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Long-Term Safety and Efficacy of Tacrolimus 0.1% in Severe Pediatric Vernal Keratoconjunctivitis

Cornea. 2021 May 21. doi: 10.1097/ICO.0000000000002751. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to evaluate the safety and efficacy of tacrolimus 0.1% eye drops in a large population of pediatric patients affected by a severe form of vernal keratoconjunctivitis (VKC) who responded poorly to cyclosporine eye drops.

METHODS: This is a retrospective study based on standardized clinical charts and data collection of consecutive patients affected by severe VKC who responded poorly to cyclosporine eye drops topical treatment but treated with tacrolimus 0.1% eye drops with a follow-up of 18 months. Four clinical signs were graded for analysis: hyperemia, tarsal papillae, giant papillae, and limbal papillae. The blood tests for kidney and liver function and the tacrolimus level were studied. Visits were scheduled at baseline and at 3, 6, 12, and 18 months. Patients received tacrolimus 0.1% eye drops in both eyes 2 times daily.

RESULTS: Four hundred thirty-one patients were included. Three hundred twenty-five patients were affected by a seasonal form, whereas the remaining 106 by a perennial form. Statistical analysis on each single score showed a positive relevance (P < 0.001) from baseline to all other visits. No local or systemic complications were recorded.

CONCLUSIONS: Tacrolimus has been proposed as a treatment for severe forms of VKC. This study has confirmed the safety and efficacy of tacrolimus 0.1% eye drops in a large pediatric population of patients affected by a severe form of VKC who responded poorly to cyclosporine eye drops.

PMID:34029239 | DOI:10.1097/ICO.0000000000002751

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Toolkit for Best Practice Use of Electronic Health Record Data in Quality Improvement

Comput Inform Nurs. 2021 May 24. doi: 10.1097/CIN.0000000000000757. Online ahead of print.

ABSTRACT

This project piloted an educational intervention focused on use and management of EHR data by Doctor of Nursing Practice students in quality improvement initiatives. Recommendations from academic and clinical nursing promote the integration of EHR data findings into practice. Nursing’s general lack of understanding about how to use and manage data is a barrier to using EHR data to guide quality improvement initiatives. Doctor of Nursing Practice students at a hospital-affiliated university participated in a pre-test, training, and post-test through an online learning management system. Training content and assessments focused on data and planning for its use in quality improvement initiatives. Sixteen students experienced a median of 17.6% increase in scores after completing the post-test. There was a statistically significant increase in scores between the pre-test and post-test (P = .0006). These results suggest educational content included in the Doctor of Nursing Practice Quality Improvement Toolkit increases knowledge about use and management of EHR data. Future considerations include use for educating a variety of students and healthcare staff.

PMID:34029265 | DOI:10.1097/CIN.0000000000000757

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Association Between Symptoms of Patients With Heart Failure and Patient Outcomes Based on Electronic Nursing Records

Comput Inform Nurs. 2021 May 24. doi: 10.1097/CIN.0000000000000763. Online ahead of print.

ABSTRACT

We examined the association between symptoms (ie, dyspnea and pain) and patient outcomes (ie, length of stay, 30-day readmission, and death in hospital) among patients with heart failure using EMRs. This was a descriptive study that was conducted from July 1, 2014, to November 30, 2017. Participants were 754 hospitalized patients with heart failure (mean age, 70.62 ± 14.78 years; male-to-female ratio, 1:1.1). Data were analyzed using descriptive statistics, χ2 tests, and logistic regression analyses. Patients’ average length of stay was 8.92 ± 13.12 days. Thirty-two patients (4.2%) were readmitted, and 100 patients (13.3%) died during hospitalization. Two-thirds (67.7%) experienced dyspnea, and 367 (48.7%) experienced pain. Symptoms and ICU admission were significantly related to patient outcomes. In the regression analyses, dyspnea, pain, and ICU admission were significantly related to higher-than-average lengths of stay. Dyspnea and ICU admission were related to death in hospital. Information regarding patients’ symptoms, which was extracted from records, was a valuable resource in examining the relationship between symptoms and patient outcomes. The use of EMRs may be more advantageous than self-reported surveys when examining patients’ symptom and utilizing big data.

PMID:34029266 | DOI:10.1097/CIN.0000000000000763

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Routine Postsurgical Anesthesia Visit to Improve 30-Day Morbidity and Mortality: A Multicenter, Stepped-Wedge Cluster Randomized Interventional Study (the TRACE Study)

Ann Surg. 2021 May 24. doi: 10.1097/SLA.0000000000004954. Online ahead of print.

ABSTRACT

OBJECTIVE: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients.

BACKGROUND: Postoperative complications are the leading cause of perioperative morbidity and mortality. While modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration.

METHODS: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in nine academic and non-academic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day one and three to routine use of MEWS in 5473 patients undergoing elective non-cardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay and intensive care unit (ICU) admission.

RESULTS: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0·56% (n = 14) in the control and 0·44% (n = 12) in the intervention group (odds ratio 0·74, 95%confidence interval 0·34-1·62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1·7% (n = 41) vs. 1·0% (n = 27), p = 0·014). Median length of hospital stay did not differ significantly between groups. During the post-anesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day one and three, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up.

CONCLUSIONS: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence to the recommendations provided and in a high-risk population might have a stronger impact on postoperative mortality remains to be determined.

TRIAL REGISTRATION: Netherlands Trial Registration, NTR5506/ NL5249, https://www.trialregister.nl/trial/5249.

PMID:34029230 | DOI:10.1097/SLA.0000000000004954

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Home-Based Reiki by Informal Caregivers: A Mixed-Methods Pilot Study

Holist Nurs Pract. 2021 May 20. doi: 10.1097/HNP.0000000000000450. Online ahead of print.

ABSTRACT

This pilot study explored whether Reiki delivered by family caregivers to cancer patients in a home setting was feasible in reducing cancer symptoms and enhancing health-related outcomes. An explanatory sequential mixed-methods study design was applied using pre-/post-Reiki questionnaires and post-Reiki interviews. Six patient-caregiver dyads from an outpatient clinic and cancer support facilities in northeast America performed daily Reiki at home for 3 weeks. Differences with symptoms, mental well-being, health-related quality of life, and satisfaction with at-home Reiki as well as qualitative content analyses were evaluated. Positive feedback was reported after at-home Reiki practice. Large statistical effects were identified for improving fatigue, memory, mood, nausea, and emotional well-being (P < .10, r = 0.51-0.59). All participants were satisfied and 83.3% of them would recommend self-practice home Reiki. High involvement and adherence to the intervention protocol illustrated intervention fidelity. The qualitative data revealed 2 major categories, perceived benefits and barriers. Overall Reiki benefits outweighed barriers in relation to time commitment and place distractions/positioning. Our preliminary findings support that the at-home Reiki protocol had potential benefits and was feasible and acceptable by both community-dwelling patients and their family caregivers in promoting cancer-related outcomes. Further studies with larger samples are warranted to examine the effectiveness of home-based Reiki for a patient-centered cancer care modality.

PMID:34029232 | DOI:10.1097/HNP.0000000000000450

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Trypan-Assisted Automated Endothelial Cell Loss Measurements Compared With Specular Microscopy

Cornea. 2021 May 21. doi: 10.1097/ICO.0000000000002756. Online ahead of print.

ABSTRACT

PURPOSE: The aims of this study were 1) to compare area of cell loss (ACL) on trypan staining with ACL on specular imaging and 2) to evaluate the use of automated software for measuring ACL on trypan staining.

METHODS: Donor corneas with transplant-grade endothelium were mechanically injured with an 18-gauge cannula and a Fogla deep anterior lamellar keratoplasty dissector tip to create an easily identifiable “bullseye” pattern of cell death. Each cornea was then stained with trypan blue 0.06% for 90 seconds and imaged at 2× magnification. ACL on staining was measured using manual (ImageJ, National Institute of Health, Bethesda, MD) versus automated software tools (custom-built Aphelion macro, ADCIS, S.A., Saint-Contest, France). The bullseye was then imaged using specular microscopy, and ACL was measured by tracing the dead cell borders. ACL was then compared between both modalities.

RESULTS: Eleven donor corneas were evaluated. Both manual (0.42 mm2) and automated (0.45 mm2) measurements of ACL after trypan staining underestimated mean ACL on specular imaging (0.54 mm2) (P < 0.01). However, on regression analysis, there was a good predictive correlation between automated trypan measurements and specular imaging (R2 = 0.99, residual SE = 0.0044, P < 0.01). When ACL on specular imaging was measured by tracing cell nuclei along the margin of injury (rather than cell borders) (0.45 mm2), there was no statistically significant difference between specular and automated trypan measurements (P = 0.95).

CONCLUSIONS: Trypan-assisted automated measurements of ACL correlated well with ACL on specular imaging, suggesting that automated software may be a useful tool for evaluating endothelium in donor corneas.

PMID:34029236 | DOI:10.1097/ICO.0000000000002756

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DPFL-Nets: Deep Pyramid Feature Learning Networks for Multiscale Change Detection

IEEE Trans Neural Netw Learn Syst. 2021 May 24;PP. doi: 10.1109/TNNLS.2021.3079627. Online ahead of print.

ABSTRACT

Due to the complementary properties of different types of sensors, change detection between heterogeneous images receives increasing attention from researchers. However, change detection cannot be handled by directly comparing two heterogeneous images since they demonstrate different image appearances and statistics. In this article, we propose a deep pyramid feature learning network (DPFL-Net) for change detection, especially between heterogeneous images. DPFL-Net can learn a series of hierarchical features in an unsupervised fashion, containing both spatial details and multiscale contextual information. The learned pyramid features from two input images make unchanged pixels matched exactly and changed ones dissimilar and after transformed into the same space for each scale successively. We further propose fusion blocks to aggregate multiscale difference images (DIs), generating an enhanced DI with strong separability. Based on the enhanced DI, unchanged areas are predicted and used to train DPFL-Net in the next iteration. In this article, pyramid features and unchanged areas are updated alternately, leading to an unsupervised change detection method. In the feature transformation process, local consistency is introduced to constrain the learned pyramid features, modeling the correlations between the neighboring pixels and reducing the false alarms. Experimental results demonstrate that the proposed approach achieves superior or at least comparable results to the existing state-of-the-art change detection methods in both homogeneous and heterogeneous cases.

PMID:34029198 | DOI:10.1109/TNNLS.2021.3079627

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Medicare reimbursement disparities persist for female otolaryngologists performing endoscopic sinonasal procedures

Int Forum Allergy Rhinol. 2021 May 24. doi: 10.1002/alr.22806. Online ahead of print.

NO ABSTRACT

PMID:34029005 | DOI:10.1002/alr.22806

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A safety and feasibility trial of (131) I-MIBG in newly diagnosed high-risk neuroblastoma: A Children’s Oncology Group study

Pediatr Blood Cancer. 2021 May 24:e29117. doi: 10.1002/pbc.29117. Online ahead of print.

ABSTRACT

INTRODUCTION: 131 I-meta-iodobenzylguanidine (131 I-MIBG) is effective in relapsed neuroblastoma. The Children’s Oncology Group (COG) conducted a pilot study (NCT01175356) to assess tolerability and feasibility of induction chemotherapy followed by 131 I MIBG therapy and myeloablative busulfan/melphalan (Bu/Mel) in patients with newly diagnosed high-risk neuroblastoma.

METHODS: Patients with MIBG-avid high-risk neuroblastoma were eligible. After the first two patients to receive protocol therapy developed severe sinusoidal obstruction syndrome (SOS), the trial was re-designed to include an 131 I-MIBG dose escalation (12, 15, and 18 mCi/kg), with a required 10-week gap before Bu/Mel administration. Patients who completed induction chemotherapy were evaluable for assessment of 131 I-MIBG feasibility; those who completed 131 I-MIBG therapy were evaluable for assessment of 131 I-MIBG + Bu/Mel feasibility.

RESULTS: Fifty-nine of 68 patients (86.8%) who completed induction chemotherapy received 131 I-MIBG. Thirty-seven of 45 patients (82.2%) evaluable for 131 I-MIBG + Bu/Mel received this combination. Among those who received 131 I-MIBG after revision of the study design, one patient per dose level developed severe SOS. Rates of moderate to severe SOS at 12, 15, and 18 mCi/kg were 33.3%, 23.5%, and 25.0%, respectively. There was one toxic death. The 131 I-MIBG and 131 I-MIBG+Bu/Mel feasibility rates at the 15 mCi/kg dose level designated for further study were 96.7% (95% CI: 83.3%-99.4%) and 81.0% (95% CI: 60.0%-92.3%).

CONCLUSION: This pilot trial demonstrated feasibility and tolerability of administering 131 I-MIBG followed by myeloablative therapy with Bu/Mel to newly diagnosed children with high-risk neuroblastoma in a cooperative group setting, laying the groundwork for a cooperative randomized trial (NCT03126916) testing the addition of 131 I-MIBG during induction therapy.

PMID:34028986 | DOI:10.1002/pbc.29117

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The effects of rotational setup errors in total body irradiation using helical tomotherapy

J Appl Clin Med Phys. 2021 May 24. doi: 10.1002/acm2.13271. Online ahead of print.

ABSTRACT

PURPOSE: Helical tomotherapy (HT) is a form of intensity-modulated radiation therapy that is employed in total body irradiation (TBI). Because TBI targets the whole body, accurate setup positioning at the edge of the treatment volume is made difficult by the whole-body rotational posture. The purpose of this study is to clarify the tolerance for rotational setup error (SE) in the vertical direction. In addition, we perform a retrospective analysis of actually irradiated dose distributions using previous patients’ irradiation data.

METHODS: To clarify the effects of rotational SE on the dose distribution, the planned CT images of 10 patients were rotated by 1-5° in the vertical (pitch) direction to create a pseudo-rotational SE image. Then, the effect of the magnitude of the rotational SE on the dose distribution was simulated. In addition, the irradiated dose to the patients was analyzed by obtaining recalculated dose distributions using megavoltage CT images acquired before treatment.

RESULTS: The simulation results showed that the average value of the lung volume receiving at least 10 Gy did not exceed the allowable value when the SE value was ≤2°. When the rotational SE was ≤3°, it was possible to maintain the clinical target volume dose heterogeneity within ±10% of the prescribed dose, which is acceptable according to the guidelines. A retrospective analysis of previous patients’ irradiation data showed their daily irradiation dose distribution. The dose to the clinical target volume was reduced by up to 3.4% as a result of the residual rotational SE. Although whole-course retrospective analyses showed a statistically significant increase in high-dose areas, the increase was only approximately 1.0%.

CONCLUSIONS: Dose errors induced by rotational SEs of ≤2° were acceptable in this study.

PMID:34028944 | DOI:10.1002/acm2.13271