Summary. Background: Soluble thrombomodulin is a promising therapeutic natural anticoagulant that is comparable to antithrombin, tissue factor pathway inhibitor and activated protein C. Objectives: We conducted a multicenter, double‐blind, randomized, parallel‐group trial to compare the efficacy and safety of recombinant human soluble thrombomodulin (ART‐123) to those of low‐dose heparin for the treatment of disseminated intravascular coagulation (DIC) associated with hematologic malignancy or infection. Methods: DIC patients (n = 234) were assigned to receive ART‐123 (0.06 mg kg−1 for 30 min, once daily) or heparin sodium (8 U kg−1 h−1 for 24 h) for 6 days, using a double‐dummy method. The primary efficacy endpoint was DIC resolution rate. The secondary endpoints included clinical course of bleeding symptoms and mortality rate at 28 days. Results: DIC was resolved in 66.1% of the ART‐123 group, as compared with 49.9% of the heparin group [difference 16.2%; 95% confidence interval (CI) 3.3–29.1]. Patients in the ART‐123 group also showed more marked improvement in clinical course of bleeding symptoms (P = 0.0271). The incidence of bleeding‐related adverse events up to 7 days after the start of infusion was lower in the ART‐123 group than in the heparin group (43.1% vs. 56.5%, P = 0.0487). Conclusions: When compared with heparin therapy, ART‐123 therapy more significantly improves DIC and alleviates bleeding symptoms in DIC patients.
Background and Aim
Although small‐bowel angioectasia is reported as the most common cause of bleeding in patients and frequently diagnosed by capsule endoscopy (CE) in patients with obscure gastrointestinal bleeding, a computer‐aided detection method has not been established. We developed an artificial intelligence system with deep learning that can automatically detect small‐bowel angioectasia in CE images.
Methods
We trained a deep convolutional neural network (CNN) system based on Single Shot Multibox Detector using 2237 CE images of angioectasia. We assessed its diagnostic accuracy by calculating the area under the receiver operating characteristic curve (ROC‐AUC), sensitivity, specificity, positive predictive value, and negative predictive value using an independent test set of 10 488 small‐bowel images, including 488 images of small‐bowel angioectasia.
Results
The AUC to detect angioectasia was 0.998. Sensitivity, specificity, positive predictive value, and negative predictive value of CNN were 98.8%, 98.4%, 75.4%, and 99.9%, respectively, at a cut‐off value of 0.36 for the probability score.
Conclusions
We developed and validated a new system based on CNN to automatically detect angioectasia in CE images. This may be well applicable to daily clinical practice to reduce the burden of physicians as well as to reduce oversight.
ObjectiveThis study investigated payments made by pharmaceutical companies to oncology specialists in Japan, what the payments were for and whether the receipt of such payments contravened any conflict of interest (COI) regulations.Design, setting and participantsPayment data to physicians, as reported by all pharmaceutical companies belonging to the Japan Pharmaceutical Manufacturers Association, were retrospectively extracted for 2016. Of the named individual recipients of payments, all certified oncologists were identified, using certification data from the Japanese Society of Medical Oncology (JSMO). The individual specialisations of each of the oncologists was also identified.OutcomePayments to individual cancer specialists and what they were for were identified. Factors associated with receipt of higher value payments and payment flows to specialties were determined. Companies selling oncology drugs with annual sales of ≥5 billion yen (£33.9 million, €40.2 million and $46.0 million) (high revenue-generating drugs) were identified.ResultsIn total, 59 companies made at least one payment to oncologists. Of the 1080 oncology specialists identified, 763 (70.6%) received at least one payment, while 317 received no payment. Of the 763, some 142 (13.1%) receiving at least 1 million yen (£6,800, €8,000 and $9200) accounted for 71.5% of the total. After adjustment of covariates, working for university hospitals and cancer hospitals and male gender were key factors associated with larger monetary payments. Payments preferentially targeted on cancer specialties using high revenue-generating drugs. The JSMO has its own COI policy for its members, but the policy did not mention any specific guidelines for certified oncology specialists.ConclusionFinancial relationships were identified and quantified between pharmaceutical companies and oncology specialists, but the extent and worth varied significantly. Given the frequency and amounts of money involved in such linkages, it would be beneficial for specific COI regulations to be developed and policed for oncologists.
Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296
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