Implementation of QL into trials

If QL is to make a serious contribution to the evaluation of treatments, scientifically acceptable studies are required [29]. It is vital that all aspects of QL are considered in detail before including the assessment of QL in a trial. The sorts of questions that need to be addressed include: Is it appropriate to include any QL questions in the trial? What QL hypothesis do we need to test? Which questionnaires should we use? When should the questionnaires be administered? What analyses are planned? How will the QL data fit in with the clinical data and how will they be presented?

These are not easy questions, and a number of cancer trials groups such as the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute of Canada (NCIC) and the Radiotherapy Oncology Group (RTOG) in the USA have set up QL subcommittees to oversee the systematic inclusion and implementation of QL in their trials.

When such in-house expertise is not available, external expert advice should always be sought as early as possible in the design of a trial to consider all aspects of QL implementation. Indeed it is important that when QL is a key component of a trial, QL expertise is available throughout the trial to advise on monitoring and compliance.

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