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Groups Potentially at Risk for Making Poorly Informed Decisions About Entry into Clinical Trials for Childhood Cancer

Christian Simon, Stephen J. Zyzanski, Michelle Eder, Pauline Raiz, Eric D. Kodish, Laura A. Siminoff

From the Rainbow Center for Pediatric Ethics, Department of Pediatrics, and Rainbow Babies’ and Children’s Hospital of University Hospitals of Cleveland, Cleveland, OH

Address reprint requests to Christian Simon, PhD, Case Western Reserve University Comprehensive Cancer Center, 11100 Euclid Ave, Cleveland, OH 44106-5065; email: cxs66{at}po.cwru.edu.

	ABSTRACT

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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 ² 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.

	INTRODUCTION

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UPSURGES IN U.S. immigration in recent years, particularly among Latino people seeking a future in Texas, California, and elsewhere, have affected a spectrum of health-care practices, including informed consent processes.^1–3 Language differences, for example, increasingly present difficulties to informed consent. As a consequence, pressure to recruit interpreters to facilitate communication between clinicians and potential research subjects has followed; a factor that introduces issues, such as interpreter inaccuracy, role conflict, and other complex dynamics of communication, into the informed consent process.^3,4

This article draws on data from an ongoing study of informed consent practices from the Informed Consent in the Children’s Cancer Group Study (CCG-S9901) to describe several differences among three groups of parents who shared the experience of being offered participation in a randomized clinical trial (RCT) for their child with newly diagnosed leukemia. The analysis describes differences in informed-consent disclosure and understanding outcomes for all three groups, with the greatest differences occurring between non–English-speaking parents of low social status and English-speaking majority (ie, white) and English-speaking minority parents.

We conclude by suggesting a number of strategies aimed at minimizing disparities in communication and understanding among future participants of informed consent for pediatric leukemia trials.

	PATIENTS AND METHODS

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Our data are part of a larger National Cancer Institute–funded study entitled Informed Consent in the Children’s Cancer Group (CCG-S9901), which examines the informed consent process for participation in RCTs for the treatment of pediatric leukemia at six leading U.S. institutions that routinely treat children with acute leukemia.

This study was approved by the institutional review board at each site. Informed consent was obtained from parents and clinicians shortly after the patient’s diagnosis with either acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).

Trained research associates observed and tape recorded the informed consent conference(s) that clinicians convened with the parents of the child for the purposes of discussing treatment options. When a conference involved an interpreter, his or her affiliation would be checked and noted down in the case files.

The taped conferences were later coded using the Observer Checklist, an instrument developed specifically for clinical discussions related to cancer.⁵ Previously developed and tested by Siminoff, ⁵ the Observer Checklist included visual analog scales (VASs) for rating on a 10-cm scale such communication-related issues as the clarity, comprehensiveness, and speed with which clinicians explained the RCT to the parents. The research associates were trained to complete these VAS in an objective manner. Three research associates, all of whom independently listened to the audiotapes and then provided their ratings, completed each VAS. Discrepancies were resolved by taking the average of the two closest ratings as the final score. This process happened 47 times during the rating of the three VASs reported here (ie, 15% of the time).

A convenience sample of 129 parents were asked to participate in this study, of which a total of 108 (84%) parents consented to participation. Forty-eight (44%) of the total number parents who were observed and interviewed were minority subjects: 29 Latinos, 10 African-Americans, four Asians, and five other minorities. Eighty-six percent of the total number of parents went on to enroll their child in an RCT, a figure consistent with national enrollment rates for pediatric clinical leukemia trials.⁶ The ethnic distribution of our sample also reflects the ethnicity of children who generally enroll on cancer trials.⁷

Parents were interviewed within 48 hours of their informed consent conference with their child’s clinician(s), and they were interviewed again once they had made a decision about whether to participate in the RCT. Parent interviews, which were available in English and Spanish, were designed to elicit information regarding the parents’ understanding of the informed consent information they received from their child’s clinician(s) and factors related to their decision about entry into the RCT. A Decision-Making Preference Questionnaire,⁸ a Satisfaction with Decision Questionnaire,⁹ and a Trust Scale¹⁰ were also administered to the parents.

Data were entered into an Microsoft Access (Version 2001; Microsoft, Redmond, WA) database, validated for data integrity, and then loaded into an SAS (Version 8; SAS Institute, Cary, NC) for analysis. All 108 cases were then sorted into three groups on the basis of ethnicity and whether subjects had been involved in an informed consent discussion with the aid of an interpreter. English-speaking minorities were separately grouped to control for ethnicity-related issues. The overall study sample was therefore divided into three groups to which we gave the following labels: (A) non–English-speaking group (n = 21), (B) English-speaking minority group (n = 27), and (C) English-speaking majority (white) group (n = 60).

Our objective in grouping subjects in this way was to test for differences among the three groups with respect to several aspects of informed consent that are acknowledged as key to the ethical conduct of clinical research.^11–14 These criteria include discussion and understanding of research risks and benefits, the right to decline participation, the meaning of randomization, the availability of standard treatment as an alternative to the research, and the right to withdraw from the research. Items that were intended to elicit whether these criteria were communicated to the parents and understood by them were included in our Observer Checklist and parent interviews.

Means, standard deviations (SDs), and percentages were calculated to describe the distribution and frequency of these criteria within each group. The wide range of questions asked by parents (0 to 132 questions) prompted us to conduct a log transformation of these data. ² tests were used to compare proportions, and for continuous outcomes, a one-way analysis of variance was used to compare means among the three groups of parents. Given that multiple hypothesis testing was performed, all bearing on a single issue, increases in the false-positive (significance) rate were inevitable. To control against interpreting increased false-positive rates when comparing means, we applied the Benjamini-Hockberg correction for multiple hypothesis testing.¹⁵ Further adjustments were made for testing multiple pairwise comparisons for a given outcome measure. For each significant omnibus test statistic, all pairwise comparisons were computed using a general linear model approach to identify specific mean differences and to control for the modest probability of making incorrect decisions.

The Hollingshead Two-Factor Index of Social Position was used to calculate social status on the basis of occupation and educational level.¹⁶ We chose this index for two reasons. First, this index has a long history of use and readers are likely to be familiar with it and with data associated with its classifications. Second, income data are often not available and, even when available, are often inaccurate. With this study population, the use of education and occupation seemed the most valid description of social status.

	RESULTS

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Demographic Data
Table 1 provides demographic information on each of the three subject groups. The non–English-speaking group consisted of 21 (19%) parents, of whom all but one was Spanish-speaking. The English-speaking minority group accounted for 25% of the total sample, whereas the English-speaking majority group accounted for 56% of the total sample.

All of the studies offered to parents were Phase-III RCTs, which were conducted nationwide under the auspices of the Children’s Oncology Group (COG). The informed consent encounter itself lasted one hour and fifteen minutes on average (range, 28 to 180 minutes), with no statistically significant differences in duration evident among the three groups (P < .63). The following section presents the differences and similarities among the three groups (summarized in Table 2).

Observed Differences in Discussion
General details about leukemia treatment. Clinicians provided some parents with more details about leukemia treatment (apart from RCT treatment) than other parents. The difference in the mean number of details provided to parents in the non–English-speaking group and the English-speaking majority group was statistically significant (P < .0077), with an average of 10.8 (65%) details out of a possible 17 in the non–English-speaking group compared with 12.3 (71%) details out of a possible 17 for the English-speaking majority group.

Specific details about the RCT. The mean number of details provided to parents about the RCT, such as risks and benefits, the right to withdraw, and other details, differed among the three groups. Differences in the mean number of RCT-related details provided to parents in the non–English-speaking group and the English-speaking majority group were significant, with an average of 10.8 (35%) details out of a possible 31 in the non–English-speaking group compared with 13.3 (42%) details out of a possible 31 in the English-speaking majority group (P < .001). Similarly, parents in the English-speaking minority group were provided an average of 13.0 (42%) details about the RCT out a possible 31, which was also statistically significantly different than the mean number of details given to the parents in the non–English-speaking group (P < .0111).

Clarification of randomization. Clinicians clarified the meaning of randomization for some parents and not for others. Eighty percent of parents in the English-speaking majority group received some clarifying statement about randomization, such as "randomization is like a flip of a coin" or "pulling a number from a hat," whereas only 57% of parents in the non–English-speaking group received some clarifying statement (P < .04). The difference in the frequency of clarifications about the meaning of randomization between the non–English-speaking group and the English-speaking minority group (82%) approached statistical significance (P < .065).

Explanation of the right to withdraw. Whereas clinicians explained to the majority of parents in both the English-speaking (ie, majority and minority) groups that they had the right to withdraw their child from the RCT if they decided to participate, they provided the same explanation to less than half of the parents in the non–English-speaking group. Eighty-seven percent of parents in the English-speaking majority group were informed of their right to withdraw, whereas only 43% of parents in the non–English-speaking group were similarly informed (P < .0003). Although not as great, the difference in the percentage of parents informed of their right to withdraw between the English-speaking majority group and the English-speaking minority group (62%) was also statistically significant (P < .01).

Explanation of consent document. Although the consent document was not always in the parents’ native language, almost all parents (96%) in our total sample were supplied with a consent document detailing the RCT. Not all parents, however, were provided with some explanation of the structure, content, or accessibility of the document. Whereas 92% of parents in the English-speaking minority group received such an explanation, less than half (48%) of parents in the non–English-speaking group received it (P < .0008). Similarly, fewer parents in the non–English-speaking group received some explanation of the structure, content, or accessibility of the consent document than did parents in the English-speaking majority group (80%); however, this difference was not statistically significant (P < .06).

Question-asking. Quantifiable differences were evident in the number of questions parents asked about the RCT and leukemia treatment. Parents in the non–English-speaking group asked approximately half (n = 20) as many questions as parents in the English-speaking majority group (n = 44). Using the log of the difference in the number of questions, this difference was statistically significant (P < .0001). Parents in the English-speaking minority group asked an average of 34 questions, which was also statistically significantly different from the number of questions asked by parents in the non–English-speaking group (P < .02).

No statistically significant differences in responses emerged among the three groups when we compared responses to the following interview question: "Did you feel that you had sufficient opportunity to ask questions about the clinical research study? " The majority of parents in each group reported that they had "much opportunity" to ask questions. Furthermore, clinicians asked most of the parents whether they had questions about the RCT and about the treatment in general. Clinicians asked the parents whether they had questions about treatment in general more frequently than they asked about the RCT; however, this difference was not statistically significantly among the three groups.

Coder Ratings of Discussion Quality
Explanation of treatment options. Using VAS, our research associates were asked to rate how well clinicians succeeded in informing parents about their child’s treatment options. Clinicians involved in discussion with parents in the English-speaking majority group were rated as "more successful" than those involved with parents in the non–English-speaking group (P < .0006). In turn, clinicians involved in discussion with parents in the English-speaking minority group were rated as "more successful" than those involved with parents in the non–English-speaking group (P < .03).

Clarity of explanation about the RCT. Our coders rated the explanations about the RCT provided to parents in the English-speaking majority group as significantly "more clear" than those provided to parents in the non–English-speaking group (P < .0001). Ratings of clarity of explanation between the non–English-speaking group and the English-speaking minority group were also statistically significantly different (P < .03).

Distinction between RCT and standard treatment. When asked to assess how well each clinician explained the distinction between the RCT and standard treatment, coders gave higher ratings to clinicians involved in discussion with parents in the English-speaking majority group than they did to those involved with parents in the non–English-speaking group (P < .01).

Parental Understanding
A portion of parents in all three groups demonstrated some degree of difficulty in understanding four central aspects of RCT participation. Table 2 summarizes these findings.

Randomization. Not all parents understood that their child’s treatment would be randomly determined and that it would not be left up to the discretion of their child’s clinician; 68% of parents in the English-speaking majority group and only 14% of parents in the non–English-speaking group understood that their child’s treatment would be randomly determined (P < .0001). Similarly, the difference in the understanding of randomization between parents in the English-speaking majority group and parents in the English-speaking minority group (26% of whom provided evidence of understanding) was also statistically significant (P < .0002).

Distinction between RCT and standard treatment. All parents were given an opportunity over the course of several interview questions to recall the different treatment options that they discussed with their child’s clinician(s). Notably, 80% of parents in the English-speaking majority group were able to distinguish the RCT from standard treatment compared with 38% of parents in the non–English-speaking group (P < .002).

Voluntary nature of the RCT. Although the majority of parents in each group understood that the RCT was voluntary, there were some differences in the understanding of that concept among the groups; 90% of parents in the English-speaking majority group and only 60% of parents in the non–English speaking group demonstrated some understanding that the RCT was voluntary (P < .01). Likewise, more English-speaking minority parents (78%) understood the voluntary nature of the RCT than did non–English-speaking parents (60%); however, this difference was not statistically significant.

Right to withdraw from the RCT. Parents among the three groups varied in their understanding of their right to withdraw their child from the RCT if they decided to participate. Half of the parents in the non–English-speaking group reported that they could stop their child’s participation in the RCT if they agreed to participate compared with 90% of the parents in the English-speaking majority group (P < .0007). The difference in the parents’ understanding of their right to withdraw their child from the RCT between English-speaking majority parents and English-speaking minority parents was also statistically significant (P < .05).

Finally, parents among the three groups differed in their responses when asked whether the consent document had been explained to them; 92% of parents in both the English-speaking majority group and the English-speaking minority group and only 69% of parents in the non–English-speaking group answered that the consent document had been explained to them (P < .03).

	DISCUSSION

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Our analysis suggests two important findings. First, clinicians in our study were more likely to omit from their discussions with non–English-speaking parents certain key information related to randomization, the right to withdraw from an RCT, and consent documentation. Qualitative aspects of their discussions, such as the clarity of their explanations about the RCT, also scored lower when clinicians were observed in discussions with non–English-speaking parents as opposed to parents in the other two English-speaking groups. Second, significantly fewer non–English-speaking parents than English-speaking majority parents grasped several key aspects of informed consent, including the concept of randomization, the distinction between the RCT and standard treatment, the voluntary nature of the RCT, and the right to withdraw from the RCT. The differences in understanding of these concepts between non–English-speaking parents and English-speaking minority parents were, however, less striking.

There are several other factors that bear mentioning. First, discussions involving non–English-speaking parents were not significantly longer than those involving the other two groups, despite the added time normally required to communicate through interpreters. This finding indicates that clinicians may have "trimmed" their discussions with non–English-speaking parents to fit a specific timeframe, thus giving non–English-speaking parents less opportunity than the parents in the other two groups to discuss treatment options with their child’s clinician(s).

Parents in the non–English-speaking group also asked fewer questions than parents in both other groups. This is an important finding because of the strong association in the literature between levels of question-asking and the quality and outcomes of patient-provider interactions, including patient understanding.^17–20 Prevailing Latino cultural norms that encourage passivity, such as respeto ("respect") and fatalismo ("fatalism"), may contribute to this disparity.¹ In addition, lower social and economic status in immigrant populations frequently correlates with high adherence to traditional values, a factor that may help explain the differences between our non–English-speaking parents and their English-speaking counterparts.^21,22 Another factor may be that for non–English-speaking parents with low educational levels, discussions about cancer are discussions in a veritable "second language"²³—one that may be as foreign and as difficult to understand as English.

Further research is needed to probe the reasons underlying these and other disparities. In particular, the role of interpreter accuracy and communication-fatigue, which commonly affects both interpreters and the original speakers,²⁴ may warrant investigation. Given our finding that far fewer non-English-speaking parents were provided with an explanation of what consent documents contain or how they should be read and interpreted, a focus on institutional disparities in the provision of these documents might be another area worthy of investigation.²⁵ Finally, the dual effect of language barriers and low education should be measured in a sample large enough to sustain regression analysis or some other advanced statistical procedure.

Our goal in this article has been to compare three groups of parents who shared the experience of being offered an RCT for their child with newly diagnosed leukemia. This study examined differences in communication and understanding among the three groups; however, our study has some limitations. The comparatively small number of parents in the non–English-speaking group and the virtual lack of non–English-speaking parents who spoke a language other than Spanish restrict our findings. In addition, our data need to be assessed against the fact that we did not test parents’ levels of English proficiency. Therefore, the degree to which our subjects were dependent on interpreters was not specifically known.

Although limited in these respects, the generalizability of our findings is enhanced by the fact that the parents in our sample reflect trends in the wider pediatric leukemia population of parents with children who are diagnosed with leukemia. Parents in both our sample and the wider population are ethnically diverse, are routinely offered an RCT as a treatment option, and are overwhelmingly inclined to enroll their children on an RCT. Given these commonalities, our findings support two main points: First, a portion of parents in all three of our groups experienced some degree of difficulty grasping key aspects of RCT design and participation, and second, problems of communication and understanding were more frequent among parents of low social status who spoke little or no English. The first of these points is important because it serves as a reminder that parents, regardless of their social status or their language proficiency, may experience informed consent processes differently. Our group of English-speaking minority parents, for example, had significantly lower understanding on several items than did the English-speaking majority parents, despite the fact that both groups were English-speaking and not significantly different from one another in terms of social status. As to the second point, it is clear from our data that several aspects related to informed consent were more frequently omitted from discussions and more often confused or misunderstood among parents of low social status who spoke little or no English. Numerous factors may have contributed to this disparity, including the complexities of language interpretation, social status, and cultural norms.

Special attention to non–English-speaking parents of low social status may, therefore, be warranted. Combined with further research, strategies may be needed to improve communication and understanding between clinicians and parents.¹¹ Increasing the number of questions that parents ask about an RCT and their rights as surrogate decision makers, may help counter parent passivity and improve their understanding.¹⁹ Given the laborious and tiring nature of the interpretive process, clinicians may not need to allocate more time for consent discussions that involve non–English speakers. Rather, follow-up discussions designed to reinforce key concepts, such as randomization, the distinctions between trial and standard treatment, and the right to withdraw, may be required. Clinicians may also want to consider debriefing with interpreters between initial and subsequent consent discussions to help identify any areas of parental concern or understanding that clinicians may not be aware of and that may require emphasis in future discussions. Finally, clinicians may wish to pay particular attention to the prevailing cultural norms that may affect their discussions with Latino parents specifically, so that these norms may be respected and maximized for the benefit of parents and their understanding of informed consent. Given the emphasis on respeto among many Latino, bluntly asking Latino parents if they "have any questions," for example, may prove less effective than prompting them for their views or opinions on a particular issue. Workshops on "cultural competency" may also benefit clinicians in this regard.¹

	NOTES

 
This study was supported in part by Rainbow Babies and Children’s Hospital Board of Trustees and the National Cancer Insitute-funded study "Informed Consent in the Children’s Cancer Group" (R01 CA83267).

	REFERENCES

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Submitted March 4, 2002; accepted January 17, 2003.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Simon, C. Articles by Siminoff, L. A. Search for Related Content PubMed PubMed Citation Articles by Simon, C. Articles by Siminoff, L. A. Social Bookmarking                            What's this?