Conceptualisation and Qualitative Development of a PRO Measure

The purpose of this chapter and the subsequent three chapters is to provide a step-by-step guide of how the framework proposed in Chap. 2 may be implemented using case studies based on research carried out in hyperhidrosis. Specifically, this chapter will lay the foundation for the practical chapters by providing a background on hyperhidrosis and presenting a disease model. Methods to generate and select questions for measuring PROs that reflect the experience of patients in hyperhidrosis will be presented (Steps I–II in the roadmap). A draft of Hyperhidrosis Quality of Life Index (HidroQoL) will be discussed (Step III). Chapter 4 will outline approaches to the assessment of fitness for purpose for PROs, by refining the content (Step IV) and pretesting the tool (Step V). Chapter 5 will outline procedures for assessing the performance of a new PROs against expectation (Step VI), and Chap. 6 will present a framework for integrating the conventional approach with more advanced techniques to fine-tune the tool (Step VII).

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