ABSTRACT
INTRODUCTION: Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy. METHODS AND ANALYSIS: This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL. ETHICS AND DISSEMINATION: All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine. TRIAL REGISTRATION NUMBER: NCT05626764.
Subject(s)
Neoplasms , Quality of Life , Adult , Humans , Cohort Studies , Prospective Studies , Artificial Intelligence , Neoplasms/drug therapy , Immunotherapy/adverse effects , Observational Studies as Topic , Multicenter Studies as TopicABSTRACT
Nowadays, manufacturers are shifting from a traditional product-centric business paradigm to a service-centric one by offering products that are accompanied by services, which is known as Product-Service Systems (PSSs). PSS customization entails configuring products with varying degrees of differentiation to meet the needs of various customers. This is combined with service customization, in which configured products are expanded by customers to include smart IoT devices (e.g., sensors) to improve product usage and facilitate the transition to smart connected products. The concept of PSS customization is gaining significant interest; however, there are still numerous challenges that must be addressed when designing and offering customized PSSs, such as choosing the optimum types of sensors to install on products and their adequate locations during the service customization process. In this paper, we propose a data warehouse-based recommender system that collects and analyzes large volumes of product usage data from similar products to the product that the customer needs to customize by adding IoT smart devices. The analysis of these data helps in identifying the most critical parts with the highest number of incidents and the causes of those incidents. As a result, sensor types are determined and recommended to the customer based on the causes of these incidents. The utility and applicability of the proposed RS have been demonstrated through its application in a case study that considers the rotary spindle units of a CNC milling machine.