Evaluation and evidence generation for diagnostics
PATH uses innovative tools and methods to generate actionable evidence that are applied to advance context-appropriate diagnostic solutions. Learn more below.
Formative user research to define requirements for users and contexts of use
Early usability assessments and persona creation are conducted to gather user feedback, attitudes, and behaviors when interacting with a device or product to gain insights into its usability. It is essential that they are fit for purpose and intentionally designed with the specific product, goals of the evaluation, and target end users in mind.
At PATH, formative usability assessments are done early in product development to shape functionality and design. Summative usability assessments are performed after a diagnostic test is fully developed and designed to inform the content of training materials, avert potential user issues during implementation, and satisfy regulatory requirements before launching a commercially available product.
Resources
- Understanding user requirements to improve adoption of influenza diagnostics in clinical care within Metro Manila
- HIV self-testing personas
- Antenatal care provider personas
Fit-for-purpose clinical evaluation to generate actionable data
Clinical evaluations are used to systematically generate evidence related to the use and performance of a device or treatment in a tightly controlled clinical setting. The data generated is used to assess device performance in its intended population. Clinical evaluations involve the prospective enrollment of human subjects to participate in the research and thus undergo rigorous scrutiny to ensure participant rights are upheld, and the study is conducted ethically.
Validation of product performance is a critical component of the diagnostic development process. As a product’s design and workflow are improved through iterative product improvements, it is vital to ensure the underlying product or test principle does not change and that it still performs as expected. A clinical evaluation aims to generate this type of data, which is usually submitted for regulatory approval before commercial availability.
Resources
- Screening for Severe Acute Respiratory Syndrome Coronavirus 2 in Close Contacts of Individuals With Confirmed Infection: Performance and Operational Considerations
- Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation.
- Diagnostic accuracy of self-administered urine glucose test strips as a diabetes screening tool in a low-resource setting in Cambodia
- Evaluation of a protein-to-creatinine dipstick diagnostic test for proteinuria screening in selected antenatal care clinics in three Districts in the Bono-East Region of Ghana
Implementation research to ensure solutions are appropriate to both users and health systems
Once a product or device’s clinical performance has been validated, it may be made commercially available. Implementation research ensures that a product is appropriately integrated into clinical systems. Health systems, policy, and workflows vary by context and can significantly impact the successful introduction and scale-up of health products.
PATH collaborates closely with national and international researchers and ministries of health to conduct pilot implementations of a product or device. Throughout the pilot implementation, PATH and partners can ensure product alignment to health system needs This includes user training that meets provider needs, costing analyses, and a consideration of public health impact. Implementation research determines the product's operational feasibility for the given context, and recommendations are provided to ensure appropriate product adoption.
Resources