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- Generating a literature-review domains or scales.
- Defining the end-point models.
- Assorting the recall period.
- Formulating the conceptual framework using clinical expert opinion.
- Qualitatively interviewing a limited number of people from the concerned pop-
ulation for revision of the preliminary framework. - Qualitative analyzing interview transcripts to produce an exhaustive list of
items from words taken from people. - Generating a preliminary items list.
- Clinical and psychometric experts review.
- Production of the conceptual framework of outcomes.
Step II: Items and Scales Identification and Refinement
- Operationalization and content analysis to classify different items on different
domains/scales of measurement. - Setting different response options and format.
- Psychometric analysis with reduction of PROM items using different item selec-
tion statistical processes. - Clinical and psychometric expert review.
- Production of the preliminary version of the instrument and its content validity.
Step III: Pretesting of the Instrument
- Semi-structured cognitive interviews with individuals from the target popula-
tion—a relatively larger number of respondents are required than step I. - Identification of problems with items: ambiguity, confusion, layout and format
of the instrument, and the proper mode of administration. - Psychometric analysis and revision of the instrument on the base of respondents’
recommendations.
Fig. 2.6 Major steps in developing a PROM instrument as conceptualized from different sources
M. El Gaafary