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.

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.

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.

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.

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.

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.

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.

Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov.

BACKGROUND: Complete and timely publication of clinical trials ensures that patients and the medical community are fully informed when making treatment decisions. The aim of this study is to assess the publication of phase III and IV clinical trials on multiple sclerosis (MS) drugs that have been carried out between 2010 and 2019 and to identify the factors associated with their publication in peer-reviewed journals. METHODS: An advanced search in ClinicalTrials.gov was performed and consecutive searches in PubMed, EMBASE and Google Scholar were conducted looking for the associated publications of all completed trials. Study design characteristics, results and other relevant information were extracted. Data was analysed following a case-control design. Clinical trials with associated publications in peer-reviewed journals were the cases and unpublished trials were the controls. A multivariate logistic regression analysis was performed to identify factors associated with trial publication. RESULTS: One hundred and fifty clinical trials were included in the analysis. Ninety-six of them (64.0%) were published in peer-reviewed journals. In the multivariate analysis, factors associated with trial publication were a favourable primary outcome (OR 12.49, 95% CI 1.28 to 122.29) and reaching the originally estimated sample size (OR 41.97, 95% CI 1.96 to 900.48), while those associated with a lower odds of publication were having 20% or more patients lost to follow-up (OR 0.03, 95% CI 0.01 to 0.52) and evaluating drugs intended to improve treatment tolerability (OR 0.01, 95% CI 0.00 to 0.74). CONCLUSIONS: Phase III and IV clinical trials on MS drugs are prone to under-reporting and publication bias. Efforts must be made to promote a complete and accurate dissemination of data in MS clinical research.

Radon exposure and its influencing factors across 3,140 workplaces in Spain.

Indoor radon exposure increases the risk of lung cancer. Radon concentration in workplaces is regulated in EU countries, including Spain, based on a reference level of 300 Bq/m3. The objective of this study is to describe workplace radon exposure in Spain and its influencing factors. To do this, we collected long-term radon measurements with alpha track detectors in 3140 workplaces mainly located in radon prone areas. Radon concentration exceeded 300 Bq/m3 in 1 out of 5 workplaces. Median radon concentration was 107 Bq/m3 in radon prone areas, 28 Bq/m3 off radon prone areas, and 101 Bq/m3 globally for the complete sample. Our results indicate that excessive radon concentrations can be expected in radon prone areas at all floor levels, especially below ground. Floor level, working sector, and location significantly influence radon concentration. The highest radon concentrations were found in the Education & Culture sector, comprising schools, universities, libraries, or cultural centers. These results indicate that radon should no longer be considered a risk for marginal occupations, but a risk everyone has if located in a radon prone area. Immediate action, including radon testing and mitigation, is needed to protect workers in Spain against radon exposure. This is already mandatory since EU regulation for radon has been recently transposed in Spain. Competent authorities should enforce this regulation without further delay, and employers must address their responsibility and communicate with workers about this risk.

Occupational exposure to respirable crystalline silica and lung cancer: a systematic review of cut-off points.

BACKGROUND: Respirable crystalline silica (RCS) is associated with the development of lung cancer. However, there is uncertainty around the exposure threshold at which exposure to RCS may pose a clear risk for the development of lung cancer. The objective of this study was to review the cut-off points at which the risk of mortality or incidence of lung cancer due to occupational exposure to RCS becomes evident through a systematic review. METHODS: We conducted a search in PubMed, including cohort and case-control studies which assessed various categories of RCS exposure. A search was also conducted on the webpages of institutional organizations. A qualitative data synthesis was performed. RESULTS: Twenty studies were included. Studies that assessed lung cancer mortality and incidence displayed wide variability both in RCS exposure categories and related risks. Although most studies found no significant association for RCS exposure categories, it appears to be a low risk of lung cancer for mean concentrations of less than 0.07mg/m3. Regulatory agencies set annual RCS exposure limits ranging from 0.025mg/m3 through 0.1mg/m3. CONCLUSIONS: There is a wide degree of heterogeneity in RCS exposure categories, with most studies observing no significant risk of lung cancer for the lowest exposure categories. Cut-off points differ between agencies but are nonetheless very similar and do not exceed 0.1mg/m3.

Maternal smoking in pregnancy and blood pressure during childhood and adolescence: a meta-analysis.

Arterial hypertension during childhood or adolescence is rising, and smoking during pregnancy may constitute a modifiable risk factor. This study aims to evaluate the effect of maternal smoking during pregnancy on diastolic (DBP) and systolic blood pressure (SBP) in childhood and adolescence. A bibliographic search was conducted in PubMed, Embase, and CENTRAL databases in March 2022. Meta-analysis was performed with the difference in mean-adjusted SBP/DBP of children and adolescents aged 3-17 years, according to maternal smoking/non-smoking in pregnancy. A random effects model was applied; a leave-one-out analysis and meta-analysis by subgroups were performed. A modified Newcastle-Ottawa scale was used to assess the quality of the studies. Evidence levels were rated using the GRADE system. Fifteen studies were included in the meta-analysis; all of them evaluated the mean-adjusted SBP difference in children or adolescents (N = 73,448), and 6 also that of DBP (N = 31,459). Results showed that maternal smoking during pregnancy significantly increased SBP (ß = 0.31 mmHg 95% CI 0.14-0.49). A greater increase in mean-adjusted SBP was observed in those studies that completed the recruitment before 1990, were conducted in non-European countries, used standard mercury or manual sphygmomanometry, adjusted for birth weight, and were in the lowest quality subgroup. No significant association was found for DBP. The GRADE level of evidence was low for SBP and very low for DBP. CONCLUSION: Smoking in pregnancy might increase SBP in childhood and adolescence. Due to the low level of evidence, solid inferences cannot be drawn about the clinical relevance of these findings. WHAT IS KNOWN: • AHT is the leading cause of premature death among adults worldwide. • Deleterious effects derived from SHS exposure on children's health have been documented since early 1970. To date, there are contradictory results about the effects of prenatal SHS exposure on children's BP. WHAT IS NEW: • Smoking in pregnancy may increase SBP during childhood and adolescence. • Maternal smoking during pregnancy could have greater influence on their offspring's SBP than on DBP.

Asbestos exposure and small cell lung cancer: Systematic review and meta-analysis.

Asbestos is a mineral that is carcinogenic to humans. Its use has been banned in many occidental countries yet it is still produced in the United States, and materials that contain asbestos remain in many occupational settings and indoor environments. Even though asbestos carcinogenicity is well known, there is scant literature on its specific effects regarding small cell lung cancer (SCLC). We therefore conducted a systematic review and meta-analysis to determine SCLC risk among workers exposed to asbestos. A systematic search of the literature was conducted to identify studies which reported occupational exposure to asbestos and SCLC-related deaths and/or incidence. We identified seven case-control studies that included 3,231 SCLC cases; four studies reported smoking-adjusted risks. A significantly increased risk of SCLC (pooled OR 1.89; 95% CI, 1.25-2.86) was observed on pooling studies on men (six studies) that displayed moderate heterogeneity (I2 = 46.0%). Overall, our synthesis suggests that occupational exposure to asbestos significantly increases the risk of SCLC on men.

[Considerations for the design and implementation of interventions for the cessation of tobacco, alcohol and cannabis use in pregnancy: A qualitative study]. / 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.

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.

[Physical activity during pregnancy and postpartum: prevalence and healthcare professionals recommendations]. / Actividad física en el embarazo y puerperio: prevalencia y recomendaciones de los profesionales sanitarios.

OBJECTIVE: To assess changes in physical activity (PA) during pregnancy and after giving birth and to explore this according to age and educational level. To analyze whether the health professionals gave recommendations on PA. DESIGN: Observational study. SITE: Information is derived from the Galician Risk Behavior Information System. PARTICIPANTS: The target population was Galician women (aged 18-49 years) who delivered between september-2015 and august-2016. MAIN MEASUREMENTS: The prevalence of walking, physical exercise and PA recommendations were estimated for three moments (pre-pregnancy, pregnancy and after delivery). RESULTS: Walking during pregnancy increased by 34,0% and the performance of physical exercise decreased by 21,0%. After delivery, walking decreased by 37,0% and physical exercise decreased by 32,0% compared to pregnancy. Women of younger age and lower educational level were those who performed less PA. 72,6% and 22,1% of women declared that a healthcare professional recommended PA during pregnancy and after delivery, respectively. CONCLUSION: The PA performed by women during pregnancy is mainly walking, and there is a concern about the abandonment of PA practice after delivery. Healthcare professionals recommend PA mainly during pregnancy, but little is recommended after delivery. It may be desirable for the improvement of this prevalence to reinforce health action.

Smoking-attributable mortality in Spain: A systematic review. / Mortalidad atribuida al consumo de tabaco en España: Revisión sistemática.

Smoking-attributable mortality (SAM) is an indicator that reflects the evolution of the tobacco epidemic at the population level. The objective of this study is to identify and to describe published studies that have estimated SAM in Spain. A search in PubMed and EMBASE databases was performed, limited to studies published until April 15th, 2021. Studies that estimated SAM in Spain or its constituent regions were included. Of the 146 studies identified, 22 met eligibility criteria. The first estimate of SAM in Spain dates from 1978 and the last from 2017. Twelve of the studies found estimated SAM at national level, 8 in regions, 1 in a province and 1 in a city. Most estimates were made for adults aged over 34, categorized as smokers, ex-smokers and never smokers. Observed mortality derived, in all studies, from official records, and relative risks mostly from Cancer Prevention Study II. In the period analyzed, a decrease in the burden of SAM was observed. In Spain, different SAM estimates are available globally, but they do not have regular periodicity, and such estimates are infrequently made by region. Due to variations in methodology and data sources, it is difficult to assess changes in SAM. Having global and regional periodic estimates would be necessary to correctly monitor the tobacco epidemic in Spain.

La mortalidad atribuida (MA) al consumo de tabaco es un indicador que refleja la evolución de la epidemia tabáquica a nivel poblacional. El objetivo de este trabajo es identificar y describir los estudios publicados que hayan estimado MA al consumo de tabaco en España. Se realizó una búsqueda en las bases de datos de PubMed y EMBASE de los trabajos publicados hasta el 15/04/2021. Se incluyeron estudios que estimaron MA en España en su conjunto o en unidades territoriales. Se identificaron 146 estudios y 22 cumplieron los criterios de elegibilidad. La primera estimación de MA en España data de 1978 y la última de 2017. En 12 estudios se estimó la MA a nivel nacional, 8 en comunidades autónomas, 1 a nivel provincial y 1 en una ciudad. La mayoría de estimaciones se realizaron en adultos mayores de 34 años categorizados como fumadores, exfumadores y nunca fumadores. La mortalidad observada derivó en todos los estudios de registros oficiales y los riesgos relativos mayoritariamente del Cancer Prevention Study II. En el periodo analizado se observó una disminución en la carga de MA en relación con la mortalidad total. En España se dispone de estimaciones de MA a nivel global, pero no tienen periodicidad regular y es infrecuente que se realicen en unidades territoriales. Debido a variaciones en la metodología y en las fuentes de datos es difícil evaluar de forma precisa cambios en la MA. Sería necesario disponer de estimaciones periódicas globales y regionales para monitorizar correctamente la epidemia tabáquica en España.

Cannabis use in adult population in Galicia: Prevalence and associated characteristics. / Consumo de cannabis en población adulta en Galicia: Prevalencias y características asociadas.

Cannabis is the most widely consumed illegal drug in Spain, with consumption concentrated mainly in adolescence and early adulthood. The objectives were to estimate the prevalence of cannabis use, cannabis use disorder (CUD) and dependent use in the Galician population aged 16 years and over, and to characterize cannabis users and cannabis dependent users. Data are from two cross-sectional studies from the Risk Behavior Information System conducted in 2017 (n = 7,841) and 2018 (n = 7,853). The Cannabis Abuse Screening Test (CAST) was used to identify users with CUD and/or dependent use. Prevalences were estimated and regression models were fitted to identify variables associated with cannabis use and dependent use. In 2017-2018, 2.7% (95% CI: 2.5-3.0) of the Galician population aged 16 years and over consumed cannabis at the time of the survey, with this prevalence being 9% in the 16-24 years age group. Prevalence decreased with age and was higher in males in all age groups. The prevalence of CUD in users was 69.5% (95% CI 61.1-78.1) and of dependent use it was 49.2% (95% CI 46.6-53.9). Tobacco use was the major determinant of being a cannabis user [OR = 19.8 (95% CI 13.8-28.4)] and daily cannabis use of being a dependent user [OR = 5.5 (95% CI 3.2-9.5)]. Cannabis use among the Galician population is high, especially among young people aged 16-24 years, who show the highest probability of dependent use. Prevention measures should be aimed especially at the younger population aged 16 years to curb its use and the development of consequences such as CUD and dependent use.

El cannabis es la droga ilegal más consumida en España con un consumo que se concentra principalmente en la adolescencia y primeros años de la edad adulta. Los objetivos de este estudio fueron estimar la prevalencia de consumo de cannabis, de trastorno por consumo de cannabis (CUD) y de consumo dependiente (CD) en la población gallega ≥16 años y caracterizar a los consumidores y a los consumidores dependientes. Los datos proceden de dos estudios transversales del Sistema de Información sobre Conductas de Riesgo realizados en 2017 (n = 7.841) y 2018 (n = 7.853). Se utilizó el test de adicción al cannabis (CAST) para identificar a los consumidores con CUD y/o CD. Se estimaron prevalencias y se ajustaron modelos de regresión para identificar variables asociadas al consumo y CD de cannabis.  El 2,7% (IC 95%: 2,5-3,0) de la población gallega ≥16 años consumía cannabis en el momento de la encuesta (2017-2018), siendo esta prevalencia del 9% en el grupo de 16-24 años. La prevalencia disminuye con la edad y es superior en hombres en todos los grupos etarios. La prevalencia de CUD en los consumidores fue del 69,5% (IC 95% 61,1-78,1) y de CD del 49,2% (IC 95% 44,6 -53,9). Consumir tabaco es el mayor determinante para ser consumidor de cannabis [OR = 19,8 (IC 95% 13,8-28,4)] y consumir diariamente cannabis para ser consumidor dependiente [OR = 5,5 (IC 95% 3,2-9,5)]. El consumo de cannabis entre la población gallega es bajo, aunque entre los jóvenes de 16-24 años, que son los que muestran más probabilidad de CD, la prevalencia es elevada. Las medidas de prevención deben dirigirse especialmente a la población más joven de 16 años para frenar su consumo y el desarrollo de consecuencias como el CUD y el CD.

Home-based blood transfusion therapy: A systematic review.

Home care is a healthcare alternative to hospitalisation. Different types of procedures are performed at home care services, such as home transfusion of blood products. However, home blood transfusion is not fully implemented and there is a great lack of knowledge about it. The aims of this study were thus to assess the safety and effectiveness of home blood transfusions and patient acceptance and satisfaction. A systematic literature review was conducted in the main biomedical databases. We included all studies that covered patients who had received a home blood transfusion, regardless of their baseline diagnosis. The literature search yielded 290 studies, 14 of which were included in this study as they met the predefined criteria. The main patient profile of a home-transfusion recipient was a person with anaemia associated with other diseases. Overall incidence of severe adverse events was 0.05%. No studies evaluated the effectiveness of home versus hospital transfusions. One study showed that 51% of patients would be willing to receive home transfusions. Home blood transfusion appears to be a feasible, safe, and well-accepted procedure. Existing studies are of low quality, however, and this is an important limitation when it comes to drawing definitive benefit-risk conclusions.

Fruits and Vegetables and Lung Cancer Risk in Never Smokers. A Multicentric and Pooled Case-Control Study.

BACKGROUND: The etiology of lung cancer in never smokers is partly unknown. We aimed to assess the effect of fruits and vegetables consumption on lung cancer risk in never smokers. METHODS: We pooled five multicenter case-control studies performed in Northwestern Spain. Cases and controls were all never smokers. All lung cancer cases had anatomopathological confirmed diagnoses. We performed a multivariate logistic regression to analyze the effect of different types of fruits and vegetables consumption on lung cancer risk. RESULTS: A total of 438 cases and 781 controls were included. We observed that a consumption from one to six times per week shows a negative association with lung cancer risk for: kiwis (OR 0.67; 95%CI 0.46-0.95), oranges (OR 0.55; 95%CI 0.37-0.80), turnip tops (OR 0.48; 95%CI 0.34-0.66), "berza gallega" (OR 0.70; 95%CI 0.51-0.97) and broccoli (OR 0.55; 95%CI 0.35-0.83) compared to less than once a week consumption. On the other hand, we found an increased risk for lung cancer with a daily consumption of tomatoes, carrots and potatoes. CONCLUSIONS: Oranges, kiwis, turnip tops, berza gallega and broccoli may play a protective role on lung cancer development in never smokers while tomatoes, carrots and potatoes might have some association with this disease.

Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology-Based Tool to Support and Review Registries.

OBJECTIVES: Health technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the "Registry Evaluation and Quality Standards Tool" (REQueST). METHODS: REQueST was developed in 4 steps: (1) A partnership between HTA bodies across Europe drafted the assessment criteria. (2) Multiple rounds of consultation across HTA bodies and the public domain developed an Excel version of REQueST. (3) This version was transformed into a web-based application. (4) An external pilot tested this REQueST tool with SMArtCARE and NeuroTransData registries. RESULTS: Haute Autorité de Santé, the National Institute for Health and Care Excellence, and the Croatian Institute of Public Health led the development of REQueST. Another 4 HTA bodies contributed regularly to development meetings, and all European Network for Health Technology Assessment partners were invited to contribute. Eight methodological, 12 essential, and 3 supplementary criteria were identified. Both pilot registries scored well, fulfilling the requirements for >70% of criteria, with none failed. Feedback by registry holders led to streamlining of the process and clarification of the criteria. CONCLUSIONS: The REQueST tool uses an iterative and collaborative methodology with registry holders. It has the potential to maximize the utility of registry data for decision making by regulatory and HTA bodies and provides a foundation for future research.

Trends in smoking-attributable mortality in Spain: 1990-2018.

BACKGROUND: This study sought to analyse the trend in smoking-attributable mortality (SAM) in Spain among the population aged ≥35 years across the period 1990-2018. METHODS: SAM was estimated by applying a prevalence-independent method, which uses lung cancer (LC) mortality as a proxy of tobacco consumption. We sourced observed mortality from the National Institute of Statistics (Spain), LC mortality rates in smokers and never smokers from the Cancer Prevention Study I-II, and relative risks from 5 US cohorts. Estimates of annual SAM by cause of death, sex and age are shown, along with crude and annual standardised SAM rates. The trend in standardised all-cause and LC rates was analysed using a joinpoint regression model. RESULTS: Tobacco caused 1 717 150 deaths in Spain in the period 1990-2018. Among men, cancers replaced cardiovascular diseases-diabetes mellitus (CVD-DM) as the leading group of tobacco-related cause of death in 1994. Among women, CVD-DM remained the leading cause of death throughout the period. Trend analysis of standardised SAM rates due to all causes and LC showed a decrease in men and an increase in women. CONCLUSIONS: The tobacco epidemic in Spain across the period 1990-2018 has had an important impact on mortality and has evolved differently in both genders. SAM is expected to increase dramatically in women in the coming years. SAM data highlight the importance of including a gender perspective in SAM analyses, in designing more effective and comprehensive public health interventions and in developing gender-specific tobacco control policies to curb tobacco consumption.