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Authorship and dissemination policies vary across NIH research consortia. We aimed to describe elements of real-life policies in use by eligible U01 clinical research consortia. Principal investigators of eligible, active U01 clinical research projects identified in the NIH Research Portfolio Online Reporting Tools database shared relevant policies. The characteristics of key policy elements, determined a priori, were reviewed and quantified, when appropriate. Twenty one of 81 research projects met search criteria and provided policies. K elements (e.g., in quotations): manuscript proposals reviewed and approved by committee (90%); guidelines for acknowledgements (86%); writing team formation (71%); process for final manuscript review and approval (71%), responsibilities for lead author (67%), guidelines for other types of publications (67%); draft manuscript review and approval (62%); recommendation for number of members per consortium site (57%); and requirement to identify individual contributions in the manuscript (19%). Authorship/dissemination policies for large team science research projects are highly variable. Creation of an NIH policies repository and accompanying toolkit with model language and recommended key elements could improve comprehensiveness, ethical integrity, and efficiency in team science work while reducing burden and cost on newly funded consortia and directing time and resources to scientific endeavors.

BACKGROUND: Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. OBJECTIVE: This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. STUDY DESIGN: A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed-effects intraclass correlation coefficient models. Chi-square, Fisher exact, or t-tests were used for mode comparisons. Convergent validity was evaluated using Pearson correlations with the external construct measures, and known-group validity was established with comparison of women known and unknown to be symptomatic of urinary conditions. RESULTS: The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbachs alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. CONCLUSION: The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in womens health research.

BackgroundLower urinary tract symptoms (LUTS) are common in children and adolescents. Non-invasive tests evaluating bladder function are generally preferred over invasive tests, yet few studies have explored the range of normative values for these tests in healthy, asymptomatic children.ObjectiveTo define normative reference ranges for non-invasive tests of bladder function in healthy, asymptomatic girls and adolescents.Study designA comprehensive search strategy was performed in seven electronic databases through October 2019. English-language studies reporting data on voiding frequency, voided and postvoid residual volumes (PVR) and uroflowmetry results in healthy, asymptomatic girls (mean age ≥ 5 years) were included. Two independent reviewers performed study review, data extraction, and quality assessment. Overall mean estimates and 95% confidence intervals for each bladder function parameter were calculated using random effects models, and 95% normative reference values were estimated.ResultsTen studies met eligibility criteria for the meta-analysis (n = 2143 girls, age range: 3-18). Mean estimates of maximum voided volume and PVR were 233.4 ml (95% CI 204.3-262.6; n = 1 study) and 8.6 ml (95% CI 4.8-12.4; n = 2 studies) respectively. Pooled mean estimates for uroflowmetry parameters were: 21.5 ml/s (95% CI 20.5-2.5) for maximum flow rate (n = 6 studies), 12.5 ml/s (95% CI 11.2-13.8) for mean flow rate (n = 6 studies), 6.8 s (95% CI 4.4-9.3) for time to maximum flow (n = 3 studies), 15.7 s (95% CI 13.0-18.5) for flow time (n = 3 studies), and 198.7 ml (95% CI 154.2-234.2) for voided volume (n = 9 studies). No studies reported estimates of voiding frequency. Between-study heterogeneity was high (89.0-99.6%).ConclusionsAlthough we were able to calculate pooled mean estimates for several parameters, the small number of included studies and the wide age ranges of participants preclude generalization of reference values to all healthy girls. Further research is needed to determine normative reference values within specific age groups.

Background: Little research to date has investigated the spectrum of bladder health in women, including both bladder function and well-being. Therefore, we expanded our previous baseline analysis of bladder health in the Boston Area Community Health (BACH) Survey to incorporate several additional measures of bladder-related well-being collected at the 5-year follow-up interview, including one developed specifically for women. Methods: At follow-up, participants reported their frequency of 15 lower urinary tract symptoms (LUTS), degree of life impact from and thought related to urinary symptoms or pelvic/bladder pain/discomfort, and perception of their bladder condition. Prevalence ratios were calculated by generalized linear models with robust variance estimation, adjusting for LUTS risk factors and individual LUTS. The BACH Survey was approved by the New England Research Institutes Institutional Review Board and all participants provided written informed consent. Results: Generally similar findings were observed in the 5-year cross-sectional analysis as at baseline, irrespective of how we categorized LUTS or measured bladder-related well-being. Approximately one in five women (16.2%-18.0% of 2527 eligible women) reported no LUTS and no diminished bladder-related well-being, the majority (55.8%-65.7%) reported some LUTS and/or diminished well-being, and a further one in five (16.9%-26.6%) reported the maximum frequency, number, or degree of LUTS and/or diminished well-being. Measures of storage function (urinating again after

AIMS: Prior research on lower urinary tract symptoms (LUTS) has focused on the treatment and management of these conditions with scant attention to prevention. The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was formed to address the complexities of preventing LUTS and promoting bladder health. METHODS: Herein, we describe challenges faced and strategies used to develop the PLUS Research Consortium into an engaged and productive transdisciplinary scientific team. We apply four previously defined team science phases (development, conceptualization, implementation, and translation) to frame our progress. RESULTS: Strategies to progress through the development phase included the generation of a shared mission, and valuing of other disciplinary perspectives. The conceptualization phase included generating a shared language and developing a team transdisciplinary orientation. During the implementation phase, the group developed roles and procedures and focused on conflict management. The translation phase includes continued refinement of the mission and goals, implementation of research protocols, and robust dissemination of the scientific work products related to bladder health. CONCLUSION: A diverse group has matured into a productive transdisciplinary team science consortium. Achieving this outcome required dedicated effort for each member to engage in activities that often required more time than single discipline research activities. Provision of the necessary time and tools has fostered a transdisciplinary team science culture and rich research agenda that reflects the complexity of the health issue to be addressed. Our experience may be useful for others embarking on team science projects.

AimTo report research terminology and definitions for describing healthy bladder function among women and girls.MethodsThe Prevention of Lower Urinary tract Symptoms (PLUS) Consortium developed research terminology and definitions for elements of healthy bladder function based on existing understanding of storage and emptying functions of the bladder and accepted definitions of lower urinary tract symptoms (LUTS). The novel concept of a bladder "bioregulatory" function was also proposed. Elements of bladder function corresponding to bladder health (BH) and LUTS were developed and refined using an iterative process. A comprehensive reference table structured by bladder function (Storage, Emptying, and Bioregulatory) and elements of each function was created to document proposed research terminology and definitions.ResultsThe BH research definitions for each bladder function are: (1) Storage: the ability to hold urine for a reasonable duration of time and sense bladder fullness without fear of or concern about urgency, discomfort or leakage; (2) Emptying: the ability to empty the bladder completely in a timely, efficient, effortless, comfortable manner; and (3) Bioregulatory: the bladder barrier protects the individual/host from pathogens, chemicals, and malignancy. Research definitions for seven Storage, seven Emptying, and three Bioregulatory elements of function are presented. Novel LUTS research definitions were developed when gaps in existing definitions were identified or nonclinical language was desired.ConclusionsPLUS BH definitions reflect a transdisciplinary approach to standardizing research definitions for elements of bladder function from a perspective of health rather than dysfunction and provide a framework for studying BH in clinical practice, public health promotion, and LUTS prevention.

Background: Little research to date has focused on lower urinary tract symptom (LUTS) prevention and bladder health promotion in women. To address this gap, the Prevention of LUTS Research Consortium developed the following working bladder health definition: "A complete state of physical, mental, and social well-being related to bladder function [that] permits daily activities [and] allows optimal well-being." To begin to inform and quantify this definition, we used data from the Boston Area Community Health Survey, drawing upon its rare collection of information on LUTS and LUTS-specific interference with activities. Methods: At baseline, participants reported their frequency of 15 LUTS and interference with 7 activities. Prevalence ratios (PRs) were calculated by generalized linear models with robust variance estimation, adjusting for LUTS risk factors and individual LUTS. Results: Of the 3169 eligible participants, 17.5% reported no LUTS or interference, whereas the remaining 82.5% reported some frequency of LUTS/interference: 15.1% rarely; 21.7% a few times; 22.6% fairly often/usually; and 22.9% almost always. LUTS independently associated with interference were urgency incontinence, any incontinence, urgency, nocturia, perceived frequency, and urinating again after

Urologic chronic pelvic pain syndrome (UCPPS), which encompasses interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, is characterized by chronic pain in the pelvic region or genitalia that is often accompanied by urinary frequency and urgency. Despite considerable research, no definite aetiological risk factors or effective treatments have been identified. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network uses a novel integrated strategy to characterize UCPPS as a systemic disorder that potentially involves multiple aetiologies. The first phase, MAPP I, included >1,000 participants who completed an intensive baseline assessment followed by a 12-month observational follow-up period. MAPP I studies showed that UCPPS pain and urinary symptoms co-vary, with only moderate correlation, and should be evaluated separately and that symptom flares are common and can differ considerably in intensity, duration and influence on quality of life. Longitudinal clinical changes in UCPPS correlated with structural and functional brain changes, and many patients experienced global multisensory hypersensitivity. Additionally, UCPPS symptom profiles were distinguishable by biological correlates, such as immune factors. These findings indicate that patients with UCPPS have objective phenotypic abnormalities and distinct biological characteristics, providing a new foundation for the study and clinical management of UCPPS.

AimsChronic, infrequent voiding may be a risk factor for lower urinary tract symptoms (LUTS) in women. To inform this hypothesis, we conducted a rapid literature review and meta-analysis of LUTS by occupation as an indirect measure of infrequent voiding behaviors.MethodsTwo independent medical librarians searched Pubmed.gov studies (1990-2017) on adult women for occupations, industries, and workplace environment and LUTS outcomes: overactive bladder (OAB), urinary incontinence (UI), urinary tract infections (UTIs), and individual voiding and storage LUTS. Two authors reviewed full text articles meeting content criteria. Among studies with similar UI definitions, we estimated the prevalence of monthly UI using a random effects meta-analysis model.ResultsOf 1078 unique citations identified, 113 underwent full article review and 33 met inclusion criteria. Twenty-six of these studies examined specific occupation groups, including nurses/midwives (n = 6 studies), healthcare workers/support staff (n = 6), military personnel (n = 3), teachers (n = 3), and other groups (n = 7), whereas eight compared findings across broad occupation groups. UI was reported in 30 studies (23% using validated measures), OAB in 6 (50% validated), and UTIs in 2 (non-validated). In pooled models, the degree of heterogeneity was too high (I2  = 96.9-99.2%) among the studies to perform valid prevalence estimates for LUTS.ConclusionsCurrent literature limits the ability to evaluate LUTS by occupation types. Future studies should characterize voiding frequency and toilet access in a consistent manner by occupation and explore its relation to LUTS development.

AimsThe Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was established by the National Institutes of Health in 2015 to expand research beyond the detection and treatment of lower urinary tract symptoms (LUTS) to the promotion and preservation of bladder health and prevention of LUTS in girls and women. While many multi-disciplinary scientific networks focus on pelvic floor dysfunction and LUTS, the PLUS Consortium stands alone in its focus on prevention. This article describes the PLUS approach to developing a conceptual framework to guide the Consortium's initial prevention research agenda.MethodsThe conceptual framework was informed by traditional social ecological models of public health, biopsychosocial models of health, Glass and McAtee's Society-Behavior-Biology Nexus, and the World Health Organization's conceptual framework for action on the social determinants of health.ResultsThe PLUS conceptual framework provides a foundation for developing prevention interventions that have the greatest likelihood of promoting and preserving bladder health among diverse populations.ConclusionsPLUS Consortium work is premised on the notion that programs, practices, and policies designed to promote health will have optimal impact if the conceptual foundation upon which efforts are based is comprehensive and informed by multiple disciplines. The PLUS conceptual framework is broadly applicable to domains of health that have historically focused on the treatment of illness and symptoms rather than the promotion of health. It is also applicable to domains of health that have been examined from a predominantly biological or social ecological perspective, without integration of both perspectives.

BACKGROUND:Bladder health in women and girls is poorly understood, in part, due to absence of a definition for clinical or research purposes. This article describes the process used by a National Institutes of Health funded transdisciplinary research team (The Prevention of Lower Urinary Tract Symptoms [PLUS] Consortium) to develop a definition of bladder health. METHODS:The PLUS Consortium identified currently accepted lower urinary tract symptoms (LUTS) and outlined elements of storage and emptying functions of the bladder. Consistent with the World Health Organization's definition of health, PLUS concluded that absence of LUTS was insufficient and emphasizes the bladder's ability to adapt to short-term physical, psychosocial, and environmental challenges for the final definition. Definitions for subjective experiences and objective measures of bladder dysfunction and health were drafted. An additional bioregulatory function to protect against infection, neoplasia, chemical, or biologic threats was proposed. RESULTS:PLUS proposes that bladder health be defined as: "A complete state of physical, mental, and social well-being related to bladder function and not merely the absence of LUTS. Healthy bladder function permits daily activities, adapts to short-term physical or environmental stressors, and allows optimal well-being (e.g., travel, exercise, social, occupational, or other activities)." Definitions for each element of bladder function are reported with suggested subjective and objective measures. CONCLUSIONS:PLUS used a comprehensive transdisciplinary process to develop a bladder health definition. This will inform instrument development for evaluation of bladder health promotion and prevention of LUTS in research and public health initiatives.

Lower urinary tract symptoms (LUTS) are highly prevalent in women, and are expected to impose a growing burden to individuals and society as the population ages. The predominance of research related to LUTS has focused on underlying pathology, disease mechanisms, or the efficacy of treatments for women with LUTS. Although this research has been vital for helping to reduce or ameliorate LUTS conditions, it has done little to prevent the onset of LUTS. Health promotion and prevention require an expansion of scientific inquiry beyond the traditional paradigm of studying disease mechanisms and treatment to the creation of an evidence base to support recommendations for bladder health promotion and, in turn, prevention of LUTS. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) introduced the concept of prevention as an important priority for women's urologic research as a prelude to supporting the formation of the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium. In this article, we introduce the PLUS research consortium to the scientific community; share the innovative paradigms by which the consortium operates; and describe its unique research mission: to identify factors that promote bladder health across the life course and prevent the onset of LUTS in girls and women.

ObjectiveTo describe guideline adherence for patients with suspected upper tract stones.Patients and methodsWe performed a cross-sectional analysis of visits recorded by the National Hospital Ambulatory Medical Care Survey (emergency department [ED] component) in 2007-2010 (most recent data). We assessed adherence to clinical guidelines for diagnostic laboratory testing, imaging, and pharmacologic therapy. Multivariable regression models controlled for important covariates.ResultsAn estimated 4,956,444 ED visits for patients with suspected kidney stones occurred during the study period. Guideline adherence was highest for diagnostic imaging, with 3,122,229 (63%) visits providing optimal imaging. Complete guideline-based laboratory testing occurred in only 2 of every 5 visits. Pharmacologic therapy to facilitate stone passage was prescribed during only 17% of eligible visits. In multivariable analysis of guideline adherence, we found little variation by patient, provider, or facility characteristics.ConclusionGuideline-recommended care was absent from a substantial proportion of acute care visits for patients with suspected kidney stones. These failures of care delivery likely increase costs and temporary disability. Targeted interventions to improve guideline adherence should be designed and evaluated to improve care for patients with symptomatic kidney stones.

Authorship and dissemination policies vary across NIH research consortia. We aimed to describe elements of real-life policies in use by eligible U01 clinical research consortia. Principal investigators of eligible, active U01 clinical research projects identified in the NIH Research Portfolio Online Reporting Tools database shared relevant policies. The characteristics of key policy elements, determined a priori, were reviewed and quantified, when appropriate. Twenty one of 81 research projects met search criteria and provided policies. K elements (e.g., in quotations): "manuscript proposals reviewed and approved by committee" (90%); "guidelines for acknowledgements" (86%); "writing team formation" (71%); "process for final manuscript review and approval" (71%), "responsibilities for lead author" (67%), "guidelines for other types of publications" (67%); "draft manuscript review and approval" (62%); "recommendation for number of members per consortium site" (57%); and "requirement to identify individual contributions in the manuscript" (19%). Authorship/dissemination policies for large team science research projects are highly variable. Creation of an NIH policies repository and accompanying toolkit with model language and recommended key elements could improve comprehensiveness, ethical integrity, and efficiency in team science work while reducing burden and cost on newly funded consortia and directing time and resources to scientific endeavors. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study is to inform our hypothesis that the workplace toileting environment may impact lower urinary tract symptoms (LUTS); we examined the prevalence of LUTS across occupational groups in the Boston Area Community Health Survey. Methods: At baseline, women (n = 3205) reported their occupation and frequency of 15 LUTS. Using the US Department of Labor's Standard Occupational Classification (SOC) system, we categorized women into 11 standard occupational groups. Prevalence ratios (PRs) were calculated by log‐link generalized linear models, adjusting for age, race, education, fluid intake, and parity. Women classified in Office and Administrative Support were used as the reference group given their potential for fewer workplace toileting restrictions. Results: Of the 3189 women with complete data, 68% of women reported any LUTS, ranging from 57% to 82% across the SOCs. Relative to women in Office and Administrative Support (n = 576), women in Computing, Engineering, and Science (n = 64) were more likely to report any LUTS (PR = 1.2, 95% confidence interval [95% CI]: 1.0–1.4) and urinating again in <2 h (PR = 1.7, 95% CI: 1.4–2.2), and women in Education, Legal, Community Service, Arts, and Media (n = 477), as well as Healthcare Practitioner and Technical Occupations (n = 162), were less likely to report perceived frequent daytime urination (PR = 0.6, 95% CI: 0.5–0.9 and PR = 0.6, 95% CI: 0.4–0.9, respectively). Conclusions: Our cross‐sectional findings suggest that urination frequency varies across understudied occupational groups with various workplace toileting environments. Future studies should examine this relationship prospectively to inform the influence of workplace toileting environments on urination frequency, as well as the development and/or worsening of LUTS. [ABSTRACT FROM AUTHOR]

Purpose: Our goal was to describe changes in bladder health, defined as "a complete state of physical, mental, and social well-being related to bladder function that permits daily activities, adapts to short-term stressors, and allows optimal well-being," in women over time. Materials and Methods: We used data on 15 lower urinary tract symptoms (LUTS) and interference from urinary experiences assessed at the baseline and 5-year followup interviews of the BACH (Boston Area Community Health) Survey to estimate changes in bladder health over time in women. Associations between baseline and followup bladder health (defined as the maximum frequency of LUTS or interference at each time point) were calculated by ordinal logistic regression and generalized linear models. Results: A total of 2,526 women provided complete information on bladder health at baseline and followup. Over the 5-year followup, 6.5% of women maintained optimal bladder health (no LUTS or interference), 33.6% developed worse bladder health (including 10.4% who transitioned from optimal to less than optimal health), 31.4% maintained their less than optimal bladder health status and 28.7% improved. Despite these changes, women with poorer bladder health at baseline were still more likely to have poorer bladder health 5 years later (eg multivariable-adjusted relative risk[3.27, 95% confidence interval: 2.49e4.29 for severe LUTS/interference at followup among those with severe LUTS/interference at baseline). Conclusions: Findings from our large secondary analysis of BACH Survey data suggest considerable variability in bladder health over time, and underscore the importance of bladder health promotion to prevent the initial onset and progression of poor bladder health in women. [ABSTRACT FROM AUTHOR]