A Systematic Review to Evaluate Patient-Reported Outcome Measures (PROMs) for Metastatic Prostate Cancer According to the COnsensus-Based Standard for the Selection of Health Measurement INstruments (COSMIN) Methodology.

INTRODUCTION: Patient-reported outcome measures (PROMs) represent important endpoints in metastatic prostate cancer (mPCa). However, the clinically valid and accurate measurement of health-related quality of life depends on the psychometric properties of the PROMs considered. OBJECTIVE: To appraise, compare, and summarize the properties of PROMs in mPCa. EVIDENCE ACQUISITION: We performed a review of PROMs used in RCTs, including patients with mPCa, using Medline in September 2021, according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This systematic review is part of PIONEER (an IMI2 European network of excellence for big data in PCa). RESULTS: The most frequently used PROMs in RCTs of patients with mPCa were the Functional Assessment for Cancer Therapy-Prostate (FACT-P) (n = 18), the Brief Pain Inventory-Short Form (BPI-SF) (n = 8), and the European Organization for Research and Treatment of Cancer quality of life core 30 (EORTC QLQ-C30) (n = 6). A total of 283 abstracts were screened and 12 full-text studies were evaluated. A total of two, one, and two studies reported the psychometric proprieties of FACT-P, Brief Pain Inventory (BPI), and BPI-SF, respectively. FACT-P and BPI showed a high content validity, while BPI-SF showed a moderate content validity. FACT-P and BPI showed a high internal consistency (summarized by Cronbach's α 0.70-0.95). CONCLUSIONS: The use of BPI and FACT-P in mPCa patients is supported by their high content validity and internal consistency. Since BPI is focused on pain assessment, we recommend FACT-P, which provides a broader assessment of QoL and wellbeing, for the clinical evaluation of mPCa patients. However, these considerations have been elaborated on in a very limited number of studies. PATIENT SUMMARY: In this paper, we review the psychometric properties of PROMs used with patients with mPCa to find the questionnaires that best assess patients' QoL, in order to help professionals in their intervention and improve patients' QoL. We recommend the use of BPI and FACT-P for their high content validity and internal consistency despite the limited number of studies considered.

Standardising the Assessment of Patient-reported Outcome Measures in Localised Prostate Cancer. A Systematic Review.

CONTEXT: Prostate cancer (PCa) is the second most common cancer among men worldwide. Urinary, bowel, and sexual function, as well as hormonal symptoms and health-related quality of life (HRQoL), were prioritised by patients and professionals as part of a core outcome set for localised PCa regardless of treatment type. OBJECTIVE: To systematically review the measurement properties of patient-reported outcome measures (PROMs) used in localised PCa and recommend PROMs for use in routine practice and research settings. EVIDENCE ACQUISITION: The psychometric properties of PROMs measuring functional and HRQoL domains used in randomised controlled trials including patients with localised PCa were assessed according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. MEDLINE and Embase were searched to identify publications evaluating psychometric properties of the PROMs. The characteristics and methodological quality of the studies included were extracted, tabulated, and assessed according to the COSMIN criteria. EVIDENCE SYNTHESIS: Overall, 27 studies evaluating psychometric properties of the Expanded Prostate Cancer Index Composite (EPIC), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), European Organisation for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) and prostate cancer 25 (QLQ-PR25) modules, International Index of Erectile Function (IIEF), and the 36-item (SF-36) and 12-item Short-Form health survey (SF-12) PROMs were identified and included in the systematic review. EPIC and EORTC QLQ-C30, a general module that assesses patients' physical, psychological, and social functions, were characterised by high internal consistency (Cronbach's α 0.46-0.96 and 0.68-0.94 respectively) but low content validity. EORTC QLQ-PR25, which is primarily designed to assess PCa-specific HRQoL, had moderate content validity and internal consistency (Cronbach's α 0.39-0.87). UCLA-PCI was characterised by moderate content validity and high internal consistency (Cronbach's α 0.21-0.94). However, it does not directly assess hormonal symptoms, whereas EORTC QLQ-PR25 does. CONCLUSION: The tools with the best evidence for psychometric properties and feasibility for use in routine practice and research settings to assess PROMs in patients with localised PCa were EORTC QLQ-C30 and QLQ-PR25. Since EORTC QLQ-C30 is a general module that does not directly assess PCa-specific issues, it should be adopted in conjunction with the QLQ-PR25 module. PATIENT SUMMARY: We reviewed and appraised the measurement properties of patient-reported outcome measure questionnaires used for patients with localised prostate cancer. We found good evidence to suggest that two questionnaires (EORTC QLQ-C30 and QLQ-PR25) can be used to measure urinary, bowel, and sexual functions and health-related quality of life.

[Psychological Assessment of a sample of women with ADPKD: quality of life, body image, anxiety and depression].

INTRODUCTION: The Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a chronic renal disease that has not yet been the subject of psychological research. There are only a few studies related to the consequences and complications of this pathology on female patients, although women affected by this disease present serious problems. AIM: The purpose of this study is to perform a psychological assessment (quality of life, anxiety, depression, body image) on a sample of 37 women with ADPKD. MATERIALS AND METHODS: The assessment is based on ad hoc social and personal record, KDQOL-SF (to evaluate health-related quality of life), HADS (for anxiety and depression) and BUT (for perceived body image). This assessment is administrated in a specific outpatient clinic. RESULTS: Results show that kidney disease has a negative impact on health-related quality of life. Concerns about body image are linked to anxious and depressive symptomatology: an increase in these concerns is related to a worsening of anxiety and depressive symptoms in patients. Moreover, a higher psychological malaise emerges in hypertensive ADPKD patients, in terms of mood and quality of life, compared to those without this concomitant pathology. Finally, it is important to note that social support, real or perceived, is of paramount importance in maintaining psychological well-being. CONCLUSIONS: The psychological evaluation of ADPKD patients can be used in clinical practice as a supplemental model in multidisciplinary Nephrology team.

[Quality of life, anxiety and distress in patients suffering from chronic kidney disease: pre-dialysis and start of dialytic treatment]. / Qualità di vita, ansia e distress nei pazienti affetti da malattia renale cronica: predialisi ed inizio del trattamento dialitico.

The psychological impact of the Chronic Kidney Disease is well known and several factors contribute to a reduction of quality of life, increase of anxiety levels and psychological distress for affected patients. Psychological intervention is becoming ever more consolidating within the Departments of Nephrology. Nevertheless, literature is lacking about the psychological intervention specificity, especially concerning the dialysis and pre-dialysis phase. The purpose of the study is to identify the mainly critical periods for the dialysed patients in terms of anxiety and distress and to examine the impact of medical management in pre-dialysis period on life quality. In this multi-centre study the sample was collected in three Dialysis Centres: the IRCCS San Raffaele, the IRCCS Multimedica and the A.O. Fatebenefratelli. The instruments used were KDQOL-SF, specific for the dialysed patient's quality of life, PDI, for the distress evaluation and STAI, for anxiety evaluation. The data showed the presence of a more severe psychological unease at the beginning of haemodialysis therapy and a better perception of the life quality for those who have received the medical adoption during the pre-dialysis phase than who did not have it. From a psychological point of view, these results highlight the importance of taking charge the patients in a pre-dialysis phase and of structuring specific psychological interventions during the initial period of substitution therapy.

[Burnout in healthcare professionals: a study carried out in the Nephrology Unit of San Raffaele Hospital]. / Il burnout negli operatori sanitari: uno studio condotto nell'U.O. di Nefrologia dell'Ospedale San Raffaele.

Burnout is a work stress syndrome caused by a prolonged contact with users which present physical and emotional suffering. C. Maslach, one of the main authors, refers that this syndrome is characterized by emotional exhaustion, depersonalization and reduced personal skills. However, the researches done within the Nephrology and Dialysis Departments on this phenomenon are still few in the literature, despite the peculiar characteristics of the care relationship that develops between caregivers and patients on dialysis treatment. The present study aims to highlight the importance of assessing the levels of burnout and strategies of adaptation to stress (coping) in healthcare workers of Nephrology and Dialysis Unit, so that their psychological well-being could be preserved, preventing the possibility of a progressive deterioration of the care relationship with the patient. The implementation of psychological training courses for healthcare workers seems to be a useful tool aimed at the prevention and management of the burnout syndrome.