Masterarbeit, 2022
62 Seiten, Note: 1.0
1 Introduction
1.1 Background and Critique of Literature
1.2 Research Gap and Rationale for Study
1.3 Research Questions, Aims, and Objectives of Study
2 Methodology
2.1 Systematic Literature Search
2.2 Grey Literature Search
2.3 Eligibility Criteria
2.4 Selection Process
2.5 Assessment of Methodological Quality
2.6 Data Extraction
2.7 Data Synthesis
2.8 Risk of Bias Assessment
3 Results
3.1 Study Selection
3.2 Characteristics of Included Studies
3.3 Critical Appraisal of Included Studies
3.4 Findings of the Review
3.5 Research Pipeline for Cost-Effectiveness of HCL
4 Discussion
4.1 Interpretation of Results in the Context of Existing Evidence
4.2 Limitations of the Evidence Included in the Review
4.3 Strengths and Limitations of the Review Process
4.4 Implications of Results for Practice and Policy
4.5 Implications of Results for the Future Research Agenda
4.6 Conclusion
5 Final Notes
5.2 Registration and Protocol
5.3 Support and Competing Interests
5.4 Availability of Material
The primary objective of this dissertation is to conduct a systematic review and critical analysis of existing economic evaluations concerning hybrid closed-loop (HCL) artificial pancreas systems for patients with type 1 diabetes, aimed at assessing their cost-effectiveness to inform clinical policy and future research.
1.1 Background and Critique of Literature
Diabetes mellitus affects 463 million people worldwide, while the global prevalence is estimated to reach 700 million by 2045 (Saeedi et al., 2019). With 10% of total global health expenditure spent on diabetes, the ‘pandemic disease’ exerts a considerable economic burden on health care systems worldwide (IDF, 2019, Toniolo et al., 2019).
Type 1 diabetes (T1D) patients can only achieve normoglycaemia through external insulin substitution and adherence to a strict insulin regimen (Kovatchev, 2018, ADA, 2020). Rigorous monitoring of blood glucose levels and insulin dosing is crucial to maintain glycaemic control and avoid acute hypoglycaemia, medical complications, and long-term comorbidities (Evans Kreider et al., 2017). Besides the lifelong burden of a chronic degressive disease patients also face time-consuming manual monitoring obligations (Hameed and Kleinberg, 2020).
By offering convenience through automation, subcutaneous continuous glucose monitoring (CGM) devices have largely replaced the practice of manual self-monitoring of blood glucose (SMBG) via finger prick testing (Benjamin, 2002, Welsh and Thomas, 2019). On the other hand, continuous subcutaneous insulin infusion (CSII) pumps – which provide a steady flow of basal insulin and partly additional meal-related bolus insulin (Pickup, 2002) – have not yet superseded manual insulin dosing practice via multiple daily injections (MDI) (ADA, 2020). Thus, potential benefits from using advanced CGM devices stay limited to human capacities. On the other hand, increased adoption of CSIIs or automated insulin delivery (AID) systems would allow for more effective diabetes management, leading to fewer complications, substantial time savings, and improved quality of life (Kowalski, 2009, Bernand, 2017, Boughton and Hovorka, 2021).
1 Introduction: Provides the global context of diabetes mellitus, the clinical challenges of T1D management, and establishes the rationale for evaluating the cost-effectiveness of HCL systems.
2 Methodology: Outlines the systematic review process, including search strategies in medical databases, eligibility criteria, and the application of JBI and CHEERS guidelines for quality assessment.
3 Results: Presents the findings from the systematic search, including study selection, characteristics, critical appraisals, and a synthesized overview of cost-effectiveness data and the future research pipeline.
4 Discussion: Interprets the review's findings, highlights strengths and limitations of the available evidence, and provides implications for clinical practice, health policy, and future research agendas.
5 Final Notes: Confirms the administrative aspects of the study, including protocol registration, non-funded status, and the location of supporting appendices.
Systematic review, diabetes technology, closed-loop systems, economic evaluation, cost-effectiveness, quality assessment, type 1 diabetes, health economics, artificial pancreas, clinical outcomes, reimbursement, insulin delivery, medical device, cost-effectiveness plane, ICER.
This work examines the cost-effectiveness of hybrid closed-loop (HCL) artificial pancreas systems compared to standard diabetes treatment options for patients with type 1 diabetes.
The themes include the clinical and economic impact of automated insulin delivery, the standardization of health economic reporting, and the appraisal of existing trial evidence.
The goal is to determine if HCL systems serve as a cost-effective alternative by aggregating and evaluating evidence from available health economic literature.
The author employs a systematic review methodology, adhering to PRISMA 2020 and JBI guidelines, complemented by a narrative synthesis of economic outcomes.
The main body covers the background of diabetes technology, systematic search strategies, methodological quality appraisal of included studies, detailed findings on ICERs, and an analysis of the future research pipeline.
The work is defined by terms such as systematic review, cost-effectiveness, HCL, type 1 diabetes, and economic evaluation.
The author applied OECD purchasing power parities and adjusted for inflation using UK consumer price indices to convert results into 2021 GBP per QALY.
The research indicates that HCL systems generally demonstrate cost-effectiveness in clinical practice, though limited long-term data and methodological heterogeneity require further high-quality research.
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