A randomized, controlled trial of team-based competition to increase learner participation in quality-improvement education.

OBJECTIVE: Several barriers challenge resident engagement in learning quality improvement (QI). We investigated whether the incorporation of team-based game mechanics into an evidence-based online learning platform could increase resident participation in a QI curriculum. DESIGN: Randomized, controlled trial. SETTING: Tertiary-care medical center residency training programs. PARTICIPANTS: Resident physicians (n = 422) from nine training programs (anesthesia, emergency medicine, family medicine, internal medicine, ophthalmology, orthopedics, pediatrics, psychiatry and general surgery) randomly allocated to a team competition environment (n = 200) or the control group (n = 222). INTERVENTION: Specialty-based team assignment with leaderboards to foster competition, and alias assignment to de-identify individual participants. MAIN OUTCOME MEASURES: Participation in online learning, as measured by percentage of questions attempted (primary outcome) and additional secondary measures of engagement (i.e. response time). Changes in participation measures over time between groups were assessed with a repeated measures ANOVA framework. RESULTS: Residents in the intervention arm demonstrated greater participation than the control group. The percentage of questions attempted at least once was greater in the competition group (79% [SD ± 32] versus control, 68% [SD ± 37], P= 0.03). Median response time was faster in the competition group (P= 0.006). Differences in participation continued to increase over the duration of the intervention, as measured by average response time and cumulative percent of questions attempted (each P< 0.001). CONCLUSIONS: Team competition increases resident participation in an online course delivering QI content. Medical educators should consider game mechanics to optimize participation when designing learning experiences.

Emergency physician perceptions of medically unnecessary advanced diagnostic imaging.

OBJECTIVES: The objective was to determine emergency physician (EP) perceptions regarding 1) the extent to which they order medically unnecessary advanced diagnostic imaging, 2) factors that contribute to this behavior, and 3) proposed solutions for curbing this practice. METHODS: As part of a larger study to engage physicians in the delivery of high-value health care, two multispecialty focus groups were conducted to explore the topic of decision-making around resource utilization, after which qualitative analysis was used to generate survey questions. The survey was extensively pilot-tested and refined for emergency medicine (EM) to focus on advanced diagnostic imaging (i.e., computed tomography [CT] or magnetic resonance imaging [MRI]). The survey was then administered to a national, purposive sample of EPs and EM trainees. Simple descriptive statistics to summarize physician responses are presented. RESULTS: In this study, 478 EPs were approached, of whom 435 (91%) completed the survey; 68% of respondents were board-certified, and roughly half worked in academic emergency departments (EDs). Over 85% of respondents believe too many diagnostic tests are ordered in their own EDs, and 97% said at least some (mean = 22%) of the advanced imaging studies they personally order are medically unnecessary. The main perceived contributors were fear of missing a low-probability diagnosis and fear of litigation. Solutions most commonly felt to be "extremely" or "very" helpful for reducing unnecessary imaging included malpractice reform (79%), increased patient involvement through education (70%) and shared decision-making (56%), feedback to physicians on test-ordering metrics (55%), and improved education of physicians on diagnostic testing (50%). CONCLUSIONS: Overordering of advanced imaging may be a systemic problem, as many EPs believe a substantial proportion of such studies, including some they personally order, are medically unnecessary. Respondents cited multiple complex factors with several potential high-yield solutions that must be addressed simultaneously to curb overimaging.

Emergency physician perceptions of shared decision-making.

OBJECTIVES: Despite the potential benefits of shared decision-making (SDM), its integration into emergency care is challenging. Emergency physician (EP) perceptions about the frequency with which they use SDM, its potential to reduce medically unnecessary diagnostic testing, and the barriers to employing SDM in the emergency department (ED) were investigated. METHODS: As part of a larger project examining beliefs on overtesting, questions were posed to EPs about SDM. Qualitative analysis of two multispecialty focus groups was done exploring decision-making around resource use to generate survey items. The survey was then pilot-tested and revised to focus on advanced diagnostic imaging and SDM. The final survey was administered to EPs recruited at four emergency medicine (EM) conferences and 15 ED group meetings. This report addresses responses regarding SDM. RESULTS: A purposive sample of 478 EPs from 29 states were approached, of whom 435 (91%) completed the survey. EPs estimated that, on average, multiple reasonable management options exist in over 50% of their patients and reported employing SDM with 58% of such patients. Respondents perceived SDM as a promising solution to reduce overtesting. However, despite existing research to the contrary, respondents also commonly cited beliefs that 1) "many patients prefer that the physician decides," 2) "when offered a choice, many patients opt for more aggressive care than they need," and 3) "it is too complicated for patients to know how to choose." CONCLUSIONS: Most surveyed EPs believe SDM is a potential high-yield solution to overtesting, but many perceive patient-related barriers to its successful implementation.

Urological chronic pelvic pain syndrome flares and their impact: qualitative analysis in the MAPP network.

INTRODUCTION AND HYPOTHESIS: Although in-depth qualitative information is critical to understanding patients' symptom experiences and to developing patient-centered outcome measures, only one previous qualitative study has assessed urological chronic pelvic pain syndrome (UCPPS) symptom exacerbations ("flares"). METHODS: We conducted eight focus groups of female UCPPS (interstitial cystitis/bladder pain syndrome) patients at four sites from the MAPP Research Network (n = 57, mean = 7/group) to explore the full spectrum of flares and their impact on patients' lives. RESULTS: Flare experiences were common and varied widely in terms of UCPPS symptoms involved, concurrent nonpelvic symptoms (e.g., diarrhea), symptom intensity (mild to severe), duration (minutes to years), and frequency (daily to < once/year), although the most commonly described flares were painful flares lasting days. These latter flares were also most disruptive to participants' lives, causing some to cancel social events, miss work or school, and in the worst cases, go to the emergency room or on disability leave. Participants also reported a longer-term impact of flares, including negative effects on their sexual functioning and marital, family, and social relationships; and the loss of employment or limited career or educational advancement. Emerging themes included the need for a sense of control over unpredictable symptoms and reduced social engagement. CONCLUSIONS: Given their negative impact, future research should focus on approaches to prevent flares, and to reduce their frequency, severity, and/or duration. Patients' quality of life may also be improved by providing them with a sense of control over their symptoms through ready access to flare medications/therapy, and by engaging them socially.

Sleep disturbances and nocturnal symptoms: relationships with quality of life in a population-based sample of women with interstitial cystitis/bladder pain syndrome.

STUDY OBJECTIVES: To characterize the nature and impact of sleep disturbances on quality of life (QOL) in women with interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: Participants were 3,397 women from a telephone probability survey who met IC/BPS symptom criteria. Sleep quality, duration, and IC/BPS nocturnal symptoms (i.e., trouble sleeping due to bladder pain, urgency, or needing to use the bathroom), general QOL (mental and physical health and sexual functioning), and IC/BPS QOL impairment were assessed via self-report during telephone interview. RESULTS: Over half of the sample reported poor sleep quality, sleep duration ≤ 6 hours, or trouble sleeping due to IC/BPS symptoms. After covariate adjustment, short sleep duration was significantly associated with greater IC/BPS QOL impairment (ß = -0.04; p < 0.001) and poorer self-reported physical health (ß = 1.86; p < 0.001). Poor sleep quality was significantly associated with greater IC/BPS QOL impairment (ß = 0.06; p < 0.001), poorer self-reported physical health (ß = -2.86; p < 0.001), and greater sexual dysfunction (ß = -0.04; p < 0.05). IC/BPS nocturnal symptoms were significantly associated with greater IC/BPS impairment (ß = 0.14; p < 0.001), poorer physical health (ß = -2.76; p < 0.001) and mental health (ß = 0.52; p < 0.01), and greater sexual dysfunction (ß = -0.10; p < 0.001), after covariate adjustment. After further adjustment for IC/BPS nocturnal symptoms, we found that poor sleep quality and short sleep duration were independent correlates of poor self-reported physical health. CONCLUSIONS: Poor sleep quality and short sleep duration, as well as disorder-specific sleep disturbances, are highly prevalent in women with IC/BPS and are associated with poorer disease-specific and general QOL.

Symptom persistence in a community cohort of women with interstitial cystitis/bladder pain syndrome (IC/BPS): 3-, 6-, 9-, and 12-month follow-up from the RICE cohort.

INTRODUCTION AND HYPOTHESIS: The persistence of interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms has been described in women seeking medical care. The purpose of this study was to determine whether symptoms persist among a population-based sample of women. METHODS: A probability sample of US women was identified through a two-stage telephone screening process using the Research and Development (RAND) Interstitial Cystitis Epidemiology (RICE) high-sensitivity case definition. A randomly selected subgroup (n = 508) was enrolled in a longitudinal study and interviewed about their symptoms at baseline, 3, 6, 9, and 12 months. Bivariate and multivariate linear regression analyses determined predictors of persistence of symptoms over the four waves. RESULTS: A total of 436 women with a mean age of 47.5 years responding to all waves were included in the analysis. Forty-one percent met the RICE high-sensitivity case definition at baseline and in all four waves; an additional 21 % met the definition at baseline and in three waves. Women with a college degree (+12 % vs. no college, p = 0.02) and who were younger (-5 % per decade of age, p < 0.01) had higher chances of symptom persistence at each wave. Scoring one standard deviation higher on the continuity of symptoms and the O'Leary-Sant Interstitial Cystitis Symptom index increased the chances of symptom persistence by 4 % and 2 %, respectively (both p < 0.01). CONCLUSIONS: The majority of women demonstrated symptom persistence across at least three of four waves over 12 months. These women tended to be younger, college-educated, and to have reported a history of greater continuity of symptoms and higher severity of symptoms at baseline.

Consequences of interstitial cystitis/bladder pain symptoms on women's work participation and income: results from a national household sample.

PURPOSE: We describe differences in work participation and income by bladder symptom impact and comorbidities among women with interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: Cross-sectional data from 2,767 respondents younger than 65 years identified with interstitial cystitis/bladder pain syndrome symptoms were analyzed. The data were taken from the RAND Interstitial Cystitis Epidemiology (RICE) survey, and included retrospective self-reports of interstitial cystitis/bladder pain syndrome impact, severity, years since onset, related comorbidities (depressive symptomatology, number of conditions), work participation and income, and personal characteristics. Multiple regressions predicted 5 current work outcomes of works now, kept from working by pain, missed work days, days worked when bothered by symptoms and real income change since symptom onset. RESULTS: Controlling for work status at symptom onset and personal characteristics, greater bladder symptom impact predicted a greater likelihood of not now working, kept more days from working by pain, missed more work days and working more days with symptoms. More depressive symptomatology and greater number of comorbidities predicted reduced work participation. Women experienced no growth in real income since symptom onset. Measures of symptom severity were not associated with any of the economic outcomes. CONCLUSIONS: Greater interstitial cystitis/bladder pain syndrome symptom impact, depressive symptomatology and count of comorbidities (but not symptom severity) were each associated with less work participation and leveling of women's long-term earnings. Management of bladder symptom impact on nonwork related activities and depressive symptomatology may improve women's work outcomes.

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities.

PURPOSE: To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores. RESULTS: Mean patient age was 45.1 (SD 15.9) years, and 83% of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: -8 points on the PCS (p < 0.001) and -6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores. CONCLUSIONS: In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.

The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study.

PURPOSE: As part of the RICE (RAND Interstitial Cystitis Epidemiology) study, we developed validated case definitions to identify interstitial cystitis/bladder pain syndrome in women and chronic prostatitis/chronic pelvic pain syndrome in men. Using population based screening methods, we applied these case definitions to determine the prevalence of these conditions in men. MATERIALS AND METHODS: A total of 6,072 households were contacted by telephone to screen for men who had symptoms of interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome. An initial 296 men screened positive, of whom 149 met the inclusionary criteria and completed the telephone interview. For interstitial cystitis/bladder pain syndrome 2 case definitions were applied (1 with high sensitivity and 1 with high specificity), while for chronic prostatitis/chronic pelvic pain syndrome a single case definition (with high sensitivity and specificity) was used. These case definitions were used to classify subjects into groups based on diagnosis. RESULTS: The interstitial cystitis/bladder pain syndrome weighted prevalence estimates for the high sensitivity and high specificity definitions were 4.2% (3.1-5.3) and 1.9% (1.1-2.7), respectively. The chronic prostatitis/chronic pelvic pain syndrome weighted prevalence estimate was 1.8% (0.9-2.7). These values equate to 1,986,972 (95% CI 966,042-2,996,924) men with chronic prostatitis/chronic pelvic pain syndrome and 2,107,727 (95% CI 1,240,485-2,974,969) men with the high specificity definition of interstitial cystitis/bladder pain syndrome in the United States. The overlap between men who met the high specificity interstitial cystitis/bladder pain syndrome case definition or the chronic prostatitis/chronic pelvic pain syndrome case definition was 17%. CONCLUSIONS: Symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome are widespread among men in the United States. The prevalence of interstitial cystitis/bladder pain syndrome symptoms in men approaches that in women, suggesting that this condition may be underdiagnosed in the male population.

Temporal ordering of interstitial cystitis/bladder pain syndrome and non-bladder conditions.

OBJECTIVE: To examine the prevalence and timing of nonbladder conditions in a community cohort of women with symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: As part of the Rand Interstitial Cystitis Epidemiology (RICE) study, we identified 3397 community women who met a validated case definition for IC/BPS symptoms. Each completed a survey asking if they had a physician diagnose them as having irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, migraines, panic attacks, or depression. If a positive response was received, subjects were asked to provide the age of symptom onset. All subjects were also asked to provide the date of IC/BPS symptom onset. RESULTS: A total of 2185 women reported a diagnosis of at least one of the nonbladder conditions. Onset of bladder symptoms was not consistently earlier or later than the onset of nonbladder symptoms. Depression tended to occur earlier (P < .05), whereas fibromyalgia generally occurred later (P < .05). Mean age of onset was lowest for migraine symptoms, depression symptoms, and panic attacks symptoms, and greatest for fibromyalgia and chronic fatigue syndrome symptoms. Mean age of irritable bowel syndrome and IC/BPS symptom onset was between these other conditions. CONCLUSION: These findings confirm the common co-occurrence of IC/BPS with chronic nonbladder conditions. In women with IC/BPS symptoms and coexistent nonbladder conditions, bladder symptoms do not uniformly predate the nonbladder symptoms. These observations suggest that phenotypic progression from isolated bladder symptoms to regional/systemic symptoms is not a predominant pattern in IC/BPS, although such a pattern may occur in a subset of individuals.

Suicidal ideation among patients with bladder pain syndrome/interstitial cystitis.

OBJECTIVE: To estimate the prevalence of suicidal ideation (SI) and compare respondents who endorsed SI with respondents who denied SI within a national probability sample of women with bladder pain syndrome or interstitial cystitis (BPS/IC). METHODS: Data were collected as part of the RAND Interstitial Cystitis Epidemiology (RICE) Study, which screened 146,246 US households to identify adult women who met BPS/IC symptom criteria. In addition to estimating SI prevalence, women with and without recent SI were compared based on demographics, depression symptoms, BPS/IC symptoms, functioning, and treatment. RESULTS: Of 1019 women with BPS/IC symptoms asked about SI, 11.0% (95% CI = 8.73-13.25) reported SI in the past 2 weeks. Those with SI were more likely to be younger, unemployed, unmarried, uninsured, less educated, and of lower income. Women who endorsed SI reported worse mental health functioning, physical health functioning, and BPS/IC symptoms. Women with SI were more likely to have received mental health treatment, but did not differ on whether they had received BPS/IC treatment. Multivariate logistic regression analyses indicated that severity of BPS/IC symptoms did not independently predict likelihood of endorsing SI. CONCLUSION: Results suggest that BPS/IC severity may not increase the likelihood of SI except via severity of depression symptoms. Additional work is needed to understand how to address the increased needs of women with both BPS/IC and SI.

Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study.

PURPOSE: The RAND Interstitial Cystitis Epidemiology survey estimated that 2.7% to 6.5% of United States women have urinary symptoms consistent with a diagnosis of interstitial cystitis/bladder pain syndrome. We describe the demographic and clinical characteristics of the symptomatic community based RAND Interstitial Cystitis Epidemiology cohort, and compare them with those of a clinically based interstitial cystitis/bladder pain syndrome cohort. MATERIALS AND METHODS: Subjects included 3,397 community women who met the criteria for the RAND Interstitial Cystitis Epidemiology high sensitivity case definition, and 277 women with an interstitial cystitis/bladder pain syndrome diagnosis recruited from specialist practices across the United States (clinical cohort). Questions focused on demographic information, symptom severity, quality of life indicators, concomitant diagnoses and treatment. RESULTS: Average symptom duration for both groups was approximately 14 years. Women in the clinical cohort reported worse baseline pain and maximum pain, although the absolute differences were small. Mean Interstitial Cystitis Symptom Index scores were approximately 11 for both groups, but mean Interstitial Cystitis Problem Index scores were 9.9 and 13.2 for the clinical cohort and the RAND Interstitial Cystitis Epidemiology cohort, respectively (p <0.001). The RAND Interstitial Cystitis Epidemiology subjects were more likely to be uninsured. CONCLUSIONS: The RAND Interstitial Cystitis Epidemiology community cohort was remarkably similar to an interstitial cystitis/bladder pain syndrome clinical cohort with respect to demographics, symptoms and quality of life measures. In contrast to other chronic pain conditions for which clinical cohorts typically report worse symptoms and functional status than population based samples, our data suggest that many measures of symptom severity and functional impact are similar, and sometimes worse, in the RAND Interstitial Cystitis Epidemiology cohort. These findings suggest that interstitial cystitis/bladder pain syndrome is significantly burdensome, and likely to be underdiagnosed and undertreated in the United States.

Validation of a quality-of-life scale for women with bladder pain syndrome/interstitial cystitis.

PURPOSE: To validate a disease-specific scale to measure the impact of symptoms of bladder pain syndrome/interstitial cystitis (BPS/IC), a condition that affects up to 6.5% of U.S. women. METHODS: Participants were drawn from the RAND Interstitial Cystitis Epidemiology (RICE) Study, a telephone probability survey of 146,231 US households. Women who met RICE BPS/IC symptom criteria (n = 3,397) completed the 6-item RAND Bladder Symptom Impact scale (RICE BSI-6). The RICE BSI-6 was adapted from a scale used to assess the impact of diabetes on life and sexuality and modified based on expert input on face validity and focus group work; items specific to diabetic symptoms were eliminated. Validated scales of symptom severity, mental- and physical-health-related quality of life (QoL), depression, coping, and perceived control were used to assess convergent validity. RESULTS: The RICE BSI-6 (α = 0.92) was significantly related to greater symptom severity, worse general mental- and physical-health-related QoL, more severe depression symptoms, and lower perceived control over life in general and over BPS/IC symptoms (P values < .05). It was also associated with less use of distancing coping (P < .05). CONCLUSION: The RICE BSI-6 shows excellent internal consistency and strong convergent validity. It can be used to examine the effects of psychosocial and treatment interventions on QoL among women with BPS/IC.

Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States.

PURPOSE: Bladder pain syndrome/interstitial cystitis is a poorly understood condition that can cause serious disability. We provide the first population based symptom prevalence estimate to our knowledge among United States adult females. MATERIALS AND METHODS: We developed and validated 2 case definitions to identify bladder pain syndrome/interstitial cystitis symptoms. Beginning in August 2007 we telephoned United States households, seeking adult women with bladder symptoms or a bladder pain syndrome/interstitial cystitis diagnosis. Second stage screening identified those subjects who met case definition criteria. Each completed a 60-minute interview on the severity and impact of bladder symptoms, health care seeking and demographics. Data collection ended in April 2009. Using population and nonresponse weights we calculated prevalence estimates based on definitions spanning a range of sensitivity and specificity. We used United States Census counts to estimate the number of affected women in 2006. The random sample included 146,231 households, of which 131,691 included an adult female. Of these households 32,474 reported an adult female with bladder symptoms or diagnosis, of which 12,752 completed the questionnaire. RESULTS: Based on the high sensitivity definition 6.53% (95% CI 6.28, 6.79) of women met symptom criteria. Based on the high specificity definition 2.70% (95% CI 2.53, 2.86) of women met the criteria. These percentages translated into 3.3 to 7.9 million United States women 18 years old or older with bladder pain syndrome/interstitial cystitis symptoms. Symptom severity and impact were comparable to those of adult women with established diagnoses. However, only 9.7% of the women reported being assigned a bladder pain syndrome/interstitial cystitis diagnosis. CONCLUSIONS: Bladder pain syndrome/interstitial cystitis symptoms are widespread among United States women and associated with considerable disability. These results suggest bladder pain syndrome/interstitial cystitis may be underdiagnosed.

Depressive disorders and panic attacks in women with bladder pain syndrome/interstitial cystitis: a population-based sample.

OBJECTIVE: We report the population prevalence of probable depressive disorders and current panic attacks in women with bladder pain syndrome/interstitial cystitis (BPS/IC) symptoms and describe their characteristics and access care. METHOD: We conducted a telephone screening of 146,231 households and telephone interviews with women with BPS/IC symptoms. A weighted probability sample of 1469 women who met the criteria for BPS/IC was identified. Measures of BPS/IC severity, depressive symptoms, panic attacks and treatment utilization were administered. T and χ(2) tests were used to examine differences between groups. RESULTS: Over one third of the sample (n=536) had a probable diagnosis of depression, and 52% (n=776) reported recent panic attacks. Women with a probable diagnosis of depression or current panic attacks reported worse functioning and increased pain and were less likely to work because of bladder pain. CONCLUSIONS: In this community-based sample, rates of probable current depression and panic attacks are high, and there is considerable unmet need for treatment. These findings suggest that clinicians should be alert to complaints of bladder pain in patients seeking treatment for depressive or anxiety disorders and to complaints of emotional or personal problems in patients seeking treatment for painful bladder symptoms.

Perceptions of "urgency" in women with interstitial cystitis/bladder pain syndrome or overactive bladder.

PURPOSE: To compare urgency symptoms in women with interstitial cystitis/bladder pain syndrome (IC/BPS) and overactive bladder (OAB). MATERIALS AND METHODS: Women with diagnoses of IC/BPS (n=194) and OAB (n=85) were recruited from the clinical practices of Urologists (n=8) and Gynecologists (n=16) with recognized expertise in the diagnosis and management of these conditions. Subjects completed a comprehensive telephone survey about their current symptoms. The questionnaire included 11 questions about urinary urgency. Responses were compared between the two groups. RESULTS: Urgency was commonly reported as a symptom by women with both conditions (81% IC/BPS and 91% OAB). Compared with IC/BPS, urgency in OAB more often resulted in leakage, and was perceived to be more of a problem. In IC/BPS, the urgency was primarily reported as due to pain, pressure, or discomfort, while in OAB the urgency was more commonly due to fear of leakage. However, approximately 40% of women with OAB also report urgency due to pain, pressure, or discomfort. Similar proportions of both groups (∼ 60%) indicated that the urgency occurred "suddenly" instead of more gradually over a period of minutes or hours. CONCLUSIONS: Urgency symptoms differed in women diagnosed with IC/BPS versus those diagnosed with OAB, but there was significant overlap. This suggests that "urgency" is not a well-defined and commonly understood symptom that can be utilized to clearly discriminate between IC/BPS and OAB. These findings reinforce the clinical observation that it is often challenging to differentiate between these two conditions.

Prevalence and correlates of sexual dysfunction among women with bladder pain syndrome/interstitial cystitis.

OBJECTIVES: To examine the prevalence and correlates of general and bladder pain syndrome/interstitial cystitis (BPS/IC)-specific sexual dysfunction among women in the RAND Interstitial Cystitis Epidemiology study using a probability sample survey of U.S. households. Sexual dysfunction can contribute to a reduced quality of life for women with bladder pain syndrome/interstitial cystitis (BPS/IC). METHODS: We telephoned 146,231 households to identify women who reported bladder symptoms or a BPS/IC diagnosis. Those who reported either underwent a second-stage screening using the RAND Interstitial Cystitis Epidemiology study high-specificity symptom criteria. The criteria were pain, pressure, or discomfort in pelvic area; daytime urinary frequency ≥10 times or urgency due to pain, pressure, or discomfort (not fear of wetting); pain that worsened as the bladder filled; bladder symptoms did not resolve after antibiotic treatment; and patients never treated with hormone injections for endometriosis. Women who met the RAND Interstitial Cystitis Epidemiology criteria (n = 1469) completed measures of BPS/IC-specific and general sexual dysfunction symptoms, bladder symptom severity, general physical health, depression, medical care-seeking, and sociodemographic characteristics. RESULTS: Of those with a current sexual partner (75%), 88% reported ≥1 general sexual dysfunction symptom and 90% reported ≥1 BPS/IC-specific sexual dysfunction symptom in the past 4 weeks. In the multivariate models, BPS/IC-specific sexual dysfunction was significantly associated with more severe BPS/IC symptoms, younger age, worse depression symptoms, and worse perceived general health. Multivariate correlates of general sexual dysfunction included non-Latino race/ethnicity, being married, and having depression symptoms. CONCLUSIONS: The results of our study have shown that women with BPS/IC symptoms experience very high levels of sexual dysfunction. Also, sexual dysfunction covaries with symptoms.

Development, validation and testing of an epidemiological case definition of interstitial cystitis/painful bladder syndrome.

PURPOSE: No standard case definition exists for interstitial cystitis/painful bladder syndrome for patient screening or epidemiological studies. As part of the RAND Interstitial Cystitis Epidemiology study, we developed a case definition for interstitial cystitis/painful bladder syndrome with known sensitivity and specificity. We compared this definition with others used in interstitial cystitis/painful bladder syndrome epidemiological studies. MATERIALS AND METHODS: We reviewed the literature and performed a structured, expert panel process to arrive at an interstitial cystitis/painful bladder syndrome case definition. We developed a questionnaire to assess interstitial cystitis/painful bladder syndrome symptoms using this case definition and others used in the literature. We administered the questionnaire to 599 women with interstitial cystitis/painful bladder syndrome, overactive bladder, endometriosis or vulvodynia. The sensitivity and specificity of each definition was calculated using physician assigned diagnoses as the reference standard. RESULTS: No single epidemiological definition had high sensitivity and high specificity. Thus, 2 definitions were developed. One had high sensitivity (81%) and low specificity (54%), and the other had the converse (48% sensitivity and 83% specificity). These values were comparable or superior to those of other epidemiological definitions used in interstitial cystitis/painful bladder syndrome prevalence studies. CONCLUSIONS: No single case definition of interstitial cystitis/painful bladder syndrome provides high sensitivity and high specificity to identify the condition. For prevalence studies of interstitial cystitis/painful bladder syndrome the best approach may be to use 2 definitions that would yield a prevalence range. The RAND Interstitial Cystitis Epidemiology interstitial cystitis/painful bladder syndrome case definitions, developed through structured consensus and validation, can be used for this purpose.

Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review.

PURPOSE: In women symptoms of interstitial cystitis are difficult to distinguish from those of painful bladder syndrome and they appear to overlap with those of urinary tract infection, chronic urethral syndrome, overactive bladder, vulvodynia and endometriosis. This has led to difficulties in formulating a case definition for interstitial cystitis, and complications in the treatment and evaluation of its impact on the lives of women. We performed a systematic literature review to determine how best to distinguish interstitial cystitis from related conditions. MATERIALS AND METHODS: We performed comprehensive literature searches using the terms diagnosis, and each of interstitial cystitis, painful bladder syndrome, urinary tract infection, overactive bladder, chronic urethral syndrome, vulvodynia and endometriosis. RESULTS: Of 2,680 screened titles 604 articles were read in full. The most commonly reported interstitial cystitis symptoms were bladder/pelvic pain, urgency, frequency and nocturia. Interstitial cystitis and painful bladder syndrome share the same cluster of symptoms. Chronic urethral syndrome is an outdated term. Self-reports regarding symptoms and effective antibiotic use can distinguish recurrent urinary tract infections from interstitial cystitis in some but not all women. Urine cultures may also be necessary. Pain distinguishes interstitial cystitis from overactive bladder and vulvar pain may distinguish vulvodynia from interstitial cystitis. Dysmenorrhea distinguishes endometriosis from interstitial cystitis, although many women have endometriosis plus interstitial cystitis. CONCLUSIONS: In terms of symptoms interstitial cystitis and painful bladder syndrome may be the same entity. Recurrent urinary tract infections may be distinguished from interstitial cystitis and painful bladder syndrome via a combination of self-report and urine culture information. Interstitial cystitis and painful bladder syndrome may be distinguished from overactive bladder, vulvodynia and endometriosis, although identifying interstitial cystitis and painful bladder syndrome in women with more than 1 of these diseases may be difficult.

Incremental treatment costs in national cancer institute-sponsored clinical trials.

CONTEXT: Concern about additional costs for direct patient care impedes efforts to enroll patients in clinical trials. But generalizable evidence substantiating these concerns is lacking. OBJECTIVE: To assess the additional cost of treating cancer patients in the National Cancer Institute (NCI)-sponsored clinical trials in the United States across a range of trial phases, treatment modalities, and patient care settings. DESIGN: Retrospective cost study using a multistage, stratified, random sample of patients enrolled in 1 of 35 active phase 3 trials or phase 1 or any phase 2 trials between October 1, 1998, and December 31, 1999. Unadjusted and adjusted costs were compared and related to trial phase, institution type, and vital status. SETTING AND PARTICIPANTS: A representative sample of 932 cancer patients enrolled in nonpediatric, NCI-sponsored clinical trials and 696 nonparticipants with a similar stage of disease not enrolled in a research protocol from 83 cancer clinical research institutions across the United States. MAIN OUTCOME MEASURES: Direct treatment costs as measured using a combination of medical records, telephone survey, and Medicare claims data. Administrative and other research costs were excluded. RESULTS: The incremental costs of direct care in trials were modest. Over approximately a 2.5-year period, adjusted costs were 6.5% higher for trial participants than nonparticipants (35,418 dollars vs 33,248 dollars; P =.11). Cost differences for phase 3 studies were 3.5% (P =.22), lower than for phase 1 or 2 trials (12.8%; P =.20). Trial participants who died had higher costs than nonparticipants who died (17.9%; 39,420 dollars vs 33,432 dollars, respectively; P =.15). CONCLUSIONS: Treatment costs for nonpediatric clinical trial participants are on average 6.5% higher than what they would be if patients did not enroll. This implies total incremental treatment costs for NCI-sponsored trials of 16 million dollars in 1999. Incremental costs were higher for patients who died and who were in early phase studies although these findings deserve further scrutiny. Overall, the additional treatment costs of an open reimbursement policy for government-sponsored cancer clinical trials appear minimal.