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ARTICLE |
a Departments of Pediatrics
b Surgery
c Anesthesia, Medical College of Wisconsin, Milwaukee, Wisconsin
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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METHODS. One of the investigators administered a questionnaire to clinicians who perform procedures on children at an academic tertiary care pediatric hospital to assess knowledge of assent for medical treatment and familiarity with the American Academy of Pediatrics policy statement on assent and to measure clinician attitudes and approaches to consent/assent in pediatrics.
RESULTS. Of 35 clinicians enrolled, 23 (66%) had heard of the term "assent," and 9 (26%) of 35 were aware of the American Academy of Pediatrics policy statement on assent. Twenty five (74%) of 34 thought 1 of the main goals of assent was to educate the child. Only 12 (35%) of 34 included the element of seeking the child's agreement as a goal of assent. In practice, the element of explaining the proposed treatment was "always" included by 26 (74%) of 35. The element of seeking the child's agreement was "always" included by 9 (26%) of 35.
CONCLUSIONS. The clinicians in this study had limited explicit knowledge of the concept of assent for medical treatment and were largely unaware of the recommendations from the American Academy of Pediatrics. Their attitudes and practice reflected implicit acceptance of the importance of including children in discussions about their medical care and reluctance to give children decision-making authority. A model of medical decision-making for children that includes education but does not allow children to share decision-making authority may be more applicable to clinical practice than the current American Academy of Pediatrics–supported model of assent.
Key Words: assent • informed consent • decision-making • clinician attitudes
Abbreviations: AAP—American Academy of Pediatrics
Over the past 4 decades, approaches to medical decision-making have changed. Advances in medical technology have resulted in numerous options for treating disease and sustaining life. Both physicians and patients must give careful consideration to the balance of perceived risk, burden, and benefit acceptable for diagnostic and therapeutic interventions. Because preferences for health care are so strongly influenced by personal values, many Americans find it unacceptable for physicians to exclude patients from the decision-making process. One method for including patients in health care decision-making is the process of informed consent. Ideally, this process demonstrates respect for a patient's autonomy by allowing the patient to make an uncoerced and educated choice about a medical course of action. It has become one of the essential aspects of ethical medical practice. Although there is clear acceptance of the right to informed consent for competent adult patients, the manner and degree to which a pediatric patient should participate in the consent process is unclear.
The American Academy of Pediatrics (AAP) first addressed the issue of informed consent in pediatric practice in the 1970s, suggesting that there were specific groups of pediatric patients who should be allowed to consent to medical treatment without the consent of their parents.1,2 These groups were those children who had an illness such as drug dependency, pregnancy, or a sexually transmitted disease that might not have been treated if the minor were forced to tell his or her parent or those who were judged by community standards to be sufficiently mature to consent to their own care, such as emancipated minors.
The concept of assent first emerged in the 1980s. It was not intended to produce a binding contract or give the child veto power. Instead, it was presented as a way to show respect for the child, satisfy the child's need to know about his illness, allay his fears, and allow him to develop the capabilities he would later need to give informed consent. In one of the early articles on assent, Leikin3 discussed the abilities of understanding and reasoning that a child must develop to be capable of giving informed consent. He proposed an approach based in developmental psychology, allowing consent for those minors who were capable, whereas allowing those who were not developmentally capable of consent to participate in the decision-making process through assent.
Over the next decade, the concept of assent shifted slightly, suggesting that children should have a more active role in the decision-making process. In 1995, the AAP published a policy statement on assent titled, "Informed consent, parental permission, and assent in pediatric practice."4 Echoing much of the earlier work of Dr William Bartholome, this statement defined assent as having at least the following 4 elements: (1) helping the patient achieve a developmentally appropriate awareness of the nature of his or her condition; (2) telling the patient what he or she can expect with tests and treatment(s); (3) making a clinical assessment of the patient's understanding of the situation and the factors influencing how he or she is responding (including whether there is inappropriate pressure to accept testing or therapy); and (4) soliciting an expression of the patient's willingness to accept the proposed care.
The policy statement stressed that patients should have the opportunity to provide assent to care whenever reasonable and that children and adolescents should not be excluded from decision-making without persuasive reasons. The policy statement also commented on a child's refusal to assent, or dissent, stating that there are clinical situations in which a refusal to assent may be ethically binding. However, the statement was clear that the child should not be led to believe that his opinion will affect treatment decisions in situations where treatment needs to be undertaken regardless of the child's wishes.
In the same year that assent was championed by the AAP, the Children's Rights Task Force of the Midwest Bioethics Center echoed the sentiment that children should be a part of the informed consent process.5 They stated, "a model for health care decision-making involving minors must include a recognition of the developing capacity of minors for rationality, autonomy, and participation in decision-making." Their published guidelines emphasized that "all persons with decisional capacity have the right to make health care treatment decisions."
Recently, many other medical specialties have also addressed assent. There are articles supporting assent in the literature of adolescent medicine,6 pediatric neurology,7 pediatric critical care,8 anesthesiology,9 pediatric oncology,10,11 and surgical nursing.12 The Confederation of European Specialists in Pediatrics also strongly supported the need to obtain assent in its recent policy statement.13 This policy statement reflects the opinion that all children have a right to give their assent or dissent and that they may effectively refuse treatment or procedures that are not necessary to save their lives or prevent serious harm.
Despite this widespread endorsement of assent, little is known about pediatric clinician awareness or understanding of the concept. Likewise, there has been little evaluation of the applicability of assent in clinical practice. To address these issues, we sought to assess clinicians' knowledge, attitudes, and practice of obtaining assent in the context of a tertiary care pediatric hospital.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Subjects
We studied physicians (pediatric anesthesiologists, pediatric surgeons, and pediatric subspecialists performing procedures using general anesthesia) and surgical nurse clinicians or physician assistants who met the following criteria: (1) completion of subspecialty training at the time of the study; (2) practice at an academic tertiary care pediatric hospital; (3) involvement with pediatric patients during the preoperative/preprocedure time period; and (4) consent for study participation.
Subjects were enrolled during October and November of 2003 by one of the authors (K.J.L.), who requested participation from a convenience sample of clinicians in the perioperative area within the surgical suite. Ten or less members of a particular specialty or subspecialty were enrolled. Interview responses were reviewed when the initial enrollment target was reached in the physician groups. The latest interviews were assessed as adding no new information to the study, and at this point enrollment was stopped. This is an accepted enrollment end point in qualitative studies.
Data Collection
Written consent for study participation was obtained. A single investigator administered the study questionnaire in a structured fashion in a private setting. The study questionnaire consisted of 19 questions and had been pretested for content validity with a sample of pediatric anesthesiologists, pediatric surgeons, and pediatric subspecialists. Of the 19 questions, 9 questions were open ended, 5 were multipart multiple choice, and 5 were simple multiple choice. The questionnaire was designed to explore the clinicians' knowledge, attitude and sense of their actual practice of assent. Questions about knowledge and attitude included whether they knew about the AAP policy statement on assent, as well as more theoretical questions of what they thought assent should encompass. Questions regarding their practice focused on clinician approach to consent/assent, who they include in the consent/assent process, and the role that they allowed the pediatric patient. Interviews were tape recorded, and the interviewer also transcribed responses during the interview process. Predictor variables recorded were clinician specialty, age, years in practice since completion of training, gender, race, and ethnicity. Outcome variables recorded were clinician reported knowledge, attitudes, and practices for seeking and obtaining assent from pediatric patients.
Data Analysis
Responses to tabular and multiple-choice questions were analyzed as a percentage of the number of respondents. Responses to open-ended questions were analyzed qualitatively. Content analysis and coding for themes was performed after review of interview audiotapes and written responses. The themes were then analyzed for trends and for associations with clinician specialty, age, gender, and time since completion of training. Statistical significance of the associations between predictor variables and outcome variables were analyzed by using 
2 or Fisher's exact test, as appropriate.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Knowledge of the Ethical Concept of Assent
When asked, "Have you heard of pediatric assent?" 23 (66%) of 35 responded "yes." Of these, 9 were pediatric subspecialists, 8 were pediatric anesthesiologists, 5 were pediatric surgeons, and 1 was a physician assistant. There was a significant difference between specialty groups, with surgeons and physician assistants being less likely to have heard the term (P = .02). When those who had never heard of assent were told that it was "a term used for the process of educating children about their illness and seeking their agreement with the treatment plan," all except 1 surgical nurse clinician said that they were familiar with the concept. The 1 respondent who was completely unfamiliar with the concept was unable to answer some of the questions, so results from some questions are based on answers from only 34 respondents. When asked, "Are you aware that the AAP published a policy statement in 1995 recommending that patient assent be obtained along with parental permission whenever it was appropriate?" 9 (26%) of 35 responded "yes." Of these, 5 were pediatric anesthesiologists, 3 were pediatric subspecialists, and 1 was a pediatric surgeon. Again, there was a significant difference between specialty groups with surgeons and physician assistants being less likely to be aware of the statement (P = .04).
Twenty four (71%) of 34 understood that explaining things to the child was a component of assent, but only 12 (35%) of 34 knew that assent also included the element of seeking the child's agreement to the proposed treatment plan or intervention. In addition to these components of assent found in the AAP policy statement, the respondents mentioned other goals of assent, such as providing reassurance (12 of 34 [35%]), showing respect for the child (4 of 34 [12%]), and allowing the child to learn to make decisions (3 of 34 [9%]).
Attitude Toward the Concept of Assent
Twenty eight (80%) of 35 thought that obtaining assent in addition to parental consent was valid and important, and 17 (49%) of 35 felt that it had become more important to them as they gained professional experience. One respondent said that children should be included in the decision-making process because it is "important to foster understanding and responsibility regarding their disease." Another said that the process of assent "respects emerging independence and personal boundaries." Those who did not feel that assent was valid or important commented, "decisions are independent of patient desires," or assent is "valid for research—not necessarily as valid for surgery," or it is "important to try (to obtain assent), but not enough to cancel a procedure."
In addition, 9 (32%) of the 28 who thought assent was valid and important thought so only because it made children more compliant and cooperative and decreased the risk of lawsuits or thought it was valid when the child agreed to the procedure but not if the child refused the proposed procedure. Two respondents who thought that the concept of assent was important elaborated that they had learned from clinical experience that trying to apply it in practice was often a waste of time.
Subjects exhibited uncertainty about the importance of assent when presented a clinical scenario. When asked if they would proceed with an elective procedure if a pediatric patient refused to give assent, 20 (57%) of 35 were "unsure," and many of those who chose yes or no answers went on to give qualifying statements and exceptions. One respondent said he would proceed "unless it was cosmetic surgery;" another said he would proceed "if it was in the child's best interest." Another respondent said it depends on "how badly the parents want the procedure done."
Respondents felt that the most important factor in preventing them from including a child in the decision-making process was the parents' wishes. When presented with a hypothetical scenario in which the respondent wanted to include a child in the consent discussion but the parents objected, 17 (49%) of 35 said they would not include the child, and 4 (11%) of 35 were undecided. Of the 14 (40%) of 35 who would include the child over the parents' objection, 7 (50%) of 14 said that they would first try to convince the parents to agree.
Twenty eight (82%) of 34 felt that success in obtaining assent should be assessed by having the child verbalize understanding and/or agreement or by witnessing the child giving nonverbal cues indicating understanding or agreement. However, 5 (15%) of 34 felt that assent had been given as long as the child was not kicking, screaming, or otherwise actively protesting.
Practice of Obtaining Assent
Most subjects reported that they included pediatric patients in the consent discussion at least some of the time. Patients were "always" included by 6 (17%) of 35, "usually" included by 9 (26%) of 35, and "sometimes" included by 17 (49%) of 35. When asked what factors they take into consideration when deciding to include the child, the list included the patient's age, maturity, intelligence, culture, language, psychological state (anxiety, etc), past medical history (chronically ill versus acute illness), current severity of illness (including mental status), the urgency or necessity of the procedure, the type of procedure, the parents' and child's own wishes to be included, and whether a preprocedural sedative had been administered at the time that the assent/consent discussion was to occur.
Of these factors, patient age and maturity were the most common considerations. The youngest age at which respondents reported including a child in the discussion was 5.6 ± 3.6 years, with a range of 0 to 16 years. The usual age at which respondents reported including the patient was 9.1 ± 4.2 years, with a range of 0 to 18 years. Some respondents reported including children from the time of birth.
Respondents were asked how often they included each of the elements of assent when speaking with children in their clinical practices. The elements of explaining the child's condition and explaining the proposed treatment were always included by 22 (63%) of 35 and 26 (74%) of 35, respectively. The element of seeking the child's agreement was always included by 9 (26%) of 35. All 9 of these respondents had finished training before 1995 (before the release of the AAP policy statement on assent). As a group, the respondents completing training before 1995 were significantly more likely to ask for the child's agreement as part of seeking assent (P = .01). This was the only demographic variable that had a significant and meaningful association with any attitudes or practices.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Dr Bartholome, one of the forefathers of the concept of assent, encouraged assent as a means of sharing the decision-making authority and responsibility to respect a child's developing autonomy.14 Following his lead, the AAP recommended that assent be included in practice "to the greatest extent feasible," and required "persuasive reasons" to exclude a child from decision-making.4 The definition of assent in the AAP policy statement clearly instructs clinicians to not only educate children about their medical condition and the proposed treatment but also to seek the child's agreement with the treatment plan, except in those instances where treatment needs to be undertaken regardless of the child's wishes.4
In contrast to the AAP policy statement, clinicians in this study minimized the importance of seeking the child's agreement as a component of assent. They thought that the process of explaining things to children was important, both to show respect for the child as a person and to foster a trusting patient-physician relationship. Obtaining a child's permission for an intervention, however, was much less important than the patient education component of the assent process. In fact, most clinicians performing procedures on children were unlikely to view the child's opinion as binding, even for elective procedures. They believed it was more appropriate to defer to parental decisions, even when these decisions went against the clinicians' own judgment, such as in a scenario where the parent wants to exclude the child from discussions with the clinician.
The respondents' attitudes were reflected in their practice. Respondents reported frequently incorporating in practice the elements of assent dealing with education and transmission of information. Despite an unawareness of the policy statement recommendations, the respondents' practice was in close agreement with the recommendations on these points. Respondents were less likely, however, to seek the child's agreement in actual clinical practice. This may reflect support for the idea of respecting the child as a developing person but discomfort with the idea of respecting the child's developing autonomy.
Respondent Characteristics
Our ability to relate specific respondent characteristics to specific attitudes and practices was somewhat limited by our small sample size; however, we did find one significant association. Clinicians who started practice before 1995 were more likely to ask for a child's permission as part of the assent process. This could reflect a stronger belief by experienced practitioners in the importance of respecting a child's emerging autonomy, or it could reflect the development over time of increased comfort and skill in including children as participants in the medical decision-making process.
Potential Limitations and Confounding Issues
Despite the respondents' relative unfamiliarity with published guidelines for assent, we found that most reported including some elements of assent in daily practice. Information about respondents' practice habits was collected at the end of the questionnaire and may have been biased by the preceding questions. It is possible that respondents reported practice habits that they perceived to be "desirable" instead of their true practice habits, skewing the responses toward agreement with the AAP policy statement.
Because this was a small pilot study of a convenience sample at a single institution, we are unable to speculate whether our findings are representative of clinician knowledge, attitudes, and practice at other institutions. A larger, multicenter study would be needed before such speculations could be made.
Is Assent the Right Model for Clinical Practice?
There are 2 ways to interpret our results. We can either declare that the clinicians in our study demonstrated attitudes and behavior that are unacceptable and in need of change or we can argue that the reported attitudes and practice are acceptable, and it is the model of assent that needs change. Although the model of parental permission and child assent is supported by the AAP and others as the preferable model of medical decision-making for children, another model may be more clinically applicable and just as ethically sound. One such model, constrained parental autonomy, allows children no decision-making authority.15 Instead, decision-making authority is given to the parents, but it is not unlimited. Parents' choices are constrained by a principle of respect for the child, which states, "Children should never be treated solely as a means, but always at the same time, as developing persons and as individuals who have actualized some of the characteristics associated with personhood."16 This principle of respect implies the prohibition of child abuse, neglect, or exploitation. It also implies a requirement that parents provide their children with the goods, skills, liberties, and opportunities necessary to become autonomous adults capable of devising and implementing their own life plans.16
Application of this model of medical decision-making for children is only appropriate for what has been termed "intimate families," which assumes that parents have the duty to obtain a threshold level of each primary good for each child. It is further defined as a group in which members "derive benefit if not identity from membership even after the group's goals are achieved or are no longer important," "make compromises ... to promote the goals of the group in addition to their individual goals," and "try to accommodate one another's needs rather than disengage."17
For the model of constrained parental autonomy, the arguments against allowing children decision-making authority are threefold. First, to promote a child's long-term autonomy, we may need to limit his short-term autonomy. Even when children have attained a threshold level of competence, they may not have developed the skills (eg, self-control) that they will need to optimize their lifetime autonomy. They need a protected period in which to develop these skills. Although it could be argued that some adults have not developed these skills either, for competent adults, the benefit of self-determination outweighs the impact of further guidance and protection on their long-term autonomy.18 Second, children's decisions are based on limited experience. They have not obtained sufficient background information to formulate a life plan, so they cannot make decisions that promote their life plan. Again, whereas it can be argued that some adults have limited experience and background knowledge, children have more potential for improvement in this area and are more deserving of a protected period in which to gain experience and knowledge. Parents also deserve the opportunity to expose their children to the experiences and knowledge that reflect their own conception of the good, thereby influencing their children's life plans. Third, respect should be given to family autonomy rather than the autonomy of a child, even a competent child. Children benefit from having autonomous parents, and parents benefit from the freedom to raise a family according to their own values. "If family intimacy is valuable both for what it does and for what it is, then family autonomy should not terminate the moment that a child attains some threshold level of competency... . Although the child's present day autonomy is overridden, respect for family autonomy serves to promote the direction and development of the child's lifetime autonomy. As such, respect for family autonomy respects the child's developing personhood."19
Whereas constrained parental autonomy does not give children decision-making authority, it does promote involvement of children in discussions about medical decisions. Although parents are not obligated to make decisions in accordance with their child's wishes, they are encouraged to weigh the child's opinion. The more characteristics of personhood a child has developed, the more respect his wishes deserve.
Constrained parental autonomy is an ethically sound model of decision-making for children, and it may be a better model to describe current clinical practice than the model of parental permission and child assent. It retains the characteristics of assent that show respect for the child as a person while limiting children's decision-making authority.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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FOOTNOTES |
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Address correspondence to K. Jane Lee, MD, Children's Hospital of Wisconsin, Division of Pediatric Critical Care, 9000 W Wisconsin Ave, PO Box 1997, MS 681, Milwaukee, WI 53201. E-mail: kjlee{at}mcw.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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