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5 results on '"hypothesized"'

1. Optimism Bias in the Design of Phase III Randomized Control Trials Evaluating PD-1/PD-L1 Targeting Monoclonal Antibodies.

Author

Al-Showbaki L, Almugbel FA, Alqaisi HA, Amir E, and Chen EX

Subjects
Antibodies, Monoclonal therapeutic use, B7-H1 Antigen, Clinical Trials, Phase III as Topic, Humans, Programmed Cell Death 1 Receptor, Randomized Controlled Trials as Topic, Antineoplastic Agents, Immunological pharmacology, Antineoplastic Agents, Immunological therapeutic use, Neoplasms drug therapy
Abstract

Background: Many randomized control trials (RCTs) evaluating programmed death receptor-1 (PD-1)/programmed death ligand-1 (PD-L1) targeting monoclonal antibodies (mAbs) have been completed or are in progress. We examined hypothesized hazard ratios (HHRs) and observed hazard ratios (OHRs) from published RCTs evaluating these mAbs., Methods: Publications of RCTs evaluating at least one PD-1/PD-L1 targeting mAbs approved by the US Food and Drug Administration were identified through PubMed searches. The primary reports of RCTs were retrieved. Two investigators extracted HHR, OHR for the primary endpoint among other data elements independently. The differences (∆HR) in HHR and OHR were analyzed statistically. A separate search was conducted for secondary reports after longer follow-ups, the updated OHR was extracted., Results: Forty-nine RCTs enrolling 36 867 patients were included. The mean HHR and OHR were 0.672 and 0.738 respectively. The mean ∆HR was 0.067 (range: -0.300 to 0.895; 95% confidence interval (CI), 0.003-0.130). HHR was met or exceeded in 22 (45%) RCTs. OHR was ≥ 1.0 in 6 RCTs (12%). PD-L1 expression was not associated with the magnitude of effect. Of 18 RCTs with follow-up reports, the magnitude of benefit decreased in 8 RCTs with extended follow-ups., Conclusion: The majority of published RCTs evaluating PD-1/PD-L1 targeting mAbs did not achieve their hypothesized magnitude of benefit. The optimism bias requires attention from the cancer clinical research community given the number of these agents in development and the intense interest in evaluating these agents in a variety of disease settings., (© The Author(s) 2022. Published by Oxford University Press.)

Published
2022
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2. An Investigation into Tetrodotoxin (TTX) Levels Associated with the Red Dorsal Spots in Eastern Newt (Notophthalmus viridescens) Efts and Adults

Author

Mackenzie M. Spicer, Amber N. Stokes, Trevor L. Chapman, Edmund D. Brodie, Brian G. Gall, and Hindawi

Subjects
0301 basic medicine, Dorsum, Pleurodeles, Article Subject, Zoology, 010501 environmental sciences, Toxicology, 01 natural sciences, 03 medical and health sciences, chemistry.chemical_compound, lcsh:RA1190-1270, hypothesized, Echinotriton andersoni, Biology, 0105 earth and related environmental sciences, lcsh:Toxicology. Poisons, Pharmacology, EFTS, biology, Spots, integumentary system, concentration of tetrodotoxin, musculoskeletal, neural, and ocular physiology, biology.organism_classification, 030104 developmental biology, chemistry, Notophthalmus viridescens, red dorsal spots, Tetrodotoxin
Abstract

We investigated the concentration of tetrodotoxin (TTX) in sections of skin containing and lacking red dorsal spots in both Eastern newt (Notophthalmus viridescens) efts and adults. Several other species, such as Pleurodeles waltl and Echinotriton andersoni, have granular glands concentrated in brightly pigmented regions on the dorsum, and thus we hypothesized that the red dorsal spots of Eastern newts may also possess higher levels of TTX than the surrounding skin. We found no difference between the concentrations of TTX in the red spots as compared to neighboring skin lacking these spots in either efts or adults. However, efts with more red dorsal spots had elevated TTX levels relative to efts with fewer spots.

Published
2018

4. Exploring changes in physical activity, sedentary behaviors and hypothesized mediators in the NEAT girls group randomized controlled trial

Author

Dewar, Deborah, Morgan, Philip J, Plotnikoff, Ronald C, Okely, Anthony D, Batterham, Marijka, Lubans, David R, Dewar, Deborah, Morgan, Philip J, Plotnikoff, Ronald C, Okely, Anthony D, Batterham, Marijka, and Lubans, David R

Abstract

Objective: To evaluate the impact of a 12-month school-based multi-component program on adolescent girls’ physical activity and sedentary behaviors, and hypothesized mediators of physical activity behavior change. Design: Group randomized controlled trial with 12-month follow-up. Methods: The intervention, guided by Social Cognitive Theory, involved 357 adolescent girls (13.2 ± 0.5 years) from 12 secondary schools (6 intervention schools, 6 control schools) in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. The intervention included enhanced school sport, lunchtime physical activity sessions, interactive seminars, student handbooks, nutrition workshops, pedometers, parent newsletters and text messages to encourage physical activity and healthy eating, and a decrease in sedentary behavior. Outcomes were assessed at baseline and 12-months and included: physical activity (accelerometers), sedentary behaviors (questionnaire and accelerometers), and social-cognitive mediators of physical activity (questionnaire). Results: There were significant between group differences in favor of the intervention group for self-reported recreational computer use (−26.0 min; 95% CI, −46.9 to −5.1), and sedentary activities summed (−56.4 min; 95% CI, −110.1 to −2.7), however objective sedentary behavior showed no differences. There were no group-by-time effects for any of the physical activity outcomes or hypothesized mediators. Conclusions: A school-based intervention tailored for adolescent girls from schools located in low-income communities significantly reduced time spent in sedentary activities. However, improvements in physical activity and hypothesized mediators of physical activity behavior were not observed. Future studies are encouraged to explore alternative mechanisms of behavior change derived from integrated and socio-ecological theories.

Published
2014

5. Relationships among the hypothesized components leading to complex reflective thinking in emergency nursing practice.

Author

Bobay, Kathleen Lynn

Subjects
Clinical Expertise, Complex, Components, Emergency Nursing, Hypothesized, Leading, Practice, Reflective Thinking, Relationships
Abstract

Although expertise has been discussed extensively in the nursing literature, there exists no clear definition of what nursing expertise is or how to measure it. As a result, it is difficult to identify clinical nursing experts or to know how to promote the development of expertise in those nurses with the ability and desire to become experts. This study explored components of complex reflective thinking, which was hypothesized to be a proxy for clinical nursing expertise. It differs from the traditional nursing expertise model, in that subjects are not placed in predetermined categories based on experience. Key variables explored included progressive problem solving, domain-specific knowledge, experience, quest for excellence, reinvestment, and complex reflective thinking. Mail surveys were sent to 1000 nurses who had taken the Certification for Emergency Nursing (CEN) examination within the previous calendar year. A total of 338 (34%) of surveys were returned. Data analysis was conducted using structural equation modeling (SEM) and t-tests. Two separate models were considered, first using RCI-Recognition component (RCI-R) as the measure for complex reflective thinking, then using RCI-Discrimination component (RCI-D) as the measure for complex reflective thinking. Although the chi square (chi2) was not significant for either the RCI-R or RCI-D model, the results are unsatisfactory. There are clear indications that RCI-D is a mis-specified model and that unexpected results occurred in RCI-R suggesting that this model may also be mis-specified. Key findings showed that experience and progressive problem solving were poor predictors of complex reflective thinking (CRT), although these are the two most frequently used proxies of expertise used in previous studies. Reinvestment, which is continuous lifelong learning, was shown to have a significant effect on the development of CRT. The quest for excellence, an intrinsic motivation factor, also had a significant impact on the development of CRT. Limitations to this research study included a small sample size and lack of large effect sizes. Results are specific to the emergency nursing sample and cannot be generalized to other nursing populations. Recommendations for further research include determining if CRT is actually a proxy for clinical nursing expertise and exploring other instruments that may better measure the concepts. Triangulation may be needed to better represent the qualitative aspects of expertise. The concepts of reinvestment, complex reflective thinking, and quest for excellence have not been previously examined in the nursing literature and deserve more attention.

Published
2003

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