Guidelines for Ethical Behavior Relating to Clinical Practice Issues in Electrodiagnostic Medicine
Approved by the American Association of Electrodiagnostic Medicine: September 1997
(Muscle Nerve 22: Supplement 8: S43-S47, 1999)
Introduction
A task of ethics is to recommend guides for action. A task of professional ethics is to state the guides for action that should govern the practice of a professional body. Guidelines for ethical behavior relating to clinical practice issues in electrodiagnostic medicine (EDX) have been developed to formalize the standards of professional behavior for physicians who practice electrodiagnostic medicine—EDX consultants. These guidelines outline professional standards that EDX consultants should observe in their clinical and scientific activities. The guidelines are modeled after the Code of Professional Conduct of the American Academy of Neurology and are consistent with the Guidelines in Electrodiagnostic Medicine of the American Association of Electrodiagnostic Medicine (AAEM) and Principles of Medical Ethics as adopted by the American Medical Association. Violation of these guidelines may provide grounds for disciplinary action under Article 10.0 of the AAEM Bylaws.
1. The Electrodiagnostic Medicine Patient-Consultant Relationship
1.1 The Patient-Consultant Relationship
The foundation for EDX consultation is the relationship between the patient and the EDX consultant (hereafter "consultant"). The consultant has an ethical duty to consider the interests of the patient first. The consultant must practice competently, respect patient autonomy and confidentiality, and take reasonable steps to protect the patient's best interest.
1.2 Beginning and Ending the Relationship
The consultant is free to decide whether or not to perform an EDX consultation on a particular person. The consultant should not decline a patient on the basis of race, religion, national origin, gender, sexual orientation, or known or suspected medical diagnoses. If possible, it is best for the consultant and the referring physician to concur on who should inform the patient (or designated surrogate) of the results of the EDX consultation. The consultant should discuss the reason for the consultation with the patient and advise the patient whether he or she will be providing the patient with the results of the test or whether the results will be provided by the referring physician. If the patient has a diagnosis that does not require EDX testing, the consultant should give the patient the right to cancel the study (see Section 5.1). Once the consultation has begun, the consultant should complete the consultation process unless the patient ends the relationship before the consultation can be completed, or medical contraindications to completing the consultation become apparent during the consultation. After completion of the consultation, the consultant should return the patient to the care of the referring physician, if there is one. If the patient does not have a referring physician, the consultant should take responsibility for urgent care of the patient until appropriate referral can be made.
1.3 Informed Consent in Clinical Consultation
The consultant must obtain valid verbal or written consent from the patient or, when the patient is not competent to give such consent, from the patient's appropriate surrogate. The consultant should disclose information that the average person would need to know to make an appropriate medical decision. This information should include the benefits and risks of the proposed tests and may include costs of the proposed tests, if the patient desires this information. Consent must be given voluntarily by the patient. If reasonable explanation fails to elicit a patient's consent to carry out the EDX consultation, the consultant should not undertake the evaluation. The patient may negate a prior consent; if this occurs the consultant should not continue the examination. Consultants should comply with applicable state law governing informed consent requirements. Federal Food and Drug Administration (FDA) and Institutional Review Board (IRB) rules should be followed when conducting experimental or investigational studies of procedures, pharmaceuticals, or medical devices that involve human subjects (see Section 7).
On occasion, EDX testing must be performed on patients who cannot give consent. If a legal guardian is present, or if the patient has designated a surrogate decision-maker through a valid health care power of attorney that is in effect, that person should be consulted. If the patient lacks decisional capacity, a guardian or surrogate is unavailable, and the situation is an emergency, the consultant may proceed without consent.
1.4 Patient Communication, Comfort, and Preparation
The consultant has a duty to communicate with the patient. The consultant should convey relevant information in terms the patient can understand and allow adequate opportunity for the patient to raise questions and discuss matters related to the EDX evaluation. Consultants should attempt to ensure that patients are adequately prepared for the planned EDX procedures and that they are made as comfortable as possible during the examination. Informing the patient of the findings of the examination should be coordinated with the referring physician (see Section 1.2). Moreover, suggestions for changes in clinical management should generally be made to the referring physician unless the referring physician has requested that the consultant participate in clinical management.
1.5 Medical Risk to the Physician
The AAEM recognizes that consultants have needs and concerns that are relevant for ethical decision making in the context of consultation. At the same time, a consultant should provide appropriate, compassionate care to all patients, including patients with human immunodeficiency virus (HIV) and other infectious diseases. A consultant should not deny care to a patient solely because of the real or perceived medical risk to the consultant. The consultant should learn and practice appropriate precautions in the examination of any patient to minimize his or her medical risk. This position is consistent with the ethical position proposed by the American Academy of Neurology.1
2. General Principles of Electrodiagnostic Medicine Consultation
2.1 Professional Competence
The consultant should perform evaluations only within the scope of his or her training, experience, and competence. The consultant should provide care that represents the prevailing standards of EDX practice.
Consultants should use only standard, well accepted, and published techniques and methods of interpretation. To this end, consultants should participate in, and maintain documentation of, a regular program of continuing education. Justifiable exceptions may occur in a research setting or during the evaluation of an unusual clinical problem. If all or part of the consultation is considered research, it must conform to the guidelines in Section 7.
2.2 Confidentiality
The consultant must maintain patient privacy and confidentiality. The patient's name and details of the patient's life or illness that would identify the patient must not be publicized or published without written permission.
2.3 Patient Records
Consultants should keep medical records that are complete, accurate, and available to appropriate persons. The consultant's records should include a statement of the problem and the indications for the study, description of the findings, statement of normality or abnormality of these findings, and clinical correlation and diagnostic conclusions. Storing recordings of actual waveforms from nerve conduction studies (NCSs) and needle electromyography (EMG) is not required. Information within the medical records should be available to patients and referring physicians.
2.4 Professional Fees
The consultant is entitled to reasonable compensation for EDX services commensurate with the difficulty of the study, time involved, and the number of procedures performed. The fee structure must be made available upon request to patients, referring physicians, or third party payers. The consultant should bill for and receive compensation for only those services actually rendered or supervised. The consultant must not receive a fee for making a referral or give a fee for receiving a referral ("fee-splitting"). The consultant should not receive a commission from anyone for an item or service he or she has ordered for a patient ("kickback").
2.5 Appropriate Electrodiagnostic Services
The EDX consultation should address the issues involved for a reasonable differential diagnosis. The consultant must be involved in the pretest evaluation of the patient and the plan of the study and should perform only those tests that are medically indicated. The consultant has the ultimate responsibility for NCS examinations, even if they are performed by a technologist or another physician under the consultant's supervision. The consultant must be readily available and must promptly review and evaluate the results of the EDX study. The patient should remain in the examination room until the supervising EDX consultant has reviewed the NCS results. This will help to minimize the number of cases in which further NCSs need to be performed based on the results of the initial NCS. Whenever possible, the NCSs and EMG examination on the same patient should be performed on the same day, by the same EDX consultant, to optimize continuity and consistency. All needle EMG examinations should be performed by or, in the case of residents or fellows, under the direction of a consultant.
3. Personal Conduct
3.1 Respect for the Patient
The consultant must treat patients with respect and honesty. The consultant must not abuse or exploit the patient psychologically, sexually, physically, or financially.
3.2 Respect for Agencies and the Law
The consultant should observe applicable laws. The consultant should cooperate and comply with reasonable requests from insurance, compensation, reimbursement, and government agencies within the constraints of patient privacy and confidentiality.
3.3 Maintenance of the Consultant's Personal Health
The consultant should strive to maintain physical and emotional health and should refrain from practices that may impair his or her ability to provide adequate patient care.
4. Conflicts of Interest
4.1 The Patient's Interest is Paramount
Whenever a conflict of interest arises, the consultant must attempt to resolve it in the best interest of the patient. Conflicts of interest that cannot be eliminated should be disclosed to the patient. If, after discussing the conflict, the patient does not want to proceed, the consultant should not perform the consultation on the patient.
4.2 Avoidance and Disclosure of Potential Conflicts
The consultant must avoid practices and financial arrangements that would, solely because of personal gain, influence decisions on the types of consultations performed on patients. Financial interests of the consultant that might conflict with appropriate medical care should be disclosed to the patient.
4.3 Healthcare Institutional Conflicts
The consultant should advocate for his or her patient's medical interests when they are threatened by policies of a healthcare institution or agency.
5. Relationships With Other Professionals
5.1 Cooperation and Communication With Healthcare Professionals
Consultants should cooperate and communicate with other healthcare professionals, including other physicians, nurses, and therapists in order to provide the best care possible to patients. Written and oral communication with other healthcare professionals should be carried out in a timely manner.
The consultant may teach fellows and residents how to perform the EDX consultation. Effective teaching requires close supervision of trainees during the actual testing and careful review of the report of the findings before it is sent to the referring healthcare professional.
On occasion, the consultant, while evaluating a patient referred for EDX testing, will determine, based on available clinical information, that the patient most likely is suffering from a problem that is not located in the peripheral neuromuscular system. The consultant should attempt to communicate this opinion to the referring healthcare professional with the goal of optimizing further care for this patient. Options include not proceeding with the planned EDX testing and redirecting the diagnostic evaluation.
5.2 Referrals
For the most part, referrals to consultants come from other physicians. Referrals may come from other healthcare professionals and lay persons, however, and patients may refer themselves. If the referral did not come from another physician, every attempt should be made to identify the patient's primary physician so that the report of the results of the EDX consultation may be sent to that physician if the patient consents. The consultant can refer a patient to a primary physician if one is needed.
If the primary care physician agrees, the consultant may actively participate in further evaluation and treatment of the patient's neuromuscular problems, and may even become the principal provider of the care for these problems.
5.3 Peer Review, Utilization Review, and Quality Assurance
The consultant should participate in peer review, utilization review, and quality assurance activities in order to promote optimal patient care.
5.4 Competence of Colleagues and Impaired Physicians
Consultants should not knowingly ignore a colleague's incompetence or professional misconduct, thus jeopardizing the safety of the colleague's present and future patients. The consultant should strive to protect the public from an impaired physician and to assist in the identification and rehabilitation of impaired colleagues.
5.5 Expert Witness Testimony
Consultants, as a matter of acting in the public interest, are encouraged to serve as impartial expert witnesses in clinical and technical matters regarding electrodiagnostic medicine. Consultants providing expert medical testimony should be adequately versed in the medical and scientific issues involved in the matter and, before giving testimony, should carefully review the relevant records and facts of the case and the standards of practice prevailing at the time of the occurrence that gave rise to the claim. It is unethical for expert witnesses to provide services under a contingent fee arrangement.
5.6 Healthcare Organizations
The consultant may enter into contractual agreements with managed healthcare organizations, prepaid practice plans, or hospitals. The consultant should retain control of medical decisions without undue interference. The patient's welfare must remain paramount.
6. Relationships with the Public and Community
6.1 Public Representation
Consultants should not represent themselves to the public in an untruthful, misleading, or deceptive manner regarding qualifications, credentials, and expertise through statements, testimonials, photographs, graphics, or other means. A patient's medical condition must not be discussed publicly without his or her consent.
6.2 Duties to Community and Society
Consultants should work toward improving the health of all members of society. This may include participation in educational programs, research, public health activities, and the provision of care to patients who are unable to pay for medical services. The consultant should be aware of the limitation of society's healthcare resources and should not squander those finite resources by performing unnecessary tests. The needs of an individual patient should be given priority.
6.3 Existing Laws
The consultant shall be obligated to obey the laws of the land and refrain from unlawful activities, but is strongly encouraged to help produce change in laws which are not in the best interest of patients and society.
7. Clinical Research
7.1 Informed Consent
Research is an activity designed to develop generalizable knowledge. Informed consent should be obtained for all research on human subjects. A full disclosure of risks, as well as benefits, must be specified. In almost all circumstances, informed consent should include a written document signed by the subject. The consultant is responsible for obtaining informed consent from the research subject. If the subject is in a dependent relationship to the consultant and there is a question that the consent may be obtained under duress, the informed consent should be obtained by an investigator completely independent of that relationship. The refusal of the patient to participate should not interfere with the patient-doctor relationship.
7.2 Institutional Review
7.3 Financial Charges to Research Subjects
While it is acceptable to mix clinical practice and clinical research procedures in the same setting, subjects should not be charged for electrodiagnostic research procedures that are without a likelihood of individual benefit to the subject.
7.4 Disclosure of Potential Conflicts
The consultant who is paid for testing patients in a clinical research project should inform the patient of any compensation he or she receives for the patient's participation. The compensation for patient testing should be reasonable in amount. The consultant should not bill the patient or the insurer for services compensated by the study sponsor.
7.5 Reporting Research Results
The consultant shall publish research results truthfully, completely, and without distortion. In reporting research results to the news media, the consultant should make statements that are clear, understandable, and supportable by the facts. Consultants shall not publicize results of research until after the data have been subjected to appropriate peer review.
References
1. Ethics and Humanities Subcommittee of the American Academy of Neurology. The ethical role of neurologists in the AIDS epidemic. Neurology 1992; May, 42:1116-1117.
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