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dc.contributor.authorStrain, W David
dc.date.accessioned2021-02-02T10:39:41Z
dc.date.available2021-02-02T10:39:41Z
dc.date.issued2020-08
dc.identifier.citationStrain WD, Paldánius PM. Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications. Diabetes Res Clin Pract. 2020 Aug;166:108310. doi: 10.1016/j.diabres.2020.108310. Epub 2020 Jul 8.en_US
dc.identifier.pmid32650033
dc.identifier.doi10.1016/j.diabres.2020.108310
dc.identifier.urihttps://rde.dspace-express.com/handle/11287/621598
dc.description.abstractAim: 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.en_US
dc.language.isoenen_US
dc.publisherElsevier Scienceen_US
dc.relation.urlhttps://linkinghub.elsevier.com/retrieve/pii/S0168-8227(20)30562-3en_US
dc.rightsCopyright © 2020 Elsevier B.V. All rights reserved.en_US
dc.subjectChronic kidney diseaseen_US
dc.subjectClinical inertiaen_US
dc.subjectPlacebo effecten_US
dc.subjectRandomised controlled trialsen_US
dc.subjectType 2 diabetes mellitusen_US
dc.subjectWessex Classification Subject Headings::Endocrinology::Diabetesen_US
dc.titleEffect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complicationsen_US
dc.typeJournal Articleen_US
dc.identifier.journalDiabetes Research and Clinical Practiceen_US
dc.description.fundingThe study was funded by Novartis. WDS holds research grants from Novo Nordisk and Takeda. WDS would like to acknowledge the support of the NIHR Exeter Clinical Research Facility and the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula. WDS would like to add that the views expressed in this publication are those of the authors and not necessarily those of the NIHR Exeter Clinical Research Facility, the NHS, the NIHR or the Department of Health in England. PMP was employed by Novartis at the time of the initial analyses.en_US
dc.type.versionPublisheden_US
dc.description.admin-notepublished version, accepted version (12 month embargo)en_US


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