Efficacy of the use of video games on mood, anxiety and depression in stroke patients: preliminary findings of a randomised controlled trial.

BACKGROUND: In the different published studies, there is no consensus on the efficacy of virtual reality as an adjuvant treatment of mood states. AIM: The aim of this study is to evaluate the impact of no immersive virtual reality with the Nintendo Switch device in rehabilitation treatment on mood, anxiety and depression in stroke patients admitted to neurorehabilitation units. METHODS: Fifty-eight patients admitted to neurorehabilitation units underwent a 1:3 multicentre randomised clinical trial. The intervention group consisted of 17 patients and the control group of 41 patients. The intervention group performed 6 virtual reality sessions together with the conventional treatment, and the control group performed only the conventional rehabilitation sessions. Primary and secondary clinical outcomes were measured before and six weeks after the intervention. RESULTS: Comparing the intervention group and control group, the anxiety levels of the intervention group decreased compared to the results observed in the control group (p = 0.01), as did the dependence of the intervention group (0.015). On the other hand, the results obtained after the intervention by the control group for anxiety (0.479) and depression (0.292) were not statistically significant. CONCLUSION: Rehabilitation VR used as an adjuvant treatment to conventional treatment has a beneficial impact on the neurological status and state of anxiety of stroke patients admitted to neurorehabilitation units. TRIAL REGISTRATION: Registered in the https://clinicaltrials.gov/ repository (NTC NCT05143385). Protocol registration date 7 October 2021, retrospectively registered.

Definition and clinical management of haemodialysis central venous catheter local infections (exit site and tunnel infection): An international consensus assessment.

AIM: To evaluate the relevance of signs and symptoms for the clinical identification of ESI and TI in HD-CVC, by means of international expert consensus, and to reach a consensus on a definition and clinical management (CM) for these infections. BACKGROUND: A recent systematic review showed a high heterogeneity in the signs/symptoms used for determining exit site infection (ESI) and tunnel infection (TI) of haemodialysis central venous catheter (HD-CVC). DESIGN: A modified Delphi ranking process was carried out between November 2020 and March 2021, consisting of four rounds using an online questionnaire with a panel of 26 experts from 12 countries. METHODS: Experts responded on the level of relevance for the identification of ESI and TI, based on a list of 22 signs/symptoms obtained from a previous systematic review, using a 4-point Likert-type scale. After reaching consensus on the signs/symptoms, they followed the same method to reach consensus on the CM. The STROBE Checklist was used to report this study. RESULTS: A high degree of consensus was reached to identify the presence of ESI based on nine signs/symptoms: presence of pain at the exit site (ES) during interdialysis period, with fever ≥38°C do not suspect other cause, local signs at the ES (inflammation, induration, swelling, hyperemia/erythema ≥2 cm from ES) and obvious abscess or purulent exudate at ES; and of TI. Likewise, 5 cm were agreed upon. CONCLUSION: This Delphi study provides international expert consensus definitions of ESI and TI in HD-CVC, laying the groundwork for the validation of an HD-CVC ES clinical assessment scale for early identification of ESI. RELEVANCE TO CLINICAL PRACTICE: In addition, this study provides a series of attitudes to consensual clinics regarding signs/symptoms of local infections in HD-CVC, which may be useful as expert opinion in clinical practice guidelines, when there is insufficient scientific evidence.

Impact of virtual reality-based therapy on post-stroke depression: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Post-stroke depression is the most common neuropsychiatric consequence and reduces rehabilitation effectiveness. However, the efficacy of virtual reality (VR) on mental health treatment for patients after a stroke is uncertain. AIMS: The aim of this study was to evaluate the efficacy of VR as a co-adjuvant form of treatment to reduce depression in stroke patients admitted to neurorehabilitation units. METHODS: We systematically searched medical databases including PubMed, CINAHL, PsycINFO, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to November 16, 2023. Clinical trials comparing the use of VR as an adjuvant form of treatment in stroke patients' rehabilitation with the usual treatment were included. Pooled standardized mean differences were calculated using a random-effects model. Subgroup analyses were performed according to type of stroke, VR characteristics, and the scale used to measure depression. Meta-regression analysis was performed for intervention duration and to determine the mean age of the participants. RESULTS: Eight studies and 388 stroke patients were included. The VR interventions were associated with a lower risk of depression in patients (ES = -0.69; 95% CI [-1.05, -0.33]; I2 = 57.6%; p ≤ .02). The estimates were not affected by the type of stroke, the type of VR used, the blinding process, the type of scale used to detect depression, the duration of the intervention (weeks and minutes), and the total number of sessions. Meta-regression shows that younger samples (p = .00; 95% CI [0.01, 0.08) and longer interventions (p = < .05; 95% CI [-0.00, -0.00) lead to a greater reduction in depression. LINKING EVIDENCE TO ACTION: This review provides an important basis for treating depression in patients after a stroke. Professionals working in stroke neurorehabilitation units should consider VR as a form of co-adjuvant treatment for depression in patients. SYSTEMATIC REVIEW REGISTRATION: CRD42022303968.

[Protocolo para la evaluación de una intervención de alfabetización en salud sobre morbimortalidad y calidad de vida en pacientes con insuficiencia cardíaca.] / Protocol for the evaluation of an efficacy of a health literacy intervention in decreasing mortality, morbidity and improving the quality of life of patients with heart failure.

OBJECTIVE: Heart failure (HF) is a complex clinical syndrome that impairs the ability to achieve proper filling or ejection, in which patients have typical symptoms and signs. It is a major Public Health problem with a high incidence and prevalence associated with high morbidity and mortality. The management of the patient with HF is complex, requiring in its treatment the work of specialized multidisciplinary teams in which the management of cardiac-healthy habits and self-care will play a leading role. Knowing the health literacy (HL) level of patients is a fundamental piece that will help us to provide a holistic attention, based on individual needs, promoting in this way the empowerment of the patient. Our aim will be to evaluate the effectiveness of an HL intervention for improving quality of life and decreasing morbidity/mortality. METHODS: A two-arm randomized controlled clinical trial will be conducted, with concealment of randomization. Patients with diagnosis of HF attended in cardiology and internal medicine consultations of 5 hospitals in Spain will be included.

OBJETIVO: La insuficiencia cardiaca (IC) es un síndrome clínico complejo con una sintomatología bien definida que constituye un problema de Salud Pública por su impacto en la morbi-mortalidad. El manejo del paciente con IC requiere el trabajo de equipos especializados multidisciplinares que enfaticen en los hábitos cardiovasculares y el autocuidado. Conocer el grado alfabetización en salud (AeS) de estos pacientes es una buena herramienta para prestarles una atención holística, basada en necesidades individuales, así como para fomentar su empoderamiento. Se ha diseñado un protocolo con el objetivo de evaluar la eficacia de una intervención en AeS en la mejora de su calidad de vida, así como en la disminución de la morbi/mortalidad. METODOS: Se llevará a cabo un estudio clínico controlado aleatorio a dos brazos multicéntrico, con ocultación del reparto aleatorio. Se incluirán pacientes con diagnóstico de IC atendidos en consultas de cardiología y medicina interna de cinco hospitales de España.

Early identification of local infections in central venous catheters for hemodialysis: A systematic review.

BACKGROUND: The use of central venous catheters (CVC) is associated with higher morbidity and mortality, related to infectious complications, contributing to poorer clinical outcomes and increased healthcare costs. According to the literature, the incidence of local infections related to CVC for hemodialysis is highly variable. This variability is related to differences in definitions of catheter-related infections. OBJECTIVE: To identify signs and symptoms for determining local infections (exit site and tunnel tract infections) used in the literature in tunnelled and nontunnelled CVC for hemodialysis. DESIGN: Systematic review METHODS: Structured electronic searches were conducted in five electronic databases, from 1 January 2000-31 August 2022, using key words and specific vocabulary, as well as manual searches in several journals. Additionally, vascular access clinical guidelines and infection control clinical guidelines were reviewed. RESULTS: After validity analysis, we selected 40 studies and seven clinical guidelines. The definitions of exit site infection and tunnel infection used in the different studies were heterogeneous. Among the studies, seven (17,5 %) used the definitions of exit site and tunnel infection based on a clinical practice guideline. Three of the studies (7.5 %) used the Twardowski scale definition of exit site infection or a modification. The remaining 30 studies (75 %) used different combinations of signs and symptoms. CONCLUSIONS: Definitions of local CVC infections are highly heterogeneous in the revised literature. It is necessary to establish a consensus regarding the definitions of hemodialysis CVC exit site and tunnel infections. REGISTRATION: PROSPERO (CRD42022351097).

Utilización de medicamentos off-label y unlicensed en una unidad de cuidados intensivos pediátricos de un hospital de alta complejidad español. Estudio descriptivo / Off-label and unlicensed drug use in a pediatric intensive care unit of a tertiary care Spanish hospital. A descriptive study

Introducción. En las unidades de cuidados intensivos pediátricos, se utiliza gran cantidad de medicamentos, muchos prescritos fuera de las condiciones establecidas en su ficha técnica (prescripciones off-label y unlicensed). El objetivo de este estudio fue describir el uso de medicamentos y estimar la prevalencia de fármacos off-label y unlicensed en una unidad de cuidados intensivos pediátricos de un hospital de tercer nivel español. Población y métodos. Estudio transversal, observacional, de una cohorte de niños ingresados en una unidad de cuidados intensivos pediátricos. El estudio se llevó a cabo en 2017. Se revisó cada fármaco prescrito, sus condiciones de uso y administración. Además, se analizaron las fichas técnicas de los fármacos implicados con la finalidad de identificar si el uso de los medicamentos se realizaba según sus condiciones de autorización, o bien se hacía fuera de prospecto (off-label) o como unlicensed. Resultados. La muestra fue de 97 pacientes. El 74,2 % (n = 72) de los pacientes recibieron algún fármaco off-label o unlicensed. El 23,8 % (n = 243) de las prescripciones fueron off-label y el 8,7 % (n = 89), unlicensed. El subanálisis realizado por grupos de edad mostró que el grupo de edad que recibió mayor número de prescripciones totales (n = 611) y el mayor porcentaje de fármacos prescritos en condiciones off-label y/o unlicensed (38,4 %) fue el de menores de 2 años. Conclusiones. La prescripción de fármacos off-label y/o unlicensed es una práctica habitual en la unidad de cuidados intensivos pediátricos. Este estudio permite documentar la complejidad de la terapéutica en niños.

Introduction. In pediatric intensive care units, a large number of drugs are used, many of which are prescribed for condition beyond those established in their summary of product characteristics (off-label and unlicensed drug prescriptions). The objective of this study was to describe drug use and estimate the prevalence of off-label and unlicensed drugs in a pediatric intensive care unit of a tertiary care Spanish hospital. Population and methods. Cross-sectional, observational study with a single cohort of children admitted to a pediatric intensive care unit. The study was conducted in 2017. Each drug prescription, its conditions of use and administration were reviewed. In addition, the summary of product characteristics of drugs used were analyzed in order to identify whether they were used according to their conditions of authorization, or whether they were used in an off-label or unlicensed manner. Results. The sample included 97 patients. At least one off-label or unlicensed drug was administered to 74.2% (n = 72) of patients; 23.8% (n = 243) corresponded to off-label prescriptions and 8.7% (n = 89), unlicensed prescriptions. A sub-analysis by age group showed that the age group that received a higher number of total prescriptions (n = 611) and a higher percentage of off-label and/or unlicensed drug prescriptions (38.4%) was under 2 years of age. Conclusions. Off-label and/or unlicensed drug prescription is a common practice in the pediatric intensive care unit. This study allowed us to document the complexity of therapeutics in children.

Off-label and unlicensed drug use in a pediatric intensive care unit of a tertiary care Spanish hospital. A descriptive study. / Utilización de medicamentos off-label y unlicensed en una unidad de cuidados intensivos pediátricos de un hospital de alta complejidad español. Estudio descriptivo.

Introduction. In pediatric intensive care units, a large number of drugs are used, many of which are prescribed for condition beyond those established in their summary of product characteristics (off-label and unlicensed drug prescriptions). The objective of this study was to describe drug use and estimate the prevalence of off-label and unlicensed drugs in a pediatric intensive care unit of a tertiary care Spanish hospital. Population and methods. Cross-sectional, observational study with a single cohort of children admitted to a pediatric intensive care unit. The study was conducted in 2017. Each drug prescription, its conditions of use and administration were reviewed. In addition, the summary of product characteristics of drugs used were analyzed in order to identify whether they were used according to their conditions of authorization, or whether they were used in an off-label or unlicensed manner. Results. The sample included 97 patients. At least one off-label or unlicensed drug was administered to 74.2% (n = 72) of patients; 23.8% (n = 243) corresponded to off-label prescriptions and 8.7% (n = 89), unlicensed prescriptions. A sub-analysis by age group showed that the age group that received a higher number of total prescriptions (n = 611) and a higher percentage of off-label and/or unlicensed drug prescriptions (38.4%) was under 2 years of age. Conclusions. Off-label and/or unlicensed drug prescription is a common practice in the pediatric intensive care unit. This study allowed us to document the complexity of therapeutics in children.

Introducción. En las unidades de cuidados intensivos pediátricos, se utiliza gran cantidad de medicamentos, muchos prescritos fuera de las condiciones establecidas en su ficha técnica (prescripciones off-label y unlicensed). El objetivo de este estudio fue describir el uso de medicamentos y estimar la prevalencia de fármacos off-label y unlicensed en una unidad de cuidados intensivos pediátricos de un hospital de tercer nivel español. Población y métodos. Estudio transversal, observacional, de una cohorte de niños ingresados en una unidad de cuidados intensivos pediátricos. El estudio se llevó a cabo en 2017. Se revisó cada fármaco prescrito, sus condiciones de uso y administración. Además, se analizaron las fichas técnicas de los fármacos implicados con la finalidad de identificar si el uso de los medicamentos se realizaba según sus condiciones de autorización, o bien se hacía fuera de prospecto (off-label) o como unlicensed. Resultados. La muestra fue de 97 pacientes. El 74,2 % (n = 72) de los pacientes recibieron algún fármaco off-label o unlicensed. El 23,8 % (n = 243) de las prescripciones fueron off-label y el 8,7 % (n = 89), unlicensed. El subanálisis realizado por grupos de edad mostró que el grupo de edad que recibió mayor número de prescripciones totales (n = 611) y el mayor porcentaje de fármacos prescritos en condiciones off-label y/o unlicensed (38,4 %) fue el de menores de 2 años. Conclusiones. La prescripción de fármacos off-label y/o unlicensed es una práctica habitual en la unidad de cuidados intensivos pediátricos. Este estudio permite documentar la complejidad de la terapéutica en niños.

Efficacy of the therapeutic use of video games on the depressive state of stroke patients: Protocol for systematic review and meta-analysis.

AIM: To assess the effects of virtual reality (VR) on the depressive state of patients with stroke admitted to neuro-rehabilitation units. Design: Systematic review and meta-analysis protocol. METHODS: Randomized Controlled Trials (RCTs) focusing on the effects of virtual reality on depressive state as a primary outcome will be included. Grey literature and the following databases will be consulted: PubMed, Cinahl, PsycInfo, Scopus, Embase, Cochrane Library and Web of Science. The recently revised Cochrane risk of bias tool will be used to assess the quality of included studies. Data will be extracted and meta-analyses will be performed within the specific condition of the emotional state of stroke patients admitted to neurorehabilitation units. Meta-regression and subgroup analyses will be used to identify effective modes and patterns of therapy delivery. The approach of assessment, development and evaluation of recommendations will be applied to reach a convincing conclusion. DISCUSSION: An accurate, transparent and standardized review process is expected to provide recommendations on the use of VR technology in the healthcare of stroke patients. IMPACT: Emotional difficulties are common after stroke and have an impact on rehabilitation outcome. VR seems to have an important role in the treatment and depression in neurological patients, as it is able to improve levels of well-being, coping strategies and social relationships. The systematic review may contribute to a more convincing and specific conclusion compared to existing studies of this type. TRIAL REGISTRATION: Systematic review registration: CRD42022303968.

Validity of a catheter exit site clinical assessment scale for the early detection of exit site infections in patients on haemodialysis with a central venous catheter: protocol for a multicentre validation study in Spain (EXITA Study).

INTRODUCTION: Haemodialysis patients with central venous catheter (HD-CVC) are at increased risk of exit site infections (ESIs) and catheter-related bloodstream infections, causing an increase of hospitalisation, morbidity and mortality rates. The main aim of the EXITA Study is to develop and validate an instrument for the early detection of HD-CVC ESIs. METHODS AND ANALYSIS: EXITA is a multicentre prospective cohort study to validate the proposed instrument with a sample of 457 HD-CVCs: 92 in the ESI group and 365 in the non-ESI group. Sample size was calculated using Epidat V.4.2 software, with 95% and 90% expected sensitivity and specificity, respectively, an ESI incidence around 20% and 5%-10% precision range. During each haemodialysis session, the absence or presence of each item will be assessed by nurses. If any item is present, a microbiological study of pericatheter skin smears and/or exit site exudate will be carried out. HD-CVC ESI will be diagnosed when the pericatheter skin smears and/or exit site exudate culture are positive (≥15 CFU/mL by semiquantitative Maki's technique or ≥1000 CFU/mL by Cleri's technique). To validate the scale, a logistic regression analysis will be performed: the ß coefficients of each of the signs/symptoms of the scale to be validated will be estimated. We will use logit function and calculate ESI probability=elogit ESI/1+elogit ESI. ETHICS AND DISSEMINATION: The study has been approved by the Research Ethics Committee with Medical Products of Cantabria (approval code 2019.146). We will obtain informed consent from all participants before data collection. We will publish the study results in a peer-reviewed scientific journal.

[Quality of life analysis in patients with an implantable cardioverter-defibrillator]. / Análisis de la calidad de vida de las personas portadoras de un desfibrilador automático implantable.

OBJECTIVES: To describe possible changes in the quality of life (QL) and to identify possible differences associated to sociodemographic and clinical variables after being given an implantable cardioverter-defibrillator (ICD). METHOD: Descriptive cross-sectional study, selecting 241 consecutive patients for a subcutaneous or subpectoral ICD implantation. One-hundred and fifty-seven patients met inclusion criteria. Introduction letter along with the assessment tool was mailed to them. Assessment tool used was the Euroqol-5D (EQ5D), validated and translated for a Spanish population. EQ5D describes health status in 5 domains: mobility (MO), self-care (SC), usual activity (UA), pain/discomfort (PD) and anxiety/depression (AD). It included a visual analogue scale (VAS) where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'; one before and another after ICD implantation. RESULTS: Ninety valid assessments were received: 80 males, mean age 61.2+/-13.1 years. Patients with EQ5D problems: MO 25 (27.7%), SC 8 (8.8%), UA 32 (35.5%), PD 22 (24.4%) and AD 29 (32.2%). Patients with ICD discharges had a higher percentage of problems in all EQ5D domains, being significant in PD and AD. Fifty four patients (60%) experienced a significant improvement in QL after ICD implant using the visual analogue scale score (75 points after vs. 50 points before; P<0.001). CONCLUSIONS: The majority of ICD patients gain QL after implantation, but this gain is more limited in younger patients and those who have received discharges.