Publications by authors named "F Pignatti"
Article Synopsis
- A study evaluated the uncertainties related to treatment outcomes for 121 oncology medicines approved by the European Medicines Agency (EMA) from 2011 to 2022, revealing a total of 800 uncertainties.
- These uncertainties were mainly classified into safety (51%) and efficacy (40%), with common concerns about specific adverse events and effect size.
- Factors like the type of medicine and marketing authorization had a significant impact on the number of uncertainties, with cell and gene therapies showing the highest levels of uncertainty.
Objective: To investigate the long-term effects of intravenous neridronate treatment in patients with complex regional pain syndrome type 1 (CRPS) in a real-life setting.
Methods: We conducted a retrospective study on consecutive CRPS patients treated at our hospital from February 2018 to July 2023. All were treated within three months of the onset of CRPS symptoms.
Article Synopsis
- Obesity is a significant risk factor for knee osteoarthritis (OA), and this pilot study investigates the impact of a Very Low-Calorie Ketogenic Diet (VLCKD) on obese women with symptomatic knee OA.
- The study involved 20 participants, where 16 completed the 20-week VLCKD protocol, resulting in a significant reduction in BMI and improvement in knee OA symptoms as measured by various health indices.
- The findings suggest that a VLCKD can effectively aid in weight loss and enhance health outcomes for women with obesity and knee OA, indicating potential for further research.
Importance: The use of real-world data (RWD) external control arms in prospective studies is increasing. The advantages, including the immediate availability of a control population, must be balanced with the requirements of meeting evidentiary standards.
Objective: To address the question of whether and to what extent the methods of RWD studies compare to standard methods used in randomized clinical trials.
Article Synopsis
- The study investigates the impact of missing data and unmeasured confounding on external comparator studies through two case studies involving randomized controlled trials in multiple myeloma and prostate cancer.
- By analyzing these cases and conducting simulations, researchers quantified how missingness and confounding variables affected bias and performance metrics of treatment effects.
- Results varied: for multiple myeloma, findings aligned with trial results despite missing data; however, for prostate cancer, missing data led to inconclusive outcomes and highlighted limitations in eligibility criteria.