Full Description
Despite more than 50 years' experience with outcome measurement in musculoskeletal clinical trials, there is little conformity in the methods used, and no standard text on clinical metrology exists. This new book reviews the methods used to assess the clinical efficacy of antirheumatic drugs in adult patients with musculoskeletal disease, focusing primarily on clinical rather than laboratory or radiographic measures. There are four parts: overviews of fundamental issues in clinical metrology; of outcome measures relevant to antirheumatic drugs; a review of current clinimetric practices in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and fibromyalgia clinical trials; and a discussion of different measurement techniques. The text is complemented by many illustrations and three appendices. The book is a highly informative text which will be of interest to all involved in evaluating treatment strategies for musculoskeletal patients, as well as those involved in the development and regulation of antirheumatic drugs.
Contents
Foreword. Preface. Part IThe Evolution of Assessment Techniques. 2. Reliability. 3. Validity. 4. Responsiveness. 5. Scaling Options. 6. Weighting and Aggregation. 7. Reporting, Application and Utilization. Part II: Unidimensional and Multidimensional Outcome Measures. 8. Pain Measurement. 9. Health Status Instruments and Functional Indices. 10. Articular Indices. 11. Mechanical and Electromechanical Devices. 12. Composite Indices. Part III: Current Clinimetric Practices in Musculoskeletal Clinical Trials. 13. Rheumatoid Arthritis. 14. Osteoarthritis. 15. Ankylosing Spondylitis. 16. Fibromyalgia. Part IV: Clinical Applications and Implications. 17. Standardised Procedures for Outcome Measurement and Parameters for Calculating Sample Size for Antirheumatic Drug Studies. 18. Future Perspective. Appendix A: Functional Indices and Health Status (1937-1992). Appendix B: Standard Deviation Tables for Sample Size Calculation in Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis and Fibromyalgia Clinical Trials. Appendix C: Estimated Sample Size Requirements for Clinical Trials in Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis and Fibromyalgia. Index.
