bluuebunny/crossref_metadata_2025 huggingface dataset:
Accelerated Approval of 17α-Hydroxyprogesterone Caproate
Authors: Godlewski Bethany J. , Sobolik Lily I. , King Valerie J. , Harrod Curtis S.
Published: April 2020

Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U.S. Food and Drug Administration (FDA) approved a commercial version of 17P (trade name “Makena”) through their Accelerated Approval Program, and the price of 17P subsequently increased by nearly 100-fold. This approval was largely based on a methodologically limited, placebo-controlled trial, which found that although 17P significantly reduced preterm births, the placebo group had significantly more participants with a history of preterm birth, potentially confounding the results. The FDA required a confirmatory trial for continued approval that demonstrated clinical benefit. Eight years after accelerated approval, the confirmatory trial, PROLONG (Progestin's Role in Optimizing Neonatal Gestation), found no evidence of an effect of Makena for reducing recurrent preterm birth or perinatal mortality. Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9–7 to recommend revoking approval of Makena for preterm birth. Although the FDA created the Accelerated Approval Program to introduce therapies for serious conditions that lacked treatment options, Makena is an example of the limitations of this program. We encourage the FDA to re-evaluate their program and consider improvements, such as shorter timeframes to complete confirmatory trials, potentially revoking approval if the studies are not completed within a predefined timeframe, and to hold manufacturers responsible, in part, for the costs of therapy if they cannot prove a clinical benefit.
Effects of Changing Diagnostic Criteria for Gestational Diabetes Mellitus in Queensland, Australia
Authors: Meloncelli Nina J. L. , Barnett Adrian G. , D'Emden Michael , De Jersey Susan J.
Published: April 2020

OBJECTIVE:

To evaluate the effects of updated gestational diabetes mellitus (GDM) screening and diagnostic criteria on selected perinatal outcomes in Queensland, Australia.

METHODS:

This was a pre–post comparison study using perinatal data the year before (2014) and after (2016) the screening and diagnostic criteria for GDM was changed in Queensland, Australia. In 2015, Queensland adopted the one-step screening and diagnostic criteria based on the International Association of the Diabetes and Pregnancy Study Groups' recommendations. The data from 62,517 women in 2014 and 61,600 women in 2016 who gave birth from 24 weeks of gestation were analyzed in three groups in each year: women with GDM; women without diagnosed GDM; and total population. The outcome measures were gestational hypertension, cesarean birth, gestational age at delivery, birth weight, preterm delivery, large-for-gestational age (LGA) neonates, small-for-gestational-age (SGA) neonates, neonatal hypoglycemia, and respiratory distress.

RESULTS:

The diagnosis of GDM increased from 8.7% (n=5,462) to 11.9% (n=7,317). After changing the diagnostic criteria, the changes to outcomes, odds ratios (OR), and adjusted odds ratios (aOR) (95% CI) for outcomes with statistically significant differences for the total population were: gestational hypertension 4.6% vs 5.0%, OR 1.09 (1.03–1.15), aOR 1.07 (1.02–1.13); preterm birth 7.6% vs 8.0%, OR 1.05 (1.01–1.09), aOR 1.06 (1.02–1.10); neonatal hypoglycemia 5.3% vs 6.8%, OR 1.31 (1.25–1.37), aOR 1.32 (1.25–1.38); and respiratory distress 6.2% vs 6.0%, OR 0.96 (0.91–1.00), aOR 0.94 (0.89–0.99). There was no change to cesarean births or LGA or SGA neonates for women with or without diagnosed GDM or the total population.

CONCLUSION:

Except for a very small decrease in respiratory distress, changing the diagnostic criteria has resulted in more GDM diagnoses with no observed changes to measured perinatal outcomes for women with and without diagnosed GDM.
Placenta Accreta Spectrum Disorder
Authors: Einerson Brett D. , Comstock Jessica , Silver Robert M. , Branch D. Ware , Woodward Paula J. , Kennedy Anne
Published: April 2020

For decades, placenta accreta spectrum disorder has been classified, staged, and described as a disorder of placental invasion. In this commentary, we argue that placenta accreta spectrum exists as a disorder of defective decidua and uterine scar dehiscence, not as a disorder of destructive trophoblast invasion. Adopting this understanding of placenta accreta spectrum will help direct research efforts and clinical resources toward the prevention, accurate diagnosis, and safe treatment of this devastating—and increasingly common—disorder.
Pentosan Polysulfate–Associated Macular Disease in Patients With Interstitial Cystitis
Authors: Lyons Riley J. , Ahmad Samera , Ansari Sana , Foote Jenelle E. , Jain Nieraj
Published: April 2020

Recent studies have implicated long-term pentosan polysulfate use with vision loss from a newly described macular condition. Affected patients report difficulty with reading and adjusting to dim lighting, and they occasionally develop severe visual disability. Macular changes resemble those seen in age-related macular degeneration, potentially leading to misdiagnosis. The objectives of this Current Commentary are to summarize studies evaluating the association between pentosan polysulfate use and macular disease, to educate pentosan polysulfate prescribers about the clinical manifestations of this condition, and to provide recommendations for screening at-risk patients.
The Imperative for Transgender and Gender Nonbinary Inclusion
Authors: Moseson Heidi , Zazanis Noah , Goldberg Eli , Fix Laura , Durden Mary , Stoeffler Ari , Hastings Jen , Cudlitz Lyndon , Lesser-Lee Bori , Letcher Laz , Reyes Aneidys , Obedin-Maliver Juno
Published: April 2020

We aim to make evident that solely referencing cisgender women in the context of sexual and reproductive health—particularly pregnancy planning and care—excludes a diverse group of transgender and gender nonbinary people who have sexual and reproductive health needs and experiences that can be similar to but also unique from those of cisgender women. We call on clinicians and researchers to ensure that all points of sexual and reproductive health access, research, sources of information, and care delivery comprehensively include and are accessible to people of all genders. We describe barriers to sexual and reproductive health care and research participation unique to people of marginalized gender identities, provide examples of harm resulting from these barriers, and offer concrete suggestions for creating inclusive, accurate, and respectful care and research environments—which will lead to higher quality health care and science for people of all genders.
Right-Sizing Prenatal Care to Meet Patients' Needs and Improve Maternity Care Value
Authors: Peahl Alex F. , Gourevitch Rebecca A. , Luo Eva M. , Fryer Kimberly E. , Moniz Michelle H. , Dalton Vanessa K. , Fendrick A. Mark , Shah Neel
Published: April 2020

Prenatal care is one of the most widely used preventive care services in the United States, yet prenatal care delivery recommendations have remained largely unchanged since just before World War II. The current prenatal care model can be improved to better serve modern patients and the health care providers who care for them in three key ways: 1) focusing more on promotion of health and wellness as opposed to primarily focusing on medical complications, 2) flexibly incorporating patient preferences, and 3) individualizing care. As key policymakers and stakeholders grapple with higher maternity care costs and poorer outcomes, including lagging access, equity, and maternal and infant morbidity and mortality in the United States compared with other high-income countries, the opportunity to improve prenatal care has been given insufficient attention. In this manuscript, we present a new conceptual model for prenatal care that incorporates both patients' medical and social needs into four phenotypes, and use human-centered design methods to describe how better matching patient needs with prenatal services can increase the use of high-value services and decrease the use of low-value services. Finally, we address some of the key challenges to implementing right-sized prenatal care, including capturing outcomes through research and payment.
Adjuvant Human Papillomavirus Vaccine to Reduce Recurrent Cervical Dysplasia in Unvaccinated Women
Authors: Lichter Katie , Krause Danielle , Xu Jingwen , Tsai Sung Huang Laurent , Hage Camille , Weston Erica , Eke Ahizechukwu , Levinson Kimberly
Published: April 2020

OBJECTIVE:

To perform a systematic review and meta-analysis evaluating the efficacy of adjuvant human papillomavirus (HPV) vaccination in preventing recurrent cervical intraepithelial neoplasia (CIN) 2 or greater after surgical excision.

DATA SOURCES:

Electronic databases (Cochrane, PubMed, EMBASE, MEDLINE, Scopus, and ClinicalTrials.gov) were searched for studies comparing surgical excision alone to surgical excision with adjuvant HPV vaccination for CIN 2 or greater. Studies published from January 1990 to January 2019 were included.

METHODS:

A total of 5,901 studies were reviewed. The primary outcomes evaluated included: recurrence of CIN 2 or greater, CIN 1 or greater, and HPV 16,18 associated CIN within 6–48 months. We used Covidence software to assist with screening, and meta-analysis was performed using Review Manager.

TABULATION, INTEGRATION, AND RESULTS:

Six studies met inclusion criteria and were included in the final analysis. In total 2,984 women were included; 1,360 (45.6%) received adjuvant HPV vaccination after surgical excision, and 1,624 (54.4%) received either placebo or surgical management alone for CIN 2 or greater. Recurrence of CIN 2 or greater occurred within 6–48 months in 115 women (3.9%) overall; however, recurrence was significantly lower for vaccinated women: 26 of 1,360 women (1.9%) vs 89 of 1,624 unvaccinated women (5.9%) (relative risk [RR] 0.36 95% CI 0.23–0.55). The risk of CIN 1 or greater was also significantly lower with adjuvant HPV vaccination, occurring in 86 of 1,360 vaccinated women (6.3%) vs 157 of 1,624 unvaccinated women (9.7%) (RR 0.67 95% CI 0.52–0.85). Thirty-five women developed recurrent CIN 2 or greater lesions specific to HPV 16,18; nine received adjuvant vaccination (0.9%) vs 26 who were unvaccinated (2.0%) (RR 0.41 95% CI 0.20–0.85).

CONCLUSION:

Adjuvant HPV vaccination in the setting of surgical excision for CIN 2 or greater is associated with a reduced risk of recurrent cervical dysplasia overall and a reduction in the risk of recurrent lesions caused by the most oncogenic strains (HPV 16,18). Human papillomavirus vaccination should therefore be considered for adjuvant treatment in patients undergoing surgical excision for CIN 2 or greater.

SYSTEMATIC REVIEW REGISTRATION:

PROSPERO, CRD42019123786.
Shikonin inhibits growth, invasion and glycolysis of nasopharyngeal carcinoma cells through inactivating the phosphatidylinositol 3 kinase/AKT signal pathway
Authors: Zhang Jingjing , Zhou Jingchun , Xiao Shuifang
Published: April 2020

Nasopharyngeal carcinoma (NPC) is a malignant tumor which is commonly found in East Asia and Africa. The present clinical treatment of NPC is still mainly based on chemotherapeutics and is prone to drug resistance and adverse reactions. Shikonin has been demonstrated to play the antitumor effect in various cancers. However, the specific effects and related regulatory mechanism of Shikonin in NPC have not been clearly declared yet. Cell viability was valued through 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay, and cell proliferation was detected through colony formation assay and Bromodeoxyuridine (BrdU) assay. Hochest 33258 staining was used to value cell apoptosis. Cell migration and invasion were valued through wound healing and transwell invasion assay, respectively. Glucose uptake, lactate release, ATP level and pyruvate kinase M2 isoform (PKM2) activity were measured using corresponding assay kits. Western blotting was used to examine the expression of proteins related to cell proliferation, cell apoptosis, cell migration and the phosphatidylinositol 3 kinase (PI3K)/AKT signal pathway. We found that Shikonin treatment effectively suppressed cell proliferation and induced obvious cell apoptosis compared with the control. Besides, Shikonin treatment suppressed cell migration and invasion effectively. The detection about glycolysis showed that Shikonin treatment suppressed cell glucose uptake, lactate release and ATP level. The activity of PKM2 was also largely inhibited by Shikonin. Further study revealed that the PI3K/AKT signal pathway was inactivated by Shikonin treatment. In addition, the inducer of the PI3K/AKT signal pathway largely abolished the antitumor effect of Shikonin on cell proliferation, cell apoptosis, cell mobility and aerobic glycolysis in NPC cells. Shikonin inhibits growth and invasion of NPC cells through inactivating the PI3K/AKT signal pathway.
LRP1 and APOA1 Polymorphisms: Impact on Warfarin International Normalized Ratio-Related Phenotypes
Authors: Li Dan , Luo Zhi-Ying , Chen Yi , Zhu Hong , Song Guo-Bao , Zhou Xin-Ming , Yan Han , Zhou Hong-Hao , Zhang Wei , Li Xi
Published: April 2020

Warfarin international normalized ratio (INR)-related phenotypes such as the percentage of INR time in the therapeutic range (PTTR) and INR variability are associated with warfarin adverse reactions. However, INR-related phenotypes greatly vary among patients, and the underlying mechanism remains unclear. As a key cofactor for coagulation proteins, vitamin K can affect warfarin INR values. The aim of this study was to address the influence of vitamin K–related single-nucleotide polymorphisms (SNPs) on warfarin INR-related phenotypes. A total of 262 patients who were new recipients of warfarin therapy and followed up for 3 months were enrolled. Twenty-nine SNPs were genotyped by matrix-assisted laser desorption/ionization time-of-flight mass array. Sixteen warfarin INR-related phenotypes were observed. After association analysis, 11 SNPs were significantly associated with at least one INR-related phenotype, and 6 SNPs were associated with at least 2 INR-related phenotypes (P < 0.05). In these SNPs, rs1800139, rs1800154, rs1800141, and rs486020 were the most representative. rs1800139, rs1800154, and rs1800141 locate in LRP1 and were found to be correlated with 1-month and 2-month INR variability (P < 0.05). Besides, the APOA1 rs486020 was significantly associated with the first month PTTR (P = 0.009), and patients with C-allele had higher PTTR than those with G-alleles almost during the entire monitoring period. In conclusion, the study revealed that the polymorphisms of LRP1 and APOA1 gene may play important roles in the variation of warfarin INR-related phenotypes. Our results provide new information for improving warfarin anticoagulation management.
Do Self-healing and Self-care Mean the Same Thing?
Authors: Tzeng Huey-Ming
Published: April 2020

This brief essay begins the conversation of whether self-healing and self-care, terms that have been used independently and together, do indeed mean the same thing. To support a holistic approach to nursing and patient-centered care, nursing professionals and educators should be familiar with self-healing processes and self-care acts.
EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT
Authors: Thomseth Vilde M. , Engelsvold David H. , Ushakova Anastasia , Forsaa Vegard A.
Published: April 2020

Purpose:

To explore the potentials of multicolor (MC) confocal scanning laser ophthalmoscopy (cSLO) to detect structural retinal pathology after macula-off rhegmatogenous retinal detachment (RRD) and to describe their appearances.

Methods:

Thirty MC cSLO images of 30 eyes after RRD repair were prospectively studied for the presence of RRD-related pathology. All MC cSLO findings were verified using swept source optical coherence tomography. Positive percent agreements were calculated using swept source optical coherence tomography as reference.

Results:

Eight RRD-related structural pathologies were identified and characterized: ellipsoid zone (EZ) disruption, foveal EZ rosette, outer retinal fold, retinal detachment line, subretinal fluid blebs, subretinal fluid layer, retinal striae, and intraretinal cysts. Multicolor cSLO positive percent agreements were as follows: EZ disruption: 79%, foveal EZ rosette: 73%, outer retinal fold: 67%, retinal detachment line: 84%, subretinal fluid blebs: 0.70%, subretinal fluid layer: 50%, intraretinal cysts: 60%, and retinal striae: 100%.

Conclusion:

En face MC cSLO imaging detected and delineated RRD-related structural pathology in high agreement with cross-sectional swept source optical coherence tomography and can supplement optical coherence tomography in the documentation and monitoring of outer retinal remodeling processes after macula-off RRD. Foveal EZ rosette is a new finding of the foveal EZ.
Trimethoprim-Sulfamethoxazole Associated Drug-Induced Liver Injury in Pediatrics: A Systematic Review
Authors: Burgos Rodrigo M. , Reynolds Kate M. , Williams Jean , Li Wenchin , Yan Connie H.
Published: April 2020

Background:

Drug-induced liver injury (DILI) is a rare but known adverse event associated with trimethoprim-sulfamethoxazole (TMP-SMX) in adults. No studies to date have looked at the risk of this association in children. We systematically reviewed the evidence for a potential association between TMP-SMX and DILI in the pediatric population.

Methods:

PubMed, Medline, Embase, Cochrane Database of Systematic Reviews, Scopus and Web of Science was searched using a combination of terms to identify reports of TMP-SMX exposure, liver injury and pediatrics (≤18 years old). We included any studies with hepatic adverse events occurring after exposure to TMP-SMX. Bibliographies were reviewed for additional relevant references. The Narajno scale was used to assess causality in case studies.

Results:

A total of 22 studies were identified: 3 randomized trials, 1 prospective observational study, 8 retrospective observational studies and 10 case reports. Among the randomized trials and prospective studies, only mild, transient hepatic function abnormalities were reported. Retrospective observational studies reported 1 fatal DILI and statistically significant increased odds of DILI with TMP-SMX use compared with nonuse. Among the 10 case reports, severe liver outcomes and mild hepatic function abnormalities were both reported. Naranjo scores suggested reported hepatic adverse events were probably because of exposure in 5, possible in 4, and doubtful in 1 case report.

Conclusions:

Evidence regarding DILI associated with TMP-SMX exposure in pediatrics is limited. Observational population studies show mild hepatic abnormalities. Case reports suggest more severe manifestations of DILI. Additional studies may reveal the association between TMP-SMX and DILI in pediatrics.
Bilateral Poorly Differentiated Adenocarcinoma of the Lacrimal Gland With Tumor Regression After Treatment With Pembrolizumab
Authors: Tran Ann Q. , Choi Catherine J. , Al-Sadah Zakeya , Yi Zhou Xiao , Dubovy Sander , Rothschild Neal E. , Lee Bradford W.
Published: April 2020

An 85-year-old man presented with a 6-month history of worsening left proptosis and painless ophthalmoplegia. Imaging revealed an extensive intraconal and extraconal tumor extending to the level of the optic foramen, as well as the scalp, cheek, and the nasal bridge. Incisional biopsy was consistent with lacrimal gland adenocarcinoma. The patient underwent a left orbital exenteration followed by immunotherapy with pembrolizumab. The treatment was stopped prematurely after 5 cycles due to development of autoimmune colitis. Four months later, the patient developed new contralateral disease in the right orbit and an incisional biopsy again showed lacrimal gland adenocarcinoma. Following the incisional biopsy, no further treatment was administered, but over the ensuing 6 months, there was dramatic spontaneous regression of the tumor both clinically and radiographically. At 28 months, the patient is still alive with relatively stable disease.
Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis
Authors: Andorn Anne C. , Haight Barbara R. , Shinde Sunita , Fudala Paul J. , Zhao Yue , Heidbreder Christian , Learned Susan M. , Fox Norma Lynn , Nadipelli Vijay R. , Hassman David , Rutrick Daniel
Published: April 2020

Background

BUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration–approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.

Methods

This open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.

Results

Overall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.

Conclusions

This study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.
Predictive model for the diagnosis of benign/malignant small pulmonary nodules
Authors: Chen Weisong , Zhu Dan , Chen Hui , Luo Jianfeng , Fu Haiwei
Published: April 2020

There is some doubt that all nodules <8 mm are really mainly benign and that simple follow-up is adequate in all cases. The purpose of this study is to create a predictive model for the diagnosis of benign and malignant small pulmonary nodules.

This was a retrospective case–control study of patients who had undergone pulmonary nodule resection at the Zhejiang University Jinhua Hospital. Patients with pulmonary nodules of ≤10 mm in size on chest high-resolution computed tomography were included. Patients’ demographic characteristics, clinical features, and high-resolution computed tomography findings were collected. Logistic regression and receiver-operating characteristic analysis were used to create a predictive model for malignancy.

A total of 216 patients were included: 160 with malignant and 56 with benign nodules. Nodule density (odds ratio [OR] = 0.996, 95% confidence interval [CI]: 0.993–0.998, P = .001), vascular penetration sign (OR = 3.49, 95% CI: 1.39–8.76, P = .008), nodule type (OR = 4.27, 95% CI: 1.48–12.29, P = .007), and incisure surrounding nodules (OR = 0.18, 95% CI: 0.04–0.84, P = .03) were independently associated with malignant nodules. These factors were used to create a mathematical model that had an area under the receiver-operating characteristic curve of 0.744. Using a cut-off of 0.762 resulted in 63.1% sensitivity and 75.0% specificity.

This study proposes a pulmonary nodule prediction model that can estimate benign/malignant lung nodules with good sensitivity and specificity. Mixed ground-glass nodules, vascular penetration sign, density of lung nodules, and the absence of incisure signs are independently associated with malignant lung nodules.
Emergency management of iatrogenic arterial injuries with a low-profile balloon-expandable stent-graft
Authors: Ruffino Maria Antonella , Fronda Marco , Varello Sara , Discalzi Andrea , Mancini Andrea , Muratore Pierluigi , Rossato Denis , Bergamasco Laura , Righi Dorico , Fonio Paolo
Published: April 2020

Endovascular treatment of arterial injuries with stent-graft is a reliable alternative approach in patients not suitable for embolization or at high risk for surgery. The aim of our study was to evaluate the efficacy and the safety of the BeGraft stent-graft, a low-profile balloon expandable covered stent, for emergency endovascular treatment of iatrogenic arterial injuries.

Between August 2015 and September 2018, 34 consecutive patients (mean age 71 ± 12 years, 9 females) underwent implantation of BeGraft stent-grafts for iatrogenic arterial injuries (22 active bleedings, 11 pseudoaneurysms, and 1 enteric-iliac fistula). The primary endpoints were technical and clinical success and rates of major and minor complications. The secondary endpoint was the patency of the device during the follow-up. Imaging follow-up was performed by duplex ultrasound and/or computed tomography angiography (according to lesion site/target vessel), at 1-6-12-15 and 24 months.

In all 34 patients (100%), the lesion or the defect was effectively excluded with a cumulative amount of 42 stent-grafts. The clinical success was documented in 30/34 patients (88.2%). Neither device- or procedure-related deaths, or major complications occurred. A minor complication was reported in 1 patient (2.9%), successfully treated during the same procedure. Thirty (88.2%) patients were available for a mean follow-up time of 390 ± 168 days (minimum 184, maximum 770), with no observed loss of patency, yielding a 100% Kaplan–Meier cumulative survival patency function. The percentage of patent patients was 30/30 at 6 months, 22/22 at 12 months, and 5/5 at 15 months.

Endovascular treatment of iatrogenic arterial injuries with the BeGraft stent-graft is minimally invasive and effective, with good patency rate at midterm follow-up.
A case report of fulminant cytokine release syndrome complicated by dermatomyositis after the combination therapy with immune checkpoint inhibitors
Authors: Ohira Junichiro , Kawamoto Michi , Sugino Yoshio , Kohara Nobuo
Published: April 2020

Introduction:

Immune-related adverse events (ir-AEs) are increasingly becoming a concern, as immune checkpoint inhibitors (ICIs) are used more frequently. Herein, we present a case of fulminant cytokine release syndrome (CRS) complicated by dermatomyositis after the combination therapy with ICIs.

Patient concerns:

A 70-year-old male developed dermatomyositis during the course of treatment with two ICIs, nivolumab and ipilimumab. He was treated by steroid pulse therapy, but the effect was limited. Afterwards, he had acute-onset high fever, hypotension, respiratory failure, impaired consciousness, renal failure, and coagulation abnormality at the same time. C reactive protein (CRP), creatinine kinase (CK), D-dimer, and ferritin levels were considerably elevated: CRP, 24 mg/dL; CK, 40,500 U/L; D-dimer, 290 μg/mL; ferritin, 329,000 ng/mL.

Diagnosis:

CRS induced by ICI combination therapy.

Interventions:

Given that high fever and elevated CRP level indicated potential sepsis, an antibiotic was used until the confirmation of negative blood cultures. All the simultaneous acute symptoms were supposed to be CRS. He was admitted to the intensive care unit (ICU), and temporary intubation and hemodialysis were needed. Immunosuppressive therapy was reinforced by mycophenolate mofetil together with steroid, and plasma exchange was performed for the elimination of abnormal proteins.

Outcomes:

The patient's clinical symptoms and laboratory parameters gradually improved and he was discharged from the ICU in a month.

Conclusion:

Fulminant CRS can be induced by ICI combination therapy. As the initial symptoms of CRS resemble sepsis, it is important to consider CRS as a differential diagnosis and to initiate immunosuppressive therapy early when needed. In steroid-resistant cases, early introduction of other immunosuppressive therapy and plasma exchange can be effective.
Verruca plana on a tattoo
Authors: Chen Yan Jing , Nabi Owais , Diao Ping , Wan Ruo Yu , LI Li
Published: April 2020

Rationale:

Tattooing is a procedure where ink is inserted typically in the intraepidermal space of the skin. Multiple incidences of viral infections following tattooing which lead to warts have been reported in recent years. The aim of this report was to show a relatively rare adverse effect after tattooing – verruca plana.

Patient concerns:

A 27-year-old female presented to our department with complains of multiple verrucous papules over her 2-year-old tattoo without itch.

Diagnoses:

Pathological investigation confirmed the diagnosis as verruca plana.

Interventions:

The patient was treated with 3 cycles of liquid nitrogen cryotherapy and 5% imiquimod cream for 5 months.

Outcomes:

A significant improvement in her lesions was observed after the combined treatment.

Lessons:

Clinically, verruca plana post-tattooing is relatively less reported. We need to combine clinical manifestations with pathological results to arrive at a definitive diagnosis. Besides, there are a large numbers of post-tattoo complications and various routes of virus inoculation. Therefore, it is important for medical professionals to caution people before considering to have a tattoo.
A CARE-compliant article: a case report of possible association between recurrence of multiple evanescent white dot syndrome and the Herpesviridae family
Authors: Haw Yu-Lin , Yu Teng-Chieh , Yang Chang-Sue
Published: April 2020

Rationale:

Multiple evanescent white dot syndrome (MEWDS) is a self-limited multifocal chorioretinopathy that typically affects otherwise healthy young females in the second to fourth decades of life. Current understanding of the pathophysiology of MEWDS is still limited. One of the possible underlying causes is an infectious etiology.

Patient concerns:

A 24-year-old female with recurrent episodes of typical MEWDS ocular manifestation was observed over 2 years. Viral-specific antibody serologic tests showed evidence of exposure to the Herpesviridae family during the acute stage of MEWDS in the first and recurrent episodes.

Diagnoses:

MEWDS was diagnosed by the clinical findings and ancillary testing results of fundus photography, optical coherence tomography, fluorescein angiography, indocyanine green angiography and electroretinogram. The laboratory serology data was positive for varicella-zoster virus (VZV) immunoglobulin M (IgM) in the first episode and exhibited high Epstein–Barr virus (EBV) elevated immunoglobulin G (IgG) titer in the recurrent episode.

Interventions:

Due to the self-limited nature of MEWDS, we observed the clinical course without intervention.

Outcomes:

During acute onset of MEWDS, serologic data for VZV IgM antibody was positive in the first episode. Two years later, the patient had recurrent episodes of MEWDS in the contralateral eye. Serologic study showed highly elevated IgG titer (1:160) of Epstein-Barr virus capsid antigen (EB-VCA) in the acute stage. The follow-up paired serum virus serology test showed that the prior EB-VCA IgG titer decreased fourfold to 1:40 in the recovery stage.

Lessons:

Recurrence of MEWDS may be associated with acute systemic infection of the Herpesviridae family or virus-induced autoimmune inflammatory reaction.
Transesophageal and intracardiac ultrasound in arrhythmogenic right ventricular dysplasia/cardiomyopathy
Authors: Cismaru Gabriel , Grosu Alin , Istratoaie Sabina , Mada Laura , Ilea Maria , Gusetu Gabriel , Zdrenghea Dumitru , Pop Dana , Rosu Radu
Published: April 2020

Rationale:

Two-dimensional echocardiography (2D echo) is a major tool for the diagnosis of Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C). However 2D echo can skip regional localized anomalies of the right ventricular wall. We aimed to determine whether transesophageal and intracardiac ultrasound can provide additional information, on the right ventricular abnormalities compared to 2D echo.

Patient concerns:

Case 1 is a 30-year-old patient that presented in the Emergency Department with multiple episodes of fast monomorphic ventricular tachycardia (VT) manifested by palpitations and diziness. Case 2 is a 65-year-old patient that also presented with episodes of ventircular tachycardia associated with low blood pressure.

Diagnosis:

Both patients had a clear diagnosis of arrhythmogenic right ventricular dysplasia/cardiomyopathy confirmed by cardiac magnetic resonance imaging.

Intervention:

In both patients transesophageal and intracardiac ultrasound was performed, which brought more information on the diagnosis of ARVD/C compared to transthoracic echocardiograpy.

Outcomes:

The first patient was implanted with an internal cardiac defibrillator and treated with Sotalol for VT recurrences. He presented episodes of VT during follow-up, treated with antitachycardia pacing. The second patient was implanted with an internal cardiac defibrillator and treated with Sotalol without any VT recurrence at 18 month-follow-up.

Lessons:

Transesophageal echocardiography and intracardiac echocardiography can provide additional information on small, focal structural abnormalities in patients with ARVD/C: bulges, saculations, aneurysms with or without associated thrombus, partial or complete loss of trabeculations and hypertrophy of the moderator band. These changes are particularly important in cases with “concealed” form of the disease in which no morphological abnormalities are evident in transthoracic echocardiograpy.
Impact of emergency department management of atrial fibrillation with amiodarone on length of stay. A propensity score analysis based on the URGFAICS registry
Authors: Cabello Irene , Jacob Javier , Arranz María , Yuguero Oriol , Guzman Jorge , Moreno-Pena Anna , Frances Paloma , Santos Julia , Esquerrà Anna , Mòdol Josep-María
Published: April 2020

Objective

Amiodarone is a widely used drug in the emergency department (ED) for control of atrial fibrillation, but it has a delayed onset of action and slow metabolism, leading to longer length of ED stay. The aim of this study was to compare the length of ED stay of atrial fibrillation patients who were treated with or without amiodarone.

Methods

We undertook a multicenter, observational, cohort study of the URGFAICS registry of older adults with atrial fibrillation who presented to five Spanish EDs and compared patients who had received amiodarone with those who had not. Afterward, we performed a propensity score matched analysis of atrial fibrillation to determine the ED length of stay related to amiodarone.

Results

Of the 1199 patients included in the registry, 225 patients (18.8%) were treated with amiodarone while 974 (81.2%) were not. We performed a univariate study depending on amiodarone administration followed by propensity score calculation according to the 14 statistically different features found previously and six significant variables, obtaining 150 patients (75 for each group) suitable for the analysis. The length of ED stay was analyzed using box plot, with a P <0.001 in the crude analysis and P = 0.012 after propensity score matching and using survival curves for the analysis of prolonged ED stay, with a log rank <0.001 in the crude analysis and log rank 0.021 after the propensity score-matched analysis.

Conclusion

Amiodarone is associated with longer length of ED stay until discharge independently of the baseline characteristics of the patients.
Risk Factors for Pancreatic Cancer and the Necessity of Long-Term Surveillance in Patients With Pancreatic Cystic Lesions
Authors: Yoshioka Teppei , Shigekawa Minoru , Ikezawa Kenji , Tamura Takeshi , Sato Katsuhiko , Urabe Makiko , Sueyoshi Hironari , Yamai Takuo , Suda Takahiro , Sakamori Ryotaro , Tatsumi Tomohide , Takehara Tetsuo
Published: April 2020

Objectives

Pancreatic cystic lesions (PCLs) are a risk factor for pancreatic cancer (PC). Which PCLs should be surveilled and necessity of long-term observation are still controversial.

Methods

From January 2000 to March 2016, we enrolled 1137 patients with PCLs observed for 1 year. We defined PCLs with cyst size of greater than 30 mm, main pancreatic duct (MPD) of greater than 5 mm or mural nodule as high-risk group, and others as low-risk group (LRG). Kaplan-Meier method and Cox proportional hazard model were applied to assess incidence and risk factors of PC.

Results

In 107 high-risk group and 1030 LRG patients, mean observation period was 4.3 years and 5.0 years, respectively, and 5-year PC incidence was 12.0% and 2.8%, respectively. In LRG, MPD of greater than 3 mm, diabetes mellitus, and presumed branch-duct intraductal papillary mucinous neoplasia (BD-IPMN), defined as PCLs fulfilling any of multilocular formation, multiplicity, or MPD communication, were independent risk factors for PC. In 450 LRG observed for 5 years, 10-year PC incidence was higher in PCLs with our identified risk factors. There was no PC occurrence in PCLs not presumed BD-IPMN after 5-year observation.

Conclusions

Continuous surveillance is needed after 5-year observation, especially in LRG with our identified risk factors. For discontinuing surveillance, PCLs not presumed BD-IPMN at fifth year could be candidates.
Acute Pancreatitis in Patients With a Medical History of Type 2 Diabetes Mellitus
Authors: Xiao Bo , Xu Hai-bo , Jiang Zhi-qiong , Hu Jin-xiang , Yang Guo-dong
Published: April 2020

Objective

To determine the characteristics of type 2 diabetes mellitus (T2DM)–related acute pancreatitis (AP) on magnetic resonance imaging (MRI).

Methods

Retrospectively studied 262 patients with AP were admitted to our institution and underwent MRI. Diagnosis of T2DM-related AP was based on clinical manifestations, laboratory tests, and MRI. Pancreatic/peripancreatic changes were assessed on MRI.

Results

Fifty-three (20.2%) patients with T2DM-related AP and 209 (79.8%) with nondiabetic AP were enrolled. On MRI, a higher prevalence of necrotizing pancreatitis (P < 0.001), pancreatic necrosis >30% (57.5% vs 29.2%; P = 0.006), hemorrhage (35.8% vs 19.1%; P = 0.009), abdominal wall edema (67.9% vs 46.8%; P = 0.006), walled-off necrosis (43.2% vs 14.6%; P < 0.001), and infected collections (P < 0.001) were registered in T2DM with AP. T2DM-related AP sustained greater magnetic resonance severity index (mean, 5.1 [range, 2–10] vs 3.4 [range, 1–10]; P < 0.001), higher incidence of moderate and severe pancreatitis (69.8% vs 40.2%; P < 0.001), higher organ failure (45.3% vs 22%; P = 0.001), and prolonged hospitalization (mean, 25.2 [range, 10–63] vs 16 [range, 5–48] days; P < 0.001).

Conclusions

Type 2 diabetes mellitus–related AP is more moderate-to-severe pancreatitis, and it correlates with MRI characteristics of the pancreas itself, hemorrhage, abdominal wall, and infected collections.
Effects of trunk stabilization training robot on postural control and gait in patients with chronic stroke: a randomized controlled trial
Authors: Min Ji Hong , Seong Hyun Yong , Ko Sung Hwa , Jo Woo-Ri , Sohn Hyun-Ju , Ahn Young Hyun , Son Ju Hyun , Seo Ho-Yeon , Son Yeong-Ran , Mun Seong-Jun , Ko Myoung-Hwan , Shin Yong-Il
Published: April 2020

Our study aimed to confirm the therapeutic effects of using a trunk stabilization training robot (3DBT-33) in patients with chronic stroke. A total of 38 patients with chronic stroke were randomly assigned to either an experimental or a control group. The robot group (n = 19) received 30 min of trunk stability robot training in addition to conventional physical therapy, while the control group (n = 19) received a similar conventional physical therapy as the robot group. All participants were assessed using the following: the Functional Ambulation Categories (FAC), timed up and go (TUG) test, Berg Balance Scale (BBS), Korean Modified Barthel Index (K-MBI), and Fugl-Meyer Assessment of Lower Extremity (FMA-LE). There were statistically significant improvements in all parameters at follow-up assessment after 4 weeks of intervention (P < 0.05). There were statistically significant differences in the FMA-LE, K-MBI, and BBS between the robot and control groups (P < 0.05). There was no significant difference in FAC (P = 0.935) and TUG (P = 0.442). Minimal detectable change was more significantly observed in the FMA-LE and BBS than in FAC, TUG, and K-MBI. The findings in the present study showed that trunk stabilization rehabilitation training using a rehabilitation robot in patients with chronic stroke was effective in improving the balance and functions in the lower extremities.
Creation of a “Patient” Hospital Escape Room Experience to Reduce Harm and Improve Quality of Care
Authors: San Martin Layla , Walsh Heather , Santerre Mary , Fortkiewicz Justine , Nicholson Laura
Published: April 2020

Background:

Increases in nursing documentation requirements, adherence to regulatory standards, and workforce diversity add to the complexity of delivering safe patient care.

Purpose:

The aim was to reinforce elements of quality and safety in patient care delivery.

Approach:

In an effort to deliver necessary, though often dull, regulatory information to nursing staff, a team of nurse educators and nursing quality leaders used the concepts of a popular social game to develop an escape room.

Outcomes:

The escape room was conducted with nearly 100 learners with both a regulatory focus and a patient safety focus with success. Participants stated that teamwork, communication, and problem-solving were necessary to escape the room; nearly 60% indicated the escape room experience would contribute to changes in their nursing practice.

Conclusions:

The escape room template can be easily modified to target a myriad of learning objectives and learners of varying levels of experience.
From Palliative Care Developed During Simulation, to Performance in Clinical Practice—Descriptions From Nursing Students
Authors: Valen Kristin , Haug Bente , Holm Anne Lise , Jensen Kari Toverud , Grov Ellen Karine
Published: April 2020

It is an international consensus that health care workers should be well trained to promote care for seriously ill and dying patients. Nursing students have reported that they feel inadequately prepared for palliative care. Simulation exercises have been described as increasing knowledge, skills, and competence, and participants have reported that they are more confident and prepared for palliative care with this learning approach than without. So far, there has not been much reported on how simulation contributes to learning in clinical practice. Therefore, this study explored whether learning outcomes from palliative care simulation further developed in practice. Second-year bachelor's-prepared nursing students voluntarily participated in a simulation activity as part of their hospital practice. Eleven students were interviewed about their learning experiences. The findings indicate that a prerequisite for further learning was to actively choose palliative care. Relationships with nurses, patients, and relatives and factors in themselves served as gatekeepers for attending learning situations. Becoming a nurse who can provide palliative care was described as an emotionally challenging experience. Elements that promoted learning outcomes in palliative care were simulation experience, clarified expectations, support, and a good dialog with the nurse before and after the learning situation.
Allied Health Care Providers Participating in Medical Assistance in Dying
Authors: Mills Anneliese , Wortzman Rachel , Bean Sally , Selby Debbie
Published: April 2020

This study explored the experience of pharmacists, social workers, and nurses who participated in Medical Assistance in Dying (MAiD) in a tertiary care Canadian hospital. Consenting staff participated in qualitative semistructured interviews, which were then analyzed for thematic content. This article reports on the broad theme of “support” from the perspective of the 3 professions, focusing on the diversity in perceptions of support, how MAiD was discussed within health care teams, feelings of gratuitous or excessive gestures of support, ambivalence over debriefs, and the importance of informal support. While pharmacists and social workers generally felt part of a community that supported MAiD, nurses more often expressed opinions as highly divergent. The key finding across all themes was the central importance of the culture on any unit with respect to MAiD and specifically the role of the unit manager in creating either a positive open space for communication or a more silent or closed space. Nursing noted that in the latter setting many gestures of support were experienced as insincere and counterproductive, as were debriefs. We outline several recommendations for managers based on the study results with the intent of tailoring support for all professionals involved in MAiD.
The COMFORT Communication Model
Authors: Goldsmith Joy V. , Wittenberg Elaine , Parnell Terri Ann
Published: April 2020

The COMFORT Model has recently been revised based on feedback from bedside nurses working in palliative care and oncology and includes the following components: Connect, Options, Making Meaning, Family Caregiver, Openings, Relating, and Team. Based on clinical and nonclinical research in hospital, hospice, palliative care, and interdisciplinary education settings, the authors present the updated COMFORT Model. Originally introduced in 2012 to support the work of the nurse, the model is not a linear guide, an algorithm, a protocol, or a rubric for sequential implementation by nurses, but rather a set of communication principles that are practiced concurrently and reflectively during patient/family care. In its restructuring, we focus on the role of health literacy throughout the COMFORT components in relationship to the health literacy attributes of a health care organization. A brief summary of COMFORT components is provided and includes strategies and competencies contributing to a health-literate care organization. Both health literacy and COMFORT are explored using specific communication challenges that underscore the role of the nurse in accomplishing person-centered and culturally responsive care, especially in chronic and terminal illness. The integration of the COMFORT Model into nursing education is proposed.