IWQOL-Lite-CT© (Impact of Weight on Quality of Life-Lite-Clinical Trials) is the gold standard patient-reported outcome (PRO) measure of weight-related quality of life in adults designed for use in clinical trials. As the exclusive licensor of IWQOL-Lite-CT©, Pattern Health works with CROs and biopharma organizations to implement the measure for regulated clinical trials. Pattern licenses linguistically validated translations available in more than 65 languages.
There are many implementation options available depending on an organization’s needs and study designs. This article details three of the most common deployment options, weighing the pros and cons of each method.
2. Pattern’s eCOA solution.
3. Third-party eCOA solution.
1. Paper-based Implementation.
✔ The simple but effort-intensive option.
✔ Manual scoring and workflow.
✔ A good option for early-phase studies or populations with low technology adoption.
Paper-based implementation is the low-tech option best suited for early-phase studies with low patient volumes or regions of the world where participants may not have access to electronic devices. After licensing, Pattern will provide a print-ready PDF for patients to fill during onsite visits. Processing the completed PROs, such as scoring and uploading to a patient’s electronic health record, is then a manual effort. Paper implementation requires little setup but significant administrative efforts on the back end.
Digital Implementation reduces patient burden & improves data quality.
On the other hand, digital implementation requires some technical effort on the front end but automates follow-up tasks, improving operational efficiency in higher-volume environments. Digital implementation meets patients where they are, reducing burden while improving compliance and data quality.
Pattern provides support for various digital implementation options, which are ideal for most clinical trials. In general, patients access surveys on mobile devices, desktop computers, or kiosks, submit their responses remotely or onsite, and the resulting data is then immediately scored and available digitally. Digital deployment options supported include both Pattern’s eCOA solution and third-party eCOA solutions.
2. Pattern’s eCOA solution.
✔ Next-gen solution with pre-built, pre-approved eCOA library.
✔ Configurable automated workflows reduce study team burden.
✔ Seamless integration with eConsent, biometric devices, and more.
Pattern’s eCOA solution is a flexible option for deploying eCOA in alignment with study design. Many IWQOL-Lite-CT© translations are pre-built on Pattern’s platform, which can expedite the approval and validation processes. Implementation options include:
Option A. Deploy Pattern’s standalone eCOA solution.
Pattern’s standalone eCOA solution is the quickest and most efficient way to implement IWQOL-Lite-CT©. End-user experiences can be configured to meet specific study designs, meet patients where they are, and reduce patient burden. Pattern’s solution is available as a web-based app that can be accessed by participants via browsers on any device, as well as native mobile apps that are available on the Google Play Store and App Store. Pattern’s standalone solution improves patient completion rates while reducing study team burden through automated workflows, including reminder notifications. Our platform includes solutions for registrations, user accounts, notifications & reminders, compliance tracking, integration with wearable devices, and much more. Here’s the basic workflow:
Option B. Integrate Pattern’s eCOA solution into an existing patient experience.
For organizations with an existing registration and patient experience platform, Pattern’s eCOA solution, with the pre-programmed and approved surveys, can be easily integrated. In this model, organizations leverage their existing application and user accounts while reducing time and costs by using the pre-built, scored, and translated IWQOL-Lite-CT© measures on Pattern’s platform. Here’s the basic workflow:Learn More about Pattern's eCOA Solution
3. Third-party eCOA solutions.
✔ Custom option for those with an existing system.
✔ Requires custom build and validation of IWQOL-Lite-CT©.
✔ Custom coding required for scoring, user accounts, workflow automation, etc.
If Pattern’s eCOA solution doesn’t fit an organization’s use case, the measure can be implemented in the platform of their choice. This method requires a custom build, review and approval of the implementation by Pattern Health, and coding to properly score of the measures. In addition to survey build, custom workflows need to be crafted to handle onboarding, user accounts, notifications, and data access. Pattern supports custom builds with implementation and scoring guides and access to the implementation of IWQOL-Lite-CT© on our platform as a reference.
IWQOL-Lite-CT© is a copyrighted, validated patient-reported outcome (PRO) measure of weight-related quality of life in adults designed for use in clinical trials. It was developed by Ronette “Ronnie” L. Kolotkin, Ph.D., owner of Quality of Life Consulting, PLLC, and consulting professor at Duke University. The IWQOL-Lite-CT© instrument is copyrighted by Duke University.
IWQOL-Lite-CT© was developed to meet the developmental rigor required by the Food and Drug Administration (FDA) to support product labeling. FDA qualification for the IWQOL-Lite-CT© is being sought for use in clinical trials to support product-labeling claims in new obesity treatments, including medications.
For more information and to license the IWQOL-Lite-CT©, visit the Pattern Exchange.