Analyzing the perspectives of patients in clinical trials, which are often overlooked, and discussing how pragmatic trials tend to answer questions regarding medical treatments
FREMONT CA: Many practical experiments, which examine the effects of medical therapies in real-world settings, either fail to obtain data directly reported by patients such as patient experience, illness burden, or quality of life or fail to include patients as research partners referred to as patient engagement.
Pragmatic trials aim to solve questions about medical treatments that are important to patients, which may be used in real-world health care settings with different patient populations. These studies should ideally examine patient-reported outcomes such as pain levels, quality of life changes, and other patient experiences. Pragmatic trials should also include a component of patient participation, in which patients participate in the study process. The inclusion of these two elements makes pragmatic trials more patient-centered.
An online database for pragmatic trials was published between January 2014 and April 2019 to evaluate how frequently pragmatic trials disclose patient-reported outcomes or include patient engagement, only to find that they examined patient-reported outcomes as a primary or secondary objective of the investigation and only around 9 percent involved patient and public interaction. Further analysis revealed that studies done in Europe were more likely to incorporate patient-reported outcomes. Still, trials involving young children or the elderly, as well as those recruiting patients from low- and middle-income countries, were less likely to do so.
Although pragmatic trials are designed to take into account the values and objectives of patients, many studies may improve and help achieve these goals. To promote a more patient-centered approach, it is advised that research funding agencies, research institutions, and scientific publications encourage researchers to include patient-reported outcomes and patient participation in pragmatic trials in the future.