Personalized Management of Fatigue in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Long COVID Using a Smart Digital mHealth Solution: Protocol for a Participatory Design Approach.

BACKGROUND: Fatigue is the most common symptom in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, impacting patients' quality of life; however, there is currently a lack of evidence-based context-aware tools for fatigue self-management in these populations. OBJECTIVE: This study aimed to (1) address fatigue in ME/CFS and long COVID through the development of digital mobile health solutions for self-management, (2) predict perceived fatigue severity using real-time data, and (3) assess the feasibility and potential benefits of personalized digital mobile health solutions. METHODS: The MyFatigue project adopts a patient-centered approach within the participatory health informatics domain. Patient representatives will be actively involved in decision-making processes. This study combines inductive and deductive research approaches, using qualitative studies to generate new knowledge and quantitative methods to test hypotheses regarding the relationship between factors like physical activity, sleep behaviors, and perceived fatigue in ME/CFS and long COVID. Co-design methods will be used to develop a personalized digital solution for fatigue self-management based on the generated knowledge. Finally, a pilot study will evaluate the feasibility, acceptance, and potential benefits of the digital health solution. RESULTS: The MyFatigue project opened to enrollment in November 2023. Initial results are expected to be published by the end of 2024. CONCLUSIONS: This study protocol holds the potential to expand understanding, create personalized self-management approaches, engage stakeholders, and ultimately improve the well-being of individuals with ME/CFS and long COVID. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50157.

Personalized Digital Solutions for Mental Health.

INTRODUCTION: Mental health is one of the major global concerns in the field of healthcare. The emergence of digital solutions is proving to be a great aid for individuals suffering from mental health disorders. These solutions are particularly useful and effective when they are personalized. The objective of this paper is to understand the personalization factors and the methods that have been used to collect information to personalize the digital mental health solutions. METHODS: This paper builds on a previous review that analyzed the personalization of digital solutions in mHealth, and expands on the extracted information for the specific case of mental health. RESULTS: Ten mental health digital solutions have been analyzed. The paper focuses on targeted conditions, personalization factors and the methods used for collecting personalization factors. DISCUSSION: The analyzed mental health digital solutions cover a wide range of health conditions. It is remarkable that most articles do not explicitly mention the factors used to personalize the solution. Among the solutions that mention them, there is a great diversity of factors utilized, such as age, gender, user preferences, and subjective behavior. The authors point out the methods for obtaining data to personalize the solutions, including in-app questionnaires, self-reports, and usage data of the solutions. CONCLUSIONS: The analysis of current mental health digital solutions emphasizes the need to create guidelines for designing personalized digital solutions for mental health.

Designing personalised mHealth solutions: An overview.

INTRODUCTION: Mobile health, or mHealth, is based on mobile information and communication technologies and provides solutions for empowering individuals to participate in healthcare. Personalisation techniques have been used to increase user engagement and adherence to interventions delivered as mHealth solutions. This study aims to explore the current state of personalisation in mHealth, including its current trends and implementation. MATERIALS AND METHODS: We conducted a review following PRISMA guidelines. Four databases (PubMed, ACM Digital Library, IEEE Xplore, and APA PsycInfo) were searched for studies on mHealth solutions that integrate personalisation. The retrieved papers were assessed for eligibility and useful information regarding integrated personalisation techniques. RESULTS: Out of the 1,139 retrieved studies, 62 were included in the narrative synthesis. Research interest in the personalisation of mHealth solutions has increased since 2020. mHealth solutions were mainly applied to endocrine, nutritional, and metabolic diseases; mental, behavioural, or neurodevelopmental diseases; or the promotion of healthy lifestyle behaviours. Its main purposes are to support disease self-management and promote healthy lifestyle behaviours. Mobile applications are the most prevalent technological solution. Although several design models, such as user-centred and patient-centred designs, were used, no specific frameworks or models for personalisation were followed. These solutions rely on behaviour change theories, use gamification or motivational messages, and personalise the content rather than functionality. A broad range of data is used for personalisation purposes. There is a lack of studies assessing the efficacy of these solutions; therefore, further evidence is needed. DISCUSSION: Personalisation in mHealth has not been well researched. Although several techniques have been integrated, the effects of using a combination of personalisation techniques remain unclear. Although personalisation is considered a persuasive strategy, many mHealth solutions do not employ it. CONCLUSIONS: Open research questions concern guidelines for successful personalisation techniques in mHealth, design frameworks, and comprehensive studies on the effects and interactions among multiple personalisation techniques.

A Proposal for a Robust Validated Weighted General Data Protection Regulation-Based Scale to Assess the Quality of Privacy Policies of Mobile Health Applications: An eDelphi Study.

BACKGROUND: Health care services are undergoing a digital transformation in which the Participatory Health Informatics field has a key role. Within this field, studies aimed to assess the quality of digital tools, including mHealth apps, are conducted. Privacy is one dimension of the quality of an mHealth app. Privacy consists of several components, including organizational, technical, and legal safeguards. Within legal safeguards, giving transparent information to the users on how their data are handled is crucial. This information is usually disclosed to users through the privacy policy document. Assessing the quality of a privacy policy is a complex task and several scales supporting this process have been proposed in the literature. However, these scales are heterogeneous and even not very objective. In our previous study, we proposed a checklist of items guiding the assessment of the quality of an mHealth app privacy policy, based on the General Data Protection Regulation. OBJECTIVE: To refine the robustness of our General Data Protection Regulation-based privacy scale to assess the quality of an mHealth app privacy policy, to identify new items, and to assign weights for every item in the scale. METHODS: A two-round modified eDelphi study was conducted involving a privacy expert panel. RESULTS: After the Delphi process, all the items in the scale were considered "important" or "very important" (4 and 5 in a 5-point Likert scale, respectively) by most of the experts. One of the original items was suggested to be reworded, while eight tentative items were suggested. Only two of them were finally added after Round 2. Eleven of the 16 items in the scale were considered "very important" (weight of 1), while the other 5 were considered "important" (weight of 0.5). CONCLUSION: The Benjumea privacy scale is a new robust tool to assess the quality of an mHealth app privacy policy, providing a deeper and complementary analysis to other scales. Also, this robust scale provides a guideline for the development of high-quality privacy policies of mHealth apps.

Assessment of the Fairness of Privacy Policies of Mobile Health Apps: Scale Development and Evaluation in Cancer Apps.

BACKGROUND: Cancer patients are increasingly using mobile health (mHealth) apps to take control of their health. Many studies have explored their efficiency, content, usability, and adherence; however, these apps have created a new set of privacy challenges, as they store personal and sensitive data. OBJECTIVE: The purpose of this study was to refine and evaluate a scale based on the General Data Protection Regulation and assess the fairness of privacy policies of mHealth apps. METHODS: Based on the experience gained from our previous work, we redefined some of the items and scores of our privacy scale. Using the new version of our scale, we conducted a case study in which we analyzed the privacy policies of cancer Android apps. A systematic search of cancer mobile apps was performed in the Spanish version of the Google Play website. RESULTS: The redefinition of certain items reduced discrepancies between reviewers. Thus, use of the scale was made easier, not only for the reviewers but also for any other potential users of our scale. Assessment of the privacy policies revealed that 29% (9/31) of the apps included in the study did not have a privacy policy, 32% (10/31) had a score over 50 out of a maximum of 100 points, and 39% (12/31) scored fewer than 50 points. CONCLUSIONS: In this paper, we present a scale for the assessment of mHealth apps that is an improved version of our previous scale with adjusted scores. The results showed a lack of fairness in the mHealth app privacy policies that we examined, and the scale provides developers with a tool to evaluate their privacy policies.

Privacy Assessment in Mobile Health Apps: Scoping Review.

BACKGROUND: Privacy has always been a concern, especially in the health domain. The proliferation of mobile health (mHealth) apps has led to a large amount of sensitive data being generated. Some authors have performed privacy assessments of mHealth apps. They have evaluated diverse privacy components; however, different authors have used different criteria for their assessments. OBJECTIVE: This scoping review aims to understand how privacy is assessed for mHealth apps, focusing on the components, scales, criteria, and scoring methods used. A simple taxonomy to categorize the privacy assessments of mHealth apps based on component evaluation is also proposed. METHODS: We followed the methodology defined by Arksey and O'Malley to conduct a scoping review. Included studies were categorized based on the privacy component, which was assessed using the proposed taxonomy. RESULTS: The database searches retrieved a total of 710 citations-24 of them met the defined selection criteria, and data were extracted from them. Even though the inclusion criteria considered articles published since 2009, all the studies that were ultimately included were published from 2014 onward. Although 12 papers out of 24 (50%) analyzed only privacy, 8 (33%) analyzed both privacy and security. Moreover, 4 papers (17%) analyzed full apps, with privacy being just part of the assessment. The evaluation criteria used by authors were heterogeneous and were based on their experience, the literature, and/or existing legal frameworks. Regarding the set of items used for the assessments, each article defined a different one. Items included app permissions, analysis of the destination, analysis of the content of communications, study of the privacy policy, use of remote storage, and existence of a password to access the app, among many others. Most of the included studies provided a scoring method that enables the comparison of privacy among apps. CONCLUSIONS: The privacy assessment of mHealth apps is a complex task, as the criteria used by different authors for their evaluations are very heterogeneous. Although some studies about privacy assessment have been conducted, a very large set of items to evaluate privacy has been used up until now. In-app information and privacy policies are primarily utilized by the scientific community to extract privacy information from mHealth apps. The creation of a scale based on more objective criteria is a desirable step forward for privacy assessment in the future.

Linear and Nonlinear Calibration Methods for Predicting Mechanical Properties of Polypropylene Pellets Using Raman Spectroscopy.

A nondestructive and faster methodology to quantify mechanical properties of polypropylene (PP) pellets, obtained from an industrial plant, was developed with Raman spectroscopy. Raman spectra data were obtained from several types of samples such as homopolymer PP, random ethylene-propylene copolymer, and impact ethylene-propylene copolymer. Multivariate calibration models were developed by relating the changes in the Raman spectra to mechanical properties determined by ASTM tests (Young's traction modulus, tensile strength at yield, elongation at yield on traction, and flexural modulus at 1% secant). Several strategies were evaluated to build robust models including the use of preprocessing methods (baseline correction, vector normalization, de-trending, and standard normal variate), selecting the best subset of wavelengths to model property response and discarding irrelevant variables by applying genetic algorithm (GA). Linear multivariable models were investigated such as partial least square regression (PLS) and PLS with genetic algorithm (GA-PLS) while nonlinear models were implemented with artificial neural network (ANN) preceded by GA (GA-ANN). The best multivariate calibration models were obtained when a combination of genetic algorithms and artificial neural network were used on Raman spectral data with relative standard errors (%RSE) from 0.17 to 0.41 for training and 0.42 to 0.88% validation data sets.

BAES Scrotal flap: anatomical bases and usefulness in complex urethral reconstruction.

OBJECTIVE: To describe the anatomical characteristics and vascularization of the biaxial hair free scrotal flap (BAES-flap) and to detail its surgical application to reconstruction of the more complex urethral strictures. METHODS: We performed macro and micro anatomical dissections of the scrotum in 15 cryopreserved cadavers for the study of the arterial microvascularization of the BAES flap, and this anatomical knowledge has been implemented with the aim to improve the anterior and posterior urethra reconstructive surgical technique. For scrotal skin conditioning we performed definitive hair removal with the alexandrite laser. RESULTS: The BAES flap, thanks to its rich biaxial vascularization, its anatomical disposition over the urethral axis, and the suitable characteristics of hair free scrotal skin, has allowed us to perform successful one-step urethral reconstruction in complex cases such as panurethral disease, multioperated hypospadias, failed urethroplasties and obliterative stenosis. CONCLUSIONS: Detailed study of scrotal skin arterial vascularization is essential to design reliable and versatile genital skin flaps that result appropriate for the most complex reconstructive urethral surgery. The BAES scrotal flap complies with these requirements offering the patient a one step reconstructive option with a very satisfactory surgical experience over more than 20 years.

Colgajo escrotal "BAES": Bases anatómicas y utilidad en reconstrucción uretral compleja / BAES Scrotal flap: Anatomical bases and usefulness in complex urethral reconstruction

OBJETIVO: Describir las características anatómicas y la vascularización del colgajo escrotal biaxial depilado ("BAES-flap"), y detallar su aplicación quirúrgica en la reconstrucción de las estenosis uretrales más complejas. MÉTODOS: Se han realizado macro y microdisecciones anatómicas de la bolsa escrotal en 15 cadáveres criopreservados para estudiar la microvascularización arterial que posee el colgajo "BAES", y este conocimiento anatómico ha sido implementado con la intención de mejorar la técnica quirúrgica reconstructiva de la uretra anterior y posterior. Para el acondicionamiento cutáneo escrotal se ha empleado la técnica de depilación definitiva con láser de Alejandrita. RESULTADOS: El colgajo "BAES" gracias a su abundante vascularización bi-axial, a su disposición anatómica sobre el eje uretral y a las características idóneas de la piel escrotal depilada, nos ha permitido desde el año 1989 reconstruir con éxito la uretra en un tiempo quirúrgico en casos complejos como son la enfermedad panuretral, los hipospadias multioperados, las uretroplastias fracasadas y las estenosis obliterantes. CONCLUSIONES: El estudio detallado de la vascularización cutánea arterial es fundamental para diseñar colgajos de piel genital fiables y versátiles que resulten aptos para la cirugía reconstructiva uretral más compleja. El colgajo escrotal "BAES" cumple con estos requisitos ofreciendo al paciente una opción reconstructiva en un solo tiempo con una experiencia quirúrgica muy satisfactoria de más de 20 años

OBJECTIVE: To describe the anatomical characteristics and vascularization of the biaxial hair free scrotal flap (BAES-flap) and to detail its surgical application to reconstruction of the more complex urethral strictures. METHODS: We performed macro and micro anatomical dissections of the scrotum in 15 cryopreserved cadavers for the study of the arterial microvascularization of the BAES flap, and this anatomical knowledge has been implemented with the aim to improve the anterior and posterior urethra reconstructive surgical technique. For scrotal skin conditioning we performed definitive hair removal with the alexandrite laser. RESULTS: The BAES flap, thanks to its rich biaxial vascularization, its anatomical disposition over the urethral axis, and the suitable characteristics of hair free scrotal skin, has allowed us to perform successful one-step urethral reconstruction in complex cases such as panurethral disease, multioperated hypospadias, failed urethroplasties and obliterative stenosis. CONCLUSIONS: Detailed study of scrotal skin arterial vascularization is essential to design reliable and versatile genital skin flaps that result appropriate for the most complex reconstructive urethral surgery. The BAES scrotal flap complies with these requirements offering the patient a one step reconstructive option with a very satisfactory surgical experience over more than 20 years

[Holmium laser enucleation of the prostatic adenoma]. / Enucleación del adenoma prostático mediante el láser de Holmio (HOLEP).

Holmium laser enucleation of the prostatic adenoma (HoLEP) represents an innovative surgical option for the treatment of bladder outlet obstruction caused by benign prostatic hypertrophy. The results of numerous randomized prospective studies and clinical case series have confirmed that HoLEP is a procedure that attains immediate bladder outlet obstruction release, that improvement of symptomatic and uroflowmetry parameters is maintained in the midterm and, it is associated with less morbidity than conventional surgery. On the other hand, the shortage of urologists with experience in this procedure, and its technical difficulty have limited its spread in our environment. In this article we describe in detail the technique we use in our center for the performance of HoLEP, emphasizing the modifications we have introduced with time to make the operation easier and to avoid complications.

Enucleación del adenoma prostático mediante el láser de holmio (HOLEP) / No disponible

La enucleación del adenoma prostático mediante el láser de holmio (HoLEP) representa una novedosa alternativa quirúrgica para el tratamiento de la obstrucción infravesical ocasionada por el crecimiento prostático benigno. Los resultados de numerosos estudios prospectivos aleatorizados y de series de casos clínicos han confirmado que HoLEP es un procedimiento que logra una desobstrucción infravesical inmediata, que la mejoría de los parámetros sintomáticos y flujométricos que consigue se mantiene a medio plazo y que se asocia a menor morbilidad que la cirugía convencional. Por contra, la escasez de urólogos con experiencia en el procedimiento y su dificultad técnica han limitado su difusión en nuestro medio. En el presente trabajo describimos detalladamente la técnica que empleamos en nuestro centro para la realización de HoLEP, haciendo hincapié en las modificaciones que hemos ido realizando con el tiempo para facilitar la cirugía y evitar las complicaciones(AU)

Holmium laser enucleation of the prostatic adenoma (HoLEP) represents an innovative surgical option for the treatment of bladder outlet obstruction caused by benign prostatic hypertrophy. The results of numerous randomized prospective studies and clinical case series have confirmed that HoLEP is a procedure that attains immediate bladder outlet obstruction release, that improvement of symptomatic and uroflowmetry parameters is maintained in the midterm and, it is associated with less morbidity than conventional surgery. On the other hand, the shortage of urologists with experience in this procedure, and its technical difficulty have limited its spread in our environment. In this article we describe in detail the technique we use in our center for the performance of HoLEP, emphasizing the modifications we have introduced with time to make the operation easier and to avoid complications(AU)

Near-infrared chemical imaging slope as a new method to study tablet compaction and tablet relaxation.

Near-infrared chemical imaging (NIR-CI) spectra of lactose monohydrate tablets were acquired and the spectral slope from each pixel in the data hypercube was used to assess tablet compaction and relaxation. Tablets were prepared at compaction pressures of 100, 300, and 500 MPa using un-lubricated and magnesium stearate lubricated lactose monohydrate. Results show that NIR slope distribution is a function of applied compaction forces and magnesium stearate lubrication. The distribution of NIR slope values was studied using histograms and statistical parameters. The mean slope value yields a linear calibration curve that predicts tablet compaction pressure as a function of spectral slope. The NIR-CI slope measurements were also used to study tablet relaxation, which occurs as tablets release some of the stored energy from compression. The NIR-CI slope method provides a qualitative description of the relaxation process and provides quantitative information describing relaxation through time.

Deconvolution of chemical and physical information from intact tablets NIR spectra: two- and three-way multivariate calibration strategies for drug quantitation.

A three-way calibration strategy has been used to develop a simple method for drug quantitation in intact pharmaceutical tablets. The experimental design defined for the three-way calibration gathers a large variation in drug concentration (15-85% w/w) and compaction pressure (100-500 MPa). These could be process variable ranges during the development of a pharmaceutical formulation following the quality by design (QbD) approach. When a large variation in both chemical and physical variables is defined, the traditional two-way calibration strategies, such as partial least squares (PLS), do not allow the obtaining of multivariate model with good predictive ability (nonlinear predictions and prediction error over 8% w/w). The presented strategy uses parallel factor analysis (PARAFAC) to deconvolute the spectra in scores associated with drug concentration variation, and loadings related with wavelength range and compaction range. The PARAFAC deconvolution was followed by multiple linear regression (MLR) to obtain the simple calibration model with a better predictive ability on the whole compaction pressure range (prediction error less than 1.4% w/w). The proposed three-way strategy can be easily designed and executed, obtaining a multivariate analytical method more robust than using a traditional two-way modeling technique.

Analysis of low content drug tablets by transmission near infrared spectroscopy: selection of calibration ranges according to multivariate detection and quantitation limits of PLS models.

The content uniformity of low dose products is a major concern in the development of pharmaceutical formulations. Near infrared spectroscopy may be used to support the design and optimization of potent drug manufacturing processes through the analysis of blends and tablets in a relatively short time. A strategy for the selection of concentration ranges in the development of multivariate calibration is presented, evaluating the detection and quantitation limits of the obtained multivariate models. The strategy has been applied to the determination of an active principle in pharmaceutical tablets of low concentration (0-5%, w/w), using Fourier Transform Near Infrared (FT-NIR) transmission spectroscopy. The quantitation and detection limits decreased as the upper concentration level of the calibration models was reduced. The results obtained show that the selection of concentration ranges is a critical aspect during model design. The selection of wide concentration ranges with high levels is not recommended for the determination of analytes at minor levels (<1%, w/w), even when the concentration of interest is within the range of the model.

Near-infrared spectroscopic method for real-time monitoring of pharmaceutical powders during voiding.

A near-infrared (NIR) spectroscopic method has been developed to monitor flowing pharmaceutical powders during their voiding and detect post-blending segregation. The method is capable of providing both chemical and physical information (particle size differences) on the flowing pharmaceutical powders. Particle size differences are widely recognized as the predominant driver for segregation. Pharmaceutical powders may segregate following blending as they are voided down pipes to compressing machines, increasing the variability of the drug content and dissolution of the final product tablets because of segregation. NIR diffuse reflectance spectra of pharmaceutical powders were obtained following voiding through a six-foot pipe. Spectral subtraction was used to eliminate baseline differences but maintain particle size differences. The NIR spectra indicated differences in the particle size of the flowing powder. Particle size differences were also tracked throughout the voiding of pharmaceutical powders by plotting the absorbance at 1536 nm. The method was also applied to the voiding of two layers of lactose particles with different particle sizes. The system described in this report provides an approach to study post-blending segregation in pharmaceutical powders and other relevant materials.