Cognitive Debriefing Subjects Don't Need to Be in Trial Disease State
Posted by Lionbridge Blogger on Thu, Jan 07, 2010 @ 08:30 AM
Today Mark Wade is sharing his opinions on why Cognitive Debriefing subjects don't need to be in the specified trial disease state.
Recently I've had some discussions with a Sponsor about whether Cognitive Debriefing subjects need to be in the specified trial disease state. Can we use healthy, non-disease state interviewees in this process?
Cognitive Debriefing (CD), also known as Pilot Testing, is part of a translation process where people are invited to review a recently translated, validated Quality of Life (QoL) instrument - a questionnaire - that will be used in a clinical trial in their country. They review the questionnaire and are asked specific questions by a Debriefer as to whether the translation is both culturally and linguistically correct. They are specifically asked whether the verbiage in the questionnaire is clear and unambiguous. The review is carried out in a structured interview fashion.
It is well established that these subjects must be based in the country where the trial is taking place; they should represent the trial's characteristics in terms of race, gender and socio-economic backgrounds. A debate continues, however, as to whether these interviewees should also have the disease pathology specified by the trial.
In 2007, a paper submitted to ISPOR spoke to this very topic. Entitled Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation, the article concluded that, where possible, patients in the disease state should be used. The language was, I would respectfully suggest, deliberately open. Recruiting people in certain disease states is almost impossible. Chronic Obstructive Pulmonary Disease (COPD) is a good example. It is extremely difficult to recruit people in the chronic disease state, so authors and instrument developers have become creative and recruited patients with emphysema and other respiratory conditions. I am quite sure it has been considered that recruiting certain patients with advanced forms of cancer to review the translations is improper, given that their participation neither promises the prospect of therapy nor the promise of good health. It is just a linguistic validation exercise.
So, the real question is: If you use participants in the disease state, do you get better data from the group or not?
There is at least one relatively strong argument I have heard for using patients in the disease state: Patient experience is important for linguistic validation of the questionnaires. There are language-based differences in understanding expressions such as fatigue and lethargy that have different meanings to cancer and non-cancer patients.
The argument is that sufferers have a different understanding and concept of fatigue and lethargy than non-sufferers. I believe this to be true. I am sure there are many differences in the way sufferers perceive the world around them. I am sure that abstract and tangible concepts, such as time, hold different meaning for both groups of people.
But where I am at a loss is why that has anything to do with linguistically validating a QoL instrument. When we perform CD, we are looking to see whether the translation is culturally correct, linguistically correct, and clear about the information the instrument is trying to elicit from the patient. Given that the interviewees DO NOT actually ANSWER the questions in the instrument at the time of validation, I fail to see the advantage of solely recruiting people in a particular disease state. Taking up their time seems selfish to me. When we look to concepts such as fatigue or lethargy, we are asking whether the question is understood. I am sure that a healthy person and a sick person would answer it differently; but, we'll never know because we don't ask them to answer the question on the questionnaire. We only ask them if they understood the question.
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