Development of a patient decision aid for the management of superficial basal cell carcinoma (BCC) in adults with a limited life expectancy

More patients are diagnosed with basal cell carcinoma (BCC) in the US than all other cancers combined, with more than 3.2 million cases of BCC each year, compared to 1.7 million other cancer cases [1]. Over 50% of all skin cancers are diagnosed in patients over 65 and by 2030 this figure is estimated to increase to 70%, notably due to the ageing population [2]. Given the major role of cumulative exposure to ultraviolet radiation from the sun in causing these cancers, most BCCs occur in people 65 years or older [2]. Furthermore, over 100, 000 BCCs are treated in individuals who have a life expectancy of less than a year [3]. In adults with a limited life expectancy (LLE), the risk of treating BCCs may in fact outweigh the benefits. Most BCCs - and specifically those categorized as low-risk - grow very slowly and rarely metastasize (in 0.0029–0.55% of cases) [4]. Given that BCCs cause problems only if left unattended for an extended period of time, it is possible that certain of the more intensive treatment options (i.e., surgical options) may present more of a risk to older patients’ health and quality of life than the BCC itself [3].

Watchful waiting (WW) has been used for other low risk cancers including prostate cancer. In low risk prostate cancer the number of patients choosing WW has increased from 14.5% in 2010 to 42.1% in 2015 [5]. In older adults with a LLE, the option of WW requires consideration of their specific goals and preferences [3]. A method of addressing the unique needs of an older adult with low risk BCC incorporates the use of shared decision making (SDM), which is facilitated by the use of Patient Decision Aids (PDAs) [6]. SDM is defined as the ‘ideal model of treatment decision making in the medical encounter’. Charles, Gafni and Whelan describe SDM as involving 4 components, which we incorporated into our PDA: 1) 2 participants – the physician and patient, 2) both parties share information, 3) both parties are involved in the steps to identify the preferred treatment and 4) a treatment agreement is reached [7].

There are several surgical and non-surgical treatments that are effective in removing BCCs that differ in their side effects. Current clinical guidelines for treatment of BCCs are based primarily on tumor location, size, and histologic type, and do not incorporate patient preferences, or a patient centered treatment approach in older adults and partially tackle life expectancy, frailty and comorbidities [8‐11].

PDAs are evidence based tools designed to help patients make specific and deliberated choices among healthcare options [12, 13]. Extensive research has shown that the majority of patients, including dermatologic patients, want to be involved in treatment decisions [14‐16]. In situations where multiple treatment options exist, PDAs facilitate patient-centered care by providing both unbiased information about the risks and benefits of various treatment options and tools to help patients consider how their values may align with these treatment options [15]. Studies have shown that older adults are often excluded from making treatment decisions [17]. Furthermore, the underlying health status is pertinent to consider in specifically older adult patients, since this may influence their values and preferences and may determine whether they choose active treatment or WW. A systematic review and meta-analysis of 105 randomized controlled trials found that PDAs increased patient knowledge about management options, reduced decisional conflict, gave patients more accurate expectations about the risks and benefits, and resulted in improved congruence between stated preferences and treatment received [16].

Within dermatology, PDAs exist for psoriasis, melanoma, acne, and oral isotretinoin [18‐23]. The existing PDA for BCC developed by Healthwise presents only surgery or medicated creams as options, and does not include WW. The current available decision aid is not specific to older adults with low risk BCC [24]. The PDA described in this paper is aimed at addressing treatment options available to patients with low-risk BCC and limited life expectancy (LLE), for whom WW may be an appropriate treatment option. This paper describes the process of developing a PDA, focusing on decisional aspects unique to BCC.

In total we collected feedback from 24 patients and 34 providers, including both general dermatologists (n = 21) and geriatricians (n = 13) (Table 1). Below we describe four themes relevant to decisional aspects specific to BCC that emerged throughout the development process and how these issues were addressed in each stage of modifications to the PDA. The final version of the PDA is presented in Additional file 1.

This paper outlining the process of developing a decision aid in older adults with a LLE has generalizable lessons for those wanting to build PDAs for other dermatologic conditions in that population. The final version of our PDA was developed according to the IPDAS checklist, outlined in Table 2 and provided information about options for decision making and presented probabilities of outcomes. PDAs have been shown to improve informed decision making and screening behavior, particularly in prostate cancer [35]. WW has been identified as a treatment option for prostate cancer, breast cancer and thyroid cancer. For patients with prostate cancer, where the risks of treatment outweigh the benefits and the tumor is slow growing, patients elect for WW as a treatment option. Within Oncology, particularly for low risk slow growing tumors, more conservative treatments are being considered by the patient community [36]. We found that it was important to address the inherent fear of cancer associated with BCCs, this helped the patients identify trade-offs associated with different treatment options through patient narratives, and indirectly broached the topic of life expectancy. When communicating risk and uncertainty we drew inspiration from existing PDAs that use grid models to allow patients to compare risks and benefits across treatment options [37‐39]. In the initial draft, the risks and benefits were communicated using natural frequencies, rather than percentages to present risk [40]. Different data sources present varying rates of recurrence after treatment of BCCs, which made it difficult to select a single number for the table [41]. During the iterative development process and with input from providers, we were able to develop a treatment options grid.

The existing literature on patient decision-making has illustrated the importance of “values clarification” to help patients integrate their values and preferences into decision-making processes [31]. However, identifying the most effective method to guide patients through this process, particularly for adults with a LLE, required successive rounds of patient and provider feedback. Within our PDA we used process narratives to help patients with ‘values clarification’. Process narratives are sample patient narratives that illustrate the values and preferences involved in health care decisions [42].

The development of this PDA for the treatment of BCCs in older adults provides not only an important tangible product that has a direct clinical application, but also contributes to the field of shared decision-making in general and the development of PDAs in particular. The lessons learnt through this development process may be valuable in creating other PDAs with multiple treatment options for patients with a LLE. Our study describes the development of a PDA, the SUNDAE guidelines added as a supplementary material are used in evaluation studies of PDAs.

Our study has some limitations. First, feedback came from participants from a single location. Although we have used the term WW as a treatment option, we are aware that active surveillance (AS) is also another term that can be used, that has a related but distinct meaning, further research on this topic will help determine whether AS or WW is the appropriate term [36]. Patients were predominantly white and may not represent regional or social differences in culture and medical decision making. Furthermore, our PDA does not include treatment options rarely used in our patient population, such as cryotherapy and radiation, which future versions of this PDA may need to include as trends change. Finally, our PDA is currently paper-based and lacks videos and interactive tools that could be achieved through a future digital interface.

Our PDA for low risk BCC has been developed collaboratively with the input of patients and providers. Next, we plan to evaluate the instrument in order to assess if it effectively conveys information and supports shared decision making. We are specifically interested in learning whether the PDA improves outcomes related to patient knowledge, engagement, and satisfaction with treatment, and whether it decreases decisional conflict. By adding WW as a potential treatment option, we anticipate that for patients with a LLE, a more patient centered approach can be taken which optimizes their quality of life.

Our long-term goal is to examine whether use of this PDA could reduce perceived side effects of BCC treatment and improve healthcare utilization and skin-cancer related health outcomes. We anticipate that physician buy-in, in the era of ever-increasing pressures on physician schedules, may present a significant barrier. Therefore, we plan to engage the physician community early and frequently to address our common goal of improving the care older adult patients with BCCs receive.