Table 2. Errors in Response Evaluation Criteria in Solid Tumor Methodology Discovered at Quality Improvement Review.
Error Category | 1st 6 Months n (%) | 2nd 6 Months n (%) | P Value for Change |
---|---|---|---|
Baseline selection of lesions | |||
Selection of target lesion when not unequivocally a metastasis | 2 (3.8) | 0 (0) | .15 |
Selection of too many target lesions at baseline | 3 (5.7) | 1 (1.2) | .30 |
Inappropriate selection of small lesions as target lesions | 3 (5.7) | 1 (1.2) | .30 |
Inappropriate selection of target lesion from within radiation field | 2 (3.8) | 0 (0) | .15 |
Reassessment of target lesions | |||
Remeasurement of lesions in a different phase of contrast than baseline | 2 (3.9) | 0 (0) | .05 |
Failure to change measurement axis with changes in lesion orientation | 1 (2.0) | 0 (0) | .23 |
Reassessment of nontarget lesions | |||
Premature assignment of PD for nontarget lesions | 3 (5.9) | 2 (1.2) | .08 |
Incorrect designation of PR for nontarget lesions | 2 (3.9) | 0 (0) | .05 |
Comparison to the incorrect prior scan | 2 (3.9) | 0 (0) | .05 |
Failure to assign CR for nontarget lymph nodes falling less than 10 mm | 1 (2.0) | 1 (0.6) | .40 |
Identification of new lesions | |||
Premature assessment of new disease on anatomic imaging | 2 (3.9) | 0 (0) | .05 |
Premature assessment of new disease on FDG-PET studies | 1 (2.0) | 0 (0) | .23 |
CR, complete response; FDG-PET, 18-F-fluorodeoxyglucose positron emission tomography; PD, progressive disease; PR, partial response.
Note: Error frequencies for the first category are reported as percentage of baseline assessments. Error frequencies for the second through fourth categories are reported as percentages of follow-up assessments. Differences in error rates evaluated in Stata 13 (StataCorp LP, College Station, TX) using Fisher's exact test.