Pediatric Oncology Research Research Articles

Thirty-Day Outcomes following Pediatric Bone and Soft Tissue Sarcoma Surgery: A NSQIP Pediatrics Analysis.

Background Pediatric bone and soft tissue sarcomas are rare; therefore, national registries are essential tools for orthopedic oncology research. Past studies provide excellent data on long-term prognosis and survival trends but fail to examine treatment-specific morbidity. The aim of this study is to use a national registry to describe patient demographics, comorbidities, and adverse events in the first thirty days following surgical management of pediatric bone and soft tissue sarcomas. Methods A retrospective review of patients in the American College of Surgeons National Surgical Quality Improvement Program—Pediatrics database (NSQIP-P) was performed. The cohort was partitioned by tumor origin (bone versus soft tissue) and tumor location (axial versus appendicular). Results One-hundred ninety-two patients were identified. Bone sarcomas were more common (71.9%) and predominately appendicular (62.3%), while soft tissue sarcomas were predominately axial (77.8%). The overall complication rate was 8.9%. The most frequent etiologies were wound dehiscence (3.6%) and infectious complications such as surgical site infections (2.6%), pneumonia (1.6%), urinary tract infections (1.6%), and C. diff colitis (1.0%). Twenty-four percent of patients experienced bleeding requiring transfusion. The unplanned readmission rate was 12.5% (3.6% related to principle procedure), and the unplanned reoperation rate was 4.7% (4.2% related to principle procedure). The mortality rate was 1.0%. Neoadjuvant chemotherapy was associated with higher rates of wound dehiscence and infectious complications. There were no differences in adverse events with respect to tumor origin or location. Conclusion Approximately 1 in 11 pediatric patients will experience a complication in the first thirty days following surgery. However, perioperative mortality remains low. This study represents the first comprehensive review of pediatric bone and soft tissue sarcoma surgery in the NSQIP-P database. As the case volume of NSQIP-P continues to grow, NSQIP-P has the potential to become a powerful tool for pediatric orthopedic oncology research.

Clinical research tools in pediatric oncology: challenges and opportunities

Survival for childhood cancers has improved significantly over the last decades. However, patient outcomes have plateaued over the last decade for difficult-to-treat diseases. With high cure rates, decreasing long-term toxicities and sequelae remains crucial. Since many advances in childhood cancer research come from the adult oncology world, one of the key areas is improving the adaptation of tools that are essential for clinical trial conduct that were developed for adults into pediatrics. These include tools to evaluate toxicity, quality of life, radiological response, statistical methodology, or indicators of cancer care quality. In this review, we present ongoing international efforts to validate and adapt these tools for children and adolescents and discuss remaining challenges. These efforts will hopefully accelerate and improve the quality of pediatric oncology research in the upcoming years.

A call to action for expanded sleep research in pediatric oncology: A position paper on behalf of the International Psycho-Oncology Society Pediatrics Special Interest Group.

Sleep and circadian rhythms are closely related to physical and psychosocial well‐being. However, sleep and circadian rhythm disruptions are often overlooked in children with cancer, as they are frequently considered temporary side effects of therapy that resolve when treatment ends. Yet, evidence from adult oncology suggests a bidirectional relationship wherein cancer and its treatment disrupt sleep and circadian rhythms, which are associated with negative health outcomes such as poor immune functioning and lower survival rates. A growing body of research demonstrates that sleep problems are prevalent among children with cancer and can persist into survivorship. However, medical and psychosocial outcomes of poor sleep and circadian rhythmicity have not been explored in this context. It is essential to increase our understanding because sleep and circadian rhythms are vital components of health and quality of life. In children without cancer, sleep and circadian disturbances respond well to intervention, suggesting that they may also be modifiable in children with cancer. We present this paper as a call to (a) incorporate sleep or circadian rhythm assessment into pediatric cancer clinical trials, (b) address gaps in understanding the bidirectional relationship between sleep or circadian rhythms and health throughout the cancer trajectory, and (c) integrate sleep and circadian science into oncologic treatment.

Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research.

Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO-CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO-CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials. Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO-CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO-CTCAE response patterns, and the authors examined how clinical context influenced grade assignment. A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa=0.73; 95% CI, 0.66-0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement. The current study provides a framework for integrating child self-reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.

Big Data for Nutrition Research in Pediatric Oncology: Current State and Framework for Advancement.

Recognition and treatment of malnutrition in pediatric oncology patients is crucial because it is associated with increased morbidity and mortality. Nutrition-relevant data collected from cancer clinical trials and nutrition-specific studies are insufficient to drive high-impact nutrition research without augmentation from additional data sources. To date, clinical big data resources are underused for nutrition research in pediatric oncology. Health-care big data can be broadly subclassified into three clinical data categories: administrative, electronic health record (including clinical data research networks and learning health systems), and mobile health. Along with -omics data, each has unique applications and limitations. We summarize the potential use of clinical big data to drive pediatric oncology nutrition research and identify key scientific gaps. A framework for advancement of big data utilization for pediatric oncology nutrition research is presented and focuses on transdisciplinary teams, data interoperability, validated cohort curation, data repurposing, and mobile health applications.

High Dose Chemotherapy with MIBG I<sup>131</sup> in Treatment of Patients with Neuroblastoma of High-Risk: a Cohort Study

Background. Poor-risk neuroblastoma treatment is still a challenge because of high relapse rate. Combination of high dose chemotherapy (HDCT) with MIBG I131 radiotherapy is a relatively new strategy for consolidation regimens in some patients with neuroblastoma. Objective. The aim of the study was to assess the safety and efficacy of a complex consolidation in a treatment of high-risk neuroblastoma patients in a pilot clinical trial. Methods. In our cohort study we analyzed toxicity along with 2- and 4- years OS and EFS in a cohort of 12 patients who got a consolidation based on Treo/ Mel HDCT in combination with MIBG I131 as a part of high-risk neuroblastoma treatment protocol since 2014 till 2018. The study was conducted in the Pediatric Oncology and Hematology Scientific Research Institute of Blokhin’s National Medical Cancer Research Center (Moscow). The treatment with MIBG I131 was done in settings of isolated ward of Russian Scientific Center of Roentgenology and Radiology. Results. Maximum cumulative organ toxicity of grade 2 or less was seen in 92% of patients. There was no treatment-related mortality. OS for 2 and 4 years was 87,5% ± 11,7% (for both time points). EFS for 2 and 4 years – 61,4 ± 15,3% and 49,1 ± 16,4%, respectively. Conclusion. Consolidation regimen based on Treo/Mel with MIBG I131 is safe. As a part of treatment program, it provides 4-years EFS for about a half of patients with poor-risk neuroblastoma with active residual tumor at the moment of consolidation.

Quality of life and psychological status of thoracic and abdominal pediatric cancer survivors

Relevance. The integrated approach in the treatment of malignant tumors in the chest or abdomen combined with achievements of surgery, chemotherapy and accompanying therapy significantly increased survival rate and recovery in paediatric patients and then specialists faced the new challenge - to improve indicators of the quality of life (QOL) in cured patients. The aim. To study indicators of the QOL and psychological characteristics of personality development in patients cured in childhood of tumors in the chest or abdomen. Materials and methods. The study included 184 patient aged between 8 and 18 years, cured of tumors in the chest or abdomen in RAMS N.N.Blokhin RCRC Pediatric Oncology and Hematology Research Institute of Ministry of Health of Russia from 1979 to 2015. The follow-up period was 3-25 years after the end of the complex antitumor treatment. The QOL analysis was held in 92 (50%) of patients. The QOL analysis was performed according to the examining children’s questioning in the PedsQL questionary. In addition, we assessed the psychological state and social adaptation measures in patients cured of tumors in the chest or abdomen. Results. The analysis demonstrated the reduction of the indicators of the QOL and psychosocial adaptation in patients cured of tumors in the chest or abdomen. Most often the reduction of adaptation occurred in adolescents (78%). We marked the increase in the frequency of medical care encounters of non-oncological profile, the decrease in cognitive function, hypererethism, indecisiveness and low self-confidence. Conclusions. We showed guidelines for the individual rehabilitation of patients cured of tumors in the chest or abdomen: sanatorium resort therapy, psychocorrective work, psychological rehabilitation for family of the patient.

Participant hopes and expectations regarding outcomes of genomic sequencing research in pediatric oncology.

10020 Background: Tumor genomic sequencing is rapidly becoming more integrated into pediatric oncology, but for only a minority of individuals does sequencing identify new treatment options or impart an increased chance of cure. Retrospective data show that participants have high hopes for this promising technology, but patient/parent hopes and expectations for the outcomes of genomic sequencing have not previously been evaluated prospectively. Methods: Surveys were administered prospectively to eligible enrollees (young adult patients ≥18y with relapsed/recurrent cancer, rare cancers, and those with poor prognoses, or parents of patients < 18y) prior to return of sequencing results in two clinical sequencing studies through the GAIN (NCT02520713) and LEAP (NCT02670525) Consortia, across 18 pediatric cancer centers. Using previously validated measures, participants were queried about what they most hoped for and thought most likely to happen (most expected) as a result of participating in the sequencing study. Comparisons were made between hopes and expectations using McNemar’s test. Separate multivariate models assessed predictors of most hoping for, and most expecting, increased chance of cure as a result of participating. Models were adjusted for gender, race, disease (leukemia/solid tumor), highest education level achieved, and survey participant (patient/parent). We present interim survey results for 124 participants (67% response rate) who completed surveys between 10/15/17 (GAIN) or 9/1/16 (LEAP) and 1/15/19. Results: 58% (70/121) of respondents selected increased chance of cure as their greatest hope in participating; only 21% (25/119) reported cure as their greatest expectation (p < 0.005). 28% (34/121) most hoped their participation would help cure future patients, and 45% (54/119) most expected this result (p < 0.005). Only 8% (10/121) most hoped to learn more about their/their child’s cancer, but 21% (25/119) most expected this result (p = 0.006). In multivariate analyses, education beyond college level was associated with most hoping for cure as a result of sequencing (OR 2.7 95% CI [1.2, 5.8], p = 0.016). A solid tumor diagnosis was associated with most expecting cure in this setting (OR 2.7 [1.0, 7.2], p = 0.048). Conclusions: Participants derive great hope from participating in pediatric cancer genomic sequencing research, but expectations are more tempered. Some subgroups express heightened expectations of cure, however, potentially identifying target populations for educational intervention.

SPORADIC AND HEREDITARY FORMS OF MULTIPLE PRIMARY MALIGNANT TUMORS IN CHILDREN

The article presents the features of the clinical manifestation of multiple primary sporadic and heritable malignant tumors in 104 children who observed at Pediatric Oncology and Hematology Research Institute of «NN Blokhin's National Medical Research Center of Oncology» from 1998 to 2012. The age of patients at the time of occurrence of the second malignant tumor ranged from 2.8 to 28 years and averaged 15.6 years. The second neoplasia occurred significantly more frequently in the group of primary hemoblastosis, compared with the group of solid tumors - 8.7% versus 3.4%, respectively (p <0.0001). In children with multiple primaries, were found tumors that occur in common the most frequency. Retinoblastoma patients have an increased risk of developing sarcoma. Patients with Hodgkin's lymphoma have an increased risk of developing leukemia. In surviving children after treatment of the first neoplasia the thyroid, bone tissue and breast have a specific risk for the development of metachronous cancer and are target organs for control. Children with new hematopoietic tumors may be candidates for metachronous development of leukemia and bone tissue tumors. The using methods Next Generation Sequencing (NGS) and Multiplex Ligation-dependent Probe Amplification (MLPA) revealed germinal mutations in 12 children with of multiple primary tumors. The mutations in the TP53, RB1, CHEK2, FANCN/PALB2, MLH1, PMS2 genes identified in patients were associated with hereditary syndromes and an increased risk of developing second tumors, among which: sarcomas, brain tumors, hematopoietic tumors were the most frequent. It was shown that the second tumors can appear at the any age. Children who survived the treatment of the first tumor in later life should be monitored annually. Clinical management of children with multiple primary tumors requires a multidisciplinary approach.

Duality of purpose: Participant and parent understanding of the purpose of genomic tumor profiling research among children and young adults with solid tumors.

Increasing use of genomic tumor profiling may blur the line between research and clinical care. We aimed to describe research participants' perspectives on the purpose of genomic tumor profiling research in pediatric oncology. We surveyed 45 participants (response rate 85%) in a pilot study of genomic profiling in pediatric solid tumors at four academic cancer centers following return of sequencing results. We defined understanding according to a one-item ("basic") definition (recognizing that the primary purpose was not to improve the patient's treatment) and a four-item ("comprehensive") definition (primary purpose was not to improve patient's treatment; primary purpose was to improve treatment of future patients; there may not be direct medical benefit; most likely result of participation was not increased likelihood of cure). Sixty-eight percent of respondents (30/44) demonstrated basic understanding of the study purpose; 55% (24/44) demonstrated comprehensive understanding. Understanding was more frequently seen in those with higher education and greater genetic knowledge according to basic (81% vs 50%, p=0.05; and 82% vs 46%, p=0.03, respectively) and comprehensive definitions (73% vs 28%, p=0.01; 71% vs 23%, p=0.01). Ninety-three percent of respondents who believed the primary purpose was to improve the patient's care simultaneously stated that the research also aimed to benefit future patients. Most participants in pediatric tumor profiling research understand that the primary goal of this research is to improve care for future patients, but many express dual goals when participating in sequencing research. Some populations demonstrate increased rates of misunderstanding. Nuanced participant views suggest further work is needed to assess and improve participant understanding, particularly as tumor sequencing moves beyond research into clinical practice.

Rare Malignant Tumors in Mexican Pediatric Patients: A Cooperative Pediatric Oncology Research Group Report

Background: Rare malignant tumors (RMT) make up 10% of all cancer in the pediatric age. The national and international cooperative projects will allow to understand their biology and improve the treatment results, making imperative the acknowledge the clinical course and the prognosis of Mexican pediatric patients with (RMT) Results: 178 patients were evaluated, with the age of 3 months to 17 years, 58% adolescents. The symptomatic presentation lag time was 7 days to 2 years. Most frequent symptoms were pain and palpable mass. The predominant histological type was thyroid carcinoma (29%) followed by 9% non-germ gonadal tumors and pancreatic exocrine tumors (6%). 27% metastatic. The treatment was surgical in 88%of the cases, and 5% received only palliative care. There were 38 patients with progression and 12 were due to toxicity. 18.9% of patients were lost of follow up due to abandonment of hospital care or transfer to adult hospital. Overall survival (OS) for all RMT was 63% at 100 months. SG for thyroid carcinomas was 68% within 109 months. Conclusion: The systematic study of RMT is not possible. Patients are staged and treated with protocols designed for adults. In our series, surgery is the cornerstone of treatment. Age establishes an organizational barrier for the treatment and follow-up of these patients in our country. Nevertheless we have taken the first step for this challenge in our country by assembling the first cooperative group of rare tumors, which hopes to become a support in the clinical decisions of pediatric oncologists in Mexico.

Advancing the field of communication research in pediatric oncology: A systematic review of the literature analyzing medical dialogue.

Historically, communication research in pediatric oncology has relied on surveys and interviews, resulting in cross-sectional and retrospective studies constrained by selection, recognition, and recall biases. This systematic review identifies and synthesizes the published literature analyzing primary data from recorded conversations between pediatric oncologists, patients with cancer, and their families, with the following objectives: (1) to identify the extent and content of the evidence base, (2) to describe methodological strategies utilized in the analysis of recorded medical dialogue, (3) to aggregate salient findings, and (4) to generate recommendations for future prospective research related to analysis of medical dialogue in pediatric oncology.

DICER1 and Associated Conditions: Identification of At-risk Individuals and Recommended Surveillance Strategies.

Pathogenic germline DICER1 variants cause a hereditary cancer predisposition syndrome with a variety of manifestations. In addition to conferring increased cancer risks for pleuropulmonary blastoma (PPB) and ovarian sex cord-stromal tumors, particularly Sertoli-Leydig cell tumor, individuals with pathogenic germline DICER1 variants may also develop lung cysts, cystic nephroma, renal sarcoma and Wilms tumor, nodular hyperplasia of the thyroid, nasal chondromesenchymal hamartoma, ciliary body medulloepithelioma, genitourinary embryonal rhabdomyosarcoma, and brain tumors including pineoblastoma and pituitary blastoma. In May 2016, the International PPB Registry convened the inaugural International DICER1 Symposium to develop consensus testing and surveillance and treatment recommendations. Attendees from North America, Europe, and Russia provided expert representation from the disciplines of pediatric oncology, endocrinology, genetics, genetic counseling, radiology, pediatric surgery, pathology, and clinical research. Recommendations are provided for genetic testing; prenatal management; and surveillance for DICER1-associated pulmonary, renal, gynecologic, thyroid, ophthalmologic, otolaryngologic, and central nervous system tumors and gastrointestinal polyps. Risk for most DICER1-associated neoplasms is highest in early childhood and decreases in adulthood. Individual and caregiver education and judicious imaging-based surveillance are the primary recommended approaches. These testing and surveillance recommendations reflect a consensus of expert opinion and current literature. As DICER1 research expands, guidelines for screening and treatment will continue to be updated. Clin Cancer Res; 24(10); 2251-61. ©2018 AACR.

Blood collection in cell-stabilizing tubes does not impact germline DNA quality for pediatric patients.

ObjectivesLiquid biopsy technologies allow non-invasive tumor profiling for patients with solid tumor malignancies by sequencing circulating tumor DNA. These studies may be useful in risk-stratification, monitoring for relapse, and understanding tumor evolution. The quality of DNA obtained for these studies is improved when blood samples are collected in tubes that stabilizing white blood cells (WBC). However, ongoing germline research in pediatric oncology generally requires obtaining blood samples in EDTA tubes, which do not contain a WBC-stabilizing preservative. In this study, we explored whether blood samples collected in WBC-stabilizing tubes could be used for both liquid biopsy and germline studies simultaneously, minimizing blood collection volumes for pediatric patients.MethodsBlood was simultaneously collected from three patients in both EDTA and Streck Cell-Free DNA BCT® tubes. Germline DNA was extracted from all blood samples and subjected to whole-exome sequencing and microarray profiling.ResultsQuality control metrics of DNA quality, sequencing library preperation and whole-exome sequencing alignment were virtually identical regardless of the sample collection method. There was no discernable difference in patterns of variant calling for paired samples by either whole-exome sequencing or microarray analysis.ConclusionOur study demonstrates that high-quality genomic studies may be performed from germline DNA obtained in Streck tubes. Therefore, these tubes may be used to simultaneously obtain samples for both liquid biopsy and germline studies in pediatric patients when the volume of blood available for research studies may be limited.

EPIDURAL MORPHINE IN PEDIATRIC ONCOLOGIC SURGERY

Epidural administration of opioids effectively prevents the sensitization of nociceptive neurons of the posterior horn of the spinal cord, induced by surgical trauma, without the development of motor and autonomic blockade. Study includes 52 patients aged 1 month to 18 years with malignant tumors who underwent surgical treatment at the Pediatric Oncology and Hematology Research Institute, during 2009-2016 years. Surgeries were combined (thoraco-laparotomy). The method of epidural use of morphine in pediatric oncosurgery is presented.

Child and adolescent self-report symptom measurement in pediatric oncology research: a systematic literature review.

Previous work in pediatric oncology has found that clinicians and parents tend to under-report the frequency and severity of treatment-related symptoms compared to child self-report. As such, there is a need to identify high-quality self-report instruments to be used in pediatric oncology research studies. This study's objective was to conduct a systematic literature review of existing English language instruments used to measure self-reported symptoms in children and adolescents undergoing cancer treatment. A comprehensive literature search was conducted in MEDLINE/PubMed, EMBASE, CINAHL, and PsycINFO to identify relevant articles published through November 10, 2016. Using pre-specified inclusion/exclusion criteria, six trained reviewers carefully screened abstracts and full-text articles for eligibility. There were 7738 non-duplicate articles identified in the literature search. Forty articles met our eligibility criteria, and within these articles, there were 38 self-report English symptom instruments. Most studies evaluated only cross-sectional psychometric properties, such as reliability or validity. Ten studies assessed an instrument's responsiveness or ability to detect changes in symptoms over time. Eight instruments met our criteria for use in future longitudinal pediatric oncology studies. This systematic review aids pediatric oncology researchers in identifying and selecting appropriate symptom measures with strong psychometric evidence for their studies. Enhancing the child's voice in pediatric oncology research studies allows us to better understand the impact of cancer and its treatment on the lives of children.

Таргетная терапия в лечении злокачественных опухолей у детей: опыт Научно-исследовательского института детской онкологии и гематологии

Actually targeted drugs became a therapeutic component for adult patients with malignancies and merge into clinical therapeutic recommendations. Targeted drugs in pediatric oncology had been using for 10-15 years and this experience under systematization and analysis. In the current issue 12-year experience of targeted therapy of Pediatric Oncology and Haematology Research Institute of N.N.Blokhin National Cancer Research Center is presented. Authors estimated efficacy and toxicity of rituximab, bortezomib, sorafenib and everolimus in 108 patients with advanced stages of mature B-cell non-Hodgkins lymphomas (B-NHL), relapsed/refractory acute lymphoblastic leukemia (ALL) and refractory osteosarcoma. Rituximab plus standard chemotherapy of advanced stages of B-NHL increased 10-years event-free survival up to 93.8±3%. Bortezomib plus anti-relapsed chemotherapy protocol (COG AALL07P1) reached minimal residual disease - negative status in 64.3% patients, but relapse-free survival was 24.5±19.4% (median 28±3.3 months). Sorafenib and everolimus were used for refractory osteosarcoma treatment, response rate was 100%, progression-free survival more than 6 months was 46% (median follow up 7±1.2 months). Toxicity profile was acceptable.Our data demonstrate a fact of significant improvement of advanced stages B-NHL treatment results by rituximab use, but relapsed/refractory ALL and osteosarcoma need treatment improvement.

Regional hyperthermia combined with chemotherapy in paediatric, adolescent and young adult patients: current and future perspectives.

Here we evaluate the current status of clinical research on regional hyperthermia (RHT) in combination with chemotherapy or radiation therapy in paediatric oncology.Data were identified in searches of MEDLINE, Current Contents, PubMed, and references from relevant articles using medical subject headings including hyperthermia, cancer, paediatric oncology, children, radiation therapy and chemotherapy. Currently, only two RHT centres exist in Europe which treat children. Clinical RHT research in paediatric oncology has as yet been limited to children with sarcomas and germ cell tumours that respond poorly to or recur after chemotherapy. RHT is a safe and effective treatment delivering local thermic effects, which may also stimulate immunological processes via heat-shock protein reactions. RHT is used chiefly in children and adolescents with sarcomas or germ cell tumours located in the abdomino-pelvic region, chest wall or extremities to improve operability or render the tumour operable. It could potentially be combined with radiation therapy in a post-operative R1 setting where more radical surgery is not possible or combined with chemotherapy instead of radiation therapy in cases where the necessary radiation dose is impossible to achieve or would have mutilating consequences. RHT might also be an option for chemotherapy intensification in the neoadjuvant first-line treatment setting for children and adolescents, as was recently reflected in the promising long-term outcome data in adults with high-risk soft tissue sarcomas (EORTC 62961/ESHO trial).The limited data available indicate that combining RHT with chemotherapy is a promising option to treat germ cell tumours and, potentially, sarcomas. RHT may also be beneficial in first-line therapy in children, adolescents and young adults. The research should focus on optimising necessary technical demands and then initiate several clinical trials incorporating RHT into interdisciplinary treatment of children, adolescents and young adults that include translational research components exploring potential immunological mechanisms of action.

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A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

BackgroundIn pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship.AimWe performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent.MethodsWe conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer.ResultsProfessionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person.ConclusionsAlthough the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.Electronic supplementary materialThe online version of this article (doi:10.1007/s40272-015-0158-9) contains supplementary material, which is available to authorized users.