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Pedro Montagut-Martínez,1 Jose Joaquin García-Arenas,2 Matilde Romero-López,3 Nicomedes Rodríguez-Rodríguez,3 David Pérez-Cruzado,2,4 Jesús González-Lama3,5 1Health Sciences PhD Program, Universidad Católica de Murcia UCAM, Murcia, 30107, Spain; 2Department of Occupational Therapy, Universidad Catolica de Murcia UCAM, Murcia, 30107, Spain; 3Cabra Clinical Management Unit, Sur de Córdoba Health Management Area, Cordoba, Spain; 4Institute of Biomedicine of Malaga (IBIMA), Málaga, Spain; 5Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, SpainCorrespondence: David Pérez-Cruzado, Department of Occupational Therapy, Universidad Catolica de Murcia UCAM, Campus de los Jerónimos n° 135, Guadalupe, Murcia, 30107, Spain, Tel +34 653141109, Email d_perez_cruzado@hotmail.comPurpose: Patients with diabetes mellitus have an increased risk of developing various serious health problems that could be life-threatening. These problems are associated with the difficulty of these patients in managing their lifestyle, which may even lead to the abandonment of treatment. The present study was designed to evaluate the feasibility of a multipurpose activity control solution for home activity (home activity control system), which will provide information on the activities of daily living carried out outside in real time, to improve adherence to each of the therapeutic objectives agreed on with the diabetic patient.Patients and Methods: A pilot randomised controlled feasibility study will be carried out to evaluate a home activity control system (Beprevent) in managing patients with type 2 diabetes mellitus. Twenty patients with type 2 diabetes mellitus will be included (10 in the intervention group and 10 in the control group). Data on satisfaction with the tool will be collected from professionals and patients, as well as other clinical/epidemiological data from their digital health records and several questionnaires, at baseline and six months. In addition, data will also be recorded regarding the degree of adherence to the behaviors agreed on with the patients before starting the study to assess changes throughout the study and their relationship with clinical results (glycosylated haemoglobin (HbA1c), cholesterol, etc), and to compare these outcomes between two study groups.Discussion: This project involves the incorporation of telemedicine in the management of patients with diabetes. Thus, according to the currently published bibliography, the use of smart devices in this population could help improve the quality of life of these people, reduce medical visits and improve adherence to home care patterns for diabetes mellitus. There are currently no published clinical trials or protocols that monitor activities of daily living in patients with diabetes individually using artificial intelligence (AI) devices.Keywords: artificial intelligence, diabetes mellitus, self-care, telemedicine

Background: Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab–cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to evaluate the safety and efficacy of tixagevimab–cilgavimab in preventing progression to severe COVID-19 or death. Methods: TACKLE is an ongoing, phase 3, randomised, double-blind, placebo-controlled study conducted at 95 sites in the USA, Latin America, Europe, and Japan. Eligible participants were non-hospitalised adults aged 18 years or older with a laboratory-confirmed SARS-CoV-2 infection (determined by RT-PCR or an antigen test) from any respiratory tract specimen collected 3 days or less before enrolment and who had not received a COVID-19 vaccination. A WHO Clinical Progression Scale score from more than 1 to less than 4 was required for inclusion and participants had to receive the study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever. Participants were randomly assigned (1:1) to receive either a single tixagevimab–cilgavimab 600 mg dose (two consecutive 3 mL intramuscular injections, one each of 300 mg tixagevimab and 300 mg cilgavimab) or placebo. Randomisation was stratified (using central blocked randomisation with randomly varying block sizes) by time from symptom onset, and high-risk versus low-risk of progression to severe COVID-19. Participants, investigators, and sponsor staff involved in the treatment or clinical evaluation and monitoring of the participants were masked to treatment-group assignments. The primary endpoints were severe COVID-19 or death from any cause through to day 29, and safety. This study is registered with ClinicalTrials.gov, NCT04723394. Findings: Between Jan 28, 2021, and July 22, 2021, 1014 participants were enrolled, of whom 910 were randomly assigned to a treatment group (456 to receive tixagevimab–cilgavimab and 454 to receive placebo). The mean age of participants was 46·1 years (SD 15·2). Severe COVID-19 or death occurred in 18 (4%) of 407 participants in the tixagevimab–cilgavimab group versus 37 (9%) of 415 participants in the placebo group (relative risk reduction 50·5% [95% CI 14·6–71·3]; p=0·0096). The absolute risk reduction was 4·5% (95% CI 1·1–8·0; p Interpretation: A single intramuscular tixagevimab–cilgavimab dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favourable. Treating mild to moderate COVID-19 earlier in the disease course with tixagevimab–cilgavimab might lead to more favourable outcomes.

ResumenObjetivosEstimar la prevalencia y los factores de riesgo de incontinencia urinaria (IU) en mujeres con dolor lumbopélvico (DLP) y describir sus características sociodemográficas y clínicas.DiseñoEstudio observacional transversal.EmplazamientoDos centros de Atención Primaria del Sur de Córdoba y un centro privado en Madrid.ParticipantesTrescientas sesenta y cuatro mujeres de 20-65 años (de 466 contactadas, 33 fueron excluidas y 69 rechazaron participar) que consultaron por dolor de espalda localizado entre la doceava costilla y el pliegue glúteo.IntervencionesEntrevista mediante cuestionario.Mediciones principalesCuestionarios (Índice de discapacidad de Oswestry y cuestionarios de IU [International Consultation on Incontinence Questionnaire SF e Cuestionario de Impacto de la Incontinencia-7]), prueba funcional (test ASLR) y comorbilidad de interés para la IU. Análisis estadístico descriptivo y multivariante.ResultadosSe encontró IU en 155 mujeres (43%; IC del 95%, 37%-48%), en su mayoría de esfuerzo (83%) y mínimo impacto (60%). Frente a las continentes, las mujeres incontinentes presentaron diferencias significativas en la edad, el índice de masa corporal (IMC), el estado civil, el nivel de instrucción y la convivencia, el consumo de fármacos/día, el número de partos vaginales y totales, las intervenciones quirúrgicas abdominopélvicas, el asma, el estreñimiento, la hipertensión, la diabetes, el porcentaje de incapacidad y el test funcional ASLR. En el análisis multivariante, las variables que más influyen en la probabilidad de ser incontinente fueron el asma, la hipertensión, el estreñimiento, el número de partos totales, el IMC y el porcentaje de incapacidad.ConclusionesLa prevalencia de IU en mujeres con DLP es mayor que la encontrada en mujeres de similar edad sin DLP. El asma, el estreñimiento y la paridad son los factores más influyentes en la aparición de IU.AbstractObjectivesEstimating prevalence and risk factors of urinary incontinence (UI) in women with low back pain (LBP) and describing their social and demographic and clinical features.DesignCross-sectional study.SettingTwo primary care health centres in south of Cordoba and a private center in Madrid.Participants364 women of 20-65 years of age (of 466 who were contacted, 33 of them were excluded and 69 refused to participate) who had low back pain located between the twelfth rib and the gluteal fold.InterventionsMedical questionnaire.Main measurementsQuestionnaires (Oswestry Disability Index and UI questionnaires [International Consultation on Incontinence Questionnaire SF and Incontinence Impact Questionnaire-7]), functional test (ASLR Test) and comorbidity of interest for the UI. Descriptive and multivariate statistical analysis.ResultsUI was detected in 155 women (43%, 95% CI: 37%-48%), the majority of stress (83%) and a minimal impact (60%). Front of the continents, incontinent women showed significant differences in age, body mass index, marital status, level of education, coexistence, consumption of drugs/day, number of vaginal and total deliveries, abdominal and pelvic surgery, asthma, constipation, hypertension, diabetes, percentage of disability and functional ASLR test. In multivariate analysis, the variables influencing the probability of being incontinent were asthma, hypertension, constipation, total parity, BMI and the percentage of disability.ConclusionsPrevalence of UI is higher than in women without low back pain. Asthma, constipation and parity are the most influential factors in the occurrence of UI.

Resumen Objetivos Estimar la prevalencia y los factores de riesgo de incontinencia urinaria (IU) en mujeres con dolor lumbopélvico (DLP) y describir sus características sociodemográficas y clínicas. Diseño Estudio observacional transversal. Emplazamiento Dos centros de Atención Primaria del Sur de Córdoba y un centro privado en Madrid. Participantes Trescientas sesenta y cuatro mujeres de 20-65 años (de 466 contactadas, 33 fueron excluidas y 69 rechazaron participar) que consultaron por dolor de espalda localizado entre la doceava costilla y el pliegue glúteo. Intervenciones Entrevista mediante cuestionario. Mediciones principales Cuestionarios (Índice de discapacidad de Oswestry y cuestionarios de IU [International Consultation on Incontinence Questionnaire SF e Cuestionario de Impacto de la Incontinencia-7]), prueba funcional (test ASLR) y comorbilidad de interés para la IU. Análisis estadístico descriptivo y multivariante. Resultados Se encontró IU en 155 mujeres (43%; IC del 95%, 37%-48%), en su mayoría de esfuerzo (83%) y mínimo impacto (60%). Frente a las continentes, las mujeres incontinentes presentaron diferencias significativas en la edad, el índice de masa corporal (IMC), el estado civil, el nivel de instrucción y la convivencia, el consumo de fármacos/día, el número de partos vaginales y totales, las intervenciones quirúrgicas abdominopélvicas, el asma, el estreñimiento, la hipertensión, la diabetes, el porcentaje de incapacidad y el test funcional ASLR. En el análisis multivariante, las variables que más influyen en la probabilidad de ser incontinente fueron el asma, la hipertensión, el estreñimiento, el número de partos totales, el IMC y el porcentaje de incapacidad. Conclusiones La prevalencia de IU en mujeres con DLP es mayor que la encontrada en mujeres de similar edad sin DLP. El asma, el estreñimiento y la paridad son los factores más influyentes en la aparición de IU.