Patient-Reported Outcomes: a systematic review on how items are generated using a qualitative research approach

Abstract

Background There is a growing interest in qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). To the best of our knowledge, the literature does not refer to any systematic review that specifically clarifies subject input through focus groups or interviews or any methodology for the collection of discourse data. Methods We adopted the PRISMA Statement as a basis for our reporting systematic review. Keywords: qualitative AND (scale OR test construction OR questionnaire development) AND items Records identified through PUBMED searching: 745 Records screening for relevance: 293 Expected results We wish to identify the current practices in qualitative research used in the construction of PRO items. Current stage of work An analysis grid has been developed to capture the qualitative methodology used. All records will be scrutinized by the end of April 2015. Different qualitative methods used to generate items will be listed Discussion The results of this study will provide guidelines to generate a sample of items from a content analysis. The contribution of health psychology to the field of PRO questionnaire development is essential.