Gut Immunomodulation with Vedolizumab prior to Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients with Inflammatory Bowel Disease.

Inborn errors of immunity (IEI) are often associated with inflammatory bowel disease (IBD). IEI can be corrected by allogeneic hematopoietic stem cell transplantation (HSCT); however, peritransplantation intestinal inflammation may increase the risk of gut graft-versus-host disease (GVHD). Vedolizumab inhibits the homing of lymphocytes to the intestine and may attenuate gut GVHD, yet its role in preventing GVHD in pediatric patients with IEI-associated IBD has not been studied. Here we describe a cohort of pediatric patients with IEI-associated IBD treated with vedolizumab before and during allogeneic HSCT. The study involved a retrospective chart review of pediatric patients with IEI-associated IBD treated with vedolizumab at 6 weeks, 4 weeks, and 1 week before undergoing HSCT. The conditioning regimen consisted of treosulfan, fludarabine, and cyclophosphamide with rabbit antithymocyte globulin, and GVHD prophylaxis included tacrolimus and steroids. Eleven patients (6 females) with a median age of 5 years (range, 0.4 to 14 years) with diverse IEI were included. IBD symptoms were characterized by abdominal pain, loose stools, and blood in stools. Four patients had developed a perianal fistula, and 1 patient had a rectal prolapse. One patient had both a gastrostomy tube and a jejunal tube in situ. Treatment of IBD before HSCT included steroids in 11 patients, anakinra in 2, infliximab in 4, sulfasalazine in 2, mesalazine in 2, and vedolizumab. IBD symptoms were considered controlled in the absence of abdominal pain, loose stools, or blood in stools. Graft sources for HSCT were unrelated donor cord in 5 patients (2 with a 5/8 HLA match, 2 with a 7/8 match, and 1 with a 6/8 match), peripheral blood stem cells in 5 patients (2 haploidentical, 1 with a 9/10 HLA match, and 2 with a 10/10 match), and bone marrow in 1 patient (10/10 matched sibling donor). The median number of vedolizumab infusions was 4 (range, 3 to 12) before HSCT and 1 (range, 1 to 3) after HSCT, and all were reported to be uneventful. All patients had engrafted. Acute GVHD occurred in 4 patients and was limited to grade I skin GVHD only. Chronic GVHD occurred in 1 patient and again was limited to the skin. There was no gut GVHD. Three patients experienced cytomegalovirus viremia, and 2 patients had Epstein-Barr virus viremia. At the time of this report, all patients were alive with no evidence of IBD at a median follow-up of 15 months (range, 3 to 39 months). Administration of vedolizumab pre- and post-HSCT in pediatric patients with IEI-associated IBD is well tolerated and associated with a low rate of gut GVHD. These findings provide a platform for the prospective study and use of vedolizumab for GVHD prophylaxis in pediatric patients with known intestinal inflammation as a pre-HSCT comorbidity.

Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Protocol for a Patient-Centered Multicenter Randomized Controlled Pilot Trial.

BACKGROUND: Treatment-resistant depression (TRD) is the inability of a patient with major depressive disorder (MDD) to accomplish or achieve remission after an adequate trial of antidepressant treatments. Several combinations and augmentation treatment strategies for TRD exist, including the use of repetitive transcranial magnetic stimulation (rTMS), and new therapeutic options are being introduced. Text4Support, a text message-based form of cognitive behavioral therapy that allows patients with MDD to receive daily supportive text messages for correcting or altering negative thought patterns through positive reinforcement, may be a useful augmentation treatment strategy for patients with TRD. It is however currently unknown if adding the Text4Support intervention will enhance the response of patients with TRD to rTMS treatment. OBJECTIVE: This study aims to assess the initial comparative clinical effectiveness of rTMS with and without the Text4Support program as an innovative patient-centered intervention for the management of patients diagnosed with TRD. METHODS: This study is a multicenter, prospective, parallel-design, 2-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for 6 weeks, observation, and a follow-up period of 6 months for participants in the study arms. In total, 200 participants diagnosed with TRD at rTMS care clinics in Edmonton, Alberta, and rTMS clinics in Halifax, Nova Scotia will be randomized to 1 of 2 treatment arms (rTMS sessions alone or rTMS sessions plus Text4Support intervention). Participants in each group will be made to complete evaluation measures at baseline, and 1, 3, and 6 months. The primary outcome measure will be the mean change in the scores of the Patient Health Questionnaire-9 (PHQ-9). The secondary outcome measures will involve the scores of the 7-item Generalized Anxiety Disorders Scale (GAD-7), Columbia-Suicide Severity Rating Scale (CSSRS), and World Health Organization-Five Well-Being Index (WHO-5). Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Qualitative data will be analyzed using the thematic analysis framework. RESULTS: The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention treatment arm of the study will achieve superior outcomes compared with the outcomes of participants enrolled in the rTMS alone arm. CONCLUSIONS: The application of the combination of rTMS and Text4Support has not been investigated previously. Therefore, we hope that this study will provide a concrete base of data to evaluate the practical application and efficacy of using the novel combination of these 2 treatment modalities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46830.

Are nutritional sufficiency of ≥75% energy and protein requirements relevant targets in patients at nutritional risk? - A one month follow-up study.

BACKGROUND & AIM: Nutrient intake in patients at nutritional risk was recorded with the aim of reaching at least 75% of estimated requirements for energy and protein. However, the cutoff at 75% has only been sparsely investigated. The aim of this study was to re-evaluate the 75% cutoff of estimated energy and protein requirements among patients at or not at nutritional risk in relation to 30-day mortality and readmissions. METHODS: A 30-day follow-up study was performed among hospitalized patients in 31 units at a Danish University Hospital. Data was collected using the nurses' quartile nutrition registration method and electronic patient journals. All patients were screened using the NRS-2002 and classified as either at nutritional risk (NRS-2002, score ≥3) or not at nutritional risk (NRS-2002, score <3). Energy and protein requirements were estimated using weighted Harris-Benedict equation and 1.3 g/kg/day, respectively. RESULTS: In total, 318 patients were included in this study. Patients at nutritional risk were older, lower BMI, male, more comorbidities and a longer primary length of stay compared to patients not at nutritional risk (p < 0.05). After 30-day follow-up, mortality was higher among patients at risk (9.5% vs. 2.0%, p < 0.05). Patients at nutritional risk showed increased risk of mortality if they did not achieve 75% of estimated requirements (energy: OR = 8.08 [1.78; 36.79]; protein: OR = 3.40 [0.74; 15:53]). Furthermore, predicted probability of mortality decreased with increased energy and protein intakes. No significant associations were found for readmissions achieving 75% of estimated energy or protein requirements. A cutoff of 76-81% for energy and 58-62% for protein was equivalent with accepting a 6-8% mortality rate. CONCLUSION: The results of this study indicate that an energy intake ≥75% of estimated requirement among patients at nutritional risk has a preventative effect regarding mortality within one month, but not for readmissions.

Canadian Consensus Statements on the Transition of Adolescents and Young Adults with Inflammatory Bowel Disease from Pediatric to Adult Care: A Collaborative Initiative Between the Canadian IBD Transition Network and Crohn's and Colitis Canada.

Objectives: With the increased prevalence of childhood-onset inflammatory bowel disease (IBD), there is a greater need for a planned transition process for adolescents and young adults (AYA). The Canadian IBD Transition Network and Crohn's and Colitis Canada joined in collaborative efforts to describe a set of care consensus statements to provide a framework for transitioning AYA from pediatric to adult care. Methods: Consensus statements were drafted after focus group meetings and literature reviews. An expert panel consisting of 20 IBD physicians, nurses, surgeon, adolescent medicine physician, as well as patient and caregiver representatives met, discussed and systematically voted. The consensus was reached when greater than 75% of members voted in agreement. When greater than 75% of members rated strong support, the statement was rendered a strong recommendation, suggesting that a clinician should implement the statement for all or most of their clinical practice. Results: The Canadian expert panel generated 15 consensus statements (9 strong and 6 weak recommendations). Areas of focus of the statements included: transition program implementation, key stakeholders, areas of potential need and gaps in the research. Conclusions: These consensus statements provide a framework for the transition process. The quality of evidence for these statements was generally low, highlighting the need for further controlled studies to investigate and better define effective strategies for transition in pediatric to adult IBD care.

Long-Term Outcomes With Adalimumab Therapy in Pediatric Crohn Disease: Associations With Adalimumab Exposure.

BACKGROUND/AIMS: Pediatric Crohn disease (CD) treatment goals have evolved. Among children receiving adalimumab (ADA) we examined long-term durability of clinical remission, linear growth, and associations of trough concentration (TC) with biomarker, endoscopic and imaging outcomes. METHODS: Single-center retrospective study. Pediatric CD activity index, C-reactive protein, fecal calprotectin, and height measured longitudinally. Discontinuation due to secondary loss of response (LOR) was assessed using Cox proportional hazards model. Associations between TC and clinical and biomarker remission, endoscopic and magnetic resonance imaging (MRI) improvements were assessed using Cox regression with time-dependent covariates. RESULTS: Between January 2007 and June 2018, 213 children (median age 14.1 years (interquartile range [IQR] 12.5-15.7) 65% males) initiated ADA. One hundred and seventy-four (82%) achieved clinical remission (PCDAI < 10). During 24.8 (IQR 15.6-38.4) months follow-up, 26 (15%) discontinued ADA due to LOR, and 10 (6%) due to adverse events. Being anti-tumor necrosis factor (TNF) naïve and inflammatory behavior associated with increased likelihood of clinical remission (odds ratio [OR] 2.39, P = 0.033, and 3.13, P = 0.013, respectively) and with decreased LOR (hazard ratio [HR] 0.3, P = 0.002, and HR 0.35, P = 0.01, respectively). Cumulative LOR among 135 anti-TNF naïve patients: 0%, 8%, 15% within 1, 2, 3 years, similarly durable with mono- and immunomodulator combination therapy. Among pre-/early pubertal children mean height (-0.82) normalized to -0.07. TC consistently >7.5 ug/mL was associated with durable clinical remission (HR = 17.24, P < 0.001); TC >10 ug/mL with durable biomarker remission (HR = 6.56, P < 0.001) and endoscopic (OR 10.4, P = 0.002) and MRI (OR 7.6, P = 0.001) improvements. CONCLUSION: ADA monotherapy maintains durable clinical remission. Biomarker remission, mucosal and transmural improvements were associated with greater ADA exposure.

Association of Early Postinduction Adalimumab Exposure With Subsequent Clinical and Biomarker Remission in Children with Crohn's Disease.

BACKGROUND: Data on the association between early postinduction serum adalimumab (ADA) trough levels (TLs) and objective outcomes are scarce. The aim of this study was to investigate whether early ADA TLs at weeks 4 and 8 are associated with clinical and biomarker remission at week 24 in pediatric Crohn's disease (CD). METHODS: Adalimumab TLs at weeks 4 and 8 were prospectively measured in anti-TNF-naïve children initiating treatment with ADA monotherapy for luminal inflammatory CD. The primary outcome was combined clinical and biomarker remission at week 24, defined as achieving steroid-free clinical remission (Pediatric CD activity index <10) and biomarker remission (fecal calprotectin <250 µg/g and CRP <5 µg/mL). RESULTS: Among 65 patients, 39 (60%) achieved combined clinical/biomarker remission at week 24 without dose escalation. Adalimumab TLs at both weeks 4 and 8 were significantly higher in remitters vs nonremitters at week 24 (P < 0.001 and P = 0.002, respectively). Adalimumab levels at weeks 4 and 8 were good predictors of combined clinical/biomarker remission at week 24 (area under the curve, 0.887, 95% CI, 0.798-0.942; and area under the curve, 0.761, 95% CI, 0.632-0.899, respectively). The best ADA TL cutoffs at weeks 4 and 8 for predicting clinical/biomarker remission at week 24 were 22.5 µg/mL (80% sensitivity, 90% specificity, positive likelihood ratio [LR+] 8.0, negative LR [LR-] 0.2) and 12.5 µg/mL (94% sensitivity, 60% specificity, LR+ 2.4, LR- 0.1), respectively. Higher induction doses per m2 correlated positively with TLs at weeks 4 and 8. CONCLUSION: Greater early ADA exposure is associated with superior clinical/biomarker outcomes at week 24.

Ramps remain a barrier to safe wheelchair user transit bus ingress/egress.

Background: Wheelchair users (WCUs) often rely on ramps for access to transit buses. Previous studies indicate WCUs have difficulty using ramps for bus ingress/egress and many transportation-related incidents occur on ramps. However, experiences of WCU ramp usage during ingress/egress have not been fully described.Methods: Cross-sectional, internet-based survey of WCUs who ride transit buses was conducted. The participants were queried on frequency of bus usage, difficulty and incidents involving ramps, and factors contributing to difficulty and incidents. Wheelchair characteristics, primary condition, and whether participants received travel training were also captured. Chi-square was used to describe relationships between wheelchair type and frequency of difficulties and incidents, and odd ratios were used to determine likelihood of the incidents.Results: The majority (55.7%) of 384 participants reported using public transportation ≥ 1 per week. Seventy-eight percent of WCUs had ≥ 1 ramp incident over the past 3 years, with an increased likelihood of incidents occurring during ingress (OR = 1.53; CI 1.21-1.86). Of those who had an incident, 22% were injured or had damage to their wheelchair. Over 60% of those who had an incident identified steep ramp slope as being the contributing factor. Steep ramp slope, exterior ramp thresholds and wet surfaces were the most common contributing factors to difficulty using ramps.Conclusion: This is the first large-scale US study enabling WCUs to describe their experiences using transit bus ramps. Despite ADA guidelines, steep ramps remain the primary factor contributing to incidents and difficulty when using ramps to access transit buses.Implications for rehabilitationThe discrepancy between ADA maximum allowable ramp slopes for the built environment and transit buses may require an increased level of effort that is a barrier to transportation accessibility for some wheelchair users.Wheelchair users who access transit buses should be made aware of, and trained, to navigate ramp configurations found in the environment.We suggest rehabilitation therapists provide skills training specific to navigating transit bus ramp slopes that may be steeper and narrower than building ramps.

Body Composition Using Air Displacement Plethysmography in Children With Inflammatory Bowel Disease.

OBJECTIVE: The aim of the study was to assess the body composition of children with inflammatory bowel disease (IBD) and to study the accuracy of clinically available tools in predicting excess body fatness. We aimed at also exploring the influence of adiposity on pharmacokinetics during early Infliximab exposure. METHODS: Prospective cohort study in 5- to 17-year-old children with IBD initiating Infliximab therapy. Patient demographic, phenotypic, and laboratory data at the time of Infliximab initiation were recorded. Body composition was assessed using air displacement plethysmography (ADP). fat mass index (FMI = fat mass [kg]/(height [m])) was calculated to determine excess adiposity (defined as FMI ≥75th centile). Anthropometrics (weight, height, mid upper arm circumference [MUAC] and triceps skin fold thickness [TSF]) were obtained and MUAC and TSF measurements were used to calculate arm fat area (AFA) and arm muscle area z-scores. Statistical analysis was applied as appropriate. RESULTS: Fifty-three (68% male; 55% Crohn disease [CD], 45% ulcerative colitis [UC], median [IQR] age 15 [13-16] years) children with IBD were included. Twenty-four percentage of children with IBD (21% CD, 29% UC) had excess adiposity. Four children (31%) with FMI ≥75th centile were not identified by body mass index (BMI) alone (kappa of 0.60), and 2 children (15%) were not identified by AFA z-score alone. The intra- and interobserver reliability of MUAC and TSFT measurements was excellent. There was no difference in Infliximab trough levels at the end of induction between those with FMI less than or ≥75th centile. CONCLUSIONS: Excess adiposity affects approximately 1 in 4 young patients with IBD and can be missed by routine obesity screening. Our exploratory study did not raise concerns of underexposure to infliximab in those children with excess adiposity during early drug exposure.

Trait Perfectionism and Psychosocial Outcomes in Adolescents With Inflammatory Bowel Disease.

OBJECTIVES: The aim of this prospective cross-sectional study was to examine perfectionism, disease self-management, and psychosocial outcomes in a sample of adolescents with inflammatory bowel disease (IBD). METHODS: Adolescent patients with IBD and caregivers were enrolled in the study. Patients completed the Child and Adolescent Perfectionism Scale, the Strengths and Difficulties Questionnaire (SDQ), and the TRANSITION-Q. Parents completed the Multidimensional Perfectionism Scale and the parent form of the SDQ. Health care providers reported on disease activity using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI). RESULTS: Ninety adolescents (mean age 15.17 ±â€Š1.49, range = 12-18) with diagnosed IBD (51 CD, 37 UC, and 2 IBD-U) and 76 primary caregivers participated in the study. Results indicated high rates of self-oriented perfectionism in adolescents with IBD (59% of sample reported elevated rates; 33% of sample in the clinical range). After accounting for age, sex, and disease activity, self-oriented perfectionistic striving was associated with better disease self-management; nonetheless, adolescent and parent perfectionistic strivings were also related to higher adolescent internalizing symptoms (standardized beta = 0.22 and 0.29, respectively). Additionally, perfectionistic concerns (self-critical and socially prescribed perfectionism) were associated with higher rates of adolescent-reported externalizing symptoms (standardized beta 0.30 and 0.24). Further, multilevel mixed modelling found no differences within-dyad in relation to perfectionism, but documented that adolescents report higher levels of externalizing symptoms compared with parents. CONCLUSIONS: The present study explores the prevalence and presentation of perfectionism in a sample of adolescents with IBD. Results suggest dimensions of perfectionism are differentially associated with psychosocial and disease management outcomes, suggesting further evidence of the relationship between perfectionism, maladaptive coping, and subsequent influences on health outcomes in the context of pediatric chronic illness.

Intensified Infliximab Induction is Associated with Improved Response and Decreased Colectomy in Steroid-Refractory Paediatric Ulcerative Colitis.

BACKGROUND: Infliximab pharmacokinetics in steroid-refractory [SR] ulcerative colitis [UC] suggest a need for higher dosing, but data concerning efficacy of intensification in this setting are lacking in children and inconsistent overall. METHODS: Paediatric patients [N = 125] treated with infliximab for SR or steroid-dependent UC were retrospectively reviewed. Outcomes [clinical response and remission, colectomy, mucosal healing, safety] with standard vs intensified induction [mean induction dose ≥7 mg/kg or interval ≤5 weeks between doses 1 and 3] were compared. RESULTS: Among 125 patients [median age 14 years, median UC duration 0.7 years, 74 SR], 73 [58%] received standard induction and 52 [42%] received intensified induction. Overall, 73 [58%] achieved remission (judged by physician global assessment [PGA] and paediatric UC activity index [PUCAI]≤10]. Among patients in remission, 7 [10%] experienced secondary loss of response by a median of 0.7 [IQR 0.4-1.0] years. Of the 74 SR patients, 17 [23%] underwent colectomy, and of the 51 steroid-dependent patients, 12 [24%] underwent colectomy. Intensified induction in SR patients was associated with a higher chance of remission (hazard ratio [HR] 3.2, p = 0.02) and a lower chance of colectomy [HR 0.4, p = 0.05], but did not improve outcomes in steroid-dependent patients. During follow-up, 46/73 [63%] patients in remission had regimen individualization, with similar rates of return to standard dosing after 1 year between those with initial intensified or standard induction. Follow-up endoscopy, performed in 35/73 patients in remission, demonstrated mucosal healing for 66%. Adverse events were rare, despite use of intensified regimens. CONCLUSIONS: These data suggest a benefit from intensified infliximab induction specifically among children with steroid-refractory UC. Prospective studies comparing dosing regimens and incorporating therapeutic drug monitoring should be undertaken.

Wheelchair tiedown and occupant restraint practices in paratransit vehicles.

The purpose of this study was to characterize wheelchair tiedown and occupant restraint system (WTORS) usage in paratransit vehicles based on observations of wheelchair and scooter (wheeled mobility devices, collectively, "WhMD") passenger trips. A retrospective review of on-board video monitoring recordings of WhMD trips was conducted. Four hundred seventy-five video recordings were collected for review and analysis. The use of all four tiedowns to secure the WhMD was observed more frequently for power WhMDs (82%) and manual WhMDs (80%) compared to scooters (39%), and this difference was significant (p< 0.01). Nonuse or misuse of the occupant restraint system occurred during 88% of WhMD trips, and was most frequently due to vehicle operator neglect in applying the shoulder belt. Despite the absence of incidents or injuries in this study, misuse and nonuse of WTORS potentially place WhMD seated passengers at higher risk of injury during transit. These findings support the need for improved vehicle operator training and passenger education on the proper use of WTORS and development of WTORS with improved usability and/or alternative technologies that can be automated or used independently.

New Onset Autoimmune Hepatitis during Anti-Tumor Necrosis Factor-Alpha Treatment in Children.

OBJECTIVES: To evaluate a large anti-tumor necrosis factor (TNF)-treated pediatric inflammatory bowel disease cohort for drug-induced liver injury (DILI) following presentation of an index case with suspected DILI with autoimmune features after infliximab exposure. To characterize the incidence, natural history, and risk factors for liver enzyme elevation with anti-TNF use. STUDY DESIGN: We reviewed the index case and performed a retrospective cohort study of 659 children receiving anti-TNF therapy between 2000 and 2015 at a tertiary pediatric inflammatory bowel disease center. Patients with alanine aminotransferase (ALT) ≥×2 the upper limit of normal were included. The incidence, evolution, and risk factors for liver injury were examined with univariate and multivariable proportional hazards regression. Causality was assessed using the Roussel-Uclaf Causality Assessment Method. RESULTS: The index case, a teenage girl with Crohn's disease, developed elevated liver enzymes and features of autoimmune hepatitis on liver biopsy 23 weeks after starting infliximab. The injury resolved entirely within 4 months of withdrawing infliximab without additional therapy. Overall, 7.7% of our cohort developed new ALT elevations while on anti-TNF. Most ALT elevations were mild and transient and attributable to alternate etiologies. No additional clear cases of autoimmune hepatitis were identified. CONCLUSIONS: Transient liver enzyme abnormalities are relatively common among anti-TNF-treated children. Anti-TNF-related DILI with autoimmune features is rare but must be recognized so that therapy can be stopped.

Healthcare utilization and associated barriers experienced by wheelchair users: A pilot study.

BACKGROUND: More than twenty-five years after passage of the ADA, little remains known about the experiences of wheelchair users when attempting to access health care and how accessibility may influence health care utilization. OBJECTIVE/HYPOTHESIS: To describe health care utilization among wheelchair users and characterize barriers encountered when attempting to obtain access to health care. METHODS: An internet-based survey of wheelchair users was conducted. Measures included demographics, condition, socioeconomic status, health care utilization and receipt of preventive services within the past year, physical barriers encountered at outpatient facilities, and satisfaction with care. RESULTS: Four hundred thirty-two wheelchair users responded to the survey. Nearly all respondents (97.2%) had a primary care appointment within the past year and most reported 3-5 visits to both primary and specialty care providers. Most encountered physical barriers when accessing care (73.8% primary, 68.5% specialty). Participants received most preventive interventions at rates similar to national averages with the exception of Pap tests. Most participants remained clothed for their primary care evaluation (76.1%), and were examined seated in their wheelchair (69.7%). More than half of participants (54.1%) felt they received incomplete care, and 57% believed their physician had no more than a moderate understanding of their disability-specific medical concerns. CONCLUSIONS: Wheelchair users face persistent barriers to care, may receive less than thorough physical evaluations, receive fewer screenings for cervical cancer, and largely believe they receive incomplete care.

Development of the IBD Disk: A Visual Self-administered Tool for Assessing Disability in Inflammatory Bowel Diseases.

BACKGROUND: The Inflammatory bowel disease (IBD) Disability Index is a validated tool that evaluates functional status; however, it is used mainly in the clinical trial setting. We describe the use of an iterative Delphi consensus process to develop the IBD Disk-a shortened, self-administered adaption of the validated IBD Disability Index-to give immediate visual representation of patient-reported IBD-related disability. METHODS: In the preparatory phase, the IBD CONNECT group (30 health care professionals) ranked IBD Disability Index items in the perceived order of importance. The Steering Committee then selected 10 items from the IBD Disability Index to take forward for inclusion in the IBD Disk. In the consensus phase, the items were refined and agreed by the IBD Disk Working Group (14 gastroenterologists) using an online iterative Delphi consensus process. Members could also suggest new element(s) or recommend changes to included elements. The final items for the IBD Disk were agreed in February 2016. RESULTS: After 4 rounds of voting, the following 10 items were agreed for inclusion in the IBD Disk: abdominal pain, body image, education and work, emotions, energy, interpersonal interactions, joint pain, regulating defecation, sexual functions, and sleep. All elements, except sexual functions, were included in the validated IBD Disability Index. CONCLUSIONS: The IBD Disk has the potential to be a valuable tool for use at a clinical visit. It can facilitate assessment of inflammatory bowel disease-related disability relevant to both patients and physicians, discussion on specific disability-related issues, and tracking changes in disease burden over time.

Public transit bus ramp slopes measured in situ.

PURPOSE: The slopes of fixed-route bus ramps deployed for wheeled mobility device (WhMD) users during boarding and alighting were assessed. Measured slopes were compared to the proposed Americans with Disabilities Act (ADA) maximum allowable ramp slope. METHODS: A ramp-embedded inclinometer measured ramp slope during WhMD user boarding and alighting on a fixed-route transit bus. The extent of bus kneeling was determined for each ramp deployment. In-vehicle video surveillance cameras captured ramp deployment level (street versus sidewalk) and WhMD type. RESULTS: Ramp slopes ranged from -4° to 15.5° with means of 4.3° during boarding (n = 406) and 4.2° during alighting (n = 405). Ramp slope was significantly greater when deployed to street level. During boarding, the proposed ADA maximum allowable ramp slope (9.5°) was exceeded in 66.7% of instances when the ramp was deployed to street level, and in 1.9% of instances when the ramp was deployed to sidewalk level. During alighting, the proposed ADA maximum allowable slope was exceeded in 56.8% of instances when the ramp was deployed to street level and in 1.4% of instances when the ramp was deployed to sidewalk level. CONCLUSIONS: Deployment level, built environment and extent of bus kneeling can affect slope of ramps ascended/descended by WhMD users when accessing transit buses. Implications for Rehabilitation Since public transportation services are critical for integration of wheeled mobility device (WhMD) users into the community and society, it is important that they, as well as their therapists, are aware of conditions that may be encountered when accessing transit buses. Knowledge of real world ramp slope conditions that may be encountered when accessing transit buses will allow therapists to better access capabilities of WhMD users in a controlled clinical setting. Real world ramp slope conditions can be recreated in a clinical setting to allow WhMD users to develop and practice necessary skills to safely navigate this environment. Knowing that extent of bus kneeling and ramp deployment level can influence ramp slope, therapists can educate WhMD users to request bus operators further kneel the bus floor and/or redeploy the ramp to a sidewalk level when appropriate, so that the least practicable slope will be presented for ingress/egress.

Accessibility of outpatient healthcare providers for wheelchair users: Pilot study.

The Americans with Disabilities Act (ADA) requires full and equal access to healthcare services and facilities, yet studies indicate individuals with mobility disabilities receive less than thorough care as a result of ADA noncompliance. The objective of our pilot study was to assess ADA compliance within a convenience sample of healthcare clinics affiliated with a statewide healthcare network. Site assessments based on the ADA Accessibility Guidelines for Buildings and Facilities were performed at 30 primary care and specialty care clinics. Clinical managers completed a questionnaire on standard practices for examining and treating patients whose primary means of mobility is a wheelchair. We found a majority of restrooms (83%) and examination rooms (93%) were noncompliant with one or more ADA requirements. Seventy percent of clinical managers reported not owning a height-adjustable examination table or wheelchair accessible weight scale. Furthermore, patients were examined in their wheelchairs (70%-87%), asked to bring someone to assist with transfers (30%), or referred elsewhere due to an inaccessible clinic (6%). These methods of accommodation are not compliant with the ADA. We recommend clinics conduct ADA self-assessments and provide training for clinical staff on the ADA and requirements for accommodating individuals with mobility disabilities.

Ramp-related incidents involving wheeled mobility device users during transit bus boarding/alighting.

OBJECTIVES: To estimate the prevalence of wheeled mobility device (WhMD) ramp-related incidents while boarding/alighting a public transit bus and to determine whether the frequency of incidents is less when the ramp slope meets the proposed Americans with Disabilities Act (ADA) maximum allowable limit of ≤9.5°. DESIGN: Observational study. SETTING: Community public transportation. PARTICIPANTS: WhMD users (N=414) accessing a public transit bus equipped with an instrumented ramp. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Prevalence of boarding/alighting incidents involving WhMD users and associated ramp slopes; factors affecting incidents. RESULTS: A total of 4.6% (n=35) of WhMD users experienced an incident while boarding/alighting a transit bus. Significantly more incidents occurred during boarding (6.3%, n=26) than during alighting (2.2%, n=9) (P<.01), and when the ramp was deployed to street level (mean slope=11.4°) compared with sidewalk level (mean slope=4.2°) (P=.01). The odds ratio for experiencing an incident when the ramp slope exceeded the proposed ADA maximum allowable ramp slope was 5.4 (95% confidence interval, 2.4-12.2; P<.01). The odds ratio for assistance being rendered to board/alight when the ramp slope exceeded the proposed ADA maximum allowable ramp slope was 5.1 (95% confidence interval, 2.9-9.0; P<.01). CONCLUSIONS: The findings of this study support the proposed ADA maximum allowable ramp slope of 9.5°. Ramp slopes >9.5° and ramps deployed to street level are associated with a higher frequency of incidents and provision of assistance. Transit agencies should increase awareness among bus operators of the effect kneeling and deployment location (street/sidewalk) have on the ramp slope. In addition, ramp components and the built environment may contribute to incidents. When prescribing WhMDs, skills training must include ascending/descending ramps at slopes encountered during boarding/alighting to ensure safe and independent access to public transit buses.

Infliximab maintains durable response and facilitates catch-up growth in luminal pediatric Crohn's disease.

BACKGROUND: Infliximab induces and maintains clinical remission in children with Crohn's disease (CD), but specifically pediatric long-term data remain sparse. METHODS: Patients (N = 195) who received infliximab ± immunomodulator for luminal CD were retrospectively reviewed. Outcomes included clinical response, linear growth, and mucosal healing. Durability of response was assessed using Cox proportional hazards models. Levels of infliximab and antibodies (antibodies to infliximab) were measured when response was lost. RESULTS: Among 195 patients (median age, 13.9 yr; median CD duration, 1.6 yr), 81% experienced complete response (judged by physician global assessment and pediatric Crohn's disease activity index ≤10). Longer duration of diagnosed CD and female gender were associated with lower response. During first year of follow-up, 35% of subjects had regimen individualized through dose escalation/interval shortening. Despite regimen optimization, 16/157 complete responders experienced loss of response at a rate of 2% to 6% per year over 5 years, associated with development of antibodies to infliximab. Concurrent immunomodulation for ≥30 weeks significantly decreased loss of response (hazard ratio = 0.25, 95% confidence interval, 0.08-0.76; P = 0.014). Follow-up endoscopic examination was performed in 40 responders, of whom 22 (73%) demonstrated complete resolution of mucosal ulceration. Patients with growth potential (Tanner 1/2 at induction) demonstrated significant improvements in mean height z-score from induction to years 1 and 2 of follow-up (P < 0.001). With infliximab initiation within the first 18 months after diagnosis, mean height z-score normalized to 0 after 3 years. CONCLUSIONS: These data demonstrate sustained effectiveness of infliximab in children and adolescents with luminal CD. Durability of response is increased by concomitant immunomodulation. Clinical response is associated with enhanced linear growth, particularly when therapy is initiated early.

Health care utilization and barriers experienced by individuals with spinal cord injury.

OBJECTIVES: To identify from whom individuals with spinal cord injury (SCI) seek health care, the percentage who receive preventative care screenings, and the frequency and types of barriers they encounter when accessing primary and specialty care services; and to examine how sociodemographic factors affect access to care and receipt of preventative screenings. DESIGN: Cross-sectional, observational study using an Internet-based survey. SETTING: Internet based. PARTICIPANTS: Adults (N=108) with SCI who use a wheelchair as their primary means of mobility in the community. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Health care utilization during the past year, barriers encountered when accessing health care facilities, and receipt of routine care and preventative screenings. RESULTS: All but 1 participant had visited a primary care provider within the past 12 months, and 85% had had ≥ 1 visit to specialty care providers. Accessibility barriers were encountered during both primary care (91.1%) and specialty care (80.2%) visits; most barriers were clustered in the examination room. The most prevalent barriers were inaccessible examination tables (primary care=76.9%; specialty care=51.4%) and lack of transfer aids (primary care=69.4%; specialty care=60.8%). Most participants had not been weighed during their visit (89%) and had remained seated in their wheelchair during their examinations (85.2%). Over one third of individuals aged ≥ 50 years had not received a screening colonoscopy, 60% of women aged ≥ 50 years had not had a mammogram within the past year, 39.58% of women had not received a Papanicolaou smear within the previous 3 years, and only 45.37% of respondents had ever received bone density testing. CONCLUSIONS: Individuals with SCI face remediable obstacles to care and receive fewer preventative care screenings than their nondisabled counterparts. We recommend that clinics conduct Americans with Disabilities Act self-assessments, ensure that their clinical staff are properly trained in assisting individuals with mobility disabilities, and take a proactive approach in discussing preventative care screenings with their patients who have SCI.

Wheelchair securement and occupant restraint system (WTORS) practices in public transit buses.

The purpose of this study was to characterize wheelchair tiedown and occupant restraint system (WTORS) usage in public transit buses based on observations of wheelchair and scooter (wheeled mobility device: WhMD) passenger trips. A retrospective review of on-board video surveillance recordings of WhMD trips on fixed-route, large accessible transit vehicles (LATVs) was performed. Two hundred ninety-five video recordings were collected for review and analysis during the period June 2007-February 2009. Results showed that 73.6% of WhMDs were unsecured during transit. Complete use of all four tiedowns was observed more frequently for manual wheelchairs (14.9%) and power wheelchairs (5.5%), compared to scooters (0.0%), and this difference was significant (p=0.013). Nonuse or misuse (lap belt use only) of the occupant restraint system occurred during 47.5% of WhMD trips. The most frequently observed (52.5%) use of the lap belt consisted of bus operators routing the lap belt around the WhMD seatback in an attempt to secure the WhMD. These findings support the need for development and implementation of WTORS with improved usability and/or WTORS that can be operated independently by WhMD passengers and improved WTORS training for bus operators.