A Clinical Outcome Assessment, or COA, is a gauge for noting, elaborating, or reflecting on how a patient feels, functions, or survives a clinical trial. COAs help to determine the effectiveness of a particular treatment method.
What are the different types of COAs?
There are four main types of Clinical Outcome Assessments that you should know about:
● Patient-reported outcome (known as PRO) measures
● Observer-reported outcome (known as ObsRO) measures
● Clinician-reported outcome (known as ClinRO) measures
● Performance outcome (known as PerfO) measures
Patient-reported outcomes (PRO) focus more on a patient’s replies to specific questions. The patient’s report encapsulates a broad spectrum of emotional and physical information. Observations are recorded verbatim, without any interference from the interviewer.
Observer-reported outcomes (ObsRo) are based more on external observations, and less focused on the patient or health professional’s perspective. ObsRo takes into account the family and non-clinical caregivers of a patient.
Clinician-reported outcomes (ClinRo) focus on the healthcare professional point of view in a patient’s evaluation. Trained professionals will compile a comprehensive report on a patient’s overall health and pain rating.
Performance outcome (PerfO) means that the patient is fully assessed under a specific task that doesn’t necessarily rely on rater judgment to give a rating.
Clinical Outcome Assessment factors
Generally speaking, COAs take into account factors such as a patient’s disease or impairment, and their population demographics.
These demographics can be split into other contexts like age, culture, language, and the severity of a patient’s disease.
What Is an eCOA?
Sometimes clinical outcome assessments are done electronically instead of using traditional paper-based methods. These are appropriately named eCOA’s (Electronic Clinical Outcome Assessments). There are various differences between COAs and eCOAs, but the main advantage is their ability to increase the quality of the study data found.
By using the internet and beneficial technological devices like handheld devices and tablets, the end data of eCOAs can be made more granular.
How Do eCOAs Improve the Quality of Data?
It’s now widely accepted that eCOAs are the most efficient way of obtaining the best, most reliable data. Here are four of the main reasons why eCOAs usually provide the highest quality data:
1) Patients comply with protocol more
Through the utilization of handy and easy-to-use electronic devices, patients are inclined to follow clinical protocols more meticulously. In fact, it’s been found that 94% of clients fully comply with eCOAs compared to 11% of patients fully complying with standard paper-based COAs.
Why? Well, electronic devices like tablets offer reminders and alerts to ensure information is imputed on time and on schedule. They also allow more dynamic and contextual messaging to engage patients as much as possible through the clinical process.
2) Transcription errors are prevented
The efforts of manual transcription leave more chances of errors. eCOAs automate these processes and prevent the chances of human errors that cause data inconsistencies. Best of all, these quality and data issues can be detected in real time.
3) No inconsistent data
By using logical guidance and sequencing, patients can understand the process and know exactly what they need to do at each step. Unfortunately skipping certain stages and questions on questionnaires is a common occurrence that causes inconsistent data. Electronic devices can prevent this by offering a more straightforward means of obtaining the correct data without any gaps.
4) Higher global standards of data
There are numerous regulatory bodies that work to make sure all obtained and reported data follows all necessary protocol. eCOAs go above and beyond the global guidelines to achieve high quality results, so ultimately they are the better option to achieve a more accurate and universally recognized conclusion.
So Why Should You Consider Using eCOAs?
If clinical methods meet global regulatory requirements, the data obtained is instantly of a higher quality. Naturally, eCOAs are the better solution for preventing any inconsistencies from human error. Errors found in more traditional paper-based are simply adding unnecessary and avoidable errors into the process of the clinical trials.
There has of course been thorough research conducted around the various benefits of eCOAs against standard COAs. The results speak for themselves. Generally, it’s considered that the continued reliance on COAs means your clinical trials are at risk.
Instead, eCOAs can offer improvements to the quality of your data, more compliance to the all-important global regulatory standards, and also a better chance of continued clinical development.
Global Clinical Outcome Assessments
Adapting any form of COA instruments to be utilized worldwide in global research studies, whether electronic or paper-based, requires innovative technologies.
With the growing regulations and complexities around COA in global translation services, it’s important to keep up to date with the latest FDA PRO Guidance, EMA Guidelines, and ISPOR Good Practice.
Translating and Adapting COAs
TransPerfect’s Linguistic Validation group(lifesciences.transperfect.com) is the foremost specialized service in linguistic validation. Their processes span a broad range of therapeutic areas to deliver conceptual equivalence and cultural appropriateness in any language.
When it comes to remaining regulatory compliant across global studies, TransPerfect’s sterling worldwide reputation for fast and accurate translation is unmatched.
Transperfect and COAs
The most prominent challenge in creating effective COA materials lies in the translation of certain key expressions and terms. Fortunately, Transperfect’s translatability evaluation process assists you in finding and removing problems within the translation process.
The approach ensures that potential issues are pinpointed during the beginning of your project. They can then be edited, removed, or replaced to create the best source language instrument without any last-minute difficulties that require backtracking and time-consuming revisions.
Clinical Outcome Assessments are a powerful method of honing and monitoring the effects of a clinical trial on a patient. It allows professionals to better understand the best next step in fighting diseases and ailments.
In translating such important documentation, there can be no room for error. Identifying problematic wording and unnecessary information at the beginning of a project allows for fast, productive, and fruitful process.