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Complementary and Alternative Practitioners’ Standard of Care: Responsibilities to Patients and Parents

AUTHORS: Joan Gilmour, LLB, JSD,a Christine Harrison, abstract MA, PHD,b Leyla Asadi, MD,c Michael H. Cohen, JDA, MBA,d and Sunita Vohra, MD, MSce,f In this article we explain (1) the standard of care that a providers must meet and (2) how these principles apply to complemen- Osgoode Hall Law School, York University, Toronto, Ontario, Canada; bDepartment of Bioethics, SickKids Hospital, Toronto, tary and practitioners. The scenario describes a Ontario, Canada; cDepartments of Medicine and fPediatrics, 14-year-old boy who is experiencing pain and whose chiropractor Faculty of Medicine, University of Alberta, Edmonton, Alberta, performed but did not recognize or take steps to Canada; dFenton Nelson LLP, Los Angeles, California; and eCARE Program for Integrative Health & , Stollery Children’s rule out serious underlying —in this case, testicular — Hospital, Edmonton, Alberta, Canada either initially or when the patient’s condition continued to deteriorate KEY WORDS despite treatment. We use care for a patient with a sore complementary , legal liability, -based back as an example, because is such a common problem and practice, clinical competence chiropracty is a common treatment chosen by both adult and pediatric ABBREVIATION patients. The scenario illustrates the responsibilities that complemen- CAM—complementary and alternative medicine tary and alternative medicine practitioners owe patients/parents, the www..org/cgi/doi/10.1542/peds.2010-2720J potential for liability when deficient care harms patients, and the im- doi:10.1542/peds.2010-2720J portance of ample formal pediatric training for practitioners who treat Address correspondence to Sunita Vohra, MD, MSc, Edmonton pediatric patients. Pediatrics 2011;128:S200–S205 General Hospital, 8B19-11111 Jasper Ave, Edmonton, Alberta, Canada T5K 0L4. E-mail: svohra@ualberta. PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2011 by the American Academy of Pediatrics FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

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Michael is a 14-year-old boy who com- was for back pain; back or CAM Practitioners’ Standard of plains of new-onset back pain with no was also the second-most common Care known precipitating cause that limits reason that young people did so.3 Regulated/Recognized CAM his activities and wakes him from Chiropractic is one of the most es- Practitioners sleep. He visits his mother’s chiroprac- tablished CAM therapies. It is a regu- When considering the more widely tor, who takes a history, completes a lated health profession in all juris- recognized CAM therapies such as physical examination, and concludes dictions in Canada and is licensed in chiropracty, US and Canadian courts that Michael has a misaligned spine. every US state.4,5 Because back pain judge practitioners by the standard He performs spinal manipulation on is such a common problem and chi- appropriate to their discipline,10–13 Michael during 12 visits over a 6-week ropracty is a common response, we that is, standards that “conform to period. When Michael begins to com- use it here to illustrate the responsi- [their] education, training, and peer plain of increasing pain and fatigue, bilities that CAM practitioners have expectations.”14(pp235–236) Courts have the chiropractor suggests that they to patients/parents and the poten- articulated the standard of care to are likely to be adverse responses to tial for liability when deficient care which chiropractors are held in the the spinal manipulation and recom- harms patients. In this article we (1) same terms that apply to : mends nutritional supplements and explain the standard of care health “that degree of care, diligence, judg- relaxation techniques for improve- care that providers must meet and ment and skill which is exercised by a ments to his overall health. Michael’s (2) examine how these principles ap- mother takes her son to his pediatri- reasonable chiropractor under like or ply to CAM providers. cian for a second opinion. On examina- similar circumstances.”15–19 tion, the pediatrician discovers that Principles generally applicable when Michael has lost 5 kg in the past month determining medical liability apply to Canadian chiropractors are required and has a mass lesion in his left scro- these CAM practitioners as well.18,20 De- tum. Additional testing confirms the by their code of ethics to “recognize parture from approved practice, al- suspicion of testicular cancer and the limitations of [their] expertise, and though not negligence per se, may un- also reveals and retroperineal when indicated, will recommend to a derpin a finding of negligence if it is nodal metastases. A unilateral ingui- patient that additional options and ser- shown that what occurred was not 6 7 nal orchiectomy is performed, and it vices be obtained.” Smith has sug- something a reasonable practitioner is determined that Michael has a gested that chiropractors have an eth- would have done in similar circum- nonseminomatous testicular tumor. ical duty to understand the limits of stances.14,18 Breach of professional or Combination chemotherapy is quickly their own competence and those of the clinical guidelines or policies, or fail- initiated. profession. Pearle8 cautioned that chi- ure to comply with regulatory require- Testicular cancer is not a common ropractors should be knowledgeable ments, may also provide evidence of cancer, but it is the most common ma- about the current literature and re- negligence.21,22 When determining the lignancy in males between the ages of search, in part so they may recognize professional standard of care, courts 15 and 35 years. Of patients with dis- the limits to their own abilities. This will consider expert evidence of other seminated disease, ϳ25% initially ethical obligation is common to all practitioners in that field,23 applica- present with symptoms that arise health care providers. ble legislation, regulations, policy from the metastasis and not the pri- statements, and guidelines issued by mary tumor.1 Back pain is the most LAW regulatory bodies or professional common symptom of metastatic In the introductory article of this sup- associations, and judicial decisions disease.2 plemental issue of Pediatrics9 we ex- on previous cases.19,21,24,25 Many people suffer from back pain, al- plain the legal duty of care that health When a chiropractor undertakes a pa- though relatively few of them have can- practitioners owe their patients and tient’s care, he or she must investigate cer. They may consult conventional, outline what a plaintiff must prove to the cause of the patient’s complaint or complementary and alternative medi- succeed in a negligence action. In this condition to determine if chiropractic cine (CAM), or a combination of health article we focus on one aspect of clini- treatment could benefit the patient care providers to find relief. In a large cians’ obligations: the legal standard and to formulate a treatment plan. 2007 survey, the most common reason of care owed to patients and how it is Health care professionals are not ex- for which American adults used CAM determined. pected to meet a standard of perfec-

Downloaded from www.aappublications.org/news by guestPEDIATRICS on October Volume 1, 2021 128, Supplement 4, November 2011 S201 tion; they can make errors in judgment tests, or perform physical examina- medicine and the patient had rejected without being found negligent unless tions; failure to do so “may be judged the only conventional medical treat- the error is one that falls below the against a biomedical standard of care, ment (), his treatment should standard of care (ie, that a reason- and constitute malpractice.”19(p230),32 not be judged by the standards of con- able practitioner in that field would Finally, Canadian cases have not uni- ventional medicine. However, he was not have made in similar circum- formly recognized the validity of differ- held to the standard of a in stances).10,12,14 When a patient’s clinical ing “schools of opinion” regarding general practice when assessing what condition warrants (eg, continued or diagnosis.33 However, courts increas- he knew or should have known about unexpected deterioration or the onset ingly accept that diagnoses may legiti- the safety of the remedies he pre- of new symptoms), the practitioner mately vary among systems of health scribed. He was ultimately not held lia- should consider other possible expla- care on the basis of different princi- ble, because the court found the med- nations. The diagnosis or assessment ples (provided the itself ical literature too equivocal to put a may have to be reconsidered, and does not fall below the standard of reasonably competent physician on treatment changed or a referral made, care).20,34,35 This is consistent with notice that the remedy was too hazard- as appropriate.14,26,29 Treatment deter- growing state acceptance of different ous to use. Although foreign judg- mined to be ineffective should be dis- types of CAM, evidenced by their inclu- ments are not binding on courts in continued. In both Canada and the sion in regulatory regimes governing other countries, this decision rein- United States, nonmedical providers health professions and statutory forces the extent of clinicians’ duty to (whether allied health or CAM) may recognition of their separate scopes take account of relevant findings from have a duty to refer the patient when it of practice and distinct forms of conventional , reevaluate becomes apparent that the patient’s diagnosis. and modify their practices accordingly condition exceeds the provider’s skill in light of reported adverse events and Unregulated/Less Recognized CAM and training.14,19,27–30 Referral must be clinical experience, and ensure that Providers timely to avoid delaying needed care. remedies they recommend or provide Many types of CAM are neither as well In some circumstances, courts do not are safe or, at least, that they make recognized nor as integrated into the patients aware of the risk of harm. use the previously described profes- health care regulatory system as chi- If a health practitioner is sued for neg- sional standard to judge the care pro- ropracty. Less well-accepted types of 20 ligence and a common professional vided. When conventional, CAM, or al- practitioners may not be recognized standard of care among practitioners lied health practitioners act outside as a profession or share a common cannot be identified or is not accepted, the scope of practice legally permitted practice.19,36 Courts will enforce statu- courts have judged the care provided or generally accepted by peer practi- tory prohibitions on unauthorized by either (1) the standard of the rea- tioners, the underlying justification for practice,37,38 but beyond that, judicial sonable person20,41 (who presumably judging them by standards that con- guidance about the standard of care form to their education, training, and applicable to these types of CAM pro- should limit care to that appropriate to a layperson) or (2) accepted medical peer expectations would no longer viders is scarce.19,39,40 A 2000 English hold.20,31 Consequently, a professional case, Shakoor v Situ, is one of the few standards (because the person repre- standard of care would be inappropri- to have addressed this issue.35 The pa- sented himself or herself as being 14,20,36,41–43 ate. In addition, a heightened standard tient died of acute failure, a rare skilled in healing). Practitio- of care may be imposed when clini- reaction to an remedy pre- ners must recognize the limits of their 44 cians’ areas of knowledge or treat- scribed for his skin condition by the capabilities. ment overlap; expert evidence from defendant, a practitioner of traditional conventional practitioners not trained Chinese . Articles in Informed Consent and CAM in the discipline concerned may be re- orthodox medical journals had sug- Practitioners lied on to establish standards of prac- gested that the remedy carried a risk Failure to obtain informed consent to tice applicable to diagnosis or treat- of liver damage. The defendant was un- treatment is a breach of practitio- ment.20,27 In the United States, Cohen aware of these articles; he believed the ners’ standard of care regardless of gave an example of chiropractors be- remedy safe in light of Chinese medical whether the is conventional or ing authorized by law to take radio- textbooks. The court concluded that alternative. As part of obtaining in- graphs, conduct urinalysis, order because the defendant did not hold formed consent to chiropractic care, blood and other routine laboratory himself out as practicing conventional clinicians must provide patients with

S202 GILMOUR et al Downloaded from www.aappublications.org/news by guest on October 1, 2021 SUPPLEMENT ARTICLE material information about their con- pertinent to this scenario, they also need for longer, more aggressive ther- dition, the treatment proposed, alter- identified 20 cases of “delayed diagno- apy, and greater physical and psycho- natives to the treatment, and material, sis and/or inappropriate provision of logical adverse effects. special, or unusual risks associated chiropractic care” that indirectly with the various options.19,44–48 Pa- caused adverse events. They consid- RECOMMENDATIONS tients/parents should be given the in- ered even this number an underesti- Scope of Practice formation that a reasonable person in mate, as it was not the focus of their similar circumstances would want to .55 Seven of the indi- Clinicians should ensure that they know to make an informed decision rect adverse events involved delayed have the necessary knowledge, skills, about treatment, which should include . and training to treat the patient’s con- dition, comply with regulatory and in- general information about the practi- Some conditions clearly indicate po- stitutional policies, and are legally au- tioner’s approach to health care and tential serious risk to health and re- thorized to provide the treatment diagnosis, particularly if it departs quire immediate referral for conven- proposed in the jurisdiction in which from the mainstream, and discussion tional medical care. In pediatrics, they practice.60,61 of what is known about the efficacy of persistent systematic symptoms of the treatment proposed. back pain that interferes with sleep Standard of Care and to self-imposed activity limi- CLINICAL RESPONSE tations are considered a “red flag” for Thorough history-taking, investigation, The US Centers for Disease Control serious disease that warrants immedi- and record-keeping are essential, as is have estimated that 2.8% of American ate further evaluation with at least an appropriate physical examination children received chiropractic treat- a plain radiograph.56 Our scenario when pertinent to the patient’s pre- ment for various conditions in 2007, raises questions about both the rea- senting complaint. and an Australian study found rates as sonableness of the initial diagnosis Clinicians must exercise reasonable high as 34%.3,49 Although there is evi- and the failure to investigate further care, skill, and judgment in diagnosing dence that chiropractic treatment can or consider other diagnoses given the the condition, explaining results to be effective in treating lower back pain patient’s condition and response to patients, and reconsidering diagnosis in adults,50,51 there are few data specif- treatment, as well as the point at and treatment when circumstances ically pertaining to pediatric chiro- which the patient should have been re- warrant. practy despite its popularity for ferred for medical care and chiroprac- Clinicians must be sure to obtain in- children. tic treatment ended. A judgment about formed consent for treatment and tell whether this practitioner fell below Data on adverse events related to pe- patients when their condition is not the standard of care because he mis- diatric chiropracty are scarce. We amenable to the type of treatment they diagnosed the condition or because he identified 4 pediatric reviews. Most provide.19 recently, a 2010 update of clinical re- failed to recognize that the patient re- The patient’s condition should be mon- search literature in the 2007 Vohra et quired different expertise and referral itored appropriately during treatment, al review, in which no serious adverse to a physician will depend on expert and treatment should be altered (with events were identified.52 Also, a 3-year and other evidence about the standard retrospective study of pediatric case of care. consent) as needed. Treatment deter- files from a teaching clinic practice did Incorporating more formal training mined to be ineffective should be not reveal any serious complications about pediatric care into chiroprac- discontinued. from 781 case files.53 Before that, re- tors’ education could reduce the risk Referral is indicated when the clinician sults of a narrative review suggested of adverse events caused by delays in cannot diagnose or assess the pa- that the risk of complications from chi- diagnosis or referral for needed tient’s condition, the patient’s condi- ropractic manipulation in pediatric pa- care.55,57,58 Treatments for testicular tion is not responsive to treatment, the tients is 1 in 250 million visits.54 Vohra cancer have improved, so despite the patient needs treatment that the clini- et al55 suggested that this study poten- progress of the disease to lung metas- cian is not competent or authorized to tially underestimated the risk, be- tasis, there is still a Ͼ90% cure rate.59 provide, the clinician cannot continue cause most harms are not reported. Nevertheless, the delay in diagnosis to treat the patient, or the clinician is Their systematic review identified 14 could very well be linked with an ad- insufficiently experienced to treat the cases of direct adverse events; more vance in the stage of the tumor, the patient.10,19,62–64 Referral must be timely

Downloaded from www.aappublications.org/news by guestPEDIATRICS on October Volume 1, 2021 128, Supplement 4, November 2011 S203 to ensure that needed care is not thorities and professional associa- received salary support from the Al- delayed. tions should develop programs to berta Heritage Foundation for Medical improve safety and quality of care and Research and the Canadian Institutes Education alert members about preventable ad- of Health Research. Clinicians who treat children should verse events (eg, an advisory guideline We thank Dr Paul Grundy and an anon- have ample formal pediatric training to that outlines the association between ymous pediatric chiropractic reviewer provide better and safer care to their back pain and cancer in young men for comments on this article; all errors youngest patients. Best-practice recom- and adolescents). and omissions remain our own. We mendations for pediatric chiropractic Continuing education (eg, through ed- also gratefully acknowledge the contri- care (based on expert opinion, because ucational programs, journal clubs, or butions of Soleil Surette and Alison high-quality research evidence is lack- self-study) is important to ensure that ing) were published in 2009.65 Henry for help in literature searching practitioners learn about new develop- and manuscript preparation, Maya Adverse Events and Patient Safety ments and reported adverse events so Goldenberg and Andrew Milroy for bio- they can modify their practices as ethics research assistance, and Os- Improving patient safety and reducing needed. error have become priorities in health goode Hall Law School students (now care.66–69 When adverse events occur, ACKNOWLEDGMENTS graduates) Nicola Simmons, David Vi- it is essential to assess what went Funding for this project was partially tale, Kristine Bitterman, and Janet wrong to learn how to avoid such oc- provided by the SickKids Foundation Chong for assistance with legal currences in the future. Regulatory au- (Toronto, Ontario, Canada). Dr Vohra research. REFERENCES

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