Confirmatory study design, data analysis, and results that matter.

Author(s):  
Matthew T. McBee ◽  
Samuel H. Field
Author(s):  
Chris Wichman ◽  
Lynette M. Smith ◽  
Fang Yu

Abstract Introduction: Rigor and reproducibility are two important cornerstones of medical and scientific advancement. Clinical and translational research (CTR) contains four phases (T1–T4), involving the translation of basic research to humans, then to clinical settings, practice, and the population, with the ultimate goal of improving public health. Here we provide a framework for rigorous and reproducible CTR. Methods: In this paper we define CTR, provide general and phase-specific recommendations for improving quality and reproducibility of CTR with emphases on study design, data collection and management, analyses and reporting. We present and discuss aspects of rigor and reproducibility following published examples of CTR from the literature, including one example that shows the development path of different treatments that address anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). Results: It is particularly important to consider robust and unbiased experimental design and methodology for analysis and interpretation for clinical translation studies to ensure reproducibility before taking the next translational step. There are both commonality and differences along the clinical translation research phases in terms of research focuses and considerations regarding study design, implementation, and data analysis approaches. Conclusions: Sound scientific practices, starting with rigorous study design, transparency, and team efforts can greatly enhance CTR. Investigators from multidisciplinary teams should work along the spectrum of CTR phases, and identify optimal practices for study design, data collection, data analysis, and results reporting to allow timely advances in the relevant field of research.


2006 ◽  
Vol 79 (2) ◽  
pp. P7-P7 ◽  
Author(s):  
S HUANG ◽  
K REYNOLDS ◽  
J STRONG ◽  
S NALLANI ◽  
L LESKO ◽  
...  

2007 ◽  
Vol 81 (2) ◽  
pp. 298-304 ◽  
Author(s):  
S-M Huang ◽  
R Temple ◽  
D C Throckmorton ◽  
L J Lesko

Author(s):  
Normalisa Ella Yunarti ◽  
Rahmawati Rahmawati ◽  
Erminawati Erminawati

Mixed ice is a beverage that is very popular with people and is very easy to find. Traders mixed ice that their hygiene is not quite right; it is very easily contaminated by pathogen bacteria. Landasan Ulin District as a trading centre in Kota Banjarbaru makes it strategic place so many mixed ice traders found in this District. This study was aiming to determine the traders mixed ice's hygiene with the contamination of Salmonella sp bacteria in blended ice. This type of research was an analytical survey with a cross-sectional study design. Data were collected by observing, interviewing and examining samples, as many as 23 mixed ice samples were analysing of salmonella sp bacteria. Data analysis was performing using Somer's d correlation test. The results showed that there was a significant correlation between personal hygiene of mixed ice traders with Salmonella sp bacteria with a negative correlation direction which could be a conclusion that the higher the personal hygiene score of combined ice traders, the Salmonella sp bacteria would be harmful in mixed ice. It is suggested to the next researcher to check the Salmonella sp bacteria on each component of blended ice so that they will know at what stage Salmonella sp bacteria have contaminated the ice mixed.


2014 ◽  
Vol 69 (1) ◽  
pp. 7-21 ◽  
Author(s):  
Hervé Lebrec ◽  
Brigitte Molinier ◽  
Darrell Boverhof ◽  
Mark Collinge ◽  
Wendy Freebern ◽  
...  

Neurosurgery ◽  
2019 ◽  
Vol 86 (3) ◽  
pp. 325-331 ◽  
Author(s):  
Han Yan ◽  
Brij S Karmur ◽  
Abhaya V Kulkarni

Abstract BACKGROUND Determining true causal links between an intervention and an outcome forms an imperative task in research studies in neurosurgery. Although the study results sometimes demonstrate clear statistical associations, it is important to ensure that this represents a true causal link. A confounding variable, or confounder, affects the association between a potential predictor and an outcome. OBJECTIVE To discuss what confounding is and the means by which it can be eliminated or controlled. METHODS We identified neurosurgical research studies demonstrating the principles of eliminating confounding by means of study design and data analysis. RESULTS In this report, we outline the role of confounding in neurosurgical studies after giving an overview of its identification. We report on the definition of confounding and effect modification, and the differences in the 2. We explain study design techniques to eliminate confounding, including simple, block, stratified, and minimization randomization, along with restriction of sample and matching. Data analysis techniques of eliminating confounding include regression analysis, propensity scoring, and subgroup analysis. CONCLUSION Understanding confounding is important for conducting a good research study. Study design techniques provide the best way to control for confounders, but when not possible to alter study design, data analysis techniques can also provide an effective control.


Author(s):  
Suhardi Suhardi

Mental revolution of education requires efforts to print educated human beings by having the motivation to meet the standards of achievement excellence, such as ethos of progress, ethics, achievement motivation, discipline, optimistic, productive, innovative and active views. This can be implemented with character education. Character education is one of the soft skill tools that can be integrated in learning in each subject. Learning activities using an active learning approach have a strategic role in instilling national character values so that students are able to behave and act on values that have become their personality. The purpose of this study was to find and analyze about: 1) Implementation of Character Education to Build Adiwiyata-Based Mental Revolution and Multiculturalism; 2) Implementation of Character Education to Build Mental Revolution in Organizational Culture. This study uses a qualitative approach with phenomenological naturatistics (phenomenology approach), with a descriptive type of case study research design. Data were analyzed using data analysis techniques: data reduction, data analysis and conclusions. The results of the study are: The application of character education to develop a mental revolution can be started from the character of building the environment. Environmental character is very important for individual development. The implementation of character education in building a mental revolution can emphasize the internalization of multicultural values and Adiwiyata which in the end will form a loving environmental awareness and foster a spirit of tolerance.


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