Aims
To conduct a systematic review and meta‐analysis of observational studies in order to assess the association between Type 1 diabetes and fractures.
Background
The risk of fracture in men and ...women with Type 1 diabetes has not been studied in a large prospective well designed cohort.
Methods
Data were selected from Medline and Embase and s from annual scientific meetings of various diabetes and bone and mineral societies. Published studies that reported the fracture risk in people with Type 1 diabetes in comparison with people without diabetes between 1990 and July 2014 and s from various annual meeting (2005 onwards) were included in the present meta‐analysis. Data were extracted from the text of included publications or from s of conferences.
Results
The 14 studies that met the inclusion criteria reported 2066 fracture events among 27 300 people with Type 1 diabetes (7.6%) and 136 579 fracture events among 4 364 125 people without diabetes (3.1%). The pooled relative risk of any fracture in people with Type 1 diabetes was 3.16 (95% CI 1.51–6.63; P = 0.002). Women and men with Type 1 diabetes had a four and two times higher risk of any fractures, respectively, compared with people without diabetes. The pooled relative risks of hip fractures and spinal fractures were 3.78 (95% CI 2.05–6.98; P < 0.001) and 2.88 (95% CI 1.71–4.82; P < 0.001), respectively, among people with Type 1 diabetes.
Conclusions
Our meta‐analysis suggests that both men and women with Type 1 diabetes might have an increased risk of any fractures. A large prospective epidemiological study is needed to confirm our findings.
Respondent fatigue, also known as survey fatigue, is a common problem in the collection of survey data. Factors that are known to influence respondent fatigue include survey length, survey topic, ...question complexity, and open-ended question type. There is a great deal of interest in understanding the drivers of physician survey responsiveness due to the value of information received from these practitioners. With the recent explosion of mobile smartphone technology, it has been possible to obtain survey data from users of mobile applications (apps) on a question-by-question basis. The author obtained basic demographic survey data as well as survey data related to an anesthesiology-specific drug called sugammadex and leveraged nonresponse rates to examine factors that influenced respondent fatigue.
Primary data were collected between December 2015 and February 2017. Surveys and in-app analytics were collected from global users of a mobile anesthesia calculator app. Key independent variables were user country, healthcare provider role, rating of importance of the app to personal practice, length of time in practice, and frequency of app use. Key dependent variable was the metric of respondent fatigue.
Provider role and World Bank country income level were predictive of the rate of respondent fatigue for this in-app survey. Importance of the app to the provider and length of time in practice were moderately associated with fatigue. Frequency of app use was not associated. This study focused on a survey with a topic closely related to the subject area of the app. Respondent fatigue rates will likely change dramatically if the topic does not align closely.
Although apps may serve as powerful platforms for data collection, responses rates to in-app surveys may differ on the basis of important respondent characteristics. Studies should be carefully designed to mitigate fatigue as well as powered with the understanding of the respondent characteristics that may have higher rates of respondent fatigue.
Background and Aims
Direct oral anticoagulants (DOAC) are important new anticoagulant therapies that are not well studied in patients with chronic liver disease. The aim of this study was to compare ...rates of bleeding in cirrhosis patients treated with DOAC (factor Xa inhibitors: rivaroxaban and apixaban) to those in cirrhosis patients treated with traditional anticoagulation (warfarin and low molecular weight heparin).
Methods
We identified a total of 39 patients with cirrhosis who received anticoagulation therapy over a 3-year period (20 DOAC and 19 traditional anticoagulation) from a research database. Medical records were reviewed to obtain clinical data to compare between the groups.
Results
Clinical characteristics between the two groups were similar. There were three documented bleeding events in the traditional anticoagulation group and four bleeding events in the DOAC group (
p
= 0.9). There were two major bleeding events in the traditional anticoagulation group and one major bleeding event in the DOAC group. There were no documented reports of drug-induced liver injury during this study period. Among all patients, no significant predictors of bleeding were identified using univariate regression and Cox proportional hazard modeling.
Conclusions
This is the first clinical study evaluating the use of DOAC in patients with cirrhosis. DOAC display similar safety characteristics when compared to traditional anticoagulation in patients with cirrhosis and are potentially attractive agents for anticoagulation therapy. Larger studies are now needed to better understand the safety and efficacy of these agents in cirrhosis.
The relatively high imaging speed of EPI has led to its widespread use in dynamic MRI studies such as functional MRI. An approach to improve the performance of EPI, EPI with Keyhole (EPIK), has been ...previously presented and its use in fMRI was verified at 1.5T as well as 3T. The method has been proven to achieve a higher temporal resolution and smaller image distortions when compared to single-shot EPI. Furthermore, the performance of EPIK in the detection of functional signals was shown to be comparable to that of EPI. For these reasons, we were motivated to employ EPIK here for high-resolution imaging. The method was optimised to offer the highest possible in-plane resolution and slice coverage under the given imaging constraints: fixed TR/TE, FOV and acceleration factors for parallel imaging and partial Fourier techniques. The performance of EPIK was evaluated in direct comparison to the optimised protocol obtained from EPI. The two imaging methods were applied to visual fMRI experiments involving sixteen subjects. The results showed that enhanced spatial resolution with a whole-brain coverage was achieved by EPIK (1.00 mm × 1.00 mm; 32 slices) when compared to EPI (1.25 mm × 1.25 mm; 28 slices). As a consequence, enhanced characterisation of functional areas has been demonstrated in EPIK particularly for relatively small brain regions such as the lateral geniculate nucleus (LGN) and superior colliculus (SC); overall, a significantly increased t-value and activation area were observed from EPIK data. Lastly, the use of EPIK for fMRI was validated with the simulation of different types of data reconstruction methods.
Signal‐detection algorithms (SDAs) are recognized as vital tools in pharmacovigilance. However, their performance characteristics are generally unknown. By leveraging a unique gold standard recently ...made public by the Observational Medical Outcomes Partnership (OMOP) and by conducting a unique systematic evaluation, we provide new insights into the diagnostic potential and characteristics of SDAs that are routinely applied to the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS). We find that SDAs can attain reasonable predictive accuracy in signaling adverse events. Two performance classes emerge, indicating that the class of approaches that address confounding and masking effects benefits safety surveillance. Our study shows that not all events are equally detectable, suggesting that specific events might be monitored more effectively using other data sources. We provide performance guidelines for several operating scenarios to inform the trade‐off between sensitivity and specificity for specific use cases. We also propose an approach and demonstrate its application in identifying optimal signaling thresholds, given specific misclassification tolerances.
Clinical Pharmacology & Therapeutics (2013); 93 6, 539–546. doi:10.1038/clpt.2013.24
Electroencephalography (EEG) frequencies have been linked to specific functions as an "electrophysiological signature" of a function. A combination of oscillatory rhythms has also been described for ...specific functions, with or without predominance of one specific frequency-band. In a simultaneous fMRI-EEG study at 3 T we studied the relationship between the default mode network (DMN) and the power of EEG frequency bands. As a methodological approach, we applied Multivariate Exploratory Linear Optimized Decomposition into Independent Components (MELODIC) and dual regression analysis for fMRI resting state data. EEG power for the alpha, beta, delta and theta-bands were extracted from the structures forming the DMN in a region-of-interest approach by applying Low Resolution Electromagnetic Tomography (LORETA). A strong link between the spontaneous BOLD response of the left parahippocampal gyrus and the delta-band extracted from the anterior cingulate cortex was found. A positive correlation between the beta-1 frequency power extracted from the posterior cingulate cortex (PCC) and the spontaneous BOLD response of the right supplementary motor cortex was also established. The beta-2 frequency power extracted from the PCC and the precuneus showed a positive correlation with the BOLD response of the right frontal cortex. Our results support the notion of beta-band activity governing the "status quo" in cognitive and motor setup. The highly significant correlation found between the delta power within the DMN and the parahippocampal gyrus is in line with the association of delta frequencies with memory processes. We assumed "ongoing activity" during "resting state" in bringing events from the past to the mind, in which the parahippocampal gyrus is a relevant structure. Our data demonstrate that spontaneous BOLD fluctuations within the DMN are associated with different EEG-bands and strengthen the conclusion that this network is characterized by a specific electrophysiological signature created by combination of different brain rhythms subserving different putative functions.