Impact of Surgical Approach on Patient-Reported Outcomes after Radical Prostatectomy: A Propensity Score-Weighted Analysis from a Multicenter, Prospective, Observational Study (The Pros-IT CNR Study)

Antonelli, Alessandro; Palumbo, Carlotta; Noale, Marianna; Porreca, Angelo; Maggi, Stefania; Simeone, Claudio; Bassi, Pierfrancesco; Bertoni, F.; Bracarda, Sergio; Buglione, Michela; Conti, Giario; Corvò, Renzo; Gacci, Mauro; Mirone, Vincenzo; Montironi, Rodolfo; Triggiani, Luca; Tubaro, Andrea; Artibani, Walter

doi:10.1159/000496980

Cited by 21 publications

(16 citation statements)

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“…The Authors concluded that both RARP and ORP yielded similar functional outcomes at 24 months, but they advised using caution in interpreting the oncological outcomes [25]. Pros-IT CNR data also support this conclusion [26].…”

Section: Discussionmentioning

confidence: 99%

Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

et al. 2019

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BackgroundThere are several treatments available to newly diagnosed prostate cancer (PCA) patients. Although surgery and radiotherapy (RT) with or without androgen deprivation therapy (ADT) are widely adopted treatment options for localized PCA together with active surveillance (AS), there is no consensus nor randomised trials on treatment selection, prospective quality of life (QOL), along with toxicity outcomes and according to treatment modality in the Italian population. The current study aimed to describe clinical-therapeutic features and QOL at PCA diagnosis, according to different treatment patterns in a large prospective, Italian population, enrolled in the Pros-IT CNR study.MethodsThe Pros-IT CNR is an on-going national, multicenter, observational, prospective study on patients affected by PCA who have been referred by 97 Italian Urology, Radiation Oncology and Medical Oncology facilities participating in the project. The possible relationships between the treatment patterns reported in the 6 month follow-up case report form and patients’ features at diagnosis were evaluated using exploratory multiple correspondence analysis (MCA) and other data analysis method.ResultsAt diagnosis, surgery and AS patients were significantly younger, had fewer comorbidities, lower PSA levels and Gleason Score (GS) values; they were also diagnosed at an earlier stage of disease with respect to the RT or ADT patients who showed significantly worse QoL scores at the time of diagnosis.ConclusionsAn analysis of the data collected at baseline and 6 months later uncovered substantial differences in ages, comorbidities, clinical and QOL features in the various treatment groups. These findings do not fully reflect the current PCA treatment guidelines and suggest the need for a multidisciplinary consensus guideline to ameliorate both the counselling and treatments of PCA patients.

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Section: Discussionmentioning

confidence: 99%

Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

et al. 2019

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“…Active surveillance retained the sexual function statistically significantly better than surgery, which led to the largest deterioration in sexual activity among the treatment lines. We did not assess differences of radical prostatectomy approaches (open, laparoscopic, and robot-assisted); however, another study found that there were significant differences in urinary and sexual dimensions, but their clinical significance seemed limited [20]. The treatment line turned out as a prognostic factor for survival and HRQoL also in our material as the choice of PC treatment is mainly based on T-classification and Gleason score, both known to be significant prognostic factors in PC.…”

Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life and Survival in Prostate Cancer Patients in a Real-World Setting

et al. 2020

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Objective: To analyze the health-related quality of life (HRQoL) and survival of real-world prostate cancer (PC) patients and to calculate quality-adjusted life-years (QALYs) experienced under different treatment strategies. Materials and Methods: PC patients undergoing active surveillance (n = 226), radiation treatment (n = 280), surgery (n = 299), or hormonal treatment (n = 62) responded to the generic 15-dimensional (15D) HRQoL questionnaire at the time of the diagnosis and were followed up 3, 6, 12, and 24 months later. QALYs experienced during the follow-up were calculated for each treatment group, and variables associated with survival were analyzed using Cox proportional hazards models. Results: HRQoL was stable during the first 2 years after diagnosis in all other treatment groups, except in patients treated with hormonal therapy. The overall survival within 6.5-year follow-up time was 84.4%. The number of QALYs experienced during the 2-year follow-up was similar in patients in active surveillance (1.790), surgery (1.784), and radiation groups (1.767), but significantly lower in the hormonal therapy group (1.665). Conclusions: Patients receiving hormonal treatment had significantly impaired HRQoL and survival compared with other treatments. Although the number of QALYs experienced was similar in the 3 other treatment lines, there were marked differences between treatment lines on some 15D dimensions.

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“…The rising number of oncological surgical procedures delivered by robotic systems and the ongoing debate over their cost‐effectiveness led to an increased interest in the collection of patient reported measures from those who undergo this kind of surgical intervention. Most of the published studies present experiences of PROMs collection in clinical trials especially for patients who receive robotic radical prostatectomy , while no evidence has been found of systematic collection of patient reported measures for robotic oncological surgery.…”

Section: Discussionmentioning

confidence: 99%

“…PROMs data have been initially introduced in clinical trials in order to integrate the clinical data with the people's subjective perception of their health status and health‐related quality of life . Most studies present the results of clinical trials and focus on radical prostatectomy and use PROMs as a comparative tool between the outcomes achieved by cohort of patients operated by the open, laparoscopic or robotic technique , while in literature the evidence of systematic collection of patient reported measures is still limited. However, the intrinsic characteristic of oncological diseases where treatment is not a one‐shot event but a pathway that moves across the different care settings requires the design of performance measurement tools that are able to overcome the “silo‐vision” and evaluate performance results of the entire care pathway .…”

Section: Introductionmentioning

confidence: 99%

Implementing successful systematic Patient Reported Outcome and Experience Measures (PROMs and PREMs) in robotic oncological surgery—The role of physicians

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Pennucci

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et al. 2019

Health Planning & Management

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Int J Health Plann Mgmt. 2020;35:773-787. wileyonlinelibrary.com/journal/hpm 773 change in their relationship and communication with patients, as clinicians accept to have their job reviewed and are not afraid to be evaluated by their patients. K E Y W O R D S patient reported experience measures, patient reported outcome measures, PREMs, PROMs, robotic surgery 1 | BACKGROUND After the approval of the da Vinci Surgical System in 2000 by the Food and Drug Administration (FDA), the past two decades have been characterised by the increased diffusion of such systems and the manufacturer's data show that as of 30 September 2017, there was an installed base of 4271 units worldwide, of which more than 60% in the USA, followed by Europe and Asia 1-3 . Although initially it was employed mainly for urologic procedures (namely radical prostatectomy), the evolution of both the surgical technique and the technology made possible the introduction of robotic surgical systems to a broader range of surgical specialties: cardiac, colorectal, general surgery, gynaecology, head and neck, and thoracic surgery.At the same time, there was a rise in the oncological conditions (OCs) that pose a great challenge to health care systems due to their increasing prevalence and expenditure. Indeed, cancer is the second leading cause of death worldwide behind cardiovascular diseases. In 2015, there were 17.5 M cancer cases worldwide, an increase by 33%with respect to 2005, and 8.7 M deaths 4,5 . However, the recent developments in personalised medicine, the continuous progress of cancer research, and the advance of mini-invasive surgical techniques have raised hope for patients and considerably improved cancer survival 6-9 . At the same time, the increasing cost of cancer treatments leads to an ongoing debate regarding both the equity and the affordability of care from individual and societal perspectives 10,11 .The continuously growing number of oncological procedures delivered by means of robotic surgical systems and the controversial debate regarding their cost-effectiveness with respect to traditional surgery led to the need of performance measurement systems to evaluate the effects of treatments, including surgery, that are able to go beyond the traditional clinical view of mortality and complications rates [12][13][14][15] . Beside the objective outcome measurements evaluated by clinicians, there are also subjective measures such as patient satisfaction, quality of life, and patient experience.PROMs have received increased attention as a useful tool to evaluate the effects of treatments and the outcomes of patients who underwent robotic oncological surgery, as the importance of the patient's perspective on disease impact has been increasingly recognised 16 . PROMs data have been initially introduced in clinical trials in order to integrate the clinical data with the people's subjective perception of their health status and health-related quality of life 17 . Most studies present the results of clinical trials and focus on radical prostatec...

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Impact of Surgical Approach on Patient-Reported Outcomes after Radical Prostatectomy: A Propensity Score-Weighted Analysis from a Multicenter, Prospective, Observational Study (The Pros-IT CNR Study)

Cited by 21 publications

References 23 publications

Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR)

Health-Related Quality of Life and Survival in Prostate Cancer Patients in a Real-World Setting

Implementing successful systematic Patient Reported Outcome and Experience Measures (PROMs and PREMs) in robotic oncological surgery—The role of physicians

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