Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes

Kheniser, Karim; Aminian, Ali; Kashyap, Sangeeta R.

doi:10.1089/met.2022.0039

Metabolic Syndrome and Related Disorders

2022

DOI: 10.1089/met.2022.0039

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Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes

Karim Kheniser

Ali Aminian

Sangeeta R. Kashyap

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2024

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Cited by 1 publication

References 119 publications

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Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs

de Wit,

van Luik,

Marrero

et al. 2024

Diabet Med

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AimRecently, efforts have been made to use and report person‐reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains.MethodsThe largest trial registries (Clinicatrials.gov, International Clinical Trial Platform and ISRCTN) were systematically searched for RCTs in people with type 1 and/or type 2 diabetes of all ages between 2018 and 2023. Coding of PROs comprised: (1) PRO measure(s) included yes or no; if yes: (2) PRO(s) as primary outcome yes or no; and (3) mapping PROMs onto predefined PRO domains and per type of intervention.ResultsN = 1543 trials met our inclusion criteria, of which n = 673 (44%) included PROs, assessed by 545 different measures. Twenty per cent of drug trials (n = 112) and 71% of behavioural interventions (n = 405) included PROs. In 149 trials (9.6%), a PRO was the primary outcome. The psychological functioning domain was most often assessed across all trials (21.6%), specifically in behavioural (44.8%) and medical device interventions (29.7%). In drug trials, the physical functioning and functional health domain was most included (9%). Across all trials, the social and family functioning domain was least assessed (3%).ConclusionsWe noticed an increase in the inclusion of PROs in diabetes RCTs. However, PROs are rarely included as primary outcomes in the majority of studies, particularly in drug trials. The heterogeneity of PROMs used in RCTs underscores the need for standardisation of PROs.

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Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs

de Wit,

van Luik,

Marrero

et al. 2024

Diabet Med

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Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes

Cited by 1 publication

References 119 publications

Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs

Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs

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