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A Risk Assessment Model for Stroke in the Early Post-Transplant Period in Adult Cardiac Allograft Recipients: A UNOS Database Analysis

Transplant Proc. 2021 Nov 13:S0041-1345(21)00715-6. doi: 10.1016/j.transproceed.2021.09.025. Online ahead of print.

ABSTRACT

BACKGROUND: Stroke risk in adult cardiac allograft recipients in the early postoperative period remains less defined. This study attempts to develop a risk assessment model in this population.

METHODS: Patients (≥18 years of age) between 2005 and 2015 who underwent cardiac transplantation were selected from the United Network for Organ Sharing database. The final study cohort had 20,915 patients. Risk factors were identified and multivariate logistic regression was used to test associations. SAS software was used for analyses.

RESULTS: Male recipients had a lower risk (odds ratio [OR] 0.7 [0.6-0.92]; P < .05) for stroke. Prolonged ischemic time (OR 1.2 [1.1-1.3), mechanical ventilation (OR 1.6 [1.2-1.9]), left ventricular assist device support (OR 1.8 [1.4-2.3]), black or Hispanic ethnicity (OR 1.33 [1.04-1.7]), days in status 1A (OR 1.05 [1.01-1.1]), recipient creatinine (OR 1.2 [1.02-1.4]), and type 2 diabetes (OR 1.4 [1.1-1.7]) were significant risk factors. A risk score was generated. Patients with a score of 8 had a 5-fold increase in event rate as compared with those with a score of 0. The c-statistic for this model was 0.65.

CONCLUSIONS: For the first time, a weighted risk score GIMVECH (female gender, ischemic time, mechanical ventilation, left ventricular assist device support, ethnicity, clinical history) was generated to assess stroke in the early post-transplant period.

PMID:34782170 | DOI:10.1016/j.transproceed.2021.09.025

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Ion release and biocompatibility of Co-Cr alloy fabricated by selective laser melting from recycled Co-Cr powder: An in vitro study

J Prosthet Dent. 2021 Nov 12:S0022-3913(21)00491-1. doi: 10.1016/j.prosdent.2021.09.003. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: As the cobalt-chromium (Co-Cr) powder used in selective laser melting (SLM) is costly, reusing the remaining powder after multiple cycles provides an economic and environmental benefit. However, knowledge of the cytotoxic effect of the alloy fabricated from recycled powder is lacking.

PURPOSE: The purpose of this in vitro study was to evaluate the biological effects of the Co-Cr ions released from the alloy fabricated from the recycled powder on the human gingival fibroblasts (HGFs) and normal oral keratinocytes (NOKs).

MATERIAL AND METHODS: Disk-shaped Co-Cr specimens were fabricated by using the SLM technique from powders with different proportions of recycled to unused and from different recycling times. Co and Cr ions released from the disks immersed in the Dulbecco Modified Eagle Medium (DMEM) for 24 hours or 7 days were measured by inductively coupled plasma mass spectrometry (ICP-MS). Biocompatibility of Co-Cr alloy was detected by incubation of HGFs and NOKs in DMEM containing Co and Cr ions for 24 hours. The ANOVA test was used to evaluate statistically significant differences among different groups (α=.05).

RESULTS: Compared with the alloy fabricated from 100% unused powder, the concentrations of Co and Cr ions increased with the increase of recycled to unused powder ratio or with the increase in the recycling times. HGFs and NOKs showed an increase in apoptosis, intracellular oxidative stress (ROS), hypoxia-inducing factor1α (HIF-1α), and proinflammatory cytokines (tumor necrosis factor alpha [TNF- α], interleukin 6 [IL-6], interleukin 8 [IL-8], and vascular endothelial growth factor [VEGF]) with the increase of Co-Cr ions in a concentration-dependent manner. A significant reduction in cell proliferation was found with the increase in the concentrations of Co and Cr ions (P<.05).

CONCLUSIONS: The results of this study indicated that Co-Cr alloy fabricated from partially recycled powder or powder with different recycling times released significantly more Co and Cr ions and showed higher cytotoxicity to HGFs and NOKs than the alloy fabricated from unused powder.

PMID:34782150 | DOI:10.1016/j.prosdent.2021.09.003

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A nationwide analysis of gallbladder surgery in England between 2000 and 2019

Surgery. 2021 Nov 12:S0039-6060(21)00985-5. doi: 10.1016/j.surg.2021.10.025. Online ahead of print.

ABSTRACT

BACKGROUND: There are no reports on nationwide trends in subtotal cholecystectomy (STC) and cholecystostomy in England. We hypothesized that, as in the United States, a substantial increase in the utilization of these surgical procedures, over time, may be observed. We aimed to generate a reliable report on 4 of the most common gallbladder surgical procedures in England to allow cross-procedure comparisons and highlight significant changes in the management of benign gallbladder disease over time.

METHODS: We obtained data from NHS Digital and extracted population estimates from the Office of National Statistics. We examined the trends in the use of STC, cholecystostomy, cholecystolithotomy and total cholecystectomy (TC) between 2000 and 2019.

RESULTS: Of the 1,234,319 gallbladder surgeries performed, TC accounted for 96.8% (n = 1,194,786) and the other 3 surgeries for 3.2% (n = 39,533). The total number of gallbladder surgeries performed annually increased by 80.4% from 2000 to 2019. We detected increases in the counts of cholecystostomies by 723.1% (n = 290 in 2000 vs n = 2,387 in 2019) and STCs by 716.6% (n = 217 in 2000 vs n = 1,772 in 2019). Consequently, there was a decrease in the ratio of TC to STC (180:1 in 2000 vs 38:1 in 2019). A similar decrease was observed in the ratio of cholecystectomy to cholecystostomy (135:1 in 2000 vs 29:1 in 2019).

CONCLUSION: Increased utilization of STC and cholecystostomy was detected in England. These findings highlight the importance of regular monitoring of nationwide trends in gallbladder surgery and the associated clinical outcomes.

PMID:34782153 | DOI:10.1016/j.surg.2021.10.025

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An Electronic Health Record-Compatible Model to Predict Personalized Treatment Effects From the Diabetes Prevention Program: A Cross-Evidence Synthesis Approach Using Clinical Trial and Real-World Data

Mayo Clin Proc. 2021 Nov 12:S0025-6196(21)00708-4. doi: 10.1016/j.mayocp.2021.09.012. Online ahead of print.

ABSTRACT

OBJECTIVE: To develop an electronic health record (EHR)-based risk tool that provides point-of-care estimates of diabetes risk to support targeting interventions to patients most likely to benefit.

PATIENTS AND METHODS: A risk prediction model was developed and validated in a large observational database of patients with an index visit date between January 1, 2012, and December 31, 2016, with treatment effect estimates from risk-based reanalysis of clinical trial data. The risk model development cohort included 1.1 million patients with prediabetes from the OptumLabs Data Warehouse (OLDW); the validation cohort included a distinct sample of 1.1 million patients in OLDW. The randomly assigned clinical trial cohort included 3081 people from the Diabetes Prevention Program (DPP) study.

RESULTS: Eleven variables reliably obtainable from the EHR were used to predict diabetes risk. This model validated well in the OLDW (C statistic = 0.76; observed 3-year diabetes rate was 1.8% (95% confidence interval [CI], 1.7 to 1.9) in the lowest-risk quarter and 19.6% (19.4 to 19.8) in the highest-risk quarter). In the DPP, the hazard ratio (HR) for lifestyle modification was constant across all levels of risk (HR, 0.43; 95% CI, 0.35 to 0.53), whereas the HR for metformin was highly risk dependent (HR, 1.1; 95% CI, 0.61 to 2.0 in the lowest-risk quarter vs HR, 0.45; 95% CI, 0.35 to 0.59 in the highest-risk quarter). Fifty-three percent of the benefits of population-wide dissemination of the DPP lifestyle modification and 73% of the benefits of population-wide metformin therapy can be obtained by targeting the highest-risk quarter of patients.

CONCLUSION: The Tufts-Predictive Analytics and Comparative Effectiveness DPP Risk model is an EHR-compatible tool that might support targeted diabetes prevention to more efficiently realize the benefits of the DPP interventions.

PMID:34782125 | DOI:10.1016/j.mayocp.2021.09.012

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Variation in treatment of hip fractures and guideline adherence amongst surgeons with different training backgrounds in the Netherlands

Injury. 2021 Nov 8:S0020-1383(21)00914-1. doi: 10.1016/j.injury.2021.11.006. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Two medical specialties, general surgery and orthopaedic surgery, with different training programs but matching trauma certification requirements, provide hip fracture surgery in the Netherlands. This study analyses treatment preferences and guideline adherence of Dutch surgeons with different surgical backgrounds.

PATIENTS AND METHODS: All hip fracture patients registered in the Dutch Hip Fracture Audit in 2018 and 2019 were included in this retrospective study. Four types of surgeons were distinguished: trauma-certified general surgeons (ST+), non-trauma certified general surgeons (ST-), trauma-certified orthopaedic surgeons (OT+) and non-trauma certified orthopaedic surgeons (OT-). Differences in patient characteristics, and practice variation in treatment choices and guideline adherence per fracture type were analysed using descriptive statistics.

RESULTS: 28,656 patients were included; 16,367 (57.1%) treated by ST+, 1,371 (4.8%) by ST-, 4,692 (16.4%) by OT+ and 6,226 (21.7%) by OT-. Few clinically relevant differences in patient characteristics and hospital processes were found between all surgeon groups. Displaced FNF were the most commonly treated fracture type for all types of surgeons. Both OT+ and OT- operated mostly (displaced) FNFs, while the fracture types treated by ST+ and ST- were more heterogeneous. For all fracture types, the orthopaedic surgeons performed THA and HA more often than general surgeons, while general surgeons more often placed SHS and IMN for specific fracture types. Guideline adherence was on average 68.4% and differed significantly per surgeon type (68.7% by ST+, 65.2% by ST-, 74.4% by OT+ and 63.6% by OT- (p<0.01)), as well as per fracture type: >90% treatment according to the guideline for trochanteric AO-31A2 and A3 fractures, 18.8% for AO-31A1 fractures and 51.7% guideline adherence for undisplaced FNF. Guideline adherence for displaced FNF varied depending on patient characteristics.

DISCUSSION: In the Netherlands, different surgical specialists treat different types of hip fractures and have different preferences concerning implants for hip fracture surgery in comparable patients. Guideline adherence of trauma- and non-trauma certified orthopaedics and general surgeons differs significantly. Reduction of practice variation should be strived for in order to improve hip fracture care.

PMID:34782116 | DOI:10.1016/j.injury.2021.11.006

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Comparison of the value of ultrasound and enhanced magnetic resonance imaging in judging cervical lymph node metastasis in patients with oral cancer

Bull Cancer. 2021 Nov 12:S0007-4551(21)00423-9. doi: 10.1016/j.bulcan.2021.09.010. Online ahead of print.

ABSTRACT

BACKGROUND: Oral cancer is the twelfth largest malignant tumor in the world. Oral cancer is prone to lymph node metastasis in the early stages of the disease, and lymph node metastasis will directly affect the treatment and survival rate. Therefore, whether the lymph node metastasis can be accurately evaluated is of great significance to the treatment and prognosis of patients.

OBJECTIVE: The diagnostic efficacy of three methods of preoperative ultrasound, enhanced magnetic resonance (enhanced MR), and ultrasound combined with enhanced MR on cervical lymph node metastasis of oral cancer were compared.

MATERIALS AND METHODS: A retrospective analysis of 399 cases of oral cancer completed by head and neck surgery at Cancer Center of Sun Yat-sen University, China. In all cases, the maxillofacial and neck enhanced MR and cervical lymph node ultrasound examinations were performed before surgery, and imaging diagnosis was made for cervical lymph node metastasis and compared with pathology. All judgment results were statistically processed using the chi-square test.

RESULTS: Compared with the above three methods, the diagnostic efficiency of ultrasound alone is better, and the diagnostic efficiency of enhanced MR combined ultrasound is not significantly better than that of ultrasound alone. There are differences in the diagnostic efficacy of the three inspection methods in different clinical sub-periods, all of which are better for the diagnosis of stage I. For patients with stage I, II, and III, there were no differences between the three examination methods. However, for stage IV patients,the diagnostic efficiency of ultrasound alone is better. For patients with stage N0, there was no difference in diagnostic efficacy between the three methods. For the assessment of lymph nodes in the I-III region, there are differences between the three methods of examination: the diagnostic efficiency of ultrasound alone is better, and enhanced MR combined ultrasound is not significantly better than ultrasound alone. For the evaluation of lymph nodes in the IV-VII region, there was no difference in diagnostic efficacy between the three methods.

CONCLUSION: According to the clinical characteristics and prognosis of patients with oral cancer, although enhanced MR can better evaluate the tumor, ultrasound may be considered as the preferred imaging method for cervical lymph node metastasis.

SIGNIFICANCE: Accurate assessment and proper and timely treatment of lymph node metastasis can help improve the survival rate of patients.

PMID:34782121 | DOI:10.1016/j.bulcan.2021.09.010

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Evaluating the effects of a Therapeutic Day Rehabilitation program and inclusion of gardening in an Australian Rural Community Health Service

Aust J Prim Health. 2021 Nov 16. doi: 10.1071/PY20294. Online ahead of print.

ABSTRACT

Therapeutic day rehabilitation (TDR) is a non-residential intensive structured program designed for individuals recovering from substance misuse. A weekly afternoon of therapeutic gardening was a new incentive initiated in a TDR program at one Australian community health service, designed to give participants the opportunity to spend time outdoors connecting with nature and each other. The aim of this study was to explore perceptions of participants enrolled in this program by employing a convergent parallel mixed-method design using qualitative individual, semi-structured interviews (n = 14) and longitudinal quantitative quality of life (QOL) data at three different intervals (n = 17). The analysis of the quantitative data showed that there was a statistically significant increase in the participants’ QOL scores in three of four domains (physical health, psychological, social relationships) when comparing baseline and post completion of the TDR. These observed changes were maintained at the 4-week follow up. The key findings from the semi-structured interviews include positive effects for participants on social connectivity, structure and achievement, understanding of recovery and relaxation from contact with nature. This study shows that a combination of TDR and therapeutic gardening can improve participants’ physical health, psychological health and social relationships.

PMID:34782059 | DOI:10.1071/PY20294

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Deep-learning image-reconstruction algorithm for dual-energy CT angiography with reduced iodine dose: preliminary results

Clin Radiol. 2021 Nov 12:S0009-9260(21)00511-0. doi: 10.1016/j.crad.2021.10.014. Online ahead of print.

ABSTRACT

AIM: To evaluate the computed tomography (CT) attenuation values, background noise, arterial depiction, and image quality in whole-body dual-energy CT angiography (DECTA) at 40 keV with a reduced iodine dose using deep-learning image reconstruction (DLIR) and compare them with hybrid iterative reconstruction (IR).

MATERIAL AND METHODS: Whole-body DECTA with a reduced iodine dose (200 mg iodine/kg) was performed in 22 patients, and DECTA data at 1.25-mm section thickness with 50% overlap were reconstructed at 40 keV using 40% adaptive statistical iterative reconstruction with Veo (hybrid-IR group), and DLIR at medium and high levels (DLIR-M and DLIR-H groups). The CT attenuation values of the thoracic and abdominal aortas and iliac artery and background noise were measured. Arterial depiction and image quality on axial, multiplanar reformatted (MPR), and volume-rendered (VR) images were assessed by two readers. Quantitative and qualitative parameters were compared between the hybrid-IR, DLIR-M, and DLIR-H groups.

RESULTS: The vascular CT attenuation values were almost comparable between the three groups (p=0.013-0.97), but the background noise was significantly lower in the DLIR-H group than in the hybrid-IR and DLIR-M groups (p<0.001). The arterial depictions on axial and MPR images and in almost all arteries on VR images were comparable (p=0.14-1). The image quality of axial, MPR, and VR images was significantly better in the DLIR-H group (p<0.001-0.015).

CONCLUSION: DLIR significantly reduced background noise and improved image quality in DECTA at 40 keV compared with hybrid-IR, while maintaining the arterial depiction in almost all arteries.

PMID:34782114 | DOI:10.1016/j.crad.2021.10.014

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Ondansetron and metoclopramide as second-line antiemetics in women with nausea and vomiting in pregnancy: the EMPOWER pilot factorial RCT

Health Technol Assess. 2021 Nov;25(63):1-116. doi: 10.3310/hta25630.

ABSTRACT

BACKGROUND: Around one-third of pregnant women suffer from moderate to severe nausea and vomiting, causing physical and emotional distress and reducing their quality of life. There is no cure for nausea and vomiting in pregnancy. Management focuses on relieving symptoms and preventing morbidity, and often requires antiemetic therapy. National guidelines make recommendations about first-, second- and third-line antiemetic therapies, although care varies in different hospitals and women report feeling unsupported, dissatisfied and depressed.

OBJECTIVES: To determine whether or not, in addition to intravenous rehydration, ondansetron compared with no ondansetron and metoclopramide compared with no metoclopramide reduced the rate of treatment failure up to 10 days after drug initiation; improved symptom severity at 2, 5 and 10 days after drug initiation; improved quality of life at 10 days after drug initiation; and had an acceptable side effect and safety profile. To estimate the incremental cost per treatment failure avoided and the net monetary benefits from the perspectives of the NHS and women.

DESIGN: This was a multicentre, double-dummy, randomised, double-blinded, dummy-controlled 2 × 2 factorial trial (with an internal pilot phase), with qualitative and health economic evaluations.

PARTICIPANTS: Thirty-three patients (who were < 17 weeks pregnant and who attended hospital with nausea and vomiting after little or no improvement with first-line antiemetic medication) who attended 12 secondary care NHS trusts in England, 22 health-care professionals and 21 women participated in the qualitative evaluation.

INTERVENTIONS: Participants were randomly allocated to one of four treatment groups (1 : 1 : 1: 1 ratio): (1) metoclopramide and dummy ondansetron; (2) ondansetron and dummy metoclopramide; (3) metoclopramide and ondansetron; or (4) double dummy. Trial medication was initially given intravenously and then continued orally once women were able to tolerate oral fluids for a maximum of 10 days of treatment.

MAIN OUTCOME MEASURES: The primary end point was the number of participants who experienced treatment failure, which was defined as the need for further treatment because symptoms had worsened between 12 hours and 10 days post treatment. The main economic outcomes were incremental cost per additional successful treatment and incremental net benefit.

RESULTS: Of the 592 patients screened, 122 were considered eligible and 33 were recruited into the internal pilot (metoclopramide and dummy ondansetron, n = 8; ondansetron and dummy metoclopramide, n = 8; metoclopramide and ondansetron, n = 8; double dummy, n = 9). Owing to slow recruitment, the trial did not progress beyond the pilot. Fifteen out of 30 evaluable participants experienced treatment failure. No statistical analyses were performed. The main reason for ineligibility was prior treatment with trial drugs, reflecting an unpredicted change in prescribing practice at several points along the care pathway. The qualitative evaluation identified the requirements of the study protocol, in relation to guidelines on anti-sickness drugs, and the diversity of pathways to care as key hurdles to recruitment while the role of research staff was a key enabler. No important adverse events or side effects were reported.

LIMITATIONS: The pilot trial failed to achieve the recruitment target owing to unforeseen changes in the provision of care.

CONCLUSIONS: The trial was unable to provide evidence to support clinician decisions about the best choice of second-line antiemetic for nausea and vomiting in pregnancy.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN16924692 and EudraCT 2017-001651-31.

FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 63. See the NIHR Journals Library website for further project information.

PMID:34782054 | DOI:10.3310/hta25630

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STI testing among young people attending music festivals in New South Wales, Australia: exploring the client segmentation concept in the ‘Down to Test’ program

Sex Health. 2021 Nov 16. doi: 10.1071/SH21101. Online ahead of print.

ABSTRACT

BACKGROUND: The ‘Down to Test (DTT)’ campaign is a sexually transmissible infection (STI) social marketing intervention delivered through outdoor music festival activations and supported by digital media communications in New South Wales, Australia. This paper investigates whether and how the tailored messages reached the intended audience.

METHODS: Data was collected through three annual rounds of online surveys post campaign exposure, targeting young people (aged 15-29years) attending 14 music festivals in NSW from October 2017 to March 2020. Descriptive statistics, principal component analysis and multivariable logic regression were applied to identify the key client segment and factors associated with a strong intention for future STI screening.

RESULTS: Of the 10044 participants with a valid urine specimen submitted, 261 (2.8%) tested positive for chlamydia. Altogether, 1776 participants (median age=22) self-completed the evaluation surveys online with more being female (73.4%) than male (26.2%). Participants were mostly Australian-born (89.5%), heterosexual (82.6%) and the majority being sexually active (96.7%). Rates of self-reported lifetime STI testing (70.4%) and intention for future STI screening (‘definitely yes’ in the next 12months, 39.0%) were also high. The most significant factor associated with future intention for STI testing is the Sexual Experience and Perception Factor (adjusted odds ratio [AOR]=2.02; 95%CI 1.76-2.32; P<0.001), followed by the Sexual Beliefs and Attitudes Factor (AOR=1.14; 95% CI 1.01-1.30; P<0.05).

CONCLUSIONS: The NSW state-wide DTT campaign has largely reached sexually active youth who are attentive to sexual health promotion messages and contributed to enhanced STI screening in a fun and peer-supportive environment.

PMID:34782058 | DOI:10.1071/SH21101