Assessing Medical Decision-Making Competence in Transgender Youth.

BACKGROUND: According to international transgender care guidelines, an important prerequisite for puberty suppression (PS) is transgender adolescents' competence to give informed consent (IC). In society, there is doubt whether transgender adolescents are capable of this, which in some countries has even led to limited access to this intervention. Therefore, this study examined transgender adolescents' medical decision-making competence (MDC) to give IC for starting PS in a structured, replicable way. Additionally, potential associated variables on MDC, such as age, intelligence, sex, psychological functioning, were investigated. METHODS: A cross-sectional semistructured interview study with 74 transgender adolescents (aged 10-18 years; 16 birth-assigned boys, 58 birth-assigned girls) within two Dutch specialized gender-identity clinics was performed. To assess MDC, judgements based on the reference standard (clinical assessment) and the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), a validated semistructured interview, were used. RESULTS: Of the transgender adolescents, 93.2% (reference standard judgements; 69 of 74) and 89.2% (MacCAT-T judgements; 66 of 74) were assessed competent to consent. Intermethod agreement was 87.8% (65 of 74). Interrater agreements of the reference standard and MacCAT-T-based judgements were 89.2% (198 of 222) and 86.5% (192 of 222), respectively. IQ and sex were both significantly related to MacCAT-T total score, whereas age, level of emotional and behavioral challenges, and diagnostic trajectories duration were not. CONCLUSIONS: By using the MacCAT-T and clinicians' assessments, 93.2% and 89.2%, respectively, of the transgender adolescents in this study were assessed competent to consent for starting PS.

Research Participation of Minor Adolescents in Foster Care.

STUDY OBJECTIVE: In this study we evaluated published studies about foster care to: (1) determine the types of data used; (2) describe the degree to which a sexual/reproductive health topic was addressed; and (3) describe the consent process. DESIGN: Analysis of published literature. SETTING: PubMed was searched using "foster care" for English articles published between January 1, 2017 and September 4, 2019. PARTICIPANTS: None. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Articles were coded into 4 data source categories: primary, secondary, peripheral, or perspective data. Articles with a primary data source were coded for participant ages: only 9 years old and younger, 10- to 17-year-olds (minor adolescents), and only 18 years old and older. Articles using a secondary data source were coded for the source of the data registry. All articles were coded for presence of a sexual/reproductive health outcome. The primary data articles that included minor adolescents were coded for the study topic and consent process. RESULTS: Of the 176 articles about foster care, 72/176 (41%) used primary data, 53/176 (30%) used secondary data, and 51/176 (29%) used peripheral/perspective data. Forty-eight of the primary data articles included minor adolescents. Secondary data sources included few national research surveys. Sexual/reproductive health outcomes were measured in 17 articles, 4 of which used primary data. The consent process for minor adolescents varied and had no consistent pattern across studies. CONCLUSION: Research on best practices for consent processes and use of registries could be developed to increase research on sexual/reproductive health outcomes among adolescents in foster care.

Variability in Informed Consent Practices for Non-Emergent Procedures in Pediatric Emergency Departments.

Although informed consent is a cornerstone of medical ethics, it is unclear if the practice for obtaining informed consent is consistent among pediatric emergency departments. This study's goal is to describe the current practice for written informed consent in academic pediatric emergency departments for non-emergent procedures. A questionnaire distributed to pediatric emergency medicine fellowship directors queried whether written informed consent was standard of care for 15 procedures and assessed departmental consent policies and use of "blanket" consent-to-treat forms. Response rate was 80% (n = 64). Institutions obtained written consent for a mean of 4.4 procedures. Written informed consent was most commonly obtained for procedural sedation (82.5%), blood transfusion (72.9%), and lumbar puncture (66.5%). Twenty-one institutions (32.8%) had policies specifying procedures requiring written consent. Thirty-five institutions (54.7%) used "blanket" consent-to-treat forms. Our results suggest that there is variability in the use of written informed consent for non-emergent procedures among academic pediatric emergency departments.

Children's views on taking medicines and participating in clinical trials.

INTRODUCTION: Limited information is available on the views of children taking medicines and participating in clinical trials. These views may contribute to a better understanding of what can be improved on in the development of medicines from their perspective. OBJECTIVE: To collect children's views on taking medicines and participating in clinical trials. MATERIALS AND METHODS: A question-based survey was conducted among children living in European Union countries between January and August 2015. RESULTS: Almost 900 children aged 10-17 years from Finland, Germany, Sweden, Spain and Hungary responded. Almost 40% had a chronic health condition. The most commonly used pharmaceutical forms were solid or liquid medicines for oral use and injectable medicines. Bad taste and pain during administration were reported as common problems. Of 785 respondents, 17% had been taking part in a clinical trial. Most respondents would potentially agree to take part in a clinical trial because the investigational medicine might improve their own health or that of other children. Concern that the investigational medicine might be harmful was the main reason to refuse participation, if asked to. Over half of the respondents were willing to learn more about clinical trials, preferably online. CONCLUSIONS: It is necessary to involve children in the development of age-appropriate pharmaceutical forms and in the design of clinical trials. Children and their carers should be provided with age-appropriate medical information in the most suitable channels. We have identified some common problems that children experience when taking medicines, and we conclude that children are interested in learning more and giving their opinions on clinical trials.

[Participation and Information in Child and Youth Psychiatry]. / Partizipation und Informationspraxis in der Kinder- und Jugendpsychiatrie.

Participation and Information in Child and Youth Psychiatry Participation is part of children's legal rights - even in psychiatric treatment. However, former studies show that most children have barely been informed about their treatment and that their opinion has not been taken into account in any decision making process. Nowadays there is an increased awareness about involving children in the decision making process and in informing them about treatment. This subject has also gathered more importance through legal actions changed in favor of the children. We have investigated to what extend children in in-patient treatment in the child and adolescent psychiatry feel informed about and included in decisions concerning their treatment. N = 114 children of the age between 12-18 years have been asked via a written survey. Results show that more than half of the young people feel that they do have the possibility to take part in decision-making. Only a third of the participants felt sufficiently informed before and during their hospital stay.

El consentimiento informado en el menor de edad en España: mayoría de edad, representación y teorías determinantes de la minoría de edad / Informed consent in minor in Spain: age of majority, representation, and determining theories minority

La minoría de edad, así como las situaciones y las figuras jurídicas que la acompañan, ocupan un lugar destacado a la hora de estudiar el consentimiento informado. La actuación del personal sanitario deberá ser muy distinta si estamos ante una persona considerada como menor o mayor de edad (AU)

The minority and legal situations and accompanying figures prominently when informed consent study the place. The performance of health workers must be very different if we have a person considered as a minor or an adult (AU)

The attitude of Flemish paediatricians regarding informed consent of adolescents.

BACKGROUND: Since 2002 the Belgian law requires an informed consent of the patient before each medical intervention. This provision applies also for adolescent patients on condition that the physician considers the young patient as competent to autonomously participate in the decision making process. AIM: The purpose of this study is to evaluate to what extent Belgian paediatricians from the Flemish part of the country have implemented the legal requirements for informed consent of adolescent patients, in particular when they consult alone. METHODS: In the frame of a larger study regarding the relation between paediatricians and their patients, a questionnaire was sent via regular mail to 570 Flemish paediatricians, evaluating how and how often they obtain an informed consent of the adolescent when consulting a physician unaccompanied. RESULTS: In only 1% of all consultations an adolescent consulted the physician alone and agreed to a medical intervention on his/her own. The information given by the paediatrician did not differ if the adolescent consulted alone or was accompanied by (one of) his/her parents for the following items: purpose and type of treatment (100% vs 100%), duration of treatment (92% vs 94%) and aftercare (89% vs 93%). However, the information differed with regard to alternatives to the treatment (65% vs 76%), degree of urgency (89% vs 95% ), treatment related risks (82% vs 90%) and cost (21% vs 45%). 18.6% of the paediatricians consider age as the single criterion to evaluate the competence of the adolescent to provide an informed consent; other criteria that are considered: experience (92%), insight into and factual understanding of the clinical picture (84%). To fulfil the tasks of providing information and asking for consent, paediatricians rarely had recourse to prior established protocols (14%), they preferred to rely on proper experience and expertise (81%). Fifty percent appealed to the opinion of other health care providers. CONCLUSIONS: Although the Belgian law stipulates regulations that should be complied with by the physician during the decision making process about any medical intervention on adolescents, this legislation has rarely been put into practice, as the adolescents used their right to autonomously consent in barely 1% of all paediatric consultations. For the majority of the respondents other criteria than age were taken into account to consider an adolescent as able to provide informed consent.