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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
         Patient burden
To reduce this burden, we suggest that additional sessions should not be planned just for data gathering, independent of clinical activity--whether experimental or usual care, but that data be gathered as much as possible during regularly scheduled clinical treatment sessions and that measures be organized according to those that can be completed by the subject at other times, such as at home and returned by mail--the latter applies particularly to baseline and follow up questionnaire data. It is strongly recommended that most questionnaire and interview data collections done in the clinic be limited to 30 minutes of patient time; baseline and final follow up assessments may be longer but only after careful explanation to the patient. In our experience, baseline questionnaires requiring more than 45-60 minutes to complete will most likely not be successful.



 

 

 

 

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