Randomized Clinical Trials in Surgery

1989 ◽  
Vol 5 (3) ◽  
pp. 317-332 ◽  
Author(s):  
Bucknam McPeek ◽  
Frederick Mosteller ◽  
Martin McKneally
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Comparative Effectiveness ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
Causal Link ◽  
Clinical Settings ◽  
Two Generations ◽  
The Relationship

When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences.This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.

scholarly journals COVID-19: Role of Nutrition and Supplementation

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 976
Author(s):  
Fiorenzo Moscatelli ◽  
Francesco Sessa ◽  
Anna Valenzano ◽  
Rita Polito ◽  
Vincenzo Monda ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Viral Infections ◽  
Overweight And Obesity ◽  
Shortness Of Breath ◽  
Nutritional Interventions ◽  
The World ◽  
Diet Regimen ◽  
Specific Diet

At the end of 2019, a new coronavirus (COVID-19) appeared on the world scene, which mainly affects the respiratory system, causing pneumonia and multi-organ failure, and, although it starts with common symptoms such as shortness of breath and fever, in about 2–3% of cases it leads to death. Unfortunately, to date, no specific treatments have been found for the cure of this virus and, therefore, it is advisable to implement all possible strategies in order to prevent infection. In this context, it is important to better define the role of all behaviors, in particular nutrition, in order to establish whether these can both prevent infection and improve the outcome of the disease in patients with COVID-19. In the literature, it is widely shown that states of malnutrition, overweight, and obesity negatively affect the immune system, leading to viral infections, and several studies have shown that nutritional interventions can act as immunostimulators, helping to prevent viral infections. Even if several measures, such as the assumption of a specific diet regimen, the use of dietary supplements, and other similar interventions, are promising for the prevention, management, and recovery of COVID-19 patients, it is important to highlight that strong data from randomized clinical trials are needed to support any such assumption. Considering this particular scenario, we present a literature review addressing several important aspects related to diet and SARS-CoV-2 infection, in order to highlight the importance of diet and supplementation in prevention and management of, as well as recovery from COVID-19.

scholarly journals Uric Acid and Hypertension: Prognostic Role and Guide for Treatment

2021 ◽  
Vol 10 (3) ◽  
pp. 448
Author(s):  
Federica Piani ◽  
Arrigo F. G. Cicero ◽  
Claudio Borghi
Keyword(s):  
Clinical Trials ◽  
Uric Acid ◽  
Mendelian Randomization ◽  
Strong Association ◽  
Epidemiological Studies ◽  
Hypertensive Disease ◽  
Genetic Studies ◽  
Lowering Therapy ◽  
The Relationship

The relationship between serum uric acid (SUA) and hypertension has been a subject of increasing interest since the 1870 discovery by Frederick Akbar Mahomed. Several epidemiological studies have shown a strong association between high SUA levels and the presence or the development of hypertension. Genetic analyses have found that xanthine oxidoreductase (XOR) genetic polymorphisms are associated with hypertension. However, genetic studies on urate transporters and Mendelian randomization studies failed to demonstrate a causal relationship between SUA and hypertension. Results from clinical trials on the role of urate-lowering therapy in the management of patients with hypertension are not uniform. Our study sought to analyze the prognostic and therapeutic role of SUA in the hypertensive disease, from uric acid (UA) biology to clinical trials on urate-lowering therapies.

The Mediating Role of Job Satisfaction in the Work Stress-Marital Interaction Relationship

1994 ◽  
Vol 24 (3) ◽  
pp. 122-130 ◽  
Author(s):  
Lynne Widrich ◽  
Karen Ortlepp
Keyword(s):  
Job Satisfaction ◽  
Work Stress ◽  
Causal Link ◽  
Work And Family ◽  
Specific Aspect ◽  
Self Report ◽  
Marital Interaction ◽  
Marital Functioning ◽  
The Relationship

The present study examined the relationship between work stress and a specific aspect of marital functioning, namely, marital interaction. An interactionist model of stress was adopted, with three role stresses, namely, role ambiguity, role conflict and role overload, being used as indicators of work stress. Despite the abundance of studies investigating the link between employment and family functioning over the past decade, the causal link between the two domains remains unclear. As previous research has indicated that the relationship between work and family is neither simple nor linear, the present study aimed to investigate the role of job satisfaction in the relationship. The final sample of the study consisted of 80 married men employed in a large financial organization. Data were gathered in the form of self-report questionnaires. Statistical analysis, using a longitudinal path analytic research design, did not support the proposed mediational model, that is, job satisfaction was not found to mediate the relationship between work stress and marital functioning.

scholarly journals Characterizing Highly Benefited Patients in Randomized Clinical Trials

2017 ◽  
Vol 13 (1) ◽  
Author(s):  
Vivek Charu ◽  
Paul B. Rosenberg ◽  
Lon S. Schneider ◽  
Lea T. Drye ◽  
Lisa Rein ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
New Method ◽  
Usual Model ◽  
Randomized Controlled ◽  
Working Model ◽  
Large Numbers ◽  
High Benefit ◽  
Two Stages

AbstractPhysicians and patients may choose a certain treatment only if it is predicted to have a large effect for the profile of that patient. We consider randomized controlled trials in which the clinical goal is to identify as many patients as possible that can highly benefit from the treatment. This is challenging with large numbers of covariate profiles, first, because the theoretical, exact method is not feasible, and, second, because usual model-based methods typically give incorrect results. Better, more recent methods use a two-stage approach, where a first stage estimates a working model to produce a scalar predictor of the treatment effect for each covariate profile; and a second stage estimates empirically a high-benefit group based on the first-stage predictor. The problem with these methods is that each of the two stages is usually agnostic about the role of the other one in addressing the clinical goal. We propose a method that characterizes highly benefited patients by linking model estimation directly to the particular clinical goal. It is shown that the new method has the following two key properties in comparison with existing approaches: first, the meaning of the solution with regard to the clinical goal is the same, and second, the value of the solution is the best that can be achieved when using the working model as a predictor, even if that model is incorrect. In the Citalopram for Agitation in Alzheimer’s Disease (CitAD) randomized controlled trial, the new method identifies substantially larger groups of highly benefited patients, many of whom are missed by the standard method.

scholarly journals MEDIATING EFFECTS OF EMPLOYEE COMMITMENT IN RELATIONSHIP BETWEEN TOXIC LEADERSHIP AND EMPLOYEES’ PERFORMANCE

2021 ◽  
Vol 9 (4) ◽  
pp. 56-64
Author(s):  
Muhammad Rahman Khan ◽  
Hamid Khan ◽  
Sajjad Ahmad Jan ◽  
Aziz Javad ◽  
Aman Ullah Khattak
Keyword(s):  
Organizational Commitment ◽  
Sample Size ◽  
Banking Sector ◽  
Employee Performance ◽  
Employee Commitment ◽  
Mediating Effect ◽  
Mediating Effects ◽  
Toxic Leadership ◽  
The Relationship

Purpose of Study: The study aimed to examine the mediating effects of employee commitment in the relationship between toxic leadership and employee performance in the context of the banking sector, KP, Pakistan. The study is expected to provide significant information to existing knowledge databases about the toxic leaders, organizational commitment, and employees’ performance. Methodology of Study: The cross-sectional design was used to conduct the study by using a 5-point Likert scale through the questionnaire to collect primary data from the high-level managers of selected commercial banks located south region of KP, Pakistan. The sample of 234 employees of both public/private sector banks was taken randomly as the sample. To compute sample, Yamane (1967) formula for selecting sample from finite population: n=population (566), level of significance, e = 0.05 & n=sample size, sample size (n) = N/1+Ne2 = 566/1+566(0.05), 2 = 234. Main Findings: The results of the study revealed that the significant and positive association among the research variables, the significant impact of the predictors on the criterion variable, and the significant partial mediating role of the employee commitment in the relationship between the toxic leadership and employees’ performance. Applications of Study: The current study focuses on examining the role of toxic leadership on employee performance with mediating effect of employee commitment within the banking sector of KP, Pakistan. This study's significance lies in the banking sector, desiring to acquire sustainable competitive advantage through increased employee performance and employee commitment. Novelty/Originality of Study: The expectation that organizational commitment can improve the relationship between toxic leadership and employee performance is missed to a certain extent in the educational context that is expected to offer a new contribution to an existing database of research.

scholarly journals The Role of Autophagy in the Progression and Treatment of Tumors

2021 ◽  
Vol 1 ◽  
pp. 62-71
Author(s):  
Ismail Al-Janabi
Keyword(s):  
Clinical Trials ◽  
Cancer Progression ◽  
Cancer Type ◽  
Homeostatic Mechanism ◽  
Context Dependent ◽  
Initiation Stage ◽  
The Relationship

Autophagy is a conserved homeostatic mechanism enabling cells to cope with various stresses. The pathways leading up to the activation of autophagy are interconnected with those of tumorigenesis. However, the relationship between the two events is not a straightforward one and very often context-dependent. Generally, autophagy appears to act against the tumor during the initiation stage and most often drives cancer progression subsequently. Published clinical trials for the treatment of various tumors, where autophagy was pharmacologically inhibited, were obtained and tabulated. Targeting autophagy for the treatment of tumors can be rewarding in the appropriate context, such as cancer type, grade, and microenvironment.

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