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BACKGROUND: It can be difficult to explain pediatric phase 1 oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. METHODS: Suggestions for improving the informed consent process were first solicited from phase 1 study clinicians via questionnaire. Eight parents who had enrolled their child on a phase 1 pediatric oncology trial were recruited for an advisory group designed to assess the clinicians' suggestions and make additional recommendations for improving informed consent for pediatric phase 1 trials. RESULTS: A phase 1 communication model was designed to incorporate the suggestions of clinicians and families. It focused on educating parents/families about phase 1 trials at specific time points during a child's illness, but specifically at the point of disease recurrence. An informative phase 1 fact sheet that can be distributed to families was also presented. CONCLUSIONS: Families who will be offered information regarding phase 1 clinical trials can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be enhanced further when oncologists address key themes, beginning at the time of diagnosis and continuing through important decision points during the child's illness. This model should be prospectively evaluated.

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PURPOSE: To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. PATIENTS AND METHODS: Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. RESULTS: The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. CONCLUSION: Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.

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BACKGROUND: Informed consent for a pediatric oncology phase 1 trial is a delicate process, and is made more complex by the difficulty of the information and the requirement for parental consent, and patient assent when applicable. This analysis identifies suggestions for improving the informed consent process received from parents and adolescent and young adult patients (aged 14 years-21 years) who had the option of participating in a phase 1 pediatric oncology trial. METHODS: A total of 57 parents and 20 patients completed interviews as part of a multisite, prospective, descriptive study. These transcribed interviews were studied using established content analysis methods. RESULTS: Parent and patient responses contained 220 suggestions and 54 suggestions, respectively. A total of 21 unique suggestions for improvement emerged in 3 main themes: 1) provision of more information; 2) structure and presentation of the informed consent process, and 3) suggestions for physicians conducting the process. Common suggestions included providing more specific information about the trial, allowing more time for decision-making, and using different methods to deliver information. CONCLUSIONS: Participants involved in the informed consent process for a phase 1 trial provided specific recommendations to research teams to enhance the process. Physician/investigators should be informed of these recommendations and develop and test interventions incorporating them.

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PURPOSE: Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies. METHODS: In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I-related concepts during the ICC. Parent interviews were analyzed to determine understanding. RESULTS: The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs. CONCLUSION: Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

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During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

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In utero diagnosis of complex progressive cardiac disease such as hypoplastic left heart syndrome presents a novel opportunity for antepartum, intrapartum, and neonatal management. The clinical possibilities and potential for differing outcomes challenge the mother-foetus dyad with regard to informed consent. Previous studies reveal that rates of termination of pregnancy for foetuses with hypoplastic left heart syndrome vary widely in the United States and Europe, leading us to surmise that informed consent may be practised differently. The purpose of this paper is to review the ethical considerations and physician responsibilities of informed consent as they relate to prenatal and postnatal patients with hypoplastic left heart syndrome. Special consideration is paid to the informed consent process as practised by the obstetrician, perinatologist, paediatric cardiologist, and paediatric cardiac surgeon as it relates to termination of pregnancy, comfort care, and surgical palliation. We will argue that informed consent as it relates to hypoplastic left heart syndrome is far from standardised and that there exists a state of bioethical equipoise concerning the extent and limits of its application in the current clinical setting.

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BACKGROUND: This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials. METHODS: A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate. RESULTS: Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no-attempt-to-influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open-ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician-family communication. CONCLUSIONS: Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted.

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PURPOSE: To improve physician communication with parents using a physician-directed intervention (PDI), emphasizing a sequenced approach to the informed consent conference (ICC) for childhood leukemia clinical trials in which physicians discuss diagnosis, prognosis, and treatment prior to the offer of a clinical trial. METHOD: Physicians and fellows at the Children's Hospital of Philadelphia and Children's National Medical Center were recruited to participate in Informed Consent Seminars and subsequent half-day booster sessions. Training was followed by a multisite study of informed consent communication. Real-life ICCs were observed and audiotaped, and parents were interviewed after the ICC to ascertain their understanding. Data from the ICC and interview were then coded and analyzed. Trained physician performances were compared with untrained physicians (controls) at two other research sites. Data were collected from 2003 to 2007 at PDI sites and control sites for comparison. RESULTS: A total of 102 cases were included for initial analyses, with 60 cases from the PDI sites and 42 control cases. Fifty-nine cases were included in the final analysis. Findings revealed that trained physicians followed the sequenced approach more often when compared with controls. Similarly, physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way and clarify parents' questions more frequently than physicians at the control sites. CONCLUSIONS: Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The "see one, do one, teach one" approach is no longer adequate for informed consent.

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Although the concept of anticipatory guidance has long been used in general pediatrics to help prepare parents for what to expect in the coming months or year, this educational concept has not been transplanted for use in other contexts. The intervention described in this article uses the principles of anticipatory guidance in an effort to prepare parents of children with newly diagnosed acute leukemia for their upcoming discussions with their child's physician. Parents of children recently diagnosed with leukemia frequently feel overwhelmed and are anxious to discover what can be done to cure their child. By using the abilities of already medically trained oncology nurses and orienting them to conduct an intervention to educate, (empathize) emphasize, and prepare parents for the informed consent conference, this anticipatory guidance-based intervention was designed to target barriers to effective communication and increase the interactivity between families and health care providers.

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OBJECTIVE: The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia. METHODS: Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4. RESULTS: The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice. CONCLUSIONS: Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.

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Language interpreters mediate a growing number of health care communication events, including the informed consent process, which underlies the ethical conduct of clinical research. This article explores a key interpretive outcome, accuracy, in 21 Spanish/English informed consent consultations. Discussions were transcribed, translated, and coded according to established techniques. Most (74%) discussion was accurately interpreted (range: 47%-98%; std. deviation: .137). Accuracy was lower in the more technical portions of the discussion when compared with nontechnical portions such as discussion of coping and quality-of-life issues (p = .024). The concept of "randomization" often was poorly communicated and interpreted. These differences may be due in part to the use of long, uninterrupted, and jargon-filled sentences by clinicians explaining research, among other factors. The article concludes that accuracy may be promoted if clinicians used less technical language and shorter sentences, and are more "process driven." Interpreters may need to be better informed about research-related concepts such as randomization. Further research is needed to determine the effects of interpretive accuracy on the informed consent process, the decision to participate in research, and other outcomes.

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BACKGROUND: Oncologists in the US increasingly face the challenge of communicating with non-English speaking parents of children with cancer. This study explores this challenge from the perspectives of a sample of pediatric oncologists, interpreters, and Spanish-speaking parents of children with newly diagnosed leukemia. PROCEDURE: Thirty-seven oncologists and 17 professional language interpreters based at two non-profit pediatric hospitals in the US were surveyed on the topic of language barriers in pediatric care. Seventeen parents who communicated with their child's oncologist through an interpreter were also surveyed. RESULTS: All groups expressed considerable concern over the process of communicating across a language barrier. For oncologists, these concerns included the accuracy and completeness of interpretations, complexity of information, and loss of confidence and control over the communication process. For interpreters, they included complexity of information, information overload, and lack of clinician sensitivity toward the cultural and socioeconomic backgrounds of limited English proficiency (LEP) families. Parent concerns included difficulties comprehending information and anxiety over the possibility of missing out on important information. All groups provided multiple suggestions for improving communication across a language barrier. CONCLUSIONS: Oncologists, interpreters, and parents expressed considerable concern over the process of communicating across a language barrier. Some of these concerns could be minimized through efforts to boost interpreter accuracy and completeness, including the use of more simple, easy to understand language. Other issues, such as differences in culture and socioeconomic background, warrant consideration of the intercultural knowledge and skills of interpreters.

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Current informed consent standards are aimed at promoting an equitable and ethical environment for conducting research across diverse patient populations. This paper explores the possible effects of ethnicity and culture on the consent process for pediatric cancer clinical trials. Informed consent discussions were observed, recorded, transcribed, and coded. Question asking by parents and clinician/parent word ratios were used to create an interactivity measure, or "I-score." Visual analog scales were used to rate the clarity of specific explanations. Cases were sorted into two groups on the basis of parents' self-reported ethnicity: Caucasian (n=79, 56%) and minority (predominantly Latino) parents (n=61, 44%). Chi-square and t-tests were used to compare the groups. A series of logistic regression analyses (controlling for ethnicity and SES) were run for variables that showed statistically significant differences (p < 0.05). Our findings suggest that the content and quality of the informed consent process is linked to parental ethnicity, or clinician attitudes toward parental ethnicity. These findings are discussed in terms of current perspectives on culture and "cultural competence" in health care. Further research is needed to understand how cultural factors affect outcomes such as parental understanding, decision making, mutual trust, and satisfaction within the informed consent process.

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BACKGROUND: Researchers have a moral responsibility to offer to return research results to participants, but the needs and attitudes of parents and adolescents with cancer in paediatric oncology regarding the issue are relatively unknown. OBJECTIVES: To explore the needs of potential research participants or their guardians with respect to the offer of a return of research results. METHODS: A questionnaire was used in a focus group and in telephone interviews with eight adolescents and 12 parents of children with cancer. The participants were asked to respond to the questions and to comment on the inclusiveness of the questionnaire. RESULTS: The majority of participants (18 of 20) wished to receive research results. Two somewhat unexpected findings are described. First, all participants in the present study felt that it was the primary responsibility of the participant to retain contact with the researchers for the purpose of obtaining research results. Second, few participants (n=2) indicated that the Internet would be a satisfactory way of transmitting these results. One-half of the participants wished to have face-to-face communication of results. CONCLUSIONS: These results provide preliminary guidance for the return of research results to participants and validate the use of the questionnaire in a larger study of this issue.

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PURPOSE: To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent. PATIENTS AND METHODS: A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using chi(2) statistics and t tests. RESULTS: Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments. CONCLUSION: Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

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PURPOSE: Some patients may be at greater risk than others of enrolling on a randomized clinical trial (RCT) without fully understanding the implications. To investigate this possibility, this study poses the question, Do non-English-speaking Latino parents of children with leukemia show differences in their discussion of and understanding of an RCT when compared with English-speaking minority parents and with English-speaking majority (ie, white) parents? This research hypothesizes that factors such as social and educational status and the role of language interpreters may account for significant differences in the discussion and understanding of an RCT among the three groups. PATIENTS AND METHODS: A total of 108 parents are reported on, all of whom were observed, interviewed, and audiotaped during informed-consent discussions about participation in an RCT with their child's oncologist. Comparisons among the groups were performed using chi2 tests and a one-way analysis of variance. RESULTS: Problems of consent-related communication and understanding were more frequent among parents of low social status who spoke little or no English than they were in the two other groups. Several factors may have contributed to this disparity, including language interpretation, social status, and prevailing cultural norms. CONCLUSION: Some patients may be at greater risk than others of enrolling on an RCT without fully understanding the implications of their decision to do so. Numerous factors may contribute to this disparity, including language interpretation, social status, and prevailing cultural norms. Some specific strategies are suggested to help address this disparity.

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