A real-world evidence study of interhospital variability in the surgical treatment of patients with benign prostatic hyperplasia: the REVALURO study

RWE studies provide real-world data (RWD) concerning the effectiveness and safety of health interventions in daily clinical practice, the use of therapeutic alternatives, patient adherence, health care resource consumption, etc. These RWD are key to supporting decision-making on health care resource allocation, thus guaranteeing the sustainability of health care systems and, ultimately, improving patients’ health by improving the quality of health care [12].

In this context, despite the descriptive and exploratory objective of the study, the REVALURO study provides insight into the actual clinical practice concerning BPH surgical management in five reference hospitals in Spain. The most remarkable finding of this study was the high variability regarding the use of surgical procedures among centers. Overall, the use of invasive techniques has increased in recent years, reducing the use of highly invasive techniques. The MISTs remained constant over the time horizon. Among the invasive procedures, AEEP increased notably, while the use of TURP decreased over the follow-up time. In the case of MISTs, the use of different techniques has remained stable since 2019. However, although the WVTT is still the selected procedure in one-third of patients, the PVP showed a slight tendency to decrease, in favor of other MISTs, such as the PUL, TIND, BPKVP or TUIP.

The decreasing use of open prostatectomy and TURP can be explained by the incidence of post-surgical complications (28.6% and 29.8%, respectively) and the mean length of hospital stay (6.1 and 3.1 days, respectively) associated with both procedures. In this sense, surgical techniques that cause fewer complications and allow hospital discharge as soon as possible, have significant advantages from the perspective of patients and health care institutions. In addition, the reduction in the use of these more invasive techniques could be motivated by the latest clinical guidelines published by the European Association of Urology, which recommends the use of HoLEP instead of open prostatectomy or TURP as long as the prostate morphology allows its use [13].

In relation to the patients’ perspective, there is no standard surgical technique that fits every patient’s needs and preferences. First, the clinical features of the patients should be addressed. Most MISTs are indicated for prostates under 80 cc in size, while open or laparoscopic prostatectomy are preferred for large prostates. In addition, procedures such as PVP should be considered for patients at high risk of bleeding. Moreover, patients’ preferences can also indicate which intervention is most adequate. For instance, patients aiming to preserve erectile and ejaculatory function should receive WVTT or PUL [13].

Incorporating the patient’s perspective in health care practice is essential to move toward person-centered medicine. Shared-decision making (SDM), which involves inviting patients and/or caregivers to cooperate on treatment decisions, is a key component of patient engagement [14]. The advantages of SDM, in terms of emotional, financial and patient-reported outcome benefits, have been widely studied [15,16,17]. In addition, the initiatives of SDM conducted in the field of urology [18,19,20], including patients with LUTS/BPH [21,22,23], highlighted the importance and feasibility of implementing this process in the daily practice of urologists, with the aim of improving patients’ experience, well-being and quality of life.

In addition to promoting SDM strategies, another aspect that should be encouraged in urological clinical practice is the use of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). These questionnaires are designed and validated to measure subjective aspects of the disease, such as symptoms, well-being or quality of life, in the case of PROMs; or aspects related to a patient’s satisfaction with a health care process, in the case of PREMs [24]. Several questionnaires, including IPSS [25], International Index of Erectile Function (IIEF) [26], Overactive Bladder Symptom Score (OABSS) [27] or Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire [28], are available for assessing different issues of LUTS/BPH [29]. The use of these tools in combination with the evaluation of conventional clinical measures should be generalized to achieve a more accurate assessment of the effectiveness of BPH treatments [30].

Beyond patients’ needs and preferences, the treatment pathway for BPH has important implications for health care institutions. There is a lack of evidence regarding the economic impact of BPH in Spain. A study conducted in 2004 revealed that the pharmacological treatment of this disease caused approximately 24% of the pharmaceutical expenditure [31]. Additionally, previous studies revealed that heterogeneity in clinical practice, which was also observed in the REVALURO study, led to important variability in health care resource consumption and costs [32]. In any case, several therapeutic strategies could decrease the cost associated with BPH management, including pharmacological [6, 33] and surgical interventions [34, 35]. Thus, this economic evidence should also be addressed to provide a solid basis for decision-making. However, further research should be conducted to assess the gaps in the knowledge on this topic.

Despite these potential benefits from the perspective of both patients and health care institutions, the decision of which technique is performed is not aligned with the criteria previously described. In the present study, the WVTT was found to cause fewer complications (0.8%) and to lead to the shortest mean hospital stay after the intervention (0.2 days). However, trends in the use of surgical techniques revealed that WVTT, which was selected for the treatment of approximately 7% of patients overall, remained constant over time. In addition to the potential reduction in costs associated with WVTT [35], this technique could also fit the preferences of patients with BPH. According to a patient preference study, males with BPH value interventions that are effective, minimize the risks of complications and enhance the recovery process [36]. The results of the present RWE study suggested that the WVTT is the intervention that best meets these patients’ preferences. Additionally, 24.3% of the patients in the REVALURO cohort were aged 35 to 65 years, mainly corresponding to working age. These patients can especially benefit from the WVTT, as the procedure is associated with short lengths of hospital stay. Given that erectile and ejaculatory dysfunction are rare after WVTT [37], sexually active patients constitute another potential group that could benefit from WVTT.

The decision of which surgical procedure should be performed for each patient with BPH could be guided by several criteria, including the patient clinical profile and preferences, risk of complications, length of hospital stay, associated costs, etc. In contrast, the REVALURO study revealed that the selection of the technique to be performed relies on the history of the hospital and the experience of the urologists in performing the different procedures. Patients and health care institutions could benefit from different surgical treatment pathways, thus, clinical practice guidelines and recommendations based on expert consensus are key to homogenizing health care regarding BPH. This would lead to an improvement in the patient’s perceived benefit (PROM) and experience (PREM), enhancing equity in accessing to surgical treatments among patients and guaranteeing the sustainability of health care systems.

Although the REVALURO results are informative and useful for decision-making, this study is not exempt from limitations that should be assessed. First, the retrospective collection of RWD through medical records may have resulted in the loss of relevant information; however, this limitation is applicable to every study with retrospective design. Second, the study included 5 hospitals in the Spanish territory. Despite being 5 reference centers for BPH management in Spain, the representativeness of the results could be compromised. Nonetheless, the heterogeneity observed among hospitals in the study could be expected to be generalizable at the national level.

In contrast, the main strengths of the present study include the large sample size and real-world population. Thus, the findings of the REVALURO, combined with the results of previous RWE studies on BPH conducted in Spain, provide a wide vision of the clinical practice regarding BPH in Spain, including the evolution of patterns of health care [38], and an exhaustive clinical characterization of the patients [39, 40].

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