GCU NUR699 What is the difference between statistically significant evidence and clinically significant evidence?

DQ2 What is the difference between statistically significant evidence and clinically significant evidence?

NUR699 Evidence Based Practice ProjectWeek 6 Discussion

DQ2 What is the difference between statistically significant evidence and clinically significant evidence? How would each of these findings be used to advance an evidenced-based project?

The scientific synergy between statistics and medical research often leads to controversy when considering statistical versus clinical significance of findings from studies that are neither overwhelmingly practice-changing nor clearly negative. Studies can reach statistical significance but provide evidence that is not clinically meaningful, or results could not be statistically significant but very clinically relevant. To fully appreciate the debate about studies that fall in this gray area, one must understand how to interpret several features of statistical design and the interpretation of results.

The conduct of clinical trials dictates that a rigorous statistical design a priori targets an effect size, which can be thought of as the true difference in outcome that a study hopes to detect when comparing two regimens with one another or when comparing a single regimen to a reliable historical control. Statistical inference, based on the distributional assumptions of the design, is used to formally test the prestated hypothesis about the effect size resulting in p values, which assist in the determination of a study’s success but do not provide any information regarding the magnitude of the observed effect size in the trial. The p values indicate statistical but not clinical significance; they are the metric for the determination of study success or failure after they are compared with the type I error rate, the probability of observing a false-positive result, allocated in the study design. A threshold of 0.05 is thought to be the conventional type I error rate; but in fact, the origin of this threshold is arbitrary, and in practice designs, often have lower or higher false-positive thresholds depending on design features such as adjustments for multiple comparisons or phase of development, respectively. For example, phase 3 studies often test coprimary end points resulting in type I error rates of less than 0.05 in the design, whereas phase 2 trials often relax type I error rates to as high as 0.10 or 0.20.

The p values should be interpreted as the probability that the study results (as good as or better than observed) occurred by chance when the null hypothesis is true.

Clinical significance is far more subjective than statistical significance. Clinical significance is defined by many parameters, including the observed effect size, primary end point, safety profile, financial toxicity, quality of life, availability of a companion diagnostic for identification of patients likely to benefit the most, demographics of the enrolled population, treatment adherence, crossover, and

GCU NUR699 What is the difference between statistically significant evidence and clinically significant evidence

many others. The past 15 years of oncology drug development have revealed monumental success in bringing forth incredibly effective targeted therapies and immunotherapy for patients with lung cancer; therefore, expectations are higher than novel therapies will result in changes to current practice and substantial benefits to patient outcomes. These outcomes could be associated solely with efficacy assessments but also could be evaluated through relative trade-offs in adverse events, cost-effectiveness, health care convenience (e.g., oral versus intravenous administration), quality of life, and others. With the lack of dramatic treatment effects, incremental advancements use precious resources and time without much benefit to patients. Statistics can be used to assist in the decision-making process to objectively define clinical relevance.

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GCU NUR699 What is the difference between statistically significant evidence and clinically significant evidence? Grading Rubric

Performance Category	100% or highest level of performance 100% 16 points	Very good or high level of performance 88% 14 points	Acceptable level of performance 81% 13 points	Inadequate demonstration of expectations 68% 11 points	Deficient level of performance 56% 9 points	Failing level of performance 55% or less 0 points
Total Points Possible= 50	16 Points	14 Points	13 Points	11 Points	9 Points	0 Points
Scholarliness Demonstrates achievement of scholarly inquiry for professional and academic topics.	Presentation of information was exceptional and included all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information was good, but was superficial in places and included all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information was minimally demonstrated in all of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in one of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in two of the following elements: Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information.	Presentation of information is unsatisfactory in three or more of the following elements Provides evidence of scholarly inquiry relevant to required TD topic(s). Presents specific information from scholarly sources to develop a comprehensive presentation of facts. Uses at least one outside scholarly reference that is relevant, less than 5 years old (use of older references requires instructor permission) and reliable for the required topic.* Uses in-text citation and full reference at end of posting when presenting another person’s thoughts as quotes or paraphrase of information
	16 Points	14 Points	13 Points	11 Points	9 Points	0 Points
Application of Course Knowledge Demonstrate the ability to analyze and apply principles, knowledge and information learned in the outside readings and relate them to real-life professional situations	Presentation of information was exceptional and included all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information was good, but was superficial in places and included all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information was minimally demonstrated in the all of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in one of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from and scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in two of the following elements: Applies principles, knowledge and information from scholarly resources to the required topic. Applies facts, principles or concepts learned from scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.	Presentation of information is unsatisfactory in three of the following elements Applies principles, knowledge and information and scholarly resources to the required topic. Applies facts, principles or concepts learned scholarly resources to a professional experience. Application of information is comprehensive and specific to the required topic.
	10 Points	9 Points			6 Points	0 Points
Interactive Dialogue Initial post should be a minimum of 300 words (references do not count toward word count) The peer and instructor responses must be a minimum of 150 words each (references do not count toward word count) Responses are substantive and relate to the topic.	Demonstrated all of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.	Demonstrated 3 of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.			Demonstrated 2 of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.	Demonstrated 1 or less of the following: Initial post must be a minimum of 300 words. The peer and instructor responses must be a minimum of 150 words each. Responses are substantive Responses are related to the topic of discussion.
	8 Points	7 Points	6 Points	5 Points	4 Points	0 Points
Grammar, Syntax, APA Points deducted for improper grammar, syntax and APA style of writing. The source of information is the APA Manual 6th Edition Error is defined to be a unique APA error. Same type of error is only counted as one error.	The following was present: 0-3 errors in APA format AND Responses have 0-3 grammatical, spelling or punctuation errors AND Writing style is generally clear, focused on topic,and facilitates communication.	The following was present: 4-6 errors in APA format. AND/OR Responses have 4-5 grammatical, spelling or punctuation errors AND/OR Writing style is somewhat focused on topic.	The following was present: 7-9 errors in APA format. AND/OR Responses have 6-7 grammatical, spelling or punctuation errors AND/OR Writing style is slightly focused on topic making discussion difficult to understand.	The following was present: 10- 12 errors in APA format AND/OR Responses have 8-9 grammatical, spelling and punctuation errors AND/OR Writing style is not focused on topic, making discussion difficult to understand.	The following was present: 13 – 15 errors in APA format AND/OR Responses have 8-10 grammatical, spelling or punctuation errors AND/OR Writing style is not focused on topic, making discussion difficult to understand. AND/OR The student continues to make repeated mistakes in any of the above areas after written correction by the instructor.	The following was present: 16 to greater errors in APA format. AND/OR Responses have more than 10 grammatical, spelling or punctuation errors. AND/OR Writing style does not facilitate communication
	0 Points Deducted					5 Points Lost
Participation Requirements	Demonstrated the following: Initial, peer, and faculty postings were made on 3 separate days					Failed to demonstrate the following: Initial, peer, and faculty postings were made on 3 separate days
	0 Points Lost					5 Points Lost
Due Date Requirements	Demonstrated all of the following: The initial posting to the graded threaded discussion topic is posted within the course no later than Wednesday, 11:59 pm MT. A minimum of one peer and one instructor responses are to be posted within the course no later than Sunday, 11:59 pm MT.					Demonstrates one or less of the following. The initial posting to the graded threaded discussion topic is posted within the course no later than Wednesday, 11:59 pm MT. A minimum of one peer and one instructor responses are to be posted within the course no later than Sunday, 11:59 pm MT.