The international Hip Outcome Tool 12 questionnaire (iHOT-12): an Italian language cross-cultural adaptation and validation.

Background: Patient-reported outcome (PRO) measures are essential for evaluating disease-related quality of life. The International Hip Outcome Tool 12 (iHOT12) assesses various aspects of hip-related symptoms, function, sports participation, and social limitations. This study aimed to adapt and validate an Italian version of the iHOT12 according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

Safety and Efficacy of Dalbavancin in Real Life: Retrospective Analysis of a Large Monocentric Case Series of Patients Treated for Skin/Soft Tissue and Other Difficult-to-Treat Infections.

Dalbavancin is a long-acting lipoglycopeptide, approved for treatment of skin and skin structure infections. Its PK/PD profile and safety allow for short hospital stays even in the case of difficult-to-treat infections requiring long courses of therapy, e.g.

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For many new oncological drugs, including target therapy and immunotherapy, the treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Drug survival or Time to treatment discontinuation (Ttd) or persistence have become important intermediate efficacy endpoints, especially in real-world settings due to their strong correlation with endpoints such as Time to treatment failure (Ttf) and Progression free survival (Pfs). Our methodology is based on validated indicators and information technology tools, to develop continuous and updated oncology drug utilization reports in hospital setting which include data about enrolment curves, Ttd, adherence, dose intensity, dose changes and budget impact.

Adherence, Persistence, Switching and Costs of Injectable and Oral Therapies for Multiple Sclerosis. Real Life Analysis Over 6 Years of Treatment.

Adherence and persistence to treatment with disease-modifying therapies (DMTs) is a predictor of the efficacy of treatment. The objectives of the study were the analysis of adherence, persistence, switches, and costs of the drugs used in MS. This is a retrospective non-interventional pharmacological observational study of 610 patients diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) under therapy between January 2007 and September 2022.

The lack of head-to-head randomised trials and the consequences for patients and national health service: The case of non-small cell lung cancer.

Introduction: To introduce a drug to the market, it's not mandatory for it to be more effective and safer than the current treatment for the same condition. Consequently, head-to-head studies between the two best treatments for the same condition are not required, and this could result in a lack of information for patients, clinicians, and decision-makers. This study aims to evaluate the presence of head-to-head studies among the drugs used for the treatment of non-small cell lung cancer (NSCLC).

Groin Pain Syndrome Italian Consensus Conference update 2023.

Groin pain syndrome (GPS) is a controversial topic in Sports Medicine. The GPS Italian Consensus Conference on terminology, clinical evaluation and imaging assessment of groin pain in athletes was organized by the Italian Society of Arthroscopy in Milan, on 5 February 2016. In this Consensus Conference (CC) GPS etiology was divided into 11 different categories for a total of 63 pathologies.

Profile, Healthcare Resource Consumption and Related Costs in ANCA-Associated Vasculitis Patients: A Real-World Analysis in Italy.

Introduction: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are rare autoimmune diseases triggering inflammation of small vessels. This real-world analysis was focused on the most common AAV forms, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), to describe patients' demographic and clinical characteristics, therapeutic management, disease progression, and the related economic burden.

Methods: A retrospective analysis was conducted on administrative databases of a representative sample of Italian healthcare entities, covering approximately 12 million residents.

Healthcare Resource Consumption and Related Costs in Patients on Antiretroviral Therapies: Findings from Real-World Data in Italy.

This real-world analysis conducted on administrative databases of a sample of Italian healthcare entities was aimed at describing the role of therapeutic pathways and drug utilization in terms of adherence, persistence, and therapy discontinuation in HIV-infected patients under antiretroviral therapies (ART) and Tenofovir Alafenamide (TAF)-based regimens on healthcare resource consumption and related direct healthcare costs. Between 2015 and 2019, adults (≥18 years) prescribed with TAF-based therapies were identified and characterized in the year prior to the first prescription (index-date) for TAF-based therapies and followed-up until the end of data availability. Overall, 2658 ART-treated patients were included, 1198 of which were under a TAF-based regimen.

Healthcare Systems across Europe and the US: The Managed Entry Agreements Experience.

This systematic study aims at analyzing the differences between the approach of the European healthcare systems to the pharmaceutical market and the American one. This paper highlights the opportunities and the limitations given by the application of managed entry agreements (MEAs) in European countries as opposed to the American market, which does not regulate pharmaceutical prices. Data were collected from the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national healthcare agencies of US and European countries.

Adherence, persistence and switching rates of apixaban, dabigatran and rivaroxaban in non-valvular atrial fibrillation: a multicentre real-life analysis at 3 years.

Introduction: Adherence to and persistence with long-term treatment with oral anticoagulants play a significant role in preventing adverse events and mortality in patients with cardiac conditions. The aim of this study was to evaluate the adherence, persistence and switching rate at 3 years in real-life patients with non-valvular atrial fibrillation receiving treatment with first-line new oral anticoagulants.

Methods: The study assessed all patients treated with drugs with the ATC codes B01AA, B01AE, B01AF and dispensed in pharmacies in the Lanciano-Vasto-Chieti and Pescara Local Health Units from 1 January 2011 to 30 September 2021.

A multicentre study with real-world data of the use of palbociclib in the treatment of breast cancer: Treatment duration correlates with dose reductions.

Objective: Palbociclib, a highly selective reversible CDK4-6 kinase inhibitor, is indicated in combination with an aromatase inhibitor or in combination with fulvestrant in women who had received prior endocrine treatment. Studies have demonstrated the efficacy of palbociclib in combination with fulvestrant in increasing progression-free survival in patients who relapsed or progressed on previous endocrine therapy, or in combination with aromatase inhibitor in patients who had not received previous treatments. We analysed the prescribing patterns of palbociclib in real practice correlating it with the evidence of treatment-related toxicity management and to time-to-treatment discontinuation and treatment adherence.

Developing and piloting a communication assessment tool assessing patient perspectives on communication with pharmacists (CAT-Pharm).

Background: Effective communication strategies in health care help to enhance patient empowerment and improve clinical outcomes.

Objective: Adapt the original Communication Assessment (CAT) instrument for the pharmacist profession (CAT-Pharm) and to test its validity and reliability in two different settings.

Setting: Five hospital pharmacies in Italy and five community pharmacies in Malta.

Medication adherence reporting in pivotal clinical trials: overview of oral oncological drugs.

Objectives: To assess how and to what extent adherence to medication is reported in pivotal clinical trials of oral cancer drugs.

Methods: All drugs authorised by the European Medicines Agency from 1 January 2014 to 31 December 2019 were considered for analysis. For each pivotal trial we extracted the journal of publication, phase of the study, posology, mention of adherence within the main text of the published article or additional material and the terms in which the adherence was reported.

The impact of COVID-19 on chronic therapies: the Pescara (ASL) local health authority experience in Italy.

Introduction: At this time in history fraught with restrictions and issues stemming from the COVID-19 pandemic, the care and management of chronic therapies is a major concern for society. The objective of the following study was to assess whether adherence and persistence in patients treated with hypoglycaemic drugs and statins during 2020 changed in comparison with pre-pandemic years.

Materials And Methods: A retrospective study was conducted, taking into account the drugs dispensed at pharmacies in the territory of the ASL (Local Health Authority) of Pescara from January 1, 2011 to December 2020 of all patients treated with ATC A10B (hypoglycaemic group) and ATC C10A (statin group).

Available information about paediatric use of onco-haematological drugs authorized by EMA since 2016.

Background: The treatment options available to children with cancer are limited. This is why for more than 10 years, the European Medicine Agency (EMA) has stated that all drugs to be marketed must be tested on the paediatric population in accordance with the Paediatric Investigation Plan (PIP). The objective of this study is to make a cross sectional analysis of the information related to the use of cancer drugs authorised on the European market in the paediatric population.

Adherence and persistence in the use of statins and ezetimibe over 8 years in a real-life study.

Background: Adherence and persistence to treatment are crucial in statin therapy as they are synonymous with efficacy and quality of care. The aim of this study was the real-life assessment of adherence and persistence over eight years in treatment-naive patients receiving atorvastatin, lovastatin, simvastatin, pravastatin, ezetimibe.

Methods: Adherence to treatment was calculated using the 'proportion of days covered' method and persistence as the difference between the start and end of the therapy under study.

Adherence, Persistence, and Effectiveness in Real Life. Multicenter Long-Term Study on the Use of Pirfenidone and Nintedanib in the Treatment of Idiopathic Pulmonary Fibrosis.

Background: In the treatment of idiopathic pulmonary fibrosis (IPF), nintedanib and pirfenidone, with their different mechanisms of action, lead to a reduction in the rate of progression of the fibrosis process measured by the reduction of functional decline, and, in particular, the decrease in forced vital capacity (FVC) and of the diffusion capacity of the lungs for carbon monoxide (DLCO). The objective of this study was to analyze real-life adherence, persistence and efficacy in the use of pirfenidone and nintedanib in the treatment of IPF.

Methods: A non-interventional multicenter retrospective observational pharmacological study in real-life treat-ment at 1 and 2 years was conducted.

Randomized clinical trials and real life studies: Comparison of baseline characteristics of patients in oral target therapies for renal cell carcinoma.

Introduction: Pivotal Randomized Controlled Trials (RCTs) constitute scientific evidence in support of therapeutic choices when a drug is authorized in the market. In RCTs, patients are selected in a rigorous manner, in order to avoid bias that may influence efficacy assessments. Therefore, patients who take the drug in Real Life Studies (RLSs) are not the same as those participating in RCTs, which, in turn, leads to low data transferability from RCTs to RLS.

Drug utilisation pattern over 3 years in the real-world treatment of type II diabetes.

Introduction: Non-adherence to therapy is very common in patients with type II diabetes, leading to an increase in morbidity and mortality. The development of new oral therapies following metformin has increased the possibilities of treatment but little has been done in terms of improving medication adherence. The goal of the following study is to evaluate adherence and persistence over a period of 3 years in real-world diabetic patients and describe the comorbidities found in the group of patients studied.

Adherence and persistence analysis in patients treated with double antiplatelet therapy (DAPT) at two years in real life.

Introduction: Double antiplatelet therapy (DAPT) is indicated for the treatment of coronary artery diseases (CAD). The optimal duration of therapy with DAPT continues to be a subject of debate in the scientific community. To improve adherence to DAPT, the FDC (fixed dose combination) of Acetylsalicylic acid (ASA) and clopidogrel was developed into a single pill instead of two separate pills thus facilitating the dosage and administration of the therapy and increasing compliance.

Adherence, persistence and efficacy of dasatinib and nilotinib in the treatment of patients resistant or intolerant to imatinib with chronic myeloid leukemia in chronic phase: an Italian multicenter study over two years in real life.

Background: The use of dasatinib and nilotinib in the treatment of patients with chronic myeloid leukemia represents a valid therapeutic option for patients resistant or intolerant to imatinib. In this multicentre study, adherence, persistence and efficacy in real life over two years of treatment were evaluated.

Materials And Methods: Adherence to treatment was calculated as the ratio between the dose received and the prescribed dose.

Adherence to and effectiveness of lenalidomide after 1 year of treatment in a real world setting.

Background: In combination with dexamethasone, lenalidomide is prescribed in the oral treatment of Multiple Myeloma for patients who have received at least one previous therapy.

Objective: The objective of this study is to evaluate medication adherence to lenalidomide of Multiple Myeloma patients, as well as Progression Free Survival and Overall Survival one year from the beginning of the treatment.

Setting: The study was carried out in Pescara Hospital, in Italy.