Facilitators and barriers to adherence to urate-lowering therapy in African-Americans with gout: a qualitative study

Gout is a chronic, inflammatory arthritis that affects 3.9% of U.S. adults [1]. Principles of appropriate long-term gout management include the appropriate use of urate-lowering therapy (ULT) to keep serum urate (sUA) at or below 6 mg/dl and to treat acute gout flares with short-term anti-inflammatory drugs such as corticosteroids, colchicine or non-steroidal anti-inflammatory drugs (NSAIDs). ULT options include xanthine oxidase inhibitors, such as allopurinol (used by the majority) and febuxostat, with a much lower use of uricosurics, including probenecid [2‐4]. Appropriate use of ULT is central to the achievement of target sUA < 6 mg/dl. Target sUA achievement is associated with a lower risk of gout flares, tophi and medical care costs [5‐10] and is recommended by gout guidelines [11, 12]. A key gap in gout management is the lack of appropriate use of ULT, characterized by a suboptimal adherence to ULT and the use of lower than needed doses of ULT [9, 13]. Of all rheumatic conditions leading to quality of life deficits, gout is one of the most well understood biochemically and pathophysiology and perhaps most amenable to good control and remission; yet it is successfully treated infrequently. This is at least partially due to our lack of understanding of why patients fail to use effective, cheap treatments.

Recent quantitative research that used surveys showed numerous patient knowledge gaps with regards to the use of ULT and other medications for gout [14]. Two recent qualitative studies of semi-structured interviews with 26 US Caucasian patients with gout and 20 UK Caucasian gout patients (15 men, 5 women) found that gout patients reported non-adherence with allopurinol and cited several reasons, such as financial concerns, forgetfulness and doubts about the benefits of long-term treatment [15, 16]. Both studies were done in Caucasian men, covered a broad array of topics ranging from the gout treatment to quality of life to patient knowledge and so on with relatively little focus on medication adherence, which is a key challenge in gout management [9, 13]. Two large knowledge gaps exist in qualitative studies in medication adherence in gout, since none of the previous studies: (1) recruited gout patients with high medication adherence or stratified patients by medication adherence (for example, medication possession ratio); and (2) recruited racial minorities.

African-Americans share a disproportionate burden of gout compared to Caucasians, since the: (1) prevalence of gout is higher (5% vs. 4%) [1]; (2) likelihood of treatment with ULT including allopurinol is lower [17, 18]; (3) non-adherence with ULT is higher (odds ratio, 1.86) [19]; and (4) baseline serum urate (7.9 vs. 7.1) is higher and odds of achieving target serum urate levels <6 mg/dl are lower (odds ratio, 0.67) [18]. To our knowledge, there are no studies investigating the reasons for poor medication adherence in African-Americans with gout. None of the previous studies recruited patients with high medication adherence to understand the facilitators of high ULT adherence.

Why do patients not take the gout medications they are prescribed? Medication adherence depends greatly on how patients perceive their disease/illness and what meaning they attach to the disease and the treatment [20, 21]. Meanings are important and fundamental in their interpretation of disease and treatments [22]. Corbin and Strauss proposed a model for chronic disease consisting of three components, namely Body, Biographical time and Conceptions of self, that is, the BBC chain [23, 24]. The model indicates that only when these three components are in balance, interactively stabilizing and reinforcing one another, do people feel healthy and well [24‐26]. Body failure and interference with identity-relevant functions by chronic diseases can lead to destabilization of the BBC chain, leading to a patient having the sense of being ill. Chronic diseases can interfere with plans, performances and meanings, which formerly contributed to valued appraisals of self, resulting in loss of previously valued self-image, described as “loss of self” and, subsequently, social isolation [23]. Patients with chronic diseases are often motivated to take medications to treat the disease to avoid or reverse illness-induced loss of self and to restore their disrupted biographies. On the other hand, medication itself may lead to body failure, be perceived to either cause or be associated with body failure or interfere with identity-relevant function (for example, dizziness as a medication side effect, preventing a patient from social activities), in which case patients will have low medication adherence or will stop the medication.

Our objective was to better understand the impact of medication and illness meanings as well as biographical disruption due to disease on the medication use and adherence in gout. To our knowledge, there are no qualitative or quantitative studies focused on medication adherence in African-Americans with gout who have a disproportionate burden of the disease and higher rates of non-adherence [1, 17‐19]. Our study aim was to assess the facilitators and barriers to adherence to ULT in African-Americans with gout, based on this chronic disease model.

Nine nominal groups were conducted with African-Americans, three with higher adherers and six with low adherers to ULT. Overall, there were 30 African-American men (seven nominal groups) and 13 African-American women (two nominal groups) and mean age (SD) was 63.9 (8.4). Several themes emerged from the nominal groups, in high adherers (three groups) vs. low adherers (six groups) that are summarized in the two sections below.

To our knowledge, this is the first qualitative study to assess facilitators and barriers to ULT adherence in African-Americans with gout and the first study to enroll gout patients with low and high ULT adherence. The main barriers to optimal ULT adherence were doubts about the effectiveness of ULT, concerns about cost and side effects (short-term and long-term cumulative), the impact of concomitant medications and of taking too many pills, forgetfulness, challenges with refilling the prescriptions on time, pill size and difficulty in swallowing, competing priorities, patient preference for alternative medicines (such as cherry juice or extract) and frequent work-related travel. The main facilitators to ULT adherence included patient realization that they needed to take ULT regularly to prevent gout flares, to prevent the severe pain and handicaps associated with acute gout and to prevent pain from becoming chronic/severe, the patients organizing their pills and their routine so that they would not forget to take their ULT, the patient’s ability to have fewer dietary restrictions and the ability to eat foods they liked in moderation once they were taking ULT regularly, lack of side effects, avoidance of side effects from alternatives such as corticosteroids, trust in physicians, and avoiding the need to seek frequent emergent/urgent care or a subspecialist’s care. Several findings from this study deserve further discussion.

It is now well-known that compared to Caucasians, African-Americans not only have a higher prevalence of gout [1], but also have more severe gout with higher baseline sUA, worse ULT adherence and lower likelihood of ULT treatment and the achievement of target sUA <6 mg/dl [17‐19]. This disproportionate burden of gout and the lack of any previously published studies on racial minorities were the key motivations for our study.

Several findings in this study are novel. Both low and high adherers to ULT identified issues related to body medication, identity-relevant functions (interference or facilitation) and meaning imparted to the mediation as key facilitators and barriers to ULT adherence, that fit our theoretical model, that is, the trajectory model with the BBC chain [23, 24]. The themes were opposite in several common domains. A key difference in low vs. high adherers was their understanding of what the medication could/would do for them. The low adherers were not convinced that ULT was needed every day or was helping their gout vs. high adherers who had the very opposite experience and perception, that is, the ULT helped them avoid severe pain and suffering. Low adherers cited lack of knowledge and communication from physicians regarding the usefulness of ULT, an important observation from our study, complimenting a survey study finding that knowledge deficits were common in gout patients [14]. High adherers had greater trust in their physicians and saw the adherence to ULT as a way to avoid more doctor visits, keep their uric acid levels in check and prevent chronic joint damage that reflected more knowledge about gout and treatments.

The current study also provides an in-depth examination of ULT adherence in African-Americans. Some quotes from patients were eye-openers; for example, one veteran who had served in the armed forces said, “I have been shot. I’d rather be shot than have my gout attack again”, signifying the severe pain of gout and its impact on patients and why it is so important to adequately treat gout. This study adds knowledge to the area by identifying additional previously not-described barriers, such as the impact of concomitant medications and of taking too many pills, ULT pill size, swallowing difficulty, patient preference for alternative medicines, travel-related and refill issues, and competing priorities. These findings indicate that non-medication alternatives are considered true alternatives to pharmacotherapy by patients and should be discussed with patients with gout. Now that these barriers have been identified, a further study into how to develop interventions targeting these barriers is needed. Patient education and patient-physician communication can target several barriers and has the potential to improve the outcomes in African-Americans with gout. Gaps in patient and physician knowledge have been demonstrated in addition to their perception of treatment related issues in gout, including non-adherence [15]. This indicates that education initiatives may also need to target both patients and health care providers to reduce the differences in perceptions.

Other key findings from this study based on studying facilitators to high ULT adherence, may help educate low-adherers and design interventions. African-American gout patients, who were our success stories (high-adherers) differed from those with poor ULT adherence (low-adherers) in several key aspects, which also map well to the Health Belief Model [36]. This model emphasizes that individuals can change their behavior if they consider themselves susceptible to disease (chronic pain), realize the disease’s consequences (frequent flares) and perceive that engagement in a particular behavior (ULT adherence) will be beneficial in preventing negative disease consequences and disease severity (preventing flares, pain, suffering [36]. Compared to low adherers, gout patients with high ULT adherence: (1) understood their disease severity, including gout related pain and suffering, better (better perception of disease severity and personal susceptibility); (2) did not have misconceptions regarding ULT and had a better perception that ULT benefits outweigh risks (side effects), that is, considered the balance of perceived barriers to treatment and benefits from treatment favorable to them and (3) had effective cues to prompt action of regular ULT intake (using a pillbox; taking medications at the same time; health belief model). Thus, they had overcome the same barriers that were faced by their peers that had poor adherence to ULT. Thus, if an intervention can incorporate ways to encourage several behaviors practiced by the high-adherers, it has the potential to improve ULT adherence and gout outcomes.

Our study is the first to confirm that several barriers to optimal allopurinol use in Caucasians [15, 16] are also barriers to optimal allopurinol use in African-Americans. In a qualitative study of 26 Caucasian patients with gout, during the phone interviews, gout patients cited financial concerns, forgetfulness, worsening of gout, potential side effects, lack of information and doubts about the length of treatment, as reasons [15]. In another study of 20 UK gout patients (15 men, 5 women), during the semi-structured interviews with gout patients that covered a wide array of topics, patients reported non-adherence often due to concern about the side-effects or the belief that gout did not warrant any long-term treatment [16]. Our study design did not allow us to compare the barriers to gout medication adherence by gender. This is an important gap in our knowledge that we plan to investigate next. Other studies have shown gender differences in medication adherence with women having slightly lower adherence than men [37‐39]. It remains to be seen if this is true in the case of gout as well, a predominantly male disease.

Our study has several limitations. While we reached saturation for our low-adherers with the six nominal groups, one may wonder if we reached saturation in high-adherers. We were able to identify and successfully recruit fewer patients with ULT adherence of 80% or more in our study, even after extensive telephone screening. However, several themes were noted to be repeating in the current sample of high adherers, supporting the notion that saturation can be attained with two to three nominal groups, as it seemed to be in our case. The number of high adherers recruited in this study is the largest nominal group sample studied to date. Second, this in-depth study has findings applicable to African-Americans with gout. We oversampled for women with gout (another understudied population) to improve the study’s generalizability. Generalizability to Caucasians was not our goal, since at least two small studies exist in Caucasians and our focus was disadvantaged minorities. However, several themes from earlier studies with Caucasians were replicated in this study, indicating some applicability to Caucasians. Study strengths included study of a difficult to reach, underserved and understudied group that bears a disproportionate burden of gout and the use of NGT to obtain an in-depth answer to the specific study question.

In conclusion, this study provides an in-depth insight into facilitators and barriers to ULT adherence in African-Americans with gout. Several new themes were identified in this study. This new knowledge should serve as a foundation for research of behavioral and non-behavioral interventions to improve ULT adherence in minorities with gout. Such studies have the potential to improve gout care and outcomes in patients suffering from this disease.