Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents: study protocol for the identification of a core outcomes set using a Delphi survey.
Core outcome set
Gestational diabetes
Insulin
Oral hypoglycaemic agents
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 Jan 2019
05 Jan 2019
Historique:
received:
15
06
2018
accepted:
19
11
2018
entrez:
7
1
2019
pubmed:
7
1
2019
medline:
29
5
2019
Statut:
epublish
Résumé
Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies. The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at 1 year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents. This protocol will describe the steps that will be taken in order to develop the COS. The study will consist of three parts: (1) A systematic review of the literature of the outcomes reported in previous randomised controlled trials of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; (2) A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; and (3) A consensus meeting where the final COS will be decided. The proposed protocol is the first step in developing a COS that will bring consistency and uniformity to outcome selection and reporting in GDM women treated with insulin and/or oral hypoglycaemic agents.
Sections du résumé
BACKGROUND
BACKGROUND
Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies. The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at 1 year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents.
METHODS/DESIGN
METHODS
This protocol will describe the steps that will be taken in order to develop the COS. The study will consist of three parts: (1) A systematic review of the literature of the outcomes reported in previous randomised controlled trials of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; (2) A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; and (3) A consensus meeting where the final COS will be decided.
DISCUSSION
CONCLUSIONS
The proposed protocol is the first step in developing a COS that will bring consistency and uniformity to outcome selection and reporting in GDM women treated with insulin and/or oral hypoglycaemic agents.
Identifiants
pubmed: 30611300
doi: 10.1186/s13063-018-3059-8
pii: 10.1186/s13063-018-3059-8
pmc: PMC6321696
doi:
Substances chimiques
Hypoglycemic Agents
0
Insulin
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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