Discrepancies in the results reported for multiple sclerosis clinical trials: A comparison between ClinicalTrials.gov and peer-reviewed journals.

OBJECTIVE: We aimed to compare the results of phase III and IV clinical trials examining drugs to treat multiple sclerosis (MS) registered at ClinicalTrials.gov to those published in peer-reviewed journals. METHODS: After identifying trials registered at ClinicalTrials.gov, consecutive searches were conducted in PubMed, EMBASE and Google Scholar for matching publications. Information regarding participants and efficacy and safety results was extracted and compared. The degree of consistency was classified as 'concordant', 'discrepant' or 'not comparable'. The Kaplan-Meier method was used to model time to reporting. RESULTS: In total, 65 trials were appraised. The median time from completion to reporting was shorter for ClinicalTrials.gov (16.4 vs 27.3 months; p = 0.010). Information availability was generally higher in journals except for serious adverse events (SAEs) (86.2% vs 100.0%, p = 0.029) and their description (78.2% vs 100.0%, p < 0.001). However, 45 trials had at least one reporting discrepancy (69.2%). Three studies omitted one or more primary outcomes in the matching journal publication. Regarding safety results, the lowest consistencies were found for causes of death (60.0%) and description of SAEs (27.9%). CONCLUSION: Consulting both ClinicalTrials.gov and journals increases the accessibility to MS clinical trial results. Some data were frequently missing or disagreed between sources, raising concerns about transparency and generalizability of results.

Influence of educational level on the prevalence of risk behaviors during the perinatal period. / Influencia del nivel de estudios en la prevalencia de conductas de riesgo durante el periodo perinatal.

The objective of this work was to assess changes during pregnancy and after childbirth in diet, consumption of tobacco, electronic cigarettes, cannabis, alcohol use and exposure to environmental tobacco smoke depending on the mother's educational level.A cross-sectional study was carried out whose target population was 18,822 Galician women aged 18-49 who gave birth between September 2015 and August 2016, and their 19,204 live-born children. A descriptive analysis was performed, and the prevalence of different behaviors was estimated at three time points - pre-pregnancy, pregnancy and after childbirth - depending on the mother's educational level. Percentages of change were calculated.Information was obtained from 6,436 women. Regardless of the educational level, during pregnancy there was an improvement in the different lifestyles. In the first months after childbirth, lifestyles worsened, except for exposure to environmental tobacco smoke and the use of electronic cigarettes. Most of the risk behaviors showed a gradient depending on the educational level; thus, the lower the educational level, the higher the prevalence of risk behaviors.In general, during pregnancy all women adopted healthier lifestyles that they abandoned in the months following childbirth. Women with a lower level of education showed a higher prevalence of risk behaviors, both in the period prior to pregnancy, as well as during pregnancy and after childbirth.

El objetivo de este trabajo fue valorar cambios durante el embarazo y tras el parto en la dieta, consumo de tabaco, cigarrillos electrónicos, alcohol, cannabis y exposición al humo ambiental de tabaco en función del nivel de estudios de la madre. Para ello, se llevó a cabo un estudio transversal cuya población objetivo fueron 18.822 mujeres gallegas de 18-49 años que dieron a luz entre septiembre 2015 y agosto 2016, y sus 19.204 hijos/as nacidos vivos. Se realizó un análisis descriptivo y se estimó la prevalencia de diferentes conductas en tres momentos temporales ­pre-embarazo, embarazo y tras el parto­ en función del nivel de estudios de la madre. Se calcularon los porcentajes de cambio. Se obtuvo información de 6.436 mujeres. Con independencia del nivel de estudios, durante el embarazo se produce una mejora en los diferentes estilos de vida. En los primeros meses tras el parto los estilos de vida empeoran, con excepción de la exposición al humo ambiental de tabaco y el consumo de cigarrillos electrónicos. La mayoría de las conductas de riesgo muestran un gradiente dependiente del nivel educativo; así, a menor nivel educativo, mayor es la prevalencia de conductas de riesgo. En general, durante el embarazo todas las mujeres adoptan estilos de vida más saludables que abandonan en los meses siguientes al parto. Las mujeres con menor nivel de estudios muestran una mayor prevalencia de conductas de riesgo, tanto en el periodo previo al embarazo, como en el embarazo y tras el parto.

[Assessment of exposure to seconhand smoke in health surveys in Spain]. / La valoración de la exposición al humo ambiental de tabaco en las encuestas de salud de España.

OBJECTIVE: To describe the questions used to assess exposure to secondhand smoke (SHS) in Spanish health surveys. METHOD: Extraction and analysis of the literals of the questions on SHS in the health surveys in Spain identified on the website of the Ministry of Health, the National Plan on Drugs and Health Departments of the autonomous communities. RESULTS: Three nationwide surveys assessed SHS exposure, with variability in questions, responses, and recall periods. Catalonia in 2022, and Galicia and the Basque Country in 2018, assessed exposure in detail. CONCLUSIONS: Questions assessing self-reported exposure to SHS are survey-dependent. There is a need for a set of questions to assess exposure in a homogeneous way in health surveys.

[Perception of cannabis use in the adolescent population: metasynthesis of qualitative studies]. / Percepción del consumo de cannabis en población adolescente: metasíntesis de estudios cualitativos.

OBJECTIVE: To assess the perceptions and beliefs of adolescents about cannabis consumption, studying the incentive and disincentive factors for consumption. METHOD: A systematic review of the literature was carried out following the PRISMA guidelines. MedLine, Embase, APA PsycInfo, Cochrane and Web of Science were searched using controlled vocabulary and free terms. We included qualitative studies published between 2000 and 2024 that assessed the perceptions of adolescents aged 10 to 19 years on the use, effects, risks of using cannabis or cannabis with other legal drugs. The quality of the studies was assessed using the CASP tool. RESULTS: Of the 3665 articles identified in the initial search, 22 complied with elegibility criteria. Data extraction yielded a series of three lines of argument linked to cannabis use: reasons for use, reasons for not using and perceived effects. The most common discourse among adolescents was related to the feeling of social and emotional well-being, fewer adverse effects than drugs, and the influence of peers on consumption. CONCLUSIONS: The review preformed reports on the reasons that adolescents allege for cannabis use and reasons for abstention with a view of the preponderance of benefits over harms. It is considered that this information may be necessary for the development of prevention programmes with the dissemination of information on the effects of consumption.

Impact of the use of small-area models on estimation of attributable mortality at a regional level.

The objective of this study is to assess the impact of applying prevalences derived from a small-area model at a regional level on smoking-attributable mortality (SAM). A prevalence-dependent method was used to estimate SAM. Prevalences of tobacco use were derived from a small-area model. SAM and population attributable fraction (PAF) estimates were compared against those calculated by pooling data from three national health surveys conducted in Spain (2011-2014-2017). We calculated the relative changes between the two estimates and assessed the width of the 95% CI of the PAF. Applying surveys-based prevalences, tobacco use was estimated to cause 53 825 (95% CI: 53 182-54 342) deaths in Spain in 2017, a figure 3.8% lower obtained with the small-area model prevalences. The lowest relative change was observed in the Castile-La Mancha region (1.1%) and the highest in Navarre (14.1%). The median relative change between regions was higher for women (26.1%), population aged ≥65 years (6.6%), and cardiometabolic diseases (9.0%). The differences between PAF by cause of death were never greater than 2%. Overall, the differences between estimates of SAM, PAF, and confidence interval width are small when using prevalences from both sources. Having these data available by region will allow decision-makers to implement smoking control measures based on more accurate data.

Mortality attributable to secondhand smoke exposure in the autonomous communities of Spain.

INTRODUCTION AND OBJECTIVES: Exposure to secondhand smoke (SHS) causes cardiovascular disease, respiratory disease, and cancer. The aim of this study was to estimate the mortality attributed to SHS in people aged ≥ 35 years in Spain and its autonomous communities (AC) by sex from 2016 to 2021. METHODS: Estimates of SHS-attributable mortality were calculated by applying the prevalence-dependent method where SHS exposure was derived from the adjustment of small-area models and based on the calculation of population-attributed fractions. Sex, age group, AC, and cause of death (ischemic heart disease and lung cancer) were included. The estimates of attributed mortality are presented with their 95% confidence interval (95%CI). Crude and age-standardized rates were estimated for each sex and AC. RESULTS: From 2016 to 2021, SHS exposure caused 4,970 (95%CI, 4,787-5,387) deaths, representing 1.6% of total mortality for ischemic heart disease and lung cancer. The burden of attributed mortality differed widely among the AC, with Andalusia having the highest burden of attributed mortality (crude rate: 46.6 deaths per 100 000 population in men and 17.0/100 000 in women). In all the AC, the main cause of death in both sexes was ischemic heart disease. The highest burden of mortality was observed in nonsmokers. CONCLUSIONS: The burden of SHS-attributable mortality was high and varied geographically. The results of this study should be considered to advance tobacco control legislation in Spain.

Perception of pregnant individuals, health providers and decision makers on interventions to cease substance consumption during pregnancy: a qualitative study.

BACKGROUND: Despite multiple recommendations and strategies implemented at a national and international level, cigarette smoking, alcohol consumption, and cannabis use during pregnancy remains high in most countries. The objective of this study was to examine key stakeholders' perception of the treatment interventions adopted in Spain, to identify political, organizational and personal factors associated with successful implementation, and to propose strategies for improvement. METHODS: A qualitative study with a phenomenological approach was conducted in 2022. The target groups were: (1) clinical decision makers in the field of addiction science, (2) health professionals who carry out treatment interventions, and (3) pregnant individuals who use tobacco, alcohol or cannabis. Two focus groups and eight in-depth interviews were conducted, recorded, and transcribed. Exploratory analysis and inductive open coding was performed, codes were merged into categories, and subcategories were identified. RESULTS: The analysis resulted in 10 subcategories which were further merged into three main categories: (1) Degree of adoption and utility of treatment interventions implemented; (2) Needs and demands with respect to the organization of treatment interventions; and, (3) Personal barriers to and facilitators for treatment. Respondents reported that despite multiple national and regional cessation initiatives, treatment interventions were rarely adopted in clinical practice. Health care administrators demanded reliable records to quantify substance use for better planning of activities. Health care professionals advocated for additional time and training and both echoed the importance of integrating cessation interventions into routine prenatal care and creating in-house specialized units. The difficulty in quitting, lack of awareness of risk for foetus and child and the controversial advice were identified as barriers by pregnant individuals. CONCLUSIONS: Consistent with previous work, this study found that cessation strategies implemented by the health authorities are not effective if they are not accompanied by organizational and behavioral changes. The current study identifies a set of factors that could be pivotal in ensuring the success of treatment interventions targeting tobacco, alcohol and cannabis use among pregnant individuals.

Consumo de antibióticos en los primeros meses de vida: un estudio transversal / Antibiotic consumption in the first months of life: A cross-sectional study

Introducción: Los factores y patrones asociados al consumo de antibióticos en los lactantes no están claros. Nuestro objetivo fue evaluar la incidencia acumulada de consumo de antibióticos desde el nacimiento hasta los 16meses e identificar los factores asociados al consumo de antibióticos entre lactantes de 4 a 16meses. Material y métodos: Se realizó un estudio transversal en 2016 que incluyó una muestra de la población de 18.882 mujeres españolas de Galicia que habían dado a luz a un niño vivo entre el 1 de septiembre de 2015 y el 31 de agosto de 2016. Se calculó la incidencia acumulada de consumo de antibióticos a partir de los resultados de la entrevista a la madre sobre el consumo del lactante desde el nacimiento hasta los 14meses; no se estimó a los 15 y 16meses debido al reducido tamaño muestral. Para valorar las características asociadas al consumo de antibióticos se anidó en el estudio transversal un estudio de casos y controles emparejando por mes de nacimiento, un control por caso. Resultados: La incidencia acumulada de consumo de antibióticos entre los lactantes de 0 a 14meses de edad aumentó del 7,5% al 66,0%. Para el estudio de casos y controles, se obtuvo información de 1.852 casos y de 1.852 controles. La asistencia a la guardería (OR: 3,8 [IC95%: 3,2-4,6]), tener hermanos/as mayores (OR: 1,8 [IC95%: 1,6-2,1]), las consultas sanitarias en la clínica privada (OR: 1,6 [IC95%:1,4-2,0]) o haber estado expuesto al humo ambiental de tabaco (OR: 1,3 [IC95%: 1,1-1,6]) se asociaron con un mayor riesgo de consumo de antibióticos. Tener madres de entre 30 y 39años o de 40años y más en el momento del parto se asoció con un menor riesgo de consumo de antibióticos (OR: 0,8 [IC95%: 0,7-1,0] y OR: 0,6 [IC95%: 0,5-0,8], respectivamente).(UA)

Introduction: The factors and patterns associated with antibiotic consumption in infants are unclear. Our aim was to assess the cumulative incidence of antibiotic consumption from birth to 16 months and identify factors associated with antibiotic consumption among infants aged 4 to 16 months. Material and methods: We conducted a cross-sectional study in 2016 in a sample of 18,882 women from Galicia, Spain, who had given birth to a live child between September 1, 2015 and August 31, 2016. We calculated the cumulative incidence of antibiotic consumption based on maternal reports regarding the infant's consumption from birth to 14 months obtained through interviews; we did not estimate consumption at ages 15 and 16 months due to the small sample size. To assess which factors were associated with antibiotic consumption, we carried out a nested case-control study matching cases and controls for birth month on a 1:1 ratio. Results: The cumulative incidence of antibiotic consumption among infants aged 0 to 14 months increased from 7.5% to 66.0%. The case-control study included data for 1,852 cases and 1,852 controls. Daycare attendance (OR: 3.8 [95%CI: 3.2-4.6]), having older siblings (OR: 1.8 [95%CI: 1.6-2.1]), health care visits to private clinics (OR: 1.6 [95%CI: 1.4-2.0]), and passive smoking (OR: 1.3 [95%CI: 1.1-1.6]) were associated with an increased probability of antibiotic consumption. Maternal age between 30-39 years or 40 years and over at the time of birth was associated with a decreased probability of antibiotic consumption (OR: 0.8 [95%CI, 0.7-1.0] and OR: 0.6 [95%CI: 0.5-0.8], respectively). Conclusions: Some of the factors associated with antibiotic consumption in infants are modifiable and should be considered in the development of public health measures aimed at reducing antibiotic consumption.(AU)

Evolución de la prevalencia de sedentarismo en la población española entre los años 1987 y 2020 / Evolution of sedentarism prevalence in Spanish population between 1987 and 2020

Antecedentes y objetivo: El sedentarismo es un factor predictivo para numerosas enfermedades. El objetivo de este estudio fue valorar la evolución de la prevalencia de sedentarismo en la población española adulta entre los años 1987-2020. Métodos: Las fuentes de datos fueron las Encuestas Nacionales y Europeas de Salud. La prevalencia de sedentarismo se valoró en 3 escenarios (actividad principal, tiempo libre y todos los escenarios). Se estimaron prevalencias de sedentarismo global, por sexo y grupo de edad. En todos los escenarios la prevalencia también se estimó por comunidad autónoma. La tendencia de las prevalencias se analizó con los porcentajes de cambio anual (PCA) obtenidos a través de modelos joinpoint. Resultados: La prevalencia de sedentarismo en la actividad principal varió entre el 31,2% en 1987 y el 38,4% en 2020 (PCA: 0,7 [0,5 a 1,0]), siendo mayor en los varones que en las mujeres, y más elevada en los más jóvenes y en los más mayores. La prevalencia de sedentarismo en el tiempo libre varió entre el 55,1% en 1993 y el 36,4% en 2020 (PCA: −1,4 [−1,9 a −0,9]), siendo siempre superior en las mujeres, más alta en los mayores de 64 años y menor en los de 16-24 años. Cantabria y Canarias fueron las comunidades autónomas con la prevalencia de sedentarismo más baja en todos los escenarios. Conclusiones: La prevalencia de sedentarismo en la actividad principal está aumentando en España, mientras que durante el tiempo libre está descendiendo. Es importante aplicar medidas de prevención y promoción de la salud dirigidas a disminuir el sedentarismo en la población.(AU)

Background and objective: Sedentary behavior is a predictive factor for numerous diseases. The objective of this study was to assess the evolution of the prevalence of sedentary behavior in the Spanish adult population between 1987 and 2020. Methods: The data sources were the National and European Health Surveys. The prevalence of sedentary behavior was assessed in three scenarios (main activity, leisure time and all scenarios). Prevalence of sedentary behavior was estimated overall, by sex and age group. In all scenarios, prevalence was also estimated by Autonomous Community. The prevalence trend was analyzed with the annual percent change (APC) obtained through joinpoint models. Results: The prevalence of sedentary in the main activity ranged from 31.2% in 1987 to 38.4% in 2020 [PCA: 0.7 (0.5-1.0)], being higher in men than in women and higher in younger and older people. The prevalence of sedentary in the leisure time varied between 55.1% in 1993 and 36.4% in 2020 [PCA: −1.4 (−1.9 to −0.9)], being always higher in women, higher in those over 64 years of age and lower in those aged 16–24 years. Cantabria and the Canary Islands were the Autonomous Communities with the lowest prevalence of sedentary behavior in all scenarios. Conclusions: The prevalence of sedentary behavior in the main activity is increasing in Spain, whereas during leisure time it is decreasing. It is important to implement prevention and health promotion measures aimed at reducing sedentary behavior in the population.(AU)

Evolution and characteristics of studies estimating attributable mortality to second-hand smoke: a systematic review.

BACKGROUND: Several studies have estimated the impact of second-hand smoke (SHS) exposure on mortality in the population of different countries. This study aimed to identify and describe studies that have estimated the attributable mortality (AM) associated with SHS exposure in the adult population. METHODS: A literature search was conducted in MEDLINE, EMBASE, Cochrane Library and CINAHL databases up to January 2023. Studies that estimated the AM associated with SHS exposure in the adult population and used a prevalence-dependent method were included. The main characteristics of the studies and their results were described. RESULTS: Fifty-three studies were included. Most of them were conducted in North America (n = 13), Europe (n = 14) and China (n = 6) and included lung cancer (n = 46) or ischaemic heart disease (n = 22) as causes of death. There was considerable variety in the population under study regarding the relationship with tobacco: non-smokers (n = 30); never-smokers (n = 9); both non and never-smokers (n = 2); the whole population (n = 1) and not known (n = 11). The age at which AM was estimated also varied between studies, ranging from 15 to 40 years and older. CONCLUSIONS: Studies estimating AM associated with SHS exposure are heterogeneous in terms of the causes of death studied, the age at which mortality is attributed, or the population to which mortality referred: consensus should be reached. Despite their importance, studies assessing AM to SHS are infrequent in low- and middle-income countries.

Occupational exposure to endotoxins and small cell lung cancer: a systematic review with meta-analysis.

The relationship of occupational exposure to endotoxins with different histologic subtypes of lung cancer has not been established. Our objective was to conduct a systematic review with meta-analysis to assess the effect of exposure to endotoxins on the development of small cell lung cancer (SCLC). A bibliographic search was conducted using MEDLINE, Embase, CENTRAL, and Web of Science databases until December 2022, including all cohort and/or case-control studies that examined occupational exposure to endotoxins and SCLC. Risk of bias was assessed using the U.S. Office of Health Assessment and Translation tool. A random effects model was applied, publication bias were assessed, and a sensitivity analysis was conducted. Four papers were selected for meta-analysis purposes. A total of 144 incident cases of SCLC and 897 population or hospital controls were included. Occupational exposure to endotoxins was considered for textile/leather industry and agricultural sector workers exposed to endotoxins originating from wool, cotton, or leather dust. Except for one study, all investigations were classified as having a low probability of risk of biases. The results of the meta-analysis were not statistically significant (pooled OR: 0.86; 95% CI:0.69-1.08). In addition, neither between-study heterogeneity (I2=0%;p=0.92) nor publication bias was observed (p=0.49). The results of the sensitivity analysis, after including five studies that assessed the risk of SCLC among textile industry and crop/livestock farm workers (not specifically exposed to endotoxins), showed a negative statistically non-significant association and low between-study heterogeneity (pooled OR: 0.90; 95% CI:0.79-1.02; I2=22%;p=0.23). Subjects exposed to occupational exposure to endotoxins seem to exhibit a negative association with the development of SCLC, although the results are not conclusive.

Antibiotic consumption in the first months of life: A cross-sectional study.

INTRODUCTION: The factors and patterns associated with antibiotic consumption in infants are unclear. Our aim was to assess the cumulative incidence of antibiotic consumption from birth to 16 months and identify factors associated with antibiotic consumption among infants aged 4-16 months. MATERIAL AND METHODS: We conducted a cross-sectional study in 2016 in a sample of 18 882 women from Galicia, Spain, who had given birth to a live child between September 1, 2015 and August 31, 2016. We calculated the cumulative incidence of antibiotic consumption based on maternal reports regarding the infant's consumption from birth to 14 months obtained through interviews; we did not estimate consumption at ages 15 and 16 months due to the small sample size. To assess which factors were associated with antibiotic consumption, we carried out a nested case-control study matching cases and controls for birth month on a 1:1 ratio. RESULTS: The cumulative incidence of antibiotic consumption among infants aged 0-14 months increased from 7.5% to 66.0%. The case-control study included data for 1852 cases and 1852 controls. Daycare attendance (OR: 3.8 [95% CI: 3.2-4.6]), having older siblings (OR: 1.8 [95% CI: 1.6-2.1]), health care visits to private clinics (OR: 1.6 [95% CI: 1.4-2.0]), and passive smoking (OR: 1.3 [95% CI: 1.1-1.6]) were associated with an increased probability of antibiotic consumption. Maternal age between 30-39 years or 40 years and over at the time of birth was associated with a decreased probability of antibiotic consumption (OR: 0.8 [95% CI, 0.7-1.0] and OR: 0.6 [95% CI: 0.5-0.8], respectively). CONCLUSIONS: Some of the factors associated with antibiotic consumption in infants are modifiable and should be considered in the development of public health measures aimed at reducing antibiotic consumption.

Towards stronger tobacco control policies to curb the smoking epidemic in Spain.

Smoking and exposure to secondhand smoke pose a significant risk to the health of populations. Although this evidence is not new, the commitment of countries to implement laws aimed at controlling consumption and eliminating exposure to secondhand smoke is uneven. Thus, in North America or in Europe, locations like California or Ireland, are pioneers in establishing policies aimed at protecting the population against smoking and secondhand smoke. Identifying measures that have worked would help control this important Public Health problem in other countries that are further behind in tobacco control policies. In Spain, there has been almost 15 years of little political action in legislation oriented to control the tobacco epidemic. If we want to achieve the tobacco endgame, new legislative measures must be implemented. In this paper, we have elucidated tobacco control policies that could be implemented and show how different countries have done so.

[Evolution of smoking prevalence in Spain and its 17 autonomous regions (1987-2020)]. / Evolución de la prevalencia de consumo de tabaco en España y sus 17 comunidades autónomas (1987-2020).

BACKGROUND AND OBJECTIVES: Continuous monitoring of smoking prevalence is essential to understand the evolution of the tobacco epidemic in a population. The objective of this study was to analyze the evolution of smoking prevalence in Spain and its 17 Autonomous Regions (ARs) in population ≥15 years during the period 1987-2020. METHODS: Tobacco consumption data were derived from the National Health Survey of Spain and the European Health Survey in Spain. A smoker was defined as a person who smoked at the time of the survey. The trend in prevalences by sex in Spain and its ARs was analyzed by applying joinpoint models. Age-standardized prevalences were calculated for Spain by applying the direct method. RESULTS: In Spain, the prevalence of consumption decreased 29 percentage points in men and 4.5 in women between 1987-2020. In men, the smoking prevalence decreased in all the ARs and the absolute change varied between -19.5% in the Balearic Islands and -33.9% in Andalusia. In women, the evolution of smoking prevalence differed between ARs. The absolute change varied between -15.4% in Basque Country and 0.5% in Andalusia. CONCLUSIONS: The number of men and women smokers has decreased in Spain between 1987-2020. Different patterns of evolution of the prevalence of consumption are observed among the ARs, especially among women. This reinforces the need for policies adapted to more local contexts and that take into account the gender perspective.

Best practices in phase III clinical trials on DMTs for multiple sclerosis: a systematic analysis and appraisal of published trials.

BACKGROUND: Great advances have been made in the field of multiple sclerosis (MS) therapy due to the publication of numerous randomised clinical trials (RCTs). In this study, we carried out a critical appraisal of phase III RCTs of disease-modifying therapies (DMTs) for MS published after 2010, intending to identify critical areas of improvement. METHODS: We performed a systematic search of published RCTs on MS from January 2010 until December 2021. RCTs were assessed using an ad-hoc tool. This tool was developed based on existing generic methodological instruments and MS-specific guidelines and methodological papers. It included 14 items grouped in 5 domains: methodological quality, adequacy and measurement of outcomes, adverse event reporting, applicability and relevance of results, and transparency and conflict of interest. RESULTS: We identified 31 phase III RCTs. Most of them were fully compliant in terms of sample size (87%), randomisation (68%), blinding (61%), participant selection (68%), adverse event reporting (84%) and clinical relevance (52%). Only a few were compliant in terms of participant description (6%), comparison (42%), attrition bias (26%), adequacy of outcome measures (26%), applicability (23%), transparency (36%) and conflict of interest (6%). None were compliant in terms of analysis and reporting of outcomes. The most common limitations related to the absence of comorbidity data, unjustified use of placebo, inadequacy of outcomes design and absence of protocol and/or prospective registration. CONCLUSIONS: RCTs for DMTs in MS have relevant and frequent limitations. These should be addressed to enhance their quality, transparency and external validity.

Genome Wide Association Studies in Small-Cell Lung Cancer. A Systematic Review.

Small cell lung cancer (SCLC) is one of the deadliest forms of lung cancer, but few information exists regarding the role of genetics, particularly on Genome Wide Association Studies (GWAS). The aim of the study is to explore the evidence available obtained through GWAS studies for SCLC using a systematic review. We performed a literature search in the main databases until July 31st, 2023. We included all human based studies on GWAS for lung cancer which presented results for SCLC. Only studies with participants diagnosed of SCLC with anatomopathological confirmation were included. Fourteen studies were identified; 8 studies showed a relationship between ASCL1 overexpression and SCLC, which may regulate CHRNA5/A3/B4 cluster, producing a consequent nAChR overexpression. Nine papers, including 8 of the previous, found a positive association between SNPs located in chromosome 15 and SCLC. The most important cluster of genes found is CHRNA5/A3/B4 but the mechanism for the role of these genes is unclear. Kyoto Encyclopaedia of Genes and Genome (KEGG) shows that these receptors were found to be overexpressed where nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-Nitrosonornicotine (NNN) acts, involving different routes in SCLC carcinogenesis.

[Evolution of sedentarism prevalence in Spanish population between 1987 and 2020]. / Evolución de la prevalencia de sedentarismo en la población española entre los años 1987 y 2020.

BACKGROUND AND OBJECTIVE: Sedentary behavior is a predictive factor for numerous diseases. The objective of this study was to assess the evolution of the prevalence of sedentary behavior in the Spanish adult population between 1987 and 2020. METHODS: The data sources were the National and European Health Surveys. The prevalence of sedentary behavior was assessed in three scenarios (main activity, leisure time and all scenarios). Prevalence of sedentary behavior was estimated overall, by sex and age group. In all scenarios, prevalence was also estimated by Autonomous Community. The prevalence trend was analyzed with the annual percent change (APC) obtained through joinpoint models. RESULTS: The prevalence of sedentary in the main activity ranged from 31.2% in 1987 to 38.4% in 2020 [PCA: 0.7 (0.5-1.0)], being higher in men than in women and higher in younger and older people. The prevalence of sedentary in the leisure time varied between 55.1% in 1993 and 36.4% in 2020 [PCA: -1.4 (-1.9 to -0.9)], being always higher in women, higher in those over 64 years of age and lower in those aged 16-24 years. Cantabria and the Canary Islands were the Autonomous Communities with the lowest prevalence of sedentary behavior in all scenarios. CONCLUSIONS: The prevalence of sedentary behavior in the main activity is increasing in Spain, whereas during leisure time it is decreasing. It is important to implement prevention and health promotion measures aimed at reducing sedentary behavior in the population.

An overview on the relationship between residential radon and lung cancer: what we know and future research

We aim to provide an overview of the research available on indoor radon and lung cancer, with a special focus on Spanish investigations. Early studies on underground miners established the link between radon and lung cancer, which was later confirmed for the general population by residential case–control studies. Spain contributed with extensive evidence, including 5 multicentric, hospital-based, case–control studies in the last 30 years, exploring diverse aspects, such as radon's effect on never-smokers, molecular pathways linking radon exposure to lung cancer risk, survival rates, mortality burden, and occupational exposure. There is a well-established causal association between radon with lung cancer. Despite pioneering research performed in our country by the Galician Radon Laboratory, particularly on driver genes, the evidence on the potential molecular pathways which makes radon a carcinogen is sparse. Also, relevant questions on the potential association of radon exposure with the induction of other diseases are still pending (AU)

Sedentary behavior and physical inactivity from a comprehensive perspective.

OBJECTIVE: To characterize the prevalence of physical activity in the population aged ≥16 years integrating sedentarism and physical inactivity. METHOD: A cross-sectional study using data from the Galician Risk Behavior Data System (n=12,928) was conducted. The population was classified into four categories: physically active (active and non-sedentary), active but sedentary (active and sedentary), lightly active (inactive and non-sedentary), and extremely sedentary (inactive and sedentary). Prevalences were calculated for each category and a multinomial logistic regression model was fitted. RESULTS: 58.0% of the population was physically active and the remaining 42.0% presented some degree of sedentarism and/or physical inactivity. Men were more likely to be extremely sedentary. The risk of sedentarism decreased with age, and workers and/or students were prone to a higher risk of extreme sedentarism in comparison to those who reported other status. Extremely sendentary behaviors were also more common in people with higher educational levels, individuals living alone, residents of urban environments, and smokers. CONCLUSIONS: Joint evaluation of sedentarism and physical inactivity provides a more comprehensive and realistic picture of population behaviors related with physical activity. Since sedentarism is the most prevalent behavior, this study recommends that interventions be conducted at work and at academic environments.

Consideraciones para el diseño e implementación de las intervenciones para la cesación de consumo de tabaco, alcohol y cannabis en el embarazo. Un estudio cualitativo / Considerations for the design and implementation of interventions for the cessation of tobacco, alcohol and cannabis use in pregnancy: A qualitative study

Objetivo: Explorar la opinión de distintos actores clave, en relación con los requisitos que deberían cumplir las intervenciones de cesación de consumo de tabaco, alcohol y/o cannabis durante el embarazo para que puedan ser implementadas y resulten aceptables y útiles. Diseño: Estudio cualitativo con aproximación fenomenológica. Sitio: Se realizó en España en 2022. Participantes: Gestores, profesionales sanitarios, embarazadas consumidoras de tabaco, alcohol y/o cannabis y sus parejas también consumidoras. Métodos: Los datos se recogieron mediante grupos focales y entrevistas en profundidad, hasta alcanzar la saturación del discurso y se transcribieron de manera exacta. Se realizó un análisis exploratorio y codificación abierta inductiva, se fusionaron los códigos en categorías y se identificaron subcategorías. Resultados: Se identificaron cuatro categorías y 18 subcategorías. Los resultados apuntan a que las intervenciones deberían de ser multicomponente. Entre las intervenciones más aceptadas por parte de las mujeres embarazadas y sus parejas, las consultas específicas de cesación, la información, el apoyo de un igual (aunque no precisan de qué manera) y los incentivos económicos. Entre otras opciones a considerar, la cooximetría, propuesta por gestores para obtener un registro objetivo. Conclusiones: Se extrae que esta intervención debe realizarse a nivel de la atención prenatal realizada en atención primaria. Existen dudas respecto de la frecuencia, fin y seguimiento de esta intervención multicomponente, así como a la posibilidad de incorporar a las parejas.(AU)

Objective: To explore the opinion of different key stakeholders regarding the requirements that tobacco, alcohol and/or cannabis cessation interventions should meet to be implemented and to be acceptable and useful during pregnancy. Design: A qualitative study with phenomenological approach. Site: The study was conducted in Spain in 2022. Participants: Decision makers, health professionals, pregnant women using tobacco, alcohol and/or cannabis and their partners who are also users. Methods: Data were collected through focus groups and in-depth interviews, until discourse saturation was reached and accurately transcribed. Exploratory analysis and inductive open coding were conducted, codes were merged into categories and subcategories were identified. Results: Four categories and 18 subcategories were identified. The results suggest that interventions should be multicomponent. Among the interventions most accepted by pregnant women and their partners were specific cessation consultations, information, peer support (although they did not specify how) and financial incentives. Among other options to consider, co-oximetry, proposed by managers to obtain an objective register. Conclusions: The conclusion is that this intervention should be carried out at the level of prenatal care in primary care. There are doubts regarding the frequency, purpose, and follow-up of this multicomponent intervention, as well as the possibility of incorporating couples.(AU)