Guidelines for Ethical Behavior Relating to Clinical Practice Issues in Neuromuscular and Electrodiagnostic Medicine Naomi A

AANEM PRACTICE TOPIC GUIDELINES FOR ETHICAL BEHAVIOR RELATING TO CLINICAL PRACTICE ISSUES IN NEUROMUSCULAR AND ELECTRODIAGNOSTIC MEDICINE NAOMI A. ABEL MD,1 EDUARDO A. DE SOUSA MD, FAAN,2 RAGHAV GOVINDARAJAN MD,3 MATTHEW P. MAYER MD,4 and DAVID A. SIMPSON DO, MS5 1 Physical Medicine and Rehabilitation, Department of Neurosurgery & Brain Repair, University of South Florida, Tampa, Florida, USA 2 Department of Neurology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA 3 Department of Neurology, University of Missouri, Columbia, Missouri, USA 4 Department of Pediatric Rehabilitation Medicine, University of Missouri–Kansas City, Children’s Mercy Kansas City, Kansas City, Missouri, USA 5 MDA Clinic and ALS Center, Michigan Institute for Neurological Disorders, Farmington Hills, Michigan, USA Received 10 June 2015; Revised 9 September 2015; Accepted 14 September 2015

ABSTRACT: The American Association of Neuromuscular & patient and physician, but also the outcome of the Electrodiagnostic Medicine (AANEM) developed guidelines to formalize the ethical standards that neuromuscular and electro- patient’s treatment. The physician has a fiduciary diagnostic (EDx) physicians should observe in their clinical and duty to first safeguard the interests of the patient. scientific activities. Neuromuscular and EDx medicine is a sub- The physician must practice competently, respect specialty of medicine that focuses on evaluation, diagnosis, and comprehensive medical management, including rehabilitation of patient autonomy and confidentiality, maintain individuals with neuromuscular disorders. Physicians working in patient safety, and protect the patient’s best interests. this subspecialty focus on disorders of the motor unit, including muscle, neuromuscular junction, axon, plexus, nerve root, ante- Beginning and Ending the Relationship. The phy- rior horn cell, and the peripheral nerves (motor and sensory). The neuromuscular and EDx physician’s goal is to diagnose sician is free to decide whether to perform an EDx or and treat these conditions to mitigate their impact and improve neuromuscular evaluation on a particular patient. the patient’s quality of life. The guidelines are consistent with The physician should not decline the evaluation on the Principles of Medical Ethics adopted by the American Medi- cal Association and represent a revision of previous AANEM the basis of the patient’s race, color, religion, national guidelines. origin, gender, disability, age, or other personal char- Muscle Nerve 52: 1122–1129, 2015 acteristics. The physician also should not decline an evaluation on the basis of the patient’s known or suspected medical diagnosis. The physician should THE PATIENT–PHYSICIAN RELATIONSHIP IN decline performance of the EDx or neuromuscular NEUROMUSCULAR AND ELECTRODIAGNOSTIC MEDICINE evaluation if he or she believes it to be unnecessary or The Patient–Physician Relationship. The relation- not beneficial to the patient. ship between the patient and the physician is a key If possible, it is best for the EDx physician and the component to assure that excellent care is provided. referring physician to concur on who should inform The quality of this relationship can impact not only the patient (or designated surrogate) of the results of the success of the outcome of the interaction between the EDx or neuromuscular evaluation. The physician should discuss with the patient the reason for the evalu-

Abbreviations: AANEM, American Association of Neuromuscular and ation and the methods to be employed. The physician Electrodiagnostic Medicine; EDx, electrodiagnostic; EMG, electromyogra- should advise the patient as to who will be providing phy; FDA, Food and Drug Administration; HIV, human immunodeficiency virus; IRB, institutional review board; LAR, legally authorized representa- the patient with the results of the test. If the patient has tive; NCS, nerve conduction study; OSHA, Occupational Safety and a diagnosis that does not require EDx or neuromuscu- Health Administration; TJC, The Joint Commission Key words: electrodiagnostic medicine; ethics; genetic testing; informed lar testing, the physician should so inform the patient consent; neuromuscular medicine and cancel the study or give the patient the right to This document, by the AANEM Ethics and Peer Review Committee, was originally drafted by the 1994 Committee: Robert G. Miller, MD (chair); Neil cancel the study (see subsection “Cooperation and A. Busis, MD; William W. Campbell, MD, MSHA; Andrew A. Eisen, MD; Communication with Healthcare Professionals”). Donna L. Frankel, MD; Mark Hallett, MD; Janice M. Massey, MD; and Lois M. Nora, MD, JD. The association also acknowledges the contributions of Once the evaluation has begun, the physician J. Russell Burck, PhD; Yasoma B. Challenor, MD; Steven H. Horowitz, MD; should complete the evaluation process unless the Glenn A. Mackin, MD; Lawrence R. Robinson, MD; and Jay V. Subbarao, MD.Developed and reviewed by the AANEM Ethics and Peer Review patient ends the relationship before the evaluation Committee. Approved by the AANEM Board of Directors, May 2015. This can be completed, or if medical contraindications manuscript did not undergo further peer review by Muscle & Nerve. to completing the evaluation become apparent Correspondence to: AANEM, 2621 Superior Drive NW, Rochester, MN during the evaluation. After completion, the physi- 55901; e-mail: [email protected] cian should return the patient to the care of the VC 2015 Wiley Periodicals, Inc. Published online 15 September 2015 in Wiley Online Library (wileyonlineli- referring physician. If the patient does not have a brary.com). DOI 10.1002/mus.24910 referring physician, the physician should take

1122 AANEM Practice Topic MUSCLE & NERVE December 2015 responsibility for urgent care of the patient until Relationship”). Moreover, suggestions for changes an appropriate referral can be made. in clinical management should generally be made to the referring physician rather than the patient, Informed Consent in Clinical Evaluation. The physi- unless the referring physician has requested that cian must obtain valid verbal or written consent the physician participate in the direct clinical man- from the patient. When the patient cannot give agement of the patient. consent or lacks decisional capacity, a verbal or written consent must be obtained from the patient’s Medical Risk to the Physician. Physicians have needs appropriate legally authorized representative (LAR), and concerns that are relevant for ethical decision- who acts as a surrogate decision-maker. If the LAR making in the context of evaluation. At the same is unavailable and the situation is urgent, the physi- time, a physician should provide appropriate, com- cian may proceed without consent. The physician passionate care to all patients, including patients with must disclose information that the average person infectious and other communicable diseases [e.g., wouldneedtoknowtomakeanappropriatemedi- human immunodeficiency virus (HIV) or antibiotic- cal decision. This information must include the resistant infections]. A physician should not deny benefits and risks of the proposed tests and should care to a patient solely because of real or perceived include the costs of the proposed tests if the patient medical risk to the physician. Physicians must utilize desires this information. If the patient is referred appropriate universal precautions during the exami- for evaluation of a painful symptom, the physician nation of any patient to minimize their own medical should explain that the EDx studies are directed risk. toward evaluation of certain measurable peripheral Ethical Considerations and the Management of nerve abnormalities, not whether pain is present or Neuromuscular Disease. Some neuromuscular dis- absent. The patient must give consent voluntarily. If orders are progressive or debilitating and may reasonable explanation fails to elicit a patient’s con- impact a patient’s autonomy or competence. Many sent to carry out the EDx examination, the physi- neuromuscular disorders have limited treatments, cian should not undertake the evaluation. The which may lead patients to seek unproven interven- patient may withdraw a prior consent; if this occurs tions. Others may have effective but costly treat- at any point during testing, the physician should ments that their insurance may not cover or which not continue with the examination. Physicians must patients may not be able to afford. Still others are comply with applicable state and federal laws govern- known to shorten a patient’s life expectancy with the ing informed consent requirements. prospect of a challenging final few months of life, Federal Food and Drug Administration (FDA) leading the patient to seek alternatives for end-of- and institutional review board (IRB) rules should life care. In addition, genetically diagnosed diseases be followed when conducting experimental or may include issues that affect relatives and future investigational studies of procedures, pharmaceuti- decision-making and have social implications. cals, or medical devices that involve human subjects (see section “Clinical Research”). Discussion of Disease Implications. First and foremost, physicians must provide patients with their best Patient Communication, Comfort, and Preparation. The diagnostic and management skills. They also have a physician has a duty to communicate with the duty to discuss openly with their patients the implica- patient. The physician should convey relevant tions of their EDx diagnosis and related illnesses. information in terms the patient can understand This discussion may require a great deal of sensitivity and allow adequate opportunity for the patient to and compassion on the physician’s part, particularly raise questions and discuss matters related to a if the diagnosis is one that will severely impact the neuromuscular and/or EDx evaluation. Physicians patient’s quality or length of life. The physician’s should make every effort to ensure that patients counsel should be honest yet allow the patient to pre- are adequately prepared for planned neuromuscu- serve some level of realistic hope. The physician has a lar evaluation and EDx procedures and that they duty to help the patient understand, decide upon, are made as comfortable as possible during the and seek reasonable treatment, should this be avail- examination. Physicians should be attentive to able, and to help avoid ineffective treatments. signs of patient discomfort and safety concerns and resolve them before proceeding. Physicians Progressive Disorders. For progressive disorders may decide whether to admit family members or the physician should provide or refer the patient significant others into the examination room dur- to services that will help maintain or prolong the ing testing to provide support. Informing the patient’s autonomy and independence. When the patient of the findings of the examination should neuromuscular diagnosis is expected to limit life be coordinated with the referring physician (see expectancy, the physician has a duty to provide previous subsection “Beginning and Ending the this information to the patient as well as to provide

AANEM Practice Topic MUSCLE & NERVE December 2015 1123 a realistic estimate of life expectancy, if possible. preconception and prenatal counseling. Physicians The patient has a right to this information in and patients should be aware of legal protections, order to be able to plan appropriately and address such as the Genetic Information Nondiscrimination end-of-life issues. The physician should be pre- Act,1 which prohibits discrimination as it relates to pared to counsel the patient regarding end-of-life employment and health insurance coverage. Social care and to provide referrals as appropriate. risks to patients may still include increased costs of health insurance, and non-insurability for disability, Treatment. Patients with neuromuscular disorders, life, and extended-care insurance. Physicians should many of whom currently have limited treatment seek expert consultation as it relates to the rapidly options, may seek out or request treatments that evolving field of genetic and epigenetic diagnosis. are not beneficial or are potentially harmful. The physician is not required to provide medical treat- GENERAL PRINCIPLES OF PATIENT CARE ment if the treatment is not medically beneficial, Professional Competence. The physician should ethically appropriate, or the risks outweigh the perform evaluations only within the scope of his or benefits. If a physician’s determination regarding her training, experience, and competence. The phy- medical care conflicts with the advance directive of sician should provide care that represents the pre- a competent patient or the LAR, then the physi- vailing standard of care for neuromuscular and EDx cian should explain his or her treatment determi- practice. Physicians should use only standard, well- nation and recommendations with the goal of accepted, and published techniques and methods of resolving the conflict. If the conflict cannot be evaluation and interpretation. Evidence-based tech- resolved and it interferes with the physician’s care niques are preferable. To this end, physicians should of the patient, then the physician should make a participate in, and keep documentation of, a regular reasonable effort to find another physician to pro- program of continuing education. Physicians should vide care for the patient. maintain current technical skills and ensure they have adequate experience before introducing new Pain Management. Many neuromuscular disorders techniques into practice. On occasion, other new or can result in significant acute or chronic pain in non-standard techniques may be necessary when affected patients. Patients in pain have a legitimate dealing with an unusual clinical problem or a right to access pain management. Pain manage- research study. If all or part of the evaluation is con- ment is a complex area of patient care and one sidered research, it must conform to the guidelines that has ethical implications for physicians. Physi- outlined in the section “Clinical Research.” cians who elect to manage acute or chronic pain in this population should be familiar with the vari- Confidentiality. The physician must maintain patient ous pharmacologic and non-pharmacologic modal- privacy and confidentiality, both in performing EDx ities and options available. Physicians who choose studies and the configuration of the examination to manage their patients’ acute or chronic pain areas in which they are performed, in accordance must have a solid working knowledge of the dosing with all state and federal laws and regulations address- schedules, side effects, and the diversion or abuse ing patient privacy. The patient’s name or other potential of the various medications available for demographic information, as well as details of the pain management. Physicians also should be very patient’s life or illness that would identify the patient, familiar with the use of pain medication or opioid must not be publicized or published without written contracts, the various professional guidelines, and permission. state or federal regulations related to the manage- Patient Records. Physicians should keep and man- ment of acute or chronic pain. Physicians who age medical records that are complete, accurate, elect to not manage a patient’s acute or chronic and in compliance with the Health Insurance Port- pain should refer the patient to another physician ability and Accountability Act (HIPAA). The physi- or pain management specialist for this manage- cian’s records should include a statement of the ment as appropriate. problem and the indications for the neuromuscular Genetics. Novel ethical dilemmas may occur when evaluation and/or the EDx study, description of the the diagnosis of neuromuscular disease is confirmed findings, assessment of normality or abnormality of by genetic testing. Physicians should strive to pro- these findings, and clinical correlation and diagnos- vide a balanced approach when interpreting genetic tic conclusions. Storing recordings of actual wave- information as it relates to environmental factors forms from nerve conduction studies (NCS) and and phenotypic variability. Physicians should help needle electromyography (EMG) is not required. In patients communicate findings and health implica- writing reports, physicians are encouraged to follow tions to extended family members. Resources for Reporting the Results of Needle EMG and NCS: An Edu- genetic counseling should be offered, including cational Report, a publication of the AANEM.2

1124 AANEM Practice Topic MUSCLE & NERVE December 2015 Information within the medical records should tests. Many of these tests may provide information be available only to appropriate individuals, includ- that can pose ethical dilemmas for the physician as ing referring physicians, patients, and others indi- well as the patient. cated in a valid release of information signed by In particular, genetic testing is increasingly the patient. Urgent information should be commu- used to diagnose neuromuscular disease. Advances nicated directly and promptly to the referring phy- in multiplex genetic testing, including whole sician and should be appropriately documented in genome and exome testing, present complex ethi- the physician’s record. cal dilemmas for physicians and patients. Physi- Professional Fees. The physician is entitled to rea- cians should strive for clear communication and sonable compensation for services commensurate shared decision-making when considering genetic with specified billing procedures, the comprehen- testing. Pre-test genetic counseling is essential and sive nature of the evaluation, difficulty of the should include traditional discussions of benefits study, time involved, and the number of proce- and risks. Attention should be given to obtaining dures performed. The fee structure must be made assent from minors when appropriate. Patients available upon request to patients, referring physi- should be educated on the potential for normal cians, or third-party payers. The physician should variants, non-specific findings, phenotypic variabili- bill for and receive compensation for only those ty, and incidental findings. At present, testing, services actually rendered or supervised. The physi- when possible, should be limited to single-gene cian must not receive a fee for making a referral or tests or masked-multiplex tests to decrease the give a fee for receiving a referral (“fee-splitting”). occurrence of incidental findings. With next gener- The physician should not receive a commission ation sequencing, the ethical dilemma will be dis- from anyone for an item or service ordered for a closure of genetic mutations and predisposition to patient (“kickback”). diseases not under consideration. Post-test genetic counseling should be provided for all positive find- Appropriate Services. The physician should per- ings, including disclosure of incidental findings. In form a sufficiently comprehensive neuromuscular many cases, physicians must be prepared to coordi- evaluation and/or EDx study that can address the nate care for the extended family as needed for issues necessary to determine or evaluate a reason- carrier testing, reproductive risk counseling, and able differential diagnosis. For the EDx study the testing of undiagnosed individuals. When benefi- physician must be involved in the pre-test evalua- cial treatments do not exist, testing asymptomatic tion (focused history and physical examination) of the patient and the plan of the study and should minors for adult-onset diseases should be delayed perform only those tests that are medically indi- until the age of consent. cated. Tests selected and procedures used should As the diagnosis and management of neuro- conform to published guidelines, when available. muscular disease evolves, new ethical questions will The physician has the ultimate responsibility continue to present themselves, especially with for NCS examinations, even if they are performed whole genome and exome testing delineating not by a technologist or another physician under the only the gene in question but also other unex- physician’s supervision. The physician must be pected gene mutations that may suggest additional readily available and must promptly review and disease(s). Society’s viewpoint on these topics also evaluate the results of the NCS. The patient should will continue to shift, requiring physicians to be remain in the examination room until the super- ever vigilant. vising EDx physician has reviewed the NCS results. PERSONAL CONDUCT All needle EMG examinations should be per- Respect for the Patient. The physician must treat formed by the appropriately trained neuromuscu- patients with respect and honesty, with particular lar or EDx physician, or, in the case of residents or sensitivity to language barriers, cultural diversity fellows, under supervision of such a physician. concerning personal modesty (appropriate use of Except in unusual circumstances, the NCS and chaperones), physical pain, and disability. The phy- EMG examination of a single patient should be sician must not abuse or exploit the patient psy- performed on the same day and by the same EDx chologically, sexually, physically, or financially. physician, for continuity and consistency. The evaluation and diagnosis of neuromuscular Respect for Agencies and the Law. The physician disease may require the use of a number of special- should observe applicable laws. The physician ized laboratory or diagnostic tests. The physician should cooperate and comply with reasonable may have the appropriate training to perform requests from insurance, compensation, reimburse- some of these specialized studies. Referral to other ment, and government agencies within the con- specialists may be necessary for some specialized straints of patient privacy and confidentiality.

AANEM Practice Topic MUSCLE & NERVE December 2015 1125 Maintenance of the Physician’s Personal Health. The Referrals from other Physicians. For the most part, physician should strive to maintain physical and referrals to physicians come from other physicians. emotional health and should refrain from prac- Referrals for neuromuscular evaluations and/or tices that may impair his or her ability to provide EDx testing may come from other healthcare pro- adequate patient care. fessionals, or patients may refer themselves. If the referral did not come from another physician, CONFLICTS OF INTEREST every attempt should be made to identify the The Patient’s Interest Is Paramount. Whenever a patient’s primary physician so that results of the conflict of interest arises, the physician must attempt to resolve the issue in the best interest of neuromuscular or EDx evaluation, with patient the patient. Conflicts of interest that cannot be consent, may be sent to the primary physician. If eliminated should be disclosed to the patient. If, the patient has no primary care physician, then after discussing the conflict, the patient does not the physician should refer the patient to a primary wish to proceed, the physician should not perform physician or specialist if one is needed. the examination. If the primary care or referring physician agrees, the EDx physician may actively participate in further Avoidance and Disclosure of Potential Conflicts. The evaluation and treatment of the patient’s neuromus- physician must avoid practices and financial cular issues and may even become the principal pro- arrangements that would, solely because of personal vider of care for these issues. gain, influence decisions on the types of examinations performed on patients. Financial interests of Studies Performed on One’s Own Patients—Self- the physician that might conflict with appropriate Referral. Most physicians see and follow patients medical care should be disclosed to the patient. for clinical, diagnostic, and therapeutic reasons. In the course of providing such evaluation and man- Healthcare Institutional Conflicts. The physician agement, a physician may recommend that a should advocate for his or her patient’s medical patient have EDx or other specialized studies, such interests when they are jeopardized by policies of a as biopsies or ultrasound, to clarify a diagnosis or healthcare institution or agency. The physician assist with treatment. Ordering and performing should inform the patient when referral restric- EDx studies, or any other specialized studies, for tions on testing would limit the validity of results. which the physician is appropriately trained and RELATIONSHIPS WITH OTHER PROFESSIONALS experienced to do, on one’s own patient is not Cooperation and Communication with Healthcare considered a “self-referral,” but is instead part of Professionals. Physicians should cooperate and the evaluation and considered to be appropriate communicate with other healthcare professionals, patient care. In fact, it may be in the best interest including other physicians, nurses, and therapists, to of the patient for the physician who knows the provide the best care possible to patients. Written patient to perform these studies. When consider- and oral communication with other healthcare pro- ing performing EDx or other specialized studies fessionals should be carried out in a timely and cour- on one’s own patient, the physician must keep in teous manner. The terms used in the communication mind that there must be a proper indication for should be useful to the referring physician and be as the study, which is consistent with relevant guide- responsive to the referral question as possible. lines. The need for and the scope of the study The physician may teach fellows and residents should be properly documented in the patient’s how to perform the EDx examination. Effective medical record. Some neuromuscular and EDx teaching requires close supervision of trainees dur- physicians may prefer to refer their patients to ing the actual testing and careful review of the other physicians for specialized or EDx testing, to report of the findings before it is sent to the refer- avoid even the appearance of a conflict of interest. ring healthcare professional. Patients also always retain the right to request spe- On occasion, while evaluating a patient cialized neuromuscular or EDx testing by an inde- referred for EDx testing, the physician will deter- pendent physician without compromising their mine, based on available clinical information, that ongoing clinical care. the patient most likely has a medical problem that Peer Review, Utilization Review, and Quality is not localized within the peripheral neuromuscu- Assurance. The physician should participate in lar system. The physician should attempt to com- peer review, utilization review, and quality assurance municate this opinion to the referring healthcare activities in order to promote optimal patient care. professional with the goal of optimizing further care for the patient. Options may include not pro- Competence of Colleagues and Impaired ceeding with the planned EDx testing and redirect- Physicians. Physicians should not knowingly ing the diagnostic evaluation. ignore a colleague’s incompetence or professional

1126 AANEM Practice Topic MUSCLE & NERVE December 2015 misconduct, which could jeopardize the safety of Physician expert witnesses are expected to be the colleague’s present and future patients. The impartial and should not adopt a position as an physician should strive to protect the public from advocate or partisan in the legal proceedings. an impaired physician and should assist in the Healthcare Organizations. The physician may enter rehabilitation of impaired colleagues. Physicians into contractual agreements with managed health- should cooperate with peer review processes. care organizations, prepaid practice plans, or hos- Expert Witness Testimony. Physicians, as an act of pitals. The physician should retain control of public interest, are encouraged to serve as impartial medical decisions without undue interference. The expert witnesses in clinical and technical matters patient’s welfare must remain paramount. regarding neuromuscular and EDx medicine. RELATIONSHIPS WITH THE PUBLIC AND COMMUNITY Expert witness testimony is opinion testimony that Public Representation. Physicians should not rep- may relate to the standard of care, nature and extent resent themselves to the public in an untruthful, of disability, causation of injury, clinical status of the misleading, or deceptive manner regarding qualifi- patient, or prognosis. Physicians cannot be required cations, credentials, or expertise through state- to provide expert witness testimony. An expert testi- ments, testimonials, photographs, graphics, or fies either for the person bringing the case (the other means. A patient’s medical condition must plaintiff or the government in a criminal matter), not be discussed publicly without his or her con- the person being sued (the defendant), or the sent (see subsection “Confidentiality”). judge. It is important for physicians who act as expert witnesses to remember that transcripts of Duties to Community and Society. Physicians should depositions and courtroom testimony are public work toward improving the health of all members records and subject to independent peer review. of society. This may include participation in educa- The minimum statutory requirements for quali- tional programs, research, public health activities, fications for an expert witness in a medical mal- and provision of care to patients who are unable practice action should reflect all of the following: to pay for medical services. The physician should be aware of the limitation of society’s healthcare (a) The expert witness should have comparable resources and should not overutilize those finite education, training, appropriate certification, and resources by performing unnecessary tests. The occupational experience in the same field of needs of an individual patient should be given expertise as the opposing physician. (b) The expert witness’s occupational experience priority. should include active medical practice or teaching Existing Laws. The physician is obligated to obey experience in the same field of expertise as the the laws of the land and refrain from unlawful opposing physician. activities but is strongly encouraged to help pro- (c) Some state statutes require the expert witness duce change in laws that are not in the best inter- to be currently in active medical practice; whereas, est of patients and society. Physicians should in most states, the expert witness needs to have cooperate with legal authorities and processes. been in active medical practice or teaching experi- They should honor reasonable requests from insur- ence within 5 years of the occurrence giving rise to ers and government agencies, consistent with ethi- the claim. cal and legal privacy protections required by law.

It is unethical for expert witnesses to provide TECHNOLOGISTS IN THE ELECTRODIAGNOSTIC services under a contingent fee arrangement or to LABORATORY link compensation to the outcome of the case. Establishing and Maintaining the Patient–Technologist Compensation should be reasonable and commen- Relationship. Although the patient–physician rela- surate with actual services rendered. tionship remains the core of all medical care pro- Physicians who provide expert medical testi- vided, EDx technologists (referred to as mony should be adequately versed in the medical technologists hereafter) are often the frontline and scientiﬁc issues involved in the matter and, staff with whom patients ﬁrst interact. It is, thus before giving testimony, should carefully review imperative that technologists develop and maintain the relevant records and facts of the case and the rapport with patients. standards of practice prevailing at the time of the Technologists should treat every patient in a occurrence that gave rise to the claim. professional and courteous manner, regardless of Physicians should testify about the medical the patient’s race, color, religion, national origin, records, the standard of care, and any other matter gender, disability, age, or other personal character- related to the case fairly, honestly, and in a bal- istics, and irrespective of the patient’s known or anced manner. suspected medical diagnosis.

AANEM Practice Topic MUSCLE & NERVE December 2015 1127 Technologists should safeguard the patient’s CLINICAL RESEARCH right to privacy and confidentiality and uphold all Informed Consent. Research is an activity designed laws governing patient information. to develop and increase generalized knowledge. Technologists should maintain patient safety All research on human subjects must be approved and cleanliness and adhere to The Joint Commis- and in compliance with current IRB rules and reg- sion (TJC) guidelines for Universal Precautions as ulations. Informed consent must be obtained for well as the Occupational Safety and Health Admin- all research on human subjects. A full disclosure of istration (OSHA) law and standards.3 risks, as well as potential benefits or lack thereof, must be specified. In all circumstances pertaining Scope of Practice. The technologist should always to research, informed consent must include a writ- work under the direct supervision and direction of a ten document signed by the subject or LAR. The physician fully qualified in the practice of EDx medi- physician or other appropriately identified investi- cine. Although Medicare regulations mandate that a gator is responsible for obtaining informed con- physician must provide a minimum of general super- sent from the research subject for any research vision over certified technologists throughout the investigation or clinical trial before enrolling the performance of NCS testing, it is the position of the subject in research. If the subject is an active AANEM that direct supervision, as defined by Medi- patient of the physician-investigator, the physician 4 care, is recommended for all NCS testing. must recognize that there is a potential for coer- Technologists may explain EDx testing to cion because of the patient’s dependent relation- patients. The technologist should perform accurate ship/position to the physician-investigator. The and unbiased electrophysiological studies with patient may feel under duress to consent to the patient comfort as their utmost priority. The tech- research whether or not this is expressed. To avoid nologist should keep records of studies and take any real or perceived duress, it is advised that, part in the overall maintenance of the EDx whenever possible, informed consent be obtained laboratory. by an investigator completely independent of the Technologists cannot give results of the NCS, patient–physician relationship. Special care should can neither perform nor give results of needle be taken with vulnerable populations, including EMG, and cannot discuss aspects of diagnosis and children, pregnant women, and cognitively management with patients.4 impaired individuals. Opting to participate or not participate in the research should not affect how Professionalism. Technologists should demon- care is provided to the patient. strate professional etiquette toward their colleagues (physicians, residents and fellows, and Institutional Review. The research project should other healthcare professionals) irrespective of conform to generally accepted scientific principles. experience level, and should provide high quality, The physician who participates in clinical research team-based, patient-centered care. Technologists must ascertain that the research has been may guide and teach the skills involved in NCS to approved by an institutional review board (IRB) or other junior technologists, residents, and fellows. other comparable body, and must adhere to the Technologists are required to maintain their requirements of the approved protocol. Any licensure and certification. They should keep up adverse events or outcomes must be documented with the latest in medical sciences and technology. and reported to the IRB, Data Safety Monitoring Although it is not required, technologists are Board, and to the sponsoring and regulatory encouraged to attend annual conferences and con- agencies. tribute to research and publications. Financial Charges to Research Subjects. Although The technologist should utilize interpersonal it is acceptable to mix clinical practice and clinical and communication skills that are patient- research procedures in the same setting, the appropriate with patients, laboratory staff, and research procedures should be clearly identified to other health professionals. the research subject in accordance with the IRB- The technologist should explain test proce- approved research protocol. Compensation for dures to the patient in order to obtain the cooper- clinical research should follow applicable study ation necessary for a complete examination. guidelines and IRB approval. Physicians should not The technologist should perform standard and bill the patient or the insurer for services for which advanced NCS in a highly skilled, patient- they have already been compensated by the study appropriate manner, recognize normal and abnor- sponsor. All federal, state, and local regulations mal results, and recognize and take reasonable pertaining to billing for clinical care/services asso- steps to eliminate physiological and non- ciated with clinical research must be observed to physiological artifact.5 avoid billing the same services more than once.

1128 AANEM Practice Topic MUSCLE & NERVE December 2015 Disclosure of Potential Conflicts. The physician shall safeguard patient confidences and privacy who is paid for testing patients in a clinical within the constraints of the law. research project should inform the patient of any V. A physician shall continue to study, apply, and compensation he or she receives for the patient’s advance scientific knowledge; maintain a commit- participation. The amount of compensation for ment to medical education; make relevant infor- patient testing should be reasonable. mation available to patients, colleagues, and the public; obtain consultation; and use the talents of Reporting Research Results. The physician should other health professionals when indicated. publish research results—both positive and nega- VI. A physician shall, in the provision of appropri- tive—truthfully, completely, and without distortion. ate patient care, except in emergencies, be free to In reporting research results to the news media, choose whom to serve, with whom to associate, the physician should make statements that are and the environment in which to provide medical clear, understandable, and supportable by the care. facts. Physicians should not publicize research VII. A physician shall recognize a responsibility to results until after the data have been subjected to participate in activities contributing to the appropriate peer review and accepted for presenta- improvement of the community and the better- tion or publication. ment of public health. APPENDIX VIII. A physician shall, while caring for a patient, AMERICAN MEDICAL ASSOCIATION PRINCIPLES OF 6 regard responsibility to the patient as paramount. MEDICAL ETHICS IX. A physician shall support access to medical Preamble. The medical profession has long sub- care for all people. scribed to a body of ethical statements developed primarily for the benefit of the patient. As a mem- Adopted by the AMA House of Delegates, June 17, ber of this profession, a physician must recognize 2001. responsibility to patients first and foremost, as well Source: Reprinted from Code of Medical Ethics of as to society, to other health professionals, and to the American Medical Association, 2012–2013 edi- self. The following principles adopted by the tion with permission of the American Medical American Medical Association are not laws but Association. VC 2012. rather standards of conduct that define the essen- tials of honorable behavior for the physician. REFERENCES Principles of Medical Ethics. 1. U.S. Equal Employment Opportunity Commission. The Genetic Information Nondiscrimination Act of 2008. http://www.eeoc.gov/ laws/statutes/gina.cfm. Accessed August 7, 2014. I. A physician shall be dedicated to providing com- 2. Jablecki CK, Busis NA, Brandstater MA, Krivickas LS, Miller RG, petent medical care, with compassion and respect Robinson JE. Reporting the results of needle EMG and nerve conduction studies: an educational report. Muscle Nerve 2005;32: for human dignity and rights. 682–685. II. A physician shall uphold the standards of pro- 3. American Association of Electrodiagnostic Technologists. The code of ethics of the American Association of Electrodiagnostic Technolo- fessionalism, be honest in all professional interac- gists. https://www.aaet.info/about/code-of-ethics/. Accessed Septem- tions, and strive to report physicians deficient in ber 3, 2015. 4. American Association of Neuromuscular and Electrodiagnostic Medicine. character or competence, or engaging in fraud or Nerve conduction studies and somatosensory evoked potentials inde- deception, to appropriate entities. pendently to be reviewed by a physician at a later time. http://www. aanem.org/getmedia/151b0cac-9450-4f2f-a1a1-ba4631ca4a69/Technologists_ III. A physician shall respect the law and also rec- Conducing_NCS_SEP-clean-version_1. Accessed September 8, 2015. ognize a responsibility to seek changes in those 5. American Association of Neuromuscular and Electrodiagnostic Medi- cine. Job Descriptions for NCS Technologists. http://www.aanem. requirements that are contrary to the best interests org/getmedia/fa2630f8-e869-4d77-b4a9-7dfd37dffb68/job_descriptions_ of the patient. edx_techs.PDF.aspx. Accessed September 3, 2015. 6. Council on Ethical and Judicial Affairs. Code of medical ethics of the IV. A physician shall respect the rights of patients, American Medical Association—current opinions with annotations, colleagues, and other health professionals, and 2012–2013 edition. Chicago: American Medical Association; 2012. p. xv.

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