Publications by authors named "Laura Helmkamp"

32 Publications

Determining the incidence of postbariatric surgery emergency department utilization: an analysis of a statewide insurance database.

Surg Obes Relat Dis 2021 Apr 28. Epub 2021 Apr 28.

Department of Surgery, University of Colorado Anschutz, Aurora, Colorado.

Background: Prior studies have found rates of emergency department (ED) visits after bariatric surgery approach 15% with the majority (>60%) not requiring admission. The timeframe for which ED utilization remains elevated postoperatively remains unknown. We hypothesize that ED utilization following bariatric surgery remains elevated for months after surgery with the majority of visits not requiring admission.

Objective: No study has determined the impact bariatric surgery has on health care resource utilization in the two years following surgery. The aim of this study is to determine the frequency of ED visitation in the 2 years following bariatric surgery.

Settings: Database study, single state-wide insurance database.

Methods: We queried the Colorado All Payers Claim Database. Patients with data 1 year before and 2 years after surgery were included. Primary outcomes of interest were ED visits or readmissions during the 2-year period. Bariatric surgeries were identified using CPT codes. Diagnoses for an ED visit or readmission were determined by ICD codes.

Results: A total of 5399 patients underwent bariatric surgery from January 2013-November 2017. Of these, 59% underwent sleeve gastrectomy, 38% Roux-en-Y, 2% gastric band, and 1% another surgery. Median age was 44 (IQR 35-54) years, and 82% were female. Overall, 3103 patients (57%) visited the ED at least once with a total of 12,988 visits, 1267 of which (9.8%) resulted in admission. ED use was highest in the 30 days following surgery (17%) but remained above presurgery baseline for 8 months (7.4% at 8 mo compared with baseline mean 6.4% [95% CI 6.0%-6.8%]).

Conclusions: ED visits remain elevated for 8 months post bariatric surgery with over 90% of visits not requiring an admission. Interventions that prevent emergency department utilization should be key focus of quality improvement projects to limit health care resource utilization following bariatric surgery.
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http://dx.doi.org/10.1016/j.soard.2021.04.016DOI Listing
April 2021

A validated modification of the vaccine hesitancy scale for childhood, influenza and HPV vaccines.

Vaccine 2021 03 4;39(13):1831-1839. Epub 2021 Mar 4.

Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, United States. Electronic address:

Introduction: Vaccine hesitancy contributes to outbreaks of preventable disease worldwide. The Vaccine Hesitancy Scale (VHS), developed by the international WHO SAGE Working Group, has been validated previously for measuring hesitancy towards childhood vaccines; some psychometric properties were suboptimal.

Methods: We collected data using large, nationally-representative samples of parents in the U.S. We adapted the VHS items, and additional hesitancy items, to assess hesitancy towards influenza and HPV vaccines in addition to routine childhood vaccines. We then used exploratory and confirmatory factor analysis to identify latent constructs and create modified scales for childhood (VHS-child), influenza (VHS-flu) and HPV (VHS-HPV) vaccines with improved psychometric properties. Finally, we compared hesitancy scores on the VHS-child, VHS-flu, and VHS-HPV, to self-reported receipt of each vaccine category, and compared subscale scores to assess whether drivers of hesitancy differed by vaccine category.

Results: 2052 parents of children <18 years old completed the VHS-child and VHS-flu while 2020 parents of adolescents completed the VHS-HPV. A two-factor structure of 'risks' and a 'lack of confidence' was found for each vaccine category. Slight modifications to the VHS improved psychometric properties. Hesitancy was strongly associated with vaccine receipt: e.g., 76% of parents not hesitant towards influenza vaccine had vaccinated their child the past season, versus 9% of hesitant parents (p < 0.0001). Subscale scores also differed significantly between vaccines: lack of confidence was greater towards influenza (Median (IQR): 2.0 (1.2, 3.3)) and HPV (2.0 (1.3, 3.0)) vaccines than childhood (1.2 (1.0, 1.8), p < 0.0001 for both) vaccines; perceived risks of HPV vaccines (2.7 (1.7, 3.7)) were greater than for childhood vaccines (2.0 (1.3, 3.0), p < 0.0001).

Conclusions: Our modified VHS scales perform well psychometrically and allow for consistent measurement of the extent and reasons for hesitancy between vaccine categories. We suggest that future work use these scales to examine hesitancy towards other vaccines and to monitor hesitancy over time.
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http://dx.doi.org/10.1016/j.vaccine.2021.02.039DOI Listing
March 2021

Outcomes After Converted Minimally Invasive to Open Esophagectomy in Patients with Esophageal Cancer.

Ann Thorac Surg 2020 Dec 14. Epub 2020 Dec 14.

Department of Surgery, Division of Cardiothoracic Surgery.

Background: The objective of this study was to evaluate the impact of unplanned conversion during minimally invasive esophagectomy (MIE) on postoperative morbidity and mortality for patients with esophageal cancer, as well as to evaluate the variables that influence the need for conversion.

Methods: We performed a retrospective analysis of patients with esophageal cancer who underwent open esophagectomy or MIE by either laparo-thoracoscopic or robotic approach from 2016-2018 using the esophagectomy-specific American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database. Poisson regression models were used to analyze 30-day outcomes and risk factors for conversion during attempted MIE.

Results: A total of 2,616 patients were identified. The overall conversion rate for MIE was 6.3%. Compared to completed MIE, patients requiring conversion had a significantly increased risk of 30-day mortality (RR 2.63, 95% CI 1.03-6.69) and experienced a variety of other postoperative complications. Patients requiring conversion during MIE also experienced worse perioperative outcomes when compared to patients who underwent planned open esophagectomy. Estimated surgical risk based on the ACS NSQIP Surgical Risk Calculator was the only variable found to be independently associated with conversion from minimally invasive to open esophagectomy (RR 1.03, 95% CI 1.01-1.04, for each 10% increase in risk score).

Conclusions: Unplanned conversion during MIE is associated with significantly greater morbidity and a 2.6-fold increased risk of death when compared to both completed MIE and planned open esophagectomy. The ACS NSQIP Surgical Risk Calculator may help identify patients preoperatively who are at higher risk for conversion during MIE.
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http://dx.doi.org/10.1016/j.athoracsur.2020.11.025DOI Listing
December 2020

An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial.

Circulation 2021 Feb 17;143(5):427-437. Epub 2020 Nov 17.

University of Colorado School of Medicine, Aurora (L.A.A., G.V., C.K.M., C.E.K., L.J.H., P.K., P.N.P., K.P., G.H., J.S.T., K.E.T., D.P.K., D.J.M., P.M.B., D.D.M.).

Background: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.

Methods: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period.

Results: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of β-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT (=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups.

Conclusions: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03334188.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051863DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855616PMC
February 2021

An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.

Am Heart J 2020 11 28;229:144-155. Epub 2020 Aug 28.

University of Colorado School of Medicine, Aurora, CO. Electronic address:

Background: Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.

Hypothesis: Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies.

Design: The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy.

Summary: The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.
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http://dx.doi.org/10.1016/j.ahj.2020.08.013DOI Listing
November 2020

Prevalence and characteristics of HPV vaccine hesitancy among parents of adolescents across the US.

Vaccine 2020 08 2;38(38):6027-6037. Epub 2020 Aug 2.

Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address:

Background: While many clinicians encounter parents or adolescents who refuse HPV vaccine, little is known about the prevalence of hesitancy for HPV vaccine nationally or its association with vaccination.

Methods: In April 2019, we surveyed families with adolescents 11-17 years using a national online panel (Knowledge Panel®) as the sampling frame. We assessed the prevalence of HPV vaccine hesitancy with the validated 9-item Vaccine Hesitancy Scale (VHS). We used multivariate analyses to assess demographic factors associated with HPV vaccine hesitancy. We also assessed practical barriers to receipt of HPV vaccine and the relationship between barriers and hesitancy. Finally, we evaluated the association between both HPV vaccine hesitancy and practical barriers on HPV vaccine receipt or refusal.

Results: 2,177 parents out of 4,185 sampled (52%) completed the survey, 2,020 qualified (lived with adolescent). Using a VHS cut-off score > 3 out of 5 points, 23% of US parents were hesitant about HPV vaccine. Hesitancy was lower among those with Hispanic ethnicity. At least one out of five parents disagreed that the HPV vaccine is beneficial for their adolescent, that the vaccine is effective, protects against HPV-related cancers, or that they followed their adolescent's health-care provider's recommendation about the vaccine. Many were concerned about vaccine side effects and the novelty of the vaccine. Adolescents living with vaccine-hesitant parents were less than one-third as likely to have received the vaccine (RR = 0.29, 95% CI 0.24, 0.35) or completed the vaccine series (RR = 0.29, 95% CI 0.23, 0.36), and were 6-fold more likely to have refused the vaccine because of parental vaccine-related concerns (RR = 6.09, 95% CI = 5.26, 7.04). Most practical barriers were independently associated with vaccine receipt but not with vaccine refusal.

Conclusions: HPV vaccine hesitancy is common nationally and strongly related to both under-vaccination and vaccine refusal.
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http://dx.doi.org/10.1016/j.vaccine.2020.06.074DOI Listing
August 2020

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Am Heart J 2020 08 20;226:161-173. Epub 2020 Apr 20.

Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.
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http://dx.doi.org/10.1016/j.ahj.2020.04.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442619PMC
August 2020

Parental Hesitancy About Routine Childhood and Influenza Vaccinations: A National Survey.

Pediatrics 2020 07 15;146(1). Epub 2020 Jun 15.

Department of Pediatrics, University of California at Los Angeles Mattel Children's Hospital and University of California at Los Angeles, Los Angeles, California.

Background And Objectives: The World Health Organization has designated vaccine hesitancy as 1 of the 10 leading threats to global health, yet there is limited current national data on prevalence of hesitancy among US parents. Among a nationally representative sample of US parents, we aimed to (1) assess and compare prevalence of hesitancy and factors driving hesitancy for routine childhood and influenza vaccination and (2) examine associations between sociodemographic characteristics and hesitancy for routine childhood or influenza vaccination.

Methods: In February 2019, we surveyed families with children using the largest online panel generating representative US samples. After weighting, we assessed hesitancy using a modified 5-point Vaccine Hesitancy Scale and labeled parents as hesitant if they scored >3.

Results: A total of 2176 of 4445 parents sampled completed the survey (response rate 49%). Hesitancy prevalence was 6.1% for routine childhood and 25.8% for influenza vaccines; 12% strongly and 27% somewhat agreed they had concerns about serious side effects of both routine childhood and influenza vaccines. A total of 70% strongly agreed that routine childhood vaccines are effective versus 26% for influenza vaccine ( < .001). In multivariable models, an educational level lower than a bachelor's degree and household income <400% of the federal poverty level predicted hesitancy about both routine childhood and influenza vaccines.

Conclusions: Almost 1 in 15 US parents are hesitant about routine childhood vaccines, whereas >1 in 4 are hesitant about influenza vaccine. Furthermore, 1 in 8 parents are concerned about vaccine safety for both routine childhood and influenza vaccines, and only 1 in 4 believe influenza vaccine is effective. Vaccine hesitancy, particularly for influenza vaccine, is prevalent in the United States.
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http://dx.doi.org/10.1542/peds.2019-3852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7329256PMC
July 2020

Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.

J Pediatr 2020 06;221:123-131.e4

Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.

Objective: To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.

Study Design: Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.

Results: In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.

Conclusions: Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.

Trial Registration: ClinicalTrials.gov: NCT03294473 and NCT03246100.
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http://dx.doi.org/10.1016/j.jpeds.2020.02.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7518461PMC
June 2020

Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial.

Acad Pediatr 2020 04 5;20(3):374-383. Epub 2019 Nov 5.

Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles (C Albertin and P Szilagyi), Los Angeles, Calif.

Objective: Centralized reminder/recall (C-R/R) by health departments using immunization information systems is more effective and cost effective than practice-based approaches for increasing childhood vaccines but has not been studied for influenza vaccination. We assessed effectiveness and cost of C-R/R for increasing childhood influenza vaccination compared with usual care.

Methods: Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, and health center) were selected proportionate to where children are served-65 practices (N = 54,353 children) in CO; 101 practices (N = 65,777) in NY. We conducted 4-arm RCTs per state (1, 2, or 3 autodial reminders vs usual care), with randomization at the patient level within practices from 10/2016 to 1/2017.

Results: In CO, the maximum absolute difference in receipt of ≥1 influenza vaccine was 1.7% between the 2 R/R group and control (adjusted risk ratio [ARR] of 1.06 [1.01, 1.10]); other R/R arms did not differ significantly. In NY, ARRs for the study arms versus control varied from 1.05 (1.01, 1.10) for 3 R/R to 1.06 (1.01, 1.11) for 1-2 R/R groups and maximum absolute increase in vaccination was 0.6%. In time-to-event analyses, study arm was a significant predictor of vaccination in CO (P = .001) but not in NY. Costs/child randomized to one message were $.17 in CO and $.23 in NY.

Conclusions: C-R/R for influenza vaccine using autodial had low-level effects on increasing influenza rates in 2 states. Given the feasibility and low cost of C-R/R in previous trials, its utility for influenza should be re-examined using different modalities.
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http://dx.doi.org/10.1016/j.acap.2019.10.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7477488PMC
April 2020

Evaluation of a water-soluble contrast protocol for small bowel obstruction: A southwestern surgical congress multicenter trial.

Am J Surg 2019 12 30;218(6):1046-1051. Epub 2019 Sep 30.

Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA; Department of Surgery, Denver Health Medical Center, Denver, CO, USA. Electronic address:

Differentiation between SBO that will resolve with supportive measures and those requiring surgery remains challenging. WSC administration may be diagnostic and therapeutic. The purpose of this study was to evaluate use of a SBO protocol using WSC challenge. A protocol was implemented at five tertiary care centers. Demographics, prior surgical history, time to operation, complications, and LOS were analyzed. 283 patients were admitted with SBO; 13% underwent immediate laparotomy; these patients had a median LOS of 7.5 days. The remaining 245 were candidates for WSC challenge. Of those, 80% received contrast. 139 (71%) had contrast passage to the colon. LOS in these patients was 4 days. Sixty-five patients (29%) failed contrast passage within 24 h and underwent surgery. LOS was 9 days. 8% of patients in whom contrast passage was observed at 24 h nevertheless subsequently underwent surgery. 4% of patients who failed WSC challenge did not proceed to surgery. Our multicenter trial revealed that implementation of a WSC protocol may facilitate early recognition of partial from complete obstruction.
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http://dx.doi.org/10.1016/j.amjsurg.2019.09.031DOI Listing
December 2019

Prospective evaluation of oral cannabis extracts in children with epilepsy.

Seizure 2019 Nov 16;72:23-27. Epub 2019 Sep 16.

Department of Pediatrics and Neurology, University of Colorado, Anschutz Medical Campus, Aurora CO 80045, United States.

Purpose: Interest in the use of artisanal cannabinoids in pediatric epilepsy has increased but safety and utility data are lacking. Our aim was to prospectively characterize the use of oral cannabis extracts (OCE) in a refractory pediatric epilepsy population.

Methods: Families considering the use of an OCE were enrolled in a prospective observational study. Baseline seizure frequency was assessed over a period of 4 weeks. Seizure frequency, CBD and THC-COOH levels were assessed every 4 weeks during a 12-week treatment period. Response was defined as at least a 50% reduction in seizure frequency over the final 8 weeks of the study relative to baseline.

Results: Consent was obtained in 32 children; 11 were excluded from analysis (3 failed to complete baseline data, 3 started OCE before completing baseline period and 5 did not start OCE) leaving 21 to be included in subsequent analyses. Median age was 10.3 years (IQR 6.8-12.6), 13 (62%) were male and median seizure frequency was 2.7 seizures/day during the baseline period. The median of the high dose of CBD that was administered during the observation period was of 0.9 (0.6-2.2) mg/kg/day. Of the 21 subjects who were included in the analysis, 5 (24%) were responders. OCE was stopped early in 3 subjects (14%) due to a perceived increase in seizures. THC-COOH and CBD blood levels did not have a significant association with response status (p = 0.95 CBD, p = 0.53 THC-COOH, N = 14).

Conclusion: The observed response rate in this study is similar to placebo rates in prospective randomized trials of pharmaceutical grade products and the withdrawal rate is greater than rates obtained with retrospective methods. Doses of OCE administered were lower than doses used in randomized trials.
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http://dx.doi.org/10.1016/j.seizure.2019.09.007DOI Listing
November 2019

A Comparison of Frailty Measures at Listing to Predict Outcomes After Lung Transplantation.

Ann Thorac Surg 2020 01 31;109(1):233-240. Epub 2019 Aug 31.

Cardiothoracic Surgery, University of Colorado, Aurora, Colorado.

Background: Sarcopenia may be an important predictive factor of outcomes after lung transplantation (LTx). Serum albumin and the 6-minute walk distance (6MWD) have been shown to be a marker of LTx outcomes. We measured sarcopenia, albumin, and 6MWD in a cohort of LTx patients and analyzed the utility of these as markers of outcomes for LTx patients.

Methods: We retrospectively identified LTx recipients from 2013-2018 at our institution who underwent computed tomographic imaging during their listing evaluation. From that image, we measured skeletal muscle cross-sectional surface area at the third lumbar vertebral level, and sarcopenia was diagnosed by established cutoffs. Associations between sarcopenia, albumin, 6MWD, and survival, and hospital length of stay, complications, readmissions, and discharge destination were evaluated.

Results: Sarcopenia was found in 72% (95 of 132) of patients, 18% (24 of 131) of patients were hypoalbuminemic, and 41% had a low 6MWD. Survival was not associated with presence of sarcopenia (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.46-2.42) or low 6MWD (HR, 0.86; 95% CI, 0.410-1.83). Hospital length of stay, complications, readmissions, and discharge destination were not influenced by sarcopenia or 6MWD. In contrast, hypoalbuminemia was independently associated with decreased survival (HR, 2.25; 95% CI, 1.04-4.85) and a higher grade of postoperative complications (P = .04).

Conclusions: Sarcopenia is prevalent in LTx patients. Neither sarcopenia nor 6MWD predicted mortality or short-term outcomes after LTx. This is in contrast to albumin levels, which were inversely associated with survival and complications. Albumin shows promise as an important predictor of mortality and short-term outcomes after LTx.
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http://dx.doi.org/10.1016/j.athoracsur.2019.07.040DOI Listing
January 2020

Improved Mortality Associated With the Use of Extracorporeal Membrane Oxygenation.

Ann Thorac Surg 2019 08 19;108(2):350-357. Epub 2019 Apr 19.

Division of Cardiothoracic Surgery, University of Colorado, Aurora, Colorado.

Background: Our objective was to evaluate the association of bridge to transplant (BTT) extracorporeal membrane oxygenation (ECMO) on survival after lung transplantation (LTx) and determine the degree to which transplant center volume affects this relationship.

Methods: Using the United Network for Organ Sharing database, we performed a retrospective cohort study evaluating the survival of patients undergoing LTx between 2005 and 2017. On the basis of previous literature, LTx centers were classified into 3 groups using their average annual LTx volume over the preceding 5 years: less than 25, 25 to 49, and more than 50. Survival of BTT ECMO and non-ECMO patients was analyzed using a log-rank test. Propensity scores for BTT ECMO were calculated, and a weighted proportional hazards model was used to compare BTT ECMO and non-ECMO patients by center volume.

Results: There were 20,976 patients who met inclusion criteria, with 611 (2.9%) undergoing BTT ECMO. Overall, BTT ECMO was associated with increased posttransplantation hazard of mortality (hazard ratio, 1.37; 95% confidence interval, 1.14 to 1.64). Kaplan-Meier plots by center volume suggest that BTT ECMO-associated mortality may be mitigated at high-volume LTx centers. In the propensity score-weighted proportional hazards model, we determined that when centers perform more than 35 LTxs per year, the increased hazard of BTT ECMO on mortality is no longer observed.

Conclusions: BTT ECMO can be performed as a bridge to LTx without significantly increasing patient mortality in high-volume centers. Patients undergoing BTT ECMO at LTx centers that perform more than 35 LTxs annually have equivalent mortality to those who do not require ECMO before transplantation.
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http://dx.doi.org/10.1016/j.athoracsur.2019.03.057DOI Listing
August 2019

Obstruction reduction: Use of water-soluble contrast challenge to differentiate between partial and complete small bowel obstruction.

Am J Surg 2019 11 28;218(5):913-917. Epub 2019 Feb 28.

Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

Differentiating SBO that will resolve conservatively from those requiring surgery remains challenging. Water-soluble contrast administration may be diagnostic and therapeutic. Our study evaluated use of a WSC challenge protocol. We hypothesize that protocol use discriminates between surgical SBO and obstructions which can be managed non-operatively. Demographics, prior surgeries, time to operation, complications, and LOS were analyzed. 108 patients were admitted with SBO. 13% underwent immediate laparotomy with concern for bowel compromise; these had a median LOS of 8.5 days. 91 received WSC protocol. Of these, 77% had contrast passage to the colon. Of the 48 in whom contrast passed between 0 and 12 h, LOS was 2 days. Of the 22 patients in whom contrast passed between 12 and 24 h, LOS was 4.5 days. 21 had failure of contrast passage; 18 of those underwent surgery after 24 h as a result. Of the 21 patients who failed WSC challenge, median LOS was 8 days. WSC protocol implementation facilitates early recognition of partial from complete obstruction and may decrease LOS. Our findings warrant further evaluation with a multicenter trial.
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http://dx.doi.org/10.1016/j.amjsurg.2019.02.034DOI Listing
November 2019

Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and Values (HYVALUE) Trial.

JMIR Res Protoc 2019 Mar 25;8(3):e12498. Epub 2019 Mar 25.

University of Colorado School of Medicine, Adult and Child Consortium for Health Outcomes Research and Delivery Science, Denver Health and Hospital Authority, Department of Medicine, Denver, CO, United States.

Background: Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient's ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies.

Objective: The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat.

Methods: The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients' adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients' prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes.

Results: This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes.

Conclusions: The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition-hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations.

Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

International Registered Report Identifier (irrid): DERR1-10.2196/12498.
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http://dx.doi.org/10.2196/12498DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6452278PMC
March 2019

End of life for patients with left ventricular assist devices: Insights from INTERMACS.

J Heart Lung Transplant 2019 04 15;38(4):374-381. Epub 2018 Dec 15.

Section of Advanced Heart Failure and Transplantation, Division of Cardiology, Department of Medicine; Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, Colorado, USA.

Background: Trial and registry data have reported mortality rates and causes of death in patients with left ventricular assist devices (LVADs); however, a more granular description is needed of end of life, including location of death and quality of life (QOL), to better guide expectations and care.

Methods: To identify where patients with an LVAD died, characterize QOL before death, and cause of death over time, we evaluated patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) implanted with a continuous-flow LVAD.

Results: From 18,733 patients implanted with an LVAD during the period 2008 to 2016, 4,916 patients were known to have died, of whom 98% had a recorded location of death. Overall, 76.9% died in the hospital, with progressively more patients dying outside of the hospital further post-LVAD implant: <1 month, 2.3%; 1 to 12 months, and 16.8%; and >12 months, 37.4%. In a multivariable analysis, increased age (RR (risk ratio) 1.06, 95% confidence interval [CI] 1.02 to 1.12, p = 0.01) and destination therapy indication (RR 1.15, 95% CI 1.03 to 1.28, p = 0.01) increased the likelihood of dying outside the hospital. Comparing 3 months post-implant with 6 months before death in a subset of patients, QOL remained clinically stable (EQ-5D Visual Analog Scale [mean ± SD]: 68.3 ± 22.2 to 66.7 ± 21.7, p = 0.11; KCCQ: 61.0 ± 22.2 to 57.8 ± 23.2, p = 0.003). The most common cause of death <1 month post-implant was multiple-organ failure (20.4%) and at >1 month post-implant it was neurologic dysfunction (28.2%).

Conclusions: Most patients with an LVAD died in the hospital. QOL remained stable months before death and causes of death were varied, but increasingly dominated by stroke. By understanding death with an LVAD in place, clinicians are in a better position to educate patients and caregivers about what to expect and provide to support tailored to patient and caregiver needs.
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http://dx.doi.org/10.1016/j.healun.2018.12.008DOI Listing
April 2019

Colorado Asthma Toolkit Implementation Improves Some Process Measures of Asthma Care.

J Am Board Fam Med 2019 Jan-Feb;32(1):37-49

From the Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado (KLC); Adult & Child Consortium for Health Outcomes Research & Delivery Science, Aurora, CO (LH); Department of Pediatrics, National Jewish Health, Denver (BGB); Department of Medicine, University of Colorado School of Medicine, Aurora (BMK, LMS); Pediatrics, University of Colorado School of Medicine, Aurora (MRS).

Background: The Colorado Asthma Toolkit Program (CATP) has been shown to improve processes of care with less evidence demonstrating improved outcomes.

Objective: To model the association between pre-and-post-CATP status and asthma-related process and outcome measures among patients ages 5 to 64 years receiving care in safety-net primary care practices.

Methods: This is an implementation study involving secondary prepost analysis of existing structured clinical, administrative, and claims data. Nine primary care practices in a federally qualified health center network implemented the CATP. Processes of care and health and utilization outcomes were evaluated prepost implementation in a cohort of patients with asthma using generalized linear mixed models.

Results: The study cohort included 2678 patients age 5 to 64 years with at least one visit to one of the 9 participating practices during the study period (March 12, 2010 to December 1, 2012). A comparison of 12 months pre- and post-CATP implementation showed improvement in some process measures of asthma care associated with the intervention, including the rate of asthma-severity measurement, although no change in 2 Health care Effectiveness Data and Information Set measures: asthma medication ratio and medication management for people with asthma. We also found no change in asthma outcomes measured across multiple domains: exacerbations, utilization, symptom scores, and pulmonary physiology measures.

Conclusions: Implementation of the CATP in a primary care setting led to some improved processes of asthma care, but no changes in measured outcomes. Recommendations for future work include supplemental follow-up training including case review.
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http://dx.doi.org/10.3122/jabfm.2019.01.180155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943943PMC
March 2020

Potential Strategies to Achieve Universal Influenza Vaccination for Children: Provider Attitudes in Two States.

Acad Pediatr 2018 Nov - Dec;18(8):873-881. Epub 2018 Jul 19.

Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS) , University of Colorado School of Medicine and Children's Hospital Colorado, Aurora; Department of Pediatrics , University of Colorado School of Medicine, Aurora.

Objective: Childhood influenza vaccination rates remain suboptimal. Provider perceptions on strategies to achieve universal vaccination are needed. We assessed the perceptions and attitudes of primary care providers across 2 states regarding 2 strategies to potentially bolster rates: centralized reminder/recall (C-R/R), such as reminder/recall (R/R) notices from state immunization registries, and influenza vaccination by complementary community vaccinators (CCVs), such as retail pharmacies, schools, and health departments.

Methods: We sent a mailed survey to a representative sample of providers across Colorado and New York. Questions addressed R/R activities for influenza vaccine, preferences and attitudes about the health department sending C-R/R notices for influenza vaccine, and attitudes about CCVs. Bivariate analyses assessed provider perceptions and compared perceptions by state.

Results: The overall response rate was 56% (n = 590/1052). Twenty-two percent of providers in Colorado and 33% in New York performed practice-based R/R for all patients during the 2015-16 influenza season. Eighty-one percent of providers in both states preferred the health department or had no preference for who sent C-R/R notices for influenza vaccine to their patients; most preferred to include their practice names on C-R/R messages. Many providers in both Colorado (75%) and New York (46%, P < .001) agreed that their patients like the option of having CCVs where children can receive influenza vaccine. Some providers expressed concerns regarding potential loss of income and/or difficulty documenting receipt of influenza vaccine at CCVs.

Conclusions: Most providers support C-R/R, and many support CCVs to increase influenza vaccination rates. Collaborations between traditional primary care providers and CCVs might boost coverage.
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http://dx.doi.org/10.1016/j.acap.2018.07.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7477487PMC
November 2019

Temporal Trends in Contemporary Use of Ventricular Assist Devices by Race and Ethnicity.

Circ Heart Fail 2018 08;11(8):e005008

University of Arizona, Tucson. Division of Cardiology, Anschutz Medical Campus (L.A.A., S.L.D., P.K., P.N.P.).

Background: The proportion of racial/ethnic minorities receiving ventricular assist devices (VADs) has previously been less than expected. It is unclear if trends have changed since the broadening of access to insurance in 2014 and the rapid adoption of VAD technology.

Methods And Results: Using the Interagency Registry of Mechanically Assisted Circulatory Support, we analyzed time trends by race/ethnicity for 10 795 patients (white, 67.4%; African-American, 24.8%; Hispanic, 6.3%; Asian, 1.5%) who had a VAD implanted between 2012 and 2015. Linear models were fit to the annual census-adjusted rate of VAD implantation for each racial/ethnic group, stratified by sex and age group. From 2012 to 2015, African-Americans had an increase in the census-adjusted annual rate of VAD implantation per 100 000 (0.26 [95% confidence interval, 0.17-0.34]) while other ethnic groups exhibited no significant changes (white: 0.06 [-0.03 to 0.14]; Hispanic: 0.04 [-0.05 to 0.12]; Asian: 0.04 [-0.04 to 0.13]). Stratified by sex, rates increased in both African-American men and women (<0.05), but the change in rate was highest among African-American men (men 0.37 [0.28-0.46]; women 0.16 [0.07-0.25]; interaction with sex =0.004). Stratified by age group, rates increased in African-Americans aged 40 to 69 years and Asians aged 50 to 59 years (<0.05). The observed differential change in VAD implantation rate by age group was significant among African-Americans (interaction with age, <0.01) and Asians (interaction with age, =0.02).

Conclusions: From 2012 to 2015, VAD implantation rates increased among African-Americans but not other racial/ethnic groups. The greatest increase in rate was observed among middle-aged African-American men, suggesting a decline in racial disparities. Further investigation is warranted to reduce disparities among women and older racial/ethnic minorities.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.118.005008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6086596PMC
August 2018

Reporting Data Quality Assessment Results: Identifying Individual and Organizational Barriers and Solutions.

EGEMS (Wash DC) 2017 Sep 4;5(1):16. Epub 2017 Sep 4.

University of Colorado Anschutz Medical Campus.

Introduction: Electronic health record (EHR) data are known to have significant data quality issues, yet the practice and frequency of assessing EHR data is unknown. We sought to understand current practices and attitudes towards reporting data quality assessment (DQA) results by data professionals.

Methods: The project was conducted in four Phases: (1) examined current DQA practices among informatics/CER stakeholders via engagement meeting (07/2014); (2) characterized organizations conducting DQA by interviewing key personnel and data management professionals (07-08/2014); (3) developed and administered an anonymous survey to data professionals (03-06/2015); and (4) validated survey results during a follow-up informatics/CER stakeholder engagement meeting (06/2016).

Results: The first engagement meeting identified the theme of unintended consequences as a primary barrier to DQA. Interviewees were predominantly medical groups serving distributed networks with formalized DQAs. Consistent with the interviews, most survey (N=111) respondents utilized DQA processes/programs. A lack of resources and clear definitions of how to judge the quality of a dataset were the most commonly cited individual barriers. Vague quality action plans/expectations and data owners not trained in problem identification and problem-solving skills were the most commonly cited organizational barriers. Solutions included allocating resources for DQA, establishing standards and guidelines, and changing organizational culture.

Discussion: Several barriers affecting DQA and reporting were identified. Community alignment towards systematic DQA and reporting is needed to overcome these barriers.

Conclusion: Understanding barriers and solutions to DQA reporting is vital for establishing trust in the secondary use of EHR data for quality improvement and the pursuit of personalized medicine.
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http://dx.doi.org/10.5334/egems.214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5982990PMC
September 2017

Physical Activity and Risk of Preterm Birth in a Cohort of African American Women.

Womens Health Issues 2018 Nov - Dec;28(6):488-494. Epub 2018 May 7.

Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.

Background: Few studies have identified modifiable risk factors that are associated with the prevention of preterm delivery (PTD). This study examined the relationship between PTD and physical activity during pregnancy.

Methods: Data were obtained by medical record review and postpartum questionnaires from a cohort of African American women (N = 1,410) delivering singleton infants. Physical activity was self-reported and analyses compared any and none. Additional analyses classified leisure time physical activity (LTPA) and walking for a purpose as 0, 1 to 19, 20 to 39, and 40 minutes per day or more and stair climbing as 0, 1 to 5, 6 to 9, and 10 or more times per day. Log-Poisson models adjusted for previous PTD, pregnancy complications, and income were used to examine the association between PTD and physical activity during pregnancy across body mass index categories.

Results: Overall, 16.4% of deliveries were preterm. LTPA was associated with a decreased prevalence of PTD (prevalence ratio [PR], 0.73; 95% confidence interval [CI], 0.55-0.96), but stratification by maternal prepregnancy body mass index suggested that LTPA was only protective against PTD among women with normal weight (PR, 0.43; 95% CI, 0.23-0.79). Stair climbing 10 or more times per day was associated with a decreased prevalence of PTD among women with normal weight (PR, 0.32; 95% CI, 0.11-0.94) and women with overweight (PR, 0.24; 95% CI, 0.07-0.80) only. Walking for a purpose (e.g., to the store, the bus stop, or to work) was not associated with PTD.

Conclusions: African American women who participate in either LTPA or stair climbing during pregnancy have a decreased prevalence of PTD, but the protective effect varied by maternal body mass index.
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http://dx.doi.org/10.1016/j.whi.2018.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6215495PMC
January 2019

Pilot Randomized Controlled Trial to Reduce Readmission for Heart Failure Using Novel Tablet and Nurse Practitioner Education.

Am J Med 2018 08 16;131(8):974-978. Epub 2018 Mar 16.

Division of Cardiovascular Medicine, Ohio State University Wexner Medical Center, Columbus.

Background: Heart failure education programs are not standardized. The best form of education is unclear. We evaluated whether addition of a novel tablet application to nurse practitioner (NP) education was superior to NP education alone in reducing 30-day readmission after heart failure hospitalization.

Methods: From February 2015-March 2016, patients admitted to a quaternary academic center with primary diagnosis of heart failure were randomized to 1) treatment - NP education plus tablet application (interactive conditional logic program that flags patient questions to medical staff), or 2) control - NP education. The primary outcome was reduction in 30-day readmission rate. Secondary outcomes included satisfaction and education assessed via survey.

Results: Randomization included 60 patients to treatment and 66 to control. A total of 13 patients withdrew prior to intervention (treatment n = 4, control n = 1) or were lost to follow-up (treatment n = 3, control n = 5). The 30-day readmission rate trended lower for treatment compared with control, but results were not statistically significant (13.2% [7/53], 26.7% [16/60], respectively, P = .08). Similarly, satisfaction trended higher with treatment than control (P = .08). Treatment patients rated explanations from their physicians higher than control (Always: 83.7%, 55.8%, respectively, P = .01).

Conclusions: NP education plus tablet use was not associated with significantly lower 30-day readmission rates in comparison with NP alone, but a positive trend was seen. Patient satisfaction trended higher and heart failure explanations were better with NP education plus tablet. A larger study is needed to determine if NP education plus tablet reduces readmission rates following heart failure admission.
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http://dx.doi.org/10.1016/j.amjmed.2018.02.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6098971PMC
August 2018

Factors Associated with Achievement of Clinically Significant Weight Loss by Women in a National Nonprofit Weight Loss Program.

J Womens Health (Larchmt) 2017 08 7;26(8):911-917. Epub 2017 Jul 7.

3 Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus , Aurora, Colorado.

Background: Clinically significant weight loss (CSWL) is ≥5% of initial weight. The purpose of the study is to determine factors associated with women achieving CSWL in Take Off Pounds Sensibly (TOPS), a national, nonprofit weight loss program.

Methods: This is a retrospective analysis of 48,674 females who joined TOPS from 2005 to 2011 and had a birth date in the database. Predictors of CSWL were evaluated using log-binomial regression and adjusted relative risks [99% CI] for participant age, initial weight, number of members per chapter, and chapter age.

Results: Older women were more likely to achieve CSWL, with women ≥70 years 1.23 (1.18, 1.28) times more likely to achieve CSWL compared to women 18 to <45 years. Women who weighed 113 to <136 kg and ≥136 kg were 1.06 (1.02, 1.10) and 1.07 (1.02, 1.14) times more likely to achieve CSWL compared to women <80 kg, respectively. Women in chapters with 25 to <35 members and ≥35 members more were 1.09 (1.05, 1.13) and 1.14 (1.10, 1.18) times more likely to achieve CSWL than those in chapters with less than 15 members. Women in older chapters were less likely to achieve CSWL, with women in chapters 10 to 20 years old 0.95 (0.92, 0.99) times as likely to lose weight as those in chapters less than 10 years old.

Conclusions: Women in TOPS were more likely to achieve CSWL if older, ≥113 kg, and in larger, newer chapters. Future studies should address ways to modify the program to improve achievement of CSWL.
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http://dx.doi.org/10.1089/jwh.2016.6264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576220PMC
August 2017

Preterm Delivery as a Unique Pathophysiologic State Characterized by Maternal Soluble FMS-Like Tyrosine Kinase 1 and Uterine Artery Resistance During Pregnancy: A Longitudinal Cohort Study.

Reprod Sci 2017 12 24;24(12):1583-1589. Epub 2017 Mar 24.

3 Department of Pediatrics, Division of Genetic, Genomic, and Metabolic Disorders, The Wayne State University School of Medicine, Detroit, MI, USA.

Background: Preterm delivery (PTD) may be characterized by altered interrelationships among angiogenic factors and measures of placental function. We analyzed the longitudinal relationship between maternal serum concentrations of soluble fms-like tyrosine kinase 1 (sFlt1), an important antiangiogenic factor, and uterine artery resistance in pregnancies resulting in preterm and term deliveries.

Methods: Data were collected in a longitudinal cohort study involving 278 women monitored at 6 to 10, 10 to 14, 16 to 20, 22 to 26, and 32 to 36 weeks of gestation. Concentrations of maternal serum sFlt1 were determined using solid-phase enzyme-linked immunosorbent assay, and uterine artery resistance indices (RI) were measured by Doppler velocimetry at each interval. Preterm delivery was defined as birth before 37-weeks completed gestation. Data analyses used multivariable repeated measures regression models.

Results: Uterine artery RI decreased across gestation. As pregnancy progressed, RI trajectories diverged for term and preterm deliveries; the mean RI was significantly higher in third trimester for pregnancies resulting in PTD ( P = .08). sFlt1 was stable through 21 3/7 weeks of gestation and then increased rapidly; women who delivered preterm had significantly higher sFlt1 levels in the third trimester ( P = .04). The relationship between uterine artery RI and sFlt1 from the prior visit was significantly different between the groups ( P < .0001). For term deliveries, higher sFlt1 concentrations were associated with a smaller RI at the subsequent visit (β = -.08, 95% confidence interval [CI]: -0.14 to -0.02). For PTD, higher sFlt1 concentrations were associated with a larger uterine artery RI (β = .14, 95% CI: 0.06 to 0.22).

Conclusion: PTD is characterized by altered relationships between angiogenic factors and placental vascular blood flow starting in early pregnancy.
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http://dx.doi.org/10.1177/1933719117698574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6343209PMC
December 2017

The Affordable Care Act Medicaid Expansion Correlated With Increased Heart Transplant Listings in African-Americans But Not Hispanics or Caucasians.

JACC Heart Fail 2017 02 18;5(2):136-147. Epub 2017 Jan 18.

University of Colorado, Anschutz Medical Campus, Division of Cardiology, Aurora, Colorado; Denver Health Medical Center, Denver, Colorado.

Objectives: The aim of this study was to determine if the Affordable Care Act (ACA) Medicaid Expansion was associated with increased census-adjusted heart transplant listing rates for racial/ethnic minorities.

Background: Underinsurance limits access to transplants, especially among racial/ethnic minorities. Changes in racial/ethnic listing rates post-ACA Medicaid Expansion are unknown.

Methods: Using the Scientific Registry of Transplant Recipients, we analyzed 5,651 patients from early adopter states (implemented the ACA Medicaid Expansion by January 2014) and 4,769 patients from non-adopter states (no implementation during the study period) from 2012 to 2015. Piecewise linear models, stratified according to race/ethnicity, were fit to monthly census-adjusted rates of heart transplant listings before and after January 2014.

Results: A significant 30% increase in the rate of heart transplant listings for African-American patients in early adopter states occurred immediately after the ACA Medicaid Expansion on January 1, 2014 (before 0.15 to after 0.20/100,000; increase 0.05/100,000; 95% confidence interval [CI]: 0.01 to 0.08); in contrast, the rates for African-American patients in non-adopter states remained constant (before and after 0.15/100,000; increase 0.006/100,000; 95% CI: -0.03 to 0.04). Hispanic patients experienced an opposite trend, with no significant change in early adopter states (before 0.03 to after 0.04/100,000; increase 0.01/100,000; 95% CI: -0.004 to 0.02) and a significant increase in non-adopter states (before 0.03 to after 0.05/100,000; increase 0.02/100,000; 95% CI: 0.002 to 0.03). There were no significant changes in listing rates among Caucasian patients in either early adopter states or non-adopter states.

Conclusions: Implementation of the ACA Medicaid Expansion was associated with increased heart transplant listings in African-American patients but not in Hispanic or Caucasian patients. Broadening of the ACA in states with large African-American populations may reduce disparities in heart transplant listings.
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http://dx.doi.org/10.1016/j.jchf.2016.10.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291811PMC
February 2017

Racism in the form of micro aggressions and the risk of preterm birth among black women.

Ann Epidemiol 2016 Jan 17;26(1):7-13.e1. Epub 2015 Oct 17.

Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, MI.

Purpose: This study sought to examine whether perceived interpersonal racism in the form of racial micro aggressions was associated with preterm birth (PTB) and whether the presence of depressive symptoms and perceived stress modified the association.

Methods: Data stem from a cohort of 1410 black women residing in Metropolitan Detroit, Michigan, enrolled into the Life-course Influences on Fetal Environments (LIFE) study. The Daily Life Experiences of Racism and Bother (DLE-B) scale measured the frequency and perceived stressfulness of racial micro aggressions experienced during the past year. Severe past-week depressive symptomatology was measured by the Centers for Epidemiologic Studies-Depression scale (CES-D) dichotomized at ≥ 23. Restricted cubic splines were used to model nonlinearity between perceived racism and PTB. We used the Perceived Stress Scale to assess general stress perceptions.

Results: Stratified spline regression analysis demonstrated that among those with severe depressive symptoms, perceived racism was not associated with PTB. However, perceived racism was significantly associated with PTB among women with mild to moderate (CES-D score ≤ 22) depressive symptoms. Perceived racism was not associated with PTB among women with or without high amounts of perceived stress.

Conclusions: Our findings suggest that racism, at least in the form of racial micro aggressions, may not further impact a group already at high risk for PTB (those with severe depressive symptoms), but may increase the risk of PTB for women at lower baseline risk.
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http://dx.doi.org/10.1016/j.annepidem.2015.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4688115PMC
January 2016

Perceived Physical and Social Residential Environment and Preterm Delivery in African-American Women.

Am J Epidemiol 2015 Sep 9;182(6):485-93. Epub 2015 Jul 9.

Perceptions of the residential environment may be associated with preterm delivery (PTD), though few studies exist. Data from the Life-course Influences on Fetal Environments (LIFE) Study (metropolitan Detroit, Michigan, 2009-2011) were used to examine whether perceptions of the current social and physical environment were associated with PTD rates among postpartum African-American women (n = 1,411). Perceptions of the following neighborhood characteristics were measured with validated multi-item scales: healthy food availability, walkability, safety, social cohesion, and social disorder. No significant associations between perceived residential environment and PTD were found in the total sample. However, education significantly modified 4 of the 5 associations (all interaction P's < 0.05). In women with ≤12 years of education, significant inverse associations were observed between PTD rates and perceptions of the following neighborhood characteristics: healthy food availability (unadjusted prevalence ratio (uPR) = 0.81, 95% confidence interval (CI): 0.68, 0.98), walkability (uPR = 0.77, 95% CI: 0.64, 0.95), and safety (uPR = 0.73, 95% CI: 0.56, 0.95). Women with ≤12 years of education also had higher PTD rates with higher social disorder (age-adjusted PR = 1.54, 95% CI: 1.10, 2.17). Null associations existed for women with >12 years of education. The PTD rates of women with lower education may be significantly affected by the physical and social residential environment.
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http://dx.doi.org/10.1093/aje/kwv106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4668760PMC
September 2015

Post-Discharge Adverse Events Among Urban and Rural Patients of an Urban Community Hospital: A Prospective Cohort Study.

J Gen Intern Med 2015 Aug 31;30(8):1164-71. Epub 2015 Mar 31.

Department of Family Medicine & Public Health Sciences, Wayne State University School of Medicine, Detroit, MI, 48201, USA,

Background: There has been little research to examine post-discharge adverse events (AEs) in rural patients discharged from community hospitals.

Objective: We aimed to determine the rate of post-discharge AEs, classify the types of post-discharge AEs, and identify risk factors for post-discharge AEs in urban and rural patients.

Design: This was a prospective cohort study of patients at risk for post-discharge adverse events from December 2011 through October 2012.

Patients: Six hundred and eighty-four patients who were under the care of hospitalist physicians and were being discharged home, spoke English, and could be contacted after discharge, were admitted to the medical service. Patients were stratified as urban/rural using zip code of residence. Rural patients were oversampled to ensure equal enrollment of urban and rural patients.

Main Measures: The main outcome of the study was post-discharge AEs based on structured telephone interviews, health record review, and adjudication by two blinded, trained physicians using a previously established methodology.

Results: Over 28% of 684 patients experienced post-discharge AEs, most of which were either preventable or ameliorable. There was no difference in the incidence of post-discharge AEs in urban versus rural patients (ARR 1.04 95% CI 0.82-1.32 ), but post-discharge AEs were associated with hypertension, type 2 diabetes mellitus, and number of secondary discharge diagnoses only in urban patients.

Conclusions: Post-discharge AEs were common in both urban and rural patients and many were preventable or ameliorable. Potentially different risk factors for AEs in urban versus rural patients suggests the need for further research into the underlying causes. Different interventions may be required in urban versus rural patients to improve patient safety during transitions in care.
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http://dx.doi.org/10.1007/s11606-015-3260-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4510218PMC
August 2015