Measuring the functional status of patients with low back pain. Assessment of the quality of four disease-specific questionnaires.

Study Design: This study was a literature review of the quality of four disease-specific functional status questionnaires for patients with low back pain: Oswestry; Million; Roland; and Waddell disability questionnaire.

Objectives: The questionnaires were evaluated in terms of general description, scale structure, reliability, validity, responsiveness, and clinical research applications.

Summary Of Background Data: Functional status is an outcome of great interest for clinical trials of low back pain.

Methods: A computer-aided search was conducted of articles published between 1981 and 1993 and references given in selected relevant publications. Articles were selected if at least one of the four functional status questionnaires was used or if the authors gave relevant information about the methodology of these questionnaires.

Results: There was not enough information available about the criteria of item selection used for the development of the questionnaires. The test-retest reproducibility of the questionnaires seemed satisfactory. The Oswestry and Roland disability questionnaires have been used and evaluated more frequently than the Million and Waddell. Therefore, we can be more certain about the validity and responsiveness of the former pair of questionnaires.

Conclusion: In the absence of a gold standard, direct comparisons of evaluative functional status questionnaires in a single patient group are needed. Through direct comparisons, comparative validity and responsiveness can be assessed. Functional status measures are not currently used in many settings in which they would be valuable. It is important to encourage their wider use in clinical trials. Additional research is needed to compare and improve the existing questionnaires.