Resolution of Systemic Rheumatologic Symptoms following Breast Implant Removal.

Reports of women with breast implants who suffer a wide variety of systemic symptoms have become more and more prevalent over the past several years. This entity has become known as breast implant illness in conventional news and social media outlets but has vague and nonspecific diagnostic criteria. As a result, the phenomenon is difficult to both identify and treat. The reported patient is a 76-year-old woman who underwent breast reconstruction with a latissimus dorsi flap and textured silicone implant 20 years before the onset of symptoms, which included debilitating joint pain. She had previously maintained an active lifestyle, but symptoms progressed to a point where she was unable to perform basic tasks. A full rheumatologic and connective tissue workup was done, but other than elevated markers of inflammation, it showed no diagnosable disease entity. After a lengthy discussion with her primary care physician and plastic surgeon, she decided to undergo removal of the implant. Following explantation, her symptoms quickly improved, and within several weeks, she was able to return to her active lifestyle.

Ethics of complementary and alternative medicine use in children.

Complementary and alternative medicine (CAM) has enjoyed tremendous public interest in North America in recent years. CAM is used most often by those who have serious, chronic, or recurrent illness, sometimes for symptom control and sometimes to combat the primary disease. Others use CAM to promote wellness or as a prophylaxis. CAM therapies are increasingly being offered in conventional medical settings and at various other centers and institutes. The relevant ethical commitments or values that must be considered are social commitment to public welfare, nonmaleficence, respect for patient autonomy/consumer choice, recognition of medical pluralism, and public accountability. This article explores the major ethical principles involved in pediatric CAM use and how they affect clinical care and research.

Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplement recommendations: a descriptive study of 19 integrative health care centers in the United States.

BACKGROUND: Little is known about policies governing the integration of complementary and alternative medical (CAM) therapies and providers. METHODS: To document emerging approaches in 19 US hospitals regarding credentialing, malpractice liability, and pharmacy policies governing integration of CAM therapies and providers into conventional medical settings, we surveyed 21 academic medical centers and 13 non-academically affiliated hospitals that are nationally visible and are integrating CAM therapies into conventional medical settings. Of the 19 respondents, 11 were tertiary care hospitals, 6 were community hospitals, 1 was a freestanding center associated with a community-based hospital, and 1 was a university-based rehabilitation hospital. RESULTS: Institutions had no consistent approach to provider mix and authority within the integrative care team, and minimum requirements for professional liability insurance, informed consent disclosure, and hiring status. Less than a third had a formal (stated) policy concerning dietary supplements; those selling supplements in their pharmacy lacked consistent, evidence-based rationales regarding which products and brands to include or exclude. Although many hospitals confiscated patient supplements on admission, institutions had inconsistent criteria regarding allowance of home supply. CONCLUSIONS: Hospitals are using heterogeneous approaches to address licensure, credentialing, scope of practice, malpractice liability, and dietary supplement use in developing models of integrative care. The environment creates significant impediments to the delivery of consistent clinical care and multisite evaluations of the safety, efficacy, and cost-effectiveness (or lack thereof) of CAM therapies (or integrative models) as applied to management of common medical conditions. Consensus policies need to be developed.

Legal issues in caring for patients with kidney disease by selectively integrating complementary therapies.

Clinical integration of complementary and alternative medical (CAM) therapies, such as acupuncture and traditional oriental medicine, chiropractic, herbal medicine, massage therapy, and "mind-body" therapies, into conventional health care raises important legal and risk management issues. Understanding which CAM therapies patients use is legally prudent, as conventional treatment advice may interact with patients' own efforts toward self-care. In addition, nephrologists may limit potential liability for medical malpractice by classifying any given therapy as follows: (1) the medical evidence supports both safety and efficacy--recommend; (2) the medical evidence supports safety, but evidence regarding efficacy is inconclusive-accept but monitor; (3) the medical evidence supports efficacy, but evidence regarding safety is inconclusive-accept but monitor; and (4) the medical evidence indicates either serious risk or inefficacy--avoid and discourage. Applying this framework whether a therapy is labeled "conventional" or "CAM" is consistent with the key recommendation of the recent report by the Institute of Medicine at the National Academy of Sciences on Complementary and Alternative Medicine, namely, to apply the same principles and standards of evidence of treatment effectiveness to all treatments. Liability risk management also includes going beyond legal and ethical informed consent requirements by engaging the patient in shared decision making concerning all material treatment options, including CAM therapies, if supported by evidence. Physicians further should familiarize themselves with documentation standards suggested by the Federation of State Medical Board Guidelines and whether these are applicable in their state or home institution. These steps aim to enable nephrologists to respond to patient interest in CAM therapies in a way that is clinically responsible, ethically appropriate, and legally defensible.

Potential physician malpractice liability associated with complementary and integrative medical therapies.

Physicians are increasingly grappling with medical liability issues as complementary and integrative health care practices are made available in conventional medical settings. This article proposes a framework in which physicians can assess potential malpractice liability issues in counseling patients about complementary and integrative therapies. The framework classifies complementary and integrative therapies according to whether the evidence reported in the medical and scientific literature supports both safety and efficacy; supports safety, but evidence regarding efficacy is inconclusive; supports efficacy, but evidence regarding safety is inconclusive; or indicates either serious risk or inefficacy. Clinical examples in each category help guide the clinician on how to counsel patients regarding use of complementary and alternative medical therapies in a given clinical situation. Specific strategies to reduce the risk for potential malpractice liability include the following: 1) determine the clinical risk level; 2) document the literature supporting the therapeutic choice; 3) provide adequate informed consent; 4) continue to monitor the patient conventionally; and 5) for referrals, inquire about the competence of the complementary and alternative medicine provider. This framework provides a basis for clinical decisions involving complementary and integrative care.

Ethical considerations of complementary and alternative medical therapies in conventional medical settings.

Increasing use of complementary and alternative medical (CAM) therapies by patients, health care providers, and institutions has made it imperative that physicians consider their ethical obligations when recommending, tolerating, or proscribing these therapies. The authors present a risk-benefit framework that can be applied to determine the appropriateness of using CAM therapies in various clinical scenarios. The major relevant issues are the severity and acuteness of illness; the curability of the illness by conventional forms of treatment; the degree of invasiveness, associated toxicities, and side effects of the conventional treatment; the availability and quality of evidence of utility and safety of the desired CAM treatment; the level of understanding of risks and benefits of the CAM treatment combined with the patient's knowing and voluntary acceptance of those risks; and the patient's persistence of intention to use CAM therapies. Even in the absence of scientific evidence for CAM therapies, by considering these relevant issues, providers can formulate a plan that is clinically sound, ethically appropriate, and targeted to the unique circumstances of individual patients. Physicians are encouraged to remain engaged in problem-solving with their patients and to attempt to elucidate and clarify the patient's core values and beliefs when counseling about CAM therapies.

Credentialing complementary and alternative medical providers.

Since the late 19th century, state legislatures and professional medical organizations have developed mechanisms to license physicians and other conventional nonphysician providers, establish standards of practice, and protect health care consumers by establishing standardized credentials as markers of competence. The popularity of complementary and alternative medical (CAM) therapies presents new challenges. This article describes the current status of, and central issues in, efforts to create models for health care credentialing of chiropractors, acupuncturists, naturopaths, massage therapists, and other CAM practitioners. It also suggests a strategy of CAM provider credentialing for use by physicians, health care administrators, insurance companies, and national professional organizations. The credentialing debate reflects fundamental questions about who determines which providers and therapies will be accepted as safe, effective, appropriate, and reimbursable. More nationally uniform credentialing mechanisms are necessary to ensure high standards of care and more generalizable clinical research. However, the result of more uniform licensure and credentialing may be excessive standardization and a decrease in individualization of services. Thus, increased standardization of credentialing for CAM practitioners may alter CAM practice substantially. Furthermore, even credentialed providers can deliver ineffective therapy. The suggested framework balances the desire to protect the public from dangerous practices against the wish to grant patients access to reasonably safe and effective therapies.

Policies pertaining to complementary and alternative medical therapies in a random sample of 39 academic health centers.

This research documents policies in 39 randomly selected academic medical centers integrating complementary and alternative medical (CAM) services into conventional care. Twenty-three offered CAM services-most commonly, acupuncture, massage, dietary supplements, mind-body therapies, and music therapy. None had written policies concerning credentialing practices or malpractice liability. Only 10 reported a written policy governing use of dietary supplements, although three sold supplements in inpatient formularies, one in the psychiatry department, and five in outpatient pharmacies. Thus, few academic medical centers have sufficiently integrated CAM services into conventional care by developing consensus-written policies governing credentialing, malpractice liability, and dietary supplement use.

Legal issues in complementary and integrative medicine. A guide for the clinician.

Physicians integrating CAM therapies into clinical practice face many legal challenges, including the fact that legal rules governing CAM providers and practices are new and evolving in many cases. Laws vary by state, and their application depends on the specific clinical scenario in question. As more evidence accumulates regarding safety and efficacy or lack thereof of specific therapies for given conditions, physicians will find clinical knowledge more abundantly mapped and that the parameters of liability are increasingly clear. Meanwhile, good clinical practice and a working knowledge of major legal rules can help provide physicians with a good measure of legal protection in situations involving integration of CAM providers and therapies in conventional medical practice.

Complementary and alternative medicine in child and adolescent psychiatry: legal considerations.

The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy.

Pediatric use of complementary and alternative medicine: legal, ethical, and clinical issues in decision-making.

In this article we introduce a series of 8 case scenarios and commentaries and explore the complex legal, ethical, and clinical concerns that arise when pediatric patients and their parents or health care providers use or are interested in using complementary and alternative medicine (CAM). People around the world rely on CAM, so similar issues face clinicians in many countries. In law, few cases have dealt with CAM use. The few that have apply the same general legal principles used in cases that involved conventional care while taking into account considerations unique to CAM. In ethics, as with conventional care, the issues surrounding pediatric CAM use usually involve questions about who the appropriate decision-makers are, on what ethical principles should clinical decision-making rely, and what obligations arise on the part of physicians and other health care providers. Clinical decision-making is made more complex by the relatively limited research on the efficacy and safety of CAM compared with conventional medicine, especially in children, which requires clinicians to make decisions under conditions of uncertainty. The clinical scenarios presented focus on patients who represent a range of ages, clinical conditions, and settings. They act as anchors to explore particular CAM policy issues and illustrate the application of and shortcomings in existing guidance and intervention principles. Although the focus on a pediatric population adds another layer of complexity to the analysis, many of the concepts, issues, principles, and recommendations also apply to adults.

Natural health product-drug interactions: evolving responsibilities to take complementary and alternative medicine into account.

Natural health products (NHPs) (known as dietary supplements in the United States) are a popular form of self-care, yet many patients do not disclose their use to clinicians. NHP-drug interactions are known to occur and can harm patients and affect the efficacy of conventional treatment. Using the example of an HIV-positive adolescent who had been responding well to antiretroviral therapy but then experienced a sudden unexplained deterioration in her condition, we review (1) clinicians' obligation to inquire about complementary and alternative medicine (CAM) use when assessing, treating, and monitoring patients, (2) how clinicians' duty to warn about risks associated with treatment has evolved and expanded, and (3) patients' and parents' responsibility to disclose CAM use. It also addresses the responsibility of hospitals and health facilities to ensure that the reality of widespread CAM/NHP use is taken into account in patient care to effectively protect patients from harm.

Treating teens: considerations when adolescents want to use complementary and alternative medicine.

In this article we examine decision-making about complementary and alternative medicine use when the patient is an adolescent. A case scenario describes patient-parent conflict when a 14-year-old boy who was diagnosed with ulcerative colitis that has continued to progress even with medication refuses recommended surgery despite his physician's and parents' support for that option; he prefers homeopathy instead. We address (1) who has decision-making authority about treatment for young people, (2) how to determine if a young person can consent to or refuse treatment, (3) special considerations when counseling and treating adolescents (whether they can decide about treatment for themselves), and (4) parent-child conflicts about treatment. In addition, we suggest ways that health care providers can foster a trusting relationship with patients and parents.

Childhood immunization: when physicians and parents disagree.

Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

Considering complementary and alternative medicine alternatives in cases of life-threatening illness: applying the best-interests test.

In this article we explore decision-making about treatment when a child faces a life-threatening illness but conventional treatment presents substantial risk and uncertain benefit. When is it acceptable for parents to decide to use complementary and alternative medicine as an alternative, rather than a complement, to conventional care? We use the example of a young child suffering from progressive glycogen storage disease, for whom liver transplant offers the only prospect of a cure. Without a liver transplant, the disease usually results in death within a few years. However, experience using transplant to treat this illness has been limited, success is far from ensured, and the risks (including death and continued progression of the disease) are substantial. The child's parents, who are first-generation immigrants, consider the risks of the transplant unjustified because it still does not offer good prospects for a healthy future. They believe that traditional Chinese medicine could help remediate their daughter's disease. In the article we (1) review parents' obligation to make treatment decisions in the best interests of their child, (2) explain limits on parents' decision-making authority, (3) explore how "best interests" are determined, focusing on cases of serious illness for which conventional treatment is risky and benefit is possible but uncertain, (4) explain the standard of care that physicians must meet in advising about treatment, and (5) outline factors that clinicians and parents should take into account when making decisions.

Referrals and shared or collaborative care: managing relationships with complementary and alternative medicine practitioners.

In this article we discuss steps that clinicians should take after deciding to include a complementary and alternative medicine (CAM) treatment that is beyond the clinician's expertise in a patient's treatment plan. We use the example of an adolescent patient with chronic recurrent headaches that have not been relieved by medication or other therapies and whose physician refers her to an acupuncturist for treatment. We focus on (1) circumstances under which referral is appropriate, (2) the nature of the relationship between the referring clinician and the practitioner to whom the referral is made (considering conventional health care and CAM, regulated and unregulated practitioners), and (3) considerations when undertaking shared or collaborative care with other health care practitioners (conventional health care or CAM). We also suggest best practices in managing such relationships.

Informed consent: advising patients and parents about complementary and alternative medicine therapies.

Although research on complementary and alternative medicine (CAM) therapies is still limited, systematic reviews have revealed sufficient evidence to conclude that CAM can be effective for certain conditions. In this article we discuss clinicians' responsibilities to inform parents/patients about CAM alternatives and use the example of acupuncture for chemotherapy-induced nausea and vomiting. Chemotherapy-induced nausea and vomiting remain significant adverse effects of cancer therapy, and some patients cannot find relief with standard therapies. When making decisions for a child with a life-threatening illness, parents must consider all reasonable options and decide what is in the child's best interests. A physician's failure to provide parents with relevant information regarding therapies with the prospect of therapeutic benefit impedes their ability to make an informed decision. Physicians have the ethical duty of beneficence; they must be aware of current research in pain and symptom management and other aspects of care. A physician's duty of care does not necessarily include the obligation to provide information about therapies outside the range of conventional treatment or those not yet supported in the medical literature. However, as CAM therapies such as acupuncture become better studied and their safety and efficacy are established, the scope of disclosure required may expand to include them. The legal and ethical obligation to obtain informed consent to treatment requires disclosure and discussion of therapies when there is reliable evidence of potential therapeutic benefit. At the same time, the more limited state of knowledge regarding effects of a particular therapy in the pediatric population must be factored into decision-making when treating a child.

Complementary and alternative medicine practitioners' standard of care: responsibilities to patients and parents.

In this article we explain (1) the standard of care that health care providers must meet and (2) how these principles apply to complementary and alternative medicine practitioners. The scenario describes a 14-year-old boy who is experiencing back pain and whose chiropractor performed spinal manipulation but did not recognize or take steps to rule out serious underlying disease-in this case, testicular cancer--either initially or when the patient's condition continued to deteriorate despite treatment. We use chiropractic care for a patient with a sore back as an example, because back pain is such a common problem and chiropracty is a common treatment chosen by both adult and pediatric patients. The scenario illustrates the responsibilities that complementary and alternative medicine practitioners owe patients/parents, the potential for liability when deficient care harms patients, and the importance of ample formal pediatric training for practitioners who treat pediatric patients.