Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial.

BACKGROUND: Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. "The COACH Program" was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed. METHODS/DESIGN: Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus "The COACH Program" or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective. DISCUSSION: The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions.

Immunoglobulin Replacement Therapy is critical and cost-effective in increasing life expectancy and quality of life in patients suffering from Common Variable Immunodeficiency Disorders (CVID): A health-economic assessment.

BACKGROUND: Common variable immunodeficiency disorders (CVID), the most common form of primary antibody deficiency, are rare conditions associated with considerable morbidity and mortality. The clinical benefit of immunoglobulin replacement therapy (IgGRT) is substantial: timely treatment with appropriate doses significantly reduces mortality and the incidence of CVID-complications such as major infections and bronchiectasis. Unfortunately, CVID-patients still face a median diagnostic delay of 4 years. Their disease burden, expressed in annual loss of disability-adjusted life years, is 3-fold higher than in the general population. Hurdles to treatment access and reimbursement by healthcare payers may exist because the value of IgGRT is poorly documented. This paper aims to demonstrate cost-effectiveness and cost-utility (on life expectancy and quality) of IgGRT in CVID. METHODS AND FINDINGS: With input from a literature search, we built a health-economic model for cost-effectiveness and cost-utility assessment of IgGRT in CVID. We compared a mean literature-based dose (≥450mg/kg/4wks) to a zero-or-low dose (0 to ≤100 mg/kg/4wks) in a simulated cohort of adult patients from time of diagnosis until death; we also estimated the economic impact of diagnostic delay in this simulated cohort. Compared to no or minimal treatment, IgGRT showed an incremental benefit of 17 life-years (LYs) and 11 quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of €29,296/LY and €46,717/QALY. These results were robust in a sensitivity analysis. Reducing diagnostic delay by 4 years provided an incremental benefit of six LYs and four QALYs compared to simulated patients with delayed IgGRT initiation, resulting in an ICER of €30,374/LY and €47,495/QALY. CONCLUSIONS: The health-economic model suggests that early initiation of IgGRT compared to no or delayed IgGRT is highly cost-effective. CVID-patients' access to IgGRT should be facilitated, not only because of proven clinical efficacy, but also due to the now demonstrated cost-effectiveness.

The burden of common variable immunodeficiency disorders: a retrospective analysis of the European Society for Immunodeficiency (ESID) registry data.

BACKGROUND: Common variable immunodeficiency disorders (CVID) are a group of rare innate disorders characterized by specific antibody deficiency and increased rates of infections, comorbidities and mortality. The burden of CVID in Europe has not been previously estimated. We performed a retrospective analysis of the European Society for Immunodeficiencies (ESID) registry data on the subset of patients classified by their immunologist as CVID and treated between 2004 and 2014. The registered deaths and comorbidities were used to calculate the annual average age-standardized rates of Years of Life Lost to premature death (YLL), Years Lost to Disability (YLD) and Disability Adjusted Life Years (DALY=YLL + YLD). These outcomes were expressed as a rate per 105 of the CVID cohort (the individual disease burden), and of the general population (the societal disease burden). RESULTS: Data of 2700 patients from 23 countries were analysed. Annual comorbidity rates: bronchiectasis, 21.9%; autoimmunity, 23.2%; digestive disorders, 15.6%; solid cancers, 5.5%; lymphoma, 3.8%, exceeded the prevalence in the general population by a factor of 34.0, 7.6, 8.1, 2.4 and 32.6, respectively. The comorbidities of CVID caused 8722 (6069; 12,363) YLD/105 in this cohort, whereas 44% of disability burden was attributable to infections and bronchiectasis. The total individual burden of CVID was 36,785 (33,078, 41,380) DALY/105. With estimated CVID prevalence of ~ 1/ 25,000, the societal burden of CVID ensued 1.5 (1.3, 1.7) DALY/105 of the general population. In exploratory analysis, increased mortality was associated with solid tumor, HR (95% CI): 2.69 (1.10; 6.57) p = 0.030, lymphoma: 5.48 (2.36; 12.71) p < .0001 and granulomatous-lymphocytic interstitial lung disease: 4.85 (1.63; 14.39) p = 0.005. Diagnostic delay (median: 4 years) was associated with a higher risk of death: 1.04 (1.02; 1.06) p = .0003, bronchiectasis: 1.03 (1.01; 1.04) p = .0001, solid tumor: 1.08 (1.04; 1.11) p < .0001 and enteropathy: 1.02 (1.00; 1.05) p = .0447 and stayed unchanged over four decades (p = .228). CONCLUSIONS: While the societal burden of CVID may seem moderate, it is severe to the individual patient. Delay in CVID diagnosis may constitute a modifiable risk factor of serious comorbidities and death but showed no improvement. Tools supporting timely CVID diagnosis should be developed with high priority.

Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis.

BACKGROUND: People with diabetes have a high risk of developing micro- and macrovascular complications associated with diminished life expectancy and elevated treatment costs. Patient education programs can improve diabetes control in the short term, but their cost-effectiveness is uncertain. Our study aimed to analyze the lifelong cost-effectiveness of a nurse-led telecoaching program compared to usual care in people with type 2 diabetes from the perspective of the Belgian healthcare system. METHODS: The UKPDS Outcomes Model was populated with patient-level data from an 18-month randomized clinical trial in the Belgian primary care sector involving 574 participants; trial data were extrapolated to 40 years; Quality Adjusted Life Years (QALYs), treatment costs and Incremental Cost-Effectiveness Ratio (ICER) were calculated for the entire cohort and the subgroup with poor glycemic control at baseline ("elevated HbA1c subgroup") and the associated uncertainty was explored. RESULTS: The cumulative mean QALY (95% CI) gain was 0.21 (0.13; 0.28) overall and 0.56 (0.43; 0.68) in elevated HbA1c subgroup; the respective incremental costs were €1,147 (188; 2,107) and €2,565 (654; 4,474) and the respective ICERs €5,569 (€677; €15,679) and €4,615 (1,207; 9,969) per QALY. In the scenario analysis, repeating the intervention for lifetime had the greatest impact on the cost-effectiveness and resulted in the mean ICERs of €13,034 in the entire cohort and €7,858 in the elevated HbA1c subgroup. CONCLUSION: Taking into account reimbursement thresholds applied in West-European countries, nurse-led telecoaching of people with type 2 diabetes may be considered highly cost-effective within the Belgian healthcare system. TRIAL REGISTRATION: NCT01612520.

A guide for the application of analytics on healthcare processes: A dynamic view on patient pathways.

OBJECTIVE: The aim of this study is to guide healthcare instances in applying process analytics on healthcare processes. Process analytics techniques can offer new insights in patient pathways, workflow processes, adherence to medical guidelines and compliance with clinical pathways, but also bring along specific challenges which will be examined and addressed in this paper. METHODS: The following methodology is proposed: log preparation, log inspection, abstraction and selection, clustering, process mining, and validation. It was applied on a case study in the type 2 diabetes mellitus domain. RESULTS: Several data pre-processing steps are applied and clarify the usefulness of process analytics in a healthcare setting. Healthcare utilization, such as diabetes education, is analyzed and compared with diabetes guidelines. Furthermore, we take a look at the organizational perspective and the central role of the GP. This research addresses four challenges: healthcare processes are often patient and hospital specific which leads to unique traces and unstructured processes; data is not recorded in the right format, with the right level of abstraction and time granularity; an overflow of medical activities may cloud the analysis; and analysts need to deal with data not recorded for this purpose. These challenges complicate the application of process analytics. It is explained how our methodology takes them into account. CONCLUSION: Process analytics offers new insights into the medical services patients follow, how medical resources relate to each other and whether patients and healthcare processes comply with guidelines and regulations.