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RRApp User Guide

For more information, visit our website: clinicalresearch-apps.com.
by

Chengcheng Tu

on 15 December 2017

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Transcript of RRApp User Guide

RRAPP
Objective

Chengcheng Tu
DPM/MPH in Biostatistics candidate
New York College of Podiatric Medicine
Graduate School in Biomedical Sciences
Icahn School of Medicine at Mount Sinai
chengcheng.tu@icahn.mssm.edu

Emma K. T. Benn, MPH, DrPH
Assistant Professor
Director of Academic Programs for the Center for Biostatistics
Department of Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
emma.benn@mountsinai.org

robust randomization App
For Junior Clinical Faculty

Increase Need
Junior clinical faculty and fellows at academic medical institutions often desire to be actively engaged in and conduct randomized clinical trials

Inadequate Supply
limited free, reliable, user-friendly, online randomization scheme generators

Feedback from 2016 ACTStat Annual Meeting
Feedback from Clinical Faculty
Add more resources in "RRApp User Resource" tab:
1. to explain RRApp in detail
2. to explain each randomization technique

Consider two types of users:
1. login-website users
2. download-package users
The rationale for RRApp stems from an NCATS-funded Institute for Translational Science initiative to generate innovative tools and resources specifically geared towards early-stage investigators conducting clinical and translational research at the Icahn School of Medicine at Mount Sinai (ISMMS).

Mentorship for the development and evaluation of RRApp was provided by faculty Master-level biostatisticians from the Center for Biostatistics at ISMMS.

"Student Award Recipient" from 2016 ACTStat annual meeting

"Blue Ribbon Recipient" from ISMMSI MPH prgroam

Aplied Biostatisticics in Clinical Trials course directed by Dr. Emilia Bagiella

Acknowledgments:
We aimed to develop a web-based, robust randomization app, RRApp, to provide junior clinical faculty with reliable and easy-to-generate randomization schemes, with the following objectives:

Background
1. Chengcheng​ ​Tu​, Emma K.T. Benn. RRApp, a Robust Randomization App, for Clinical and Translational Research. Manuscript accepted by Journal of Clinical and Translational Science JCTS-SC-17-0038.
2. Suresh, KP. “An Overview of Randomization Techniques: An Unbiased Assessment of Outcome in Clinical Research.” Journal of Human Reproductive Sciences 4.1 (2011): 8–11. PMC. Web. 5 May 2016.
3. Armitage, Peter. The role of randomization in clinical trials. Statistics in medicine 1.4 (1982): 345-352.
4. Cleophas, Ton J, and Aeilko H Zwinderman. Randomized Clinical Trials, History, Designs. Understanding Clinical Data Analysis. Springer International Publishing, 2017. 33-60.
5. Kang, Minsoo, Brian G Ragan, and Jae-Hyeon Park. Issues in outcomes research: an overview of randomization techniques for clinical trials. Journal of athletic training 43.2 (2008): 215-221.
...
6. YouTube website: basic guide for Simple Randomization
7. YouTube website: basic guide for Simple Stratified Randomization
8. YouTube website: basic guide for Block Randomization
9. YouTube website: basic guide for Stratified Block Randomization






Resource:
Feedback from Peers
We should use social media to disseminate RRApp, and gather feedback from users
RRAPP User Guide
Seeds
-pin number to ensure a reproducible result
Number of Total Participants
-total number of people in the study
Number of Treatment arms
-include control and treatments (min: 2)
Motivating
Example
Mary, a junior clinical faculty from Mount Sinai, wants to design a clinical study for a new drug.

She intends to recruit 60 participants in her study, but final number of total participants is subject to change in reality.

She has some rough ideas about randomization, but due to her time and funding, she decides not to see biostatisticians at the current stage.

Can she use RRApp?
What is the best randomization technique for her study?

Basic Elements:
Output Sheet 1
1. Simple Randomization
2. Simple Stratified Randomization
3. Block Randomization
4. Stratified Block Randomization
5. Permuted Block Randomization
6. Stratified Permuted Block Randomization
- Educate users about the importance of randomization in RCTs;
- Allow users to select and use a variety of commonly used randomization methods;
- Implement an effective strategy for quality improvement.
Randomization Techniques




1. 3-4 minutes short videos for each randomization techniques
2. Update RRApp based on email survey results

Plan In 2017-2018:
Feedback from Biostatisticians
1. Provided a REDCap version to streamline the randomization process
2. Notified users of this app that they should not be involved in the screening process of any studies
3. Added an optional user-email feature to survey the users; thus, improve quality and usability of RRApp
Input
Output Sheet 2 (REDCap)
Simple Randomization
Input Elements:
Pin number
Number of total participants
Number of treatment arms


Simple Stratified Randomization
Input Elements:
Pin number
Number of total participants
Number of treatment arms
Number of strata

Output Sheet 1
Output Sheet 2 (REDCap)
Input
Block Randomization
Input Elements:
Pin number
Number of total participants
Number of treatment arms (e.g. 2)
Block size (e.g. 4 or 6 or 8)

Output Sheet 1
Input
Output Sheet 2 (REDCap)
Stratified Block Randomization
Input Elements:
Pin number
Number of total participants
Number of treatment arms (e.g. 3)
Block size (e.g. 6 or 9 or 12)
Number of strata


Input
Output Sheet 1
Output Sheet 2 (REDCap)
Permuted Block Randomization
Input Elements:
Pin number
Number of total participants
Number of treatment arms

Input
Output Sheet 1
Output Sheet 2 (REDCap)
STRATIFIED PERMUTED BLOCK RANDOMIZATION
Input Elements:
Pin number
Number of total participants
Number of treatment arms
Number of Strata
Input
Output Sheet 1
Output Sheet 2 (REDCap)
Attention!!!
Output Sheet 2 (REDCap)
R-SHINY PACKAGE
Additional Elements:
Block size
-Must be a multiple of number of treatment arms;
-to allocate and balance ppl into a relative small unit
Number of Strata
- subgroups depending on study design; could be centers, age groups, genders, or other demographic factors...
Screenshot of Server Scirpt
Screenshot of UI Scirpt
Website 1:
Graphpad.com
Website 2:
Randomizer.org
Website 3:
Randomization.com
3 Top Hits Free Randomization Generators:
Summary: Steps to Generate Randomization Schemes
No Change from
Simple Randomization
Feedback from Clinical Faculty
1. Increased the block size limit
2. Updated a new randomization technique
3. Included a side-table in each randomization scheme to clarify the content


Working on it...
Working on it ...
"Thank You" to Dr. Emma Benn
Full transcript