Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.

This retrospective, matched-cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split-thickness skin allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with standard of care alone (controls), by using propensity matching to create nearly identical cohorts. Both cohorts received standard wound care, including surgical debridement, moist wound care, and offloading. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was performed. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Diabetic ulcers were 59% more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). The healing rate with the graft was better than standard of care across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90-179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). The amputation rate in the treatment cohort was 41.7% less than that of the control cohort at 20 weeks (0.9% vs. 1.5%, respectively). This study demonstrated that diabetic ulcers treated with a cryopreserved bioactive split-thickness skin allograft were more likely to heal and remain closed compared to ulcers treated with standard of care alone.

Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems.

Race-specific trends in HPV vaccinations and provider recommendations: persistent disparities or social progress?

OBJECTIVES: Although racial and ethnic differences in HPV vaccination initiation are well established, it is unclear whether these disparities have changed over time. The role of health provider recommendations in reducing any racial and ethnic inequalities is also uncertain. This study addresses these gaps in the literature. STUDY DESIGN: Repeated cross-sectional design. METHODS: Using data from the National Immunization Survey-Teen (2008-2013), we estimated a series of binary logistic regressions to model race-specific trends in (1) provider recommendations to vaccinate against HPV and (2) HPV vaccine initiation for males (n = 56,632) and females (n = 77,389). RESULTS: Provider recommendations to vaccinate and HPV vaccination uptake have increased over time for adolescent males and females and across all racial and ethnic groups. Among girls, minority youths have seen a sharper increase in provider recommendations and HPV vaccination uptake than their White counterparts. Among boys, minority teens maintain higher overall rates of HPV vaccine uptake, however, Hispanics have lagged behind non-Hispanic Whites in the rate of increase in provider recommendations and HPV vaccinations. CONCLUSIONS: Our results suggest that racial and ethnic disparities in provider recommendations and HPV vaccinations have waned over time among males and females. While these trends are welcomed, additional interventions are warranted to increase overall rates of vaccination across race, ethnicity, and gender.

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments.

OBJECTIVE: To describe the distribution and occurrence of adverse events recorded during hyperbaric oxygen (HBO) therapy from 2012 to 2015. In this analysis, events are defined as otic/sinus barotrauma, confinement anxiety, hypoglycemia, oxygen toxicity, pneumothorax, seizure, and shortness of breath. DATA AND ANALYSIS: The data for the analysis were drawn from a proprietary electronic health data system that contained information on 1,529,859 hyperbaric treatments administered during 53,371 treatment courses from 2012 to 2015 in outpatient wound care centers across the United States managed by Healogics, Inc, Jacksonville, Florida. RESULTS: Of the 1.5 million treatments included in the analysis, 0.68% were associated with an adverse event. Barotrauma and confinement anxiety were the most frequently reported events. Medically severe events were extremely uncommon, with fewer than 0.05 instances of oxygen toxicity per 1000 treatments and only 1 confirmed case of pneumothorax. CONCLUSIONS: Results indicate that the occurrence of adverse events associated with HBO therapy is infrequent and typically not serious. The findings of this study suggest that when administered according to the appropriate therapeutic protocols HBO therapy is a safe and low-risk intervention.

Still penalized? Parity, age at first birth and women's income in later life.

Despite policies aimed at decreasing old-age income inequality, such as Social Security and Supplemental Security Income, research consistently finds that later-life poverty is highly concentrated among women. While the early-life economic disadvantages of motherhood are well established, little work has examined whether these disadvantages persist into later life. Life course research consistently demonstrates the relationship between early-life choices and later-life inequality, but few studies have examined whether the reproductive phase of a woman's life is associated with her later-life income. Using data from the 2003 wave of the National Longitudinal Survey of Mature Women cohort, this research examines whether women's age at first birth and parity are associated with her later-life income within the context of marriage. From a set of multivariate analyses, I find that despite a marginal statistically significant effect, substantively for the women in this cohort the effects of childbearing are not particularly consequential for later-life income. The results suggest that as women age the economic penalties associated with motherhood are less important to financial well-being than are other factors.

Development of a Model to Predict Healing of Chronic Wounds Within 12 Weeks.

Objective: Chronic wounds represent a highly prevalent but little recognized condition with substantial implications for patients and payers. While better wound care products and treatment modalities are known to improve healing rates, they are inconsistently used in real-world practice. Predicting healing rates of chronic wounds and comparing to actual rates could be used to detect and reward better quality of care. We developed a prediction model for chronic wound healing. Approach: We analyzed electronic medical records (EMRs) for 620,356 chronic wounds of various etiologies in 261,398 patients from 532 wound care clinics in the United States. Patient-level and wound-level parameters influencing wound healing were identified from prior research and clinician input. Logistic regression and classification tree models to predict the probability of wound healing within 12 weeks were developed using a random sample of 70% of the wounds and validated in the remaining data. Results: A total of 365,659 (58.9%) wounds were healed by week 12. The logistic and classification tree models predicted healing with an area under the curve of 0.712 and 0.717, respectively. Wound-level characteristics, such as location, area, depth, and etiology, were more powerful predictors than patient demographics and comorbidities. Innovation: The probability of wound healing can be predicted with reasonable accuracy in real-world data from EMRs. Conclusion: The resulting severity adjustment model can become the basis for applications like quality measure development, research into clinical practice and performance-based payment.

Impact of Hyperbaric Oxygen on More Advanced Wagner Grades 3 and 4 Diabetic Foot Ulcers: Matching Therapy to Specific Wound Conditions.

Objective: The goal of this research was to identify a population of diabetic foot ulcer patients who demonstrate a significant response to hyperbaric oxygen therapy (HBOT) using a large sample size to provide guidance for clinicians when treating these complicated patients. Approach: The effect of HBOT on diabetic foot ulcers, Wagner grades 3 and 4, was evaluated using a retrospective observational real-world data set. The study reported on the overall healing rate, (74.2%) at the population level, for >2 million wounds. Results: When a subgroup of patients of only foot ulcers with a Wagner grade 3 or 4 were considered, the healing rate was only 56.04%. The use of HBOT, without filtering for the number of treatments received, improved the healing rate to 60.01% overall. Healing rates for this same subgroup, however, were improved to 75.24% for patients who completed the prescribed number of hyperbaric treatments. Innovation: This observational study discusses the importance of reporting at the population level, specific wound etiology level, a risk-stratified level, and to then overlay the effect of treatment adherence on those outcomes to provide clinicians with a comprehensive understanding of when to prescribe an advanced modality such as hyperbaric oxygen. Conclusion: The authors provide healing outcomes data from several prior HBOT studies as well as other advanced modalities that have been used in diabetic foot ulcer care for comparison and context.

Use of a National Electronic Health Record Network to Describe Characteristics and Healing Patterns of Sickle Cell Ulcers.

Objective: Sickle cell ulcers affect as many as 15% of patients with sickle cell disease in the United States and severely impact quality of life. An understanding of baseline healing patterns is important to inform study design for future trials that test therapies for this disease. Approach: In this study, an electronic wound management system was leveraged to analyze retrospective data on 133 unique sickle cell patients who were treated across 114 wound healing centers, and to describe their characteristics and healing patterns as compared with those of venous ulcer patients. The data included 198 care episodes for 427 wounds. Results: Patients with sickle cell ulcers were younger and had fewer comorbid diseases than those with venous ulcers. Larger size and longer duration were predictors of poor healing. Between the first and fourth assessments, mean change in area for sickle cell ulcers showed a 58% increase, compared with a 13% decrease for venous ulcers. Kaplan-Meier curves showed poorer healing in sickle cell ulcers than in venous ulcers across all categories of size and duration. Patients with sickle cell ulcers had longer care episodes and were more likely to re-present for care. Innovation: This study reports on the largest data set of sickle cell ulcer patients analyzed to date in the published literature to provide a more detailed understanding of wound healing patterns of this disease. Conclusion: A national network of electronic health records can effectively identify a large number of patients with sickle cell ulcers to support analysis of epidemiology, healing patterns, and health care utilization.