Towards a Computational Approach for the Assessment of Compliance of ALCOA+ Principles in Pharma Industry.

The pharmaceutical industry is a data-intensive environment and a heavily-regulated sector, where exhaustive audits and inspections are performed to ensure the safety of drugs. In this context, processing and evaluating the data generated in the manufacturing lines is a relevant challenge since it requires compliance with pharma regulations. This work combines data integrity metrics and blockchain technology to evaluate the compliance-degree of ALCOA+ principles among different levels of drug manufacturing data. We propose the DIALCOA tool, a software to assess the compliance-degree for each ALCOA+ principle, based on the assessment of data from manufacturing batch reports and its different levels of information.

Objective evaluation of static and dynamic behavior of different toric silicone-hydrogel contact lenses.

PURPOSE: The present study aimed to estimate how orientation position, recovery time, and contact lens decentration, associated with visual performance, may vary on several designs of the most recent toric silicone-hydrogel toric contact lenses in two-time different moments. METHODS: To evaluate the toric silicone-hydrogel toric contact lens position and stability, it was conducted with a prospective, observational, randomized, and single-center case series including 95 astigmatic eyes wearing four toric silicone-hydrogel toric contact lenses for two weeks. Orientation and decentration were analyzed with ImageJ software from video-frames extracted with a Python application. Recovery time was evaluated after 45 degrees of inferior-temporal misorientation. RESULTS: Evaluation of misorientation after 20 min of wear revealed the highest amount for Saphir RX, -20.41 ± 10.84 deg, and lowest for Air Optix Aqua for Astigmatism, -1.43 ± 7.48 deg. The highest horizontal misalignment was found for Air Optix Aqua for Astigmatism, -0.627 ± 0.330 mm, and lowest for Biofinity Toric, 0.004 ± 0.270 mm. Vertical misalignment presented the highest value for Acuvue Vita for Astigmatism, -0.652 ± 0.369 mm, and lowest for Air Optix Aqua for Astigmatism, -0.126 ± 0.231 mm. Recovery time showed the highest amount for Saphir RX, 80.70 ± 33.26 s, and lowest for Biofinity Toric 43.67 ± 23.70 s. Only Air Optix Aqua for Astigmatism presented significant differences after two-week of wear for misorientation (P = 0.02) and horizontal misalignment (P < 0.001). When pairwise comparisons are made between toric silicone-hydrogel toric contact lenses, significant differences (P < 0.001) are found. CONCLUSIONS: Although there was acceptable fitting, based upon decentration, orientation, and recovery with the study contact lenses, the stabilization and profile design used in the Air Optix Aqua for Astigmatism helped to minimize rotation and vertical misalignment. In addition, the peri-ballast and thickness profile of the Biofinity Toric improved rotational recovery and horizontal misalignment compared to the other contact lenses. Finally, lenses with a better fitting profile showed better visual performance.

Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects.

Quality of life (QoL) indicators are now being adopted as clinical outcomes in clinical trials on cancer treatments. Technology-free daily monitoring of patients is complicated, time-consuming and expensive due to the need for vast amounts of resources and personnel. The alternative method of using the patients' own phones could reduce the burden of continuous monitoring of cancer patients in clinical trials. This paper proposes monitoring the patients' QoL by gathering data from their own phones. We considered that the continuous multiparametric acquisition of movement, location, phone calls, conversations and data use could be employed to simultaneously monitor their physical, psychological, social and environmental aspects. An open access phone app was developed (Human Dynamics Reporting Service (HDRS)) to implement this approach. We here propose a novel mapping between the standardized QoL items for these patients, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and define HDRS monitoring indicators. A pilot study with university volunteers verified the plausibility of detecting human activity indicators directly related to QoL.

Vision-Specific Quality of Life: Laser-Assisted in situ Keratomileusis Versus Overnight Contact Lens Wear.

OBJECTIVES: To compare the visual-related quality of life in myopic subjects with different refractive treatments such as continuous wear of silicone-hydrogel contact lenses (CL), corneal refractive therapy (CRT), and laser-assisted in situ keratomileusis (LASIK). METHODS: The National Eye Institute Refractive Error Quality of Life Instrument (NEI RQL-42) questionnaire was administered to 96 subjects with a mean age of 30.0±7.9 years. There were 72 myopic subjects with a mean spherical equivalent of -2.74±0.98 D (-5.50 to -1.25 D). Subjects were corrected with LASIK (n=24), Paragon CRT orthokeratology lenses (n=24), and lotrafilcon A silicone-hydrogel CL under continuous wear (n=24). The NEI RQL-42 survey was used to compare differences between groups as well as with an emmetropic group (n=24). RESULTS: After 1 year of treatment, significant differences were found among all groups in the subscales glare (P=0.017), symptoms (P=0.016), dependence on correction (P<0.001), and worry (P<0.001). The mean difference compared with emmetropes were -5.5% (P=0.063) for LASIK patients, -2.0% (P=0.212) for orthokeratology subjects, and +1.6% (P=0.934) for the silicone-hydrogel CL group. CONCLUSIONS: Myopic subjects analyzed in this study reported better vision-related quality of life when they were corrected with continuous wear silicone-hydrogel lenses. The average score reached by CRT was similar to emmetropes, which showed the main disadvantage in worry subscale. The patients who underwent LASIK had the lowest valuation, highlighting the decreases in scores of diurnal fluctuations, glare, and especially in expectations and worry subscales, due to the first and second subscales, but especially to the false expectations created about treatment.