Background: Clinical trials should ideally use patient-important outcomes to ensure their results are clinically relevant. We aimed to determine if the proportion of patient-important outcomes in surgical trials has changed over the last decade, and to determine whether patient-important outcomes are more likely to be specified as primary outcomes.
Methods: The 350 most recent randomized controlled trials examining surgical interventions on humans and published in English were included. Outcomes were classified as patient-important, surrogate or laboratory using standardized definitions, along with either primary, secondary or unspecified. Mean proportions were calculated across all trials and a chi-squared test was used to detect the difference between time periods. Contingency tables were populated with each trial's outcomes, characterizing whether each outcome was patient-important or not, and whether it was specified as primary or secondary. Odds ratios were then combined in a random-effects meta-analysis to calculate a pooled odds ratio.
Results: A total of 64% of all outcomes were patient-important. The mean (standard deviation) proportion of patient-important outcomes per trial was 66% (31.4), which significantly increased over the last decade, from 60% (31.6) in 2009. The mean proportion of primary outcomes which were patient-important increased from 64% (46.0) in 2009 to 77% (40.6) in 2019. Patient-important outcomes were not significantly associated with being a primary outcome and this did not change significantly over the decade.
Conclusion: Patient-important outcomes are still poorly represented as primary outcomes. The ongoing impact of updated reporting guidelines may improve the reporting of patient-important outcomes in surgical trials.
Keywords: health care/standard; human; operative/standard; outcome assessment; patient outcome assessment; randomized controlled trials as topic/standard; surgical procedures.
© 2021 Royal Australasian College of Surgeons.