Symptoms of incontinence and/or their effect on quality. Symptom Severity and QOL Scales for Urinary Incontinence

Transcription

1 GASTROENTEROLOGY 2004;126:S114 S123 Symptom Severity and QOL Scales for Urinary Incontinence MICHELLE J. NAUGHTON,* JENNY DONOVAN, XAVIER BADIA, JACQUES CORCOS, MOMOKAZU GOTOH, CON KELLEHER, # BERTRAND LUKACS, ** and CHRISTINE SHAW *Wake Forest University, Winston-Salem, North Carolina; University of Bristol, Bristol, United Kingdom; Health Outcomes Research, Barcelona, Spain; McGill University, Canada; Nagoya University, Nagoya, Japan; # King s College London, London, United Kingdom; ** Paris, France; and University Wales College of Medicine, Cardiff, United Kingdom Symptoms of incontinence are common, particularly among older people, and incontinence can have a severe effect on the quality of life of some individuals at any age. A number of treatments are available, most of which aim to reduce the occurrence of incontinent episodes or to limit the effects of the disorder on everyday life. In research and clinical practice, it is essential that the symptoms and effects of incontinence be properly assessed and recorded. The only valid means of measuring patients perspectives is through the use of psychometrically robust self-report questionnaires. Incontinence may be experienced as part of the symptom complex of a range of conditions (e.g., benign prostatic diseases or fistulas), and the effect of incontinence on quality of life varies depending on the severity of the condition and other psychosocial and medical factors. Questionnaires with acceptable levels of psychometric testing are identified and recommended for use in clinical practice and research investigations according to the following categories: (1) questionnaires to assess symptoms of incontinence, (2) generic health-related quality-of-life questionnaires to assess the effect of incontinence on quality of life, and (3) incontinence-specific measures to assess the effect and bothersomeness of incontinence on quality of life. Symptoms of incontinence and/or their effect on quality of life can be assessed in a variety of ways. Traditionally, the clinical history has been used to gain a summary view of the symptoms of incontinence experienced by patients and the effects on their lives. Increasingly, patient-completed methods of measuring incontinence are being used, including voiding diaries and self-report questionnaires. Taking a thorough clinical history for patients with incontinence is an important method of assessing symptoms and the degree of bothersomeness. Clinical histories can be problematic, however, in that they are unstandardized and most likely take on a different form for each clinician and patient encounter. The first questionnaires developed the Boyarsky schedule for lower urinary tract symptoms 1 and the Stamey score for incontinence 2 were attempts to standardize the clinical history. These instruments have not been tested for validity or reliability, are crude, and require a clinician to mediate and interpret a patient s symptoms. This method has been shown to be unreliable and often not representative of the patient s perspective. 3 6 In general, clinicians ratings of patient quality of life tend to be lower than ratings by patients themselves. 6 The use of only clinician-based measures of symptoms and quality of life is not recommended in research. Voiding diaries (also known as frequency volume charts or urinary diaries) are widely used to assess a limited number of lower urinary tract symptoms usually frequency, nocturia, and incontinent episodes. Patients are typically asked to complete these diaries daily, recording frequency of urination day and night, incontinent episodes, and sometimes also the volume voided. Patient diaries have been shown to have reasonable test retest reliability, particularly for incontinent episodes, 7 but have not been able to differentiate patients with urodynamic diagnoses. 8 Whereas voiding diaries can be helpful and may be accurate if completed regularly, they rely on recall of episodes, which can be unreliable. 9 In the area of incontinence, patient diaries are also limited by the range of symptoms that can be accommodated usually only frequency, nocturia, and incontinence episodes. Although it is acknowledged that urodynamic studies provide the most accurate representation of leakage and the soundest basis for clinical diagnosis of incontinence, Abbreviations used in this paper: BFLUTS, Bristol Female Lower Urinary Tract Symptoms; BPH, benign prostatic hyperplasia; ICS, International Continence Society; ICSQoL, ICS Quality of Life; IIQ, Incontinence Impact Questionnaire; I-QoL, Quality of Life in Persons With Urinary Incontinence questionnaire; KHQ, King s Health Questionnaire; MCS, mental composite score; PCS, physical composite score; SF-36, Medical Outcomes Study Short Form-36; SIP, Sickness Impact Profile; UDI, Urogenital Distress Inventory; UDI-6, short-form version of the Urogenital Distress Inventory; VAS, visual analogue scale by the American Gastroenterological Association /04/$30.00 doi: /j.gastro

2 January Supplement 2004 SYMPTOM AND QOL SCALES FOR URINARY INCONTINENCE S115 questionnaires are primarily designed to measure patients perspectives; at times, the diagnosis of incontinence may be less important than the way in which urinary leakage is perceived by patients and the effect it has on their quality of life. Relationships Between Questionnaires and Clinical Measures The relationship among urinary symptoms, the results of urodynamic investigations, and quality-of-life impairment is complex. Each of these parameters is important in the assessment of patients with urinary incontinence, and it is tempting to speculate that they might be related in direct and meaningful ways. On the whole, however, few and weak relationships have been found between the presence of lower urinary tract symptoms (including incontinence) and clinical measures, including the results of urodynamic studies The severity of urinary symptoms is also often used as a measure of the effect of lower urinary tract dysfunction in both clinical practice and clinical trials. At its simplest level, severity may reflect symptom magnitude for example, the number of incontinent episodes, the number of daily voids, or the number of episodes of nocturia. Symptom severity alone, however, does not adequately assess the effects of urinary incontinence on an individual s life. Such assessment requires the use of symptom- or generic/ condition-specific questionnaires, although again, relationships between these measures and clinical assessments are relatively weak What is demonstrated clinically is distinct and different from what is perceived as troublesome by patients in their everyday lives; clinical measures and validated questionnaires measure different but related aspects of incontinence. Recommended Questionnaires Self-completed questionnaires are the most suitable method for assessing patients perspectives on incontinence and its effect on quality of life. Questionnaires may be long and detailed for use in research, but they need to be short and easy to use to be relevant for clinical practice. In addition to being valid and reliable, they need to be easy to complete, and if they are being used to measure outcome, they should be sensitive to change. Developing a new questionnaire and testing it thoroughly is time consuming and is necessary only if an existing instrument is not available. Although many questionnaires are available for assessing incontinence and its effect on quality of life, there is no simple, robust measure that is relevant to a wide range of patients. In 1998, the First International Consultation on Incontinence, cosponsored by the World Health Organization and the International Union Against Cancer, was held in the Republic of Monaco. 18 Groups of international experts were convened to summarize the published literature in specific topic areas to enhance clinical care and research in urinary incontinence. The Second International Consultation on Incontinence convened in Paris in July The following section summarizes the work of the Symptom and Quality of Life Subcommittee of these 2 international consultations on incontinence. This subcommittee was chaired in both years by Jenny Donovan, University of Bristol, United Kingdom. The goal of the subcommittee was to review the published literature on psychometrically based self-report questionnaires both generic and condition specific that had been used to assess the symptoms and effect of urinary incontinence in adults. Literature Search Strategy A number of electronic databases were searched to locate published journal articles, book chapters, and abstracts on the assessment of symptoms and quality of life related to urinary incontinence. The search was limited to research related to adult populations over the age of 18 years. Literature searches were conducted internationally, but most articles identified were found to have originated in the United States, the United Kingdom, and Western Europe. The database searches identified more than 1300 published articles relating to symptoms of urinary incontinence, effects on quality of life, and outcomes assessments of incontinence treatments. Grading of Recommended Questionnaires Recovered articles were evaluated by a priori criteria and graded for quality. To be highly recommended (grade A), an instrument or questionnaire had to have published data providing evidence of its reliability, validity, and responsiveness to change. Generic measures related to quality of life also had to have demonstrated relevance for use in assessing urinary incontinence. For a grade B recommendation, questionnaires had to have published data providing evidence of their reliability and validity and relevance to persons with urinary incontinence. Questionnaires must have reached grade B or higher to be recommended for use. The following sections provide brief descriptions of the recommended questionnaires. In-depth descriptions of all of these questionnaires can be found elsewhere

3 S116 NAUGHTON ET AL. GASTROENTEROLOGY Vol. 126, No. 1 Table 1. Questionnaires Recommended to Assess Symptoms of Urinary Incontinence Grade A: highly recommended Urogenital Distress Inventory (UDI) 21 UDI-6 16 Urge-Urinary Distress Inventory (Urge-UDI) 22 King s Health Questionnaire (KHQ) 23 Incontinence Severity Index 24 (women only) Danish Prostatic Symptom Score 25 (DAN-PSS-1) (men only) International Continence Society (ICS)male 26 (men only) ICSmale Short Form (SF) 27 (men only) Grade B: recommended Bristol Female Lower Urinary Tract Symptoms (BFLUTS) 28 Symptom Severity Index (SSI) 29 International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) 19 Questionnaires to Assess Symptoms of Incontinence Table 1 lists the questionnaires and grades of recommendation for assessing symptoms of incontinence. The original questionnaires to assess symptoms of incontinence were developed separately for men and women and often presupposed the presence of other lower urinary tract symptoms. However, increasingly, the questionnaires reaching the highest level of recommendation are being tested for use in both men and women for example, the Urogenital Distress Inventory (UDI), the King s Health Questionnaire (KHQ), and the International Continence Society (ICS) male/bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaires. Urogenital distress inventory (grade A). The UDI was developed in the United States for women to assess the degree to which symptoms associated with incontinence are troubling. 21 It lists 19 lower urinary tract symptoms. The questionnaire has been shown to have acceptable levels of validity, reliability, and responsiveness for a community-dwelling population of women with incontinence and for women older than 60 years of age. 30 The UDI is being used increasingly for male patients, although data on its psychometric properties have not yet been reported as fully as they have for female patients. Urogenital distress inventory-6 (short form; grade A). A short-form version of the UDI (UDI-6), produced by regression analysis, has been preliminarily validated with samples of older adult men and women. 16,31 It has been suggested that the UDI-6 may provide predictive information regarding urodynamic findings in women, particularly with regard to stress urinary incontinence, bladder outlet obstruction, and detrusor overactivity. 32,33 A French language version of the UDI-6 has been reported in the literature. 34 Urge-urinary distress inventory (grade A). The Urge-Urinary Distress Inventory measures the symptoms and distress specific to urge incontinence in women. 22,35 The UDI was modified by adding and deleting questionnaire items to measure symptoms associated with urge incontinence on the basis of focus group information, expert clinical opinion, and reviews of scientific literature. The final Urge-Urinary Distress Inventory contains questions assessing frequent urination; urgency to empty the bladder; difficulty holding urine; urine leakage; urine leakage related to the feeling of urgency; urine leakage related to physical activity, coughing, or sneezing; urine leakage not related to urgency or activity; nighttime urination; and bed-wetting. Participants indicate whether they have experienced these problems and then rate the bothersomeness of these symptoms on a 4-point scale: not at all, slightly, moderately, and greatly. The items in the questionnaire are averaged to form 2 scales 1 summarizing urge symptoms and an overall score summarizing the effect of mixed and urge symptoms. Higher scores indicate a greater degree of bothersomeness. Information on its reliability, validity, and responsiveness is available. 22,35 King s health questionnaire (grade A). The KHQ, developed in Great Britain, 23 assesses 10 domains related to health-related quality of life and urinary symptoms: incontinence effects, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, severity coping measures, general health perceptions, and symptom severity. The KHQ has been shown to have good reliability and validity for both men and women. Eight validated cultural adaptations of the questionnaire are available in 26 languages, including German, Spanish, Swedish, Greek, Italian, and Japanese. Studies are currently under way to develop a weighting system for the symptom subscale of the questionnaire to derive a quality-adjusted life year measure from the questionnaire and to establish clinically meaningful interpretations of KHQ scores. Additional language translations are also being performed. Incontinence severity index (grade A). The Incontinence Severity Index was developed in Norway to provide a simple severity index of female incontinence for use in epidemiological surveys. 24 It is composed of 2 questions: How often do you experience urine leakage? (4 levels) and How much urine do you lose? (2 levels). The index is calculated by multiplying the 2 responses together and is categorized as slight, moderate, severe, or very severe. The authors advocated its routine use as a semiobjective and quantitative measure that does not assess the woman s subjective perception of whether

4 January Supplement 2004 SYMPTOM AND QOL SCALES FOR URINARY INCONTINENCE S117 her leakage is a problem. The index has good levels of validity, reliability, and responsiveness. It was able to distinguish between women with and without incontinence, and it confirmed a higher rate of urinary incontinence prevalence in middle age. 24 It has also been shown to have good test retest reliability and to be sensitive to change after surgery. 36 Danish prostatic symptom score (grade A). The Danish Prostatic Symptom Score was designed to measure the degree to which men are bothered by urinary symptoms. 25,37,38 The Danish Prostatic Symptom Score contains twelve 2-part items, including questions concerned with urge, stress, and other forms of incontinence. Items inquire about the presence and level of occurrence of symptoms, followed by an assessment of the degree of problems that they cause. A composite score is achieved by multiplying the symptom score by the bother score, with a total range of 0 to 108. The questionnaire has shown acceptable levels of validity and reliability and has been responsive in assessing the outcome of transurethral resection of the prostate and drug therapies. International continence society male and international continence society male short-form questionnaires (grade A). The ICSmale 26 questionnaire was developed for use with men only. (The BFLUTS questionnaire for women is almost identical.) The ICS male questionnaire contains 22 questions on 20 urinary symptoms; for most questions, subjects rate the degree of problems that the symptom causes. The questionnaire has acceptable levels of validity, reliability, and sensitivity to change after a range of treatments, including surgery, minimally invasive therapies, and drug treatments. 26,39,40 A short form of the ICS has been produced. 27 The developmental version of the questionnaire was subjected to a range of statistical tests, including factor analysis and Cronbach s and regression models, within a randomized trial of treatments for men with lower urinary tract symptoms. The questionnaire was reduced to 2 major sections: the ICSmale voiding subscore, which contains 5 questions (hesitancy, straining, reduced stream, intermittency, and incomplete emptying), and the ICSmale incontinence subscore, which contains 6 questions (urge, stress, unpredictable incontinence, nocturnal incontinence, urgency, and postmicturition dribble). The total score is obtained by adding the 2 subscores. The investigators indicate that questions to assess nocturia, frequency, and effect on quality of life should be added to provide full data, but these questions should not be included in the score because they are separate constructs, as indicated by the statistical analysis. 27 Bristol female lower urinary tract symptoms (grade B). This questionnaire, developed in the United Kingdom for use with women only, follows the pattern established for the questionnaire developed for the ICS study on benign prostatic hyperplasia (BPH). 28 The BFLUTS questionnaire covers the occurrence and bothersomeness of symptoms relating to incontinence and other lower urinary tract symptoms. It has shown good levels of validity and reliability. Studies on responsiveness and a scoring scheme are under development. The questionnaire has also been used to assess incontinence in both sexes in Austria 41 and is being used increasingly in epidemiological and outcome studies. 19 Symptom severity index (grade B). The Symptom Severity Index was developed in the United Kingdom for women to assess stress incontinence. 29 It has shown acceptable levels of validity and reliability, but responsiveness has not been assessed. International consultation on incontinence questionnaire short form (grade B). The International Consultation on Incontinence Questionnaire Short Form, devised under the auspices of the ICS 19 for use among a broad range of adults, covers 6 major areas: frequency of leakage, bothersomeness of leakage, protection use and type, interference with everyday life, interference with social life, and interference with sex life. The International Consultation on Incontinence Questionnaire Short Form now has documented evidence of its reliability and validity, and studies regarding its sensitivity to clinical change are under way. Questionnaires to Assess Effects on Quality of Life Health-related quality of life is a multidimensional concept referring to a person s physical, social, and psychological functioning and the overall assessment of his or her life quality. 42 Other dimensions are often assessed, depending on the research questions to be investigated, including personal productivity, neuropsychological or cognitive functioning, sexual functioning, pain, symptoms, sleep, overall life satisfaction, and spirituality. Quality-of-life measures can be classified as generic measures (multidimensional questionnaires designed to be used across a wide range of conditions and populations) and condition-specific measures (designed to assess quality of life in specific types of conditions or illnesses). Recommended questionnaires are discussed for each of these categories. Generic measures. These self-administered questionnaires do not contain specific questions on incontinence, but they have been widely used to assess the quality of life of incontinent adults on the basis of the

5 S118 NAUGHTON ET AL. GASTROENTEROLOGY Vol. 126, No. 1 Table 2. Questionnaires Recommended to Assess Generic Health Status in Persons With Incontinence Grade A: highly recommended Medical Outcomes Study (MOS) Short Form (SF) EuroQoL (EQ)-5D 44 (EuroQoL group) Grade B: recommended The following questionnaires have reached the highest levels of evidence relating to psychometric testing but have only rarely been used in incontinence: Sickness Impact Profile (SIP) 45 Nottingham Health Profile (NHP) 46 Göteborg Quality of Life 47 assumption that incontinence has an effect on general well-being. They tend, however, to be relatively insensitive to changes in incontinence. All questionnaires listed in Table 2 have reached the highest levels of evidence relating to psychometric testing. Those given a grade A recommendation are the most commonly used for incontinence. Medical outcomes study short-form 36 (grade A). The Medical Outcomes Study Short Form-36 (SF- 36) 43 is a 36-item measure developed in the United States that contains 8 separate subscales or domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions. The SF-36 has been found to have good construct validity, discriminant validity, and internal consistency in several research investigations of persons with incontinence, BPH, or urinary symptoms Test retest reliability has been moderate to high (r ). 53 However, responsiveness has been reported to be poor in 2 studies, 54,55 specifically in BPH patients, 56 prostate cancer patients, 57 and women with stress urinary incontinence. 58 Two summary scores for the SF-36 a physical composite score (PCS) and a mental composite score (MCS) have been used with the SF-36 to assess incontinence. 59 In a study of 37,814 women from the Women s Health Australia Project, the adjusted PCS and MCS scores were lower in young (aged 18 to 23 years), middle-aged (aged 45 to 50 years), and older (aged 70 to 75 years) women who reported leaking urine. 60 However, the greatest differences were reported in the MCS scores in the young and middle-aged women, indicating that the quality-oflife effect was greater in the younger age group. No information was provided regarding the reliability of the measures, although the adjusted means reported were comparable to the norms for the PCS and MCS published elsewhere. 59,61 The SF-36 has been culturally adapted and/or translated into several languages, including German, Spanish, and French. A shorter form of the SF-36, which contains only 12 items, performed poorly when administered to prostatectomy patients. 62 EuroQoL-5D (grade A). The EuroQoL-5D is a standardized instrument used to measure health outcomes. 63 This questionnaire, developed by the EuroQoL group, consists of the EuroQoL-5D self-classifier, the EuroQoL visual analogue scale (VAS), and the EuroQoL standard set of sociodemographic questions. Respondents are asked to describe their health status by using a 5-dimensional health state classification system of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of these dimensions records 3 levels of severity, which are indicated by numbers. No problems are coded 1, some problems or moderate problems are coded 2, and extreme problems are coded 3. A health state can therefore be described with a 5-digit number, for instance, This means no problems on the dimension of mobility, some problems on the dimension of self-care, no problems with respect to usual activities and pain/discomfort, and severe problems on the dimension of anxiety/depression. The classification system defines 243 different health states. In addition, the states of unconsciousness and death are included. The EuroQoL-5D has been translated into a host of different languages. The EuroQoL VAS is a standard vertical 20-cm VAS for recording respondents rating of their current health state on a0to100scale. A similar VAS is used when participants are asked to rate health states in hypothetical situations. The EuroQoL-5D is designed for self-completion by respondents and is ideally suited for use in mail surveys, in clinics, and in face-to-face interviews. It is cognitively simple and takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. Applicable to a wide range of health conditions and treatments, the questionnaire provides a simple descriptive profile and a single index value for health status, from which quality-adjusted life years can be calculated; that information can be used in the clinical and economic evaluation of health care and in population health surveys. The EuroQoL-5D has been specially designed to complement other quality-of-life measures such as the SF-36, the Nottingham Health Profile, the Sickness Impact Profile (SIP), and disease-specific measures. The construct validity of the EuroQoL-5D has been shown. 64 Strong associations were found between the EuroQoL index score and general quality-of-life ques-

6 January Supplement 2004 SYMPTOM AND QOL SCALES FOR URINARY INCONTINENCE S119 Table 3. Questionnaires Recommended to Assess Bothersomeness in Persons With Incontinence Grade A: highly recommended DAN-PSS-1 25,37 (Danish Prostatic Symptom Score) ICSmale 26 (International Continence Society) Grade B: recommended Bristol Female Lower Urinary Tract Symptoms (BFLUTS) 28 tions in the ICSQuality of Life (ICSQoL), including a moderate relation with the questionnaire associated with incontinence. 49 Much weaker relationships have been found, however, with other specific-effect questions. Sensitivity to change has also been shown in a clinical trial of women with overactive bladders. 65 Sickness impact profile (grade B). The full 136- item version of the SIP was used in Norway to assess the quality of life of women with urinary incontinence. 15 Overall, the effect of incontinence was greatest on sleep and rest, emotional behavior, and social interaction and recreation/pastimes. The SIP was able to discriminate between women of different ages and by type of incontinence (stress or urge). Information on the general psychometric properties of the SIP can be found elsewhere. 66,67 No new reports on the use of the SIP in observational and clinical trials of urinary incontinence and BPH have been published in the past decade. Nottingham health profile (grade B). The Nottingham Health Profile has been used in Sweden to assess the quality of life of women with incontinence compared with an age-matched sample. 68 Overall, all women with incontinence were more socially isolated and had greater emotional disturbance than those in the general population. The use of the Nottingham Health Profile to assess incontinence has been minimal in recent years. General information on the psychometric properties of the Nottingham Health Profile is provided elsewhere. 66,69 Göteborg quality of life instrument (grade B). The Göteborg Quality of Life Instrument was designed in Sweden to assess general levels of health and their effects on well-being. 47 It was constructed originally for men but has been tested on women. Its reliability and validity were shown in a study of community-based women in Sweden. Those with incontinence had significantly lower scores than continent women on 4 of the instrument s subscales: health, sleep, fitness, and work satisfaction. 70 Generic measures: conclusion. In general, although several of the generic measures have achieved acceptable reliability and validity for individuals with incontinence, no measure has been shown to have sufficient sensitivity to detect changes in condition severity as a result of either treatment or a worsening or improving physical condition. The generic instruments, however, may be useful for comparing across chronic conditions or for describing the general health status of incontinent adults. Condition-specific measures: bothersomeness. Condition-specific measures are designed to assess the effect of incontinence on quality of life. The simplest are those concerned with the particular effects of incontinence symptoms, otherwise known as bothersomeness (Table 3). For details of these questionnaires, see above. Condition-specific measures: effect of incontinence on quality of life. A number of condition-specific measures have been designed to assess the wider effects of incontinence on aspects of everyday quality of life. Most have been developed for either men or women, although a small number are being evaluated for use in both sexes (Table 4). Quality of life in persons with urinary incontinence (grade A). The Quality of Life in Persons With Urinary Incontinence (I-QoL) questionnaire was designed for use in clinical trials to measure the effect of incontinence on men and women. 71 It has 22 items, scored on a 4-point Likert scale, which are summed and then transformed to a scale. The questionnaire has high levels of validity and reliability. 71 Reports of the use of the I-QoL in a multicenter, double-blind, placebo-controlled, randomized trial confirmed the value of an overall score and 3 subscale scores (avoidance and limiting behaviors, psychosocial effects, and social embarrassment). 78 All scores achieved high internal consistency ( ) and reproducibility (intraclass correlations, ). Responsiveness statistics using changes in stress test pad weight, number of incontinent episodes, and patients Table 4. Questionnaires Recommended to Assess the Effect of Incontinence on Quality of Life Grade A: highly recommended Quality of Life in Persons With Urinary Incontinence (I-QoL) 71 (men and women) King s Health Questionnaire (KHQ) 23 (men and women) Incontinence Impact Questionnaire (IIQ) 67 (women only) IIQ-7 16 (women only) Urge-IIQ 22 (women only) Modified IIQ and IIQ-7 73 (men only) Grade B: recommended Symptom Impact Index (SII) 29 (women only) ICSQoL 49 (men only) European Organization for Research and Treatment in Cancer (EORTC) Metastatic Prostate Cancer 74 (men only) Changes in Urinary Function 75 (men only) Prostate-Targeted Health-Related Quality of Life 57 (men only) Functional Assessment of Cancer Therapy Bladder Form (FACT-BL) scale 71,72 (men only)

7 S120 NAUGHTON ET AL. GASTROENTEROLOGY Vol. 126, No. 1 global impressions of the improvement of their condition ranged from 0.4 to 0.8. Minimally important changes ranged from 2% to 5% in association with these measures and effect sizes. 78 Psychometric information on translated versions of the I-QoL has been reported for French, Spanish, Swedish, and German language versions. 78 King s health questionnaire (grade A). See the previous description. Incontinence impact questionnaire (grade A). The Incontinence Impact Questionnaire (IIQ) was developed to assess the psychosocial effect of urinary incontinence in women. 16 The IIQ consists of 30 items (24 on the degree to which incontinence affects activities and 6 on the feelings engendered). Scores are obtained for 4 subscales determined by factor and cluster analyses: physical activity, travel, social relationships, and emotional health. An overall score can also be obtained. The IIQ has acceptable levels of validity, reliability, and responsiveness. 21,72 It has been used in several clinical trials and observational studies, as well as in several studies in Europe and Australia. 19 A modified version has also been used with men. 74 Incontinence impact questionnaire-7 (short form; grade A). A short, 7-item version of the IIQ has been found to have acceptable validity and reliability. 16,31 There is also a French version of the IIQ Urge-incontinence impact questionnaire (grade A). A version of the IIQ has been developed for specific assessment of urge incontinence. 22,35 The IIQ was modified by adding items that measure symptoms associated with urge incontinence and deleting other items, on the basis of focus group information, expert clinical opinion, and reviews of scientific literature. The final Urge-Incontinence Impact Questionnaire contains 32 questions arranged into 6 domains (travel, activities, feelings, physical activities, relationships, and sexual function), 2 single items (night bladder control and satisfaction with treatment), and a mean summary score composed of the 6 domain scales. The response categories were increased from a 4-point Likert scale to a 6-point Likert scale to allow for greater responsiveness to therapeutic changes. 35 For some questions, response categories of never regularly do this and does not apply to me were added to better characterize the effect of urinary incontinence. Higher scores on the subscales and individual items indicate a greater effect on daily life. The internal consistency and reliability of the Urge- Incontinence Impact Questionnaire has ranged from 0.74 to 0.96 (Cronbach s ) for the individual subscales, 22,35 and the overall index score was Intraclass correlation coefficients of test retest reliability have ranged from 0.68 to ,35 Guyatt s statistics assessing responsiveness to change were reported as 0.62 to 0.83 for participants with a stable number of incontinent episodes and 1.00 to 1.61 for participants who showed an improvement in the number of incontinent episodes. 22 The scale has demonstrated acceptable convergent and discriminant validity. 35 Modified incontinence impact questionnaire and incontinence impact questionnaire-7 (grade A). Modified versions of the IIQ and the IIQ-7 have been used in 2 studies examining the efficacy of artificial urinary sphincters in men who had developed stress incontinence after radical prostatectomy. Fleshner and Herschorn 73 used 17 items of the IIQ to examine activities of daily living and self-perception. They also changed the response choices to some of the items and added 2 questions from the American Urologic Association Symptoms Index. They compared 30 men who had received artificial urinary sphincters with 31 men who had also undergone radical prostatectomy but who had not developed incontinence. Urinary control was similar in both groups, yet several IIQ questions discriminated between groups. However, the total score was not given or analyzed. The questions from the American Urologic Association Symptoms Index did not differentiate between groups. 73 The IIQ-7 and the short form of the UDI have also been used in men with artificial urinary sphincters, who were compared with postprostatectomy men with incontinence. 79 Some information regarding its psychometric properties was provided. Symptom impact index (grade B). This questionnaire was developed in the United Kingdom to assess the effect of stress incontinence. 29 This brief measure contains only 4 items, each of which is scored from 0 to 4. It has acceptable levels of validity and reliability, but its responsiveness has not yet been reported. ICS quality of life (grade B). This questionnaire, developed for the ICS BPH study, 39 includes 6 items addressing general and specific aspects of quality of life. 49 The ICSQoL has good validity but poor reliability, and, hence, questions have to be considered independently. 49 European organization for research and treatment in cancer metastatic prostate cancer (grade B). Developed in Portugal and Belgium, the Metastatic Prostate Cancer questionnaire is based on other European Organization for Research and Treatment in Cancer measures and aims to assess quality of life in patients with metastatic prostate cancer. 74 It has high internal consistency, but test retest reliability has not been confirmed. There is some evidence that it is responsive to change after prostate cancer treatments. 74

8 January Supplement 2004 SYMPTOM AND QOL SCALES FOR URINARY INCONTINENCE S121 Changes in urinary function (grade B). The Changes in Urinary Function questionnaire was tested for validity and reliability as part of a Radiation Therapy Oncology Group study and was found to have adequate validity and reliability. 75 Data on its responsiveness have not been reported. Prostate-targeted health-related quality of life (grade B). This questionnaire consists of 20 items in 3 domains: sexual function, urinary function, and bowel function. 57 The measure has adequate validity and reliability. Functional assessment of cancer therapy bladder form (grade B). A group of measures has been developed under the general umbrella of the Functional Assessment of Cancer Therapy. 76,77 The Functional Assessment of Cancer Therapy bladder version has been used with patients recruited to a trial of radiation therapy in prostate cancer and includes questions concerned with micturition, fatigue, and sexuality. More information on the Functional Assessment of Cancer Therapy scales and their psychometric properties is described elsewhere. 76,77 Conclusion Much progress has been made in recent years in the development and testing of questionnaires to assess symptoms and quality of life related to urinary incontinence. Researchers are strongly encouraged to use the recommended questionnaires identified in this article in clinical research. These instruments have achieved basic standards of sound psychometric properties necessary in self-report instruments. Investigators are also encouraged to publish findings on the reliability, validity, and responsiveness of instruments they use in research investigations to further our knowledge of assessment tools for urinary incontinence. In addition, there is also a need to conduct head-to-head comparisons of instruments to clarify which instruments might perform better with similar patients and clinical settings. Further, adding terms such as quality of life, bothersomeness, or symptoms to the list of key words in published articles would also be helpful to investigators completing literature searches on the topic of urinary incontinence. References 1. Boyarsky S, Jones G, Paulson DF, Prout GR. New look at bladder neck obstruction by the Food and Drug Administration regulators. Am Assoc Genitourinary Surg 1977;68: Korman HJ, Sirls LT, Kirkemo AK. Success rate of modified Pereyra bladder neck suspension determined by outcomes analysis. J Urol 1994;152: Slevin ML, Plant H, Lynch D, Drinkwater J, Gregory W. Who should measure quality of life, the doctor or the patient? Cancer 1988; 57: Coscarrelli-Schag C, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity and guidelines. J Clin Oncol 1984;2: Hutchinson TA, Boyd NF, Feinstein AR. Scientific problems in clinical scales. J Chronic Dis 1979;32: Pearlman RA, Uhlmann RF. Quality of life in chronic diseases: perceptions of elderly patients. J Gerontol 1988;43:M25 M Wyman JF, Choi SC, Harkins SW, Wilson MS, Fantl AJ. The urinary diary in evaluation of incontinent women: a test-retest analysis. Obstet Gynecol 1988;71: Barnick C. Frequency volume chart. In: Cardozo L, ed. Urogynaecology. London: Churchill Livingstone, 1997: Follick M, Ahern D, Laser-Wolston N. Evaluation of a daily activity diary for chronic low back pain. Pain 1984;19: de la Rosette JJMC, Witjes WPJ, Schäfer W, Abrams P, Donovan JL, Peters TJ, Millard RJ, Frimodt-Moller C, Kalomiris P. Relationships between lower urinary tract symptoms and bladder outlet obstruction: results from the ICS-BPH study. Neurourol Urodyn 1998;17: Barry MJ, Cockett ATK, Holtgrewe HL, McConnell JD, Sihelnik SA, Winfield HN. Relationship of symptoms of prostatism to commonly used physiological and anatomical measures of the severity of benign prostatic hyperplasia. J Urol 1993;150: el Din KE, Koch WF, de Wildt MJ, Kiemeney LA, Debruyne FM, de la Rossette JJ. Reliability of the International Prostate Symptom Score in the assessment of patients with lower urinary tract symptoms and/or benign prostatic hyperplasia. J Urol 1996;155: Reynard JM, Yang Q, Donovan JL, Peters TJ, Schäfer W, de la Rosette JJ, Dabhoiwala NF, Osawa D, Lim AT, Abrams P. The ICS- BPH study: uroflowmetry, lower urinary tract symptoms and bladder outlet obstruction. Br J Urol 1998;82: Norton C. The effects of urinary incontinence in women. Int Rehabil Med 1982;4: Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the sickness impact profile.j Am Geriatr Soc 1991;39: Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl AJ. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 1995;14: Wyman JF, Harkins SW, Taylor JR, Fantl JA. Psychosocial impact of urinary incontinence in women. Obstet Gynecol 1987;70: Donovan JL, Naughton M, Gotoh M, Corcos J, Jackson S, Kelleher C, Lukacs B, Costa P. Symptom and quality of life assessment. In: Abrams P, Khoury S, Wein AJ, eds. Incontinence. Plymouth, UK: Health Publication Ltd, 1999: Donovan JL, Badia X, Corcos J, Gotoh M, Kelleher C, Naughton M, Shaw C, Lukacs B. Symptom and quality of life assessment. In: Abrams P, Cardozo L, Khoury S, Wein AJ, eds. Incontinence. Plymouth, UK: Health Publication Ltd, 2002: Corcos J, Beaulieu S, Donovan J, Naughton M, Gotoh M. Quality of life assessment in men and women with urinary incontinence. J Urol 2002;168: Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Qual Life Res 1994;3: Lubeck DP, Prebil LA, Peeples P, Brown JS. A health related quality of life measure for use in patients with urge urinary incontinence: a validation study. Qual Life Res 1999;8: Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 1997;104: Sandvik H, Hunskaar S, Seim A, Hermstad R, Vanvik A, Bratt H.

9 S122 NAUGHTON ET AL. GASTROENTEROLOGY Vol. 126, No. 1 Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health 1993;47: Hald T, Nordling J, Andersen JT, Bilde T, Meyhoff HH, Walter S. A patient weighted symptom score system in the evaluation of uncomplicated benign prostatic hyperplasia. Scand J Urol Nephrol Suppl 1991;138: Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, de la Rosette JJ, Kondo A. The ICS- BPH Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol 1996;78: Donovan JL, Peters TJ, Abrams P, Brookes ST, de la Rosette JJ, Schäfer W. Scoring the ICSmaleSF questionnaire. J Urol 2000; 164: Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol 1996;77: Black N, Griffiths J, Pope C. Development of a symptom severity index and a symptom impact index for stress incontinence in women. Neurourol Urodyn 1996;15: Robinson D, Pearce K, Preisser J, Dugan E, Suggs P, Cohen S. Relationship between patient reports of urinary incontinence symptoms and quality of life measures. Obstet Gynecol 1998; 91: Dugan E, Cohen SJ, Robinson D, Anderson R, Preisser J, Suggs P, Pearce K, Poehling U, McGann P. The quality of life of older adults with urinary incontinence: determining generic and condition specific predictors. Qual Life Res 1998;7: Gordon E, Stanton S. Urinary incontinence in elderly women. Eur Urol 1998;33: Lemack GE, Zimmern PE. Predictability of urodynamic findings based on the Urogenital Distress Inventory-6 questionnaire. Urology 1999;54: Blanc E, Hermieu JF, Ravery V, Moulinier F, Delmas V, Boccon- Gibod L. Value of the use of a questionnaire in the evaluation of incontinence surgery. Prog Urol 1999;9: Brown JS, Posner S, Stewart AL. Urge incontinence: new healthrelated quality of life measures. J Am Geriatr Soc 1999;47: Hanley J, Capewell A, Hagen S. Validity study of the severity index, a simple measure of urinary incontinence in women. BMJ 2001;322: Meyhoff HH, Hald T, Nordling J, Andersen JT, Bilde T, Walter S. A new patient weighted symptom score system (DAN-PSS-1). Clinical assessment of indications and outcomes of transurethral prostatectomy for uncomplicated benign prostatic hyperplasia. Scand J Urol Nephrol 1993;27: Hansen BJ, Flyger H, Brasso K, Schou J, Nordling J, Thorup Andersen J, Mortensen S, Meyhoff HH, Walter S, Hald T. Validation of the self-administered Danish Prostatic Symptom Score (DAN-PSS-1) system for use in benign prostatic hyperplasia. Br J Urol 1995;76: Abrams P, Donovan JL, de la Rosette JJ, Schäfer W. International Continence Society Benign Prostatic Hyperplasia Study: background, aims, and methodology. Neurourol Urodyn 1997;16: Donovan JL, Brookes ST, de la Rosette JJ, Peters TJ, Porru D, Kondo A, Dabhoiwala N, Millard R, Bosch R, Nordling J, Matos Ferreira A, Hofner K, Mostafid H, Walter S, Nissenkorn I, Frimodt Moller C, Mendes Silva M, Chapple C, Abrams P. The responsiveness of the ICSmale questionnaire to outcome: evidence from the ICS- BPH study. BJU Int 1999;83: Temml C, Haidinger G, Schmidbauer J, Schatzl G, Madersbacher S. Urinary incontinence in both sexes: prevalence rates and impact on quality of life and sexual life. Neurourol Urodyn 2000; 19: Naughton MJ, Shumaker SA. Assessment of health-related quality of life. In: Furberg CD, ed. Fundamentals of clinical trials. St. Louis: Mosby, 1997: Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30: The EuroQol Group. EuroQol a new facility for the measurement of health-related quality of life. Health Policy 1990;16: Bergner M, Bobbett RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981;19: Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract 1985;35: Sullivan M, Karlsson J, Bengtsson C, Furunes B, Lapidus L, Lissner L. The Göteborg Quality of Life Instrument a psychometric evaluation of assessments of symptoms and well-being among women in a general population. Scand J Prim Health Care 1993;11: Hunter JW, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36. Urology 1995;45: Donovan JL, Kay HE, Peters TJ, Abrams P, Coast J, Matos-Ferreira A, Rentzhog L, Bosch JL, Nordling J, Gajewski JB, Barbalias G, Schick E, Silva MM, Nissenkorn I, de la Rosette JJ. Using ICSQoL to measure the impact of lower urinary tract symptoms on quality of life: evidence from the ICS- BPH Study. International Continence Society Benign Prostatic Hyperplasia. Br J Urol 1997;80: McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32: Mozes B, Maor Y, Shmueli A. The competing effects of disease states on quality of life of the elderly: the case of urinary symptoms in men. Qual Life Res 1999;8: Schlenk EA, Erlen JA, Dunbar-Jacob J, McDowell J, Engberg S, Sereika SM, Rohay JM, Bernier MJ. Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36. Qual Life Res 1998;7: Brazier JE, Harper R, Jones NM, O Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992; 305: Jenkinson C, Lawrence K, McWhinnie D, Gordon J. Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36. Qual Life Res 1995;4: Gliklich RE, Hilinski JM. Longitudinal sensitivity of generic and specific health measures in chronic sinusitis. Qual Life Res 1995;4: Epstein RS, Deverka PA, Chute CG, Panser L, Oesterling JE, Lieber MM, Schwartz S, Patrick D. Validation of a new quality of life questionnaire for benign prostatic hyperplasia. J Clin Epidemiol 1992;45: Litwin MS, Hays RD, Fink A, Ganz PA, Leake B, Leach GE, Brook RH. Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 1995;273: Sand PK, Richardson DA, Staskin DR, Swift SE, Appell RA, Whitmore KE, Ostergard DR. Pelvic floor electrical stimulation in the treatment of genuine stress incontinence: a multicenter, placebocontrolled trial. Am J Obstet Gynecol 1995;173: Ware J, Kosinski M, Keller S. SF-36 physical and mental health summary scales: a user s manual, Boston: Medical Outcomes Trust, Chiarelli P, Brown W, McElduff P. Leaking urine: prevalence and