Goal Attainment Scaling Training: Ensuring Successful Implementation

Clinician training is central to a successful GAS implementation, assuring data integrity and reducing bias. In our model, sites are taken through a comprehensive onboarding where CRAs and GAS raters complete a multi-module bespoke online training course prior to goal-setting with participants. This ensures that the healthcare professionals are able to set SMART (Specific, Measurable, Achievable, Relevant, Time-bound) goals that capture the symptoms and challenges most meaningful to the patient. Our comprehensive five-module GAS  training covers the following:

• Introduction and overview of goal attainment scaling
• Detailed practical scenarios and specific examples
• Comprehension quizzes and self-assessment tools
• Study-specific module outlining all details relevant to GAS implementation as outlined in the protocol

Goal Inventory Development

Ardea Outcomes is a pioneer in the development and use of Goal Inventories for GAS training and implementation. Working in collaboration with sponsors, patients, and clinician experts, we use qualitative research to outline the most common and meaningful goal areas in a particular disease area. Using a qualitative research approach, we conduct in-depth interviews with patients and their caregivers and facilitate focus groups with clinician experts to gain profound insights into individuals' daily hurdles and priorities. Goal inventories can be further adapted and refined with iterative research or by sponsors to ensure that they reflect the potential impact of the therapeutic intervention being tested. Through in-depth interviews with patients and their caregivers and facilitated focus groups with clinician experts, we gain profound insights into individuals' daily hurdles and priorities in coping with these health issues.

Goal inventories increase the feasibility of GAS implementation, orient the patients and their families to the GAS process, and may result in a wider variety of goals being set.

GoalNav® Platform: Streamlining GAS Data Collection

Built with the user in mind, the GoalNav® GAS electronic Clinical Outcomes Assessment (eCOA) walks the clinician through the GAS data collection process to identify, scale, and rank goals.

• Highly Configurable
  GoalNav® can be configured to any study protocol, including hybrid and fully decentralized trials. Fields are customizable, and additional outcomes and surveys can be included.
• FDA CFR Part 11 and EU Annex 11 Compliant
  GoalNav® facilitates compliance with FDA CFR Part 11 and EU Annex 11 required for electronic source data capture in clinical trials through e-signatures, access control, versioning, and audit records.
• Supports Data Monitoring and Quality Assurance
  Data monitoring is enabled through query creation, follow-up, and resolution workflows. The Ardea Outcomes support team can review goals using our quality assurance process and provide timely feedback and additional training to sites.
• myGoalNav® Patient Portal
  Patients can log in remotely to track goals in hybrid trials or decentralized real world evidence studies.