医学英語のインタビュ

Question by Melinda Hull: Could you just start out by telling us a little bit about what a quality of life questionnaire is and the reasons for its existence?

Answer by Raoul Breugelmans: Ok. Well quality of life questionnaires are really only one kind of patient-reported outcome measures. When a new drug is developed or a new treatment is developed, it is, of course, very important to evaluate how effective that drug or treatment is in treating the disease. But it is also very important to find out how the patient actually feels -- not just in terms of symptoms, but in terms of quality of life. Evaluating the effectiveness of a treatment or a drug is not all that difficult, but evaluating how the patient feels is, of course, much more difficult because it is very subjective. And also comparing one patient to another or comparing the quality of life of one group to another is even more difficult. So a very rigid methodology was developed for making instruments that can measure, that can evaluate quality of life (or) not only quality of life but also symptoms or functioning and other things that all together are referred to as patient-reported outcomes.

One of the very important things in patient-reported outcomes or PROs is that they should really be patient reported. And they should not include any interpretation by a physician or another healthcare professional. My own specialty is not really the development of quality of life or PRO questionnaires, but it is more the translation of questionnaires. I do know that developing a questionnaire has to be done according to a very strict methodology which involves focus groups with patients to find out what is important for patients. Of course, it all has to be based on medicine, so input from physicians is important in developing a questionnaire, but in the end it really has to be based mainly on what patients themselves think is important. And so to do that, focus groups and individual interviews are held and then based on the results of those, items are generated and they're classified into different groups. And then a questionnaire is made based on that, which is then again tested on patients in what they call cognitive debriefings. And based on the results, the items are rewritten, items are deleted to finally produce the final version of the questionnaire.

Hull: Now you and I have both participated in actually creating, based on English questionnaires, Japanese questionnaires. Could you describe exactly what that process is? And also some of the problems that arise with the process, going from English to Japanese that you have encountered.

Breugelmans: Well most questionnaires are developed in the West, either in UK English or US English. But of course they are not used only in the West. Clinical trials nowadays are often done in multiple countries and quality of life is very often included in clinical trials nowadays. And so when a pharmaceutical company does a clinical trial in a number of countries including a quality of life questionnaire, then that questionnaire has to be translated into all the different language versions. I have been coordinating projects like that into Japanese for about ten years now. Typically a pharmaceutical company will go to a coordinating center, often in Europe, and that center is then in charge of producing all the different language versions. So it is not simply done English to Japanese, it is English into all the different languages that are needed and that is done simultaneously and all coordinated by one center.

I, of course, have only been in charge of the Japanese translation, so let me talk about that a little more. It's not simply translating the questionnaire into Japanese, that would be very easy. Typically these questionnaires are a couple of pages, usually not more than five or six pages, so if it were just translating that into Japanese, it wouldn't take more than a day. But typically a project like that takes three, four . . . sometimes, five to six months to do. So it is quite a complex process. The questionnaire is first translated into Japanese by two Japanese translators. They do that separately. They don't know of each other's work.

Hull: When you say Japanese, you mean native Japanese speakers. Correct?

Breugelmans: That's correct, yes. Native Japanese professional translators. They have to be native Japanese speakers. And so they are both given the questionnaire. They cannot consult each other and they produce, their own, what we call forward translations. When they're ready, then there is a meeting with the two forward translators and the coordinator to discuss the translations, to compare them. And then to turn them into one, what we call reconconciled forward translation.

Typically in those meetings there are different problems that come up. One translator interprets something in a different way or has a different term for something, so all those problems are then written up in a report and how they were solved. And that report is then discussed with the coordinating center. Sometimes the author of the questionnaire, the developer, is consulted and in some cases, the client, the pharmaceutical company, the sponsor, is consulted. And there is quite a bit of discussion going back and forward, usually by email. And when all that discussion is finished, we end up with the first Japanese version, which we call the first intermediary Japanese translation.

That is not the end of the project. In the next step, the first Japanese version is translated back into English by a back translator who should be a native English speaker. And that back translator should not have access to the original English, so it is just looking at the Japanese translation, putting that back into English and then having a meeting with the coordinator to compare the back translation with the original English questionnaire to see if there are any differences and if there are, then we need to determine whether that is due to a faulty back translation or whether that is due to problems in the Japanese and both happen.