Quality CriteriaImportant to Drug Treatment TrialsImportant in Studies Relating PFS to QoLUnique to Trials Comparing PFS and QoL
Selection bias
Subjects in different groups recruited from same populationXX
Subjects in different groups recruited over same time periodXX
Inclusion/exclusion criteria clearly statedXX
Randomization usedX
Comparable baseline characteristics between groupsX
Apart from treatment under investigation, groups treated equallyX
Similarity between groups in potentially important confounders (e.g., those with and without PFS) or adequate adjustment for confoundingX
Patients are not censored at progressionX
Performance bias
PFS assessed in valid and reliable manner (central radiology review, RECIST criteria used, inter- and intra- observer variability reported)XX
Subjects and investigators blind to treatment groupXX
Subjects awareness of PFS status is describedX
Attrition bias
Missing data addressed through description and analysisXX
Results unlikely to be affected by losses to follow-upXX
Missing data likely to be at randomXX
Detection bias
Outcome (progression) assessors blind to treatment groupXX
PFS and other endpoints definedXX
QOL administration process was describedXX
A priori hypothesis regarding the relationship between PFS and QOLX

From: Appendix F, Relevance of Quality Assessment Items

Cover of Progression-Free Survival: What Does It Mean for Psychological Well-Being or Quality of Life?
Progression-Free Survival: What Does It Mean for Psychological Well-Being or Quality of Life? [Internet]
Gutman SI, Piper M, Grant MD, et al.

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