Electronic health records (EHRs) in clinical research and platform trials: Application of the innovative EHR-based methods developed by EU-PEARL.

OBJECTIVE: Electronic Health Record (EHR) systems are digital platforms in clinical practice used to collect patients' clinical information related to their health status and represents a useful storage of real-world data. EHRs have a potential role in research studies, in particular, in platform trials. Platform trials are innovative trial designs including multiple trial arms (conducted simultaneously and/or sequentially) on different treatments under a single master protocol. However, the use of EHRs in research comes with important challenges such as incompleteness of records and the need to translate trial eligibility criteria into interoperable queries. In this paper, we aim to review and to describe our proposed innovative methods to tackle some of the most important challenges identified. This work is part of the Innovative Medicines Initiative (IMI) EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project's work package 3 (WP3), whose objective is to deliver tools and guidance for EHR-based protocol feasibility assessment, clinical site selection, and patient pre-screening in platform trials, investing in the building of a data-driven clinical network framework that can execute these complex innovative designs for which feasibility assessments are critically important. METHODS: ISO standards and relevant references informed a readiness survey, producing 354 criteria with corresponding questions selected and harmonised through a 7-round scoring process (0-1) in stakeholder meetings, with 85% of consensus being the threshold of acceptance for a criterium/question. ATLAS cohort definition and Cohort Diagnostics were mainly used to create the trial feasibility eligibility (I/E) criteria as executable interoperable queries. RESULTS: The WP3/EU-PEARL group developed a readiness survey (eSurvey) for an efficient selection of clinical sites with suitable EHRs, consisting of yes-or-no questions, and a set-up of interoperable proxy queries using physicians' defined trial criteria. Both actions facilitate recruiting trial participants and alignment between study costs/timelines and data-driven recruitment potential. CONCLUSION: The eSurvey will help create an archive of clinical sites with mature EHR systems suitable to participate in clinical trials/platform trials, and the interoperable proxy queries of trial eligibility criteria will help identify the number of potential participants. Ultimately, these tools will contribute to the production of EHR-based protocol design.

Influence of waves on the three-dimensional distribution of plastic in the ocean.

The world's oceans are facing plastic pollution, 80 % of which of terrestrial origin flowing from the mismanaged waste of coastal populations and from river discharge. To study the fate of this pollution, the three-dimensional trajectories of neutral plastic particles continuously released for 24 years according to realistic source scenarios are computed using currents from a global ocean-wave coupled model at 14∘ resolution and from a reference ocean-only model. These Lagrangian simulations show that neutral particles accumulate at the surface in the subtropical convergence zones from where they penetrate to about 250 m depth and strongly disperse over 40∘ of latitude. About 5.3 % of the particles remain at the surface with the wave-coupled model currents, whereas only 2 % for the uncoupled model, with some modulation in the location of the convergence zones. Increased surface retention results from upward vertical velocities induced by widespread divergence of waves-induced Stokes transport in the surface layers.

Fate of floating plastic debris released along the coasts in a global ocean model.

Marine plastic pollution is a global issue, from the shores to the open ocean. Understanding the pathway and fate of plastic debris is fundamental to manage and reduce plastic pollution. Here, the fate of floating plastic pollution discharged along the coasts is studied by comparing two sources, one based on river discharges and the other on mismanaged waste from coastal populations, using a Lagrangian numerical analysis in a global ocean circulation model. About 1/3 of the particles end up in the open ocean and 2/3 on beaches. The input scenario largely influences the accumulation of particles toward the main subtropical convergence zones, with the South Pacific and North Atlantic being mostly fed by the coastal population inputs. The input scenario influences the number of beached particles that end up in several coastal areas. Beaching occurs mainly locally, although a significant number of particles travel long distances, allowing for global connectivity.

Large impact of Stokes drift on the fate of surface floating debris in the South Indian Basin.

In the open ocean, floating surface debris such as plastics concentrate in five main accumulation zones centered around 30° latitude, far from highly turbulent areas. Using Lagrangian advection of numerical particles by surface currents from ocean model reanalysis, previous studies have shown long-distance connection from the accumulation zones of the South Indian to the South Pacific oceans. An important physical process affecting surface particles but missing in such analyses is wave-induced Stokes drift. Taking into account surface Stokes drift from a wave model reanalysis radically changes the fate of South Indian particles. The convergence region moves from the east to the west of the basin, so particles leak to the South Atlantic rather than the South Pacific. Stokes drift changes the South Indian sensitive balance between Ekman convergence and turbulent diffusion processes, inducing either westward entrainment in the north of the accumulation zone, or eastward entrainment in the south.

Iron from a submarine source impacts the productive layer of the Western Tropical South Pacific (WTSP).

In the Western Tropical South Pacific, patches of high chlorophyll concentrations linked to the occurrence of N2-fixing organisms are found in the vicinity of volcanic islands. The survival of these organisms relies on a high bioavailable iron supply whose origin and fluxes remain unknown. Here, we measured high dissolved iron (DFe) concentrations (up to 66 nM) in the euphotic layer, extending zonally over 10 degrees longitude (174 E-175 W) at ∼20°S latitude. DFe atmospheric fluxes were at the lower end of reported values of the remote ocean and could not explain the high DFe concentrations measured in the water column in the vicinity of Tonga. We argue that the high DFe concentrations may be sustained by a submarine source, also characterized by freshwater input and recorded as salinity anomalies by Argo float in situ measurements and atlas data. The observed negative salinity anomalies are reproduced by simulations from a general ocean circulation model. Submarine iron sources reaching the euphotic layer may impact nitrogen fixation across the whole region.

Tracking the origins of plastic debris across the Coral Sea: A case study from the Ouvéa Island, New Caledonia.

Contamination of the marine environment by human-made plastic litter is a growing and global problem. Our study attempts to explain the presence of two plastic bottles beached on the Ouvéa Island, in the southwest Pacific Ocean, with trademarks from the Solomon Islands and Papua New Guinea (PNG). We simulate the oceanic drift tracks and associated transit times with a Lagrangian interpretation of the surface currents of a high-resolution ocean model. Our results show that it takes less than 2-3months for drifting objects to connect these archipelagos (New Caledonia, Solomon Islands and PNG) and highlight the role of the meridional component of the circulation rather than the dominant zonal jets. This study shows that the origin or traceability of trash represent valuable information that can be used to test and, ultimately, improve our understanding of ocean circulation.

Thai traditional massage: efficiency-assessment of three traditional massage methods on office workers: an explorative study.

Thai Traditional Massage (TTM) is popular and widely spread in Thailand. This project is aimed at studying the physiological efficiency of three popular TTM methods based on acupressure Meridian basal lines: the Sen Sib(SS) ten lines, Ratchsamnak (RS), Royal style; and Chaloeysak (CS), Folk style. Thirty healthy female administrative employees participated as patients. All were treated for 30 min with the 3 types of massage with a two-week interval between each treatment. Muscle strain was objectified by measuring strength and endurance with surface electromyography of muscle put under stress during office work: the M. Trapezius (static postural load) and the wrist muscles (M. flexors & extensors Carpi-Radialis) (dynamic contractions) as well as measuring the subjective Visual Analogue Scale (VAS) before and after the sessions. An ANOVA-statistical analysis showed that strength in shoulders was not significantly different, but some forearm fatigue was decreased significantly among the three massage techniques.

Musculoskeletal disorders: a new approach.

Musculoskeletal disorders are still a major problem in daily occupational life. Despite the high incidence rates and important consequences for employees, employers and society, efficient preventive strategies seem to fail in efficiency. The reason may be found in approaching the issue via the classic post-factum analysis. The preventive measures are almost not implemented because of the low predictability to be injured which affects the awareness of the problem and the low identification with the improvement proposals. MSD belong to the cumulative diseases which require and anticipating strategy based on early detection of pre-indicating symptoms.

Observed impact of upwelling events on water properties and biological activity off the southwest coast of New Caledonia.

The upwelling events that follow strong trade wind episodes have been described in terms of their remarkable signature in the sea surface temperature southwest off New Caledonia. Upwelling brings deeper, and colder waters to the surface, causing 2-4 degrees C drops in temperature in a few hours, followed by a slower relaxation over several days. Upwelling may sporadically bring nutrients to the surface under certain conditions, and increase the biological productivity. Two multidisciplinary hydrographic cruises allow the impact of upwelling on the chemical and biological properties of the water to be documented. Both cruises took place in austral summer (December 2004 and December 2005), but the first cruise occurred during a strong upwelling event, while the second cruise occurred in calm conditions. The water properties and planktonic composition show important contrasts, with a strong southeastward current (the "ALIS current of New Caledonia") competing with the upwelling system. Our analysis suggests that, while observed productivities are far less than those of typical upwelling systems, some wind events in New Caledonia may contribute to biological activity. A currentmeter mooring, deployed during the second cruise, documents the ocean response to a changing wind field and the local impact of upwelling on currents and temperatures on the water column. The results are discussed, with the help of climatology, Argo float profiler data, satellite data and of a high-resolution numerical simulation.