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.

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.

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.

Supporting Evidence-Informed Teaching in Biomedical and Health Professions Education Through Knowledge Translation: An Interdisciplinary Literature Review.

Phenomenon: The purpose of "systematic" reviews/reviewers of medical and health professions educational research is to identify best practices. This qualitative article explores the question of whether systematic reviews can support "evidence informed" teaching and contrasts traditional systematic reviewing with a knowledge translation (KT) approach to this objective. APPROACH: Degrees of freedom analysis (DOFA) is used to examine the alignment of systematic review methods with educational research and the pedagogical strategies and approaches that might be considered with a decision-making framework developed to support valid assessment. This method is also used to explore how KT can be used to inform teaching and learning. FINDINGS: The nature of educational research is not compatible with most (11/14) methods for systematic review. The inconsistency of systematic reviewing with the nature of educational research impedes both the identification and implementation of "best-evidence" pedagogy and teaching. This is primarily because research questions that do support the purposes of review do not support educational decision making. By contrast to systematic reviews of the literature, both a DOFA and KT are fully compatible with informing teaching using evidence. A DOFA supports the translation of theory to a specific teaching or learning case, so could be considered a type of KT. The DOFA results in a test of alignment of decision options with relevant educational theory, and KT leads to interventions in teaching or learning that can be evaluated. Examples of how to structure evaluable interventions are derived from a KT approach that are simply not available from a systematic review. Insights: Systematic reviewing of current empirical educational research is not suitable for deriving or supporting best practices in education. However, both "evidence-informed" and scholarly approaches to teaching can be supported as KT projects, which are inherently evaluable and can generate actionable evidence about whether the decision or intervention worked for students, instructors, and the institution. A DOFA can also support evidence- and theory-informed teaching to develop an understanding of what works, why, and for whom. Thus KT, but not systematic reviewing, can support decision making around pedagogy (and pedagogical innovation) that can also inform new teaching and learning initiatives; it can also point to new avenues of empirical research in education that are informed by, and can inform, theory.

Examination of the Factor Structure of a Global Cognitive Function Battery across Race and Time.

Older African Americans tend to perform more poorly on cognitive function tests than older Whites. One possible explanation for their poorer performance is that the tests used to assess cognition may not reflect the same construct in African Americans and Whites. Therefore, we tested measurement invariance, by race and over time, of a structured 18-test cognitive battery used in three epidemiologic cohort studies of diverse older adults. Multi-group confirmatory factor analyses were carried out with full-information maximum likelihood estimation in all models to capture as much information as was present in the observed data. Four different aspects of the data were fit to each model: comparative fit index (CFI), standardized root mean square residuals (SRMR), root mean square error of approximation (RMSEA), and model $$\chi ^{2} $$ . We found that the most constrained model fit the data well (CFI=0.950; SRMR=0.051; RMSEA=0.057 (90% confidence interval: 0.056, 0.059); the model $$\chi ^{2} $$ =4600.68 on 862 df), supporting the characterization of this model of cognitive test scores as invariant over time and racial group. These results support the conclusion that the cognitive test battery used in the three studies is invariant across race and time and can be used to assess cognition among African Americans and Whites in longitudinal studies. Furthermore, the lower performance of African Americans on these tests is not due to bias in the tests themselves but rather likely reflect differences in social and environmental experiences over the life course. (JINS, 2016, 22, 66-75).

Cardiometabolic Syndrome in People With Spinal Cord Injury/Disease: Guideline-Derived and Nonguideline Risk Components in a Pooled Sample.

OBJECTIVE: To assess cardiometabolic syndrome (CMS) risk definitions in spinal cord injury/disease (SCI/D). DESIGN: Cross-sectional analysis of a pooled sample. SETTING: Two SCI/D academic medical and rehabilitation centers. PARTICIPANTS: Baseline data from subjects in 7 clinical studies were pooled; not all variables were collected in all studies; therefore, participant numbers varied from 119 to 389. The pooled sample included men (79%) and women (21%) with SCI/D >1 year at spinal cord levels spanning C3-T2 (American Spinal Injury Association Impairment Scale [AIS] grades A-D). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We computed the prevalence of CMS using the American Heart Association/National Heart, Lung, and Blood Institute guideline (CMS diagnosis as sum of risks ≥3 method) for the following risk components: overweight/obesity, insulin resistance, hypertension, and dyslipidemia. We compared this prevalence with the risk calculated from 2 routinely used nonguideline CMS risk assessments: (1) key cut scores identifying insulin resistance derived from the homeostatic model 2 (HOMA2) method or quantitative insulin sensitivity check index (QUICKI), and (2) a cardioendocrine risk ratio based on an inflammation (C-reactive protein [CRP])-adjusted total cholesterol/high-density lipoprotein cholesterol ratio. RESULTS: After adjustment for multiple comparisons, injury level and AIS grade were unrelated to CMS or risk factors. Of the participants, 13% and 32.1% had CMS when using the sum of risks or HOMA2/QUICKI model, respectively. Overweight/obesity and (pre)hypertension were highly prevalent (83% and 62.1%, respectively), with risk for overweight/obesity being significantly associated with CMS diagnosis (sum of risks, χ(2)=10.105; adjusted P=.008). Insulin resistance was significantly associated with CMS when using the HOMA2/QUICKI model (χ(2)2=21.23, adjusted P<.001). Of the subjects, 76.4% were at moderate to high risk from elevated CRP, which was significantly associated with CMS determination (both methods; sum of risks, χ(2)2=10.198; adjusted P=.048 and HOMA2/QUICKI, χ(2)2=10.532; adjusted P=.04). CONCLUSIONS: As expected, guideline-derived CMS risk factors were prevalent in individuals with SCI/D. Overweight/obesity, hypertension, and elevated CRP were common in SCI/D and, because they may compound risks associated with CMS, should be considered population-specific risk determinants. Heightened surveillance for risk, and adoption of healthy living recommendations specifically directed toward weight reduction, hypertension management, and inflammation control, should be incorporated as a priority for disease prevention and management.

The Mastery Rubric for Evidence-Based Medicine: Institutional Validation via Multidimensional Scaling.

UNLABELLED: CONSTRUCT: In this study we describe a multidimensional scaling (MDS) exercise to validate the curricular elements composing a new Mastery Rubric (MR) for a curriculum in evidence-based medicine (EBM). This MR-EBM comprises 10 elements of knowledge, skills, and abilities (KSAs) representing our institutional learning goals of career-spanning engagement with EBM. An MR also includes developmental trajectories for each KSA, beginning with medical school coursework, including residency training, and outlining the qualifications of individuals to teach and mentor in EBM. The development was not part of the validation effort, as our curriculum is focused at a single stage (undergraduate medical students). BACKGROUND: An MR comprises the desired KSAs for an entire curriculum, together with descriptions of a learner's performance and/or capabilities as they develop from novice to proficiency of the curricular target(s). The MR construct is intended to support curriculum development or refinement by capturing the KSAs that support the articulation of concrete learning goals; it also promotes assessment that demonstrates development in the target KSAs and encourages reflection and self-directed learning throughout the learner's career. Two other MRs have been published, and this is the first one specific to teaching and learning in medicine; this is also the first one created specifically to evaluate an existing curriculum. APPROACH: To validate the dispersion of the elements of the EBM curriculum, the nine clinical instructors in the EBM two-course curriculum completed an MDS exercise, rating the similarities of the 10 curricular elements. MDS is a mathematical approach to understanding relationships among concepts/objects when these relationships are difficult to quantify. Eliciting similarity ratings biased the responses toward the null hypothesis (that the elements are not different). RESULTS: MDS results suggested that the MR represents 10 different, although related, facets of the construct "evidence-based medicine." The results support the makeup of the MR-EBM, and its use to revise our EBM curriculum so that it is more closely aligned with this MR. CONCLUSIONS: An MR is a tool, and the MR-EBM that we describe can be useful to develop or evaluate a curriculum in EBM. The MR tool is particularly compatible with the objectives of training for EBM and practice and can be applied to create or evaluate a curriculum using any topical KSA framework. The MR-EBM we describe could be adopted or adapted to represent other institutional objectives for EBM training.

Using Ethical Reasoning to Amplify the Reach and Resonance of Professional Codes of Conduct in Training Big Data Scientists.

The use of Big Data--however the term is defined--involves a wide array of issues and stakeholders, thereby increasing numbers of complex decisions around issues including data acquisition, use, and sharing. Big Data is becoming a significant component of practice in an ever-increasing range of disciplines; however, since it is not a coherent "discipline" itself, specific codes of conduct for Big Data users and researchers do not exist. While many institutions have created, or will create, training opportunities (e.g., degree programs, workshops) to prepare people to work in and around Big Data, insufficient time, space, and thought have been dedicated to training these people to engage with the ethical, legal, and social issues in this new domain. Since Big Data practitioners come from, and work in, diverse contexts, neither a relevant professional code of conduct nor specific formal ethics training are likely to be readily available. This normative paper describes an approach to conceptualizing ethical reasoning and integrating it into training for Big Data use and research. Our approach is based on a published framework that emphasizes ethical reasoning rather than topical knowledge. We describe the formation of professional community norms from two key disciplines that contribute to the emergent field of Big Data: computer science and statistics. Historical analogies from these professions suggest strategies for introducing trainees and orienting practitioners both to ethical reasoning and to a code of professional conduct itself. We include two semester course syllabi to strengthen our thesis that codes of conduct (including and beyond those we describe) can be harnessed to support the development of ethical reasoning in, and a sense of professional identity among, Big Data practitioners.

Systematic training in internal medicine-pediatrics end of residency handoffs: residency director attitudes and perceived barriers.

BACKGROUND: It is unclear why systematic training in end-of-residency clinic handoffs is not universal. PURPOSES: We assessed Internal Medicine-Pediatrics (Med-Peds) residency program directors' attitudes regarding end-of-residency clinic handoff systems and perceived barriers to their implementation. METHODS: We surveyed all Med-Peds program directors in the United States about end-of-residency outpatient handoff systems. RESULTS: Program directors rated systems as important (81.5%), but only 31 programs (46.3%) utilized them. Nearly all programs with (29/31 [93.5%]), and most programs without systems (24/33 [72.7%]) rated them as important. Programs were more likely to have a system if the program director rated it important (p = .049), and less likely if they cited a lack of faculty interest (p = .023) or difficulty identifying residents as primary providers (p = .04). CONCLUSIONS: Most program directors believe it important to formally hand off outpatients. Barriers to establishing handoff systems can be overcome with modest curricular and cultural changes.

Multiple choice questions can be designed or revised to challenge learners' critical thinking.

Multiple choice (MC) questions from a graduate physiology course were evaluated by cognitive-psychology (but not physiology) experts, and analyzed statistically, in order to test the independence of content expertise and cognitive complexity ratings of MC items. Integration of higher order thinking into MC exams is important, but widely known to be challenging-perhaps especially when content experts must think like novices. Expertise in the domain (content) may actually impede the creation of higher-complexity items. Three cognitive psychology experts independently rated cognitive complexity for 252 multiple-choice physiology items using a six-level cognitive complexity matrix that was synthesized from the literature. Rasch modeling estimated item difficulties. The complexity ratings and difficulty estimates were then analyzed together to determine the relative contributions (and independence) of complexity and difficulty to the likelihood of correct answers on each item. Cognitive complexity was found to be statistically independent of difficulty estimates for 88 % of items. Using the complexity matrix, modifications were identified to increase some item complexities by one level, without affecting the item's difficulty. Cognitive complexity can effectively be rated by non-content experts. The six-level complexity matrix, if applied by faculty peer groups trained in cognitive complexity and without domain-specific expertise, could lead to improvements in the complexity targeted with item writing and revision. Targeting higher order thinking with MC questions can be achieved without changing item difficulties or other test characteristics, but this may be less likely if the content expert is left to assess items within their domain of expertise.

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.

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.

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.

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.

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.