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Journal of Clinical Oncology, Vol 22, No 13 (July 1), 2004: pp. 2708-2717 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.10.034 Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult OncologyFrom the Department of Bioethics and the Rainbow Center for Pediatric Ethics, Department of Pediatrics, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, OH Address reprint requests to Christian M. Simon, PhD, Department of Bioethics/Oncology, Case Western Reserve University School of Medicine, 10900 Euclid Ave, Cleveland, OH 44106; e-mail: cxs66{at}po.cwru.edu
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 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.
Properly informing and gaining the consent of potential research subjects is a critical ethical safeguard in the ongoing search for new and improved cancer therapies.1-4 In both pediatric and adult oncology, the goals of informed consent are similar: To provide decision makers with easy-to-understand information about treatment goals and procedures, anticipated risks and benefits, alternative procedures or therapies, and voluntariness.5,6 However, pediatric and adult cancer care environments are different in significant ways, and it follows that these differences may impact how these goals are interpreted and met in reality. In this report, we compare the informed consent processes for phase III pediatric and adult oncology randomized clinical trials (RCTs). Our aim is to identify any significant differences between these two processes and to suggest that these differences be addressed in current efforts to strengthen the informed consent process for RCTs. Ultimately, both the protection and enrollment of human subjects on RCTs may be better served by policies and guidelines that acknowledge these differences.
Comparative data were derived from two studies: (1) Informed Consent in the Children's Cancer Group, which was conducted at six US pediatric oncology centers active in clinical trials research; and (2) Therapeutic Research Consent: Empirical/Ethical Analysis, which was conducted in a university-based adult comprehensive cancer center in northern Ohio. The pediatric study examined the informed consent process for children newly diagnosed with either acute lymphoblastic leukemia or acute myeloid leukemia. The adult study examined cancer patients who were eligible for adjuvant therapy after having received definitive surgical management for melanoma, breast, and colon cancers. Both studies were approved by Institutional Review Boards at participating institutions. Written consent was obtained from all participants before data collection. Similar data-gathering instruments and methods were used in both studies. Research assistants in both studies observed and tape-recorded the treatment consultations, in which oncologists offered their patients (or surrogates) the option of participating in a clinical trial. Both studies used an observer checklist (OC) to conduct a fine-grained analysis of the tape-recorded consultations. Originally developed by one of the authors (L.A.S.7) and adapted for use in the pediatric study, the OC allowed for a side-by-side comparison of numerous communication aspects of the adult and pediatric oncology consultations. Visual Analog Scales were included in the OC for rating such issues as the clarity, comprehensiveness, and speed with which clinicians explained the clinical trial to patients or surrogates. All OC items were independently coded by three research assistants and then reconciled according to a rule book designed to limit misinterpretation of each coded item. OC items that were specific to either the adult or pediatric samples and not comparable, were eliminated for purposes of this analysis.
A semistructured interview with cancer patients or their surrogates was administered to elicit data on their comprehension of core informed consent issues, their demographic background, and other key variables. Both studies also administered: (1) a Satisfaction with Decision Questionnaire—a six-item scale with excellent reliability (Cronbach's The independent variable of interest for all analyses was dichotomous (adult cancer patients v surrogate decision makers for pediatric cancer patients). The dependent variables of interest included items from the OC, the interviews, and the standardized instruments described above. The dichotomous items from the OC had yes or no responses indicating whether or not the behavior had occurred. The OC variables used in this analysis assessed elements of informed consent, characteristics of the communication and interaction between the physician and the decision maker, as well as decision makers' comprehension and preference for trial participation. More specifically, five basic elements of informed consent were measured: (1) treatment goals and procedures, including randomization; (2) anticipated risks; (3) anticipated benefits; (4) alternative procedures or therapies; and (5) voluntariness.5,6 Relational factors such as partnership building and clinician recommendations regarding treatment were also measured. Decision-maker comprehension was measured with three dichotomous items having "yes" or "no" responses indicating whether individuals understood the concept of randomization, that they would not have to participate in the trial to receive treatment, and that they could stop participation at any time. Additional questions assessed whether the subject had read the consent form, and the patient's preference to enroll in the trial with yes or no responses. Continuous variables assessed voluntariness, elements of communication and interaction, and decision makers' perceptions. Voluntariness and partnership building were created from dichotomous items found in the OC, using a simple additive algorithm. The voluntariness outcome was constructed from three dichotomous items measuring whether the clinician explained that (1) the trial was voluntary, (2) the participant could withdraw at any time, and (3) the decision maker could take his/her time in choosing to participate in the trial. Scores for the voluntariness variable ranged from 0 to 3 (mean, 2.11; standard deviation [SD], 0.95). A partnership-building composite variable used to assess communication and interaction was constructed out of four OC items: (1) clinician asks for opinions and/or preferences about treatment options, (2) clinician explains rationale for treatment, (3) clinician discusses why patient is eligible for the clinical trial, and (4) clinician asks patient/surrogate if they have any questions about the trial. Scores for partnership building ranged from 0 to 4 (mean, 2.4; SD, 1.1). Additional continuous variables used to assess the physician and patient interaction were the length of the consultation, number of decision-maker questions adjusted for length of consultation, and clinician's rate of speech. The length of the interaction ranged from 9 to 183 minutes (mean, 70.67 minutes; SD, 31.78 minutes). The number of questions that were asked adjusted for length of consultation ranged from 0 to 2.12 per minute (mean, 0.52 questions per minute; SD, 0.36 questions per minute). A Visual Analog Scale measured a rating (on a scale of 0 to 10, with 0 being "very quickly" and 10 being "very slowly") of the speed of the clinician's speech (mean, 5.01; SD, 2.06; range, 0 to 10). Three continuous items were used to assess decision makers' perceptions of regret in the decision, satisfaction with the decision, and trust in the oncologist. The regret decision scale scores ranged from 5 to 16 (mean, 7.14; SD, 2.68). Satisfaction with the treatment decision scores ranged from 6 to 19 (mean, 9.79; SD, 3.35). The trust in the oncologist scores ranged from 15 to 105 (mean, 95.29; SD, 10.44).
All analyses were conducted using the SPSS 11.0.3 statistical package. The
Demographics The total sample size was 219 decision makers—79 in the adult study and 140 in the pediatric study. In both studies, the majority of decision makers were female (n = 160; 73.1%). Because the adult study included a preponderance of female breast cancer patients, more females than males made decisions in the adult oncology setting (n = 75; 94.9%) when compared with the pediatric oncology setting (n = 85; 60.7%) (  2 = 30.05; P < .001). Decision makers in the pediatric setting were ethnically more diverse than decision makers in the adult setting (2 = 19.67; P < .001). Specifically, adult decision makers included 67 whites (85.9%) and 11 African Americans (14.1%). Pediatric decision makers included 79 whites (56.4%) and 61 minorities (43.6%), including African American, Latino, Asian American, and other groups. The pediatric sample was more diverse, as it was drawn from six major urban areas around the country.
Adult decision makers were more likely to have a high school education or greater (n = 71; 97.3%), when compared with pediatric (n = 111; 79.9%) decision makers (
Elements of the Disclosure Process The process of informed consent should include information about: (1) treatment goals and procedures, including randomization; (2) anticipated risks; (3) anticipated benefits; (4) alternative procedures or therapies; and (5) voluntariness.5,6 Each of these issues must be covered if patients are to be fully informed of their treatment options and their rights as potential research subjects. We therefore conducted the following analyses, which are summarized in Table 2.
Element 1: Treatment Goals and Procedures Rationale for treatment. We analyzed the treatment consultations to find out whether decision makers were told why they or their children needed treatment for their cancer. Decision makers in the adult oncology consultations were more often (n = 78; 98.7%) provided an explanation concerning why they needed cancer treatment when compared with decision makers in the pediatric oncology (n = 119; 85.0%) consultations ( 2 = 10.54; P = .001).
Survival or cure.
We also considered the extent to which decision makers were given information about the chances for survival or cure if they received medical treatment. Consultations in the pediatric oncology setting were more likely (n = 134; 95.7%) to include information about long-term survival and cure following treatment in general when compared with the consultations in the adult oncology (n = 48; 61.5%) setting (
Eligibility.
Decision makers in the adult oncology consultations were more often (n = 50; 64.1%) provided an explanation as to why they were eligible for a clinical trial when compared with decision makers in the pediatric oncology (n = 52; 37.1%) consultations (
Inconvenience.
Only a minority of consultations demarcated the inconveniences of clinical trial participation versus standard treatment. Compared with 19.2% (n = 15) of adult consultations, no pediatric consultations demarcated treatment inconvenience in terms of both the clinical trial and standard treatment (
Randomization.
For many patients or their surrogates, the prospect of random assignment to a specific medical treatment may be a difficult and uncomfortable concept to grasp. The concept of randomization was explained in the majority of the adult (n = 55; 69.6%) and pediatric (n = 114; 83.2%) consultations we analyzed, though it occurred more frequently in the pediatric group (
Element 2: Anticipated Risks
Numerical information about risks.
Compared with one-third (n = 26) of the adult oncology consultations that included some numerical information to help decision makers assess the level or likelihood of risk involved in participating in the clinical trial, no pediatric consultations provided such information (
Element 3: Anticipated Benefits
Numerical information about benefits.
Decision makers in the adult setting (n = 16; 20.5%) were more likely to receive numerical information to help them assess the benefits of the clinical trial when compared with decision makers in the pediatric (n = 11; 7.9%) setting (
Altruism.
A final difference was found when comparing discussion about altruism, a (societal) benefit that researchers have associated with the decision to enroll in clinical research.5 The pediatric group was more likely (n = 104; 74.3%) to discuss altruism as a reason for participating in the clinical trial when compared with the adult (n = 30; 38.0%) group (
Element 4: Treatment Alternatives
Element 5: Voluntariness
Elements of Communication and Interaction
Clinician-initiated behaviors: Explicit recommendation of the clinical trial. Patients place considerable stock in physicians' treatment recommendations and advice.11 We therefore analyzed the pediatric and adult consultations for evidence of explicit recommendations of the clinical trial. Adult consultations more frequently (n = 56; 75.7%) included an explicit recommendation of the clinical trial when compared with the pediatric (n = 53; 37.9%) consultations ( 2 = 27.706; P < .001). Clinician-initiated behaviors: Partnership building. Partnership-building behaviors in which clinicians and patients build an alliance by engaging in mutual question asking, for example, have been positively associated with reduced anxiety and shock, improved understanding, and higher satisfaction among patients.12 On average, adult oncologists in our study scored higher (mean, 3.23; SD, 0.852) than the pediatric oncologists (mean, 1.94; SD, 0.95) on partnership-building behaviors (t216 = 9.95; P < .001). Clinician-initiated behaviors: Duration of disclosure process. Factors such as patient comprehension and decision-making capacity may be affected by the amount of time clinicians spend discussing treatment issues with their patients. We therefore also measured (by totaling the amount of time participants spent in all observed consultations before making a decision on whether or not to participate in the clinical trial) the duration of the disclosure process involving pediatric and adult subjects. The pediatric disclosure process lasted significantly longer on average (mean, 78.76 minutes; SD, 32.59 minutes) than the adult (mean, 54.73 minutes; SD, 23.06 minutes) process (t186.99 = –6.19; P < .001). Clinician-initiated behaviors: Rate of clinician's speech. Rate of speech may also facilitate or hinder effective communication. The rate of speech among pediatric oncologists (mean, 5.37; SD, 1.88) was on average faster than that of adult (mean, 4.36; SD, 2.21) oncologists (t217 = –3.57; P < .001) in this study. Patient/surrogate-initiated behaviors: Question asking. Patients who ask more questions of their clinicians tend to have a better understanding of their condition and treatment.13,14 In our study, there was no significant difference in questions asked per minute between adult decision makers (mean, 0.55, SD, 0.45) and pediatric decision makers (mean, 0.51, SD, 0.51) (t103.352 = 0.801; P = .425).
Decision-Maker Comprehension, Perceptions, and Preferences
Comprehension: Randomization. Because of the randomized nature of RCTs, the exact treatment course that a patient will receive on an RCT cannot be known beforehand or determined by the patient, their surrogate, or their oncologist. We therefore asked decision makers, "Will you be able to choose the treatment option you want if you enrolled in the trial?" Significantly more adult decision makers (n = 49; 92.5%) correctly reported that they would not be able to choose the treatment option they wanted, when compared with the pediatric (n = 84; 60%) decision makers ( 2 = 18.90; P < .001). Using logistic regression, we examined this item controlling for ethnicity and education. Pediatric decision makers were more likely than adult decision makers to report that they would be able to choose the treatment they wanted if they enrolled their child in the trial (odds ration [OR], 3.67; 95% CI, 1.18 to 11.47). Decision makers' level of education (OR, 0.61; 95% CI, 0.45 to 0.84), and ethnicity (OR, 3.25; 95% CI, 1.57 to 6.73) were associated with an incorrect understanding of this issue.
Comprehension: Voluntariness.
All adult decision makers understood that they did not have to participate in the clinical trial in order to receive treatment, compared with fewer pediatric (n = 115; 82.1%) decision makers (
Comprehension: Reading the consent document.
More adult decision makers (n = 45; 90.0%) reported reading the consent document when compared with the pediatric decision makers (n = 102; 80.3%), but the difference was not significant ( Perceptions and preferences: Trust in the oncologist. Trust is a vital component of the physician-patient relationship.15,16 Adult decision makers reported a higher overall level of trust (mean, 99.72; SD, 11.68) in their oncologists compared with pediatric (mean, 92.77; SD, 8.75) decision makers (t216= 4.98; P < .001).
Perceptions and preferences: Enrollment decision.
Decision makers in both studies were asked whether or not they had decided to participate in the clinical trial. More than 80% (n = 112) of pediatric decision makers reported opting for the clinical trial compared with 40% (n = 22) of the adult decision makers ( Perceptions and preferences: Satisfaction with decision and decisional regret. A scale designed to measure how satisfied decision makers were with their decision to participate or not to participate in the clinical trial was administered shortly after they had made their decision. No significant differences were evident in the measurements taken at that time (t206 = –1.00; P = .318). However, differences were evident in the decisional regret data derived 6 to 8 months after the consultations. Asked to reflect on their decision to participate in the clinical trial, pediatric decision makers reported an overall higher level of regret (mean, 7.71; SD, 2.79) than adult (mean, 6.48; SD, 2.40) decision makers (t166.94 = –3.08; P = .002).
Our data revealed a number of significant differences between the adult and pediatric informed consent process for cancer clinical trials. These differences may be indicative of key differences between pediatric and adult care environments. Although united by the goal of caring and improving treatments for patients with cancer, pediatric and adult oncology environments are unique in several important respects. Pediatrics is centered on children. This may disproportionately heighten the impact of emotional and psychosocial stressors on the capacity of parents to absorb, process, and act on the information they receive about their child's treatment options.17 This may partly explain why pediatric decision makers understood some kinds of information less often than adult decision makers, even when a greater number of pediatric decision makers received that information (ie, "voluntariness"). The pediatric informed consent process is also primarily focused not on the patient but on a surrogate figure such as a parent or guardian. Oncologists in adult care confront this issue only in special situations.18,19 Consequently, the adult informed consent process is less frequently affected by issues of patient autonomy, the possibility of familial coercion, and other factors related to the ethics of proxy decision making. The adult oncology environment is possibly characterized by a more direct, unambiguous relationship between oncologist and patient, a factor that may help explain why adult decision makers trusted their oncologists more and less frequently regretted their decision to enroll or not to enroll in the clinical trial. More research is needed to fully understand the possible effects of these and other factors on the informed consent process. We provide the following recommendations to help improve the disclosure and understanding of key informed consent information in pediatric and adult oncology. Table 5 is provided in an effort to prioritize our recommendations.
Perhaps most importantly, pediatric decision makers need help distinguishing the clinical trial from standard treatment. Many were provided with information about the anticipated goals, procedures, and risks and benefits of treatment, but without clear indication of whether this information pertained to the clinical trial or standard treatment. It is doubtful whether other core elements of informed consent can be fully understood without prior explanation of the differences between treatment options. If these differences are not made clear, decision makers may find it difficult or impossible to fully grasp elements such as voluntariness or randomization even after these have been explained to them. Pediatric oncologists therefore need, first and foremost, to clearly indicate to parents when they are discussing trial-related issues and when they are discussing standard treatment issues. Statements such as, "This applies to the clinical trial but not to the standard treatment" or "This will happen whether or not you decide on the clinical trial" are vitally important and need to be repeated throughout the informed consent process. "Randomization" may also need to be better explained to pediatric decision makers. They need to be clearly informed that random assignment is one of the procedures that most distinguishes participating in the RCT from standard treatment. This is likely to help pediatric decision makers better understand that clinical trial participation can involve one of several possible treatments, including the treatment their child would receive if they declined the RCT. The pediatric informed consent process could also benefit from more partnership-building and comprehension-enhancing behaviors. One practical strategy here might include more frequently prompting decision makers for questions, a behavior that has been positively associated with partnership-building and patient comprehension.20 Questions should be asked to determine how much decision makers have learned and remembered, and whether they are ready for new material. Before assuming that decision makers understand that their child may receive the standard treatment even if they are enrolled on the clinical trial, for example, a pediatric oncologist should ask, "Earlier, I talked about ‘randomization.’ Can you recall what this means?" The oncologist should be prepared to again discuss and assess understanding of these and other topics, if necessary. The informed consent process in adult oncology is in specific need of strategies aimed at providing more information about survival or cure, or the overall goals of treatment. For example, almost 40% of adult patients were not provided with information about their chances of survival or cure following further treatment. It is possible they may have received this information in their previous discussions with their clinicians. However, the decision to undergo further treatment after already having received lengthy treatment with limited success may be especially difficult. Adult patients offered adjuvant therapy in the form of a clinical trial therefore deserve the opportunity to review and discuss their current, remaining treatment options in light of past and present projections of treatment success and cure. Finally, more adult oncology consent discussions need to include information about randomization and voluntariness, including the right to withdraw from the clinical trial. Information delivery strategies aimed at promoting comprehension among minority decision makers and those of low social and economic status may also be needed. Although the adult care group was not as demographically diverse as the pediatric group, diversity is increasingly common in many informed consent settings. Studies show that low education, minority status, and other factors may place individuals at greater risk of not understanding a clinical trial and its implications for individual care.21,22 Among these individuals, medical jargon should be especially avoided. Consent documents may need to be easier to read or explained to those who are unable to read. Clinicians need to be aware of the role of cultural values such as respeto (respect), which may discourage question asking and interactivity among Latino decision makers. Avoidance of "yes" or "no" questions (ie, do you understand what I just said?)" in favor of requests for more substantive signs of understanding (ie, "can you tell me in your own words what I just said?") may be required. Several qualifications accompany our findings. Pediatric consultations occurred closer to the initial diagnosis of cancer than adult consultations. The pediatric informed consent process may therefore have been disproportionately affected by factors such as parental anxiety, shock, and pressure to discuss and understand diagnostic issues, survival/cure rates, and other nontrial issues.23 Also, the fact that the adult decision makers received other treatments before being consulted about a clinical trial may have affected their eligibility and decision to participate in the clinical trial. We were also unable to fully explore the effects of race, education, and income on the differences observed. Our regression analysis did reveal that race and education were significantly associated with the differences observed in at least one comprehension item. Others evidenced no significant association. This suggests a need for further research on the role of demographic variables in shaping the differences between adult and pediatric informed consent processes in oncology. Finally, it needs to be noted that only a small number of adult male decision makers were included in our study, and that this may have affected our findings. Informed consent for research involving humans is a vital ethical safeguard.22,24,25 Current ethical standards and guidelines for conducting such research are much the same throughout oncology and medicine as a whole. They are derived from the principles of autonomy, beneficence, and justice.26 They emphasize the need for adequate disclosure, understanding, and decision-making support among individuals offered a clinical trial as a treatment option. Despite this shared ground, significant differences may characterize the informed consent process in "sister" environments such as pediatric and adult oncology. Our report revealed a number of these differences. Decision makers in the adult care setting were better informed than pediatric decision makers in some respects and not in others. The question for future research will be whether and to what extent these differences are attributable to the culture of the care environment, surrogate versus primary decision maker status, psychosocial factors, and other issues. Currently, a "one-size-fits-all" approach characterizes many informed consent regulations and guidelines. The effectiveness of this approach may need to be reassessed given the unique ways in which clinical trials are offered, discussed, and responded to. Efforts aimed at tailoring informed consent to the needs and preferences of specific care environments, informed consent providers, and subject populations may be needed as a result.
The authors indicated no potential conflicts of interest.
We thank the institutions involved in both the pediatric and adult studies for their cooperation and support. These include: Children's Hospital of Cincinnati; M.D. Anderson in Houston, Texas; Children's Hospital of Los Angeles; Children's Hospital of Philadelphia; Children's National Medical Center in Washington, DC; and, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, and Case Comprehensive Cancer Center. Special thanks go to the patients, parents, clinicians, and other subjects who agreed to participate. Thanks also to the many research staff who helped collect and process the data, and, especially to Michelle Eder, MA, for her comments on an early draft.
This is original, previously unpublished work supported by grants from the Rainbow Board of Trustees, NIH RO1 CA83267 (E.D.K.), and NCI R01-CA78210 (L.A.S.). Authors' disclosures of potential conflicts of interest are found at the end of this article.
1. Berg J: Informed Consent. Oxford, UK, Oxford University Press, 2001 2. Farnell SM: Medical research: Why trouble the patient for informed consent? Med Pediatr Oncol 39:207-209, 2002[CrossRef][Medline] 3. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Protecting Human Subjects. Washington, DC, 1982, pp 64-66 4. Sussman EJ, Dorn LD, Fletcher JC: Participation in biomedical research: The consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 121:547-552, 1992[CrossRef][Medline]
5. Erb TO, Schulman SR, Sugarman J: Permission and assent for clinical research in pediatric anesthesia. Anesth Analg 94:1155-1160, 2002 6. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358:1772-1777, 2001[CrossRef][Medline] 7. Siminoff LA, Fetting J. Factors affecting treatment decisions for a life-threatening illness: The case of medical treatment of breast cancer. Soc Sci Med 32:813-818, 1991
8. Holmes-Rovner M, Kroll J, Schmitt N, et al: Patient satisfaction with health care decisions. Med Decis Making 16:58-64, 1996 9. Wheeless L: A follow-up study of the relationships among trust, disclosure, and interpersonal solidarity. Hum Commun Res 4:143-157, 1978[CrossRef] 10. Brehaut J, O'Connor A, Wood T, et al: Validation of a Decision Regret Scale. Med Decis Making 23:281-292, 2003[Abstract] 11. Gurmankin A, Baron J, Hershey JC, et al: The role of physicians' recommendations in medical treatment decisions. Med Decis Making 22:262-271, 2002[Abstract] 12. Roter D: The enduring and evolving nature of the patient-physician relationship. Patient Educ Couns 39:5-15, 2000[CrossRef][Medline] 13. Roter DL, Hall JA: Doctors Talking with Patients, Patients Talking with Doctors. Westport, CT, Auburn House, 1992
14. Rowland-Morin PA, Carroll JG: Verbal communication skills and patient satisfaction: A study of doctor-patient interviews. Eval Health Prof 13:168-185, 1990 15. Gilligan T, Raffin TA: Physician virtues and communicating with patients. New Horiz 5:6-14, 1997[Medline] 16. Pearson SD, Raeke LH: Patients' trust in physicians: Many theories, few measures, and little data. J Gen Intern Med 15:509-513, 2000[CrossRef][Medline] 17. McGrath P: Beginning treatment for childhood acute lymphoblastic leukemia: Insights from the parents' perspective. Oncol Nurs Forum 29:988-996, 2002[Medline]
18. Quill TE, Brody H: Physician recommendations and patient autonomy: Finding a balance between physician power and patient choice. Ann Intern Med 125:763-769, 1996 19. Weithorn LA. Involving children in decisions involving their own welfare, in Melton GB, Koocher GP, Saks MJ (eds) Children's Competence to Consent. New York, NY, Plenum Press, 1983, pp 235-260 20. Roter DL: Patient participation in the patient-provider interaction: The effects of patient question asking on the quality of interaction, satisfaction and compliance. Health Educ Monogr 5:281-315, 1977[Medline] 21. Agre P, Campbell FA, Goldman BD, et al: Improving informed consent: The medium is not the message. IRB 25:S11-S19, 2003 (suppl 25)
22. Simon C, Zyzanski S, Eder M, et al: Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer. J Clin Oncol 21:2173-2178, 2003 23. Levi RB, Marsick R, Drotar D, et al: Diagnosis, disclosure, and informed consent: Learning from parents of children with cancer. J Pediatr Hematol Oncol 22:3-12, 2000[CrossRef][Medline] 24. Siminoff LA, Fetting JH, Abeloff MD: Doctor-patient communication about breast cancer adjuvant therapy. J Clin Oncol 7:1192-1200, 1989[Abstract] 25. Kodish ED, Pentz RD, Noll R, et al: Informed consent in the Children's Cancer Group: Results of preliminary research. Cancer 82:2467-2481, 1998[CrossRef][Medline] 26. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York, NY, Oxford University Press, 1986 Submitted October 3, 2003; accepted April 6, 2004. This article has been cited by other articles:
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
= .86) and good discriminant validity in measuring how satisfied patients or surrogates are with their decision to enroll or not to enroll in a clinical trial
