Clinical Outcome Assessments: Accurately Reporting Measurements in any Language

welocalize March 19, 2020

Clinicians and health care systems are prioritizing patient outcomes, according to a recent survey from the Johnson & Johnson Medical Devices Companies. They are focused on improving operational efficiency and clinical performance, while creating a deeper connection with patients as consumers. Implementing patient-centric technology is one way to make the patient experience more convenient, comfortable, and connected, while producing highly accurate data that allows for a better path to drug or device approval.

From COA to eCOA

Clinical outcome assessments (COA) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. Electronic clinical outcome assessments (eCOAs) use technology such as smartphones, tablets, and personal computers to allow patients, clinicians, and their caregivers to directly report outcomes. eCOA solutions are designed to support the patient throughout the trial—such as prompting them if they miss a question or sending an alarm to alert them to make a diary entry. Additionally, eCOAs allow for a better understanding of the patient experience in clinical trials.

Incorporating technology with patient-centered components can have a positive effect on health outcomes that matter to patients and the health care industry. In this two-part blog series, Dana Weiss, a linguistic validation specialist who has managed and advised global companies on multilingual instruments for more than 15 years, shares how eCOAs are changing the clinical space, the role language places in accurately reporting measurements, and best practices for migrating to eCOAs.

Q. What is driving the change to electronic data reporting?

A. Digital evolution has significantly penetrated the field of clinical trials. Through activities such as digitalization of patient access and recruitment tools, implementation of new monitoring processes which include risk-based monitoring, and the electronic transformation of patient data capture (e.g. Electronic Data Capture, COA, e-diaries). The value that these technologies bring to clinical trials stakeholders has continuously grown, building efficiencies and creating a huge avenue for the optimization of time, resource, and cost.

According to Research Report Insights, the global eCOA market is anticipated to account for a market valuation of approximately US$ 3 billion by 2025, expanding at a compound annual growth rate of 15.3% between 2020-2025. In… Click To Tweet

Q. What are the benefits of an electronic report system?

A. There are numerous benefits, including:

  • Data confidentiality and security. The user of the electronic report system has a unique ID code, so it is clear who has completed the questionnaire; passwords further improve patient confidentiality. Automated servers and electronic backup systems means that data is not mislaid or lost. This also allows an automatic audit trail within the electronic system.
  • Patient adherence. The use of electronic time stamps removes any doubt over adherence to a planned schedule and encourages the user to complete on time.
  • Reduced human error. Logic-checks and real-time edit checks reduce the amount of missing, incomplete, and inconsistent data. Additionally, there is a reduced number of questions since those not applicable based on earlier responses are automatically skipped. And, finally, issues over legibility of handwriting or contradictory responses are eliminated. These all help reduce human error.

The improved accuracy of data collection means that the variability of study endpoint parameters is reduced, leading to better statistical power and the need for fewer patients to reach the same statistical endpoint and resulting in overall cost savings. Further, an electronic system allows automatic calculation of diagnostic and other patient scores and provides reassurance to both the patient and the physician that any worsening of a score is flagged up immediately. In this way, eCOA systems can be integrated into routine clinical practice in addition to being used in clinical and epidemiological studies.

Q. What is the role of language and translation in the clinical outcomes process?

A. As clinical trials become increasingly global, so, too, grows the need for translation and localization of all clinical trial documentation. COAs measure observable concepts, unobservable concepts, and physiological or lab findings, measured with or without human assessment. The aim of translation is to deliver both linguistic and conceptual equivalence between all translated versions of a COA used in a clinical trial. This allows for results to be pooled across different populations and demographics.

When migrating to eCOA, retaining the measurement properties of the original validated COA is essential if the resulting data are to be considered valid and equivalent to results acquired from the paper version. Failure to recreate eCOAs properly can alter the measurement properties of the COA measure, possibly wasting a lot of time, effort, and money for everybody involved.

Q. What are factors that affect the translation and localization process?

A. The time required for all process steps needed for licensing, translation, and localization, as well as transfer to electronic devices is often underestimated by clinical research personnel in charge of eCOA implementation. There is a growing demand for knowledge sharing of these steps to increase the familiarity of good practices among all involved in clinical trials.

When migrating to eCOA, retaining the measurement properties of the original validated COA is essential if the resulting data are to be considered valid and equivalent to results acquired from the paper version. Failure to recreate… Click To Tweet

Q. What can sponsors do to be better prepared?

A. Sponsors or CROs, localization service providers, and eCOA solutions providers should ideally communicate as soon as the study protocol is known. Currently, those involved in managing clinical trials wait until the English version is ready before involving their language service provider. Given that the English build may take six to eight weeks to build, all parties would benefit from translation vendor involvement at the very beginning so that they can plan and help advise on process and workflows. Sponsors also benefit from leveraging the relationships they have with their translation vendor when coordinating licensing and developer reviews.

Contact Welocalize Life Sciences for information on how we can assist with translation of COAs and eCOAs, as well as linguistic validation and cognitive debriefing services.

About Dana Weiss

Dana Weiss is an experienced director with a demonstrated history of working in the translation and localization industry. She is skilled in intercultural communication, linguistics, translation, and foreign languages. For more than 15 years she has focused on linguistic validation of COAs and eCOAs, translatability assessments, and concept definition creation, as well as development of global clinician databases for cognitive interviews.