Improving patient recruitment to randomised trials can be cost-effective: A case-study of dexamethasone from the RECOVERY trial.

Abstract

BackgroundThe RECOVERY trial assessed the effectiveness of treatments on preventing severe outcomes from COVID-19 disease in hospitalised patients from 176 NHS hospitals. Clinical benefits of Dexamethasone were observed for hospitalised COVID-19 patients. About 15% of all eligible patients were recruited into the trial. Had patient recruitment been higher the study would have been completed more rapidly.AimTo estimate the cost-effectiveness of improving recruitment to the RECOVERY trial from 15% to 50%, by employing or redeploying two research nurses to each hospital participating in the RECOVERY trial. The analysis is restricted to the evaluation of Dexamethasone versus No Dexamethasone.MethodsA decision tree model was developed to estimate the cost-effectiveness of Dexamethasone, against No Dexamethasone. Probability, utility, and cost inputs were used for each pathway and treatment. Then, a cost-utility analysis of clinical practice post-RECOVERY trial (83% Dexamethasone, 17% No Dexamethasone) versus previous clinical practice (100% No Dexamethasone) was undertaken; this analysis was aggregated at the population level and the cost of employing or redeploying two research nurses at each hospital was added, to estimate the cost-effectiveness of faster recruitment to the RECOVERY trial.ResultsFaster recruitment to the RECOVERY trial could have generated an incremental net benefit of £13,955,476 related to the evaluation of Dexamethasone against No Dexamethasone, thus highlighting the magnitude of the foregone incremental net benefit due to not adopting a more cost-effective clinical practice (83% Dexamethasone, 17% No Dexamethasone) earlier. The findings remain robust following variations in the model's parameters, with a 85% and 94% probability of faster recruitment being cost-effective given a cost-effectiveness threshold of £20,000 and £30,000 per Quality Adjusted Life Year respectively.ConclusionSlow recruitment to randomised trials can have huge implications for healthcare systems as a result of not introducing a more cost-effective treatment earlier through faster patient recruitment.