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INTRODUCTION: To evaluate the safety and efficacy of the temporarily implanted nitinol device (iTind) versus prostatic urethral lift (PUL) for minimally invasive surgical treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in a matching-adjusted indirect comparison (MAIC). MATERIALS AND METHODS: Seven clinical trials were identified via a systematic literature review. Individual patient data from iTind trials and aggregated data from PUL trials were used in the MAIC. Safety and efficacy outcomes at 12 months post-treatment were compared between the adjusted iTind population and the pooled PUL population. RESULTS: iTind patients were significantly less likely than PUL patients to experience treatment-related adverse events within 3 months (25.0% vs. 79.8%; p < 0.001), including dysuria (17.8% vs. 34.7%; p = 0.001), hematuria (12.0% vs. 25.9%; p = 0.002), and pain (9.5% vs. 18.7%; p = 0.023). Rates of treatment-related adverse events from 3 to 12 months were also significantly lower among iTind than PUL patients (2.6% vs. 24.4%; p < 0.001). iTind and PUL efficacy outcomes were statistically equivalent on changes from baseline to 12 months on the International Prostate Symptom Score, quality of life, Qmax, post-void residual volume, and the Sexual Health Inventory for Men (all p > 0.05). CONCLUSIONS: This MAIC found superior safety and reduced risks of early and later treatment-related adverse events with iTind versus PUL. The 12-month efficacy was equivalent on subjective and objective urinary and sexual health metrics. This study finds that the iTind temporary device provides equivalent efficacy with lower adverse event risks versus the PUL permanent implants for patients with benign prostatic hyperplasia with lower urinary tract symptoms.
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Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Próstata , Calidad de Vida , Síntomas del Sistema Urinario Inferior/cirugía , Síntomas del Sistema Urinario Inferior/complicaciones , Resultado del TratamientoRESUMEN
BACKGROUND: Speech contains neuromuscular, physiological and cognitive components, and so is a potential biomarker of mental disorders. Previous studies indicate that speaking rate and pausing are associated with major depressive disorder (MDD). However, results are inconclusive as many studies are small and underpowered and do not include clinical samples. These studies have also been unilingual and use speech collected in controlled settings. If speech markers are to help understand the onset and progress of MDD, we need to uncover markers that are robust to language and establish the strength of associations in real-world data. METHODS: We collected speech data in 585 participants with a history of MDD in the United Kingdom, Spain, and Netherlands as part of the RADAR-MDD study. Participants recorded their speech via smartphones every two weeks for 18 months. Linear mixed models were used to estimate the strength of specific markers of depression from a set of 28 speech features. RESULTS: Increased depressive symptoms were associated with speech rate, articulation rate and intensity of speech elicited from a scripted task. These features had consistently stronger effect sizes than pauses. LIMITATIONS: Our findings are derived at the cohort level so may have limited impact on identifying intra-individual speech changes associated with changes in symptom severity. The analysis of features averaged over the entire recording may have underestimated the importance of some features. CONCLUSIONS: Participants with more severe depressive symptoms spoke more slowly and quietly. Our findings are from a real-world, multilingual, clinical dataset so represent a step-change in the usefulness of speech as a digital phenotype of MDD.
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Trastorno Depresivo Mayor , Habla , Humanos , Trastorno Depresivo Mayor/diagnóstico , Depresión , Lenguaje , IndividualidadRESUMEN
BACKGROUND: Remote measurement technologies (RMT) such as mobile health devices and apps are increasingly used by those living with chronic neurological and mental health conditions. RMT enables real-world data collection and regular feedback, providing users with insights about their own conditions. Data visualizations are an integral part of RMT, although little is known about visualization design preferences from the perspectives of those living with chronic conditions. OBJECTIVE: The aim of this review was to explore the experiences and preferences of individuals with chronic neurological and mental health conditions on data visualizations derived from RMT to manage health. METHODS: In this systematic review, we searched peer-reviewed literature and conference proceedings (PubMed, IEEE Xplore, EMBASE, Web of Science, Association for Computing Machinery Computer-Human Interface proceedings, and the Cochrane Library) for original papers published between January 2007 and September 2021 that reported perspectives on data visualization of people living with chronic neurological and mental health conditions. Two reviewers independently screened each abstract and full-text article, with disagreements resolved through discussion. Studies were critically appraised, and extracted data underwent thematic synthesis. RESULTS: We identified 35 eligible publications from 31 studies representing 12 conditions. Coded data coalesced into 3 themes: desire for data visualization, impact of visualizations on condition management, and visualization design considerations. Data visualizations were viewed as an integral part of users' experiences with RMT, impacting satisfaction and engagement. However, user preferences were diverse and often conflicting both between and within conditions. CONCLUSIONS: When used effectively, data visualizations are valuable, engaging components of RMT. They can provide structure and insight, allowing individuals to manage their own health more effectively. However, visualizations are not "one-size-fits-all," and it is important to engage with potential users during visualization design to understand when, how, and with whom the visualizations will be used to manage health.
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BACKGROUND: The mobility of an individual measured by phone-collected location data has been found to be associated with depression; however, the longitudinal relationships (the temporal direction of relationships) between depressive symptom severity and phone-measured mobility have yet to be fully explored. OBJECTIVE: We aimed to explore the relationships and the direction of the relationships between depressive symptom severity and phone-measured mobility over time. METHODS: Data used in this paper came from a major EU program, called the Remote Assessment of Disease and Relapse-Major Depressive Disorder, which was conducted in 3 European countries. Depressive symptom severity was measured with the 8-item Patient Health Questionnaire (PHQ-8) through mobile phones every 2 weeks. Participants' location data were recorded by GPS and network sensors in mobile phones every 10 minutes, and 11 mobility features were extracted from location data for the 2 weeks prior to the PHQ-8 assessment. Dynamic structural equation modeling was used to explore the longitudinal relationships between depressive symptom severity and phone-measured mobility. RESULTS: This study included 2341 PHQ-8 records and corresponding phone-collected location data from 290 participants (age: median 50.0 IQR 34.0, 59.0) years; of whom 215 (74.1%) were female, and 149 (51.4%) were employed. Significant negative correlations were found between depressive symptom severity and phone-measured mobility, and these correlations were more significant at the within-individual level than the between-individual level. For the direction of relationships over time, Homestay (time at home) (φ=0.09, P=.01), Location Entropy (time distribution on different locations) (φ=-0.04, P=.02), and Residential Location Count (reflecting traveling) (φ=0.05, P=.02) were significantly correlated with the subsequent changes in the PHQ-8 score, while changes in the PHQ-8 score significantly affected (φ=-0.07, P<.001) the subsequent periodicity of mobility. CONCLUSIONS: Several phone-derived mobility features have the potential to predict future depression, which may provide support for future clinical applications, relapse prevention, and remote mental health monitoring practices in real-world settings.
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BACKGROUND: Major Depressive Disorder (MDD) is prevalent, often chronic, and requires ongoing monitoring of symptoms to track response to treatment and identify early indicators of relapse. Remote Measurement Technologies (RMT) provide an opportunity to transform the measurement and management of MDD, via data collected from inbuilt smartphone sensors and wearable devices alongside app-based questionnaires and tasks. A key question for the field is the extent to which participants can adhere to research protocols and the completeness of data collected. We aimed to describe drop out and data completeness in a naturalistic multimodal longitudinal RMT study, in people with a history of recurrent MDD. We further aimed to determine whether those experiencing a depressive relapse at baseline contributed less complete data. METHODS: Remote Assessment of Disease and Relapse - Major Depressive Disorder (RADAR-MDD) is a multi-centre, prospective observational cohort study conducted as part of the Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) program. People with a history of MDD were provided with a wrist-worn wearable device, and smartphone apps designed to: a) collect data from smartphone sensors; and b) deliver questionnaires, speech tasks, and cognitive assessments. Participants were followed-up for a minimum of 11 months and maximum of 24 months. RESULTS: Individuals with a history of MDD (n = 623) were enrolled in the study,. We report 80% completion rates for primary outcome assessments across all follow-up timepoints. 79.8% of people participated for the maximum amount of time available and 20.2% withdrew prematurely. We found no evidence of an association between the severity of depression symptoms at baseline and the availability of data. In total, 110 participants had > 50% data available across all data types. CONCLUSIONS: RADAR-MDD is the largest multimodal RMT study in the field of mental health. Here, we have shown that collecting RMT data from a clinical population is feasible. We found comparable levels of data availability in active and passive forms of data collection, demonstrating that both are feasible in this patient group.
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Trastorno Depresivo Mayor , Aplicaciones Móviles , Enfermedad Crónica , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/epidemiología , Humanos , Estudios Prospectivos , Recurrencia , Teléfono InteligenteRESUMEN
BACKGROUND: The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes a clinical illness Covid-19, has had a major impact on mental health globally. Those diagnosed with major depressive disorder (MDD) may be negatively impacted by the global pandemic due to social isolation, feelings of loneliness or lack of access to care. This study seeks to assess the impact of the 1st lockdown - pre-, during and post - in adults with a recent history of MDD across multiple centres. METHODS: This study is a secondary analysis of an on-going cohort study, RADAR-MDD project, a multi-centre study examining the use of remote measurement technology (RMT) in monitoring MDD. Self-reported questionnaire and passive data streams were analysed from participants who had joined the project prior to 1st December 2019 and had completed Patient Health and Self-esteem Questionnaires during the pandemic (n = 252). We used mixed models for repeated measures to estimate trajectories of depressive symptoms, self-esteem, and sleep duration. RESULTS: In our sample of 252 participants, 48% (n = 121) had clinically relevant depressive symptoms shortly before the pandemic. For the sample as a whole, we found no evidence that depressive symptoms or self-esteem changed between pre-, during- and post-lockdown. However, we found evidence that mean sleep duration (in minutes) decreased significantly between during- and post- lockdown (- 12.16; 95% CI - 18.39 to - 5.92; p < 0.001). We also found that those experiencing clinically relevant depressive symptoms shortly before the pandemic showed a decrease in depressive symptoms, self-esteem and sleep duration between pre- and during- lockdown (interaction p = 0.047, p = 0.045 and p < 0.001, respectively) as compared to those who were not. CONCLUSIONS: We identified changes in depressive symptoms and sleep duration over the course of lockdown, some of which varied according to whether participants were experiencing clinically relevant depressive symptoms shortly prior to the pandemic. However, the results of this study suggest that those with MDD do not experience a significant worsening in symptoms during the first months of the Covid - 19 pandemic.
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COVID-19 , Trastorno Depresivo Mayor , Adulto , Estudios de Cohortes , Control de Enfermedades Transmisibles , Depresión , Trastorno Depresivo Mayor/epidemiología , Humanos , SARS-CoV-2 , TecnologíaRESUMEN
Aims: An investigation of the impact of a multidisciplinary bone infection unit (BIU) undertaking osteomyelitis surgery with a single-stage protocol on clinical outcomes and healthcare utilisation compared to national outcomes in England. Patients and Methods: A tertiary referral multidisciplinary BIU was compared to the rest of England (ROE) and a subset of the 10 next busiest centres based on osteomyelitis treatment episode volume (Top Ten), using the Hospital Episodes Statistics database (HES). A total of 25â¯006 patients undergoing osteomyelitis surgery between April 2013 and March 2017 were included. Data on secondary healthcare resource utilisation and clinical indicators were extracted for 24 months before and after surgery. Results: Patients treated at the BIU had higher orthopaedic healthcare utilisation in the 2 years prior to their index procedure, with more admissions ( p < â¯0.001) and a mean length of stay (LOS) over 4 times longer than other groups (10.99â¯d, compared to 2.79â¯d for Top Ten and 2.46â¯d for the ROE, p < â¯0.001). During the index inpatient period, the BIU had fewer mean theatre visits (1.25) compared to the TT (1.98, p < â¯0.001) and the ROE (1.64, p = â¯0.001). The index inpatient period was shorter in the BIU (11.84â¯d), 33.6â¯% less than the Top Ten (17.83â¯d, p < â¯0.001) and 29.9â¯% shorter than the ROE (16.88â¯d, p < â¯0.001). During follow-up, BIU patients underwent fewer osteomyelitis-related reoperations than Top Ten centres ( p = â¯0.0139) and the ROE ( p = â¯0.0137). Mortality was lower (4.71â¯%) compared to the Top Ten (20.06â¯%, p < â¯0.001) and the ROE (22.63â¯%, p < â¯0.001). The cumulative BIU total amputation rate was lower (6.47â¯%) compared to the Top Ten (15.96â¯%, p < â¯0.001) and the ROE (12.71â¯%, p < â¯0.001). Overall healthcare utilisation was lower in the BIU for all inpatient admissions, LOS, and Accident and Emergency (A&E) attendances. Conclusion: The benefits of managing osteomyelitis in a multi-disciplinary team (MDT) specialist setting included reduced hospital stays, lower reoperation rates for infection recurrence, improved survival, lower amputation rates, and lower overall healthcare utilisation. These results support the establishment of centrally funded multidisciplinary bone infection units that will improve patient outcomes and reduce healthcare utilisation.
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BACKGROUND: Epilepsy, multiple sclerosis (MS), and depression are chronic conditions where technology holds potential in clinical monitoring and self-management. Over 5 years, the Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) consortium has explored the application of remote measurement technology (RMT) to the management and self-management of patients in these clinical areas. The consortium is large and includes clinical and nonclinical researchers as well as a patient advisory board. OBJECTIVE: This formative development study aimed to understand how consortium members viewed the potential of RMT in epilepsy, MS, and depression. METHODS: In this qualitative survey study, we developed a methodological tool, universal points of care (UPOC), to gather views on the potential use, acceptance, and value of a novel RMT platform across 3 chronic conditions (MS, epilepsy, and depression). UPOC builds upon use case scenario methodology, using expert elicitation and analysis of care pathways to develop scenarios applicable across multiple conditions. After developing scenarios, we elicited views on the potential of RMT in these different scenarios through a survey administered to 28 subject matter experts, consisting of 16 health care practitioners; 5 health care services researchers; and 7 people with lived experience of MS, epilepsy, or depression. Survey results were analyzed thematically and using an existing framework of factors describing links between design and context. RESULTS: The survey elicited potential beneficial applications of the RADAR-CNS RMT system as well as patient, clinical, and nonclinical requirements of RMT across the 3 conditions of interest. Potential applications included recognition of early warning signs of relapse from subclinical signals for MS, seizure precipitant signals for epilepsy, and behavior change in depression. RMT was also thought to have the potential to overcome the problem of underreporting, which is especially problematic in epilepsy, and to allow the capture of secondary symptoms that are not generally collected in MS, such as mood. CONCLUSIONS: Respondents suggested novel and unanticipated uses of RMT, including the use of RMT to detect emerging side effects of treatment, enable behavior change for sleep regulation and activity, and offer a way to include family and other carers in a care network, which could assist with goal setting. These suggestions, together with others from this and related work, will inform the development of the system for its eventual application in research and clinical practice. The UPOC methodology was effective in directing respondents to consider the value of health care technologies in condition-specific experiences of everyday life and working practice.
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We report the case of an 83-year-old man who presented with a history of fluctuating delirium of insidious onset, secondary to an amoebic liver abscess more than 30 years after acute exposure. We describe a 2-year clinical journey that started with a fall and was additionally complicated by severe weight loss and acute kidney injury (AKI). The likely prognosis for such a combination of comorbidities in an older person is for lasting morbidity, institutionalisation and significant mortality. However, the case demonstrates that with timely assessment and care complete recovery is possible though it may take many months. It reminds us of the catalytic implications of falls for older persons and to maintain a differential diagnostic approach to delirium of insidious onset avoiding misdiagnosis as dementia with which it may be associated. Our case report includes extracts from the patient's own account providing added insight into such experiences.
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Accidentes por Caídas , Amebicidas/uso terapéutico , Delirio/terapia , Absceso Hepático Amebiano/tratamiento farmacológico , Paromomicina/uso terapéutico , Lesión Renal Aguda/complicaciones , Anciano de 80 o más Años , Delirio/etiología , Alucinaciones/etiología , Humanos , Absceso Hepático Amebiano/complicaciones , Masculino , Recuperación de la FunciónRESUMEN
Unintentional weight loss and Undernutrition are major problems among older people living in Long-Term Care Facilities (LTCF). Undernutrition manifests in LTCF particularly as weight loss and low Body Mass Index (BMI) and is associated with increased morbidity and mortality as well as with functional decline. There are many factors associated with poor nutritional status and affecting protein-energy intake and/or energy expenditure. These include age of 85 years or older, low nutrient intake, loss of ability to eat independently, swallowing and chewing difficulties, becoming bed-ridden, pressure ulcers, history of hip fracture, dementia, depressive symptoms and suffering from two or more chronic illnesses. Nutritional evaluation is an essential part of the Comprehensive Geriatric Assessment (CGA). This evaluation ranges from methods such as BMI to several validated tools such as Mini-Nutritional Assessment (MNA). After diagnosis, the management of undernutrition in LTCF requires a multidisciplinary approach which may involve dietary and environmental improvements and managing multiple co-morbidities, while avoiding polypharmacy as far as possible. Finally, the need for supplementation or artificial (tube) feeding may be considered taking into account the CGA and individual needs. This document presents a succinct review and recommendations of evaluation and treatment of undernutrition.
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Evaluación Geriátrica , Evaluación Nutricional , Desnutrición Proteico-Calórica , Anciano , Anciano de 80 o más Años , Índice de Masa Corporal , Ingestión de Energía , Metabolismo Energético , Femenino , Evaluación Geriátrica/métodos , Hogares para Ancianos , Humanos , Cuidados a Largo Plazo , Masculino , Casas de Salud , Estado Nutricional , Desnutrición Proteico-Calórica/diagnóstico , Desnutrición Proteico-Calórica/etiología , Desnutrición Proteico-Calórica/terapia , Factores de Riesgo , Pérdida de PesoRESUMEN
An 82-year-old woman was admitted with severe vomiting and progressive dysphagia mainly to solids. She gave a 3-month history of increasing heartburn, vomiting, tiredness, lethargy, anorexia and 13 kg weight loss. Her past medical history was unremarkable and she was a non-smoker. Physical examination revealed evidence of significant weight loss and dehydration only. Gastroscopy revealed mild oesophagitis, tongues of Barrett oesophagus and mild antral gastritis. CT scan of the thorax and abdomen was normal. Unfortunately her condition deteriorated rapidly and she died from aspiration pneumonia. Postmortem examination revealed thickening of the muscular wall of lower oesophagus and pylorus, but without any malignancy. The histological assessment of the oesophageal as well as gastric biopsies confirmed the diagnosis of gastrointestinal amyloidosis accounting for her symptoms of dysphagia and vomiting respectively.
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We have observed the force resulting from sudden stretches (3-10 mm in 10-20 ms) of human adductor pollicis muscle during voluntary contractions maintaining different proportions of the maximum voluntary force from 20% to 100%. The ratio of the peak force during stretch (S) to the voluntary force (I) just before the start of the stretch was calculated. The S/ I ratio was dependent both on the level of activation and the speed of the stretch. At all levels of activation S/ I increased exponentially with velocity towards a plateau value with an exponential constant of about 150 mm/s. The plateau values reached were dependent on activation level (P<0.02, linear regression, n=24). At 96% activation the plateau value of the S/ I ratio was 1.82+/-0.13 (mean+/-95% confidence limits); at 32% activation the value was 2.72+/-0.23.