Quality of Life Assessment in Men and Women With Urinary Incontinence

0022-5347/02/1683-0896/0 THE JOURNAL OF UROLOGY® Copyright © 2002 by AMERICAN UROLOGICAL ASSOCIATION, INC.®

Vol. 168, 896 –905, September 2002 Printed in U.S.A.

DOI: 10.1097/01.ju.0000024401.79394.21

Review Article QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE JACQUES CORCOS, SYLVIE BEAULIEU, JENNY DONOVAN, MICHELLE NAUGHTON, MOMOKAZU GOTOH AND MEMBERS OF THE SYMPTOM AND QUALITY OF LIFE ASSESSMENT COMMITTEE OF THE FIRST INTERNATIONAL CONSULTATION ON INCONTINENCE* From the Department of Urology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada, Department of Social Medicine, University of Bristol, Bristol, United Kingdom, Wake Forest University, Winston-Salem, North Carolina, and Nagoya University, Nagoya, Japan

ABSTRACT

Purpose: The literature on assessment of quality of life from 1993 to 2001 was reviewed to evaluate and compare existing measures through their psychometric value and make adequate recommendations on their clinical use and future research. Materials and Methods: We selected quality of life articles and abstracts from Current Content 1996 to 1997 and MEDLINE 1993 to 1996 for our first report presented at the first consultation on incontinence in Monaco in 1998. This report was then updated up to September 2001 using the same strategy. We made our recommendations based on our clinical and research experience with these tools. Results: Several quality of life generic or disease specific questionnaires have been published for male and female urinary incontinence. However, their psychometric value is far from uniform and for most of them responsiveness is weak or has never been reported. Conclusions: Few quality of life questionnaires are at an advanced enough stage of development to be applied in clinical practice. However, even with these questionnaires more study remains to be done to make them shorter, sometimes even more specific and easier to use in different populations. KEY WORDS: bladder, quality of life, urinary incontinence, questionnaires, psychometrics

The concept of health related quality of life is directly related to the work of WHO, which defined health as a state of complete physical, emotional and social well-being, refuting the idea that it was merely the absence of disease or infirmity.1 Consequently a consensus conference of international experts has stated that health related quality of life instruments should include physical, social and emotional functioning as well as perceptions of overall quality of life or general life satisfaction.2 Urinary incontinence is not a disease, but rather a symptom resulting from impairment of the bladder or of the sphincteric mechanism.3 The International Continence Society (ICS) Standardization Committee defined urinary incontinence as “a condition in which involuntary loss of urine is a social or hygienic problem and is objectively demonstrable.”4 Women are more prone to urinary incontinence than men. Whereas prevalence rates for any type of urinary incontinence in general populations of adult women are estimated to be 10% to 58%, the prevalence rates in men have been estimated to be between 3% and 11%.5 A conservative estimate is that urinary incontinence disrupts the lives of approximately 20% of women.6 The most common outcome measures in clinical studies of urinary incontinence examine the quantity and frequency of urine loss, whether it be through voiding diaries, the pad test or urodynamic tests, such as detrusor or stress leak point

pressure. These observations may reflect the degree of leakage but they do not reflect how it disrupts the quality of daily activity. Norton first hypothesized that after treatment there was no direct relationship of objective measures of urinary incontinence with the degree of improvement experienced by the patient.7 Consequently several others have found only weak relationships of the perceived impact of incontinence with measures of frequency and quantity of urine loss.8 –11 In response to such situations Wood-Dauphinee and Troidl advocated the use of quality of life instruments as an outcome measure for surgical interventions.12 It is mainly in the last decade that researchers have developed and proposed the use of several self-administered questionnaires for urinary incontinence. They include measures of bother, symptom impact and quality of life. This review concentrates on quality of life measures in men and women with urinary incontinence and it is limited to questionnaires available in English. Although children are also affected by urinary incontinence, we did not find any article reporting quality of life of children with urinary incontinence. A report of enuresis and self-esteem in childhood13 was identified but considered to be outside of the scope of this review. ASSESSING QUALITY OF LIFE

Quality of life measures have been used in a wide variety of patients and have proved to be appropriate outcome measures in clinical trials. These measures consider the impacts of disease or treatment on individual subjective perception of

* Participants: Con Kelleher, Simon Jackson, Pierre Costa and Bertrand Lukacs. 896

QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE 12

physical, psychological and social well-being. The information that they yield on the psychosocial impact of the condition and the benefits or adverse effects of treatment can greatly inform decision making among treatment alternatives that have similar survival or cure rates.14 Quality of life measures can be useful outcomes in benign diseases such as incontinence, in which survival is not an issue. In general terms there are 2 types of quality of life measures, namely generic and disease specific. Generic measures can be used in various populations regardless of the affecting disease. They are applicable to different patient groups and permit comparisons across patient populations. Disease or condition specific measures are designed for a particular patient group and focus on aspects that are specific to the condition and are clinically important. Therefore, they should better reflect patient change in response to treatment. This assumption has held true in studies of prostate cancer, in which disease specific measures were more sensitive to treatment group differences than generic measures even when the concepts being assessed were similar in the 2 types of measures.15 For an assessment tool to be accepted it must be simple, relevant and capable of rapid completion. Moreover, selfadministered questionnaires are the most practical, efficient and inexpensive method of obtaining patient based information.16 The advantages of self-assessment are also supported by others.17, 18 Self-administration implies that patient capability (mental status, language, reading and writing ability, and so forth) has been considered when developing and using the questionnaire.19, 20 Questionnaires must also be tested in the population in which they are to be used. A particularity of measuring quality of life is that it cannot be assumed that the psychometric properties of an instrument remain stable across various populations and settings. The interpretation of quality of life is influenced by culture and quality of life measures should always be pretested in the specific population before being used in a clinical trial.16 Another important avenue is the translation and cultural adaptation of existing measures. With international studies becoming the norm in clinical trials it is imperative that questionnaires should be applicable in several languages and cultures. Researchers should refer to the guidelines of Guillemin et al on cross cultural adaptation.21 The process often begins with translation by qualified translators. It is followed by back translation by translators blinded to the intent of the original instrument. Notably translators should always translate into their native tongue. This translation is followed by committee review to compare source and back translated versions. At this point any discrepancies in the versions are identified and a final version is developed that is ready for pretesting. Pretesting is often done by a probe technique with unilingual individuals in the target population or by submitting the source and final versions to bilingual lay people. This last option is rarely practical or feasible. A last point to mention regarding cultural adaptation is the use of weighted scores. In the context in which a questionnaire has a scoring method using weights, such as the Sickness Impact Profile (SIP) and 36-Item Short Form Health Survey (SF-36), weighting may not apply to the new cultural situation. In these situations the cross-cultural validity of the weighting of items must be examined by experts.21 The psychometric performance of a questionnaire refers to reliability, validity and responsiveness, which are the 3 pillars of a good questionnaire. Reliability to the extent to which a measure obtains similar results when the presence or magnitude of a stable characteristic is determined repeatedly.12 Two main aspects of reliability are examined in psychometric studies. As measured by Cronbach’s ␣, internal reliability estimates how the individual items of a questionnaire relate to each other and to the total score. These ␣coefficients are influenced by the number of items. Values greater than 0.7

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are considered acceptable, greater than 0.8 are good and greater than 0.9 are excellent.22 Test-retest reliability addresses the reproducibility of assigned ratings. It is evaluated by correlation coefficients, such as Pearson’s r, Spearman’s ␳ or intraclass correlation coefficients.23 A value of 0.8 or greater is indicative of high reliability regardless of the correlation coefficients used.24 Validity. Validity refers to the degree to which an instrument measures what it is intended to measure. Content validity is most often addressed in the early phase of questionnaire development. It concerns how representative the contents are and it is often achieved through a literature review and consultations with experts, such as patients. Construct validity assesses hypothetical relationships of the quality of life measure with other domains, such as pain, anxiety and life satisfaction.25 Pearson or Spearman coefficients are again used to quantify expected correlations. No set norms exist because a priori determined relationships and not only the magnitude of the relationship support construct validity. For example, one could hypothesize that quality of life and anxiety would correlate moderately. Criterion validity is the comparison of a new measure to an existing gold standard. Often the new measure is shorter or easier to use than the existing measure. In this situation Fleiss interpretations of the strength of the correlations with the Pearson or Spearman coefficient are used.24 Responsiveness. Responsiveness is studied to ascertain that a given questionnaire reflects a clinically important change in patient condition.26 Most commonly the questionnaire being studied is completed before and after a treatment of known efficacy and scores are compared to determine whether they reflect change due to treatment.27–29 The Student t test is commonly used as additional evidence of responsiveness. Patient perception of change is measured and correlations of reported change in status with differences in quality of life scores are examined.29 –32 Furthermore, effect size calculations are also used. An effect size of 1.00 is the equivalent of a change in scores of 1 standard deviation in the original sample and it is considered a large effect size.33 Ideally responsiveness studies should also include a control group to ensure that the quality of life questionnaire truly demonstrates change in treated patients and stability in nontreated patients. However, in reality most studies use a pretest-posttest experimental design and compare patients to their baseline values or to a comparison group randomized to a different therapy. Quality of life measures should not be used in clinical trials until the purported measure has demonstrated sound psychometric performance, including responsiveness. Otherwise potentially useful treatments may be disregarded simply because the outcome measures were unable to show change in patient status. Briefly, a good measure of quality of life should be self-rated, easy to understand and demonstrated to be reliable, valid and responsive. The Appendix lists the points to consider when evaluating a quality of life questionnaire for clinical use. METHODOLOGY

The core of the current review was presented at the International Consultation on Incontinence in June 1998.34 In that report the searching strategies for quality of life assessments were Current Contents 1996 to 1997 and MEDLINE 1993 to 1997. The terms urinary incontinence and quality of life were searched for in the abstract and title or as key words. This first search resulted in 112 abstracts. Any articles mentioning quality of life but that did not actually measure quality of life and articles on spinal cord injured patients were not investigated further. All remaining articles were examined to ascertain the quality of life measure used. Quality of life measures not available in English or not undergoing translation into English, or measures for which no psy-

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chometric data were presented or referred to were excluded from further analysis. This first search was updated to September 2001 for the current report using the same search techniques. REVIEW OF EXISTING MEASURES

Review of generic measures used in men and women. Although generic questionnaires do not contain specific questions on urinary incontinence, they have been widely used to assess quality of life in incontinent adults on the assumption that incontinence has an impact on the general well-being of a given individual. Most of them can be self-administered. The Nottingham Health Profile contains 38 dichotomous items (2 response choices) grouped in 6 sections, including physical mobility, pain, sleep, social isolation, emotional reactions and energy level.35 It has been used extensively in the United Kingdom and has demonstrated good validity and reliability. Internal consistency for the different sections is high (␣ ⫽ 0.90 to 0.94), as is test-retest reliability (r ⫽ 0.75 to 0.88).36 However, when administered to 433 elderly Swedish women, only 2 sections showed a significant difference in continent and incontinent women.37 Responsiveness was not reported. The SIP contains 136 items divided into 12 categories, including sleep and rest, eating, work, home management, recreation and pastimes, ambulation, mobility, body care and movement, social interaction, alertness behavior, emotional behavior and communication.38 It can be administered by an interviewer in 20 to 30 minutes or self-administered. Respondents check the items that describe them on a given day. Items are weighted and a total percent score or category scores may be calculated. An American-Spanish version also exists,39 as does as a version adapted in the United Kingdom called the Functional Limitations Profile.36 In a descriptive study of incontinent women in Norway the SIP demonstrated that urge incontinence had more impact on quality of life in elderly women than stress incontinence.8 The Medical Outcomes Trust SF-36 has been used for quality of life assessment in men and women.40 It contains 36 items rated on Likert scales. They cover 8 dimensions, including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health. Scores on the different dimensions can be combined to create physical, mental and general health subscales.40 When used in men who present with moderate to severe urinary symptoms, the SF-36 profile was worse than in the general population.41 The SF-36 also showed good validity when used in men or women with urinary incontinence.42 Kutner et al applied the SF-36 to 352 community dwelling elderly individuals, of whom 47 (14%) had urinary incontinence.42 Individuals with urinary incontinence had significantly lower scores on each subscale. However, the internal consistency of the scales was 0.78 to 0.93. Therefore, McHorney et al claimed that the SF-36 is appropriate for group comparison but not for individual comparison.43 When used as an interview instead of a selfadministered scale, the SF-36 shows internal consistency of 0.8 or better.44 Test-retest reliability has been moderate to

high (r ⫽ 0.6 to 0.8).45 However, responsiveness has been reported to be poor in several studies,33, 46, 47 specifically in men with benign prostatic hyperplasia (BPH)48 and prostate cancer,15 and in women with stress urinary incontinence.49 In our experience with a randomized clinical trial comparing surgery and collagen injections for treating stress urinary incontinence we found similar poor responsiveness with an effect size of 0.13 to 0.34 for collagen injections and 0.01 to 0.35 for surgery.50 The SF-36 has been culturally adapted and/or translated into several languages, including German, Spanish and French. A modified version of the SF-36 has also performed poorly in patients who underwent prostatectomy.51 Two cancer generic measures have been used in prostate cancer studies, namely the Cancer Rehabilitation Evaluation System Short Form (CARES-SF)52 and Functional Assessment of Cancer Therapy General Form (FACT-G).53 The FACT-G was unable to show any significant difference in groups of patients with prostate cancer receiving treatment and a comparison group of men without any history of cancer. The CARES-SF performed slightly better. Patients receiving treatment did significantly worse than the comparison group on 2 of the 5 subscales, namely sexual function and medical interaction. This study also compared the 3 treatment options of surgery, irradiation and observation. None of the generic measures was able to show any difference among the treatments (table 1).15 Review of disease specific measures in women. The 1990s saw the development of a plethora of disease specific quality of life measures. Many were constructed for a particular study with no report of their psychometric performance. Therefore, this review is limited to disease specific questionnaires for which at least some form of validity or reliability has been reported. Furthermore, some questionnaires were developed to measure the impact of urinary incontinence on quality of life, whereas other questionnaires assess how much a person is bothered by urinary incontinence symptoms. Because the difference in impact on quality of life and bother of a symptom is not always well defined, questionnaires assessing the presence of symptoms were included in this review if they examine the impact of these symptoms on individual quality of life or the bother associated with these symptoms by the patient. Some questionnaires, such as the Incontinence Impact Questionnaire (IIQ), may at first glance resemble a symptoms questionnaire. However, the difference lies in the underlying principle that was investigated in the developmental phase of the questionnaire. For example, when developing the IIQ, items were chosen based on their reported impact on quality of life by patients with urinary incontinence. Some of these items may reflect the presence of certain symptoms but all were deemed to reflect the impact of urinary incontinence on daily life. The Bristol Female Lower Urinary Tract Symptoms questionnaire was “developed to be extremely sensitive to any change in lower urinary tract symptomatology.”54 It contains 20 items scored on 4 to 5-point Likert scales. It is a dual questionnaire in the sense that these items are scored twice, that is once to quantify the presence of symptoms and a second time to assess bother. Discriminant validity was dem-

TABLE 1. Generic quality of life questionnaires used in women and men with urinary incontinence References al35

Questionnaire

Nottingham Health Profile Hunt et SIP Bergner et al38 40 SF-36 Ware 52 CARES-SF Schag et al 53 FACT-G Cella et al There were no urinary incontinence specific items. * Based on descriptors in Appendix.

No. Items

Test-Retest Reliability*

38 136 36 45 29

Moderate–good Not reported Moderate–good Not reported Not reported

Validity* Good Not reported Good Moderate Moderate

Responsiveness* Not reported Not reported Poor Not reported Not reported

QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE

onstrated when 17 of the 20 symptom items showed a significant difference in score in a group of women who presented for urodynamic assessment and group of women with no clinical symptoms of urinary incontinence. Moderate to high correlations with pad tests and voiding charts supported construct validity. Internal consistency was acceptable (␣ ⫽ 0.78). Test-retest reliability was high for the total score (Spearman’s r ⫽ 0.86 and 0.9 for symptoms and bother, respectively). Its responsiveness has not been reported. It is principally a questionnaire examining the presence of urinary incontinence symptoms. However, because of the good psychometric performance of the scoring concerning the bother of these symptoms, it is included in this review. Recently a variation of this questionnaire was used by Temml et al.55 The Symptom Impact Index (SII) is a short 3-item questionnaire that was developed for use with the 5-item Symptom Severity Index.56 The 2 questionnaires were published in 1996 in a report of Black et al.56 Content validity is supported by interviews and pilot studies done in the development phase of the questionnaire. Internal reliability of the SII is good (␣ ⫽ 0.8). Good test-retest reliability is reported for the SII with 83% of women scoring exactly the same on the second set of questionnaires. Questions are scored on Likerttype or dichotomous scales. No information on responsiveness was reported. The IIQ10 is a self-administered measure based on the study of Norton.7 It consists of 30 items rated on a 4-point Likert-type scale with the highest score indicating greatest psychosocial impact. The items were generated through patient interviews, a review of the literature and consultation with clinicians, and they are subdivided into the 4 subscales of physical activity, travel, social and emotional.57 A Cronbach’s ␣ of 0.75 has been reported for the total IIQ with high reliability on each subscale (␣ ⫽ 0.88 to 0.91).58 Test-retest reliability in a 1-week period was good (r ⫽ 0.73).10 Scores on this scale correlated significantly but weakly with frequency (r ⫽ 0.34) and quantity of urine loss, as measured by pad tests (r ⫽ 0.27).57 We have recently reported the good responsiveness of the IIQ in a prospective study of 57 women with genuine stress incontinence who were treated with surgery, injectables or pelvic floor exercises.59 Effect size was 1.14. The IIQ was presented in full in 1994 by Shumaker et al.57 A modified version and a short form of the IIQ (IIQ-7) have been used with men and are discussed. The King’s Health Questionnaire is composed of 2 parts.60 The first part (2 questions) addresses perceptions of general health and the impact of incontinence. The second part (19 questions) addresses limitations in roles, physical, social and personal domains as well as emotional problems, sleep disturbance and severity of incontinence. It has demonstrated acceptable internal consistency (␣ ⫽ 0.72 to 0.92) and good test-retest reliability (␳ ⱖ0.8). Construct validity is supported by significant correlations with SF-36 subscales. Responsiveness has not been reported, although it has been used to assess the results of surgery.61 The Incontinence Quality of Life Instrument contains 22 items and was developed for men and women after interviews with patients with incontinence.62 Responses are scored on a 5-point Likert scale. It is a reliable questionnaire

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(Cronbach’s ␣ ⫽ 0.95) with a test-retest reliability of 0.93. Construct validity is supported by significant correlation with the role, physical and social function of the SF-36. Responsiveness with an effect size of 0.4 was reported only recently.63 Questionnaire items and response scale were presented in 1999 by Patrick et al.63 The Incontinence Stress Index was developed for the elderly nursing home population.64 It is a 32-item questionnaire examining the psychological impact of urinary incontinence. Content validity was supported by factor analysis, and internal reliability was excellent (␣ ⫽ 0.93). Unfortunately no further study was reported of the development of this questionnaire (table 2). Review of disease specific questionnaires for men. In men no questionnaires have been developed to assess specifically the effect of urinary incontinence. However, items concerned with urinary incontinence often appear in questionnaires designed to assess the impact of prostate symptoms. Therefore, a review of the quality of life questionnaires for men with urinary incontinence becomes a review of BPH and prostate cancer quality of life questionnaires. We discuss only self-administered questionnaires that address the problem of urinary incontinence. Questionnaires developed for patients with BPH are presented first, followed by those for men with prostate cancer. Questionnaires Developed for Patients With BPH: The BPH Health-Related Quality of Life (BPH-HRQoL) Survey is composed of existing standardized items and 2 items developed specifically for the Olmsted County Study of Urinary Symptoms and Health Status Among Men.65 The new questionnaire examines BPH specific interference with activity and sexual satisfaction. The BPH-HRQoL Survey includes 49 questions divided into 6 domains. There are 4 questions eliciting the presence and bother of urine leakage. Although BPH specific interference with activity questions do not specifically mention urinary incontinence, 6 of 7 items are similar to items in the IIQ and are relevant to individuals with urinary incontinence. All domains have good internal consistency (Cronbach’s ␣ ⫽ 0.81 to 0.96).48 Reproducibility of the domains is fair to good for a median interval of 10 weeks in men with BPH (intraclass correlation coefficient 0.41 to 0.68).48 All domains except the general health scale are responsive at p ⱕ0.05 when comparing men before and after prostate surgery.47 The overall survey had good sensitivity and specificity (76% and 81%, respectively) when comparing men with BPH to men without any history of urology symptoms.65 The survey was presented in full in 1992 by Epstein et al.48 A group from the Department of Veterans Affairs developed a quality of life questionnaire that contains 42 dichotomous items examining 5 subscales, including perception of urinary difficulties, sexual performance, daily activity , general well-being and social activity.66 At least 4 items are directly concerned with urine leakage. More items may be relevant but it is difficult to ascertain since the exact phrasing of the questions was not published. Construct validity was supported by strong correlations with BPH symptoms. However, internal reliability was only fair for some scales (␣ ⫽ 0.54 to 0.82). Although it was used in a large study of

TABLE 2. Urinary incontinence specific questionnaires used in women References al54

Jackson et Black et al56 Wyman et al10 Kelleher et al60 Wagner et al62 Yu64 * Based on descriptors

Questionnaire Bristol Female Lower Urinary Tract Symptoms SII IIQ King’s Health Questionnaire I-QOL Incontinence Stress Index in Appendix.

No. Items

Test-Retest Reliability*

Validity*

Responsiveness*

20 3 30 21 22 32

Good Good Moderate Good Very good Not reported

Good Moderate Good Good Good Moderate

Not reported Not reported Very good Not reported Poor Not reported

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707 men, no other information was found concerning this instrument. The ICS-BPH study questionnaire contains 50 items and it is divided into 3 sections, namely ICSmale, ICSQoL and ICSsex.67 The presence of urinary symptoms (20 items) and whether they are a problem (19 items) form the ICSmale. The ICSsex contains 4 sexual function items. The ICSQoL comprises 5 multiple choice questions and an open ended question examining the impact of lower urinary tract symptoms on quality of life. The psychometric performance of the ICSQoL and the questionnaire were described in 1997 by Donovan et al.68 Content validity of the ICSQoL was ascertained through consultation with urologists and interviews with patients in the development phase. Furthermore, few missing data were reported in the ICS-BPH study, in which more than 1,000 men completed the questionnaire. Construct validity was examined in several ways. Different trends in scores were observed in men living in the community and patients consulting for BPH symptoms. Symptoms scores on the ICSmale correlated significantly with quality of life items. This analysis also supports the use of the ICSQoL with urinary incontinence because only 1 of the 6 items had no significant correlation with urinary incontinence symptoms. In addition, all ICSQoL items except 1 (need to change clothes) correlated significantly with the physical functioning, vitality and social functioning scales of the SF-36, which is a generic health-related quality of life measure. The ICSQoL also demonstrated good reliability. Internal consistency was acceptable for a 5-item questionnaire (␣ ⫽ 0.59) because Cronbach’s ␣ calculations were highly influenced by the small number of items in the questionnaire. Only scores on the multiple choice questions can be used to calculate Cronbach’s ␣. ⌻est-retest reliability was assessed in a group of 40 patients. The pattern of change of response categories was examined for the 5 multiple choice questions and deemed reasonable. The responsiveness of the ICSQoL was not reported. The ICS BPH study questionnaire was developed in English and underwent professional forward-backward translation into 10 other languages. The BPH Specific Quality of Life Scale was developed in France for use in a large cohort study of alfuzosin treatment for BPH.69 It contains 20 items grouped into physical, psychological, social and global subscores. Of the 2 items that examine urinary incontinence directly 1 addresses urgency and 1 addresses the need to stop an activity to urinate. Other items may also be relevant to urinary incontinence but the exact phrasing of the questions is not available. Construct validity was supported by significant correlations of quality of life scores with modified Boyarsky symptom index scores (r ⫽ ⫺0.46). The quality of life scores also discriminated among patients with mild, moderate and severe symptoms.70 Internal consistency was not reported but test-retest reliability of the overall score was good (r ⫽ 0.93).69 The BPH Specific Quality of Life Scale demonstrated good responsiveness with scores statistically different from baseline to followups. Moreover, scores improved an average of 29% after 90 days of treatment69 and by more than 40% after 1 and 2 years of treatment.70, 71 The items are listed in the study of Lukacs et al69 but to our knowledge the questionnaire has not been published. The BPH Specific Quality of Life Scale was reduced to a 9-item questionnaire (BPHQL9) by principal component analysis.69 It includes 3 questions on each of certain domains, including general quality of life, BPH specific interference with activity and sexuality. The need to stop activity to urinate item was maintained as well as items on social activity and leisure activities. However, the item on urgency was eliminated. The BPHQL9 demonstrated discriminant validity by showing a significant difference in men with BPH and age matched controls (p ⬍0.001). Internal consistency was good for a 9-item questionnaire (␣ ⬎0.7) and test-retest

reliability was acceptable (intraclass correlation coefficient greater than 0.7). Responsiveness was good in a 6-month cohort of alfuzosin treatment for BPH (effect size 0.9).72 Furthermore, the BPHQL9 showed statistically significant improvement in all 3 domains during a 12-month treatment period.73 The BPHQL9 should be available after the completion of translation and testing in 10 other countries.74 However, the authors recommend the use of the BPHQL9 since it is shorter and has acceptable psychometric properties.72 The BPH Impact Index is a short, 4-item, disease specific health status measure.75 It can be considered as a quality of life questionnaire because it examines how BPH affects the patient physically and mentally as well as his participation in regular activity. Moreover, the questions are phrased to incorporate any symptoms and all are relevant to urinary incontinence. The BPH Impact Index has good internal consistency (Cronbach’s ␣ ⫽ 0.87) and test-retest reliability (r ⫽ 0.89). Correlations with the American Urological Association (AUA) symptom score support its validity (r ⫽ 0.83). It also discriminates patients and controls well (receiver operating characteristics curve area 0.9). Responsiveness is supported by a large effect size of 1.07. The Symptom Problem Index was developed simultaneously and it incorporates the concept of bother to the symptoms listed in the AUA scale. It has 7 items for a total score of 0 to 28 with 1 item examining urinating with little warning. As one would expect, the Symptom Problem Index correlated highly with the AUA total score (r ⫽ 0.84). It also had acceptable internal reliability (␣ ⫽ 0.78) and good test-retest reliability (r ⫽ 0.89). It was able to discriminate patients and controls at almost the same level as the AUA score with a receiver operating characteristics curve area of 0.87 and 0.9 for the Symptom Problem Index and AUA score, respectively. The Symptom Problem Index was slightly more responsive to change in patient status than the BPH Impact Index (effect size 1.18). The Symptom Problem Index and BPH Impact Index were presented in full in 1995 by Barry et al.75 In closing the presentation of BPH quality of life scales one should mention the International Prostate Symptom Score (I-PSS).76 This short questionnaire consists of the 7-item AUA BPH symptoms questionnaire and an additional question on quality of life. The symptoms questionnaire includes 1 item on “having difficulty to postpone urination.” It has been translated into and validated in several languages and is used intensely in research since its adoption by the WHO International Consultation on BPH. The questionnaire can be self-assessed or administered by a physician.77 The quality of life question has demonstrated construct validity through correlations with the symptoms score in several studies78 – 80 and it has shown good responsiveness.80 – 82 However, to our knowledge test-retest reliability of the quality of life question has not been reported (table 3). Questionnaires Developed For Patients With Prostate Cancer: The European Organization for Research and Treatment of Cancer (EORTC) developed a questionnaire specific to prostate cancer, namely the EORTC-Prostate Cancer Questionnaire (PCQ).83 It has 8 domains assessed by 30 questions, namely physical functioning, social role functioning, urological symptoms, fatigue, sexual functioning, emotional functioning, social functioning and pain. The EORTCPCQ was developed by adding disease specific domains to the existing EORTC generic cancer questionnaire. The physical functioning and pain scales demonstrated construct validity in a clinical trial of 63 patients newly diagnosed for prostate cancer by correlating weakly to moderately with clinical data (r ⫽ 0.30 and 0.43, respectively).83 In that study internal reliability was above 0.7 for all scales except social role functioning (␣ ⫽ 0.65). No information on test-retest reliability with this specific population was found. In the clinical trial noted only the 2 scales on pain and urological symptoms were shown to be responsive. The quality of life questionnaire for

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QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE TABLE 3. Disease specific questionnaires used in men with BPH References

Questionnaire

No. Items

Epstein et al48 Anonymous66 Donovan et al68 Lukacs et al69

BPH-HRQoL Department of Veterans Affairs ICSQoL BPH specific quality of life scale BPHQL9 BPH Impact Index Symptom Problem Impact Index I-PSS

49 42 6 20 9 4 7 8 (7 symptom ⫹ 1 quality of life questions)

Barry et al75 Cockett et al76

No. Urinary Incontinence Specific Items

Test-Retest Reliability*

Validity*

Responsiveness*

4 4 or Greater 4 2 or Greater 1, Perhaps 3 4 Relate to any symptoms 1 1

Poor Very good Moderate Very good Moderate Good Good Quality of life question not reported

Good Good Good Good Good Good Good Quality of life question good

Good Not reported Not reported Good Good Very good Very good Good

* Based on descriptors in Appendix.

compared 30 men who received an artificial urinary sphincter to a group of 31 who also underwent radical prostatectomy but in whom incontinence had not developed. Urinary control was similar in the 2 groups and yet several IIQ questions discriminated between the groups. However, the total score was not given or analyzed. Questions on the AUA symptoms index did not differentiate the groups. The IIQ-7 and short form of the Urogenital Distress Inventory were used in a study of 52 men implanted with an artificial urinary sphincter and compared with a group of 15 with postprostatectomy incontinence. In this study IIQ-7 scores significantly correlated with the use of protective pads (r ⫽ 0.75), and mean scores on the IIQ-7 and Urogenital Distress Inventory were significantly greater after implantation than before in the artificial sphincter group.92, 93 Moore and Jensen tested the IIQ in 58 men with stress urinary incontinence after radical prostatectomy and concluded that the questionnaire had good reliability but expressed concern about its construct validity, which may require more testing.93 It is unfortunate that none of these 3 studies mentioned the responsiveness of the questionnaires in this population (table 4). Summary of review of existing measures. The current review of the literature reveals that several good generic quality of life questionnaires have been published. However, for men and women none of the generic measures has sufficient responsiveness to warrant use in the routine evaluation of patients with urinary incontinence or in research on the efficacy of treatment interventions. However, they are surely important when comparing the effect of different conditions on individual quality of life, as in health care management issues. Of the urinary incontinence specific questionnaires developed for women the IIQ57 has the most complete published psychometric performance. The Bristol Female Lower Urinary Tract Symptoms,54 SII56 and King’s Health Questionnaire60 are also valid and reliable measures. The SII also has the advantage of brevity but it is important to determine whether such a short questionnaire of only 3 items can also be responsive to patient change in status. The I-QOL is an interesting measure that can be used in men and women62 but it may be limited by poor responsiveness, although few published studies of the I-QOL are available to date.

EORTC Protocol 30853 was presented in full in 1993 by da Silva et al.84 The University of California-Los Angeles Prostate Cancer Index is a 20-item questionnaire developed for use with men treated for early stage prostate cancer. It examines sexual function and bother, urinary function and bother, and bowel function and bother. The 6 urinary items are concerned with urine leakage.85 Validity of the questionnaire is supported in several ways. Focus groups with patients and spouses were used in the development phase to ensure content validity. Significant correlations with sections of the SF-36 and CARES-SF support construct validity. Moreover, sexual and urinary domain scores differentiated between patients with and without prostate cancer, supporting discriminant validity. Patients who had undergone surgery also scored significantly lower than those under observation on these domains.15 Sexual, urinary and bowel function scales also demonstrated good internal consistency (Cronbach’s ␣ ⫽ 0.78 to 0.88).86 Test-retest reliability was good to very good for each domain (intraclass correlation 0.66 to 0.92).85, 87, 88 Changes in scores 1 year after radical prostatectomy supported responsiveness.89 The questionnaire was presented in full in 1998 by Litwin et al.85 The Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q) also examines bowel, urinary and sexual functions.90 The urinary scale consists of 22 items on urine flow, frequency, pain, bleeding, urgency, leakage and the use of protection. The impact of urinary symptoms on quality of life is also assessed. Although the complete questionnaire is not published, at least 4 questions examine leakage, including leakage once or more daily, leakage with coughing, leakage with sneezing and using protection. Content validity of the PCTO-Q was assessed by health professionals working with prostate cancer patients. Internal consistency was not reported. Test-retest reliability was addressed in a pilot test of 25 patients. Percent agreement was found to be 91.2% when accepting scores within a 1-point difference. Responsiveness has not been reported. A modified version of the IIQ and the IIQ-7 has been used in 3 studies of the efficacy of artificial urinary sphincters in men in whom stress urinary incontinence developed after prostatectomy. Fleshner and Herschorn used 17 items of the IIQ to examine activities of daily living and self-perception.91 They also changed the response choices to some items and added 2 questions from the AUA symptoms index. They

TABLE 4. Disease specific questionnaires used in men with prostate cancer References al84

da Silva et Litwin et al85

Questionnaire EORTC-PCQ University of CaliforniaLos Angeles Prostate Ca Index PCTO-Q IIQ-7

Shrader-Bogen et al90 Uebersax et al9 ⫹ Moore Jensen93 *Based on descriptors in Appendix.

No. Items

No. Urinary Incontinence Specific Items 1–4

Test-Retest Reliability*

Validity*

Responsiveness*

30 20

6

Not reported Moderate–very good

Good Good

Moderate Moderate

44 7

4 or Greater 7

Good Moderate

Moderate Good

Not reported Not reported

902

QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE

In men the BPH-HRQoL Survey,65 ICS-BPH,67 BPHQL969 and University of California-Los Angeles Prostate Cancer Index85 have demonstrated good validity, reliability and responsiveness. However, the burden of fulfilling the BPHHRQoL survey or ICSmale may be a factor in a busy clinic or with ill patients, such as those with terminal phase prostate cancer. The BPHQL9 has the advantages of brevity and availability in several languages. The University of California-Los Angeles Prostate Cancer Index is of moderate length and has the most urinary incontinence specific items of the 4 questionnaires. DISCUSSION

Quality of life was unseen in urinary incontinence research projects 20 years ago. Since then, quality of life has been introduced progressively into clinical trials of urinary incontinence and related fields, such as prostate cancer and BPH. However, it is often measured as a secondary outcome. Considering the choice of existing measures and ongoing work to assess and enhance their psychometric performance we hypothesize that more and more clinical trials may incorporate quality of life as a primary outcome. The question now remains of whether this useful research tool may become a practical clinical instrument used by health professionals for assessing their interventions. In reference to the criteria shown in the Appendix few reviewed questionnaires met all criteria. Psychometric data are incomplete for several questionnaires, mainly responsiveness and to a lesser degree test-retest reliability. We are confident that responsiveness data on the newer measures (that is published after 1995) are forthcoming. For women the IIQ and I-QOL met all psychometric criteria and yet they may be too lengthy for everyday use in a busy clinic (30 and 22 items, respectively). The 3 questionnaires used in men that have good psychometric properties and are brief are the BPHQL9, BPH Impact Index and Symptom Problem Impact Index. However, none of these measures was developed specifically for urinary incontinence and, therefore, few of the questions specifically examine urinary incontinence. The IIQ-7 is brief and specifically addresses urinary incontinence but the reliability of the measure in men has not been reported. Brevity is an important clinical requirement and it concerns subject completion and professional interpretation. A good example of brevity is the I-PSS. The success of the I-PSS is largely due to the fact that it has only 7 items, is easy to understand and requires only a few minutes to complete by the patient and a few seconds to be interpreted by the health professional. It also has an additional quality of life item, which is scored independently on a Likert type scale. However, the I-PSS is mainly a symptoms questionnaire with only 1 question addressing quality of life. Furthermore, testretest reliability of the quality of life question has not been reported. What should be the future development of quality of life assessment for urinary incontinence? Do we need more questionnaires? As mentioned, there are already some excellent questionnaires available for research purposes. However, most disease specific questionnaires were developed for women with stress urinary incontinence. To our knowledge the IIQ and I-QOL are the only measures that have been used successfully in patients with various types of urinary incontinence. The IIQ-7 and I-QOL are the only urinary incontinence specific measures that have been used in men and women but psychometric data on the IIQ-7 are incomplete. It remains to be demonstrated whether the majority of urinary incontinence specific quality of life questionnaires can be used without any modifications in patients of each gender and with various types of urinary incontinence. Separate questionnaires may be needed considering that it has been shown that urge urinary incontinence is more disruptive than stress urinary incontinence in

women.8, 94 Therefore, more study is needed to verify whether existing questionnaires are applicable to such different patient populations. If not, the development of new questionnaires is warranted. Another avenue may be the refinement of existing questionnaires by identifying the most representative items for each patient population and, thus, creating shorter versions. Another issue that is lacking in many publications is the question of questionnaire validity by age group. The impact of urinary incontinence may differ in middle-aged and elderly individuals due to the social roles that evolve as one advances in age. Sandvik et al ascertained that women with stress urinary incontinence who were younger than 67 years reported more mental distress and social restrictions than women older than 67 years old who also had stress urinary incontinence.94 However, Donovan et al found no difference according to age in a study of men with BPH.68 Age specific questionnaires are probably unnecessary but these contrasting results in men and women warrant further study. They also point toward pretesting a questionnaire if the clinical population in which one wishes to use the questionnaire is different from the population in the development phase. In this era of globalization one must also consider the effect of cultural differences in the interpretation of questions. The adaptation of existing questionnaires is an area that is currently being widely studied. As mentioned, it goes beyond translation and includes verifying that items are pertinent to the target population. RECOMMENDATIONS

Certain precautions should be taken to reduce bias or influence by others when using quality of life questionnaires in the clinical setting. 1) Questionnaires must be selfadministered by the patient. 2) Patients must be provided with a definite time frame regarding their answers. There is considerable debate about the most suitable time frame for quality of life questionnaires. Many questionnaires ask individuals to think about their symptoms in the previous month, which has been found to be reasonable in a clinical practice. However, Huisman et al found that a longer time frame inadvertently measures how a person feels or acts in general, thus, decreasing responsiveness.95 They recommended that patients should be instructed to refer to the last week to measure a specific situation. Even if we agree that 1 week may be the ideal, 4 weeks are definitively more commonly used and more suitable for repeat measures and followup. 3) The psychological effect of surgery must be considered. It has been shown that due to the release of anxiety and stress quality of life measurements immediately after surgery may be biased by feelings of enhanced well-being regardless of the effects of surgery.96 This finding is consistent with clinical observations. All surgeons can acknowledge that the results of urinary incontinence surgery cannot be assessed too soon after the surgical procedure. 4) Before incorporating an already validated quality of life questionnaire into a clinical routine the questionnaire must be pretested in a sample of approximately 20 patients. Any difficulties with practical and/or methodological issues related to this specific clinical situation would be identified and hopefully alleviated. 5) All patients must complete the questionnaires in the same setting. It may be done before the medical consultation, at home or via the mail. Whatever strategy is used must be consistent for all patients. In many clinical settings the most practical scenario is to have patients complete the questionnaires while they are waiting to see the physician. This scenario has the advantage of reducing physician influence on the patient response and ensuring completion of the questionnaires. 6) Patients completing questionnaires must not be assisted unless specially trained personnel are used. Well intentioned staff can induce inconsistent bias by offering personal explanations to questions. Therefore, staff should be instructed to

QUALITY OF LIFE ASSESSMENT IN MEN AND WOMEN WITH URINARY INCONTINENCE

limit the response to queries by patients with comments such as do the best you can or choose what you think is the best answer. CONCLUSIONS

This review does not aim to discuss all questionnaires presented in the literature, but rather to help the reader make a judicious choice among the many tools available. One can understand that, although there is still the need for refining existing measures, we hope that this review may encourage health professionals to use them and understand the scope of quality of life as it relates to urinary incontinence. It is also hoped that by being made aware of the rigorous psychometric evaluation involved in quality of life measures clinicians may use published and validated measures instead of developing more measures. Health professionals are presently in a process of change regarding their attitude toward quality of life. Most have developed a concern for the quality of life of their patients. Clinicians are now exposed to questionnaires that can measure the impact of an intervention on quality of life. The next step is the incorporation of these tools into routine patient assessment, so that we as clinicians are not only assessing symptoms, but also their impact on individual daily life. APPENDIX: GUIDELINES FOR EVALUATING A QUALITY OF LIFE QUESTIONNAIRE FOR CLINICAL USE

1. The number of items is adapted to clinical reality or completion time is adequate for your clinic. 2. The language is clear for your treatment population. 3. The translation (if necessary) was professionally done. Forward/backward translation Committee review Pretested with the target population Weighting of scores verified (if applicable) 4. Psychometric assessment has been reported. Reliability Internal consistency.22 Caution: Cronbach’s ␣ is influenced by the number of items in a questionnaire. Scale 0.1, poor—0.2, 0.3, 0.4, 0.5 and 0.6, moderate— 0.7, good—0.8 and excellent—0.9, and 1. Test-retest reliability. Generally accepted descriptors of the magnitude of correlation coefficients.97 Scale slight—0.1, low correlation—0.2 and 0.3, moderate— 0.4, 0.5 and 0.6, good to high—0.7 and 0.8, very high—0.9, and 1. Validity. Examine the type of validity reported and the strength of the correlations using the criteria proposed by Guilford.97 Scale moderate—content validity only, good—content validity and construct or criterion validity, and very good—content validity, and construct and criterion validity. Responsiveness. Descriptors of magnitude of effect size results according to Cohen.96 Scale 0.1, small—0.2, 0.3 and 0.4, moderate—0.5, 0.6 and 0.7, good/large— 0.8 and 0.9, and very good—1 or greater. REFERENCES

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