Chronic toxicity and long-term outcome in intraoperative electron radiotherapy as boost followed by whole-breast irradiation

Purpose The administration of a dose boost to the tumor bed after breast-conserving surgery has proven to reduce local recurrence. Intra-operative electron radiotherapy (IOERT) offers an alternative method to deliver a boost with several advantages, such as direct visualization of the tumor bed, less inter- and intrafraction motion and a reduction in the number of medical appointments. The objective of our study is to assess chronic toxicity and long-term outcome for our patients after IOERT boost. Material and methods Forty-six patients treated at our institution between July 2013 and June 2020 with IOERT boost during Breast-Conserving Surgery and consecutive whole breast irradiation were prospectively analyzed. A 10–12 Gy boost was prescribed to 42 patients and 4 patients received a 20 Gy boost. An analysis for overall survival, local relapse and distant progression was performed. Acute and chronic toxicity was assessed by CTCAE 4.0. Results The median age was 64.5 years (40–90). The median follow-up was 62 months (4–86). We had no local recurrences but 2 patients (4.3%) presented a distant recurrence. Mean pathological tumor size was 16 mm (6–52). 84.8% (39) of the patients had invasive ductal carcinoma. 52.2% (24) presented histological grade II. 52.2% (24) were Luminal A like, 21.7% (10) Luminal B like, 13% (6) HER2 positive, 13% (6) triple negative. No Grade 3–4 chronic toxicity was observed. Grade 1–2 fibrosis was evidenced in 13% (6) of the patients, 4.3% (2) patients presented fat necrosis, 6.5% (3) presented seroma, 4.3% (2) had localized pain, 2.2% (1) presented localized hematoma and 2.2% (1) presented localized edema. Conclusions IOERT boost in breast cancer treatment during BCS is a safe option with low chronic toxicity. The recurrence rates are comparable to published data and emphasize that IOERT as boost is an effective treatment (AU)

Chronic toxicity and long-term outcome in intraoperative electron radiotherapy as boost followed by whole-breast irradiation.

PURPOSE: The administration of a dose boost to the tumor bed after breast-conserving surgery has proven to reduce local recurrence. Intra-operative electron radiotherapy (IOERT) offers an alternative method to deliver a boost with several advantages, such as direct visualization of the tumor bed, less inter- and intrafraction motion and a reduction in the number of medical appointments. The objective of our study is to assess chronic toxicity and long-term outcome for our patients after IOERT boost. MATERIAL AND METHODS: Forty-six patients treated at our institution between July 2013 and June 2020 with IOERT boost during Breast-Conserving Surgery and consecutive whole breast irradiation were prospectively analyzed. A 10-12 Gy boost was prescribed to 42 patients and 4 patients received a 20 Gy boost. An analysis for overall survival, local relapse and distant progression was performed. Acute and chronic toxicity was assessed by CTCAE 4.0. RESULTS: The median age was 64.5 years (40-90). The median follow-up was 62 months (4-86). We had no local recurrences but 2 patients (4.3%) presented a distant recurrence. Mean pathological tumor size was 16 mm (6-52). 84.8% (39) of the patients had invasive ductal carcinoma. 52.2% (24) presented histological grade II. 52.2% (24) were Luminal A like, 21.7% (10) Luminal B like, 13% (6) HER2 positive, 13% (6) triple negative. No Grade 3-4 chronic toxicity was observed. Grade 1-2 fibrosis was evidenced in 13% (6) of the patients, 4.3% (2) patients presented fat necrosis, 6.5% (3) presented seroma, 4.3% (2) had localized pain, 2.2% (1) presented localized hematoma and 2.2% (1) presented localized edema. CONCLUSIONS: IOERT boost in breast cancer treatment during BCS is a safe option with low chronic toxicity. The recurrence rates are comparable to published data and emphasize that IOERT as boost is an effective treatment.

Challenges to Detecting and Addressing Intimate Partner Violence Among Roma Women in Spain: Perspectives of Primary Care Providers.

The objective of this study is to identify challenges and facilitators for detecting and addressing cases of intimate partner violence (IPV) against Roma women, from the perspectives of health personnel and representatives of Roma organizations, and to compare both perspectives. A total of 28 semi-structured interviews were carried out between November 2014 and February 2015 in different Spanish cities. A thematic analysis was carried out, guided by Aday and Andersen's model regarding barriers to access to health services. Both groups signaled the following as principal challenges: (a) consideration of IPV as a private problem among the Roma population, (b) little use of primary care providers for prevention, (c) distrust of Roma women toward primary care professionals as resources for seeking help, (d) the inexistence of Roma professionals in health services, (e) health professionals' lack of cultural sensitivity related to Roma people, and (f) the focus of health protocols for action against IPV on filing a police report. Potential facilitating factors included Roma women's trust in nurses, social workers, and pediatricians and ethnic heterogeneity. There is need to promote action to address the identified challenges through a health equity approach that includes greater training and awareness raising among health professionals about Roma culture and the specific needs of Roma women.

PositivMasc: masculinities and violence against women among young people. Identifying discourses and developing strategies for change, a mixed-method study protocol.

INTRODUCTION: Despite public policies and legislative changes aiming to curtail men's violence against women (VAW) around the world, women continue to be exposed to VAW throughout their life. One in three women in Europe has reported physical or sexual abuse. Men who display unequitable masculinities are more likely to be perpetrators. VAW is increasingly appearing at younger ages. The aims of the project are fourfold: (1) to explore and position the discourses that young people (men and women, 18-24 years) in Sweden, Spain, Ireland and Israel use in their understanding of masculinities, (2) to explore how these discourses influence young people's attitudes, behaviours and responses to VAW, (3) to explore individual and societal factors supporting and promoting anti-VAW masculinities discourses and (4) to develop actions and guidelines to support and promote anti-VAW masculinities in these settings. METHODS AND ANALYSIS: A participatory explorative mixed-method study will be used. In Phase 1, qualitative methods will be used to identify the discourses that young people and stakeholders use to conceptualise masculinities, VAW and the actions that are needed to support and promote antiviolence masculinities. In Phase 2, concept mapping will be used to quantify the coherence, relative importance and perceived relationship between the different actions to support and promote anti-VAW masculinities. Phase 3 is a knowledge creation and translation phase, based on findings from Phases 1 and 2, where actions and guidelines to promote and support anti-VAW masculinities will be developed. ETHICS AND DISSEMINATION: Ethical clearance has been obtained from ethics review boards in each country. Results will be disseminated through peer-reviewed publications, presentations at international conferences, policy briefs, social media and through the project online hub. With its multicountry approach, our project results seek to inform policies and interventions aimed at promoting discourses which challenge hegemonic masculinities.

Lights4Violence: a quasi-experimental educational intervention in six European countries to promote positive relationships among adolescents.

BACKGROUND: Preventing intimate partner violence or dating violence (DV) among adolescents is a public health priority due to its magnitude and damaging short and long-term consequences for adolescent and adult health. In our study protocol, we complement prior experiences in DV prevention by promoting protective factors (or assets) against gender violence such as communication skills, empathy and problem-solving capability through "Cinema Voice", a participatory educational intervention based on adolescents' strengths to tackle DV. METHODS/DESIGN: A longitudinal quasi-experimental educational intervention addressed to boys and girls ages 13-17 years, enrolled in secondary education schools in Alicante (Spain), Rome (Italy), Cardiff (UK), Iasi (Romania), Poznan (Poland) and Matosinhos (Portugal). Both process and results evaluations will be carried out with 100-120 intervention and 120-150 control group students per city at three time periods: before, after and 6 months after the implementation of the following interventions: 1) Training seminar with teachers to promote knowledge and skills on the core issues of intervention; 2) Workshops with intervention groups, where participants produce their own digital content presenting their perspective on DV; and 3) Short film exhibitions with participants, their families, authorities and other stakeholders with the objective of share the results and engage the community. Outcome measures are self-perceived social support, machismo, sexism, tolerance towards gender violence, social problem-solving and assertiveness as well as involvement in bullying/cyberbullying. Other socio-demographic, attitudes and violence-related co-variables were also included. DISCUSSION: This study may provide relevant information about the effectiveness of educational interventions that combine a positive youth development framework with educational awareness about the importance of achieving gender equality and preventing and combating gender violence. To our knowledge, this is the first study that involves six European countries in an educational intervention to promote violence protective assets among enrolled adolescents in secondary schools. This study may provide the needed tools to replicate the experience in other contexts and other countries. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03411564 . Unique Protocol ID: 776905. Date registered: 18-01-2018.

No effect of unemployment on intimate partner-related femicide during the financial crisis: a longitudinal ecological study in Spain.

BACKGROUND: Spain's financial crisis has been characterized by an increase in unemployment. This increase could have produced an increase in deaths of women due to intimate partner-related femicides (IPF). This study aims to determine whether the increase in unemployment among both sexes in different regions in Spain is related to an increase in the rates of IPF during the current financial crisis period. METHODS: An ecological longitudinal study was carried out in Spain's 17 regions. Two study periods were defined: pre-crisis period (2005-2007) and crisis period (2008-2013). IPF rates adjusted by age and unemployment rates for men and women were calculated. We fitted multilevel linear regression models in which observations at level 1 were nested within regions according to a repeated measurements design. RESULTS: Rates of unemployment have progressively increased in Spain, rising above 20 % from 2008 to 2013 in some regions. IPF rates decreased in some regions during crisis period with respect to pre-crisis period. The multilevel analysis does not support the existence of a significant relationship between the increase in unemployment in men and women and the decrease in IPF since 2008. DISCUSSION: The increase in unemployment in men and women in Spain does not appear to have an effect on IPF. The results of the multilevel analysis discard the hypothesis that the increase in the rates of unemployment in women and men are related to an increase in IPF rates. CONCLUSIONS: The decline in IPF since 2008 might be interpreted as the result of exposure to other factors such as the lower frequency of divorces in recent years or the medium term effects of the integral protection measures of the law on gender violence that began in 2005.

Social determinants of self-perceived discrimination in Spain.

OBJECTIVES: To analyse the association between self-perceived discrimination and social determinants (social class, gender, country of origin) in Spain, and further to describe contextual factors which contribute to self-perceived discrimination. METHODS: Cross-sectional design using data from the Spanish National Health Survey (2006). The dependent variable was self-perceived discrimination, and independent and stratifying variables were sociodemographic characteristics (e.g. sex, social class, country of origin, educational level). Logistic regression was used. RESULTS: The prevalence of self-perceived discrimination was 4.2% for men and 6.3% for women. The likelihood of self-perceived discrimination was higher in people who originated from low-income countries: men, odds ratio (OR) 5.59 [95% confidence interval (CI) 4.55-6.87]; women, OR 4.06 (95% CI 3.42-4.83). Women were more likely to report self-perceived discrimination by their partner at home than men [OR 8.35 (95% CI 4.70-14.84)]. The likelihood of self-perceived discrimination when seeking work was higher among people who originated from low-income countries than their Spanish counterparts: men, OR 13.65 (95% CI 9.62-19.35); women, OR 10.64 (95% CI 8.31-13.62). In comparison with Spaniards, male white-collar workers who originated from low-income countries [OR 11.93 (95% CI 8.26-17.23)] and female blue-collar workers who originated from low-income countries (OR 1.6 (95% CI 1.08-2.39)] reported higher levels of self-perceived discrimination. CONCLUSIONS: Self-perceived discrimination is distributed unevenly in Spain and interacts with social inequalities. This particularly affects women and immigrants.

Análisis de los costes y la efectividad del uso de cilostazol frente a naftidrofurilo y pentoxifilina en el tratamiento de la claudicación intermitente en España / Cost-effectiveness analysis of cilostazol vs naftidrofuryl and pentoxifylline for the treatment of intermittent claudication in Spain

Introducción: El cilostazol es un inhibidor reversible de la fosfodiesterasa III que presenta actividad antiagregante plaquetaria y vasodilatadora. El objetivo de este estudio fue estimar las consecuencias clínicas y económicas del uso de cilostazol en comparación con naftidrofurilo y pentoxifilina en el tratamiento de la claudicación intermitente (CI) en España. Métodos: Se ha construido un modelo fármaco económico basado en la literatura para describir el manejo de la CI y sus consecuencias clínicas y económicas para cada opción terapéutica evaluada en pacientes con 40 o más años y una historia de CI sintomática, secundaria a enfermedad vascular periférica de las extremidades inferiores. Los resultados clínicos provienen de una revisión de los ensayos clínicos respectivos. Se utilizaron costes unitarios españoles para medir las consecuencias económicas asociadas al uso de recursos sanitarios a partir de un estudio similar realizado en el Reino Unido. Resultados: Iniciar el tratamiento con cilostazol en lugar de pentoxifilina aumentaría la distancia máxima recorrida en un 72%, reduciendo los costes en un 11,5%. En comparación con naftidrofurilo, cilostazol se asoció a un aumento de la efectividad del 34% y un aumento de los costes sanitarios del 11,2%. Estos resultados suponen que cilostazol, naftidrofurilo y pentoxifilina presentarían ratios de coste por punto porcentual de aumento de la distancia máxima recorrida de 7,8, 9,1 y 14,7 € respectivamente. Conclusiones: Los resultados de este estudio muestran que iniciar tratamiento con cilostazol presenta una relación de costes y efectividad más favorable respecto a otros tratamientos para la CI en España(AU)

Introduction: Cilostazol is a reversible selective inhibitor of phosphodiesterase III which has platelet antiaggregating and vasodilatory activity. The aim of this study was to estimate the clinical and economic consequences of the use of cilostazol compared with naftidrofuryl and pentoxifylline in the treatment of intermittent claudication (IC) in Spain. Methods: A pharmaco economic model was built based on the literature to describe the management of IC and its clinical and economic consequences for each treatment option evaluated in patients 40 years or older with a medical history of symptomatic IC secondary to peripheral vascular disease of the lower extremities. Clinical results were obtained from a review of clinical trials of the comparators. Spanish unit costs were used to measure the economic consequences associated with the use of healthcare resources based on a similar study performed in the UK. Results: Starting treatment with cilostazol instead of pentoxifylline would increase the maximum distance covered by 72%, reducing costs by 11.5%. Compared with naftidrofuryl, cilostazol was associated with an increase in effectiveness of 34% and an increase in healthcare costs of 11.2%. These results mean that cilostazol, naftidrofuryl and pentoxifylline would have a cost, per one percentage point increase of the maximum distance covered, of € 7.8, € 9.1 and € 14.7, respectively. Conclusions: The study results demonstrate that starting treatment with cilostazol has a more favourable cost-effectiveness ratio compared to other treatments for IC in Spain(AU)

The effect of television news items on intimate partner violence murders.

BACKGROUND: This study has been carried out in order to explore the effect of the growing appearance of IPV in television news items on deaths by this cause. METHODS: Ecological study based on 340 deaths by intimate partner violence (IPV) and 3733 television news items covering this topic on Spanish television channels (2003 and 2007). Logistic regression analysis was carried out. Dependent variable: the difference between the number of IPV deaths in the 7 days following a news item broadcast and the number of IPV deaths in the 7 days before a media item. This outcome variable was conceptualised as a binary variable: increase vs. no increase. INDEPENDENT VARIABLES: days with IPV news items-in general, concerning deaths, measures or other IPV crimes. Adjusted variables: day of the week, month, year and public holidays. RESULTS: A small copycat effect was observed in the IPV murder rate (RR = 1.32, CI(95%) = 1.07 - 1.62) for IPV-related news item days compared with days without such news. This effect continued when information about deaths was broadcast (RR = 1.28, CI(95%) = 1.01 - 1.62). News items concerning measures (RR = 0.90, CI(95%) = 0.82 - 0.98) or other IPV crimes (0.84, CI(95%) = 0.82 - 0.98) were related to a lower possibility of an increase in deaths compared with days with death-related news. CONCLUSION: Given the results observed in the case of IPV-related news, there is an evident need to develop a journalistic style guide in order to determine what type of information is recommended due to the potential positive or negative effects.

Alcohol and intimate partner violence: do we have enough information to act?

BACKGROUND: Male alcohol consumption is one of the accepted risk factors for intimate partner violence. The aim of this study is to assess the magnitude of the association between male alcohol consumption and intimate partner violence against women and the quality of the evidence of published papers exploring this relationship empirically. METHODS: Systematic review and meta-analysis of quantitative studies (1966-2004). Eight databases from Social and Behavioural Sciences, Clinical Medicine, and Life Sciences were reviewed. Studies with available 2 x 2 table or odds ratio were analysed using meta-analytic techniques. RESULTS: A total of 22 studies fulfilled the inclusion criteria for the systematic review: 14 (63.6%) were cross-sectional studies, 6 (27.3%) case-series, 2 (9.1%) case-control studies. Ten studies analysed the relationship between alcohol and violence as their primary hypothesis and only two used a direct measure of alcohol consumption. Of them, 11 papers were included in the meta-analysis. The overall pooled odds ratio was 4.57 (95% confidence limits 3.30-6.35), but a high degree of heterogeneity was observed. The magnitude of the effect was inversely associated with the year of publication. The biggest odds ratios were obtained in the studies with the smallest sample sizes. CONCLUSIONS: The evidence about the relationship between alcohol consumption and intimate partner violence is of low quality in the study designs and maybe biased by publication of positive results. Currently there is not enough empirical evidence to support preventive policies based on male alcohol consumption as a risk factor in the particular case of intimate partner violence.

El dolor en procesos traumáticos agudos leves / Pain in mild acute traumatic process

La evaluación de la intensidad del dolor en los pacientes con procesos accidentales continúa planteando un problema, así como las medidas analgésicas empleadas, citándose con frecuencia la baja utilización de procedimientos analgésicos. La limitación en la información es uno de los elementos que con frecuencia afectan la calidad asistencial en urgencias, la utilización de información estructurada podría mejorar la calidad percibida. Método: Estudio de intervención multicéntrico con dos fases en la primera no se modifica la pauta asistencial y en la segunda se introduce una información estructurada. Se realiza seguimiento mediante encuesta telefónica al 3er día. Se utiliza una escala numérica (0-10) para la valoración del dolor. Resultados: Los médicos infraestiman la intensidad del dolor tanto en reposo como al ser manipulada la lesión, en un 28,3% y en un 35,8% de los casos respectivamente. La predicción del dolor a los tres días también está infraestimada en un 24,1%. La capacidad para incorporarse a sus labores habituales está subestimada: se incorporan un 8% más que los estimados. La intervención mejora la calidad percibida aumentando en un 6,5% la valoración superior a la media tras el aporte de información estructurada. Conclusiones: En el estudio se confirma la infraestimación del dolor por parte del médico y las dificultades en la valoración de su evolución. La intervención informativa aplicada mejora la calidad percibida (AU)

Evaluation and management of pain is still one of the emergency department challenges. Often oligoanalgesia is refer with less than optimal care to traumatic patients. Information is one of the weakest part of the process of care provide to urgent cases, on quality assurance evaluation usually ranked as an area of improvement. To improve the quality perception structured information can be of help. Design: Multicenter intervention study, two phases where organized in the first one no modification on the process of care, in the second structured information was provided, and modifications on the patient quality perception was asses trough a telephone enquire. Pain was evaluated by doctors and patients using a numerical scale (0-10). Follow- up at 3º day was done using a phone interview. Results: Doctors underestimated pain evaluated at rest and with manipulation in 28,3% and 35,5% respectively. Third day pain prediction by doctors is also underestimated in 24%. Return to work is also underestimated by 8%. The structured information provided improves de quality perception of management in 6,5%. Conclusions: Underestimation of pain by doctors is confirmed, and difficulties on pain estimation are stress, structure information improves quality perception (AU)

Helicobacter pylori eradication versus one-year maintenance therapy: effect on relapse and gastritis outcome.

OBJECTIVE: The aim of this study was to determine ulcer healing and H. pylori eradication rates obtained with triple therapy (omeprazole, amoxicillin and clarithromycin). Ulcer relapsing rate one year after eradication was also assessed. Maintenance therapy with placebo was compared with ranitidine therapy and the effect of eradication on histological variables of the gastric mucosa was studied. METHODS: A prospective, double-blind parallel study was performed in 85 patients endoscopically diagnosed of duodenal ulcer H. pylori positive. Patients were randomized to a 7-days triple therapy (group A) or omeprazole plus antibiotic placebo (group B). All patients were treated only with omeprazole for the next three weeks. Patients with ulcer healing after treatment were entered in a one-year follow up phase with ranitidine placebo (group A) or ranitidine (group B). Endoscopy and biopsies were performed at baseline, after treatment (5 weeks) and after 12 months of follow-up or when relapsing symptoms appeared. RESULTS: Healing rate was 90.2% in group A and 85.7% in group B. Eradication rate was 78% in group A and 0% in group B. Out of 37 healed patients in group A, eradication was achieved in 29 and only one relapse was found (3.4%). Three out of eight patients with healing but without eradication relapsed at 12 months (35%) (p < 0.05). Histopathological results showed statistically significant differences (p < 0.05) between eradicated and non eradicated patients in terms of severity of inflammation and intestinal metaplasia, but not in terms of atrophy. CONCLUSIONS: H. pylori eradication is useful to prevent ulcer relapse and to improve gastric mucosa status.

Erradicación de helicobacter pylori, versus tratamiento de mantenimiento / Helicobacter pylory eradication versus oneyear maintenance therapy: effect on relapse and gastritis outcome

Objetivo: el objetivo de este estudio fue evaluar las tasas de curación de úlcera y erradicación de H. pylori conseguidas con triple terapia (omeprazol, amoxicilina y claritromicina). También se evaluó la tasa de recidivas tras un año de la erradicación y tratamiento de mantenimiento con placebo comparado con terapia con ranitidina y se evaluó el efecto de la erradicación sobre variables histológicas de la mucosa gástrica. Métodos: se realizó un ensayo clínico, doble ciego y de grupos paralelos con 85 pacientes con úlcera duodenal comprobada endoscópicamente y H. pylori positivos. Los pacientes fueron randomizados a recibir triple terapia durante 7 días (grupo A) u omeprazol más placebo de antibióticos (grupo B). Todos los pacientes fueron tratados con omeprazol durante las tres semanas siguientes. Los pacientes en los que cicatrizó la úlcera entraron en la fase de seguimiento de 1 año de duración con placebo de ranitidina (grupo A) o ranitidina (grupo B). Se realizaron endoscopias y biopsias al inicio, tras el tratamiento erradicador (a las 5 semanas) y a los 12 meses de seguimiento o cuando aparecieran síntomas de recidiva. Resultados: la tasa de curación fue del 90,2 por ciento en el grupo y del 85,7 por ciento en el grupo B. La tasa de erradicación fue del 78 por ciento en el grupo A y del 0 por ciento en el grupo B. Entre los 37 pacientes del grupo A que cicatrizaron la úlcera, 29 habían sido erradicados y sólo uno recidivó (3,4 por ciento). Tres de los 8 pacientes que cicatrizaron pero no erradicaron mostraron recidiva a los 12 meses (35 por ciento) (p < 0,05). Los resultados histopatológicos mostraron diferencias estadísticamente significativas entre los pacientes erradicados y no erradicados por lo que se refiere a la intensidad de la inflamación y a la metaplasia intestinal (p < 0,05) pero no por lo que respecta a la atrofia. Conclusión: la erradicación de H. pylori es útil para prevenir la recaída ulcerosa y mejorar el estado de la mucosa gástrica, incluida la metaplasia intestinal (AU)

[Participation rates for those aged 25 to 60: age and generation effects]. / Les taux d'activites des 25-60 ans: les effets de l'age et de la generation.

Labor force participation for those aged 25 to 60 in France is analyzed over the period 1975 to 1994. "Over these two decades, female participation rates rose sharply, particularly among the young and intermediate age groups and the least qualified. At the same time, the overall male participation rate dropped slightly due mainly to more frequent retirement at the end of working life and among the least qualified. An econometric analysis of female participation rates shows, in contrast to the men, an extensive change in working patterns between generations. The sharp rise in participation rates for the generations born from the 1930s to the 1960s has only been slightly tempered by the relative economic downturn posted after 1977." (SUMMARY IN ENG AND GER AND SPA)

Calcium channel antagonist omega-conotoxin binds to intramembrane particles of isolated nerve terminals.

Voltage-sensitive calcium channels play a key role in evoked neurotransmitter release and their distribution in presynaptic membranes can be critical for fast signalling at chemical synapses. Using a biotinylated derivative of the neuronal calcium channel antagonist, omega-conotoxin, and a combination of colloidal gold labeling and freeze-fracture techniques, we have labeled calcium channels present at the membrane of nerve terminals isolated from the electric organ of Torpedo marmorata. The biotinylated blocker exerts an inhibitory action on the high potassium-evoked release of adenosine triphosphate as the native toxin does and its interaction with biological membranes is specific as shown in displacement experiments. This study shows that an antagonist specific for voltage-activated calcium channels binds to intramembrane particles in presynaptic membranes, reinforcing the idea that these particles, concentrated at neurotransmitter release sites, effectively represent calcium channels.

Evaluation of the methodological quality of clinical trial protocols. A preliminary experience in Spain.

The methodological quality of 50 clinical trial protocols submitted to our hospital has been assessed by means of a check-list. The most frequent methodological deficiencies found were related to statistical analysis, selection criteria, sample size, incorrect use of placebo, homogeneity of the groups, concomitant medication, randomisation plan, monitoring of adverse events and study design. Lack of insurance for the patients and inadequacies in the investigators' brochure and case report forms were observed in a significant number of cases. The results suggest the importance of a multidisciplinary team in the elaboration of clinical trial protocols to prevent methodological errors.