Clinical trial on nurse training through virtual reality simulation of an operating room: assessing satisfaction and outcomes.

INTRODUCTION: Virtual reality (VR) provides a firsthand active learning experience through varying degrees of immersion. The aim of this study is to evaluate the use of VR as a potential tool for training operating room nurses to perform thoracic surgery procedures. METHODS: This is an open parallel-group randomized clinical trial. One group received basic formation followed by an assessment module. The experimental group received the same basic formation, followed by thoracic surgery training and an assessment module. RESULTS: Fifty-six nurses participated in the study (51 females), with a mean age of 41.6 years. Participants achieved a median evaluation mode score of 480 points (IQR = 32 points). The experimental group (520 points) achieved an overall higher score than the control group (440 points; P = .04). Regarding age, women in the second quartile of age among the participants (35-41 years) achieved significantly better results than the rest (P = .04). When we evaluated the results based on the moment of practice, exercises performed in the last 10 min obtained better results than those performed in the first 10 min (1064 points versus 554 points; P < .001). Regarding adverse effects blurred vision was the most frequent. The overall satisfaction rating with the experience was 8.5 out of 10. CONCLUSION: Virtual reality is a useful tool for training operating room nurses. Clinical trial with ISRCTN16864726 registered number.

Economic impact of outpatient follow-up using telemedicine vs in-person visits for patients in general surgery: A secondary analysis of a randomized clinical trial.

INTRODUCTION: Innovation in internet connectivity and the Covid 19 pandemic have caused a dramatic change in the management of patients in the medical field, boosting the use of telemedicine. A comparison of clinical outcomes and satisfaction between conventional face-to-face and telemedicine follow-up in general surgery, an economic evaluation is mandatory. The aim of the present study was to compare the differences in economic costs between these two outpatient approaches in a designed randomized controlled trial (RCT). METHODS: A RCT was conducted enrolling 200 patients to compare conventional in-person vs. digital health follow-up using telemedicine in the outpatient clinics in patients of General Surgery Department after their planned discharge. After a demonstration that no differences were found in clinical outcomes and patient satisfaction, we analyzed the medical costs, including staff wages, initial investment, patent's transportation and impact on social costs. RESULTS: After an initial investment of 7527.53€, the costs for the Medical institution of in-person conventional follow-up were higher (8180.4€) than those using telemedicine (4630.06€). In relation to social costs, loss of productivity was also increased in the conventional follow-up. CONCLUSION: The use of digital Health telemedicine is a cost-effective approach compared to conventional face-to-face follow-up in patients of General Surgery after hospital discharge.

Use of antidepressants in the treatment of chronic orofacial pain caused by temporomandibular disorders: A randomized controlled clinical trial.

BACKGROUND AND OBJECTIVE: Temporomandibular disorders (TMDs) are a common pathology, associated with pain in the facial territory and with associated psychological disorders, such as anxiety and depression. The aim of this study was to evaluate the efficacy of antidepressants in the treatment of pain associated with TMD. MATERIALS AND METHODS: Sixty four patients suffering from chronic orofacial pain, randomly distributed in 3 groups: control group treated with night splint, group treated with 10mg/day of citalopram and group treated with 25mg/day of amitriptyline. Pain intensity was assessed, randomly, by a single blinded evaluator, according to the VAS at baseline and after one, three, six and nine weeks. RESULTS: All groups showed a reduction of pain throughout the period of time evaluated, however, the group treated with amitriptyline showed the best pain reduction results 3.3±1.5, 1.5±1.4 and 0.9±1.3 at 3, 6 and 9 weeks, respectively. CONCLUSIONS: Low doses of amitriptyline appear to be a good therapeutic option in patients with TMDs suffering from chronic orofacial pain.

Multidisciplinary consensus document on the current treatment of bacille Calmette-Guérin-unresponsive non-muscle invasive bladder tumor.

Radical cystectomy is the current treatment of choice for patients with BCG-unresponsive non-muscle invasive bladder tumor (NMIBC). However, the high comorbidity of this surgery and its effects on the quality of life of patients require the investigation and implementation of bladder-sparing treatment options. These must be evaluated individually by the uro-oncology committee based on the characteristics of the BCG failure, type of tumor, patient preferences and treatment options available in each center. Based on FDA-required oncologic outcomes (6-month complete response rate for CIS: 50%; duration of response in responders for CIS and papillary: 30% at 12 months and 25% at 18 months), there is not currently a strong preference for one treatment over another, although the intravesical route seems to offer less toxicity. This work summarizes the evidence on the management of BCG-unresponsive NMIBC based on current scientific evidence and provides consensus recommendations on the most appropriate treatment.

Efectos de Cinnamomum zeylanicum en niveles glucémicos en pacientes con diabetes tipo 2: ensayo clínico aleatorizado / Effects of Cinnamomum zeylanicum on glycemic levels in patients with type 2 diabetes: Randomized clinical trial

Objetivo: Evaluar el efecto del consumo de suplemento de Cinnamomum zeylanicum (canela) en los niveles glucémicos de adultos mexicanos con diabetes tipo 2. Métodos: Se realizó un ensayo clínico aleatorizado simple ciego con 30 pacientes >18 años con diabetes tipo 2, se aleatorizaron en los grupos: intervención y control; donde consumieron cápsulas con 2 gramos de C. zeylanicum o harina de trigo (placebo) diario por 12 semanas y se midieron variables antropométricas y bioquímicas (HbA1c, GPa, triglicéridos, colesterol total, HDL y LDL). Se utilizó el software IBM SPSS versión 23 y se aplicó la prueba T-Student y U-Mann Withney para muestras independientes (según el comportamiento de la variable) para las diferencias entre grupos, valores p<0.05 fueron considerados estadísticamente significativos. Resultados: No se observaron cambios significativos en HbA1c entre grupos (p>0.05). Sin embargo, post-tratamiento el grupo intervención disminuyó significativamente HbA1c al compararlo con su línea base (-0.41%, p=0.01) mientras que no se encontraron diferencias en el grupo control (+0.03%, p=0.64). No hubo diferencias significativas en variables antropométricas ni bioquímicas. Conclusiones: El consumo de 2 g de C. zeylanicum en mexicanos con diabetes tipo 2 no produjo cambios significativos entre grupos. Se sugieren nuevos estudios donde se evalúe el suplemento de canela con una muestra mayor. ClinicalTrials.gov; NCT04023539. (AU)

Objective: To evaluate the effect of Cinnamomum zeylanicum (cinnamon) supplement use on the glycemic levels of Mexican adults with type 2 diabetes. Methods: A single-blind randomized clinical trial was conducted with 30 patients over 18 years of age with type 2 diabetes. They were randomized into intervention and control groups where they took 2-gram capsules of Cinnamomum zeylanicum or wheat flour (placebo) daily for 12 weeks; then the anthropometric and biochemical variables HbA1c, FPG, triglycerides, total cholesterol, HDL and LDL were measured. IBM SPSS version 23 software was used and the Student's t-test and Mann-Whitney U test for independent samples (according to the behavior of the variable) were applied for differences between groups, p-values <0.05 were considered statistically significant. Results: No significant changes in HbA1c were seen between the two groups (p>0.05). However, post-treatment, the HbA1c value in the intervention group decreased significantly when compared to their baseline (-0.41%, p=0.01), while no differences were found in the control group (+0.03%, p=0.64). There were no significant differences in the anthropometric or biochemical variables. Conclusions: The consumption of 2 g of Cinnamomum zeylanicum in Mexican people with type 2 diabetes did not produce significant changes between the groups. New studies evaluating cinnamon supplementation on a larger sample size are suggested. ClinicalTrials.gov; NCT04023539. (AU)

AVIP Project (Prosthetic Virtual Friend): Study of clinical-functional outcomes and satisfaction with a mobile application in the perioperative management and follow-up of hip arthroplasty. / Proyecto AVIP (Amigo VIrtual Protésico): estudio de resultados clínico-funcionales y de satisfacción con una aplicación móvil en el manejo perioperatorio y seguimiento de implantes protésicos de cadera.

OBJECTIVE: To analyze the clinical, quality of life, and healthcare quality outcomes obtained in a series of patients undergoing total hip arthroplasty (THA), who were empowered and monitored using the AVIP application. These results will be compared with a control group followed through a standard protocol. MATERIAL AND METHOD: Randomized clinical trial with parallel groups involving patients with an indication for THA. Clinical variables were measured and compared using the WOMAC and mHHS, pain assessed by the VAS, quality of life with the SF-12 test. Walking capabilities were analyzed using the Functional Gait Assessment Scale, along with satisfaction levels assessed through the SUCE questionnaire, and perceived anxiety levels related to the process. RESULTS: A total of 68 patients were evaluated, with 31 patients in the AVIP group and 33 in the Control group completing the follow-up. Both groups demonstrated improvement in clinical outcomes based on the WOMAC and mHHS hip tests, a reduction in perceived pain, and an enhancement in quality of life according to the SF-12 test. Patients in the AVIP study group exhibited non-inferiority in clinical outcomes and satisfaction compared to the control group, as well as lower anxiety levels and improved walking capabilities after the first month of follow-up. Notably, 82.25% of the follow-up visits for this group were conducted remotely. CONCLUSION: The implementation of a mHealth application like AVIP can be safely offered to selected patients undergoing hip arthroplasty, enabling effective monitoring and providing continuous information and training.

Pre-incisional local infiltration with levobupivacaine in laparoscopic cholecystectomy: a randomized and clinical trial.

OBJECTIVE: Laparoscopic cholecystectomy (LC), despite its minimally invasive nature, requires effective control of post-operative pain. The use of local anesthetics (LA) has been studied, but the level of evidence is low, and there is little information on important parameters such as health-related quality of life (HRQoL) or return to work. The objective of the study was to evaluate the efficacy of 0.50% levobupivacaine infiltration of incisional sites in reducing POP after LC. METHODS: This was a prospective, randomized, double-blind study. Patients undergoing elective LC were randomized into two groups: no infiltration (control group) and port infiltration (intervention group). POP intensity (numerical rating scale, NRS), need for rescue with opioid drugs, PONV incidence, HRQoL, and return to work data, among others, were studied. RESULTS: Two hundred and twelve patients were randomized and analyzed: 105 (control group) and 107 (intervention group). A significant difference was observed in the NRS values (control group mean NRS score: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) and in the incidence of PONV (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONS: Levobupivacaine infiltration is safe and effective in reducing POP, although this does not lead to a shorter hospital stay and does not influence HRQoL, return to work, or overall patient satisfaction.

OBJETIVO: la colecistectomía laparoscópica (CL), a pesar de su carácter mínimamente invasivo, requiere un control efectivo del dolor postoperatorio (POP). El uso de anestésicos locales (AL) ha sido estudiado pero el nivel de evidencia es bajo y existe poca información acerca de parámetros relevantes como la calidad de vida relacionada con la salud (CVRS) o la reincorporación laboral. El objetivo de este estudio es analizar la eficacia de la infiltración de los sitios incisionales con levobupivacaína 0,50% en la reducción del dolor postoperatorio tras la CL. MATERIAL Y MÉTODOS: estudio prospectivo, aleatorizado y doble ciego. Pacientes sometidos a CL programada fueron aleatorizados en dos grupos: sin infiltración (grupo control) y con infiltración preincisional (grupo intervención). La intensidad del dolor (escala de puntuación numérica, NRS), la necesidad de rescates con opioides, la incidencia de náuseas o vómitos postoperatorios (NVPO) y datos de CVRS o reincorporación laboral, entre otros, fueron recogidos. RESULTADOS: 212 pacientes fueron aleatorizados y analizados: 105 en el grupo control y 107 en el grupo de intervención. Se observó una diferencia estadísticamente significativa en la intensidad del dolor (puntuación media NRS: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) y en la incidencia de NVPO (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONES: La infiltración con levobupivacaína es segura y efectiva en la reducción del dolor postoperatorio, aunque esto no conlleva una menor estancia hospitalaria y no influye en los resultados de CVRS, reincorporación laboral o satisfacción del paciente.

Healing grief - an online self-help intervention programme for bereaved Chinese with prolonged grief: study protocol for a randomised controlled trial.

Background: In China, mental health services do not currently meet the needs of bereaved people with symptoms of prolonged grief disorder (PGD). Internet-based grief interventions may help fill this gap, but such programmes have not yet been developed or evaluated in China. The proposed study aims to investigate the effectiveness, acceptability, and feasibility of an online self-help intervention programme named Healing Grief for bereaved Chinese with prolonged grief, and to explore the psychological mechanisms of potential improvements.Methods: We designed a two-arm randomised controlled trial. At least 128 participants will be randomly assigned to either an Internet-based intervention group or a waitlist-control group. The Internet-based intervention will be developed based on the dual process model, integrating techniques of psychoeducation, behavioural activation, cognitive reappraisal, and meaning reconstruction, and will be delivered via expressive writing. The intervention comprises six modules, with two sessions in each module, and requires participants to complete two sessions per week and complete the intervention in 6 weeks. The primary outcomes include effectiveness, acceptability, and feasibility. The effectiveness will be assessed by measures of prolonged grief, posttraumatic stress, anxiety, and depressive symptoms. Acceptability and feasibility will be evaluated using survey and interview on user experience characteristics. Secondary outcomes include moderators and mediators, such as dual process coping, grief rumination, mindfulness, and continuing bond, to explore the psychological mechanisms of potential improvement. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.Conclusion: The proposed study will determine the effectiveness, acceptability, and feasibility of the newly developed online self-help intervention for bereaved Chinese with prolonged grief and clarify how the intervention helps with symptom improvements. Such an intervention may play an important role in easing the imbalance between the delivery and receipt of bereavement psychological services in China.

In China, mental health services are not widely available for bereaved people.The proposed study will be the first one to develop and evaluate an Internet-based self-help grief intervention for bereaved Chinese with prolonged grief.The proposed study will determine whether and how the intervention helps to improve the mental health of bereaved Chinese with prolonged grief.

Revisión sistemática de los ensayos clínicos sobre terapia antitrombótica con inhibidores del factor XI / Systematic review of clinical trials on the antithrombotic therapy with factor XI inhibitors

Antecedentes y objetivo La información proveniente de los ensayos clínicos fase 2 sugiere que los inhibidores del factor XI podrían mostrar un perfil de eficacia/seguridad más favorable que las terapias antitrombóticas actuales. El objetivo de esta revisión sistemática es analizar la evidencia disponible derivada de esos estudios. Métodos Se realizó una búsqueda bibliográfica en las bases de datos PubMed, Cochrane Library, Scopus y EMBASE, y en las plataformas de registro de ensayos clínicos Clinical Trials y Cochrane Central Register of Controlled Trials. Los resultados se publicaron según la declaración PRISMA. Resultados Se identificaron un total de 18 ensayos clínicos concluidos o en curso abordando múltiples escenarios, incluyendo fibrilación auricular, ictus, infarto de miocardio y tromboembolismo venoso. Se analizó la evidencia procedente de 8 estudios con resultados disponibles. En general, los estudios fase 2 con inhibidores del factor XI mostraron un perfil adecuado de eficacia y seguridad. El balance beneficio/riesgo fue más favorable en términos de reducción de tromboembolismo venoso en pacientes sometidos a artroplastia total de rodilla. Para esta indicación, los inhibidores del factor XI mostraron una reducción global del 50% en la tasa de complicaciones trombóticas y del 60% en la tasa de hemorragias comparado con enoxaparina. En los estudios de pacientes con fibrilación auricular, ictus e infarto de miocardio se observaron resultados más modestos. Conclusión Los inhibidores del Factor XI abren nuevas perspectivas en el tratamiento y la profilaxis antitrombótica. Los estudios fase 3 en curso permitirán definir los fármacos e indicaciones más idóneas. (AU)

Background and objective Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favourable efficacy/safety profile than current antithrombotic therapies. This systematic review aims to analyze the available evidence derived from these studies. Methods A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. The results were reported in accordance with the PRISMA statement. Results A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Overall, phase 2 studies with factor XI inhibitors demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favourable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. Conclusions Factor XI inhibitors offer new prospects in antithrombotic treatment and prevention. Ongoing phase 3 studies will help define the most suitable drugs and indications. (AU)

Eficacia de la práctica de yoga y del ejercicio aeróbico frente al standard of care en pacientes con fibromialgia. Estudio FIB-YOGA-EA-SOC / Efficacy of Yoga Practice and Aerobic Exercise compared to Standard of Care in Patients with Fibromyalgia. FIB-YOGA-EA-SOC Study

Objetivo: evaluar los efectos de una intervención integral de yoga y de ejercicio aeróbico (EA) frente al ejercicio de la práctica habitual o standard of care (SOC) sobre el impacto general y la gravedad de la fibromialgia (FM). Métodos: ensayo clínico aleatorizado de tres brazos en mujeres diagnosticadas de FM (grupos: YOGA, serie de asanas de Satyananda Saraswasi (n= 31); EA, 7.000 pasos diarios (n= 31); SOC (n= 61)). Variables e instrumentos: datos antropométricos, sociodemográficos y clínicos; Fibromyalgia Impact Questionnaire (FIQ); dolor (Widespread pain Index -WPI-); gravedad de los síntomas (Symptom Severity Score -SSS-); calidad de vida (índice combinado de afectación en pacientes con FM -ICAF-); capacidad funcional (Fibromyalgia Health Assessment Questionnaire -FHAQ-). Para la comparación entre los grupos se utilizó la prueba t de Student . Resultados: se estudiaron 96 mujeres con FM. Con respecto al grupo SOC, se han observado mejorías estadísticamente significativas (p< 0,05), y a nivel clínico con las intervenciones YOGA y EA en el índice de dolor (WPI), impacto general y gravedad de la FM (FIQ), gravedad de los síntomas (SSS) y calidad de vida (ICAF). Sin embargo, no se observó una mejoría en la capacidad funcional (FHAQ). Comparando ambas intervenciones, YOGA versus EA, se vieron diferencias estadísticamente significativas en los síntomas específicos (SSS) y la calidad de vida (ICAF). Conclusiones: los profesionales de la salud se enfrentan a numerosos desafíos en el tratamiento de estos pacientes. Los hallazgos de este ensayo son prometedores respecto a los efectos beneficiosos del YOGA y EA para disminuir el dolor, el impacto general y gravedad, y gravedad de los síntomas, así como en mejorar la calidad de vida en pacientes con FM.(AU)

Objective: to assess the effects of a comprehensive yoga and aerobic exercise (AE) intervention versus standard of care (SOC) exercise on the overall impact and severity of fibromyalgia (FM). Methods: three-arm randomised clinical trial in women diagnosed with FM (groups: YOGA, Satyananda Saraswasi asana series (n=31); AE, 7,000 steps per day (n= 31); SOC (n= 61)). Variables and instruments: anthropometric, sociodemographic and clinical data; Fibromyalgia Health Assessment Questionnaire (FIQ); pain (Widespread pain Index (WPI)); symptom severity (Symptom Severity Score (SSS); quality of life (Combined Index of Severity of Fibromyalgia (CISF)); functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ)). For comparison between groups, Student's t-test was used. Results: ininety-six women with FM were studied. With respect to the SOC group, statistically significant (p<0.05), and clinically significant improvements were observed with the YOGA and AE interventions in pain index (WPI), overall impact and severity of FM (FIQ), symptom severity (SSS) and quality of life (CISF). However, no improvement in functional capacity (FHAQ) was observed. Comparing both interventions, yoga versus AE, statistically significant differences were seen in specific symptoms (SSS) and quality of life (CISF). Conclusions: healthcare professionals face numerous challenges in the management of these patients. The findings of this trial are promising regarding the beneficial effects of YOGA and AE in decreasing pain, global impact and severity, and symptom severity, as well as improving quality of life in patients with FM.(AU)

Systematic review of clinical trials on antithrombotic therapy with factor XI inhibitors.

INTRODUCTION AND OBJECTIVE: Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favorable efficacy/safety profile compared to current antithrombotic therapies. The aim of this systematic review is to analyze the available evidence derived from these studies. METHODS: A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. In accordance with the PRISMA statement, results were reported. RESULTS: A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Phase 2 studies with factor XI inhibitors, overall, demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favorable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in the rate of bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. CONCLUSIONS: Factor XI inhibitors offer new prospects in antithrombotic treatment and prophylaxis. Ongoing phase 3 studies will help define the most suitable drugs and indications.

Metodología científica para Cirugía Vascular. Estudios analíticos experimentales. El ensayo clínico / Experimental analytical studies. The clinical trial

Como hemos comentado anteriormente en un artículo previos, los estudios analíticos son aquellos en los que hay grupos de comparación que nos permiten el estudio de asociación de factores de estudio con eventos finales o resultados, como por ejemplo el tabaquismo y el desarrollo de AAA. En este artículo trataremos los estudios analíticos experimentales o, simplemente experimentales ya que podemos considerar que siempre los experimentales son analíticos al existir 2 grupos de comparación, por ejemplo, supervivencia de 2 tipos diferentes de tratamiento. (AU)

As we have previously discussed in a previous article, analytical studies are those in which there are comparison groups that allow us to study the association of study factors with final events or outcomes, such as smoking and the development of AAA. In this article, we will analyze the experimental analytical studies or, simply, experimental ones, because we can consider experimental studies to be analytical by nature, given the presence of 2 comparison groups, for example, the survival rates of 2 different types of treatment. (AU)

Towards the personalization of septic shock resuscitation: the fundamentals of ANDROMEDA-SHOCK-2 trial.

Septic shock is a highly lethal and prevalent disease. Progressive circulatory dysfunction leads to tissue hypoperfusion and hypoxia, eventually evolving to multiorgan dysfunction and death. Prompt resuscitation may revert these pathogenic mechanisms, restoring oxygen delivery and organ function. High heterogeneity exists among the determinants of circulatory dysfunction in septic shock, and current algorithms provide a stepwise and standardized approach to conduct resuscitation. This review provides the pathophysiological and clinical rationale behind ANDROMEDA-SHOCK-2, an ongoing multicenter randomized controlled trial that aims to compare a personalized resuscitation strategy based on clinical phenotyping and peripheral perfusion assessment, versus standard of care, in early septic shock resuscitation.

Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial.

BACKGROUND: Critical COVID-19 survivors are at risk of developing Post-intensive Care Syndrome (PICS) and Chronic ICU-Related Pain (CIRP). We determined whether a specific care program improves the quality of life (QoL) of patients at risk of developing PICS and CIRP after COVID-19. METHODS: The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm's self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits. CONCLUSIONS: This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population. TRIAL REGISTRATION: # NCT04394169, registered on 5/19/2020.

Feasibility and acceptability of a culturally adapted psychological first aid training intervention (Preparing Me) to support the mental health and well-being of front-line healthcare workers in China: a feasibility randomized controlled trial.

Background: Psychological first aid (PFA) training helps to prepare healthcare workers (HCWs) to manage trauma and stress during healthcare emergencies, yet evidence regarding its effectiveness and implementation is lacking.Method: A two-arm feasibility randomized controlled trial design was conducted in a Chinese tertiary hospital. Participants were randomly allocated to receive either a culturally adapted PFA training (the intervention arm) or psychoeducation (the control arm). Feasibility indicators and selected outcomes were collected.Results: In total, 215 workers who expressed an interest in participating in the trial were screened for eligibility, resulting in 96 eligible participants being randomly allocated to the intervention arm (n = 48) and control arm (n = 48). There was a higher retention rate for the face-to-face PFA training session than for the four online group PFA sessions. Participants rated the PFA training as very helpful (86%), with a satisfaction rate of 74.25%, and 47% reported being able to apply their PFA skills in responding to public health emergencies or providing front-line clinical care. Positive outcome changes were observed in PFA knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth. Their scores on depression, anxiety, stress, and burnout measures all declined. Most of these changes were sustained over 3 months (p < .05). Repeated measures analysis of variance found statistically significant interaction effects on depression (F2,232 = 2.874, p = .046, ηp2 = .031) and burnout (F2,211 = 3.729, p = .018, ηp2 = .037), indicating a greater reduction in symptoms of depression and burnout with PFA compared to psychoeducation training.Conclusion: This culturally adapted PFA training intervention was highly acceptable among Chinese HCWs and was feasible in a front-line care setting. Preliminary findings indicated positive changes for the PFA training intervention on knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth, especially a reduction of depression and burnout. Further modifications are recommended and a fully powered evaluation of PFA training is warranted.

Psychological first aid (PFA) training was culturally adapted and evaluated to help prepare healthcare workers to manage trauma and stress during healthcare emergencies.This culturally adapted PFA training was highly acceptable among Chinese healthcare workers and was feasible in a front-line care setting.Preliminary findings show positive changes for the PFA training intervention on knowledge, skills, attitudes, resilience, self-efficacy, compassion satisfaction, and post-traumatic growth, especially a reduction of depression and burnout.

Eficacia y seguridad del supositorio Proctokinasa® en el tratamiento de la enfermedad inflamatoria pélvica aguda

Introducción: La enfermedad inflamatoria pélvica aguda es una entidad frecuente en mujeres jóvenes en edad reproductiva, y constituye la causa principal de infertilidad. La búsqueda de un tratamiento antiinflamatorio eficaz y seguro que alivie el dolor, evite complicaciones y secuelas, es una prioridad para su tratamiento. Objetivo: Evaluar la eficacia y seguridad del tratamiento con Proctokinasa® en la enfermedad inflamatoria pélvica aguda grados I y II. Materiales y métodos: Se desarrolló un ensayo clínico, controlado, abierto, de enero de 2017 a enero de 2018, que incluyó 76 pacientes con diagnóstico de enfermedad inflamatoria pélvica aguda en la atención primaria de salud, quienes fueron asignadas aleatoriamente a dos grupos de tratamiento: grupo principal Proctokinasa®, que recibió una unidad/8 h por 2 días, y el grupo Piroxicam, un supositorio de 20 mg/24 h por 7 días. La antibioticoterapia oral recomendada se inició simultáneamente. Se evaluó la respuesta clínica y ecográfica al tratamiento. Los eventos adversos fueron evaluados. Resultados: Se constató respuesta clínica a partir de las 72 horas de tratamiento en más del 50 % de las pacientes en ambos grupos, y fue del 100 % de los casos para el grupo Proctokinasa® en las dos últimas evaluaciones realizadas (días 10 y 15). Se evidenció la remisión de las alteraciones ecográficas en el 96,9 % del grupo Proctokinasa®. Los eventos adversos fueron escasos y leves. Conclusiones: El empleo de Proctokinasa® resultó eficaz y seguro en el tratamiento de la enfermedad inflamatoria pélvica aguda grados I y II.

Introduction: Acute pelvic inflammatory disease is a common entity in young women of reproductive age and it is a leading cause of infertility. The search for an effective and safe anti-inflammatory treatment that relieves pain, avoids complications and sequels, it is priority for its treatment. Objective: To evaluate the efficacy and safety of the treatment with Proctokinasa® in acute pelvic inflammatory disease grades I and II. Materials and methods: An open, controlled clinical trial was carried out from January 2017 to January 2018 which included 76 patients diagnosed with acute pelvic inflammatory disease in primary health care; they were randomize assigned to two treatment groups: Proctokinasa® main group, who received one unity/8h for 2 days, and the Piroxican group, 1 suppository of 20 mg/24h per 7 days. The recommended oral antibiotic therapy was started simultaneously. Clinical and ultrasound response to treatment were evaluated. Adverse events were evaluated. Results: Clinical response was stated after 72 hours of treatment inmore than 50% of the patients in both groups, and it was 100% for the Proctokinasa® group in the last two evaluations (days 10 and 15). Remission of ultrasound alterations was evident in 96.9% of the Proctokinasa® group. Adverse events were few and mild. Conclusions: The use of Proctokinasa® was effective and safe in the treatment of acute pelvic inflammatory disease grades I and II.

Randomized crossover clinical trial of a Mindfulness-based intervention for nurse leaders: A pilot study / Ensayo clínico aleatorizado cruzado de una intervención basada en mindfulness con enfermeros líderes: estudio piloto / Ensaio clínico randomizado cruzado de uma intervenção baseada em mindfulness em enfermeiros líderes: estudo-piloto

Objective: to analyze the effects of a Mindfulness-based intervention on nurse leaders' emotional intelligence and resilience. Method: a pilot study of a randomized crossover clinical trial. The sample (n=32) was randomized into Group A (n=18) and Group B (n=14) and evaluated at the pre-test, post-test and follow-up moments. The outcomes were assessed using the Emotional Intelligence Measure, the Connor-Davidson Resilience Questionnaire and the Five Facet Mindfulness Questionnaire, and analyzed using Generalized Linear Mixed Models. Results: a total of 32 nurses with a mean age of 42.6 years old were evaluated. The analyses showed significant interactions between the effects of the group x moment factors on the Self-motivation (p=0.005), Sociability (p<0.001), Self-control (p=0.013), and Total (p=0.002) emotional intelligence skill scores; as well as on the Observe (p=0.042), Describe (p=0.008), Non-judgment (p<0.001), Act with awareness (p=0.004) and Total (p<0.001) mindfulness facets. Post-test: there was a statistically significant increase in the Sociability (p=0.009) and Self-control (p=0.015) emotional intelligence skills; as well as in the Non-judgment (p=0.022) and Total (p=0.002) mindfulness facets. Follow-up: a significant increase was observed in the Non-judgment (p=0.024) and Total (p=0.026) mindfulness facets. The "resilience" variable did not present statistical significance in the "group x moment" factor, both in the post-test and during follow-up. Conclusion: the Mindfulness-based intervention used proved to be effective in increasing nurse leaders' emotional intelligence and dispositional mindfulness skills. Brazilian Registry of Clinical Trials (RBR-3c62gy), registered on March 4 th , 2020, updated on September 16 th , 2022.

Objetivo: analizar los efectos de una intervención basada en mindfulness sobre la inteligencia emocional y la resiliencia de enfermeros líderes. Método: estudio piloto de un ensayo clínico aleatorizado cruzado. Muestra (n=32) aleatorizada en el grupo A (n=18) y grupo B (n=14), se los evaluó en el pretest, postest y seguimiento. Los resultados fueron evaluados mediante la Medida de Inteligencia Emocional, el Cuestionario de Resiliencia de Connor-Davidson y el Cuestionario Mindfulness de Cinco Facetas, y analizados por el Generalized Linear Mixed Models . Resultados: fueron evaluadas 32 enfermeras con una edad promedio de 42,6 años. Los análisis mostraron interacciones significativas de los efectos de los factores grupo vs. momento en los puntajes de las habilidades de automotivación (p=0,005), sociabilidad (p<0,001), autocontrol (p=0,013) y total (p=0,002) de inteligencia emocional; de las facetas observar (p=0,042), describir (p=0,008), no juzgar (p<0,001), actuar con conciencia (p=0,004) y total (p<0,001) de mindfulness. Postest: hubo un aumento estadísticamente significativo de las habilidades de sociabilidad (p=0,009) y autocontrol (p=0,015) de inteligencia emocional; de las facetas no juzgar (p=0,022) y total (p=0,002) de mindfulness . Seguimiento: se observó un aumento significativo en las facetas no juzgar (p=0,024) y total (p=0,026) de mindfulness . La variable resiliencia no presentó significación estadística en el factor grupo vs. momento en el postest y seguimiento. Conclusión: la intervención basada en mindfulness utilizada demostró ser eficaz para aumentar la inteligencia emocional y las habilidades de mindfulness disposicional de los enfermeros líderes. Registro Brasileño de Ensayos Clínicos (RBR-3c62gy), registrado el 4 de marzo de 2020, actualizado el 16 de septiembre de 2022.

Objetivo: analisar os efeitos de uma intervenção baseada em mindfulness na inteligência emocional e resiliência de enfermeiros líderes. Método: estudo-piloto de ensaio clínico randomizado cruzado. Amostra (n=32) randomizada em grupo A (n=18) e grupo B (n=14), avaliados nos momentos pré-teste, pós-teste e seguimento. Os desfechos foram avaliados pela Medida de Inteligência Emocional, pelo Questionário de Resiliência Connor-Davidson e pelo Questionário das Cinco Facetas de Mindfulness , e analisados pelo Generalized Linear Mixed Model . Resultados: foram avaliadas 32 enfermeiras com idade média de 42,6 anos. As análises mostraram interações significativas dos efeitos dos fatores Grupo x Momento nos escores das habilidades de automotivação (p=0,005), sociabilidade (p<0,001), autocontrole (p=0,013) e total (p=0,002) de inteligência emocional; das facetas observar (p=0,042), descrever (p=0,008), não julgar (p<0,001), agir com consciência (p=0,004) e total (p<0,001) de mindfulness . Pós-teste: houve aumento estatisticamente significante das habilidades de sociabilidade (p=0,009) e autocontrole (p=0,015) de inteligência emocional; das facetas não julgar (p=0,022) e total (p=0,002) de mindfulness . Seguimento: observou-se aumento significativo das facetas não julgar (p=0,024) e total (p=0,026) de mindfulness . A variável resiliência não apresentou significância estatística no fator Grupo x Momento, no pós-teste e seguimento. Conclusão: a intervenção baseada em mindfulness utilizada mostrou-se efetiva no aumento das habilidades de inteligência emocional e mindfulness disposicional de enfermeiros líderes. Registro Brasileiro de Ensaios Clínicos (RBR-3c62gy), registrado em 04 de março de 2020, atualizado em 16 de setembro de 2022.

Tips and tricks for successfully conducting a multicenter study. / Reglas y consejos para desarrollar con éxito un estudio multicéntrico.

Multicenter studies play a crucial role in medical research and advancement, facilitating the application of new knowledge to clinical practice. These studies are associated with multiple benefits but are more complex than those involving a single center. With the philosophy that most of the qualities required to lead a multicenter study depend on attitude and can be learned, developed, and improved, in this manuscript, we share with the reader a series of recommendations that we consider important for successfully conducting such studies. The tips and tricks that will be discussed in detail are as follows: effectively leading the project; clearly defining viable and relevant objectives; designing a clear and detailed protocol; carefully selecting centers and collaborating investigators; meticulously designing the case report form; centrally managing the project efficiently; maintaining fluent communication with investigators; and, finally, designing a clear authorship policy and ensuring the appropriate publication of the study results. We hope that these suggestions encourage potential researchers to conduct multicenter studies, thereby collectively enhancing the quality of research and its application to clinical practice.

El centenario de dos Castillas del Pino: el intelectual y el psiquiatra / The Centenary of Two Castillas del Pino: the Intellectual and the Psychiatrist

Con ocasión del centenario de Carlos Castilla del Pino (15 de octubre de 2022) se analiza la relación que existe entre sus dos facetas públicas: la psiquiátrica y la intelectual. Al revisar cronológicamente sus publicaciones aparecen claramente cuatro etapas que oscilan entre esos dos polos: empiezan siendo puramente psiquiátricas (1946-66), se desplazan lue-go hacia lo ensayístico (1966-71), vuelve a predominar la psiquiatría (1971-87) y finalmente se decanta por el ensayo literario-memorístico (1989-2010). El análisis de la recepción que tuvo Castilla del Pino por la psiquiatría académica (hostil) y por la intelectualidad progresista (entusiasta), junto con algunos testimonios personales, acaba de ilustrar esas dos facetas de su personalidad. (AU)

On the occasion of Carlos Castilla del Pino's centenary (15 October 2022), we analyse the relationship between his two public facets: the psychiatric and the intellectual. A chronological review of his publications clearly shows four stages that os-cillate between those two poles: they begin as purely psychiatric (1946-66), then move towards essays (1966-71), psychiatry again predominates (1971-87) and finally he opts for literary-memoiristic essays (1989-2010). The analysis of Castilla del Pino's reception by academic psychiatry (hostile) and by the progressive intelligentsia (enthusiastic), together with some personal testimonies, just illustrate these two facets of his personality. (AU)

Vacunación contra la COVID-19 en la Universidad de Alicante (España): detección de anticuerpos neutralizantes frente al SARS-CoV-2 mediante test serológico rápido, un estudio transversal / COVID-19 vaccination at the University of Alicante (Spain): detection of neutralizing antibodies against SARS-CoV-2 by rapid serological test, a cross-sectional study

Fundamentos: Los anticuerpos neutralizantes frente al SARS-CoV-2 han resultado una herramienta eficaz para el análisis de la inmunidad generada frente a la COVID-19. Numerosos estudios de seroprevalencia realizados en diferentes colectivos han permitido trazar un mapa global sobre la cobertura vacunal mediante el uso de pruebas serológicas rápidas de inmunocromatografía de flujo lateral con fines clínicos y epidemiológicos. El objetivo de nuestro estudio fue determinar el grado de inmunidad frente al SARS-CoV-2 asociado a la presencia de anticuerpos neutralizantes en personal administrativo, docentes y estudiantes de la Universidad de Alicante, mediante un test serológico rápido, así como conocer su experiencia sobre la vacunación frente a la COVID-19. Métodos: Se diseñó un estudio epidemiológico, transversal, basado en la prevalencia de anticuerpos frente a la proteína S (espícula o Spike) del SARS-CoV-2. Participaron un total de 888 personas. El estudio se llevó a cabo con un único test (6 de julio a 22 de julio de 2021). Mediante regresión logística se calcularon Odds Ratios ajustadas según sexo, edad, tipo de vacuna, número de dosis de vacuna recibidas, pauta completa de vacunación y haber padecido la COVID-19. Resultados: Las vacunas recibidas mayoritariamente fueron Vaxzevria® y Comirnaty ® , con un 73,3% entre ambas; el 67,2% presentó pauta completa. Los resultados del test rápido de anticuerpos neutralizantes OJABIO dieron un resultado positivo en el 61,4% de la muestra. La posibilidad de un resultado positivo en el test OJABIO estuvo fuertemente asociada a haber padecido la COVID-19, haber recibido dos dosis, estar vacunado con Spikevax® o Comirnaty® o pertenecer al grupo de dieciocho a veintinueve años. Un total de 712 sujetos respondieron a un cuestionario (80%) paralelo sobre los efectos adversos y las preferencias entre las distintas vacunas contra la COVID-19...(AU)

Background: Neutralizing antibodies against SARS-CoV-2 have shown to be an effective tool for the analysis of the immunity generated against COVID-19. Numerous seroprevalence studies carried out in different groups have made it possible to draw a global map of vaccination coverage through the use of rapid lateral flow immunochromatography serological tests for clinical and epidemiological purposes. The objective of our study was to determine the degree of immunity against SARS-CoV-2 associated with the presence of neutralizing antibodies in administrative staff, teachers and students at the University of Alicante by means of a rapid serological test and to learn about their experience with vaccination against COVID-19. Methods: A cross-sectional epidemiological study was designed, based on the prevalence of antibodies against the S protein (spike) of SARS-CoV-2. A totalof 888 people participated. The study was carried out with a single test (July 6 to July 22, 2021). Using logistic regression, adjusted Odds Ratios were calculated according to sex, age, type of vaccine, number of vaccine doses received, complete vaccination schedule, and having had COVID-19. Results: The vaccines received mostly were Vaxzevria® and Comirnaty® , with 73.3% between both, although 67.2% presented a complete regimen. The results of the OJABIO rapid neutralizing antibody test gave a positive result in 61.4% of the sample. There was a high association between the variables COVID-19 infection, two doses of vaccine, Spikevax® or Comirnaty® vaccine, and eighteen/twenty-nine years old group with a positive result on the OJABIO test. A total of 712 subjects answered the parallel survey (80%) on adverse effects and preferences between the different vaccines against COVID-19...(AU)