Abstract
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.
Methods
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)
Results
There was excellent test—retest reliability and correlation between PGI-I and other outcome measures.
Conclusion
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.
Similar content being viewed by others
References
Swift SE (2000) The distribution of pelvic organ support in a population of female subjects seen for routine gynaecological health care. Am J Obstet Gynecol 183:277–285
Swift SE, Woodman P, O'Boyle A et al (2005) Pelvic Organ Support Study (POSST): the distribution, clinical definition and epidemiology of pelvic organ support defects. Am J Obstet Gynecol 192:795–806
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, France
Olsen AL, Smith VJ, Berstrom VO, Colling JC, Clark AL (1997) Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 89:501–506
Black N, Griffiths J, Pope C, Bowling A, Abel P (1997) Impact of surgery for stress incontinence on morbidity: cohort study. BMJ 315:1493–1498
Barber MD, Kuchibhatla MN, Pieper CF, Bump RC (2001) Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 185:1388–1395
Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Qualls C (2001) A new instrument to measure sexual function in women with urinary incontinence and pelvic organ prolapse. Am J Obstet Gynecol 184:552–558
Yalcin I, Bump RC (2003) Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 189(1):98–101
Feinstein AR (1987) Global indexes and scales. Clinimatrics. Yale University Press, New Haven (CT), pp 267–316
Gill TM, Feinstein AR (1994) A critical appraisal of the quality of life measurements. JAMA 272:6619–6626
Bump RC, Mattiasson A, Bo K et al (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17
Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S (2005) P-QoL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J 16:176–181
Guy W (1976) ECDEU assessment manual for psychopharmacology. Rockville (MD): National Institute of Mental health, US department of Health, Education and Welfare, p 217–222
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 print
Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I, Serpell M (2009) Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin 25:1677–1687
Jelovsek JE, Barber MD (2006) Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol 294(5):1455–1461
Digesu GA, Chaliha C, Salvatore S, Hutchings A, Khullar VM (2005) The relationship of vaginal prolapse severity to symptoms and quality of life. BJOG 112(7):971–976
Kelleher CJ, Pleil AM, Reese PR, Burgess SM, Brodish PH (2004) How much is enough and who says so? Br J Obstet Gynaecol 111:605–612
Srikrishna S, Robinson D, Cardozo L (2008) Is there a difference in patient and physician Quality Of Life evaluation in pelvic organ prolapse? Int Urogynecol J Pelvic Floor Dysfunct 19(4):517–520
Hullfish KL, Bovbjerg VE, Gibson J, Steers WD (2002) Patient centred goals for pelvic floor dysfunction surgery: what is success and is it achieved? Am J Obstet Gynaecol; 187:88–92
Hullfish KL, Bovbjerg VE, Steers WD (2004) Patient centred goals for pelvic floor dysfunction surgery: long-term follow up. Am J Obstet Gynaecol 191:201–205
Crosby RD, Kolotkin RL, Rhys Williams G (2003) Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56:395
Conflicts of interest
Sushma Srikrishna
Speaker Honorarium: Recordati
Consultant: Astellas
Travel grant to attend ICS: Boston Scientific, Recordati
Dudley Robinson
Consultant: Astellas, Ferring, Gynaecare, Uroplasty, Pfizer, Recordati, Novo-Nordisk
Speaker Honorarium: Astellas, Ferring, Gynaecare, Uroplasty, Pfizer, Recordati
Trial participation: Astellas, Pfizer
Linda Cardozo
Consultant: Astellas, Pfizer, Rottapharm, Schering-Plough
Speaker Honorarium: Astellas, Pfizer, Rottapharm, SCA
Trial Participation: Astellas, Pfizer, Bioexcell
Research grant: Pfizer
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Srikrishna, S., Robinson, D. & Cardozo, L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 21, 523–528 (2010). https://doi.org/10.1007/s00192-009-1069-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00192-009-1069-5