Title
Author
DOI
Article Type
Special Issue
Volume
Issue
Practical Implications of Noncompliance in Randomized Clinical Trials for Temporomandibular Disorders
1Departrnent of Bioststistics, School of Public Health, University of Washington, Seattle, Washington
2Department of Denial Public Health Sciences, School of Dentistiy, University of Washington, Seattle, Washington
3Department of Oral Medicine, School of Dentistry, University of Washington, Seattle, Washington
4Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, University of Washington
*Corresponding Author(s): Coralyr W. Whitney E-mail:
Randomized clinical trials are recognized as providing the most rigorous evidence of treatment efficacy. For temporomandibular disorders, randomized clinical trials have been used to evaluate the efficacy of low-cost occlusal appliances or the adjunct use of cognitive behavioral interventions. However, noncompliance with treatment regimens and losses to follow up are common randomized clinical trial protocol violations that compromise the desired rigor of the trial. At times it is not clear to the investigator how to deal with these issues during the trial and at the data analysis phase. Often treatment efficacy is based on the compliant subjects, subjects who may no longer represent randomized groups or yield the desired "fair" estimate of treatment efficacy. This study focuses on management of compliance issues, the description and collection of data needed to obtain a more accurate assessment of treatment efficacy, and results particularly relevant to actual clinical practice and patient care decisions. These are applied to a randomized clinical trial evaluating the efficacy of a cognitive-behavioral intervention for temporomandibular disorders.
noncompliance; randomized clinical trials; temporomandibular disorders; intention-to-treat
Coralyr W. Whitney,Samuel F. Dworkin. Practical Implications of Noncompliance in Randomized Clinical Trials for Temporomandibular Disorders. Journal of Oral & Facial Pain and Headache. 1997. 11(2);130-138.
Science Citation Index (SCI)
Science Citation Index Expanded (SCIE)
BIOSIS Previews
Scopus
Cumulative Index to Nursing and Allied Health Literature (CINAHL)
Top