Publications by authors named "Eric Thomas"

204 Publications

The Entrainment Frequency of Cardiolocomotor Synchronization in Long-Distance Race Emerges Spontaneously at the Step Frequency.

Front Physiol 2020 4;11:583030. Epub 2021 Feb 4.

Exercise Research Laboratory, Rio Grande do Sul Federal University, Porto Alegre, Brazil.

In forced conditions, where the heart rate and step frequency have been matched, cardiolocomotor synchronization (CLS) has been recognized. However, knowledge about the occurrence of CLS and its triggers in sports gesture in real contexts is little known. To address this gap, the current study tested the hypothesis that CLS in running spontaneous conditions would emerge at entrainment bands of muscle activation frequencies associated with a freely chosen step frequency. Sixteen male long-distance runners undertook treadmill assessments running ten three-minute bouts at different speeds (7, 7.5, 8, 9, 10, 11, 12, 13, 14, and 15 km⋅h). Electrocardiography and surface electromyography were recorded simultaneously. The center frequency was the mean of the frequency spectrum obtained by wavelet decomposition, while CLS magnitude was determined by the wavelet coherence coefficient (WCC) between the electrocardiography and center frequency signals. The strength of CLS affected the entrainment frequencies between cardiac and muscle systems, and for WCC values greater than 0.8, the point from which we consider the emerging CLS, the entrainment frequency was between 2.7 and 2.8 Hz. The CLS emerged at faster speeds (13-15 km⋅h) most prevalently but did not affect the muscle activation bands. Spontaneous CLS occurred at faster speeds predominantly, and the entrainment frequencies matched the locomotor task, with the entrainment bands of frequencies emerging around the step frequencies (2.7-2.8 Hz). These findings are compatible with the concept that interventions that determine conditions of CLS may potentiate the benefits of the cardiac and muscle systems synchronized in distance runners.
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http://dx.doi.org/10.3389/fphys.2020.583030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890119PMC
February 2021

Intra- and inter-site variability of soil contamination in road shoulders - Implications for maintenance operations.

Sci Total Environ 2020 Dec 31;769:144862. Epub 2020 Dec 31.

LEESU, École des Ponts ParisTech, University of Paris-Est Créteil. 6-8 avenue Blaise Pascal, Cité Descartes, 77455 Marne-la-Vallée cedex 2, France.

This study addresses soil contamination in vegetated road shoulders with diffuse inflow of runoff. It aims (i) to characterize the spatial distribution of three metals (copper, lead, zinc) and PAHs, and (ii) to identify influencing factors for the inter-site differences. An extensive sampling campaign was carried out on forty road segments in the Paris region, targeting various distances and soil depths. Copper and zinc contamination was found to be mainly restricted to the first 30 cm from the road, where their concentrations ranged respectively between 40 and 270 mg.kg, and between 150 and 950 mg.kg (with a few additional extreme values related to the presence of a galvanized steel guardrail). Lead contamination was moderate (< 100 mg.kg in more than 75% of the sites) and relatively uniform across the width of the shoulders. Conversely, highest PAH concentrations were found further from the road. These differences between contaminants were likely due to the varying importance of wet weather-related processes and atmospheric transport in their dispersion mechanisms. Copper and zinc concentrations correlated well with the traffic density, which alone explained ≥ 69% of the inter-site variability, whereas lead and PAHs did not exhibit such dependence. Soil organic matter was found to control the "ceiling" concentration of metals, thus limiting the maximum amounts that can be intercepted from road runoff. These results illustrate the feasibility of estimating contamination levels on road shoulders, and thus offer interesting perspectives for better consideration of the infrastructures' maintenance needs and improved routine operations.
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http://dx.doi.org/10.1016/j.scitotenv.2020.144862DOI Listing
December 2020

Early Experience with Salvage Retzius-sparing Robotic-assisted Radical Prostatectomy: Oncologic and Functional Outcomes.

Urology 2021 Jan 5. Epub 2021 Jan 5.

Division of Urology, Department of surgery, Augusta University Health, Augusta, GA.

Objective: To report on feasibility, safety, and continence outcomes using the Retzius-sparing approach in the salvage setting (sRS-RARP).

Materials And Methods: A total of 26 patients underwent robotic salvage prostatectomy at our institution from January 2012 to May 2020 by a single surgeon (RM). Twenty patients underwent sRS-RARP and 6 underwent the standard approach (sRARP). Pre-, intra-, and postoperative outcomes were compared between these groups with emphasis on continence and oncologic safety.

Results: Patients had comparable preoperative characteristics with no significant difference in age, race, prostate-specific antigen level, and Gleason score. Most patients underwent primary external beam radiation therapy (69.2%). Median time to biochemical failure was 7.9 years (IQR 6.1-13.4). sRS-RARP required less console time (141.5 vs 199.5.0 minutes, P = .008) and less blood loss (50.0 mL vs 100.0 mL, P = .045) compared to sRARP. Postoperative course was uneventful with a median hospital stay of 1 day. Median catheterization time was 14.0 days (IQR 11.5-17). Patients undergoing sRS-RARP had better immediate (25.0% vs 0.0%, P < .001), 3 month (80.0% vs 0%, P < .001), and 12 month continence rates (100% vs 44%, P = .0384) compared to sRARP patients. Likewise, median time to continence was significantly shorter for sRS-RARP patients (90.0 vs 270.0 days, P = .0095). Biochemical recurrence rate was 20.0% in the sRS-RARP group and 33.3% in the sRARP group (P = .60).

Conclusion: Early experience suggests that sRS-RARP is feasible, oncologically safe, and may offer improved continence compared to the sRARP approach.
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http://dx.doi.org/10.1016/j.urology.2020.12.029DOI Listing
January 2021

Upgrading on radical prostatectomy specimens of very low- and low-risk prostate cancer patients on active surveillance: A population-level analysis.

Can Urol Assoc J 2020 Dec 15. Epub 2020 Dec 15.

Section of Urology, Department of Surgery, Medical College of Georgia-Augusta University, Augusta, GA, United States.

format accepted as a poster presentation at the Southeastern Sectional Meeting of the American Urological Association in New Orleans, LA, on March 21, 2020INTRODUCTION: A proportion of prostate cancer (PCa) patients initially managed with active surveillance (AS) are upgraded to a higher Gleason score (GS) at the time of radical prostatectomy (RP). Our objective was to determine predictors of upgrading on RP specimens using a national database.

Methods: The Surveillance, Epidemiology, and End Results Prostate with Watchful Waiting database was used to identify AS patients diagnosed with very low- or low-risk PCa who underwent delayed RP between 2010 and 2015. The primary outcome was upgrading to GS 7 disease or worse. Logistic regression analyses were used to evaluate demographic and oncological predictors of upgrading on final specimen.

Results: A total of 3775 men underwent RP after a period of AS, 3541 (93.8%) of whom were cT2a; 792 (21.0%) patients were upgraded on RP specimen, with 85.4%, 10.6%, and 3.4% upgraded to GS 7(3+4), 7(4+3), and 8 diseases, respectively. On multivariable analysis, higher prostate-specific antigen (PSA) at diagnosis (5-10 vs. 0-2 ng/ml, odd ratio [OR] 2.59, p<0.001) and percent core involvement (80-100% vs. 0-20%, OR 2.52, p=0.003) were significant predictors of upgrading on final RP specimen, whereas higher socioeconomic status predicted lower odds of upgrading (highest vs. lowest quartile OR 0.75, p=0.013).

Conclusions: Higher baseline PSA and percent positive cores involvement are associated with significantly increased risk of upgrading on RP after AS, whereas higher socioeconomic status predicts lower odds of such events. These results may help identify patients at increased risk of adverse pathology on final specimen who may benefit from earlier definitive treatment.
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http://dx.doi.org/10.5489/cuaj.6868DOI Listing
December 2020

Helping healthcare teams save lives during COVID-19: Insights and countermeasures from team science.

Am Psychol 2021 01 29;76(1):1-13. Epub 2020 Oct 29.

Department of Psychological Sciences, Rice University.

As the COVID-19 pandemic has ravaged the United States, health care teams are on the frontlines of this global crisis, often navigating harrowing conditions at work, such as a lack of personal protective equipment and staffing shortages, and distractions at home, including worries about elderly relatives or making childcare arrangements. While the nature and severity of stressors impacting health care teams are in many ways unprecedented, decades of psychological research exploring teamwork in extreme contexts can provide insights to understand and improve outcomes for teams in a crisis. This review highlights the psychological principles that apply to teams in a crisis and illustrates how psychologists can use this knowledge to improve teamwork for medical teams in the midst of the COVID-19 pandemic., The review also provides a glimpse toward the future, noting both how psychologists can help health care teams recover and rebound, as well as how additional research can improve psychologists' understanding of teamwork in times of crisis. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/amp0000750DOI Listing
January 2021

Measuring Collaboration in Health Care: Insights from the Science of Teamwork.

Jt Comm J Qual Patient Saf 2020 12 12;46(12):661-663. Epub 2020 Sep 12.

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http://dx.doi.org/10.1016/j.jcjq.2020.09.003DOI Listing
December 2020

Introduction from the new editors-in-chief.

BMJ Qual Saf 2020 11 24;29(11):873-874. Epub 2020 Sep 24.

UTHealth - Memorial Hermann Center for Healthcare Quality and Safety, McGovern Medical School at The University of Texas Health Science Center Houston (UTHealth), Houston, Texas, USA.

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http://dx.doi.org/10.1136/bmjqs-2020-012361DOI Listing
November 2020

Pediatric Trainees' Speaking Up About Unprofessional Behavior and Traditional Patient Safety Threats.

Acad Pediatr 2020 Jul 14. Epub 2020 Jul 14.

Division of General Internal Medicine, Vanderbilt University Medical Center, (W Martinez), Nashville, Tenn. Dr Shelburne is now with the Texas Children's Hospital, Baylor College of Medicine, Houston Tex.

Objective: Speaking up is increasingly recognized as essential for patient safety. We aimed to determine pediatric trainees' experiences, attitudes, and anticipated behaviors with speaking up about safety threats including unprofessional behavior.

Methods: Anonymous, cross-sectional survey of 512 pediatric trainees at 2 large US academic children's hospitals that queried experiences, attitudes, barriers and facilitators, and vignette responses for unprofessional behavior and traditional safety threats.

Results: Responding trainees (223 of 512, 44%) more commonly observed unprofessional behavior than traditional safety threats (57%, 127 of 223 vs 34%, 75 of 223; P < .001), but reported speaking up about unprofessional behavior less commonly (48%, 27 of 56 vs 79%, 44 of 56; P < .001). Respondents reported feeling less safe speaking up about unprofessional behavior than patient safety concerns (52%, 117 of 223 vs 78%, 173 of 223; P < .001). Respondents were significantly less likely to speaking up to, and use assertive language with, an attending physician in the unprofessional behavior vignette than the traditional safety vignette (10%, 22 of 223 vs 64%, 143 of 223, P < .001 and 12%, 27 of 223 vs 57%, 128 of 223, P < .001, respectively); these differences persisted even among respondents that perceived high potential for patient harm in both vignettes (20%, 16 of 81 vs 69%, 56 of 81, P < .001 and 20%, 16 of 81 vs 69%, 56 of 81, P < .001, respectively). Fear of conflict was the predominant barrier to speaking up about unprofessional behavior and more commonly endorsed for unprofessional behavior than traditional safety threats (67%, 150 of 223 vs 45%, 100 of 223, P < .001).

Conclusions: Findings suggest pediatric trainee reluctance to speak up when presented with unprofessional behavior compared to traditional safety threats and highlight a need to improve elements of the clinical learning environment to support speaking up.
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http://dx.doi.org/10.1016/j.acap.2020.07.014DOI Listing
July 2020

Novel LC-MS/MS method for the determination of selumetinib (AZD6244) in whole blood collected with volumetric absorptive microsampling.

Bioanalysis 2020 Jul 6;12(13):883-892. Epub 2020 Jul 6.

Clinical Pharmacology & Safety Sciences, AstraZeneca, Da Vinci Building, Melbourn Science Park, Melbourn, Hertfordshire, SG8 6HB, UK.

A method has been developed and validated for quantitation of selumetinib in human whole blood collected using a Mitra™ volumetric absorptive microsampling device. This device is patient-friendly, affording less-invasive sampling with broad applicability to clinical and diagnostic applications - specifically in pediatric populations. In this method, drug is extracted from the Mitra device via sonication in methanol: Ammonium hydroxide, then analyzed by LC-MS/MS. The linear range for selumetinib analysis is 2.00-2000 ng/ml. All validation parameters met acceptance criteria established in agreement with current regulatory guidance for bioanalytical method validation. The stability of selumetinib in Mitra tips was established at both ambient and frozen conditions. A simple method has been developed and validated for determination of selumetinib from human whole blood, collected using volumetric absorptive microsampling and analyzed by LC-MS/MS.
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http://dx.doi.org/10.4155/bio-2020-0062DOI Listing
July 2020

Managing teamwork in the face of pandemic: evidence-based tips.

BMJ Qual Saf 2021 Jan 29;30(1):59-63. Epub 2020 May 29.

Department of Psychological Sciences, Rice University, Houston, Texas, USA

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http://dx.doi.org/10.1136/bmjqs-2020-011447DOI Listing
January 2021

Intradiscal glucocorticoids injection in chronic low back pain with active discopathy: A randomized controlled study.

Ann Phys Rehabil Med 2020 Aug 27:101396. Epub 2020 Aug 27.

Euromov, Montpellier university, Montpellier, France; Service de médecine physique et de réadaptation, CHU Nimes, Univ Montpellier, Nimes, France. Electronic address:

Background: The benefit of an intradiscal injection of corticosteroids for low back pain with active discopathy is not totally resolved.

Objective: The objective of this study was to estimate the clinical efficacy of an intradiscal injection of glucocorticoids versus lidocaine in patients with low back pain and active discopathy (Modic 1 changes).

Methods: A prospective, single-blind, randomized controlled study was conducted in 2 tertiary care centers with spine units. We enrolled 50 patients (mean age 50 years; 46% women) with lumbar active discopathy on MRI and failure of medical treatment for more than 6 weeks. Participants were randomly assigned to receive an intradiscal injection of glucocorticoids [50mg prednisolone acetate (GC group), n=24] or lidocaine [40mg (L group), n=26] by senior radiologists. Outcome measures were low back pain in the previous 8 days (10-point visual analog scale), Dallas Pain Questionnaire, Oswestry Disability Index, analgesic treatment and work status at 1, 3 and 6 months as well as pain at 1, 2 and 3 weeks. The primary outcome was change in pain between baseline and 1 month.

Results: Data for 39 patients (78%; 17 in the GC group, 22 in the L group) were analyzed for the primary outcome. Pain intensity was significantly reduced at 1 month in the GC versus L group [mean (SD) -2.7 (2.3) and +0.1 (2.0), P<0.001] but not at 3 and 6 months. At 1 and 3 months, the groups significantly differed in daily activities of the Dallas Pain Questionnaire in favour of the GC group. The groups did not differ in consumption of analgesics or professional condition at any time. No serious intervention-related adverse events occurred. Study limitations included patients lost to the study because of injection-related technical issues in the L5/S1 disc and short time of follow-up.

Conclusion: As compared with intradiscal injection of lidocaine, intradiscal injection of prednisolone acetate for low back pain with active discopathy may reduce pain intensity at 1 month but not at 3 and 6 months.
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http://dx.doi.org/10.1016/j.rehab.2020.05.003DOI Listing
August 2020

Hospital-wide ELectronic medical record evaluated computerised decision support system to improve outcomes of Patients with staphylococcal bloodstream infection (HELP): study protocol for a multicentre stepped-wedge cluster randomised trial.

BMJ Open 2020 02 10;10(2):e033391. Epub 2020 Feb 10.

Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany

Introduction: are the most commonly identified pathogens in bloodstream infections. Identification of in blood culture (SAB) requires a prompt and adequate clinical management. The detection of coagulase-negative staphylococci (CoNS), however, corresponds to contamination in about 75% of the cases. Nevertheless, antibiotic therapy is often initiated, which contributes to the risk of drug-related side effects. We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with bacteraemia. The CDSS is evaluated using data of the (DIC) established at each clinic. DICs transform heterogeneous primary clinical data into an interoperable format, and the HELP-CDSS displays information according to current best evidence in bacteraemia treatment. The overall aim of the HELP-CDSS is a safe but more efficient allocation of infectious diseases specialists and an improved adherence to established guidelines in the treatment of SAB.

Methods And Analysis: The study is conducted at five German university hospitals and is designed as a stepped-wedge cluster randomised trial. Over the duration of 18 months, 135 wards will change from a control period to the intervention period in a randomised stepwise sequence. The coprimary outcomes are hospital mortality for all patients to establish safety, the 90-day disease reoccurrence-free survival for patients with SAB and the cumulative vancomycin use for patients with CoNS bacteraemia. We will use a closed, hierarchical testing procedure and generalised linear mixed modelling to test for non-inferiority of the CDSS regarding hospital mortality and 90-day disease reoccurrence-free survival and for superiority of the HELP-CDSS regarding cumulative vancomycin use.

Ethics And Dissemination: The study is approved by the ethics committee of Jena University Hospital and will start at each centre after local approval. Results will be published in a peer-reviewed journal and presented at scientific conferences.

Trial Registration Number: DRKS00014320.
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http://dx.doi.org/10.1136/bmjopen-2019-033391DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044885PMC
February 2020

Association of open communication and the emotional and behavioural impact of medical error on patients and families: state-wide cross-sectional survey.

BMJ Qual Saf 2020 11 20;29(11):883-894. Epub 2020 Jan 20.

Health Policy and Management, School of Public Health, Yale University, New Haven, Connecticut, USA.

Background: How openly healthcare providers communicate after a medical error may influence long-term impacts. We sought to understand whether greater open communication is associated with fewer persisting emotional impacts, healthcare avoidance and loss of trust.

Methods: Cross-sectional 2018 recontact survey assessing experience with medical error in a 2017 random digit dial survey of Massachusetts residents. Two hundred and fifty-three respondents self-reported medical error. Respondents were similar to non-respondents in sociodemographics confirming minimal response bias. Time since error was categorised as <1, 1-2 or 3-6 years before interview. Open communication was measured with six questions assessing different communication elements. Persistent impacts included emotional (eg, sadness, anger), healthcare avoidance (specific providers or all medical care) and loss of trust in healthcare. Logistic regressions examined the association between open communication and long-term impacts.

Results: Of respondents self-reporting a medical error 3-6 years ago, 51% reported at least one current emotional impact; 57% reported avoiding doctor/facilities involved in error; 67% reported loss of trust. Open communication varied: 34% reported no communication and 24% reported ≥5 elements. Controlling for error severity, respondents reporting the most open communication had significantly lower odds of persisting sadness (OR=0.17, 95% CI 0.05 to 0.60, p=0.006), depression (OR=0.16, 95% CI 0.03 to 0.77, p=0.022) or feeling abandoned/betrayed (OR=0.10, 95% CI 0.02 to 0.48, p=0.004) compared with respondents reporting no communication. Open communication significantly predicted less doctor/facility avoidance, but was not associated with medical care avoidance or healthcare trust.

Conclusions: Negative emotional impacts from medical error can persist for years. Open communication is associated with reduced emotional impacts and decreased avoidance of doctors/facilities involved in the error. Communication and resolution programmes could facilitate transparent conversations and reduce some of the negative impacts of medical error.
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http://dx.doi.org/10.1136/bmjqs-2019-010367DOI Listing
November 2020

Preoccupation with failure and adherence to shared baselines: Measuring high-reliability organizational culture.

J Patient Saf Risk Manag 2019 Aug 31;24(4):147-152. Epub 2019 Jul 31.

Division of Neonatal and Developmental Medicine, Stanford University.

Objective: To create, administer, and psychometrically examine a survey to measure two new organizational culture factors - preoccupation with failure and adherence to shared baselines - in healthcare settings.

Method: Direct care providers (n = 4484) from a large healthcare system in the Southern United States completed a survey as part of their annual safety culture assessment.

Results: We provide evidence about the internal consistency (Cronbach's alpha ranged from .80 to .89) factor structure, concurrent validity (correlation with overall patient safety grade ranged from .60 to .67, p <.05), and discriminant validity (correlations less than .85 with safety and teamwork culture) of these two factors.

Conclusions: We established evidence for internal consistency and validity of two new factors that measure aspects of organizational culture - preoccupation with failure and adherence to shared baselines - that are distinct from safety culture and teamwork culture.
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http://dx.doi.org/10.1177/2516043519838185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941901PMC
August 2019

Quantification of the anti-murine PD-1 monoclonal antibody RMP1-14 in BALB/c mouse plasma by liquid chromatography-tandem mass spectrometry and application to a pharmacokinetic study.

Anal Bioanal Chem 2020 Jan 12;412(3):739-752. Epub 2019 Dec 12.

Covance Laboratories, Inc., 8211 SciCor Drive, Indianapolis, IN, 46214, USA.

RMP1-14 is a monoclonal antibody that targets the murine PD-1 protein, and has been used extensively to probe the effects of PD-1 inhibition in preclinical murine models. However, to date, no quantitative analytical methods have been published for RMP1-14. To evaluate its anti-tumor activity in BALB/c mice inoculated with CT26.WT murine colon cancer cells, a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to quantify RMP1-14 in BALB/c mouse KEDTA plasma was developed and validated. The methodology used a signature peptide (GFYPPDIYTEWK) as a surrogate for RMP1-14 quantitation and an isotopically labeled analog of the signature peptide as the internal standard. Initial method development focused on a hybrid LC-MS/MS assay involving Protein G immunoprecipitation, but this strategy was abandoned due to lack of selectivity. The final validated method consisted of dilution with Tris-buffered saline, trypsin digestion, and desalting using micro solid-phase extraction. Analytical run time was 3.50 min, and the method demonstrated linearity between 0.500 and 50.0 μg/mL of intact RMP1-14. Accuracy, precision, and robustness were all acceptable, and the method was demonstrated to be comparable to a commercially available fit-for-purpose enzyme-linked immunosorbent assay (ELISA) capable of measuring RMP1-14. The validated method was used to generate pharmacokinetic parameters from tumor-bearing BALB/c mice dosed with RMP1-14 at either 2.50 or 7.50 mg/kg. Overall, the validated method represents a novel tool that can be used to evaluate RMP1-14 activity in future immuno-oncology studies.
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http://dx.doi.org/10.1007/s00216-019-02292-1DOI Listing
January 2020

The Reliability of Intraoperative Assessment on Predicting Tumor Size, Myometrial Invasion, and Cervical Involvement in Patients With a Preoperative Diagnosis of Complex Atypical Hyperplasia or (Clinical Stage I) Endometrial Cancer: A Prospective Cohort Study.

Am J Clin Oncol 2020 02;43(2):122-127

Division of Gynecologic Oncology.

Objectives: The objective of this study is to assess the reliability of intraoperative uterine assessment compared with the final pathologic evaluation in patients with endometrial cancer (EC) and whether assessment improves with experience.

Methods: After Institutional Review Board approval, a prospective cohort study of women surgically managed with biopsy-proven complex atypical hyperplasia (CAH) or EC between March 2015 and December 2016 was performed. Demographics, preoperative biopsy results, procedure, intraoperative and final pathologic evaluation of lesion size, myometrial invasion, and lower uterine segment/cervical involvement were abstracted. The agreement between the intraoperative and final pathologic evaluation of tumor involvement of the uterus was determined using the kappa statistic and the intraclass correlation coefficient.

Results: A total of 264 patients with a preoperative diagnosis of CAH or EC were included-71 (26.9%) with CAH and 193 (73.1%) with EC. The mean age was 62.6±11.5, and mean body mass index was 37.2±10.1. The majority of women were white (67%). A total of 227 (85.9%) patients underwent a laparoscopic or robotic hysterectomy, whereas 36 (13.6%) underwent an abdominal hysterectomy. 233 (88.3%) patients had EC and 21 (7.9%) patients had CAH on final pathology. There was a fair agreement between the intraoperative estimation of myometrial invasion (κ=0.37). A moderate agreement exists between the intraoperative estimation of lower uterine segment/cervical involvement (κ=0.57). There was a strong agreement between intraoperative tumor size assessment and the final path (intraclass correlation coefficient=0.74). The intraoperative correlation of tumor size was similar for the first half of the cohort (κ=0.50) and the second half (κ=0.46) chronologically.

Conclusions: Despite only a fair correlation in the myometrial invasion, intraoperative assessment of cervical involvement and especially tumor size is more readily identified and overall accurate. Therefore, intraoperative evaluation is an additional tool to use when making the decision to proceed with surgical staging.
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http://dx.doi.org/10.1097/COC.0000000000000643DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6982578PMC
February 2020

Drunk Without Drinking: A Case of Auto-Brewery Syndrome.

ACG Case Rep J 2019 Sep 9;6(9):e00208. Epub 2019 Sep 9.

Division of General Internal Medicine, Department of Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.

Information on auto-brewery syndrome is limited in the medical literature. This rare syndrome occurs when yeast overgrowth leads to ethanol fermentation in the gut. We present a patient presenting with symptoms of alcohol intoxication with objective laboratory data of elevated blood ethanol levels without a history of alcohol consumption. We reviewed the literature and have discussed the current diagnostic and therapeutic options.
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http://dx.doi.org/10.14309/crj.0000000000000208DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6831150PMC
September 2019

Safety climate, safety climate strength, and length of stay in the NICU.

BMC Health Serv Res 2019 Oct 22;19(1):738. Epub 2019 Oct 22.

Perinatal Epidemiology and Health Outcomes Research Unit, Division of Neonatology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.

Background: Safety climate is an important marker of patient safety attitudes within health care units, but the significance of intra-unit variation of safety climate perceptions (safety climate strength) is poorly understood. This study sought to examine the standard safety climate measure (percent positive response (PPR)) and safety climate strength in relation to length of stay (LOS) of very low birth weight (VLBW) infants within California neonatal intensive care units (NICUs).

Methods: Observational study of safety climate from 2073 health care providers in 44 NICUs. Consistent perceptions among a NICU's respondents, i.e., safety climate strength, was determined via intra-unit standard deviation of safety climate scores. The relation between safety climate PPR, safety climate strength, and LOS among VLBW (< 1500 g) infants was evaluated using log-linear regression. Secondary outcomes were infections, chronic lung disease, and mortality.

Results: NICUs had safety climate PPRs of 66 ± 12%, intra-unit standard deviations 11 (strongest) to 23 (weakest), and median LOS 60 days. NICUs with stronger climates had LOS 4 days shorter than those with weaker climates. In interaction modeling, NICUs with weak climates and low PPR had the longest LOS, NICUs with strong climates and low PPR had the shortest LOS, and NICUs with high PPR (both strong and weak) had intermediate LOS. Stronger climates were associated with lower odds of infections, but not with other secondary outcomes.

Conclusions: Safety climate strength is independently associated with LOS and moderates the association between PPR and LOS among VLBW infants. Strength and PPR together provided better prediction than PPR alone, capturing variance in outcomes missed by PPR. Evaluations of NICU safety climate consider both positivity (PPR) and consistency of responses (strength) across individuals.
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http://dx.doi.org/10.1186/s12913-019-4592-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6805564PMC
October 2019

The harms of promoting 'Zero Harm'.

Authors:
Eric J Thomas

BMJ Qual Saf 2020 01 9;29(1):4-6. Epub 2019 Oct 9.

McGovern Medical School at The University Texas Health Science Center at Houston, Houston, Texas, USA

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http://dx.doi.org/10.1136/bmjqs-2019-009703DOI Listing
January 2020

An Ethnography of Parents' Perceptions of Patient Safety in the Neonatal Intensive Care Unit.

Adv Neonatal Care 2019 Dec;19(6):500-508

Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston (Drs Ottosen and Engebretson); Senior Biobehavioral Scientist, RAND Corporation, Santa Monica, California (Dr Etchegaray); Department of Neonatology, McGovern Medical School, The University of Texas Health Science Center at Houston (Dr Arnold); and Department of Internal Medicine, The University of Texas-Memorial Hermann Center for Healthcare Quality and Safety, McGovern Medical School, The University of Texas Health Science Center at Houston (Dr Thomas).

Background: Parents of neonates are integral components of patient safety in the neonatal intensive care unit (NICU), yet their views are often not considered. By understanding how parents perceive patient safety in the NICU, clinicians can identify appropriate parent-centered strategies to involve them in promoting safe care for their infants.

Purpose: To determine how parents of neonates conceptualize patient safety in the NICU.

Methods: We conducted qualitative interviews with 22 English-speaking parents of neonates from the NICU and observations of various parent interactions within the NICU over several months. Data were analyzed using thematic content analysis. Findings were critically reviewed through peer debriefing.

Findings: Parents perceived safe care through their observations of clinicians being present, intentional, and respectful when adhering to safety practices, interacting with their infant, and communicating with parents in the NICU. They described partnering with clinicians to promote safe care for their infants and factors impacting that partnership. We cultivated a conceptual model highlighting how parent-clinician partnerships can be a core element to promoting NICU patient safety.

Implications For Practice: Parents' observations of clinician behavior affect their perceptions of safe care for their infants. Assessing what parents observe can be essential to building a partnership of trust between clinicians and parents and promoting safer care in the NICU.

Implications For Research: Uncertainty remains about how to measure parent perceptions of safe care, the level at which the clinician-parent partnership affects patient safety, and whether parents' presence and involvement with their infants in the NICU improve patient safety.
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http://dx.doi.org/10.1097/ANC.0000000000000657DOI Listing
December 2019

Safety Culture: An Integration of Existing Models and a Framework for Understanding Its Development.

Hum Factors 2021 Feb 19;63(1):88-110. Epub 2019 Aug 19.

Rice University, Houston, Texas, USA.

Objective: This study reviews theoretical models of organizational safety culture to uncover key factors in safety culture development.

Background: Research supports the important role of safety culture in organizations, but theoretical progress has been stunted by a disjointed literature base. It is currently unclear how different elements of an organizational system function to influence safety culture, limiting the practical utility of important research findings.

Method: We reviewed existing models of safety culture and categorized model dimensions by the proposed function they serve in safety culture development. We advance a framework grounded in theory on organizational culture, social identity, and social learning to facilitate convergence toward a unified approach to studying and supporting safety culture.

Results: Safety culture is a relatively stable social construct, gradually shaped over time by multilevel influences. We identify seven enabling factors that create conditions allowing employees to adopt safety culture values, assumptions, and norms; and four behaviors used to enact them. The consequences of these enacting behaviors provide feedback that may reinforce or revise held values, assumptions, and norms.

Conclusion: This framework synthesizes information across fragmented conceptualizations to clearly depict the dynamic nature of safety culture and specific drivers of its development. We suggest that safety culture development may depend on employee learning from behavioral outcomes, conducive enabling factors, and consistency over time.

Application: This framework guides efforts to understand and develop safety culture in practice and lends researchers a foundation for advancing theory on the complex, dynamic processes involved in safety culture development.
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http://dx.doi.org/10.1177/0018720819868878DOI Listing
February 2021

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

Bioanalysis 2019 Jun 19;11(12):1129-1138. Epub 2019 Jul 19.

WuXi Apptec, Plainsboro, NJ 08536, USA.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.
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http://dx.doi.org/10.4155/bio-2019-0131DOI Listing
June 2019

Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A.

Arch Phys Med Rehabil 2019 12 28;100(12):2403-2406. Epub 2019 Jun 28.

Service de Médecine Physique et de Réadaptation, Centre hospitalier universitaire Clermont-Ferrand, Institut national de la recherche agronomique, Université Clermont Auvergne, Clermont-Ferrand, France. Electronic address:

Objective: To evaluate in a preliminary methodologic study, the Foot Function Index (FFI), a 3-subscale (pain, disability, and activity restriction) foot disability assessment questionnaire, in patients with Charcot-Marie-Tooth disease type 1A (CMT1A).

Design: Monocentric exploratory cross-sectional study with 2 identical evaluations by the same physical medicine and rehabilitation physician at 14-day intervals (test-retest) according to international guidelines for validating health-related patient-reported outcomes, the Consensus-based Standards for the Selection of Health Measurement Instruments Criteria.

Setting: Physical medicine and rehabilitation and neurology departments in a French academic hospital.

Participants: Patients with CMT1A confirmed by molecular biology (N=26).

Intervention: The FFI and a health-related quality-of-life questionnaire (Medical Outcomes Study Short Form 36 [SF-36] with mental and physical composite scores) combined with quantitative walk analysis by instrumental gait analysis and evaluation of isokinetic quadriceps and hamstrings peak torque by isokinetic dynamometer.

Main Outcome Measures: FFI score and its dimensions.

Results: Acceptability was satisfactory, with less than 5% missing data and good distribution of results. Internal consistency was very satisfactory, with Cronbach α of 0.95. Reproducibility was very satisfactory, with Lin concordance coefficient 0.82. External consistency was satisfactory, with expected correlation coefficients: the FFI was significantly correlated with the SF-36 physical composite score and gait parameters (cadence) (r=-0.58 and r=-0.52; P<.005) but not with peak torque or SF-36 mental composite score.

Conclusions: This study confirms the very good metrologic properties of the FFI in patients with CMT1A. The FFI could be a promising questionnaire to assess foot-related disability in a neurologic disease. Complementary studies are still needed to confirm these promising preliminary results.
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http://dx.doi.org/10.1016/j.apmr.2019.06.003DOI Listing
December 2019

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.

Bioanalysis 2019 Apr 17;11(7):645-653. Epub 2019 Apr 17.

WuXi Apptec, Plainsboro, NJ, USA.

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members' opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.
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http://dx.doi.org/10.4155/bio-2019-0072DOI Listing
April 2019

Approaching Clinical Data Transformation from Disparate Healthcare IT Systems Through a Modular Framework.

Stud Health Technol Inform 2019 ;258:85-89

Data Integration Center, IT Department, Jena University Hospital, Jena, Germany.

Many healthcare IT systems in Germany are unable to interoperate with other systems through standardised data formats. Therefore it is difficult to store and retrieve data and to establish a systematic collection of data with provenance across systems and even healthcare institutions. We outline the concept for a Transformation Pipeline that can act as a processor for proprietary medical data formats from multiple sources. Through a modular construction, the pipeline relies on different data extraction and data enrichment modules as well as on interfaces to external definitions for interoperability standards. The developed solution is extendable and reusable, enabling data transformation independent from current format definitions and entailing the opportunity of collaboration with other research groups.
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August 2019

Distinct progenitor populations mediate regeneration in the zebrafish lateral line.

Elife 2019 03 5;8. Epub 2019 Mar 5.

Department of Biological Structure, University of Washington, Seattle, United States.

Mechanosensory hair cells of the zebrafish lateral line regenerate rapidly following damage. These renewed hair cells arise from the proliferation of surrounding support cells, which undergo symmetric division to produce two hair cell daughters. Given the continued regenerative capacity of the lateral line, support cells presumably have the ability to replenish themselves. Utilizing novel transgenic lines, we identified support cell populations with distinct progenitor identities. These populations show differences in their ability to generate new hair cells during homeostasis and regeneration. Targeted ablation of support cells reduced the number of regenerated hair cells. Furthermore, progenitors regenerated after targeted support cell ablation in the absence of hair cell damage. We also determined that distinct support cell populations are independently regulated by Notch signaling. The existence of independent progenitor populations could provide flexibility for the continued generation of new hair cells under a variety of conditions throughout the life of the animal.
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http://dx.doi.org/10.7554/eLife.43736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6433462PMC
March 2019

Towards 20,20-difluorinated bryostatin: synthesis and biological evaluation of C17,C27-fragments.

Org Biomol Chem 2019 02;17(6):1487-1505

The School of Chemistry, The University of Manchester, Manchester, M13 9PL, UK.

Bryostatins with modified C17-C27 fragments have not been widely studied. The synthesis of 20,20-difluorinated analogues was therefore investigated. Such substitution would inhibit dehydration involving the C19-hydroxyl group and stabilise the ring-closed hemiacetal tautomers. Following preliminary studies, allyldifluorination was used to prepare difluorinated alkenols. Oxidation followed by stereoselective Wittig reactions of the resulting α,α-difluorinated ketones gave (E)-α,β-unsaturated esters that were taken through to complete syntheses of 2-hydroxytetrahydropyrans corresponding to C17-C27 fragments of 20,20-difluorinated bryostatin. These compounds showed modest binding to protein kinase Cα isozyme. Attempts were also undertaken to synthesise macrocyclic 20,20-difluorinated analogues. During preliminary studies, allyldifluorination was carried out using a 2-alkyl-3-bromo-1,1-difluoropropene.
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http://dx.doi.org/10.1039/c8ob03152eDOI Listing
February 2019

Estimates and Temporal Trend for US Nationwide 30-Day Hospital Readmission Among Patients With Ischemic and Hemorrhagic Stroke.

JAMA Netw Open 2018 08 3;1(4):e181190. Epub 2018 Aug 3.

Department of Neurology, The Institute for Stroke and Cerebrovascular Diseases, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth).

Importance: Readmission reduction is linked to improved quality of care, saves cost, and is a desirable patient-centered outcome. Nationally representative readmission metrics for patients with stroke are unavailable to date. Such estimates are necessary for benchmarking performance.

Objectives: To provide US nationwide estimates and a temporal trend for overall, planned, and potentially preventable 30-day hospital readmission among patients with ischemic and hemorrhagic stroke; to investigate the association between hospitals' stroke discharge volume, teaching status, and 30-day readmission; and to highlight reasons for 30-day readmission and explore the association of 30-day readmission in terms of mortality, length of stay, and cost of care among patients with stroke.

Design, Setting, And Participants: Cohort, year-wise analysis of the Nationwide Readmissions Database between January 1, 2010, and September 30, 2015. The setting was a population-based cohort study providing national estimates of 30-day readmission. The database represents 50% of all US hospitalizations from 22 geographically dispersed states. Participants were adult (≥18 years) patients with a primary discharge diagnosis of intracerebral hemorrhage, acute ischemic stroke, or subarachnoid hemorrhage. Hospitals were categorized by their annual stroke discharge volume and were classified as teaching hospitals if they had an American Medical Association-approved residency program or had a ratio of full-time equivalent interns and residents to beds of 0.25 or higher.

Main Outcomes And Measures: Readmission was defined as any admission within 30 days of index hospitalization discharge. Using Centers for Medicare & Medicaid Services-defined algorithms, events were classified as planned or unplanned and as potentially preventable.

Results: Based on study criteria, 2 078 854 eligible patients were included (mean [SE] age, 70.02 [0.07] years; 51.9% female). Thirty-day readmission was highest for patients with intracerebral hemorrhage (13.70%; 95% CI, 13.40%-13.99%), followed by patients with acute ischemic stroke (12.44%; 95% CI, 12.33%-12.55%) and patients with subarachnoid hemorrhage (11.48%; 95% CI, 11.01%-11.96%). On average, there was a 3.3% annual decline in readmission between 2010 and 2014, which was statistically significant for the period of investigation (odds ratio, 0.96; 95% CI, 0.95-0.97). Patients discharged from nonteaching hospitals with high stroke discharge volume were at a significantly higher risk of 30-day readmission, and the top 2 reasons for readmission were acute cerebrovascular disease and septicemia.

Conclusions And Relevance: This study suggests that nationally representative readmission metrics can be used to benchmark hospitals' performance, and a temporal trend of 3.3% may be used to evaluate the effectiveness of readmission reduction strategies.
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http://dx.doi.org/10.1001/jamanetworkopen.2018.1190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324273PMC
August 2018

Cumulative mitochondrial activity correlates with ototoxin susceptibility in zebrafish mechanosensory hair cells.

Elife 2018 12 31;7. Epub 2018 Dec 31.

Department of Biological Structure, University of Washington, Seattle, United States.

Mitochondria play a prominent role in mechanosensory hair cell damage and death. Although hair cells are thought to be energetically demanding cells, how mitochondria respond to these demands and how this might relate to cell death is largely unexplored. Using genetically encoded indicators, we found that mitochondrial calcium flux and oxidation are regulated by mechanotransduction and demonstrate that hair cell activity has both acute and long-term consequences on mitochondrial function. We tested whether variation in mitochondrial activity reflected differences in the vulnerability of hair cells to the toxic drug neomycin. We observed that susceptibility did not correspond to the acute level of mitochondrial activity but rather to the cumulative history of that activity.
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http://dx.doi.org/10.7554/eLife.38062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6345563PMC
December 2018

Development of a framework to describe patient and family harm from disrespect and promote improvements in quality and safety: a scoping review.

Int J Qual Health Care 2019 Nov;31(9):657-668

Department of Health Care Quality, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Purpose: Patients and families may experience 'non-physical' harm from interactions with the healthcare system, including emotional, psychological, socio-behavioral or financial harm, some of which may be related to experiences of disrespect. We sought to use the current literature to develop a practical, improvement-oriented framework to recognize, describe and help prevent such events.

Data Sources: Searches were performed in PubMed, Embase, PsychINFO, CINAHL, Health Business Elite and ProQuest Dissertations & Theses: Global: Health & Medicine, from their inception through July 2017.

Study Selection: Two authors reviewed titles, abstracts, full texts, references and cited-by lists to identify articles describing approaches to understanding patient/family experiences of disrespect.

Data Extraction: Findings were evaluated using integrative review methodology.

Results Of Data Synthesis: Three-thousand eight hundred and eighty two abstracts were reviewed. Twenty three articles were identified. Components of experiences of disrespect included: (1) numerous care processes; (2) a wide range of healthcare professional and organizational behaviors; (3) contributing factors, including patient- and professional-related factors, the environment of work and care, leadership, policies, processes and culture; (4) important consequences of disrespect, including behavioral changes and health impacts on patients and families, negative effects on professionals' subsequent interactions, and patient attrition from organizations and (5) factors both intrinsic and extrinsic to patients that can modify the consequences of disrespect.

Conclusion: A generalizable framework for understanding disrespect experienced by patients/families in healthcare may help organizations better prevent non-physical harms. Future work should prospectively test and refine the framework we described so as to facilitate its integration into organizations' existing operational systems.
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http://dx.doi.org/10.1093/intqhc/mzy231DOI Listing
November 2019