Kerry Avery

AIMS: To develop and evaluate the International Consultation on Incontinence Questionnaire (ICIQ), a new questionnaire to assess urinary incontinence and its impact on quality of life (QoL). METHODS: A developmental version of the questionnaire was produced following systematic literature review and views of an expert committee and patients. Several studies were undertaken to evaluate the psychometric properties of the questionnaire, including content, construct and convergent validity, reliability and sensitivity to change. RESULTS: The ICIQ was easily completed, with low levels of missing data (mean 1.6%). It was able to discriminate among different groups of individuals, indicating good construct validity. Convergent validity was acceptable, with most items demonstrating 'moderate' to 'strong' agreement with other questionnaires. Reliability was good, with 'moderate' to 'very good' stability in test-retest analysis and a Cronbach's alpha of 0.95. Items identified statistically significant reductions in symptoms from baseline following surgical and conservative treatment. Item reduction techniques were used to determine the final version and scoring scheme, which also demonstrated good psychometric properties. CONCLUSIONS: The final ICIQ comprises three scored items and an unscored self-diagnostic item. It allows the assessment of the prevalence, frequency, and perceived cause of urinary incontinence, and its impact on everyday life. The ICIQ is a brief and robust questionnaire that will be of use in outcomes and epidemiological research as well as routine clinical practice.

OBJECTIVES: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. DESIGN: A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. RESULTS: There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. CONCLUSIONS: Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials.

PURPOSE: In 1998 the first ICI was held in Monaco, sponsored by WHO and organized by the International Continence Society and International Consultation on Urological Diseases. The Scientific Committee recognized the need to develop a universally applicable questionnaire for wide application across international populations in clinical practice and research to assess urinary incontinence, facilitating the comparison of findings from different settings and studies, in a manner similar to the International Prostate Symptom Score. MATERIALS AND METHODS: An Advisory Board was formed to steer the development of the ICIQ and a decision was made to extend the concept further, developing the ICIQ Modular Questionnaire. RESULTS: The first module developed was the ICIQ Short Form Questionnaire for urinary incontinence. ICIQ modules have been developed or adapted for urinary tract symptoms and they are being developed for vaginal and lower bowel symptoms. Additional sexual matters and quality of life modules will become available for each condition area. Modules to assess patient satisfaction are expected to be of particular use for assessing treatment effectiveness. The ICIQ Advisory Board recently proposed the development of the ICIQ website, which is anticipated to be crucial for informing potential users of the phase of development of all ICIQ modules. CONCLUSION: The ICIQ can offer a full range of urinary tract symptom questionnaires. The website will aim to attract collaborators committed to the concept of this internationally accepted modular questionnaire who are willing to help with its development.

AIMS: To compare the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) with the Incontinence Severity Index (ISI), and to propose intervals for four severity levels of ICIQ-UI SF. METHODS: Cross-sectional, Internet-based study of 1,812 women responding to a general health questionnaire. Four severity levels for the ICIQ-UI SF scores were constructed by iteratively adjusting the ranges for these levels until maximum Kappa scores were obtained when cross-tabulated with the ISI in a random sample of half of the women with urinary incontinence. Using these intervals, weighted Kappa was calculated for the remaining women as a validation process. RESULTS: Three hundred forty-three women had urinary incontinence, and completed the ISI and the ICIQ-UI SF. A high correlation between the ISI and ICIQ-UI SF scores with versus without the QoL item was found (Spearman's rho = 0.62, P < 0.01 vs. rho = 0.71, P < 0.01, respectively). Maximum Kappa with quadratic weighting was obtained for the following scale for the ICIQ-UI SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21) (Kappa = 0.61), and without the QoL item: slight (1-3), moderate (4-5), severe (6-9) and very severe (10-11) (Kappa = 0.71) in the development sample. Correspondingly, for the validating sample, maximum Kappa with quadratic weighting was 0.61 and 0.74. CONCLUSIONS: A high correlation between the ICIQ-UI SF and the ISI was found. The ICIQ-UI SF may be divided into the following four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Neurourol. Urodynam. 28:411-415, 2009. (c) 2009 Wiley-Liss, Inc.

BACKGROUND: Pragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really important RCTs are not undertaken because recruitment is thought to be too difficult. The 'QuinteT Recruitment Intervention' (QRI) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment. This paper presents the development and implementation of the QRI. METHODS: The QRI developed iteratively as a complex intervention. It emerged from the National Institute for Health Research (NIHR) ProtecT trial and has been developed further in 13 RCTs. The final version of the QRI uses a combination of standard and innovative qualitative research methods with some simple quantification to understand recruitment and identify sources of difficulties. RESULTS: The QRI has two major phases: understanding recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator (CI) and the Clinical Trials Unit (CTU). The plan of action usually includes RCT-specific, as well as generic, aspects. The QRI can be used in two ways: it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start, or it can be applied to an ongoing RCT experiencing recruitment shortfalls, with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure. CONCLUSIONS: The QRI provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. It can facilitate recruitment to the most controversial and important RCTs. QRIs are likely to be of interest to the CIs and CTUs developing proposals for 'difficult' RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs.