Journal of Neuroscience Nursing:
Enhancing Adherence Through Education
Smrtka, Jennifer; Caon, Christina; Saunders, Carol; Becker, Brenda L.; Baxter, Nancy
Christina Caon, MSN NP-C, is an assistant director of clinical research at the Multiple Sclerosis Center at Wayne State University School of Medicine, Detroit, MI.
Carol Saunders, RN MSCN, is in private practice in Oceanside, CA.
Brenda L. Becker, Expert Medical Education, Washington, DC.
Nancy Baxter, Expert Medical Education, Washington, DC.
Questions or comments about this article may be directed to Jennifer Smrtka, ANP-BC MSCN, at email@example.com. She is a board certified adult nurse practitioner and an IOMSN certified MS nurse at the Ft. Lauderdale MS Center, Pompano Beach, FL.
This supplement was supported by a grant from Teva Neuroscience. Expert Medical Education contributed to the editorial refinement of this article and to the production of this supplement. Authors may have accepted honoraria for their supplement contributions.
The treatment of multiple sclerosis (MS) has advanced greatly since the introduction of disease-modifying therapies (DMTs) in the early 1990s. Although the DMTs have exhibited significant efficacy in relapsing-remitting MS and other forms of the disease, the degree of benefit depends heavily on patient adherence to recommended regimens. This article addresses some of the most pressing areas of unmet need in educating advanced-practice nurses, neurologists, patients, and support care partners regarding strategies that can overcome obstacles to adherence. The observations presented here are based on clinical experience with real-life cognitive, psychosocial, and cultural impediments to adherence. The article also explores the ways in which adherence may be affected by emerging therapies for MS (such as oral agents) as well as the educational needs that will arise with the further evolution of MS care.
Multiple sclerosis (MS) is a chronic neurological disease that affects approximately 400,000 people in the United States and some 2.5 million people worldwide (National Multiple Sclerosis Society, 2010). Since the advent of disease-modifying therapy (DMT) in 1993, much has changed in the way of the clinical course of relapsing-remitting MS (RRMS). Although the disease course remains highly variable and unpredictable, DMTs have significantly altered and improved MS from a disease that once brought only despair and hopelessness to one where the accumulation of disability can be delayed and relapse rate lowered.
Now, 7 DMTs are available for the treatment of RRMS in the United States. Five are self-administered via a subcutaneous (SC) or intramuscular (IM) injection: SC interferon (IFN) β-1a (Rebif, 2009), IM IFN β-1a (Avonex, 2008), SC IFN β-1b (Betaseron, 2008; Extavia, 2009), and SC glatiramer acetate (Copaxone, 2009). Two DMTs are administered via IV infusions: natalizumab (Tysabri, 2008) and mitoxantrone (Novantrone, 2008). In patients with RRMS, these agents reduce the frequency and severity of clinical attacks (relapses or exacerbations, defined as the sudden worsening of a symptom or symptoms) as well as the appearance of new symptoms (Lim, & Constantinescu, 2010; National Multiple Sclerosis Society, 2009b). Furthermore, DMTs reduce the accumulation of lesions (damaged or active areas of disease) in the brain and spinal cord as observed on magnetic resonance imaging (MRI). There is evidence that these medications also appear to slow the rate at which disability progresses.
Apart from their use in RRMS, all DMTs except SC IFN β-1a, natalizumab, and mitoxantrone are approved for use in patients who have experienced an initial clinical episode and MRI features consistent with MS are present, a condition known as clinically isolated syndrome (CIS; Avonex, 2008; Betaseron, 2008; Copaxone, 2009; Extavia, 2009). In addition, mitoxantrone is approved for the treatment of secondary-progressive MS (SPMS; Novantrone, 2008), Unfortunately, despite the advances in the treatment of RRMS with the introduction of DMTs, no therapy is yet available for primary-progressive MS.
Early and continuous use of DMTs in RRMS has been associated with improved long-term outcomes (Baumhackl, 2008; Carroll, 2009; Goodin & Bates, 2009). Furthermore, delayed or discontinued treatment has been shown to deliver less benefit than continuous therapy in long-term studies of the original patients in pivotal randomized, controlled trials of DMT (Carroll, 2009). However, it remains a challenge to maintain patient adherence to injectable therapies that deliver neither short-term symptomatic relief nor long-term cure (Costello, Kennedy, & Scanzillo, 2008; Ross, 2008). Often, individuals with RRMS, their support care partners, and their healthcare providers harbor misconceptions or require a deeper understanding of important issues that affect adherence and treatment efficacy.
Nurses and other healthcare practitioners are vitally important in educating the patient and their support care partners to enhance adherence and treatment outcomes (Baumhackl, 2008). Educational topics include potential side effects of the DMTs and efforts to mitigate those effects, overcoming injection anxiety, consequent social isolation, and treatment expectations, the most critical area of education. Often, engaging patients regarding these difficult topics can result in a deeper, more fulfilling therapeutic relationship in the management of RRMS, one characterized by open communication, trust, and patient empowerment.
Education Opportunities for the Patient
Adherence is defined as the ongoing, voluntary, and collaborative involvement in a mutually acceptable behavior (e.g., injecting a DMT) that results in a therapeutic outcome, as opposed to compliance, which is how well a patient's behavior matches the clinical prescription (Namey, 2007). Adherence to DMTs is affected by external factors such as adverse events to therapy and internal factors such as self-image and expectations of therapy (Brandes, Callender, Lathi, & O'Leary, 2009). The MS nurse (DNP, NP, RN, etc.), at diagnosis and throughout the course of disease, is an invaluable resource in assessing the educational needs of patients and care support partners in filling knowledge gaps as well as addressing misconceptions, fears, and feelings of hopelessness that can undermine adherence and attenuate the benefits of treatment. In particular, the role of the nurse permits a close, ongoing observation of the many adherence variables as they change over time (Table 1; Costello & Halper, 2010).
As discussed during the summit, people with MS are more likely to be adherent over the long term if they initiate DMT as well-informed partners in their own care, assured of the support and resources they need as their condition changes over time. (For more on the summit, please see the accompanying Introduction article by Caon et al. in this supplement.) Due to the unpredictable and variable nature of this disease, fears, misconceptions, and unrealistic expectations may emerge at diagnosis or at any point in the course of the disease. Whether in the general neurology practice or in MS specialty care settings, the nurse counsels, collaborates, and facilitates the communication process needed to address the issues with education and maintaining adherence to therapy. Some of the top concerns often encountered in the management of MS are listed in Table 2.
Confronting the MS Diagnosis and Discussing Treatment Options
Reactions to a diagnosis of RRMS vary widely and include denial (particularly in patients with very mild symptoms as their initial presentation), relief (for those who have endured a long and frustrating path to diagnosis), determination and a desire for further knowledge, and fear, especially if a first relapse involved more severe neurological symptoms or marked MRI evidence of disease. Especially in young, otherwise healthy patients, it may take intense and ongoing education to convey the rationale for participating in early treatment for a disease whose underlying neurological damage may be mostly silent, particularly when the benefits of reduced relapses and delayed disability may seem intangible and distant.
The disclosure of an MS diagnosis is a critical moment in the patient-clinician relationship that must be handled with great care. Patients should be encouraged to bring their care partners to every visit, and especially to the training session for their first self-injection. Several visits may be necessary to solidify a therapeutic regimen, and frequent follow-up visits should be standard early in the course of therapy.
The MS patient participant at the summit noted that a negative initial experience-one that is hurried, offhand, alarming, or confusing-can damage the patient-clinician relationship permanently. MS patients recollect upsetting and discouraging counseling experiences that busy clinicians might easily overlook, such as a casual referral to an educational handout, a lack of eye contact, distraction by a cell phone during the discussion, or a hasty presentation of available DMT agents without adequate guidance in choosing among them.
The selection of a disease-modifying agent is usually done collaboratively between clinician and patient, with guidance based on the individual's life style and overall clinical profile. Patients need information about agents' efficacy, tolerability, and potential adverse effects and of the availability of assistive devices for injection therapy (Ben-Zacharia & Lublin, 2009). A respectful, compassionate, and thorough explanation of the disease and its available treatment options creates a strong start for a productive therapeutic partnership. Talking points about DMT adherence for nurses caring for people with MS are listed in Table 3. Given the current time pressures and economic incentives in many healthcare practices to see more patients in less time, the role of the nurse is imperative in this initial phase of education and establishment of therapeutic goals.
Patients who receive a diagnosis of RRMS may have inaccurate or outdated perceptions of the course of the disease and available treatment options. Although effective treatment for primary-progressive MS remains elusive, the management of RRMS has evolved rapidly in the last 2 decades. Evidence now supports the initiation of treatment with disease-modifying agents at the initial episode of demyelination to postpone the development of clinically definite MS. Such early treatment with either interferon-β agents or glatiramer acetate has been shown to delay conversion to clinically definite MS in patients with CIS and brain lesions detected on MRI scans (Comi et al., 2009; Goodin & Bates, 2009; National Multiple Sclerosis Society, 2009a).
This current standard of care has begun to pay off in a generation whose RRMS may be characterized by fewer relapses and longer delay in the development of disability. Although DMTs are neither a cure nor an agent of symptomatic relief, they have markedly extended disease-free intervals, lessened MRI-documented burden of disease, and prolonged time to key markers of disability in RRMS. Findings from the CHAMPS, BENEFIT, and PreCISe trials have prompted a shift in the paradigm of treatment standards toward earlier DMT use in clinical practice, but adherence outside the clinical trial setting requires intensive support and education (Webb, 2008).
When educating a patient, the healthcare professional must elicit each individual's preconceptions and fears about MS as well as accurately portray MS in the current era of immunomodulatory therapies. Although it is devastating to be diagnosed with MS, a newly diagnosed individual with RRMS today has access to an array of unprecedented therapeutic advances, which are poised to expand in the immediate future. This message of hope and empowerment, if conveyed accordingly and accepted by the patient, may serve to motivate behaviors that can enhance the coping experience.
Initially, the news of a lifelong, chronic, and potentially progressive disease with the prospect of long-term injectable therapy to manage, but not cure, can be overwhelming concepts for the newly diagnosed patient. Consequently, patients may ask if they are expected to take DMTs "for the rest of their lives" because of the indefinite and unpredictable nature of disease in RRMS. The clinician should remain flexible and negotiable, shifting the therapeutic paradigm from that of passive victimhood to proactive empowerment and focusing on the positive benefits of therapy and the ongoing availability of options. As one of the coauthors of this paper, an MS nurse, tells newly diagnosed patients, "Until we have something better, disease-modifying therapy is one thing you do have control over in a disease where you may often feel out of control." As one MS patient explained to these authors, "It's harder than taking a pill, but I like having the ability to do something; the [only other] option is taking no medication and waiting to see if I get worse."
Coping styles vary, as some patients are eager to take action and others are more conservative in their approach to treatment. Some patients may not be ready to discuss injectable therapy until they have accepted that they have MS and are willing to engage in active treatment. Age, gender, educational background, attitudes toward disability, and many other factors will shape their responses. It may be very challenging to convince patients of viable treatment options if they do not fully believe that they have MS, doubt that therapy will offer benefits, or have absorbed misinformation from various sources. Some patients may refuse therapy but continue to come for appointments, thereby presenting ongoing opportunities to discuss therapeutic options. In this case, it is important that the healthcare professional keep the lines of communication open and continue to present the case for disease modification without pressure or judgment. Subsequent visits with watchful waiting for such patients, involving close clinical and MRI monitoring, may permit these patients to adjust to the reality of MS and may enhance their compliance once therapy is begun (Goodin & Bates, 2009).
Overcoming Injection Anxiety
Issues relating to needles and self-injection are major obstacles to the initiation of DMT, and injection anxiety remains a long-term barrier to adherence even among patients on established therapy (Turner, Williams, Sloan, & Haselkorn, 2009). For some patients, a marked phobia of needles may preclude therapy without effective management of their fears. The MS nurse or other clinician can do much to address these fears, starting with initial demonstrations and instruction in injection technique for the patient and care partner. Autoinjector devices and delivery systems with thinner needles may reduce the incidence of injection-site reactions, discomfort, and anxiety. Newly developed electronic devices can record dosing history and be adjusted for patient comfort (Lugaresi, 2009). For patients with deeply held fears relating to needle use, techniques such as visualization, deep breathing, and other phobia management tools may prove valuable. Education should focus on the benefits of treatment and on forging connections to fellow patients who have dealt successfully with the issue and can serve as role models on how to remain adherent while under stress.
Setting Reasonable Expectations for the Disease-Modifying Agents
Educating the patient with RRMS on therapeutic options involves a balancing act between hope and realism: The benefits of DMT must be presented, along with a candid assessment of the limitations and risks of treatment. The 2 most commonly reported reasons for discontinuation of DMT are lack of efficacy and adverse effects. Knowing what to expect and what not to expect from a DMT and being assured of the care and support of the clinician and nurse during therapy can help reduce the number of patients who are not able to consistently administer DMT or who opt to give up on it all together (Ross, 2008).
The importance of realistic expectations for therapy cannot be overstated. In one study, about 50% of patients taking interferon β-1b had unrealistically optimistic expectations for treatment; approximately 20% discontinued the agent within 6 months, and of these, 64% reported excessive optimism about therapy (Mohr et al., 1996). It is essential that the healthcare team explain to patients that the available disease-modifying medications are intended neither as symptom relief nor as a cure, but to keep RRMS from getting worse in the future by reducing the number of relapses and the associated damage to the brain and central nervous system. After receiving this information, the patient's understanding should be assessed again because patients, especially those under stress, may not be able to absorb conveyed information.
For some patients, adherence boils down to measuring their response to medication. Patients who feel as if they are worsening despite therapy may discontinue; others may lack motivation because they are doing well and do not feel "sick enough" to warrant treatment. Unlike diabetes or hypertension, MS offers no easily accessible laboratory results or clinical findings as benchmarks of disease control or therapeutic efficacy. Although the absence of no new MRI findings or the lack of relapse suggest that a DMT is effective, it could be argued that neither provides an obvious reinforcement for adherence.
Thus, the single most effective factor in keeping patients on treatment is their connection with the members of the healthcare team. Summit participants noted that through this connection, patients know that someone expects them to take their medication and will work with them to manage adverse events or, if necessary, seek alternative agents. Telephone counseling can augment the therapeutic relationship and be a valuable adjunct to office visits in this regard (Bombardier et al., 2008).
Furthermore, education must be ongoing and dynamic; the variable course of RRMS may mean that patients' expectations of therapy are not met, causing anger and frustration; this can strain the patient-clinician relationship. The healthcare team must also assess adherence, through regular inquiries (including care partners) and, if necessary, pharmacy records. Studies using electronic monitoring of needle disposals have shown that patients underreport missed doses (Bruce, Hancock, & Lynch, 2009). In a trusting relationship care team-patient relationship, both parties should be comfortable with direct questions that reveal exactly how many injections are being missed a month so that adherence information is captured accurately.
Living With MS: Not a Solo Journey
At diagnosis and throughout the course of disease, a critical component of adherence to therapy is the patient's understanding that he or she is not alone in living with MS. Members of the healthcare team must create a working partnership with the patient that will evolve over time because the manifestations of the disease fluctuate and evolve. Ideally, the patient will become the "hub" of a patient-centric, transdisciplinary team consisting of a neurologist, an MS nurse, a nurse practitioner, a social worker, a physical therapist, an occupational therapist, a mental health counselor. It is within this team that a patient will form collaborative relationships and extend treatment over the course of their disease. Moreover, once a patient has an identified MS healthcare team, these professionals can offer resources and guidance to assist patients in developing an individualized network of support that can include a spouse or other support care partners within a patient's family or community.
The psychosocial and emotional effects of MS differ at each stage of the disease for each person. In the early stages of RRMS, sources for anxiety include the disease's uncertain course, the prospect of eventual disability, and the fear of not being able to fulfill everyday personal and work responsibilities. In addition, anxiety may arise from thoughts of not reaching long-term life goals as originally conceived or perhaps in a modified version. Financial concerns and long-term healthcare coverage may exacerbate anxiety, not to mention the day-to-day symptoms of MS. Fatigue, an almost universal symptom reported by patients, may require new coping strategies just to navigate everyday life. Due to unpredictable relapses and daily symptoms, patients may confront distressing prospects of loss of control, changing life roles, and self-concepts, all of which can lead to despair and feelings of hopelessness. Depression is a significant risk, which is increased by a sense of isolation in grappling with the burden of MS.
It is a foundation of long-term MS care, particularly in nursing, to provide patients with the tools for creating a support network and coping strategies. Support may be logistical (assistance with injections, housework, meal preparation, day care, transportation to medical appointments, reimbursement paperwork, etc.), but it should also reach deeper into social, psychological, and spiritual domains, integrating the needs of the whole individual and addressing the different stages of MS and their concomitant needs.
Summit participants concluded that the components of a supportive environment for living with MS, which can buttress adherence to therapy, include, in addition to the healthcare team, the patient's support care partner, family and friends, workplace issues and relationships, and support and advocacy.
The Patient's Support Care Partner
Patients with strong support from family and friends are those who tend to be most adherent to their therapy regimen, especially if they have a care partner willing to actually administer injections. A care partner is most commonly a spouse or a significant other, but he or she may be a parent, an adult child, a sibling, a paid companion, or an aide.
Support care partners also face uncertainty. They may have role shifts from spouse to caretaker and be inundated with disease-related burdens; resentment, grief, and anger may coexist with determination and a newfound closeness with their MS-affected partner. They should be included in the initial MS care plan whenever possible and be encouraged to share their concerns candidly, which ideally will help foster a trusting and nonjudgmental relationship. Educating support care partners about the many dimensions of coping with MS should extend well beyond the technical aspects of injection therapy to the day-to-day realities of MS, such as fatigue, cognitive issues, and the unpredictable course of the disease. This knowledge can help improve understanding, foster empathy, and reinforce that the patient is not at fault for MS-related deficits that may shift responsibilities onto the support care partner's shoulders.
Support care partners also benefit from contact with those who share their experience, which can be facilitated through support groups specifically for caregivers via the Internet or sponsored at MS specialty centers or clinics. When MS-related disability progresses, the healthcare team should help identify and access additional services or respite care for the patient as needed to ease the strain on the care partner. In a recent survey of caregivers to relatively more disabled people with MS, more than a quarter of caregivers believed they would benefit from mental health counseling or treatment; however, only about one third of such caregivers actually sought these services, often citing healthcare coverage and out-of-pocket expense as barriers to access (Buchanan, Radin, Chakravorty, & Tyry, 2009). The healthcare team must also remain aware of the possibility for support care partner "burnout" related to stress and for the possibility of abuse in the patient-care partner relationship.
Often, relationships with support care partners grow stronger after diagnosis, and many patients report that the response from those caregivers to their MS is a source of gratitude, inspiration, and renewal. However, it must also be acknowledged that not every MS care partner will fulfill their role ideally over time. Cultural biases, longstanding interpersonal issues, and other obstacles may weaken or even break the relationship with a spouse or other care partner. In these unfortunate instances, the MS care team, often the nurse, must meet the patient's urgent need for compassion, understanding, and the creation of alternative resources for care and support.
Enhancing Education Beyond the Patient: Social/Work Situations
Other members of the patient's circle will share his or her MS experience, with its shifting roles and expectations. Patients should be encouraged to educate friends and family members, including age-appropriate information for children, about MS, medication issues, and the need for a positive outlook and support.
Furthermore, because RRMS usually affects individuals in their 20s and 30s, a time when many may be in the early or peak years of their career, workplace issues and the fear of lost income, status, and productivity can loom large. Despite mandated accommodations and nondiscrimination for people with disabilities in many areas of public life that are assured under the American With Disabilities Act of 1990 (ADA), the disclosure of a diagnosis of RRMS to others, especially work colleagues, is fraught with worry for many patients. For some employees, talking about RRMS to employers can be problematic. Some patients wish to delay having their disease become common knowledge to postpone anticipated negative responses, whereas others find it burdensome to keep a secret. Patients may return to work prematurely because of lack of sick leave or fear of job loss, status, or chance of promotion. Some may believe (correctly or not) that their workplace will be hostile to making accommodations to their condition. In addition, relapses, fatigue, and medication regimens can negatively affect productivity; even if none of these problems exist, superiors may fear the prospect of them occurring, therefore suspecting a future transferred burden onto other colleagues. For those who work outdoors, heat and humidity may exacerbate symptoms that may impede work performance.
The healthcare team can contribute to a positive workplace experience through education and advocacy tailored to a patient's specific needs: Often, an individual can maintain job performance and responsibilities with minor accommodations such as scheduled breaks or rest intervals or adjustments to injection timing. For some patients, newly diagnosed or progressive MS may prompt a reevaluation of priorities. The role of the MS nurse and the healthcare team is to educate and to empower the patient to know his or her rights to disability accommodation under the ADA and to navigate the workplace in a manner that will optimize job fulfillment, job security, a personal sense of productivity, and pride, and will enhance relationships with supervisors and colleagues. The full text of the ADA as well as free information and resources can be found at www.ada.gov.
Support and Advocacy
No matter how sympathetic or well-intentioned one's support care partner or colleagues, there is no substitute for the shared experience, understanding, and advice of people who have "been there" or are experienced with living with MS. Although some studies that have found no statistically significant benefits of support groups on the quality of life in patients with MS (Messmer Uccelli, Mancuso Mohr, Battaglia, Zagami, & Mohr, 2004; Schwartz, 1999), other studies (Rigby, Thornton, & Young, 2008; Schwartz, & Frohner, 2005) as well as anecdotal evidence from both healthcare professionals and patients suggest that the social support that peer support groups provide can help patients and their families cope with MS and the changes it brings.
The nursing staff should identify and refer the patient to support groups for people with MS when such groups are available. For newly diagnosed patients, groups created specifically for them are preferable to groups whose members may have more advanced levels of disability because the concerns, needs, and coping levels among these 2 groups will most likely be quite different. Knowing "you are not alone" in coping with MS is very important. Peers solidify a social connection as well as share the collective experience of fellow patients and support care partners. In this era of DMT therapy, newly diagnosed people may have the chance to meet people with RRMS who have lived with few relapses and little disability over time and who can offer optimism, help assuage anxiety about the future, and offer encouragement for adherence to treatment.
For patients who lack access to an MS group, consider referral to another patient coping well with the disease, one who can offer peer-to-peer support, ideally someone who has successfully integrated injectable therapy into his or her daily routine. In addition, each of the major pharmaceutical companies who manufacture the DMT agents has a patient-support program, which could augment other support groups. The Internet is another major resource for information, community, and advocacy; however, it is important to point out that Web sites may be independently operated without peer review or content regulation. As a result, patients should be encouraged to start with reliable national advocacy groups such as the National Multiple Sclerosis Society (www.nationalmssociety.org), the Multiple Sclerosis Foundation (www.msfocus.org), and the Multiple Sclerosis Association of America (www.msassociation.org). Some RRMS patients have found renewed hope and purpose through involvement in advocacy, education, and fundraising for MS, for example, MS Hope for a Cure (www.mshopeforacure.org).
Seeking Help for Emotional Health
Depression is a significant issue, particularly given the high prevalence of depression among people with MS and depression's negative impact on adherence. The 12-month prevalence of major depression in people with MS has been estimated at 15%, and most MS patients with depression do not receive adequate recognition and treatment (Goldman Consensus Group, 2005; Ziemssen, 2009). The counseling clinician must remind the patient that depression is common in MS, has a biochemical component unrelated to character or determination, and can be readily treated. Most important, the healthcare team should remain aware of the possibility of depression, substance abuse, and other mental health issues and be proactive in asking about them as they would any other domain affected by MS. The need for mental health services (including recovery from substance abuse) no longer carries the secrecy and stigma of a previous generation, but many people remain reluctant to ask for the help they need. Summit participants cautioned that patients may take offense at the offer of a referral to counseling or evaluation for antidepressant therapy, antianxiety therapy, or addiction. They may also be ashamed to let family or friends know they may need such help, and for some, it may even prompt a break in the patient-clinician relationship. They also noted that reimbursement coverage may also present a barrier to psychiatric care, and the healthcare team needs to be aware of resources and advocacy measures to improve access to care.
Education Opportunities for the Healthcare Professional
Patients' capacity for understanding and change ebbs and flows over time. Success depends on the consistent reinforcement of the value of treatment, preferably through multiple channels. For example, the patient may initially learn about the risks and benefits of DMT verbally in the clinician's office. In addition, take-home literature, audiovisual educational tools, and referrals to Internet resources present those messages in a different format and can be absorbed at the patient's own pace. Finally, shared experiences of MS in a support group may expand and validate educational messages and provide reassurance that these messages can be associated with a positive outcome.
The value of repeated messaging is keenly felt when attempting to set realistic expectations for therapy. Even after several explanations, patients may question the rationale for therapy during or after relapses. If an individual is depressed or angry, effective communication may have to wait for another opportunity-and effective education depends on creating such opportunities across the entire course of the disease.
The transtheoretical model of behavior change provides a helpful tool in developing strategies to encourage the acceptance and long-term use of DMTs (Holland et al., 2001; Prochaska, Redding, Harlow, Rossi, & Velicer, 1994). This model of intervention in chronic illness describes a long-term, dynamic process of change and acknowledges that patients may experience its stages in a nonlinear fashion (Table 4).
Communicating Risks and Benefits
Tolerability and safety concerns are central issues in long-term adherence to DMT, but they may differ in priority level for clinician and patient. For both the prescriber and the person with RRMS, risk perception presents an ongoing opportunity for education. The clinician may attempt to give a balanced presentation of risks versus benefits for an agent, but this ratio may only become meaningful with a real-world point of reference, such as a media report of a drug safety issue or another patient's experience with an adverse effect. These reports and anecdotes may not contribute to an accurate risk perception, but they may deeply influence patients' emotional response to therapy.
Adherence: Goals and Realities
Those who counsel people with RRMS know that adherence to DMT will never be 100%, but full adherence must remain the goal. The growing body of evidence that DMTs reduce disability and delay the progression of RRMS has evolved into treating aggressively initially, even before we can confirm diagnosis of clinically definite MS; the standard has become to initiate DMTs with confirmed clinically isolated syndrome (CIS) suggestive of MS.
Pursuing optimal adherence, while staying aware of the realities in living with RRMS, is the challenge of the MS clinician who is educating the patient and their support care partner. A leading reason given for missing an injection is simply forgetting to take it (Treadaway et al., 2009). Other factors noted in surveys of RRMS patients include injection-site reactions, quality of life, patients' perceptions on the injectable medications, hope, depression, and support (Treadaway et al., 2009). Open communication permits the nurse and care team to identify these barriers as they develop and address them with education and support.
Diversity and Difference: Respect and Respond
Culturally influenced health beliefs and attitudes may deeply affect how patients react to RRMS and its management, and healthcare providers must sensitively elicit and address the educational, psychosocial, and practical issues raised by these differences with respect and patience. Sometimes, that will involve giving patients the right to make choices that may cause a difference of opinion between the patient and the healthcare professional while allowing for keeping options open later. Ultimately, no demographic characteristic predicts how an individual will respond to and cope with RRMS, and a trusting patient-clinician relationship is the key to effective management with any group. In addition, cultural awareness and acknowledgement of ethnic barriers to adherence, along with gender- and class-based perspectives on the disease and its management present opportunities for education.
Cognitive Changes: A Delicate Balance
The impairment of cognitive function is one of the most distressing prospects for RRMS patients, but it must be addressed in the context of education for adherence. Some degree of cognitive impairment is experienced by about 50% of people with MS and CIS, with some estimates as high as 70% (Fischer et al., 1994; Glanz et al., 2007; LaRocca & Kalb, 1997; Potagas et al., 2008; Winkelmann, Engel, Apel, & Zettl, 2007). The most common deficit is memory loss, particularly problems in learning and recalling new material (Fischer et al., 1994; LaRocca & Kalb, 1997; Winkelmann et al., 2007).
Education about cognitive changes associated with MS can give patients and families insight, offer coping mechanisms, and present the possibility of neuropsychiatric testing when appropriate. At medical visits, the care partner can help by taking notes on counseling and medication issues and reinforcing them at home, including advice on how to handle missed doses. Over time, cognitive decline may shift the locus of control within the relationship of patient, support care partner, and healthcare team, with increasing responsibility and decision making moving away from the patient. Discussion of cognitive and long-term care issues with the patient and care partner early in the course of disease will offer guidance to the team as disability may progress.
SPMS: Going the Distance
Breakthrough disease and transition to SPMS are very difficult for both the patient and the healthcare team, especially if both have worked hard at treatment adherence. A limited but growing body of evidence suggests that DMT may be beneficial throughout the longer term of MS management, and DMTs may remain an option for this later phase of MS (National Multiple Sclerosis Society, 2009a). However, a sense of disappointment and dwindling options may strain the therapeutic relationship at this juncture. New therapies such as natalizumab or mitoxantrone indicated for relapsing forms of MS will require additional educational efforts, with discussion consisting of safety, potential adverse effects, and adherence (National Multiple Sclerosis Society, 2009a).
Relapses cause patients to worry that their RRMS is transitioning to a progressive stage. It may help to explain that the stages of MS are somewhat arbitrary, more useful for research purposes than actual clinical practice. As disability progresses with impact on functions like employment, driving, and family caregiving, the role of the nurse and other healthcare team members becomes more vital than ever as a source of reassurance and support.
The Oral Therapy Era: Hope With Caution
The advent of oral agents for the treatment of RRMS has ignited widespread anticipation among patients and clinicians. Five oral agents, fingolimod, cladribine, laquinimod, teriflunomide, and BG00012, are already under study in phase III clinical trials for RRMS and CIS (Spain, Cameron, & Bourdette, 2009). Some of these emerging therapies targeting immune-mediated mechanisms of MS suggest the promise of greater efficacy than currently approved DMTs, but with a tradeoff in the potential for serious adverse effects (Giacomini, Darlington, & Bar-Or, 2009).
Whenever they become available, it is certain that the long-awaited alternatives to injectable therapy will add new complexity to RRMS management. These medications will not simply be oral versions of currently used injectable agents but new therapies with distinctive mechanisms of action and safety profiles. Although oral therapies may offer simpler administration and greater efficacy than current ones, they may also carry greater risks and will lack the longer term safety data accumulated for injectable DMTs over several decades (Spain, Cameron, & Bourdette, 2009). Patient education in the coming era of oral pharmacotherapy for RRMS will still require the setting of realistic expectations for these drugs, which will not necessarily be safer, better tolerated, less expensive, or less demanding of monitoring and follow-up than currently available agents. The relative long-term efficacy of these agents compared to current DMTs has also not yet been established.
In addition to oral agents for RRMS, monoclonal antibodies represent a new therapeutic concept that will require extensive education for the healthcare professional and patient. These agents, which target specific antigens, include alemtuzumab, daclizumab, and rituximab. All have shown promising results in clinical trials for RRMS, although the safety issues raised by the first approved monoclonal agent, natalizumab, will be an ongoing concern (Rommer et al., 2008).
If clinical trial data continue to demonstrate a favorable balance between efficacy and safety, most patients with RRMS may be considered candidates for oral MS agents as an alternative for established users of injectable therapy. Their appeal will depend on patients' values and priorities, on their perception of injected therapy and its benefits, and on their willingness to accept some tradeoff in demonstrated long-term safety for efficacy and convenience.
The treatment of RRMS has advanced in one generation from supportive and symptomatic care to DMT that can improve quality of life and reduce future disease activity (National Multiple Sclerosis Society, 2009a). The next generation will see a further extension of therapeutic options with the possibility of even greater efficacy. With each treatment advance, the relationship of patient and nurse will encounter new opportunities to address the challenges of managing RRMS through education, partnership, and trust.
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© 2010 American Association of Neuroscience Nurses