It is time for an organised, scientific approach to the application of patient-reported outcome measures in clinical studies and trials

Abstract

Too often, clinicians and researchers assume that patient-reported outcome measures (PROMs) are simply designed, can be changed to suit specific circumstances and should be freely available for use without seeking permission. If a version is not easily available, they believe they can produce a new translation without relevant experience or expertise. Copyright issues are inconvenient and commonly ignored, despite some journals requesting confirmation from authors that permission had been granted for use of copyrighted materials. When informed that authors of an article did not have such permission, the response from an editor was that nothing could be done as he had to rely on the word of the authors. In fact, high quality PROMs are carefully designed, developed for new cultures by means of proven standardised methodologies, carefully re-validated in the new culture and then administered by a responsible organisation to ensure that they are used appropriately in studies. If such care has not been taken, questions should be raised about the quality of the measure and the information it generates. Several problems have arisen with the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). This is probably because it is recognised as the most appropriate measure of quality of life for people with Ankylosing Spondylitis and has been widely used in international clinical trials and studies. Fifty-seven official language adaptations of the questionnaire have been produced. Unfortunately, as a result of unauthorised adaptation and use, questions are raised about the validity of several publications that have used the ASQoL.

Conscientious use of patient-reported outcome measures in supportive care

“…This convenience combined with their versatility has led to PROs becoming a cornerstone of both clinical evaluation and research in the oncologic patient population [ 2 , 3 ]. However, studies have suggested that the PRO measures are generally limited in their impact as a result of a lack of understanding in the community as to how these measures should be used to inform decision-making [ 4 , 5 ] and a lack of disease-specific tools in oncology [ 6 ].…”

International Development of the Alzheimer’s Patient Partners Life Impact Questionnaire (APPLIQue)

“…While HRQL measures may be useful in evaluating clinical interventions, the true impact of a condition (or role) on an individual should be a holistic assessment of outcome that takes account of both clinical and non-clinical influences on life quality. 24 A widely implemented approach to such measurement in health research is the need-based QoL model. This conceptual model grew out of qualitative research into the impact of depression on the lives of patients.…”