Centering wound treatment on the patient rather than the disease permits patients more active engagement in their own care, and can lead to better outcomes. This author explains how to make your practice more patient centered, with an eye on the unique challenges of practicing hyperbaric medicine in a patient-centered way.
Patient-centered care” has been identified by the Institute of Medicine as one of the fundamental approaches needed to improve the quality of U.S. health care.1 It is defined as “care that is respectful of and responsive to individual patient preferences, needs, and values” and which ensures that “patient values guide all clinical decisions.” The goal is to shift the focus of our health care system away from the disease, and focus instead on the patient.
The hope is that the patient will be actively engaged in deciding which path to take whenever the crossroads of an important healthcare decision are reached. That philosophy presupposes that the patient is able to engage in this process and is capable of understanding the choices before them if presented with clear information. The practice of wound care often involves life-changing decisions such as whether a limb should be amputated, and wound care practitioners often encounter patients near the end of life when the skin begins to break down due to the failure of multiple organ systems. Decisions regarding the use of advanced technology, for example, should be undertaken only after obtaining a clear understanding of the goals and expectations of the patient and family. Framing these choices can be difficult under the best of circumstances but it can be particularly challenging in wound care and hyperbaric medicine.
Hyperbaric medicine poses a special challenge since it may require an explanation of the physics of gas laws which, as will be discussed below, seem to have confused even some investigators in the field. As the U.S. health care system undergoes a highly publicized restructuring around principles like “patient centeredness,” access to hyperbaric oxygen therapy (HBOT) for accepted indications (e.g. radiation proctitis and failing flaps) is diminishing just as the availability of HBOT for off-label use is increasing. New therapies enter the wound care market almost weekly, but their effectiveness among our highly compromised patients is unclear. It is also impossible to ignore the financial incentives to provide certain types of care. Institutions, hospitals and employers are understandably focused on the financial bottom line and not providing certain well-reimbursed treatments when they are not in the best interest of the patient can be hard to explain. How can we keep the best interests of the patient at the center of the decision-making process in these changing times?
Building a Patient-Centered Wound Care Practice
The nature of the doctor-patient relationship is an unequal one. Patients are vulnerable in part because they may be ill, but also because the difference in education creates a knowledge gap between the physician and the patient. As a result, for many generations, the model of medical practice was a paternalistic one. However, dramatic societal changes have altered patient expectations, technological advances make it impossible for the physician to be knowledgeable about everything, and changes in payment models often require patients to make difficult financial decisions pertaining to health care choices. As a result of these and many other factors, collaboration between the physician and the patient regarding health care decisions is now the expected norm.
The technological advances of the past century have come with definite trade-offs. The internet allows information (including inaccurate information), to spread rapidly. Unproven therapies are available if the patient wishes to pay for them. Patient expectations of technology are high, overuse of (or over-reliance on) technology is a common temptation, and profit motives can drive therapeutic decisions. We need a framework to guide us. Nothing should change the practitioner’s commitment to the principle of nonmaleficence, which is often referred to as “First do no harm.” Preventing harm is more important philosophically, morally and legally than “doing good.” Practitioners should also maintain their commitment to beneficence, or “Always acting in the patient’s best interest.” This is required because patients often cannot act on their own for a variety of reasons, including ignorance, illness, or fear. Although these commitments are a valuable ethical infrastructure, they don’t provide a specific approach to patient-centered practice.
The Picker Institute identified 8 indicators that define patient-centered, quality medical care from the perspective of patients.2 These are: respect for the patient’s values, preferences, and expressed needs; coordinated and integrated care; clear, high-quality information and education for the patient and family; physical comfort, including pain management; emotional support and alleviation of fear and anxiety; involvement of family members and friends, as appropriate; continuity, including through care-site transitions; and access to care. As an illustration, I have provided 2 patient vignettes and then in Table 1, have described the manner in which these eight principles were addressed.
Mrs. A is a 78-year-old woman with adult onset diabetes who is in hospice care due to end-stage cardiac disease, with a life expectancy of less than 6 months. She has severe peripheral arterial and cerebrovascular disease, is status post-stroke with residual left side paralysis, and is not ambulatory. She has a recurrent first metatarsal head lesion on her right foot. Sometimes the toe joint is visible and this is distressing to her family. Osteomyelitis is likely, based on X-ray findings. The wound is not painful but she has ischemic leg pain. Transcutaneous oximetry values suggest that she would require an above the knee amputation to reach a level where healing would be likely, but she is not a candidate for general anesthesia.
Mr. B is a 70-year-old man who lives alone and has no family. He has poorly controlled insulin dependent diabetes and severe peripheral arterial disease. He also is a paraplegic due to a motor vehicle accident 15 years earlier, which left him wheelchair bound. He presents to the wound center with multiple bilateral lower extremity leg ulcers that expose tendons and bone. At presentation he has cellulitis and a fever. Transcutaneous oximetry values below the knee are less than 20 mmHg on both legs. He has no pain in his legs due to his spinal cord injury. His cardiac status is good and he is mentally alert and highly independent.
These cases illustrate the way in which two patients may be best managed with completely different treatment plans, based on their preferences and needs. Mrs. A is best served with comfort care; Mr. B is best served with bilateral amputations. While an amputation might have been medically reasonable for Mrs. A due to her osteomyelitis, it was not a patient-centered decision. Although limb salvage is usually the goal and usually desired by most patients, for Mr. B—who was paralyzed and whose ischemic limbs represented only a source of infection and difficulty with transfers—amputation offered the ideal management plan.
A Patient Centered Approach to Off-label Use of HBOT
For many years, the U.S. Food and Drug Administration (FDA) has deferred to the Undersea and Hyperbaric Medical Society (UHMS) to establish the list of indications for which HBOT has sufficient evidence to support its use.3,4 In the U.S., the FDA classifies hyperbaric chambers as “Class II medical devices,” because they do not support or sustain human life (Class III), but are not as innocuous as, for example, a tongue depressor (Class I).5
The Food, Drug and Cosmetic Act requires medical device manufacturers to notify the FDA of their intent to market a new medical device at least 90 days in advance using a process known as premarket notification, often referred to by the name of the subsection of the act in which it is found, “510(k).” This process allows the FDA to determine whether a new device (not in commercial distribution prior to May 28, 1976) is substantially equivalent to a device which has already been classified. The 510(k) clearance process is relatively uncomplicated for hyperbaric chambers that have not undergone substantial changes in design or composition when compared to predecessor chambers. In the 510(k) process, manufacturers must also stipulate that there are no substantial changes to the intended use of the chamber. This means that since 1978, all hyperbaric chambers cleared by the FDA can only be promoted for those conditions that are listed as approved in the UHMS Hyperbaric Oxygen Therapy Committee report.3
In order for a chamber to be approved to treat an indication that is not listed by the UHMS, the manufacturer must provide the FDA with compelling evidence to support the use of HBOT for that condition. A health care entity that advertises or promotes the off-label use of HBOT is in breach of FDA regulations, even if promoting an institutional review board (IRB)-approved research protocol, and the FDA is within its purview to seize its assets, including the hyperbaric chamber.5 An entity wishing to use a hyperbaric chamber for an unapproved indication must request an investigational device exemption (IDE) from the FDA. Updated guidelines regarding the promotion of off-label uses are pending from the FDA in the wake of several lawsuits successfully arguing that off-label promotion is protected as free speech and thus, allowable as long as the information provided is “truthful and non-misleading.”6,7
The above explanation notwithstanding, it is obvious from perusing the internet that that purveyors of hyperbaric therapy completely ignore restrictions on the promotion of its off-label use. HBOT is widely promoted for autism, cerebral palsy, chronic neurological deficits due to stroke, Lyme disease, Meniere’s disease, migraine, multiple sclerosis, Parkinson’s disease, and chronic fatigue syndrome, among many others.9 The FDA has released a statement strongly cautioning health care consumers that HBOT is not clinically proven to be an effective treatment for these conditions, has filed complaints against centers using HBOT for off-label conditions, and issued warning letters to the manufacturers of inflatable, low-pressure hyperbaric chambers for misbranding their devices.4,9,10
The UHMS reviewed the ethics of off-label use in 2001 in response to growing interest in the use of HBOT for cerebral palsy. Fifteen years later, the framework of this ethics review remains current.11 The lack of enforcement resources by the FDA, the desperation of patients suffering from otherwise untreatable conditions, and the decreasing revenue experienced by many hyperbaric centers are creating the ideal environment for a new model of HBOT delivery. This new model of HBOT delivery might be “patient centered” in that it meets a demand for low cost, available HBOT, but it could also set the stage for a safety disaster and allow vulnerable patients to be exploited. In this new and unregulated marketplace, mandated safety standards for equipment and properly trained personnel are far less likely to be in place. Individuals are enticed to undergo off-label HBOT treatment by convincing testimonials readily available online touting the benefits of HBOT for conditions without successful alternative options (e.g. autism), and most consumers do not have the necessary scientific background to critically evaluate the evidence provided.12,13
The complete text of the Chan and Brody paper is available from the UHMS Rubicon Foundation and is a valuable resource.12 The authors concluded that it is not unethical to treat a patient for an unproven or off-label indication. Nearly every day, clinicians utilize a drug or device for an indication different than the one for which the FDA originally cleared or approved it. This practice is not considered unethical simply because a device or drug proven to work for one indication is used for a different one, although patients should be informed of the off-label use. Case-by-case medical decisions to use HBOT for off-label indications do not require IRB approval, but if data are being collected with the intention of using that information to direct the care of future patients, then the activity should be considered research and IRB approval should be sought.
It is also not unethical to charge a patient for off-label use. Charges must be reasonable and transparent, and patients must understand in advance what the charges are. The focus of the patient centered approach to off-label use is in the process of informed consent.
Patient Reported Outcomes and Registry Participation
It is not possible to have a patient-centered health care system without obtaining patient-reported data. While there is much discussion about the value of patient-reported data, manufacturers and professional associations support patient-reported outcomes in the same way that beauty pageant contestants support world peace: Everyone is in favor of it, but no one actually contributes to it.
The U.S. Wound Registry (USWR) is a 501(c)(3) non-profit organization that exists to improve the quality of care of patients with chronic non-healing wounds and to increase the use of evidence based treatment by their providers.14 To accomplish these goals, as a Qualified Clinical Data Registry (QCDR), the USWR collaborates with wound care stakeholders (e.g. the Alliance of Wound Care Stakeholders, the Undersea and Hyperbaric Medical Society) in the development of wound care and hyperbaric oxygen specific quality measures. In 2014, the USWR was among the first group of QCDRs recognized by CMS. Among the measures developed by the USWR and recognized by CMS are a patient-reported wound outcome measure and a patient-reported nutritional screening measure.15
Reporting these measures to CMS requires collaboration between the USWR and your electronic medical records (EHR) vendor. Patients with chronic wounds are likely to be members of vulnerable populations (e.g. minority races, the disabled, patients with dementia or at the extremes of age). These patients are almost never enrolled in wound care or HBOT clinical trials. To obtain data on the effectiveness or the safety of wound care products or HBOT among these disproportionately affected individuals, the best (and perhaps the only) mechanism will be through registry reporting of real world data. Clinicians who report wound care and hyperbaric specific quality measures are committed to providing the best possible care for their patients, as well as contributing to the learning health care system that will provide better data in the future. That is the epitome of patient-centered health care.
Caroline E. Fife is Chief Medical Officer at Intellicure Inc., The Woodlands, TX; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands; and co-chair of the Alliance of Wound Care Stakeholders.
This article was originally published in the Textbook of Chronic Wound Care (editors Jayesh B. Shah, MD, Paul J. Sheffield, PhD, Caroline E. Fife, MD), 2018, Best Publishing Company, North Palm Beach, FL, as “Chapter 31: Patient-Centered Decision Making in Wound Care & Hyperbaric Medicine,” pp. 671-688.
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4. Undersea & Hyperbaric Medical Society (UHMS). Indications for Hyperbaric Oxygen Therapy. UHMS, 2015. Available at https://www.uhms.org/resources/hbo-indications.html. Accessed 23 July 2015.
5. U.S. Food and Drug Administration (FDA). Hyperbaric Oxygen Therapy: Don’t Be Misled. FDA, 2013. Updated 15 May 2015. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm. Accessed 20 July 2015.
6. U.S. Food and Drug Administration. Regulatory Information. FD&C Act Chapter V: Drugs and Devices. Updated September 25, 2015. Available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm. Accessed 30 September 2015.
7. Boumil MM. Off-label marketing and the First Amendment. N Engl J Med. 2013;368(2):103–5.
8. Inside Health Policy. Federal Judge Lets Amarin Promote Vascepa Off-Label, Says FDA Policies Violate 1st Amendment. August 7, 2015. Available at http://insidehealthpolicy.com/login-redirect-no-cookie?n=84883&destination=node/84883. Accessed 10 August 2015.
9. Healing-arts.org. Hyperbaric Oxygen Therapy Providers and Treatment Centers in the United States Treating Autism, Cerebral Palsy and Other Neurological Disorders. 2008. Available at http://www.healing-arts.org/children/hyperbaric oxygen therapy_hbot.htm. Accessed 15 August 2015.
10. Gaffney A. FDA Says Medical Device Popular with Elite Athletes Regularly Misbranded. Regulatory Affairs Professionals Society. 22 August 2013. Available at http://www.raps.org/focus-online/news/news-article-view/article/3980/. Accessed 30 November 2015.
11. Portable Hyperbaric Chambers Australia. The Salus 36. Portable Hyperbaric Holdings Pty Ltd, 2014. Available at http://02hyperbaricchambers.com/salus36-chamber/ . Accessed July 20, 2015.
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13. Cronin S. Mild hyperbaric oxygen chambers. 12 May 2012. Available at http://www.omlifeme.com/hyperbaric/. Accessed 20 July 2015.
14. Walker J. Hyperbaric oxygen therapy gets more popular as unapproved treatment. Wall Street Journal. 5 January 2015. Available at http://www.wsj.com/articles/hyperbaric-oxygen-therapy-gets-more-popular-as-unapproved-autism-treatment-1420496506. Accessed 20 July 2015.
15. U.S. Wound Registry. Available at https://www.uswoundregistry.com/ accessed 10/6/16
16. U.S. Wound Registry. Available at https://www.uswoundregistry.com/Specifications.aspx accessed 10/6/16