Primary Collection: Qualitative and Quantitative Methods

If existing data are deemed insufficient, a host of methods can be employed for primary collection of impact data from other stakeholders. These methods parallel those used collecting patient-reported impacts. Consult the previous section in this Blueprint on collection of data from patients for more details. 

Numerous qualitative approaches are listed below, with potential resources to support work in these areas.

Qualitative Methodology Options may include:

• Town halls or listening sessions
• Focus Groups
• Interviews
• Invitational roundtables and convenings

Resources include:

• The U.S. Food and Drug Administration’s (FDA’S) Patient-Focused Drug Development (PFDD) Guidance 1, Focus Group guidance 
• NHC Patient Experience Mapping Toolbox (PEMT) Interviewer Training Guide and Project Coordinator Guide pages 4-7
• FDA Voice of the Patient Reports (pediatric asthma , Juvenile Idiopathic Arthritis (JIA), and United Mitochondrial Disease Foundation)  

Myriad mixed methods are also available for use in primary data collection. Mixed Methods options include:

• Patient-Important Outcomes in the Long-Term Treatment of Bipolar Disorder Case Example
• PFMD Book of Good Practices and Patient Engagement Landscape paper (page 7)
• The Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Handbook Chapter 3
• The Core Outcome Set-STAdards for Development (COS-STAD) Guidelines for Core Outcome Set (COS)
• Innovative Medicines Initiative (IMI), Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) Methodology

Arthritis Use Case

Arthritis Foundation, Primary Collection of Other Stakeholder Data