PEDIATRICS Vol. 119 No. 4 April 2007, pp. e849-e859 (doi:10.1542/peds.2006-2208)
ARTICLE |
Improving Informed Consent: Suggestions From Parents of Children With Leukemia
a Center for Health Research, Kaiser Permanente, Portland, Oregon
b Department of Bioethics, Cleveland Clinic Foundation, Cleveland, Ohio
c Department of Pediatrics, Lerner College of Medicine, Cleveland, Ohio
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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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.
Key Words: informed consent • leukemia • clinical trials
Abbreviations: RCT—randomized clinical trial • ICC—informed consent conference • PAGIC—parent advisory group on informed consent
In the United States today, most children with cancer are treated in clinical research trials,1–4 and these high participation rates often are linked to significant improvements in treatment.5 The informed consent of the parents or guardians is an ethical requirement for enrollment of children in these clinical trials. However, communication and decision-making in the context of newly diagnosed pediatric cancer are fraught with difficulties for both physicians and families. Physicians report many obstacles to a good informed consent process, including explanation of extremely complex treatment protocols to parents who are in a state of shock after a recent diagnosis of cancer for their child, as well as time constraints on the informed consent process as a result of clinical urgency to begin treatment.6 Pediatric oncologists who were surveyed about the quality of informed consent for bone marrow transplantation reported a lack of patient and parent participation in the consent process.7 In addition, research has shown that many parents do not understand many critical components of clinical trial participation.8,9
These problems with communication and deficits in understanding have prompted a search for ways to improve the informed consent process.10,11 Many have called for inclusion of participants' views of the informed consent process, citing trial participants as an "underutilized resource"12 whose "voice [is] largely ignored."13 In the pediatric context, a number of researchers have gathered information on the parents' perspective of the informed consent process.14–27 These studies include reports of parents' motives for trial participation,15,19,25–27 as well as ratings of their satisfaction with their decision regarding participation,22 the amount of anxiety and feelings of pressure from the consent process,22 their self-assessed understanding of information,25 the amount and clarity of information,19,20,25 and whether there was adequate time for decision-making.20,25 Some of these authors use parent ratings to then develop suggestions for improving the informed consent process.19,23,25 Unfortunately, the predominant use of closed-ended questions in these studies does not allow parents the opportunity to speak in their own terms and expand on issues that are relevant to them. Therefore, the suggestions that were developed by these researchers may reflect the views and interests of the researchers rather than aspects of the informed consent process that parents consider most important and in need of improvement.
Several researchers have taken the critical next step of asking the parents themselves for suggestions on how to improve the informed consent process, using various methods including focus groups,15,18 questionnaires,14 and interviews.16,17 These authors have moved informed consent evaluation research beyond parent ratings of the quality of the consent process to specific recommendations for improving it. These previous studies are limited, however, by their small sample sizes, geographic homogeneity, use of a single method, and cross-sectional design. In addition, only 1 of these studies reported the opinions of parents who decided not to enroll their children in a clinical trial,18 a group that may have particularly insightful suggestions for improving informed consent.
The data reported here provide crucial information on the parents' perspective of informed consent from a large, diverse sample of parents, using a longitudinal design and multiple methods. The suggestions that were provided by parents in our study offer honest, useful guidance in our efforts to improve informed consent for future families of children who receive a diagnosis of cancer. Moreover, these recommendations are equally relevant to the informed consent process for clinical trials in numerous other adult and pediatric contexts.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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This article uses data from Informed Consent in the Children's Cancer Group (CCG-S9901), a large study that was funded by the National Cancer Institute and examined the informed consent process for pediatric leukemia randomized clinical trials (RCTs). We recruited parent-participants from 6 Children's Cancer Group institutions that routinely treat children with acute leukemia: Rainbow Babies & Children's Hospital (Cleveland, OH), Children's Hospital of Philadelphia (Philadelphia, PA), Children's Hospital Medical Center (Cincinnati, OH), Children's Hospital of Los Angeles (Los Angeles, CA), MD Anderson Cancer Center (Houston, TX), and Children's National Medical Center (Washington, DC). The study was approved by the institutional review board at each site.
A thorough description of the methods that were used in the larger study was published previously.8 We obtained the informed consent of the parents, physicians, and patient (when appropriate) shortly after the patient's diagnosis with either acute lymphoblastic leukemia or acute myeloid leukemia. Trained researchers observed and tape-recorded the informed consent conference(s) (ICC) that clinicians convened for the purposes of discussing treatment options, including RCT participation. This article uses data from 4 subsequent stages of the research. An overview of the research method is shown in Fig 1.
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Parents were interviewed within 72 hours of the ICC with their child's clinician(s), after they had made a decision about whether to participate in the RCT. Whenever possible, the parent who was most active during the ICC was interviewed. During the interview, parents were asked, "In your opinion, how can we make the process of decision-making better?" During follow-up interviews that were conducted over the telephone 6 to 8 months after diagnosis, these parents were again asked for suggestions with the question, "In your opinion, how can we improve the process of decision-making about clinical research studies?"
After the observation and interview phase of the study was complete, focus groups were held at each of the participating sites with a sample of 72 parents who had participated in the observation/interview phase of our research. These focus groups were designed to elicit more in-depth parent perspectives on aspects of the informed consent process using a more open-ended, interactive method. A professional facilitator who had a background in education and was unknown to the participants facilitated the discussions, with an observer taking notes. Each session lasted 2 hours and was audiotaped. Participants were purposefully selected to ensure inclusion of the perspectives of both mothers and fathers, ethnic majority and minority parents, and clinical trial participants and those who declined trial participation for their child. The facilitator used a question list to guide the discussions, which included the following questions regarding improving the informed consent process: "What do you think could be done to help parents better understand and make a decision about the research study?" and, "What would you tell doctors to help them help parents to make the most informed or best decision possible about participating in a research study?"
During each focus group, participants were asked to nominate a parent to represent their group in the parent advisory group on informed consent (PAGIC). A 2-day meeting of the 9 PAGIC parents was convened in October 2002. During the meeting, members of PAGIC were asked to provide their interpretations of the data that we had collected during observation of ICCs, parent interviews, and focus groups. They also worked together to develop recommendations for how to improve the informed consent process.
The audiotaped interviews, focus groups, and PAGIC meeting were transcribed, and dialogue in Spanish was translated into English. Responses to the questions in the parent interviews regarding improving the informed consent process were extracted, along with suggestions that were found in the transcripts of the focus groups and PAGIC meeting. A parent's comment or response was considered a suggestion when he or she (1) directly stated a method for improving the process of informed consent or (2) reported a negative characteristic of their informed consent process that should be improved. All parental suggestions were then reviewed for common themes by the first author (Dr Eder), using an approach that was based on grounded theory, an inductive process that identifies important themes in data through multiple readings of the transcripts.28 The second author (Ms Yamokoski) verified the themes to ensure that they were mutually exclusive and exhaustive. A set of suggestion categories were developed from the themes. Two coders (Ms Yamokoski and Mr Wittmann) then independently assigned each suggestion to the appropriate category. Dr Eder served as a third independent coder in situations in which there was disagreement. For the parent interview and follow-up telephone interview, the number of suggestions within each category was tallied. Multiple suggestions within the same category that were given by a parent during an interview were counted only once. In addition, suggestions from the parent interview that were repeated by a parent during the follow-up telephone interview were counted only once. Suggestions that were given during the focus groups and PAGIC meeting were categorized but were not counted because of the unstructured discussion format.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Parent Interviews
Demographic characteristics for the sample are shown in Table 1. Eight of the 140 parent-participants were unable to recall discussing a clinical trial with their child's physician; therefore, these parents were not asked any questions about the informed consent process during the parent interview. Seventy (53%) of the 132 parents who completed the parent interview offered at least 1 suggestion for improving the informed consent process, and these 70 parents gave a total of 103 suggestions. Thirty participants were lost to follow-up in the interval between the parent interview and the follow-up telephone interview. Fifty-eight (53%) of the 110 parents who completed the follow-up telephone interview offered at least 1 suggestion for improving the informed consent process, and these 58 parents gave a total of 74 suggestions. The 177 suggestions that were given during both interviews were grouped into 9 different categories according to the topic of the suggestion. Table 2 shows the 9 suggestion categories in decreasing order of frequency, and examples from each of the categories are in Table 3.
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More Time for Decision
The most frequently cited (44 [25%] of 177) suggestion relates to giving parents more time to make a decision about participation in the clinical trial. Parents who offered this suggestion pointed to needing an opportunity to consult with others and cope with their emotions before making the decision. Many of these parents also exhibited knowledge of the trial protocol and wondered why a decision had to be made so far in advance of the randomization portion of the treatment.
Amount of Information
Twenty-nine suggestions relating to the amount of information were given during the 2 interviews. Suggestions in this category were of 3 major types, including recommendations that (1) more information be given to parents about the trial, (2) less information be given to parents about the trial, and (3) the amount of information given be tailored to each family's individual needs and preferences for information. The majority (23 [79%] of 29) of suggestions in this category stressed the need for more information. Other parents (5 [17%] of 29) felt overwhelmed by the amount of information that they were given, and 2 of these parents specified that they were given too much information in too short a time. One parent offered a solution to this problem of different parent information preferences by suggesting that the amount of information be tailored to individual parent needs.
Details of RCT
Parents offered 27 suggestions that focused on provision of specific information about the clinical trial, including comparison of standard treatment to the trial, description of the various arms of the trial, the risks and benefits of participation, and results to date.
Organization of ICC
Parents offered 22 suggestions concerning the organization of the informed consent process, including the need for repetition and breaking the process into at least 2 meetings.
Additional Materials
Parents made 19 suggestions regarding the need for additional or better materials about the RCT, including improvement of the consent document as well as provision of videos, books, and other literature.
Communication Style
Thirteen suggestions regarding the doctor's communication style were given during the interviews. Parents emphasized the importance of doctors communicating in an honest, empathic manner, with limited jargon and plenty of opportunity and encouragement to ask questions.
Support
The 11 suggestions in this category relate to provision of support during the ICC or during decision-making. Many of these suggestions refer specifically to speaking with other parents of children with leukemia who have already been through the clinical trial decision-making process.
Translation Issues
Eight parents whose native language is not English stressed the need for translated materials and qualified interpreters during the informed consent process.
Decision-Making Preference
Parents offered 4 suggestions regarding their preferences for decision-making responsibility. Three parents advocated for a recommendation from the physician, whereas 1 parent advised leaving the choice regarding participation in the RCT completely up to the parents.
Focus Groups
During the focus groups, parent participants introduced and discussed suggestions that revolved around the same themes that were found in the parent interview responses. Although these focus group discussions took place months or years after the ICC, parents still recalled problems with the process and continued to stress the need for improvements related to the 9 suggestion categories listed. Examples of each are shown in Table 3.
PAGIC Meeting
During the meeting, PAGIC parents divided into small groups to listen to segments of audiotaped ICCs from the direct observation phase of the research and evaluate the positive and problematic aspects of the consent communication. Parents then regrouped to share their perspectives with the others. The ICC segments were selected by the research team to be representative of the range of ICC contextual variables in our study, such as institution, protocol, and type of leukemia. There was no a priori discussion agenda, and the parents were allowed to drive the discussion of the audiotape segments.
The conversation among parents during the PAGIC meeting touched on all of the themes outlined above, but the vast majority of suggestions focused on organization of the information that is presented during the ICC. The discussion culminated in the development of the PAGIC Model of Informed Consent (Fig 2), the 7 major components are (1) timing, (2) sequence, (3) checklist, (4) checking for understanding, (5) anticipatory guidance, (6) segue into RCT discussion with historical perspective, and (7) choice. Descriptions of each component in the words of the PAGIC members are given in Table 4.
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Timing
Members of PAGIC suggested that the ICCs be scheduled in a way to give parents as much time as possible to make their decision. They also stressed the need for the informed consent process to be broken into at least 2 distinct meetings with a break in between for absorbing the information that they had been given and coping with their emotions. The PAGIC participants argued that because parents go through stages in responding to their emotions and the complex information that they are receiving, physicians should gauge how parents are doing, both emotionally and cognitively, and break up the discussion accordingly. Therefore, the timing of discussion of current treatment should depend on parents' ability to absorb more information after hearing the information about leukemia (see Fig 2).
Sequence
Figure 2 shows the order in which the major topics of the informed consent process should be covered. PAGIC parents clearly articulated the need for presenting information in a logical sequence to aid comprehension.
Checklist
The PAGIC members developed a checklist of major topics that should be covered consistently in all ICCs. The topics and the meeting in which they should be addressed are shown in Fig 2. Parents also suggested that it might be helpful if another member of the health care team is present to assist in managing the checklist to allow the physician to be engaged fully with the family during the discussion.
Checking for Understanding
Parents emphasized the importance of checking for understanding of the information just presented before moving on to the next topic. The arrows in Fig 2 demonstrate that physicians should be prepared to explain a subject in various ways until parents understand it clearly and are ready to progress to the next concept. Open-ended questions such as, "What do you understand about X?" are better at eliciting parental understanding than easily dismissed, closed-ended questions such as, "Do you understand?"
Anticipatory Guidance
PAGIC parents stressed the importance of the doctor clearly laying out at the end of each discussion what is to come next, including when the next discussion will be, what the next discussion will cover, and when a decision will need to be made.
Segue Into RCT Discussion With Historical Perspective
PAGIC parents recommended transitioning into discussion of the RCT by presenting the improvement of the cure rate through time. They suggested that this historical perspective puts the current cure rate in a positive light, which helps parents accept the diagnosis and prognosis. Explaining the role that RCTs have played in the improvement of the cure rate provides an opportunity for physicians to introduce the RCT by explaining the need for additional research to improve the cure rate for future children.
Choice
PAGIC parents highlighted how critical understanding of the voluntary nature of the trial is to the informed consent process. They advised using the word "choice" at least 3 times during the ICC to ensure that parents have a full appreciation of the concept.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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At 4 different points during their child's treatment for leukemia, the parents in our study shared many practical suggestions for improving the informed consent process. Unlike previous work in this area, our research design allowed parents to go beyond simple ratings of aspects of the consent process to provision of explicit recommendations for change on the basis of their own experiences with informed consent.
Parents continually reiterated the need for more time to make the trial decision, which is consistent with the results of many other studies of parental perspectives on the consent process.14,16,17,21,23 The time allowed for decision-making about trial participation varies according to the trial offered for a particular child. In this study, 74% of patients were offered participation in a trial that required a decision within 72 hours of the child receiving his or her first chemotherapy. The CCG-1991 study that was offered to 26% of the families incorporated a staged consent process that allowed parents to consent up front to the first 28 days of therapy, which is the same on or off the trial, and then make a decision about the randomized portion of the trial by the 28th day. We have reported elsewhere on the improved understanding and trust levels that were found in the group of parents who were involved in the staged consent process.29 These data, as well as the parental opinions reported here, suggest the need for additional efforts that aim to increase the number of protocols that allow more time for decision-making. In addition, physicians should plan the consent process in such a way as to allow for as much time for decision-making as possible within the limits of the child's medical condition and the particular trial protocol being offered.
A common recommendation made by parents was that more information about the clinical trial be provided. Time constraints that are imposed by busy clinical schedules and requirements of the protocol make it a challenge for physicians to spend more time discussing the trial with parents. Greater attention to the quality and organization of the information provided, rather than strictly quantity, may mitigate the additional time burdens that would result from simply providing more information. Parental suggestions on how to organize the informed consent process culminated in the development of the PAGIC Model of Informed Consent during the PAGIC meeting. The PAGIC Model of Informed Consent closely parallels many features of the communication sequence that was proposed by Brown et al30 to increase patient understanding of information, including presentation of standard treatment before discussion of the clinical trial, some type of segue into the clinical trial discussion, and regular opportunities for patients to respond to the information that they have been provided. PAGIC parents in our study provided additional information on the form that the segue should take and focused more on opportunities for asking questions and ensuring understanding of information after each section. Parents who were interviewed by Kupst et al17 also recommended explaining information 1 step at a time and checking parents' understanding before moving on to the next topic. Better organization of the ICC through the use of the PAGIC model may ultimately save time for physicians by making backtracking unnecessary and reducing parents' confusion. In addition, parents may be less likely to feel overwhelmed by the volume and the content of the information if it is presented in a logical order during the course of multiple meetings, rather than jumbled together in 1 long conference. The regular feedback loops that are built into the PAGIC model also serve to increase parental participation in the ICC, which in turn can lead to better understanding.
Many parents in our study made specific requests for greater disclosure of details of the clinical trial, but the particular information desired varied from parent to parent. The finding by Tait et al24 of differences in priorities for disclosure of elements of informed consent between parents and investigators underscores the importance of eliciting parent information preferences to ensure that they obtain the information they want and need. The variability in parental preferences for decision-making responsibility that was found in our study and others27,31 adds emphasis to the need for open communication about individual parent preferences during the ICC.
Parents' suggestions for limiting the use of jargon and simplifying information have been reported in other studies14,15,18 and are likely to contribute to an improved informed consent process. Implementation of parental recommendations for strategic use of the consent document and other materials as educational tools could further enhance the communication process and lead to more informed decision-making. Likewise, provision of skilled interpreters and translated documents is a basic necessity for communication with non–English-speaking parents. Finally, our results reinforce previous research that stressed the importance of ensuring that parents have access to various social supports, both during the ICC and throughout the decision-making process.15,18,23
Some might argue that many of the suggestions made by these parents should be intuitive to physicians already. However, these suggestions come from 140 parents who reported on their actual experience of ICCs that were led by 65 different physicians at 6 hospitals that routinely treat children with acute leukemia. Therefore, these recommendations generally are not being put into practice during the informed consent process. Physicians may find it challenging to implement some of these parental suggestions, especially those that require more discussion and decision-making time. The parents developed the PAGIC Model of Informed Consent to alleviate these challenges by providing an organizational structure that enhances the quality and efficiency of the communication process.
A possible limitation of the study is that the PAGIC parents who developed the PAGIC Model of Informed Consent were both vocal and articulate, and their views may not be representative of the majority of parents. However, these parents were asked to review the transcript of the focus group in which they participated and summarize the perspectives of their group during the meeting, and these summaries served as a foundation on which the PAGIC model was built. In addition, the suggestions that were discussed during all 4 stages of the research were fairly consistent; therefore, it is likely that the recommendations developed in the later stages represent the views of the larger group of parents. Furthermore, the suggestions presented here are generalizable to most other adult and pediatric patient populations with minimal adaptation.
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CONCLUSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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By using several methods and data collection time points, this study presents a robust plan for improving informed consent. Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the process. Our findings show that parents have valuable advice to offer and therefore are appropriate consultants in our research endeavors. The communication process in which the parents in our study were involved is not fundamentally different from other adult and pediatric contexts that involve a new diagnosis; therefore, there is potential for broad application of the parental recommendations reported here, which could lead to greater patient and parent satisfaction, enhanced understanding, and more informed decision-making in many situations.
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ACKNOWLEDGMENTS |
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This study was supported by the National Cancer Institute (RO1 CA83267).
These data were collected via a limited-institution study in the Children's Cancer Group (CCG-S9901). We thank Omar Jadue for his valuable assistance throughout the project, the Children's Oncology Group (formerly Children's Cancer Group) for their leadership and support, and our research staff for their dedication and excellent work. We appreciate the clinicians, parents, and children who participated in this research and especially acknowledge the tremendous efforts of the members of the PAGIC.
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FOOTNOTES |
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Accepted Oct 13, 2006.
Address correspondence to Eric D. Kodish, MD, Cleveland Clinic Foundation, Department of Bioethics, 9500 Euclid Ave, JJ60, Cleveland, OH 44195. E-mail: kodishe{at}ccf.org
The authors have indicated they have no financial relationships relevant to this article to disclose.
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