Comment on: Gap between glycemic, patient-reported outcomes in HypoDE study
The study is a good one, and the authors are to be commended for exploring the different effect sizes, but they say it themselves in the conclusion – the study simply wasn’t powered on patient-reported outcomes. It was powered on glycemic control. Patient-reported outcomes are always a secondary outcome to glycemic control in clinical trials – something that has been argued to be inappropriate for some time by many.
Research funding is competitive with an emphasis on biomedical outcomes at the lowest cost. This “race to the bottom” unfortunately dictates that the smallest number of participants are recruited and patient-reported outcomes, as a secondary outcome, are inevitably insufficiently powered to demonstrate an effect. Glycemic control cannot and will not aid understanding of the potential burden of living with real-time continuous glucose monitoring in terms of carrying the device, additional visibility of disease state, nor intrusion of alarms. All of which are fundamentally important to whether an individual will actually be able or willing to use the device.
This could account for the small effect on diabetes distress [with] the device potentially adding to burden but [having a] medium effect size on satisfaction with device and fear of hypos – being able to see and react quickly to the data. Life’s full of trade-offs. This is why it is so important to conduct mixed methods psychosocial evaluation, ie, questionnaires and interviews. The depth of rich data gathered in well-planned and well-conducted interviews adds meaning and context to the numbers.