Review article: towards the optimization of symptom evaluation in reflux disease

A recent workshop has taken stock of the processes used for the evaluation of reflux disease symptoms. Such evaluations are vital both for routine clinical practice and for the critical assessment and comparison of therapeutic options. The workshop endorsed the importance of the assessment of symptom patterns for the diagnosis of reflux disease. Patient self-report symptom questionnaires were considered to be potentially valuable instruments, but have been researched relatively little in reflux disease. On the basis of a survey of the literature and data from generic methodological research, the workshop concluded that virtually all trials of the therapy of reflux disease have used too few response options for a sensitive definition of symptom status, and recommended that six to seven response options be used. Modified Likert scales with defined individual response options and structured patient self-report, rather than physician assessment, were considered to be the best approaches. These views on symptom status assessment are not reflected fully in the current practice of reflux disease clinical trials. Furthermore, the terminology used to describe symptom status is frequently ambiguous or tautological. Quality of life measures were acknowledged as valid and useful secondary measures of therapeutic benefit. By contrast, evaluation of the state of the art of assessment of patient satisfaction with therapy led to the conclusion that the methodology for this particular assessment was still in its infancy. The outputs of the workshop revealed many aspects of the assessment of reflux disease that would benefit from further research and development. A report on the detailed outputs of the workshop has been published recently.