The value of Real-World Studies with Patient-Reported Outcomes (PROs) and how to implement them
by Ana-Díaz Roncero, November 30, 2022
We are becoming more accustomed to the implementation of studies using Real-Life Data or Real-World Data (RWD) for the generation of evidence that helps us to better understand the management of diseases and the use of treatments in real life. This information helps us gain a more concrete view of the patient’s daily life outside of the hospital, as well as the effectiveness of the therapy prescribed by the healthcare professional, thus complementing the clinical studies. These studies have become more and more important, to the point where, between 2018 and 2019, 40% of the new applications for commercialization of products contained studies using Real-World Evidence (RWE).
These Real-World Studies can be generated using data reported by healthcare professionals during their daily clinical practice and/or using data reported by patients (PROs). We have already discussed the use of PROs in other articles, and they are continuing to provide more value to these kinds of studies.
The PROs enable an understanding of the real current status of the patient and his or her treatment during the course of the disease, through the collection of symptoms, events, quality of life, etc. directly from the patient, without intervention by the healthcare professional. In addition, the PROs also help to empower the patients, enabling them to participate actively in the investigation of their disease or treatment.
In order to do this, validated digital platforms are being used more and more. These enable a reduction in data loss or data entry errors, immediate access to the information, an increased willingness to communicate sensitive information, and real-time tracking of compliance, as noted in “Patient-reported outcomes: A new era in clinical research”. In this way, the patient’s information can be collected at the time it occurs, promoting accuracy and reliability of the data.
In addition, some studies have demonstrated that patient adherence to data collection through an electronic device is usually high, and the results appear conclusive. This was the case with a study of patients with multiple sclerosis that demonstrated that, in addition to high adherence to the technology, the changes in PROs over time enabled the prediction of clinical relapses. This suggests a potential for generating clinical research and improving the care for patients with this disease.
Caaring®, our digital platform for patients, enables the generation of research about the management of diseases in real life, using data that are 100% reported by patients. The patients report information about events, therapy, quality of life… at the right time, without the need for the investigator to intervene. The results obtained from these data help to improve and adapt the way in which diseases are managed, as well as developing personalized therapies based on the patient’s condition.
Ultimately, Real-World Studies provide evidence about diseases and treatments that complement the results from clinical studies. The use of PROs is gaining special relevance, as they help to understand the real-time situation of the patient without intervention by the healthcare professional, thus enabling the professional to adapt the patient’s care and treatment as needed. It is to be hoped that this is just the beginning, and that, through technology, their use will continue increasing in the future.