Ilana Halperin

Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis

BACKGROUND The effectiveness of quality improvement (QI) strategies on diabetes care remains unclear. We aimed to assess the effects of QI strategies on glycated haemoglobin (HbA(1c)), vascular risk management, microvascular complication monitoring, and smoking cessation in patients with diabetes. METHODS We identified studies through Medline, the Cochrane Effective Practice and Organisation of Care database (from inception to July 2010), and references of included randomised clinical trials. We included trials assessing 11 predefined QI strategies or financial incentives targeting health systems, health-care professionals, or patients to improve management of adult outpatients with diabetes. Two reviewers independently abstracted data and appraised risk of bias. FINDINGS We reviewed 48 cluster randomised controlled trials, including 2538 clusters and 84,865 patients, and 94 patient randomised controlled trials, including 38,664 patients. In random effects meta-analysis, the QI strategies reduced HbA(1c) by a mean difference of 0·37% (95% CI 0·28-0·45; 120 trials), LDL cholesterol by 0·10 mmol/L (0·05-0.14; 47 trials), systolic blood pressure by 3·13 mm Hg (2·19-4·06, 65 trials), and diastolic blood pressure by 1·55 mm Hg (0·95-2·15, 61 trials) versus usual care. We noted larger effects when baseline concentrations were greater than 8·0% for HbA(1c), 2·59 mmol/L for LDL cholesterol, and 80 mm Hg for diastolic and 140 mm Hg for systolic blood pressure. The effectiveness of QI strategies varied depending on baseline HbA(1c) control. QI strategies increased the likelihood that patients received aspirin (11 trials; relative risk [RR] 1·33, 95% CI 1·21-1·45), antihypertensive drugs (ten trials; RR 1·17, 1·01-1·37), and screening for retinopathy (23 trials; RR 1·22, 1·13-1·32), renal function (14 trials; RR 128, 1·13-1·44), and foot abnormalities (22 trials; RR 1·27, 1·16-1·39). However, statin use (ten trials; RR 1·12, 0·99-1·28), hypertension control (18 trials; RR 1·01, 0·96-1·07), and smoking cessation (13 trials; RR 1·13, 0·99-1·29) were not significantly increased. INTERPRETATION Many trials of QI strategies showed improvements in diabetes care. Interventions targeting the system of chronic disease management along with patient-mediated QI strategies should be an important component of interventions aimed at improving diabetes management. Interventions solely targeting health-care professionals seem to be beneficial only if baseline HbA(1c) control is poor. FUNDING Ontario Ministry of Health and Long-term Care and the Alberta Heritage Foundation for Medical Research (now Alberta Innovates--Health Solutions).

Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.

The role of lifestyle interventions in the prevention of gestational diabetes.

Gestational diabetes is associated with adverse pregnancy outcomes, increased costs, and long-term risk of type 2 diabetes mellitus (T2DM) in the mother. Observational data have shown an association between reduced weight gain, healthy eating, and physical activity and reduced rates of gestational diabetes mellitus (GDM). Despite this, most randomized controlled trials of lifestyle interventions to prevent GDM have been negative. Dietary approaches appear to be more successful than exercise or a combination of diet and exercise at decreasing GDM. Reasons for negative studies may include lack of power, lack of intervention uptake, and severity of placenta mediated insulin resistance. Future studies should be powered for a reduction in GDM, monitor lifestyle changes closely, and include a psychological component in the intervention.

Quality improvement needed in quality improvement randomised trials: systematic review of interventions to improve care in diabetes.

Objective Despite the increasing numbers of published trials of quality improvement (QI) interventions in diabetes, little is known about the risk of bias in this literature. Design Secondary analysis of a systematic review. Data sources Medline, the Cochrane Effective Practice and Organisation of Care (EPOC) database (from inception to July 2010) and references of included studies. Eligibility criteria Randomised trials assessing 11 predefined QI strategies or financial incentives targeting health systems, healthcare professionals or patients to improve the management of adult outpatients with diabetes. Analysis Risk of bias (low, unclear or high) was assessed for the 142 trials in the review across nine domains using the EPOC version of the Cochrane Risk of Bias Tool. We used Cochran-Armitage tests for trends to evaluate the improvement over time. Results There was no significant improvement over time in any of the risk of bias domains. Attrition bias (loss to follow-up) was the most common source of bias, with 24 trials (17%) having high risk of bias due to incomplete outcome data. Overall, 69 trials (49%) had at least one domain with high risk of bias. Inadequate reporting frequently hampered the risk of bias assessment: allocation sequence was unclear in 82 trials (58%) and allocation concealment was unclear in 78 trials (55%). There were significant reductions neither in the proportions of studies at high risk of bias over time nor in the adequacy of reporting of risk of bias domains. Conclusions Nearly half of the included QI trials in this review were judged to have high risk of bias. Such trials have serious limitations that put the findings in question and therefore inhibit evidence-based QI. There is a need to limit the potential for bias when conducting QI trials and improve the quality of reporting of QI trials so that stakeholders have adequate evidence for implementation.

Increasing Timely Postpartum Oral Glucose Tolerance Test Completion in Women with Gestational Diabetes: A Quality-Improvement Initiative

Gestational diabetes (GDM) is defined as hyperglycemia that is first recognized during pregnancy. It affects 5% of pregnancies, and higher rates occur in certain ethnic minorities (1). GDM increases the risk for the development of type 2 diabetes and other metabolic complications later in life. Of women with GDM, 4% will be diagnosed with type 2 diabetes, and 20% of womenwith GDMwill have developed type 2 diabetes within 10 years postpartum (2). Within the first 6 months after delivery, upwards of 25% of women will have persistent abnormalities in their postpartum glucose levels in the form of impaired glucose tolerance (IGT), which is detectable only by a formal 2-hour 75 g oral glucose tolerance test (OGTT) (3). Identification of IGT prior to a subsequent pregnancy is important because these women experience dysglycemia with the onset of pregnancy and require ongoing monitoring and treatment. The Canadian Diabetes Association guidelines recommend a 75 g OGTT 6 weeks to 6 months postpartum; however, the rates of compliance with this guideline are less than 20% (4). Diabetes and its complications are a major financial burden on the healthcare system and are associated with major morbidity for patients. Screening programs in this population have been shown to be cost saving and to improve quality of life (5). There is high-level evidence that intensive lifestyle interventions can prevent the development of diabetes in patients with impaired glucose tolerance (6). The diabetes-prevention program showed

Gestational Diabetes Mellitus is Associated with Adverse Outcomes in Twin Pregnancies

BACKGROUND: Among singleton pregnancies, gestational diabetes mellitus is associated with adverse outcomes. In twin pregnancies, this association may be attenuated, given the higher rate of prematurity and the a priori increased risk of some of these complications. OBJECTIVE: Our aim was to test the hypothesis that gestational diabetes mellitus is less likely to be associated with adverse pregnancy outcomes in twin compared with singleton gestations. METHODS: This retrospective cohort study comprised all twin and singleton live births in Ontario, Canada, 2012–2016. Pregnancy outcomes were compared between women with vs without gestational diabetes mellitus, analyzed separately for twin and singleton births. Adjusted risk ratios and 95% confidence intervals were generated using modified Poisson regression, adjusting for maternal age, nulliparity, smoking, race, body mass index, preexisting hypertension, and assisted reproductive technology. RESULTS: A total of 270,843 women with singleton (n = 266,942) and twin (n = 3901) pregnancies met the inclusion criteria. In both the twin and singleton groups, gestational diabetes mellitus was associated with (adjusted risk ratio, [95% confidence interval]) cesarean delivery (1.11 [1.02–1.21] and 1.20 [1.17–1.23], respectively) and preterm birth at <370/7 weeks (1.21 [1.08–1.37] and 1.48 [1.39–1.57]) and at <340/7 weeks (1.45 [1.03–2.04] and 1.25 [1.06–1.47]). In singletons, but not twins, gestational diabetes mellitus was associated with gestational hypertension (1.66 [1.55–1.77]) and preeclampsia. With respect to neonatal outcomes, gestational diabetes mellitus was associated with birthweight greater than the 90th percentile in both twins and singletons, with the risk being 2‐fold higher in twins (2.53 [1.52‐4.23] vs 1.18 [1.13‐1.23], respectively, P = .004). Gestational diabetes mellitus was associated with jaundice in both twins (1.56 [1.10–2.21]) and singletons (1.49 [1.37–1.62) but was associated with the following complications only in singletons: neonatal intensive care unit admission (1.44 [1.38–1.50]), respiratory morbidity (1.09 [1.02–1.16]), and neonatal hypoglycemia (3.20 [3.01–3.40]). CONCLUSION: In contrast to singleton pregnancies, gestational diabetes mellitus in twins was not associated with hypertensive complications and certain neonatal morbidities. Still, the current study highlights that gestational diabetes mellitus is associated with some adverse pregnancy outcomes including accelerated fetal growth also in twin pregnancies.