Perceived health-related quality of life in people living with HIV co-infected with SARS-CoV-2 in France.

PURPOSE: We aimed to assess health-related quality of life (HRQL) and its correlates among people living with HIV/AIDS (PLWHA) co-infected with SARS-CoV-2 in France. METHODS: This cross-sectional was study conducted among PLWHA co-infected with SARS-CoV-2. HRQL was measured using the four dimensions of the PROQOL-HIV scale. Factors associated with each dimension were identified using linear regression. RESULTS: mean (SD) scores for HRQL dimensions: 76.7 (± 21.1) for Physical Health and Symptoms (PHS), 79.2 (± 23.6) for Social Relationships (SR), 67.3 (± 27.4) for Mental and Cognitive (MC), and 83.9 (± 16.5) for Treatment Impact (TI). Employment status and COVID-19 knowledge were associated with higher PHS score, while blood transfusion-acquired HIV, CDC HIV, hospital discharge instructions, and self-reported symptoms were associated with lower PHS score. Couple status was associated with higher SR score, whereas, hospital discharge instructions, CDC HIV stage C, drug injection-acquired HIV, self-reported symptoms, and COVID-19 vulnerability perception were associated with lower SR score. Employment status and French birth were associated with higher MC score, while female sex, detectable HIV viral load, hospital discharge instructions, COVID-19 vulnerability perception, smoking, and self-reported symptoms were associated with lower MC score. French birth and homosexual/bisexual relationships-acquired HIV were associated with higher TI score, while detectable HIV viral load, psychiatric disorders, and self-reported symptoms were associated with lower TI score CONCLUSION: Among PLWHA co-infected with SARS-CoV-2, the scores of HRQL were impaired, particularly in the MC dimension. Findings underscore the multidimensional nature of HRQL, with notable variations across different dimensions. Understanding these correlates is crucial for tailored interventions aimed at improving the well-being of this population.

Enhanced clinical decisions for management of benign prostatic hyperplasia using patient-reported outcomes: protocol for a prospective observational study.

BACKGROUND: Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) significantly impact quality of life among older men. Despite the prevalent use of the American Urological Association Symptom Index (AUA-SI) for BPH, this measure overlooks key symptoms such as pain and incontinence, underscoring the need for more comprehensive patient-reported outcome (PRO) tools. This study aims to integrate enhanced PROs into routine clinical practice to better capture the spectrum of LUTS, thereby improving clinical outcomes and patient care. METHODS: This prospective observational study will recruit men with LUTS secondary to BPH aged ≥ 50 years from urology clinics. Participants will be stratified into medical and surgical management groups, with PRO assessments scheduled at regular intervals to monitor LUTS and other health outcomes. The study will employ the LURN Symptom Index (SI)-29 alongside the traditional AUA-SI and other non-urologic PROs to evaluate a broad range of symptoms. Data on comorbidities, symptom severity, and treatment efficacy will be collected through a combination of electronic health records and PROs. Analyses will focus on the predictive power of these tools in relation to symptom trajectories and treatment responses. Aims are to: (1) integrate routine clinical tests with PRO assessment to enhance screening, diagnosis, and management of patients with BPH; (2) examine psychometric properties of the LURN SIs, including test-retest reliability and establishment of clinically meaningful differences; and (3) create care-coordination recommendations to facilitate management of persistent symptoms and common comorbidities measured by PROs. DISCUSSION: By employing comprehensive PRO measures, this study expects to refine symptom assessment and enhance treatment monitoring, potentially leading to improved personalized care strategies. The integration of these tools into clinical settings could revolutionize the management of LUTS/BPH by providing more nuanced insights into patient experiences and outcomes. The findings could have significant implications for clinical practices, potentially leading to updates in clinical guidelines and better health management strategies for men with LUTS/BPH. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov (NCT05898932).

Relationships Between Urinary and Nonurinary Symptoms in Treatment-Seeking Women in LURN.

IMPORTANCE: Physical health and psychological health represent modifiable factors in the causal pathway of lower urinary tract symptoms (LUTS). OBJECTIVES: Understand the relationship between physical and psychological factors and LUTS over time. STUDY DESIGN: Adult women enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study completed the LUTS Tool and Pelvic Floor Distress Inventory, including urinary (Urinary Distress Inventory), prolapse (Pelvic Organ Prolapse Distress Inventory), and colorectal anal (Colorectal-Anal Distress Inventory) subscales at baseline, 3 months, and 12 months. Physical functioning, depression, and sleep disturbance were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires; relationships were assessed using multivariable linear mixed models. RESULTS: Of 545 women enrolled, 472 had follow-up. Median age was 57 years; 61% and 78% reported stress urinary incontinence and overactive bladder, respectively; and 81% reported obstructive symptoms. The PROMIS depression scores were positively associated with all urinary outcomes (range, 2.5- to 4.8-unit increase per 10-unit increase in depression score; P < 0.01 for all). Higher sleep disturbance scores were associated with higher urgency, obstruction, LUTS Total Severity, Urinary Distress Inventory, and Pelvic Floor Distress Inventory (1.9- to 3.4-point increase per 10-unit increase, all P < 0.02). Better physical functioning was associated with less severe urinary symptoms except stress urinary incontinence (2.3- to 5.2-point decrease per 10-unit increase, all P < 0.01). All symptoms decreased over time; however, no association was detected between baseline PROMIS scores and trajectories of LUTS over time. CONCLUSIONS: Nonurologic factors demonstrated small to medium cross-sectional associations with urinary symptom domains, but no significant association was detected with changes in LUTS. Further work is needed to determine whether interventions targeting nonurologic factors reduce LUTS in women.

Clinically Important Differences for Pain and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study.

PURPOSE: Symptom heterogeneity in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively termed urological chronic pelvic pain syndrome, has resulted in difficulty in defining appropriate clinical trial endpoints. We determine clinically important differences for 2 primary symptom measures, pelvic pain severity and urinary symptom severity, and evaluate subgroup differences. MATERIALS AND METHODS: The Multidisciplinary Approach to the Study of Chronic Pelvic Pain Symptom Patterns Study enrolled individuals with urological chronic pelvic pain syndrome. We defined clinically important differences by associating changes in pelvic pain severity and urinary symptom severity over 3 to 6 months with marked improvement on a global response assessment using regression and receiver operating characteristic curves. We evaluated clinically important differences for absolute and percent change and examined differences in clinically important differences by sex-diagnosis, presence of Hunner lesions, pain type, pain widespreadness, and baseline symptom severity. RESULTS: An absolute change of -4 was clinically important in pelvic pain severity among all patients, but clinically important difference estimates differed by pain type, presence of Hunner lesions, and baseline severity. Pelvic pain severity clinically important difference estimates for percent change were more consistent across subgroups and ranged from 30% to 57%. The absolute change urinary symptom severity clinically important difference was -3 for female participants and -2 for male participants with chronic prostatitis/chronic pelvic pain syndrome only. Patients with greater baseline severity required larger decreases in symptoms to feel improved. Estimated clinically important differences had lower accuracy among participants with low baseline symptoms. CONCLUSIONS: A reduction of 30%-50% in pelvic pain severity is a clinically meaningful endpoint for future therapeutic trials in urological chronic pelvic pain syndrome. Urinary symptom severity clinically important differences are more appropriately defined separately for male and female participants.

The 10-item LURN Symptom Index (LURN SI-10) Detects Additional Symptoms and Shows Convergent Validity With the IPSS in Men Presenting With Lower Urinary Tract Symptoms.

OBJECTIVE: To determine how the LURN-SI-10, a novel questionnaire developed by the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN), compares with the International Prostate Symptom Score (IPSS) in men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Specifically, to assess convergent validity and determine how frequently the LURN-SI-10 identifies symptoms not captured by the IPSS. MATERIALS AND METHODS: Men presenting with BPH/LUTS were prospectively administered LURN-SI-10 and IPSS questionnaires. Urinary incontinence (UI) including post-void dribbling (PVD), urgency urinary incontinence (UUI), stress urinary incontinence (SUI), as well as bladder pain were considered present if the patient reported "about half the time or more" on LURN-SI-10. Correlations between LURN-SI-10 and IPSS were assessed as continuous and categorical variables. Multivariable linear regression analysis was performed to determine associations with symptom scores. RESULTS: LURN-SI-10 and IPSS were highly correlated in men with BPH/LUTS (r = 0.82, n = 429), as were respective bother and quality of life scores (ρ = 0.74). The LURN-SI-10 identified additional symptoms including PVD (24%), UUI (13%), SUI (2%), and pain (8%). Men with any UUI, SUI, or PVD had on average a 7.6-point higher LURN-SI-10 score than those without UI (P<.001) and 8.0-point higher IPSS score than those without UI (P<.001). CONCLUSION: The LURN-SI-10 correlates strongly with the IPSS, but the LURN-SI-10 identifies additional important symptomatology in men with LUTS. This additional information may improve the evaluation and treatment of men with BPH/LUTS. Further prospective studies of the LURN-SI-10 is warranted.

Clinical Phenotyping for Pain Mechanisms in Urologic Chronic Pelvic Pain Syndromes: A MAPP Research Network Study.

Three categories of pain mechanisms are recognized as contributing to pain perception: nociceptive, neuropathic, and nociplastic (ie, central nervous system augmented pain processing). We use validated questionnaires to identify pain mechanisms in Urologic Chronic Pelvic Pain Syndrome (UCCPS) patients (n = 568, female = 378, male = 190) taking part in the Symptom Patterns Study of the Multidisciplinary Approach to the study of chronic Pelvic Pain Research Network. A cutoff score of 12 on the painDETECT questionnaire (-1 to 38) was used to classify patients into the neuropathic category while the median score of 7 on the fibromyalgia survey criteria (0-31) was used to classify patients into the nociplastic category. Categories were compared on demographic, clinical, psychosocial, psychophysical and medication variables. At baseline, 43% of UCPPS patients were classified as nociceptive-only, 8% as neuropathic only, 27% as nociceptive+nociplastic, and 22% as neuropathic+nociplastic. Across outcomes nociceptive-only patients had the least severe symptoms and neuropathic+nociplastic patients the most severe. Neuropathic pain was associated with genital pain and/or sensitivity on pelvic exam, while nociplastic pain was associated with comorbid pain conditions, psychosocial difficulties, and increased pressure pain sensitivity outside the pelvis. A self-report method classifying individuals on pain mechanisms reveals clinical differences that could inform clinical trials and novel targets for treatment. PERSPECTIVE: This article presents differences in clinical characteristics based on a simple self-report method of classifying pain mechanisms for Urologic Chronic Pelvic Pain Syndrome patients. This method can be easily applied to other chronic pain conditions and may be useful for exploring pathophysiology in pain subtypes.

Reliability and Validity of Pain and Urinary Symptom Severity Assessment in Urological Chronic Pelvic Pain: A MAPP Network Analysis.

PURPOSE: We assessed the reliability and validity of an efficient severity assessment for pelvic pain and urinary symptoms in urological chronic pelvic pain syndrome, which consists of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 578 patients were assessed using brief, empirically derived self-report scales for pelvic pain severity (PPS) and urinary symptom severity (USS) 4 times during a 1-month period and baseline clinic visit that included urological, pain and illness-impact measures. Mild, moderate and severe categories on each dimension were examined for measurement stability and construct validity. RESULTS: PPS and USS severity categories had adequate reliability and both discriminant validity (differential relationships with specific clinical and self-report measures) and convergent validity (common association with nonurological somatic symptoms). For example, increasing PPS was associated with pelvic tenderness and widespread pelvic pain, whereas USS was associated with urgency during a bladder filling test and increased sensory sensitivity. PPS and USS categories were independently associated with nonurological pain and emotional distress. A descriptive analysis identified higher likelihood characteristics associated with having moderate to severe PPS or USS or both. Lack of sex interactions indicated that the measures are comparable in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. CONCLUSIONS: Women and men with urological chronic pelvic pain syndrome can be reliably subgrouped using brief self-report measures of mild, moderate or severe pelvic pain and urinary symptoms. Comparisons with a broad range of clinical variables demonstrate the validity and potential clinical utility of these classifications, including use in clinical trials, health services and biological research.

Temporal Relationships between Pain, Mood and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study.

PURPOSE: We sought to determine the time-lagged, bidirectional relationships among clinical variables of pelvic pain, urinary symptoms, negative mood, nonpelvic pain and quality of life in men and women with urological chronic pelvic pain syndrome, incorporating interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: A total of 204 female and 166 male patients were assessed up to 24 times over a 48-week period on the 5 primary outcomes. A lagged autoregressive analysis was applied to determine the directional relationship of one variable to another 2 weeks later, beyond that of the concurrent relationships at each time point and autocorrelations and trends over time. RESULTS: The results show clear evidence for a bidirectional positive relationship between changes in pelvic pain severity and urinary symptom severity. Increases in either variable predicted significant increases in the other 2 weeks later, beyond that explained by their concurrent relationship at each time point. Pelvic pain and to a lesser degree urinary frequency also showed similar bidirectional relationships with negative mood and decreased quality of life. Interestingly, neither pelvic pain or urinary symptom severity showed lagged relationships with nonpelvic pain severity. CONCLUSIONS: Results document for the first time specific short-term positive feedback between pelvic pain and urinary symptoms, and between symptoms of urological chronic pelvic pain syndrome, mood and quality of life. The feedforward aspects of these relationships can facilitate a downward spiral of increased symptoms and worsening psychosocial function, and suggest the need for multifaceted treatments and assessment to address this possibility in individual patients.

Natural bladder filling alters resting brain function at multiple spatial scales: a proof-of-concept MAPP Network Neuroimaging Study.

Neural circuitry regulating urine storage in humans has been largely inferred from fMRI during urodynamic studies driven by catheter infusion of fluid into the bladder. However, urodynamic testing may be confounded by artificially filling the bladder repeatedly at a high rate and examining associated time-locked changes in fMRI signals. Here we describe and test a more ecologically-valid paradigm to study the brain response to bladder filling by (1) filling the bladder naturally with oral water ingestion, (2) examining resting state fMRI (rs-fMRI) which is more natural since it is not linked with a specific stimulus, and (3) relating rs-fMRI measures to self-report (urinary urge) and physiologic measures (voided volume). To establish appropriate controls and analyses for future clinical studies, here we analyze data collected from healthy individuals (N = 62) as part of the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. Participants orally ingested approximately 350 mL of water, and had a 10 min "fuller bladder" rs-fMRI scan approximately 1 h later. A second 10 min "empty bladder" rs-fMRI scan was conducted immediately following micturition. We examined multiple spatial scales of brain function, including local activity, circuits, and networks. We found changes in brain function distributed across micturition loci (e.g., subregions of the salience, sensorimotor, and default networks) that were significantly related to the stimulus (volume) and response (urinary urge). Based on our results, this paradigm can be applied in the future to study the neurobiological underpinnings of urologic conditions.

Longitudinal changes in symptom-based female and male LUTS clusters.

AIMS: Lower urinary tract symptoms (LUTS) are diverse in type and variable in severity. We examined symptom change within the Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Observational Cohort study identified clusters over time and tested associations with treatments received. METHODS: Patient-reported LUTS and treatment data were collected at multiple time points between baseline and 12 months from the LURN Observational Cohort study. LUTS severity scores were calculated to summarize changes in symptom reporting over time in previously identified LURN clusters. Repeated measures linear regression models tested adjusted associations between cluster membership and severity scores. RESULTS: Four-hundred seventeen men and 396 women were classified into improved, unchanged, and worsened symptoms between baseline and 12 months (men: 44.1%, 40.5%, and 15.3%; women: 55.8%, 33.1%, 11.1%, respectively). Improvement in LUTS severity scores varied by cluster (estimated adjusted mean change from baseline range: -.04 change in standard deviations of severity scores (ΔSD) to -.67 ΔSD). Prostate surgery was associated with improved severity scores (-.63 ΔSD) in men, while stress incontinence surgery was associated with improved severity scores (-.88 ΔSD) in women. CONCLUSION: Symptom improvement varied by cluster indicating response to therapy differs amongst subtypes of patients with LUTS. The differential improvement of patients in clusters suggests mechanistic differences between clusters and may aid in selecting more targeted treatments in the future.

CEDRA: A Tool to Help Consumers Assess Risk for Ear Disease.

This article introduces the Consumer Ear Disease Risk Assessment (CEDRA) tool. CEDRA is a brief questionnaire designed to screen for targeted ear diseases. It offers an opportunity for consumers to self-screen for disease before seeking a hearing device and may be used by clinicians to help their patients decide the appropriate path to follow in hearing healthcare. Here we provide highlights of previously published validation in the context of a more thorough description of CEDRA's development and implementation. CEDRA's sensitivity and specificity, using a cut-off score of 4 or higher, was 90% and 72%, respectively, relative to neurotologist diagnoses in the initial training sample used to create the scoring algorithm (n = 246). On a smaller independent test sample (n = 61), CEDRA's sensitivity and specificity were 76% and 80%, respectively. CEDRA has readability levels similar to many other patient-oriented questionnaires in hearing healthcare, and informal reports from pilot CEDRA-providers indicate that the majority of patients can complete it in less than 10 min. As the hearing healthcare landscape changes and provider intercession is no longer mandated, CEDRA provides a measure of safety without creating a barrier to access.

A longitudinal analysis of urological chronic pelvic pain syndrome flares in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

OBJECTIVE: To describe the frequency, intensity and duration of urological chronic pelvic pain syndrome symptom exacerbations ('flares'), as well as risk factors for these features, in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Epidemiology and Phenotyping longitudinal study. PARTICIPANTS AND METHODS: Current flare status ('urological or pelvic pain symptoms that are much worse than usual') was ascertained at each bi-weekly assessment. Flare characteristics, including start date, and current intensity of pelvic pain, urgency and frequency (scales of 0-10), were assessed for participants' first three flares and at three randomly selected times when they did not report a flare. Generalized linear and mixed effects models were used to investigate flare risk factors. RESULTS: Of the 385 eligible participants, 24.2% reported no flares, 22.9% reported one flare, 28.3% reported 2-3 flares, and 24.6% reported ≥4 flares, up to a maximum of 18 during the 11-month follow-up (median incidence rate = 0.13/bi-weekly assessment, range = 0.00-1.00). Pelvic pain (mean = 2.63-point increase) and urological symptoms (mean = 1.72) were both significantly worse during most flares (60.6%), with considerable within-participant variability (26.2-37.8%). Flare duration varied from 1 to 150 days (94.3% within-participant variability). In adjusted analyses, flares were more common, symptomatic, and/or longer-lasting in women and in those with worse non-flare symptoms, bladder hypersensitivity, and chronic overlapping pain conditions. CONCLUSION: In this foundational flare study, we found that pelvic pain and urological symptom flares were common, but variable in frequency and manifestation. We also identified subgroups of participants with more frequent, symptomatic, and/or longer-lasting flares for targeted flare management/prevention and further study.

The Promise of PROMIS in Pelvic Organ Prolapse.

OBJECTIVES: The aims of the study were to determine the relationship between pelvic organ prolapse (POP) and health-related quality of life dimensions and to evaluate the utility of the PROMIS Profile in women undergoing surgical treatment for POP. METHODS: We performed a planned ancillary analysis of 103 women recruited between January 2014 and December 2015 to the Restricted Convalescence Outcomes following Urogynecologic Procedures study. All participants underwent surgery for POP and completed the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Severity Scale, and the 57-item Patient Reported Outcomes Measurement Information System (PROMIS-57) questionnaire, preoperatively and at 3 months postoperatively. Data were analyzed using Pearson and Spearman correlations. RESULTS: Preoperative PFDI-20 and PFIQ-7 scores were significantly correlated with all PROMIS domains including physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, pain interference, and higher pain intensity. Worse self-reported condition assessments on the Patient Global Impression of Severity were significantly correlated with worse physical function, more pain interference, and higher pain intensity on the PROMIS Profile at baseline. Postoperatively, PFDI-20, PFIQ-7, and all PROMIS Profile domain scores improved significantly (P ≤ 0.05). Correlations between PDFI-20, PFIQ-7, and PROMIS domains persisted at 3 months. CONCLUSIONS: In a cohort of women undergoing surgery for POP, pelvic floor symptom severity is associated with health-related quality of life domains measured by the PROMIS-57.

A Retrospective Estimate of Ear Disease Detection Using the "Red Flags" in a Clinical Sample.

OBJECTIVES: The purpose of this study was to evaluate the specificity and sensitivity of two red flag protocols in detecting ear diseases associated with changes in hearing. DESIGN: The presence of red-flag symptoms was determined in a chart review of 307 adult patients from the Mayo Clinic Florida Departments of Otorhinolaryngology and Audiology. Participants formed a convenience sample recruited for a separate study. Neurotologist diagnosis was the criterion for comparisons. RESULTS: Of the 251 patient files retained for analysis, 191 had one or more targeted diseases and 60 had age- or noise-related hearing loss. Food and Drug Administration red flags sensitivity was 91% (confidence interval [CI], 86 to 95%) and specificity was 72% (CI, 59 to 83%). American Academy of Otolaryngology-Head and Neck Surgery red flags sensitivity was 98% (CI, 95 to 99%) and specificity was 20% (CI, 11 to 32%). CONCLUSIONS: Stakeholders must determine which diseases are meaningful contraindications for hearing aid use and whether these red-flag protocols have acceptable levels of sensitivity and specificity. As direct-to-consumer models of hearing devices increase, a disease detection method that does not require provider intercession would be useful.

Prevalence and Characteristics of Urinary Incontinence in a Treatment Seeking Male Prospective Cohort: Results from the LURN Study.

PURPOSE: Male urinary incontinence is thought to be infrequent. We sought to describe the prevalence of urinary incontinence in a male treatment seeking cohort enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network). MATERIALS AND METHODS: Study inclusion and exclusion criteria, including men with prostate cancer or neurogenic bladder, were previously reported. LURN participants prospectively completed questionnaires regarding lower urinary tract symptoms and other clinical variables. Men were grouped based on incontinence type, including 1) no urinary incontinence, 2) post-void dribbling only and 3) urinary incontinence. Comparisons were made using ANOVA and multivariable regression. RESULTS: Of the 477 men 24% reported no urinary incontinence, 44% reported post-void dribbling only and 32% reported urinary incontinence. African American men and those with sleep apnea were more likely to be in the urinary incontinence group than in the no urinary incontinence group (OR 3.2, p = 0.02 and OR 2.73, p = 0.003, respectively). Urinary incontinence was associated with significantly higher bother compared to men without leakage (p <0.001). Compared to men without urinary incontinence and men with only post-void dribbling those with urinary incontinence were significantly more likely to report higher scores (more severe symptoms) on the PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires regarding bowel issues, depression and anxiety than men without urinary incontinence (p <0.01). CONCLUSIONS: Urinary incontinence is common among treatment seeking men. This is concerning because the guideline recommended questionnaires to assess male lower urinary tract symptoms do not query for urinary incontinence. Thus, clinicians may be missing an opportunity to intervene and improve patient care. This provides a substantial rationale for a new or updated symptom questionnaire which provides a more comprehensive symptom assessment.

Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study.

PURPOSE: The primary objective of this study was to evaluate reasons for seeking care among men and women with lower urinary tract symptoms. MATERIALS AND METHODS: Participants were recruited from urology and urogynecology clinics, and the community. The sample was enriched with persons expected to have abnormal or diminished bladder sensations (eg participants with lower back surgery and participants 65 years old or older). Interviews were performed in person beginning with an open-ended assessment of urinary symptoms and associated bother followed by more directed questions, including reasons for seeking or not seeking treatment. We also examined the relationship between symptom frequency and bother using the LUTS (Lower Urinary Tract Symptoms) Tool. RESULTS: A total of 88 participants, including 38 men and 50 women, with a mean ± SD age of 52.2 ± 14.3 years provided information about urinary symptoms, including a range of quality of life consequences and coping behaviors. They sought treatment mostly because of new, continuing or bothersome symptoms. Factors associated with not seeking treatment included low symptom severity and concerns about the costs vs the benefits of treatment (eg side effects of medication). Symptom frequency and bother were associated with each other across symptoms assessed by the LUTS Tool. CONCLUSIONS: In this large qualitative study we obtained useful insights into the impact of lower urinary tract symptoms from the perspective of the person with the symptoms. Removing barriers and misconceptions about the treatment of lower urinary tract symptoms may increase the number of people who seek clinical care and improve the clinical course of men and women who experience lower urinary tract symptoms.

Development and Initial Validation of a Consumer Questionnaire to Predict the Presence of Ear Disease.

Importance: The already large population of individuals with age- or noise-related hearing loss in the United States is increasing, yet hearing aids remain largely inaccessible. The recent decision by the US Food and Drug Administration to not enforce the medical examination prior to hearing aid fitting highlights the need to reengineer consumer protections when increasing accessibility. A self-administered tool to estimate ear disease risk would provide disease surveillance without posing an unreasonable barrier to hearing aid procurement. Objective: To develop and validate a consumer questionnaire for the self-assessment of risk for ear diseases associated with hearing loss. Design, Setting, and Participants: The questionnaire was developed using established methods including expert opinion to validate and create questions, and cognitive interviews to ensure that questions were clear to respondents. Exploratory structural equation modeling, logistic regression, and receiver operating characteristic curve analysis were used to determine sensitivity and specificity with blinded neurotologist opinion as the criterion for evaluation. Patients 40 to 80 years old with ear or hearing complaints necessitating a neurotologic examination and a control group of participants with a diagnosis of age- or noise-related hearing loss participated at the Departments of Otorhinolaryngology and Audiology of Mayo Clinic Florida. Main Outcomes and Measures: Sensitivity and specificity of the prototype questionnaire to identify individuals with targeted diseases. Results: Of 307 participants (mean [SD] age, 62.9 [9.8] years; 148 [48%] female), 75% (n = 231) were enrolled with targeted disease(s) identified on neurotologic assessment and 25% (n = 76) with age- or noise-related hearing loss. Participants were randomly divided into a training sample (80% [n = 246; 185 with disease, 61 controls]) and a test sample (20% [n = 61; 46 with disease, 15 controls]). Using a simple scoring method, a sensitivity of 94% (95% CI, 89%-97%) and specificity of 61% (95% CI, 47%-73%) were established in the training sample. Applying this cutoff to the test sample resulted in 85% (95% CI, 71%-93%) sensitivity and 47% (95% CI, 22%-73%) specificity. Conclusions and Relevance: This is the first self-assessment tool designed to assess an individual's risk for ear disease. Our preliminary results demonstrate a high sensitivity to disease detection. A further validated and refined version of this questionnaire may serve as an efficacious tool for improving access to hearing health care while minimizing the risk for missed ear diseases.

Clinical and Psychosocial Predictors of Urological Chronic Pelvic Pain Symptom Change in 1 Year: A Prospective Study from the MAPP Research Network.

PURPOSE: We examined baseline clinical and psychosocial characteristics that predict 12-month symptom change in men and women with urological chronic pelvic pain syndromes. MATERIALS AND METHODS: A total of 221 female and 176 male patients with urological chronic pelvic pain syndromes were recruited from 6 academic medical centers in the United States and evaluated at baseline with a comprehensive battery of symptom, psychosocial and illness-impact measures. Based on biweekly symptom reports, a functional clustering procedure classified participant outcome as worse, stable or improved on pain and urinary symptom severity. Cumulative logistic modeling was used to examine individual predictors associated with symptom change as well as multiple predictor combinations and interactions. RESULTS: About 60% of participants had stable symptoms with smaller numbers (13% to 22%) showing clear symptom worsening or improvement. For pain and urinary outcomes the extent of widespread pain, amount of nonurological symptoms and poorer overall health were predictive of worsening outcomes. Anxiety, depression and general mental health were not significant predictors of outcomes but pain catastrophizing and self-reported stress were associated with pain outcome. Prediction models did not differ between men and women and for the most part they were independent of symptom duration and age. CONCLUSIONS: These results demonstrate for the first time in a large multisite prospective study that presence of widespread pain, nonurological symptoms and poorer general health are risk factors for poorer pain and urinary outcomes in men and women. The results point to the importance of broad based assessment for urological chronic pelvic pain syndromes and future studies of the mechanisms that underlie these findings.

Identifying and Prioritizing Diseases Important for Detection in Adult Hearing Health Care.

PURPOSE: The purpose of this research note is to identify and prioritize diseases important for detection in adult hearing health care delivery systems. METHOD: Through literature review and expert consultation, the authors identified 195 diseases likely to occur in adults complaining of hearing loss. Five neurotologists rated the importance of disease on 3 dimensions related to the necessity of detection prior to adult hearing aid fitting. RESULTS: Ratings of adverse health consequences, diagnostic difficulty, and presence of nonotologic symptoms associated with these diseases resulted in the identification of 104 diseases potentially important for detection prior to adult hearing aid fitting. CONCLUSIONS: Current and evolving health care delivery systems, including direct-to-consumer sales, involve inconsistent means of disease detection vigilance prior to device fitting. The first steps in determining the safety of these different delivery methods are to identify and prioritize which diseases present the greatest risk for poor health outcomes and, thus, should be detected in hearing health care delivery systems. Here the authors have developed a novel multidimensional rating system to rank disease importance. The rankings can be used to evaluate the effectiveness of alternative detection methods and to inform public health policy. The authors are currently using this information to validate a consumer questionnaire designed to accurately identify when pre- fitting medical evaluations should be required for hearing aid patients.