Patient reported outcomes: the ICIQ and the state of the art.
BACKGROUND
Following the first International Consultation on Incontinence (ICI) in 1998, a multidisciplinary committee was established to develop a universally applicable, brief urinary incontinence patient-reported outcome (PRO) questionnaire: the ICIQ-UI Short Form. The project was expanded to recommend and develop high quality, validated questionnaires for all lower pelvic dysfunction related to incontinence. The ICI Modular Questionnaire project (ICIQ) was then established to include a wider spectrum of urinary, bowel and vaginal symptoms and their impact on health related quality of life (HRQL). Three aims underpin the ICIQ project: To recommend high quality, validated PRO questionnaires. To promote wider use of questionnaires to standardize assessment of lower pelvic dysfunction and its impact on HRQL. To facilitate communication in different patient settings and patient groups.


CONCLUSIONS
The authors, both ICIQ committee members, debated the title. If the conceptualization of the ICIQ is correct, the PROs recommended by the ICIQ need to be under constant evolution and improvement to ensure the aims of the ICIQ project. A modular questionnaire design, recognized and implemented internationally, would add greatly to the universal inclusion, interpretation and understanding of PRO data in clinical practice and clinical research. However, in order to achieve the goals of the ICIQ project, we must ensure that the scientific quality of PRO development, documentation and validation meets current scientific standards, as well as societal and governmental regulatory guidelines. These topics are discussed along with recommendations for future areas of research and need for the ICIQ committee to explore these issues.
Coyne
Karin
K
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA. karin.coyne@unitedbiosource.com
Kelleher
Con
C
D006801:Humans; D038622:Internationality; D011788:Quality of Life; D011795:Surveys and Questionnaires / Q000592:standards*; D014549:Urinary Incontinence / Q000175:diagnosis*