Mary Kay Margolis

Validation of an overactive bladder awareness tool for use in primary care settings.

Overactive bladder (OAB)—a syndrome characterized by urinary urgency, with or without urge incontinence, urinary frequency and nocturia—is estimated to affect 10% to 20% of the US and European populations. This study was carried out to validate a patient-administered screening awareness tool to identify patients with bothersome OAB symptoms. Patients were recruited from 12 primary care and 1 gynecology practice during regularly scheduled appointments. Enrollees completed an 8-item questionnaire assessing the amount of “bother” they associated with OAB symptoms. Clinicians then asked the patients 4 questions regarding urinary frequency, urgency, nocturia, and incontinence. If the screening was positive for symptoms of OAB or if the patient provided positive responses to the urinary symptom questions, the clinician asked additional questions regarding lifestyle and coping behaviors. The clinician then diagnosed the patient, placing him or her in the “No OAB,” “Possible OAB,” or “Probable OAB” category. Multivariable logistic regressions controlling for age and sex were performed to assess the applicability of the tool for identifying patients with OAB. A total of 1299 patients were enrolled, and 1260 provided complete data. Patients were aged 51.6±17.0 years, 62% were female, most (89%) were Caucasian, 22% experienced urinary urgency, and 18% experienced urge incontinence. The prevalence of Probable OAB was 12%. The c-index of the model identifying patients with a diagnosis of Probable OAB was 0.96, with a sensitivity and specificity of 98.0 and 82.7. For OAB-V8 scores ≥8, the odds ratio for Probable OAB was 95.7 (95% Cl: 29.3; 312.4). The OAB-V8 performed well in helping clinicians identify patients with bothersome OAB symptoms in a primary care setting and will assist clinicians in identifying patients who may benefit from treatment.

Vision-Specific Instruments for the Assessment of Health-Related Quality of Life and Visual Functioning: A Literature Review

Clinically objective measures such as visual acuity or visual field provide an assessment of a patient’s visual status. However such measures may not reflect the degree of visual impairment the patient experiences in his or her daily activities. Visual impairment has been shown to have negative effects on health-related quality of life (HR-QOL) and a significant impact on daily functioning, including social activities. As such, there is a growing recognition of the importance of patient-reported outcomes of visual functioning.This review examines the development and psychometric properties of 22 vision-specific instruments assessing visual functioning and/or the impact of visual impairment on HR-QOL or daily activities. Issues relevant to assessing vision-specific subjective outcomes are reviewed, with specific application of the reviewed instruments.Three instruments, the Activities of Daily Vision Scale, National Eye Institute Visual Function Questionnaire, and Visual Function Index have been well validated and widely used, but others also show promise. To fully capture the benefits of a new ophthalmology treatment (or new treatment for eye disease) a valid and reliable visual instrument, in which the psychometric performance has been demonstrated in the particular ocular condition being treated, should be utilised.

ORIGINAL RESEARCH—OUTCOMES ASSESSMENT: Overactive Bladder and Women's Sexual Health: What is the Impact?

INTRODUCTION Overactive bladder (OAB) is quite prevalent and significantly affects health-related quality of life and daily functioning. AIM The impact of OAB on sexual health is currently not known. This qualitative study was conducted to gain a thorough understanding of OABs impact. METHODS Sexually active women with continent or incontinent OAB were recruited from urology and urogynecology clinics. Six focus groups of women (three continent and three incontinent) were conducted to assess the sexual health of women with OAB. Data were analyzed descriptively and qualitatively. MAIN OUTCOME MEASURES Qualitative data, Sexual Quality of Life Questionnaire-Female, Overactive Bladder Questionnaire. RESULTS Thirty-four women (11 continent; 23 incontinent) participated; mean age was 48.4 years; 76% were white, 67% postmenopausal, and 88% in a long-term relationship. Continent women reported more frequent sexual activity than incontinent women; 91% reported intercourse >or=1-3 times per month vs. 50% of incontinent women. Half of the incontinent women reported a reduction in sexual desire related to OAB, aging, and menopause. Over half of continent women experienced pain with intercourse, and the majority complained of having to interrupt intercourse to void. Although not all incontinent women reported incontinence during intercourse, the majority were embarrassed by their incontinence and OAB with resulting loss of self-image. Both continent and incontinent women reported difficulty achieving orgasm because of pain, fear of incontinence, or anxiety related to intercourse. Approximately a third of the women would not initiate discussion of sexual issues with their physicians, but all women expressed concern about the impact of OAB on their sexual life. CONCLUSION Overactive bladder with or without incontinence negatively affects womens sexual health, reducing sexual desire and ability to achieve orgasm. Given the impact of OAB on sexual health, sexual health should be routinely assessed by clinicians and addressed by researchers.

Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in Age-Related Macular Degeneration

PURPOSE Patient-reported measures of visual function are increasingly incorporated into clinical trials of new treatments for age-related macular degeneration (AMD). Limited information is available regarding the associations between distance visual acuity (VA), reading speed, or contrast sensitivity and the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscales judged relevant to these measures. This studys objective was to evaluate such associations along with questions on restricted activity days. METHODS This cross-sectional study was conducted in patients with clinical diagnoses of neovascular AMD. Patient-reported outcome measures included the NEI VFQ-25 and restricted activity days. Clinical assessments included best-corrected visual acuity (BCVA), reading speed, and contrast sensitivity. The better-seeing eye was defined based on the BCVA of each patient. Psychometric properties of the NEI VFQ-25 were examined; analyses a priori focused on the Near Activities, Distance Activities, and Vision-Specific Dependency subscales. RESULTS The final study group included 92 participants (mean age, 78 years). Cronbachs α for the subscales ranged from 0.67 to 0.92. The NEI VFQ-25 overall composite, Near Activities, Distance Activities, and Vision-Specific Dependency scores were correlated with BCVA (r = -0.48 to -0.54, all P < 0.0001), reading speed (r = 0.43 to 0.56, all P < 0.0001), and contrast sensitivity (r = -0.39 to -0.46, all P < 0.001) of the better-seeing eye and with restricted activity days (r = -0.52 to -0.55, all P < 0.0001). CONCLUSIONS This study provides additional evidence supporting the validity of the NEI VFQ-25 in neovascular AMD patients by demonstrating correlations with a spectrum of vision measurements and a daily function measure.

Using GI-specific patient outcome measures in renal transplant patients: Validation of the GSRS and GIQLI

Introduction: Gastrointestinal (GI) side-effects occur frequently as a result of immunosuppressant regimens used in renal transplant patients. Little effort has been made to quantify the impact of these side-effects on patients’ health-related quality of life and symptom severity. Objective: To assess the psychometric characteristics of two GI-specific outcome instruments (the Gastrointestinal Rating Scale (GSRS) and the Gastrointestinal Quality of Life Index (GIQLI)) for use in post-renal transplant patients. Methods: Cross-sectional study conducted at 5 clinical centers in 4 countries. Patients were required to be on mycophenolate mofetil and a calcineurin inhibitor. Patients completed the GSRS, GIQLI and two generic instruments (the Psychological General Well-Being Index and the EQ-5D) at one timepoint. Reliability, construct and known groups validity were assessed. Results: In general the GSRS and the GIQLI demonstrated Cronbach’s alphas higher than 0.70. The GIQLI was moderately to highly correlated with the PGWB and EQ-5D. Correlations among the GSRS and generic instruments were slightly lower. The GSRS and GIQLI both distinguished between patients with and without GI complaints (all p<0.05). Conclusions: The GSRS and the GIQLI are appropriate for use in a post-renal transplant population. Scores on both instruments demonstrated significant differences between renal transplant patients with GI complications and without GI complications.

Evaluating the Impact of Overactive Bladder on Sexual Health in Women: What Is Relevant?

INTRODUCTION To assess sexual health, relevant, valid, and reliable questionnaires need to be used. AIM To assess the relevance and content validity of three sexual health questionnaires in women with overactive bladder (OAB) and urinary incontinence. MAIN OUTCOME MEASURES Sexual Quality of Life Questionnaire--Female (SQoL-F), Sexual Function Questionnaire (SFQ), and Pelvic Organ Prolapse-Incontinence Sexual Function Questionnaire (PISQ). METHODS Women with OAB and urinary incontinence were recruited from five urology clinics in the United States; those who were interested in participating were mailed questionnaire packets with instructions. Each questionnaire item was followed by three questions regarding the understandability, relevance, and impact of bladder condition when responding to the question. Patients returned the completed questionnaires by mail; clinical information was obtained from chart review. RESULTS A total of 129 patients (74% response) returned the questionnaires. The mean age was 56 years; 78% were white; 64% were married. In this sample, 64% had urge incontinence; 32% had mixed incontinence; and 4% had stress incontinence. Participants experienced bladder symptoms for a mean of 12.2 years with the following treatments: surgery (43%), bladder training (26%), exercise/biofeedback (42%), and medications (67%). SQoL-F items were understood by more than 97% of the respondents, more than 89% for SFQ, and more than 82% for PISQ. There were two SQoL-F items, one SFQ item, and 11 PISQ items that less than 60% of the respondents deemed relevant to their bladder condition. Correlations among questionnaire items and relevance to bladder condition ranged from 0.04 to 0.64 for the SQoL-F, 0.04 to 0.47 for the SFQ, and 0.01 to 0.58 for the PISQ. CONCLUSION Women with OAB found the majority of items on all three questionnaires to be relevant to their bladder condition. Of these questionnaires, the SQoL-F had the highest understandability, fewest questions considered irrelevant, and correlated well with OAB symptoms.

An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system

ABSTRACT Background: The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patients health-related quality of life (HRQoL) is less well known. Objective: To evaluate HRQoL outcomes in CLBP patients treated with transdermal fentanyl. Research design and methods: An observational study was conducted at 17 clinical centers in the US. Eligible patients had CLBP diagnosis for at least 3 months and were taking short-acting opioids chronically, and then initiated transdermal fentanyl treatment. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF‐36 Health Survey, at baseline and ≥ 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing CLBP patients’ SF‐36 scores to the general US population and low back pain patient norms. HRQoL outcomes were determined by comparing baseline and follow-up TOPS and SF‐36 scores. Additionally, HRQoL outcomes were evaluated across patient groups stratified by changes in pain intensity ratings as measured by an 11-point numerical rating scale. Results: At baseline CLBP patients (N = 131) scored one-to-two standard deviations (SD) below age and gender adjusted SF‐36 general population norms (MANOVA F = 127.1, p < 0.0001) and significantly lower than low back pain norms (MANOVA F = 125.3, p < 0.0001). At follow-up, significant improvement ( p < 0.05) was observed on six of the SF‐36 scales and both SF‐36 summary measures and five of the six TOPS pain-related scales. The magnitude of change in scores in effect size units among these scales ranged from 0.17 to 0.80, which are considered small to large effect size changes. HRQoL score improvement was greatest among patients experiencing the greatest pain relief. Conclusion: CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden. Favorable HRQoL outcomes were observed among patients who reported pain relief.

Content Validity of the Female Sexual Function Index (FSFI) in Pre‐ and Postmenopausal Women with Hypoactive Sexual Desire Disorder

INTRODUCTION The Female Sexual Function Index (FSFI) has consistently been shown to have discriminant validity, test-retest reliability, and internal consistency as a measure of female sexual function. However, the content validity (relevance, clarity, comprehensiveness) of the instrument in women with hypoactive sexual desire disorder (HSDD) must also be established. AIM The aim of this study were to assess the content validity of the FSFI, specifically the FSFI desire domain, in pre- and postmenopausal women with HSDD. METHODS Two single-visit content validation studies were conducted in the United States. Eligible premenopausal (both studies) and postmenopausal (second study only) women with HSDD completed the FSFI followed by one-on-one, face-to-face cognitive debriefing interviews including open-ended questions to capture information on their perceptions of the instrument. Information on womens experiences of decreased sexual desire was also captured. MAIN OUTCOME MEASURES The main outcome measures of this study were the womens ratings of the clarity, ease of understanding, comprehensiveness, and relevance of the 19 items of the FSFI. RESULTS Interviews with 15 premenopausal women (first study), and 30 pre- and 31 postmenopausal women (second study), were analyzed. Across the whole sample, most women (80-100%) found every item of the FSFI clear and easy to understand. The majority (53-70%) felt that the FSFI captured all their feelings about decreased sexual desire and other sexual problems, and most (84-90%) indicated that additional questions were unnecessary. Most women in both studies (93-100%) reported that the two items comprising the FSFI desire domain were clear, easy to understand, and were relevant to them. The majority of women thought that a recall period of ≥7 days is most relevant for recall of their sexual desire. CONCLUSIONS These studies establish the content validity of the FSFI in pre- and postmenopausal women with HSDD, supporting the use of this instrument as a measure of sexual function in women with this condition.

Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time

PURPOSE Estimate rate of laxative inadequate response (LIR) over time among patients with chronic noncancer pain with opioid-induced constipation (OIC). METHODS A prospective longitudinal study was conducted in United States, Canada, Germany, and United Kingdom. Patients on opioid therapy for ≥4 weeks for chronic noncancer pain and OIC completed an Internet-based survey at Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24. 1xLIR was defined as sufficient laxative use (≥1 laxative ≥ 4 times in past 2 weeks) and inadequate response (<3 bowel movements or ≥ 1 constipation symptom rated Moderate or greater). 2xLIR was sufficient laxative use of ≥2 laxatives from different drug classes and inadequate response. Descriptive statistics and logistic regressions were performed. RESULTS 489 patients (62% female; 85% white) completed Baseline; 27% reported no laxative use; 25% had insufficient laxative use; 48% had sufficient laxative use. During follow-up, 21-28% of patients had no or insufficient laxative use. Prevalence of 1xLIR was 93% at Baseline and ranged from 59-81% across follow-up; 26% met criteria for 2xLIR (follow-up range: 11-20%). CONCLUSIONS OIC among noncancer pain patients is a persistent and significant condition with varying utilization and response to laxatives thus increasing the ongoing burden of chronic pain.

Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment

BACKGROUND Patient-reported outcomes assessment enhances the understanding of disease impact in a range of disorders. At mild levels of cognitive impairment the patient perspective on functioning, behavior and symptoms can be particularly valuable for syndrome characterization when clinical and neuropsychological findings are limited. We have evaluated the psychometric performance of the 55-item Patient-Reported Outcomes in Cognitive Impairment (PROCOG), a new patient-reported measure, to measure mild to moderate cognitive impairment symptoms and their impact from the perspective of patients with dementia of the Alzheimers type (DAT) and mild cognitive impairment (MCI). METHODS The sample of 75 DAT patients, 78 MCI patients and 33 cognitively intact control subjects (> 64 years) was recruited through medical centers in the U.SA. Validity was assessed through correlation to the Quality of Life--Alzheimers Disease (QOL-AD) and Centers for Epidemiologic Studies--Depression Scale (CES-D) and neuropsychological assessments (WAIS subscales and MMSE). RESULTS PROCOG scores for MCI patients were generally intermediate between DAT and control subjects. Internal consistency and test-retest reliability were acceptable. Correlations with the CES-D and QOL-AD were in the moderate to high range; correlations with the neuropsychological measures were low to moderate. CONCLUSIONS The PROCOG demonstrated good to excellent psychometric properties among a sample of older adults with MCI and DAT as well as cognitively intact older adult control subjects and provides a method for collecting unique information on the patient experience of cognitive impairment. Subscales permit focused evaluation of domains relevant to the patients experience of cognitive impairment.