Suffering and Quality of Life Impairment in Patients with Eczematous Diseases: Results from an Observational Study Assessing the Relevance of the Involvement of Two Sensitive Body Sites, Namely, the Face and Hands.

BACKGROUND: Quality of life (QoL) impairment by eczematous diseases, with reference to body site involvement, has not been deeply addressed. OBJECTIVES: The aims of this study were to assess: (1) the impact on QoL of eczematous diseases affecting the face or hands; (2) any differences in QoL impairment in the case of face versus hand involvement; (3) sensitivity of Pictorial Representation of Illness and Self Measure (PRISM) and Dermatology Life Quality Index (DLQI) in measuring disease-related burden. METHODS: Adults with eczematous diseases of the face or hands were involved. Patients were patch tested and underwent DLQI and PRISM. RESULTS: 143 patients were included, 43.36% with face and 56.64% with hands involvement. PRISM and DLQI scores showed a moderate to strong inverse correlation, but PRISM revealed a higher sensitivity in capturing patients' suffering than DLQI, especially in the case of face involvement. Itching was the sole parameter significantly associated with both PRISM and DLQI scores. CONCLUSIONS: PRISM appeared to be more accurate in detecting the burden of eczematous diseases involving the face, probably due to the interception of the emotional impact, while DLQI, focusing on patient functioning, was more affected by hand involvement. Site involvement could be a criterion for selecting the best QoL assessment tool.

Assessment of the perceived burden associated with Malignant Melanoma with Pictorial Representation of Illness and Self Measure (PRISM) and Melanoma Concerns Questionnaire (MCQ-28).

PURPOSE: The impact of malignant melanoma (MM) on patients' psychophysical well-being has been poorly addressed. We aimed to assess the perceived burden in patients with a diagnosis of MM, using two different tools, one generic and one specific for MM, such as Pictorial Representation of Illness and Self Measure (PRISM) and Melanoma Concerns Questionnaire (MCQ-28), respectively. The correlation between PRISM and MCQ-28 subscales and the relevance of disease and patient-related variables were also investigated. METHODS: This single-centre, cross-sectional study included all adult consecutive MM patients who attended our Dermatology Unit from December 2020 to June 2021. Demographics and disease-related data were recorded. PRISM and MCQ-28 were administered. RESULTS: One hundred and seventy-one patients were included (mean age: 59.5 ±14.9 years.; 48.0% males). Median time from MM diagnosis to inclusion was 36 months. Nearly 80% of the patients had in situ or stage I MM. Overall, 22.2% of the patients reported a PRISM score <100mm and similar percentages provided scores indicating impaired quality of life, as assessed with MCQ-28 subscales. A weak, albeit significant, correlation was found between PRISM scores and ACP, CON and SOC2 subscales. The most relevant association found was that between lower PRISM scores and higher-stage MM. CONCLUSIONS: In the study population, mostly affected with superficial MM, their perception of the burden associated with MM did not appear either particularly dramatic or disabling. PRISM seems a reliable system for capturing and quantifying the domains correlated with the emotive dimension of MM, especially MM-related concerns and willingness to face life.

The inpatient hospital burden of comorbidities in HCV-infected patients: A population-based study in two Italian regions with high HCV endemicity (The BaCH study).

BACKGROUND & AIMS: Hepatitis C (HCV) is associated with several extrahepatic manifestations, and estimates of the hospitalization burden related to these comorbidities are still limited. The aim of this study is to quantify the hospitalization risk associated with comorbidities in an Italian cohort of HCV-infected patients and to assess which of these comorbidities are associated with high hospitalization resource utilization. METHODS: Individuals aged 18 years and older with HCV-infection were identified in the Abruzzo's and Campania's hospital discharge abstracts during 2011-2014 with 1-year follow-up. Cardio-and cerebrovascular disease, diabetes and renal disease were grouped as HCV-related comorbidities. Negative binomial models were used to compare the hospitalization risk in patients with and without each comorbidity. Logistic regression model was used to identify the characteristics of being in the top 20% of patients with the highest hospitalization costs (high-cost patients). RESULTS: 15,985 patients were included; 19.9% had a liver complication and 48.6% had one or more HCV-related comorbidities. During follow-up, 36.0% of patients underwent at least one hospitalization. Liver complications and the presence of two or more HCV-related comorbidities were the major predictors of hospitalization and highest inpatient costs. Among those, patients with cardiovascular disease had the highest risk of hospitalization (Incidence Rate Ratios = 1.42;95%CI:1.33-1.51) and the highest likelihood of becoming high-cost patients (Odd Ratio = 1.37;95%CI:1.20-1.57). CONCLUSION: Beyond advanced liver disease, HCV-related comorbidities (especially cardiovascular disease) are the strongest predictors of high hospitalization rates and costs. Our findings highlight the potential benefit that early identification and treatment of HCV might have on the reduction of hospitalization costs driven by extrahepatic conditions.

Increasing trend in admission rates and costs for acute diverticulitis during 2005-2015: real-life data from the Abruzzo Region.

BACKGROUND: Scarce data are available on the epidemiological trend of diverticulitis and its financial burden in Italy. The aim of this work was to explore a potential variation in the rate and costs of hospital admissions for uncomplicated and complicated diverticulitis over the last decade. METHODS: We selected all hospitalizations for diverticulitis of residents in the Abruzzo Region, Italy between 2005 and 2015. Age-standardized hospitalization rates (HRs) per 100,000 inhabitants for overall, uncomplicated and complicated diverticulitis were calculated. A linear model on the log of the age-standardized rates was used to calculate annual percentage changes (APC). Costs were derived from the official DRG tariff. RESULTS: From 2005 to 2015, the HR for acute diverticulitis increased from 38.9 to 45.2 per 100,000 inhabitants (APC + 1.9%). The HR for complicated diverticulitis increased from 5.9 to 13.3 (APC + 7.6%), whereas it remained stable for uncomplicated diverticulitis. The mean hospital cost was 1.8-times higher for complicated diverticulitis compared with that for uncomplicated disease and 3.5-times higher for patients with a surgery stay compared with that for patients with a medical stay. CONCLUSION: During the last decade, in the Abruzzo Region, the HRs for diverticulitis and their costs increased significantly, mainly due to disease complications. Further studies are needed to explore strategies to prevent complications and to realise cost-saving policies.

Impact of comorbidity on the risk and cost of hospitalization in HIV-infected patients: real-world data from Abruzzo Region.

BACKGROUND: Due to the success of antiretroviral therapy, human immunodeficiency virus (HIV) infection has been transformed into a lifelong condition. In Italy, little is known about the impact of comorbidities (CMs) on the risk of hospitalization and related costs for people who live with HIV (PWLHIV). The objective of the study was to quantify the risk of hospitalization and costs associated with CMs in an Italian cohort of PWLHIV. METHODS: The study population included subjects aged ≥18 years with HIV infection, identified in the Abruzzo's hospital discharge database among files stored from 2004 until 2013 and then followed up until December 2015. Patients' CMs (Charlson Comorbidity Index [CCI)] were extracted from International Classification of Diseases, Ninth Revision, Clinical Modification codes in the hospital discharge abstracts. Poisson regression was used to compare the incidence rate of hospital admissions in patients with and without each CM class. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were adjusted for age, sex and the other CMs. A generalized linear model under gamma distribution was used to estimate adjusted mean hospital costs. Costs were derived from official Italian Diagnosis-related group (DRG) based reimbursements. RESULTS: Among 1,026 HIV patients identified (mean age 47 years), 30% had at least one CM and 14.5% underwent hospital admission during the follow-up period. The risk of acute hospitalization significantly increased among patients with hepatitis C virus (HCV) coinfection (adjusted IRR 1.98; 95% CI: 1.59-2.47), renal (adjusted IRR 2.27; 95% CI: 1.45-3.56), liver (adjusted IRR 2.21; 1.57-3.13) and chronic pulmonary CMs (adjusted IRR 2.31; 1.63-3.32). Adjusted mean hospital costs were €2,494 in patients without CMs and €4,422 and €9,734 in those with CCI=1 or CCI ≥2, respectively. CONCLUSION: The presence of renal, liver and chronic pulmonary CMs, as well as HCV coinfection doubled the risk of hospitalization in the PWLHIV cohort. A CCI ≥2 is associated with a fourfold increase in hospitalization costs. Our study provides new evidence that CMs in PWLHIV increase the risk of hospitalization and local health service facilities.

Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey.

OBJECTIVES: To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. METHODS: We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories ("inbred" if the compared drugs were owned by the same company or its partners/subsidiaries, "competitive" if the compared drugs were owned by competing companies, and "apparently nonprofit"), and time to publication was evaluated with Cox analysis. RESULTS: We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials (P=.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). CONCLUSION: Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.

Physical assessment techniques performed by Italian registered nurses: a quantitative survey.

AIMS AND OBJECTIVES: The aims of the study were to describe which of the core techniques of the physical assessment are regularly performed by a sample of Italian nurses, and to investigate the potential predictors of a more complete examination. BACKGROUND: Physical examination is among the essential tasks of nursing professionals, who are requested to perform a correct and complete physical assessment. DESIGN: Cross-sectional survey. METHODS: The study was performed between August 2013 and January 2014 in 17 Italian regions. A total of 1182 questionnaires were collected. RESULTS: Most participants were females (age range 41-50 years), and worked in Internal Medicine, Intensive Care and Surgical hospital units. Of the 30 core techniques that are currently taught and performed according to the Italian Baccalaureate degree requirements, 20 were routinely performed, 6 were seldom used and 4 were learnt but almost never performed (auscultation of lung, heart and bowel sounds and spine inspection). Graduate and postgraduate nurses, working in Intensive Care Units and Nursing Homes, were more prone than the others to carry out a more complete physical assessment. CONCLUSIONS: The skills to perform a physical assessment are suboptimal among this sample of Italian nurses. Health and educational providers should pose more attention and efforts to provide nurses with an acceptable training in physical examination practice. RELEVANCE TO CLINICAL PRACTICE: This study describes the specific physical techniques performed by nurses in real practice and provides information on which skills require more attention in nursing educational programmes.

Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor.

OBJECTIVES: To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. STUDY DESIGN AND SETTING: From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥ 100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. RESULTS: We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have "favorable" results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with "favorable" findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable "favorable" results. CONCLUSION: The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved.

Assessment and potential determinants of compliance and persistence to antiosteoporosis therapy in Italy.

OBJECTIVES: To analyze adherence to antiosteoporosis drugs (AODs) and to assess the influence of patient-related and drug-related factors. STUDY DESIGN: Observational, retrospective study. METHODS: Data on prescriptions for AODs from 2007 through 2008 were retrieved from administrative databases of 10 Italian local health units. Key measurements included compliance and persistence at 1 year. Multivariate regression analyses were performed to estimate adjusted risk ratios for compliance less than 80% and adjusted hazard ratios for no persistence. RESULTS: Of 40,004 new patients (89.9% women, mean age 69.8 years), 84.0% were treated with bisphosphonates and 74.6% of administration regimens were weekly. Overall, 75.1% of patients had suboptimal levels of compliance and 84.7% were not persistent; almost one-third had only 1 prescription. In regression analyses, younger age, change of drug, and concomitant corticosteroid therapy were significantly associated to compliance and persistence in both genders. In women, weekly and monthly regimens reduced the risk for poor compliance (sex-adjusted relative risks 0.729 [0.697-0.762], 0.846 [0.817-0.876], respectively) and no persistence (sex-adjusted hazard ratios 0.591 [0.541-0.646], 0.508 [0.461-0.560], respectively) compared with a daily regimen. CONCLUSIONS: In our study, 75% of subjects had discontinuous treatment and inadequate drug supply. Age and frequency of administration were strongly associated with adherence. Improvement is urgently needed, and occasional prescriptions represent the main target.