Modernization of a Large Spinal Cord Injuries and Disorders Registry: The Veterans Administration Experience.

Since the 1990s, Veterans Health Administration (VHA) has maintained a registry of Veterans with Spinal Cord Injuries and Disorders (SCI/Ds) to guide clinical care, policy, and research. Historically, methods for collecting and recording data for the VHA SCI/D Registry (VSR) have required significant time, cost, and staffing to maintain, were susceptible to missing data, and caused delays in aggregation and reporting. Each subsequent data collection method was aimed at improving these issues over the last several decades. This paper describes the development and validation of a case-finding and data-capture algorithm that uses primary clinical data, including diagnoses and utilization across 9 million VHA electronic medical records, to create a comprehensive registry of living and deceased Veterans seen for SCI/D services since 2012. A multi-step process was used to develop and validate a computer algorithm to create a comprehensive registry of Veterans with SCI/D whose records are maintained in the enterprise wide VHA Corporate Data Warehouse. Chart reviews and validity checks were used to validate the accuracy of cases that were identified using the new algorithm. An initial cohort of 28,202 living and deceased Veterans with SCI/D who were enrolled in VHA care from 10/1/2012 through 9/30/2017 was validated. Tables, reports, and charts using VSR data were developed to provide operational tools to study, predict, and improve targeted management and care for Veterans with SCI/Ds. The modernized VSR includes data on diagnoses, qualifying fiscal year, recent utilization, demographics, injury, and impairment for 38,022 Veterans as of 11/2/2022. This establishes the VSR as one of the largest ongoing longitudinal SCI/D datasets in North America and provides operational reports for VHA population health management and evidence-based rehabilitation. The VSR also comprises one of the only registries for individuals with non-traumatic SCI/Ds and holds potential to advance research and treatment for multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and other motor neuron disorders with spinal cord involvement. Selected trends in VSR data indicate possible differences in the future lifelong care needs of Veterans with SCI/Ds. Future collaborative research using the VSR offers opportunities to contribute to knowledge and improve health care for people living with SCI/Ds.

Effect of the Affordable Care Act on healthcare utilization for Veterans with spinal cord injuries and disorders.

Context/Objective: Provisions of the Affordable Care Act (ACA) potentially increase insurance options for Veterans with disabilities. We examined Veterans with spinal cord injuries and disorders (SCI/D) to assess whether the ACA was associated with changes in healthcare utilization from Department of Veterans Affairs (VA) healthcare facilities.Design: Using national VA data, we investigated impacts on VA healthcare utilization pre- (2012/13) and post-ACA (2014/15) implementation with negative binomial regression models.Setting: VA healthcare facilities.Participants: 8,591 VA users with SCI/D. Veterans with acute myelitis, Guillain-Barré syndrome, multiple sclerosis, or amyotrophic lateral sclerosis were excluded as were patients who died during the study period.Interventions: We assessed VA healthcare utilization before and after ACA implementation.Outcome Measures: Total numbers of VA visits for SCI/D care, diagnostic care, primary care, specialty care, and mental health care, and VA admissions.Results: The number of VA admissions was 7% higher in the post than pre-ACA implementation period (P < 0.01). The number of VA visits post-implementation increased for SCI/D care (8%; P < 0.01) and specialty care (12%; P < 0.001). Conversely, the number of mental health visits was 17% lower in the post-ACA period (P < 0.001). Veterans with SCI/D who live <5 miles from their nearest VA facility received VA care more frequently than those ≥40 miles from VA (P < 0.001).Conclusion: Counter to expectations, results suggest that Veterans with SCI/D sought more frequent VA care after ACA implementation, indicating Veterans with SCI/D continue to utilize the lifelong, comprehensive care provided at VA.

Virtual Care in the Veterans Affairs Spinal Cord Injuries and Disorders System of Care During the COVID-19 National Public Health Emergency.

Telehealth reduces disparities that result from physical disabilities, difficulties with transportation, geographic barriers, and scarcity of specialists, which are commonly experienced by individuals with spinal cord injuries and disorders (SCI/D). The Department of Veterans Affairs (VA) has been an international leader in the use of virtual health. The VA's SCI/D System of Care is the nation's largest coordinated system of lifelong care for people with SCI/D and has implemented the use of telehealth to ensure that Veterans with SCI/D have convenient access to their health care, particularly during the restrictions that were imposed by the COVID-19 pandemic.

Healthcare facility-onset, healthcare facility-associated Clostridioides difficile infection in Veterans with spinal cord injury and disorder.

Objective: To describe the burden and risk of healthcare facility-onset, healthcare facility-associated (HO-HCFA) Clostridioides difficile infection (CDI) in Veterans with spinal cord injury and disorder (SCI/D). Design: Retrospective, longitudinal cohort study from October 1, 2001-September 30, 2010. Setting: Ninety-four acute care Veterans Affairs facilities. Participants: Patients with SCI/D. Outcomes: Incidence rate of HO-HCFA CDI. Methods: Rates of CDI were determined, and crude unadjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated. Multivariable Poisson random-effects regression analyses were used to assess factors independently associated with the rate of CDI. Results: 1,409 cases of HO-HCFA CDI were identified. CDI rates in 2002 were 13.9/10,000 person-days and decreased to 5.5/10,000 person-days by 2010. Multivariable regression analyses found that antibiotic (IRR = 18.79, 95% CI 14.09-25.07) and proton-pump inhibitor (PPI) or H2 blocker use (IRR = 7.71, 95% CI 5.47-10.86) were both independently associated with HO-HCFA CDI. Exposure to both medications demonstrated a synergistic risk (IRR = 37.55, 95% CI 28.39-49.67). Older age, Northeast region, and invasive respiratory procedure in the prior 30 days were also independent risk factors, while longer SCI duration and care at a SCI center were protective. Conclusion: Although decreasing, CDI rates in patients with SCI/D remain high. Targeted antimicrobial stewardship and pharmacy interventions that reduce antibiotic and PPI/H2 blocker use could have profound benefits in decreasing HO-HCFA CDI in this high-risk population.

Potential of personal health record portals in the care of individuals with spinal cord injuries and disorders: Provider perspectives.

CONTEXT/OBJECTIVE: Although personal health record (PHR) portals are designed for patients, healthcare providers are a key influence in how patients use their features and realize benefits from them. A few studies have examined provider attitudes toward PHR portals, but none have focused on those who care for individuals with spinal cord injuries and disorders (SCI/D). We characterize SCI/D provider perspectives of PHR portals, including perceived advantages and disadvantages of PHR portal use in SCI/D care. DESIGN: Cross-sectional; semi-structured interviews. SETTING: Spinal Cord Injury (SCI) Centers in the Veterans Health Administration. PARTICIPANTS: Twenty-six SCI/D healthcare providers. INTERVENTIONS: None. OUTCOME MEASURES: Perceived advantages and disadvantages of PHR portals. RESULTS: The complex situations of individuals with SCI/D shaped provider perspectives of PHR portals and their potential role in practice. Perceived advantages of PHR portal use in SCI/D care included the ability to coordinate information and care, monitor and respond to outpatient requests, support patient self-management activities, and provide reliable health information to patients. Perceived disadvantages of PHR portal use in SCI/D care included concerns about the quality of patient-generated health data, other potential liabilities for providers and workload burden, and the ability of individuals with SCI/D to understand clinical information accessed through a portal. CONCLUSION: Our study highlights advantages and disadvantages that should be considered when promoting engagement of SCI/D healthcare providers in use of PHR portals, and portal features that may have the most utility in SCI/D care.

Sociotechnical Perspective on Implementing Clinical Video Telehealth for Veterans with Spinal Cord Injuries and Disorders.

BACKGROUND: Real-time videoconferencing technology such as clinical video telehealth (CVT) offers a means to reach patient populations who face limited access to healthcare. The Veterans Health Administration has invested in CVT to improve care access for U.S. military veterans with spinal cord injuries and disorders (SCI/D); however, no studies have assessed the factors that influence implementation of this technology in clinical practice for individuals with SCI/D. INTRODUCTION: Guided by a sociotechnical perspective, the purpose of this study was to identify factors that influence implementation of CVT for veterans with SCI/D. MATERIALS AND METHODS: We conducted semistructured telephone interviews with 40 healthcare providers who use CVT to deliver services to veterans with SCI/D. RESULTS: Factors related to workflow and communication were widely reported as implementation barriers. Coordinating logistics for CVT appointments was challenging, and effective communication between CVT team members across facilities was considered crucial. Providers also cited factors related to technical infrastructure, people, and organizational features, including the need for appropriate equipment, space, personnel, and support for using CVT equipment. DISCUSSION: The implementation of CVT in the care of veterans with SCI/D was influenced by an interrelated set of social and technical factors. Key among them were social factors related to people, workflow, and communication, given that CVT supports healthcare teams interacting remotely in real time. CONCLUSIONS: CVT implementation requires teams working together to negotiate a complex, distributed process across multiple sites. Such complexity places a premium on teamwork and communication among healthcare teams before, during, and after a CVT encounter.

Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic.

Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic strategies for patients with this disease. Unfortunately, its long and asymptomatic natural history, the uncertainties about disease progression, the fact that most patients are undiagnosed, and the requirement for sequential liver biopsies create substantial challenges for clinical development. Adaptive design methods are increasingly used in clinical research as they provide the flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation and make prompt preplanned adaptations without undermining the validity or integrity of the trial. Given the high unmet medical need and the lack of validated surrogate endpoints in NASH, the use of adaptive design methods appears reasonable. Furthermore, due to the limited number of patients willing to have multiple liver biopsies and the need for long-term exposure to assess an impact in outcomes, a continuous seamless adaptive design may reduce the overall sample size while allowing patients to continue after each one of the phases. Here, we review strategic frameworks that include potential surrogate endpoints as well as statistical and logistical approaches that could be considered for applying adaptive designs to clinical trials in NASH with the goal of facilitating drug development for this growing medical need. (Hepatology Communications 2017;1:577-585).

Unique Risks and Clinical Outcomes Associated With Extended-Spectrum ß-Lactamase Enterobacteriaceae in Veterans With Spinal Cord Injury or Disorder: A Case-Case-Control Study.

OBJECTIVES To describe the burden of extended-spectrum ß-lactamase (ESBL) Enterobacteriaceae in veterans with spinal cord injury or disorder (SCI/D), to identify risk factors for ESBL acquisition, and to assess impact on clinical outcomes DESIGN Retrospective case-case-control study PATIENTS AND SETTING Veterans with SCI/D and utilization at a Veterans' Affairs medical center from January 1, 2012, to December 31, 2013. METHODS Patients with a positive culture for ESBL Klebsiella pneumoniae, Escherichia coli, or Proteus mirabilis were matched with patients with non-ESBL organisms by organism, facility, and level of care and to uninfected controls by facility and level of care. Inpatients were also matched by time at risk. Univariate and multivariate matched models were assessed for differences in risk factors and outcomes. RESULTS A total of 492 cases (62.6% outpatients) were matched 1:1 with each comparison group. Recent prior use of fluoroquinolones and prior use of third- and fourth-generation cephalosporins were independently associated with ESBL compared to the non-ESBL group (adjusted odds ratio [aOR], 2.61; 95% confidence interval [CI], 1.77-3.84; P<.001 for fluoroquinolones and aOR, 3.86; 95% CI, 2.06-7.25; P<.001 for third- and fourth-generation cephalosporins) and the control group (aOR, 2.10; 95% CI, 1.29-3.43; P = .003 for fluoroquinolones; and aOR, 3.31; 95% CI, 1.56-7.06; P=.002 for third- and fourth-generation cephalosporins). Although there were no differences in mortality rate, the ESBL group had a longer post-culture length of stay (LOS) than the non-ESBL group (incidence rate ratio, 1.36; 95% CI, 1.13-1.63; P=.001). CONCLUSIONS All SCI/D patients with ESBL were more likely to have had recent exposure to fluoroquinolones or third- and fourth-generation cephalosporins, and hospitalized patients were more likely to have increased post-culture LOS. Programs targeted toward reduced antibiotic use in SCI/D patients may prevent subsequent ESBL acquisition. Infect Control Hosp Epidemiol 2016;37:768-776.

A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control.

BACKGROUND: Type 2 diabetes mellitus (T2DM) treatment generally requires multiple antihyperglycemic agents. When diet, exercise, and treatment with sulfonylurea and metformin do not achieve glycemic goals, several options are available. The present study evaluated the efficacy and tolerability of sitagliptin 100 mg/day added to therapy with sulfonylurea and metformin. METHODS: Patients with HbA1c ≥7.5% and ≤10.5% while on a sulfonylurea and metformin were randomized 1: 1 to sitagliptin 100 mg/day or placebo for 24 weeks. At Week 24, patients in the placebo group switched to pioglitazone 30 mg/day and both groups continued treatment for another 30 weeks. RESULTS: Of 427 patients randomized, 339 (79.4%) completed the study. At Week 24, significantly greater (P < 0.001) mean reductions from baseline were seen in the sitagliptin versus placebo group for HbA1c (-0.84% vs -0.16%, respectively), 2-h post-meal glucose (-2.0 vs -0.2 mmol/L, respectively) and fasting plasma glucose (-0.7 vs 0.3 mmol/L, respectively). At Week 54, improvements in glycemic control continued. At Week 24, the incidence of adverse events (AEs) was numerically greater with sitagliptin than placebo, primarily because of a higher incidence of hypoglycemia. At Week 54, the incidence of AEs was similar in both groups, primarily because of a higher incidence of hypoglycemia and edema in the placebo/pioglitazone group after Week 24. The only meaningful change in body weight was an increase in the placebo/pioglitazone group at Week 54. CONCLUSIONS: In this study, sitagliptin 100 mg/day was generally well tolerated and provided improvement in glycemic control when added to the combination of sulfonylurea and metformin in patients with T2DM.

Health Information Seeking and Technology Use Among Veterans With Spinal Cord Injuries and Disorders.

BACKGROUND: Access to health information is crucial to persons living with a spinal cord injury or disorder (SCI/D). Although previous research has provided insights on computer and Internet use among persons with SCI/D, as well as how and where persons with SCI/D gather health information, few studies have focused on U.S. veterans with SCI/D. OBJECTIVE: To characterize health information seeking among veterans with SCI/D and to examine the association between technology use and the characteristics of veterans with SCI/D. DESIGN: Cross-sectional. SETTING: Veterans Health Administration (VHA). PARTICIPANTS: Sample of 290 veterans with SCI/D who utilize services at 2 VHA SCI/D Centers. METHODS: Postal mail survey. MAIN OUTCOME MEASUREMENTS: Extent of computer, Internet, and text messaging use, information source use, and e-Health literacy rates. RESULTS: The survey response rate was 38%. The majority of respondents were male (97.2%), younger than 65 years (71.0%), and white (71.7%). Of the respondents, 64.8% indicated that they use a computer, 62.9% reported use of the Internet, and 26.2% reported use of text messaging. The mean overall e-Health Literacy Scale score was 27.3 (standard deviation = 7.2). Similar to findings reported in studies focused outside the veteran population, the most frequent source that veterans turned to for information about SCI/D was a health professional (85.1%); this was also the most frequent source that veterans indicated they would turn to first to get information about SCI/D (75.9%). Other frequently reported sources of information included other persons with SCI/D (41.0%), Internet resources (31.0%), and family and friends (27.9%). CONCLUSIONS: Fairly high levels of computer and Internet use exist among veterans with SCI/D. Veterans with SCI/D also have a strong preference for people-particularly health professionals, and to a lesser extent peers and family and friends-as sources of information about SCI/D. These findings highlight the importance of combining technology and human interaction to meet the information needs of this population.

Increasing specialty care access through use of an innovative home telehealth-based spinal cord injury disease management protocol (SCI DMP).

BACKGROUND: A spinal cord injury disease management protocol (SCI DMP) was developed to address the unique medical, physical, functional, and psychosocial needs of those living with spinal cord injuries and disorders (SCI/D). The SCI DMP was piloted to evaluate DMP clinical content and to identify issues for broader implementation across the Veterans Affairs (VA) SCI System of Care. METHODS: Thirty-three patients with SCI/D from four VA SCI centers participated in a 6-month pilot. Patients received customized SCI DMP questions through a data messaging device (DMD). Nurse home telehealth care coordinators (HTCC) monitored responses and addressed clinical alerts daily. One site administered the Duke Severity of Illness (DUSOI) Checklist and Short Form-8 (SF-8™) to evaluate the changes in comorbidity severity and health-related quality of life while on the SCI DMP. RESULTS: Patients remained enrolled an average of 116 days, with a mean response rate of 56%. The average distance between patient's home and their VA SCI center was 59 miles. Feedback on SCI DMP content and the DMD included requests for additional clinical topics, changes in administration frequency, and adapting the DMD for functional impairments. Improvement in clinical outcomes was seen in a subset of patients enrolled on the SCI DMP. CONCLUSION: SCI HTCCs and patients reported that the program was most beneficial for newly injured patients recently discharged from acute rehabilitation that live far from specialty SCI care facilities. SCI DMP content changes and broader implementation strategies are currently being evaluated based on lessons learned from the pilot.

Evaluating implementation of methicillin-resistant Staphylococcus aureus (MRSA) prevention guidelines in spinal cord injury centers using the PARIHS framework: a mixed methods study.

BACKGROUND: To prevent methicillin-resistant Staphylococcus aureus (MRSA) in Spinal Cord Injury and Disorder (SCI/D) Centers, the "Guidelines for Implementation of MRSA Prevention Initiative in the Spinal Cord Injury Centers" were released in July 2008 in the Veterans Affairs (VA) Health Care System. The purpose of this study was to use the Promoting Action on Research Implementation in Health Systems (PARiHS) framework to evaluate the experiences of implementation of SCI/D MRSA prevention guidelines in VA SCI/D Centers approximately 2-3 years after the guidelines were released. METHODS: Mixed methods were used across two phases in this study. The first phase included an anonymous, web-based cross-sectional survey administered to providers at all 24 VA SCI/D Centers. The second phase included semi-structured telephone interviews with providers at 9 SCI/D Centers. The PARiHS framework was used as the foundation of both the survey questions and semi-structured interview guide. RESULTS: The survey was completed by 295 SCI/D providers (43.8 % response rate) from 22 of the 24 SCI/D Centers (91.7 % participation rate). Respondents included nurses (57.3 %), therapists (24.4 %), physicians (11.1 %), physician assistants (3.4 %), and other health care professionals (3.8 %). Approximately 36 % of the SCI/D providers surveyed had not seen, did not remember seeing, or had never heard of the MRSA SCI/D guidelines, whereas 42.3 % of providers reported that the MRSA SCI/D guidelines were fully implemented in their SCI/D Center. Data revealed numerous barriers and facilitators to guideline implementation. Facilitators included enhanced leadership support and provider education, focused guideline dissemination to reach SCI/D providers, and strong perceived evidence supporting the guidelines. Barriers included lack of awareness of the guidelines among physical therapists and physician assistants and challenges in cohorting/isolating MRSA-positive patients and following contact precautions. CONCLUSIONS: Successful implementation of MRSA infection prevention guidelines in SCI/D settings requires (1) guideline dissemination that reaches the full range of SCI/D providers working in inpatient, outpatient, and other care settings, (2) provider education that is frequent and systematic, (3) strong leadership support, and (4) that barriers unique to the recommendations are addressed. These findings may be used to inform selection of implementation strategies and optimize infection prevention beyond MRSA as well as in other specialty care populations.

Treatment-Induced Changes in Plasma Adiponectin Do Not Reduce Urinary Albumin Excretion in the Diabetes Prevention Program Cohort.

BACKGROUND AND OBJECTIVES: Molecular data suggests that adiponectin may directly regulate urinary albumin excretion. In the Diabetes Prevention Program (DPP) we measured adiponectin and albuminuria before and after intervention, and we previously reported increases in adiponectin with interventions. Here we have used the DPP dataset to test the hypothesis that treatment-related increases in adiponectin may reduce albuminuria in obesity. DESIGN, SETTING, PARTICIPANTS AND METHODS: We evaluated cross-sectional correlations between plasma adiponectin and urinary albumin excretion at baseline, and the relationship of treatment-related changes in adiponectin and albuminuria. Baseline and follow-up urine albumin to creatinine ratios (ACR (albumin to creatinine ratio)) and plasma adiponectin concentration were available in 2553 subjects. RESULTS: Adjusting for age, sex and race/ethnicity, we observed a statistically significant but weak inverse relationship between adiponectin and ACR at baseline (conditional Spearman's rho = (-) 0.04, p = 0.04). Although DPP treatments significantly increased plasma adiponectin, there were no treatment effects on ACR and no differences in ACR across treatment groups. There was a weak direct (not inverse) association between change in adiponectin and change in albuminuria (adjusted Spearman's rho = (+) 0.04, p = 0.03). CONCLUSIONS: In a large, well-characterized cohort of obese dysglycemic subjects we observed a weak inverse association between circulating adiponectin concentrations and urinary albumin excretion at baseline. Contrary to the hypothesized effect, treatment-related increases in plasma adiponectin were not associated with a reduction in ACR. The association of change in adiponectin with change in ACR should be assessed in populations with overt albuminuria before excluding a beneficial effect of increasing adiponectin to reduce ACR in obesity.

Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes.

OBJECTIVE: This study was conducted to determine the optimal dose of omarigliptin, a once-weekly (q.w.) dipeptidyl peptidase IV (DPP-4) inhibitor, for the treatment of patients with type 2 diabetes and evaluate the long-term safety of that dose. RESEARCH DESIGN AND METHODS: In a multicenter, double-blind, 12-week, dose-range finding study, 685 oral antihyperglycemic agent-naïve or washed-out subjects with type 2 diabetes were randomized to one of five once-weekly doses of omarigliptin (0.25 mg, 1 mg, 3 mg, 10 mg, or 25 mg) or placebo. The primary efficacy end point was change from baseline in HbA1c, and secondary end points were 2-h postmeal glucose (PMG) and fasting plasma glucose (FPG). Analysis included all patients who received at least one dose of the study medication. Subjects who completed the base study were eligible to enter a 66-week extension study. RESULTS: Once-weekly treatment for 12 weeks with omarigliptin provided dose-related reductions in HbA1c, 2-h PMG, and FPG. At week 12, the omarigliptin 25-mg dose provided the greatest glycemic efficacy. The placebo-adjusted least-squares mean reductions from baseline in HbA1c, 2-h PMG, and FPG were -0.72% (-7.8 mmol/mol), -2.5, and -1.3 mmol/L, respectively (all P < 0.001). The incidence of adverse events was similar across dose groups, with a low incidence of symptomatic hypoglycemia and no effect on body weight. Omarigliptin was generally well-tolerated throughout the base and extension studies. CONCLUSIONS: Omarigliptin 25 mg q.w., compared with placebo, provided significant glucose lowering and was generally well tolerated for up to 78 weeks in patients with type 2 diabetes.

Non-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval Pathway.

The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is increasing world-wide in parallel to the increase of the obesity epidemic. Insulin resistance (IR) and the accumulation of triglyceride-derived toxic lipid metabolites play a key role in its pathogenesis. Multiple biomarkers are being evaluated for the non-invasive diagnosis of NASH. However, a percutaneous liver biopsy is still the gold standard method; the minimal diagnostic criteria include the presence of >5% macrovesicular steatosis, inflammation, and liver cell ballooning. Several pharmaceutical agents have been evaluated for the treatment of NASH; however, no single therapy has been approved so far. Due to the increasing prevalence and the health burden, there is a high need to develop therapeutic strategies for patients with NASH targeting both those with early-stage disease as well as those with advanced liver fibrosis. There are unique challenges in the design of studies for these target populations. Collaborative efforts of health authorities, medical disease experts, and the pharmaceutical industry are ongoing to align options for a registrational pathway. Several companies pursuing different mechanisms of action are nearing the end of phase II with their candidates. This manuscript reviews those compounds with a variety of mode of actions that have been evaluated and/or are currently being tested with the goal of achieving a NAFLD/NASH indication.

Healthcare worker influenza declination form program.

BACKGROUND: Health care worker (HCW) vaccination rates have been low for many years (approximately 50%). Our goal was to implement an influenza declination form program (DFP) to assess feasibility, participation, HCW vaccination, and costs. METHODS: This was a prospective interventional pilot study using mixed methods to evaluate the DFP implementation processes and outcomes. We conducted a formative evaluation and interviews; data were transcribed and coded into themes. Secondary outcomes included self-reported HCW influenza vaccine uptake (pre-/postsurvey) and program costs; data were evaluated using descriptive and bivariate analyses. RESULTS: The DFP was compatible with ongoing strategies and unit culture. Barriers included multiple hospital shifts and competing demands. Facilitators included complementary ongoing strategies and leadership engagement. HCW vaccination rates were higher post- versus preimplementation (77.4% vs 53.5%, P =.01). To implement the DFP at site 1, using a mobile flu cart, 100% of declination forms were completed in 42.5 staff hours over <2 months. At site 2, using a vaccination table on all staff meeting days, 49% of forms were completed in 26.5 staff hours over 4.5 months. Average cost of staff time was $2,093 per site. CONCLUSION: DFP implementation required limited resources and resulted in increased HCW influenza vaccine rates; this may have positive clinical implications for influenza infection control/prevention.

Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials.

INTRODUCTION: Impaired renal function is a major complication of type 2 diabetes mellitus (T2DM). Mild renal impairment is present in 38% of patients with T2DM and may impact choice of antihyperglycemic agent. Sulfonylureas and dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly used to treat hyperglycemia in patients with T2DM and renal impairment. Although in general sulfonylurea use is associated with an increased risk of hypoglycemia and weight gain, while DPP-4 inhibitor use is associated with a low risk of hypoglycemia, and is weight neutral, the relative efficacy and tolerability of these agents in patients with mild renal impairment has not been evaluated. METHODS: In a post hoc analysis, data from 1,211 subjects with T2DM and mild renal impairment (estimated glomerular filtration rates of 60 to <90 mL/min/1.73 m(2)), who completed 25 or 30 weeks of one of three double-blind clinical trials comparing the DPP-4 inhibitor sitagliptin 100 mg/day with sulfonylureas in titrated doses, were pooled. The analysis compared change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, incidence of symptomatic hypoglycemia and the percentages of subjects meeting a composite endpoint of HbA1c decrease >0.5% without symptomatic hypoglycemia or body weight gain between sitagliptin and sulfonylurea treatment groups. RESULTS: HbA1c and FPG decreased similarly with sitagliptin or sulfonylurea. A lower incidence of hypoglycemia was observed with sitagliptin. Body weight decreased with sitagliptin but increased with sulfonylurea. A greater percentage of subjects treated with sitagliptin (41.1%) than treated with sulfonylurea (16.9%) achieved the composite endpoint of >0.5% HbA1c reduction with no symptomatic hypoglycemia or body weight gain. CONCLUSION: In this analysis of subjects with T2DM and mild renal impairment, treatment with sitagliptin provided glycemic efficacy similar to sulfonylurea, with less hypoglycemia and with body weight loss compared to body weight gain seen with sulfonylurea. TRIAL REGISTRATIONS: ClinicalTrials.gov #NCT00482079, #NCT00094770, #NCT00701090.

Influenza antiviral treatment in spinal cord injury patients, 2007-2010.

OBJECTIVE: This study assessed antiviral medication use for treatment of influenza-like illness (ILI) in Veterans with spinal cord injury or disorder (SCI/D) and examined whether antiviral prescribing improved over time. DESIGN: Retrospective cohort study of Department of Veterans Affairs (VA) facilities. PARTICIPANTS: Veterans with SCI/D and matched non-SCI/D controls (matched by facility and date of visit/admission) who were diagnosed by a clinician with ILI during the period 1 October 2007 to 31 May 2010. MAIN OUTCOME MEASURES: Antiviral receipt and appropriateness were examined. Appropriate antiviral prescribing was defined as patients who received an antiviral medication within 2 days of collection of a sample for diagnostic testing or within 2 days of symptom onset. RESULTS: We identified 101 influenza visits/admissions for veterans with SCI/D and 123 for controls. Antiviral prescribing for Veterans with SCI/D increased from 37.1% in 2007/2008 to 67.6% in 2009/2010 (P = 0.01) and appropriate antiviral prescribing increased from 20.0 to 41.2% (P = 0.05). Predictors of antiviral prescribing included being treated in the 2009/2010 influenza season (vs. 2007/2008) and having a cough. Fever, aches/myalgia, or a positive influenza test was associated with appropriate antiviral treatment. SCI/D was an independent predictor of receiving antiviral treatment (adjusted odds ratio = 1.16, 95% confidence interval 1.04-1.29), but having SCI/D was not associated with receiving appropriate treatment. CONCLUSIONS: Influenza antiviral prescribing increased over time and in a larger proportion in veterans with SCI/D (vs. controls). This suggests that providers treating patients with SCI/D recognize treatment guidelines and their importance in a high-risk population. Continued efforts are needed to improve appropriate influenza antiviral prescribing.

Health care provider practices, barriers, and facilitators for weight management for individuals with spinal cord injuries and disorders.

BACKGROUND: Even though weight management is essential for the health of individuals with spinal cord injuries and disorders (SCI/D), little is known about current practices, barriers, and facilitators. OBJECTIVE: To describe weight management delivery in the Veterans Affairs (VA) SCI/D System of Care, including barriers and facilitators experienced by health care providers. METHODS: Qualitative focus groups were conducted in person at 4 geographically dispersed VA medical facilities delivering care to Veterans with SCI/D. Thirty-two employees involved in weight management efforts participated. Audio-recordings were transcribed and analyzed using qualitative content analysis techniques. RESULTS: Participants at SCI centers reported that weight management treatment was delivered through the center by a multidisciplinary team using education (eg, written materials) and counseling/consults. Participants at SCI spoke facilities generally depended on facility-level programs (eg, MOVE!) to deliver treatment. Spoke facilities discussed barriers to delivering treatment through their SCI team, including staff shortages and resource and structural issues. MOVE! staff discussed barriers, including limited wheelchair space in classrooms. Staff participants across facilities noted that Veterans with SCI/D were hesitant to use facility-level programs, because of nonspecific SCI-relevant information and discomfort attending sessions with general Veterans. Other barriers, for both centers and spoke facilities, included necessary medications that increase weight, lack of evidence-based guidelines for weight management, safety concerns, and facility layout/accessibility. Facilitators included facility leadership support, provider involvement/prioritization, and community resources. CONCLUSIONS: Weight management programs delivered through the SCI team, with peers and SCI-relevant content, are likely more acceptable and beneficial to individuals with SCI/D. Program classrooms should provide ample space for individuals with SCI/D.