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Biomedical subjects

Michael H Cohen

Publications and source records attributed to Michael H Cohen.

16 recordsLinked to original sources
PubMed2005

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

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

Complementary Therapies↗
PubMed2005

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

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

Complementary Therapies↗
PubMed2005

Long natural history of recurrent granulosa cell tumor of the ovary 23 years after initial diagnosis: a case report and review of the literature.

BACKGROUND: Granulosa cell tumors (GCTs) of the ovary are rare, hormonally active neoplasms characterized by endocrine manifestations, an indolent course, and late relapse. CASE: We report a case of a prolonged history of ovarian GCT managed primarily with repeat surgical resections. CONCLUSION: This case illustrates the benefits of cytoreductive surgery for the management of recurrent disease, the use of serum tumor markers to help guide therapy, and the importance of extended follow-up.

Female↗
PubMed2005

Complementary therapies in pediatrics: a legal perspective.

Increasing use of complementary and alternative medicine (CAM) therapies such as chiropractic, massage therapy, and herbal medicine, raises questions about the clinically appropriate use of CAM in pediatrics. Nonjudicious use of CAM therapies may cause either direct harm or, by creating an unwarranted financial and emotional burden, indirect harm. When advising patients concerning CAM therapies, pediatricians face 2 major legal risks: medical malpractice and professional discipline. Pediatricians can incorporate these considerations into advising and clinical decision-making about CAM therapies to address the best interest of the pediatric patient while helping to manage potential liability risk. This article provides a suggested framework, including asking the following questions: (1) Do parents elect to abandon effective care when the child's condition is serious or life-threatening? (2) Will use of the CAM therapy otherwise divert the child from imminently necessary conventional treatment? (3) Are the CAM therapies selected known to be unsafe and/or ineffective? (4) Have the proper parties consented to the use of the CAM therapy? (5) Is the risk-benefit ratio of the proposed CAM therapy acceptable to a reasonable, similarly situated clinician, and does the therapy have at least minority acceptance or support in the medical literature? Such an approach ideally can help guide the pediatrician toward clinical conduct that is clinically responsible, ethically appropriate, and legally defensible.

Child↗
PubMed2005

Pediatric use of complementary therapies: ethical and policy choices.

OBJECTIVE: Many pediatricians and parents are beginning to integrate use of complementary and alternative medical (CAM) therapies with conventional care. This article addresses ethical and policy issues involving parental choices of CAM therapies for their children. METHODS: We conducted a literature search to assess existing law involving parental choice of CAM therapies for their children. We also selected a convenience sample of 18 states of varying sizes and geographic locations. In each state, we inquired within the Department of Health and Human Services whether staff were aware of (1) any internal policies concerning these issues or (2) any cases in the previous 5 years in which either (a) the state initiated proceedings against parents for using CAM therapies for their children or (b) the department received telephone calls or other information reporting abuse and neglect in this domain. We asked the American Academy of Pediatrics and the leading CAM professional organizations concerning any relevant, reported cases. RESULTS: Of the 18 state Departments of Health and Human Services departments surveyed, 6 reported being aware of cases in the previous 5 years. Of 9 reported cases in these 6 states, 3 involved restrictive dietary practices (eg, limiting children variously to a watermelon or raw foods diet), 1 involved dietary supplements, 3 involved children with terminal cancer, and 2 involved religious practices rather than CAM per se. None of the professional organizations surveyed had initiated proceedings or received telephone calls regarding abuse or neglect concerning parental use of CAM therapies. CONCLUSIONS: Pediatric use of CAM therapies raises complex issues. Clinicians, hospitals, state agencies, courts, and professional organizations may benefit from a policy framework to help guide decision making.

Child↗
PubMed2003

Regulation, religious experience, and epilepsy: a lens on complementary therapies.

Complementary and alternative medical (CAM) therapies include chiropractic, acupuncture and traditional Oriental medicine, massage therapy, and herbal remedies; mind-body therapies (such as meditative practices and visualization); and folk practices and religious healing. Of these, modalities based on spiritual healing create a number of conundrums for the clinician, including legal, regulatory, and ethical issues. Further, the historic relationship between the study of epilepsy and religious experience suggests particular, potential associations between CAM therapies (and especially spiritual healing) and care for epileptic patients. There are at least two dimensions to this exploration: first, the widespread use of spiritual healing for treatment of epilepsy; and second, the hypothesized connection between epileptic seizures and mystical states. A number of legal rules help address potential abuse of authority by health care professionals, and include: (1) medical licensure; (2) scope of practice; (3) professional discipline; (4) malpractice; and (5) fraud. This article offers a preliminary resource for clinicians interested in these topics.

Complementary Therapies↗
PubMed2003

Microfabricated porous silicon particles enhance paracellular delivery of insulin across intestinal Caco-2 cell monolayers.

PURPOSE: Novel porous silicon microparticles were fabricated and loaded with fluorescein isothiocyanate (FITC)-insulin, a model hydrophilic pharmacologically active protein, along with varied doses of sodium laurate (C12), a well-known permeation enhancer. METHODS: Particle and liquid formulations were compared as a function of apical to basolateral flux of FITC-insulin across differentiated human intestinal Caco-2 cell monolayers grown on Transwell inserts. RESULTS: The flux of FITC-insulin from silicon particles across cell monolayers was nearly 10-fold higher compared with liquid formulations with permeation enhancer and approximately 50-fold compared with liquid formulations without enhancer. By increasing C12 dose per particle with a concomitant decrease in total particles added per monolayer, the percent of FITC-insulin transport resulted in a linear increase up to 25% monolayer coverage. CONCLUSIONS: Although maintaining monolayer integrity and transepithelial electrical resistance, maximum drug transport (20%/h) was achieved with 0.337 microg C12 dose per particle, and total particle loading at 25% monolayer coverage.

Animals↗
PubMed2003

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is defined as unskillful practice which fails to conform to a standard of care in the profession and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Ultimately research will or will not establish a specific CAM therapy as an important part of the standard of care for the condition in question. Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation.

Complementary Therapies↗
PubMed2002

Credentialing complementary and alternative medical providers.

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

Acupuncture↗
PubMed2002

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

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

Adenocarcinoma↗
PubMed2002

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

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

Complementary Therapies↗
PubMed2002

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

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

Complementary Therapies↗
PubMedDate not supplied

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

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

Academic Medical Centers↗