46% of female adults suffer from stress urinary incontinence (SUI). The informed consent and decision-making process have been reexamined in light of ongoing concerns with surgical treatments, such as the risks of mesh complications and chronic pain from mid-urethral slings (MUS). We sought to determine the management decision needs of SUI-affected female adults. Specifically, we aimed to ascertain the needs, conflicts and barriers involved in decision-making, the current knowledge gaps and support needs of patients, and the role of health professionals. The purpose of this data collection is to allow for the creation of an evidence-based patient decision aid (PDA) aligned with the needs of patients experiencing SUI to support the decision-making process.

In order to gain a deeper understanding of both healthcare professional and patient perspectives, this study used two methods of data collection to maximize the potential for triangulation. The first was individual patient semi-structured interviews, and the second was focus groups of practicing health care professionals. 
For individual patient interviews, we recruited female participants who presented with SUI and were undergoing care at urology or urogynecology clinics. The semi-structured interviews consisted of 13 questions evaluating their knowledge of SUI management, pertinent values, biases, as well as their decisional needs, barriers, and facilitators. 
Healthcare professionals were selected from professionals in the field known to the team of co-investigators. Two separate semi-structured, 1-hour virtual focus groups were conducted to assess health professional perspectives on SUI management (one conducted in English, and one in French, based on participant preference).  Focus group participants were prompted to provide their opinions on 12 questions concerning decisional needs, barriers, knowledge, support needs and the role of healthcare professionals in informed decision-making. 
Both patients and healthcare professionals were asked to answer baseline demographic questions prior to the interviews and focus groups. Direct content qualitative analysis assessed recurrent themes from the interviews by using the Ottawa Decision Support Framework and the International Standards for Decision Support as references.

Overall, of the 13 patients with SUI that were contacted, nine agreed to partake in the interviews. Median age of patients interviewed was 65 ± 18.5 years. 56% had previously tried conservative interventions such as physiotherapy or incontinence pessaries, and 78% underwent ≥1 surgical procedure. Patient satisfaction with their management choice ranged from not satisfied at all to completely satisfied, with lack of communication from their healthcare provider being one of the factors influencing this satisfaction. Direct content analysis showed that 78% of patients had limited knowledge of invasive surgical procedures. This is described by 56% of patients who were uncertain of what invasive and semi-invasive procedures were accessible. Financial factors, specifically pelvic floor physiotherapy which is not covered by most patients’ insurance plans in our healthcare setting heavily influenced the decision-making process in 78% of participants. 44% of the participants voiced fears about undergoing invasive procedures and 56% were specifically concerned about possible complications related to MUS secondary to recent media scrutiny of the procedure.
Of the 16 healthcare professionals invited, 13 responded to the baseline questionnaire and attended the focus groups. Among the 13 health professionals who attended, 9 were physicians (6 urogynecologists and 3 urologists) and 4 were physiotherapists. Of the physicians who attended: two had <1 year of experience, three had 1-5 years, two had 6-10 years, and two had 11-20 years of experience. All four physiotherapists who attended had 11-20 years of experience. Analysis of themes emerging from the focus groups revealed that providers perceive inconsistent knowledge among SUI patients concerning their potential management options. Providers also reported a need for further education facilitated by a new format of PDAs consisting of accessible educational material. Healthcare professionals were in agreement that new PDAs for the management options of SUI should be developed, emphasizing both conservative and surgical management. Moreover, conservative methods including physiotherapy and pessaries should be described in more detail in those PDAs. New PDAs should incorporate more visual aids and diagrams allowing for improvement of patient understanding. Healthcare providers also found a link between patient knowledge and their acceptance of risk and satisfaction, specifically that the more that patients felt they understood, the more satisfied they were with the outcomes. Additionally, health professionals also reported financial factors to be a barrier to patients, especially since pelvic floor physiotherapy is only available within the private healthcare sector. Similar to patients, physicians were also concerned about the misinformation surrounding MUS, which has led to longer consultations in order to address patients’ concerns. This phenomenon has led to the hesitancy of physicians to perform MUS procedures.
The impact of quality of life and discomfort on patients' decisions regarding SUI was a common theme between groups. Patients acknowledged that the discomfort brought on by SUI symptoms had an impact on their decision-making, and medical experts concurred that patients took these symptoms into account when choosing their SUI treatments. Both patients and healthcare professionals confirmed the importance of the influence patients’ family and friends had in the decision-making process. Healthcare professionals and patients were in accordance that pamphlet/PDF formats were still essential, but most agreed that supplemental websites presenting diverse information would be beneficial for both parties. Our group also identified a need for inclusive language to be included within any new PDAs developed.

In general, we found agreement between patients and healthcare professionals on a number of factors related to the decision-making process for SUI management. There was consensus among physicians and physiotherapists that patient knowledge about SUI management is overall poor. This was also supported by our finding that 78% of patients felt they did not have enough information regarding SUI invasive management, hindering their ability to provide informed consent. 
Another major barrier to patient care mentioned by both groups was financial factors influencing the level of care patients could afford. During discussions, patients and health professionals recognized some treatments that were not covered by many patients’ insurance plans (i.e physiotherapy). As a result, these management options were typically less accessible to patients, thus restricting patients from receiving appropriate continuity of care. 
Moreover, the media’s influence and misinformation regarding MUS was observed to be a major influencer in the decision-making process. Most patients interviewed were concerned about mesh complications due to media scrutiny. Similarly, physicians were concerned about the misinformation spread regarding mesh complications, resulting in a reluctance to perform MUS procedures. This misinformation may be added by the development of a new PDA encompassing both conservative and surgical management, as supported by the healthcare professionals interviewed.

In general, there was a consensus that knowledge regarding SUI management options was incomplete among female participants with SUI. There is a need for the development of an improved PDA that is visually engaging describing SUI management options in order to better serve patients and help health providers provide optimal decision support. Such a PDA should be offered in pamphlet/PDF format supplemented with hyperlinks to facilitate the understanding and comprehension of all patient age groups, and in inclusive language.