Defining "Ethical Mathematical Practice" Through Engagement with Discipline-Adjacent Practice Standards and the Mathematical Community.

This project explored what constitutes "ethical practice of mathematics". Thematic analysis of ethical practice standards from mathematics-adjacent disciplines (statistics and computing), were combined with two organizational codes of conduct and community input resulting in over 100 items. These analyses identified 29 of the 52 items in the 2018 American Statistical Association Ethical Guidelines for Statistical Practice, and 15 of the 24 additional (unique) items from the 2018 Association of Computing Machinery Code of Ethics for inclusion. Three of the 29 items synthesized from the 2019 American Mathematical Society Code of Ethics, and zero of the Mathematical Association of America Code of Ethics, were identified as reflective of "ethical mathematical practice" beyond items already identified from the other two codes. The community contributed six unique items. Item stems were standardized to, "The ethical mathematics practitioner…". Invitations to complete the 30-min online survey were shared nationally (US) via Mathematics organization listservs and other widespread emails and announcements. We received 142 individual responses to the national survey, 75% of whom endorsed 41/52 items, with 90-100% endorsing 20/52 items on the survey. Items from different sources were endorsed at both high and low rates. A final thematic analysis yielded 44 items, grouped into "General" (12 items), "Profession" (10 items) and "Scholarship" (11 items). Moreover, for the practitioner in a leader/mentor/supervisor/instructor role, there are an additional 11 items (4 General/7 Professional). These results suggest that the community perceives a much wider range of behaviors by mathematicians to be subject to ethical practice standards than had been previously included in professional organization codes. The results provide evidence against the argument that mathematics practitioners engaged in "pure" or "theoretical" work have minimal, small, or no ethical obligations.

Urinary Symptoms Among People With Neurogenic Lower Urinary Tract Dysfunction (NLUTD) Vary by Bladder Management.

Objectives: To determine whether assessment and decision-making around urinary symptoms in people with neurogenic lower urinary tract dysfunction (NLUTD) should depend on bladder management. Methods: Three surveys of urinary symptoms associated with NLUTD (USQNBs) were designed specific to bladder management method for those who manage their bladders with indwelling catheter (IDC), intermittent catheter (IC), or voiding (V). Each was deployed one time to a national sample. Subject matter experts qualitatively assessed the wording of validated items to identify potential duplicates. Clustering by unsupervised structural learning was used to analyze duplicates. Each item was classified into mutually exclusive and exhaustive categories: clinically actionable ("fever"), bladder-specific ("suprapubic pain"), urine quality ("cloudy urine"), or constitutional ("leg pain"). Results: A core of 10 "NLUTD urinary symptoms" contains three clinically actionable, bladder-specific, and urine quality items plus one constitutional item. There are 9 (IDC), 11 (IC), and 8 (V) items unique to these instruments. One decision-making protocol applies to all instruments. Conclusion: Ten urinary symptoms in NLUTD are independent of bladder management, whereas a similar number depend on bladder management. We conclude that assessment of urinary symptoms for persons with NLUTD should be specific to bladder management method, like the USQNBs are.

An international consensus on effective, inclusive, and career-spanning short-format training in the life sciences and beyond.

Science, technology, engineering, mathematics, and medicine (STEMM) fields change rapidly and are increasingly interdisciplinary. Commonly, STEMM practitioners use short-format training (SFT) such as workshops and short courses for upskilling and reskilling, but unaddressed challenges limit SFT's effectiveness and inclusiveness. Education researchers, students in SFT courses, and organizations have called for research and strategies that can strengthen SFT in terms of effectiveness, inclusiveness, and accessibility across multiple dimensions. This paper describes the project that resulted in a consensus set of 14 actionable recommendations to systematically strengthen SFT. A diverse international group of 30 experts in education, accessibility, and life sciences came together from 10 countries to develop recommendations that can help strengthen SFT globally. Participants, including representation from some of the largest life science training programs globally, assembled findings in the educational sciences and encompassed the experiences of several of the largest life science SFT programs. The 14 recommendations were derived through a Delphi method, where consensus was achieved in real time as the group completed a series of meetings and tasks designed to elicit specific recommendations. Recommendations cover the breadth of SFT contexts and stakeholder groups and include actions for instructors (e.g., make equity and inclusion an ethical obligation), programs (e.g., centralize infrastructure for assessment and evaluation), as well as organizations and funders (e.g., professionalize training SFT instructors; deploy SFT to counter inequity). Recommendations are aligned with a purpose-built framework-"The Bicycle Principles"-that prioritizes evidenced-based teaching, inclusiveness, and equity, as well as the ability to scale, share, and sustain SFT. We also describe how the Bicycle Principles and recommendations are consistent with educational change theories and can overcome systemic barriers to delivering consistently effective, inclusive, and career-spanning SFT.

Urinary Symptoms Are Unrelated to Leukocyte Esterase and Nitrite Among Indwelling Catheter Users.

Objectives: To explore the association between dipstick results and urinary symptoms. Method: This was a prospective 12-month observational study of real-time self-administered urine dipstick results and symptoms in a community setting that included 52 spinal cord injury/disease (SCI/D) participants with neurogenic lower urinary tract dysfunction (NLUTD) who use an indwelling catheter. Symptoms were collected using the Urinary Symptom Questionnaire for Neurogenic Bladder-Indwelling Catheter (USQNB-IDC). The USQNB-IDC includes actionable (A), bladder (B1), urine quality (B2), and other (C) symptoms; analyses focused on A, B1, and B2 symptoms. Dipstick results include nitrite (NIT +/-), and leukocyte esterase (LE; negative, trace, small, moderate, or large). Dipstick outcomes were defined as strong positive (LE = moderate/large and NIT+), inflammation positive (LE = moderate/large and NIT-), negative (LE = negative/trace and NIT-), and indeterminate (all others). Results: Nitrite positive dipsticks and moderate or large LE positive dipsticks were each observed in over 50% of the sample in every week. Strong positive dipstick results were observed in 35% to 60% of participants in every week. A, B1, or B2 symptoms co-occurred less than 50% of the time with strong positive dipsticks, but they also co-occurred with negative dipsticks. Participants were asymptomatic with a strong positive dipstick an average of 30.2% of the weeks. On average, 73% of the time a person had a negative dipstick, they also had no key symptoms (95% CI, .597-.865). Conclusion: No association was observed between A, B1, and B2 symptoms and positive dipstick. A negative dipstick with the absence of key symptoms may better support clinical decision-making.

Intravesical Lactobacillus rhamnosus GG versus Saline Bladder Wash: Protocol for a Randomized, Controlled, Comparative Effectiveness Clinical Trial.

Background: Complicated urinary tract infection (cUTI) is pervasive and costly among people with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD). Objectives: To describe the protocol for a comparative effectiveness randomized controlled trial of intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash (BW) for self-management of urinary symptoms. Methods: Comparative effectiveness trial of self-administered LGG versus saline bladder wash among 120 participants with SCI+NLUTD at least 6 months post SCI. The study has both treatment and prophylaxis phases. After predictive enrichment at screening, randomized participants will enter the treatment phase (6 months) in which they instill either LGG or normal saline after trigger symptoms occur (more cloudy or more foul-smelling urine). In the prophylaxis phase (6 months), participants will instill their respective intervention every 3 days after the first occurrence of trigger symptoms. Results: Study results will provide a comparison of effects on Urinary Symptom Questionnaire for Neurogenic Bladder (USQNB) bladder and urine symptoms and episodes of "presumed UTIs"; number of days antibiotics were used (both self-reported); days of work, school, rehabilitation, or other activity lost due to urinary symptoms; engagement with the health care system; number of instillations; satisfaction; and safety. Conclusion: cUTI is a variable clinical entity. Unlike clinical trials that assume a single, simple entity (UTI) in inclusion or outcome criteria, this protocol targets the mechanisms underlying cUTI causes and phenotypes. Featuring reliable and valid outcome measures with analytic methods specifically appropriate for quantifying self-report, patient self-management, inclusion of both intervention and prophylactic phases, and predictive enrichment, these design elements may be adopted for future research.

Development and Assessment of SCI Model Systems Complicated UTI Consensus Guidelines: A Psychometrically Designed Mixed-Methods Protocol.

Background: Complicated UTI (cUTI) is highly prevalent among people with spinal cord injury and disease (SCI/D), but neither consistent nor evidence-based guidelines exist. Objectives: We propose a two-phase, mixed-methods study to develop consensus around diagnostic and decision-making criteria for cUTI among people with SCI/D and the clinicians who treat them. Methods: In phase 1 (qualitative), we will engage Spinal Cord Injury Model Systems (SCIMS) clinicians in focus groups to refine existing cUTI-related decision making using three reliable and validated Urinary Symptom Questionnaires for Neurogenic Bladder (USQNBs; intermittent catheterization, indwelling catheterization, and voiding) as points of departure, and then we will conduct a Delphi survey to explore and achieve consensus on cUTI diagnostic criteria among a nationally representative sample of clinicians from physical medicine and rehabilitation, infectious disease, urology, primary care, and emergency medicine. We will develop training materials based on these new guidelines and will deploy the training to both clinicians and consumers nationally. In phase 2 (quantitative), we will assess clinicians' uptake and use of the guidelines, and the impact of the guidelines training on consumers' self-management habits, engagement with the health care system, and antibiotic use over the 12 months after training. Results: The output of this study will be diagnostic guidelines for cUTI among people with neurogenic lower urinary tract dysfunction (NLUTD) due to SCI/D, with data on uptake (clinicians) and impact (patients). Conclusion: This mixed-methods protocol integrates formal psychometric methods with large-scale evidence gathering to derive consensus around diagnostic guidelines for cUTI among people with NLUTD due to SCI/D and provides information on uptake (clinicians) and impact (patients).

Independence of Urinary Symptoms and Urinary Dipstick Results in Voiders With Neurogenic Bladder.

Background: Urinary symptoms and urinary tract infection (UTI) are frequent and burdensome problems associated with neurogenic lower urinary tract dysfunction. Objectives: To determine whether an association exists between urinary symptoms and urine dipstick results among individuals with spinal cord injury (SCI) or multiple sclerosis (MS). Methods: Prospective 12-month cohort study of 76 participants with SCI or MS who manage their bladders by voiding. Eligibility criteria included adults ≥18 years old, at least three UTIs since diagnosis, and residence in the United States. Participants completed the Urinary Symptoms Questionnaire for Neurogenic Bladder-Voider version (USQNB-V) biweekly (26 assessments) and tested their urine by dipstick at the same time. Symptom burden was estimated based on endorsements of USQNB-V symptoms classified as clinically actionable (9), bladder function (8), and urine quality (4). Urine dipstick results assessed were leukocyte esterase (LE) and nitrite (NIT). Results: Participants were stratified into four groups based on etiology of neurologic dysfunction and whether they ever experienced any urinary symptoms (USx): SCI+USx (n = 14), SCI+NoUSx (n = 5), MS+USx (n = 32), and MS+NoUSx (n = 25). In descending order, symptom burden was greatest for the MS+USx group, followed by both SCI groups; it was lowest for MS+NoUSx. We assessed multiple definitions of "positive" dipstick and found evidence of independence of USQNB-V symptoms and urinary dipstick results with each definition. In each group, the median (and majority) of strong positive dipsticks did not coincide with any symptoms. Conclusion: Among people with SCI or MS who void, self-administered urine dipstick results and urinary symptom reporting contribute independent information for clinical decision making.

Race-Dependent Association of Single-Nucleotide Polymorphisms in TrkB Receptor in People Living with HIV and Depression.

Human immunodeficiency virus (HIV)-associated cognitive disorders (HAND) is characterized by impaired motor and intellectual functions, as well as mood disorders. Brain-derived neurotrophic factor and its receptor TrkB (or NTRK2) mediate the efficacy of antidepressant drugs. Genomic studies of BDNF/TrkB have implicated common single-nucleotide polymorphisms in the pathology of depression. In the current study, we investigated whether single-nucleotide polymorphisms (SNPs) (rs1212171, rs1439050, rs1187352, rs1778933, rs1443445, rs3780645, rs2378672, and rs11140800) in the NTRK2 has a functional impact on depression in HIV-positive subjects. We have utilized the Central Nervous System (CNS) HIV Antiretroviral Therapy Effects Research (CHARTER) cohort. Our methods explored the univariate associations of these SNPs with clinical (current and lifetime) diagnosis of depression via chi-square. The distribution of alleles was significantly different for African-Americans and Caucasians (non-Hispanic) for several SNPs, so our regression analyses included both "statistical controls" for race group and models for each group separately. Finally, we applied a method of simultaneous analysis of associations, estimating the mutually shared information across a system of variables, separately by race group. Our results indicate that there is no significant association between clinical diagnosis of major depression and these SNPs for either race group in any analysis. However, we identified that the SNP associations varied by race group and sex.

Reliability of the Urinary Symptom Questionnaires for people with neurogenic bladder (USQNB) who void or use indwelling catheters.

STUDY DESIGN: This is a descriptive psychometrics study. OBJECTIVES: Neurogenic lower urinary tract dysfunction (NLUTD), also called Neurogenic Bladder (NB), is a common and disruptive condition in a variety of neurologic diagnoses. Our team developed patient-centered instruments, Urinary Symptom Questionnaires for people with neurogenic bladder (USQNB), specific to people with NLUTD who manage their bladders with intermittent catheterization (IC), indwelling catheters (IDC), or who void (V). This article reports evidence of reliability of the IDC and V instruments. SETTING: Online surveys completed by individuals in the United States with NLUTD due to spinal cord injury (SCI), or multiple sclerosis (MS) who manage their bladder with IDC (SCI, n = 306), or by voiding (SCI, n = 103; MS, n = 383). METHODS: Reliability estimates were based on endorsement of the items on the USQNB-IDC and USQNB-V. Reliability evidence was representativeness of these symptoms for a national sample (by determining if endorsement > 10%); internal consistency estimates (by Cronbach's alpha and item correlation coefficient, ICC); and interrelatedness of the items (by inferred Bayesian network, BN). We also tested whether a one-factor conceptualization of "urinary symptoms in NLUTD" was supportable for either instrument. RESULTS: All items were endorsed by >20% of our samples. Urine quality symptoms tended to be the most commonly endorsed on both instruments. Cronbach's alpha and ICC estimates were high (>0.74), but not suggestive of redundancy. BNs showed interpretable associations among the items, and did not discover uninterpretable or unexpected associations. Neither instrument fit a one-factor model, as expected. CONCLUSIONS: The USQNB-IDC and USQNB-V instruments show sufficient, multidimensional reliability for implementation and further study.

Validity of the Urinary Symptom Questionnaires for people with neurogenic bladder (USQNB) who void or use indwelling catheters.

STUDY DESIGN: Descriptive Psychometrics Study OBJECTIVES: Neurogenic lower urinary tract dysfunction (NLUTD), or "neurogenic bladder" is a common and disruptive condition for individuals with spinal cord injury (SCI) and disease (including multiple sclerosis, MS). Our team has developed patient-centered instruments of urinary symptoms specific to patients with NLUTD, across bladder management methods. Validity evidence is needed to support the use of two new instruments, Urinary Symptom Questionnaires for people with Neurogenic Bladder (USQNB) for those who manage their bladder with indwelling catheters (IDC), or who void (V). SETTING: Online surveys completed by individuals in the United States with NLUTD due to either SCI or MS who manage their bladder with indwelling catheters (SCI, n = 306; MS, n = 8), or by voiding (SCI, n = 103; MS, n = 383). A total of n = 381 USQNB-IDC respondents (five control groups), and 351 USQNB-V respondents (four control groups), contributed to our convergent and divergent validity evidence. METHODS: Data were collected online to estimate key aspects of psychometric validity (content, reflection of the construct to be measured; face, recognizability of the contents as representing the construct to be measured; structural, the extent to which the instrument captures recognizable dimensions of the construct to be measured). Divergent and convergent validity evidence was derived from multiple control groups, while evidence of criterion validity was derived from attribution of each item to their experience "with a UTI". RESULTS: Evidence of face, content, criterion, convergent, and divergent validity was compiled for each instrument. CONCLUSIONS: The instruments demonstrate adequate, multi-dimensional, validity evidence to recommend their use for decision-making by patients, clinicians, and researchers.

Clinical Profiles and Symptom Burden Estimates to Support Decision-Making Using the Urinary Symptom Questionnaire for People with Neurogenic Bladder (USQNB) using Intermittent Catheters.

OBJECTIVE: To describe the scoring approach, considering interpretability, validity, and use, of a new patient-centered patient reported outcome (PRO), the Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter version (USQNB-IC). DESIGN: Subject matter experts (researchers, clinicians, a consumer, a psychometrician) classified USQNB-IC items. Profiles were then composed based on self-management decisions made by patients; patient management decisions made by clinicians; and research-oriented decisions made by investigators. Participants in an 18-month pilot study completed the USQNB-IC every week. Differences in decisions based on traditional 'total scores' and profiles were examined. Validity was defined based on alignment of scoring method with decisions. SETTING: A new set of patient-centered PROs enable monitoring and decision-making around urinary signs and symptoms among people with neurogenic bladder (NB). PARTICIPANTS: Classifications of USQNB-IC items by subject matter experts. Utility of the classifications and profiles that were created was assessed using weekly responses from the 6-month baseline period from 103 participants in a pilot study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Classification of the 29 symptoms resulted in four categories with exchangeability within-category and nonexchangeability across categories. The burden of each symptom type is one approach to scoring the USQNB-IC. Five profiles, based on these categories, emerged based on, and supportive of, decisions to be made according to symptoms, representing a categorical approach to scoring the USQNB-IC. RESULTS: USQNB-IC items are not all exchangeable. Four symptom classifications comprise within-class exchangeable items. Five profiles emerged to summarize these items to promote decision-making and identification of change over time. Both ways to "score" the USQNB-IC are described and discussed. CONCLUSIONS: "Profiling" promotes valid and interpretable decisions by patients and clinicians, based on a patient's urinary symptoms with the USQNB-IC cross-sectionally and longitudinally. Alternatively, four subsets of the 29 USQNB-IC symptoms can be used as continuous outcomes representing "burden" in clinical management or research.

Effects of Intravesical Lactobacillus Rhamnosus GG on Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.

OBJECTIVE: To test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC). DESIGN: A three-phase study (6 months each in baseline, intervention, and washout). Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly. SETTING: Nationwide (United States). PARTICIPANTS: Ninety-six adults and seven children with SCI/D. INTERVENTIONS: In response to one or both of the SMP-Pro trigger urinary symptoms, "cloudier" or "foul smelling" urine, participants self-administered using a clean urinary catheter an LGG+ Normal Saline instillate once or twice in a 30-hour period. MAIN OUTCOME MEASURES: Change in USQNB-IC burden was adjusted individually according to the previous phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other. RESULTS: During the intervention phase, participants met SMP-Pro instillation criteria 3.83 times on average (range 1-20). An average of 5.6 doses of LGG were instilled. For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted P < .05). CONCLUSIONS: Self-instilled LGG seemed to improve "clinically actionable" (A) and "urine quality" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesical LGG, and the SMP-Pro for urinary symptoms.

An Actigraphy-Based Validation Study of the Sleep Disorder Inventory in the Nursing Home.

Background: Disrupted sleep is common among nursing home patients with dementia and is associated with increased agitation, depression, and cognitive impairment. Detecting and treating sleep problems in this population are therefore of great importance, albeit challenging. Systematic observation and objective recordings of sleep are time-consuming and resource intensive and self-report is often unreliable. Commonly used proxy-rated scales contain few sleep items, which affects the reliability of the raters' reports. The present study aimed to adapt the proxy-rated Sleep Disorder Inventory (SDI) to a nursing home context and validate it against actigraphy. Methods: Cross-sectional study of 69 nursing home patients, 68% women, mean age 83.5 (SD 7.1). Sleep was assessed with the SDI, completed by nursing home staff, and with actigraphy (Actiwatch II, Philips Respironics). The SDI evaluates the frequency, severity, and distress of seven sleep-related behaviors. Internal consistency of the SDI was evaluated by Cronbach's alpha. Spearman correlations were used to evaluate the convergent validity between actigraphy and the SDI. Test performance was assessed by calculating the sensitivity, specificity, and predictive values, and by ROC curve analyses. The Youden's Index was used to determine the most appropriate cut-off against objectively measured sleep disturbance defined as <6 h nocturnal total sleep time (TST) during 8 h nocturnal bed rest (corresponding to SE <75%). Results: The SDI had high internal consistency and convergent validity. Three SDI summary scores correlated moderately and significantly with actigraphically measured TST and wake-after-sleep-onset. A cut-off score of five or more on the SDI summed product score (sum of the products of the frequency and severity of each item) yielded the best sensitivity, specificity, predictive values, and Youden's Index. Conclusion: We suggest a clinical cut-off for the presence of disturbed sleep in institutionalized dementia patients to be a SDI summed product score of five or more. The results suggest that the SDI can be clinically useful for the identification of disrupted sleep when administered by daytime staff in a nursing home context. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03357328.

The Mastery Rubric for Bioinformatics: A tool to support design and evaluation of career-spanning education and training.

As the life sciences have become more data intensive, the pressure to incorporate the requisite training into life-science education and training programs has increased. To facilitate curriculum development, various sets of (bio)informatics competencies have been articulated; however, these have proved difficult to implement in practice. Addressing this issue, we have created a curriculum-design and -evaluation tool to support the development of specific Knowledge, Skills and Abilities (KSAs) that reflect the scientific method and promote both bioinformatics practice and the achievement of competencies. Twelve KSAs were extracted via formal analysis, and stages along a developmental trajectory, from uninitiated student to independent practitioner, were identified. Demonstration of each KSA by a performer at each stage was initially described (Performance Level Descriptors, PLDs), evaluated, and revised at an international workshop. This work was subsequently extended and further refined to yield the Mastery Rubric for Bioinformatics (MR-Bi). The MR-Bi was validated by demonstrating alignment between the KSAs and competencies, and its consistency with principles of adult learning. The MR-Bi tool provides a formal framework to support curriculum building, training, and self-directed learning. It prioritizes the development of independence and scientific reasoning, and is structured to allow individuals (regardless of career stage, disciplinary background, or skill level) to locate themselves within the framework. The KSAs and their PLDs promote scientific problem formulation and problem solving, lending the MR-Bi durability and flexibility. With its explicit developmental trajectory, the tool can be used by developing or practicing scientists to direct their (and their team's) acquisition of new, or to deepen existing, bioinformatics KSAs. The MR-Bi is a tool that can contribute to the cultivation of a next generation of bioinformaticians who are able to design reproducible and rigorous research, and to critically analyze results from their own, and others', work.

A developmental trajectory supporting the evaluation and achievement of competencies: Articulating the Mastery Rubric for the nurse practitioner (MR-NP) program curriculum.

BACKGROUND: Advanced practice registered nursing (APRN) competencies exist, but there is no structure supporting the operationalization of the competencies by APRN educators. The development of a Mastery Rubric (MR) for APRNs provides a developmental trajectory that supports educational institutions, educators, students, and APRNs. A MR describes the explicit knowledge, skills, and abilities as performed by the individual moving from novice (student) through graduation and into the APRN career. METHOD: A curriculum development tool, the Mastery Rubric (MR), was created to structure the curriculum and career of the nurse practitioner (NP), the MR-NP. Cognitive task analysis (CTA) yielded the first of the three required elements for any MR: a list of knowledge, skills, and abilities (KSAs) to be established through the curriculum. The European guild structure and Bloom's taxonomy of cognitive behaviors provided the second element of the MR, the specific developmental stages that are relevant for the curriculum. The Body of Work method of standard setting was used to create the third required element of the MR, performance level descriptors (PLDs) for each KSA at each of these stages. Although the CTA was informed by the competencies, it was still necessary to formally assess the alignment of competencies with the resulting KSAs; this was achieved via Degrees of Freedom Analysis (DoFA). Validity evidence was obtained from this Analysis and from the DoFA of the KSAs' alignment with principles of andragogy, and with learning outcomes assessment criteria. These analyses are the first time the national competencies for the NP have been evaluated in this manner. RESULTS: CTA of the 43 NP Competencies led to seven KSAs that support a developmental trajectory for instruction and documenting achievement towards independent performance on the competencies. The Competencies were objectively evaluable for the first time since their publication due to the psychometric validity attributes of the PLD-derived developmental trajectory. Three qualitatively distinct performance levels for the independent practitioner make the previously implicit developmental requirements of the competencies explicit for the first time. DISCUSSION: The MR-NP provides the first articulated and observable developmental trajectory for the NP competencies, during and beyond the formal curriculum. A focus on psychometric validity was brought to bear on how learners would demonstrate their development, and ultimately their achievement, of the competencies. The MR-NP goes beyond the competencies with trajectories and PLDs that can engage both learner and instructor in this developmental process throughout the career.

Intravesical Lactobacillus rhamnosus GG is safe and well tolerated in adults and children with neurogenic lower urinary tract dysfunction: first-in-human trial.

BACKGROUND: Urinary symptoms are common for people with neurogenic lower urinary tract dysfunction (NLUTD). No nonprescription approach has been proven safe and effective for self-management of urinary symptoms. Our objective was to describe the safety and tolerability of Lactobacillus rhamnosus GG (LGG®) instilled intravesically for self-management of inflammatory urinary symptoms in adults and children with NLUTD due to spinal cord injury or disease (SCI/D) and who use intermittent catheterization (IC). METHODS: A total of 103 individuals with SCI/D enrolled in an 18-month study consisting of three 6-month stages: baseline (weekly observation of urinary symptoms); intervention (self-instilled intravesical LGG® in response to more cloudy or foul-smelling urine); and washout (weekly observation of urinary symptoms). Urinary symptoms were assessed using the Urinary Symptom Questionnaire for people with neurogenic bladder using intermittent catheters (USQNB-IC). Safety was based on serious adverse events and adverse events (S/AEs) and trends in symptoms. Tolerability was defined as the independence of AE experience and willingness to use/pay for this intervention. RESULTS: A total of 74 (77%) adults and 6 (86%) of children completed the study, of whom 64 instilled LGG® for a total of 357 instillations (range 1-41 per person). There were 59 S/AEs, 44% (26/59) of which were categorized as infectious genitourinary. There was no statistical relationship between S/AEs and use or dose of the intervention. CONCLUSIONS: One or two doses of self-instilled intravesical LGG® in response to more cloudy or foul-smelling urine was safe and well tolerated among this sample of adults and children with SCI/D who have NLUTD and use IC.

Degrees of freedom analysis in educational research and decision-making: leveraging qualitative data to promote excellence in bioinformatics training and education.

Qualitative data are commonly collected in higher, graduate and postgraduate education; however, perhaps especially in the quantitative sciences, utilization of these qualitative data for decision-making can be challenging. A method for the analysis of qualitative data is the degrees of freedom analysis (DoFA), published in 1975. Given its origins in political science and its application in mainly business contexts, the DoFA method is unlikely to be discoverable or used to understand survey or other educational data obtained from teaching, training or evaluation. This article therefore introduces and demonstrates the DoFA with modifications specifically to support educational research and decision-making with examples in bioinformatics. DoFA identifies and aligns theoretical or applied principles with qualitative evidence. The demonstrations include two hypothetical examples, and a case study of the role of scaffolding in an independent project ('capstone') of a graduate course in biostatistics. Included to promote inquiry, inquiry-based learning and the development of research skills, the capstone is often scaffolded (instructor-supported and therefore, formative), although it is intended to be summative. The case analysis addresses the question of whether the scaffolding provided for a capstone assignment affects its utility for formative or summative assessment. The DoFA is also used to evaluate the relative efficacies of other models for scaffolding the capstone project. These examples are intended to both explain this method and to demonstrate how it can be used to make decisions within a curriculum or for bioinformatics training.

A new pan-European Train-the-Trainer programme for bioinformatics: pilot results on feasibility, utility and sustainability of learning.

Demand for training life scientists in bioinformatics methods, tools and resources and computational approaches is urgent and growing. To meet this demand, new trainers must be prepared with effective teaching practices for delivering short hands-on training sessions-a specific type of education that is not typically part of professional preparation of life scientists in many countries. A new Train-the-Trainer (TtT) programme was created by adapting existing models, using input from experienced trainers and experts in bioinformatics, and from educational and cognitive sciences. This programme was piloted across Europe from May 2016 to January 2017. Preparation included drafting the training materials, organizing sessions to pilot them and studying this paradigm for its potential to support the development and delivery of future bioinformatics training by participants. Seven pilot TtT sessions were carried out, and this manuscript describes the results of the pilot year. Lessons learned include (i) support is required for logistics, so that new instructors can focus on their teaching; (ii) institutions must provide incentives to include training opportunities for those who want/need to become new or better instructors; (iii) formal evaluation of the TtT materials is now a priority; (iv) a strategy is needed to recruit, train and certify new instructor trainers (faculty); and (v) future evaluations must assess utility. Additionally, defining a flexible but rigorous and reliable process of TtT 'certification' may incentivize participants and will be considered in future.

Preliminary validation of a Urinary Symptom Questionnaire for individuals with Neuropathic Bladder using Intermittent Catheterization (USQNB-IC): A patient-centered patient reported outcome.

BACKGROUND: We developed a Urinary Symptom Questionnaire for individuals with neurogenic bladder due to spinal cord injury (SCI) and spina bifida (SB) who manage their bladders with intermittent catheterization, the USQNB-IC. This project followed an approach to patient-centered patient reported outcomes development that we created and published in 2017, specifically to ensure the primacy of the patient's perspective and experience. PARTICIPANTS: Two sets of responses were collected from individuals with neurogenic bladder due to either SCI (n = 336) and SB (patients, n = 179; and caregivers of patients with NB, n = 66), and three sets of "controls", individuals with neurogenic bladder who do not have a history of UTIs (n = 49) individuals with chronic mobility impairments (neither SCI nor SB) and without neurogenic bladder (n = 46), and those with no mobility impairment, no neurogenic bladder, and no history of UTIs (n = 64). METHOD: Data were collected from all respondents to estimate these psychometric or measurement domains characterizing a health related PRO: Reliability (minimization of measurement error; internal consistency or interrelatedness of the items; and maximization of variability that is due to "true" difference between levels of the symptoms across patients), and validity (content, reflection of the construct to be measured; face, recognizability of the contents as representing the construct to be measured; structural, the extent to which the instrument captures recognizable dimensions of the construct to be measured; and criterion, association with a gold standard). RESULTS: Evidence from these five groups of respondents suggest the instrument has face, content, criterion, convergent, and divergent validity, as well as reliability. The items were all more descriptive of our patient (focus) groups and were only weakly endorsed by the control groups. CONCLUSIONS: The instrument is unique in its emphasis on, and origination from, the lived experiences of patients with neurogenic bladder who use intermittent catheterization; this preliminary psychometric evidence suggests the instrument could be useful for research and in the clinic. These results justify further development of the instrument, including formal exploration of the scoring and estimation of responsivity of these items to clinical interventions as well as patient-directed self care.

Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes.

The objectives of this study were to describe and demonstrate a new model of developing patient reported outcomes (PROs) that are patient-centered, and to test the hypothesis that following this model would result in a qualitatively different PRO than if the typical PRO development model were followed. The typical process of developing PROs begins with an initial list of signs or symptoms originating from clinicians or PRO developers; patient validation of this list ensures that the list (i.e., the new PRO) is interpretable by patients, but not that patient perspectives are central or even represented. The new model begins with elicitation from clinicians and patients independently and separately. These perspectives are formally analyzed qualitatively, and the results are iteratively integrated by researchers, supporting clinical relevance and patient centeredness. We describe the application of this new model to the development of a PRO for urinary signs and symptoms in individuals with neuropathic bladder, and test the hypothesis that the two processes generate qualitatively different instruments using a national validation sample of 300 respondents. Of its 29 items, the new instrument included 13 signs/symptoms derived from existing clinical practice guidelines, with 16 others derived from the patient/focus groups. The three most-endorsed items came from the patients, and the three least-endorsed items came from clinical guidelines. Thematic qualitative analysis of the elicitation process, as well as the results from our national sample, support the conclusion that the new model yields an instrument that is clinically interpretable, but more patient-centered, than the typical model would have done in this context.