What if patients completed questionnaires without understanding the words or context used in the questions? What if patients were offended by a particular word? Or what if patients gave responses thinking the questions were asking something else instead?
These dangers quickly undermine instruments like patient-reported outcomes (PROs), a common type of questionnaire where primary responses can be gathered for clinical trials. Even when an instrument has been expertly designed for patient understanding, when translation becomes involved those original psychometric properties can get lost. It isn’t just a matter of language and context, but of culture as well. For these reasons, cognitive debriefing becomes an invaluable step in the linguistic validation of translated instruments, essential to the integrity of clinical trials, both overseas and in the USA.
Pilot testing is another process where the draft of a translated instrument is tested on a sample of people who belong to the instrument’s target population. Cognitive debriefing helps researchers ensure they are asking the right questions to elicit meaningful answers about their area of research inquiry.
Effective debriefing begins with recruitment. Respondents must belong to the instrument’s target population, such as adults with asthma, post-menopausal women or post-operative patients; be native speakers of the instrument’s language; and belong to the target culture. Respondents should ideally represent a cross-section within the target population; for example, both men and women, adults of different ages and people from different socioeconomic groups.
Specific recommendations for the cognitive debriefing process may vary, such as MAPI recommending that the sample size be approximately 35 respondents; however, the principles are typically the same. Responsive Translation provides the critical translation component to clients approaching these challenges.
The instrument is administered to the participating respondents. Afterwards they are personally interviewed about the instructions, the response format itself and all the instrument items, unless an abbreviated pilot testing was planned. Participants are asked questions such as if an item was clear or unclear, if there were any words they did not understand or found unacceptable, what they thought the item was asking, if they can reformulate the item in their own words, how they arrived at their answer and what they associated with particular words. If there are alternative word choices, participants are asked which option they consider more natural.
Findings are culled together for a final report, which includes relevant details about participants and the interviews, as well as final recommendations on improving the instrument. Translators believe (naturally enough) that clinical trial data is only as strong as the translation used to collect it.
Cognitive debriefing is an important step in linguistic validation. It helps translated instruments to gather relevant data in clinical trials and studies, especially when they take place abroad. In today’s global world where medical knowledge and clinical trials transcend borders, translation serves as an invaluable link among multiple clinical trial sites, subjects, researchers and trial sponsors. Good clinical trial translation is more necessary than ever.
For additional information, please see our white paper “Maintaining Cognitive and Psychometric Integrity of Testing Instruments in Translation.”