Background: Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes.
Methods/design: This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups.
Discussion: The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly.
Trial Registration: The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956 . Registered January 2017.
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http://dx.doi.org/10.1186/s13063-018-2805-2 | DOI Listing |
JAMA Netw Open
January 2025
Department of Global Health, School of Public Health, Boston University, Boston, Massachusetts.
Importance: Semaglutide, a novel glucagon-like peptide-1 (GLP-1) receptor agonist medication, was approved for weight management in individuals with obesity in June 2021. There is limited evidence on factors associated with uptake among individuals in this subgroup without diabetes.
Objective: To explore factors associated with semaglutide initiation among a population of commercially insured individuals with obesity but no diagnosed diabetes.
JAMA Netw Open
January 2025
Department of Family Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Importance: There is limited evidence regarding the association between age at menopause and incident type 2 diabetes (T2D).
Objective: To investigate whether age at menopause and premature menopause are associated with T2D incidence in postmenopausal Korean women.
Design, Setting, And Participants: This population-based cohort study was conducted among a nationally representative sample from the Korean National Health Insurance Service database of 1 125 378 postmenopausal women without T2D who enrolled in 2009.
JAMA Intern Med
January 2025
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Importance: Evidence on cardiovascular benefits and safety of sodium-glucose cotransporter 2 (SGLT-2) inhibitors is mainly from placebo-controlled trials. Therefore, the comparative effectiveness and safety of individual SGLT-2 inhibitors remain unknown.
Objective: To compare the use of canagliflozin or dapagliflozin with empagliflozin for a composite outcome (myocardial infarction [MI] or stroke), heart failure hospitalization, MI, stroke, all-cause death, and safety outcomes, including diabetic ketoacidosis (DKA), lower-limb amputation, bone fracture, severe urinary tract infection (UTI), and genital infection and whether effects differed by dosage or cardiovascular disease (CVD) history.
JAMA Intern Med
January 2025
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Importance: No large randomized clinical trial has directly compared empagliflozin with dapagliflozin, leaving their comparative effectiveness regarding kidney outcomes unknown.
Objective: To compare kidney outcomes between initiation of empagliflozin vs dapagliflozin in adults with type 2 diabetes who were receiving antihyperglycemic treatment.
Design, Setting, And Participants: This target trial emulation used nationwide, population-based routinely collected Danish health care data to compare initiation of empagliflozin vs dapagliflozin in adults with type 2 diabetes who received antihyperglycemic treatment between June 1, 2014, and October 31, 2020.
JAMA Pediatr
January 2025
Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Importance: Data regarding the long-term impact of treating childhood obesity on the risk of obesity-related events, including premature mortality, are limited.
Objective: To evaluate the long-term effect of different responses to pediatric obesity treatment on critical health outcomes in young adulthood.
Design, Setting, And Participants: The study included a dynamic prospective cohort of children and adolescents with obesity within The Swedish Childhood Obesity Treatment Register (BORIS) and general population comparators, linked with national registers.
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