Dataset Information

Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey.

ABSTRACT:

Aims/hypothesis

Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents.

Methods

The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided.

Results

Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding.

Conclusions/interpretation

This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.

SUBMITTER: Bogdanet D

PROVIDER: S-EPMC6805965 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionMost adults with type 2 diabetes (T2D) have several chronic conditions treated with complex regimens and multiple medications. The burden and complexity of multiple medication use are associated with worse patient outcomes, including reduced adherence and increased costs, hospitalizations, mortality rates, and HbA1c. This study quantifies the chronic medication burden, regimen complexity, and potential medication interactions in patients with T2D using a nationwide claims database in the USA.MethodsAdults with T2D treated for greater than half of the year with at least one glucose-lowering agent (GLA) in 2017 were included in this descriptive study. Chronic medications were defined as all GLAs and non-GLA medications prescribed for at least 90 days in 2017 to at least 2% of the cohort. Medication burden, defined as the number of medications prescribed, was examined. Medication complexity, proxied by the Medication Regimen Complexity Index (MRCI), and potential use of interacting medications were also examined. Results were investigated for all chronic medications and were reported on the basis of the disease treated (diabetes or other condition) and the route of administration (oral or other).ResultsOn average, in 2017, the 814,156 patients included in the study filled prescriptions for 4.1 chronic medications (standard deviation [SD]?=?2.0), 3.7 oral chronic medications (SD?=?1.9), 1.5 GLAs (SD?=?0.8), and 1.1 oral GLAs (SD?=?0.7). The average MRCI was 14.7 for all chronic medications (SD?=?7.4), with a mean of 12.4 for all oral chronic medications (SD?=?6.3), 6.6 for all GLAs (SD?=?3.8), and 4.9 for oral GLAs (SD?=?2.6).ConclusionOn average, patients with T2D used multiple medications, had a complex medication regimen, and were at potential risk of medication interactions. These findings suggest that patients, practitioners, pharmacists, and payers may benefit from interventions which decrease medication burden, complexity, and/or adverse events related to the treatment of T2D.

Project description:AIMS/HYPOTHESIS:The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS:We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS:Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION:This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION:This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

Project description:ObjectivesA core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).DesignSystematic review.Data sourcesEMBASE, Medline, Web of Science, COMET database and hand-searching.Eligibility criteriaProtocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.Data extraction and synthesisDelphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.ResultsOf 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30-113) vs 30 (IQR 14-66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37-78) vs 20% (IQR 0-68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.ConclusionsThere is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.Prospero registration numberCRD42019138519.