Minimal vs Specialized Exercise Equipment for Pulmonary Rehabilitation: A Randomized Clinical Trial.

Importance: Pulmonary rehabilitation (PR) improves exercise tolerance, symptom burden, and health-related quality of life for people with chronic respiratory conditions. However, demand for PR outstrips supply. Traditionally, PR has been delivered using specialist, gym-based exercise equipment.

Rising Unmet Need in Multiple Myeloma Management After First-Line Treatment With DRd: Expected Epidemiological Evolution in Italy.

Background: In Italy, newly diagnosed Multiple Myeloma (MM) patients not eligible for autologous stem cell transplantation (ASCT) recently benefitted from a therapeutic advancement with the reimbursement of the combination daratumumab plus lenalidomide and dexamethasone (DRd) as frontline treatment. The introduction of this combination in first-line (1 L) is expected to generate an unmet medical need in second-line (2 L), since there are only three 2 L therapeutic options recommended by ESMO guidelines and reimbursed in Italy for lenalidomide-refractory patients post-DRd.

Materials And Methods: An epidemiological model was developed to estimate the number of Italian patients progressing to 2 L therapy after receiving DRd in 1 L over a 3-year time horizon (2025-2027) following a three-step procedure: (1) identification of the cohort of patients starting 1 L therapy with DRd in each quarterly cycle; (2) estimation of the number of patients experiencing disease progression or death in each cycle, through the long-term extrapolation of the progression-free survival (PFS) curve from the DRd clinical trial; (3) calculation of the number of patients eligible for 2 L therapy in each cycle.

Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults.

Background: Incontinence-associated dermatitis (IAD) is a common skin problem in adults with urinary incontinence, faecal incontinence, or both. Prevention involves skin care interventions such as skin cleansing and the application of skin protectants/barriers (leave-on products).

Objectives: To assess the effects of skin care cleansers, leave-on products, and procedures for preventing incontinence-associated dermatitis in adults.

Combination Cytoreductive Surgery, Radiotherapy, or Ablation for De Novo Metastatic Prostate Cancer: The IP2-ATLANTA Internal Pilot, Phase 2, Randomised Controlled Trial.

Background And Objective: Cytoreduction of the primary prostate cancer, involved lymph nodes, and metastases may confer improved cancer control in de novo synchronous metastatic hormone-sensitive prostate cancer (mHSPC). Herein, we aimed to examine the safety and feasibility of novel cytoreductive therapies.

Methods: We report the internal pilot of IP2-ATLANTA, a phase 2, multicentre, three-arm, randomised controlled trial.

Prostate Pathway Embedded Comparative Trial: Outcomes from the Pilot Phase of the Imperial Prostate 3-PROState Pathway Embedded Comparative Trial.

Background And Objective: Rapid innovations in prostate cancer diagnosis and treatment have led to the adoption of innovative trial designs. The Imperial Prostate 3-PROState Pathway Embedded Comparative Trial (IP3-PROSPECT) aims to explore the feasibility and acceptability of a cohort multiple randomised controlled trial (cmRCT) design within the prostate cancer pathway.

Methods: Eligible participants were approached at the point of referral for a clinical suspicion of prostate cancer and were invited to join the cohort, agreeing in principle to future randomisations, without knowledge of the details of those interventions.

Price regulation and competition among on-patent anticancer drugs in Italy.

In recent years, the Italian Medicines Agency has adopted several measures aimed at curbing public pharmaceutical expenditure, including temporary and confidential price reductions, and Managed Entry Agreements. Besides, the Agency plays a pivotal role in price negotiations, serving as a tool for cost containment and financial sustainability for the Italian NHS. Our study aims at testing one potentially relevant channel for pursuing this objective and analyze if the Agency anchors the treatment cost of on-patent market entrants with those of on-patent therapeutic alternatives that previously obtained reimbursement in a given market.

Effect of immuno-oncology on clinical and economic outcomes for a selection of cancers in Italy.

Objectives: This study assesses the impact of immune-oncology (IO) drugs' availability on cancer incidence-adjusted mortality rates from melanoma, lung, and renal cancers at population level in Italy between 2008 and 2019.

Methods: We conducted a retrospective study on cross-sectional time-series aggregated data collected from publicly available sources and IQVIA proprietary databases. Three fixed-effects regression models were used to estimate how IO availability affects incidence-adjusted mortality for each cancer type.

Attitudes towards protecting Emergency Medical Services (EMS) staff from violence and aggression: a survey of adults in Wales.

Objective: To explore the Welsh public's views of violence and aggression (V&A) directed at EMS (emergency medical services) staff, awareness of policy changes and the reach of media campaigns.

Design/setting/participants: Survey involving non-probabilistic purposive sampling of 1010 Wales adults (aged 18+) from a matched panel, representative of the population, derived from a UK YouGov panel of >360 000 adults registered.

Results: Most (62.

Economic Burden of Intravenous Decitabine Administration in Patients Affected by Acute Myeloid Leukemia Ineligible for Induction Chemotherapy and Impact of Oral Formulation Introduction: A Micro-Costing Study in Italy.

Purpose: Intravenous (IV) decitabine is a therapeutic option for patients with newly diagnosed acute myeloid leukemia (AML) ineligible for induction chemotherapy. Recently, the oral formulation of decitabine-cedazuridine demonstrated comparable efficacy and safety to IV decitabine, and pharmacokinetic equivalence. This study estimates the direct non-drug healthcare costs of IV decitabine administration in Italy, including central venous catheter (CVC) and infection management, and assesses the economic impact of oral decitabine introduction.

PREVENTion and treatment of incontinence-associated dermatitis through a codesigned manual (PREVENT-IAD): a study protocol for a feasibility cluster randomised controlled trial with a nested process evaluation.

Introduction: Incontinence is commonly experienced by adults who receive care support in a residential facility or in their own home. These individuals are at risk of developing incontinence-associated dermatitis (IAD), which is caused by prolonged and repeated exposure of the skin to urine or faeces. An IAD manual was developed providing an evidence-based clinical algorithm and an e-learning training programme for the prevention and treatment of IAD.

Hereditary breast and ovarian cancer genetic testing in unselected patients: example of private supplementation of public healthcare service.

In the Emilia-Romagna region (Northern Italy), the identification and management of women at familial/hereditary risk of breast and ovarian cancer is guided by a well-established regional protocol. Here we report the results of the experience of private supplementation of public healthcare service in offering the possibility to undergo BRCA1/2 testing and/or multigene panel testing (MGPT) within a well-defined pathway to women unfulfilling regional criteria. Out of 177 patients referred to our center who underwent BRCA1/2 testing, 175 tested negative while two (1.

IL-1 Signal Inhibition in Alcohol-Related Hepatitis: A Randomized, Double-Blind, Placebo-Controlled Trial of Canakinumab.

Background And Aims: Short-term mortality in alcohol-related hepatitis (AH) is high, and no current therapy results in durable benefit. A role for interleukin (IL)-1β has been demonstrated in the pathogenesis of alcohol-induced steatohepatitis. This study explored the safety and efficacy of canakinumab (CAN), a monoclonal antibody targeting IL-1β, in the treatment of patients with AH.

Estimation of lifetime costs for patients receiving a transplant: the case of liver transplantation related to hepatitis B in Italy.

Introduction: In Italy, post-liver transplant (LT) hepatitis B virus (HBV) reinfection prophylaxis is frequently based on a combined regimen of anti-HBV immunoglobulin (HBIG) and oral antivirals. However, little information is available at the national level on the cost of LT and the contribution of HBV prophylaxis. This study aimed to quantify the direct healthcare cost for adult patients undergoing LT for HBV-related disease over a lifetime horizon and from the perspective of a National Healthcare Service.

Antibody Responses to Influenza Vaccination are Diminished in Patients With Inflammatory Bowel Disease on Infliximab or Tofacitinib.

Background And Aims: We sought to determine whether six commonly used immunosuppressive regimens were associated with lower antibody responses after seasonal influenza vaccination in patients with inflammatory bowel disease [IBD].

Methods: We conducted a prospective study including 213 IBD patients and 53 healthy controls: 165 who had received seasonal influenza vaccine and 101 who had not. IBD medications included infliximab, thiopurines, infliximab and thiopurine combination therapy, ustekinumab, vedolizumab, or tofacitinib.

Neutralising antibody responses against SARS-CoV-2 Omicron BA.4/5 and wild-type virus in patients with inflammatory bowel disease following three doses of COVID-19 vaccine (VIP): a prospective, multicentre, cohort study.

Background: Patients with inflammatory bowel disease (IBD) receiving anti-TNF and JAK-inhibitor therapy have attenuated responses to COVID-19 vaccination. We aimed to determine how IBD treatments affect neutralising antibody responses against the Omicron BA.4/5 variant.

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

Methods: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication.

Measuring the value of solidarity: The financial assistance program for out-of-pocket payments on pharmacy medicines in Portugal.

Objective: Out-of-pocket payments for prescribed medicines are still comparatively high in Portugal. The program was launched in Portugal in May 2016 to aid vulnerable groups by completely covering out-of-pocket costs of prescribed medicines in community pharmacies. This study assesses the impact of the program on poverty and catastrophic health expenditures.

COVID-19 impact on the decision process of the Italian Medicine Agency: a quantitative assessment.

Background: Since the COVID-19 pandemic has placed more attention on drugs' approval process and the importance of rapid decision-making in the healthcare sector, it is crucial to assess how time to market (TTM) of drugs varied.

Objective: To estimate the impact of the COVID-19 pandemic on TTM of drugs in Italy.

Methods: An IQVIA database was used to retrieve information on drugs that obtained positive opinion from the Committee for Medicinal Products for Human Use between January 2015 and December 2021.

An Evaluation of Screening Pathways Using a Combination of Magnetic Resonance Imaging and Prostate-specific Antigen: Results from the IP1-PROSTAGRAM Study.

Background: The use of prostate-specific antigen (PSA) testing to screen for prostate cancer has been fraught with under- and overdiagnosis. Short, noncontrast magnetic resonance imaging (MRI) might detect more grade group ≥2 cancers with similar rates of biopsy.

Objective: To evaluate strategies that combined PSA and MRI to select men based in the community for a prostate biopsy.

Perceived patient burden and acceptability of MRI in comparison to PSA and ultrasound: results from the IP1-PROSTAGRAM study.

Background: The IP1-PROSTAGRAM study showed that a short, non-contrast MRI detected more significant cancers with similar rates of biopsy compared to PSA. Herein, we compare the expected and perceived burden of PSA, MRI and ultrasound as screening tests.

Methods: IP1-PROSTAGRAM was a prospective, population-based, paired screening study of 408 men conducted at seven UK primary care practices and two imaging centres.