Bladder Cancer Survivors Who Do Not Smoke Have Better Longitudinal Health-Related Quality of Life Measures: An Assessment of the Comparative Effectiveness and Survivorship Health in Bladder Cancer (CEASE-BC) Study.

PURPOSE: Cigarette smoking is the most common risk factor for the development of bladder cancer (BC), yet there is a paucity of data characterizing the relationship between smoking status and longitudinal health-related quality of life (HRQoL) outcomes in patients with BC. We examined the association between smoking status and HRQoL among patients with BC. MATERIALS AND METHODS: Data were sourced from a prospective, longitudinal study open between 2014 and 2017, which examined HRQoL in patients aged ≥ 18 years old diagnosed with BC across North Carolina. The QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core instrument) was administered at 3, 12, and 24 months after BC diagnosis. Our primary exposure of interest was current smoking status. Linear regression using generalized estimating equations was used to analyze the relationship between smoking status and various domains of the QLQ-C30. RESULTS: A total of 154 patients enrolled in the study. Eighteen percent were classified as smoking at 3 months from diagnosis, and packs per day ranged from < 0.5 to 2. When controlling for time from diagnosis, demographic covariates, cancer stage, and treatment type, mean differences for physical function (7.4), emotional function (5.6), and fatigue measures (-8.2) were significantly better for patients with BC who did not smoke. CONCLUSIONS: Patients with BC who do not smoke have significantly better HRQoL scores in the domains of physical function, emotional function, and fatigue. These results underscore the need to treat smoking as an essential component of BC care.

Longitudinal impact of bladder cancer diagnosis on common psychiatric disorders.

BACKGROUND: The presence of psychiatric disorders in patients with cancer is associated with increased morbidity and poorer outcomes. We sought to determine the impact of a new bladder cancer diagnosis on the incidence of depression and anxiety. METHODS: We used a database of billing claims (MarketScan®) to identify patients newly diagnosed with bladder cancer between 2009 and 2018. Patients with preexisting psychiatric disorders or use of anxiolytics/antidepressants were excluded. We matched cases to patients without a bladder cancer or psychiatric diagnosis. Our primary outcome was a new diagnosis of depression, anxiety, or use of anxiolytics/antidepressants. Other exposures of interest included gender and treatment received. We used multivariable regression to estimate odds ratios for these exposures. RESULTS: We identified 65,846 cases with a new diagnosis of bladder cancer (31,367 privately insured; 34,479 Medicare-eligible). Compared to controls, bladder cancer patients were more likely to develop new-onset depression/anxiety at 6 months (privately insured: 6.9% vs. 3.4%, p < 0.001; Medicare-eligible: 5.7% vs. 3.4%, p < 0.001) and 36 months (privately insured: 19.2% vs. 13.5%, p < 0.001; Medicare-eligible: 19.3% vs. 16.0%, p < 0.001). Women (vs. men, privately insured: OR 1.65, 95%CI 1.53-1.78; Medicare-eligible: OR 1.63, 95%CI 1.50-1.76) and those receiving cystectomy and chemotherapy (vs. no treatment, privately insured: OR 4.94, 95%CI 4.13-5.90; Medicare-eligible: OR 2.35, 95%CI 1.88-2.94) were more likely to develop significant depression/anxiety. CONCLUSION: A new diagnosis of bladder cancer was associated with increased burden of significant depression/anxiety compared with matched controls. Women and patients receiving more radical treatments had higher rates of depression and anxiety.

Self-perceived burden and its associations with health-related quality of life among urologic cancer patients.

OBJECTIVE: This study examined the prevalence of self-perceived burden (SPB) and its association with health-related quality of life (HRQoL) among urologic cancer patients. METHODS: This was a prospective, cross-sectional study. A total of 429 respondents diagnosed with urologic cancers (prostate, bladder and renal cancer) from Sarawak General Hospital and Subang Jaya Medical Centre in Malaysia were interviewed by using a structured questionnaire. SPB and HRQoL were measured by the Self-perceived Burden Scale and the Functional Assessment of Cancer Therapy-General 7 Item Scale respectively. RESULTS AND CONCLUSION: Self-perceived burden was experienced by 73.2% of the respondents. Respondents who had a lower education level, a monthly household income

The effect of multiple recruitment contacts on response rates and patterns of missing data in a survey of bladder cancer survivors 6 months after cystectomy.

PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.

Assessment of the use of the Internet and social media among people with bladder cancer and their carers, and the quality of available patient-centric online resources: a systematic review.

OBJECTIVE: To conduct a systematic synthesis of the literature evaluating the use of the Internet and social media by people with bladder cancer (BCa) and their carers, and to synthesize the evidence on the quality of available online resources for patients with BCa. METHODS: We selected studies published between January 2000 and September 2018, written in the English language and meeting the inclusion criteria. Data sources included PubMed, PsycINFO, EMBASE, Web of Science and Scopus. RESULTS: A total of 15 studies were included in the review. Four studies explored patterns of Internet use among patients with BCa, five studies investigated social media use related to BCa and six studies evaluated the quality of online resources available for patients with BCa. Evidence in all these three dimensions was limited in its ability to establish rigorously if use of the Internet, social media and online resources for BCa is effective in improving the care outcomes for patients with BCa. CONCLUSION: Our review emphasizes the forgotten status of BCa by establishing that, despite its high global incidence, it remains underrepresented in the building of evidence on patient information needs and the possible role of online spaces. Our synthesis establishes that further research is needed to examine the full impact of online information and social media use on the health management of people with BCa.

Assessment of quality of life, information, and supportive care needs in patients with muscle and non-muscle invasive bladder cancer across the illness trajectory.

BACKGROUND: To date, little research has examined the quality of life and cancer-associated needs of bladder cancer patients. The objective of the current study was to assess the quality of life (QoL), informational needs, and supportive care needs (SCN) in a large sample of muscle invasive (MIBC) and non-muscle invasive (NMIBC) bladder cancer survivors across the treatment trajectory (newly diagnosed and undergoing treatment, post-treatment follow-up, and treatment for advanced/recurrent disease). METHODS: Questionnaires were distributed to a convenience sample of patients registered with Bladder Cancer Canada, the Princess Margaret Cancer Centre, or The Ottawa Hospital. Eligibility criteria included being > 18 years of age, English-speaking, and diagnosed with bladder cancer. The questionnaire included an adapted tool to measure informational needs, and validated measures for QoL (Bladder Utility Symptom Scale, BUSS) and SCN (Cancer Survivors' Unmet Needs Measure, CaSUN). QoL scores and unmet needs were calculated and compared between disease groups and cancer trajectory groups. RESULTS AND LIMITATIONS: Of the 1126 surveys distributed, 586 were completed (response = 52%). Mean age was 67.3 ± 10.2 years, and 401 participants (68.7%) were male. The mean QoL score (BUSS) for the sample was 78.1 ± 17.9 (median 81.7). Respondents with MIBC had significantly lower QoL scores compared to NMIBC. Further, scores differed across the cancer phase groups with the follow-up surveillance group having significantly higher QoL scores compared to the newly diagnosed and advance/recurrent disease groups. The ten most highly ranked informational needs were from the medical, physical, and practical domains. Eighty-eight percent (95% CI 85-91%) of respondents reported at least one SCN, with a median of 12. Over half of the participants (54%, 95% CI 49-59%) had at least one unmet need and 15% had ≥ 10 unmet needs. Newly diagnosed participants had the highest number of unmet needs. CONCLUSION: We found that the number of unmet supportive care needs and quality of life differed across cancer trajectory and disease groups. Future efforts should focus on the development and evaluation of tailored resources and programs to address the needs of people diagnosed and treated for BC.

Assessment of Pain Management, Acceptance of Illness, and Adjustment to Life with Cancer in Patients with Nonmuscle Invasive Bladder Cancer.

PURPOSE: According to the European Association of Urology bladder cancer is the seventh most commonly diagnosed malignancy in the world's male population. Despite its high incidence, papers evaluating psychological state in those patients' group are lacking. The purpose of the study was to evaluate pain management, disease acceptance, and adjustment to cancer in homogenous group of patients diagnosed with nonmuscle-invasive bladder cancer (NMIBC). METHODS: Group of 252 male patients who were scheduled for NMIBC treatment were prospectively evaluated. Patients fulfilled Acceptance of Illness Scale (AIS), Mini-Mental Adjustment to Cancer (Mini-MAC) and Coping Strategies (CSQ) questionnaires before treatment introduction. RESULTS: Highest CSQ score was achieved by the coping self-statements subscale (mean=18,37). The catastrophizing subscale score was the lowest (mean=11,24). Place of residence affected results of CSQ statement about pain control. Catastrophizing and coping self-statements strategies were associated with matrimonial status. In the Mini-MAC questionnaire the fighting spirit way of coping had the highest (21,73) and the helplessness-hopelessness subscale had the lowest mean value (13,3). Matrimonial status was strongly associated with anxious preoccupation, fighting spirit, and helplessness - hopelessness way of coping. The mean AIS test score was 28.8. AIS result was influenced by patient's marital status, yet not by education, place of residence, nor any clinical factor. CONCLUSIONS: In the examined group, the level of acceptance of the disease reached values that were slightly higher than the average. It indicated a fairly good adaptation to cancer. Among the methods of coping with cancer, the constructive style is definitely dominant with a high intensity of the fighting spirit strategy. The destructive style of cancer coping reached low values with a low intensity of helplessness/hopelessness strategy. From pain coping strategies, self-statements and praying/hoping were the most commonly chosen ways, whereas catastrophizing was the rarest. Many associations between various questioners' results were also observed.

Bladder Cancer Survivorship.

PURPOSE OF REVIEW: Bladder cancer (BC) is the second most common genitourinary malignancy, with a growing population of survivors globally. Over the past two decades, there has been a growing awareness of not only the oncologic, but also the quality of life ramifications of a BC diagnosis, treatment, and surveillance. In the current review, the literature surrounding the many domains that encompass bladder cancer survivorship is summarized and analyzed. RECENT FINDINGS: There have been ongoing efforts to decrease perioperative morbidity, particularly in patients undergoing radical cystectomy, with mixed results. There is a growing emphasis on the short and long-term health-related quality of life (HR-QoL) impacts of bladder cancer spanning the domains of physical and mental QoL related to urinary function, sexual function, and financial and psychological burden, with validated measures specific to BC patients. There continue to be disparities in oncologic outcomes by race and gender. The impact of BC is prolonged and there is an unmet need for long term support and survivorship resources to address this. There is a growing global population of bladder cancer patients, and their needs are complex and vary by stage, treatment, and certain demographic features. Outcome-centered perioperative strategies show potential to diminish treatment morbidity, and validated BC specific HR-QoL tools have helped to define the impact and burden of BC, but there continue to be large areas of unmet need that warrant greater study and intervention.

Patient-Centered Outcomes in Bladder Cancer.

PURPOSE OF REVIEW: To summarize current knowledge on patient-prioritized outcomes for their bladder cancer care. RECENT FINDINGS: Patient-centered outcomes research seeks to help patients identify the right treatment for the right patient at the right time in their care. As such, patient-centered outcomes research relies on studying a treatment's impact on patient-centered outcomes. Some outcomes, like survival, are commonly prioritized by patients and by clinical experts. Patients often place greater emphasis than experts on quality of life outcomes. Thus, many patient-centered outcomes are also patient-reported outcomes. Unique domains that are often prioritized by patients, but overlooked by experts, include the costs and financial impact of care, anxiety, and depression related to a health condition, and the impact of a condition or its treatment on a caregiver or loved one. Patient-centered outcomes are realizing greater recognition for their innate importance and potential to augment the impact of research studies. Although patient-centered outcomes are often patient-reported outcomes, this is not universal. Unique to bladder cancer, the availability of a research-oriented Patient Survey Network intended to identify research questions that are important to patients may be an opportunity to broadly solicit input on patient-centered outcomes for bladder cancer research questions.

Unmet informational and supportive care needs of patients with muscle invasive bladder cancer: A systematic review of the evidence.

BACKGROUND: Little is known about the unmet supportive care needs of patients affected by muscle invasive bladder cancer (MIBC). We set out to determine the different domains of unmet supportive care needs for patients affected by MIBC. LITERATURE SEARCH: A systematic review was conducted according to the PRISMA Statement Guidelines. A sensitive search was performed in electronic databases (DARE, Cochrane, MEDLINE, BNI, PsychINFO, EMBASE and CIHAHL) from the earliest date available to January 2017. DATA EVALUATION: 1405 references were retrieved, 8 articles met the eligibility criteria and were appraised and ranked by strength using the levels of evidence. SYNTHESIS: Individual unmet needs were classified into the following domains: patient-clinician communication, daily living needs, health system/information needs, practical needs, family-related needs, social needs, psychological needs, physical needs and intimacy needs. Patients reported high unmet needs at diagnosis and into survivorship. CONCLUSIONS: This review contributes to a greater understanding of the unmet supportive care needs of patients affected by MIBC. Findings reflect a paucity of research, but existing studies indicated needs commonly related to intimacy, informational, physical and psychological needs. Despite the emerging evidence-base, the current within study limitations precludes our understanding about how the needs of patients evolve over time.

Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review.

OBJECTIVE: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. METHODS: We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. RESULTS: Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. CONCLUSIONS: Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.

Bladder health in patients treated with BCG instillations for T1G2-G3 bladder cancer - a follow-up five years after the start of treatment.

OBJECTIVE: Investigate symptoms and how they affect daily life in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) treated with Bacillus Calmette-Guérin (BCG) instillations. MATERIALS AND METHODS: Patients treated with BCG were included. After an initial transurethral resection (TURB) followed by a second-look resection, the patients were given an induction course with BCG for 6 weeks followed by maintenance therapy for 2 years. The patients answered a questionnaire before, during and after the treatment. The questionnaire contained questions about specific symptoms combined with bother questions on how each symptom affected patients' life. RESULTS: In total, 113 of 116 patients responded to the first questionnaire. Thirty per cent of all patients were bothered by disease-specific symptoms before the start of BCG. Few patients reported fever, haematuria, illness or urinary tract symptoms. No difference in symptoms was found between patients with or without concomitant CIS (carcinoma in situ). Patients younger than 65 years of age reported a greater worry about the symptom burden in the future than those who were older. Patients younger than 65 years reported a decreased level of mental well-being. CONCLUSION: Patients with bladder cancer T1G2-G3 had disease-specific symptoms present already before the start of the BCG. The burden of symptoms was reduced over time and showed that the bladder might recover. BCG instillations had side-effects that negatively affected the patient's well-being. It is important to record the patients' baseline bladder and voiding status before as well as during the BCG-instillation period in order to understand symptoms caused by the treatment.

Health Related Quality of Life Following Radical Cystectomy: Comparative Analysis from the Medicare Health Outcomes Survey.

PURPOSE: Health related quality of life after radical cystectomy and ileal conduit is not well quantified at the population level. We evaluated health related quality of life in patients with bladder cancer compared with noncancer controls and patients with colorectal cancer using data from SEER (Surveillance, Epidemiology and End Results)-MHOS (Medicare Health Outcomes Survey). MATERIALS AND METHODS: SEER-MHOS data from 1998 to 2013 were used to identify patients with bladder cancer and those with colorectal cancer who underwent extirpative surgery with ileal conduit or colostomy creation, respectively. A total of 166 patients with bladder cancer treated with radical cystectomy were propensity matched 1:5 to 830 noncancer controls and compared with 154 patients with colorectal cancer. Differences in Mental and Physical Component Summary scores as well as component subscores were determined between patients with bladder cancer, patients with colorectal cancer and noncancer controls. RESULTS: SEER-MHOS patients were more commonly male and white with a mean ± SD age of 77 ± 6 years. Patients treated with radical cystectomy had significantly lower Physical Component Summary scores, select physical subscale scores and all mental subscale scores compared with noncancer controls. These findings were similar in the subset of 40 patients treated with radical cystectomy who had available preoperative and postoperative survey data. Global Mental Component Summary scores did not differ significantly between the groups. No significant differences were observed in global Mental Component Summary, Physical Component Summary or subscale scores between patients with bladder cancer and patients with colorectal cancer. CONCLUSIONS: Patients with bladder cancer who undergo radical cystectomy have significant declines in multiple components of physical and mental health related quality of life vs noncancer controls, which mirror those of patients with colorectal cancer. Further longitudinal study is required to better codify the effectors of poor health related quality of life after radical cystectomy to improve patient expectations and outcomes.

A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer.

PURPOSE: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can be life-long. In this context, health-related quality of life (HRQOL) is important to patients and managing clinicians, and integral to treatment recommendations for NMIBC. The aim of this study was to develop a conceptual framework of patient-reported NMIBC symptoms, treatment side effects, and HRQOL impacts from three sources: (1) literature, (2) patients and (3) treating clinicians. METHODS: First, we undertook a scoping literature review for studies reporting patient-reported outcomes associated with NMIBC. Outcomes were extracted and grouped conceptually. Then, we conducted semi-structured interviews with patients with NMIBC and treating clinicians. Patients were asked about symptoms and HRQOL impacts experienced from their NMIBC and treatments. Clinicians were asked about commonly reported outcomes, and outcomes they felt were important to assess clinically. Interviews were audio recorded, transcribed and content analysed. RESULTS: A total of 125 symptom- and functioning-related expressions from 18 studies, 26 patients and 20 clinicians were coded into three themes and 18 sub-themes. Patients commonly reported blood in urine and frequent urination. Clinicians considered BCG sepsis and flu-like symptoms important outcomes to assess during treatment for NMIBC. CONCLUSION: Our empirically derived conceptual framework identifies patient-reported outcomes that are important to people with NMIBC, provides the basis for the development of a new NMIBC-specific symptom index, and guides the design of a comprehensive PRO assessment plan for clinical practice in NMIBC and future clinical trials of treatments for NMIBC.

Idiographic quality of life assessment before radical cystectomy.

BACKGROUND: We sought to determine if idiographic, or self-defined, measures added to our understanding of patients with bladder cancer's quality of life (QOL) prior to radical cystectomy (RC). We tested whether idiographic measures increased prediction of global QOL beyond standard (nomothetic) measures of QOL components. METHODS: We administered the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ)-C30 and QLQ-BLM30, and our own idiographic Quality of Life Appraisal Profile prior to RC. Idiographic measures included number of goal statements, distance from goal attainment, and ability to complete goal attainment activities. Multivariate linear regression was used to predict measures of global QOL and related constructs of life satisfaction and mental health. RESULTS: Two hundred fiftheen patients reported a median of 8 (interquartile range [IQR] 6, 11) goals and half had an average goal attainment rating above 6.9 out of 10 (IQR 5.5, 8.2). On multivariable analysis, QLQ-C30 role functioning and QLQ-BLM30 future perspective explained 15.7% of the variability in preoperative global QOL. Including goal attainment and activity difficulty explained an additional 12% of global QOL variance. Smaller gains were seen on measures of global health, life satisfaction, mental health, and activity, suggesting that idiographic measures capture aspects of QOL distinct from health and functional status defined by nomothetic scales. CONCLUSIONS: Idiographic assessment of QOL added to prediction of global QOL above and beyond health-related components measured using nomothetic instruments. This self-defined information may be valuable in communicating with cancer patients about their QOL. Copyright © 2015 John Wiley & Sons, Ltd.

The relative contributions of function, perceived psychological burden and partner support to cognitive distress in bladder cancer.

OBJECTIVE: Bladder cancer is a genitourinary disease of increasing incidence. Despite improvements in treatment, outcomes remain equivocal with high recurrence rates. It is associated with poor psychosocial outcomes due to reduced functioning of the genitourinary system. The objective of these analyses was to query whether reported loss of function or the perception of psychological burden caused by this functional impedance was the key to understanding psychosocial outcomes. METHODS: The sample comprised 119 participants with a confirmed diagnosis of bladder cancer. They completed a self-report questionnaire comprising the Bladder Cancer Index, Mini-mental Adjustment to Cancer Scale, Psychosocial Adjustment to Illness Scale and standard sociodemographic details. Simple mediation and serial mediation were used to explore the potential for psychological burden to mediate associations between loss of function and cognitive distress, and the potential additional contribution of positive partner support on these relationships. Age and duration of cancer were considered as covariates. RESULTS: Simple mediation demonstrated that the association between function and cognitive distress was fully mediated by perceived psychological burden. Serial mediation, which allowed for the addition of partner support, again demonstrated full mediation, with partner support being the key predictive variable. CONCLUSIONS: These analyses emphasise the importance of an appreciation of individuals' interpretation of the burden occasioned by bladder cancer and the role of a supportive partner. The implications for management discussions and support services in alleviating negative psychological outcomes in bladder cancer are highlighted. Copyright © 2015 John Wiley & Sons, Ltd.

Quality of Life Assessment With Orthotopic Ileal Neobladder Reconstruction After Radical Cystectomy: Results From a Prospective Italian Multicenter Observational Study.

OBJECTIVE: To assess health-related quality of life (HRQoL) parameters in patients who received radical cystectomy (RC) with ileal orthotopic neobladder (IONB) reconstruction and to identify clinic-pathologic predictors of HRQoL. PATIENTS AND METHODS: From January 2010 to December 2013, a multicenter, retrospective on 174 RC-IONB patients was carried out. All patients completed the following questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the IONB-Patient Reported Outcome (IONB-PRO). Univariate and multivariate analyses were computed to identify clinic-pathologic predictors of HRQoL. RESULTS: Median age was 66 years (range, 31-83), and 91.4% of patients were men. Median follow-up period was 37 months (range, 3-247). The EORTC QLQ-C30 revealed that age >65 years, absence of urinary incontinence, and absence of peripheral vascular disease were independent predictors of deteriorated body image. A follow-up > 36 months and the presence of urinary incontinence were independent predictors of worsened urinary symptoms, whereas the absence of urinary incontinence was an independent predictor of a worsened body image according to EORTC QLQ-BLM30 results. A follow-up >36 months and the absence of urinary incontinence were independent predictors of better functioning in terms of relational life, emotional life, and fatigue as revealed by the IONB-PRO. CONCLUSION: Age, presence of urinary incontinence, length of follow-up, and comorbidity status may influence postoperative HRQoL and should all be taken into account when counseling RC-IONB patients.

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review.

OBJECTIVES: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer. METHODS: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research. RESULTS: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data. CONCLUSIONS: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.

Korean version of the functional assessment of cancer therapy (FACT)-vanderbilt cystectomy index (VCI): translation and linguistic.

PURPOSE: To develop a Korean version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI) from the original English version, with subsequent linguistic validation in Korean patients who underwent radical cystectomy with urinary diversion. MATERIALS AND METHODS: Translation and linguistic validation were carried out between January and May of 2013, which consisted of the following stages:(1) permission for translation;(2) forward translation;(3) reconciliation;(4) backward translation;(5) cognitive debriefing and(6) final proof-reading. RESULTS: During the forward translation phases,word as such as "bother","spend time", "support", "coping" and "concern" were adjusted to be more comprehensible to the target population. There conciled Korean version was accepted without certain objections because the original version and the backward translation were almost congruent except for minor differences in a subset of questions. The translation was tested using 5 Korean-speaking subjects. The subjects took an average of 8.2 minutes to complete the questionnaire, without difficulty and found the questionnaire clear and easy to understand. The panel discussed each of the issues raised by subjects and most terms were judged by the panel as to not require further changes because the overall comprehension levels were relatively high and because the translated terms were accurately rendered in the target languages. CONCLUSION: This report has demonstrated that despite translation difficulties, the linguistic validation of the FACT-VCI in the Korean language was successful. The next step is to assess the psychometric properties of the Korean version of FACT-VCI.

The burden of bladder cancer care: direct and indirect costs.

PURPOSE OF REVIEW: Bladder cancer is a common, complex, and costly disease. Every year in the USA, bladder cancer is responsible for 70 ,000 diagnosed cases and over 15, 000 deaths. Once diagnosed, patients with nonmuscle invasive bladder cancer (NMIBC) are committed to a lifetime of invasive procedures and potential hospitalizations that result in substantial direct and indirect costs. RECENT FINDINGS: Bladder cancer is the most costly cancer among the elderly, estimated at nearly $4 billion per year, and has the highest cost of any cancer when categorized on a per patient basis. The direct economic cost of NMIBC is fueled by the need for lifelong cystoscopic examination and variations in treatment algorithms. This fiscal burden is further compounded by the indirect impact on psychological health and quality of life of patients and their families. Despite the development of new technologies, such as novel urinary biomarkers and innovative cystoscopic methods, no alternative to cystoscopic surveillance has been established. SUMMARY: The management of patients with NMIBC is responsible for a substantial financial burden with indirect costs that extend beyond quantifiable direct costs.