DISCUSSION
toxicity, prostate cancer
REGRESSION, AIDS, RECRUITMENT, PROSTATE CANCER
This study evaluated an intervention to improve cost discussions between urologic surgeons and patients when deciding how to manage low‐risk prostate cancer. Most decision aids and decision aid standards do not include cost information,It is possible that those enroled in the study early in the recruitment period had higher financial toxicity and financial uncertainty due to the onset of the COVID‐19 pandemic. We did note that more participants early in the study reported lower incomes and higher financial toxicity scores; these challenges were faced by many individuals in 2020 as jobs required individuals to stay home to avoid spreading illness, and the economy suffered from widespread shutdowns which were necessary but placed financial strain on individuals and businesses. It is also possible that the use of telehealth (which was more common early in the study, common in 2020 for those with nonurgent needs and those who did not need in‐person care) impacted the way in which clinicians and patients discussed options and costs openly. In our study's regression analyses adjusting for these factors, neither visit type (telehealth or in‐person) nor visit date were significantly associated with our outcomes. It was important to adjust for these factors in our analyses, but we might not have been able to detect intervention effects above and beyond these differences.In addition, it is possible that clinicians need more than a conversation‐based decision aid and brief training to encourage cost conversations. Clinicians were enthusiastic about the intervention, but it is difficult to change typical conversational flow and content. Perhaps more documented impact on patient outcomes and more in‐depth role‐playing interventions could serve as stronger motivators and increase self‐efficacy for discussing costs. Alternatively, perhaps the patients in our study were less concerned about costs because many were employed with relatively high incomes. A larger study could engage a more socioeconomically diverse group of patients.It is interesting to note that the intervention might not have encouraged cost‐related referrals. The conversation‐based decision aid listed resources for patients to contact for assistance or questions with financial aspects of care (e.g., social workers, financial navigators, hospital billing representatives and community organisations). It also listed questions patients could ask if they wanted to learn more about their costs. Perhaps clinicians using the intervention felt that the conversation‐based decision aid covered this information without having to bring it up directly, or that many patients in this study did not need additional referrals to discuss costs.Despite the limited impact on cost conversations and decision outcomes as measured, clinicians reported that they approved of the intervention and most wanted to use it beyond the study period. Some noted verbally that patients appreciated the intervention and even referenced it over time at subsequent visits. Clinicians provided suggestions for ways to improve the cost‐related information in the decision aid that might help future work. For example, some clinicians commented that while active surveillance may cost less to the patient up front, the cost of repeated biopsies and imaging over time adds to these costs and could make active surveillance equivalent to surgery/radiation costs in 5–10 years. In addition, although the cost to patients between surgery or radiation might be equivalent or close to it, the cost to the healthcare system might be much higher for those who choose external beam radiation. We looked into the literature to clarify these questions raised by clinicians, and the data were limited or outdated on actual costs to patients and to the healthcare system. Future studies could explore more precise costs to patients and the healthcare system over time.Finally, the number of people in the intervention arm who deliberated about options—remaining undecided upfront and resolving their uncertainty over time—warrants further investigation. One of the main goals of shared decision‐making is to encourage patients to choose a treatment that aligns with preferences, taking the time they need to think through options. Most people in the control group (75%) made decisions upfront at the time of their appointment, while almost 40% were undecided in the intervention arm at the time of their appointment. At the 3 months follow‐up, however, this uncertainty resolved, and only 2% remained undecided in the intervention arm. Perhaps those assigned to use the OG spent more time weighing their options. Future work could explore the process of shared decision‐making and deliberation with and without a decision aid.Strengths of the study included the highly engaged clinical team, many of whom thanked the research staff during and after the study for the intervention and resources. Some reported anecdotally that patients were bringing the intervention back to the clinic at their follow‐up visit(s) months or even a year later. In addition, adding exact costs to decision aids is resource‐intensive and often varies widely by patient. We used relative cost information and referrals to incorporate costs into an existing, previously tested conversation aid. The engagement of patient and stakeholder advisors also allowed us to adapt an intervention and develop a study flow that met the needs of end users even during difficult times such as the onset of the COVID‐19 pandemic. The intervention was rated feasible and acceptable, and some plan to continue using even beyond the study period.However, limitations included the small sample size (of about 60% of that planned) and heterogeneity of the number of patients by clinician, which impacted our statistical power to detect differences between groups. In addition, the timing of early recruitment began during the early stages of the COVID‐19 pandemic limiting our ability to identify patients in‐person and audio‐record conversations. In addition, COVID‐related delays in seeking care could have impacted the representativeness of our sample based on our inclusion criteria that men had to have low‐risk prostate cancer. Low‐risk prostate cancer is generally less commonly diagnosed among Black men, and Black men often delayed seeking care for prostate cancer during 2020.Future work should explore ways to engage clinicians and patients in shared decision‐making and cost conversations during or after the clinical visit. Such work could involve additional member(s) of the care team, explore the best time to address these important issues, consider the amount, specificity and quality of cost information presented, directly ask about deliberation, and record or observe visits to assess outcomes.