[New care models for transgender people in the Spanish Health System: demands, controversies and reflections.] / Nuevos modelos de atención sanitaria para las personas transgénero en el Sistema Sanitario Español: demandas, controversias y reflexiones.

Health care for transgender people in Spain has been progressively established since 1999 when the first multidisciplinary unit for the treatment of sex reassignment was created in Andalusia. In this document, the social changes, the demands and debates of users and professionals, the new models of health care for trans people, and reflections on the current situation, have been analysed. The social openness in Spain regarding sexual and gender diversity has evolved quite positively. The health demands of the transgender users are not uniform and do not always match with the criteria of the professionals. In some Spanish regions, health care is distancing itself from the internationally recommended multidisciplinary model. The new healthcare models have been established under the aegis of primary care and/or endocrinologist in the area, without a required psychological assessment. The main contributing factors for this change of model have been the pressure from some associations with demands for "depathologization" and "decentralization". The professionals of gender units, while recognizing the need for a broader vision of trans reality, warn of the risk of treating trans people without the involvement of mental health specialists or by professionals in proximity with little experience. Moreover, the decentralization would not allow acting on large cohorts, which hinders the advance of knowledge and contrasted evaluations with neighbouring countries. In summary, the new health models, although intended to facilitate care through proximity, do not guarantee improvements in quality and difficult to make a comparative evaluation of the results.

La atención sanitaria a las personas transgénero en España se ha establecido de manera progresiva desde 1999, año en que Andalucía crea la primera unidad multidisciplinar para el tratamiento integral de la reasignación de sexo. Este documento analiza los cambios sociales, las demandas y debates entre usuarios y profesionales y los nuevos modelos de atención sanitaria, y también plantea reflexiones sobre la situación actual. La apertura social en España en la concepción de la diversidad sexual y de género es bastante favorable. Las demandas de los usuarios no son uniformes y no siempre coinciden con los criterios de los profesionales. En algunas comunidades autónomas la asistencia sanitaria se está distanciando del modelo recomendado internacionalmente, que basa la atención en equipos especializados o Unidades de Identidad de Género (UIG). Estos nuevos modelos centran la asistencia en la Atención Primaria, además de en endocrinólogos y pediatras de área sin una evaluación coordinada con Salud Mental. Los principales factores contribuyentes al cambio reciente han sido las demandas desde algunas asociaciones de "despatologización" y "descentralización". Estos nuevos modelos centran la asistencia en la Atención Primaria, además de en endocrinólogos y pediatras de área sin una evaluación coordinada con Salud Mental. Los profesionales que integran las unidades de género, si bien reconocen la necesidad de una visión amplia de la realidad transgénero, alertan del riesgo que supone tratar a personas trans sin una colaboración de especialistas en Salud Mental o por profesionales de área con escasa experiencia. Además, anticipan que la descentralización no facilita el estudio de grandes cohortes, dificultando el avance del conocimiento y la evaluación contrastada con países del entorno. En resumen, los nuevos modelos sanitarios, aunque ofrecen la atención en proximidad, no garantizan mejoras en la calidad ni promueven el análisis comparado de los resultados.

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

OBJECTIVES: To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. DESIGN: Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). PARTICIPANTS: 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. INTERVENTIONS: The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. MAIN OUTCOMES: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. RESULTS: The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. CONCLUSIONS: Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. TRIAL REGISTRATION NUMBERS: NCT01476007; EUDRACT (2010-024129-20).

[Is Sexual Identity Optional? A Study of The Genetics of Transsexuality]. / ¿La Identidad Sexual Es una Opción? Un Estudio Sobre la Base Genética de la Transexualidad.

Transsexualism in the ICD-10 (International Classification of Diseases, Tenth Revision), Gender Dysphoria in adolescents and adults in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), is characterized by a marked incongruence between one's experienced gender and biological sex. The etiology is complex, but some hypotheses suggest that Gender Dysphoria (GD) arises from discrepant cerebral and biological sexual differentiation. Increasing evidence supports the idea of genetic vulnerability. Henningsson et al, (2004) found significant differences when they examined estrogen receptor ß (ERß) in a male-to- female (MtF) population. They suggested that a long ERß polymorphism is more common in MtFs. Hare et al, (2009) also examined an MtF population and found a significant association between the androgen receptor (AR) and GD. Our group analyzed the same polymorphisms and found an association between ERα, ERß and AR in GD. Our results suggest a genetic basis of GD in MtF and FtM populations. Our data corroborate the implication of the two estrogen receptors, ERα and ß, and the androgen receptor in the genetic basis of GD, and advise the importance of estrogens and androgens in cerebral masculinization. Our data also confirm that sexual identity is not optional, but is determined prenatally by the genes, although it has a very important hormonal component. Therefore, its substrate is cerebral, not ideological.