Clinical Outcome Assessment, or “COA” is an all-encompassing term that includes multiple subcategories, based on how and by whom clinical outcomes are reported. There are four measures that fall under the COA umbrella:
- Patient-reported outcomes (PROs), in which the patient directly reports on his or her condition
- Clinican-reported outcomes (ClinROs), in which a healthcare provider observes and reports on the patient’s condition
- Observer-reported outcomes (ObsROs), in which a healthcare proxy or parent observes and reports on the patient’s condition when the patient cannot do so.
- Performance outcomes (PerfOs), which measure a patient’s cognitive or physical performance
The linguistic validation process ensures that any translation is properly revised for the target population and that the same meaning is conveyed, regardless of language. Without LV and cognitive debriefing, patients may misunderstand questions, leading to inconsistent survey data and possible rejection of the clinical trial research.
While regulatory guidance exists when it comes to translating, culturally adapting, and linguistically validating PROs, there are no standard recommendations associated with ClinROs, ObsROs, or PerfOs. As a result, linguistic validation methodologies for these COA types have historically been completed inconsistently.
Defining a standard process for all COA translations
For years, experts have been creating their own processes and systems to ensure the highest-quality, most accurate translation, cultural adaptation, and linguistic validation of each COA type. This past year, the ISOQOL Translation and Cultural Adaptation Special Interest Group—including our own Shawn McKown, Vice President of Clinical Outcome Assessments—developed recommendations specific to each of the three COA types currently lacking documentation. To quote Shawn, “The ISOQOL TCA-SIG saw that this gap in guidance had a significant impact throughout the industry, and decided to pool the resources and knowledge of our members to design some useful and actionable recommendations”
The Group surveyed representatives from 10 industry-leading experts, who have decades of global, cross-cultural COA and linguistic validation expertise and experience. Participants expressed broad agreement regarding the translation and linguistic validation methodology across projects, with key differences for each specific COA type when it came to review of the preferred cognitive interviewing process. A general consensus emerged regarding recommendations for most types:
A vast majority—over 70%—of respondents recommended the following guidance for the cognitive interview process relating to ObsROs:
- Cognitive interviews with the patients’ caregivers
- Cognitive interviews with other observers of the patient
- For adult patients, interviews should be completed in-person with observer, with patient not in the room
- For pediatric patients, interviews should be completed in-person with the child not in the room
Likewise, over 70% of respondents made the following recommendations for the cognitive interview process related to PerfOs:
- Pilot testing with patients should be performed
- Cognitive interviews with patients should be performed where patient-facing parts are reviewed
- PerfO tasks should be administered by the interviewer
- Cognitive interviews with clinicians/healthcare professionals are not required
When it came to ClinROs, though, an overwhelming consensus did not emerge. No specific testing process steps were recommended by over 70% of respondents. A smaller majority recommended interviews with patients in cases where the ClinRO measure contains patient-facing text, and similarly a small majority indicated a preference for including cognitive interviews with clinicians.
The Group parsed this and other information in order to create a complete set of cognitive interview recommendations by COA type.
What’s next for LSPs
As a result of this project, the Group identified substantial differences in the preferred approach to the cognitive interviewing process across COA types. Consequently, the Group was able to develop specific practices and process recommendations for each type.
That’s a huge benefit to LSPs like RWS, which will now be able to systematically align processes across service providers, COA instrument developers, and industry sponsors. While this makes the COA translation, cultural adaptation, and linguistic validation process easier and more standardized for LSPs, it is also incredibly helpful to trial sponsors. The existence of standard, industry-wide guidance will result in greater consistency and accuracy of translations. Shawn feels that “It is the hope of the TCA-SIG that these recommendations will be helpful to all stakeholders, from pharmaceutical sponsors to eCOA providers, and from COA copyright holders to LSPs.”
The true beneficiary of a more consistent, more accurate approach to trial management is, of course, the patient. We’re proud of Shawn for his involvement in this important group and delighted with the work he and his colleagues have done to keep moving the industry forward—for us, for our clients, and, ultimately, for patients around the globe.
As the market leader for our Linguistic Validation (LV) services, including cognitive debriefing and usability testing. We can assist you and affiliated CROs to linguistically validate Clinical Outcome Assessments (COAs) and electronic eCOAs. We have accumulated significant experience and a wealth of knowledge by linguistically validating over 20,000 COAs into 500+ language pairs. RWS is the primary provider of COA Licensing, Linguistic Validation, Cognitive Debriefing, and Usability Testing services which has enabled us to develop strong relationships with many COA developers, including exclusive relationships with 31 instrument developers.