eCOA Clinical Outcomes Assessments

eCOA - Clinical Outcome Assessments

Clinical Outcome Assessments: Introduction

Medical data can save lives. Therefore, Clinical Outcome Assessments are vital tools in research and practice. Clinical outcome assessments measure aspects, such as patients’ symptoms, emotional well-being, cognitive state, and social functioning. Since such tools provide detailed medical information, they can be employed in various professional settings and diseases. It’s not surprising that clinical outcome assessments can be extremely beneficial in clinical trials; for instance, they can be used as indicators of the safety and effectiveness of new drugs or treatments.

On top of that, as patients are the main participants in medicine – patients’ thoughts, opinions, and observations are vital. Unlike biomarkers or specimens, clinical outcome assessments rely on people’s interpretations. As such, they can reveal impressive insights and hidden information.

Clinical Outcome Assessments: Types

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.

Clinical Outcome Assessments: Usage

Clinical outcome assessments are extremely beneficial in research. As explained above, all types of clinical outcome assessments have broad applications in clinical trials and treatment. They provide sensitive information that lab tests may miss.

The type of clinical outcome assessment employed in research depends on the research goal itself and the study design in general (“Clinical Outcome Assessment Qualification Program,” 2018).

Let’s say that a research team may need more information about the actual functional performance on a task. In this case, performance outcomes will be implemented, and patients will be instructed to complete an activity. For instance, a Corsi Block Test can be performed to test patient’s visuospatial working memory.

Clinical Outcome Assessments: Usage & Technology

As technology plays a vital role in medicine, electronic clinical outcome assessments have slowly replaced paper formats. They can facilitate research and care, for sure. By employing technology, such as smartphones, researchers can motivate patients to participate in clinical trials. Consequently, this can reduce costs and delays. Most of all, online data collection is precise, quick, and accurate – all that thanks to the numerous digital solutions out there. Technology also makes data storage and access transparent and safe. Last but not the least, electronic forms foster multi-center approach.

In other words, electronic clinical outcome assessments (eCOAs):

Help researchers collect data in real time
Improve visualization of results
Facilitate research by introducing alerts and push-on notifications
Store data in the cloud
Maintain clear audit trials
Motivate participants and staff
Foster multi-center approach

Clinical Outcome Assessments: Assessments & Regulations

Since clinical outcome assessments help researchers improve clinical trials and healthcare practices, these assessments need to meet all the official regulatory requirements. One of the main regulations in research is the popular ALCOA-C. According to ALCOA-C, all medical data should be attributable to its source, legible and easy to read, contemporaneous and credible, original and reliable, accurate and honest, and complete and accessible.

Of course, ethical principles should also be considered, and research should always aim to improve patients’ well-being. Note that survival rates are not the only goal in medicine, but better emotional and social well-being.

Clinical Outcome Assessments: Conclusion

To sum up, clinical outcome assessments are a vital tool in research and clinical trials. All four types – reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes – are extremely valuable, and their implementation depends on the study goals. Yet, regulations should always be a focus of research.

With the powerful role technology plays in medicine, platforms like Qolty can facilitate the implementation of electronic clinical outcome assessments, benefit clinical trials, and improve patients’ lives. Data does save lives.

References

Acaster, S., (2017). Patient-Reported Outcome and Observer-Reported Outcome

Assessment in Rare Disease Trials. Value in Health, 20, p. 856-857.

Clinical Outcome Assessment Qualification Program (2018, January 22). Retrieved from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm

Deshpande, P., Rajan, S., Sudeepthi, L., & Nazir, A. (2011). Patient-reported outcomes: A new era in clinical research. Perspectives in Clinical Research, 2(4), p.137-144.

Powers, J., Patrick, D., Walton, M., Marquis, P., Cano, S., Hibart, J., Isaac, M., Vamvakas, S., Slagle, A., Molsen, E., & Burke, L. (2017). Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force. Value in Health, 20(1), p. 2-14.