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1.
Digit Health ; 10: 20552076241284910, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39351311

RESUMEN

Objective: This study aims to assess the accuracy and stability of smartwatches in predicting acute mountain sickness (AMS). Methods: In locations exceeding an altitude of 2500 m, a cohort of 42 subjects had their Lake Louise AMS self-assessment score, blood oxygen saturation (SpO2), heart rate, and perfusion index measured using smartwatches, with the data seamlessly conveyed to the Huawei Cloud. Results: A significant decrease in SpO2 was observed in individuals positive for AMS compared to those negative (p < 0.05), with the mild AMS group exhibiting significantly lower SpO2 levels than the non-AMS group (p < 0.05). Furthermore, SpO2 emerged as a significant, independent predictor of AMS [ß=-0.086, p < 0.01, OR (95% CI) = 0.92 (0.87-0.97)], indicating that each unit increase in SpO2 decreases the probability of AMS occurrence by 8.6%. Conclusion: The Huawei smartwatches have demonstrated efficacy in diagnosing and foretelling AMS at elevations exceeding 4000 m, showcasing significant reliability and high precision in SpO2 measurement.

2.
Digit Health ; 10: 20552076241258362, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39351312

RESUMEN

Background: Reduced cardiorespiratory fitness levels are associated with increased short-term complications after surgery, and potentially exert long-lasting effects on the postoperative lives, work and educational pursuits of patients. Currently, research suggests that lifestyle interventions, such as preoperative physical exercise undertaken by patients themselves, may improve patients' cardiopulmonary fitness and reduce post-operative complications. This study aims to investigate the effectiveness and feasibility of a remote medical supervision model for prehabilitation exercise in patients undergoing thoracoscopic lung tumour resection surgery. Methods/Design: All enrolled patients will participate in a 4-week pre-operative exercise intervention to improve their cardiorespiratory fitness. During this period, patients will wear wearable devices and exercise at home based on exercise prescriptions. The exercise prescription comprises aerobic exercise (three times a week or more), muscle strengthening exercise (twice a week or more), and respiratory muscle exercise (once a day). The primary aim is to investigate whether baseline VO2max could be improved following a 4-week preoperative exercise program. Secondary objectives include changes in forced expiratory volume in 1 s and forced vital capacity, degree of acceptance of the technology, quality of life, handgrip strength, postoperative complication rate and length of hospital stay. Discussion: This study aims to evaluate the influence of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection. As such, results of this trial might have some impact on future implementations of group- and home-based prehabilitation exercises in lung cancers. Trial registration: This study was approved by the Medical Ethics Committee of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (approval number: TJ-IRB20220564) with registration at ClinicalTrials.gov (identifier: NCT05608759).

3.
J Biophotonics ; : e202400297, 2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-39351628

RESUMEN

The paper is devoted to the study of perfusion and amplitude-frequency spectra of laser Doppler flowmetry (LDF) signals in patients with diabetes mellitus (DM) in different skin areas of the upper and lower extremities using a distributed system of wearable LDF analysers. LDF measurements were performed in the areas of the fingers, toes, wrists and shins. The mean perfusion values, the amplitudes of blood flow oscillations in endothelial, neurogenic, myogenic, respiratory and cardiac frequency ranges, and the values of nutritive blood flow were analysed. The results revealed a decrease in tissue perfusion and nutritive blood flow in the lower extremities and an increase in these parameters in the upper extremities in patients with DM. A decrease in the amplitudes of endothelial and neurogenic oscillations was observed. The obtained results confirm the possibility of using wearable LDF analysers to detect differences in the blood flow regulation in normal and pathological conditions.

4.
Anal Bioanal Chem ; 2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-39352471

RESUMEN

Electrophoretic microfluidic paper-based analytical devices (e-µPADs) are promising for low-cost and portable technologies, but quantitative detection remains challenging. In this study, we develop a paper-based isotachophoretic preconcentration and separation method for the herbicide glyphosate as a model analyte. The device, consisting of two electrode chambers filled with leading and terminating electrolytes and a nitrocellulose strip as the separation carrier, was illuminated by a flat light source and operated with a voltage supply of 400 V. Detection was accomplished using a simple camera. Colorimetric detection was optimized through competitive complexation between glyphosate, copper ions, and pyrocatechol violet as a dye. The buffer system was optimized using simulations, (i) ensuring the pH was optimal for the demetallation of the blue pyrocatechol violet-copper complex [PV] to the yellow free dye and (ii) ensuring the electrophoretic migration of glyphosate into the slower [PV] for the colorimetric reaction. A new data evaluation method is presented, analyzing the RGB channel intensities. The linear range was between 0.8 and 25 µM, with a LOD of approximately 0.8 µM. The ITP separation preconcentrated glyphosate by a factor of 820 in numerical simulations. The method may be applied to control glyphosate formulations, especially in developing countries where herbicide sales and applications are poorly regulated.

5.
BMC Med Inform Decis Mak ; 24(1): 263, 2024 Sep 19.
Artículo en Inglés | MEDLINE | ID: mdl-39300415

RESUMEN

BACKGROUND: Recognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils. METHODS: Through a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils' use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana's largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints. RESULTS: A total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method. CONCLUSIONS: Generating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.


Asunto(s)
Embolización Terapéutica , Vigilancia de Productos Comercializados , Humanos , Embolización Terapéutica/instrumentación , Embolización Terapéutica/normas , Registros Electrónicos de Salud/normas , Masculino , Femenino , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Indiana , Adulto , Seguridad de Equipos/normas
6.
Clin Lung Cancer ; 2024 Aug 23.
Artículo en Inglés | MEDLINE | ID: mdl-39306555

RESUMEN

BACKGROUND: Patient-generated health data (PGHD), which includes patient-reported outcomes (PROs) and wearable device data, may have prognostic value for cancer patients. We tested that hypothesis using data from several prospective trials where patients with locally advanced non-small cell lung cancer (LA-NSCLC) were treated with definitive chemoradiotherapy. METHODS: Cox proportional hazards models were utilized to identify the baseline patient-reported symptom that best predicted progression-free survival (PFS) duration in a trial that involved PRO-CTCAE collection (Cohort 1). Using data from trials that included EORTC QLQ-C30 questionnaires and wearable devices (Cohort 2), the same symptom was tested as a predictor of PFS. Baseline physical inactivity was also tested as a predictor of PFS. A simple risk stratification tool utilizing PROs and physical activity was proposed. RESULTS: In Cohort 1 (n = 50), anorexia was the only pretreatment PRO that was significantly associated with PFS after Bonferroni correction (HR = 3.94, P = .002). In Cohort 2 (n = 58), baseline anorexia was also significantly associated with PFS (HR = 2.48, P = .018), as was physical inactivity (HR = 3.11, P < .001). Median PFS duration for patients in Cohort 2 with anorexia or physical inactivity was 6 months, compared to 18 months for other patients (HR = 3.08, P < .001). Median overall survival duration for patients with anorexia or physical inactivity was 19 months, compared to 65 months for other patients (HR = 2.44, P = .021). CONCLUSION: PGHD, including PROs and wearable device data, can provide valuable prognostic information for LA-NSCLC patients treated with definitive chemoradiotherapy. These findings should be validated using larger datasets.

7.
J Extra Corpor Technol ; 56(3): 128-135, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39303136

RESUMEN

INTRODUCTION: Ventricular assist devices represent a treatment option for patients with advanced heart failure, offering control over various haemodynamic variables. Similarly, the prescription of exercise within a cardiac rehabilitation programme for heart failure patients is recommended to reduce symptoms, and hospitalisations, improve cardiorespiratory fitness, and increase exercise tolerance. Therefore, exercise prescription can impact those with ventricular assist devices. Given the limited evidence on exercise-based cardiac rehabilitation programmes for this population, this review aims to describe the most commonly used strategies and their health benefits when physical exercise is included in a cardiac rehabilitation programme for patients with ventricular assist devices. MATERIALS AND METHODS: An exploratory review was conducted through searches in the databases: PubMed, SCOPUS, PeDro, and ScienceDirect. The search was limited to studies published between 2013 and 2023. Filters were applied independently by title, abstract, and full text. The included articles were analysed based on the description of the types of cardiac rehabilitation strategies used in patients with ventricular assist devices. RESULTS: Seven articles were included. Each programme employed a cardiopulmonary exercise test before prescribing physical exercise. The most commonly used strategy was aerobic exercise, predominantly high-intensity interval training (HIIT) with intensities close to 90% of peak VO2, followed by continuous moderate-intensity exercise. Limb strength exercises were included in three programmes. CONCLUSIONS: The analysed literature suggests that cardiac rehabilitation in patients with ventricular assist devices is safe and can provide benefits in cardiorespiratory fitness and exercise tolerance. High-intensity interval training is identified as an appropriate strategy for achieving results, offering short-term improvements.


Asunto(s)
Rehabilitación Cardiaca , Terapia por Ejercicio , Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Rehabilitación Cardiaca/métodos , Terapia por Ejercicio/métodos , Terapia por Ejercicio/instrumentación , Insuficiencia Cardíaca/rehabilitación , Tolerancia al Ejercicio
8.
J Orthop Surg Res ; 19(1): 583, 2024 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-39304891

RESUMEN

OBJECTIVE: Given the recent application of two new types of intramedullary nail devices in the treatment of comminuted femoral intertrochanteric fractures (CFIFs), there is still a lack of deep understanding and comparative evaluation of their biomechanical properties. Therefore, this study aims to systematically compare the advantages and disadvantages of these two new devices with traditional proximal femoral nail antirotation (PFNA) and InterTan nails in the fixation of CFIFs through finite element analysis. METHODS: Based on the validated finite element model, this study constructed an accurate CFIFs model. In this model, PFNA, InterTan nails, proximal femoral bionic nails (PFBN), and new intramedullary systems (NIS) were implanted, totaling four groups of finite element models. Each group of models was subjected to simulation tests under a vertical load of 2100 N to evaluate the displacement and Von Mises stress (VMS) distribution of the femur and intramedullary nail devices. RESULTS: Under a vertical load of 2100 N, a comparative analysis of the four finite element models showed that the NIS device exhibited the most superior performance in terms of peak displacement, while the PFNA device performed relatively poorly. Although the NIS device had the highest peak stress in the femur, it had the smallest peak displacement of both the femur and intramedullary nail devices, and the peak stress was mainly concentrated on the lateral side of the femur, with significantly lower stress in the proximal femur compared to the other three intramedullary nail devices. In contrast, the PFBN device had the lowest peak stress in the femur, and its peak displacement of both the femur and intramedullary nail devices was also less than that of PFNA and InterTan nails. CONCLUSION: This study demonstrates that in the treatment of CFIFs, PFBN and NIS devices exhibit superior biomechanical performance compared to traditional PFNA and InterTan nail devices. Especially the NIS device, which can achieve good biomechanical results when fixing femoral intertrochanteric fractures with missing medial wall. Therefore, both PFBN and NIS devices can be considered reliable closed reduction and internal fixation techniques for the treatment of CFIFs, with potential clinical application value.


Asunto(s)
Clavos Ortopédicos , Análisis de Elementos Finitos , Fijación Intramedular de Fracturas , Fracturas Conminutas , Fracturas de Cadera , Humanos , Fijación Intramedular de Fracturas/métodos , Fijación Intramedular de Fracturas/instrumentación , Fenómenos Biomecánicos , Fracturas de Cadera/cirugía , Fracturas Conminutas/cirugía , Fémur/cirugía
9.
Epilepsy Behav ; 161: 110034, 2024 Sep 21.
Artículo en Inglés | MEDLINE | ID: mdl-39306979

RESUMEN

OBJECTIVES: As epilepsy management medical devices emerge as potential technological solutions for prediction and prevention of sudden death in epilepsy (SUDEP), there is a gap in understanding the features and priorities that should be included in the design of these devices. This study aims to bridge the gap between current technology and emerging needs by leveraging insights from persons with epilepsy (PWE) and caregivers (CG) on current epilepsy management devices and understanding how SUDEP awareness influences preferences and design considerations for potential future solutions. METHODS: Two cross-sectional surveys were designed to survey PWE and CG on medical device design features, SUDEP awareness, and participation in medical device research. Data analysis included both qualitative thematic analysis and quantitative statistical analysis. RESULTS: The survey revealed that among 284 responses, CG were more aware of SUDEP than PWE. Comfort was identified as the primary concern regarding wearable medical devices for epilepsy management with significant differences between PWE and CG regarding acceptance and continuous use preferences. The thematic analysis identified integration with daily life, aesthetic and emotional resonance, adaptability to seizure characteristics, and user-centric design specifications as crucial factors to be considered for enhanced medical device adoption. The integration of a companion app is seen as an important tool to enhance communication and data sharing. DISCUSSION: This study reveals that while SUDEP awareness can promote the development of future SUDEP predictive and preventive medical devices, these should be designed to mitigate its impact on daily life and anxiety of both PWE and CG. Comfort and acceptance are seen as key priorities to support continuous use and are seen as a technical requirement of future medical devices for SUDEP prediction and prevention. Widespread adoption requires these technologies to be customizable to adapt to different lifestyles and social situations. A holistic approach should be used in the design of future medical devices to capture several dimensions of PWE and CG epilepsy management journey and uphold communication between healthcare professionals, PWE and CG. CONCLUSION: Data from this study highlight the importance of considering user preferences and experiences in the design of epilepsy management medical devices with potential applicability for SUDEP prediction and prevention. By employing user-centered design methods this research provides valuable insights to inform the development of future SUDEP prediction and prevention devices.

10.
Small ; : e2408182, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39308200

RESUMEN

Disposable wearable electronics are valuable for diagnostic and healthcare purposes, reducing maintenance needs and enabling broad accessibility. However, integrating a reliable power supply is crucial for their advancement, but conventional power sources present significant challenges. To address that issue, a novel paper-based moist-electric generator is developed that harnesses ambient moisture for power generation. The device features gradients for functional groups and moisture adsorption and architecture of nanostructures within a disposable paper substrate. The nanoporous, gradient-formed spore-based biofilm and asymmetric electrode deposition enable sustained high-efficiency power output. A Janus hydrophobic-hydrophilic paper layer enhances moisture harvesting, ensuring effective operation even in low-humidity environments. This research reveals that the water adsorption gradient is crucial for performance under high humidity, whereas the functional group gradient is dominant under low humidity. The device delivers consistent performance across diverse conditions and flexibly conforms to various surfaces, making it ideal for wearable applications. Its eco-friendly, cost-effective, and disposable nature makes it a viable solution for widespread use with minimal environmental effects. This innovative approach overcomes the limitations of traditional power sources for wearable electronics, offering a sustainable solution for future disposable wearables. It significantly enhances personalized medicine through improved health monitoring and diagnostics.

11.
Small ; : e2407359, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39308281

RESUMEN

Against the backdrop of rapid advancements in 5G and Internet of Things (IoT) technologies, there is an urgent need to upgrade food sensing systems to achieve automation, digitalization, and intelligence. However, this transformation process faces numerous challenges. Triboelectric nanogenerators (TENGs), as an emerging energy conversion and sensing technology, play a crucial role in this context. They not only provide power to functional devices but also serve as sensors in multifunctional self-powered food sensing systems, capable of detecting various physical and chemical information. This review explores the development of TENGs in the field of food sensing, focusing on the working principles of their self-powered sensing. The review also systematically organizes and classifies the material and device designs used for TENGs in various food applications. Based on the performance of TENGs, a detailed introduction is provided on the specific applications of self-powered food sterilization, self-powered food quality monitoring, and self-powered taste sensing in the field of food safety. Finally, this paper discusses the challenges and corresponding strategies of TENGs in the food sensing field. The aim is to further promote unmanned and smart services and management in the food sector and to provide new research perspectives.

12.
ACS Appl Bio Mater ; 2024 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-39279649

RESUMEN

Neuromorphic vision systems, particularly those stimulated by ultraviolet (UV) light, hold great potential applications in portable electronics, wearable technology, biological analysis, military surveillance, etc. Organic artificial synaptic devices hold immense potential in this field due to their ease of processing, flexibility, and biocompatibility. In this work, we have fabricated a flexible organic field-effect transistor (OFET) that utilizes chitosan-silver nanoparticles (AgNPs) composite material as the active dielectric material. During UV light illumination, both silver nanoparticles and the pentacene layer generate a large number of charge carriers. The photogenerated carriers lead to a more significant hole accumulation at the pentacene interface, resulting in a current rise. In the absence of light, the trapped electron in the silver nanoparticles persists for a longer duration, preventing the instant recombination with holes. This extended retention of electrons leads to the observed synaptic performance of the transistor. The use of aluminum oxide (Al2O3) as one of the dielectric layers enables the device to operate effectively at low voltage (<1 V). The device mimics various crucial synaptic properties of the brain, including short-term potentiation and long-term potentiation (STP and LTP), paired-pulse facilitation (PPF), spike-duration dependent plasticity (SDDP), spike-number dependent plasticity (SNDP), and spike-rate dependent plasticity (SRDP), etc. This work introduces an approach to develop flexible organic synaptic transistors that operate efficiently at low voltages, paving the way toward high-performance, UV light-driven neuromorphic vision systems.

13.
Artículo en Inglés | MEDLINE | ID: mdl-39279687

RESUMEN

OBJECTIVE: We assessed whether the administration of oral ketorolac with an analgesic provides effective pain relief during placement of an intrauterine device (IUD) in nulligravid women. METHODS: We conducted a double-blinded randomised trial in the Department of Obstetrics and Gynaecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. We randomised participants who voluntarily agreed to participate to receive either one pill containing ketorolac 20 mg together with one pill containing dipyrone 300 mg, scopolamine 6.5 µg, hyoscyamine 104 µg, and homatropine 1 mg or placebo 60 min before IUD placement. The participants and providers were blinded to the randomisation group. The primary outcome was pain assessment (measured on a 0-10 visual analogue scale) during IUD placement. RESULTS: We enrolled participants and randomised them 1:1 between November 7, 2023, and January 31, 2024. We analysed 60 women in each group. There were no differences between the groups in the pain score during tenaculum placement, uterine sounding, and IUD placement, and in the overall perception of pain. However, the pain score was significantly lower 10 min after the procedure in women who received the treatment compared with women who received the placebo. CONCLUSION: Oral ketorolac associated with an analgesic administered 60 min before IUD placement was not significantly better than placebo during tenaculum placement, uterine sounding, and IUD insertion, and did not significantly reduce the overall pain perception. However, this treatment did significantly reduce pain 10 min after the procedure. TRIAL REGISTRATION: The trial was registered at Registro Brasileiro de Ensaios Clínicos (REBEC; in English: The Brazilian Registry of Clinical Trials) under number RBR-7phn8yv on November 6, 2023. https://ensaiosclinicos.gov.br/rg/RBR-7phn8yv.


Pain at IUD placement after one pill containing ketorolac 20 mg together with one analgesic pill given 60 min before placement were similar than placebo.

14.
ACS Appl Mater Interfaces ; 16(37): 49620-49627, 2024 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-39231382

RESUMEN

Optoelectronic logic devices (OELDs) provide a cure for many visually impaired individuals. However, traditional OELDs have limitations, such as excessive channel resistance and complex structure, leading to high supply voltage and decreased efficiency of signal transmission. We report ultralow-voltage OELDs by seriating two 2D MoTe2 transistors with sub-10 nm channel lengths. The short channel length and atomically flat interface result in a low-resistance light-sensing unit that can operate with a low supply voltage and function well in weak-light conditions. The devices achieve an on state without light signal input and an off state with light signal input at an ultralow supply voltage of 50 mV, lower than the retinal bearing voltage of 70 mV. Additionally, MoTe2's excellent optoelectronic properties allow the device to perceive light from visible to near-infrared wavelengths with high sensitivity to weak light signals. The specific perception of visible light intensity is 0.03 mW·mm-2, and the near-infrared light intensity is 0.1 mW mm-2. The device also has a response time of 8 ms, meeting human needs. Our findings provide a promising solution for developing low-voltage artificial retinas.

15.
ACS Appl Mater Interfaces ; 16(37): 48927-48936, 2024 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-39238144

RESUMEN

Ionic gels are emerging as a promising solution for improving the functionality of electrochromic devices. They are increasingly drawing attention in the fields of electrochemistry and functional materials due to their potential to address issues associated with traditional liquid electrolytes, such as volatility, toxicity, and leakage. In extreme scenarios and/or the design of flexible devices, ionic gel electrolytes offer unique and invaluable advantages. This perspective delves into the application of ionic gels in electrochromic devices, exploring various methods to enhance their performance. After briefly introducing developments in ionic gels for electrochromic devices, the trends and key points of future development are discussed in detail.

16.
Sci Rep ; 14(1): 21576, 2024 09 16.
Artículo en Inglés | MEDLINE | ID: mdl-39285189

RESUMEN

Adolescents' extensive use of digital devices raises significant concerns about their visual health. This study aimed to adapt and validate the computer vision syndrome questionnaire (CVS-Q©) for adolescents aged 12-17 years. A mixed-method sequential design was used. First, a qualitative study was involved two nominal groups to assess the instrument's acceptability. A subsequent cross-sectional quantitative study with 277 randomly selected adolescents assessed reliability and validity. Participants completed the adapted CVS-Q©, an ad hoc questionnaire, and the ocular surface disease index (OSDI) questionnaire. Repeatability was tested in 54 adolescents after 7-14 days. The Rasch-Andrich rating scale model was used. Instructions and symptoms were modified to obtain the 14-item CVS-Q teen©. It showed unidimensionality, no local dependence between items, and respected monotonicity. Adequate internal consistency (person reliability = 0.69, item reliability = 0.98) and intraobserver reliability (intraclass correlation coefficient = 0.77, Cohen's Kappa = 0.49) were observed. A significant correlation (0.782, p < 0.001) between CVS-Q teen© and OSDI supported construct validity. A score of ≥ 6 points indicated computer vision syndrome (CVS) (sensitivity = 85.2%, specificity = 76.5%, and area under the curve = 0.879). In conclusion, CVS-Q teen© is a valid and reliable instrument for assessing CVS in adolescents using digital devices, applicable in research and clinical practice for early identification and recommendations for visual health.


Asunto(s)
Trastornos de la Visión , Humanos , Adolescente , Femenino , Masculino , Encuestas y Cuestionarios , Niño , Estudios Transversales , Reproducibilidad de los Resultados , Trastornos de la Visión/diagnóstico , Síndrome
17.
J Pharm Policy Pract ; 17(1): 2399722, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39291054

RESUMEN

Background: Good Manufacturing Practices (GMP) is the bedrock of quality assurance in the pharmaceutical industry that ensures that products are consistently produced and controlled according to quality standards. This study compared the GMP conformance of pharmaceutical facilities across two fiscal years, 2018/2019 and 2019/2020, using the East African GMP Compendium on Good Manufacturing Practices, 2014, as a benchmark. Methods: We analyzed the proportion of conformance of foreign pharmaceutical industries to GMP standards and reported the aggregated data over a two-year period. Results: Inspected facilities had notable non-conformances, most commonly related to laboratory quality control and premises. We noted a downward trend in conformance in 2019/2020 compared with 2018/2019, with only 32.9% of facilities adhering to EAC GMP requirements, down from 50% in the previous year. The COVID-19 pandemic has affected the ability to conduct on-site inspections, and may have contributed to the lower conformance rate. Conclusions: These findings underscore the crucial need to continue GMP inspections and the importance of taking corrective actions to ensure adherence to the quality standards for products marketed in Tanzania. The study further revealed the significance of desk reviews in assisting regulatory authorities in facing unforeseen challenges such as pandemics.

18.
Digit Health ; 10: 20552076241277150, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39291151

RESUMEN

Objective: Wearable monitors are increasingly used to assess sleep. However, validity is unknown for certain monitors and populations. We tested the Garmin Vivofit 4 in a pediatric clinical sample. Methods: Participants (n = 25) wore the monitor on their nondominant wrist during an overnight polysomnogram. Garmin and polysomnography were compared using 95% equivalence testing, mean absolute error, and Bland-Altman analysis. Results: On average (mean ± SD), the Garmin predicted later sleep onset (by 0.84 ± 1.60 hours) and earlier sleep offset (by 0.34 ± 0.70 hours) than polysomnography. The resulting difference for total sleep time was -0.55 ± 1.21 hours. Sleep onset latency was higher for Garmin than polysomnography (77.4 ± 100.9 and 22.8 ± 20.0 minutes, respectively), while wake after sleep onset was lower (5.2 ± 9.3 and 43.2 ± 37.9 minutes, respectively). Garmin sleep efficiency averaged 3.3% ± 13.8% lower than polysomnography. Minutes in light sleep and deep sleep (the latter including rapid eye movement) were within ±3.3% of polysomnography (both SDs = 14.9%). No Garmin means were significantly equivalent with polysomnography (adjusted p > 0.99). Mean absolute errors were 0.47 to 0.95 hours for time-based variables (sleep onset, offset, and latency, plus total sleep time and wake after sleep onset), and 8.9% to 21.2% for percentage-based variables (sleep efficiency and sleep staging). Bland-Altman analysis showed systematic bias for wake after sleep onset, but not other variables. Conclusions: The Vivofit 4 showed consistently poor individual-level validity, while group-level validity was better for some variables (total sleep time and sleep efficiency) than others.

19.
J Rehabil Assist Technol Eng ; 11: 20556683241280733, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39290655

RESUMEN

People with transtibial limb loss frequently experience suboptimal gait outcomes. This is partly attributable to the absence of the biarticular gastrocnemius muscle, which plays a unique role in walking. Although a recent surge of biarticular prostheses aims to restore gastrocnemius function, the broad design space and lack of consensus on optimal hardware and control strategies present scientific and engineering challenges. This study introduces a robotic biarticular prosthesis emulator, comprising a uniarticular ankle-foot prosthesis and knee flexion exoskeleton, each actuated by a custom off-board system. Benchtop experiments were conducted to characterize the emulator's mechatronic performance. Walking experiments with one transtibial amputee demonstrated the system's capability to provide knee and ankle assistance. The -3 dB bandwidths for the knee exoskeleton's torque and motor velocity controllers were measured at approximately 5 Hz and 100 Hz, respectively. A feedforward iterative learning controller reduced the root-mean-squared torque tracking error from 6.04 Nm to 0.99 Nm in hardware-in-the-loop experiments, an 84% improvement. User-preference-based tuning yielded a peak knee torque of approximately 20% of the estimated biological knee moment. This biarticular prosthesis emulator demonstrates significant potential as a versatile research platform that can offer valuable insights for the advancement of lower-limb assistive devices.

20.
Sleep Biol Rhythms ; 22(4): 471-479, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39300986

RESUMEN

This study aimed to examine the effects of "adaptive" bedtime routines on a child's well-being, either directly or indirectly through sleep health. A web-based survey was conducted on 700 adults (321 male, 379 female, mean age = 39.98 years, SD = 6.33 years) responsible for preschool children aged 4-6 years old. Results of the mediation analysis showed that the bedtime routines index (BTR-Index[S]) could not confirm any significant regression coefficient with the total disturbance score of the Strengths and Difficulties Questionnaire (SDQ_TDS) (ß = -0.063, p = 0.094) and the total sleep disturbance of Children's Sleep Habits Questionnaire (CSHQ_TSD) (ß = -0.013, p = 0.736) in a single regression analysis. Sobel's test did not confirm any significant indirect effect (Z = -0.337, p = 0.736). As exploratory examination of the relationships between each of the items of BTR-Index(S) with SDQ_TDS and CSHQ_TSD, multiple regression analysis showed a significant positive partial regression coefficient for "Reading/sharing a story before bed" (ß = 0.228, p = 0.006) and a significant negative partial regression coefficient for"Avoiding the use of electronic devices before bed" (ß = -0.222, p = 0.011) towards CSHQ_TSD, with no significant partial regression coefficient identified for SDQ_TDS in any of the items. These findings suggest that bedtime routines do not directly either indirectly, through their sleep health, affect a child's well-being. However, caregivers' deliberate attempt to avoid stimuli that increases children's wakefulness before bedtime may serve as protection for the child's sleep health.

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