Remarks of a paediatrician on informed consent in children

In medical practice, patients are frequently in a passive role with respect to consenting to medical measures. The basic threshold element of informed consent is medical competence to be controlled by individual self-criticism. The elements of information, such as disclosure and understanding, have to be adapted to the individual situation in order to achieve voluntariness and active autonomous authorization. In the paediatric age group, disclosure of information has to be guided by the age-dependent ability of understanding, leading to voluntariness and consent. Since force cannot be totally avoided in the management of children, parental information and consent should be as precise and conclusive as possible. The interaction between the paediatrician on the one hand, and the children and their parents on the other, is discussed.     

Participation in research: informed consent, motivation and influence

OBJECTIVE: To investigate the process and quality of informed consent, motivation and influence in parents who were invited to enroll their baby in a research project. METHODOLOGY: A mixed quantitative/qualitative questionnaire was sent to a cohort invited to participate in a physiological research project on sudden infant death syndrome (SIDS) at the Dunedin Public Hospital, Dunedin, New Zealand. Separate questionnaires were used for parents who participated (94) and those who declined to participate (103). Response rates were 69% and 47%, respectively. RESULTS: All consenting parents felt they understood the purpose and procedure of the study. The majority (90%) thought the information about the study was very good; 6.5% felt more detail was required. Eighty-five per cent found the verbal explanation the most useful source of information. All participated for altruistic reasons such as to aid SIDS research. Although 27% had concerns about safety of the tests, after the tests all responders felt happy with the safety of the tests. Inconvenience was the main reason (53%) for declining to participate. Twenty-eight per cent of declining parents were concerned about the safety of the tests. CONCLUSION: Of those who responded to the questionnaire, the process for obtaining informed consent in the SIDS studies was satisfactory. Parents' motives for participating were mostly altruistic. The role of recall bias and selection bias may make the implications of this study unclear.     

Pediatric oncology research in low income countries: ethical concepts and challenges

Uneven strides in research and care have led to discrepancies in childhood cancer outcomes between high and low income countries (LICs). Collaborative research may help improve outcomes in LICs by generating knowledge for local scientific communities, augmenting knowledge translation, and fostering context-specific evaluation of treatment protocols. However, the risks of such research have received little attention. This paper investigates the relationship between pediatric oncology research in LICs and four core issues in the ethics literature: standard of care, trial benefits, ethics review, and informed consent. Our aims are to highlight the importance of this field and the need for further inquiry.     

Characteristics of parental decision-making for children with advanced cancer who are offered enrollment in early-phase clinical trials: A systematic review

Abstract

Limited research is available on parental decision-making regarding their children’s participation in pediatric phase I oncology trials compared with the adult population. The objectives of this review were to describe: (1) the process of parental decision-making in this situation; (2) the optimal communication features physicians need when proposing inclusion in such trials; and (3) the place of the child/adolescent in the assent process. Thirty relevant studies meeting inclusion criteria were identified by searching five computerized databases (PubMed, Web of Science, Cairn, Psychinfo, EM Premium). Parental decision-making is a complex process based on hopeful expectations, multiple family considerations and the child’s previous cancer experience. It is highly impacted by the quality of physicians’ communication. A therapeutic alliance along with an empathetic attitude and a timely delivery of accurate information is essential. Due weight should be given to the voice of children or adolescents and their optimal level of involvement may be discussed depending on their age and maturity. They should be given age-adapted information in order to empower them to be rightfully and meaningfully involved in early-phase research. This review highlights the main gaps and necessary remedial actions to support an optimal patient care management in this situation. Physicians’ training in communication, structured interdisciplinary teamwork and early integration of palliative care are three key challenges which need to be implemented to actively engage in optimization strategies which would improve patient care and family support when offering enrollment in a phase I trial.     

Parental consent in paediatric clinical research

Aims

To assess parental understanding and memorisation of the information given when seeking for consent to their child''s participation to clinical research, and to identify the factors of significant influence on parents'' decision making process.

Methods

Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation.

Results

Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory.

Conclusion

There was an apparent discrepancy between parents'' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process.     

Valid informed consent and participative decision‐making in children with cancer and their parents: A report of the SIOP working committee on psychosocial issues in pediatric oncology

This is the tenth official document of the SIOP Working Committee on psychosocial issues in pediatric oncology, instituted in 1991. It is addressed to the pediatric oncology community. Children clearly have a right to participate in medical decisions regarding their own treatment, based on the developmental level of the child. The objective of these guidelines is to encourage physicians to share with the child developmentally relevant medical information specific to that particular child's health status, in the context of the child's own culture, so that he or she can actively participate in the decision‐making process regarding his or her own health. These guidelines, geared toward this objective, discuss the child's right to medical information, the parents' legal responsibility for but not exclusive right over the child's health, and ways of encouraging the younger child's active participation in his or her own health care at an age‐appropriate level of understanding. For adolescents, there should be a full and legally mandated power to make their own decisions regarding medical treatment. Med Pediatr Oncol 2003;40:244–246. © 2003 Wiley‐Liss, Inc.     

When parents refuse consent to treatment for children and young persons

One of the most difficult ethical dilemmas in paediatric practice is parental refusal to consent to life-saving treatment for their children. The ethical principles in such situations are complex. Although the 'best interests' of the child are of primary concern, these must be understood widely, as including all and not just medical interests. Though ultimately the courts must decide on a course of action where refusal is continued, we believe that in non-emergency cases consultation with a properly constituted multidisciplinary group will be of assistance. A national group of this kind has been recommended for New Zealand. This will ensure that all aspects of the cases are considered and can lessen the sense of 'parent versus medical profession' opposition. If this does not lead to a resolution, the opinion of the courts may be of assistance. Following a brief discussion of important ethical considerations, this article outlines a suggested constitution for an advisory committee and a set of guidelines for clinicians faced with parental refusal of treatment for their children.     

Treatment challenges and outcomes for pediatric intracranial ependymoma at a single institution in Iran

Background: The scarcity of information on pediatric ependymoma in Iran motivated this study. Our main objectives were to determine outcomes, identify clinical management challenges at a nongovernment hospital in Iran, and devise guidelines for improving care.

Procedure: A retrospective chart review was performed for pediatric patients with ependymoma who were younger than 15 years and treated at MPCTRC between 2007 and 2015. Records included patient demographics, treatment regimens used, duration of follow-up, and outcomes. Clinical outcomes [ie, 3-year overall survival (OS) and progression-free survival (PFS)] were determined based on the age at diagnosis (younger or older than 3 years) by using the Kaplan–Meier method.

Results: In total, 73 eligible patients were enrolled; 20 patients were in the younger group, and 53 were in the older group. The majority (91.8%, n = 67) of patients underwent initial gross-total or partial surgical resection, and 6 (8.2%) had a biopsy. Twenty-one patients experienced ependymoma recurrence. The median time to relapse was 1 year. The median duration of follow-up and PFS were 25 and 17 months, respectively. The 3-year OS and PFS were 61% and 59.5%, respectively. At the time of this project, 27 patients had died, and 35 were alive with no evidence of disease.

Conclusion: Our study demonstrated inferior outcomes of Iranian children with ependymoma. To improve our care for these children, a paradigm shift must occur that includes radiation therapy as standard of care, second-look surgery, a multidisciplinary team approach, and potentially twinning initiatives.     

Screening for psychosocial risk in pediatric cancer

Major professional organizations have called for psychosocial risk screening to identify specific psychosocial needs of children with cancer and their families and facilitate the delivery of appropriate evidence‐based care to address these concerns. However, systematic screening of risk factors at diagnosis is rare in pediatric oncology practice. Subsequent to a brief summary of psychosocial risks in pediatric cancer and the rationale for screening, this review identified three screening models and two screening approaches [Distress Thermometer (DT), Psychosocial Assessment Tool (PAT)], among many more articles calling for screening. Implications of broadly implemented screening for all patients across treatment settings are discussed. Pediatr Blood Cancer 2012; 59: 822–827. © 2012 Wiley Periodicals, Inc.     

Host factors and consequence of chemotherapy in pediatric cancer patients

The 5-year survival rates for childhood ALL are approaching 80%, but therapy-related toxicities are common. One of the challenges in this population is determining the most efficacious therapeutic regimens for these individuals. Factors such as drug metabolism, genetics, and concomitant disease affect drug efficacy and may be important in determining therapeutic outcomes in these patients. This review will focus on these factors in the treatment of childhood ALL.     

Outcomes of a pediatric surgical oncology fellowship in a pediatric cancer institution

Surgery plays an important role as part of the treatment plan in most children with malignant solid tumors in regards to initial biopsy, upfront resection, and delayed resection. Surgeons also play a critical role in the treatment of surgical complications that may arise during medical treatment. The pediatric surgical oncologist should be familiar with the current treatment guidelines, histology implications, chemotherapy and radiation side effects, tumor staging, and overall care of the child with cancer. Specific training in pediatric surgical oncology is not widespread internationally and it represents a potential undervalued intervention for improving global pediatric cancer care.