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Clinical Trials in TMD Sections
Author Bio
Introduction
The Biopsychosocial Model
Designing Multicenter RCTs
Players in an RCT
Randomization
Trial Design Quality
TMD Case Definition
Endpoints and Outcome Measures
Blinding & Masking
Study Sample Size
Number and Nature of Interventions
Study Length and Follow up
Intent-to-treat Analyses and Sample Size
Currently selected section: Compliance
Multicenter RCTs
Implementing RCTs: Practical Issues
Analysis of TMD Trials
Conclusions
Acknowledgments
Appendix A
Appendix B

 

Chapter 22: Clinical Trials in Temporomandibular: Compliance
        

Compliance or adherence to the study protocol should be actively encouraged throughout the design and conduct of any trial. It is imperative that TMD RCT compliance be viewed from two perspectives:

  • For the patient, there are issues relating to patient burden and patient compensation.
  • For the clinician, there is the need for adherence to treatment protocols.

A practical consideration in planning RCTs using TMD clinical cases is the burden the trial may place on the patient, above and beyond the burden of customary treatment. In an RCT, which remains one of the more expensive forms of clinical investigation, loss of subjects for any reason is regrettable, but it is especially regrettable when the investigators contribute to drop out rates by not being sensitive to the RCT study patient burden.


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