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 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.

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.

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.

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.

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.

Population Pharmacokinetics of Amikacin Administered Once Daily in Patients with Different Renal Functions.

The aim of this work was to evaluate the pharmacokinetics of amikacin in Mexican patients with different renal functions receiving once-daily dosing regimens and the influence of clinical and demographical covariates that may influence the optimization of this antibiotic. A prospective study was performed in a total of 63 patients with at least one determination of amikacin plasma concentration. Population pharmacokinetic (PK) parameters were estimated by nonlinear mixed-effects modeling; validations were performed for dosing recommendation purposes based on PK/pharmacodynamic simulations. The concentration-versus-time data were best described by a one-compartment open model with proportional interindividual variability associated with amikacin clearance (CL) and volume of distribution (V); residual error followed a homoscedastic trend. Creatinine clearance (CLCR) and ideal body weight (IBW) demonstrated significant influence on amikacin CL and V, respectively. The final model [CL (liters/h) = 7.1 × (CLCR/130)0.84 and V (liters) = 20.3 × (IBW/68)2.9] showed a mean prediction error of 0.11 mg/liter (95% confidence interval, -3.34, 3.55) in the validation performed in a different group of patients with similar characteristics. There is a wide variability in amikacin PK parameters in Mexican patients. This leads to inadequate dosing regimens, especially in patients with augmented renal clearance (CLCR of >130 ml/min). Optimization based on the final population PK model in Mexican patients may be useful, since reliability and clinical applicability have been demonstrated in this study.

Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain.

PURPOSE: Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of information for independent studies on drug safety and support of medicines regulation activities. This article aim is to describe the characteristics of BIFAP, how to access the database and a summary of its potential for research. METHODS: Health problems are registered by primary care physicians as episodes of care and include socio-demographic data, results of diagnostic procedures, lifestyle data, general data, and interventions. A proportion of data on hospitalizations and specialist care are currently available through linkage with other data sources. EMRs of the Spanish healthcare system are provided by the regional administrations. Specific data extraction and standardization processes are performed. RESULTS: BIFAP includes data from 12 million patients starting in 2001 and updated annually. Validation of drug and diagnosis definitions has been ascertained. Participation in international collaborative projects and a number of articles in peer reviewed journals reflect its contribution to the knowledge of the risks associated with medicines and drug utilization patterns. CONCLUSIONS: BIFAP is a useful tool for generating scientific evidence on medicines related issues, helping regulatory decision making in Europe. The main strengths of BIFAP are related to large sample size, population-based, longitudinal nature and annual update of data. BIFAP shares common challenges with similar data sources including accurate and efficient identification of health outcomes and of treatment exposure.

Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

BACKGROUND: Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions. METHODS/DESIGN: This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish "Prescribe Vida Saludable") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time. DISCUSSION: The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system. TRIAL REGISTRATION: NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.

Anthropometric and Genetic Factors Associated With the Exposure of Rifampicin and Isoniazid in Mexican Patients With Tuberculosis.

BACKGROUND: Tuberculosis (TB) remains a critical infectious, contagious disease worldwide with high prevalence and mortality rate. The directly observed treatment short-course therapy includes rifampicin (RMP) and isoniazid (INH) for at least 6 months. The purposes of this scheme are to interrupt the transmissibility of the Mycobacterium tuberculosis complex and to avoid secondary complications. Low plasma concentrations of these anti-TB drugs have been associated with extended treatment duration, therapeutic failure, and relapse. The determination of anthropometric, genetic, and clinical variables that may affect plasma concentrations of RMP and INH might facilitate the detection of patients at increased risk of therapeutic failure. METHODS: A prospective observational study was performed in patients with TB diagnosis. A fixed-dose combined formulation was administered following clinical guidelines, and 12 venous blood samples were collected within 24 hours after dose for the quantification of plasma levels of RMP and INH by high-performance liquid chromatography-ultraviolet. The plasma concentrations versus time for each drug in each patient were assessed by a noncompartmental approach to obtain Cmax, and the area under the concentration-time curve to the last observation point (AUC0-24 h) was calculated by the linear trapezoidal rule. Genetic polymorphisms of the enzyme involved in INH metabolism (NAT2) and proteins involved in RMP transport (glycoprotein-P and OATP1B1) were determined. RESULTS: A total of 34 patients aged between 18 and 72 years with the diagnosis of TB were included in the current study. A multivariate analysis was performed to determine the anthropometric and genetic characteristics that modified the Cmax and AUC0-24 h of RMP and INH. Results indicated that RMP Cmax and AUC0-24 h were affected by sex, dose/weight, and single nucleotide polymorphism of MDR1. In addition, age, body mass index, and NAT2 acetylator genotype were shown to determine the Cmax and AUC0-24 h for INH. CONCLUSIONS: Anthropometric, genetic, and dosage characteristics of Mexican patients with TB are an important source of risk for subtherapeutic plasma concentrations of anti-TB drugs. Factors such as lower-than-recommended RMP dose, male patients with TB, and MDR1 3435 genotype, in addition to age group, body mass index, and INH acetylator phenotype based on NAT2 genotype, should be considered during treatment.

Temporal remodeling of the cell cycle accompanies differentiation in the Drosophila germline.

Development of multicellular organisms relies upon the coordinated regulation of cellular differentiation and proliferation. Growing evidence suggests that some molecular regulatory pathways associated with the cell cycle machinery also dictate cell fate; however, it remains largely unclear how the cell cycle is remodeled in concert with cell differentiation. During Drosophila oogenesis, mature oocytes are created through a series of precisely controlled division and differentiation steps, originating from a single tissue-specific stem cell. Further, germline stem cells (GSCs) and their differentiating progeny remain in a predominantly linear arrangement as oogenesis proceeds. The ability to visualize the stepwise events of differentiation within the context of a single tissue make the Drosophila ovary an exceptional model for study of cell cycle remodeling. To describe how the cell cycle is remodeled in germ cells as they differentiate in situ, we used the Drosophila Fluorescence Ubiquitin-based Cell Cycle Indicator (Fly-FUCCI) system, in which degradable versions of GFP::E2f1 and RFP::CycB fluorescently label cells in each phase of the cell cycle. We found that the lengths of the G1, S, and G2 phases of the cell cycle change dramatically over the course of differentiation, and identified the 4/8-cell cyst as a key developmental transition state in which cells prepare for specialized cell cycles. Our data suggest that the transcriptional activator E2f1, which controls the transition from G1 to S phase, is a key regulator of mitotic divisions in the early germline. Our data support the model that E2f1 is necessary for proper GSC proliferation, self-renewal, and daughter cell development. In contrast, while E2f1 degradation by the Cullin 4 (Cul4)-containing ubiquitin E3 ligase (CRL4) is essential for developmental transitions in the early germline, our data do not support a role for E2f1 degradation as a mechanism to limit GSC proliferation or self-renewal. Taken together, these findings provide further insight into the regulation of cell proliferation and the acquisition of differentiated cell fate, with broad implications across developing tissues.

Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study.

OBJECTIVE: To examine the potential efficacy and safety of autologous platelet-rich plasma (PRP) in comparison with the conventional treatment (standard care, SoC) for the treatment of leg ulcers in patients with chronic venous insufficiency, in a primary health-care setting. METHOD: A Phase I-II, open-label, parallel-group, multicentre, randomised pilot study was conducted. The outcome variables at baseline and at weeks five and nine included reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, cost of the treatment for up to nine weeks and average weekly cure rate. RESULTS: A total of eight patients, each with at least a six-month history of venous leg ulcer (VLUs), were included in the study. A total of 12 ulcers were treated with either autologous PRP or standard SoC. Patients treated with PRP required wound care only once per week. In the SoC group, patients required intervention 2-3 times per week. A reduction in the mean ulcer size in the PRP group was 3.9cm2 compared with the SoC group at 3.2cm 2 , although the sample size was insufficient to reach statistical significance. Improvement in quality of life (QoL) score was observed in the patients in the PRP group. CONCLUSION: This study offers proof-of-concept of the feasibility and safety of PRP treatment to inform larger clinical trials in patients with VLUs. Our preliminary results suggest that PRP delivers a safe and effective treatment for VLU care that can be implemented in primary health-care settings.

The legalization of cannabis derivatives in Spain: Hypothesis on a potential emerging market. / La legalización de los derivados del cannabis en España: Hipótesis sobre un potencial mercado emergente.

First, this paper estimates the dimensions of the market for cannabis in Spain using data on the extent of consumption and the main patterns of use of consumers. Then the paper reviews the hypothetical production and distribution costs of these drugs in different production regimes under different legal conditions. The review shows that current prices of cannabis in the illegal market could be notably reduced if production and distribution of cannabis were decriminalized and even more if they were performed by legal enterprises. Thirdly, we examine the relationship between prices and consumption levels by analysing the price elasticity of demand. A fall in the prices of cannabis products will likely result in an increase in the number of users and in the total amount consumed. Lastly we consider several alternatives for the taxation of cannabis derivatives to counteract the likely fall in prices, and their pros and cons.

En este artículo se analiza en primer lugar las dimensiones que tiene el mercado de cannabis en España en base a los datos disponibles sobre la extensión del consumo y las pautas de uso de los consumidores. A continuación se repasan y comparan los costes de producción y distribución del cannabis en distintos regímenes de producción y diversas condiciones jurídicas. Se observa cómo los precios del cannabis al detalle en el mercado ilegal son bastante altos y podrían reducirse considerablemente si se legalizasen la producción y la comercialización. En tercer lugar, se examina la relación que hay entre los precios y el consumo a través del análisis de la elasticidad del precio de la demanda. Se pone de manifiesto cómo una caída de los precios probablemente resulte en un aumento tanto en el número de usuarios como en la cantidad total consumida por estos. Por último, se consideran distintas alternativas de fiscalización destinadas a contrarrestar la caída de precios de los derivados del cannabis, mostrando sus fortalezas y debilidades.

Do case-only designs yield consistent results across design and different databases? A case study of hip fractures and benzodiazepines.

BACKGROUND: The case-crossover (CXO) and self-controlled case series (SCCS) designs are increasingly used in pharmacoepidemiology. In both, relative risk estimates are obtained within persons, implicitly controlling for time-fixed confounding variables. OBJECTIVES: To examine the consistency of relative risk estimates of hip/femur fractures (HFF) associated with the use of benzodiazepines (BZD) across case-only designs in two databases (DBs), when a common protocol was applied. METHODS: CXO and SCCS studies were conducted in BIFAP (Spain) and CPRD (UK). Exposure to BZD was divided into non-use, current, recent and past use. For CXO, odds ratios (OR; 95%CI) of current use versus non-use/past were estimated using conditional logistic regression adjusted for co-medications (AOR). For the SCCS, conditional Poisson regression was used to estimate incidence rate ratios (IRR; 95%CI) of current use versus non/past-use, adjusted for age. To investigate possible event-exposure dependence the relative risk in the 30 days prior to first BZD exposure was also evaluated. RESULTS: In the CXO current use of BZD was associated with an increased risk of HFF in both DBs, AORBIFAP = 1.47 (1.29-1.67) and AORCPRD = 1.55 (1.41-1.70). In the SCCS, IRRs for current exposure was 0.79 (0.72-0.86) in BIFAP and 1.21 (1.13-1.30) in CPRD. However, when we considered separately the 30-day pre-exposure period, the IRR for current period was 1.43 (1.31-1.57) in BIFAP and 1.37 (1.27-1.47) in CPRD. CONCLUSIONS: CXO designs yielded consistent results across DBs, while initial SCCS analyses did not. Accounting for event-exposure dependence, estimates derived from SCCS were more consistent across DBs and designs.

Hip/femur fractures associated with the use of benzodiazepines (anxiolytics, hypnotics and related drugs): a methodological approach to assess consistencies across databases from the PROTECT-EU project.

BACKGROUND: Results from observational studies may be inconsistent because of variations in methodological and clinical factors that may be intrinsically related to the database (DB) where the study is performed. OBJECTIVES: The objectives of this paper were to evaluate the impact of applying a common study protocol to study benzodiazepines (BZDs) (anxiolytics, hypnotics, and related drugs) and the risk of hip/femur fracture (HFF) across three European primary care DBs and to investigate any resulting discrepancies. METHODS: To measure the risk of HFF among adult users of BZDs during 2001-2009, three cohort and nested case control (NCC) studies were performed in Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) (Spain), Clinical Practice Research Datalink (CPRD) (UK), and Mondriaan (The Netherlands). Four different models (A-D) with increasing levels of adjustment were analyzed. The risk according to duration and type of BZD was also explored. Adjusted hazard ratios (cohort), odds ratios (NCC), and their 95% confidence intervals were estimated. RESULTS: Adjusted hazard ratios (Model C) were 1.34 (1.23-1.47) in BIFAP, 1.66 (1.54-1.78) in CPRD, and 2.22 (1.55-3.29) in Mondriaan in cohort studies. Adjusted odds ratios (Model C) were 1.28 (1.16-1.42) in BIFAP, 1.60 (1.49-1.72) in CPRD, and 1.48 (0.89-2.48) in Mondriaan in NCC studies. A short-term effect was suggested in Mondriaan, but not in CPRD or BIFAP. All DBs showed an increased risk with the concomitant use of anxiolytic and hypnotic drugs. CONCLUSIONS: Applying similar study methods to different populations and DBs showed an increased risk of HFF in BZDs users but differed in the magnitude of the risk, which may be because of inherent differences between DBs.

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.

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.

Prevalence of multimorbidity according to the deprivation level among the elderly in the Basque Country.

BACKGROUND: Multimorbidity is clearly a major challenge for healthcare systems. However, currently, its magnitude and impact on healthcare expenditures is still not well known. The objective of this paper is to present an overview of the prevalence of multimorbidity by deprivation level in the elderly population of the Basque Country. METHODS: We conducted a cross-sectional analysis that included all the inhabitants of the Basque Country aged 65 years and over (N = 452,698). This was based on data from primary care electronic medical records, hospital admissions, and outpatient care databases, for a 4-year period. The health problems of the patients were identified from their diagnoses and prescriptions. Multimorbidity was defined as the presence of two or more chronic diseases out of a list of 47 of the most important and common chronic conditions consistent with the literature. In addition, we explored socio-economic and demographic variables such as age, sex, and deprivation level. RESULTS: Multimorbidity was found in 66.13% of the population aged 65 and over and increases with age until 80 years. The prevalence of multimorbidity was higher in deprived (69.94%) than better-off (60.22%) areas. This pattern of differences between the most and least disadvantaged areas was observed in all age groups and more marked in female (70.96-59.78%) than in male (68.54-60.86%) populations. In almost all diseases studied (43 out of 47), 90% of patients had been diagnosed with at least one other illness. It was also frequent the coexistence of mental and physical health problems in the same person and the presence of multiple physical diseases is higher in patients with mental disease than in the rest of population (74.97% vs. 58.14%). CONCLUSION: Multimorbidity is very common among people over 65 years old in the Basque Country, particularly in unfavourable socioeconomic environments. Given the ageing population, multimorbidity and its consequences should be taken into account in healthcare policy, organization of care and medical research. Administrative health databases are readily available sources of a range of information that can be useful for such purposes.

Socioeconomic variation in the burden of chronic conditions and health care provision--analyzing administrative individual level data from the Basque Country, Spain.

BACKGROUND: Chronic diseases are posing an increasing challenge to society, with the associated burden falling disproportionally on more deprived individuals and geographical areas. Although the existence of a socioeconomic health gradient is one of the main concerns of health policy across the world, health information systems commonly do not have reliable data to detect and monitor health inequalities and inequities. The objectives of this study were to measure the level of socioeconomic-related inequality in prevalence of chronic diseases and to investigate the extent and direction of inequities in health care provision. METHODS: A dataset linking clinical and administrative information of the entire population living in the Basque Country, Spain (over 2 million individuals) was used to measure the prevalence of 52 chronic conditions and to quantify individual health care costs. We used a concentration-index approach to measure the extent and direction of inequality with respect to the deprivation of the area of residence of each individual. RESULTS: Most chronic diseases were found to be disproportionally concentrated among individuals living in more deprived areas, but the extent of the imbalance varies by type of disease and sex. Most of the variation in health care utilization was explained by morbidity burden. However, even after accounting for differences in morbidity, pro-poor horizontal inequity was present in specialized outpatient care, emergency department, prescription, and primary health care costs and this fact was more apparent in females than males; inpatient costs exhibited an equitable distribution in both sexes. CONCLUSIONS: Analyses of comprehensive administrative clinical information at the individual level allow the socioeconomic gradient in chronic diseases and health care provision to be measured to a level of detail not possible using other sources. This frequently updated source of information can be exploited to monitor trends and evaluate the impact of policy reforms.

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.