What Is This Project About?

This project is focused on creating a set of questionnaires (called a Core Outcome Set or COS) for Type 1 diabetes (T1D) screening. The COS will be made up of a list of outcomes that will help guide how we measure success and track results in our pilot (trial) T1D screening program. Outcomes are the specific results or effects we want to measure to understand how well the T1D screening works and what impact it has on people.

What Will The Project Deliver?

This project will create questionnaires (list of specific questions), or COS, for T1D screening. This means we will:

  • Develop a list of important concepts to measure for T1D screening.
  • Use this COS to guide how we evaluate the pilot screening program.
Graphic of papers falling down towards a notepad with a survey clipped to it. On the papers falling, there are icons of question marks, survey results and a conversation bubble.

Why Is This Important?

When people are part of a T1D screening program, it is important to keep track of how the process affects them. This includes their thoughts, feelings, and behaviors. Studies have shown that parents, especially mothers, can feel anxious or worried when they learn their child has a higher risk for T1D. They might also feel upset about the procedures or extra monitoring involved. This project will help us understand these impacts better. We can use this information to improve the screening process.

Right now, researchers are using many different ways to measure the impact of T1D screening, making it hard to compare results. By creating a COS, we will create a guide for other researchers so that we can ensure that we all measure the same factors in the same way. This will make it easier to understand and compare the impact of T1D screening across different programs.

What Is The Goal Of This Research?

Our goal is to develop a COS for T1D screening that is approved by people living with T1D, families, and healthcare providers. This COS will help us make sure the pilot screening program is measured in the best way possible. Here is what we will do:

  1. Identify outcomes: We will look at the concepts that have been measured in recent T1D screening studies.
  2. Add important outcomes: We will ask families with T1D, parents, and health care providers (doctors) what else should be measured.
  3. Get agreement: We will work with all the key groups to agree on a final list of outcomes for T1D screening.
  4. Pick the best tools: We will also find the best ways to measure each outcome in the COS.

How Will We Achieve Our Goal?

We will follow a six-step process to develop the COS that follows the guidelines set by the COS-Standardised Protocol Statement and the Core Outcome Measures in Effectiveness Trials (COMET) Initiative guidelines.

Step 1a: Rapid Review

We will start with a rapid review of the research to find out:

  • What outcomes have been measured in recent T1D screening programs.
  • What questionnaires were used to measure those outcomes.

Step 1b: Candidate Outcomes Survey

At the same time, we will ask the people from our members of public or citizen panels (from the ‘Citizen Engagement and Stakeholder Dialogue’ project) to complete a survey. They will list up to three outcomes that are important to them for T1D screening. These outcomes will be combined with the outcomes from the rapid review to create a list of potential outcomes for the COS.

Step 2: Outcome Preparation

Next, we will ask people from our collaborator or stakeholder dialogue (from the ‘Citizen Engagement and Stakeholder Dialogue’ project) to fill out a survey to make sure the list of outcomes we have is complete. This will help us make sure we are including all the important outcomes. The results from this step will be combined with the previous steps and form the basis for the next phase: prioritizing the outcomes.

Step 3: Delphi Process

A Delphi Process is a strategy for coming to consensus among a large group of people. We will ask them to fill out 2 to 3 surveys (a method of collecting data through questions) to reach an agreement on which outcomes should be included in the COS.

The participants will include parents, caregivers of children with T1D, healthcare providers, and health policy decision-makers. There will be 50 to 75 participants. We will ask participants to rate each outcome’s importance. The outcomes with the highest scores in the surveys will move onto the next step of this project.

Step 4: Final Meeting

After the Delphi process, we will hold a meeting online to make sure that the team agrees with the list of outcomes. These outcomes will be used to create a final list that forms the COS.

Step 5: Establishing Outcome Measurement Instruments

Next, the COS Advisory Committee (a group of people who give advice and help make decisions about the COS) will decide on the best questionnaires to measure each outcome listed in the COS. For example, if it is decided that the outcome “anxiety” is part of the final list, we need to find the best questionnaire to measure anxiety. They will consider factors like how easy, reliable, and valid each questionnaire is.

Step 6: Dissemination

Finally, the results will be shared with international colleagues and patient organizations for feedback. We will then use our team’s knowledge-sharing strategy to make sure the COS is shared with the right people in ways that are useful for each group.

What Happens Next?

After the COS is developed, we will use it to evaluate our trial T1D screening program. This will help us make sure the program works to the best of its ability and that we are capturing the most important information about how it affects people living in Canada.