Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications. (August 2020)

• Record Type: Journal Article
• Authors: Strain, William David; Paldánius, Päivi Maria
• Is Part Of: Diabetes research and clinical practice. Volume 166(2020)
• Publication Date: 2020-08
• Subjects: Chronic kidney disease -- Clinical inertia -- Placebo effect -- Randomised controlled trials -- Type 2 diabetes mellitus; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2020.108310
• Languages: English
• ISSNs: 0168-8227

Abstract

Highlights: The placebo effect of RCTs is a proxy for non-pharmacological clinical inertia. We explored the placebo effect in 3081 placebo treated patients in RCTs. Placebo effects were comparable irrespective of age and multimorbidity. We propose that clinical inertia can be improved irrespective of demographics. Abstract: Aim: Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required. Methods: We compared improvement in glycaemic control in a pooled set of people assigned to the "placebo" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated. Results: The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between −0.23% (−2.50 mmol/mol) and −0.32% (−3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months. Conclusions: Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.