Table 1

 Coding method and reliability for benefit paragraphs

Direct benefits+1“This drug may result in tumour shrinkage”Pearson coefficient based on mean for each formBenefits possibility: 0.984
“You may experience relief of your symptoms”
“Results in animals are promising”
“This may induce an immune response to your cancer”
0“You may or may not benefit”
“Direct benefit can not be guaranteed”
“You may not benefit from the procedures”Direct benefits proportion: 0.982
“You are the first person to receive this drug”
−1“You are unlikely to benefit from the drug”
“This treatment is not a cure”
“Despite treatment, your condition will likely worsen”
“Any improvement will stop when study ends”
OtherA“Your participation may benefit others with the disease”Cohen’s kappa0.981
“You will be helping scientists to learn whether…”
P“The goal of this study is to test the drug’s safety”0.987
“The study is designed to determine if…”
H“The treatment you receive may even be harmful”1.00
“The approach may prove to be toxic”
Agent+1“drug”, “gene therapy”, “medicine”, “vaccine”, “therapy”, “treatment”, “immunisation”Pearson coefficient based on mean for each form0.987
0“approach”, “gene transfer”, “injection”, “method”, “procedure”, “product”, “regimen”, “substance”, “technique”; technical terms (eg “vector”, “virus”, “modified cells”, “Ad-p53”); tradenames (eg “TRICOM”, “TNFerade”), “treated cells”
−1Any of the above when preceded by adjectives “experimental”, “investigational”, “research”, “study”, “test” (eg “study drug”, “experimental gene therapy”, etc)