Tiffany Fitzpatrick

High-cost health care users in Ontario, Canada: demographic, socio-economic, and health status characteristics

BackgroundHealth care spending is overwhelmingly concentrated within a very small proportion of the population, referred to as the high-cost users (HCU). To date, research on HCU has been limited in scope, focusing mostly on those characteristics available through administrative databases, which have been largely clinical in nature, or have relied on ecological measures of socio-demographics. This study links population health surveys to administrative data, allowing for the investigation of a broad range of individual-level characteristics and provides a more thorough characterization of community-dwelling HCU across demographic, social, behavioral and clinical characteristics.MethodsWe linked three cycles of the Canadian Community Health Survey (CCHS) to medical claim data for the years 2003-2008 for Ontario, Canada. Participants were ranked according to gradients of cost (Top 1%, Top 2-5%, Top 6-50% and Bottom 50%) and multinomial logistic regression was used to investigate a wide range of factors, including health behaviors and socio-demographics, likely associated with HCU status.ResultsUsing a total sample of 91,223 adults (18 and older), we found that HCU status was strongly associated with being older, having multiple chronic conditions, and reporting poorer self-perceived health. Specifically, in the fully-adjusted model, poor self-rated health (vs. good) was associated with a 26-fold increase in odds of becoming a Top 1% HCU (vs. Bottom 50% user) [95% CI: (18.9, 36.9)]. Further, HCU tended to be of lower socio-economic status, former daily smokers, physically inactive, current non-drinkers, and obese.ConclusionsThe results of this study have provided valuable insights into the broader characteristics of community-dwelling HCU, including unique demographic and behavioral characteristics. Additionally, strong associations with self-reported clinical variables, such as self-rated general and mental health, highlight the importance of the patient perspective for HCU. These findings have the potential to inform policies for health care and public health, particularly in light of increasing decision-maker attention in the sustainability of the health care system, improving patient outcomes and, more generally, in order to achieve the common goal of improving population health outcomes.

Looking Beyond Income and Education: Socioeconomic Status Gradients Among Future High-Cost Users of Health Care.

INTRODUCTION Healthcare spending occurs disproportionately among a very small portion of the population. Research on these high-cost users (HCUs) of health care has been overwhelmingly cross-sectional in nature and limited to the few sociodemographic and clinical characteristics available in health administrative databases. This study is the first to bridge this knowledge gap by applying a population health lens to HCUs. We investigate associations between a broad range of SES characteristics and future HCUs. METHODS A cohort of adults from two cycles of large, nationally representative health surveys conducted in 2003 and 2005 was linked to population-based health administrative databases from a universal healthcare plan for Ontario, Canada. Comprehensive person-centered estimates of annual healthcare spending were calculated for the subsequent 5 years following interview. Baseline HCUs (top 5%) were excluded and healthcare spending for non-HCUs was analyzed. Adjusted for predisposition and need factors, the odds of future HCU status (over 5 years) were estimated according to various individual, household, and neighborhood SES factors. Analyses were conducted in 2014. RESULTS Low income (personal and household); less than post-secondary education; and living in high-dependency neighborhoods greatly increased the odds of future HCUs. After adjustment, future HCU status was most strongly associated with food insecurity, personal income, and non-homeownership. Living in highly deprived or low ethnic concentration neighborhoods also increased the odds of becoming an HCU. CONCLUSIONS Findings suggest that addressing social determinants of health, such as food and housing security, may be important components of interventions aiming to improve health outcomes and reduce costs.

Prevalence of Prediabetes and Undiagnosed Diabetes in Canada (2007–2011) According to Fasting Plasma Glucose and HbA1c Screening Criteria

OBJECTIVE To provide the first population-based estimates of prediabetes and undiagnosed type 2 diabetes prevalence in Canada. RESEARCH DESIGN AND METHODS We combined two fasting subsamples of the Canadian Health Measures Survey, which were restricted to nonpregnant adults ≥20 years of age (N = 3,494). Undiagnosed diabetes was defined as not having self-reported type 2 diabetes but having blood glucose measures that met Canadian guidelines (i.e., fasting plasma glucose [FPG] level of ≥7.0 mmol/L or hemoglobin A1c [HbA1c] level of ≥6.5% [≥48 mmol/mol]). Prediabetes was defined as an FPG level of ≥6.1 and <7.0 mmol/L or an HbA1c level of ≥6.0% and <6.5% (≥42 and <48 mmol/mol). All estimates were weighted using survey sampling weights. CIs were calculated with the bootstrap method. RESULTS According to FPG levels, the prevalence of undiagnosed type 2 diabetes in Canadian adults was 1.13% (95% CI 0.79, 1.62), contributing to ∼20% of total type 2 diabetes prevalence (5.62 [95% CI 4.52, 6.95]). Compared with FPG levels, the undiagnosed prevalence was greater using HbA1c level as a criterion (3.09% [95% CI 1.97, 4.81]), ∼41% of the total number of cases of diabetes (7.55 [95% CI 5.98, 9.49]). The HbA1c-only criterion resulted in a threefold increase in prediabetes prevalence overall and a sixfold increase among females (FPG 2.22%, HbA1c 13.31%). Screening based on FPG only identified older undiagnosed case patients, with a mean age of 58.7 years (95% CI 59.9, 63.4). Similarly, using HbA1c identified younger individuals with prediabetes, with reduced BMI and waist circumference compared with FPG levels. CONCLUSIONS In this first study of a nationally representative sample with biospecimen measures, we found that the prevalence of undiagnosed type 2 diabetes and prediabetes was significantly higher using HbA1c levels compared with FPG levels. Further evaluation is needed to fully assess the impact of using the HbA1c criterion.

Risk of Bias in Systematic Reviews of Non-Randomized Studies of Adverse Cardiovascular Effects of Thiazolidinediones and Cyclooxygenase-2 Inhibitors: Application of a New Cochrane Risk of Bias Tool

Background Systematic reviews of the effects of healthcare interventions frequently include non-randomized studies. These are subject to confounding and a range of other biases that are seldom considered in detail when synthesizing and interpreting the results. Our aims were to assess the reliability and usability of a new Cochrane risk of bias (RoB) tool for non-randomized studies of interventions and to determine whether restricting analysis to studies with low or moderate RoB made a material difference to the results of the reviews. Methods and Findings We selected two systematic reviews of population-based, controlled non-randomized studies of the relationship between the use of thiazolidinediones (TZDs) and cyclooxygenase-2 (COX-2) inhibitors and major cardiovascular events. Two epidemiologists applied the Cochrane RoB tool and made assessments across the seven specified domains of bias for each of 37 component studies. Inter-rater agreement was measured using the weighted Kappa statistic. We grouped studies according to overall RoB and performed statistical pooling for (a) all studies and (b) only studies with low or moderate RoB. Kappa scores across the seven bias domains ranged from 0.50 to 1.0. In the COX-2 inhibitor review, two studies had low overall RoB, 14 had moderate RoB, and five had serious RoB. In the TZD review, six studies had low RoB, four had moderate RoB, four had serious RoB, and two had critical RoB. The pooled odds ratios for myocardial infarction, heart failure, and death for rosiglitazone versus pioglitazone remained significantly elevated when analyses were confined to studies with low or moderate RoB. However, the estimate for myocardial infarction declined from 1.14 (95% CI 1.07–1.24) to 1.06 (95% CI 0.99–1.13) when analysis was confined to studies with low RoB. Estimates of pooled relative risks of cardiovascular events with COX-2 inhibitors compared with no nonsteroidal anti-inflammatory drug changed little when analyses were confined to studies with low or moderate RoB. The exception was a rise in the relative risk associated with ibuprofen from 1.07 (95% CI 0.97–1.18) to 1.14 (95% CI 1.03–1.26). The main limitation of our study was testing the instrument on a narrow range of pharmacoepidemiological studies; we cannot assume our findings extend to a broader range of interventions and settings. Conclusions The Cochrane RoB tool highlighted a wide range of risks of bias in studies included in two widely cited reviews and had the potential to change the conclusions of the reviews. Systematic reviews that incorporate non-randomized studies of medical interventions should include a detailed assessment of RoB for each included study.

The Prevalence of Undiagnosed and Prediabetes Diabetes in Canada (2007–2011) According to Fasting Plasma Glucose and HbA1c Screening Criteria

OBJECTIVE To provide the first population-based estimates of prediabetes and undiagnosed type 2 diabetes prevalence in Canada. RESEARCH DESIGN AND METHODS We combined two fasting subsamples of the Canadian Health Measures Survey, which were restricted to nonpregnant adults ≥20 years of age (N = 3,494). Undiagnosed diabetes was defined as not having self-reported type 2 diabetes but having blood glucose measures that met Canadian guidelines (i.e., fasting plasma glucose [FPG] level of ≥7.0 mmol/L or hemoglobin A1c [HbA1c] level of ≥6.5% [≥48 mmol/mol]). Prediabetes was defined as an FPG level of ≥6.1 and <7.0 mmol/L or an HbA1c level of ≥6.0% and <6.5% (≥42 and <48 mmol/mol). All estimates were weighted using survey sampling weights. CIs were calculated with the bootstrap method. RESULTS According to FPG levels, the prevalence of undiagnosed type 2 diabetes in Canadian adults was 1.13% (95% CI 0.79, 1.62), contributing to ∼20% of total type 2 diabetes prevalence (5.62 [95% CI 4.52, 6.95]). Compared with FPG levels, the undiagnosed prevalence was greater using HbA1c level as a criterion (3.09% [95% CI 1.97, 4.81]), ∼41% of the total number of cases of diabetes (7.55 [95% CI 5.98, 9.49]). The HbA1c-only criterion resulted in a threefold increase in prediabetes prevalence overall and a sixfold increase among females (FPG 2.22%, HbA1c 13.31%). Screening based on FPG only identified older undiagnosed case patients, with a mean age of 58.7 years (95% CI 59.9, 63.4). Similarly, using HbA1c identified younger individuals with prediabetes, with reduced BMI and waist circumference compared with FPG levels. CONCLUSIONS In this first study of a nationally representative sample with biospecimen measures, we found that the prevalence of undiagnosed type 2 diabetes and prediabetes was significantly higher using HbA1c levels compared with FPG levels. Further evaluation is needed to fully assess the impact of using the HbA1c criterion.

Liberating the data from clinical trials

Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research

Effect of Vitamin D3 Supplementation on Inflammatory Markers and Glycemic Measures among Overweight or Obese Adults: A Systematic Review of Randomized Controlled Trials.

Background Obesity induced low-grade chronic inflammation disrupts proper immune and metabolic function. Vitamin D deficiency increases inflammation, which is associated with cardiometabolic risk. This systematic review examines the association between oral vitamin D (VD) supplementation and circulating inflammatory biomarkers and glycemic outcomes from randomized controlled trials (RCTs) of overweight and/or obese adults. Methods MEDLINE OVID, EMBASE and the Cochrane Central Register of Controlled Trials were searched according to a predefined protocol. Eligible RCTs included adults randomized to receive either oral VD or placebo. Two reviewers independently assessed RCTs for inclusion. Bias was assessed using the Cochrane Collaboration risk of bias tool. Mean differences were calculated comparing end-of-study sample means between the independent VD and placebo groups. Results Eleven unique RCTs met inclusion criteria from a total of 3,383 identified citations, including 79 screened articles and 14 full text data extractions. Inflammatory and glycemic measures were reported in 7 and 10 RCTs, respectively. Most trial findings were non-significant with considerable heterogeneity in design, participants and outcomes. All but one trial was rated as either high or unclear risk of bias. Two RCTs reported significant changes in inflammatory biomarkers; however, the mean difference between groups was not statistically significant: C-reactive protein 0.19 mg/L (p = 0.88); Tumor Necrosis Factor -0.54 pg/ml (p = 0.20). Two other trials found significant mean differences in fasting plasma glucose -0.32 mmol/L (p = 0.03), Hemoglobin A1c -0.13% (p = 0.04), and Homeostatic Model Assessment -0.86 (p = 0.02) following VD supplementation. Conclusions Overall, there is no clear established benefit of VD supplementation on inflammatory biomarkers among overweight/obese adults. Baseline serum VD possibly influences the effect of VD repletion on inflammatory markers. Risk of bias was present in most studies, thus supporting the need for higher quality studies in this area to more conclusively understand the role VD supplementation has on inflammatory pathways.

The development and validation of a meta-tool for quality appraisal of public health evidence: Meta Quality Appraisal Tool (MetaQAT)

OBJECTIVES Most quality appraisal tools were developed for clinical medicine and tend to be study-specific with a strong emphasis on risk of bias. In order to be more relevant to public health, an appropriate quality appraisal tool needs to be less reliant on the evidence hierarchy and consider practice applicability. Given the broad range of study designs used in public health, the objective of this study was to develop and validate a meta-tool that combines public health-focused principles of appraisal coupled with a set of design-specific companion tools. STUDY DESIGN Several design methods were used to develop and validate the tool including literature review, synthesis, and validation with a reference standard. METHODS A search of critical appraisal tools relevant to public health was conducted; core concepts were collated. The resulting framework was piloted during three feedback sessions with public health practitioners. Following subsequent revisions, the final meta-tool, the Meta Quality Appraisal Tool (MetaQAT), was then validated through a content analysis of appraisals conducted by two groups of experienced public health researchers (MetaQAT vs generic appraisal form). RESULTS The MetaQAT framework consists of four domains: relevancy, reliability, validity, and applicability. In addition, a companion tool was assembled from existing critical appraisal tools to provide study design-specific guidance on validity appraisal. Content analysis showed similar methodological and generalizability concerns were raised by both groups; however, the MetaQAT appraisers commented more extensively on applicability to public health practice. CONCLUSIONS Critical appraisal tools designed for clinical medicine have limitations for use in the context of public health. The meta-tool structure of the MetaQAT allows for rigorous appraisal, while allowing users to simultaneously appraise the multitude of study designs relevant to public health research and assess non-standard domains, such as applicability.

Risk factors for serious outcomes associated with influenza illness in high- versus low- and middle-income countries: Systematic literature review and meta-analysis

To determine factors associated with a serious outcome (hospital admission or severe outcome: critical care or death) and associated with illness caused by laboratory‐confirmed influenza, with a specific interest in low‐ and middle‐income countries (LMIC).

Acute respiratory infection case definitions for young children: a systematic review of community‐based epidemiologic studies in South Asia

To explore the variability in childhood acute respiratory infection case definitions for research in low‐income settings where there is limited access to laboratory or radiologic investigations.