A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care.

INTRODUCTION: The clinical effect of domperidone against COVID-19 has been investigated in a double-blind phase III clinical trial (EudraCT number 2021-001228-17). Domperidone has shown in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential immudolatory properties through the stimulation of prolactin secretion. PATIENTS AND METHODS: The efficacy of oral domperidone plus standard of care (SOC; n = 87) versus placebo plus SOC (n = 86) was evaluated in a 28-day randomized double-blind multicentre study in primary health care centres. A total of 173 outpatients with mild-to-moderate COVID-19 were included. Three daily doses of 10 mg (30 mg/day) of domperidone or placebo were administered for 7 days. Reduction of viral load on day 4 was the primary efficay endpoint. It was estimated in saliva samples by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), as the cycle thresholds detected ORF1ab, N Protein and S Protein genes. RESULTS: A significant reduction in the viral load was observed (p < 0.001) from baseline to days 4, 7 and 14 of the three genes studied with non-significant differences between domperidone and placebo groups. Twenty-three patients (13.3%) experienced adverse events, 14 patients in the domperidone group (16.1%) and 9 patients in the placebo group (10.5%). No patients needed to be hospitalized. CONCLUSION: Results do not prove the use of domperidone as antiviral in patients with COVID-19.

A 28-day double-blind clinical trial was performed to investigate the antiviral effect of domperidone, 30 mg/day for 7 days (n = 87) versus placebo (n = 86) in outpatients with mild-to-moderate COVID-19.The primary efficacy endpoint was the reduction of viral load on day 4 as compared with baseline, estimated as the cycle thresholds to detect ORF1ab, N Protein and S Protein genes by RT-qPCR in saliva samples.The study findings do not prove the use of domperidone as antiviral in patients with COVID-19.

A Pilot Study of the Effects of Individualized Home Dual Task Training by Mobile Health Technology in People with Dementia.

The objective of this pilot study was to evaluate the effects of dual-task training implemented by mobile health technology on performance on motor and dual-task tests in subjects with dementia. Nineteen subjects with a medical diagnosis of dementia were assigned to an experimental group (EG, n = 12) or control group (CG, n = 7). The EG participated in 24 sessions (3/week) of a homebase dual-task exercises program, in addition to their ongoing cognitive and physiotherapy treatment. The training program was implemented individually in the patient's home by caregivers or relatives through electronic devices controlled by a mobile application. Before (Pre) and after (Post) the program, performance on motor and motor/cognitive (dual-task) tests were evaluated. Motor evaluation included gait at preferred and maximal speed, the Up and Go, and the Handgrip Strength test. Dual-task tests included gait with subtraction 3 s from 100 and naming animals (verbal fluency). The CG only performed the evaluations in addition to their cognitive and physiotherapy treatment. The statistical analysis (ANOVA Group*Test) showed a statically significant improvement for both dual-task tests in the EG after the training program, while the CG showed an impairment in the verbal fluency test. Conclusion: the implementation of a home exercise program carried out with mobile technology in people with dementia is feasible and positively affects their performance on dual tasks.

Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children.

BACKGROUND: In September 2015, the four-component, protein-based meningococcal serogroup B vaccine (4CMenB; Bexsero) became available for private purchase in Spain. METHODS: We conducted a nationwide matched case-control study to assess the effectiveness of 4CMenB in preventing invasive meningococcal disease in children. The study included all laboratory-confirmed cases of invasive meningococcal disease in children younger than 60 months of age between October 5, 2015, and October 6, 2019, in Spain. Each case patient was matched with four controls according to date of birth and province. 4CMenB vaccination status of the case patients and controls was compared with the use of multivariate conditional logistic regression. RESULTS: We compared 306 case patients (243 [79.4%] with serogroup B disease) with 1224 controls. A total of 35 case patients (11.4%) and 298 controls (24.3%) had received at least one dose of 4CMenB. The effectiveness of complete vaccination with 4CMenB (defined as receipt of at least 2 doses, administered in accordance with the manufacturer's recommendations) was 76% (95% confidence interval [CI], 57 to 87) against invasive meningococcal disease caused by any serogroup, and partial vaccination was 54% (95% CI, 18 to 74) effective. Complete vaccination resulted in an effectiveness of 71% (95% CI, 45 to 85) against meningococcal serogroup B disease. Vaccine effectiveness with at least one dose of 4CMenB was 64% (95% CI, 41 to 78) against serogroup B disease and 82% (95% CI, 21 to 96) against non-serogroup B disease. With the use of the genetic Meningococcal Antigen Typing System, serogroup B strains that were expected to be covered by 4CMenB were detected in 44 case patients, none of whom had been vaccinated. CONCLUSIONS: Complete vaccination with 4CMenB was found to be effective in preventing invasive disease by serogroup B and non-serogroup B meningococci in children younger than 5 years of age.

Conocimientos y actitudes de los profesionales sanitarios en Cantabria e Islas Baleares sobre voluntades previas / What do health professionals know about living wills in Cantabria and the Balearic Islands

Objetivo: Explorar los conocimientos y actitudes de los profesionales sanitarios con relación a las voluntades previas en dos regiones de España: Cantabria e Islas Baleares. Metodología: Estudio descriptivo transversal mediante cuestionario autoadministrado online. Se analizaron variables sociodemográficas, conocimientos y actitudes relacionados con las voluntades previas. El estudio se aprobó por el Comité Ético de Investigación Clínica de Cantabria. Resultados: Respondieron al cuestionario 274 profesionales sanitarios, de Cantabria 222 y de Islas Baleares 52. Un 75,6% respondió que otorgaría documento de voluntades previas y un 86,6% que lo recomendarían a sus pacientes crónicos. Un 15,5% expresó sentirse preparado para informar, un 95,2% que desearía recibir formación. Las enfermeras tuvieron más conocimientos concretos que otros profesionales con relación al procedimiento, validez y consulta del documento. Cantabria y Baleares presentaron diferencias estadísticamente significativas en intención de otorgar (p = 0,005) y en haber consultado o propuesto consultar el Registro de Voluntades Previas durante la práctica profesional (p = 0,000), en ambos casos con mayor porcentaje en Cantabria. Conclusiones: La percepción de los profesionales acerca de sus conocimientos relacionados con las voluntades previas es escasa, y su actitud es de respeto a estas, y las consideran útiles para todos los implicados. Su especial relevancia en la población de mayor edad constituye a las enfermeras especialistas en enfermería geriátrica-gerontológica principales beneficiarias e impulsoras de las voluntades previas (AU)

Objective: To explore knowledge and attitudes towards advance directives in health professionals from Cantabria and the Balearic Islands. Methodology: Cross-sectional study using an online validated questionnaire. Main measurements were sociodemographic variables, knowledge and attitudes towards Advance directives. The study was approved by the Cantabrian Ethics Committee. Results: 274 health professionals, from Cantabria 222 and the Balearic Islands 52, responded to the questionnaire. 75.6% of professionals would grant their own Living Will Declaration, and 86.6% would tell their chronic patients to. 15.5% felt prepared enough to inform their patients, 95.2% would like to receive training. Nurses have higher knowledge about procedure, validity and consulting the living will than other health professionals. Cantabria and the Balearic Islands show statistical significance in two items: intending to grant (p = 0.005) and had consulted or proposed to consult the living will of a patient during professional practice (p = 0.000), being higher for Cantabria for both items. onclusions: Health professionals have low knowledge about Advance Directives. They think it is a useful instrument for patients and for themselves. They would respect them. Professionals have little training in living wills and do not feel they could inform their patients properly. They would like to receive training irrespective of age, time working, current job, or experience. Specially important in elderly people, advance directives turn capital for geriatric specialized nurses both as receptors and as developers of this issue (AU)

Mindfulness-Based Intervention for the Reduction of Compassion Fatigue and Burnout in Nurse Caregivers of Institutionalized Older Persons with Dementia: A Randomized Controlled Trial.

The recent COVID-19 pandemic has severely impacted the mental health of nurses caring for institutionalized older people. Caring in this environment can be complex, with higher levels of burnout and compassion fatigue in staff. It is therefore important to find interventions to increase the well-being of staff. Mindfulness training is known to be effective in treating a variety of physical and mental health conditions. This study sought to conduct a direct evaluation of the effectiveness of a combined online training in two types of mindfulness-based therapies for the reduction of compassion fatigue and burnout in geriatric nurses caring for institutionalized elderly people with dementia. In a randomized controlled trial (n = 39 experimental group, n = 35 control group), we explored whether individuals with high levels of burnout and compassion fatigue would benefit more from an online mindfulness training program. The outcome variable was the ProQoL professional quality of life scale, which was collected at baseline, at six weeks, and at three months after completion of the intervention. Significant differences were found between both groups for the subscales Compassion Fatigue and Burnout (p < 0.05), with a significant improvement in the experimental group (significant effect size). These findings were maintained at three months after the end of the intervention for both compassion fatigue (F1,28 = 18.14, p = 0.003) and burnout (F1,28 = 7.25, p = 0.040). However, there were no differences between groups for the satisfaction subscale. The effect of time and the effects of comparing the two groups after controlling for time were statistically significant for all three subscales of the questionnaire (all p values < 0.001), with effect sizes ranging from small to large (R2 change 0.10-0.47). These data indicate that the experimental condition was more effective, explaining between 10 and 18% more of the variance. A short, online intervention based on mindfulness training appears to be effective for reducing compassion fatigue and burnout in geriatric nurses, with sustained effects over time.

Knowledge and attitudes towards living wills among healthcare professionals, residents and relatives in nursing homes: A qualitative study.

Living wills are a tool to support the principle of autonomy in end-of-life situations, when the person does not have the capacity to make decisions. The aim was to explore the knowledge and attitudes of residents, relatives and healthcare professionals in nursing homes in Cantabria regarding living wills. A qualitative phenomenological design was conducted. Two focus groups were held with seven participants in each group. A sample of 14 people participated in this study: four residents, five relatives and five professionals. This study was approved by the Clinical Research Ethics Committee of Cantabria. Two main categories were found, with six subcategories each: death, with six subcategories-as a social taboo, as a natural process, facing death, accompanying uncertainties, unnecessary lengthening of life and guilt-and living wills, with six subcategories-knowledge, unknowingness or misconceptions, usefulness, strategies to promote dissemination, intention of granting a living will and the professional's role in restricting or promoting autonomy. Unknowingness or misconceptions and uncertainties in relation to death were the most represented subcategories of each category. Although the attitudes among the study participants were mostly positive, there is a lack of knowledge concerning living wills, which is enhanced by the social taboo related to death.

Efficacy of Bromhexine versus Standard of Care in Reducing Viral Load in Patients with Mild-to-Moderate COVID-19 Disease Attended in Primary Care: A Randomized Open-Label Trial.

A 28-day randomized open-label multicenter study was conducted to assess the efficacy of bromhexine plus standard of care (SOC) (n = 98) vs. SOC alone (n = 93) in 191 outpatients with mild-to-moderate COVID-19 in the primary health care setting. Bromhexine three daily doses of 10 mL (48 mg/day) were administered for seven days. The primary efficacy endpoint was the reduction of viral load estimated as the cycle thresholds (Ct) to detect ORF1ab, N Protein, and S Protein genes by RT-qPCR in saliva samples on day 4 as compared with baseline. Ct values of the three genes increased from baseline throughout days 4 to 14 (p < 0.001) but significant differences between the study groups were not found. Differences in the percentages of patients with low, medium, and high viral loads at 4, 7, and 14 days were not found either. In summary, treatment with bromhexine plus SCO was associated with a viral load reduction of ORF1ab, N Protein, and S Protein genes at day 4, which was not significantly different than similar viral load reductions observed with SOC alone. The present findings do not seem to favor the use of bromhexine as an antiviral in patients with COVID-19.

Predictive Model of Preventive Behaviors against COVID-19 in the Older Adult: The PREASOC-COVID-19 Study.

BACKGROUND: The purpose of this study was to analyze the relationship between COVID-19 preventive behaviors, as the dependent variable, with risk perception, coping style and sense of coherence, as independent variables, in older people living in the community. METHODS: An observational design for predictive model development. This study was reported following the STROBE statement. The subjects were people over 65 years of age living in the community. Data collection included sociodemographic variables related to COVID-19, risk perception and types, coping styles in the face of contagion, sense of coherence, and preventive behaviors in the face of COVID-19. The data collection period was from November 2020 to January 2021. RESULTS: A total of 305 people participated in this study (71.5% women, mean age 71.34 years; 6.9% suffered from COVID-19 and 44.3% knew someone close to them who suffered from the virus). The coping style variables problem-focused, emotion-focused, and sense of coherence subscales Significance and manageability explained 17% of the variable preventive behaviors against COVID-19. There were statistically significant differences by gender in all subscales, with women scoring higher in all of them; Conclusions: Men with low risk perception, extrinsic risk perception, and low sense of coherence presented worse COVID-19 preventive behaviors. It would be interesting to develop specific prevention and health education campaigns for this population.

Valoración por Patrones Funcionales en alumnado con Necesidades Educativas Especiales por motivos de salud / Assessment by Functional Patterns in students with Special Educational Needs for health reasons

Objetivo principal: explorar el papel de la enfermera escolar en el cuidado del alumnado con Necesidades Educativas Especiales. Metodología: búsqueda bibliográfica en las bases de datos Pubmed, Cuiden y Google Académico relacionados con las enfermedades crónicas y raras en la población pediátrica y los Patrones Funcionales de Gordon para establecer posteriormente la relación entre ambos. Resultados principales: se identificaron 42 publicaciones de las cuales se seleccionaron 22 tomando en consideración título, autores, año de publicación, novedades aportadas, bases de datos en las que están indexadas, tipo de estudio realizado y metodología utilizada. Conclusión principal: una valoración de enfermería con carácter preferente para el alumnado con Necesidades Educativa Especiales, atendiendo a las diferentes respuestas humanas, garantiza la continuidad del cuidado integral y maximiza la seguridad del menor en los tiempos escolares. (AU)

Aims: explore the role of the school nurse in the care of the students with Special Educational Needs. Methods: bibliographic search in the Pubmed, Cuiden and Google Academic databases related to chronic and/or rare diseases in the paediatric population and Gordon's Functional Patterns to subsequently establish the relationship between the two. Main results: 42 publications were identified from which 22 were selected taking into account title, authors, year of publication, novelties provided, databases in which they are indexed, type of study carried out and methodology used. Main conclusions: a nursing assessment preferably for students with Special Educational Needs, taking into account different human responses, ensures the continuity of comprehensive care and maximizes the safety of the child in school times. (AU)

Educational intervention: Improving the knowledge and attitudes of health professionals on living wills.

BACKGROUND: Health professionals have limited knowledge of advanced directives or living wills, which may hamper understandings among the general population. This could impact on the current low registration rates for advanced directives. OBJECTIVE: To evaluate a single-group educational intervention to improve the knowledge and attitudes concerning advanced directives in the short and medium term among health professionals working in nursing homes for older adults. DESIGN: An educational intervention was carried out. SETTINGS: Fourteen nursing homes in Cantabria, Spain. PARTICIPANTS: 201 healthcare professionals. METHODS: A theoretical presentation, questions and debates took place between November 2018 and May 2019. Baseline, post-intervention, and follow-up measurements were made to evaluate knowledge and attitudes towards advanced directives. Descriptive and inferential statistical analyses were performed using the Student's t-test and the one-factor ANOVA. ETHICAL CONSIDERATIONS: This study was approved by the Clinical Research Ethics Committee of Cantabria. FINDINGS: No statistically significant differences were found for any of the socio-demographic variables at baseline, post-intervention, or follow-up. In relation to the baseline questionnaire, knowledge and attitudes increased after the intervention (p = .000 for both blocks of questions) as well as in the follow-up questionnaire (p = .000 for both blocks). DISCUSSION: A single-group educational intervention increases knowledge and improves attitudes towards advanced directives. Educated professionals can become health agents in this area, which can lead to an increase in the registration of advanced directives. CONCLUSIONS: Educational interventions represent a cost-effective measure that may provide benefits at the end of life for patients and their families, as well as for the healthcare team.

Burnout, Compassion Fatigue and Psychological Flexibility among Geriatric Nurses: A Multicenter Study in Spain.

Nurses working at nursing homes are one of the most vulnerable populations for suffering burnout and compassion fatigue. In Spain, the concept of compassion fatigue and psychological flexibility related to stress in geriatric nurses has not been fully explored until now. It is important to analyze their situation in order to design robust coping and management strategies. The aim was to analyze the relationship between burnout, compassion fatigue and psychological flexibility in geriatric nurses in Spain. Participants included 291 nurses from 97 centers in 51 cities across Spain. Psychological flexibility (AAQ-II), burnout (MBI) and compassion fatigue (ProQOL) were evaluated. Responses were recievced from 281 nurses (91% women), with an average of 7.6 years of work experience. The MBI results were average (26.71), and the ProQOL scores were average for compassion fatigue (40.2%) and high for compassion satisfaction (70.3%), whereas for AAQ-II, the mean score was 37.34 (SD 4.21). The correlation was significant and negative for flexibility, burnout and compassion fatigue, and positive for compassion satisfaction. The ANOVA indicated a significant association between all variables (p < 0.05). We can conclude that geriatric nurses suffer from medium levels of burnout and compassion fatigue, together with high levels of psychological flexibility, which appears to act as a stress reliever, supporting compassion satisfaction.

Experiences of geriatric nurses in nursing home settings across four countries in the face of the COVID-19 pandemic.

AIM: To explore the emotional impact and experiences of geriatric nurses working in nursing homes and caring for patients with coronavirus 2019 disease (COVID-19). DESIGN: This is a qualitative study with phenomenological method and data were gathered through in-depth interview. METHODS: The experiences and expectations that nurses are facing during their care duties were explored via video conference, using a semi-structured interview guide. We have followed the Consolidated criteria for reporting qualitative research COREQ. RESULTS: Interviews (N=24) were conducted with nurses from four countries (Spain, Italy, Peru, and Mexico) during April 2020. Three main categories were extracted: fear of the pandemic situation, the sense of duty and professional commitment, and emotional exhaustion. CONCLUSIONS: Regardless of the country and situation, in the face of the pandemic, dramatic situations have been experienced in nursing homes worldwide, with nursing staff feeling exhausted and overwhelmed, and reflection is urged on a global level to consider the most appropriate model of care in nursing homes.

Validation of the Spanish Version of the ICECAP-O for Nursing Home Residents with Dementia.

BACKGROUND: Measurement of health-related quality of life (HRQoL) is important for a chronic disease, such as dementia, which impairs the quality of life of affected patients in addition to their length of life. This is important in the context of economic evaluations when interventions do not (only) affect HRQoL and these other factors also affect overall quality of life. OBJECTIVE: To validate the Spanish translation of the ICECAP-O's capability to measure Health-related quality of life in elderly with dementia who live in nursing homes. METHOD: Cross-sectional study. For 217 residents living in 8 Spanish nursing homes, questionnaires were completed by nursing professionals serving as proxy respondents. We analyzed the internal consistency and other psychometric properties. We investigated the convergent validity of the ICECAP-O with other HRQoL instruments, the EQ-5D extended with a cognitive dimension (EQ-5D+C), the Alzheimer's Disease Related Quality of Life (ADRQL) measures, and the Barthel Index measure of activities of daily living (ADL). RESULTS: The ICECAP-O presents satisfactory internal consistency (alpha 0.820). The factorial analysis indicated a structure of five principal dimensions that explain 66.57% of the total variance. Convergent validity between the ICECAP-O, EQ-5D+C, ADRQL, and Barthel Index scores was moderate to good (with correlations of 0.62, 0.61, and 0.68, respectively), but differed between dimensions of the instruments. Discriminant validity was confirmed by finding differences in ICECAP-O scores between subgroups based on ADL scores (0.70 low, 0.59 medium, and 0.39 high level care), dementia severity (0.72 mild, 0.63 medium, and 0.50 severe), and ages (0.59 below 75 years and 0.84 above 75 years). CONCLUSIONS: This study presented the first use of a Spanish version of the ICECAP-O. The results indicate that the ICECAP-O appears to be a reliable Health-related quality of life measurement instrument showing good convergent and discriminant validity for people with dementia.

Restricción física: revisión y reflexión ética / Physical restraint: review and ethical reflection

La restricción física es una medida terapéutica utilizada para controlar pacientes que presentan un riesgo de lesión para ellos mismos o para terceras personas. Dado que son técnicas que coartan la libertad de movimientos, algunos derechos de los pacientes pueden ser vulnerados. Para evitar esto, existen diversos protocolos a nivel nacional, una amplia base legal y preceptos éticos que respetar. En este artículo se revisarán los protocolos, se identificarán los aspectos legales y se analizarán sus implicaciones éticas. Como reflexión principal, se hace imperativo que los profesionales conozcan las bases legales y las implicaciones éticas de estas medidas terapéuticas, así como las técnicas y los protocolos existentes, para lo cual se hace imprescindible la formación e información de los profesionales

Physical restraint is a therapeutic measure useful to manage patients who are at risk of hurting themselves or others. These techniques restrict freedom of movement of the patients, so their rights may be violated. To avoid this, there are protocols all around the country. There is also a large legal basis, and the ethical precepts should be respected. This paper will briefly review those protocols, the legal issues, and the ethical implications of the use of the technique. The main conclusion is that it’s essential that professionals know the legal and the ethical implications, the techniques and protocols of this treatment. To achieve this aim, it becomes necessary that all the professionals receive the correct training

Relajación muscular e hipertensión arterial: estudio controlado con pacientes medicados y no medicados / Muscular relaxation and arterial hypertension: a controlled study with medicated and unmedicated patients

Cuarenta pacientes hipertensos, veinte medicados y veinte sin medicación, fueron asignados al azar a 4 grupos, dos grupos experimentales y dos control: G 1 (Relajación no medicado), G2 (Control no medicado), G3 (Relajación medicado) y G4 (Control medicado). Los grupos experimentales fueron sometidos a un pro-grama de entrenamiento en relajación muscular y los grupos control a un control semanal de la presión arterial (PA) y de la frecuencia cardíaca (FC) Las variables dependientes utilizadas fueron la PA y la FC, evaluadas en el ámbito clínico, y la reactividad cardiovascular estudiada a través de pruebas de éstres en laboratorio. Los resultados mostraron que el entrenamiento en relajación muscular provocó una reducción significativamente superior en la PA sistolica y diastólica de los grupos experimentales G 1 y G3 que en los grupos control G2 y G4. En la FC sólo el G1 fue superior a su correspondiente grupo control G2. Dichos descensos se mantenían en el periodo de seguimiento. Del mismo modo, en las pruebas de reactividad cardiovascular se observo un descenso significativamente mayor de la PA sistolica y diastólica en los dos grupos experimentales G1 y G3 que en los grupos control En la FC el grupo experimental no medicado G1 fue superior a su control G2 Se discuten los resultados dentro del marco del tratamiento no farmacológico de la hipertensión arterial (AU)