Development of a patient decision aid for the surgical management of lower urinary tract symptoms secondary to benign prostatic hyperplasia

There are several surgical options to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). These treatment options vary in their treatment intensity, need for anaesthesia, risk of morbidity, functional outcomes, durability, effects on patient’s health-related quality of life (HRQoL), and accessibility [1]. Given the growing number of options available to treat BPH, patients and urologists are exposed to a tremendous amount of information when deciding on the best surgical management option for an individual patient. It may be challenging for urologists to ensure patients are aware of the options, and have the ability to incorporate their values and preferences to help inform a high-quality decision [2]. Patient decision aids (PtDAs) can be used to overcome this challenge by providing evidence-based and standardised education. A PtDA is a clinical tool that is used to facilitate shared decision-making between a patient and their healthcare provider using a structured development process [2-4]. PtDAs have been shown to increase patients’ knowledge of their health condition, decrease indecisiveness, and improve patients’ satisfaction with the choice made [2, 3]. With the help of patient advocates, a PtDA was developed to facilitate shared decision-making for patients considering surgical options for the management of BPH. We planned to include all guideline-approved surgical treatments for BPH in the PtDA. This article aims to present a detailed description of the development process of this BPH decision aid, provide insight into patient’s perception of this development process, and review the literature on this topic. The International Patient Decision Aids Standards (IPDAS) and the Ottawa Decision Support Framework were used to guide the systematic development of the PtDA [4]. A steering committee consisting of two patient advocates who had previously undergone surgery for BPH (J.S. and H.G.), two methodological experts (K.M. and L.T.L.), and six clinical experts that were either community (P.M.) or academic-based urologists (N.B., H.R., D.S.E., K.C.Z. and R.P.) was formed (Fig. 1). Two medical students (D.B. and D.D.N.) supported the activities of the steering committee. Using an iterative feedback process, each step in the development of the PtDA was planned and reviewed by the steering committee. First, a literature review was performed to identify similar PtDAs. Then, the American Urological Association (AUA), European Association of Urology (EAU), and Canadian Urological Association (CUA) BPH guidelines were reviewed to identify the recommended surgical modalities (Fig. 1). Society guidelines and the literature were reviewed for the best method to stratify patients based on risk factors. Based on the review of society guidelines, the PtDA was divided according to patient’s prostate volumes, as many studies and society guidelines follow volume cut-offs when selecting a treatment modality for patient’s LUTS secondary to BPH. Therefore, stratifying this PtDA according to prostate volume cut-offs determined by these guidelines will enable patients and urologists to follow these evidence-based recommendations and make the appropriate decision when selecting a treatment option. Then, a literature review was performed across a number of areas identified by the steering committee as important to patients and providers when selecting a surgical modality to characterise the outcomes of each treatment (Fig. 1). Notably, these areas included clinical and quality of life outcomes as well as treatment-related costs. The Medical Literature Analysis and Retrieval System Online (MEDLINE) was searched for the surgical management of LUTS secondary to BPH. This was done using pre-defined search terms that included all treatment modalities in combination with BPH, benign prostatic enlargement (BPE), benign prostatic obstruction (BPO), and bladder outlet obstruction (BOO). Additionally, the AUA, EAU, and CUA guidelines were hand-searched. After collectively discussing the outcomes retrieved, the ones the committee considered important were included in the development of the PtDA (Fig. 1). If the information could not be found based on the review of the literature, or the evidence was conflicting, issues were resolved by expert consensus. The quality of the evidence used to inform the creation of the PtDA was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach (Table 1) [5]. Less number of RCTs available Less number of reports Greater reliance on expert opinion for outcomes Greater number of unclear effect estimates The PtDA was initially drafted and formatted using the Ottawa PtDA template (Fig. 1) [6]. This template introduces both the decision being made and the question that the aid is designed to address, clarifies the target audience, and describes the medical condition and the treatment options included in the aid in simple language. Then, each treatment option’s risks and benefits are described in an unbiased manner using evidence-based outcomes from the medical literature. Once this is completed, patients are asked to clarify and communicate their values. In the final section of the template, the aid evaluates the patients’ understanding of the different treatment options with the help of a short questionnaire summarising the evidence presented. After completing the questionnaire, the SURE test is used to screen for decisional conflict and patients are asked to identify any of their unresolved needs [2]. The Ottawa PtDA template was then completed with the relevant information related to the treatments for BPH and their relevant outcomes. Methodological experts provided feedback regarding the structure and formatting of the PtDA. The clinical experts were tasked with approving and improving the technical aspects in the inclusion and description of the surgical approaches offered. The patient advocates focussed on the PtDA’s clarity of language by improving the contents’ readability and ease of understanding from a patient’s point of view (Fig. 1). The PtDA’s readability was assessed using the Simple Measure of Gobbledygook (SMOG) online tool, which estimates the years of education a person requires to understand a text [2]. Once finalised, the PtDA will be converted into an online format that will allow the PtDA to be more accessible to the targeted population (Fig. 1). Upon reviewing the existing PtDAs for the treatment of LUTS due to BPH, these were found to be either focussed on medical management, outdated, and/or pay-for-use. These included two PtDA’s developed by Healthwise, one developed by the Dutch Society for Urology, and one developed by WiserCare [7-11]. Patients were stratified according to the following prostate volume cut-offs: small-to-moderate prostates (30–80 mL), moderate-to-large prostates (80–150 mL), and large prostates (>150 mL) [12]. The treatment options included in the small-to-moderate prostate group (30–80 mL) were monopolar transurethral resection of the prostate (TURP), bipolar TURP, greenlight laser photovaporisation (PVP), enucleation, Rezum, Urolift, and Aquablation [12]. The moderate-to-large prostate category (80–150 mL) options included: PVP, enucleation, Aquablation, open retropubic prostatectomy and robot-assisted retropubic prostatectomy [12]. The large prostate category (>150 mL) options included: PVP, enucleation, open retropubic prostatectomy and robot-assisted retropubic prostatectomy [12]. Following consultation with the steering committee, the outcomes of greatest importance to this PtDA are: International Prostate Symptom Score (IPSS) and IPSS-QoL improvement scores, post-treatment urine retention within 30 days, length of stay, catheterisation time, recurrence of symptoms, temporary incontinence, erectile dysfunction, retrograde ejaculation, requiring blood transfusions, and the development of urinary tract infections. A preview of the developed PtDA can be found in Fig. 2. The literature review performed to characterise the outcomes of each treatment identified 41 studies; 19 were used for the small-to-moderate prostate group, 16 for the moderate-to-large prostate group, and six for the large prostate group. The quality of the evidence used for the benefits and risks treatment section varied [5]. Based on the GRADE approach, the quality was moderate for surgical modalities used for the treatment of patients with prostates measuring 30–80 mL, low for patients with prostates measuring 80–150 mL, and very low for patients with prostates measuring >150 mL (Table 1). The readability of the PtDA was calculated to have a SMOG score of 8.4. In the present article, we describe a systematic approach to creating an evidence-based PtDA addressing the gap in patient-centred, surgical treatment of LUTS secondary to BPH. Within the assembled steering committee, discrepancies related to patient and clinician perspectives were observed. Patient advocates had a tendency to emphasise functional and relatable outcomes, and were less interested in quantitative outcomes alone if these were not correlated to concrete outcomes. For example, patient advocates were interested in outcomes such as time to return to work. Conversely, urologists were more concerned with traditionally reported outcomes such as IPSS improvement. This underscored the need to present findings that may not be reported in the literature and to present traditional outcomes in relatable ways to patients, notably via the use of infographics. This observation also highlights the importance of patient involvement in the development process. An important discussion among the steering committee was whether to include outcomes of management with medications and watchful waiting. In the end, the description of both these options was included, as an important component of PtDA construct is the inclusion of alternative management options; however, specific outcomes of these were not included, and it was specified that the PtDA focussed on surgical management only. Patients were however informed to consult with their physician about these options. Another important issue encountered in the development of the PtDA concerned treatment availability. When developing the PtDA, we considered the possibility that urologists who do not offer all the treatments included in the PtDA may refrain from using it. However, there is value in informing patients of management options that may be offered by other physicians and more in keeping with their personal values and preferences. To overcome this issue, we included a feature in the online version of the PtDA that enables users to select an ‘only show treatments offered by my urologist’ checkbox at any time throughout the decision process. This allows patients to have the chance to explore treatment options not offered by their urologist and at the same time encourages urologists that do not offer all of the presented treatments to use the PtDA effectively, while still educating their patients about all possible options. Existing PtDAs for the surgical treatment of LUTS due to BPH are either outdated, and/or pay-for-use [7-10, 13, 14]. Among the four previously developed PtDA’s related to BPH treatment, the one developed by the Dutch Society for Urology was the only one that described and shared their development process in a peer-reviewed journal [10]. Within the description of this development process there are differences that can be observed. For one, the Dutch BPH PtDA is not specific to surgical treatments; only four out of the nine surgical treatments described in our PtDA are included in the Dutch PtDA. Similarly to the PtDA described in the present paper, within the development process of the Dutch PtDA there is also an emphasis placed upon patient preferences. However, there was no direct communication between the urologists and patients. Communication was done through surveys with open comment fields [10]. Therefore, importantly, contrary to the development process described in the present paper, no patients were directly involved as members of the steering committee in charge of the Dutch PtDA’s development, and so patient perspectives could not be highlighted. The development of this PtDA is not without limitations. The outcomes included on the PtDA represent the best available evidence at this time. Therefore, it is possible that newly-published important references were not included if they were not available at the time of the PtDA’s development. However, as further evidence becomes available, the PtDA will be regularly updated to ensure that it includes all relevant and the most recent information. The next step of the present PtDA is to evaluate its acceptability and validate it. The acceptability testing of the PtDA is underway and will be completed soon. Acceptability and validation testing will ensure that the finalised PtDA is acceptable with all stakeholders, including patients and urologists, and is improving quality of decision-making by BPH surgery patients. Using a systematic approach, an evidence-based PtDA was developed to facilitate shared decision-making for patients who are deciding among surgical treatment options for LUTS secondary to BPH. The next steps for the present PtDA include prospectively evaluating the acceptability and effectiveness of the aid.

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