Nikki Cotterill

Psychometric evaluation of a new patient-completed questionnaire for evaluating anal incontinence symptoms and impact on quality of life: the ICIQ-B.

BACKGROUND: A psychometrically robust patient-completed questionnaire for anal incontinence, which reflects issues of importance to both clinicians and patients, was lacking for assessment purposes. OBJECTIVE: This study aimed to determine the psychometric properties of a new questionnaire developed to address this need, the International Consultation on Incontinence Questionnaire-Bowels module. DESIGN: Qualitative studies were used to refine the developmental version of the questionnaire. Quantitative studies were conducted to evaluate its psychometric properties. SETTINGS: Patients were invited to complete the questionnaire via postal administration. PATIENTS: Two hundred sixty-one patients with known bowel symptoms participated in the study (244 females, 17 males; mean age, 59.7 years (range, 24–92)). MAIN OUTCOME MEASURES: The aspects of validity were evaluated in comparison with available evidence, responses to existing instruments, and physiological findings. Reliability was assessed through repeat administration of the questionnaire and evaluation of internal consistency by the Cronbach &agr; coefficient. Responsiveness following treatment was evaluated by the use of the Wilcoxon signed rank test. Exploratory factor analysis was used to derive the final version of the questionnaire with evidence from the above studies. RESULTS: The final questionnaire contains 17 questions arranged in 3 scored domains: bowel pattern, bowel control, and quality of life, with 4 unscored items included to evaluate important issues from a clinical or patient perspective. The questionnaire demonstrated acceptable validity, “good” to “very good” reliability, and reasonable response to changes in symptom and quality-of-life status following intervention. LIMITATIONS: Response rates varied according to location. CONCLUSIONS: The International Consultation on Incontinence Questionnaire Bowel module is a psychometrically robust, self-report instrument for the evaluation of anal incontinence and its impact on quality of life. It is suitable for use in individuals with anal incontinence of varying causes. It includes a scoring system for use in clinical practice and research.

A Patient-Centered Approach to Developing a Comprehensive Symptom and Quality of Life Assessment of Anal Incontinence

PurposeThis study was designed to identify question items required for a comprehensive symptom and quality of life assessment for individuals with anal incontinence.MethodsThree substudies addressed the goals: 1) convenience sample of clinical experts was asked to identify symptom items essential to characterize anal incontinence; 2) free-text comments by patients involved in a treatment intervention trial (Norton et al., Gastroenterology 2003;125:1320–9) underwent content analysis to highlight themes regarding life restriction caused by anal incontinence; and 3) qualitative interviews were conducted by using a grounded theory approach with symptomatic patients to identify issues causing impact on quality of life. Terminology for this condition was explored in the interviews to identify the most acceptable phraseology. Finally, the capability of existing anal incontinence questionnaires to capture and assess issues identified as important by patients was assessed.ResultsSeven clinical experts reached consensus that assessment should include the type, frequency and severity of incontinence, whether passive or associated with urgency, ability to delay and discriminate stool type, and “normal” bowel pattern. A total of 284 patients’ comments were reviewed and 31 patients were interviewed, highlighting five key issues: unpredictability, toilet location, coping strategies, embarrassment, and social activity restriction. Assessment of available questionnaires for their inclusion of these themes indicates that none currently captures comprehensive information on these issues identified as important by patients.ConclusionsFundamental issues as identified by patients are not currently represented in one overall comprehensive measure. The mixed method approach identified key issues to be assessed to ensure accurate symptomatic assessment and a comprehensive assessment of quality of life impact associated with anal incontinence.

Developing and Validating the International Consultation on Incontinence Questionnaire Bladder Diary

BACKGROUND Despite the common use of urinary diaries to assess lower urinary tract symptoms (LUTS), a standardised validated diary does not exist. OBJECTIVE To develop a validated urinary diary, using the psychometric validation protocol used in previous International Consultation on Incontinence Questionnaire (ICIQ) modules. DESIGN, SETTING, AND PARTICIPANTS We invited 400 consecutive patients attending the urology department for assessment of LUTS to complete a urinary diary (developed and validated for content in a previous study), and the ICIQ Male or Female LUTS questionnaire. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS To establish construct validity, the urinary diary was compared with known theories from published literature; to establish criterion validity, the diary was compared with questionnaire responses and/or urodynamic observations. Optimal diary duration was tested by comparing the 4-d diary against shorter durations. Patients completed a second diary after 2-3 wk for test-retest analysis, and a subset receiving sacral nerve stimulation completed the diary before and after treatment for analysis of responsiveness. A variety of statistical tests were used for different stages of the study. RESULTS AND LIMITATIONS The urinary diaries and ICIQ LUTS questionnaires were completed by 264 patients. Construct validity was established for two of three tested hypotheses. Criterion testing showed good agreement between questionnaire and diary recordings of nocturia (κ=0.653; p<0.001; 92.2%) and incontinence (κ=0.351; p<0.001; 64.5%), whereas good agreement (κ=0.378; p<0.001; 69.2%) was observed between urodynamically proven incontinence and diary reports (n=104). Diary recordings of urgency showed weak agreement with questionnaire responses (κ=-0.215; p<0.001; 36%) and urodynamic observations (κ=-0.105; p=0.256; 43.7%). The 3-d diary explained at least 94% of the total variance of the 4-d diary. A second diary for test-retest analysis was returned by 59 patients, demonstrating fair to excellent agreement (Spearman correlations: 0.49-0.88). Pre- and post-treatment analysis, on pilot testing, showed that the diary is responsive to change. CONCLUSIONS Using the ICIQ psychometric validation methodology, a bladder diary was developed for the assessment of LUTS and shown to be valid, reliable, and responsive to change. The 3-d diary has been accepted as the ICIQ bladder diary. PATIENT SUMMARY In this study, patients and clinicians developed and tested a diary in which patients can record their urinary symptoms. The resulting 3-d diary is called the ICIQ bladder diary and is available for adult men and women with urinary symptoms.

The impact of urinary incontinence on quality of life in a real-world population of women aged 45-60 years: results from a survey in France, Germany, the UK and the USA

To develop a clear understanding of the relationship between severity of urinary incontinence (UI) and health‐related quality of life (HRQoL) and mental well‐being in a population of women of working age with the requisite demands of a busy, active life.

The impact of urinary incontinence on health‐related quality of life (HRQoL) in a real‐world population of women aged 45–60 years: results from a survey in France, Germany, the UK and the USA

To develop a clear understanding of the relationship between severity of urinary incontinence (UI) and health‐related quality of life (HRQoL) and mental well‐being in a population of women of working age with the requisite demands of a busy, active life.

Developing a validated urinary diary: phase 1.

To develop and validate a urinary diary, using the psychometric validation protocol applied to all International Consultation on Incontinence Questionnaire (ICIQ) modules.

Qualitative Exploration of the Patient Experience of Underactive Bladder

BACKGROUND Underactive bladder (UAB) is considered the symptom complex associated with the urodynamic diagnosis of detrusor underactivity. OBJECTIVE The aim of this research was to investigate the patient reported experience of the symptoms, signs, and impact of UAB. This research is also part of the initial qualitative phase for the development of a new patient reported outcome measure for the assessment of UAB. DESIGN, SETTING, AND PARTICIPANTS Qualitative methods were used to understand the experience of UAB from a patient perspective, in a purposive sample of male (n=29) and female (n=15) patients aged 27-88 yr (mean: 64 yr), diagnosed with a primary diagnosis of detrusor underactivity, with or without coexisting urological conditions. Semistructured interviews were conducted in Bristol, UK. RESULTS Male and female patients reported a variety of lower urinary tract symptoms and associated impact on quality of life. Storage symptoms of nocturia, increased daytime frequency, and urgency, and the voiding symptoms of slow stream, hesitancy, and straining were reported by over half of the patients. A sensation of incomplete emptying and postmicturition dribble were also frequently described. Most had a post void residual >30ml (n=34, 77%, median: 199ml) with many reporting urinary tract infections, a history of self-catheterisation, and some experiencing occasional acute retention episodes. These symptoms and signs can have a broad impact on quality of life including having to plan their daily activities around the location of toilets, disruption to sleep, social life, and associated effect on family and friends. CONCLUSIONS Knowledge of the lived experience of UAB obtained in the current study will be used for the development of a new patient reported outcome measure and help inform the current working definition of UAB. PATIENT SUMMARY The symptoms, signs, and impact on quality of life of underactive bladder are described by patients with the condition.

What are the best outcome measures when assessing treatments for LUTD?--achieving the most out of outcome evaluation: ICI-RS 2011.

A think tank was convened at the third ICI‐RS meeting held in the UK, June 2011, to consider the best outcome measures when assessing treatments for lower urinary tract dysfunction (LUTD). Given the vast array of measures available a focus on questionnaires was decided upon, which continued to highlight a plethora of available tools. The decision was therefore taken to approach this topic from an alternative perspective and instead ask the audience of gathered experts in this field to consider, “What we need to ask as a minimum in order to capture the most fundamental parameters when evaluating new treatments for LUTD?” Discussions highlighted the need for inclusion of a global measure in all outcome evaluations in order to increase comparability between different treatment evaluations and different populations. More specific categories of evaluation identified were: treatment satisfaction, symptom quantification, health related quality of life and adverse events. Further optional components were identified for inclusion where relevant, such as health economic, goal setting and psychosocial evaluation. A “Minimum Outcome Set for Testing (MOST)” was therefore proposed by selecting a health outcome measure from each category while not being prescriptive about specific outcome measurement selection. The ‘MOST’ toolkit is therefore proposed to promote standardized evaluation in this field and represents a useful starting point for further consideration of this concept. Neurourol. Urodynam. 31:400–403, 2012.

Development of a core set of outcome measures for OAB treatment

Introduction and hypothesisStandardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB).MethodsThe International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input.ResultsThe standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included.ConclusionsThe standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Development and initial validation of a disease-specific bowel continence questionnaire for inflammatory bowel disease patients: the ICIQ-IBD.

Background and aims Faecal incontinence (FI) related to inflammatory bowel disease (IBD) affects up to 74% of patients and is often under-reported in clinical encounters. A previous study found that several important bowel function concerns of patients with IBD are not addressed by existing FI questionnaires, especially differences between symptoms in relapse and remission. We have therefore adapted an existing FI assessment questionnaire specifically for patients with IBD. Methods A total of 190 people participated in this study. Phase 1 (development): the initial draft of the new questionnaire was developed from previously collected data and from results of a modified Delphi survey of IBD clinicians; questions were refined through six rounds of cognitive interviewing (n=24). Phase 2 (validation): the final version was tested (n=166) and retested (n=143) 3–4 weeks later. Results Missing data were minimal (1–4%). Weighted kappa analysis showed moderate-to-good agreement for test–retest data. Factor rotational analysis revealed the relationship of questions with each other. The new questionnaire has two domains: ‘Symptoms’ and ‘Quality of Life’, recording remission and relapse scores with simple summary scores for each. An additional 10 stand-alone questions address issues of specific concern to patients with IBD. The questionnaire demonstrates the ability to capture changing symptoms and concerns between remission and relapse. Conclusion The new questionnaire has good content validity and is stable and reliable. Further testing to establish sensitivity to change is needed. The scale can be used by patients, researchers and practitioners to assess severity, fluctuation and impact of IBD-related FI.