Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse
- 1.4k Downloads
Introduction and hypothesis
Currently, there is no global outcome assessment index in prolapse research. Patient Global Impression of Improvement (PGI-I) has only been validated in incontinence. Our aim was to validate its use following prolapse surgery.
Women with prolapse were recruited from waiting lists and assessed objectively (pelvic organ prolapse quantification system (POP-Q)). Quality of life (QoL) was assessed with prolapse QoL questionnaire (pQoL). Patient goal achievement (visual analogue scale (VAS)) determined subjective satisfaction and PGI-I indicated overall satisfaction. We established construct validity of PGI-I by correlating final PGI-I response with other measures of response, measured at 1 year: (POP-Q/pQoL/VAS)
There was excellent test—retest reliability and correlation between PGI-I and other outcome measures.
We believe this is the first study validating PGI-I as a global index of response to prolapse surgery. This may be a valuable addition not only in clinical practice but also in trials comparing surgical interventions.
KeywordsConstruct validity Global index Outcome assessment Prolapse PGI-I Reliability
Conflicts of interest
Speaker Honorarium: Recordati
Travel grant to attend ICS: Boston Scientific, Recordati
Consultant: Astellas, Ferring, Gynaecare, Uroplasty, Pfizer, Recordati, Novo-Nordisk
Speaker Honorarium: Astellas, Ferring, Gynaecare, Uroplasty, Pfizer, Recordati
Trial participation: Astellas, Pfizer
Consultant: Astellas, Pfizer, Rottapharm, Schering-Plough
Speaker Honorarium: Astellas, Pfizer, Rottapharm, SCA
Trial Participation: Astellas, Pfizer, Bioexcell
Research grant: Pfizer
- 3.Slieker-ten HMCP, Vierhout M, Bloembergen H, Schoenmaker G (2004) Distribution of pelvic organ prolapse in a general population: prevalence, severity, aetiology and relation with function of pelvic floor muscles. Abstract presented at the Joint Meeting of ICS and IUGA, 25–27 August 2004, Paris, FranceGoogle Scholar
- 9.Feinstein AR (1987) Global indexes and scales. Clinimatrics. Yale University Press, New Haven (CT), pp 267–316Google Scholar
- 13.Guy W (1976) ECDEU assessment manual for psychopharmacology. Rockville (MD): National Institute of Mental health, US department of Health, Education and Welfare, p 217–222Google Scholar
- 14.Oberg M, Wanstrom G, Hjertman H, Lunner T, Andersson G (2009) Development and initial validation of the 'Clinical Global Impression' to measure outcomes for audiological rehabilitation. Disabil Rehabil 19:1–9, Epub ahead of printGoogle Scholar
- 18.Kelleher CJ, Pleil AM, Reese PR, Burgess SM, Brodish PH (2004) How much is enough and who says so? Br J Obstet Gynaecol 111:605–612Google Scholar