Primary Care Lifestyle Redesign® Clinical Trial: Diabetes Outcomes, Healthcare Utilization, and Costs.

Only 51 of the 73 people offered the programme took it up, so the comparison is partly between people who chose the treatment and people who were never offered it. The study is small, and the authors say it may not have had the numbers to detect a real difference (reduced statistical power). People were randomised after their provider had referred them, and every participant had already been judged willing to make lifestyle changes, which the authors say may have skewed the two groups and made differences harder to detect. Clinical data came out of routine care records, so it was collected sporadically; the authors could not run an intention-to-treat analysis or compare participants with non-participants. Everything happened in one clinic, so the authors cannot say how much of the change came from system-wide shifts in how that public health system delivered care during the study. The cost analysis left out overheads such as treatment space and administrative time, and the full-time projection simply assumes the savings double when the hours double, which the authors say will not hold exactly. Eight of the 51 people who started the programme (15.7%) were lost after their initial assessment.

Funded by the Southern California Clinical and Translational Science Institute through the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors disclose close professional ties to the approach being tested: one facilitates the OT Primary Care Learning Collaborative, a network that advocates for integrating occupational therapy into primary care, and two direct and co-direct Lifestyle Redesign Strategic Partnerships within a university initiative that promotes integrating Lifestyle Redesign into practice settings. One of those authors is also the editor of the special issue in which the paper appears, and recused herself from editorial decisions on it. The occupational therapist who delivered the treatment was a faculty member of the university partner in the study.

Do not tell patients this programme brings their diabetes under control. Blood sugar, blood pressure, cholesterol and BMI all changed without reaching significance, and the authors say so themselves. The gains shown here are in emergency visits, hospital days and cost, not in measured diabetes control. The 236% return on investment is a projection for a full-time post, worked out by doubling the half-time results.