Effectiveness of an App for tobacco cessation in pregnant smokers (TOBBGEST): study protocol.

BACKGROUND: Tobacco consumption during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant smokers and their foetus. Even though pregnant smokers are conscious about the negative effects of tobacco consumption, they also had barriers for smoking cessation and most of them continue smoking, being a major public health problem. The aim of this study is to determine the effectiveness of an application (App) for mobile devices, designed with a gamification strategy, in order to help pregnant smokers to quit smoking during pregnancy and in the long term. METHODS: This study is a multicentre randomized community intervention trial. It will recruit pregnant smokers (200 participants/group), aged more than 18 years, with sporadically or daily smoking habit in the last 30 days and who follow-up their pregnancy in the Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Departments. All the participants will have the usual clinical practice intervention for smoking cessation, whereas the intervention group will also have access to the App. The outcome measure will be prolonged abstinence at 12 months after the intervention, as confirmed by expired-carbon monoxide and urinary cotinine tests. Results will be analysed based on intention to treat. Prolonged abstinence rates will be compared, and the determining factors will be evaluated using multivariate statistical analysis. DISCUSSION: The results of this study will offer evidence about the effectiveness of an intervention using a mobile App in smoking cessation for pregnant smokers, to decrease comorbidity associated with long-term smoking. If this technology is proven effective, it could be readily incorporated into primary care intervention for all pregnant smokers. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT05222958 . Trial registered 3 February 2022.

Effects of hesperidin in orange juice on blood and pulse pressures in mildly hypertensive individuals: a randomized controlled trial (Citrus study).

PURPOSE: To assess the sustained and acute effects, as well as the influence of sustained consumption on the acute effects, of orange juice (OJ) with a natural hesperidin content and hesperidin-enriched OJ (EOJ) on blood (BP) and pulse (PP) pressures in pre- and stage-1 hypertensive individuals. METHODS: In a randomized, parallel, double-blind, placebo-controlled trial, participants (n = 159) received 500 mL/day of control drink, OJ, or EOJ for 12 weeks. Two dose-response studies were performed at baseline and after 12 weeks. RESULTS: A single EOJ dose (500 mL) reduced systolic BP (SBP) and PP, with greater changes after sustained treatment where a decrease in diastolic BP (DBP) also occurred (P < 0.05). SBP and PP decreased in a dose-dependent manner relative to the hesperidin content of the beverages throughout the 12 weeks (P < 0.05). OJ and EOJ decreased homocysteine levels at 12 weeks versus the control drink (P < 0.05). After 12 weeks of EOJ consumption, four genes related to hypertension (PTX3, NLRP3, NPSR1 and NAMPT) were differentially expressed in peripheral blood mononuclear cells (P < 0.05). CONCLUSION: Hesperidin in OJ reduces SBP and PP after sustained consumption, and after a single dose, the chronic consumption of EOJ enhances its postprandial effect. Decreases in systemic and transcriptomic biomarkers were concomitant with BP and PP changes. EOJ could be a useful co-adjuvant tool for BP and PP management in pre- and stage-1 hypertensive individuals.

Complex chronic patients as an emergent group with high risk of intracerebral haemorrhage: an observational cohort study.

BACKGROUND: Demographic aging is a generalised event and the proportion of older adults is increasing rapidly worldwide with chronic pathologies, disability, and complexity of health needs. The intracerebral haemorrhage (ICH) has devastating consequences in high risk people. This study aims to quantify the incidence of ICH in complex chronic patients (CCP). METHODS: This is a multicentre, retrospective and community-based cohort study of 3594 CCPs followed up from 01/01/2013 to 31/12/2017 in primary care without a history of previous ICH episode. The cases were identified from clinical records encoded with ICD-10 (10th version of the International Classification of Diseases) in the e-SAP database of the Catalan Health Institute. The main variable was the ICH episode during the study period. Demographic, clinical, functional, cognitive and pharmacological variables were included. Descriptive and logistic regression analyses were carried out to identify the variables associated with suffering an ICH. The independent risk factors were obtained from logistic regression models, ruling out the variables included in the HAS-BLED score, to avoid duplication effects. Results are presented as odds ratio (OR) and 95% confidence interval (CI). The analysis with the resulting model was also stratified by sex. RESULTS: 161 (4.4%) participants suffered an ICH episode. Mean age 87 ± 9 years; 55.9% women. The ICH incidence density was 151/10000 person-years [95%CI 127-174], without differences by sex. Related to subjects without ICH, presented a higher prevalence of arterial hypertension (83.2% vs. 74.9%; p = 0.02), hypercholesterolemia (55.3% vs. 47.4%, p = 0.05), cardiovascular disease (36.6% vs. 28.9%; p = 0.03), and use of antiplatelet drugs (64.0% vs. 52.9%; p = 0.006). 93.2% had a HAS-BLED score ≥ 3. The independent risk factors for ICH were identified: HAS-BLED ≥3 [OR 3.54; 95%CI 1.88-6.68], hypercholesterolemia [OR 1.62; 95%CI 1.11-2.35], and cardiovascular disease [OR 1.48 IC95% 1.05-2.09]. The HAS_BLED ≥3 score showed a high sensitivity [0.93 CI95% 0.89-0.97] and negative predictive value [0.98 (CI95% 0.83-1.12)]. CONCLUSIONS: In the CCP subgroup the incidence density of ICH was 5-60 times higher than that observed in elder and general population. The use of bleeding risk score as the HAS-BLED scale could improve the preventive approach of those with higher risk of ICH. TRIAL REGISTRATION: This study was retrospectively registered in ClinicalTrials.gov ( NCT03247049 ) on August 11/2017.

[Impact of the COVID-19 pandemic on patient-reported patient safety in Primary Care]. / Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria.

OBJECTIVE: To evaluate the impact of the changes introduced in response to the pandemic on patient-reported patient safety in Primary Care. DESIGN: Prospective observational panel study (health center) based on two cross-sectional surveys. SETTING: 29 Primary Health Care centers from three Spanish health regions (Mallorca, Catalunya Central and Camp de Tarragona). PARTICIPANTS: Random sample of patients visiting their centers before (n=2199 patients) and during the pandemic (n=1955 patients) MAIN MEASUREMENTS: We used the PREOS-PC questionnaire, a validated instrument which assesses patient-reported patient safety in Primary Care. We compared mean scores of the "experiences of errors" and "harm" scales in both periods, and built multilevel regression analyzes to study the variations in patient and center characteristics associated with worse levels of safety. A qualitative (content) analysis of patients' experiences during the pandemic was also performed. RESULTS: The "experiences of errors" and "harm" scales scores significantly worsened during the COVID-19 period (92.65 to 88.81 (Cohen's d=0.27); and 96.92 to 79.97 (d=0.70), respectively). Patient and center characteristics associated to worsened scores were: women, people with a lower educational level, worse health status, more years assigned to the center, and health region. CONCLUSIONS: During the pandemic, a perceptible worsening in patient safety perceived by patients treated in Primary Care has been observed, which has differentially affected patients according to their sociodemographic characteristics or health center profiles.

[Patient safety incidents reported before and after the start of the COVID-19 pandemic in Primary Care in Tarragona]. / Incidentes de seguridad del paciente notificados antes y después del inicio de la pandemia de COVID-19 en atención primaria en Tarragona.

OBJECTIVE: To analyse and compare the epidemiology of patient safety incidents reported in Primary Health Care, before and after the start of the COVID-19 pandemic. DESIGN AND SETTING: Analytical descriptive study comparing reported incidents from March 1st 2019 to February 28th 2020, and from March 1st 2020 to February 28th 2021, notified through the TPSC Cloud™ platform accessible from the Intranet corporative in 25 Primary Health Care centres from Tarragona district, in Catalonia (Spain). MEASUREMENTS: Data obtained from voluntary notifications, through electronic, standardized and anonymized forms. VARIABLES: Centre, professional, incident type, risk matrix, causal factors and contributing factors, and avoidability. STATISTICAL ANALYSIS: Every notification was included in descriptive analysis, and another one specifically for adverse events, comparing both periods. RESULTS: 2231 incidents were reported. Comparing both periods, during the pandemic a reduction in the number of reported incidents was observed (only represented 20% of the total). However, the percentage of reported notifications from health care professionals and adverse events that required observation were increased. Causal factors related to attendance and diagnosis were incremented whereas the causal factors related to medication were decreased. In addition, an increase in contributing factors related to the professional was observed. Avoidability was high (>95%) in both periods. CONCLUSIONS: During the pandemic, fewer patient safety incidents have been reported, but proportionally more adverse events, most of which are preventable. The professional himself becomes the main contributing factor.

Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial.

BACKGROUND: The effects of probiotic Bifidobacterium animalis subsp. lactis CECT 8145 (Ba8145) and those of its heat-killed form (h-k Ba8145) on human anthropometric adiposity biomarkers are unknown. OBJECTIVE: To assess the effect of Ba8145 and h-k Ba8145 ingestion on anthropometric adiposity biomarkers. DESIGN: Randomized, parallel, double-blind, placebo-controlled trial with abdominally obese individuals. Participants (n = 135) consumed 1 capsule/day containing 1010 colony forming unit (CFU) of Ba8145, 1010 CFU of h-k Ba8145, or placebo (maltodextrin) for 3 months. RESULTS: Ba8145 ingestion decreased waist circumference, waist circumference/height ratio, and Conicity index (P < 0.05) versus its baseline. Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment. Ba8145 decreased the body mass index compared with baseline and placebo group (P < 0.05). The decrease in visceral fat area after Ba8145 treatments reached significance (P < 0.05) only after h-k Ba8145. When analyses by gender were performed, significance remained only for women. Diastolic blood pressure and HOMA index decreased (P < 0.05) after h-k Ba8145. Gut microbiome analyses showed an increase in Akkermansia spp. after Ba8145 treatment, particularly in the live form, which was inversely related to weight (P = 0.003). CONCLUSIONS: In abdominally obese individuals, consumption of Ba8145, both as viable and mainly as heat-killed cells, improves anthropometric adiposity biomarkers, particularly in women. An increase in the gut Akkermansia genus appears as a possible mechanism involved. Our results support Ba8145 probiotic as a complementary strategy in obesity management.

Dietary patterns are associated with lung function among Spanish smokers without respiratory disease.

BACKGROUND: Diet can help preserve lung function in smokers, in addition to avoidance of smoking. The study aimed to evaluate associations between dietary patterns and lung function in smokers without respiratory disease. METHODS: This cross-sectional study analysed baseline data from randomised representative smokers without respiratory disease (n = 207, aged 35-70 years), selected from 20 primary health-care centres. Participants completed a validated semi-quantitative food-frequency questionnaire. Dietary patterns were identified by Principal Component Analysis (PCA). Impaired lung function was defined as FVC <80% and/or FEV1 < 80% of predicted value and/or FEV1/FVC <0.7. Associations were determined by logistic regression. RESULTS: Three major dietary patterns were identified. In multivariate-adjusted model, impaired lung function was associated with the Alcohol-consumption pattern (OR 4.56, 95% CI 1.58-13.18), especially in women (OR 11.47, 95% CI 2.25-58.47), and with the Westernised pattern in women (OR 5.62, 95% CI 1.17-27.02), whereas it not was associated with the Mediterranean-like pattern (OR 0.71, 95% CI 0.28-1.79). CONCLUSION: In smokers without respiratory disease, the Alcohol-consumption pattern and the Westernised pattern are associated with impaired lung function, especially in women. The Mediterranean-like pattern appears to be associated with preserved lung function because no statistical association is observed with impaired lung function. In addition to smoking cessation, modifying dietary patterns has possible clinical application to preserve lung function.

Adiposity markers and lung function in smokers: a cross-sectional study in a Mediterranean population.

BACKGROUND: The aim of this study was to assess the association of key adiposity markers with lung function in smokers without respiratory disease in a Mediterranean population. METHODS: We performed a cross-sectional study with baseline data from a representative sample of the ESPITAP study in Spain. Participants were 738 smokers (52.3% men) without respiratory disease, aged 35 to 70, selected from 12 primary health care centres. We assessed weight, height, body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). The pulmonary functional parameters were forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and FEV1/FVC ratio. RESULTS: In this cohort of smokers, 22.2% of individuals had central obesity. FVC% was inversely associated with all anthropometric measures (BMI, WC and WHtR) in the overall population and in men; in women, only BMI was associated with FVC%. FEV1% was inversely associated to BMI and WC in the overall population, and to all anthropometric measures in men. Furthermore, both BMI and obesity were positively associated with FEV1/FVC ratio overall and when stratified by sex; this suggests a restrictive pattern explained by the altered ventilator mechanics experienced by people with obesity. CONCLUSION: In a Mediterranean population of smokers without respiratory symptoms, abdominal obesity, evaluated not only by BMI and WC but also WHtR, is inversely associated with lung function. Fat distribution appears more strongly related to pulmonary function parameters in men than in women. In smokers with high values for WC, WHtR and BMI, assessment of lung function is recommended. TRIAL REGISTRATION: Current Controlled Trials NCT01194596 . Registered 2 September 2010.

Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

BACKGROUND: Spirometry is the recommended method of evaluating pulmonary function when respiratory disease is suspected in smokers. Nonetheless, no evidence exists of the usefulness of information obtained from this test as a motivational strategy for smoking cessation. The primary objective of this study is to evaluate the effectiveness of a motivational intervention based on spirometry results in achieving long-term smoking cessation. METHODS/DESIGN: We propose a multicenter randomized clinical trial in the primary care setting. STUDY SUBJECTS: We will recruit active smokers of both sexes, aged 35-70 years, with a cumulated smoking habit exceeding 10 packs/year and who consult for any reason with their primary care physician in the 20 health centers in the province of Tarragona (Spain). Patients with a history of lung disease or who have undergone exploratory measures of pulmonary function in the preceding 12 months will be excluded. All patients who agree to participate will provide signed informed consent prior to their inclusion. A total of 1000 smokers will be consecutively randomized to a control or intervention group (1:1). INTERVENTION: Participants in both groups will receive brief (5-minute) health counseling, in accordance with usual clinical practice. In a consultation lasting about 15 minutes, participants in the intervention group will also receive detailed, personalized information about the results of a spirometry test and about their lung age compared with their chronological age. Both groups will be followed up for 12 months. Main variables and analysis: The main variable will be sustained smoking abstinence at 12 months after the intervention, as confirmed by CO breath testing and urine cotinine test. Results will be analyzed based on intention to treat, using the chi-square test and logistical regression if necessary to adjust for confounding variables. DISCUSSION: We expect the rate of prolonged smoking abstinence in the intervention group will be at least 5% higher than in the control group. If this strategy proves effective, it could easily be included in the health promotion activities offered in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02153047 . Registered on 28/05/2014.

Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol.

BACKGROUND: There is evidence of an association between pulmonary function and various nutrients, although no association has been observed in our setting between the Mediterranean Diet (MD) eating pattern and improved lung function. The objective of this study is to evaluate the effect of an intervention designed to increase MD adherence on lung function in smokers with no previous respiratory disease. METHODS/DESIGN: Randomized, controlled, parallel clinical trial. SETTING: primary health care centers in Catalonia (Spain). PARTICIPANTS: Current smokers (cumulative > 10 pack-years) aged 35-70 years, with Internet access, who provide signed informed consent to participate. INTERVENTION: A nutritionist will conduct a 2-year multicomponent intervention to increase MD adherence, based on: 1) a personalized dietary-nutritional education intervention, 2) a Web 2.0 approach, the DIET Blog of nutritional information, and 3) group sessions to increase motivation to increase MD adherence and motivation to make changes in eating habits. Annually, an office visit and one group session will reinforce the nutritional intervention. The control group will follow their usual diet, with general nutritional counselling. In both groups, a 14-item questionnaire will evaluate individual MD dietary patterns and forced spirometry will assess lung function. ANALYSIS: Intention to treat. The unit of analysis will be the individual smoker. Primary outcome is lung function indicated by spirometry, FVC, FEV1 and FEV1/FVC %. Lung function parameters in both groups will be compared by adherence to the MD pattern. DISCUSSION: The DIET study could contribute data on a protective action of the MD pattern on lung function in smokers. If so, this population may benefit from a nutritional intervention, along with the fundamental recommendation to stop smoking. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02151669 . Registered 26 May 2014.

Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol.

INTRODUCTION: Sudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator (AED) use, has proven to double survival rates. Recognising the challenges of timely emergency services in rural areas, the implementation of basic CPR training programmes can improve survival outcomes. This study aims to evaluate the effectiveness of online CPR-AED training among residents in a rural area of Tarragona, Spain. METHODS: Quasi-experimental design, comprising two phases. Phase 1 involves assessing the effectiveness of online CPR-AED training in terms of knowledge acquisition. Phase 2 focuses on evaluating participant proficiency in CPR-AED simulation manoeuvres at 1 and 6 months post training. The main variables include the score difference between pre-training and post-training test (phase 1) and the outcomes of the simulated test (pass/fail; phase 2). Continuous variables will be compared using Student's t-test or Mann-Whitney U test, depending on normality. Pearson's χ2 test will be applied for categorical variables. A multivariate analysis will be conducted to identify independent factors influencing the main variable. ETHICS AND DISSEMINATION: This study adheres to the tenets outlined in the Declaration of Helsinki and of Good Clinical Practice. It operated within the Smartwatch project, approved by the Clinical Research Ethics Committee of the Primary Care Research Institute IDIAP Jordi Gol i Gurina Foundation, code 23/081-P. Data confidentiality aligns with Spanish and European Commission laws for the protection of personal data. The study's findings will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05747495.

Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study.

BACKGROUND: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia. AIM: The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF. METHODS AND ANALYSIS: Two-year follow-up of a cohort of individuals aged 65-85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves. ETHICS AND DISSEMINATION: This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen. TRIAL REGISTRATION NUMBER: NCT05772806.

Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire.

BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .

Patient Safety Incidents in Primary Care: Comparing APEAS-2007 (Spanish Patient Safety Adverse Events Study in Primary Care) with Data from a Health Area in Catalonia (Spain) in 2019.

The initial APEAS study, conducted in June 2007, examined adverse events (AEs) in Spanish Primary Healthcare (PHC). Since then, significant changes have occurred in healthcare systems. To evaluate these changes, a study was conducted in the Camp de Tarragona PHC region (CTPHC) in June 2019. This cross-sectional study aimed to identify AEs in 20 PHC centres in Camp de Tarragona. Data collection used an online questionnaire adapted from APEAS-2007, and a comparative statistical analysis between APEAS-2007 and CTPHC-2019 was performed. The results revealed an increase in nursing notifications and a decrease in notifications from family doctors. Furthermore, fewer AEs were reported overall, particularly in medication-related incidents and healthcare-associated infections, with an increase noted in no-harm incidents. However, AEs related to worsened clinical outcomes, communication issues, care management, and administrative errors increased. Concerning severity, there was a decrease in severe AEs, coupled with an increase in moderate AEs. Despite family doctors perceiving a reduction in medication-related incidents, the overall preventability of AEs remained unchanged. In conclusion, the reporting patterns, nature, and causal factors of AEs in Spanish PHC have evolved over time. While there has been a decrease in medication-related incidents and severe AEs, challenges persist in communication, care management, and clinical outcomes. Although professionals reported reduced severity, the perception of preventability remains an area that requires attention.

Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Prenatal Factors Associated with Maternal Cardiometabolic Risk Markers during Pregnancy: The ECLIPSES Study.

To examine the associations of sociodemographic, lifestyle, and clinical factors with cardiometabolic risk and each of its components during pregnancy in a pregnant population from Catalonia (Spain). A prospective cohort study of 265 healthy pregnant women (39 ± 5 years) in the first and third-trimesters. Sociodemographic, obstetric, anthropometric, lifestyle and dietary variables were collected, and blood samples were taken. The following cardiometabolic risk markers were evaluated: BMI, blood pressure, glucose, insulin, HOMA-IR, triglycerides, LDL, and HDL-cholesterol. From these, a cluster cardiometabolic risk (CCR)-z score was created by summating all z-scores (except insulin and DBP) computed for each risk factor. Data were analyzed using bivariate analysis and multivariable linear regression. In the multivariable models, the first-trimester CCRs was positively associated with overweight/obesity status (ß: 3.54, 95%CI: 2.73, 4.36) but inversely related to the level of education (ß: -1.04, 95%CI: -1.94, 0.14) and physical activity (PA) (ß: -1.21, 95%CI: -2.24, -0.17). The association between overweight/obesity and CCR (ß:1.91, 95%CI: 1.01, 2.82) persisted into the third-trimester, whereas insufficient GWG (ß: -1.14, 95%CI: -1.98, -0.30) and higher social class (ß: -2.28, 95%CI: -3.42, -1.13) were significantly associated with a lower CCRs. Starting pregnancy with normal weight, higher socioeconomic and educational levels, being a non-smoker, non-consumer of alcohol, and PA were protective factors against cardiovascular risk during pregnancy.

Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial.

BACKGROUND: The effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence. OBJECTIVES: To assess the effectiveness of a motivational intervention based on spirometry results in achieving prolonged smoking abstinence (12 months post-intervention). DESIGN AND SETTING: A randomised, controlled, observer-blinded, multicentre clinical trial was conducted (from January 2012 to December 2015) in 20 primary healthcare centres in the Tarragona province, Spain. METHODS: Participants, active smokers aged 35-70 without known respiratory disease, were recruited from primary healthcare centres by family doctors and nurses. They were randomly assigned to either the intervention group (IG = 308) or the control group (CG = 306). Both groups received brief smoking cessation counselling. Additionally, the IG underwent spirometry and received detailed information about the results, including lung age. The primary outcome was prolonged abstinence, defined as lasting at least 12 months and validated through cotinine measurement in urine. RESULTS: The prolonged abstinence rate was 7.8% in the IG, compared to 2.6% in the CG (p = 0.004). At 12 months, in the multivariate analysis, the intervention was identified as an independent factor for smoking cessation (OR 2.8; 95%CI 1.2 to 7.7), a trend maintained throughout the follow-up (HR 2.74; 95%CI 1.13 to 6.62). Moreover, according to the Prochaska and DiClemente model, the preparation or action phase to quit was also associated with smoking cessation (HR 2.55, 95%CI 1.07 to 6.09). CONCLUSION: A primary care-delivered intervention involving brief counselling and detailed spirometry information proves effective in increasing abstinence rates among active smokers without known respiratory disease. Additionally, smoking cessation is also influenced by the individual's stage of change. TRIAL REGISTRATION: ClinicatTrials.gov NCT02153047.

Gender differences in GPs' strategies for coping with the stress of the COVID-19 pandemic in Catalonia: A cross-sectional study.

BACKGROUND: The Covid-19 pandemic has increased stress levels in GPs, who have resorted to different coping strategies to deal with this crisis. Gender differences in coping styles may be contributing factors in the development of psychological distress. OBJECTIVES: To identify differences by gender and by stress level in coping strategies of GPs during the Covid-19 pandemic. METHODS: A cross-sectional, web-based survey conducted with GPs in Catalonia (Spain), in June-July 2021. via the institution's email distribution list, all GPs members of the Catalan Society of Family and Community Medicine were invited to complete a survey assessing sociodemographic, health and work-related characteristics, experienced stress (Stress scale of the Depression, Anxiety and Stress Scales-DASS 21) and the frequency of use of a range of coping strategies (Brief-COPE) classified as problem-focused, emotion-focused and avoidant strategies, some of which are adaptive and others maladaptive. We compared the scores of each strategy by gender and stress level using Student's t-test. RESULTS: Of 4739 members, 522 GPs participated in the study (response rate 11%; 79.1% women; mean age = 46.9 years, SD = 10.5). Of these, 41.9% reported moderate-severe stress levels. The most common coping strategies were acceptance, active coping, planning, positive reframing and venting. More frequently than men, women resorted to emotional and instrumental support, venting, distraction and self-blame, whereas men used acceptance and humour more commonly than women. Moderate-severe stress levels were associated with non-adaptive coping, with increased use of avoidance strategies, self-blame, religion and venting, and decreased use of positive reframing and acceptance. CONCLUSION: The most common coping strategies were adaptive and differed by gender. However, highly stressful situations caused maladaptive strategies to emerge.

Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project.

BACKGROUND: Previous studies have shown that adherence to the Mediterranean Diet (MeDi) has a positive impact on lung function in subjects with lung disease. In subjects free of respiratory diseases, but at risk, this association is not yet well established. METHODS: Based on the reference data from the MEDISTAR clinical trial (Mediterranean Diet and Smoking in Tarragona and Reus; ISRCTN 03.362.372), an observational study was conducted with 403 middle-aged smokers without lung disease, treated at 20 centres of primary care in Tarragona (Catalonia, Spain). The degree of MeDi adherence was evaluated according to a 14-item questionnaire, and adherence was defined in three groups (low, medium, and high). Lung function were assessed by forced spirometry. Logistic regression and linear regression models were used to analyse the association between adherence to the MeDi and the presence of ventilatory defects. RESULTS: Globally, the pulmonary alteration prevalence (impaired FEV1 and/or FVC) was 28.8%, although it was lower in participants with medium and high adherence to the MeDi, compared to those with a low score (24.2% and 27.4% vs. 38.5%, p = 0.004). Logistic regression models showed a significant and independent association between medium and high adherence to the MeDi and the presence of altered lung patterns (OR 0.467 [95%CI 0.266, 0.820] and 0.552 [95%CI 0.313, 0.973], respectively). CONCLUSIONS: MeDi adherence is inversely associated with the risk impaired lung function. These results indicate that healthy diet behaviours can be modifiable risk factors to protect lung function and reinforce the possibility of a nutritional intervention to increase adherence to MeDi, in addition to promoting smoking cessation.