Application of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief: A randomized clinical trial

Introduction

A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk.

Methods

This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention.

Results

There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023).

Discussion

A behavioral economics-informed video did not increase patients’ intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management.

Conclusion

Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.     

Bioassays for itraconazole blood levels: an interlaboratory collaborative study.

Duplicate bioassays for itraconazole and hydroxy-itraconazole were run with 30 serum samples in five laboratories, each using a different method. Both itraconazole and hydroxy-itraconazole were used as standards. Despite quantitative variations, the results of the bioassays correlated sufficiently to indicate the relative level of antifungal activity in the test samples.