The International Consultationon Incontinence QuestionnairesICIQAn Update On Status and Direction
The International Consultationon Incontinence QuestionnairesICIQAn Update On Status and Direction
The International Consultationon Incontinence QuestionnairesICIQAn Update On Status and Direction
DOI: 10.1002/nau.24437
SOUNDING BOARD
1
Department of Urology, Southmead
Hospital, Bristol Urological Institute, Abstract
Bristol, UK Aims: In its 22nd year, the International Consultation on Incontinence
2
Department of Urology, Southmead Questionnaire (ICIQ) project continues to promote its primary objective; the
Hospital, University of the West of
England and the Bristol Urological development and dissemination of patient completed questionnaires for the
Institute, Bristol, UK standardized, high‐quality assessment of urinary, bowel, and vaginal symp-
toms. The paper gives an update on the ICIQ in the context of current scientific
Correspondence
Alan D. Uren, Bristol Urological Institute, developments of PROM design and regulatory requirements, and plans are
Bristol BS10 5NB, UK. outlined for its future direction.
Email: [email protected]
Methods: An online library of all questionnaires, including over 300 trans-
lations has been launched to facilitate access through a semi‐automated re-
gistration system. The ICIQ project continues to update its protocol to meet
current scientific standards and incorporate methodological advances within
PROM development.
Results: Nineteen psychometrically validated patient‐reported outcome measures
(PROMs) are published for use in clinical practice and research, including
amongst others, a bladder diary, male and female lower urinary tract symptoms,
long term catheter, pad use, and bowel symptom questionnaires. The original
ICIQ‐UI Short Form for the assessment of urinary incontinence continues to be
the most internationally used questionnaire and has been translated into over 60
languages. New questionnaires which are under development include the ICIQ‐
Underactive Bladder and ICIQ‐Satisfaction. We anticipate the new website and
online library will further facilitate the ease of dissemination and availability of
the questionnaires for clinical practice and research.
Conclusion: The ICIQ continues to successfully achieve its primary objective.
Going forward, a greater focus on promoting routine clinical use and the potential
for electronic integration into databases and medical records is envisaged.
KEYWORDS
ICIQ, LUTS, patient reported outcome measures, PROM, quality of life, questionnaire
formally launched in 1999, to meet the requirement for defining the subject matter of their respective chapter,
universally applicable questionnaires for use in clinical and forming an expert committee who collaborate to
practice and research.1,2 The result was the development perform a systematic review of the relevant literature.
of the ICIQ‐Urinary Incontinence Short form (ICIQ‐UI‐ During each consultation, the chairs of the individual
SF) for the assessment of urinary incontinence and its committee make recommendations for the assessment
impact on quality of life.3 The main aims of the ICIQ and treatment of patients based on the committee find-
project were, and are, as follows: ings. The committee 5B of the most recent 6th ICI was
comprised of a number of experts on symptom and
1. To develop psychometrically validated questionnaires quality of life (QoL) assessment. As a result, the pub-
to evaluate symptoms and impact of dysfunction of the lication is a comprehensive review of the available
lower urinary tract, lower bowel, and pelvic organ PROMs related to the assessment of LUTS, bowel and
prolapse. vaginal symptoms and other important aspects of as-
2. The adoption of existing questionnaires, that are psy- sessment and management, such as sexual function and
chometrically valid and complement the existing ICIQ quality of life.4 Each PROM received a grade, from A+ to
questionnaires. C, based on the published evidence of the reliability,
3. To increase the use of patient‐reported questionnaires validity, and responsiveness of the questionnaire. The
to standardize the assessment of lower urinary tract, grading of A was given if there is “published evidence of
lower bowel, and pelvic organ prolapse and their im- validity, reliability, and responsiveness to change” and is
pact on patients’ lives. therefore “highly recommended.” If there was additional
4. To use the questionnaires to facilitate communication evidence of content validity (ie, evidence of patient in-
in different patient settings and different patient volvement in the item development process) then the
groups both in clinical practice and wider clinical highest grade of grade A+ was awarded. If was less evi-
research.4 dence of validity or reliability, a grading of B meant that it
was ‘recommended’, and a grade C that the questionnaire
The first questionnaire to be developed, the ICIQ‐ had ‘potential’ but required further validation, before it
UI SF, remains the most widely used and requested could be recommended. All the ICIQ questionnaires ex-
questionnaire and has now been translated into over cept one are recommended with the grades of A or A+,
sixty languages. Since the modular structure was fi- by sixth ICI.4 It should be noted that the grading of A
nalized, the ICIQ has expanded to offer nineteen reflects that historically, although patient were inter-
psychometrically validated patient‐reported outcome viewed for the development of all ICIQ questionnaires,
measures (PROMs) for lower pelvic dysfunction in- the evidence may not have been published or docu-
cluding incontinence, 1 which includes amongst oth- mented to current standards.2 Table 1 outlines the cur-
ers, a bladder diary, male and female lower urinary rent PROMS that are included as part of the ICIQ
tract symptoms (LUTS), long term catheter use, pad modular questionnaire and information on their re-
use, and bowel symptom questionnaires. The purpose spective grades.
of the following paper is to provide an update on the
ICIQ since its conception, in the context of current
scientific developments of PROM design and reg- 1.2 | ICIQ development process and
ulatory requirements, and to outline plans for its fu- protocol
ture. The ICIQ project is based in the Bristol
Urological Institute, at Southmead Hospital, Bristol, The development of a PROM has become a rigorous and
in the United Kingdom. standardized, scientific process with the aim of providing
evidence that the instrument is measuring what is in-
tended, in a reliable and reproducible way, and is ap-
1.1 | ICI consultation 2017 and propriate to the target population for which it is designed.
recommendations The process begins by establishing the clear rationale and
reason for the initial development, before a series of sub‐
Since the first ICI in 1998 held in Monaco, there have studies which are designed to demonstrate validity (ac-
been five consultations, resulting in six editions of a curacy), reliability (stability), and responsiveness to
publication that comprehensively covers matters relating change (ability to measure change where it occurs) in the
to the investigation and management of functional pelvic target patient population. The publication in 2009 of the
floor disorders. For each consultation, the executive United States FDA “Guidance for Industry: Patient‐
committee appoints chairs who are responsible for Reported Outcome Measures: Use in Medical Product
UREN
ET AL.
Core questionnaires
Condition Recommended questionnaires Optional questionnaires HRQoL questionnaires Sexual matters Post treatment
Urinary symptoms Males: ICIQ‐MLUTS(13) Males: ICIQ‐MLUTS Long Form ICIQ‐LUTSqol(31) Males: ICIQ‐MLUTSsex ICIQ‐
Females: ICIQ‐FLUTS(30) Females: ICIQ‐FLUTS Long Form Female: ICIQ‐FLUTSsex Satisfaction31a
Vaginal symptoms ICIQ‐VS(32)
Bowel symptoms ICIQ‐B(33,34)
Urinary incontinence ICIQ‐UI short form(3) ICIQ‐LUTSqol Males: ICIQ‐MLUTSsex
ICIQ‐UI SF Females: ICIQ‐FLUTSsex
Prospective bladder ICIQ‐bladder diary(29)
events
Specific patient groups
Note: The ICIQ‐LUTSqol, ICIQ‐B, ICIQ‐Nqol, and ICIQ‐bladder diary all have an ICI Grade of A+. All others have an grade of A except the ICIQ‐LTCqol which has a grade of B (4). The following modules were
adopted as ICIQ modules with author's permission: ICIQ‐Nqol, ICIQ‐OABqol, ICIQ‐LUTSqol.
a
These questionnaires are currently in development.
|
3
4 | UREN ET AL.
launched where questionnaires and translations can be re- population to check its validity. The ICIQ group retains
quested through a semi‐automated system, increasing the copyright for any translations that are produced, and the
accessibility of the questionnaires for use in academic re- distribution is managed centrally through the ICIQ
search and clinical practice. A potential user is asked to website.
complete a brief electronic request form and user agreement
and then access to the ICIQ online library is given. Permis-
sion for the use of the questionnaires remains free of charge 1.8 | ICIQ scoring
for small grant‐funded research, student projects, and clinical
use. Commercial and research organizations with nationally The scoring of the ICIQ questionnaires is statistically
supported funding (eg, NIH in the USA, and NIHR in the derived by employing factor analysis methods to ascer-
UK, or equivalent) are asked to pay royalties for permission tain groups of items that are related to each other: each
to use the questionnaires and any monies raised are used to group is termed a domain. For example, the ICIQ‐
fund the not‐for‐profit research and the continuing devel- MLUTS has a ‘voiding’ domain which relates items that
opment of the ICIQ questionnaires. The ICIQ twitter ac- record the presence and frequency of hesitancy, straining,
count (@ICIQ_PROMs) has also been in operation since strength of urinary stream, intermittency, sensation of
2019, to boost the social media presence and further pub- incomplete emptying. A ‘voiding’ score can then be cal-
licise the ICIQ. Updates can be shared on this platform culated by simply totaling up the score for each of these
whenever a new questionnaire or new translation is devel- items.14 These may be used to compare scores over time,
oped, including new publications that are of interest to fol- or between groups of patients. There is a part ‘b’ to each
lowers and the urology, gynecology, and coloproctology of the symptom items which asks ‘'how much does this
fields. bother you?’. This part of the item is not scored, but the
user may use this to review which of the symptoms are of
most concern to the patient and to target their manage-
1.6 | The use of the ICIQ in research ment to the most bothersome symptoms. Detailed scoring
instructions for all the questionnaires may be found on
A search on EMBASE revealed that as of October 2019 the ICIQ website or by request to the ICIQ develop-
there have been over 3700 publications that mention the ment team.
“ICIQ” or the questionnaires. The average number of
publications has increased from 5 per year in the period
from 1999 until 2003, to 370 per year in the period from 1.9 | Score interpretation
2015 to 2019. We anticipate the improved presence of
ICIQ online through the updated website, the ICIQ li- A common question about the questionnaires is ‘what
brary, and social media will increase the dissemination of does a particular score actually mean?’. For some ques-
the questionnaires further, and continue the uptake of tionnaires, studies have been carried out to establish
the ICIQ both in clinical practice and research. bands of severity, for example, the ICIQ‐UI SF (range,
0‐21) is given four scoring categories: slight (1‐5), mod-
erate (6‐12), severe (13‐18) and very severe (19‐21).15 A
1.7 | Translations recent study has also ascertained scoring bands for the
ICIQ‐MLUTS (range, 0‐44; mild (0‐16), moderate (17‐25),
The ICIQ has a large library of over 300 translations for and severe (26‐44)).16 A minimally important difference
its questionnaires. All of the available translations for (MID) is available for some instruments which provides
each of its questionnaires are listed on the ICIQ website. further clarity. This represents the smallest change in
If a translation is not available then the ICIQ team are scores between administrations detected by the ques-
happy to collaborate with the development of the new tionnaire that the patient perceives as important, and
translation and will help with the process. There is a might potentially lead to the patient or clinician to con-
standard protocol for the translation of ICIQ ques- sider a change in management.17 For example, a change
tionnaires. In summary, a native speaker of the target of score of 5 to 12 points on the ICIQ‐LUTSqol (formerly
language first produces the new language version, fol- the King's Health Questionnaire) is deemed to be clini-
lowed by a back‐translation by a native English speaker. cally significant.18 However, as there are multiple meth-
This is reviewed by one of the ICIQ team and any dif- ods for determining MIDs and scoring bands, and it can
ferences between the original English and the back vary for each target population, it should be noted that
translation are reconciled. The new language version is these should be interpreted carefully. During ques-
then tested with a small number of the target language tionnaire development, the ICIQ does not routinely
6 | UREN ET AL.
assess MIDs or scoring categories for its questionnaires, the ICIQ project is to find ways of successfully integrating
but encourages further research to be carried out to the ICIQ into clinical practice using digital means. A
empirically derive MIDs for its questionnaires. common vision of the purpose and rationale for collecting
PROM data has to be shared, by patients, clinicians, and
other stakeholders if this goal is to succeed.24
1.10 | Current PROM development Patients attending the Bristol Urological Institute pre-
methodology senting with LUTS complete the ICIQ‐FLUTS30 or ICIQ‐
MLUTS13 on paper, either before or during their first visit to
The ICIQ questionnaires have historically been developed the urological out‐patient clinic, or the urodynamic unit. The
using traditional classical psychometric methods. In addition responses are used during history taking and entered onto an
to factor analysis, the use of item response theory (IRT) or online secure database for analysis. The ICIQ bladder diary is
Rasch methods can be complementary and maximize the also used in the Uroflow clinic, as well as to assess the pa-
content validity of a PROM,19 as modeling the item char- tient's suitability for sacral nerve device implantation. The
acteristics can provide additional information to make deci- patient records voided volumes, incontinence episodes,
sions on item removal, or to assess how well response bladder sensations, fluid intake, and pad use over 3 days.31
options are working. IRT or Rasch methods allow items to be Other questionnaires can be used at initial assessment by
calibrated onto a common scale, or underlying construct.19,20 patients presenting with LUTS at clinics. Condition‐specific
Item banks for SUI and OAB have recently been developed ICIQ questionnaires such as the ICIQ‐N or ICIQ‐OAB may
for using this methodology, by the PROMIS method.21 As for be used when a specific assessment of a condition in a
the ICIQ, the use of Rasch analysis alongside classical psy- particular population is required. Scores are calculated to
chometric methods was used for the initial development of allow the monitoring of patients over time, or to evaluate the
the ICIQ‐Cog10 and it is to be encouraged as another tool in effectiveness of interventions. The original ICIQ‐UI SF is
the protocol for the development of existing and future ICIQ recommended in national guidelines (NICE clinical guide-
questionnaires. line 171) for the assessment of severity, impact, and type of
urinary incontinence at initial presentation.
Despite their wide use in research, both as primary and Now in its 22nd year, the ICIQ project continues to
secondary measures in clinical trials,22,23 PROMs are still successfully achieve the main objectives of developing
relatively underused during routine clinical practice, in and disseminating robust patient completed ques-
urology, gynecology, and coloproctology. However, when tionnaires for research and clinical practice through a
asked about their use, health professionals are positive new website, an online library and by increasing social
about their potential to inform their clinical decisions.24,25 media presence. The ICIQ questionnaires are inter-
Barriers identified to the successful integration of PROMs nationally used for research but going forward, a greater
into clinical practice include fitting into clinical work pat- focus on promoting clinical use and the potential for their
terns, patient data security concerns, how to integrate data electronic integration into routine clinical practice is
efficiently into IT or paperless systems, and how to process envisaged.
or use the data for patient benefit.24,26 There are no easy
solutions to these issues (which are not specific to PROMs). ORCID
However, the use of apps, web‐based platforms or tablet Alan D. Uren http://orcid.org/0000-0001-7486-2322
computers may help the efficiency of data capture.27 We Nikki Cotterill http://orcid.org/0000-0001-6921-2712
recognize the potential for the ICIQ questionnaires to be Paul Abrams http://orcid.org/0000-0003-2776-2200
supplied and completed electronically and there is an on-
going drive in the UK NHS to ‘go digital’. The integration of
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