Impact of diabetes mellitus on clinical outcomes of pancreatic cancer after surgical resection: A systematic review and meta-analysis

Patient activation has been recognised as a reliable driver of self-management decision-making. This systematic review and meta-analysis examines existing evidence on whether embedding patient activation within Type 2 diabetes mellitus (T2DM) self-management programs can improve patient outcomes. This review has included 10 randomised controlled trials (RCTs) conducted between 2004 and 2019 retrieved from well-known databases such as MEDLINE, PubMed, CINAHL Plus, Scopus, ProQuest and ScienceDirect. The eligible RCTs were excluded if they scored low according to Cochrane Collaboration’s ‘risk of bias’ criteria. Random-effects meta-analyses showed that there were no significance changes in haemoglobin A1C (HbA1c), body mass index (BMI) and patient activation measure (PAM) between intervention and control groups after the intervention; however, the systematic review findings indicated that an improved patient activation level led to significant improvements in T2DM self-management and clinical outcomes including HbA1c level. Studies with a longer follow-up period conducted in community settings and delivered by peer coaches were more likely to lead to significant improvement in both patient activation levels and T2DM self-management and clinical outcomes. This review concludes that patient activation can be used as a reliable tool for improving T2DM self-management and clinical outcomes.

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Glycated hemoglobin as a surrogate for evaluating the effectiveness of drugs in diabetes mellitus trials: a systematic review and trial-level meta-analysis

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321001689 ◽

2021 ◽

Vol 38 (1) ◽

Author(s):

Paola Andrea Rivera ◽

Milton J. M. Rodríguez-Zúñiga ◽

José Caballero-Alvarado ◽

Fabián Fiestas

Keyword(s):

Diabetes Mellitus ◽

Myocardial Infarction ◽

Heart Failure ◽

Systematic Review ◽

Clinical Outcomes ◽

Randomized Clinical Trials ◽

Glycated Hemoglobin ◽

Meta Analysis ◽

Strong Association ◽

Kidney Injury

Abstract Objective The objective of this study was to investigate whether glycated hemoglobin (HbA1c) is a valid surrogate for evaluating the effectiveness of antihyperglycemic drugs in diabetes mellitus (DM) trials. Methods We conducted a systematic review of placebo-controlled randomized clinical trials (RCTs) evaluating the effect of a treatment on HbA1c (mean difference between groups) and clinical outcomes (relative risk of mortality, myocardial infarction, stroke, heart failure, and/or kidney injury) in patients with DM. Then, we investigated the association between treatment effects on HbA1c and clinical outcomes using regression analysis at the trial level. Lastly, we interpreted the correlation coefficients (R) using the cut-off points suggested by the Institute for Quality and Efficiency in Healthcare (IQWiG). HbA1c was considered a valid surrogate if it demonstrated a strong association: lower limit of the 95 percent confidence interval (95 percent CI) of R greater than or equal to .85. Results Nineteen RCTs were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate for any clinical outcome: mortality (R = .34; 95 percent CI −.14 to .69), myocardial infarction (R = .20; −.30 to .61), heart failure (R = .08; −.40 to .53), kidney injury (R = −.04; −.52 to .47), and stroke (R = .81; .54 to .93). Conclusions The evidence from multiple placebo-controlled RCTs does not support the use of HbA1c as a surrogate to measure the effectiveness of antihyperglycemic drugs in DM studies.

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