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Group Hotel: Jacob Altmire Danielle Niderman Muhaimin Moin Inessa Yusupova:

Group Hotel: Jacob Altmire Danielle Niderman Muhaimin Moin Inessa Yusupova

Slide2:

Randomized Control Trials

Slide3:

Evidence Based Practice (Dentistry) EBP/ EBD The Evidence Hierarchy

Slide4:

Evidence-Based Practice The classical definition of EBP comes from the “Father of Evidence Based Medicine”, Dr. David Sackett , who explained EBP to be “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research”. 2

Slide5:

How do practitioners decide what the best available evidence is ?

Slide6:

The Hierarchy of Evidence!

Key concepts in research (RCT):

Key concepts in research (RCT) Reject the Null Hypothesis Allocation Concealment Randomization Blinding (Double vs. Single) (Minimize) Bias Control vs. Experimental Group

What is a RCT?:

What is a RCT? “Gold Standard” for a clinical trial Participants are randomly assigned to treatment groups Participants receive the same care (Allocation, follow-up, and analysis) EXCEPT the only difference is the type of intervention they receive RANDOM CONTROLLED On TRIAL

Why use a RCT?:

Why use a RCT? The use of RCT gives the investigator confidence that differences in outcomes between treatment and control were actually caused by the treatment Randomization = Less Bias = More confidence in Results Many advantages that alternative methods do not have to offer

Advantages and Disadvantages of Randomized Control Trials (RCT):

Advantages and Disadvantages of Randomized Control Trials (RCT)

When is RCT used?:

When is RCT used? Large Sample Size Need to have a true measure of efficacy Need to be planned before intervention

Advantages of RCT:

Advantages of RCT High Internal Validity Control of Exposure Randomization which influences balance of factors that can influence outcomes

When is RCT not Useful?:

When is RCT not Useful? Small Sample Size If quick answers are needed Hard to measure or various results to compare from Low number of Units of Analysis

Disadvantages of RCT:

Disadvantages of RCT Strict eligibility criteria can limit generalizability Difficult to conduct, expensive and time consuming Ethical considerations Contamination Selection Bias

Null Hypothesis:

Null Hypothesis There is no statistically significant difference between the mean distress scores for children on which bupivacaine was used and those on which sterile water was used. FAILED TO REJECT Note that the there were significant increases in distress scores for both groups post-operatively. Suggesting that bupivacaine is not effective in reducing distress, but we cannot say for sure

Randomization:

Randomization Sample: 135 children ages 2-12 undergoing outpatient general anesthesia post-simple dental extractions Control group: 67 children in the sterile water group Study group: 68 children in the bupivacaine group Double Blind Neither participants nor examiners know who is in which group

Methods:

Methods Swabs soaked in the appropriate solution (bupivacaine or sterile water) are placed over the exposed teeth sockets Distress assessed on 5-point scale Pre-operatively Post-operatively (on recovery from general anesthesia) 15 minutes post-operatively (15 minutes after recovery from general anesthesia)

Conclusion:

Conclusion EBP provides the most effective and reliable treatment that is available, based on the most current and best available evidence to date, with the goal of improving patient care. RCT’s are considered to be the optimal type clinical research design. Key Concepts Randomization, Blinding, and M inimizing Bias Why Use an RCT?  ”Gold Standard” Advantages of RCT includes large sample size, true measure of efficacy, control of exposure and randomization of subjects. Disadvantages of RCT includes limited generalizability, contamination, selection bias and difficulty in conducting the research. Example Study: No statistically significant difference between mean distress scores for children in bupivacaine group and sterile group FAILED TO REJECT Note: significant increases in distress scores for both groups post-operatively Suggesting bupivacaine is not effective in reducing distress (but cannot say for sure)

References:

References Wadhwani , Vik. "INTERNAL VALIDITY." INTERNAL VALIDITY . N.p ., 5 Jan. 1999. Web. 06 Nov. 2016. Cama , Vanessa. "Overview of Impact Evaluation." Overview of Impact Evaluation . UNICEF, 2016. Web. 06 Nov. 2016. Reeves, Mathew J., PhD. "Course Notes - Lecture 7 The RCT." Web. 6 Nov. 2016. <http:// learn.chm.msu.edu /epi/ Coursepack /EPI546_Lecture_7_course_notes.pdf>. Randomized Controlled Trials (RCT's) . Prod. UNICEF INNOCENTI. UNICEF INNOCENTI, 29 Oct. 2014. Web. 6 Nov. 2016. <https:// www.youtube.com / watch?v =Wy7qpJeozec>. MacKenzie , Gray. "If You Can't Measure It, You Can't Improve It." If You Can't Measure It, You Can't Improve It . GuavaBox , 2015. Web. 06 Nov. 2016. <http:// www.guavabox.com /blog/if-you-cant-measure-it-you-cant-improve-it >. Reed, Joshua. "Your Most Valuable Possession: Time." Odyssey . Morehouse College, 23 Feb. 2016. Web. 06 Nov. 2016. <https:// www.theodysseyonline.com /your-most-valuable-possession-time>. Winifred, J. (2013). Are YOU in CONTROL?. Psych Central . Retrieved on November 7, 2016, from http:// blogs.psychcentral.com /wellness/2013/03/are-you-in-control/

References:

References MacGill , Markus. "What is a randomized controlled trial in medical research?." Medical News Today . MediLexicon , Intl., 29 Jan. 2016. Web. 6 Nov. 2016. <http:// www.medicalnewstoday.com /articles/280574.php> "Randomized Controlled Trial." Wikipedia . Wikimedia Foundation, n.d. Web. 06 Nov. 2016. <https:// en.wikipedia.org /wiki/ Randomized_controlled_trial >. West, Amy, PhD. "Randomized Controlled Trials." EBBP . N.p ., n.d. Web. 06 Nov. 2016. <http:// www.ebbp.org / course_outlines / randomized_controlled_trials />. SMARTUVC, TRU-D. "The Importance and Hierarchy of Research Studies." TruD SmartUVC Comments . N.p ., 07 July 2016. Web. 06 Nov. 2016. <http:// tru-d.com /the-importance-and-hierarchy-of-research-studies />. Reisnek -Weisz, Vera. "Do You Willingly Accept the Blindfold?" Jerusalem Homeopathy Clinic . N.p ., 13 July 2012. Web. 06 Nov. 2016. <https:// jerusalemhomeopath.wordpress.com /2012/07/13/do-you-willingly-accept-the-blindfold/>. Kuroda, Max. "What Are Null and Alternative Hypotheses?" NYSORA . N.p ., 24 Sept. 2015. Web. 06 Nov. 2016. <http:// www.nysora.com /educational-tools/statistics-in-small-doses/5139-what-are-null-and-alternative-hypotheses.html >. [Untitled photo of word jumble]. Retrieved October 26 th , 2016 http://www.123rf.com/photo_16720017_abstract-word-cloud-for-randomized-controlled-trial-with-related-tags-and-terms.html

References:

References [Untitled photo of human population]. http :// www.aecf.org/m/blogimg/blog-loiforlowcostrandomizedcontroltrials-2015.jpp [Untitled photo of hierarchy pyramid of research]. http:// tru-d.com/wp-content/uploads/2016/07/hierarchy-of-research-studies.gif Barrett, Helen. "The Hierarchy of Research Evidence - from Well Conducted Meta-analysis down to Small Case Series, Publication Bias." Health Knowledge . N.p ., 20 June 2010. Web. 06 Nov. 2016. <http:// www.healthknowledge.org.uk /public-health-textbook/research-methods/1a-epidemiology/hierarchy-research-evidence >. Caelli , Lesley. "Library Guides." Hierarchy of Evidence . N.p ., n.d. Web. 06 Nov. 2016. <http:// canberra.libguides.com / content.php?pid =591487&sid=5015301 >.

References:

References Sibbald , Dr. "Understanding Controlled Trials: Why Are Randomised Controlled Trials Important?" BMJ . N.p ., 17 Jan. 1997. Web. 06 Nov. 2016. <http:// www.bmj.com /content/316/7126/201 >. "The Hierarchy of Research Evidence - from Well Conducted Meta-analysis down to Small Case Series, Publication Bias." Health Knowledge . N.p ., 20 June 2010. Web. 06 Nov. 2016. <http:// www.healthknowledge.org.uk /public-health-textbook/research-methods/1a-epidemiology/hierarchy-research-evidence >. Gazel , G. "A Double-blind Randomized Controlled Trial Investigating the Effectiveness of Topical Bupivacaine in Reducing Distress in Children following Extrac ..." National Center for Biotechnology Information . U.S. National Library of Medicine, 14 Nov. 2004. Web. 06 Nov. 2016. <https:// www.ncbi.nlm.nih.gov / pubmed /15525311>.

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