Pediatric Annals

Feature 

Shared Decision Making in Complementary and Alternative Medicine Therapies

Lauren L. Jansons, BS; Rachel L. Lynch, MD; Annie LeBlanc, PhD; Jon C. Tilburt, MD

Abstract

In Minnesota, 13-year-old Daniel had been diagnosed with non-Hodgkin’s lymphoma. The oncologists he had seen said he could die without treatment, but Daniel and his mother opted to pursue an alternative healing therapy: an American Indian tradition called “Nemenhah,” for which the scientific community has little evidence of benefit.

After an emotional battle with his local county district court, he and his mother fled. A multi-state search for Daniel resulted in his apprehension, and chemotherapy was mandated by the county’s district judge. Eventually, Daniel’s parents were allowed to retain custody of him, predicated on their promise to adhere to the medical treatments recommended by Daniel’s oncology team.1

Daniel’s case illustrates the poignant interpersonal and legal challenges that arise when pediatric patients and families choose alternative therapies while rejecting conventional medical care for children. When the stakes are high, such as in cancer therapy, conflicting opinions can pose serious challenges for conventionally trained health care teams.

Additionally, many clinicians admit to a lack of knowledge about alternative therapies and believe they are poorly equipped to discuss these issues with families.2 Treatment decisions that utilize the principles of shared decision making — collaborative deliberations informed by the best available evidence while accounting for patient values — remain the ideal in these complex situations.3

Recent data suggest that 1 in 9 children use some form of complementary and alternative medicine (CAM).4,5 In most of these cases, patients and families may not be fleeing conventional care, but rather are seeking ways to blend a variety of conventional and alternative health approaches to maximize health, mitigate illness, and prevent disease.

The American Academy of Pediatrics (AAP) recently published a report describing many common CAM therapies encountered by pediatricians.6 The report suggested physicians “work together with parents as a team to consider and evaluate all appropriate treatments.”6

Shared decision making has been proposed by many clinicians as the ideal model for the clinical relationship for choices considered to be “preference-sensitive,” where the evidence of benefit is uncertain and there is a large role for patient values.7 The integration of CAM into discussions in pediatric care is a prime example of circumstances in which shared decision making should be employed to address the motivation and inclinations of the patient and family while teaching children and adolescents about their active role in promoting health.

How to best engage patients and families in constructive conversations about CAM treatment remains unclear.8 Through use of a more participatory model, patients and families can increase their understanding of health care decisions and over time exercise discernment about alternative and complementary options.

To bring further specificity to a very difficult and vague process, pediatricians should discuss patient and family preferences, evidence of safety and efficacy of the CAM therapy, and trade-offs associated with any available conventional treatment options (see Figure 1). In addition, the treating physicians should account for important mitigating practical concerns, including time, finances, and CAM variability, while maintaining the emphasis on the underlying concerns of the patient and family. As children increase their ability to articulate their concerns and preferences, they are encouraged to take a more active role in this dialogue.

Figure 1. A structured approach for pediatricians wishing to use shared decision making when responding to a request for complementary and alternative medicine (CAM).Image courtesy of Jon C. Tilburt, MD. Reprinted with permission.

Understanding the family and patient’s motivation for wanting CAM treatment and not dismissing it as a non-standard or unfamiliar therapy can help foster a sense of trust and responsiveness in both the patient and family. By talking with the family about past reactions to treatment,…

In Minnesota, 13-year-old Daniel had been diagnosed with non-Hodgkin’s lymphoma. The oncologists he had seen said he could die without treatment, but Daniel and his mother opted to pursue an alternative healing therapy: an American Indian tradition called “Nemenhah,” for which the scientific community has little evidence of benefit.

After an emotional battle with his local county district court, he and his mother fled. A multi-state search for Daniel resulted in his apprehension, and chemotherapy was mandated by the county’s district judge. Eventually, Daniel’s parents were allowed to retain custody of him, predicated on their promise to adhere to the medical treatments recommended by Daniel’s oncology team.1

Daniel’s case illustrates the poignant interpersonal and legal challenges that arise when pediatric patients and families choose alternative therapies while rejecting conventional medical care for children. When the stakes are high, such as in cancer therapy, conflicting opinions can pose serious challenges for conventionally trained health care teams.

Additionally, many clinicians admit to a lack of knowledge about alternative therapies and believe they are poorly equipped to discuss these issues with families.2 Treatment decisions that utilize the principles of shared decision making — collaborative deliberations informed by the best available evidence while accounting for patient values — remain the ideal in these complex situations.3

Recent data suggest that 1 in 9 children use some form of complementary and alternative medicine (CAM).4,5 In most of these cases, patients and families may not be fleeing conventional care, but rather are seeking ways to blend a variety of conventional and alternative health approaches to maximize health, mitigate illness, and prevent disease.

The American Academy of Pediatrics (AAP) recently published a report describing many common CAM therapies encountered by pediatricians.6 The report suggested physicians “work together with parents as a team to consider and evaluate all appropriate treatments.”6

Shared decision making has been proposed by many clinicians as the ideal model for the clinical relationship for choices considered to be “preference-sensitive,” where the evidence of benefit is uncertain and there is a large role for patient values.7 The integration of CAM into discussions in pediatric care is a prime example of circumstances in which shared decision making should be employed to address the motivation and inclinations of the patient and family while teaching children and adolescents about their active role in promoting health.

How to best engage patients and families in constructive conversations about CAM treatment remains unclear.8 Through use of a more participatory model, patients and families can increase their understanding of health care decisions and over time exercise discernment about alternative and complementary options.

Structured Approach

To bring further specificity to a very difficult and vague process, pediatricians should discuss patient and family preferences, evidence of safety and efficacy of the CAM therapy, and trade-offs associated with any available conventional treatment options (see Figure 1). In addition, the treating physicians should account for important mitigating practical concerns, including time, finances, and CAM variability, while maintaining the emphasis on the underlying concerns of the patient and family. As children increase their ability to articulate their concerns and preferences, they are encouraged to take a more active role in this dialogue.

A structured approach for pediatricians wishing to use shared decision making when responding to a request for complementary and alternative medicine (CAM).Image courtesy of Jon C. Tilburt, MD. Reprinted with permission.

Figure 1. A structured approach for pediatricians wishing to use shared decision making when responding to a request for complementary and alternative medicine (CAM).Image courtesy of Jon C. Tilburt, MD. Reprinted with permission.

Assessment of Patient/Family Values, Preferences, and Concerns

Understanding the family and patient’s motivation for wanting CAM treatment and not dismissing it as a non-standard or unfamiliar therapy can help foster a sense of trust and responsiveness in both the patient and family. By talking with the family about past reactions to treatment, current disease burdens, and their beliefs and stressors, the physician will learn about the potential for side effects and whether there is a lack of fit between alternative and conventional treatments and the patient’s lifestyle, as well as develop an appreciation for what frustrates the patient and family about their options.

Additionally, the physician can gain insight into the level of understanding of the patient/family regarding treatment options. Adolescents in particular often appreciate feeling understood in this context and such clinical encounters help to cultivate the young person’s relationship with the provider. This process sets the relational tone for deliberating about the available evidence.

Evidence of Safety

The physician also has a duty to present and appraise available evidence of safety and efficacy for CAM treatments, which carry complexities such as lack of standardization, contamination, herb-drug interactions, and adverse events associated with some therapies.9–11 Until recently, high-quality evidence from rigorous research in CAM was the exception.12

While the quality of that evidence is improving, current evidence of safety may be in the form of case reports or observational studies, which often can be less convincing. Ways of dealing with weak evidence have been proposed,13 and increasingly, information clearing houses such as Natural Medicines, Natural Standard, Consumer Labs, and www.nccam.nih.gov have been created to help physicians translate that evidence into clinical conversations. Ideally, tools such as age-specific decision aids could eventually be available to illustrate patient options while transparently presenting evidence to children and parents, which would help facilitate shared decision making about CAM.

As an advocate of the child and based on the principle of nonmaleficence (the ethical obligation to not promote harm), the pediatrician is obligated to counsel families about any known risks associated with a particular CAM treatment. If the CAM therapy is deemed to be unsafe for use in children, the physician has an obligation to discourage its use and thoroughly explain the detrimental effects associated with the treatment. This step is especially important in pediatrics to ensure that the child’s welfare is being prioritized.

While the clinician’s opinion regarding an inappropriate option should be firm, other safe treatments can be proposed in the place of the originally requested therapy. In the experience of the authors, this re-focusing is a crucial step in helping to empower the child and family toward health, despite a negative response to the requested CAM therapy.

Opportunity Costs and Options

If the CAM treatment has no known evidence of serious harm, the conversation about its use can focus on how the treatment fits with the available conventional treatments. It may be possible to use a CAM treatment cooperatively with the conventional treatment to avoid treatment delays.

If such accommodations cannot be reasonably arranged, the physician must advocate for the welfare of the child and discourage the use of the CAM treatment in favor of a conventional treatment with known efficacy. Particularly in pediatrics, affirming a “safety first” posture toward the integration of alternative therapies with available conventional options is crucial in maintaining the professional obligation to “do no harm” while respecting family values and preferences.

Evidence of Efficacy

Once safety and the relationship with conventional options have been entertained, evidence of efficacy of the CAM treatment in children must be examined. Especially if coordination of a conventional treatment with the CAM treatment is possible, or if there is no known efficacious conventional treatment, then one can reasonably accept weaker evidence of benefit.

Conversely, therapies that have direct evidence of benefit may be used if they are appropriate for the child’s situation. More often, many CAM treatments have been found to be equal to placebo in benefit, which prompts the provider to consider the pros and cons of placebo efficacy, as well as the ethics of doing so in the pediatric setting.14

Some might argue that without definitive evidence of efficacy, any therapy including alternative medicine is unwarranted. Such a standard suggests that we need a high burden of proof to justify recommending a treatment for any child.

While this is a respectable position, we argue that such a standard (which if applied consistently would preclude most current pediatric interventions) sets the bar too high for evidentiary standards and would needlessly limit options that are worth trying. Especially in situations where the stakes are low, the treatment is cheap, safe, and readily available, not having definitive evidence of efficacy in children is arguably of secondary importance.

Cost, Conflict and Care Context

In circumstances where there are no safety concerns but the evidence of efficacy for the CAM treatment is uncertain, deliberations using a shared decision making approach might focus on other key mitigating issues, including costs to the family’s finances, time, and the child’s energy. Here, the family preferences often play a large role in whether to pursue the CAM treatment. If there is a strong preference from the child toward trying a CAM treatment, a discussion of practical considerations might lead to an agreement to try the requested therapy. However, if the child and/or family were merely curious about the CAM treatment, a discussion of all the possible options might identify other avenues.

Some conflicts are harder to unravel. Family members may persist in their resolution to pursue unsafe treatments. Pediatricians may fail to establish a bond of trust and open communication with the family. The physician must consider the risk to the child that comes from delaying conventional care and might be obligated to take action to prevent harm.

Physicians must clearly communicate a recommendation from the medical community that represents the balance of risks and benefits to the degree that they are known and promote the well-being of the child. If done in a way that allows the child and family to feel respected and that their preferences are recognized, these difficult conversations can build trust in the therapeutic relationship, rather than conclude in conflict.

Other contextual considerations affect these important discussions as well. Unfortunately, busy clinics with phone messages about the appropriateness of therapies are not ideal scenarios in which to promote shared decision making. A scheduled appointment devoted to a specific request improves the ability to more fully explore these issues empathetically. Even without specific knowledge of the CAM treatment, the provider can help guide a patient and family through a discussion of all treatment options in a collaborative manner.

Case Analyses

Case 1

Noah is a 5-month-old male infant whose mother seeks recommendation regarding the use of the herbal remedy fenugreek, which her friend says can stimulate lactation. She wants to make sure that it is safe to use when breastfeeding her son. The physician is unfamiliar with this supplement and is reluctant to recommend it after a quick search of the medical literature yields a description of common side effects and little information regarding its efficacy.

Discussion

In this case, the mother hopes her pediatrician has advice on whether or not to trust anecdotal evidence from a friend. She understands that the purported benefits of the supplement align with her goals of providing support for her nursing child. The clinician is skeptical of the effects, due to a perceived or real lack of medical literature on the subject, and hesitates to promote a supplement that costs the patient money but may offer little prospect of benefit.

A respectful inquiry into the mother’s thought process may reveal that she wants to better care for her child’s health and her own health, a goal shared by the physician. The provider might be able to constructively refocus the conversation from a binary conflict over a specific treatment into a discussion that can uncover unaddressed concerns, working to create a mutually agreeable solution.

Some herbal supplements are detrimental to health and clearly should be avoided, particularly in breast-feeding women. It is the physician’s duty to warn against these adverse effects, as a matter of nonmaleficence. More frequently, however, alternative therapies have an uncertain safety profile. In the case of fenugreek, a common culinary spice, traditional Chinese medicine has promoted its use as a galactogogue, but commonly reported side effects include wheezing and mild gastrointestinal upset.15

These side effects merit giving advice to the mother about symptoms associated with use of fenugreek. Depending on the reputability of the product’s manufacturing, there may be legitimate concerns about the purity of the formulation that could increase the physician’s opinion against recommending its use.

Because the physician took time to recognize the underlying apprehension on the part of the mother, the opportunity exists to discuss how best to meet the perceived needs of the child without exposing him to harm. This reframes the mother’s concerns and affirms the mother’s desire for the baby’s optimal well-being, regardless of whether the specific herb in question is agreed upon.

The primary determinants of the clinician’s opinion in this case relates to the safety profile of the requested therapy and the value structure of the mother. If the herbal product is deemed safe, there is room to accommodate a trial of the product for a specified and limited time. If the product has serious safety concerns, such a trial would not be advisable from the medical prospective, even if using the product was consistent with deeply held beliefs, due to the potential exposure of the mother and baby to risk.

Case 2

Christina is a 7-year-old female with an acute onset of sore throat. Her rapid strep antigen test comes back positive. As the physician writes the prescription for antibiotics, her parents state that it is important they first get a remedy from a yerbero (a traditional medicine man) in order to cure their daughter, prior to taking any conventional medicine. The physician knows that antibiotics should be initiated within 9 days of symptom onset for a group A streptococcal infection to prevent potential complications, and feels frustrated that the family might chose to delay treatment in order to consult an alternative healer.

Discussion

The physician can begin with a nonjudgmental inquiry into the beliefs and culture of the patient/family, seeking to understand their prioritization of one health system over another, as well as any cultural stigma that might be associated with forgoing a traditional treatment.

It is important to acknowledge in these types of situations that conventional medicine does not hold all of the answers to healing, and that there are risks associated with many medications. By building a foundation of enhanced understanding and communication, the physician can mitigate any animosity, which might hinder open dialogue.

Safety is a tricky issue to navigate in this case due to the unpredictability of the treatment that the child might receive from the yerbero. A brief Internet search would show that, most commonly, a yerbero uses herbs and plants in creating a treatment. Knowing which herbs are used and whether they are associated with any toxicity or drug interactions will be helpful to ensure that treatment by the yerbero will not interact negatively with the conventional therapy.

A discussion of opportunity costs will also be central to the process of shared decision making in the resolution of this case. While taking care to acknowledge the importance of belief and culture, it is important that the physician explain to the family the known progression of the disease and the potential consequences of postponed antibiotic therapy. Ideally, with a better appreciation of the disease, the family might choose to hasten their pursuit of cultural healing options so that any prescription medication can be started in an appropriate amount of time to diminish the possibility of developing rheumatic fever.

On the other hand, the physician should discern if there is a psychological burden associated with not seeing a traditional healer that might negatively impact the child. Such an approach demonstrates respect for the family’s traditions, focuses on harm reduction, and also avoids making potential ideological differences the central focus of the therapeutic relationship.

Case 3

Erin is a 14-year-old female with chronic back pain who has been worked up by neurologist and physiatrist without a definitive etiology. She and her parents are frustrated by the amount of time and money they have spent on medications and physical therapy, without much symptom reduction. At this visit to the pediatrician, Erin mentions that she would like to try acupuncture to reduce her pain. Her parents express concern that their insurance might not cover these treatments and ask if the pediatrician will write a letter to the insurance company to persuade them to pay for acupuncture. The pediatrician’s search of the literature suggests that acupuncture has been shown to decrease back pain, but is often no better than sham acupuncture in randomized, placebo-controlled trials.

Discussion

While all parties in this case hopefully acknowledge the long-term nature of this condition, they understandably hope to see improvement and observe benefit from the prescribed course of treatment, into which they invest money and time. Erin asserts her treatment strategy preference. Her parents express their desire to help their daughter, as well as their practical concern for the financial implications of beginning a course of treatments for which they might be required to pay out-of-pocket.

The physician must decide if a treatment merits an endorsement from a medical expert. On the one hand, equivalence to placebo has been the definition of inefficacy in recent decades.16 Yet witnessed placebo effects may give real relief notwithstanding their mechanism. Exploring the patient’s and/or family’s concerns about the current and/or previous treatments may help inform the provider about the patient’s present state and shed light on areas that may be improved (see Figure 1, page 523).

Thereafter, the physician should review the evidence of safety for acupuncture. While the reported side effects of acupuncture are generally minor,17 there are other important factors to consider and disclose such as standardization among practitioners. Five acupuncturists might offer five completely different treatment plans for a patient presenting with the same complaint, which increases the complexity of researching the effects of these techniques.

Some practitioners may mix and match techniques with varying degrees of expertise. This variation amplifies the hesitation on the part of the physician to give the family a recommendation for such therapy because the physician cannot guarantee the type of treatment the patient will receive.

A careful discussion of acupuncture should include the disclosure of the research evidence and any concerns the physician might have about safety or the integration of conventional care with alternative therapies. If the physician believes that the patient would benefit from continued physical therapy, he/she should ask the family if they can support both acupuncture along with physical therapy appointments on a regular basis with regard to limits on time and/or finances. The creation of timelines for a trial of therapy can be a helpful tool for setting realistic expectations.

In cases of refractory, chronic conditions, the addition of alternative therapies can be a reasonable option even if the evidence of efficacy is uncertain, particularly when a patient displays a strong belief that such a treatment will be beneficial. The potential for placebo pain reduction represents a significant benefit to such patients, regardless of mechanism. In this case, for a patient who has tried most or all other options, and who presents desiring to try an alternative therapy with a favorable safety profile, the physician would be justified in recommending the therapy. There are times when accepting a lower standard of efficacy such as equivalence to placebo (but superior to no treatment) is warranted, so long as the financial and logistical burdens are not excessive and no other therapies exist that would be more beneficial.

Conclusion

The incorporation of shared decision making principles in discussions of CAM in the pediatric setting can facilitate thorough and fulfilling clinical encounters between patient, family, and provider, even in the constraints of a busy practice. This approach emphasizes integration of the available information about the therapy with the patient and family values, helping the physician to guide constructive conversations about risks, benefits, and recommendations. Through the use of the proposed approach, pediatricians can feel empowered to consistently evaluate a patient or family’s request for CAM in a way that engages all participants and aims to enrich the therapeutic alliance through trust and open communication.

References

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Authors
Lauren L. Jansons, BS, is a medical student at Mayo Medical School, Rochester, MN. Rachel L. Lynch, MD, is an Instructor in Pediatrics, Division of Community Pediatrics and Adolescent Medicine, Mayo Clinic, Rochester, MN. Annie LeBlanc, PhD, is an Assistant Professor of Health Services Research, Knowledge and Encounter Research Unit and Division of Healthcare Policy and Research, Mayo Clinic, Rochester, MN. Jon C. Tilburt, MD, is an Assistant Professor of Biomedical Ethics and Associate Professor of Medicine, Mayo Clinic, Rochester, MN.
Address correspondence to: Jon C. Tilburt, MD, 200 First Street SW, Rochester, MN 55905; fax: 507-284-4959; email: Tilburt.jon@mayo.edu.
Disclosure: The authors have no relevant financial relationships to disclose. This publication was made possible by Mayo Clinic Department of Medicine and career development funding to Dr. Tilburt from Grant Number 1 KL2 RR024151 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.

10.3928/00904481-20121126-14

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