Assessing the feasibility, acceptability, and fidelity of a tele-retinopathy-based intervention to encourage greater attendance to diabetic retinopathy screening in immigrants living with diabetes from China and African-Caribbean countries in Ottawa, Canada: a protocol.

BACKGROUND: Diabetic retinopathy is a leading cause of preventable blindness in Canada. Clinical guidelines recommend annual diabetic retinopathy screening for people living with diabetes to reduce the risk and progression of vision loss. However, many Canadians with diabetes do not attend screening. Screening rates are even lower in immigrants to Canada including people from China, Africa, and the Caribbean, and these groups are also at higher risk of developing diabetes complications. We aim to assess the feasibility, acceptability, and fidelity of a co-developed, linguistically and culturally tailored tele-retinopathy screening intervention for Mandarin-speaking immigrants from China and French-speaking immigrants from African-Caribbean countries living with diabetes in Ottawa, Canada, and identify how many from each population group attend screening during the pilot period. METHODS: We will work with our health system and patient partners to conduct a 6-month feasibility pilot of a tele-retinopathy screening intervention in a Community Health Centre in Ottawa. We anticipate recruiting 50-150 patients and 5-10 health care providers involved in delivering the intervention for the pilot. Acceptability will be assessed via a Theoretical Framework of Acceptability-informed survey with patients and health care providers. To assess feasibility, we will use a Theoretical Domains Framework-informed interview guide and to assess fidelity, and we will use a survey informed by the National Institutes of Health framework from the perspective of health care providers. We will also collect patient demographics (i.e., age, gender, ethnicity, health insurance status, and immigration information), screening outcomes (i.e., patients with retinopathy identified, patients requiring specialist care), patient costs, and other intervention-related variables such as preferred language. Survey data will be descriptively analyzed and qualitative data will undergo content analysis. DISCUSSION: This feasibility pilot study will capture how many people living with diabetes from each group attend the diabetic retinopathy screening, costs, and implementation processes for the tele-retinopathy screening intervention. The study will indicate the practicability and suitability of the intervention in increasing screening attendance in the target population groups. The study results will inform a patient-randomized trial, provide evidence to conduct an economic evaluation of the intervention, and optimize the community-based intervention.

Evaluating an Integrated Local System Response to the COVID-19 Pandemic: Case Study of East Toronto Health Partners.

Introduction: East Toronto Health Partners (ETHP) is a network of organizations that serve residents of East Toronto, Ontario, Canada. ETHP is a newly formed integrated model of care in which hospital, primary care, community providers and patients/families work together to improve population health. We describe and evaluate the evolution of this emerging integrated care system as it responded to a global health crisis. Description: This paper begins by describing ETHP's pandemic response mapping out over two years of data. To evaluate the response, semi-structured interviews were conducted with 30 decision makers, clinicians, staff, and volunteers who were part of the response. The interviews were thematically analyzed, and emergent themes mapped onto the nine pillars of integrated care. Discussion: The ETHP pandemic response evolved rapidly. Early siloed responses gave way to collaborative efforts and equity emerged as a central priority. New alliances formed, resources were shared, leaders emerged, and community members stepped forward to contribute. Interviewees identified positives as well as many opportunities for improvement post-pandemic. Conclusion: The pandemic was a catalyst for change in East Toronto that accelerated existing initiatives to achieve integrated care. The East Toronto experience may serve as a useful guide for other emerging integrated care systems.

Cancer Epidemiology in Hispanic Populations: An Analysis of Funded Observational Research at the National Cancer Institute.

BACKGROUND: More than 62 million people self-identified as Hispanic/Latino (H/L) in the 2020 United States census. The U.S. H/L population has higher burden of certain cancers compared with their non-Hispanic White counterparts. METHODS: Key term search using the NIH Query/View/Report (QVR) system, along with Research, Condition, and Disease Categorization codes identified cancer epidemiology research grants in H/L populations funded by the NCI as a primary or secondary funder from fiscal years 2016 through 2021. Three reviewers identified eligible grants based on specified inclusion/exclusion criteria and a codebook for consistency extracting key characteristics. RESULTS: A total of 450 grants were identified through the QVR system using key words related to H/Ls; 41 cancer epidemiology grants remained after applying exclusion criteria. These grants contained specific aims focused on H/Ls (32%) or included H/Ls as part of a racial/ethnic comparison (68%). NCI was the primary funder of the majority of the grants (85%), and most of the research grants focused on cancer etiology (44%) and/or survivorship (49%). Few grants (10%) investigated environmental exposures. CONCLUSIONS: This article provides an overview of NCI-funded cancer epidemiology research in H/L populations from 2016 to 2021. Future cancer epidemiology research should reflect the changing dynamics of the U.S. demography with diverse, representative populations and well-characterized ethnicity. IMPACT: Research that carefully measures the relevant biological, environmental, behavioral, psychologic, sociocultural, and clinical risk factors will be critical to better understanding the nuanced patterns influencing cancer-related outcomes in the heterogenous H/L population.

The Cost-Effectiveness of Intermediate-Acting, Long-Acting, Ultralong-Acting, and Biosimilar Insulins for Type 1 Diabetes Mellitus: A Systematic Review.

OBJECTIVES: The incidence of type 1 diabetes mellitus is increasing every year requiring substantial expenditure on treatment and complications. A systematic review was conducted on the cost-effectiveness of insulin formulations, including ultralong-, long-, or intermediate-acting insulin, and their biosimilar insulin equivalents. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, HTA, and NHS EED were searched from inception to June 11, 2021. Cost-effectiveness and cost-utility analyses were included if insulin formulations in adults (≥ 16 years) with type 1 diabetes mellitus were evaluated. Two reviewers independently screened titles, abstracts, and full-text articles, extracted study data, and appraised their quality using the Drummond 10-item checklist. Costs were converted to 2020 US dollars adjusting for inflation and purchasing power parity across currencies. RESULTS: A total of 27 studies were included. Incremental cost-effectiveness ratios ranged widely across the studies. All pairwise comparisons (11 of 11, 100%) found that ultralong-acting insulin was cost-effective compared with other long-acting insulins, including a long-acting biosimilar. Most pairwise comparisons (24 of 27, 89%) concluded that long-acting insulin was cost-effective compared with intermediate-acting insulin. Few studies compared long-acting insulins with one another. CONCLUSIONS: Long-acting insulin may be cost-effective compared with intermediate-acting insulin. Future studies should directly compare biosimilar options and long-acting insulin options and evaluate the long-term consequences of ultralong-acting insulins.

Environmental Scan on Canadian Interactive Knowledge Translation Tools to Prevent Diabetes Complications in Patients With Diabetes.

In this study, we identify existing interactive knowledge translation tools that could help patients and health-care professionals to prevent diabetes complications in the Canadian context. We conducted an environmental scan in collaboration with researchers and 4 patient partners across Canada. We conducted searches among the research team members, their networks and Twitter, and through searches in databases and Google. To be included, interactive knowledge translation tools had to meet the following criteria: used to prevent diabetes complications; used in a real-life setting; used any instructional method or material; had relevance in the Canadian context, written in English or French; developed and/or published by experts in diabetes complications or by a recognized organization; created in 2013 or after; and accessibility online or on paper. Two reviewers independently screened each record for selection and extracted the following data: authorship, objective(s), patients' characteristics, type of diabetes complications targeted, type of knowledge users targeted and tool characteristics. We used simple descriptive statistics to summarize our results. Thirty-one of the 1,700 potentially eligible interactive knowledge translation tools were included in the scan. Tool formats included personal notebook, interactive case study, risk assessment tool, clinical pathway, decision support tool, knowledge quiz and checklist. Diabetes complications targeted by the tools included foot-related neuropathy, cardiovascular diseases, mental disorders and distress and any complications related to diabetes and kidney disease. Our results inform Canadian stakeholders interested in the prevention of diabetes complications to avoid unnecessary duplication, identify gaps in knowledge and support implementation of these tools in clinical and patients' decision-making.

Mobilizing a Whole Community: Policy and Strategy Implications of an Integrated Local System Response to a Global Health Crisis.

The East Toronto Health Partners (ETHP) include more than 50 organizations working collaboratively to create an integrated system of care in the east end of Toronto. This existing partnership proved invaluable as a platform for a rapid, coordinated local response to the COVID-19 pandemic. Months after the first wave of the pandemic began, with the daily numbers of COVID-19 cases finally starting to decline, leaders from ETHP provided preliminary reflections on two critical questions: (1) How were existing integration efforts leveraged to mobilize a response during the COVID-19 crisis? and (2) How can the response to the initial wave of COVID-19 be leveraged to further accelerate integration and better address subsequent waves and system improvements once the pandemic abates?

Impact of a Comprehensive Guideline Dissemination Strategy on Diabetes Diagnostic Test Rates: an Interrupted Time Series.

BACKGROUND: Diabetes Canada launched a comprehensive Dissemination and Implementation (D&I) strategy to optimize uptake of their 2013 Clinical Practice Guidelines; the strategy involved continuing professional development courses, webinars, an interactive website, applications for mobile devices, point-of-care decision support tools, and media awareness campaigns. It included a focus on promoting HbA1c as the recommended diagnostic test for diabetes. OBJECTIVE: To determine the impact of Diabetes Canada's 2013 D&I strategy on physician test-ordering behavior, specifically HbA1c testing, for the diagnosis of diabetes, using provincial healthcare administrative data. DESIGN: Population-based interrupted time series. SETTING: Ontario, Canada. PARTICIPANTS: Ontario residents aged 40-79 not previously diagnosed with diabetes. MEASUREMENTS: For each quarter between January 2005 and December 2014, we conducted an interrupted time series analysis on the first-order difference of the proportion of patients receiving HbA1c tests per quarter with an autoregressive integrated moving average model with the intervention step occurring in quarter 2 of 2013. Subgroup analyses by rurality, physician graduation year, and practice size were also conducted. RESULTS: There were 32 quarters pre-intervention and 6 post-intervention; average sample size per quarter was 5,298,686 individuals. Pre-intervention, the quarter-to-quarter growth was 1.51 HbA1c tests per quarter per 1000 people. Post-intervention, the quarter-to-quarter growth increased by 8.45 tests per 1000 people (p < 0.005). Growth of HbA1c ordering differed significantly by region, years since physician graduation, and practice size. LIMITATIONS: Incomplete data collection, inadequate stratification, and other unidentified confounders. CONCLUSION: The D&I strategy resulted in a significant increase in the growth of HbA1c tests. The successful uptake of this recommendation may be due to its simplicity; guideline developers should consider this when drafting recommendations. Furthermore, differential uptake by user groups suggests that future strategies should include targeted barrier analysis and interventions to these groups.

Process Evaluation of the Diabetes Canada Guidelines Dissemination Strategy Using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) Framework.

OBJECTIVES: Our purpose was to disseminate and implement the Diabetes Canada (formerly the Canadian Diabetes Association) 2013 Clinical Practice Guidelines and evaluate the impact of the dissemination and implementation strategy on process outcomes (reach, adoption, implementation and maintenance). METHODS: Our patient- and provider-directed strategy consisted of a guidelines website, electronic point-of-care decision-support tools, mobile applications, electronic medical record templates, laboratory prompts, continuing professional development modules, a communications campaign and printed education materials. We used the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to assess process-level outcomes. We report on the reach, adoption, implementation and organizational maintenance by using mixed methods and multiple data sources (communications reports, mailing lists, website-usage statistics, accreditation logs, session-evaluation forms, budgets). RESULTS: A total of 1,786,910 contacts were made with health-care professionals, the majority of whom were nurses. The greatest reach was through the website. A total of 35,573,154 contacts were made with the general population; the greatest reach occurred through media channels. We contacted 149 and collaborated with 18 governmental, professional and health advocacy organizations about activities such as distributing resources and implementing team-based care initiatives and screening policies. Most website users were young women, with use occurring during working hours. Interactive clinical decision-support tools were most commonly accessed. Website use increased with time. The institutionalization of guidelines occurred in a few areas such as the use of an adapted screening policy in the Northwest Territories. CONCLUSIONS: Our interactive tools were repeatedly accessed, signifying their relevance to problems in clinical care. Our synthesized analyses indicate that the guidelines website is resource intensive, with a wide reach and the potential to change outcomes.

Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE: The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS: This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS: The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS: This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION: ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).

Safety, effectiveness, and cost effectiveness of long acting versus intermediate acting insulin for patients with type 1 diabetes: systematic review and network meta-analysis.

OBJECTIVE: To examine the safety, effectiveness, and cost effectiveness of long acting insulin for type 1 diabetes. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Cochrane Central Register of Controlled Trials, Embase, and grey literature were searched through January 2013. STUDY SELECTION: Randomized controlled trials or non-randomized studies of long acting (glargine, detemir) and intermediate acting (neutral protamine Hagedorn (NPH), lente) insulin for adults with type 1 diabetes were included. RESULTS: 39 studies (27 randomized controlled trials including 7496 patients) were included after screening of 6501 titles/abstracts and 190 full text articles. Glargine once daily, detemir once daily, and detemir once/twice daily significantly reduced hemoglobin A1c compared with NPH once daily in network meta-analysis (26 randomized controlled trials, mean difference -0.39%, 95% confidence interval -0.59% to -0.19%; -0.26%, -0.48% to -0.03%; and -0.36%, -0.65% to -0.08%; respectively). Differences in network meta-analysis were observed between long acting and intermediate acting insulin for severe hypoglycemia (16 randomized controlled trials; detemir once/twice daily versus NPH once/twice daily: odds ratio 0.62, 95% confidence interval 0.42 to 0.91) and weight gain (13 randomized controlled trials; detemir once daily versus NPH once/twice daily: mean difference 4.04 kg, 3.06 to 5.02 kg; detemir once/twice daily versus NPH once daily: -5.51 kg, -6.56 to -4.46 kg; glargine once daily versus NPH once daily: -5.14 kg, -6.07 to -4.21). Compared with NPH, detemir was less costly and more effective in 3/14 cost effectiveness analyses and glargine was less costly and more effective in 2/8 cost effectiveness analyses. The remaining cost effectiveness analyses found that detemir and glargine were more costly but more effective than NPH. Glargine was not cost effective compared with detemir in 2/2 cost effectiveness analyses. CONCLUSIONS: Long acting insulin analogs are probably superior to intermediate acting insulin analogs, although the difference is small for hemoglobin A1c. Patients and their physicians should tailor their choice of insulin according to preference, cost, and accessibility. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42013003610.

Safety, effectiveness, and cost of long-acting versus intermediate-acting insulin for type 1 diabetes: protocol for a systematic review and network meta-analysis.

BACKGROUND: Type 1 diabetes mellitus (T1DM) causes progressive destruction of pancreatic beta cells leading to absolute insulin deficiency. Treatment of T1DM requires insulin, and some evidence suggests that longer acting insulin analogues might have a higher effectiveness and greater safety profile compared to intermediate-acting insulin. Our objective is to evaluate the comparative effectiveness, safety, and cost of long-acting insulin versus intermediate-acting insulin through a systematic review and network meta-analysis. DESIGN/METHODS: Studies examining long-acting versus intermediate-acting insulin or placebo preparations for adult T1DM patients will be included. The primary outcome is glycosylated hemoglobin (A1C), and secondary outcomes include emergency department and physician visits, hospital admissions, weight gain, quality of life, microvascular complications (e.g., retinopathy), macrovascular complications (e.g., cardiovascular disease), all-cause mortality, incident cancers, and cost. We will include experimental [randomized clinical trials (RCTs), quasi-RCTs, non-RCTs], quasi-experimental (controlled before-after, interrupted time series), observational (cohort), and cost studies, of any duration of follow-up, conducted during all time periods, and disseminated in any language.We will conduct comprehensive searches of electronic databases from inception onwards, including MEDLINE, Cochrane Central Register of Controlled Trials, and EMBASE. We will also search for difficult to locate and unpublished literature by searching dissertation databases, public health organization websites, and trial registries. After a calibration exercise using our eligibility criteria and data abstraction forms, two reviewers will screen all citations, full-text articles, and abstract data in duplicate. Conflicts will be resolved by team discussion. Using a similar process, the Cochrane Effective Practice and Organization of Care Risk of Bias tool will be used to appraise the risk of bias of experimental and quasi-experimental studies, while the Newcastle Ottawa Scale will be used to assess the methodological quality of cohort studies. If feasible and appropriate, we will conduct a random effects meta-analysis, as well as a network meta-analysis. DISCUSSION: Our systematic review will be of utility to healthcare providers, policy-makers, T1DM patients and family members regarding treatment options of long-acting versus intermediate-acting insulin preparations. TRIAL REGISTRATION: PROSPERO registry number: CRD42013003610.

Safety, effectiveness, and cost of dipeptidyl peptidase-4 inhibitors versus intermediate acting insulin for type 2 diabetes: protocol for a systematic review and network meta-analysis.

BACKGROUND: Type 2 diabetes mellitus (T2DM) results from insulin resistance and relative insulin deficiency. T2DM treatment is a step-wise approach beginning with lifestyle modifications (for example, diet, exercise), followed by the addition of oral hypoglycemic agents (for example, metformin). Patients who do not respond to first-line therapy are offered second-line therapy (for example, sulfonylureas). Third-line therapy may include insulin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors.It is unclear whether DPP-4 inhibitors are safer and more effective than intermediate acting insulin for third-line management of T2DM. As such, our objective is to evaluate the comparative effectiveness, safety and cost-effectiveness of DPP-4 inhibitors versus intermediate acting insulin for T2DM patients who have failed both first- and second-line diabetes treatments. DESIGN/METHODS: Electronic searches of MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, and grey literature (for example, trial registries, public health websites) will be conducted to identify studies examining DPP-4 inhibitors compared with each other, intermediate acting insulin, no treatment, or placebo for adults with T2DM. The outcomes of interest include glycosylated hemoglobin (A1C) (primary outcome), as well as emergency department visits, physician visits, hospital admissions, weight gain, quality of life, microvascular complications, macrovascular complications, all-cause mortality, and cost (secondary outcomes). Randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort studies, and cost studies reporting data on these outcomes will be included. Eligibility will not be restricted by publication status, language of dissemination, duration of study follow-up, or time period of study conduct.Two reviewers will screen the titles and abstracts resulting from the literature search, as well as potentially relevant full-text articles, in duplicate. Data will be abstracted and quality will be appraised by two team members independently. Conflicts at all levels of screening and abstraction will be resolved through team discussion.Our results will be described narratively. Random effects meta-analysis and network meta-analysis will be conducted, if feasible and appropriate. DISCUSSION: Our systematic review results can be used to determine the most effective, safe and cost-effective third-line strategies for managing T2DM. This information will be of great use to health policy-makers and clinicians, as well as patients living with T2DM and their families. TRIAL REGISTRATION: PROSPERO registry number: CRD42013003624.

Systematic review and evaluation of web-accessible tools for management of diabetes and related cardiovascular risk factors by patients and healthcare providers.

OBJECTIVE: To identify and evaluate the effectiveness, clinical usefulness, sustainability, and usability of web-compatible diabetes-related tools. DATA SOURCES: Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, world wide web. STUDY SELECTION: Studies were included if they described an electronic audiovisual tool used as a means to educate patients, care givers, or clinicians about diabetes management and assessed a psychological, behavioral, or clinical outcome. DATA EXTRACTION: Study abstraction and evaluation for clinical usefulness, sustainability, and usability were performed by two independent reviewers. RESULTS: Of 12,616 citations and 1541 full-text articles reviewed, 57 studies met inclusion criteria. Forty studies used experimental designs (25 randomized controlled trials, one controlled clinical trial, 14 before-after studies), and 17 used observational designs. Methodological quality and ratings for clinical usefulness and sustainability were variable, and there was a high prevalence of usability errors. Tools showed moderate but inconsistent effects on a variety of psychological and clinical outcomes including HbA1c and weight. Meta-regression of adequately reported studies (12 studies, 2731 participants) demonstrated that, although the interventions studied resulted in positive outcomes, this was not moderated by clinical usefulness nor usability. LIMITATION: This review is limited by the number of accessible tools, exclusion of tools for mobile devices, study quality, and the use of non-validated scales. CONCLUSION: Few tools were identified that met our criteria for effectiveness, usefulness, sustainability, and usability. Priority areas include identifying strategies to minimize website attrition and enabling patients and clinicians to make informed decisions about website choice by encouraging reporting of website quality indicators.