De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease.

INTRODUCTION: This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention. METHODS AND ANALYSIS: A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45-74 years and men aged 40-74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR<7.5%), who attend at least one appointment with any of the participating FPs (May 2022-May 2023), and will be followed until May 2024. We use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes. The main outcome will be the change in the incidence rate of PIP of statins and healthy lifestyle counselling in the study population 12 and 24 months after FPs' exposure to the strategies. Moreover, FPs' perception of their feasibility and acceptability, and patient experience regarding the quality of care received will be evaluated. ETHICS AND DISSEMINATION: The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04022850.

Ansiedad y depresión en el embarazo. Variables asociadas durante el periodo de pandemia COVID-19 / Anxiety and depression in pregnancy. Associated variables during the covid-19 pandemic period

Objetivo: Evaluar la asociación entre edad, paridad, nacionalidad, estudios, empleo y apoyo de la pareja con la depresión y ansiedad durante el embarazo. Determinar el impacto de la evolución de la pandemia COVID-19 en los niveles de ansiedad y depresión de las participantes. Método: Estudio descriptivo correlacional transversal realizado en el Osakidetza/Servicio Vasco de Salud, Atención primaria, Bizkaia (España). Participaron 295 gestantes entre ocho y 41 semanas. Se midió la asociación entre edad, paridad, nacionalidad, nivel de estudios, empleo, apoyo de la pareja y tasas de incidencia de COVID-19 durante el periodo del estudio y las puntuaciones de depresión (medido con la Escala de Depresión Posnatal de Edimburgo) y de ansiedad (medido con la subescala de ansiedad estado-rasgo del State-Anxiety Inventory [STAI-S]) durante el embarazo. Se construyó un modelo de regresión logística y se estimaron las odds ratios (OR) y sus intervalos de confianza de 95% (IC 95%). Resultados: La puntuación media en ansiedad fue de 18,75 puntos (DE = 8,69) y en depresión 6,45 puntos (DE = 4,32). Las mujeres que esperaban su segundo hijo o más obtuvieron puntuaciones más altas en depresión (OR 2,51 [IC 95%: 1,26-5,01]) y ansiedad (OR 1,98 [IC 95%: 1,01-3,89]). Haber cursado estudios universitarios se asocia con puntuaciones más bajas en depresión (OR 0,28 [IC 95%: 0,11-0,77]) y ansiedad (OR 0,2 [IC 95%:0,08-0,54]). Una buena calidad en la relación de pareja se asocia con menores niveles de ansiedad (OR 0,45 [IC 95%: 0,24-0,81). La puntuación media en ansiedad y depresión se relacionan con la incidencia de casos COVID-19; la puntuación en ansiedad fue significativamente más alta en los periodos de mayor incidencia. Conclusiones: Mayor atención emocional a las gestantes con bajo nivel de estudios, multíparas y con un débil apoyo de su pareja, permitiría reducir la ansiedad y depresión en el embarazo. Situaciones de emergencia sanitaria afectan a la salud mental durante la ges...(AU)

Objective: To assess the association between age, parity, nationality, educational level, employment and partner support with depression and anxiety during pregnancy. To determine the impact of the evolution of the COVID-19 pandemic on the anxiety and depression levels of the participants. Method: Cross-sectional descriptive correlational study carried out in the Osakidetza/Basque Health Service, Primary Care, Bizkaia (Spain). A total of 295 pregnant women between 8 and 41 weeks participated. The association between age, parity, nationality, educational level, employment, partner support and COVID-19 incidence rates during the study period and depression (measured with the Edinburgh Postnatal Depression Scale) and anxiety (measured with the State-Anxiety Inventory/STAI-S subscale) scores during pregnancy was measured. A logistic regression model was constructed and odds ratios and their 95% confidence intervals were estimated. Results: The mean score was 18.75 points for anxiety (SD 8.69) and 6.45 points for depression (SD 4.32). Women expecting their second or later child had higher scores for depression (OR 2.51 [95%IC: 1.26-5.01]) and anxiety (OR 1.98 [95%IC: 1.01-3.89]). Having completed university studies was associated with lower scores in depression (OR 0.28 [95%IC: 0.11-0.77]) and in anxiety (OR 0,2 [95%IC: 0.08-0.54]). A good relationship with the partner was associated with lower levels of anxiety (OR 0.45 [95%IC: 0.24-0.81]). The mean anxiety and depression scores are related to the incidence of COVID-19 cases; the anxiety score was significantly higher in periods of higher incidence. Conclusions: Greater emotional care for pregnant women with low educational level, multiparous and with weak support from their partner, would reduce anxiety and depression in pregnancy. Health emergency situations affect mental health during gestation.(AU)

Anxiety and depression in pregnancy: associated variables during the COVID-19 pandemic period.

OBJECTIVE: To assess the association between age, parity, nationality, educational level, employment and partner support with depression and anxiety during pregnancy. To determine the impact of the evolution of the COVID-19 pandemic on the anxiety and depression levels of the participants. METHOD: Cross-sectional descriptive correlational study carried out in the Osakidetza/Basque Health Service, Primary Care, Bizkaia (Spain). A total of 295 pregnant women between 8 and 41 weeks participated. The association between age, parity, nationality, educational level, employment, partner support and COVID-19 incidence rates during the study period and depression (measured with the Edinburgh Postnatal Depression Scale) and anxiety (measured with the State-Anxiety Inventory/STAI-S subscale) scores during pregnancy was measured. A logistic regression model was constructed and odds ratios and their 95% confidence intervals were estimated. RESULTS: The mean score was 18.75 points for anxiety (SD=8.69) and 6.45 points for depression (SD=4.32). Women expecting their second or later child had higher scores for depression (OR 2.51[95%IC: 1.26-5.01)) and anxiety (OR 1.98 [95%IC: 1.01-3.89]). Having completed university studies was associated with lower scores in depression (OR 0.28 [95%IC: 0.11-0.77]) and in anxiety (OR 0,2 [95%IC: 0.08-0.54]). A good relationship with the partner was associated with lower levels of anxiety (OR 0.45 [95%IC: 0.24-0.81]). The mean anxiety and depression scores are related to the incidence of COVID-19 cases; the anxiety score was significantly higher in periods of higher incidence. CONCLUSIONS: Greater emotional care for pregnant women with low educational level, multiparous and with weak support from their partner, would reduce anxiety and depression in pregnancy. Health emergency situations affect mental health during gestation.

Does the birth plan match what is relevant to women? Preferences of Spanish women when giving birth.

BACKGROUND: To support women in making shared decisions, it is important to know what is relevant to them. The aim is to explore which of the options included in birth plans (BP) are of most interest to women, and which are more controversial. In addition, the possible association of this variability with personal characteristics. METHODS: The data are part of a cross-sectional descriptive study, carried out in xxx, on the clinimetric characteristics of two instruments to measure women's needs in labour and postpartum. Women were recruited consecutively by their midwives during pregnancy check-ups, receive a link to a digital questionnaire and were allowed to provide links to the questionnaires to other pregnant women. Women were asked to determine their level of agreement with statements about the birth environment, accompaniment, pain relief, medical intervention and neonatal care. The relationship between agreement with each statement, socio-demographic variables and fear of childbirth (W-DEQ-A) was analysed using a combination of descriptive statistics to analyse frequencies, and regression models to test the effect of socio-demographic variables and fear of childbirth on those items with the greatest variability. RESULTS: Two hundred forty-seven women responded. More than 90% preferred a hospital delivery, with information about and control over medical intervention, accompanied by their partner and continuous skin-to-skin contact with the newborn. There are other questions to which women attach less importance or which show greater variability, related to more clinical aspects, like foetal monitoring, placenta delivery, or cord clamping… Various factors are related to this variability; parity, nationality, educational level, risk factor or fear of childbirth are the most important. CONCLUSIONS: Some items referring to the need for information and participation are practically unanimous among women, while other items on technical interventions generate greater variability. That should make us think about which ones require a decision after information and which ones should be included directly. The choice of more interventional deliveries is strongly associated with fear of childbirth.

Development and evaluation of the psychometric properties of a digital questionnaire for the evaluation of perinatal psychosocial needs.

BACKGROUND: If the purpose of maternal education is for women to take control of their own health and that of their family in the process, it is essential to have a simple instrument that allows them to self-assess, globally, how prepared they are to face future childbirth and maternity. As there is nothing similar in our area, the objective of this study was to design a complete, specific measurement questionnaire, with good metric quality and in digital format, for the assessment of perinatal psychosocial needs. METHODS: A cross-sectional study was carried out, to evaluate the psychometric properties of a digital measurement questionnaire. The questionnaire was developed in 4 steps following the recommendations of the International Test Commission. The participants were 263 pregnant women who were recruited in primary health care appointments in the Basque Healthcare Service (Osakidetza); they completed the newly created questionnaire and all the test selected as gold standard. Their mean age was 33.55 (SD = 4.73). The analysis of the psychometric characteristics was based on mixed expert judgment procedures (focus group of healthcare professionals, item assessment questionnaire and interviews with users) and quantitative procedures (EFA, CFA, association with the gold standard and classification agreement index, ordinal alpha and McDonald's omega). RESULTS: The final version of the questionnaire was made up of 55 items that evaluate 8 aspects related to perinatal psychosocial well-being (anxious-depressive symptoms, pregnancy acceptance, partner support, coping, internal locus of control, childbirth self-efficacy, perception of childbirth as a medicalized event, and fear of childbirth). Various tests were made of the validity and reliability of the scores, providing metric guarantees for their use in our context. CONCLUSIONS: The use of this complete, quick-to-use tool with good psychometric properties will allow pregnant women to take stock of their situation, assess whether they have the necessary resources in the psychological and social sphere, and work together with midwives and other health professionals in the areas that are lacking.

Development and evaluation of the psychometric properties of a digital questionnaire for the self-management of health and well-being in the postpartum period.

BACKGROUND: Despite the fact that the Global Strategy for Women's, Children's and Adolescents' Health (2016-2030) recognises the special importance of care for women during the postpartum period, thus highlighting the need to identify and measure any condition that may affect the welfare of pregnant women in any way, this is one of the most neglected stages in the health system. Given the absence in our area of global, efficient instruments, the objective of this study was to design a complete, specific measurement tool with good metric qualities in digital format for the evaluation of self-reported health and well-being during the puerperium, to conform to what was proposed by the ICHOM. METHODS: A cross-sectional study was carried out to evaluate the psychometric characteristics of a digital measurement tool. The development of the tool was carried out in 4 steps, following the recommendations of the International Test Commission. It was tested on 280 puerperas attending primary healthcare appointments in the Basque Healthcare System (Osakidetza), and they did the newly created survey, answering all the questions that had been selected as the gold standard. The average age of the women was 34.93 (SD = 4.80). The analysis of the psychometric characteristics was based on mixed procedures of expert judgment (a focus group of healthcare professionals, an item evaluation questionnaire and interviews with users) and quantitative evaluations (EFA, CFA, and correlation with gold standard, ordinal alpha and McDonald's omega). RESULTS: The final version of the tool comprised 99 items that evaluate functional state, incontinence, sexuality, breastfeeding, adaptation to the role of mother and mental health, and all of these questions can be used globally or partially. It was found that the scores were valid and reliable, which gives metric guarantees for using the tool in our area. CONCLUSIONS: The use of this comprehensive concise tool with good psychometric properties will allow women to take stock of their situation, assess if they have the necessary resources, in psychological and social terms, and work together with midwives and other healthcare professionals on the most deficient areas.

Association between Phase Angle and Subjective Perceptions of Health Variables in Cancer Patients.

The phase angle, an increasingly studied healthcare tool, was studied to explore its relationship with psychological factors in cancer patients. The aim of this study was to investigate the relationship between the phase angle (PhA), obtained by the bioimpedance analysis of body composition, and psychological factors measured by questionnaire in cancer patients. The study included 311 patients who underwent bioimpedance testing to determine their PhA value; their psychological profiles were assessed using SF-36, FACIT, QLQ-C30, and GHQ-12 questionnaires. Mixed linear regression models were used to analyze the relationship between PhA and the psychological tests. The results showed a statistical correlation between PhA and the GHQ-12, FACIT, and SF-36 questionnaires, with higher PhA values associated with better results on the questionnaires. In the QLQ-C30 questionnaire, a correlation was observed between PhA and the functioning scales (p < 0.001), except for emotional and cognitive functioning (p = 0.148 and p = 0.544, respectively), but not in most of the symptom scales. The PhA is a useful tool for assessing the subjective health perception of cancer patients, especially with regard to psychological factors. While there is a statistically significant correlation, further research is required before confidently applying it in clinical practice. The current predictive value of this predictor for certain psychological aspects is limited, underscoring the need for additional research.

Standardization and validation of a novel UPLC-MS/MS method to quantify first line anti-tuberculosis drugs in plasma and dried blood spots.

Tuberculosis (TB) is a high-burden infectious disease with high prevalence and mortality rates. The first-line anti-TB drugs include isoniazid (INH), rifampicin (RMP), pyrazinamide (PZA), and ethambutol (EMB). At present, the standard method of blood sampling for therapeutic drug monitoring (TDM) analysis is venipuncture. Dried blood spots (DBS) are a minimally invasive method for collecting small quantities of whole blood from fingertips. The aim of the current study was to develop an ultrahigh-performance liquid chromatography technique coupled to tandem mass spectrometry (UPLC-MS/MS) for simultaneous quantification of the first-line anti-TB drugs in human plasma and DBS as a sampling alternative. The separation and detection conditions were optimized to quantify INH, RMP, PZA, and EMB in both matrices in an ACQUITY UPLC H Class system coupled to a XEVO TQD detector. Chromatographic separation was performed through an Acquity HSS T3 column (2.1 × 100 mm, 1.8 µm) with 0.1% formic acid in water and acetonitrile as the mobile phase. The total run time was 7 min for both methods, with retention time in plasma of 0.85, 1.22, 3.16, and 4.04 min and 0.74, 0.87, 0.97, and 4.16 min for EMB, INH, PZA, and RMP in DBS, respectively. The bioanalytical methods developed were proved selective, linear, precise, and accurate (inter- and intra-assay); the matrix effect was demonstrated to be within the established limits. Short- and long-term stability, freeze-thaw cycles for plasma, and short-term stability for DBS were established. A total of 15 patients with 46 ± 17 (mean ± SD) years old were included, and anti-TB drug concentrations were quantified on plasma and DBS as proof of concept. Based on RMP and INH plasma concentrations (Cp), and Bayesian estimation of individual pharmacokinetic parameters, a dose adjustment was necessary for 93% of patients. The slopes of the correlation lines between plasma and DBS concentrations of RMP, EMB, INH, and PZA were 0.5321, 0.8125, 0.5680, and 0.6791, respectively. Finally, significant correlations (p < 0.05) were observed between DBS and plasma concentrations for RMP (r2 = 0.6961), EMB (r2 = 0.4369), INH (r2 = 0.8675) and PZA (r2 = 0.7363). A simple, fast, and reliable UPLC-MS/MS method was developed to quantify first-line anti-TB drugs in plasma and DBS, which provides an easy sampling and storage to be applied as a new strategy for TDM in patients with TB.

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial.

OBJECTIVES: To assess the effectiveness of the EFICANCER individualized and supervised exercise program for people with gastrointestinal, breast, or non-small cell lung stage IV cancer, in terms of quality of life and functional capacity. DATA SOURCES: Randomized controlled clinical trial with two parallel groups: EFICANCER (n = 47) and control (n = 43). Both groups received standard oncological care. In addition, the EFICANCER group participated in a nurse-supervised exercise program. Primary outcome was cancer-specific (EORTC QLQ-C30 questionnaire) and general quality of life (SF-36) at baseline and after 2, 6, and 12 months. Secondary outcomes were functional capacity (6-minute walking test), strength, and fatigue. The evolution in both groups was compared over 12 months using mixed-effect longitudinal models; 74.47% of patients completed at least one session of the program. At 12 months, EFICANCER group had better scores in cancer-related quality of life, with a difference between groups of 15.7 points (95% confidence interval 4.4 to 25.9) and in functional capacity, with a difference of 4.5 points (95% confidence interval -0.5 to 9.5). No significant differences in any other secondary variables were observed. CONCLUSION: The EFICANCER primary care nurse supervised exercise program is safe and feasible and improves cancer patient's outcomes. IMPLICATIONS FOR NURSING PRACTICE: Providing the best care and trying to improve the quality of life of cancer patients are essential parts of nursing practice. Eficancer adds a new dimension to nursing practice by providing greater attention and care to patients during treatment through the supervision of physical exercise, thereby contributing to improve the quality of life of this population.

Coping strategies during pregnancy and their relationship with anxiety and depression.

How individuals perceive and cope with stressful situations may determine their level of anxiety or depression. The identification of coping strategies (CS) in pregnancy could help prevent depression and anxiety (D&A), and their consequent effects on the health of the mother and the baby. A cross-sectional descriptive correlational study was conducted to identify the CS most commonly used by pregnant women in a Spanish population and to evaluate the association of these CS with D&A. A consecutive sample of 282 pregnant women over 18 years of age were recruited when attended midwife consultations and through snowball sampling between December 2019 and January 2021 in the Basque public health system. CS were measured using the RevisedPrenatal Coping Inventory (NuPCI) questionnaire, assigning the score to an avoidant, preparatory or spiritual scale. Cutoff points were established to categorize anxiety and depressive symptomatology, using the STAI-S and EPDS scales. Multivariate logistic regression models were constructed to analyze the association between CS and D&A. The results show that the higher the score on the avoidance subscale, the higher the likelihood of having an anxiety disorder (OR: 8.88  (95 percent Confidence Interval [CI] 4.26-20.1), and depressive symptoms (OR: 8.29 (95 percent CI 4.24-17.4). Multiparous women are more likely to have anxiety (OR: 3.41  (95 percent CI 1.58-7.5) or depressive symptomatology (OR: 4.1 (95 percent CI 2.04-8.53) during pregnancy. These results highlight the need to consider the evaluation of CS used during pregnancy to tailor the care provided, but further studies on the implementation and effectiveness of interventions are needed.

Association between PhA and Physical Performance Variables in Cancer Patients.

Maintaining the physical performance of cancer patients is increasingly considered due to the growing number of cancer patients and the aggressiveness of the treatments. For this reason, bioimpedance is now being used to record patients' body composition by obtaining the phase angle (PhA). Although there is a direct relationship between PhA, age, sex and disease prognosis, it has not been measured as an analysis of physical performance in oncology patients and is a valid tool in the follow-up of cancer patients. For this purpose, 311 patients were evaluated, and both bioelectrical impedance analysis (BIA) and physical performance measurements were performed. The modification of the results concerning PhA was found to be highly relational, as a variation in one of the variables affected the other. It was concluded that each degree increase in PhA modified -22.57 s [-27.58; -17.53] in 400-m walking test (400 mWT); 13.25 kg [10.13; 16.35] in upper-body strength (UBS); 6.3 [4.95; 7.65] in lower-body strength (LBS); 1.55 mL/kg/min [0.98; 2.12] in VO2peak; 6.53 Watts [3.83; 9.20] in ventilatory threshold 1 (VT1); 10.36 Watts [7.02; 13.64] in ventilatory threshold 2 (VT2). It was also noted that age was a factor that affected the relationship between PhA and 400 mWT; the older the age, the higher the relationship. PhA data has been shown to be highly correlated with physical performance. This is of great importance in clinical practice because a cancer patient's physical performance levels can be assessed during treatment.

Any increment in physical activity reduces mortality risk of physically inactive patients: prospective cohort study in primary care.

BACKGROUND: It is unclear how engaging in physical activity after long periods of inactivity provides expected health benefits. AIM: To determine whether physically inactive primary care patients reduce their mortality risk by increasing physical activity, even in low doses. DESIGN AND SETTING: Prospective cohort of 3357 physically inactive patients attending 11 Spanish public primary healthcare centres. METHOD: Change in physical activity was repeatedly measured during patients' participation in the 'Experimental Program for Physical Activity Promotion' clinical trial between 2003 and 2006, using the '7-day Physical Activity Recall'. Mortality to 31 December 2018 (312 deaths) was recorded from national statistics, and survival time from the end of the clinical trial analysed using proportional hazard models. RESULTS: After 46 191 person-years of follow-up, compared with individuals who remained physically inactive, the mortality rates of those who achieved the minimum recommendations of 150-300 min/week of moderate- or 75-150 min/week of vigorous-intensity exercise was reduced by 45% (adjusted hazard ratio [aHR] 0.55; 95% confidence interval [95% CI] = 0.41 to 0.74); those who did not meet these recommendations but increased physical activity in low doses, that is, 50 min/week of moderate physical activity, showed a 31% reduced mortality (aHR 0.69, 95% CI = 0.51 to 0.93); and, those who surpassed the recommendation saw a 49% reduction in mortality (aHR 0.51, 95% CI = 0.32 to 0.81). The inverse association between increased physical activity and mortality follows a continuous curvilinear dose-response relationship. CONCLUSION: Physically inactive primary care patients reduced their risk of mortality by increasing physical activity, even in doses below recommended levels. Greater reduction was achieved through meeting physical activity recommendations or adopting levels of physical activity higher than those recommended.

Estrategia curricular de Medicina Natural y Tradicional desde la disciplina inglés en la educación médica / Curricular strategy of Herbal and folk Medicine from the English discipline in medical education

La formación de profesionales demanda que el proceso enseñanza aprendizaje tenga una visión integradora para alcanzar los objetivos generales con los niveles de profundidad y dominio requeridos. A partir de ello, es que se introduce una novedosa forma de abordar la interdisciplinariedad, aplicando estrategias curriculares. La aplicación de la Medicina Natural y Tradicional en la formación de los médicos generales no ha sido sistemática ni de forma coordinada por el colectivo de profesores de inglés en la Universidad de Ciencias Médicas de Villa Clara. Es objetivo de los autores describir una tesis de maestría que contiene: metodología y acciones para implementarla desde la disciplina y asignaturas de inglés, un curso de posgrado para profesores de este idioma y ofertas de bibliografías actualizadas impresas y digitales como materiales de consulta para el estudio independiente, cuyos contenidos se aplican de forma satisfactoria para solucionar las carencias mencionadas.

The training of professionals demands that the teaching-learning process have an integrating vision to achieve the general objectives with the required levels of depth and mastery. From this, a new way of approaching interdisciplinarity is introduced, applying curricular strategies. The application of herbal and folk Medicine in the training of general practitioners has not been systematic or coordinated by the group of English teachers at the Villa Clara University of Medical Sciences. The authors' objective is to describe a master's thesis that contains: methodology and actions to implement it from the discipline and subjects of English, a postgraduate course for teachers of this language and offers of updated printed and electronic bibliographies as reference materials for the independent study whose contents are satisfactorily applied to solve the aforementioned deficiencies.

EMAeHealth, a digital tool for the self-management of women's health needs during pregnancy, childbirth and the puerperium: protocol for a hybrid effectiveness-implementation study.

INTRODUCTION: EHealth can help health service users take a more active role in decision-making and help health professionals guide the patient in this process. A digital tool has been designed to support maternal education (ME), and it is organised into four areas: (1) information, (2) communication, (3) health self-management and (4) clinical data. The main objective of the study is to evaluate the effectiveness of the EMAeHealth digital tool, and assess its usability and acceptability under routine conditions. METHODS AND ANALYSIS: Hybrid implementation-effectiveness design: (1) A cluster randomised, prospective, longitudinal, multicentre clinical trial to evaluate the effectiveness of EMAeHealth in (A) improving health-related quality of life (primary outcome), (B) improving self-efficacy for labour and childbirth and self-efficacy in breast feeding and (C) reducing the number of visits to the obstetric emergency services and health centre in situations of 'non-pathological pregnancy', 'false labour pains' and 'non-pathological puerperium'. The EMAeHealth intervention plus usual care will be compared with receiving only usual care, which includes traditional ME. N=1080 participants, 540 for each study arm. Two measurements will be made throughout the pregnancy and three in the first 16 weeks post partum. (2) A mixed-method study to evaluate the usability and acceptability of the tool, barriers and facilitators for its use, and implementation in our health system: focus groups (women, professionals and agents involved) and a quantitative analysis of implementation indicators. ANALYSIS: It will be carried out by intention to treat, using mixed models taking into account the hierarchical structure of the data and per protocol to evaluate the effectiveness of the express use of the digital tool. ETHICS AND DISSEMINATION: Clinical Research Ethics Committee of Euskadi, Spain, (Ref: PI2020044) approved this study. The results will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04937049.

Autoimmune encephalitis after BBIBP-CorV (Sinopharm) COVID-19 vaccination: a case report.

BACKGROUND: Vaccination is an important public health strategy; however, many neurological adverse effects are associated with COVID-19 vaccination, being encephalitis a rare manifestation. CASE PRESENTATION: We present the case of a 33-year-old woman who received the first dose of the BBIBP-CorV vaccine against COVID-19 on April 4 and the second dose on April 28, 2021. Three days after receiving the second dose, she experienced a subacute episode of headache, fever, insomnia, and transient episodes of environment disconnection. We obtained negative results for infectious, systemic, and oncological causes. Brain magnetic resonance imaging showed lesions in the bilateral caudate nucleus and nonspecific demyelinating lesions at the supratentorial and infratentorial compartments. The results of the neuronal autoantibodies panel were negative. She had an adequate response to immunoglobulin and methylprednisolone; however, she experienced an early clinical relapse and received a new cycle of immunosuppressive treatment followed by a satisfactory clinical evolution. CONCLUSIONS: We report the first case of severe encephalitis associated with BBIBP-CorV (Sinopharm) vaccination in Latin America. The patient had atypical imaging patterns, with early clinical relapse and a favorable response to corticosteroid therapy.

A comparison of pharmacokinetics software for therapeutic drug monitoring of piperacillin in patients with severe infections.

OBJECTIVE: To evaluate the predictive performance of population pharmacokinetic models for piperacillin (PIP) available in the software MwPharm, TDMx and ID-ODs for initial dosing selection and therapeutic drug monitoring (TDM) purposes. METHODS: This is a prospective observational study in adult patients with severe infections receiving PIP treatment. Plasma concentrations were quantified by ultra-high performance liquid chromatography coupled to tandem mass spectrometry. The differences between predicted and observed PIP concentrations were evaluated with Bland-Altman plots; additionally, the relative and absolute bias and precision of the models were determined. RESULTS: A total of 145 PIP plasma concentrations from 42 patients were analysed. For population prediction, MwPharm showed the best predictive performance with a mean relative difference of 34.68% (95% CI -197% to 266%) and a root mean square error (RMSE) of 60.42 µg/mL; meanwhile TDMx and ID-ODs under-predicted PIP concentrations. For individual prediction, the TDMx model was found to be the most precise with a mean relative difference of 7.61% (95% CI -57.63 to 72.86%), and RMSE of 17.86 µg/mL. CONCLUSION: Current software for TDM is a valuable tool, but it may also include different population pharmacokinetic models in patients with severe infections, and should be evaluated before performing a model-based TDM in clinical practice. Considering the heterogeneous characteristics of patients with severe infections, this study demonstrates the need for therapy personalisation for PIP to improve pharmacokinetic/pharmacodynamic target attainment.

Post-Vaccinal Encephalitis with Early Relapse after BNT162b2 (COMIRNATY) COVID-19 Vaccine: A Case Report.

We describe the case of a 72-year-old man who received the first dose of the BNT162b2 (COMIRNATY) vaccine against COVID-19 on 18 May 2021, and the second dose on 9 September 2021. One day after receiving the first dose, he cursed with malaise, headache, fever, confusion, aggressiveness, and gait alterations. We performed serum and cerebrospinal fluid (CSF) tests (finding elevated proteins in CSF) with negative results for infectious, systemic, and neoplastic causes. We performed brain nuclear magnetic resonance imaging (MRI), finding circumscribed encephalitis at the anterior frontal and bilateral temporal lobes. We were unable to perform a panel of antineuronal antibodies. The patient was readmitted due to early clinical relapse four days after receiving his second dose. We found sequelae lesions at the frontal level but with new demyelinating lesions at the left temporal level in brain MRI. We indicated methylprednisolone, and he presented a favorable improvement. We report an encephalitis case of probable autoimmune etiology after vaccination with BNT162b2, which presented early clinical relapse after receiving the second dose and presented a favorable response to methylprednisolone.

Attitudes toward medicalization in childbirth and their relationship with locus of control and coping in a Spanish population.

The dominant model of childbirth in most Western countries is medicalized childbirth. Women's beliefs about whether childbirth should be a medicalized process to a greater or lesser degree may be related, in addition to contextual factors, to internal factors. The objective of the study is to find out if women's locus of control (LC) and stress coping strategies (CS) are related to having a more favourable or less favourable attitude towards medicalization (ATMC). A cross-sectional study was carried out with the participation of 248 women recruited in primary care centres by their midwives. All the women filled in answers on a mobile phone app with various different measurement instruments: the questionnaire created by Benyamini to evaluate their ATMC; the Spanish version of the Wallston MLC to evaluate their LC; and the Spanish adaptation of the "Revised Prenatal Coping Inventory (NuPCI)" scale for the assessment of their CS. The women presented a favourable attitude towards medicalization, with a mean ATMC score of 3.42. Both the LC and the CS of women during pregnancy are related to this attitude. Specifically, having an internal LC and using preparative CS both lower the probability of presenting a favourable attitude towards medicalization, while the lack of a paid job raises the probability. For each point in internal locus and preparatory coping, the ATMC score decreased by 0.02 and 0.23 points, respectively, while it increased by 0.18 for not having a paid job. The influence of these psychological factors must be taken into account in the development of content and interventions that promote a more natural birth.

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. OBJECTIVE: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. METHODS: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. RESULTS: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. CONCLUSIONS: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24835.