Bias due to changes in specified outcomes during the systematic review process

Ref ID 539
First Author J. J. Kirkham
Journal PLOS ONE
Year Of Publishing 2010
URL https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842442/pdf/pone.0009810.pdf
Keywords Cochrane
Protocols
Multiplicity
General medical
Problem(s) Undocumented or unjustified deviations to the review protocol
Multiplicity of outcomes and lack of pre-specification for outcome reporting
Failure to define clinically meaningful outcomes
Number of systematic reviews included 297
Summary of Findings 22% of the 297 included protocol/review pairings contained a discrepancy in at least one outcome measure, of which 75% were attributable to changes in the primary outcome measure. Where lead authors could recall a reason for the discrepancy in the primary outcome, 29% of these reviews made changes after knowledge of the results from individual trials. Only 6% of reviews with an outcome discrepancy described the reason for the change in the review.
Did the article find that the problem(s) led to qualitative changes in interpretation of the results? Yes
Are the methods of the article described in enough detail to replicate the study? No