Population Of Italian Patients Research Articles

Disease Stage and Motor Fluctuation Duration Predict Drug Tolerability: A Real-Life, Prospective Italian Multicenter Study on the Use of Opicapone in Parkinson's Disease.

Opicapone is a third-generation catechol-O-methyl-transferase inhibitor currently used for the treatment of motor fluctuations in Parkinson's disease. Its benefit and safety have been established by clinical trials; however, data about its use in a real-life context, and particularly in an Italian population of patients with Parkinson's disease, are missing. We aimed to gather data about the real-life tolerability/safety of opicapone when used for the treatment of Parkinson's disease-related motor fluctuations. We enrolled 152 consecutive patients with Parkinson's disease and followed them for 2 years after opicapone introduction. We obtained baseline clinical and demographical information, including disease duration, stage, phenotype, as well as axial and non-motor symptoms. We collected the reasons for any treatment interruption and adverse events emerging after opicapone introduction. Eighty-nine (58%) patients reported adverse events and 46 (30%) patients discontinued the treatment. Adverse events occurred less frequently in "earlier" patients accordingly to the disease course and L-Dopa treatment pathway; a motor fluctuation duration ≥12 months and Hoehn and Yahr scale score ≥2.5 were the main predictors of therapy withdrawal. This study confirms the good tolerability/safety profile of opicapone in a real-life setting and provides country-specific data for Italian patients with Parkinson's disease.

Genetic Alterations in a Large Population of Italian Patients Affected by Neurodevelopmental Disorders.

Neurodevelopmental disorders are a group of complex multifactorial disorders characterized by cognitive impairment, communication deficits, abnormal behaviour, and/or motor skills resulting from abnormal neural development. Copy number variants (CNVs) are genetic alterations often associated with neurodevelopmental disorders. We evaluated the diagnostic efficacy of the array-comparative genomic hybridization (a-CGH) method and its relevance as a routine diagnostic test in patients with neurodevelopmental disorders for the identification of the molecular alterations underlying or contributing to the clinical manifestations. In the present study, we analysed 1800 subjects with neurodevelopmental disorders using a CGH microarray. We identified 208 (7%) pathogenetic CNVs, 2202 (78%) variants of uncertain significance (VOUS), and 504 (18%) benign CNVs in the 1800 patients analysed. Some alterations contain genes potentially related to neurodevelopmental disorders including CHRNA7, ANKS1B, ANKRD11, RBFOX1, ASTN2, GABRG3, SHANK2, KIF1A SETBP1, SNTG2, CTNNA2, TOP3B, CNTN4, CNTN5, and CNTN6. The identification of interesting significant genes related to neurological disorders with a-CGH is therefore an essential step in the diagnostic procedure, allowing a better understanding of both the pathophysiology of these disorders and the mechanisms underlying their clinical manifestations.

Clinical Characteristics of an Italian Patient Population with Advanced BCC and Real-Life Evaluation of Hedgehog Pathway Inhibitor Safety and Effectiveness

Background: Advanced basal cell carcinoma (aBCC) represents a complex and clinically heterogeneous group of lesions for which curative surgery and/or radiotherapy is unlikely. Systemic therapy with hedgehog pathway inhibitors (HHIs) changed the treatment landscape for this complex patient population. Objectives: The aims of the present study are to describe the clinical characteristics of a real-life Italian cohort diagnosed with aBCC and to investigate effectiveness and safety of HHI. Methods: A multicenter observational study was performed by twelve Italian centers in the period January 1, 2016 – October 15, 2022. Patients aged ≥18 years and diagnosed with aBCC (locally advanced [laBCC] and metastatic BCC [mBCC]) were eligible for the study. Methods for investigating tumor response to HHI included clinical and dermatoscopic evaluation, radiological imaging, and histopathology. For HHI safety assessment, therapy-related adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: We enrolled 178 patients under treatment with HHI: 126 (70.8%) and 52 patients (29.2%) received sonidegib and vismodegib, respectively. Comprehensive data on HHI effectiveness and disease outcome were available for 132 (74.1%) of 178 patients: 129 patients had a diagnosis of laBCC (n = 84, sonidegib; n = 45, vismodegib) and 3 patients of mBCC (n = 2, vismodegib; n = 1, sonidegib, off-label). Objective response rate was 76.7% (95% confidence interval [CI]: 82.3–68.7) and 33.3% (95% CI: 88.2–1.7) for laBCC (complete response [CR]: 43/129; PR: 56/129) and mBCC (CR: 0/3; PR: 1/3), respectively. High-risk aBCC histopathological subtypes and occurrence of >2 therapy-related AEs were significantly associated with nonresponse to HHI therapy ([OR: 2.61; 95% CI: 1.09–6.05; p: 0.03] and [OR: 2.74; 95% CI: 1.03–7.9; p: 0.04]), respectively. Majority of our cohort (54.5%) developed at least 1 therapy-related AE, most of which were mild-moderate in severity. Conclusions: Our results demonstrate the effectiveness and safety profile of HHI and confirm the reproducibility of pivotal trial results in real-life clinical setting.

Italian cross-cultural adaptation of the patient-reported outcome measure of ataxia.

The patient-reported outcome measure of ataxia (PROM-Ataxia) is the first patient-reported questionnaire specifically developed for use in patients with cerebellar ataxia. The scale was recently designed and validated in English language, and it consists of 70 items encompassing all aspects associated with the patient experience, including physical and mental health and their consequences on activities of daily living. The aim of the study was to translate and culturally adapt into Italian the PROM-Ataxia questionnaire, before assessing its psychometric properties. We translated and culturally adapted into Italian the PROM-Ataxia following the ISPOR TCA Task Force guidelines. The questionnaire was field tested via cognitive interviews with users. The Italian patients found that the questionnaire was complete, and no significant contents related to the physical, mental, and functional dimensions were missing. Some items were found redundant or ambiguous. Most of the identified issues pertained to semantic equivalence, and a few to conceptual and normative equivalence, while the questionnaire did not contain any idiomatic expression. The translation and cultural adaptation of the PROM-Ataxia questionnaire in the Italian patient population represent the pre-requisite for the subsequent psychometric validation of the scale. This instrument may be valuable for cross-country comparability that would allow the merging of the data in collaborative multinational research studies.

Inherited mutations in DNA damage gene repair (gDDR) in Italian men with metastatic prostate cancer.

223 Background: The need for genetic prognostic and predictive markers is urgent in order to identify potential target therapies or personalized therapeutic sequences for men with metastatic prostate cancer (mPC). The prevalence of pathogenic germline mutations in DNA damage repair (gDDR) such as germline mutations in BRCA2 (gBRCA) is well established: in the Anglo-American population with mPC was 5.3%, while in the Chinese population was 4.3% and in Spanish population 3.3%. This prospective multicenter cohort study evaluated the prevalence of gDDR alterations in the Italian population affected by mPC. Methods: In an observational prospective trial, 300 consecutive Italian patients affected by mPC were recruited between 2015 and 2019 and were screened for gDDR mutations in 107 genes. The primary aim was to assess the frequency of ATM/BRCA1/BRCA2/PALB2 germline mutations in the Italian population of patients with mPC. Secondary aims included the association of gDDR subgroups with metastatic onset, Gleason Score ≥8, and time to castration resistance. Results: We analyzed 300 patients and we identified 297 valuable patients. 46 patients had a pathogenic/likely pathogenic variants (15.4%): the more frequent is gBRCA2 in ten cases, gATM in five (1.7%), gMUTYH in four cases (1.3%), gCHEK2 in three cases (1%) and one case in PALB2 (0.3%). No mutations in BRCA1 were identified. We also highlighted six patients (2%) with clonal hematopoiesis of indeterminate potential (CHIP) interference in ATR (n=2), ATM (n=2), CHEK1 (n=1) and BRIP1 (n=1). Finally, we identified 117 alterations of variants of unknown significance (VUS) in 98 patients. In a univariate analysis, the median time to castration resistance in gBRCA2 patients was 11.6 months versus 22.3 months in patients with other mutation versus 23.4 months in no mutated patients. There were no associations of gDDR subgroups with metastatic onset and Gleason Score ≥8. Conclusions: The prevalence of gBRCA2 in the Italian population is 3%, which is similar to those of Spanish population, identifying interesting similarities between people of the Western Mediterranean area. The presence of gBRCA2 mutations correlates with lower time to the onset of castration resistant disease, according to a more aggressive phenotype.

Effectiveness and Validation of the Italian Translation of the Low Anterior Resection Syndrome Score in an Italian High-Volume University Hospital.

BackgroundThe low anterior resection syndrome (LARS) score is a validated questionnaire developed in Denmark to measure the severity of bowel dysfunction after low anterior resection. This retrospective study aimed to assess the effectiveness of the LARS score in the Italian language in a population of Italian patients who underwent low anterior resection for rectal cancer. The convergent and discriminative validity and the test-retest reliability of the score were investigated.MethodsA cohort of two hundred and five patients treated with low anterior resection were enrolled in an Italian high-volume university hospital between January 2000 and April 2018. The Italian version of the LARS score (tested twice), as translated from English original version, a single question on quality of life and the EORTC QLQ-C30 questionnaire were submitted to patients.ResultsA high proportion of patients showed a perfect or moderate fit between the LARS score and QoL categories (convergent validity, p < 0.0005). All differences regarding the items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30) functional scales were statistically significant (p < 0.0005). The LARS score was able to discriminate between groups of patients who received or did not receive preoperative chemoradiotherapy (p < 0.0005) and those who received total or partial mesorectal excision (p < 0.0005). The test-retest reliability was excellent (intraclass correlation coefficient 0.96).ConclusionThe Italian translation of the LARS score is an easy and reliable tool for assessing bowel dysfunction after low anterior resection and its routine use in clinical practice should be recommended.Trial registration number at www.clinicaltrials.gov: NCT04406311.

Diet and Lifestyle Habits in Early-Onset Colorectal Cancer: A Pilot Case-Control Study

Background: Early-onset colorectal cancer (eoCRC), defined as a colorectal cancer (CRC) in patients younger than 50 years old, shows an increasing incidence worldwide in the latest years. The role of exogenous factors associated with CRC has been largely overlooked in eoCRC. Here, we conducted a case-control study to evaluate the diet and the lifestyle habits in an Italian population of patients with eoCRC, compared to age-matched healthy controls (HCs). Methods: We enrolled 118 subjects (47 cases, 71 controls) in a third-level academic hospital. We analyzed epidemiological features (age, sex, body mass index), lifestyle behaviors (smoking habits, physical activity, type of diet, use of dietary supplements), and eating habits (semiquantitative food-frequency questionnaire) in eoCRCs and HCs, covering the previous 5 years. Results: In our cohort, positive family history of CRC was significantly associated with the development of eoCRC (p = 0.004). Fresh meat (p = 0.003), processed meat (p < 0.001), dairy products (p = 0.013), and smoking (p = 0.0001) were significantly associated with eoCRC compared to controls. Other variables did not differ significantly between the two groups. Conclusion: Fresh and processed meat, dairy products, and smoking could be considered significant risk factors for eoCRC, although further confirmation by international multicenter studies is desirable. Diet and smoking could be the main areas of future interventions for eoCRC primary prevention.

P463 COVID-19 vaccination willingness and hesitancy in patients with Inflammatory Bowel Diseases (IBD): analysis of determinants in a national survey of the Italian IBD patients’ association (AMICI Onlus)

BackgroundVaccine hesitancy, the delay in acceptance or refusal of vaccination despite its availability, represents a threat to the diffusion and lethality of infectious diseases. COVID-19 vaccination has been recommended by national and international organizations in patients with Inflammatory Bowel Diseases (IBD). The aim of the study was to evaluate COVID-19 vaccine willingness and hesitancy in a population of Italian patients with IBD, and their determinants.MethodsIn February 2021 an online questionnaire focused on COVID-19 vaccine was proposed to a representative sample of Italian IBD patients. Socio-demographic characteristics, IBD features, lifestyle, perception of COVID-19, general attitude towards vaccinations and to COVID-19 vaccines were investigated. Patients were divided into willing, hesitant and refusive towards COVID-19 vaccine. The hesitation reasons were investigated. The associations between baseline characteristics and willingness (determinants) were evaluated by calculating crude and adjusted Odds Ratio (AdjOR) with 95% confidence intervals (CI).ResultsThe baseline characteristics are shown below. 1252 surveys were collected. 1005 (80.3%), 222 (18.1%) and 33 (2.63 %) patients were defined as willing, hesitant and refusive, respectively. Concerns for vaccine adverse effects constituted the main reason for refusal (73.4%) (Figure). 49.1% of hesitant patients reported that presence of IBD exerted an influence on their answer. Among the patients willing to be vaccinated whenever possible, 78.2% (786) thought that their IBD represented a valid motivation to access vaccination with priority. Willingness to COVID-19 vaccine was significantly associated with adherence to previous vaccinations (AdjOR 17.6, 95% CI 11.4–27.2), male gender (1.68 95% CI 1.16–2.43), graduation degree (1.48, 95% CI 1.03–2.13), perceived higher risk of COVID-19 due to IBD (1.47, 95% CI 1.05–2.08), alcohol intake (1.69, 95% CI 1.16–2.45). Conversely, the hesitancy was significantly associated with use of complementary and alternative medicines (0.58, 95% CI 0.36–0.92). Notably, 54.5% of patients were under the impression to have a higher risk of COVID-19 and 31.8% a more severe course due to their IBD.Age, years, median (IQR)48 (37–58)Female, n (%)729 (58.2%)Disease type, n (%)-CD613 (48.9%)-UC612 (48.9%)Disease duration, n (%)-≤ 5 years161 (12.9%)-> 5 years1,091 (87.1%)Past surgeries475 (37.9%)Immunosuppressive drug584 (46.7%) ConclusionMost IBD patients would accept COVID-19 vaccines, though one out of five is hesitant to date, principally due to fear of adverse events. The knowledge of determinants and reasons for COVID-19 vaccination acceptance could be a key element in developing targeted communication strategies to address vaccine hesitancy.

Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis

IntroductionNatalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended...

Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Background and AimsThe MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and MethodsAchievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. ResultsThe SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. ConclusionGlecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.

Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

IntroductionDelta-δ-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were...

Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS).

Background:The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry.Methods:Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan–Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model.Results:Time span under observation in the Italian MS Registry was 1–137 (median 80.3) months. In the total Italian patient population (n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5–39.5) months.Conclusion:CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2.

Validation and Cross-Cultural Adaptation of the Volitional Questionnaire in an Italian Population with Psychiatric Disorders: A Cross-Sectional Study

The aims of this study were to translate and culturally adapt the Volitional Questionnaire (VQ) into Italian and to evaluate its psychometric properties in an Italian population of patients with psychiatric disorders. The translation process from English into Italian was carried out in agreement with the authors of the original scale. The study was carried out in three psychiatric facilities, with 33 patients with psychiatric diagnoses, who were older than 18 years, and two raters (6 total) for each facility in Rome, Italy. The psychometric properties were assessed via its internal consistency, test-retest and inter-rater reliability and construct validity through comparisons with the Barthel Index, Short Form-12, Beck Depression Inventory-II and Camberwell Assessment of Need (CAN). Results showed internal consistency, using Cronbach’s alpha, was significant at 0.92. In the test-retest reliability evaluation, the intraclass correlation coefficient was 0.97 and the interclass correlation coefficient was 0.99. The Spearman correlation showed significant results in the comparison with the CAN (r = −0.45, p < 0.05). These results suggest that the IT-VQ may be a valid, standardized and reliable evaluation tool that can be used to detect volitional performance improvements in a population of Italian psychiatric patients.

Glycaemic control, antidiabetic medications and influenza vaccination coverage among patients with diabetes in Udine, Italy

The objectives of this study were to estimate influenza vaccination coverage among patients with diabetes mellitus in an Italian 250 000-inhabitant area in the 2017–2018 season and to assess whether...

Prevalence of peri-implant diseases among an Italian population of patients with metabolic syndrome: A cross-sectional study.

Over the years, only few authors have studied the association of systemic conditions with peri-implantitis. The aim of this study is to detect frequency and severity of peri-implant diseases among an Italian population of patients affected by metabolic syndrome (MetS). In this cross-sectional study, patients with at least one dental implant with>5 years of functional loading were screened to evaluate metabolic, periodontal, and peri-implant status. MetS diagnosis was established in accordance with the National Cholesterol Education Program (NCEP) ATP III criteria, while case definitions of the 2017 World Workshop were adopted for peri-implant diseases. For each implant, probing depths, mucosal redness, bleeding on probing, suppuration, plaque index, and marginal bone loss were recorded. Multinomial logistic regression analyzed the relationship between sex, diagnosis of MetS, presence of periodontitis, smoking, type of prosthesis, and location of implants and peri-implant mucositis and peri-implantitis. A total of 183 patients were enrolled: in MetS subjects, peri-implantitis was detected in 36.9% (n=31) of implants, and mucositis in 60.7% (n=51), with an OR of 10.01(P=0.005) for mucositis and OR 15.26 (P=0.001) for peri-implantitis, compared with subjects without MetS, where 26.3% of implants showed peri-implantitis and 55.5% mucositis. No differences were found for smoking, implant location, sex, and type of prosthetic rehabilitation. Patients with periodontitis showed a higher association with peri-implant mucositis (OR=4.33) and peri-implantitis (OR=9.00). Based on the results of this study, patients affected by MetS showed a greater prevalence of peri-implant diseases, but further studies are needed to confirm the possibility of this new possible risk indicator.

Construction of new personal meanings by cancer patients: a qualitative analysis in an Italian patient population.

The goal of this study is to investigate the meaning that cancer patients in active therapy and/or rehabilitation give to their illness and resources they rely on to build new experiences of meaning and a future perspective. The present study consisted in a summative content analysis of answers to open questions of the Purpose In Life (PIL) Questionnaire administered to 158 consecutive patients with non-advanced cancer (no metastases). The PIL is an attitude scale that indicates the degree of attainment of meaning and purpose in life and is divided into three sections: a first 20-item quantitative section, with statements rated on a 7-point verbal scale with two anchoring phrases (part A); a qualitative section with 13 open-end items and paragraph composition section addressing the future goals (part B) and past meaningful experience (part C). For the present study, we analyzed the answers to open questions, most interesting in a therapeutic contest related to the meanings associated with life, illness, and suffering to understand the experienced of the cancer patients. The main recurring themes in PIL section B analyzed associated to the sense of life, disease, and death are as follows: meaning (positive/negative), personal dimension, religiousness; physical health, family, normal life; negative sense of death, the end, natural transition, religious belief, consolation, mystery, rejection; opportunity, negativity. Whereas main themes emerging from section C were associated to life goals of the interviewed patients: the desire of realization in the future perspective; the value of life; physical health and healing; guiding values; plus three more themes, distinguishable, but with a minor recurrence: legacy responsibility, religiousness, lack of purpose/resignation. The use of summative content analysis evidenced the recurrence of a strong sense of positivity, present in the majority of the interviews. In particular, this positivity is shown by the use of words associated frequently to self-consciousness and self-evaluation, desire of happiness, and desire of contributing to the good of significant others and of taking care of your own life in order to give a positive contribution.

The Cost-effectiveness of Sativex®: The Italian Experience Based on " in Resistant Multiple Sclerosis Spasticity: Discontinuation Study in a Large Population of Italian Patients, SA.FE. Study"

The Cost-effectiveness of Sativex®: The Italian Experience Based on " in Resistant Multiple Sclerosis Spasticity: Discontinuation Study in a Large Population of Italian Patients, SA.FE. Study"

Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study).

BackgroundThe approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients.MethodsWe collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis.ResultsDuring the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher NRS score at T1 (adjHR 2.23, 95% 2.07–2.41, p<0.001) and a lower baseline NRS score (adjHR 0.51 95% CI 0.46–0.56, p<0.001) were predictive of treatment discontinuation.ConclusionThese data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation.

Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

BackgroundThe approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our...

Hope Herth Index (HHI): a validation study in Italian patients with solid and hematological malignancies on active cancer treatment.

Although hope is a widely used term, the experience of hope in patients with chronic or even life-threatening diseases is often disregarded due to the scarcity of carefully designed and validated assessment tools. The aim of this study was to validate the Hope Herth Index (HHI) questionnaire in the Italian population of patients with solid or hematological malignancies during active cancer treatment. After the translation procedures, the psychometric properties of the Italian version of HHI were evaluated in 266 patients with non-advanced cancer cared for in four different settings. Summative scores ranged from 12-48, with a higher score denoting greater hope. Confirmative factorial analysis was performed to assess dimensionality. The test-retest reliability was assessed by means of the Lin concordance coefficient (two weeks' interval, 80 patients). Concurrent validity was assessed through the following questionnaires: Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), Edmonton Symptom Assessment Scale (ESAS), and System Belief Inventory (SBI-15R). A total of 266 patients were enrolled. Confirmative factor analysis did not confirm the original three-factor solution, whereas a one-factor solution did perform well. Cronbach's alpha was 0.84 and the test-retest reliability was 0.64 (95% CI 0.51; 0.76). Large convergence was found with spiritual well-being as measured by the FACIT-Sp (0.69) and with anxiety-depression as measured by the HADS (inverse correlation: -0.51). Physical symptoms and religiousness were only slightly correlated, as expected. The Italian version of HHI is a valid and reliable assessment tool - useful to initiate conversation with someone who is troubled but finds it difficult to talk - in patients with either solid or hematological malignancies on active cancer treatment during the non-advanced stages of the disease.