Intermittent Catheter Reimbursement in the United States: The Experience of Nine Stakeholders Through the Lens of Actor-Network Theory

A narrow interpretation of “medical necessity” can result in poorer health as well as a more restricted life for people with disabilities. We examined the impact of US policy on reimbursement of intermittent catheters (ICs) on the lives of people with neurogenic bladder (NB) who require catheters to urinate. We conducted in-depth, longitudinal interviews with nine stakeholders. Actor-Network Theory was used to describe interactions among human agents, IC products, and policies in the reimbursement arena. Restrictions on the type and quantities of ICs reimbursed emerged as the most potent inhibitor to health and wellbeing among consumers with NB. IC suppliers, due to the large number of other stakeholders with whom they interact in the reimbursement process, emerged as strong enablers of preferred IC use among people with NB. Lack of an impartial central clearinghouse on IC products and coverage impeded consumers’ ability to make informed decisions

Integrated next-generation sequencing of 16S rDNA and metaproteomics differentiate the healthy urine microbiome from asymptomatic bacteriuria in neuropathic bladder associated with spinal cord injury

Background Clinical dogma is that healthy urine is sterile and the presence of bacteria with an inflammatory response is indicative of urinary tract infection (UTI). Asymptomatic bacteriuria (ABU) represents the state in which bacteria are present but the inflammatory response is negligible. Differentiating ABU from UTI is diagnostically challenging, but critical because overtreatment of ABU can perpetuate antimicrobial resistance while undertreatment of UTI can result in increased morbidity and mortality. In this study, we describe key characteristics of the healthy and ABU urine microbiomes utilizing 16S rRNA gene (16S rDNA) sequencing and metaproteomics, with the future goal of utilizing this information to personalize the treatment of UTI based on key individual characteristics. Methods A cross-sectional study of 26 healthy controls and 27 healthy subjects at risk for ABU due to spinal cord injury-related neuropathic bladder (NB) was conducted. Of the 27 subjects with NB, 8 voided normally, 8 utilized intermittent catheterization, and 11 utilized indwelling Foley urethral catheterization for bladder drainage. Urine was obtained by clean catch in voiders, or directly from the catheter in subjects utilizing catheters. Urinalysis, urine culture and 16S rDNA sequencing were performed on all samples, with metaproteomic analysis performed on a subsample. Results A total of 589454 quality-filtered 16S rDNA sequence reads were processed through a NextGen 16S rDNA analysis pipeline. Urine microbiomes differ by normal bladder function vs. NB, gender, type of bladder catheter utilized, and duration of NB. The top ten bacterial taxa showing the most relative abundance and change among samples were Lactobacillales, Enterobacteriales, Actinomycetales, Bacillales, Clostridiales, Bacteroidales, Burkholderiales, Pseudomonadales, Bifidobacteriales and Coriobacteriales. Metaproteomics confirmed the 16S rDNA results, and functional human protein-pathogen interactions were noted in subjects where host defenses were initiated. Conclusions Counter to clinical belief, healthy urine is not sterile. The healthy urine microbiome is characterized by a preponderance of Lactobacillales in women and Corynebacterium in men. The presence and duration of NB and method of urinary catheterization alter the healthy urine microbiome. An integrated approach of 16S rDNA sequencing with metaproteomics improves our understanding of healthy urine and facilitates a more personalized approach to prevention and treatment of infection

Inflammatory Stress Effects on Health and Function After Spinal Cord Injury

Injury to the spinal cord produces immediate, adaptive inflammatory responses that can exacerbate the initial injury and lead to secondary damage. Thus far, researchers and clinicians have focused on modulating acute inflammation to preserve sensorimotor function. However, this singular approach risks overlooking how chronic inflammation negatively impacts the broader health of persons with a spinal cord injury (SCI). The aim of this monograph was to discuss interrelated processes causing persistent inflammatory stress after SCI, along with associated health risks. We review archetypal factors that contribute to a chronic inflammatory state, including response to injury, acute infection, and autonomic dysreflexia. Secondary complications producing and exacerbating inflammation are also discussed, including pain, depression, obesity, and injury to the integumentary and skeletal systems. Finally, we discuss the role of bacteria and the gut microbiome in this process and then conclude with a discussion on how a pro-inflammatory phenotype promotes an elevated risk for cardiovascular disease after injury. Effectively managing chronic inflammation should be a high priority for clinicians and researchers who seek to improve the health and life quality of persons with SCI. Chronic inflammation worsens secondary medical complications and amplifies the risk for cardiometabolic disorders after injury, directly impacting both the quality of life and mortality risk after SCI. Inflammation can worsen pain and depression and even hinder neurological recovery. It is, therefore, imperative that countermeasures to chronic inflammation are routinely considered from the point of initial injury and proceeding throughout the lifespan of the individual with SCI

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

Recovery Off-Kinetics Following Exhaustive Upper Body Exercise in Spinal Cord Injury

People with spinal cord injury (SCI) present with impaired autonomic control when the lesion is above T6. This could lead to delayed cardiorespiratory recovery following vigorous physical activity. To characterize and compare gas exchange off-kinetics following exhaustive exercise in individuals with SCI and an apparently healthy control group. Participants were 19 individuals with SCI who presented with the inability to voluntarily lift their legs against gravity (age, 44.6 ± 14.2 years; AIS A, = 5; AIS B, = 7; AIS C, = 7; paraplegia, = 14; tetraplegia, = 5) and 10 healthy comparisons (COM; age, 30.5 ± 5.3 years). All participants performed an arm ergometer cardiopulmonary exercise test (aCPET) to volitional exhaustion followed by a 10-minute passive recovery. O uptake ( ) and CO output ( ) off-kinetics was examined using a mono-exponential model in which tau ( ) and mean response time (MRT) were determined. The off-kinetics transition constant ( ) was calculated as Δ /MRT. Student tests were used to compare SCI versus COM group means. COM had a significantly higher relative peak compared to SCI (1.70 ± 0.55 L/min vs 1.19 ± 0.51 L/min, = .019). No difference was observed for between the groups, however for both and was significantly lower in the SCI compared to the COM group. A reduced during recovery may suggest inefficiencies in replenishing muscle ATP stores and lactate clearance in these participants with SCI. These findings may contribute to the observed lower cardiorespiratory fitness and greater fatigability typically reported in individuals with SCI

The Relationship Between Perceived Exertion and Physiologic Indicators of Stress During Graded Arm Exercise in Persons With Spinal Cord Injuries

Lewis JE, Nash MS, Hamm LF, Martins SC, Groah SL. The relationship between perceived exertion and physiologic indicators of stress during graded arm exercise in persons with spinal cord injuries. To examine the relationship between psychologic cues of somatic stress and physiologic responses to exercise in persons with paraplegia and tetraplegia. Repeated measures with 2 comparison groups. Academic medical center. Forty-two subjects between 18 and 69 years of age with motor-complete spinal cord injury (SCI) resulting in paraplegia or tetraplegia (American Spinal Injury Association grades A and B). Not applicable. Subjects underwent peak graded arm ergometry during which heart rate, oxygen consumption (V̇ o 2), minute ventilation (V̇ e), and ratings of perceived exertion (RPE) (Borg Categorical 6–20 Scale) were measured at successive work rate increments from baseline to fatigue. There were inconsistent associations among the outcomes. For subjects with tetraplegia, RPE related positively to heart rate at the initial work rate, but there were no other significant correlations. For subjects with paraplegia, RPE did not correlate significantly with heart rate, V̇ o 2, or V̇ e. V̇ o 2 and V̇ e related positively at the first and last work rates. In general, heart rate, V̇ o 2, and V̇ e increased as the exercise intensity increased, and were more pronounced in subjects with paraplegia. While RPE values increased with increasing work rates for each group, we found no differences between groups. Our findings contradict the well-accepted relationships between RPE and both heart rate and V̇ o 2 during exercise by people without disabilities, and challenge the use of RPE as a valid psychophysiologic index of perceived exertion in persons with SCI

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

The urine microbiome of healthy men and women differs by urine collection method

Copyright © 2020 Korean Continence Society. Purpose: Compared to the microbiome of other body sites, the urinary microbiome remains poorly understood. Although noninvasive voided urine specimens are convenient, contamination by urethral microbiota may confound understanding of the bladder microbiome. Herein we compared the voiding- versus catheterization-associated urine microbiome of healthy men and women. Methods: An asymptomatic, healthy cohort of 6 women and 14 men underwent midstream urine collection, followed by sterile catheterization of the bladder after bladder refilling. Urine samples underwent urine dipstick testing and conventional microscopy and urine cultures. Samples also underwent Illumina MiSeq-based 16S ribosomal RNA gene amplification and sequencing. Results: All organisms identified by urine culture were also identified by 16S amplification; however, next-generation sequencing (NGS) also detected bacteria not identified by cultivation. Lactobacillus and Streptococcus were the most abundant species. Abundances of the 9 predominant bacterial genera differed between the urethra and bladder. Voided and catheterized microbiomes share all dominant (\u3e 1%) genera and Operational Taxonomic Units but in similar or different proportions. Hence, urethra and bladder microbiomes do not differ in taxonomic composition, but rather in taxonomic structure. Women had higher abundance of Lactobacillus and Prevotella than men. Conclusions: Our findings lend credence to the hypothesis that Lactobacilli are important members of the healthy urine microbiome. Our data also suggest that the microbiomes of the urethra and bladder differ from one another. In conclusion, urine collection method results in different 16S-based NGS data, likely due to the sensitivity of NGS methods enabling detection of urethral bacteria present in voided but not catheterized urine specimens