Systematic collection of patient reported outcomes and experiences in multiple sclerosis: its role on quality of life: an open-labelled controlled clinical trial

Abstract

BACKGROUND: Multiple sclerosis (MS) is a chronic, immune-inflammatory disease of the central nervous system. It is the main cause of non-traumatic disability in young adults, affecting more than 2 million people worldwide. Despite the research carried out by the scientific community to know the pathophysiology, today it remains uncertain. Therefore, the only treatments currently available are aimed at preventing relapse and stopping the progression of the disease, as well as treating the accompanying symptoms. MS presents a very heterogeneous symptomatology with a great impact on the quality of life of the patient, and this is the main reason why they are not properly collected. OBJECTIVE: The main objective of this trial is to determine if the proper collection and management of symptoms that afflict MS patients can have a positive effect on their quality of life (QoL). Furthermore, its influence on the quality of care will be evaluated secondarily. DESIGN: multi-centric, open-labelled, randomized controlled clinical trial. PARTICIPANTS: 450 patients with an age ranged 18 to 65 diagnosed with MS according to McDonald 2017 criteria that carry out their follow-ups in the Neuroimmunology and Multiple Sclerosis Unit of Santa Caterina Hospital and other reference hospitals of Catalonia. INTERVENTION: participants will be randomly allocated in two groups of equal size. The members of one group will conduct Patient Reported Outcomes Measures (PROMs) questionnaires during five consecutive visits and the results of each of them will be analysed in real time by the neurologist before consultation. Additionally, in the first and last visit of the study they will have to fill out a QoL form and a Patient Reported Experience Measures (PREMs) questionnaire to assess the quality of care. The other group will only have to fill the QoL and PREMs questionnaires at the beginning and at the end of the study