Patient-reported outcomes: A smart way of collecting powerful datasets
This blog post highlights the importance and the benefits of researching complementary and alternative practices by using Patient Reported Outcomes.Â
In November 2013, South Africaâ€™s Medicines Control Council (MCC) released official guidelines for Complementary and Alternative medicines (CAMs) that could effectively see between 60 – 85% of products being removed from shelves. Currently, this industry is estimated to be worth a whopping R7-billion, with more than Â±40 000 products on the market. The regulations have now defined a new category of medicines under law, Category D: Complementary Medicines. Products that do not fit the description of a Category D Medicine will automatically move into Category A: General medicines, which are classified as, and subject to, pharmaceutical drug regulations.
As a result of increasing popularity by general consumers, the need for data collection on CAMs has become increasingly highlighted by the release and hype of these new guidelines. Due to the exorbitant costs involved in clinical research, required for Category A medicines, CAM companies are forced to seek alternate ways of collecting powerful datasets that could be used in support of their claims, registrations and used as powerful marketing material for their product portfolios.
Although medical technology allows us to measure physical, physiological or biochemical parameters of data for a patient; it is not able to give all the data about the treatment or the disease itself. Some data can be obtained only from the patients themselves.
In short, patients can provide much more insightful data about things like thoughts, complaints or opinions that technology or any observer canâ€™t, which would be considered as valuable data. Furthermore, quality of life also plays an essential role in the treatment as in some diseases, survival is not the ultimate goal of the treatment.
Patient-reported outcomes research (PROs) that stresses the importance of research â€œinformed by the perspectives, interests and values of patientsâ€ throughout the research process has become increasingly more attractive to the CAMs industry as a powerful way of collecting valuable data. Aiming to provide practical evidence to support real-world decision-making â€“ PROs particularly emphasises the patient perspective and are commonly used as outcome measures in clinical trials and observational studies. Identifying valuable information on the benefits and harms of interventions in a real-world setting can be valuable to a company and their consumers.
Compared to the older paper-based process of data collection (being expensive, labour intensive, error-inducing and lengthy), recent technological developments that facilitate the electronic collection process of PROs and the linkage of PRO data with other clinical data offer new opportunities for faster more effective ways of data collection. Across all levels of PRO application, the collection of PRO data is difficult â€“ albeit not impossible â€“ without electronic data methods. Electronic data capturing improves feasibility of collection, decreases burden and enables sophisticated survey administration.
The outcomes are broadly classified into- clinical (e.g. cure, survival), humanistic (e.g. emotional status) and economical (e.g. expenses, saving).
Ideal properties of a PRO instrument:
- As seen in literature, the following ideal properties can be extracted:
- It should be specific to the concept being measured;
- It should be based on end-point model;
- It should have conceptual equivalence;
- It should be based on the conceptual framework;
- It should have proper evidence for the conceptual framework;
- It should contain optimum number of items;
- It should have easy and specific measurement properties i.e. use of the scales which is easiest for the intended population to understand;
- It should maintain the confidentiality.
PRO measurements can provide critically important information to CAM companies about the quality of improvement initiatives, enabling them to focus on what is most important to patients: how they feel and function. PRO measurement is advancing quickly and is currently the subject of international attention. With increasing pressure being applied to the CAMs industry, PROs could be the alternative option many companies are searching for in aiding them to meet the MCCâ€™s requirements to gather real-world data in support of their registrations.
TCD Outcomes Research specialises in late phase research and is well equipped for undertaking such data collection, where focus is given to the patient. Combining our pharmaceutical experience together with our â€œHigh Tech, Low Touchâ€ philosophy, we provided creative solutions that are tailored specifically to the projectâ€™s objectives. TCD Outcomes Research regards PROs as a powerful tool and aims to make high use of its impact with future endeavours.