Approximate Bayesian Bootstrap procedures to estimate multilevel treatment effects in observational studies with application to type 2 diabetes treatment regimens

Randomized clinical trials are considered as the gold standard for estimating causal effects. Nevertheless, in studies that are aimed at examining adverse effects of interventions, randomized trials are often impractical because of ethical and financial considerations. In observational studies, matching on the generalized propensity scores was proposed as a possible solution to estimate the treatment effects of multiple interventions. However, the derivation of point and interval estimates for these matching procedures can become complex with non-continuous or censored outcomes. We propose a novel Approximate Bayesian Bootstrap algorithm that results in statistically valid point and interval estimates of the treatment effects with categorical outcomes. The procedure relies on the estimated generalized propensity scores and multiply imputes the unobserved potential outcomes for each unit. In addition, we describe a corresponding interpretable sensitivity analysis to examine the unconfoundedness assumption. We apply this approach to examine the cardiovascular safety of common, real-world anti-diabetic treatment regimens for type 2 diabetes mellitus in a large observational database.

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Selenium and Type 2 Diabetes: Systematic Review

Nutrients ◽

10.3390/nu10121924 ◽

2018 ◽

Vol 10 (12) ◽

pp. 1924 ◽

Cited By ~ 12

Author(s):

Lindsay Kohler ◽

Janet Foote ◽

Connor Kelley ◽

Ana Florea ◽

Colleen Shelly ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Clinical Trials ◽

Observational Studies ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Positive Association ◽

Significant Positive Association

Several studies have investigated the potential role of selenium (Se) in the development of type 2 diabetes (T2D) with disparate findings. We conducted a systematic review and meta-analysis to synthesize the evidence of any association between Se and T2D. PubMed, Embase, and Scopus were searched following the Preferred Reporting Items for Systematic Reviews and Meta-analysis Approach (PRISMA). Sixteen studies from 15 papers met inclusion criteria defined for this review. Of the 13 observational studies included, 8 demonstrated a statistically significant positive association between concentrations of Se and odds for T2D, with odds ratios (95% confidence intervals) ranging from 1.52 (1.01–2.28) to 7.64 (3.34–17.46), and a summary odds ratio (OR) (95% confidence interval (CI)) of 2.03 (1.51–2.72). In contrast, among randomized clinical trials (RCTs) of Se, a higher risk of T2D was not observed for those who received Se compared to a placebo (OR = 1.18, 95% CI 0.95–1.47). Taken together, the results for the relationship between Se and T2D differ between observational studies and randomized clinical trials (RCTs). It remains unclear whether these differences are the result of uncontrolled confounding in the observational studies, or whether there is a modest effect of Se on the risk for T2D that may vary by duration of exposure. Further investigations on the effects of Se on glucose metabolism are needed.

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Vitamin D Status, Calcium Intake and Risk of Developing Type 2 Diabetes: An Unresolved Issue

Nutrients ◽

10.3390/nu11030642 ◽

2019 ◽

Vol 11 (3) ◽

pp. 642 ◽

Cited By ~ 16

Author(s):

Araceli Muñoz-Garach ◽

Beatriz García-Fontana ◽

Manuel Muñoz-Torres

Keyword(s):

Type 2 Diabetes ◽

Vitamin D ◽

Clinical Trials ◽

Calcium Intake ◽

Observational Studies ◽

Randomized Clinical Trials ◽

Vitamin D Status ◽

Hydroxyvitamin D ◽

25 Hydroxyvitamin D

The relationship between vitamin D status, calcium intake and the risk of developing type 2 diabetes (T2D) is a topic of growing interest. One of the most interesting non-skeletal functions of vitamin D is its potential role in glucose homeostasis. This possible association is related to the secretion of insulin by pancreatic beta cells, insulin resistance in different tissues and its influence on systemic inflammation. However, despite multiple observational studies and several meta-analyses that have shown a positive association between circulating 25-hydroxyvitamin D concentrations and the risk of T2D, no randomized clinical trials supplementing with different doses of vitamin D have confirmed this hypothesis definitively. An important question is the identification of what 25-hydroxyvitamin D levels are necessary to influence glycemic homeostasis and the risk of developing T2D. These values of vitamin D can be significantly higher than vitamin D levels required for bone health, but the currently available data do not allow us to answer this question adequately. Furthermore, a large number of observational studies show that dairy consumption is linked to a lower risk of T2D, but the components responsible for this relationship are not well established. Therefore, the importance of calcium intake in the risk of developing T2D has not yet been established. Although there is a biological plausibility linking the status of vitamin D and calcium intake with the risk of T2D, well-designed randomized clinical trials are necessary to answer this important question.

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The association of dietary energy density and the risk of obesity, type 2 diabetes and metabolic syndrome: a systematic review and meta‐analysis of observational studies

International Journal of Clinical Practice ◽

10.1111/ijcp.14291 ◽

2021 ◽

Author(s):

Elham Bazshahi ◽

Fatemeh Sheikhhossein ◽

Mohammad Reza Amini ◽

Sakineh Shab‐Bidar

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Metabolic Syndrome ◽

Energy Density ◽

Observational Studies ◽

Meta Analysis ◽

Dietary Energy ◽

Dietary Energy Density

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Water intake and risk of type 2 diabetes: A systematic review and meta-analysis of observational studies

Diabetes & Metabolic Syndrome Clinical Research & Reviews ◽

10.1016/j.dsx.2021.05.029 ◽

2021 ◽

Author(s):

Nasim Janbozorgi ◽

Ramesh Allipour ◽

Kurosh Djafarian ◽

Sakineh Shab-Bidar ◽

Mostafa Badeli ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Water Intake ◽

Observational Studies ◽

Meta Analysis

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Glucagon-Like Peptide 1 Receptor Agonist (GLP1RA) Exposure and Outcomes in Type 2 Diabetes: A Systematic Review of Population-Based Observational Studies

Diabetes Therapy ◽

10.1007/s13300-021-01021-1 ◽

2021 ◽

Author(s):

Thomas M. Caparrotta ◽

Jack B. Templeton ◽

Thomas A. Clay ◽

Sarah H. Wild ◽

Rebecca M. Reynolds ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Observational Studies ◽

Receptor Agonist ◽

Population Based ◽

Glucagon Like Peptide ◽

Glucagon Like Peptide 1

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Cost-effectiveness of empagliflozin in patients with type 2 diabetes and established cardiovascular disease in China

Cost Effectiveness and Resource Allocation ◽

10.1186/s12962-021-00299-z ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Mafalda Ramos ◽

Peng Men ◽

Xu Wang ◽

Anastasia Ustyugova ◽

Mark Lamotte

Keyword(s):

Risk Factors ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Cost Effectiveness ◽

Willingness To Pay ◽

Incremental Cost ◽

Treatment Effects ◽

Specific Treatment ◽

Treatment Comparison

Abstract Background In several cardiovascular outcome trials (CVOTs), empagliflozin (SGLT-2 inhibitor), sitagliptin (DPP-4 inhibitor) and liraglutide (GLP-1 receptor agonist) + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and liraglutide + SoC based on the respective CVOT. Methods The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes. EMPA-REG OUTCOME baseline characteristics and CVOT specific treatment effects on risk factors for cardiovascular disease (HbA1c, BMI, blood pressure, lipids) were applied. Three-year observed cardiovascular events of empagliflozin + SoC versus sitagliptin + SoC and liraglutide + SoC were derived from EMPA-REG OUTCOME and an indirect treatment comparison. Relative risk adjustments to calibrate the CDM were obtained after a trial and error process to match as closely the observed and CDM-predicted outcomes. The drug-specific treatment effects were considered up until HbA1c reached 8.5% and treatment switch occurred. After this switch, the United Kingdom Prospective Diabetes Study 82 risk equations predicted events based on co-existing risk factors and treatment intensification to basal bolus insulin were applied. The analysis was conducted from the perspective of the Chinese healthcare system applying 3% discounting. The time horizon was lifelong. Results Empagliflozin + SoC provides additional Quality Adjusted Life years (QALY + 0.564) for an incremental cost of 42,497RMB (US$6053) compared to sitagliptin + SoC, resulting in an Incremental Cost Utility Ratio of 75,349RMB (US$10,732), thus below the willingness-to-pay threshold of 212,676RMB, corresponding to three times the Gross Domestic Product in China (2019). Compared to liraglutide + SoC, empagliflozin + SoC use leads to 0.211QALY gained and cost savings of 71,427RMB (US$10,173) and is as such dominant. Scenario and probabilistic sensitivity analyses demonstrated the robustness of the results. Conclusion Results suggest that empagliflozin + SoC is cost-effective compared to sitagliptin + SoC and liraglutide + SoC at a willingness-to-pay threshold of 212,676RMB ($30,292)/QALY.

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Breakfast skipping and the risk of type 2 diabetes: a meta-analysis of observational studies

Public Health Nutrition ◽

10.1017/s1368980015000257 ◽

2015 ◽

Vol 18 (16) ◽

pp. 3013-3019 ◽

Cited By ~ 71

Author(s):

Huashan Bi ◽

Yong Gan ◽

Chen Yang ◽

Yawen Chen ◽

Xinyue Tong ◽

...

Keyword(s):

Type 2 Diabetes ◽

Observational Studies ◽

Meta Analysis ◽

Adjusted Relative Risk ◽

China National Knowledge Infrastructure ◽

Cross Sectional ◽

Breakfast Skipping ◽

Risk Estimates ◽

Increased Risk

AbstractObjectiveBreakfast skipping has been reported to be associated with type 2 diabetes (T2D), but the results are inconsistent. No meta-analyses have applied quantitative techniques to compute summary risk estimates. The present study aimed to conduct a meta-analysis of observational studies summarizing the evidence on the association between breakfast skipping and the risk of T2D.DesignSystematic review and meta-analysis.SettingRelevant studies were identified by a search of PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI) and SINOMED up to 9 August 2014. We also reviewed reference lists from retrieved articles. We included studies that reported risk estimates (including relative risks, odds ratios and hazard ratios) with 95 % confidence intervals for the association between breakfast skipping and the risk of T2D.SubjectsEight studies involving 106 935 participants and 7419 patients with T2D were included in the meta-analysis.ResultsA pooled adjusted relative risk for the association between exposure to breakfast skipping and T2D risk was 1·21 (95 % CI 1·12, 1·31; P=0·984; I2=0·0 %) in cohort studies and the pooled OR was 1·15 (95 % CI, 1·05, 1·24; P=0·770; I2=0·0 %) in cross-sectional studies. Visual inspection of a funnel plot and Begg’s test indicated no evidence of publication bias.ConclusionsBreakfast skipping is associated with a significantly increased risk of T2D. Regular breakfast consumption is potentially important for the prevention of T2D.

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