Partnership and Consent in MS Decision-Making
With 10 disease-modifying therapies for MS, decision-making is becoming ever more complex, and clinicians should seek to form therapeutic partnerships with patients
The range of choices for managing multiple sclerosis (MS) is increasing, with 10 new therapies having become available over the past 20 years. However, along with those increasing choices has come more complexity in the decision-making process, for both patients and their physicians.
In an article published online ahead of print in the Journal of Neurological Sciences, Jacqueline Palace, FRCP, DM, a clinical neurologist at Oxford University Hospitals Trust in Oxford, U.K., provided an update on the decision process in the rapidly evolving multidrug environment and offered suggestions to clinicians on how to foster decision-making partnerships with patients (Palace, 2013).
"It is clear that patients should be involved in making decisions about their own treatment and that this improves outcomes, adherence, and is cost effective," Dr. Palace wrote. "However, there is an obligation on the doctor as the expert to ensure their patient is sufficiently informed to do this, and to be aware of the patient's ability to make decisions and of any outside influences that might detrimentally affect this."
Patient involvement on the rise
In recent years, patients have become more involved in making decisions about their care, with many physicians offering minimal advice when requested or even limiting their role solely to exchange of information. "Patient preference for the role they wish to play in decision making will vary within and across populations and some patients will prefer a more passive role whereas others choose a collaborative or active option," Dr. Palace wrote.
Patient involvement is likely to be greatest in clinical situations where all available options are in "equipoise," that is, when they are more or less equally desirable or undesirable, she noted.
One factor that may figure into treatment decisions is physician bias. Dr. Palace noted that marked variability in medical care has been documented over the years.
A good example of that phenomenon, she noted, comes from the U.K., where during a surveillance period four disease-modifying treatments (three formulations of interferon-beta and glatiramer acetate) were available to all 72 prescribing centers throughout the country. The relative use of those agents from center to center varied markedly.
In addition, she said, the percentage of MS specialists in each of the treatment centers who were prescribing disease-modifying drugs to patients with secondary progressive MS (versus relapsing-remitting MS) varied from 0% to nearly 50%. Dr. Palace believes those variations are likely attributable to physician preferences rather than patient preferences. "It is hoped that with greater patient involvement in treatment decisions these site variations will reduce," she wrote.
Commenting on that point in an email interview, Robert J. Fox, M.D., medical director of the Mellon Center for Multiple Sclerosis at the Cleveland Clinic in Cleveland, Ohio, told MSDF he is not so sure lack of patient involvement is a major factor in prescribing variations. "Different clinicians view the efficacy and side effect profile of the injectables differently," he said. "I don't see how patient involvement in decision-making would have reduced that variation."
Guidelines for decision-making
The decision-making process has garnered attention from governmental health authorities in the U.K. In 2008, the General Medical Council (GMC) published guidelines for obtaining patient consent (General Medical Council, 2008). The guidelines stress the importance of patients and their physicians working together to come up with the most appropriate therapy.
In her paper, Dr. Palace listed key points in the GMC guidelines. They are:
- Work in partnership;
- Inform patients: use objective decision aids;
- Individualize: listen, be receptive;
- Maximize patient ability to make decisions;
- Maintain awareness of patient capacity;
- Maintain awareness of outside influences;
- Respect patients' views and decisions.
Among the most significant challenges facing clinicians is ensuring that patients fully understand treatment options. Given the array of new treatments, Dr. Palace noted, "It is perhaps not surprising that patients may not grasp all the information they need to make the best decision."
That reality was underscored by an assessment of 19,000 adults conducted in the U.S. in 2003 (Weiss, 2007). It concluded that 36% of American adults had inadequate literacy skills regarding health issues.
Value of decision aids
Since helping patients understand treatment options can be time-consuming, providing effective educational aids to patients is an invaluable tool for decision-making, Dr. Palace emphasized. Whether pamphlets, videos, or web-based tools, these sorts of aids are especially useful when more than one reasonable treatment option is available and when the comparative advantages and disadvantages of available options are uncertain.
Ethnic and cultural differences, as well as influence from patients' family members, also affect the decision-making process, Dr. Palace noted, and it is therefore vital that physicians remain alert for signs of outside coercion or pressure on their patients.
Dr. Fox of the Cleveland Clinic agreed. "Recognizing cultural differences is important, but will be difficult to achieve perfectly," he wrote. "Family factors are important too, since decision-making can be different from one family to another."
Dr. Fox also agreed that involving MS patients in decision-making offers what he termed "a huge advantage." However, he added that he is unsure whether hurdles to achieving patient involvement arise primarily due to physicians or to patients. "Does the patient know his or her role in medical decision-making? There is a societal opportunity to educate patients regarding their role," he said.
Another point Dr. Fox stressed is the increasing role of mass media in educating patients. He and his colleagues recently published a study (Marrie et al., 2013) in which more than 8,500 people with MS were surveyed regarding how they acquire information on health issues. "Interesting, 83% reported that mass media was their first source of information, and not interpersonal information sources (i.e. clinicians)," he wrote. "Clearly, the source of information about treatment decisions is shifting with a large role coming from outside the clinician's office."
One example: The National Multiple Sclerosis Society has recently unveiled a new program aimed at helping physicians and patients sort out the advantages and disadvantages of various treatment approaches. That program can be accessed via the web here.
Decision-making: Case by case
MSDF also solicited comments from Amit Bar-Or, M.D., FRCPC, of the Montreal Neurological Institute and Hospital at McGill University in Montreal, Canada, an Accelerated Cure Project scientific adviser.
He stressed the importance of dealing with patients on a case-by-case basis. "While my guiding principle is to inform and support the patient reaching a decision that suits him/her best, one keeps in mind that there is a broad range of personalities, needs, and preferences," he wrote in an email. "There are occasional patients who essentially relinquish any decision-making to the care team, but I find these patients to be the minority."
Dr. Bar-Or agreed that considering cultural and family factors is crucial in forging decision-making relationships with patients. "The prescriber should not adopt a 'singular’ approach to treatment preferences, rather an approach that seeks to understand such factors and incorporate that knowledge into discussion and the decision-making process," he wrote.
The potential for cognitive impairment in MS also needs to be considered in decision-making. To overcome such obstacles, Dr. Bar-Or suggested, "Start discussions early to get a sense of the patient's attitudes and preferences, and plan ahead. Encourage note taking and memory aids to help patients keep track of discussions related to treatment choices. If needed, involve supportive individuals (family, friends) as appropriate."
What about directions for future research regarding decision-making? Dr. Fox commented, "I've not seen a questionnaire asking patients to rate a previous medication decision-making process, and then looking at what factors were associated with their satisfaction. That would be a fruitful area of future study."
Key open questions
- What factors are associated with patient satisfaction in regard to medical decision-making?
- What influences account for variations in physician prescribing of treatments for multiple sclerosis?
Dr. Palace has received support for scientific meetings and honoraria from Schering and unrestricted grants from Merck Serono and Bayer Schering. Dr. Fox has received personal consulting fees from Allozyne, Avanir, Biogen Idec, Novartis, Questcor, Teva, and XenoPort; has served on advisory committees for Biogen Idec and Novartis; and has received research grant funding from Novartis. Dr. Bar-Or has participated as a speaker at meetings sponsored by, received consulting fees, and/or received grant support from Amplimmune, Bayhill Therapeutics, Berlex/Bayer, Biogen Idec, BioMS, Diogenix, Eli Lilly, Genentech, GlaxoSmithKline, Guthy-Jackson/GGF, Merck/EMD Serono, MedImmune, Mitsubishi Pharma, Novartis, Ono Pharma, Receptos, Roche, Sanofi-Genzyme, Teva Neuroscience, and Wyeth.