No abstract

There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

Current methods of clinical assessment in osteoarthritis show a high degree of variability. By contrast, patients with rheumatoid arthritis may be evaluated using a number of standardised and validated indices. One hundred patients with primary osteoarthritis of the hip and knee were interviewed in order to determine the dimensionality of their discomfort and disability and to define the clinical importance of each component item. The symptomatology of osteoarthritis was captured by five pain, one stiffness, twenty-two physical, eight social and eleven emotional items. In spite of a high degree of variability in the frequency of involvement of the individual items, their clinical importance was similar both within as well as across dimensions. Further studies are indicated to determine the reliability, validity and responsiveness of each of the items identified as a prelude to developing a standardized method of assessing patients with osteoarthritis of the hip and knee.

This data driven and experts' opinion approach is the basis for proposing an optimal simplified set of responder criteria for OA clinical trials. Other studies, using other sets of OA patients, are required in order to further validate this proposed OMERACT-OARSI set of criteria.