Qualitative research and content validity: developing best practices based on science and experience.
OBJECTIVE
Establishing content validity for both new and existing patient-reported outcome (PRO) measures is central to a scientifically sound instrument development process. Methodological and logistical issues present a challenge in regard to determining the best practices for establishing content validity.


METHODS
This paper provides an overview of the current state of knowledge regarding qualitative research to establish content validity based on the scientific methodological literature and authors' experience.


RESULTS
Conceptual issues and frameworks for qualitative interview research, developing the interview discussion guide, reaching saturation, analysis of data, developing a theoretical model, item generation and cognitive debriefing are presented. Suggestions are offered for dealing with logistical issues regarding facilitator qualifications, ethics approval, sample recruitment, group logistics, taping and transcribing interviews, honoraria and documenting content validity.


CONCLUSIONS
It is hoped this paper will stimulate further discussion regarding best practices for establishing content validity so that, as the PRO field moves forward, qualitative research can be evaluated for quality and acceptability according to scientifically established principles.
Brod
Meryl
M
The Brod Group, 219 Julia Avenue, Mill Valley, CA 94941, USA. mbrod@thebrodgroup.net
Tesler
Laura E
LE
Christensen
Torsten L
TL
D055317:Evidence-Based Practice; D017144:Focus Groups; D006801:Humans; D007407:Interviews as Topic; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D036301:Qualitative Research; D011788:Quality of Life / Q000523:psychology; D015203:Reproducibility of Results