Scientific Merit Screening

Guidelines for Scientific Merit Pre-Screening

The 200 word abstract provided on the Scientific Merit Pre-ScreenForm should include the following:

1. Background and Impact

Why is it important to do this study?

2. Objectives

What are the objectives of the study?

Example:

A) To examine differences in the allocation of treatment A versus treatment B for individuals diagnosed with colorectal cancer from 2010 to 2013.
B) To compare overall survival between individuals diagnosed with colorectal cancer by treatment type.
C) To compare the rate of recurrence between individuals that received treatment A versus treatment B.

3. Study Design

What is the study design you plan to use?

Example:

This study will use a retrospective cohort design.

4. Participants/Subjects

Who will be included in the study?

Example:

This study will include all individuals diagnosed with colorectal cancer from 2010 to 2013 that received treatment A or treatment B.

5. Outcomes for each objective

What are the outcomes for each objective?

Example:

The outcomes for each objective are as follows:
Objective A - Allocation of treatment
Objective B - Overall survival
Objective C – Recurrence

6. Data

What data is required and where will you get it?

Example:

Individuals with colorectal cancer will be identified using the Manitoba Cancer Registry. Tumour characteristics, treatment, and date of death will be identified from the Manitoba Cancer Registry. Recurrence will be determined by reviewing the CancerCare Manitoba electronic medical record (Aria).

7. Analysis

What analysis will be used for each objective?

Example:

The following analyses will be used for each objective:
Objective A - Logistic regression predicting treatment selection
Objective B - Cox regression predicting overall survival
Objective C - Competing risk analysis predicting recurrence

8. Sample size

What is your estimated sample size? Note – you will want to include power calculations for each outcome in your full study proposal.

Example:

Based on estimated from the MCR, there are 500 individuals that received either treatment A or treatment B from 2010 to 2015.