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BACKGROUND: Individuals with advanced multiple sclerosis (MS) have complex care requirements and are more likely to use long-term facilities. This study determined the associations between mood and social care-related quality of life (SCRQOL), and health-related quality of life (HRQOL) and examined the association between HRQOL and SCRQOL. METHODS: Baseline data from a cohort study were used. Patients completed questionnaires, including the Hospital Anxiety and Depression Scale (HADS), Adult Social Care Outcomes Toolkit (ASCOT), and EuroQOL 5D-5L (EQ-5D-5L) and EQ-Visual Analogue Scale (EQ-VAS). Linear regression analyses were employed to assess the relationships between mood and both outcomes of QOL while controlling for relevant confounding factors (ßs; 95% CI). The cross-sectional association between SCRQOL and HRQOL was examined using Pearson correlation coefficients (r). RESULTS: A total of 75 patients, with a mean age of 56.1 years and a disease duration of 17.3 years, were enrolled from a long-term care facility in the Netherlands. Results showed that after controlling for confounders, HADS is an independent determinant of ASCOT (ßs = -.368; 95% CI, -.581 to -.154) and EQ-5D-5L (ßs = -.297; 95% CI, -.507 to -.087). Also, there are significant but weak correlations between ASCOT and EQ-5D-5L (r = 0.242; 95% CI, .015-.468), between ASCOT and EQ-VAS (r = 0.230; 95% CI, .003-.457) and between EQ-5D-5L and EQ-VAS (r = 0.227; 95% CI, .000-.454). CONCLUSIONS: Mood, especially the depression component, is an important determinant of both HRQOL and SCRQOL in advanced MS. Focusing on mood in health care and social care may contribute to the improvement of QOL in a broader sense.
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BACKGROUND: Although the prescription of physical activity in clinical care has been advocated worldwide, in the Netherlands, "Exercise is Medicine" (E = M) is not yet routinely implemented in clinical care. METHODS: A set of implementation strategies was pilot implemented to test its feasibility for use in routine care by clinicians in 2 departments of a university medical center. An extensive learning process evaluation was performed, using structured mixed methods methodology, in accordance with the Reach, Effect, Adoption, Implementation, and Maintenance framework. RESULTS: From 5 implementation strategies employed (education, E = M tool embedded in the electronic medical records, lifestyle coach situated within the department, overviews of referral options, and project support), the presence of adequate project support was a strong facilitator of the implementation of E = M. Also, the presence of the lifestyle coach within the department seemed essential for referral rate. Although clinicians appreciated the E = M tool, barriers hampered its use in practice. CONCLUSIONS: Specific implementation strategies, tailored to the setting, are effective in facilitating the implementation of E = M with specific regard to education for clinicians on E = M, deployment of a lifestyle coach within a department, and project coordination. Care providers do see a future for lifestyle coaches who are structurally embedded in the hospital, to whom they can easily refer.
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Ejercicio Físico , Humanos , Países Bajos , Masculino , Femenino , Evaluación de Procesos, Atención de Salud , Derivación y Consulta , Proyectos Piloto , Estilo de VidaRESUMEN
BACKGROUND: Digital monitoring of people with multiple sclerosis (PwMS) using smartphone-based monitoring tools is a promising method to assess disease activity and progression. OBJECTIVE: To study cross-sectional and longitudinal associations between active and passive digital monitoring parameters and MRI volume measures in PwMS. METHODS: In this prospective study, 92 PwMS were included. Clinical tests [Expanded Disability Status Scale (EDSS), Timed 25 Foot Walk test (T25FW), 9-Hole Peg Test (NHPT), and Symbol Digit Modalities Test (SDMT)] and structural MRI scans were performed at baseline (M0) and 12-month follow-up (M12). Active monitoring included the smartphone-based Symbol Digit Modalities Test (sSDMT) and 2 Minute Walk Test (s2MWT), while passive monitoring was based on smartphone keystroke dynamics (KD). Linear regression analyses were used to determine cross-sectional and longitudinal relations between digital and clinical outcomes and brain volumes, with age, disease duration and sex as covariates. RESULTS: In PwMS, both sSDMT and SDMT were associated with thalamic volumes and lesion volumes. KD were related to brain, ventricular, thalamic and lesion volumes. No relations were found between s2MWT and MRI volumes. NHPT scores were associated with lesion volumes only, while EDSS and T25FW were not related to MRI. No longitudinal associations were found for any of the outcome measures between M0 and M12. CONCLUSION: Our results show clear cross-sectional correlations between digital biomarkers and brain volumes in PwMS, which were not all present for conventional clinical outcomes, supporting the potential added value of digital monitoring tools.
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OBJECTIVE: To examine the relationship between perceived and physiological strains of real-time societal participation in people with multiple sclerosis. DESIGN: Observational study. SUBJECTS/PATIENTS: 70 people with multiple sclerosis. METHODS: Perceived and physiological strain of societal participation (10 participation-at-location and 9 transport domains) were measured in real time using the Whereabouts smartphone app and Fitbit over 7 consecutive days. Longitudinal relationships between perceived (1 not strenuous to 10 most strenuous) and physiological strains (heart rate reserve) were examined using mixed-model analyses. Type of event (participation-at-location or transport) was added as covariate, with further adjustments for fatigue and walking ability. RESULTS: Median perceived strain, summarized for all societal participation domains, varied between 3 and 6 (range: 1-10), whereas physiological strain varied between 18.5% and 33.2% heart rate reserve. Perceived strain (outcome) and physiological strain were not associated (ß -0.001, 95%CI -0.008; 0.005, with a 7-day longitudinal correlation coefficient of -0.001). Transport domains were perceived as less strenuous (ß -0.80, 95%CI -0.92; -0.68). Higher fatigue levels resulted in higher perceived strain (all societal participation domains) (ß 0.05, 95%CI 0.02; 0.08). CONCLUSION: Societal participation resulted in low-to-moderate perceived and physiological strain. Perceived and physiological strain of societal participation were unrelated and should be considered different constructs in multiple sclerosis.
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Fatiga , Esclerosis Múltiple , Participación Social , Humanos , Esclerosis Múltiple/fisiopatología , Esclerosis Múltiple/rehabilitación , Esclerosis Múltiple/psicología , Masculino , Femenino , Persona de Mediana Edad , Adulto , Fatiga/fisiopatología , Fatiga/etiología , Frecuencia Cardíaca/fisiología , PercepciónRESUMEN
PURPOSE: To synthesize evidence on the effect of early post-stroke spasticity interventions. METHODS: Systematic literature search (PubMed, Embase, and Web of Science) encompassing studies on spasticity reducing interventions within 3 months post stroke on outcome defined within the International Classification of Functioning (ICF). RESULTS: In total, 27 studies were identified with n = 1.658 cases. Botulinum toxin (2-12 weeks; 10 studies, n = 794) showed consistent and significant reduced spasticity by Modified Ashworth Scale (MAS) or electromyography (EMG). Electrical muscle stimulation (1-8 weeks; 6 studies, n = 335) showed lower MAS/Composite Spasticity Scale scores in 4 studies. Transcranial stimulation (3 studies; n = 131), oral spasmolytics (1 study; n = 38), shockwave (1 study; n = 40), orthotics (3 studies; n = 197 and robot-assisted therapy (3 studies; n = 123) showed inconclusive results. Effects on ICF activity domain could not be established due to limited data and large outcome measures heterogeneity. One out of two studies showed significant benefit for early compared to late BoNT intervention (< 90 vs> 90 days). CONCLUSION: This study provides evidence for early applied (<3 months) BoNT to effectively reduce spasticity and probable effectiveness of electrical stimulation. Establishing effects of interventions in the acute/hospitalization phase (<7 days) needs further work, specifically on the ICF activity domain. Standardization of outcome measures is required.
Spasticity, which may develop in the first weeks after stroke, is now mostly treated in the chronic phase.This study shows that early applied Botulinum Toxin (within three months after stroke) effectively reduces spasticity and suggests that electrical stimulation may reduce spasticity.Early application of treatment with Botulinum Toxin should be considered when spasticity occurs within three months post-stroke.
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OBJECTIVE: Severe fatigue is a prevalent and disabling symptom in multiple sclerosis (MS). This study tested if a fatigue- and physical activity-related attentional bias (AB) and a somatic interpretation bias (IB) are present in severely fatigued patients with MS. Biases were compared to healthy controls and patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). METHOD: Severely fatigued patients with MS or ME/CFS and healthy controls completed a Visual Probe Task (VPT) assessing fatigue- and physical activity-related AB and an IB task that assesses the tendency to interpret ambiguous information in either a somatically threatening way or in a more neutral manner. The VPT was completed by 38 MS patients, 44 ME/CFS patients, and 46 healthy controls; the IB task was completed by 156, 40 and 46 participants respectively. RESULTS: ANOVA showed no statistically significant group differences in a fatigue-related AB or physical activity-related AB (omnibus test of interaction between topic × condition: F2,125 = 1.87; p = .159). Both patient groups showed a tendency to interpret ambiguous information in a somatically threatening way compared to healthy controls (F1,2 = 27.61, p < .001). This IB was significantly stronger in MS patients compared to ME/CFS patients. IB was significantly correlated with cognitive responses to symptoms in MS patients. CONCLUSION: MS patients tend to interpret ambiguous information in a somatically threatening way. This may feed into unhelpful ways of dealing with symptoms, possibly contributing to the perpetuation of severe fatigue in MS.
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Sesgo Atencional , Síndrome de Fatiga Crónica , Fatiga , Esclerosis Múltiple , Humanos , Femenino , Masculino , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/psicología , Adulto , Fatiga/psicología , Persona de Mediana Edad , Síndrome de Fatiga Crónica/psicología , Síndrome de Fatiga Crónica/complicaciones , Sesgo Atencional/fisiología , Índice de Severidad de la Enfermedad , Estudios de Casos y Controles , AtenciónRESUMEN
OBJECTIVE: To examine the energy demand of walking relative to aerobic capacity in people with multiple sclerosis. DESIGN: Cross-sectional cohort study. PATIENTS: A total of 45 people with multiple sclerosis (32 females), median disease duration 15 years (interquartile range (IQR) 9; 20), median Expanded Disability Status Scale 4 (min-max range: 2.0; 6.0). METHODS: Aerobic capacity, derived from a cardiopulmonary exercise test and gas exchange measurements, assessed during a 6-min overground walk test at comfortable speed, were analysed. The relative aerobic load of walking was determined as the energy demand of walking relative to oxygen uptake at peak and at the first ventilatory threshold. Healthy reference data were used for clinical inference. RESULTS: People with multiple sclerosis walk at a mean relative aerobic load of 60.0% (standard deviation 12.8%) relative to peak aerobic capacity, and 89.1% (standard deviation 19.9%) relative to the first ventilatory threshold. Fourteen participants walked above the first ventilatory threshold (31%). Peak aerobic capacity was reduced in 45% of participants, and energy demands were increased in 52% of participants. CONCLUSION: People with multiple sclerosis walk at a relative aerobic load close to their first ventilatory threshold. A high relative aerobic load can guide clinicians to improve aerobic capacity or reduce the energy demands of walking.
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Esclerosis Múltiple , Femenino , Humanos , Estudios Transversales , Caminata , Prueba de Esfuerzo , Tolerancia al EjercicioRESUMEN
BACKGROUND: To assess the barriers and facilitators associated with upscaling the Transmural Trauma Care Model (TTCM), a multidisciplinary and patient-centred transmural rehabilitation care model. METHODS: Semi-structured interviews were conducted with eight trauma surgeons, eight hospital-based physiotherapists, eight trauma patients, and eight primary care physiotherapists who were part of a trauma rehabilitation network. Audio recordings of the interviews were made and transcribed verbatim. Data were analysed using a framework method based on the "constellation approach". Identified barriers and facilitators were grouped into categories related to structure, culture, and practice. RESULTS: Various barriers and facilitators to upscaling were identified. Under structure, barriers and facilitators belonged to one of five themes: "financial structure", "communication structure", "physical structures and resources", "rules and regulations", and "organisation of the network". Under culture, the five themes were "commitment", "job satisfaction", "acting as a team", "quality and efficiency of care", and "patients' experience". Under practice, the two themes were "practical issues at the outpatient clinic" and "knowledge gained". CONCLUSION: The success of upscaling the TTCM differed across hospitals and settings. The most important prerequisites for successfully upscaling the TTCM were adequate financial support and presence of "key actors" within an organisation who felt a sense of urgency for change and/or expected the intervention to increase their job satisfaction. TRIAL REGISTRATION: NL8163 The Netherlands National Trial Register, date of registration 16-11-2019.
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Comunicación , Servicios Médicos de Urgencia , Humanos , Investigación Cualitativa , Hospitales , Países BajosRESUMEN
BACKGROUND: To better understand physical activity behavior and its health benefits in people living with health conditions, we studied people with and without 20 different self-reported health conditions with regard to (1) their physical activity levels, (2) factors correlated with these physical activity levels, and (3) the association between physical activity and all-cause mortality. METHODS: We used a subsample (n = 88,659) of the Lifelines cohort study from the Netherlands. For people living with and without 20 different self-reported health conditions, we studied the aforementioned factors in relation to physical activity. Physical activity was assessed with the Short Questionnaire to Assess Health-Enhancing Physical Activity Questionnaire, and mortality data were obtained from the Dutch death register. RESULTS: People with a reported health condition were less likely to meet physical activity guidelines than people without a reported health condition (odds ratios ranging from 0.55 to 0.89). Higher body mass index and sitting time, and lower self-rated health, physical functioning, and education levels were associated with lower odds of meeting physical activity guidelines across most health conditions. Finally, we found a protective association between physical activity and all-cause mortality in both people living with and without different health conditions. CONCLUSION: People living with different health conditions are generally less physically active compared with people living without a health condition. Both people living with and without self-reported health conditions share a number of key factors associated with physical activity levels. We also observed the expected protective association between physical activity and all-cause mortality.
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Ejercicio Físico , Actividad Motora , Humanos , Estudios de Cohortes , Encuestas y Cuestionarios , AutoinformeRESUMEN
BACKGROUND: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. AIMS: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL). METHODS: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) 'strengthening the brain' - a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) 'strengthening the mind' - a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group-receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don't be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions. DISCUSSION: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023.
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Disfunción Cognitiva , Esclerosis Múltiple , Humanos , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/terapia , Calidad de Vida , Desempleo , Disfunción Cognitiva/prevención & control , Ejercicio Físico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Cognitive impairment occurs in up to 65% of people with multiple sclerosis (PwMS), negatively affecting daily functioning and health-related quality of life. In general, neuropsychological testing is not part of standard MS-care due to insufficient time and trained personnel. Consequently, a baseline assessment of cognitive functioning is often lacking, hampering early identification of cognitive decline and change within a person over time. To assess cognitive functioning in PwMS in a time-efficient manner, a BICAMS-based self-explanatory digital screening tool called the Multiple Screener©, has recently been developed. The aim of the current study is to validate the Multiple Screener© in a representative sample of PwMS in the Netherlands. Additionally, we aim to investigate how cognitive functioning is related to psychological factors, and both work and societal participation. METHODS: In this cross-sectional multicentre study, 750 PwMS (aged 18-67 years) are included. To obtain a representative sample, PwMS are recruited via 12 hospitals across the Netherlands. They undergo assessment with the Minimal Assessment of Cognitive Functioning in MS (MACFIMS; reference-standard) and the Multiple Screener©. Sensitivity, specificity, and predictive values for identifying (mild) cognitive impairment are determined in a subset of 300 participants. In a second step, the identified cut-off values are tested in an independent subset of at least 150 PwMS. Moreover, test-retest reliability for the Multiple Screener© is determined in 30 PwMS. Information on psychological and work-related factors is assessed with questionnaires. DISCUSSION: Validating the Multiple Screener© in PwMS and investigating cognition and its determinants will further facilitate early identification and adequate monitoring of cognitive decline in PwMS.
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Disfunción Cognitiva , Esclerosis Múltiple , Humanos , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/psicología , Calidad de Vida/psicología , Reproducibilidad de los Resultados , Estudios Transversales , Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/etiología , Cognición , Pruebas Neuropsicológicas , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings. OBJECTIVE: To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up. METHOD: A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week tailored CBT for MS-related fatigue. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale 1 year after start of treatment (T52). Mixed model analysis was performed by a statistician blinded for treatment-allocation to determine between-group differences in fatigue severity. RESULTS: Fatigue severity at 1-year follow-up did not differ significantly between the booster (N = 62) and control condition (N = 64) (B = -2.01, 95% confidence interval (CI) = -4.76 to 0.75). No significant increase in fatigue severity was found at T52 compared with directly post-treatment (T20) in both conditions (B = 0.44, 95% CI = -0.97 to 1.85). CONCLUSION: Effects of CBT were sustained up to 1 year in both conditions. The booster programme did not significantly improve the long-term outcome of CBT for MS-related fatigue. TRIAL REGISTRATION: Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782.
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Terapia Cognitivo-Conductual , Fatiga , Esclerosis Múltiple , Humanos , Fatiga/etiología , Fatiga/terapia , Resultado del Tratamiento , Esclerosis Múltiple/complicacionesRESUMEN
BACKGROUND: Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients. METHODS: In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events. DISCUSSION: The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery. TRIAL REGISTRATION: The trial has been registered at the International Clinical Trials Registry Platform at 14-10-2021 with registration number NL9793. Trial registration data are presented in Table 1.
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Neoplasias Pulmonares , Aplicaciones Móviles , Adulto , Humanos , Neoplasias Pulmonares/cirugía , Resultado del Tratamiento , Ejercicio Físico , Hospitalización , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Exercise as a subset of physical activity is a cornerstone in the management of multiple sclerosis (MS) based on its pleiotropic effects, but continued progression of the field requires better future designs and methodologies. OBJECTIVES: This paper outlines the work of the 'Study design and methodology' group of the MoXFo (moving exercise research forward) initiative, and addresses critical aspects and future directions when defining the research question of interest, and subsequently, designing the study and exercise intervention in MS patients. METHODS: The work is based on the formation of an international expert panel formed within the MoXFo initiative. We provide a structured and concise synthesis of exercise-specific MS research challenges and considerations when designing randomized controlled trials (RCTs). RESULTS: Challenges and considerations are presented using the Patient population, Intervention, Comparator, Outcomes, Timing, Setting (PICOTS) framework, thereby forming a new and specific MS exercise PICOTS framework. CONCLUSION: We propose that researchers should carefully consider and align all elements of this MS exercise PICOTS framework when developing future research questions and study designs, ultimately improving the quality of new exercise studies in people with MS.
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Esclerosis Múltiple , Humanos , Esclerosis Múltiple/terapia , Ejercicio Físico , Terapia por Ejercicio , Proyectos de InvestigaciónRESUMEN
This case report concerns a patient suffering from traumatic spinal cord injury with severe spasticity treated with intrathecal baclofen therapy. After revision surgery for a confirmed catheter obstruction, progressive spasticity reappeared. Diagnostics demonstrated signs of catheter fracture or disconnection adjacent to the pump. During revision surgery, the silicone layer surrounding the sutureless pump connector was shown to be curled up, revealing the cause of dysfunction. As far as we know, this form of malconnection has not been reported before. Therefore, surgeons must be aware of this complication and additional inspection of the silicone connector prior to definite connection is advised.
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Fracturas Óseas , Traumatismos de la Médula Espinal , Humanos , Baclofeno/uso terapéutico , Catéteres , Traumatismos de la Médula Espinal/cirugía , SiliconasRESUMEN
BACKGROUND: Cognitive behavioural therapy (CBT) reduces multiple sclerosis (MS)-related fatigue. Implementation of face-to-face CBT is hindered by limited treatment capacity and traveling distances to treatment locations. OBJECTIVE: Evaluate whether blended CBT (online treatment modules supported with guidance by a therapist) is non-inferior to face-to-face CBT in reducing fatigue severity in severely fatigued patients with MS. METHOD: A non-inferiority multicentre randomized clinical trial, in which 166 patients with MS were allocated to either face-to-face or blended CBT. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale directly post-treatment (week 20). Mixed model analysis was used by a statistician blinded for allocation to determine between-group differences post-treatment. The upper limit of the 95% confidence interval (CI) was compared to a pre-specified non-inferiority margin of 5.32. RESULTS: Blended CBT (N = 82) was non-inferior to face-to-face CBT (N = 84) (B = 1.70, 95% CI: -1.51 to 4.90). Blended CBT significantly reduced therapist time (B = -187.1 minutes, 95% CI: 141.0-233.3). Post hoc analysis showed more improvement (B = -5.35, 95% CI: -9.22 to -1.48) when patients received their preferred treatment. No harm related to treatment was reported. DISCUSSION: Blended CBT is an efficient alternative to face-to-face CBT. Offering the preferred CBT format may optimize treatment outcome.
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Terapia Cognitivo-Conductual , Esclerosis Múltiple , Humanos , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/terapia , Fatiga/etiología , Fatiga/terapia , Resultado del Tratamiento , InvestigadoresRESUMEN
BACKGROUND: In clinical practice the diagnosis of diabetic foot osteomyelitis (DFO) relies on cultures of bone or ulcer bed (UB) biopsies, of which bone biopsy is reference standard. The slow growth or fastidious nature of some bacteria, hamper expeditious detection and identification. Rapid molecular techniques may solve both issues, but their additional value for everyday practice is unknown. We investigated the concordance between conventional culture, the molecular techniques Molecular Culture (MC), and illumina 16S rRNA gene amplicon (16S) sequencing in people with DFO. METHODS: In the BeBoP trial, bone and UB biopsies were obtained from people with DFO who visited Amsterdam UMC. These biopsies were analysed using 1) conventional culture, 2)MC, a rapid broad range PCR analysing the 16S-23S ribosomal-interspace-region, and 3) 16S sequencing, and evaluated concordance among these techniques. RESULTS: We analysed 20 samples (11 bone and 9 UB) of 18 people. A total of 84 infectious agents were identified, 45 (54%) by all techniques, an additional 22 (26.5%, overall 80.5%) by both MC and 16S, and the remaining 16 species by culture and MC or 16S, or by a single method only. MC and 16S identified anaerobes not detected by culturing in 5 samples, and the presence of bacteria in 7 of 8 culture-negative (6 bone, 2 UB) samples. CONCLUSION: The high level of concordance between MC and 16S and the additional ability of molecular techniques to detect various bacteria not detected by culturing opens up prospects for routine use of fast molecular techniques, in clinical settings including DFO. TRIAL REGISTRATION: The BeBoP trial is retrospectively registered on 05-03-2019 in Netherlands Trial Register: NL 7582.
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Diabetes Mellitus , Pie Diabético , Osteomielitis , Humanos , Pie Diabético/diagnóstico , Pie Diabético/microbiología , ARN Ribosómico 16S/genética , Genes de ARNr , Úlcera , Bacterias/genética , Osteomielitis/diagnóstico , Osteomielitis/microbiología , BiopsiaRESUMEN
INTRODUCTION: Physical exercise is receiving increasing interest as an augmentative non-pharmacological intervention in Parkinson's disease (PD). This pilot study primarily aimed to quantify individual response patterns of motor symptoms to alternating exercise modalities, along with non-motor functioning and blood biomarkers of neuroplasticity and neurodegeneration. MATERIALS & METHODS: People with PD performed high-intensity interval training (HIIT) and continuous aerobic exercise (CAE) using a crossover single-case experimental design. A repeated assessment of outcome measures was conducted. The trajectories of outcome measures were visualized in time series plots and interpreted relative to the minimal clinically important difference (MCID) and smallest detectable change (SDC) or as a change in the positive or negative direction using trend lines. RESULTS: Data of three participants were analyzed and engaging in physical exercise seemed beneficial for reducing motor symptoms. Participant 1 demonstrated improvement in motor function, independent of exercise modality; while for participant 2, such a clinically relevant (positive) change in motor function was only observed in response to CAE. Participant 3 showed improved motor function after HIIT, but no comparison could be made with CAE because of drop-out. Heterogeneous responses on secondary outcome measures were found, not only between exercise modalities but also among participants. CONCLUSION: Though this study underpins the positive impact of physical exercise in the management of PD, large variability in individual response patterns to the interventions among participants makes it difficult to identify clear exercise-induced adaptations in functioning and blood biomarkers. Further research is needed to overcome methodological challenges in measuring individual response patterns.
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AIM: Cold atmospheric plasma (CAP) has antimicrobial properties. We studied the safety of a novel CAP device (PLASOMA prototype; Plasmacure, The Netherlands) that is simple to use and could be applied at a patient's home for the treatment of diabetic foot ulcers (DFUs). Secondary objectives were to investigate the effect of CAP on bacterial load and on ulcer size. METHOD: We included subjects with non-infected, superficial DFUs and treated them with CAP on a daily basis for 10 days. The primary endpoint was the occurrence of serious adverse device effects (SADE). We defined safety as: ≤10% of patients experiencing a SADE other than infection (non-infectious SADE), and ≤60% of patients developing infection of the foot (infectious serious adverse event (SAE)). RESULTS: We enrolled 20 patients. No SADE occurred, but three infectious SAEs occurred at the site of application within one month of treatment; three SAEs unrelated to treatment occurred, and 55% of subjects reported transient mild adverse device effects. Staphylococcus aureus bacterial load decreased directly after CAP application (p=0.01). The mean decrease of ulcer surface area was 43% (95% confidence interval: 20.2%-65.9%). CONCLUSION: CAP treatment in DFUs was safe and well tolerated. Ulcer size and Staphylococcus aureus colonisation decreased during treatment.
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Diabetes Mellitus , Pie Diabético , Gases em Plasma , Infecciones Estafilocócicas , Humanos , Pie Diabético/epidemiología , Staphylococcus aureus , Gases em Plasma/uso terapéutico , Carga Bacteriana , Infecciones Estafilocócicas/tratamiento farmacológico , Diabetes Mellitus/tratamiento farmacológicoRESUMEN
BACKGROUND: Remote smartphone-based 2-minute walking tests (s2MWTs) allow frequent and potentially sensitive measurements of ambulatory function. OBJECTIVE: To investigate the s2MWT on assessment of, and responsiveness to change in ambulatory function in MS. METHODS: One hundred two multiple sclerosis (MS) patients and 24 healthy controls (HCs) performed weekly s2MWTs on self-owned smartphones for 12 and 3 months, respectively. The timed 25-foot walk test (T25FW) and Expanded Disability Status Scale (EDSS) were assessed at 3-month intervals. Anchor-based (using T25FW and EDSS) and distribution-based (curve fitting) methods were used to assess responsiveness of the s2MWT. A local linear trend model was used to fit weekly s2MWT scores of individual patients. RESULTS: A total of 4811 and 355 s2MWT scores were obtained in patients (n = 94) and HC (n = 22), respectively. s2MWT demonstrated large variability (65.6 m) compared to the average score (129.5 m), and was inadequately responsive to anchor-based change in clinical outcomes. Curve fitting separated the trend from noise in high temporal resolution individual-level data, and statistically reliable changes were detected in 45% of patients. CONCLUSIONS: In group-level analyses, clinically relevant change was insufficiently detected due to large variability with sporadic measurements. Individual-level curve fitting reduced the variability in s2MWT, enabling the detection of statistically reliable change in ambulatory function.