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  • 1
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 144, No. 23 ( 2021-12-07), p. 1845-1855
    Abstract: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery. Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting. Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63–0.92] ; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56–0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50–0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%–10.2%) in first events, with a number needed to treat of 16 (95% CI, 10–44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups. Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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  • 2
    In: Neurology, Ovid Technologies (Wolters Kluwer Health), Vol. 97, No. 18 ( 2021-11-02), p. 864-873
    Type of Medium: Online Resource
    ISSN: 0028-3878 , 1526-632X
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 3
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Neurosurgery Vol. 84, No. 4 ( 2019-04), p. E251-E256
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 84, No. 4 ( 2019-04), p. E251-E256
    Type of Medium: Online Resource
    ISSN: 0148-396X , 1524-4040
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 1491894-8
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  • 4
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 1995
    In:  The American Journal of Surgical Pathology Vol. 19, No. 5 ( 1995-05), p. 563-570
    In: The American Journal of Surgical Pathology, Ovid Technologies (Wolters Kluwer Health), Vol. 19, No. 5 ( 1995-05), p. 563-570
    Type of Medium: Online Resource
    ISSN: 0147-5185
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 1995
    detail.hit.zdb_id: 2029143-7
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  • 5
    In: Journal of Trauma and Acute Care Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 85, No. 5 ( 2018-11), p. 867-872
    Abstract: Standard low-molecular-weight heparin dosing may be suboptimal for venous thromboembolism prophylaxis. We aimed to identify independent predictors of subprophylactic Xa (subXa) levels in trauma patients treated under a novel early chemoprophylaxis algorithm. METHODS A retrospective analysis of trauma patients from July 2016 to June 2017 who received enoxaparin 40 mg twice daily and had peak Xa levels drawn was performed. Patients were divided into cohorts based on having a subXa ( 〈 0.2 IU/mL) or prophylactic (≥0.2 IU/mL) Xa level. RESULTS In all, 124 patients were included, of which 38 (31%) had subXa levels, and 17 (14%) had Xa levels greater than 0.4 IU/mL. Of the subXa cohort, 35 (92%) had their dosage increased, and the repeat Xa testing that was done in 32 revealed that only 75% reached prophylactic levels. The median time to the initiation of chemoprophylaxis was 21.9 hours (interquartile range [IQR], 11.45–35.07 hours). Patients who were defined as having lower risk of having a complication as a result of bleeding had a shorter time to starting prophylaxis than those at higher risk (18.39 hours [IQR 5.76–26.51 hours] vs. 29.5 hours [IQR 16.23–63.07 hours], p 〈 0.01). There was no difference in demographics, weight, body mass index, creatinine, creatinine clearance, injury severity score, type of injury, weight-based dose, time to chemoprophylaxis, or bleeding complications between the cohorts. No independent predictors of subXa level were identified on multivariable logistic regression. CONCLUSIONS A significant number of trauma patients fail to achieve prophylactic Xa levels. Intrinsic factors may prevent adequate prophylaxis even with earlier administration and higher dosing of low-molecular-weight heparin. LEVEL OF EVIDENCE Therapeutic, level IV
    Type of Medium: Online Resource
    ISSN: 2163-0763 , 2163-0755
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 2651313-4
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  • 6
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Journal of the American College of Surgeons Vol. 225, No. 4 ( 2017-10), p. e95-e96
    In: Journal of the American College of Surgeons, Ovid Technologies (Wolters Kluwer Health), Vol. 225, No. 4 ( 2017-10), p. e95-e96
    Type of Medium: Online Resource
    ISSN: 1072-7515
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 7
    In: Pediatric Infectious Disease Journal, Ovid Technologies (Wolters Kluwer Health), Vol. 37, No. 11 ( 2018-11), p. 1130-1136
    Abstract: Drug-resistant Gram-negative bacteria are a growing threat to children; thus new antibiotics are needed to treat infections caused by these pathogens. Ceftolozane/tazobactam is active against many Gram-negative pathogens and is approved for treatment of complicated intra-abdominal and urinary tract infections in adults, but has not been evaluated in children. Methods: This phase 1, noncomparative, open-label, multicenter study characterized the pharmacokinetics (by noncompartmental analysis), safety, and tolerability of single intravenous doses of ceftolozane/tazobactam in pediatric patients (birth [7 days postnatal] to 〈 18 years of age) with proven/suspected Gram-negative infection or receiving perioperative prophylaxis (clinicaltrials.gov NCT02266706). Patients were enrolled into 1 of 6 age groups to receive a single, age-based ceftolozane/tazobactam dose, with timed blood sample collection for determining plasma concentrations of ceftolozane and tazobactam. Safety and tolerability were also evaluated. Results: Thirty-seven patients received study drug; 34 were included in the pharmacokinetic population. Ceftolozane and tazobactam pharmacokinetic parameters were generally comparable for patients 3 months to 〈 18 years of age. Patients from birth (7 days postnatal) to 〈 3 months of age had lower clearance than older children, likely due to the immature renal function of these young infants. No deaths, study drug-related serious adverse events, or clinically significant laboratory abnormalities were observed after administration of ceftolozane/tazobactam. Conclusions: The doses evaluated in this study yielded ceftolozane/tazobactam exposure levels generally comparable with those in adults. Single doses of ceftolozane/tazobactam were well-tolerated, and no safety concerns were identified. These data informed pharmacokinetic/pharmacodynamic models to derive pediatric dose recommendations for phase 2 ceftolozane/tazobactam clinical trials.
    Type of Medium: Online Resource
    ISSN: 0891-3668
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 2020216-7
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  • 8
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Clinical Orthopaedics & Related Research Vol. 481, No. 8 ( 2023-08), p. 1491-1500
    In: Clinical Orthopaedics & Related Research, Ovid Technologies (Wolters Kluwer Health), Vol. 481, No. 8 ( 2023-08), p. 1491-1500
    Abstract: Although biomedical preprint servers have grown rapidly over the past several years, the harm to patient health and safety remains a major concern among several scientific communities. Despite previous studies examining the role of preprints during the Coronavirus-19 pandemic, there is limited information characterizing their impact on scientific communication in orthopaedic surgery. Questions/purposes (1) What are the characteristics (subspecialty, study design, geographic origin, and proportion of publications) of orthopaedic articles on three preprint servers? (2) What are the citation counts, abstract views, tweets, and Altmetric score per preprinted article and per corresponding publication? Methods Three of the largest preprint servers (medRxiv, bioRxiv, and Research Square) with a focus on biomedical topics were queried for all preprinted articles published between July 26, 2014, and September 1, 2021, using the following search terms: “orthopaedic,” “orthopedic,” “bone,” “cartilage,” “ligament,” “tendon,” “fracture,” “dislocation,” “hand,” “wrist,” “elbow,” “shoulder,” “spine,” “spinal,” “hip,” “knee,” “ankle,” and “foot.” Full-text articles in English related to orthopaedic surgery were included, while nonclinical studies, animal studies, duplicate studies, editorials, abstracts from conferences, and commentaries were excluded. A total of 1471 unique preprints were included and further characterized in terms of the orthopaedic subspecialty, study design, date posted, and geographic factors. Citation counts, abstract views, tweets, and Altmetric scores were collected for each preprinted article and the corresponding publication of that preprint in an accepting journal. We ascertained whether a preprinted article was published by searching title keywords and the corresponding author in three peer-reviewed article databases (PubMed, Google Scholar, and Dimensions) and confirming that the study design and research question matched. Results The number of orthopaedic preprints increased from four in 2017 to 838 in 2020. The most common orthopaedic subspecialties represented were spine, knee, and hip. From 2017 to 2020, the cumulative counts of preprinted article citations, abstract views, and Altmetric scores increased. A corresponding publication was identified in 52% (762 of 1471) of preprints. As would be expected, because preprinting is a form of redundant publication, published articles that are also preprinted saw greater abstract views, citations, and Altmetric scores on a per-article basis. Conclusion Although preprints remain an extremely small proportion of all orthopaedic research, our findings suggest that nonpeer-reviewed, preprinted orthopaedic articles are being increasingly disseminated. These preprinted articles have a smaller academic and public footprint than their published counterparts, but they still reach a substantial audience through infrequent and superficial online interactions, which are far from equivalent to the engagement facilitated by peer review. Furthermore, the sequence of preprint posting and journal submission, acceptance, and publication is unclear based on the information available on these preprint servers. Thus, it is difficult to determine whether the metrics of preprinted articles are attributable to preprinting, and studies such as the present analysis will tend to overestimate the apparent impact of preprinting. Despite the potential for preprint servers to function as a venue for thoughtful feedback on research ideas, the available metrics data for these preprinted articles do not demonstrate the meaningful engagement that is achieved by peer review in terms of the frequency or depth of audience feedback. Clinical Relevance Our findings highlight the need for safeguards to regulate research dissemination through preprint media, which has never been shown to benefit patients and should not be considered as evidence by clinicians. Clinician-scientists and researchers have the most important responsibility of protecting patients from the harm of potentially inaccurate biomedical science and therefore must prioritize patient needs first by uncovering scientific truths through the evidence-based processes of peer review, not preprinting. We recommend all journals publishing clinical research adopt the same policy as Clinical Orthopaedics and Related Research ® , The Bone & Joint Journal, The Journal of Bone and Joint Surgery, and the Journal of Orthopaedic Research , removing any papers posted to preprint servers from consideration.
    Type of Medium: Online Resource
    ISSN: 0009-921X , 1528-1132
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2018318-5
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  • 9
    In: Medicine & Science in Sports & Exercise, Ovid Technologies (Wolters Kluwer Health), Vol. 40, No. 5 ( 2008-05), p. S239-
    Type of Medium: Online Resource
    ISSN: 0195-9131
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2008
    detail.hit.zdb_id: 2031167-9
    SSG: 31
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  • 10
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Journal of the American Academy of Orthopaedic Surgeons Vol. 27, No. 5 ( 2019-03-1), p. e215-e226
    In: Journal of the American Academy of Orthopaedic Surgeons, Ovid Technologies (Wolters Kluwer Health), Vol. 27, No. 5 ( 2019-03-1), p. e215-e226
    Abstract: Notable shortcomings exist in the currently available surgical options for reconstruction of bone and articular cartilage defects. Three-dimensional (3D) printing incorporating viable cells and extracellular matrix, or 3D bioprinting, is an additive manufacturing tissue engineering technique that can be used for layer-by-layer fabrication of highly complex tissues such as bone and cartilage. Because of the scalability of 3D bioprinting, this technology has the ability to fabricate tissues in clinically relevant volumes and addresses the defects of varying sizes and geometries. To date, most of our in vitro and in vivo success with cartilage and bone tissue bioprinting has been with extrusion-based bioprinting using alginate carriers and scaffold free bioinks. Fabrication of composite tissues has been achieved, including bone which includes vascularity, a necessary requisite to tissue viability. As this technology evolves, and we are able to integrate high-quality radiographic imaging, computer-assisted design, computer-assisted manufacturing, with real-time 3D bioprinting and ultimately in situ surgical printing, this additive manufacturing technique can be used to reconstruct both bone and articular cartilage and has the potential to succeed where our currently available clinical technologies and tissue manufacturing strategies fail.
    Type of Medium: Online Resource
    ISSN: 1067-151X , 1940-5480
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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