[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.

A Complex Interplay: Navigating the Crossroads of Tobacco Use, Cardiovascular Disease, and the COVID-19 Pandemic: A WHF Policy Brief.

The Coronavirus Disease 2019, commonly referred to as COVID-19, is responsible for one of the deadliest pandemics in human history. The direct, indirect and lasting repercussions of the COVID-19 pandemic on individuals and public health, as well as health systems can still be observed, even today. In the midst of the initial chaos, the role of tobacco as a prognostic factor for unfavourable COVID-19 outcomes was largely neglected. As of 2023, numerous studies have confirmed that use of tobacco, a leading risk factor for cardiovascular and other diseases, is strongly associated with increased risks of severe COVID-19 complications (e.g., hospitalisation, ICU admission, need for mechanical ventilation, long COVID, etc.) and deaths from COVID-19. In addition, evidence suggests that COVID-19 directly affects multiple organs beyond the respiratory system, disproportionately impacting individuals with comorbidities. Notably, people living with cardiovascular disease are more prone to experiencing worse outcomes, as COVID-19 often inherently manifests as thrombotic cardiovascular complications. As such, the triad of tobacco, COVID-19 and cardiovascular disease constitutes a dangerous cocktail. The lockdowns and social distancing measures imposed by governments have also had adverse effects on our lifestyles (e.g., shifts in diets, physical activity, tobacco consumption patterns, etc.) and mental well-being, all of which affect cardiovascular health. In particular, vulnerable populations are especially susceptible to tobacco use, cardiovascular disease and the psychological fallout from the pandemic. Therefore, national pandemic responses need to consider health equity as well as the social determinants of health. The pandemic has also had catastrophic impacts on many health systems, bringing some to the brink of collapse. As a result, many health services, such as services for cardiovascular disease or tobacco cessation, were severely disrupted due to fears of transmission and redirection of resources for COVID-19 care. Unfortunately, the return to pre-pandemic levels of cardiovascular disease care activity has stagnated. Nevertheless, digital solutions, such as telemedicine and apps, have flourished, and may help reduce the gaps. Advancing tobacco control was especially challenging due to interference from the tobacco industry. The industry exploited lingering uncertainties to propagate misleading information on tobacco and COVID-19 in order to promote its products. Regrettably, the links between tobacco use and risk of SARS-CoV-2 infection remain inconclusive. However, a robust body of evidence has, since then, demonstrated that tobacco use is associated with more severe COVID-19 illness and complications. Additionally, the tobacco industry also repeatedly attempted to forge partnerships with governments under the guise of corporate social responsibility. The implementation of the WHO Framework Convention on Tobacco Control could address many of the aforementioned challenges and alleviate the burden of tobacco, COVID-19, and cardiovascular disease. In particular, the implementation of Article 5.3 could protect public health policies from the vested interests of the industry. The world can learn from the COVID-19 pandemic to better prepare for future health emergencies of international concern. In light of the impact of tobacco on the COVID-19 pandemic, it is imperative that tobacco control remains a central component in pandemic preparedness and response plans.

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.

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.

Changes in prevalence and socioeconomic inequalities in secondhand smoke exposure in Spanish children, 2016-2019.

INTRODUCTION: Children are vulnerable to secondhand smoke (SHS) exposure, especially those with lower socioeconomic status. This study assesses the changes in prevalence and socioeconomic inequalities in SHS exposure in children younger than 12 years old in Spain between 2016 and 2019. METHODS: We conducted two cross-sectional studies among representative samples of households with children aged <12 years in Spain, in 2016 (n=2411) and 2019 (n=2412). Families were interviewed to assess children's SHS exposure in private settings and outdoor public venues and their adoption of home and car smoke-free rules. We used the education level of the home main earner as a proxy for socioeconomic position. Changes over time in the prevalence and socioeconomic inequalities of SHS exposure and smoke-free rules were estimated through adjusted Poisson regression models with robust variance according to sociodemographic covariates (adjusted prevalence ratios, APRs). RESULTS: In 2019, 70.5% of children were exposed to SHS in Spain. No changes between 2016 and 2019 were found for overall SHS exposure, exposure at home, and at school entrances. SHS exposure increased at public transport stations (APR=1.24; 95% CI: 1.03-1.49) and outdoor hospitality venues (APR=1.17; 95% CI: 1.07-1.29) while it decreased in cars (APR=0.74; 95% CI: 0.56-0.98) and parks (APR=0.87; 95% CI: 0.77-0.98). Households with lower education level had higher prevalence of SHS exposure at home in 2019 compared with those with university studies (primary: APR=1.30; 95% CI: 1.11-1.51; secondary: APR=1.12; 95% CI: 1.00-1.25) and were less likely to adopt home indoor smoke-free rules (primary: APR=0.88; 95% CI: 0.79-0.99; secondary: APR=0.95; 95% CI: 0.89-1.02). Socioeconomic inequalities in SHS exposure at home persisted between 2016 and 2019 (p>0.05), while decreased in smoke-free rules in cars (p=0.039). CONCLUSIONS: Reported SHS exposure among children in Spain remained high between 2016 and 2019. Inequalities persisted at home, highlighting the need for measures to reduce such exposure with an equity perspective.

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.

Early life exposure to secondhand tobacco smoke and eating behaviors at age 12 years.

BACKGROUND: Prenatal or early childhood secondhand tobacco smoke (SHS) exposure increases obesity risk. However, the potential mechanisms underlying this association are unclear, but obesogenic eating behaviors are one pathway that components of SHS could perturb. Our aim was to assess associations of prenatal and early childhood SHS exposure with adolescent eating behaviors. METHODS: Data came from a prospective pregnancy and birth cohort (N = 207, Cincinnati, OH). With multiple informant models, we estimated associations of prenatal (mean of 16 and 26 weeks of gestation maternal serum cotinine concentrations) and early childhood cotinine (average concentration across ages 12, 24, 36, and 48 months) with eating behaviors at age 12 years (Child Eating Behaviors Questionnaire). We tested whether associations differed by exposure periods and adolescent's sex. Models adjusted for maternal and child covariates. RESULTS: We found no statistically significant associations between cotinine measures and adolescent's eating behaviors. Yet, in females, prenatal cotinine was associated with greater food responsiveness (ß: 0.23; 95% CI: 0.08, 0.38) and lower satiety responsiveness (ß: -0.14; 95% CI: -0.26, -0.02); in males, prenatal and postnatal cotinine was related to lower food responsiveness (prenatal: ß: -0.25; 95% CI: -0.04, -0.06; postnatal: ß: -0.36; 95% CI: -0.06, -0.11). No significant effect modification by sex or exposure window was found for other eating behaviors. CONCLUSION: Prenatal and early childhood SHS exposures were not related to adolescent's eating behavior in this cohort; however, biological sex may modify these associations.

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.

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.

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.

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.

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.

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.

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.

[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.