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Nikolaos Mastellos

Publications and source records attributed to Nikolaos Mastellos.

2 recordsLinked to original sources

Estimating blood pressure trends and the nocturnal dip from photoplethysmograph

Objective: Evaluate a method for the estimation of the nocturnal systolic blood pressure (SBP) dip from 24-hour blood pressure trends using a wrist-worn photoplethysmography (PPG) sensor and a deep neural network in free-living individuals, comparing the deep neural network to traditional machine learning and non-machine learning baselines. Approach: A wrist-worn PPG sensor was worn by 106 healthy individuals for 226 days during which 5111 reference values for blood pressure (BP) were obtained with a 24-hour ambulatory BP monitor and matched with the PPG sensor data. Features based on heart rate variability and pulse morphology were extracted from the PPG waveforms. Long- and short term memory (LSTM) networks, dense networks, random forests and linear regression models were trained and evaluated in their capability of tracking trends in BP, as well as the estimation of the SBP dip. Main results: Best performance for estimating the SBP dip were obtained with a deep LSTM neural network with a root mean squared error (RMSE) of 3.12$\pm$2.20 $Δ$mmHg and a correlation of 0.69 $(p=3*10^{-5})$. This dip was derived from trend estimates of BP which had an RMSE of 8.22$\pm$1.49 mmHg for systolic and 6.55$\pm$1.39 mmHg for diastolic BP (DBP). While other models had similar performance for the tracking of relative BP, they did not perform as well as the LSTM for the SBP dip. Significance: The work provides first evidence for the unobtrusive estimation of the nocturnal SBP dip, a highly prognostic clinical parameter. It is also the first to evaluate unobtrusive BP measurement in a large data set of unconstrained 24-hour measurements in free-living individuals and provides evidence for the utility of LSTM models in this domain.

physics.med-ph↗

eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial

Objective: The Learning Health System (LHS) requires integration of research into routine practice. eSource or embedding clinical trial functionalities into routine electronic health record (EHR) systems has long been put forward as a solution to the rising costs of research. We aimed to create and validate an eSource solution that would be readily extensible as part of a LHS. Materials and Methods: The EU FP7 TRANSFoRm project's approach is based on dual modelling, using the Clinical Research Information Model (CRIM) and the Clinical Data Integration Model of meaning (CDIM) to bridge the gap between clinical and research data structures, using the CDISC Operational Data Model (ODM) standard. Validation against GCP requirements was conducted in a clinical site, and a cluster randomised evaluation by site nested into a live clinical trial. Results: Using the form definition element of ODM, we linked precisely modelled data queries to data elements, constrained against CDIM concepts, to enable automated patient identification for specific protocols and prepopulation of electronic case report forms (e-CRF). Both control and eSource sites recruited better than expected with no significant difference. Completeness of clinical forms was significantly improved by eSource, but Patient Related Outcome Measures (PROMs) were less well completed on smartphones than paper in this population. Discussion: The TRANSFoRm approach provides an ontologically-based approach to eSource in a low-resource, heterogeneous, highly distributed environment, that allows precise prospective mapping of data elements in the EHR. Conclusion: Further studies using this approach to CDISC should optimise the delivery of PROMS, whilst building a sustainable infrastructure for eSource with research networks, trials units and EHR vendors.

cs.CY↗