Selection of measures suitable for evaluating change in fibromyalgia (FM) clinical trials

OBJECTIVE: To use growth curve model methods to investigate which of
46 variables associated with fibromyalgia (FM) clinical trials
are potentially useful in measuring change.

METHODS: For each of the 46 variables the reliability of change and
corresponding standard error were estimated. Data were from a
randomized clinical trial designed to compare the
effectiveness of biofeedback/relaxation, exercise, and a
combined program for the treatment of FM. There was also a
control group.

RESULTS: The reliabilities of change for the outcome variables
Myalgic Score, Tenderpoint Count, and Tenderpoint Index, as well
as the variable, number of words chosen from the McGill Pain
Questionnaire were quite acceptable for both the 18 and 58 week time
periods. There were 9 other variables that had reliabilities of change in the acceptable range.

CONCLUSION: Thirteen of 46 variables
considered had desirable reliabilities of change by the
methods used. The 3 variables often used as measures of
disease activity as well as one pain variable were among the
13. Data from this study produced no acceptable reliabilities
of change for the 33 other variables. For these variables,
further evaluation is required.
EM- 0

Hewett JE, Buckelew SP, Johnson JC, Shaw SE, Huyser B, Fu YZ

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