Measuring treatment burden in people with Type 2 Diabetes Mellitus (T2DM): A Mixed-methods Systematic Review

Abstract

Background: Workload related to Type 2 Diabetes Mellitus (T2DM) treatment imposes a substantial yet overlooked burden on patients, highlighting the need to identify optimal patient-reported outcome measures capable of capturing the unique treatment burdens faced by this population. The purpose of this systematic review was to identify the most robust approach for measuring treatment burden in people with Type 2 Diabetes Mellitus (T2DM) based on existing evidence. Methods: The review included quantitative, mixed methods and qualitative studies measuring treatment burden in adults with T2DM and/or reporting patient treatment experiences. Articles from seven databases(Embase, PubMed, CINAHL, APA PsycInfo, CINAHL, CNKI, Wanfang and CBMWeb) were retrieved. Quality of included studies were assessed using the JBI Critical Appraisal Tool. The measurement properties of instrument were assessed using the COSMIN checklist. A mixed-methods design of systematic review was applied, synthesizing findings through a convergent segregated approach. Results: 21,584 records were searched, and 26 articles were included for analysis, comprising 11 quantitative, 11 qualitative, and 4 mixed-methods studies. A thematic analysis of qualitative data engendered a conceptual framework that includes seven core measurements relevant to the treatment burden in T2DM. Themes less supported by current evidence were categorized as associated measurements. This conceptual framework directly guided the subsequent evaluation with COSMIN checklist. PETS, TBQ, and MTBQ achieved multiple positive ratings (between 6 and 8) on the COSMIN checklist, indicating strong Patient-Reported Outcome Measure (PROM) development process and ranking in the upper tertile among all evaluated instruments. PETS was identified as the top-performing instrument because it assessed most of the core measurements delineated in the conceptual framework and enabled separately calculated score for each component. Furthermore, the review found that the majority of existing research on the treatment burden of T2DM originates from developed countries, thereby potentially neglecting the variability present in developing or under-resourced settings. Conclusions: This systematic review provides evidence for currently superior option of measuring treatment burden in people with T2DM. It also advocates for further research in under-resourced settings. Protocal registration: A protocol was registered on the International Prospective Register of Systematic Reviews (CRD42022244190).