Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided i on procedures featured or ii by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications.
It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. This edition is dedicated to my wife, Elizabeth, and my children, Jonathan, Michael, Clare, and Kelley, without whose encouragement I could not have finished the project. I am indebted to the many authors who have worked diligently to prepare the content of this book.
To the learners who use this book, I wish you every success as you prepare to practice the art and science of medicine. To my wife, Jill, and my children, Laura, Nolan, and Caleb, thank you for supporting me in all my endeavors. In an attempt to accomplish this goal, we have turned to our colleagues who are involved in clinical education, as either core faculty or clinical preceptors, who are very knowledgable of the clinical procedure skills that clinical practice requires.
Although we recognize that this text does not cover every procedure that clinicians may be asked to perform in practice, it does address a majority of the commonly occurring clinical procedures. Most were selected on the basis of data that support the frequency with which physician assistants PAs perform these procedures in primary care settings.
We are forever indebted to the hundreds of bright, caring, compassionate, and pioneering men and women who founded the PA profession. They ventured into this career with little assurance that they would have a job or a career, much less a dependable income.
They have made it one of the most rewarding professions in existence today. Their vision, dedication, endurance, ingenuity, and concern for the best interests of their patients continue to be a motivating force for both of us as PA educators. We recognize the hundreds of colleagues with whom we share the role and title of PA educator.
These individuals often freely give up the opportunity for the greater income and greater control of their schedule that can often be found in clinical practice to help prepare the next generation of PAs. We find the dedication and commitment of PA educators to their profession truly inspiring. We owe a great debt of gratitude to our students. Without their eager thirst for information and knowledge, we would find our responsibility to teach them clinical procedures to be simply another job.
However, their passion and excitement about learning clinical procedures for the purpose of taking care of their future patients make this task a true pleasure. Finally, we acknowledge our publisher for its commitment to making educational materials like this available to clinicians. Specifically, we thank Shirley Kuhn for pursuing the idea of this book with us and encouraging us to take the leap of faith necessary to publish the first edition.
We also thank Rolla Couchman for his help in preparing the second edition. Finally, we thank Julie Mirra and Joanie Milnes for help in preparing the third edition.
Ruback 1 Schneider 2. Hendrix and Richard M. Sabulsky Jr. Danielsen 25 5. Harbert 37 6. Rahr and Salah Ayachi 85 Roberts, Kirby A. Bell, and Charles S. King Stone Varalli-Claypool, Gary R. Sharp, Daniel L. Fetters Gail Curtis Winegardner Frosch and Patrick T.
Knott Newell Auth and George S. Bottomley Jacques Babcock Nyberg xiii xiv Contents Katalanos 3 0. Nyberg Muma Gietzen Enking Asprey Ruback Procedure Goals and Objectives GOAL: To provide clinicians with the necessary knowledge and understanding of the principles of informed consent for all clinical procedures. Respect for patient autonomy in clinical practice and the shift from paternalistic medical decision-making to the patient-centered approach of today has improved the quality of medical care.
The process of obtaining informed consent from a patient is the moral, ethical, and legal responsibility of all ethical, and legal responsibility of all health care providers and provides the foundation health care providers. Informed consent should be obtained from a patient before all medical interventions that have the potential for harm.
Weighing requiring medical the risks and deciding on a course of action then becomes the responsibility of the painformed consent. Legal actions against health care professionals for failure to obtain informed consent to treatment have been pursued under two separate theories of liability—one based on the concept of battery and the other on the concept of negligence. General categories of information that must be provided include the nature of the proposed procedure, the alternatives, the risks and benefits of the procedure, and the alternatives.
The patient must be given the opportunity to ask questions. After , most lawsuits alleging lack of informed consent have been brought under the legal theory of negligence. When applied in a case of informed consent, the alleged negligence results from a failure to disclose sufficient information about the risks or complications of a treatment. Three essential conditions must be met to ensure effective informed consent.
First, the patient must have the capacity and competence to make an informed decision. Second, the patient must be given adequate clear information about the procedure or treatment and the alternatives sufficient to allow him or her to make an informed choice.
Third, the patient must give consent to treatment voluntarily, without coercion, manipulation, or duress. In general, an adult is presumed to be legally competent unless he or she has been formally and legally declared incompetent. Minors, on the other hand, are generally presumed to be legally incompetent for medical decision-making based on their emotional maturity and cognitive development.
Additionally, in the case of minors, specific legislation sometimes grants minors legal status to make some medical decisions for themselves, for example, in the areas of testing and treatment for sexually transmitted infections, reproductive decisions, substance abuse treatment, and mental health evaluation and treatment.
To make a rational choice, patients must be able to understand the treatments available and the likely outcomes in each case. They must also be able to deliberate and consider their options and weigh them one against another to choose the best alternative.
To do so effectively, the options must be evaluated in relation to a set of values and goals that provide the bases for preferring one outcome over any other. The second requirement of informed consent is that the patient must be provided with adequate and clear information with which to make a decision. The right to informed consent is embedded in the nature of fiduciary relationships, wherein one party has differential power and thus the inherent responsibility to protect the interests of the other and to share necessary information.
General categories of information that must be provided include the diagnosis; the nature, risks, consequences, and benefits of the procedure; an assessment of the likelihood that the procedure will accomplish the desired outcome; and any available alternatives to treatment, including the alternative of not having the procedure, and the risks and benefits of each. In clinical practice, the information required to be disclosed is frequently summarized by using the abbreviation PARQ: P the recommended medical procedure , A the reasonable alternatives to the recommended procedure , and R the risks of the procedure.
In the acronym, Q represents the additional step of asking patients if they have any questions about the proposed procedure not adequately disclosed in the discussion. Disclosure of information is judged adequate by two competing standards that have emerged in the laws governing informed consent.
The older standard, known as the professional standard or reasonable physician or professional community standard , bases disclosure of information on the prevailing practice within the profession. It requires the health care provider to disclose information that another practitioner with the same skill set and practicing in the same or similar community would disclose.
The second standard of disclosure, introduced in , is the reasonable person standard or materiality standard. Risks that are not serious or are unlikely are not considered material. The great advantage of the reasonable person standard is the focus on patient preferences. Instead it bases the requirements on what a hypothetical reasonable person would want to know.
The disadvantages include its failure to articulate the nature of the hypothetical reasonable person. In addition, the retrospective application of this standard presents a significant problem in that any complication of a procedure is likely to seem material after it has occurred. Communication of highly technical the process, written and specialized knowledge to someone who is not conversant in the subject presents a and oral, should formidable challenge. Patient-centered barriers to informed consent, such as anxiety, be provided at the language differences, and physical or emotional impairments, can impede the process.
Process-centered barriers, including readability of consent forms, timing of the consent discussion, and amount of time devoted to the process, also may interfere with the realization of respect for the autonomy of the patient. To optimize information-sharing, explanations should be given clearly and simply; questions should be asked frequently to assess understanding.
When possible, a variety of communication techniques should be used, including written forms of educational material and material in other media formats. Computers can be an effective tool when integrated into a clinical setting.
Voluntariness in the clinical setting may be influenced by the vulnerability of the patient and the inherent imbalance in knowledge and power between the health care professional and the patient.
Consent may take many forms, including implied, general, and special. Implied consent is often used when immediate action is required. In the emergency department, consent is presumed when inaction may cause greater injury or would be contrary to good medical practice.
General consent is often obtained on hospital admission to provide consent for routine services and routine touching by health care staff. Special consent is required for specific high-risk procedures or treatments.
However, when disagreements arise, oral consent becomes difficult to prove. Verbal consent should always be documented explicitly by the health care provider in the medical record. Written consent is the preferred form of consent. Documenta- the patient and some assent obtained. In cases that do not require specific forms, a general consent form can be was ensured.
Pertinent questions asked should be documented as well. The note should specify that the patient authorizes the provider obtaining consent to perform the procedure. Most states require a consent form to be witnessed. Consent forms are often written in great detail and use medical and legal terminology far beyond the capacity of many patients. Initiatives to improve health literacy suggest that important documents be written at a fifth grade level.
If necessary, an adequate interpreter should be made available during the informed consent conference. The issue of comprehension is vital to the process. Health care providers should not make the mistake of equating the written and signed document with informed consent. The provider should always take care to make sure that information-transferring communication did occur. The signature of a witness right to refuse treatis helpful in these circumstances.
Several types of legitimate exceptions to the right of informed consent have been described. Such tions to the right of exceptions include emergencies, patients unable to consent, patient waiver of consent, informed consent public health requirements, and therapeutic privilege.
In all of these instances, the proexist. According to the emergency exception, if treatment is required to prevent death or other serious harm to a patient, that treatment may be provided without informed consent. Courts have upheld that the emergent nature of the situation and the impracticality of conferring with the patient preclude the need for informed consent.
Despite this exception, a competent patient may refuse interventions even if life-saving. However, this exception does not imply that no consent is necessary; instead, informed consent is required from a surrogate acting on behalf of the patient.
In other cases, surrogates are more difficult to determine. The decision-making authority of surrogates is directed by defined standards. These standards require surrogates to rely first on any treatment preferences specifically indicated by the patient, either written or oral, before he or she lost decision-making capacity.
Patients can choose to waive their right to receive the relevant information and give informed consent to treatment. Health care providers should not feel obligated to accept the responsibility for making treatment decisions for patients if they are asked to do so. Instead, they can request patients make their own choice or designate another person to serve as surrogate.
Sometimes medical interventions have a potential benefit not only to the patient, but also to others in the community. This exception overrides individual patient autonomy in specific circumstances to protect important public health interests. The final exception to informed consent is the concept of therapeutic privilege, which allows the health care provider to let considerations about the physical, mental, and emotional state of the patient affect what information is disclosed to the patient.
The practitioner should believe that the risk in giving information would pose a serious detriment to the patient. The sole justification of concern that the patient might refuse needed therapy is not considered adequate to justify invoking this exception.
The therapeutic privilege is extremely controversial and not universally recognized. Thus the value of therapeutic privilege as an independent exception to informed consent is limited. The moral and legal doctrine of informed consent and its counterpart, the refusal of treatment, are products of the last half of the twentieth century.
Informed consent requires the health care practitioner to provide to the patient an adequate disclosure and explanation of the treatment and the various options and consequences.
Informed consent, however, is more than a legal necessity. When conducted properly, the process of communicating appropriate information to patients about treatment alternatives can help establish a reciprocal relationship between health care provider and patient that is based on good and appropriate communication, considered advice, mutual respect, and rational choices.
Such a sense of participation strengthens the therapeutic alliance between provider and patient. In the area of informed consent, as in every other area of risk management, the best recommendation is to practice good medicine.
Informed consent is an essential part of good medical practice today and is an ethical and moral responsibility of all health care providers.
New York: Oxford University Press; Ethical dilemmas in the care of minors in the emergency department. Emerg Med Clin North Am. Principles of Biomedical Ethics, ed 5.
A comprehensive primer of surgical informed consent. Surg Clin North Am. Professionals-patient relationships and informed consent. Postgrad Med J. Informed consent in the emergency department. Emerg Clin North Am. Medicolegal aspects of informed consent. Neurol Clin North Am. Medical informed consent: general considerations for physicians. Mayo Clin Proc. The medical record: informing your patients before they consent.
Clin Plast Surg. New York: McGraw-Hill; Kaibara PD. J Fam Pract. Although infected and noninfected patients were separated, nosocomial transmission continued, largely because of the lack of minimal aseptic procedures, coupled with the fact that infected patients were not separated from each other by disease.
By to , nursing textbooks discussed recommendations for practicing aseptic procedures and designating separate floors or wards for patients with similar diseases, thereby beginning to solve the problems of nosocomial transmission. These practices were used in U. By the s, the designation of specifically designed single- or multiple-patient isolation rooms in general hospitals and outpatient treatment for tuberculosis caused these specialized hospitals which since the s had housed tuberculosis patients almost exclusively to close.
Decisions regarding individual patient precautions were to be based on factors such as patient age, mental status, or possible need to prevent sharing of contaminated articles and were to be determined by the individual who placed the patient on isolation status. Decisions regarding the need for decreasing exposure to infected material by wearing masks, gloves, or gown were to be left to the patient caregiver.
In using the disease-specific isolation precautions, the issue of mistakes in applying the precautions arose if the patient carried a disease not often seen or treated in the hospital,11,13 if the diagnosis was delayed, or if a misdiagnosis occurred.
This happened even if additional training of personnel was encouraged. Recommendation was also made that personnel be immunized if proof of immunity could not be documented when barriers, such as masks, could not prevent transmission by airborne routes e.
This revised 10th Edition continues the tradition of excellence with a focus on high-yield core knowledge of key importance to anyone entering or established in the field of internal medicine.
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