for 6-months. Between 12/16 and 12/17, 140 participants declined randomization, chose their preferred anticoagulant and were followed for 6-months. The preference cohort was closed when predetermined stopping criteria were met. Final follow-up was 11/30/20. Randomized patients were assigned 1:1 to receive either a DOAC or a LMWH. If assigned to LMWH, transitions to warfarin were allowed. Physicians and patients could choose among any DOAC or LMWH. Doses were suggested based on FDA-approved labeling but not mandated. Patients from 67 practices in the US with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of symptomatic or radiographically detected VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified-into to treat popululation, (all subjects who received study drug). The 1° outcome was recurrent VTE. The aim was to establish noninferiority of anticoagulation with a DOAC as defined by the upper limit of the 2-sided 90% CI for the difference in the event rate at 6 months of < 3%. Secondary outcomes included death and bleeding. Hypothesis testing included only the randomized cohort but propensity score adjusted results for the preference and combined cohorts are also shown. Results: The non-inferiority criteria for recurrent VTE was met. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in a noninferior risk of recurrent VTE with no differences in rates of bleeding or death in randomized patients. Clinical trial information: NCT02744092. [Table: see text]

scholarly journals Design of Auto-tuning Relay Feedback controller for Shell Heavy Oil Fractionator

2018 ◽  
Vol 218 ◽  
pp. 02007
Author(s):  
Wahyudi ◽  
Sela Martasia ◽  
Budi Setiyono ◽  
Iwan Setiawan
Keyword(s):  
Heavy Oil ◽  
System Modeling ◽  
Control Technique ◽  
System Response ◽  
Relay Feedback ◽  
End Point ◽  
Column Type ◽  
Point Composition ◽  
Auto Tuning ◽  
The Difference

Auto-tuning relay feedback is one of the control techniques, which is used to solve the non-linear, long delay time, and disturbance's problems. This control technique is the development of Ziegler-Nichols that can be done automatically without doing system modeling. In this paper, auto-tuning relay feedback is used in the control system response to optimization of Shell Heavy Oil Fractionator (SHOF) system so the output of product composition as expected. SHOF is a distillation column type used to separate crude oil into desired products based on the difference in the boiling point of each product. PI regulators of relay feedback are used to control the valves on the SHOF with three inputs and three outputs that has been decoupled. Based on the tests, the average values of IAE at top end point composition (Y1) obtained with disturbance and no disturbance are 83.17 and 10.933, respectively. At the side end point composition (Y2), the average values of IAE with disturbance and no disturbance are obtained respectively, 336.38 and 42.3467. The average values of IAE at bottom reflux temperature (Y3) with disturbance and no disturbance are obtained 0.15 and 0.13, respectively.

scholarly journals Relationship of Physiotherapy Intervention and the Level of Community Reintegration of Stroke Survivors In Accra, Ghana

2021 ◽  
Vol 3 (1) ◽  
pp. 31-39
Author(s):  
Dorcas Kyela Yusuf ◽  
◽  
Samuel Koranteng Kwakye ◽  
Jonathan Quartey ◽  
◽  
...  
Keyword(s):  
P Value ◽  
Stroke Survivors ◽  
Community Reintegration ◽  
Chi Square ◽  
Disability Score ◽  
End Point ◽  
Physiotherapy Intervention ◽  
The Mean ◽  
The Difference ◽  
Relationship Of

Background: Stroke is one of the major causes of death and disability in the world. During rehabilitation, there appears to be little or no emphasis placed on reintegrating the stroke survivors into their communities.The study sought out to determine the relationship between physiotherapy and the level of community reintegration among stroke survivors.Method: This observational study involved51 stroke survivors referred to physiotherapy departments of selected hospitals in Accra. Participants completed the Reintegration to Normal Living Index and the Modified Rankin Scale at baseline and after 8 weeks of physiotherapy sessions. Wilcoxon’s test was used to assess the difference between the baseline and end point scores for reintegration and disability while Chi square and Spearman correlation were used to test for associations between physiotherapy intervention and community reintegration. A p-value of 0.05 was set.Results: The mean reintegration score at baseline was 55.5±17.00 and 76±14.00 at end point (p = 0.001) while the mean disability score at baseline was 3.43±0.67 and 2.31±0.68 at end point (p = 0.001) showing a significant level of improvement from baseline to endpoint of the reintegration and disability scores. There was a low association between duration of stroke (p=0.008) and duration of physiotherapy (p=0.038) with regards to reintegration 8 weeks post physiotherapy.Conclusion: Physiotherapy plays a role in the reintegrating of stroke survivors into their communities. Incorporation of community reintegration into rehabilitation programmes for stroke survivors could be useful. Efforts to include physiotherapy to reintegrate stroke survivors could therefore be strengthened

Conclusion

2019 ◽  
pp. 203-222
Author(s):  
Andrew M. Riggsby
Keyword(s):  
Information Technology ◽  
High Intensity ◽  
Information Technologies ◽  
Information Storage ◽  
Wide Scope ◽  
Information Structures ◽  
Fine Grained ◽  
End Point ◽  
The Subject ◽  
The Difference

The conclusion begins with a summary of the conclusions of the preceding chapters. Most generally, uses of Roman information technologies, even ones that are broadly similar to each other, manifest enough difference in detail to discourage their extension or combination. This is both a cause and an effect of the close focus of both users and designers on extremely specific use-contexts. It then goes on to suggest several contexts for the application and/or extension of its findings. First, a fine-grained understanding of information storage, use, and transfer lends itself to integration with modern theoretical understandings of the economy and of power. Information structures are important “institutions” that give shape to particular economies. Information technology may also have served as a brake on the conversion of the high intensity of absolute imperial rule to “a wide scope of actual mastery over the conduct of the subject population.” Second, there is evidence both that the use of information technology changed radically after the end point of this study (c. 300 CE) and for the roots of the difference in a variety of external historical circumstances.

Systematic review of three decades of clinical trials in metastatic colorectal cancer: Making lemonade out of lemons?

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 656-656
Author(s):  
Daniel Tannenbaum ◽  
Kanwal Pratap Singh Raghav ◽  
Robert Asa Horn ◽  
Michael J. Overman ◽  
Cathy Eng ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Significant Shift ◽  
End Point ◽  
Negative Results ◽  
Study Characteristics ◽  
The Difference ◽  
Over Time

656 Background: Despite multiple trials of new agents in metastatic colorectal cancer (mCRC), long term outcomes remain poor. This study explores the changing trends in the design, interpretation and outcomes of phase III randomized controlled trials (RCT) in mCRC over time. Methods: Phase III RCTs of systemic therapy for mCRC with enrollment between 1986 and 2016 were identified through 4 electronic databases and grouped into 3 time periods (1986-1996 – T1; 1997-2006 – T2 & 2007-2016 – T3). Study selection, quality appraisal and data collection were performed by 2 independent investigators. Study characteristics, primary and secondary endpoints, and authors’ interpretation of results and conclusions were analyzed. Improvement in overall survival (OS) was the difference between experimental and control arms. A study was deemed positive if it met its end point, was recommended for further study or for adoption for clinical use (p ≤ 0.05 significant for all analyses). Results: One hundred fifty trials (T1=36, T2=62, T3=52) with 77494 patients (T1=12406, T2=39158, T3=25930) were included. Although 1st line therapy trials continued to be the most common across all T, the percentage (%) of trials evaluating 3rd line and beyond (T1=0, T2=3, T3=27) have increased significantly over time as have trials with targeted agents (T1=11, T2=34, T3=79). Although OS remains the most common primary end point, more trials in T2 & T3 have used progression-free survival instead (14 vs 47 & 44). The % of trials with negative results but interpreted as positive increased over time (T1=18; T2=42; T3=35). Across all T, the median improvement in OS (months, m) of these trials was significantly lower compared to the trials that met primary end point across all T (T1 = 0 vs 1.8 m, T2 = -0.1 vs 3.25, T3 = -0.25 vs 2.55). Conclusions: A significant shift has occurred over the past three decades in the design and interpretation of phase III trials in advanced CRC. Any interpretations of potential survival benefits from trials that have not met primary end point must be made with significant caution.

THE β- AND γ-RAYS OF ACTINIUM B AND ACTINIUM C″

1939 ◽  
Vol 17a (5) ◽  
pp. 82-102 ◽  
Author(s):  
B. W. Sargent
Keyword(s):  
Growth Curves ◽  
Absorption Curve ◽  
End Points ◽  
End Point ◽  
Order Of Magnitude ◽  
Γ Rays ◽  
Γ Ray ◽  
The Difference ◽  
First Time ◽  
Excitation Probability

The absorption method of finding the end-point of a β-ray spectrum has been made more precise and free of errors that are due to straggling and the γ-ray background. The absorption curves of the β-rays of radium E and uranium X2 were taken as standard, since, from experiments with the magnetic spectrograph, their end-points are known to be 1.15 and 2.32 Mev respectively. The extrapolated ranges of these fastest β-rays are, from experiments with homogeneous beams, 0.51 and 1.12 gm. per cm.2 of aluminium. In general the extrapolated range R can be expressed in terms of the energy E in Mev by the equation:[Formula: see text]for E > 0.6 Mev. It is shown that the final portions of the absorption curves of the β-rays from radium E and uranium X2 have the same shape when plotted against m/R, where m is the mass in gm. per cm.2 of absorber and R is the range of the fastest β-rays in the spectrum. The range and end-point of another β-spectrum can be found by fitting its absorption curve to the standard one.The absorption curve of the β-rays of actinium B was obtained separately from that of actinium C″ for the first time. Growth curves were plotted from measurements of the β-activity of the active deposit obtained by exposing aluminium foils to filtered actinon for a few minutes. The β-activity was measured through thickness of aluminium up to 0.32 gm. per cm.2 From the initial portions of the growth curves and from the absorption curve of the β-rays of actinium (B + C) in equilibrium, separate absorption curves were plotted which indicated ranges of 0.64 and 0.68 gm. per cm.2 of aluminium for the β-rays of actinium B and actinium C″ respectively. The corresponding end-points are 1.39 and 1.47 Mev.There is some evidence that the β-spectrum of actinium B consists of two primary components, namely, a strong one having an end-point at 1.39 Mev and a weak one having an end-point at about 0.5 Mev. The difference between the two end-points is approximately equal to the energy (0.83 Mev) of a γ-ray emitted in the transformation actinium B.C. The ratio of the numbers of β-particles in the two partial spectra is approximately 1:7. This gives an excitation probability of 0.12 for the 0.83 Mev level of the actinium C nucleus, which is of the same order of magnitude as that obtained from the intensities of the γ-rays.

THE DECIDUOMA ASSAY: A METHOD FOR MEASURING PROLACTIN

1963 ◽  
Vol 28 (1) ◽  
pp. 45-58 ◽  
Author(s):  
NADA KOVAČÍC
Keyword(s):  
Corpus Luteum ◽  
Positive Response ◽  
Parallel Line ◽  
Mechanical Injury ◽  
Uterine Horn ◽  
End Point ◽  
Simultaneous Study ◽  
The Difference ◽  
Ovine Prolactin ◽  
Dose Levels

SUMMARY Mice 3 months of age were hypophysectomized on the 1st day of dioestrus and treated with prolactin for 5 consecutive days commencing immediately after hypophysectomy. One uterine horn was traumatized on the 3rd day of the experiment and autopsy was performed on the 6th day. Prolactin maintained the function of the corpus luteum and induced the formation of deciduomata in the injured uterine horn. The increase in weight of the damaged uterine horn compared with the control horn was used as the end point. Since mechanical injury alone caused an increase of up to 10·4 mg., a positive response was taken as an increase of 11 mg. or more. The response was treated as quantal and the percentage of positive responses was transferred to probits. Parallel line assays were used with three or two dose levels of the standard and the unknown. The design permitted a simultaneous study of the effects of a preparation on both the damaged and the undamaged horns of the uterus. Prolactin caused an increase in weight of the damaged horn and gonadotrophin an increase in weight of both horns, but when prolactin was contaminated with gonadotrophin it could still be assayed by the difference in weight between the two. Three different preparations of ovine prolactin (Armour) were assayed against the 2nd International Prolactin Standard and the results compared favourably with the maker's estimate of potency. Two preparations were also assayed by the pigeon crop gland and by the dioestrus methods and the results were similar. The index of discrimination was about unity.

scholarly journals Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study

2014 ◽  
Vol 74 (6) ◽  
pp. 979-984 ◽  
Author(s):  
P Emery ◽  
J E Gottenberg ◽  
A Rubbert-Roth ◽  
P Sarzi-Puttini ◽  
D Choquette ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Real Life ◽  
Clinical Effectiveness ◽  
Inadequate Response ◽  
Tnf Inhibitor ◽  
Point Change ◽  
Life Study ◽  
End Point ◽  
Comparative Effectiveness Study ◽  
The Difference

ObjectivesTo compare the effectiveness of rituximab versus an alternative tumour necrosis factor (TNF) inhibitor (TNFi) in patients with rheumatoid arthritis (RA) with an inadequate response to one previous TNFi.MethodsSWITCH-RA was a prospective, global, observational, real-life study. Patients non-responsive or intolerant to a single TNFi were enrolled ≤4 weeks after starting rituximab or a second TNFi. Primary end point: change in Disease Activity Score in 28 joints excluding patient's global health component (DAS28-3)–erythrocyte sedimentation rate (ESR) over 6 months.Results604 patients received rituximab, and 507 an alternative TNFi as second biological therapy. Reasons for discontinuing the first TNFi were inefficacy (n=827), intolerance (n=263) and other (n=21). A total of 728 patients were available for primary end point analysis (rituximab n=405; TNFi n=323). Baseline mean (SD) DAS28-3–ESR was higher in the rituximab than the TNFi group: 5.2 (1.2) vs 4.8 (1.3); p<0.0001. Least squares mean (SE) change in DAS28-3–ESR at 6 months was significantly greater in rituximab than TNFi patients: −1.5 (0.2) vs −1.1 (0.2); p=0.007. The difference remained significant among patients discontinuing the initial TNFi because of inefficacy (−1.7 vs −1.3; p=0.017) but not intolerance (−0.7 vs −0.7; p=0.894). Seropositive patients showed significantly greater improvements in DAS28-3–ESR with rituximab than with TNFi (−1.6 (0.3) vs −1.2 (0.3); p=0.011), particularly those switching because of inefficacy (−1.9 (0.3) vs −1.5 (0.4); p=0.021). The overall incidence of adverse events was similar between the rituximab and TNFi groups.ConclusionsThese real-life data indicate that, after discontinuation of an initial TNFi, switching to rituximab is associated with significantly improved clinical effectiveness compared with switching to a second TNFi. This difference was particularly evident in seropositive patients and in those switched because of inefficacy.

scholarly journals Shaping ability of reciprocating single-file and full-sequence rotary instrumentation systems in simulated curved canals

2015 ◽  
Vol 09 (03) ◽  
pp. 346-351 ◽  
Author(s):  
Demet Altunbas ◽  
Betul Kutuk ◽  
Alper Kustarci
Keyword(s):  
Material Removal ◽  
Digital Camera ◽  
Nickel Titanium ◽  
Total Width ◽  
End Point ◽  
Single File ◽  
Kolmogorov Smirnov ◽  
The Mean ◽  
The Difference ◽  
Shaping Ability

ABSTRACT Objective: The purpose of this study was to evaluate the shaping ability of three nickel-titanium systems in simulated curved canals. Materials and Methods: Sixty simulated canals were prepared to apical size 25 with Reciproc, S5, and twisted file (TF) instruments. Standardized pre and postoperative images were taken using a digital camera, were superimposed and aberrations were recorded. Material removal was measured at five points: The canal orifice, halfway to the orifice, beginning of the curve, the apex of the curve, and end-point. The data were analyzed using Kolmogorov–Smirnov, analysis of variance, and Tukey tests. Results: The mean total width of the prepared canals in the Reciproc group was greater than the TF and S5 groups at halfway to the orifice, the beginning of the curve, the apex of the curve, and the end-point (P < 0.05). Mean absolute transportation was always <0.16 mm; however, significant differences occurred between the three systems at the orifice, halfway to the orifice, and the beginning of the curve (P < 0.05). TF created minimal absolute transportation at halfway to the orifice and the beginning of the curve, and greater absolute transportation at the orifice compared with the Reciproc and S5 instruments. However, the difference between the S5 and TF groups was not statistically significant at halfway to the orifice (P > 0.05). Conclusions: Under the conditions of the study, Reciproc produced widest canal shapes. TF provided more centered apical preparation and maintained the original canal shape well.

Sign in / Sign up

Export Citation Format

Share Document