eCOA - Clinical Outcome Assessments

There are four types of clinical outcome assessments, which are often used by researchers and sponsors in clinical trials. They can be divided into patient-reported outcomes (PROs), clinician-reported outcomes (ClinRos), observer-reported outcomes (ObsRo), and performance outcomes (PerfOs) (“Clinical Outcome Assessment Qualification Program,” 2018).

• Patient-reported outcomes are paramount clinical outcome assessments in medicine. The implementation of this approach proves that patients are active participants in medicine. Patient-reported outcomes can be defined as a report about a patient’s health condition given directly by the patient. These reports often include symptoms known only to the subject, such as depression or morning stiffness. The reported symptoms can be taken as objective behavioral measures, which can indicate the specific impact diseases and treatments may have on people (Deshpande et al., 2011). Note that health-related quality of life is an innovative type of patient-reported outcomes, which provides information about multiple domains of life and aims to improve the overall well-being of patients.
• Clinician-reported outcomes are another vital type of clinical outcome assessment used widely in research. Usually, these reports are delivered by trained staff. Reports may include factors, such as dementia assessments or severity of skin disease. As clinician-reported outcomes measure a patient’s status and may be used to interpret the effect of a drug in clinical trials, training of staff is needed (Powers et al., 2017). In the end, data needs to be accurate, clear, and transparent.
• Observer-reported outcomes are also important clinical outcome assessments. They use data given by an observer who’s not a health professional. This can be a parent or a caregiver. For instance, in infants, observer-reported outcomes are highly valued. They can give more information about symptoms, such as frequency of vomiting, etc. (Acaster, 2017). Note that the implementation of observer-reported outcomes in infants with a rare disease requires special consideration due to high mortality rates.
• Performance outcomes are the fourth type of clinical outcome assessment. They are based on information collected from actual tasks, performed by patients and as instructed by medical professionals. Such tasks can be related to fall-risk assessment, spatial memory, and verbal working memory. Performance outcomes can help researchers understand if the new treatment leads to physical improvements. This information can help experts gain a better understanding and can improve patients’ overall performance.