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Biomedical subjects

Eric Kodish

Publications and source records attributed to Eric Kodish.

At least 19 recordsLinked to original sources
PubMed2006

The role of the consent document in informed consent for pediatric leukemia trials.

PURPOSE: To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent. METHODS: Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences. RESULTS: Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy. CONCLUSIONS: Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.

Adolescent↗
PubMed2006

Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

PURPOSE: To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. METHODS: Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. RESULTS: Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. CONCLUSION: Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

Adult↗
PubMed2006

How low is too low? Use of cluster analysis to define low levels of mercaptopurine metabolites.

BACKGROUND: To group patients receiving treatment for acute lymphoblastic leukemia (ALL) according to their oral mercaptopurine (6-MP) metabolite levels and to establish cut-off points to screen for potential poor clinical outcome. PROCEDURE: Methodological study using 6-MP metabolite levels from 48 adolescent ALL patients enrolled in a multicenter adherence study. Cluster analysis was the primary analytical technique. We used two validation methods (a split-sampling and a simulation technique) for validating the results. RESULTS: Four clusters were retained in our initial analysis using our first group of patients (n = 27). Three clusters (labeled 1, 2, and 4) exhibited the expected negative correlation between the two metabolites, that is, "high" values of one were associated with "low" values of the other. One cluster (labeled 3) had "low" levels for both TGN and MMP. Five of the 27 adolescents had their 6-MP "held" during the study. Post-hoc examination of the results revealed that all five grouped in Cluster 3 during the time that their medications were stopped, but grouped in other clusters at other times. The median ANC was highest in Cluster 3, consistent with low therapeutic drug levels. Parameters were reproducible with both validation methods. Values below the respective 75th centile for both TGN and MMP in Cluster 3 for the complete sample (n = 48) are suggested as representing a potentially higher risk for relapse. CONCLUSIONS: This study provides an objective method for identifying patients at risk for treatment failure due to suboptimal 6-MP therapy; the clinical significance of this approach should be examined in future studies.

Adolescent↗
PubMed2006

Understanding confidentiality: perspectives of African American adolescents and their parents.

PURPOSE: To identify adolescents' and parents' understanding of confidentiality in the patient/doctor relationship. METHODS: In the teen clinic of an academic hospital, questionnaires were administered separately to 50 accompanying parents and 50 adolescents aged 13 to 17 years. The true/false questions were designed to identify both adolescents' and parents' perceptions of the general breadth and limitations of confidentiality and specifically related to selected high-risk behaviors. RESULTS: Most adolescents and parents understood confidentiality to mean that conversations, testing and treatments about certain aspects of health care could be kept private between a doctor and patient. However, most parents felt that confidentiality guidelines did not apply to patients under 18 years. In contrast to 36% of adolescents, 96% of parents believe that the doctor would discuss any conversation the doctor had with the patient that might be important to the parent in spite of adolescents' wish for them not to be told. Parent/adolescent dyads agreed regarding the general value of a confidential adolescent/doctor relationship and the application of confidentiality to certain topics but disagreed with respect to others. CONCLUSIONS: The adolescents and parents in this study have a good understanding of the meaning of confidentiality but are less clear on its application to the adolescent patient/doctor relationship. Nearly all adolescents and their parents appreciate the circumstances under which confidentiality will be breached. The protections confidentiality offers adolescents are understood less well by both parties, but parents seem to have a greater degree of misunderstanding. Parents believe that the doctor will inform them about many of their adolescents' high-risk behaviors. These false impressions may lead to assumptions, miscommunication, and conflict in the adolescent patient/doctor/parent triad.

Adolescent↗
PubMed2006

Pediatric ethics in the age of molecular medicine.

Many scientific advances in molecular medicine, such as those made in genomics, stem cell transplantation, and neurobiology, raise important ethical issues that are relevant to pediatrics. Although some of these novel issues appear to be nearly without precedent, others are illuminated by reflection on prior challenges. How do we approach such complex ethical questions in the context of pluralism? This article examines several important areas in molecular medicine exemplifying fundamental ethical questions that are broadly applicable.

Embryo Research↗
PubMed2005

Clinician-parent communication during informed consent for pediatric leukemia trials.

OBJECTIVE: To address the need to describe informed consent in pediatric settings and to identify barriers to parent understanding, this study assessed how aspects of clinician-parent communication during the informed consent conference (ICC) relate to parent understanding of informed consent and parent perception of the impact of the ICC on their anxiety and control. METHODS: Parents of 127 children with newly diagnosed leukemia who were eligible for clinical trials were the participants. The study used comprehensive methods including both observational and self-report assessment methods. RESULTS: Structural equation modeling demonstrated that parent race and socioeconomic status (SES) were powerful predictors of clinician-parent communication, parent anxiety and control as a result of the ICC, and parent understanding. Clinician information giving and partnership building predicted parent participation during the ICC. CONCLUSIONS: These findings may be used to design interventions that increase the effectiveness of the ICC by identifying specific elements of the conference that influence parent affect and understanding.

Adolescent↗
PubMed2005

Anti-infective therapy at the end of life: ethical decision-making in hospice-eligible patients.

Clear guidelines addressing the ethically appropriate use of anti-infectives in the setting of hospice care do not exist. There is lack of understanding about key treatment decisions related to infection treatment for patients who are eligible for hospice care. Ethical concerns about anti-infective use at the end of life include: (1) delaying transition to hospice, (2) prolonging a dying process, (3) prescribing regimens incongruent with a short life expectancy and goals of care, (4) increasing the reservoir of potential resistant pathogens, (5) placing unreasonable costs on a capitated hospice system. Although anti-infectives are thought to be relatively safe, they can place a burden on patients and be inconsistent to particular care plans. The current complex, and at times fragmented, medical care often fails to address these issues in decision-making. In many ways, the ethics governing the end of life decisions related to dialysis, hydration/nutrition, and hypercalcemia parallel those of anti-infectives. In this article we articulate important elements in ethical decision-making in the application of anti-infectives for patients who are eligible for hospice care, and we point to the need for prospective studies to help refine particular guidelines in these cases.

Adult↗
PubMed2004

Communication of randomization in childhood leukemia trials.

CONTEXT: Most children diagnosed as having leukemia become research subjects in randomized clinical trials (RCTs), but little is known about how randomization is explained to or understood by parents. OBJECTIVE: To investigate physicians' explanation and parental understanding of randomization in childhood leukemia RCTs. DESIGN AND SETTING: A multisite study of the informed consent communication process for RCTs of childhood leukemia. Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US children's hospitals associated with major academic medical centers from July 1, 1999, until December 31, 2001. The informed consent conferences were observed and audiotaped, and the information obtained was coded and analyzed. Parents were interviewed shortly after the conference to ascertain their understanding. PARTICIPANTS: Parents and members of the health care team who participated in 137 informed consent conferences for children with newly diagnosed acute leukemia. MAIN OUTCOME MEASURES: Observed explanations of randomization and parental understanding of randomization after the consent conference. RESULTS: Randomization was explained by physicians in 83% of cases and a consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (P<.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial. CONCLUSIONS: Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.

Adolescent↗
PubMed2004

Correlates of parental participation during informed consent for randomized clinical trials in the treatment of childhood leukemia.

This study described parent participation in the informed consent conference for randomized clinical trials (RCTs) in childhood leukemia and documented the relationship of physician communication to parent participation. Parents of 140 children with newly diagnosed leukemia who were eligible for RCTs were studied at six sites using comprehensive methods involving direct observation and transcripts of parent-physician communication based on audiotapes. Parent participation during the informed consent conference reflected a wide range of content categories. Consistent with hypotheses, Physician Rapport and Partnership Building related to parent participation in the informed consent conference but Information Giving did not. Higher parent socioeconomic status also was related to greater parent participation for two of the three measures of parent participation. Findings suggest that physician behaviors that provide support and facilitate communication may enhance parental participation in the informed consent conference for RCTs in childhood leukemia.

Child↗
PubMed2004

Children's competence for assent and consent: a review of empirical findings.

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identifies several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interest approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence and comparison of children's competence for treatment and research decisions.

Adolescent↗
PubMed2003

Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group.

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated.

Child↗
PubMed2003

Offering to return results to research participants: attitudes and needs of principal investigators in the Children's Oncology Group.

PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs. RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified.

Academies and Institutes↗