Liderazgo de la mujer en la investigación clínica: estudio observacional retrospectivo durante dos décadas en España / Women's leadership in clinical research: A retrospective observational study over two decades in Spain

Antecedentes y objetivo Los datos disponibles avalan las diferencias por género en el liderazgo de las investigaciones clínicas (IC). Este estudio analiza en qué medida las mujeres lideran estas investigaciones. Materiales y métodos Estudio observacional retrospectivo en un hospital universitario terciario asociado a uno de los institutos de investigación sanitaria más importantes de España. Analizamos los investigadores principales (IP) por género (2001-2020). Variable principal: proporción de IC lideradas por mujeres durante el período de estudio. Variables secundarias: diferencias de IP por género según el tipo de estudio: ensayos clínicos (EC) o estudios de no-intervención (ENI) y según la financiación. Fuentes de datos: registros del Comité de Ética en Investigación con medicamentos (CEIm) y del Departamento de Recursos Humanos. Resultados Durante el estudio, el CEIm aprobó 8.466 protocolos; el 52% (4.408/8.466) fueron EC y el resto, ENI. Las mujeres lideraron un 39,7% (3.360/8.466) del total. La brecha de género se observó principalmente en EC: las mujeres fueron IP de un 31,5% de ellos (1.391/4.408) y de un 48,5% (1.969/4.058) de los ENI. Ello a pesar de la tendencia creciente del número de facultativas. Los estudios de financiación privada fueron más comúnmente liderados por hombres. Conclusiones Nuestros resultados demuestran que existe una infrarrepresentación de las mujeres en puestos de liderazgo en la investigación, principalmente en aquellos con financiación privada. Este estudio refuerza la idea de que todavía queda un largo camino por recorrer en este campo. Se necesitan más estudios para la identificación de diferencias existentes que permitan implantar cambios a nivel institucional y cultural que promuevan la igualdad de género en el ámbito de la investigación clínica (AU)

Background and objective Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. Materials and method Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. Main outcome: proportion of CI led by female doctors (FD) during the study period. Secondary outcomes: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. Data sources: Research Ethics Committee (REC) and Human Resources Department registries. Result During the study, the REC approved 8,466 protocols, 52% (4,408/8,466) were EC, the rest were NIR. Women led 39.7% (3,360/8,466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1,391/4,408) and 48.5% (1,969/4,058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. Conclusions Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research (AU)

Women's leadership in clinical research: A retrospective observational study over two decades in Spain.

BACKGROUND AND OBJECTIVE: Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. MATERIALS AND METHODS: Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. MAIN OUTCOME: proportion of CI led by female doctors (FD) during the study period. SECONDARY OUTCOMES: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. DATA SOURCES: Research Ethics Committee (REC) and Human Resources Department registries. RESULTS: During the study, the REC approved 8466 protocols, 52% (4408/8466) were EC, the rest were NIR. Women led 39.7% (3360/8466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1391/4408) and 48.5% (1969/4058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. CONCLUSIONS: Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research.

Multidisciplinary severe asthma management: the role of hospital pharmacists in accredited specialized adult asthma units in Spain

No disponible

Safety of antitumour necrosis factor treatments in chronic rheumatic diseases: therapy discontinuations related to side effects.

WHAT IS KNOWN AND OBJECTIVE: The appearance of antitumor necrosis factor drugs (ATDs) has been a major advance in the management of these patients. However, due to the immunosuppressive effect of these therapies, side effects that require treatment discontinuations can appear. The purpose of this study was to evaluate the frequency of ATD discontinuation due to adverse drug effects (ADEs) and the influence of different factors such as diagnosis, ATD prescribed and concomitant disease-modifying antirheumatic drugs (DMARDs). METHODS: Observational study from a prospective cohort conducted in a tertiary hospital (1350 beds) in Spain. Data were obtained from the database of the Rheumatology Outpatient Unit of the hospital and patients' clinical files. Included patients had a diagnosis of RA or peripheral or axial SpA (ankylosing spondylitis, psoriatic SpA, non-radiographic SpA, SpA associated with inflammatory bowel disease or reactive arthritis) treated between November 2000 and March 2014 with infliximab (IFX), etanercept (ETN) or adalimumab (ADA). RESULTS AND DISCUSSION: Study cohort included 531 rheumatic patients (282 patients with RA, 53·1%, and 249 patients with SpA, 46·9%). ATDs were discontinued in 62 cases (11·7%) because of ADEs, mainly inmunogenicity and infections (mainly due to infusion reactions, 58·1%, and infections, 19·3%). ATD discontinuation was higher in the group of RA patients compared with SpA (44/282 (15·6%) in RA vs. 18/249 (7·23%) in SpA). The appearance of ADEs that led to drop out was more frequent in patients under IFX therapy (45 (18·6%) with IFX vs. 12 (7·59%) with ETN and 5 (3·81%) with ADA). We observed a significantly increased risk of ADEs when patients received IFX than when ETN or ADA were used (P < 0·001); 444 patients (83·6%) received DMARDs in combination with ATDs. The risk of ATD withdrawal was significantly higher in patients treated with leflunomide as compared to those who do not (OR = 1·984, P < 0·05). WHAT IS NEW AND CONCLUSION: Discontinuation of ATD due to ADEs is relatively frequent and it depends on the diagnosis and ATD administered. The risk of treatment discontinuation is higher in patients diagnosed with RA vs. SpA or treated with IFX (rather than with ETN or ADA). The addition of DMARDs to ATDs increased the frequency of treatment discontinuation, up to three concomitant medications. Leflunomide in combination with an ATD significantly increased the probability of treatment discontinuation due to adverse reactions.

Juego de patentes. Sobre medicamentos genéricos y biosimilares / The patents game. Generic and biosimilar drugs

La protección mediante patentes a los medicamentos es limitada y, al expirar estos títulos de propiedad intelectual, entran en el mercado otros medicamentos copiados que compiten con los innovadores. Inicialmente estos fueron idénticos a los originales, los llamados medicamentos genéricos, pero, en los últimos años, a raíz de la irrupción de las terapias biológicas y la expiración de muchas de sus patentes han aparecido también los medicamentos biosimilares. Aunque no son copias exactas del original, al igual que los medicamentos genéricos, los medicamentos biosimilares tienen que demostrar equivalencia en calidad seguridad y eficacia respecto a los originales. A pesar de su importancia y su contribución a la sostenibilidad del sistema sanitario, a veces hay desconocimiento sobre las diferencias entre medicamentos genéricos y medicamentos biosimilares y qué implica su utilización en términos clínicos y económicos. Con esta revisión pretendemos aclarar aspectos que a menudo se desconocen a pesar del uso cada vez mayor de estos fármacos (AU)

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use (AU)

[The patents game. Generic and biosimilar drugs]. / Juego de patentes. Sobre medicamentos genéricos y biosimilares.

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use.

Análisis de las preferencias de los profesionales sanitarios respecto a la prescripción electrónica de tratamientos farmacológicos en pacientes hospitalizados / Health personnel assessment about medical order entry systems of pharmacologic treatments in hospitalized patients

Objetivo. Evaluar preferencias de profesionales sanitarios acerca de la prescripción electrónica (PE) sobre las condiciones de trabajo, riesgo de errores de medicación y utilidad de ventajas aportadas por este sistema. Material y métodos. Estudio transversal mediante entrevista a una muestra de usuarios de PE en un hospital terciario. El cuestionario se estructuró en 3 categorías para valorar: su repercusión en la carga de trabajo, en el riesgo de errores de medicación y sus ventajas teóricas, inconvenientes y sugerencias. Resultados. Participaron 76 profesionales (58 médicos, 9 farmacéuticos y 9 DUE). Sobre su repercusión en la rutina lo mejor valorado fue la reducción de la carga de trabajo y el tiempo empleado (bueno o muy bueno para el 85,5%; IC 95%: 75,5-92,5). Opinaron que la reducción de errores se debía principalmente a soportes de ayuda predefinidos. Las ventajas mejor valoradas fueron: legibilidad y alertas (las consideraron positivamente un 98,7% [IC 95%: 92,9-99,9] y 97,4% [IC 95%:90,81-99,68]). Estimaron como principales inconvenientes los tecnológicos: excesiva dependencia, falta de equipos y fallos informáticos, así como la falta de continuidad farmacoterapéutica entre las distintas unidades de hospitalización durante el ingreso. La necesidad de unificación entre aplicaciones informáticas del hospital fue la sugerencia de mejora más repetida. Conclusión. Los profesionales sanitarios manifestaron un alto grado de satisfacción sobre la PE, a la que consideraron eficaz y segura. Como principal inconveniente destacaron la dependencia de la tecnología y falta de infraestructura. También opinaron que sería deseable una mayor integración entre las distintas aplicaciones informáticas (AU)

Objective: to evaluate health personnel perceptions about medical order entry systems concerning the effect on workflow, medication errors risk and assessment of its potential advantages. Material and methods: A cross-section opinion interview was conducted in a tertiary care hospital. Questionnaire consisted of three sections: perception of its effect on workflow, influence on medication error risk and assessment of potential advantages. We also asked them to assess drawbacks and provide suggestions about this prescription system. Results: 76 health professionals were interviewed (58 physicians, 9 pharmacists and 9 nurses). They were satisfied mainly due to decrease the workload (85.5%; IC 95%: 75.58-92.55). They thought that the main characteristics that contribute to reduce medication errors are clinical decision supports related to predefined aspects which the program provided by default. Among potential benefits of medical order entry systems, legibility and warnings triggered by the program (98.7%; IC 95%: 92.90-99.97 and 97,4%; IC 95%: 90.81-99.68 respectively) were the most valuable. High technology dependence, IT failures and lack of infrastructure and medication therapy discontinuities at times of transition between different hospitals’ units were the main drawbacks considered. The most repeated suggestion was related to the improvement of links between other health informatics applications used in the hospital. Conclusion: health personnel were highly satisfied with the CPOE system, which is considered to be effective and safe. Technology dependence and IT failures were the main disadvantages reported. According to them, a greater coordination and unification of all software applications available in the hospital would be desirable (AU)

[Health personnel assessment about medical order entry systems of pharmacologic treatments in hospitalized patients]. / Análisis de las preferencias de los profesionales sanitarios respecto a la prescripción electrónica de tratamientos farmacológicos en pacientes hospitalizados.

OBJECTIVE: to evaluate health personnel perceptions about medical order entry systems concerning the effect on workflow, medication errors risk and assessment of its potential advantages. MATERIAL AND METHODS: A cross-section opinion interview was conducted in a tertiary care hospital. Questionnaire consisted of three sections: perception of its effect on workflow, influence on medication error risk and assessment of potential advantages. We also asked them to assess drawbacks and provide suggestions about this prescription system. RESULTS: 76 health professionals were interviewed (58 physicians, 9 pharmacists and 9 nurses). They were satisfied mainly due to decrease the workload (85.5%; IC 95%: 75.58-92.55). They thought that the main characteristics that contribute to reduce medication errors are clinical decision supports related to predefined aspects which the program provided by default. Among potential benefits of medical order entry systems, legibility and warnings triggered by the program (98.7%; IC 95%: 92.90-99.97 and 97,4%; IC 95%: 90.81-99.68 respectively) were the most valuable. High technology dependence, IT failures and lack of infrastructure and medication therapy discontinuities at times of transition between different hospitals' units were the main drawbacks considered. The most repeated suggestion was related to the improvement of links between other health informatics applications used in the hospital. CONCLUSION: health personnel were highly satisfied with the CPOE system, which is considered to be effective and safe. Technology dependence and IT failures were the main disadvantages reported. According to them, a greater coordination and unification of all software applications available in the hospital would be desirable.