The Development of a Valid Qualitative Standardized Interview Manual

OBJECTIVES:

The authors developed a qualitative standardized interview manual (SIM) that can be readily used for capturing and analyzing patient-experience data, tailoring for various conditions and phases of drug development. The SIM seeks to build upon current methods for instrument development to address gaps in systematic qualitative methodologies.

METHODS:

Following the methodology in the FDA’s PFDD series, the SIM creation included an iterative process with a systematic literature review, consultation with PRO experts, and a series of cognitive interviews. Each step was documented in an item-tracking matrix summarizing the creation, deletion, and modification of item content.

RESULTS:

Following PRISMA guidelines, a qualitative literature search resulted in 23 articles focused on the effect of investigational drugs/treatments in relation to patients’ disease and treatment experiences, satisfaction, and trial experiences. The review resulted in a framework of seven modules written for pre-, interim, and post-trial implementation.

Subsequently, expert consultation furthered the scope, applicability, and adaptability of the modules including burden of disease, patient preference, patient satisfaction, trial participation, treatment outcome, meaningful change, and benefit-risk assessment. Modifications more directly connected qualitative questions to commonly used PROs, including the SF-36, EQ-5D, and the WHO-DAS 2.0. Further, instructional content was augmented to clarify instrument adaptability.

Cognitive interviews with people experiencing a particular condition verify the SIM is meaningful with relevance, comprehension, and completeness, and explore health literacy, recall periods, and response options with resultant modifications. A sample of case study results from this phase will be presented to show how it can be tested in future studies.

CONCLUSIONS:

With the expectations for improved content validity in interview manuals yet the need for more efficient solutions to integrate patient voice, the application of the FDA iterative developmental process proved constructive, even though labor-intensive, in developing a qualitative interview manual for use in drug development.