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.

Analysis of Diagnostic Delay and its Impact on Lung Cancer Survival: Results From the Spanish Thoracic Tumor Registry.

BACKGROUND: Early detection is crucial to improve lung cancer survival rates. Delays in diagnosis might negatively impact the prognosis of the disease. This study aims to analyze the diagnostic delay in lung cancer patients and describe if there is an association between delay and survival. METHODS: The data source used was the Thoracic Tumor Registry of the Spanish Lung Cancer Group. This analysis was restricted to lung cancer cases with information on the first date of consultation by symptoms and date of diagnosis. The delay was calculated as the number of days between the two dates. A descriptive analysis was performed, and ordinal logistic regressions were fitted with delay as the dependent variable. Kaplan-Meier survival analysis and Cox regression were performed. RESULTS: 22,755 lung cancer cases were included. Never smokers were 1.16 (95%CI: 1.06-1.27) times more likely to register longer delay than smokers. Stage 0-I-II cases had a 3.09 (95%CI: 2.88-3.32) higher risk of longer delay compared to III-IV stages. Overall, 5-year survival rate after diagnosis was 23.64% (95%CI: 22.88-24.41). In those categorized as having the shortest delay 5-year survival was 17.67% (95%CI: 16.31-19.07) and in the extreme delay it was 32.98% (95%CI: 31.28-34.69) (p<0.001). Adjusted mortality risk was higher in those with the shortest delay (HR 1.36, CI95%: 1.30-1.43) in comparison with the extreme delay. CONCLUSIONS: Diagnostic delay is short among Spanish lung cancer patients, indicating a relatively quick diagnostic process. Extreme delays appear to be associated with higher survival rates, possibly attributed to slow-growing tumors, earlier stage at diagnosis or basically the natural history of this disease.

Time Dependence Between Tobacco Consumption and Lung Cancer Mortality in Spain.

OBJECTIVES: Lung cancer is the leading cause of cancer death and the second most common cancer in both sexes worldwide, with tobacco being its main risk factor. The aim of this study is to establish the temporal relationship between smoking prevalence and lung cancer mortality in Spain. METHODS: To model the time dependence between smoking prevalence and lung cancer mortality, a distributed lag non-linear model was applied adjusting for sex, age, year of mortality and population at risk. Smoking prevalence data from 1991-2020 were used. Considering a maximum lag of 25 years, mortality data from 2016-2020 were included. The effect of prevalence on mortality for each lag is presented in terms of relative risk (RR). To identify the lag at which smoking prevalence has the greatest effect on mortality, the RR of the different lags were compared. RESULTS: The optimal lag observed between smoking prevalence and lung cancer mortality in Spain was 15 years. The maximum RR was 2.9 (95%CI: 2.0-4.3) for a prevalence of 71% and a 15-year lag. The RR was 1.8 for a prevalence of 33%, an approximate median value between 1991-2020, and a 15-year lag. CONCLUSIONS: In Spain, lung cancer mortality is affected by smoking prevalence 15 years prior. Knowing the evolution of the smoking prevalence series in a country and establishing a lag time is essential to predict how lung cancer incidence and mortality will evolve.

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.

Retracted papers originating from paper mills: a cross-sectional analysis of references and citations.

OBJECTIVES: The aims of this study are (1) to analyze the references cited by retracted papers originated from paper mills; (2) to analyze the citations received by retracted papers originated from paper mills; and (3) to analyze the potential relationships existing between paper mill papers and their references and their citations. STUDY DESIGN AND SETTING: This study was a cross-sectional study. All original papers retracted in 2022 identified as having originated from paper mills and had been published at least 12 months before their retraction (hereinafter "source-retracted papers") were included. The Retraction Watch database was used to identify the source-retracted papers and Web of Science was used to identify the references contained within them and the citations received by them. We described the characteristics of the papers and journals. Additionally, 2 networks of source-retracted papers mutually interconnected via their citations and references were built: 1 with only retracted references and retracted citations and the other with all references and citations (retracted or unretracted). RESULTS: A total of 416 paper mill papers retracted in 2022 (sourced retracted papers) were identified, with a median of 1247 (interquartilic range, 907.8-1673.5) days between publication and retraction. Of all authors identified, 92.3% were affiliated with Chinese institutions. There were 14,411 references contained in the source-retracted papers and 8479 citations received by them; the median number of references and citations was 35 (29-40) and 16 (9-25), respectively. In total, 473 references and citations had also been retracted for being paper mill papers. Among the 416 sourced-retracted papers, 169 (41.9%) and 178 (42.8%) were referenced or were cited by at least another retracted paper, the majority of which also originated from paper mills. The first network analysis, which included source-retracted papers along with their retracted references and citations, found 3 clusters of 53, 48, and 44 retracted papers that were mutually interconnected. The second network analysis, with all references and citations (retracted or unretracted) identified a large cluster of 2530 interconnected papers. CONCLUSION: Retracted papers originating from paper mills frequently reference and are cited by papers that are later retracted for having originated from paper mills, displaying inter-relationships. Detecting these inter-relationships can serve as an indicator for identifying potentially fraudulent publications.

Lung Function and Symptoms of Exposure to the Volcanic Eruption in the Canary Islands: First Follow-Up of the ASHES Study.

INTRODUCTION: Exposure to gases and particulate matter released during volcanic eruptions can prove harmful to population health. This paper reports the preliminary results of the ASHES study, aimed at ascertaining the respiratory health effects of the 2021 volcanic eruption in La Palma Island (Spain) on the adult population without previous respiratory disease. METHODS: Ambispective cohort study on the healthy adult population. Three exposure groups were considered: Group 1, high exposure; Group 2, moderate exposure; and Group 3, minor or no exposure. We carried out a descriptive analysis of symptoms during and after the eruption, as well as measure lung function after the eruption (through forced spirometry and diffusing capacity of carbon monoxide). RESULTS: The analysis included 474 subjects: 54 in Group 1, 335 in Group 2, and 85 in Group 3. A significant increase in most symptoms was observed for subjects in the groups exposed during the eruption. After the eruption, this increase remained for some symptoms. There seems to be a dose-response relationship, such that the higher the exposure, the higher the odds ratio. A prebronchodilator FEV1/FVC ratio<70% was observed in 13.0% of subjects in Group 1, 8.6% of subjects in Group 2, and 7.1% of subjects in Group 3. CONCLUSIONS: This study is the first to report a dose-response relationship between exposure to volcanic eruptions and the presence of symptoms in adults. Furthermore, there is a tendency toward obstructive impairment in individuals with higher exposure.

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.

Does lung function mediate the role of environmental pollution on overall and cardiovascular disease mortality?

Lung function and its mediation role on environmental pollution and mortality https://bit.ly/3pdVYJX.

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.

Assessing conflict of interest reporting and quality of clinical trials on infant formula: a systematic review.

OBJECTIVES: This study aims to assess the quality, risk of bias, and conflicts of interest (COIs) of clinical trials conducted on the effects of fortified infant formula. STUDY DESIGN AND SETTTING: Systematic review including all randomized clinical trials targeting healthy children and using three arms: fortified infant formula; standard formula; and breastfeeding. We performed a descriptive analysis of the studies reviewed, assessed their quality using the "Risk of Bias 2- RoB 2" tool, and identified COIs. RESULTS: A total of 40 studies were included. All showed a high overall risk of bias, with this being especially noteworthy in the "deviations from intention to treat" and "missing outcome data" domains. Of the total included studies, 29 reported conclusions in favor of the fortified formula; 15 studies reported multiple conclusions that were either contradictory or not in line with the results. COIs with industry were identified in 33 studies, and in 17 studies, these conflicts were not declared in the appropriate section. CONCLUSION: From a methodological perspective, studies on fortified infant formula display low quality, made evident by the high risk of bias. Additionally, there are frequent COIs. These aspects must be considered by health professionals and the population when drawing up recommendations for the use of this product.

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.

Prevalence of obesity in Spain and its autonomous communities, 1987-2020.

INTRODUCTION AND OBJECTIVES: Obesity is a public health concern with a strong impact on the health of the population. The aim of this study was to analyze the trend in the prevalence of obesity and to identify changes in this trend in Spain and its 17 autonomous communities (AC) among the population aged ≥ 15 years from 1987 to 2020. METHODS: A trend analysis of the prevalence of obesity was conducted with data extracted from the complete historical series of the Spanish National Health Survey and the European Health Survey in Spain using joinpoint regression models. For each period identified in the trend analysis, we estimated the annual percentage change (APC) and its 95% confidence interval (95%CI). The results are presented for crude and standardized prevalences by the direct method accompanied by 95%CI, sex ratios, and relative changes in prevalences between periods. RESULTS: The prevalence of obesity increased from 7.3% (95%CI, 7.0-7.7) in 1987 to 15.7% (95%CI, 15.1-16.3) in 2020. In men, the prevalence increased until 2009 (APC,4.3; [95%CI, 3.8-5.0]) and then stabilized. In women, the prevalence increased until 2001 (APC,4.2; [95%CI, 2.7-8.8]) and subsequently also stabilized. The prevalence of obesity and its trend varied between AC, with three different patterns being observed with standardized prevalences: AC with a continuous increase, AC with an increase and subsequent stabilization, and AC with an increase and subsequent decrease. CONCLUSIONS: The prevalence of obesity has increased in Spain since 1987, although in the last decade it has remained stable at values above 15%. However, in the group aged 15 to 24 years, the prevalence of obesity showed an increasing trend throughout the study period.

Comparison of Clinical and Genetic Characteristics Between Younger and Older Lung Cancer Patients

Introduction The aim of this study was to analyze the clinical and genetic characteristics of young lung cancer cases, and to compare them with those of older cases. Methods We used the Thoracic Tumors Registry (TTR) as a data source representative of lung cancer cases diagnosed in Spain, and included all cases registered until 9/01/2023 which had information on age at diagnosis or the data needed to calculate it. We performed a descriptive statistical analysis and fitted logistic regressions to analyze how different characteristics influenced being a younger lung cancer patient. Results A total of 26,336 subjects were included. Lung cancer cases <50 years old had a higher probability of being women (OR: 1.38; 95% CI: 1.21–1.57), being in stage III or IV (OR: 1.32; 95% CI: 1.08–1.62), not having comorbidities (OR: 5.21; 95% CI: 4.59–5.91), presenting with symptoms at diagnosis (OR: 1.53; 95% CI: 1.29–1.81), and having ALK translocation (OR: 7.61; 95% CI: 1.25–46.32) and HER2 mutation (OR: 5.71; 95% CI: 1.34–24.33), compared with subjects ≥50 years. Among subjects <35 years old (n=61), our study observed a higher proportion of women (59.0% vs. 26.6%; p<0.001), never smokers (45.8% vs. 10.3%; p<0.001), no comorbidities (21.3% vs. 74.0%; p<0.001); ALK translocation (33.3% vs. 4.4%; p<0.001) and ROS1 mutation (14.3% vs. 2.3%; p=0.01), compared with subjects ≥35 years. Conclusions Lung cancer displays differences by age at diagnosis which may have important implications for its clinical management (AU)

The role of sex and gender in the diagnosis and treatment of lung cancer: the 6th ICAPEM Annual Symposium

The incidence and mortality of lung cancer in women are rising, with both increasing by 124% between 2003 and 2019. The main risk factor for lung cancer is tobacco use, but indoor radon gas exposure is one of the leading causes in nonsmokers. The most recent evidence demonstrates that multiple factors can make women more susceptible to harm from these risk factors or carcinogens. For this consensus statement, the Association for Lung Cancer Research in Women (ICAPEM) invited a group of lung cancer experts to perform a detailed gender-based analysis of lung cancer. Clinically, female patients have different lung cancer profiles, and most actionable driver alterations are more prevalent in women, particularly in never-smokers. Additionally, the impact of certain therapies seems to be different. In the future, it will be necessary to carry out specific studies to improve the understanding of the role of certain biomarkers and gender in the prognosis and evolution of lung cancer (AU)