IntroductionExisting mobility endpoints based on functional performance, physical assessments and patient self-reporting are often affected by lack of sensitivity, limiting their utility in clinical practice. Wearable devices including inertial measurement units (IMUs) can overcome these limitations by quantifying digital mobility outcomes (DMOs) both during supervised structured assessments and in real-world conditions. The validity of IMU-based methods in the real-world, however, is still limited in patient populations. Rigorous validation procedures should cover the device metrological verification, the validation of the algorithms for the DMOs computation specifically for the population of interest and in daily life situations, and the users’ perspective on the device.Methods and analysisThis protocol was designed to establish the technical validity and patient acceptability of the approach used to quantify digital mobility in the real world by Mobilise-D, a consortium funded by the European Union (EU) as part of the Innovative Medicine Initiative, aiming at fostering regulatory approval and clinical adoption of DMOs.After defining the procedures for the metrological verification of an IMU-based device, the experimental procedures for the validation of algorithms used to calculate the DMOs are presented. These include laboratory and real-world assessment in 120 participants from five groups: healthy older adults; chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, proximal femoral fracture and congestive heart failure. DMOs extracted from the monitoring device will be compared with those from different reference systems, chosen according to the contexts of observation. Questionnaires and interviews will evaluate the users’ perspective on the deployed technology and relevance of the mobility assessment.Ethics and disseminationThe study has been granted ethics approval by the centre’s committees (London—Bloomsbury Research Ethics committee; Helsinki Committee, Tel Aviv Sourasky Medical Centre; Medical Faculties of The University of Tübingen and of the University of Kiel). Data and algorithms will be made publicly available.Trial registration numberISRCTN (12246987).
Atmospheric pressure chemical ionization liquid chromatography/mass spectrometry was used in the identification of diacylglycerol and triacylglycerol (TAG) molecular species in a sample of a structured lipid. In the study of acylglycerol standards, the most distinctive differences between the diacylglycerol and TAG molecules were found to be the molecular ion and the relative intensity of monoacylglycerol fragment ions. All saturated TAG ranging from tricaproin to tristearin, and unsaturated TAG including triolein, trilinolein, and trilinolenin, had ammonium adduct molecular ions [M + NH 4 ] + . Protonated molecular ions were also produced for TAG containing unsaturated fatty acids and the intensity increased with increasing unsaturation. Diacylglycerol fragment ions were also formed for TAG. The ammonium adduct molecular ion was the base peak for TAG containing polyunsaturated fatty acids, whereas the diacylglycerol fragment ion was the base peak for TAG containing saturated and monounsaturated medium-and long-chain fatty acids; the relative intensities of the ammonium adduct molecular ions were between 14 and 58%. The most abundant ion for diacylglycerols, however, was the molecular ion [M − 17] + , and the relative intensity of the monoacylglycerol fragment ion was also higher than that for TAG. These distinctive differences between the diacylglycerol and TAG spectra were utilized for rapid identification of the acylglycerols in the sample of a structured lipid.Lipase-catalyzed interesterification has been used in lipid modification for the production of different kinds of lipids according to specific requirements, for instance the enrichment of triacylglycerols (TAG) with polyunsaturated fatty acids, especially essential fatty acids (1,2), and the incorporation of medium-or short-chain fatty acids into TAG (3-5). Since the interesterification alters the fatty acid composition and distribution in the acylglycerols, a group of new TAG is produced in the interesterification. Diacylglycerols are formed as the intermediates and are also found in the interesterified products; the level of diacylglycerols varied in different interesterification processes or under different reaction parameters (6,7).Reversed-phase-high-performance liquid chromatography (RP-HPLC) is a practical method for the separation of TAG molecular species according to the differences in carbon numbers and unsaturation levels of fatty acids in TAG (8-12). Equivalent carbon number (ECN) or partition number, a summary of both the carbon number and the degree of unsaturation of fatty acids, is commonly used for the tentative identification of TAG (8)(9)(10)13,14). However, it was difficult to distinguish diacylglycerols from TAG on the RP-HPLC using the ECN. Even though it is possible to separate and identify the diacylglycerol and TAG molecular species by thin-layer chromatography followed by HPLC fractionation and analysis using gas-liquid chromatography (9), the procedure is tedious and seldom used.Mass spectrometry (MS) is a sensitive method for...
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