Patient reported outcome measures after incontinence and prolapse surgery: are the pictures painted by the ICIQ and PGI-I accurate?
Int Urogynecol J
Patient reported outcome measures after incontinence and prolapse surgery: are the pictures painted by the ICIQ and PGI-I accurate?
Rufus Cartwright 0 1 2
Heidi Brown 0 1 2
Diaa Rizk 0 1 2
0 Department of Obstetrics and Gynaecology, College of Medicine and Medical Sciences, Arabian Gulf University , Manama , Bahrain
1 Departments of Obstetrics & Gynecology and Urology, Female Pelvic Medicine & Reconstructive Surgery Section , Madison, WI , USA
2 Department of Urogynaecology, Imperial College London , London , UK
3 Rufus Cartwright
Following surgery to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), it is important to assess both objective and subjective outcomes. While not life-threatening, SUI and POP have potential for a significant adverse impact on quality of life, and thus the patient perspective has become increasingly important when evaluating treatment outcomes. Patient reported outcome measures (PROMs) are frequently used for subjective evaluation of the benefits of a treatment or intervention by gauging patients views on any change in their symptoms, function and health-related quality of life. In this issue, Larsen et al. report on the assessment of postoperative outcomes of SUI and POP surgery using PROMs [1]. It is commonly accepted in urogynaecological research and practice that different PROMs will measure different things. Although newly developed outcome measures are typically validated against a combination of existing objective and subjective measures, time and again, studies find limited correlations between different measures of disease severity or treatment improvement [2]. As a consequence, the available PROMs are often seen as complementary to one other. It is frequently recommended that clinicians should employ a range of PROMs, and it is usual for studies to employ a
-
multitude of PROMs to fully capture different aspects of the
patient experience of pelvic floor dysfunction [
3, 4
].
Larsen and colleagues compare the results of two different
widely used PROMs. The International Consultation on
Incontinence Questionnaire (ICIQ) system, developed from
the earlier Bristol Female Lower Urinary Tract Symptoms
(BFLUTS) questionnaire, measures the severity and bother
of individual symptoms. In the format used in this study the
ICIQ also provides separate global measures of interference in
everyday life for urinary incontinence and POP. The Patient
Global Impression of Improvement (PGI-I) is a seven-point
scale that provides a single global measure of condition
improvement. It was initially developed during the licensing
trials of duloxetine for the treatment of SUI, but has
subsequently been revalidated as a measure for improvement following
treatment for POP and urgency incontinence.
Larsen et al.’s study has some remarkable features, most
notably its sample size, with the underlying database
including more than 90 % of all surgeries performed for SUI and
POP in Denmark during 2013, likely representing the largest
ever reported surgical cohort study in urogynaecology. They
find that overall results for both SUI and POP surgeries are
excellent, with very substantial mean improvements on both
the ICIQ and the PGI-I at the 3-month post-operative
followup. The response rate of 60 % also suggests some potential for
bias, but regardless, these are largely reassuring data.
Interestingly, the age trends in this study lead in the opposite
directions for SUI and POP surgery, with younger women
reporting better results for SUI surgery and worse results for
POP surgery.
To make comparisons between the ICIQ and the PGI-I
measures, individual scores for each were converted to the
same scale. This procedure is likely fraught with difficulties,
as the numerical values assigned to each category in the
underlying items is somewhat arbitrary, and it is certainly
Having raised a significant concern about an inherent bias
in the PGI-I, the authors conclude that it should be used
cautiously, and perhaps only in combination with other measures
of treatment success. These findings should not detract from
the importance of the PGI-I, or other global measures, as
adjuncts to symptom-specific or disease-specific PROMs, which
may miss important effects of complicated interventions, such
as pelvic floor surgery.
1. Larsen MD , Lose G , Guldberg R , Gradel KO ( 2015 ) Discrepancies between patient reported outcome measures when assessing urinary incontinence or pelvis prolapse surgery . Int Urogynecol J DOI: 10. 1007/s00192-015-2840-4
2. Castillo PA , Espaillat-Rijo LM , Davila GW ( 2010 ) Outcome measures and definition of cure for female stress urinary incontinence surgery: a survey of recent publications . Int Urogynecol J 21 : 343 - 348
3. Ghoniem G , Stanford E , Kenton K , Achtari C , Goldberg R , Mascarenhas T et al ( 2008 ) Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IU (...truncated)