Primary Collection: Key Considerations

If substantial gaps in existing data are identified, primary data collection may be required to fill those gaps. Before embarking upon qualitative or quantitative research, it may be helpful to review some best practices, in partnership with the research members of your team. Things to consider include seeking Institutional Review Board (IRB) approval, understanding the ethical considerations and regulations that govern research, and how to design forms for and collect informed consent.

Keep in mind that the task is to collect impact data and not to identify specific tools or measures at this point in Patient-Centered Core Impact Set (PC-CIS) development. The identification, adaptation, or development of measures is a “next phase,” after the creation of the PC-CIS and is not covered under the resources and guidance provided within this Blueprint.

Before embarking upon primary data collection, there are several steps and preparations to consider. Pages 6-9 of the NHC’s Patient Experience Mapping Toolkit Project Coordinator Guide, which outlines general research considerations and best practices for primary data collection, may be useful as you are contemplating how to prepare for data collection.

Primary Collection: Qualitative and Quantitative Methods

A host of methods can be employed for primary collection of impacts from patients. The most important aspect of data collection is that it is done in partnership with patients, not in a manner that integrates patients only as research “subjects.” 

Numerous qualitative approaches exist with resources to support work in this area.

Qualitative methodology options include:

• Town hall meetings, listening sessions
• Focus groups
• Interviews
• Social media listening
• Shadowing
• Participatory observation
• Roundtable meetings, invitational 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) 

Various mixed methods approaches are also available for use in primary data collection. Be mindful that purely quantitative methods may fall short of PC-CIS standards unless the survey (or other tool) was co-created with patients, and patients are involved in data analysis, interpretation, and application. A survey developed in isolation by researchers — even if posed to patients and even if patients are the sole and independent responders — should not automatically be considered patient-centered data. Patients are often asked to provide responses to questions they do not care about or understand. Just because patients answered the questions does not make the resulting data patient centered.

Mixed-methods approaches include:

• The Patient-Centered Outcomes Research Institute’s (PCORI’s) Methodology Standards for Patient Centeredness
• FDA PFDD data collection guidance including FDA PFDD Guidance 1, Guidance 2 , and Guidance 3
• University of Maryland “What Works When” methods guidance
• National Health Council and Duke University Real-World Evidence training webinar series
• NHC Patient-Centered Real-World Evidence (RWE) Methods Recommendations White Paper, manuscript, and Real-World Evidence Classroom
• Example project from Patient Focused Medicines Development (PFMD)
• Innovative Medicines Initiative (IMI), Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) Methodology
• A resource on understanding Triangulation
• The Core Outcome Measures in Effectiveness Trial’s (COMET’s) plain-language summaries of methods for nominal group technique and Delphi process
• Medical Device Innovation Consortium (MDIC)’s catalog of method