Plos One
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Randomized Controlled Trial Multicenter Study
Effect of preconception low dose aspirin on pregnancy and live birth according to socioeconomic status: A secondary analysis of a randomized clinical trial.
Low socioeconomic status (SES) is associated with adverse pregnancy outcomes and infertility. Low-dose aspirin (LDA) was shown to improve livebirth rates in certain subsets of women, and therefore, may impact pregnancy rates differentially by SES status. Therefore, the aim of the current study was to examine whether daily preconception-initiated LDA affects rates of pregnancy, livebirth, and pregnancy loss differently across strata of socioeconomic status (SES). ⋯ LDA, a low-cost and widely available treatment, may be particularly beneficial to women at the highest and lowest ends of the socioeconomic spectrum, though underlying mechanisms of this disparity are unclear. Confirming these findings and identifying factors which may modulate the effectiveness of LDA will ultimately facilitate personalized clinical care and improvements in population-level reproductive health. Trial registration number: ClinicalTrials.gov, NCT00467363.
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Postural orthostatic tachycardia syndrome is a disorder of the autonomic nervous system. Approximately 30% of patients experience orthostatic headaches. Orthostatic headaches also are a hallmark symptom in spontaneous intracranial hypotension. While the cause of orthostatic headaches in spontaneous intracranial hypotension can be linked to the cerebrospinal fluid loss at the spinal level and consecutively reduced intracranial pressure in the upright position, the cause of orthostatic headaches in postural orthostatic tachycardia syndrome still remains unknown. The present study examined orthostatic changes of intracranial pressure using dynamic ultrasound of the optic nerve and optic nerve sheath diameter in postural orthostatic tachycardia syndrome, spontaneous intracranial hypotension and healthy subjects. ⋯ This study shows that the size of the optic nerve sheath diameter dynamically decreases during orthostatic stress in spontaneous intracranial hypotension, but not in postural orthostatic tachycardia syndrome with or without orthostatic headaches, which indicates different underlying causes.
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Randomized Controlled Trial
Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial.
Therapeutic virtual reality (VR) has emerged as an effective, drug-free tool for pain management, but there is a lack of randomized, controlled data evaluating its effectiveness in hospitalized patients. We sought to measure the impact of on-demand VR versus "health and wellness" television programming for pain in hospitalized patients. ⋯ VR significantly reduces pain versus an active control condition in hospitalized patients. VR is most effective for severe pain. Future trials should evaluate standardized order sets that interpose VR as an early non-drug option for analgesia.
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Multicenter Study Clinical Trial Observational Study
Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study.
Direct oral anticoagulants (DOACs) have shown similar efficacy and safety with respect to warfarin in patients with atrial fibrillation (AF). However, the proportion of patients aged ≥85 years enrolled in clinical trials was low and the applicability of their results to very elderly patients is still uncertain. We have carried out a prospective cohort study on AF patients aged ≥85 years enrolled in the Survey on anticoagulaTed pAtients RegisTer (START2-Register) and treated with either VKAs or DOACs, with the aim to evaluate mortality, bleeding and thrombotic rates during a long-term follow-up. ⋯ Patients on DOACs showed a higher rate of thrombotic events during treatment (rate 1.84 and 0.50,respectively). Mortality rate was higher in patients on VKAs than in patients on DOACs (HR 0.64 (95% CI 0.46-0.91). In conclusion, we confirm the overall safety and effectiveness of anticoagulant treatment in very elderly AF patients, with lower mortality rates in DOACs patients, similar bleeding risk, and a higher risk for cerebral thrombotic events in DOACs patients.
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Multicenter Study Comparative Study
Comparison of quality control methods for automated diffusion tensor imaging analysis pipelines.
The processing of brain diffusion tensor imaging (DTI) data for large cohort studies requires fully automatic pipelines to perform quality control (QC) and artifact/outlier removal procedures on the raw DTI data prior to calculation of diffusion parameters. In this study, three automatic DTI processing pipelines, each complying with the general ENIGMA framework, were designed by uniquely combining multiple image processing software tools. Different QC procedures based on the RESTORE algorithm, the DTIPrep protocol, and a combination of both methods were compared using simulated ground truth and artifact containing DTI datasets modeling eddy current induced distortions, various levels of motion artifacts, and thermal noise. ⋯ However, the pipeline based on the RESTORE algorithm was the most accurate when analyzing the artifact containing DTI datasets. The pipeline that combined the DTIPrep protocol and the RESTORE algorithm produced the lowest standard deviation in FA measurements in normal appearing WM across subjects. We concluded that this pipeline was the most robust and is preferred for automated analysis of multisite brain DTI data.