To identify trends of patients' urinary and sexual dysfunctions from a clinical and psychological perspective and understand whether sociodemographic and medical predictors could differentiate among ...patients following different one-year longitudinal trajectories.
An Italian sample of 478 prostate cancer patients undergone Robot-Assisted Radical Prostatectomy completed the EPIC-26 survey between July 2015 and July 2016 at the pre-hospitalization (T0), 45 days (T1) and 3 (T2), 6 (T3), 9 (T4), and 12 months (T5) after surgery. Sociodemographic and clinical characteristics (age, BMI, diabetes, nerve-sparing procedure) were also collected. Latent Class Growth Analysis was conducted separately for sexual dysfunction and urinary incontinence EPIC-26 subscales. The association between membership in the two longitudinal trajectories of urinary and sexual dysfunctions was assessed by considering Chi-square test and its related contingency table.
People who have a high level of urinary incontinence at T1 are likely to have a worse recovery. Age, BMI and pre-surgical continence may affect the level of incontinence at T1 and the recovery trajectories. Patients with low and moderate sexual problems at T1 can face a moderate linear recovery, while people with high level of impotence immediately after surgery may take a longer period to solve sexual dysfunctions. Age and the pre-surgical sexual condition may impact the recovery. Finally, a great proportion of patients reported both steady problems in sexual function and constant high levels of urinary incontinence over time.
This study highlights different categories of patients at risk who may be important to know in order to develop personalized medical pathways and predictive models in a value-based healthcare.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
This study aims to validate and evaluate the psychometric properties and reliability of the Italian version of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26), a measure of ...quality of life (QoL) for prostate cancer patients.
Two hundred and eighty-four prostate cancer patients completed the Italian version of the EPIC-26 questionnaire at 45 days (T1) and 3 months (T2) after robot-assisted radical prostatectomy (RARP). Psychometric properties were evaluated using structural equation modeling: the goodness of fit of the correlated five-factor model (CFFM) for the EPIC-26 was assessed using the confirmatory factor analysis (CFA), while longitudinal invariance was conducted to assess the ability of the EPIC-26 to measure QoL construct over time. Test-retest reliability was assessed as well by considering intraclass correlations.
At T1, the CFFM model displayed a good fit to data. Similarly, the model showed an adequate fit also at T2. Results of the reliability analysis attested the acceptable internal consistency and test-retest reliability of each dimension: all Cronbach's alphas could be classified as acceptable (i.e., above .65) except for low Cronbach's alpha for hormonal dysfunction at T1 (i.e., .638) and urinary irritation at both waves. (i.e., respectively .585 and .518). Finally, psychometric properties were invariant over time and each of the five dimensions of QoL displayed from moderate (all ICCs above .500) to good test-retest reliability (i.e. ICC for urinary incontinence = .764).
Results of the CFA and the measurement invariance analysis demonstrated the validity of the Italian version of the EPIC-26 to assess QoL in prostate cancer patients. Its reliability and good psychometric qualities are well-supported, thus providing a valid tool to assess health-related quality of life and its change over time in prostate cancer patients.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Quality of Life (QoL) is an important predictor of patient's recovery and survival in lung cancer patients. The aim of the present study is to identify 1-year trends of lung cancer patients' QoL ...after robot-assisted or traditional lobectomy and investigate whether clinical (e.g., pre-surgery QoL, type of surgery, and perioperative complications) and sociodemographic variables (e.g., age) may predict these trends.
An Italian sample of 176 lung cancer patients undergoing lobectomy completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) at the pre-hospitalization (t0), 30 days (t1), 4 months (t2), 8 months (t3), and 12 months (t4) after surgery. Sociodemographic and clinical characteristics (age, gender, perioperative complications, and type of surgery) were also collected. The individual change over time of the 15 dimensions of the EORTC QLQ-C30 and the effects of pre-surgery scores of QoL dimensions, type of surgery, perioperative complications, and age on patients' QoL after surgery were studied with the individual growth curve (IGC) models.
Patients had a good recovery after lobectomy: functioning subscales improved over time, while most of the symptoms became less severe over the care process. Perioperative complications, type of surgery, pre-surgery status, and age significantly affected these trends, thus becoming predictors of patients' QoL.
This study highlights different 1-year trends of lung cancer patients' QoL. The measurement of pre- and post-surgery QoL and its clinical and sociodemographic covariables would be necessary to better investigate patients' care process and implement personalized medicine in lung cancer hospital divisions.
This study aims to validate and evaluate the psychometric properties and measurement invariance of the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) ...Quality of Life Questionnaire-Core 30 (QLQ-C30), which is a measure of quality of life (QoL) for lung cancer patients after surgery.
A total of 167 lung cancer patients completed the Italian version of the EORTC QLQ-C30 questionnaire at 30 days after they received a lobectomy. The factor structure of this scale was assessed by performing confirmatory factor analysis (CFA). Measurement invariance was evaluated by considering differential item functioning (DIF) due to age, gender, and type of surgery (i.e., robot- or not robot-assisted).
The CFA demonstrated the validity of the factor structure of the EORTC QLQ-C30 in assessing overall health and eight distinct subscales of adverse events and functioning. Moreover, the results highlighted a minimal DIF with only trivial consequences on measurement invariance. Specifically, the DIF did not affect the mean differences of latent scores of QoL between patients undergoing robot-assisted surgery or traditional surgery.
These findings supported the validity and suitability of the EORTC QLQ-C30 for the assessment of QoL in lung cancer patients of diverse ages and genders undergoing lobectomy with or without robot-assisted surgery.
Biobanks are biorepositories that collect, process, store, catalog, and distribute human biological samples, and record the associated data. The role and action field of these strategic ...infrastructures for implementing precision medicine in translational research is continuously evolving. To ensure the optimal quality at all stages of biobanking, specific protocols are required and should be elaborated according to updated guidelines, recommendations, laws, and rules. This article illustrates the standard operating procedures, including protocols, troubleshooting, and quality controls, of a fully certified biobank in a referral Cancer Center. This model involves all clinical departments and research groups to support the dual mission of academic cancer centers, i.e. to provide high-quality care and high-quality research. All biobanking activities based on the type of biological specimens are detailed and the most tricky methodological aspects are discussed, from patients’ informed consent to specimen management.
Biobanks are necessary resources for the storage and management of human biological materials, such as biofluids, tissues, cells, or nucleotides. They play a significant role in the development of ...new treatments and the advancement of basic and translational research, especially in the field of biomarkers discovery and validation. The regulatory landscape for biobanks, which is necessary to safeguard both privacy and scientific discoveries, exhibits significant heterogeneity across different countries and regions. This article outlines the standards that modern biobanks should fulfill in the European Union (EU), including general, structural, resource, process, and quality requirements. Special attention is given to the importance of transparency and donor consent following the General Data Protection Regulation (GDPR) and the ISO 20387:2018, the international standard specifies general requirements for biobanks. A dedicated section covers the preparation of donor information materials, emphasizing consent for research involvement and personal data processing. The delicate balance between donors' privacy rights and scientific research promotion is also discussed, with a focus on the patenting and economic use of biological material- derived inventions and data. Considering these factors, it would be warranted to refine legal frameworks and foster interdisciplinary collaboration to ethically and responsibly expand biobanking.
Biobanks are key research infrastructures aimed at the collection, storage, processing, and sharing of high-quality human biological samples and associated data for research, diagnosis, and ...personalized medicine. The Biobank for Translational and Digital Medicine Unit at the European Institute of Oncology (IEO) is a landmark in this field. Biobanks collaborate with clinical divisions, internal and external research groups, and industry, supporting patients' treatment and scientific progress, including innovative diagnostics, biomarker discovery, and clinical trial design. Given the central role of biobanks in modern research, biobanking standard operating procedures (SOPs) should be extremely precise. SOPs and controls by certified specialists ensure the highest quality of samples for the implementation of science-based, diagnostic, prognostic, and therapeutic personalized strategies. However, despite numerous efforts to standardize and harmonize biobanks, these protocols, which follow a strict set of rules, quality controls, and guidelines based on ethical and legal principles, are not easily accessible. This paper presents the biobank standard operating procedures of a large cancer center.
Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? ...How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non‐predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.
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