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Arietti P, Boye KS, Guidi M, Rachman J, Federici MO, Raiola R, Avitabile A, Valentine WJ. Improving outcomes with early and intensive metabolic control in patients with type 2 diabetes: a long-term modeling analysis of clinical and cost outcomes in Italy. J Diabetes Metab Disord 2025; 24:58. [PMID: 39886102 PMCID: PMC11780239 DOI: 10.1007/s40200-024-01553-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 12/16/2024] [Indexed: 02/01/2025]
Abstract
Objectives This analysis quantifies the potential long-term clinical and cost benefits of early and intensive metabolic control (EIMC) versus conventional management in patients newly diagnosed with type 2 diabetes in Italy. Methods The PRIME T2D Model was used to project clinical and cost outcomes over long-term time horizons for a newly diagnosed cohort of patients receiving EIMC or conventional management. EIMC was associated with a mean glycated hemoglobin reduction of 0.6% from baseline and a mean weight loss of 9.5 kg (8.2%) for a duration of 6 years, before gradually returning to the same levels as the conventional management arm over 6 years. Modifiable risk factors were assumed to progress over time based on published regression functions. Direct and indirect costs associated with diabetes-related complications were accounted in 2021 Euros (EUR), with unit costs and health state utilities derived from published sources. Future costs and clinical benefits were discounted at 3% annually. Results For the population diagnosed with type 2 diabetes in 2021 (estimated at 216,417 cases), EIMC was projected to add approximately 33,112 years of life and 55,403 quality-adjusted life years versus conventional management. Cost savings with EIMC were estimated at EUR 494 million, EUR 608 million and EUR 628 million in the incident population at 10- and 20- and 50-year time horizons, respectively. Conclusions According to this modeling study, early and intensive metabolic control has the potential to substantially improve clinical outcomes and reduce economic burden compared with conventional management of patients with type 2 diabetes in Italy. Supplementary Information The online version contains supplementary material available at 10.1007/s40200-024-01553-w.
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Affiliation(s)
| | | | | | | | | | | | | | - William J. Valentine
- Ossian Health Economics and Communications GmbH, Bäumleingasse 20, Basel, 4051 Switzerland
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Elnaggar M, Mansinho JN, Malkin SJP, Whitaker J, Hunt B, Glah D, MacLellan M, Ali S. The Long-Term Cost-Effectiveness of Oral Semaglutide Versus Lower-Cost Liraglutide in the UK. Diabetes Ther 2025; 16:613-628. [PMID: 39969755 PMCID: PMC11926313 DOI: 10.1007/s13300-025-01691-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/11/2024] [Accepted: 01/08/2025] [Indexed: 02/20/2025] Open
Abstract
INTRODUCTION Glucagon-like peptide-1 (GLP-1) receptor agonists represent efficacious therapies for treating type 2 diabetes. Oral semaglutide is the only orally administered GLP-1 receptor agonist currently available and has been associated with reductions in glycated hemoglobin and body weight versus once-daily injectable liraglutide after 52 weeks in the PIONEER 4 clinical trial. As lower-cost liraglutide formulations have recently been developed, the present analysis evaluated the long-term cost-effectiveness of oral semaglutide 14 mg versus liraglutide 1.8 mg at lower acquisition costs in the UK. METHODS The published and validated PRIME Type 2 Diabetes Model was used to project clinical and cost outcomes over patient lifetimes. Baseline cohort characteristics, as well as treatment-specific changes in physiological parameters and hypoglycemia rates, were sourced from PIONEER 4. Patients were modeled to receive oral semaglutide or liraglutide until HbA1c exceeded 8.0% (64 mmol/mol), after which treatment was intensified to basal insulin. Annual disutilities associated with treatment administration were applied to capture the differential impact of a once-daily oral versus once-daily injectable medication on quality of life. Costs, expressed in 2022 pounds sterling (GBP), were calculated from a National Health Service (NHS) perspective. The acquisition cost of liraglutide was reduced by up to 50% at increments of 5% across a range of scenarios. RESULTS Oral semaglutide was associated with improved quality-adjusted life expectancy of 0.18 quality-adjusted life years versus liraglutide 1.8 mg due to a reduced incidence of diabetes-related complications and a reduced treatment-administration burden. Direct, per-person complication costs were estimated to be GBP 187 lower with oral semaglutide. Oral semaglutide remained dominant or cost-effective in the majority of scenarios, even with liraglutide price reductions of 50% applied. CONCLUSIONS Oral semaglutide 14 mg was projected to be cost-effective versus lower-cost liraglutide 1.8 mg in the UK.
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Affiliation(s)
- Mohamed Elnaggar
- Endocrinology, Diabetes and Metabolism Department, University Hospitals of Morecambe Bay NHS Foundation Trust, Kendal, UK
| | | | - Samuel J P Malkin
- Ossian Health Economics and Communications GmbH, Bäumleingasse 20, 4051, Basel, Switzerland.
| | | | - Barnaby Hunt
- Ossian Health Economics and Communications GmbH, Bäumleingasse 20, 4051, Basel, Switzerland
| | | | | | - Samina Ali
- NHS Greater Glasgow and Clyde, Glasgow, UK
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Xie S, Liu X, Li M, Wu J. Disutilities of treatment-related attributes for type 2 diabetes mellitus: a systematic review. Qual Life Res 2025:10.1007/s11136-025-03945-8. [PMID: 40131683 DOI: 10.1007/s11136-025-03945-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/07/2025] [Indexed: 03/27/2025]
Abstract
OBJECTIVES To synthesize the literature on eliciting disutilities associated with treatment-related attributes in type 2 diabetes (T2DM). METHODS We searched Medline, Embase, Cochrane Library, PsycINFO, EconLit and CINAHL databases from inception to December, 2024. This systematic review followed PRISMA guidelines, quality and risk of bias of the included studies were assessed using the NICE and ROBINS-I checklist. RESULTS Nine studies involving 59 to 4060 participants were included and most studies (n=6) were conducted in the UK. The perspective of preference included T2DM patients (n=7) and the general public (n=3), with one study included both. Elicitation approaches used were time trade-off (n=5) and standard gamble (n=4). Eight treatment-related attributes were identified, including weight change (n=5), dosing frequency (n=4), gastrointestinal side effects (n=2), flexible dosing (n=2), administration requirement (i.e., reconstitution, waiting, and needle handling) (n=2), injection site reaction (n=1), fear of hypoglycemia (n=1), and HbA1c levels (n=1). For the attribute of weight change, the (dis)utility value ranged from -0.106 to 0.047. Respondents showed a preference for weekly over daily administration (range: 0.023 to 0.095), once-daily over multiple-daily (range: 0.015 to 0.123). The (dis)utility values for the rest of six attributes ranged from -0.04 to 0.034. CONCLUSIONS This review provides evidence synthesize of published disutilities related to T2DM treatment-related attributes which have a nonnegligible effect. Weight change and dosing frequency were the most reported with the largest impact. Given the considerable heterogeneity in current studies, care should be taken in selecting appropriate estimates between different elicitation methods, populations and countries.
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Affiliation(s)
- Shitong Xie
- School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China
- Center for Social Science Survey and Data, Tianjin University, Tianjin, China
| | - Xinran Liu
- School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China
- Center for Social Science Survey and Data, Tianjin University, Tianjin, China
| | - Meixuan Li
- Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Jing Wu
- School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China.
- Center for Social Science Survey and Data, Tianjin University, Tianjin, China.
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Huang C, Lan C, Chen Z, Yu Y, Gao J, Yang H. Knowledge, attitude and practice regarding screening and managing diabetic microvascular complications among general practitioners of community health centres: a cross-sectional study in Shanghai, China. BMJ Open 2025; 15:e085784. [PMID: 39890145 PMCID: PMC11784367 DOI: 10.1136/bmjopen-2024-085784] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Accepted: 01/10/2025] [Indexed: 02/03/2025] Open
Abstract
OBJECTIVE To evaluate the knowledge, attitude and practice (KAP) regarding screening and managing diabetic microvascular complications, encompassing diabetic retinopathy (DR), diabetic kidney disease (DKD) and diabetic neuropathy (DN), among general practitioners (GPs). DESIGN Cross-sectional study. SETTING The online questionnaire survey was conducted between April and July 2023. PARTICIPANTS GPs from community health centres (CHCs) in all 16 districts of Shanghai were recruited. PRIMARY AND SECONDARY OUTCOME MEASURES The data of sociodemographic characteristics, KAP scales, training experience and screening instruments for community screening and managing diabetic microvascular complications were collected. Multiple stepwise linear regression was used to explore the influencing factors of KAP. Restricted cubic spline curves with four knots (5%, 35%, 65%, 95%) were used to determine the association between KAP score and duration of general practice. RESULTS A total of 1243 questionnaires were included in the analysis. The total KAP score was 66.6±8.8/100, and the knowledge, attitude and practice scores were 64.7±8.7, 83.5±10.5 and 51.6+17.8, respectively. Male (β=-2.419, p=0.012), shorter practice duration (β=-1.033, p=0.031), practice in rural area (β=3.230, p=0.001), not attending training in diabetic microvascular complications (β=-6.346, p<0.001), not managing diabetic patients (β=-4.503, p<0.001), less number of diabetes patients under management (β=-0.007, p=0.035), less number of screening instruments based on self-report of GP (β=-1.681, p<0.001), lower knowledge score (β=-0.190, p<0.001) and lower attitude score (β=-0.414, p<0.001) were associated with lower practice score of GPs. The KAP total score increased with the working years of general practice; however, this effect was no longer observed in knowledge score after 15 years, while the attitude and practice scores showed a continuously increasing trend. CONCLUSIONS GPs showed insufficient knowledge and poor clinical practice on screening and managing diabetic microvascular complications. There is an urgent need to improve their capacity to provide better care for those with diabetic microvascular complications through targeted training.
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Affiliation(s)
- Cuiling Huang
- Department of General Practice, Zhongshan Hospital Fudan University（Xiamen Branch）, Xiamen, Fujian, China
| | - Chengdian Lan
- Department of General Practice, Zhongshan Hospital Fudan University（Xiamen Branch）, Xiamen, Fujian, China
| | - Zhangyan Chen
- Department of General Practice, Zhongshan Hospital Fudan University（Xiamen Branch）, Xiamen, Fujian, China
| | - Ying Yu
- Department of General Practice, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
| | - Jian Gao
- Department of Nutrition, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
- Center of Clinical Epidemiology and Evidence-Based Medicine, Fudan University, Shanghai, Shanghai, China
| | - Hua Yang
- Department of General Practice, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
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Wang Y, Xu Y, Shan H, Pan H, Chen J, Yang J. Health state utility values of type 2 diabetes mellitus and related complications: a systematic review and meta-regression. Health Qual Life Outcomes 2024; 22:74. [PMID: 39244536 PMCID: PMC11380328 DOI: 10.1186/s12955-024-02288-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2024] [Accepted: 08/26/2024] [Indexed: 09/09/2024] Open
Abstract
BACKGROUND This study aimed to synthesize and quantitatively examine Health State Utility Values (HSUVs) for Type 2 Diabetes Mellitus (T2DM) and its complications, providing a robust meta-regression framework for selecting appropriate HSUV estimates. METHOD We conducted a systematic review to extract HSUVs for T2DM and its complications, encompassing various influencing factors. Relevant literature was sourced from a review spanning 2000-2020, supplemented by literature from PubMed, Embase, and the Web of Science (up to March 2024). Multivariate meta-regression was performed to evaluate the impact of measurement tools, tariffs, health status, and clinical and demographic variables on HSUVs. RESULTS Our search yielded 118 studies, contributing 1044 HSUVs. The HSUVs for T2DM with complications varied, from 0.65 for cerebrovascular disease to 0.77 for neuropathy. The EQ-5D-3L emerged as the most frequently employed valuation method. HSUV differences across instruments were observed; 15-D had the highest (0.89), while HUI-3 had the lowest (0.70) values. Regression analysis elucidated the significant effects of instrument and tariff choice on HSUVs. Complication-related utility decrement, especially in diabetic foot, was quantified. Age <70 was linked to increased HSUVs, while longer illness duration, hypertension, overweight and obesity correlated with reduced HSUVs. CONCLUSION Accurate HSUVs are vital for the optimization of T2DM management strategies. This study provided a comprehensive data pool for HSUVs selection, and quantified the influence of various factors on HSUVs, informing analysts and policymakers in understanding the utility variations associated with T2DM and its complications.
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Affiliation(s)
- Yubo Wang
- Department of Pharmacy, 1/F, Science and Technology Building, The First Affiliated Hospital of Xinjiang Medical University, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
- Xinjiang Key Laboratory of Clinical Drug Research, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
| | - Yueru Xu
- School of Pharmacy, Xinjiang Medical University, No.393 XinYi Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
| | - Huiting Shan
- Department of Pharmacy, 1/F, Science and Technology Building, The First Affiliated Hospital of Xinjiang Medical University, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
- Xinjiang Key Laboratory of Clinical Drug Research, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
| | - Huimin Pan
- Department of Pharmacy, 1/F, Science and Technology Building, The First Affiliated Hospital of Xinjiang Medical University, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
- Xinjiang Key Laboratory of Clinical Drug Research, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China
| | - Ji Chen
- Department of Pharmacy, 1/F, Science and Technology Building, The First Affiliated Hospital of Xinjiang Medical University, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China.
- Xinjiang Key Laboratory of Clinical Drug Research, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China.
| | - Jianhua Yang
- Department of Pharmacy, 1/F, Science and Technology Building, The First Affiliated Hospital of Xinjiang Medical University, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China.
- Xinjiang Key Laboratory of Clinical Drug Research, No.137 Liyushan Road, Xinshi District, Urumqi, Xinjiang Uygur Autonomous Region, China.
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Lee P, Hargreaves E, Jiang Y, Calder A, Marsh S, Gray C, Hunt K, Eyles H, Draper N, Heke I, Kara S, Maddison R, Gao L. Long-term cost-effectiveness analysis of rugby fans in training-New Zealand: a body weight reduction programme for males. BMJ Open 2024; 14:e073740. [PMID: 39043600 PMCID: PMC11268026 DOI: 10.1136/bmjopen-2023-073740] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2023] [Accepted: 06/28/2024] [Indexed: 07/25/2024] Open
Abstract
OBJECTIVES We sought to extrapolate the long-term costs and clinical impacts attributed to the rugby fans in training-New Zealand (RUFIT-NZ) trial in Aotearoa, New Zealand. DESIGN A modelled cost-effectiveness analysis using efficacy data from RUFIT-NZ was conducted from the Aotearoa New Zealand healthcare perspective. SETTING A Markov cohort model was constructed with a lifetime time horizon. The model simulated events of myocardial infarction (MI), stroke and type 2 diabetes mellitus (T2DM) occurring among a hypothetical cohort of 10 000 individuals receiving either the RUFIT-NZ intervention or no intervention. Efficacy data were based on the RUFIT-NZ trial, and the latest Global Burden of Disease study was used to extrapolate the impact of body weight reduction on clinical outcomes of T2DM, MI or stroke. Cost and utility data were drawn from the RUFIT-NZ trial and published sources. PRIMARY OUTCOME MEASURES The incremental cost-effectiveness ratio (ICER). RESULTS Over a lifetime time horizon, participants in the RUFIT-NZ intervention gained 0.02 (discounted) quality-adjusted life years (QALYs) at an additional cost of NZ$863, relative to no intervention. The estimated ICER was NZ$49 515 per QALY gained (discounted), which is above the arbitrary willingness-to-pay threshold of NZ$45 000 per QALY. Sensitivity analyses supported the robustness of these findings. CONCLUSIONS RUFIT-NZ was associated with a reduction in cardiovascular and endocrine events for overweight and obese males. However, based on conservative assumptions, RUFIT-NZ was unlikely to be cost-effective from a healthcare system perspective. TRIAL REGISTRATION NUMBER ACTRN12619000069156.
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Affiliation(s)
- Peter Lee
- Deakin Health Economics, School of Social Health and Development, Institute for Health Transformation, Deakin University, Burwood, Victoria, Australia
| | - Elaine Hargreaves
- School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand
| | - Yannan Jiang
- Department of Statistics, The University of Auckland, Auckland, New Zealand
| | - Amanda Calder
- National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand
| | - Samantha Marsh
- National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand
| | - Cindy Gray
- Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Kate Hunt
- Institute for Social Marketing, University of Stirling, Stirling, UK
| | - Helen Eyles
- National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand
| | - Nick Draper
- School of Health Sciences, University of Canterbury, Christchurch, New Zealand
| | | | - Stephen Kara
- Axis Sport Medicine Clinic, Auckland, New Zealand
| | - Ralph Maddison
- Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia
| | - Lan Gao
- Deakin Health Economics, School of Social Health and Development, Institute for Health Transformation, Deakin University, Burwood, Victoria, Australia
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Valentine WJ, Norrbacka K, Boye KS. Utilities for Complications Associated with Type 2 Diabetes: A Review of the Literature. Adv Ther 2024; 41:2655-2681. [PMID: 38771477 PMCID: PMC11213775 DOI: 10.1007/s12325-024-02878-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2023] [Accepted: 04/17/2024] [Indexed: 05/22/2024]
Abstract
INTRODUCTION Utility values are used in health economic modeling analyses of type 2 diabetes (T2D) to quantify the effect of acute and long-term complications on quality of life (QoL). For accurate modeling projections, it is important that the utility values used are up to date, accurate and representative of the simulated model cohort. METHODS A literature review was performed to identify utility values for health states representing acute and chronic T2D-related complications including cardiovascular complications, stroke, renal disease, ophthalmic complications, neuropathy, diabetic foot, amputation and hypoglycemia. Searches were performed using the PubMed, Embase and Cochrane Library databases and limited to articles published since 2010. Supplementary searches were performed to identify data published at congresses in 2019-2023. RESULTS A total of 54 articles were identified that reported utility values for T2D-related complications. The most frequently used elicitation method/instrument was the EQ-5D (n = 42 studies) followed by the Short Form-6 dimensions (n = 6), time tradeoff (n = 5), the Health Utilities Index Mark 2 or Mark 3 (n = 2), 15D (n = 1), visual analog scale (n = 1) and standard gamble (n = 1). Stroke and amputation were consistently associated with the largest decrements in QoL. There is a lack of published data that distinguishes between severity of several complications including renal disease, retinopathy and neuropathy. CONCLUSIONS Diabetes-related complications can have a profound impact on QoL; therefore, it is important that these are captured accurately and appropriately in health economic models. Recently published utility values for diabetes-related complications that can be used to inform health economic models are summarized here.
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Affiliation(s)
- William J Valentine
- Ossian Health Economics and Communications GmbH, Bäumleingasse 20, 4051, Basel, Switzerland.
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Lui JNM, Lau ESH, Yang A, Wu H, Fu A, Lau V, Loo K, Yeung T, Yue R, Ma RCW, Kong APS, Ozaki R, Luk AOY, Chow EYK, Chan JCN. Temporal associations of diabetes-related complications with health-related quality of life decrements in Chinese patients with type 2 diabetes: A prospective study among 19 322 adults-Joint Asia Diabetes Evaluation (JADE) register (2007-2018). J Diabetes 2024; 16:e13503. [PMID: 37984378 PMCID: PMC11128750 DOI: 10.1111/1753-0407.13503] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2023] [Revised: 10/13/2023] [Accepted: 11/02/2023] [Indexed: 11/22/2023] Open
Abstract
BACKGROUND Patients with type 2 diabetes (T2D) are at high risk of developing multiple complications, affecting their health-related quality of life (HRQoL). Existing studies only considered impact of complication on HRQoL in the year of occurrence but not its residual impacts in subsequent years. We investigated temporal impacts of diabetes-related complications on HRQoL in a 12-year prospective cohort of ambulatory Chinese patients with T2D enrolled in the clinic-based Joint Asia Diabetes Evaluation (JADE) Register. METHODS HRQoL utility measures were derived from EuroQol five-dimensional three-level questionnaire (EQ-5D-3L) questionnaires completed by 19 322 patients with T2D in Hong Kong (2007-2018). Temporal EQ-5D utility decrements associated with subtypes of cardiovascular-renal events were estimated using generalized linear regression model after stepwise selection of covariates with p < .01 as cutoff. RESULTS In this cohort (mean ± SD age:61.2 ± 11.5 years, 55.3% men, median [interquartile range] duration of diabetes:10.1 [3.0-15.0] years, glycated hemoglobin [HbA1C] 7.5 ± 1.5%), EQ-5D utility was 0.860 ± 0.163. The largest HRQoL decrements were observed in year of occurrence of hemorrhagic stroke (-0.230), followed by ischemic stroke (-0.165), peripheral vascular disease (-0.117), lower extremity amputation (-0.093), chronic kidney disease (CKD) G5 without renal replacement therapy (RRT) (-0.079), congestive heart failure (CHF) (-0.061), and CKD G3-G4 without RRT (-0.042). Residual impacts on HRQoL persisted for 2 years after occurrence of CHF or ischemic stroke and 1 year after hemorrhagic stroke or CKD G3-G4 without RRT. CONCLUSION This is the first comprehensive report on temporal associations of HRQoL decrements with subtypes of diabetes-related complications in ambulatory Asian patients with T2D. These data will improve the accuracy of cost-effectiveness analysis of diabetes interventions at an individual level in an Asian setting.
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Affiliation(s)
- Juliana N. M. Lui
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
- Asia Diabetes FoundationShatinHong Kong
| | - Eric S. H. Lau
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
- Asia Diabetes FoundationShatinHong Kong
| | - Aimin Yang
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
| | - Hongjiang Wu
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
| | - Amy Fu
- Asia Diabetes FoundationShatinHong Kong
| | | | - Kitman Loo
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
| | - Theresa Yeung
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
| | - Rebecca Yue
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
| | - Ronald C. W. Ma
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
| | - Alice P. S. Kong
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
| | - Risa Ozaki
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
| | - Andrea O. Y. Luk
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
- Asia Diabetes FoundationShatinHong Kong
| | - Elaine Y. K. Chow
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
| | - Juliana C. N. Chan
- Department of Medicine and Therapeutics, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Hong Kong Institute of Diabetes and Obesity, Prince of Wales HospitalThe Chinese University of Hong KongShatinHong Kong
- Li Ka Shing Institute of Health SciencesThe Chinese University of Hong Kong Prince of Wales HospitalShatinHong Kong
- Asia Diabetes FoundationShatinHong Kong
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Emad-Eldin M, Balata GF, Elshorbagy EA, Hamed MS, Attia MS. Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges. World J Diabetes 2024; 15:828-852. [PMID: 38766443 PMCID: PMC11099362 DOI: 10.4239/wjd.v15.i5.828] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2023] [Revised: 02/01/2024] [Accepted: 03/20/2024] [Indexed: 05/10/2024] Open
Abstract
Insulin therapy plays a crucial role in the management of type 2 diabetes as the disease progresses. Over the past century, insulin formulations have undergone significant modifications and bioengineering, resulting in a diverse range of available insulin products. These products show distinct pharmacokinetic and pharmacodynamic profiles. Consequently, various insulin regimens have em-erged for the management of type 2 diabetes, including premixed formulations and combinations of basal and bolus insulins. The utilization of different insulin regimens yields disparate clinical outcomes, adverse events, and, notably, patient-reported outcomes (PROs). PROs provide valuable insights from the patient's perspective, serving as a valuable mine of information for enhancing healthcare and informing clinical decisions. Adherence to insulin therapy, a critical patient-reported outcome, significantly affects clinical outcomes and is influenced by multiple factors. This review provides insights into the clinical effectiveness of various insulin preparations, PROs, and factors impacting insulin therapy adherence, with the aim of enhancing healthcare practices and informing clinical decisions for individuals with type 2 diabetes.
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Affiliation(s)
- Mahmoud Emad-Eldin
- Department of Pharmacy Practice, Faculty of Pharmacy, Zagazig University, Zagazig HFQM+872, Al-Sharqia Governorate, Egypt
| | - Gehan F Balata
- Department of Pharmacy Practice, Faculty of Pharmacy, Heliopolis University, Cairo 44519, Egypt
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Eman A Elshorbagy
- Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mona S Hamed
- Department of Community at Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mohamed S Attia
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
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Tan MHP, Ong SC, Tahir NAM, Ali AM, Mustafa N. Health state utility values ranges across varying stages and severity of type 2 diabetes-related complications: A systematic review. PLoS One 2024; 19:e0297589. [PMID: 38574169 PMCID: PMC10994347 DOI: 10.1371/journal.pone.0297589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2023] [Accepted: 01/09/2024] [Indexed: 04/06/2024] Open
Abstract
INTRODUCTION Health state utility values (HSUV) for Type 2 diabetes mellitus (T2DM) complications are useful in economic evaluations to determine cost effectiveness of an intervention. However, there is a lack of reference ranges for different severity and stages of individual complications. This study aimed to provide an overview of HSUV decrement ranges for common T2DM complications focusing on different severity and stages of complications. METHOD A systematic search was conducted in MEDLINE, SCOPUS, WEB OF SCIENCE. (Jan 2000 to April 2022). Included studies for HSUV estimates were from outpatient setting, regardless of treatment types, complication stages, regions and HRQoL instruments. Health Related Quality of Life (HRQoL) outcomes was to be presented as HSUV decrement values, adjusted according to social demographics and comorbidities. Adjusted HSUV decrements were extracted and compiled according to individual complications. After which, subsequently grouped into mild or severe category for comparison. RESULTS Searches identified 35 studies. The size of the study population ranged from 160 to 14,826. The HSUV decrement range was widest for cerebrovascular disease (stroke): -0.0060 to -0.0780 for mild stroke and -0.035 to -0.266 for severe stroke; retinopathy: mild (-0.005 to -0.0862), moderate (-0.0030 to -0.1845) and severe retinopathy (-0.023 to -0.2434); amputation: (-0.1050 to -0.2880). Different nature of complication severity defined in studies could be categorized into: those with acute nature, chronic with lasting effects, those with symptoms at early stage or those with repetitive frequency or episodes. DISCUSSION Overview of HSUV decrement ranges across different stages of each T2DM diabetes-related complications shows that chronic complications with lasting impact such as amputation, severe stroke with sequelae and severe retinopathy with blindness were generally associated with larger HSUV decrement range. Considerable heterogeneities exist across the studies. Promoting standardized complication definitions and identifying the most influential health state stages on HSUV decrements may assist researchers for future cost-effectiveness studies.
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Affiliation(s)
- Michelle Hwee Pheng Tan
- Pharmacy Department, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Pulau Pinang, Malaysia
| | - Siew Chin Ong
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Pulau Pinang, Malaysia
| | - Nurul Ain Mohd Tahir
- Department of Pharmacy, Kampus Kuala Lumpur Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Adliah Mhd Ali
- Department of Pharmacy, Kampus Kuala Lumpur Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Norlaila Mustafa
- Department of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
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Lord J, Reid K, Duclos C, Mai A, Odoi A. Investigation of predictors of severity of diabetes complications among hospitalized patients with diabetes in Florida, 2016-2019. BMC Public Health 2023; 23:2424. [PMID: 38053065 PMCID: PMC10698929 DOI: 10.1186/s12889-023-17288-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2023] [Accepted: 11/22/2023] [Indexed: 12/07/2023] Open
Abstract
BACKGROUND Severe diabetes complications impact the quality of life of patients and may lead to premature deaths. However, these complications are preventable through proper glycemic control and management of risk factors. Understanding the risk factors of complications is important in guiding efforts to manage diabetes and reduce risks of its complications. Therefore, the objective of this study was to identify risk factors of severe diabetes complications among adult hospitalized patients with diabetes in Florida. METHODS Hospital discharge data from 2016 to 2019 were obtained from the Florida Agency for Health Care Administration through a Data Use Agreement with the Florida Department of Health. Adapted Diabetes Complications Severity Index (aDCSI) scores were computed for 1,061,140 unique adult patients with a diagnosis of diabetes. Severe complications were defined as those with an aDCSI ≥ 4. Population average models, estimated using generalized estimating equations, were used to identify individual- and area-level predictors of severe diabetes complications. RESULTS Non-Hispanic Black patients had the highest odds of severe diabetes complications compared to non-Hispanic White patients among both males (Odds Ratio [OR] = 1.20, 95% Confidence Interval [CI]: 1.17, 1.23) and females (OR = 1.27, 95% CI: 1.23, 1.31). Comorbidities associated with higher odds of severe complications included hypertension (OR = 2.30, 95% CI: 2.23, 2.37), hyperlipidemia (OR = 1.29, 95% CI: 1.27, 1.31), obesity (OR = 1.24, 95% CI: 1.21, 1.26) and depression (OR = 1.09, 95% CI: 1.07, 1.11), while the odds were lower for patients with a diagnosis of arthritis (OR = 0.81, 95% CI: 0.79, 0.82). Type of health insurance coverage was associated with the severity of diabetes complications, with significantly higher odds of severe complications among Medicare (OR = 1.85, 95% CI: 1.80, 1.90) and Medicaid (OR = 1.83, 95% CI: 1.77, 1.90) patients compared to those with private insurance. Residing within the least socioeconomically deprived ZIP code tabulation areas (ZCTAs) in the state had a protective effect compared to residing outside of these areas. CONCLUSIONS Racial, ethnic, and socioeconomic disparities in the severity of diabetes complications exist among hospitalized patients in Florida. The observed disparities likely reflect challenges to maintaining glycemic control and managing cardiovascular risk factors, particularly for patients with multiple chronic conditions. Interventions to improve diabetes management should focus on populations with disproportionately high burdens of severe complications to improve quality of life and decrease premature mortality among adult patients with diabetes in Florida.
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Affiliation(s)
- Jennifer Lord
- Department of Biomedical and Diagnostic Sciences, College of Veterinary Medicine, The University of Tennessee, Knoxville, TN, USA
| | - Keshia Reid
- Florida Department of Health, Tallahassee, FL, USA
| | - Chris Duclos
- Florida Department of Health, Tallahassee, FL, USA
| | - Alan Mai
- Florida Department of Health, Tallahassee, FL, USA
| | - Agricola Odoi
- Department of Biomedical and Diagnostic Sciences, College of Veterinary Medicine, The University of Tennessee, Knoxville, TN, USA.
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Yildirim G, Rashidi M, Karaman F, Genç A, Jafarov GÜ, Kiskaç N, Ulusoy İ, Elki N N, Çakmak S. The relationship between diabetes burden and health-related quality of life in elderly people with diabetes. Prim Care Diabetes 2023; 17:595-599. [PMID: 37673762 DOI: 10.1016/j.pcd.2023.08.007] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2023] [Revised: 07/27/2023] [Accepted: 08/29/2023] [Indexed: 09/08/2023]
Abstract
BACKGROUND One of the most common chronic diseases in the elderly is diabetes. When diabetes is not well controlled, it can cause complications and affect health-related quality of life. Determining the burden of diabetes in elderly patients can provide a good health-related quality of life. AIM The study was conducted to examine the relationship between diabetes burden and health-related quality of life in elderly patients with diabetes. METHODS This is a descriptive and correlational study of 207 patients who applied to the diabetes outpatient clinics of a private and a public hospital in Istanbul. Respondents were completed with "Personal Information Form for Elderly People", "Elderly Diabetes Burden Scale" and the "Quality of Life in the Elderly Scale". Data were analyzed by SPSS. The tests used are Kolmogorov-Smirnov, Mann-Whitney U, Kruskal Wallis and Spearman Correlation tests. RESULTS The mean total score from the Elderly Diabetes Burden Scale was 47.13 ± 11.95 (18-88), and the mean score from the Quality of Life in the Elderly Scale was 19.36 ± 7.00. In the study, as the total diabetes burden score of the elderly patients increased, the Quality of Life in the Elderly Scale score decreased. There was a difference between the mean total score of the Elderly Diabetes Burden Scale and gender, education, living alone and using oral antidiabetic (p < 0.05). CONCLUSIONS As a result it was determined, a negative correlation was found between the diabetes CASP-19 scale total score and the total EDBS. Determining the burden of diabetes and affecting factors in elderly is important in terms of increasing the health-related quality of life. It may be recommended to plan diabetes education programs that will reduce the burden of diabetes and increase the health-related quality of life in elderly patients.
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Affiliation(s)
- Gülay Yildirim
- Trakya University, Keşan Hakkı Yörük School of Health, Department of Nursing, Edirne, Turkey.
| | - Mahruk Rashidi
- İstanbul Gelişim University, Faculty of Health Sciences, Department of Nursing, Turkey
| | - Funda Karaman
- İstanbul Gelişim University, Faculty of Health Sciences, Department of (English) Nursing, Istanbul, Turkey
| | - Aslı Genç
- İstanbul Esenyurt University, Faculty of Health Sciences, Department of Nursing Istanbul, Turkey
| | - Gülşah Ünsal Jafarov
- İstanbul Gelişim University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey
| | - Neşe Kiskaç
- İstanbul Gelişim University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey
| | - İbrahim Ulusoy
- Istanbul Provincial Directorate of Health, Avcılar Murat Kölük State Hospıtal, Istanbul, Turkey
| | - Nurten Elki N
- İstanbul Gelişim University / Faculty of Health Sciences, Department of Child Development, İstanbul, Turkey
| | - Sultan Çakmak
- İstanbul Gelişim University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey
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Tan MHP, Ong SC, Bujang MA, Shah SA, Mustafa N. Evaluation of the health-related quality of life of patients with type 2 diabetes in relation to macrovascular and microvascular complications. Acta Diabetol 2023; 60:1735-1747. [PMID: 37542199 DOI: 10.1007/s00592-023-02164-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2023] [Accepted: 07/18/2023] [Indexed: 08/06/2023]
Abstract
PURPOSE The complications of type 2 diabetes (T2DM) have a negative impact on health-related quality of life (HRQoL) and could lead to increased healthcare costs. However, there is a lack of evidence regarding how and to what extent T2DM complications, particularly macrovascular and microvascular complications, affect the patients' HRQoL. This study aimed to evaluate the HRQoL in relation to diabetes complications and identify associated factors among patients with T2DM. METHODS A cross-sectional study was conducted over six months on T2DM patients at a National University Hospital, Malaysia. Since Malaysia is a multiethnic country with majority Malay-speaking and English widely used, the Malay and English versions of the revised version Diabetes Quality of life (DQoL) questionnaire was used to measure HRQoL. Multiple Linear Regression was applied to estimate association of individual DQoL domains with T2DM-related complications, sociodemographic and clinical characteristics. RESULTS A total of 513 patients were recruited in the study. Sociodemographic (age, gender, ethnicity, employment, education) and body mass index affected satisfaction, impact and worry domains while complications affected the impact domain. Poorer HRQoL were demonstrated for severe stages heart failure (p = 0.001), nephropathy (p = 0.029), retinopathy (p < 0.001). The presence of neuropathy (p = 0.004) and foot ulcer (p = 0.039) showed poor HRQoL regardless of severity stage. Increase frequencies of hypoglycaemia (p < 0.001) showed poorer HRQoL compared to those with lesser frequencies. CONCLUSION The complications, sociodemographic and clinical characteristics of patients with T2DM affect the HRQoL domains differently. Understanding the point of which complication types and stages impact HRQoL the most can provide insights to clinicians to prioritise on effective interventions. The study findings may assist researchers and policymakers in selecting appropriate health state values when conducting cost-effectiveness studies to aid decision making.
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Affiliation(s)
- Michelle Hwee Pheng Tan
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Penang, Malaysia
- Pharmacy Department, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Siew Chin Ong
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Science, Universiti Sains Malaysia, Penang, Malaysia.
| | - Mohamad Adam Bujang
- Clinical Research Centre, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Sarawak, Malaysia
| | - Shamsul Azhar Shah
- Department of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Norlaila Mustafa
- Department of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
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Ben Chmo M, Matricciani L, Kumar S, Graham K. "I know what I'm supposed to do, but I don't do it": patient-perceived risk factors that lead to their lower extremity amputations. J Foot Ankle Res 2023; 16:79. [PMID: 37957636 PMCID: PMC10642033 DOI: 10.1186/s13047-023-00675-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2023] [Accepted: 10/16/2023] [Indexed: 11/15/2023] Open
Abstract
BACKGROUND The purpose of this study is to extend on our previous research by exploring patient-perceived factors that lead to their Lower Extremity Amputations (LEA). LEA are a serious complication of Type 2 Diabetes Mellitus (T2DM), LEA are thought to be preventable with early detection and management of risk factors. Our previous study identified that these factors extend beyond the typical biological and modifiable risk factors and may also extend to patient awareness and competing priorities. Therefore, this research explored these issues in further detail, identifying patient-perceived factors that lead to their LEA. METHODS A qualitative descriptive methodology involving non-probability purposive sampling was used to recruit inpatients at a tertiary metropolitan hospital in South Australia. Semi-structured interviews were conducted, and data were transcribed verbatim. Data from the interviews were analysed using thematic analysis and the constant comparison approach. RESULTS A total of 15 participants shared their perspectives of risk factors for LEA. Two main themes emerged: intrinsic and extrinsic factors. Intrinsic factors identified in this study included identity, ambivalence, denial, inevitability, and helplessness. Extrinsic factors related to resources, rapport with healthcare professionals, and management of care. CONCLUSIONS Through identifying that a combination of perceived personal attributes (intrinsic) and system-level (extrinsic) factors likely contribute to LEA, this study highlights the complexity of factors that contribute to patients' perceptions of what led to their diabetes related LEA. These findings support the importance of a nuanced approach in managing patients with diabetes who are at risk of LEA as it's likely patients' personal circumstances, day-to-day life's requirements and responsibilities, their interaction with healthcare professionals all seemingly contribute to how risks are viewed and managed. Tackling this challenge will require reimagining diabetes care, acknowledgement of risk factors beyond the obvious and addressing persistent access and workforce issues.
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Affiliation(s)
- Marcelle Ben Chmo
- Allied Health & Human Performance, The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia.
| | - Lisa Matricciani
- Clinical and Health Sciences, The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia
| | - Saravana Kumar
- Allied Health & Human Performance, The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia
- Innovation, IMPlementation and Clinical Translation (IIMPACT in Health), The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia
| | - Kristin Graham
- Allied Health & Human Performance, The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia
- Innovation, IMPlementation and Clinical Translation (IIMPACT in Health), The University of South Australia, North Terrace, Adelaide, SA, 5000, Australia
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Volčanšek Š, Lunder M, Janež A. Health-Related Quality of Life Assessment in Older Patients with Type 1 and Type 2 Diabetes. Healthcare (Basel) 2023; 11:2154. [PMID: 37570394 PMCID: PMC10418676 DOI: 10.3390/healthcare11152154] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2023] [Revised: 07/20/2023] [Accepted: 07/25/2023] [Indexed: 08/13/2023] Open
Abstract
Type 1 (T1D) and type 2 diabetes (T2D) are determinants of health-related outcomes including health-related quality of life (HRQOL). We aimed to determine differences in HRQOL between older adults with T1D and T2D and specific factors influencing HRQOL in this age group. This study used a cross-sectional design with 56 age- and HbA1c-matched T1D and T2D patients (aged 68.9 ± 7.8 years; 55% had T2D). We employed several validated questionnaires (Short Form-36 (SF-36) and the EuroQol-5 Dimensions/Visual Analog Scale (VAS)) to investigate the relationships between HRQOL domains and diabetes type, glycemic control, complications, and comorbidities. T1D was associated with better self-reported general health (assessed with the SF-36 general health domain (p = 0.048) and the EuroQol-5 VAS (p = 0.002), whereas no significant differences in the other SF-36 domains, self-reported diabetes distress, anxiety, or depression were found. Most HRQOL domains were not associated with HbA1c or the presence of diabetes complications. The most significant reduction in HRQOL was experienced by patients with higher BMIs, irrespective of the diabetes type. The obtained HRQOL data could be used in clinical settings for evidence-based patient education focused on specific subgroups of patients, as well as in national healthcare policies, e.g., interventions designed to alleviate obesity.
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Affiliation(s)
- Špela Volčanšek
- Clinical Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia; (M.L.); (A.J.)
- Medical Faculty, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia
| | - Mojca Lunder
- Clinical Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia; (M.L.); (A.J.)
- Medical Faculty, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia
| | - Andrej Janež
- Clinical Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia; (M.L.); (A.J.)
- Medical Faculty, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia
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Rognoni C, Segantin G, Scarsini R, Valgimigli M, Loizzi F, Costa F, Armeni P. Cost-effectiveness analysis of pressure-controlled intermittent coronary sinus occlusion in elective percutaneous coronary intervention. Expert Rev Pharmacoecon Outcomes Res 2023; 23:1101-1111. [PMID: 37589294 DOI: 10.1080/14737167.2023.2249612] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2023] [Revised: 07/17/2023] [Accepted: 08/14/2023] [Indexed: 08/18/2023]
Abstract
OBJECTIVES Percutaneous coronary intervention (PCI) represents the standard treatment for ST-elevated myocardial infarction, nevertheless, mortality and heart failures are frequent. Pressure-controlled intermittent coronary sinus occlusion (PiCSO) might reduce infarct size showing better patients' outcomes. We evaluated the cost-effectiveness of PCI+PiCSO compared to PCI from the National Healthcare Service (NHS) perspective in Italy. METHODS A Markov model was developed to estimate life years (LYs), quality-adjusted life years (QALYs) and costs. A micro-costing analysis has been performed to inform the cost of PCI+PiCSO procedure. Sensitivity analyses were performed to test the robustness of the model results. RESULTS Considering a willingness-to-pay threshold of 50,000€/QALY for the ICUR and a cost for PCI+PiCSO procedure of 14,654€, the innovative strategy may be cost-effective compared to PCI alone from the Italian NHS perspective, showing an ICUR of 17,530€/QALY (ICER 14,631€/LY) over a lifetime horizon; the probabilistic sensitivity analysis showed that PCI+PiCSO is cost-effective in 78.8% of simulations.Considering the above mentioned willingness-to-pay threshold, PCI+PiCSO strategy would be cost-effective over a lifetime horizon considering a cost for PCI+PiCSO procedure lower than 28,160€. CONCLUSION PCI+PiCSO procedure may be considered a cost-effective technology that allows reducing cardiac events, while improving patients' life expectancy and quality of life.
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Affiliation(s)
- Carla Rognoni
- Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy
| | - Gaia Segantin
- Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy
| | - Roberto Scarsini
- Azienda Ospedaliera Universitaria di Verona, Dipartimento di Cardiologia, Verona, Italia
| | - Marco Valgimigli
- EOC - Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano, Istituto Cardiocentro Ticino, Lugano, Svizzera
| | - Francesco Loizzi
- EOC - Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano, Istituto Cardiocentro Ticino, Lugano, Svizzera
| | - Francesco Costa
- Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy
| | - Patrizio Armeni
- Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy
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Zhang X, McAdam Marx C. Short-term cost-effectiveness analysis of tirzepatide for the treatment of type 2 diabetes in the United States. J Manag Care Spec Pharm 2023; 29:276-284. [PMID: 36840958 PMCID: PMC10388019 DOI: 10.18553/jmcp.2023.29.3.276] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/26/2023]
Abstract
BACKGROUND: Tirzepatide is a novel once-a-week dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that is used as an addition to diet and exercise to improve blood glucose in adults with type 2 diabetes. It is the first dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonist that has been approved by the US Food and Drug Administration. The SURPASS-2 clinical trial demonstrated superiority of tirzepatide 10 mg and 15 mg over semaglutide 1 mg in glycated hemoglobin A1c reduction and weight loss from baseline to week 40. Economic analyses to support coverage and access decision-making for tirzepatide are limited. OBJECTIVES: To evaluate the cost-effectiveness of tirzepatide 10 mg vs semaglutide 1 mg injection over 52 weeks of treatment regarding A1c reduction and weight loss from the perspective of the US health care payer. METHODS: A decision tree model over a 52-week time horizon was developed to identify incremental treatment-related costs of once-weekly tirzepatide 10 mg vs semaglutide 1 mg injection. Costs were divided by mean reduction in A1c and change in body weight from baseline to week 52 observed in the SURPASS-2 clinical trial. In addition to efficacy, probabilities of adverse events, discontinuation, and need for rescue therapy were derived from the SURPASS-2 study. Drug costs in 2022 US dollars were based on wholesale acquisition cost. Costs associated with adverse events were sourced from the published literature. One-way sensitivity analyses were conducted. RESULTS: Treatment with once-weekly tirzepatide 10 mg injection was associated with a higher cost and larger reduction in A1c and body weight after 52 weeks, compared with once-weekly semaglutide 1 mg injection. The incremental cost-effectiveness ratio for tirzepatide vs semaglutide was $2,247 per 1% reduction in A1c and $237 per 1 kg weight loss. One-way sensitivity analysis suggested that incremental cost-effectiveness ratios were most sensitive to the drug costs and treatment effect on A1c and weight. CONCLUSIONS: Once-weekly tirzepatide 10 mg was associated with higher cost and greater reduction in A1c and weight vs semaglutide. Tirzepatide 10 mg is cost-effective compared with semaglutide 1 mg if payers' willingness-to-pay threshold exceeds $2,247 for 1% reduction in A1c level and $237 for 1 kg weight loss.
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Affiliation(s)
- Xiaotong Zhang
- University of Nebraska Medical Center, Department of Pharmacy Practice and Science, College of Pharmacy, Omaha
| | - Carrie McAdam Marx
- University of Nebraska Medical Center, Department of Pharmacy Practice and Science, College of Pharmacy, Omaha
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Redenz G, Ibaceta MC, Aceituno D, Balmaceda C, Espinoza MA. Health State Utility Values of Type 2 Diabetes Mellitus and Related Complications: A Systematic Review and Meta-Analysis. Value Health Reg Issues 2023; 34:14-22. [PMID: 36371899 DOI: 10.1016/j.vhri.2022.09.005] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2022] [Revised: 09/01/2022] [Accepted: 09/25/2022] [Indexed: 11/13/2022]
Abstract
OBJECTIVES This study aims to synthesize health state utility values (HSUVs) of type 2 diabetes mellitus (T2DM) and its related complications published in the literature, conducting a meta-analysis of the data when possible. METHODS We conducted a systematic search in MEDLINE and School of Health and Related Research Health Utilities Database repository. Studies focused on T2DM and its complications reporting utility values elicited using direct and indirect methods were selected. We categorized the results according to the instrument to describe health and meta-analyzed them accordingly. Data included in the analysis were pooled in a fixed-effect model by the inverse of variance mean and random-effects DerSimonian-Laird method. Two approaches on sensitivity analysis were performed: leave-one-out method and including data of HSUVs obtained by foreign population value sets. RESULTS We identified 70 studies for the meta-analysis from a total of 467 studies. Sufficient data to pool T2DM HSUVs from EQ-5D instrument, hypoglycemia, and stroke were obtained. HSUVs varied from 0.7 to 0.92 in direct valuations, and the pooled mean of 3-level version of EQ-5D studies was 0.772 (95% confidence interval 0.763-0.78) and of 5-level version of EQ-5D 0.815 (95% confidence interval 0.808-0.823). HSUVs of complications varied from 0.739 to 0.843, or reductions of HSUVs between -0.014 and -0.094. In general, HSUVs obtained from 3-level version of EQ-5D and Health Utility Index 3 instruments were lower than those directly elicited. A considerable amount of heterogeneity was observed. Some complications remained unable to be pooled due to scarce of original articles. CONCLUSIONS T2DM and its complications have a considerable impact on health-related quality of life. 5-level version of EQ-5D estimates seems comparable with direct elicited HSUVs.
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Affiliation(s)
- Gunther Redenz
- Escuela de Kinesiología, Facultad de Medicina, Universidad de los Andes, Santiago, Chile
| | - Marcela Cárcamo Ibaceta
- Departamento de Epidemiología y estudios en salud, Universidad de los Andes, Santiago, Chile
| | - David Aceituno
- Departamento de psiquiatría, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
| | - Carlos Balmaceda
- Unidad de Evaluación de Tecnologías Sanitarias, Centro de Investigaciones Clínicas, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
| | - Manuel A Espinoza
- Departamento de Salud Pública, Pontificia Universidad Católica de Chile, Santiago, Chile.
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19
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Wohlfahrt P, Jenča D, Stehlik J, Melenovský V, Mrázková J, Staněk V, Kettner J, Šramko M, Želízko M, Adámková V, Piťha J, Kautzner J. Heart failure-related quality-of-life impairment after myocardial infarction. Clin Res Cardiol 2023; 112:39-48. [PMID: 35304902 DOI: 10.1007/s00392-022-02008-z] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2021] [Accepted: 03/07/2022] [Indexed: 01/21/2023]
Abstract
AIMS Recent advances in therapy led to a significant decrease in mortality and morbidity after myocardial infarction (MI). However, little is known about quality of life (QoL) after MI. We examined heart failure (HF)-related quality-of-life (QoL) impairment, its trajectories, and determinants after MI. METHODS Data from a single-center prospectively designed registry of consecutive patients hospitalized for MI at a large tertiary cardiology center were utilized. At 1 month and 1 year after hospital discharge, patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ). RESULTS In total, 850 patients (aged 65 ± 12 years, 27% female) hospitalized between June 2017 and October 2020 completed KCCQ at 1 month after discharge. Of these, 38.7% showed HF-related QoL impairment (KCCQ ≤ 75). In addition to characteristics of MI (MI size, diuretics need, heart rate), comorbidities as renal dysfunction and anemia were associated with QoL impairment. Of the 673 eligible, 500 patients (74.3%) completed KCCQ at 1 year after MI. On average, QoL improved by 5.9 ± 16.8 points during the first year after MI (p < 0.001); but, in 18% of patients QoL worsened. Diabetes control and hemoglobin level at the time of hospitalization were associated with QoL worsening. CONCLUSION Two out of 5 patients after MI present with HF-related QoL impairment. In addition to guideline-directed MI management, careful attention to key non-cardiac comorbidities as chronic kidney disease, anemia and diabetes may lead to further augmentation of the benefit of modern therapies in terms of QoL.
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Affiliation(s)
- Peter Wohlfahrt
- Department of Preventive Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. .,Center for Cardiovascular Prevention, Charles University in Prague, First Faculty of Medicine and Thomayer Hospital, Videnska 800, 140 59, Prague, Czech Republic.
| | - Dominik Jenča
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Josef Stehlik
- University of Utah School of Medicine, Salt Lake City, UT, USA
| | - Vojtěch Melenovský
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Jolana Mrázková
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Vladimír Staněk
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Jiří Kettner
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Marek Šramko
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Michael Želízko
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Věra Adámková
- Department of Preventive Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Jan Piťha
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
| | - Josef Kautzner
- Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
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20
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Systemic Diseases with Oral Manifestations and Their Impact on Health-Related Quality of Life. SERBIAN JOURNAL OF EXPERIMENTAL AND CLINICAL RESEARCH 2022. [DOI: 10.2478/sjecr-2021-0074] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/02/2023] Open
Abstract
Abstract
Health-related quality of life is a multidimensional concept established to evaluate the physical, psychological, and social impacts of health conditions on individuals’ well-being. Various tools for measuring health-related quality of life can be categorized into two subsets: generic and disease–specific instruments. The oral cavity can be stricken by a broad range of local and systemic diseases and their systemic treatment modalities. The most common systemic illnesses associated with oral lesions are hematologic disorders, endocrinopathies, neurological disorders, gastrointestinal conditions, mucocutaneous and rheumatic diseases, and neoplastic processes. Their manifestations in the oral cavity are, in most cases, rather nonspecific but should not be overlooked. Oral health is one of the most important parts of overall health, thus it has been proposed that poor oral health may affect health–related quality of life. The presence of oral manifestations of systemic diseases has a negative impact on the daily functioning of patients, decreasing their overall well-being. This article will review the most common systemic diseases with oral manifestations and their impact on the health–related quality of life. Oral health researchers should put a stronger emphasis on the patient-reported quality of life as a primary outcome in future clinical trials. The significance of this area has still not been widely understood in the current dental literature even though it could help improve patients’ health-related quality of life.
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21
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Ernstsson O, Hagberg K, Janssen MF, Bonsel GJ, Korkmaz S, Zethraeus N, Heintz E. Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry. Disabil Rehabil 2022; 44:8471-8479. [PMID: 34932426 DOI: 10.1080/09638288.2021.2015628] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
PURPOSE To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. RESULTS The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. CONCLUSION The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities.
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Affiliation(s)
- Olivia Ernstsson
- Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden
| | - Kerstin Hagberg
- Advanced Reconstruction of Extremities and Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden.,Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Mathieu F Janssen
- Department of Psychiatry, Erasmus Medical Center, Rotterdam, the Netherlands.,EuroQol Foundation, Rotterdam, the Netherlands
| | - Gouke J Bonsel
- EuroQol Foundation, Rotterdam, the Netherlands.,Department Public Health, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Seher Korkmaz
- Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden.,Department of Digitalization and IT, Health and Care Administration, Region Stockholm, Sweden
| | - Niklas Zethraeus
- Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden
| | - Emelie Heintz
- Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden
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22
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Keng MJ, Leal J, Bowman L, Armitage J, Mihaylova B. Hospital costs associated with adverse events in people with diabetes in the UK. Diabetes Obes Metab 2022; 24:2108-2117. [PMID: 35676793 PMCID: PMC9796307 DOI: 10.1111/dom.14796] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2022] [Revised: 05/27/2022] [Accepted: 06/06/2022] [Indexed: 01/01/2023]
Abstract
AIM To estimate the annual hospital costs associated with a range of adverse events for people with diabetes in the UK. METHODS Annual hospital costs (2019/2020) were derived from 15 436 ASCEND participants from 2005 to 2017 (120 420 person-years). The annual hospital costs associated with cardiovascular events (myocardial infarction, coronary revascularization, transient ischaemic attack [TIA], ischaemic stroke, heart failure), bleeding (gastrointestinal [GI] bleed, intracranial haemorrhage, other major bleed), cancer (GI tract cancer, non-GI tract cancer), end-stage renal disease (ESRD), lower limb amputation and death (vascular, non-vascular) were estimated using a generalized linear model following adjustment for participants' sociodemographic and clinical factors. RESULTS In the year of event, ESRD was associated with the largest increase in annual hospital cost (£20 954), followed by lower limb amputation (£17 887), intracranial haemorrhage (£12 080), GI tract cancer (£10 160), coronary revascularization (£8531 if urgent; £8302 if non-urgent), heart failure (£8319), non-GI tract cancer (£7409), ischaemic stroke (£7170), GI bleed (£5557), myocardial infarction (£4913), other major bleed (£3825) and TIA (£1523). In subsequent years, most adverse events were associated with lasting but smaller increases in hospital costs, except for ESRD, where the additional cost remained high (£20 090). CONCLUSIONS Our study provides robust estimates of annual hospital costs associated with a range of adverse events in people with diabetes that can inform future cost-effectiveness analyses of diabetes interventions. It also highlights the potential cost savings that could be derived from prevention of these costly complications.
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Affiliation(s)
- Mi Jun Keng
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- British Heart Foundation Centre of Research ExcellenceOxfordUK
| | - Jose Leal
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Louise Bowman
- Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Medical Research Council Population Health Research Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Jane Armitage
- British Heart Foundation Centre of Research ExcellenceOxfordUK
- Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Medical Research Council Population Health Research Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Borislava Mihaylova
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Wolfson Institute of Population HealthQueen Mary University of LondonLondonUK
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23
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Alsayed Hassan D, Helaluddin F, Chahestani OH, Mohamed O, Islam N. Diabetes Self-Management and Health-Related Quality of Life among Primary Care Patients with Diabetes in Qatar: A Cross-Sectional Study. Healthcare (Basel) 2022; 10:2124. [PMID: 36360465 PMCID: PMC9691062 DOI: 10.3390/healthcare10112124] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2022] [Revised: 10/02/2022] [Accepted: 10/12/2022] [Indexed: 08/13/2023] Open
Abstract
Diabetes self-management (DSM) practices are an important determinant of health-related outcomes, including health-related quality of life (HRQOL). The purpose of this study is to explore DSM practices and their relationship with the HRQOL of patients with type 2 diabetes in primary health care centers (PHCCs) in Qatar. In this cross-sectional study, data were collected from PHCC patients with diabetes via interview-administered questionnaires by utilizing two instruments: the DSM questionnaire (DSMQ) and the HRQOL Short Form (SF-12). Frequencies were calculated for categorical variables and medians were calculated for continuous variables that were not normally distributed. A statistical comparison between groups was conducted using chi-square for categorical data. Binary logistic regression was utilized to examine the relationship between the significant independent factors and the dependent variables. A total of 105 patients completed the questionnaire, 51.4% of whom were male. Approximately half of the participants (48.6%) reported poor overall DSM practices, and 50.5% reported poor physical health quality of life (PC) and mental health quality of life (MC). Female participants showed significantly higher odds of reporting poor DSM than male participants (OR, 4.77; 95% CI, 1.92-11.86; p = 0.001). Participants with a secondary education (OR, 0.18; 95% CI, 0.04-0.81; p = 0.025) and university education (OR, 0.18; 95% CI, 0.04-0.84; p = 0.029) showed significantly lower odds of reporting poor DSM than participants with no/primary education. Older participants showed higher odds of reporting poor PC than younger participants (OR 11.04, 95% CI, 1.47-82.76 and OR 8.32; 95% CI, 1.10-62.86, respectively). Females also had higher odds for poor PC than males (OR 7.08; 95% CI, 2.21-22.67), while participants with a secondary (OR, 0.13; 95% CI, 0.03-0.62; p = 0.010) and university education (OR, 0.11; 95% CI, 0.02-0.57; p = 0.008) showed significantly lower odds of reporting poor MC. In conclusion, patients with diabetes reported poor overall DSM practices and poor HRQOL. Our findings suggest intensifying efforts to deliver culturally appropriate DSM education to patients and to empower patients to take charge of their health.
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Affiliation(s)
- Diana Alsayed Hassan
- Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
| | - Fatema Helaluddin
- Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
| | - Ozra Hajebi Chahestani
- Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
| | - Omnia Mohamed
- Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
| | - Nazmul Islam
- Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada
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24
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Zhang G, Sun X, Yuan T, Guo C, Zhou Z, Wang L, Dou G. Certain Dietary Nutrients Reduce the Risk of Eye Affliction/Retinopathy in Individuals with Diabetes: National Health and Nutrition Examination Survey, 2003-2018. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:12173. [PMID: 36231475 PMCID: PMC9566346 DOI: 10.3390/ijerph191912173] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/09/2022] [Revised: 09/19/2022] [Accepted: 09/22/2022] [Indexed: 06/16/2023]
Abstract
As the global trend of diabetes intensifies, the burden of vision-threatening retinopathy, particularly diabetic retinopathy (DR), is increasing. There is an urgent need to seek strategies for early prevention and control of DR. This study attempted to comprehensively evaluate the relationship between dietary nutrient intake and the risk of DR to provide assistance for doctors in guiding the diet of diabetic patients. Data from eligible participants with diabetes from the US National Health and Nutrition Examination Survey (NHANES) from 2003-2018 were analyzed. Univariate logistic regression was used to assess the association between 58 dietary nutrient intakes and self-reported eye disease risk. Multivariate logistic regression model was used to further evaluate the relationship between the two groups after adjusting relevant confounding factors. A total of 4595 diabetic patients were included. People with self-reported eye affliction/retinopathy had lower dietary fiber, butanoic, octanoic, vitamin A, alpha-carotene, folate, magnesium, copper and caffeine intake compared to those without self-reported eye affliction/retinopathy. The pooled ORs (95% CIs) were 0.78 (0.62-0.98), 0.79 (0.63-0.99), 0.72 (0.58-0.91), 0.74 (0.59-0.93), 0.70 (0.55-0.88), 075 (0.60-0.95), 0.79 (0.64-0.99), 0.67 (0.54-0.84) and 0.80 (0.64-0.99). Dietary cholesterol and hexadecenoic intake were higher, with the pooled ORs (95% CIs) of 1.26 (1.01-1.58) and 1.27 (1.02-1.59), respectively. Our research found that among dietary nutrients, dietary fiber, butanoic, octanoic, vitamin A, alpha-carotene, folate, magnesium, copper and caffeine intake reduced the occurrence of DR. Cholesterol and hexadecenoic intake promoted the occurrence of DR. This suggests that certain dietary nutrients should be paid more attention in the prevention of DR.
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Affiliation(s)
- Guoheng Zhang
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
- Department of Ophthalmology, 942 Hospital of the Joint Logistics Support Force of the Chinese People’s Liberation Army, Yinchuan 750000, China
| | - Xiaojia Sun
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
| | - Tianhao Yuan
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
| | - Changmei Guo
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
| | - Ziyi Zhou
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
| | - Ling Wang
- Department of Health Statistics, Faculty of Preventive Medicine, Fourth Military Medical University, Xi’an 710032, China
| | - Guorui Dou
- Department of Ophthalmology, Eye Institute of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
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25
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Kheniser K, Aminian A, Kashyap SR. Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes. Metab Syndr Relat Disord 2022; 20:497-508. [PMID: 35881869 DOI: 10.1089/met.2022.0039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
The assessment and management of patient-reported outcomes (PROs) is considered secondary to that of cardiometabolic outcomes. When assessed, health-related quality of life (HRQOL), a PRO, can yield pertinent information that cannot be obtained from cardiometabolic assessments. For instance, physical and mental distress can be quantified and treated. Moreover, treatment convenience and satisfaction can be gaged. Behavioral modification, bariatric surgery, and pharmacotherapy can improve PROs. Typically, HRQOL is responsive to changes in weight. Specifically, weight loss and weight gain are associated with positive and negative changes in quality of life, respectively. In addition, patient satisfaction can be influenced by glycemic control. Therefore, hypoglycemia and hyperglycemic episodes can negatively affect patient satisfaction. When managing type 2 diabetes (T2D), it is important to consider how therapies impact PROs. Generally, changes in clinical outcomes mirror changes in PROs. To best manage T2D, integrating the assessment of PROs with clinical outcomes is needed.
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Affiliation(s)
- Karim Kheniser
- Department of General Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Ali Aminian
- Department of General Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Sangeeta R Kashyap
- Department of Endocrinology and Metabolism, Cleveland Clinic, Cleveland, Ohio, USA
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26
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Leal J, Becker F, Lim L, Holman RR, Gray AM. Health utilities in Chinese patients with coronary heart disease and impaired glucose tolerance (ACE): A longitudinal analysis of a randomized, double-blind, placebo-controlled trial. J Diabetes 2022; 14:455-464. [PMID: 35876124 PMCID: PMC9310045 DOI: 10.1111/1753-0407.13294] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/11/2021] [Revised: 06/09/2022] [Accepted: 06/17/2022] [Indexed: 11/29/2022] Open
Abstract
BACKGROUND We estimate health-related quality of life and the impact of four cardiovascular events (myocardial infarction [MI], stroke, congestive heart failure, angina) and gastrointestinal events in 6522 Chinese patients with coronary heart disease (CHD) and impaired glucose tolerance (IGT) participating in the Acarbose Cardiovascular Evaluation (ACE) trial. METHODS Health-related quality of life was captured using the EuroQol-5 Dimension-3 Level (EQ-5D-3L), with data collected at baseline and throughout the trial. Multilevel mixed-effects linear regression with random effects estimated health-related quality of life over time, capturing variation between hospital sites and individuals, and a fixed-effects linear model estimated the impact of cardiovascular and gastrointestinal events. RESULTS Patients were followed for a median of 5 years (interquartile range 3.4-6.0). The average baseline EQ-5D score of 0.930 (SD 0.104) remained relatively unchanged over the trial period with no evidence of statistically significant differences in EQ-5D score between randomized treatment groups. The largest decrement in the year of an event was estimated for stroke (-0.107, P < .001), followed by heart failure (-0.039, P = .022), MI (-0.021, P = .047), angina (-0.012, P = .047), and gastrointestinal events (-0.005, P = .430). MI and stroke reduced health-related quality of life beyond the year in which the event occurred (-0.031, P = .006, and -0.067, P < .001, respectively). CONCLUSIONS Acarbose treatment had no impact on health-related quality of life in ACE trial participants with CHD and IGT. Events such as MI, stroke, heart failure, and angina reduce health-related quality of life around the time they occurred, but only MI and stroke impacted on longer-term health-related quality of life.
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Affiliation(s)
- José Leal
- Health Economics Research CentreUniversity of OxfordOxfordUK
| | - Frauke Becker
- Health Economics Research CentreUniversity of OxfordOxfordUK
| | - Lee‐Ling Lim
- Department of MedicineUniversity of MalayaKuala LumpurMalaysia
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27
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Stafford S, Bech PG, Fridhammar A, Miresashvili N, Nilsson A, Willis M, Liu A. Cost-Effectiveness of Once-Weekly Semaglutide 1 mg versus Canagliflozin 300 mg in Patients with Type 2 Diabetes Mellitus in a Canadian Setting. APPLIED HEALTH ECONOMICS AND HEALTH POLICY 2022; 20:543-555. [PMID: 35344191 PMCID: PMC9206917 DOI: 10.1007/s40258-022-00726-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 02/27/2022] [Indexed: 06/14/2023]
Abstract
OBJECTIVE Our objective was to evaluate the long-term cost-effectiveness of once-weekly semaglutide 1 mg versus once-daily canagliflozin 300 mg in patients with type 2 diabetes mellitus (T2DM) uncontrolled with metformin from the healthcare payer and societal perspectives in Canada. METHODS Head-to-head data from the SUSTAIN 8 randomised trial (NCT03136484) were extrapolated over 40 years using economic simulation modelling. The cost-effectiveness of once-weekly semaglutide 1 mg versus canagliflozin 300 mg for treating T2DM was estimated using the Swedish Institute for Health Economics-Diabetes Cohort Model (IHE-DCM) and the Economic and Health Outcomes Model of T2DM (ECHO-T2DM). Unit costs and disutility weights capturing treatments and key macro- and microvascular complications were sourced from the literature to best match the Canadian setting. A probabilistic base-case simulation and sensitivity analyses were conducted. RESULTS Once-weekly semaglutide 1 mg was associated with reductions in macro- and microvascular complications, yielding incremental cost-effectiveness ratios (ICERs) of (Canadian dollars [CAD]) CAD16,392 and 18,098 per incremental quality-adjusted life-year (QALY) gained versus canagliflozin 300 mg for IHE-DCM and ECHO-T2DM, respectively, from a healthcare payer perspective. Accounting for productivity loss as well, ICERs were CAD14,127 and 13,188 per QALY gained for IHE-DCM and ECHO-T2DM, respectively, from a societal perspective. Sensitivity analyses confirmed that the base-case results were robust to changes in input parameters and assumptions used. CONCLUSIONS At a willingness-to-pay threshold of CAD50,000 per QALY gained, once-weekly semaglutide 1 mg was cost-effective over 40 years versus once-daily canagliflozin 300 mg for the treatment of T2DM in patients failing to maintain glycemic control with metformin alone.
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Affiliation(s)
- Sara Stafford
- Fraser Health Division of Endocrinology, 902-13737 96th Avenue, Surrey, BC, V3V 0C6, Canada.
| | - Peter G Bech
- Novo Nordisk Canada Inc., 2476 Argentia Rd, Mississauga, ON, L5N 6M1, Canada
| | - Adam Fridhammar
- The Swedish Institute for Health Economics, Box 2127, 220 02, Lund, Sweden
| | | | - Andreas Nilsson
- The Swedish Institute for Health Economics, Box 2127, 220 02, Lund, Sweden
| | - Michael Willis
- The Swedish Institute for Health Economics, Box 2127, 220 02, Lund, Sweden
| | - Aiden Liu
- Novo Nordisk Canada Inc., 2476 Argentia Rd, Mississauga, ON, L5N 6M1, Canada
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28
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Westerink J, Matthiessen KS, Nuhoho S, Fainberg U, Lyng Wolden M, Østergaard HB, Visseren F, Sattar N. Estimated Life-Years Gained Free of New or Recurrent Major Cardiovascular Events With the Addition of Semaglutide to Standard of Care in People With Type 2 Diabetes and High Cardiovascular Risk. Diabetes Care 2022; 45:1211-1218. [PMID: 35263432 PMCID: PMC9174968 DOI: 10.2337/dc21-1138] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Accepted: 02/01/2022] [Indexed: 02/03/2023]
Abstract
OBJECTIVE Semaglutide, a glucagon-like peptide 1 receptor agonist, reduced major adverse cardiovascular events (MACE) in people with type 2 diabetes (T2D) at high risk of cardiovascular disease (CVD) in a post hoc analysis of pooled data from Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN) 6 and Peptide Innovation for Early Diabetes Treatment (PIONEER) 6. We estimated the benefit of adding semaglutide to standard of care (SoC) on life-years free of new/recurrent CVD events in people with T2D at high risk of CVD. RESEARCH DESIGN AND METHODS The Diabetes Lifetime-perspective prediction (DIAL) competing risk-adjusted lifetime CVD risk model for people with T2D was developed previously. Baseline characteristics of the pooled cohort from SUSTAIN 6 and PIONEER 6 (POOLED cohort) (N = 6,480) were used to estimate individual life expectancy free of CVD for patients in the POOLED cohort. The hazard ratio of MACE from adding semaglutide to SoC was derived from the POOLED cohort (hazard ratio [HR] 0.76 [95% CI 0.62-0.92]) and combined with an individual's risk to estimate their CVD benefit. RESULTS Adding semaglutide to SoC was associated with a wide distribution in life-years free of CVD gained, with a mean increase of 1.7 (95% CI 0.5-2.9) life-years. Estimated life-years free of CVD gained with semaglutide was dependent on baseline risk (life-years free of CVD gained in individuals with established CVD vs. those with cardiovascular risk factors only: 2.0 vs. 0.2) and age at treatment initiation. CONCLUSIONS Adding semaglutide to SoC was associated with a gain in life-years free of CVD events that was dependent on baseline CVD risk and age at treatment initiation. This study helps contextualize the results of semaglutide clinical trials.
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Affiliation(s)
- Jan Westerink
- Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
| | | | | | | | | | | | - Frank Visseren
- Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Naveed Sattar
- Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, U.K
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Nicolucci A, Chen H, Cooper A, Fenici P, Gomes MB, Hammar N, Ji L, Khunti K, Kosiborod M, Medin J, Shestakova MV, Shimomura I, Tang F, Vora J, Watada H, Arnold SV. Quality of life in people with type 2 diabetes in the 3 years following initiation of second-line therapy: The DISCOVER study. Diabetes Res Clin Pract 2022; 185:109218. [PMID: 35114299 DOI: 10.1016/j.diabres.2022.109218] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/28/2021] [Revised: 12/23/2021] [Accepted: 01/25/2022] [Indexed: 11/19/2022]
Abstract
AIMS To assess changes in health-related quality of life (HRQoL) in DISCOVER, a 3-year, longitudinal, observational study of patients with type 2 diabetes initiating a second-line glucose-lowering therapy. METHODS HRQoL was assessed using the physical and mental component summary (PCS and MCS) scores of the 36-item Short-Form Health Survey version 2 (score ranges: 0-100; higher denotes better HRQoL) and the Hypoglycaemia Fear Survey II (HFS-II; score range: 0-132 scale; higher indicates greater fear of hypoglycaemia). Latent class growth modelling (LCGM) was used to identify patients with similar score trajectories. RESULTS Mean baseline PCS (n = 7428), MCS (n = 7453), and HFS-II (n = 5005) scores were 48.0, 45.4, and 15.4, respectively, and remained stable during follow-up. LCGM revealed subgroups with low or decreasing HRQoL. Patients in these subgroups tended to be older, had more comorbidities, and a lower socioeconomic status than in other subgroups. Use of insulin and sulfonylureas was highest in the subgroup with the highest fear of hypoglycaemia. CONCLUSIONS Overall, HRQoL remained stable in DISCOVER patients during follow-up. However, LCGM suggests that some patient characteristics and use of sulfonylureas or insulin are associated with low or decreasing HRQoL, potentially warranting the use of alternative therapies.
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Affiliation(s)
- Antonio Nicolucci
- Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
| | - Hungta Chen
- AstraZeneca, Gaithersburg, MD, United States
| | | | | | | | - Niklas Hammar
- Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden; AstraZeneca Gothenburg, Mölndal, Sweden
| | - Linong Ji
- Peking University People's Hospital, Beijing, China
| | | | - Mikhail Kosiborod
- Saint Luke's Mid America Heart Institute, Kansas City, MO, United States; University of Missouri, Kansas City, MO, United States; The George Institute for Global Health and University of New South Wales, Sydney, Australia
| | | | - Marina V Shestakova
- Endocrinology Research Center, Diabetes Institute, Moscow, Russian Federation
| | | | - Fengming Tang
- Saint Luke's Mid America Heart Institute, Kansas City, MO, United States
| | - Jiten Vora
- Royal Liverpool University Hospital, Liverpool, United Kingdom
| | - Hirotaka Watada
- Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Suzanne V Arnold
- Saint Luke's Mid America Heart Institute, Kansas City, MO, United States; University of Missouri, Kansas City, MO, United States
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Keng MJ, Leal J, Bowman L, Armitage J, Mihaylova B. Decrements in health-related quality of life associated with adverse events in people with diabetes. Diabetes Obes Metab 2022; 24:530-538. [PMID: 34866309 PMCID: PMC9361007 DOI: 10.1111/dom.14610] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2021] [Revised: 11/12/2021] [Accepted: 12/01/2021] [Indexed: 11/30/2022]
Abstract
AIM To estimate the decrements in health-related quality of life (QoL) associated with a range of adverse events to inform assessments of the effects of diabetes treatments on QoL in contemporary clinical practice. METHODS Participants' QoL utility measures were derived from the five-level EuroQoL five-dimensional (EQ-5D-5L) questionnaires completed by 11 683 ASCEND participants (76% of 15 480 recruited). EQ-5D utility decrements associated with cardiovascular (myocardial infarction, coronary revascularization, transient ischaemic attack [TIA], ischaemic stroke, heart failure), bleeding (gastrointestinal [GI] bleed, intracranial haemorrhage, other major bleed), cancer (GI tract cancer, non-GI tract cancer), and microvascular events (end-stage renal disease [ESRD], amputation) were estimated using a linear regression model following adjustment for participants' sociodemographic and clinical risk factors. RESULTS Amputation was associated with the largest EQ-5D utility decrement (-0.206), followed by heart failure (-0.185), intracranial haemorrhage (-0.164), GI bleed (-0.091), other major bleed (-0.096), ischaemic stroke (-0.061), TIA (-0.057), and non-GI tract cancer (-0.026). We were unable to detect decrements in EQ-5D utility associated with myocardial infarction, coronary revascularization, GI tract cancer, or ESRD. EQ-5D utility was lower at older age, independent of other factors. CONCLUSION These estimated decrements in QoL associated with cardiovascular, bleeding, cancer, and other adverse events can inform assessments of the overall value of treatments in patients with diabetes.
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Affiliation(s)
- Mi Jun Keng
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- British Heart Foundation Centre of Research ExcellenceOxfordUK
| | - Jose Leal
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Louise Bowman
- Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Medical Research Council Population Health Research Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Jane Armitage
- British Heart Foundation Centre of Research ExcellenceOxfordUK
- Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Medical Research Council Population Health Research Unit, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - Borislava Mihaylova
- Health Economics Research Centre, Nuffield Department of Population HealthUniversity of OxfordOxfordUK
- Wolfson Institute of Population HealthQueen Mary University of LondonLondonUK
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García AA, Huang YC, Zuñiga JA. Illness Perceptions Mediate the Impact of Depressive Symptoms on Quality of Life Among Latinos with Type 2 Diabetes. J Immigr Minor Health 2022; 24:1517-1525. [PMID: 35195797 DOI: 10.1007/s10903-022-01338-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/26/2022] [Indexed: 10/19/2022]
Abstract
Latinos' type 2 diabetes (T2DM) and concurrent depression significantly lower quality of life (QoL). Patients' beliefs about their diabetes, called illness perceptions (IP), may account for the impact of depression on QoL. Using secondary data, we explored predictive and mediation relationships among IP, depression, and QoL among Mexican American adults with T2DM using hierarchical multiple regression and mediation analyses. Participants (n = 75) were predominately middle-aged, female, most scoring low on depressive-symptoms, who believed that diabetes was a chronic disease with serious consequences, controllable by treatment and personal self-management. Participants with higher acculturation and weak perceptions about negative consequences of diabetes reported better QoL. Depressive symptoms' impact on QoL were mediated by overall IP and perceptions about diabetes consequences, in particular. By eliciting patients' perceptions about disease consequences and teaching realistic ways to avoid them, clinicians may alleviate the impact of depression on QoL.
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Affiliation(s)
- Alexandra A García
- School of Nursing, The University of Texas at Austin, 1710 Red River Street, Austin, TX, 78712, USA.
| | - Ya-Ching Huang
- St. David's School of Nursing, Texas State University, 1555 University Drive, Round Rock, TX, 78665, USA
| | - Julie A Zuñiga
- School of Nursing, The University of Texas at Austin, 1710 Red River Street, Austin, TX, 78712, USA
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Evaluation of definitions for oral anticoagulant-associated major bleeding: A population-based cohort study. Thromb Res 2022; 213:57-64. [DOI: 10.1016/j.thromres.2022.02.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2021] [Revised: 02/14/2022] [Accepted: 02/19/2022] [Indexed: 11/23/2022]
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Lambert-Obry V, Lafrance JP, Savoie M, Lachaine J. The Impact of Hypoglycemia on Productivity Loss and Utility in Type 2 Diabetes Patients Treated with Insulin in Real-World Canadian Practice: Protocol for a Prospective Study (Preprint). JMIR Res Protoc 2021; 11:e35461. [PMID: 35343912 PMCID: PMC9002599 DOI: 10.2196/35461] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2021] [Revised: 02/24/2022] [Accepted: 02/25/2022] [Indexed: 12/03/2022] Open
Abstract
Background Type 2 diabetes mellitus (T2DM) imposes a substantial burden owing to its increasing prevalence and life-threatening complications. In patients who do not achieve glycemic targets with oral antidiabetic drugs, the initiation of insulin is recommended. However, a serious concern regarding insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and the use of health care resources. However, health economics and outcomes research (HEOR) data for economic modelling are limited, particularly regarding utility values and productivity losses. Objective This real-world prospective study aims to assess the impact of hypoglycemia on productivity and utility in insulin-treated adults with T2DM from Ontario and Quebec, Canada. Methods This noninterventional, multicenter, 3-month prospective study will recruit patients from 4 medical clinics and 2 endocrinology or diabetes clinics. Patients will be identified using appointment lists and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be aged ≥18 years, diagnosed with T2DM, and treated with insulin. Utility and productivity will be measured using the EQ-5D-5L questionnaire and Institute for Medical Technology Assessment Productivity Cost Questionnaire, respectively. Questionnaires will be completed 4, 8, and 12 weeks after recruitment. Generalized estimating equation models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure the precision of HEOR estimates. Results This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for the economic modeling of T2DM. Conclusions Insulin therapy is expensive, and hypoglycemia is a significant component of economic evaluation. Robust HEOR data may help health technology assessment agencies in future reimbursement decision-making. International Registered Report Identifier (IRRID) PRR1-10.2196/35461
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Affiliation(s)
| | | | - Michelle Savoie
- Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada
| | - Jean Lachaine
- Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada
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Chen CC, Chen JH, Chen CL, Lai TJ, Ko Y. Health Utilities in Patients with Type 2 Diabetes in Taiwan. Healthcare (Basel) 2021; 9:healthcare9121672. [PMID: 34946402 PMCID: PMC8701244 DOI: 10.3390/healthcare9121672] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2021] [Revised: 11/26/2021] [Accepted: 11/30/2021] [Indexed: 11/16/2022] Open
Abstract
We aimed to measure health utilities in patients with diabetes mellitus (DM) in Taiwan and to estimate the impact of common DM-related complications and adverse effects (AEs) on health utilities. The present study was a cross-sectional survey of DM patients at a metropolitan hospital. Respondents’ health-related quality of life (HRQoL) was assessed by the EQ-5D-5L, and ordinary least-squares (OLS) regression was used to estimate the impact of self-reported DM-related complications and AEs on health utilities after controlling for age, gender, and duration of DM. A total of 506 eligible adults with type 2 DM (T2DM) were enrolled. The EQ-5D index values in our study sample ranged from −0.13 to 1, with a mean ± standard deviation of 0.88 ± 0.20. As indicated by the negative regression coefficients, the presence of any complication or AE was associated with lower EQ-5D index values, and the greatest impact on the score was made by amputation (−0.276), followed by stroke (−0.211), and blindness (−0.203). In conclusion, the present study elicited health utilities in patients with T2DM in Taiwan using the EQ-5D-5L. These estimated utility decrements provided essential data for future DM cost–utility analyses that are needed as a result of the increasing prevalence and health expenditures of DM.
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Affiliation(s)
- Chia-Chia Chen
- Department of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei 11031, Taiwan;
| | - Jin-Hua Chen
- Graduate Institute of Data Science, College of Management, Taipei Medical University, Taipei 11031, Taiwan;
- Statistics Center, Office of Data Science, Taipei Medical University, Taipei 11031, Taiwan
| | - Chien-Lung Chen
- Division of Nephrology, Landseed International Hospital, Taoyuan 32449, Taiwan;
| | - Tzu-Jung Lai
- Center for Drug Evaluation, Taipei 11557, Taiwan;
| | - Yu Ko
- Department of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei 11031, Taiwan;
- Research Center for Pharmacoeconomics, College of Pharmacy, Taipei Medical University, Taipei 11031, Taiwan
- Correspondence: ; Tel.: +886-2-2736-1661 (ext. 6174)
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Hallström S, Svensson AM, Pivodic A, Ólafsdóttir AF, Löndahl M, Wedel H, Lind M. Risk factors and incidence over time for lower extremity amputations in people with type 1 diabetes: an observational cohort study of 46,088 patients from the Swedish National Diabetes Registry. Diabetologia 2021; 64:2751-2761. [PMID: 34494137 PMCID: PMC8563633 DOI: 10.1007/s00125-021-05550-z] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2021] [Accepted: 06/14/2021] [Indexed: 01/30/2023]
Abstract
AIMS/HYPOTHESIS The aim of this work was to study the incidence over time of lower extremity amputations and determine variables associated with increased risk of amputations in people with type 1 diabetes. METHODS Individuals with type 1 diabetes registered in the Swedish National Diabetes Registry with no previous amputation from 1 January 1998 and followed to 2 October 2019 were included. Time-updated Cox regression and gradient of risk per SD were used to evaluate the impact of risk factors on the incidence of amputation. Age- and sex-adjusted incidences were estimated over time. RESULTS Of 46,088 people with type 1 diabetes with no previous amputation (mean age 32.5 years [SD 14.5], 25,354 [55%] male sex), 1519 (3.3%) underwent amputation. Median follow-up was 12.4 years. The standardised incidence for any amputation in 1998-2001 was 2.84 (95% CI 2.32, 3.36) per 1000 person-years and decreased to 1.64 (95% CI 1.38, 1.90) per 1000 person-years in 2017-2019. The incidence for minor and major amputations showed a similar pattern. Hyperglycaemia and renal dysfunction were the strongest risk factors for amputation, followed by older age, male sex, cardiovascular comorbidities, smoking and hypertension. Glycaemic control and age- and sex-adjusted renal function improved during the corresponding time period as amputations decreased. CONCLUSIONS/INTERPRETATION The incidence of amputation and of the most prominent risk factors for amputation, including renal dysfunction and hyperglycaemia, has improved considerably during recent years for people with type 1 diabetes. This finding has important implications for quality of life, health economics and prognosis regarding CVD, indicating a trend shift in the treatment of type 1 diabetes.
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Affiliation(s)
- Sara Hallström
- Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
- Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.
| | - Ann-Marie Svensson
- Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
- Center of Registers in Region Västra Götaland, Gothenburg, Sweden
| | - Aldina Pivodic
- Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Statistiska Konsultgruppen, Gothenburg, Sweden
| | - Arndís F Ólafsdóttir
- Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
- Department of Medicine, NU-Hospital Group, Uddevalla, Sweden
| | - Magnus Löndahl
- Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden
- Department of Endocrinology, Skane University Hospital, Lund, Sweden
| | - Hans Wedel
- Department of Health Metrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Marcus Lind
- Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
- Department of Medicine, NU-Hospital Group, Uddevalla, Sweden
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Nicolucci A, Chen H, Cid-Ruzafa J, Cooper A, Fenici P, Gomes MB, Hammar N, Khunti K, Kosiborod M, Leigh P, Medin J, Rathmann W, Shestakova MV, Shimomura I, Siddiqui A, Tang F, Watada H, Ji L. Health-related quality of life in patients with type 2 diabetes initiating a second-line glucose-lowering therapy: The DISCOVER study. Diabetes Res Clin Pract 2021; 180:108974. [PMID: 34302913 DOI: 10.1016/j.diabres.2021.108974] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/22/2021] [Revised: 07/14/2021] [Accepted: 07/19/2021] [Indexed: 11/19/2022]
Abstract
AIM To investigate factors associated with health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus (T2D) at initiation of second-line glucose-lowering therapy. METHODS DISCOVER is a 3-year, prospective observational study of patients with T2D initiating second-line glucose-lowering therapy, conducted in 38 countries. HRQoL at baseline was assessed using the physical and mental component summary (PCS; MCS) scores of the 36-Item Short Form Health Survey version 2 (SF-36v2) in 31 countries (n = 8309) and the Hypoglycaemia Fear Survey-II (HFS-II) in 23 countries (n = 6516). Factors associated with differences in HRQoL were assessed using multivariable hierarchical regression models. RESULTS Mean PCS and MCS scores were 48.0 (standard deviation [SD]: 7.8) and 45.5 (SD: 10.4), respectively. Factors associated with significantly lower SF-36v2 scores included being female, having a history of macrovascular complications and first-line treatment with oral combinations (vs metformin monotherapy). Mean HFS-II behaviour and worry scores were 8.2 (SD: 9.9) and 7.3 (SD: 11.8), respectively. Increased fear of hypoglycaemia was significantly associated with lower SF-36v2 scores. CONCLUSIONS Several patient-, disease- and treatment-related characteristics correlated with HRQoL, indicating that a multifactorial approach is needed to maintain HRQoL in patients with T2D.
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Affiliation(s)
- Antonio Nicolucci
- Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
| | | | | | | | | | | | - Niklas Hammar
- AstraZeneca Gothenburg, Mölndal, Sweden; Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden
| | | | - Mikhail Kosiborod
- Saint Luke's Mid America Heart Institute, Kansas City, MO, USA; University of Missouri-Kansas City, Kansas City, MO, USA; The George Institute for Global Health, Sydney, NSW, Australia
| | | | | | | | - Marina V Shestakova
- Endocrinology Research Centre, Diabetes Institute, Moscow, Russian Federation
| | | | | | - Fengming Tang
- Saint Luke's Mid America Heart Institute, Kansas City, MO, USA
| | | | - Linong Ji
- Peking University People's Hospital, Beijing, China
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Kuo S, Yang C, Chen H, Ou H. Valuing health states of people with type 2 diabetes: Analyses of the nationwide representative linked databases. J Diabetes Investig 2021; 12:1749-1758. [PMID: 33539655 PMCID: PMC8409834 DOI: 10.1111/jdi.13520] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2020] [Revised: 01/29/2021] [Accepted: 02/02/2021] [Indexed: 11/27/2022] Open
Abstract
AIMS/INTRODUCTION To estimate preference-based measures of health-related quality of life associated with sociodemographic and clinical characteristics in type 2 diabetes patients. MATERIALS AND METHODS Individuals with EuroQol-5 dimensions-3 levels data were identified from Taiwan's National Health Interview Survey in 2009 and 2013. Status of diabetes, comorbidities, complications and treatments were ascertained through data linkage to Taiwan's National Health Insurance Research Database. Multivariable ordinary least squares, Tobit and median regression analyses were used to estimate the coefficients that represented independent impacts of patients' characteristics on health-related quality of life. RESULTS The mean health utility score for 2,104 participants was 0.838. Being female, aging, divorced/widowed, never worked or underweight, or having a lower monthly household income, injectable glucose-lowering therapy, comorbid connective tissue disease or depression were associated with lower health utilities. Having an amputation led to the largest reduction by 0.288 in health utilities, followed by debilitating stroke (0.266), heart failure (0.237), other coronary heart disease (0.185), kidney dialysis/transplant (0.148), coronary revascularizations (0.093), transient ischemic attack/stroke (0.078), diabetic neuropathy (0.062), polyneuropathy (0.055) and other neuropathy (0.043). CONCLUSIONS Major vascular complications, connective tissue disease and depression are associated with considerably worse health-related quality of life. These health utility estimates can facilitate health economic evaluations to determine cost-effective strategies for diabetes management.
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Affiliation(s)
- Shihchen Kuo
- Division of Metabolism, Endocrinology & DiabetesDepartment of Internal MedicineUniversity of Michigan Medical SchoolAnn ArborMichiganUSA
| | - Chun‐Ting Yang
- Institute of Clinical Pharmacy and Pharmaceutical SciencesCollege of MedicineNational Cheng Kung UniversityTainanTaiwan
| | - Hsuan‐Ying Chen
- Institute of Clinical Pharmacy and Pharmaceutical SciencesCollege of MedicineNational Cheng Kung UniversityTainanTaiwan
| | - Huang‐Tz Ou
- Institute of Clinical Pharmacy and Pharmaceutical SciencesCollege of MedicineNational Cheng Kung UniversityTainanTaiwan
- Department of PharmacyCollege of MedicineNational Cheng Kung UniversityTainanTaiwan
- Department of PharmacyNational Cheng Kung University HospitalTainanTaiwan
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Choi D, Kim BY, Jung CH, Kim CH, Mok JO. Association between Sleep Quality and Painless Diabetic Peripheral Neuropathy Assessed by Current Perception Threshold in Type 2 Diabetes Mellitus. Diabetes Metab J 2021; 45:358-367. [PMID: 32794384 PMCID: PMC8164947 DOI: 10.4093/dmj.2019.0219] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2019] [Accepted: 03/20/2020] [Indexed: 01/03/2023] Open
Abstract
BACKGROUND It is known that the painful sensation of diabetic peripheral neuropathy (DPN) results in sleep problems in type 2 diabetes mellitus (T2DM). However, it is not known that the painless DPN also is associated with poor sleep quality in T2DM. The purpose of the current study was to investigate the association between painless DPN and poor sleep quality in T2DM. METHODS A total of 146 patients of T2DM who do not have any painful symptoms of DPN were recruited into the study. Among the patients, painless DPN was diagnosed by using the current perception threshold test. Sleep quality was assessed using the Pittsburgh Sleep Quality Index questionnaire. RESULTS The percentage of painless DPN was significantly higher in the poor sleep quality group than the good sleep quality group (70.0% vs. 35.5%, P<0.001). In the subscale results, stimulus values at 2,000 Hz, hypoesthesia and hyperesthesia were more common in the poor sleep quality group than in the good sleep quality group (45.7% vs. 25.0%, P=0.009; 34.3% vs. 18.4%, P=0.029; 40.0% vs. 19.7%, P=0.007, respectively). The association of painless DPN and poor sleep quality remained significant after adjustment for significant covariates (odds ratio, 3.825; 95% confidence interval, 1.674 to 8.742; P<0.001). CONCLUSION The current study showed that painless DPN was associated with poor sleep quality. Future studies are required to clarify the pathophysiologic causal relationship between painless DPN and sleep quality.
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Affiliation(s)
- Dughyun Choi
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Bo-Yeon Kim
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Chan-Hee Jung
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Chul-Hee Kim
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Ji-Oh Mok
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
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Kuo S, Ye W, de Groot M, Saha C, Shubrook JH, Hornsby WG, Pillay Y, Mather KJ, Herman WH. Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II. Diabetes Care 2021; 44:874-882. [PMID: 33608260 PMCID: PMC7985429 DOI: 10.2337/dc20-1639] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 01/17/2021] [Indexed: 02/03/2023]
Abstract
OBJECTIVE We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.
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Affiliation(s)
| | - Wen Ye
- University of Michigan, Ann Arbor, MI
| | - Mary de Groot
- Indiana University School of Medicine, Indianapolis, IN
| | - Chandan Saha
- Indiana University School of Medicine, Indianapolis, IN
| | - Jay H Shubrook
- Touro University College of Osteopathic Medicine in California, Vallejo, CA.,Heritage College of Osteopathic Medicine, Ohio University, Athens, OH
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Laxy M, Becker J, Kähm K, Holle R, Peters A, Thorand B, Schwettmann L, Karl FM. Utility Decrements Associated With Diabetes and Related Complications: Estimates From a Population-Based Study in Germany. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2021; 24:274-280. [PMID: 33518034 DOI: 10.1016/j.jval.2020.09.017] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/03/2020] [Revised: 08/24/2020] [Accepted: 09/29/2020] [Indexed: 06/12/2023]
Abstract
OBJECTIVES Health utility decrement estimates for diabetes and complications are needed for parametrization of simulation models that aim to assess the cost-utility of diabetes prevention and care strategies. This study estimates health utility decrements associated with diabetes and cardiovascular and microvascular complications from a population-based German study. METHODS Data were obtained from the population based cross-sectional KORA (Cooperative Health Research in the Augsburg Region) health questionnaire 2016 and comprised n = 1072 individuals with type 2 diabetes and n = 7879 individuals without diabetes. Health utility was assessed through the EQ-5D-5L. We used linear regression models with interaction terms between type 2 diabetes and different cardiovascular and microvascular complications while adjusting for demographic and socio-economic factors and other comorbidities. RESULTS Type 2 diabetes (β = -0.028, standard error [SE] = 0.014), stroke (β = -0.070, SE = 0.010), cardiac arrhythmia (β = -0.031, SE = 0.006), heart failure (β = -0.073, SE = 0.009), coronary heart disease (β = -0.028, SE = 0.010), myocardial infarction (β = -0.020, SE = 0.011, estimates of main effect), and neuropathy (β = -0.067, SE = 0.020), diabetic foot (β = -0.042, SE = 0.030), nephropathy (β = -0.032, SE = 0.025), and blindness (β = -0.094, SE = 0.056, estimates of interaction terms) were negatively associated with health utility. The interaction term for diabetes x stroke (β = -0.052, SE = 0.021) showed that the utility decrement for stroke is significantly larger in people with type 2 diabetes than in people without diabetes. CONCLUSIONS Diabetes, cardiovascular, and microvascular conditions are associated with significant health utility decrements. Utility decrements for some conditions differ between people with and without type 2 diabetes. These results are of high relevance for the parametrization of decision analytic simulation models and applied health economic evaluations in the field of prevention and management of type 2 diabetes in Germany.
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Affiliation(s)
- Michael Laxy
- Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany; Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; German Centre for Diabetes Research (DZD), Neuherberg, Germany; Global Diabetes Research Center, Rollins School of Public Health, Emory University, Atlanta, GA.
| | - Jana Becker
- Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, WHO Collaborating Centre for Occupational Health, University Hospital Munich, Munich, Germany
| | - Katharina Kähm
- Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; German Centre for Diabetes Research (DZD), Neuherberg, Germany
| | - Rolf Holle
- Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; German Centre for Diabetes Research (DZD), Neuherberg, Germany; Institute for Medical Information Processing, Biometry, and Epidemiology (IBE), Ludwig-Maximilians-University Munich, Munich, Germany
| | - Annette Peters
- German Centre for Diabetes Research (DZD), Neuherberg, Germany; Institute of Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany
| | - Barbara Thorand
- German Centre for Diabetes Research (DZD), Neuherberg, Germany; Institute of Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany
| | - Lars Schwettmann
- Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; Department of Economics, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
| | - Florian M Karl
- Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany; German Centre for Diabetes Research (DZD), Neuherberg, Germany
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Neuwahl SJ, Zhang P, Chen H, Shao H, Laxy M, Anderson AM, Craven TE, Hoerger TJ. Patient Health Utility Equations for a Type 2 Diabetes Model. Diabetes Care 2021; 44:381-389. [PMID: 33277301 PMCID: PMC7818320 DOI: 10.2337/dc20-1207] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/20/2020] [Accepted: 10/29/2020] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To estimate the health utility impact of diabetes-related complications in a large, longitudinal U.S. sample of people with type 2 diabetes. RESEARCH DESIGN AND METHODS We combined Health Utilities Index Mark 3 data on patients with type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Look AHEAD (Action for Health in Diabetes) trials and their follow-on studies. Complications were classified as events if they occurred in the year preceding the utility measurement; otherwise, they were classified as a history of the complication. We estimated utility decrements associated with complications using a fixed-effects regression model. RESULTS Our sample included 15,252 persons with an average follow-up of 8.2 years and a total of 128,873 person-visit observations. The largest, statistically significant (P < 0.05) health utility decrements were for stroke (event, -0.109; history, -0.051), amputation (event, -0.092; history, -0.150), congestive heart failure (event, -0.051; history, -0.041), dialysis (event, -0.039), estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (event, -0.043; history, -0.025), angina (history, -0.028), and myocardial infarction (MI) (event, -0.028). There were smaller effects for laser photocoagulation and eGFR <60 mL/min/1.73 m2. Decrements for dialysis history, angina event, MI history, revascularization event, revascularization history, laser photocoagulation event, and hypoglycemia were not significant (P ≥ 0.05). CONCLUSIONS With use of a large study sample and a longitudinal design, our estimated health utility scores are expected to be largely unbiased. Estimates can be used to describe the health utility impact of diabetes complications, improve cost-effectiveness models, and inform diabetes policies.
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Affiliation(s)
| | - Ping Zhang
- Centers for Disease Control and Prevention, Atlanta, GA
| | - Haiying Chen
- Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC
| | - Hui Shao
- Centers for Disease Control and Prevention, Atlanta, GA
- Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, Florida
| | - Michael Laxy
- Centers for Disease Control and Prevention, Atlanta, GA
- Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany
- German Center for Diabetes Research (DZD), Munich-Neuherberg, Germany
- Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, Neuherberg, Germany
| | - Andrea M Anderson
- Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC
| | - Timothy E Craven
- Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC
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Julian GS, Accetturi Pititto LM, Miresashvili N, Broe Honoré J, Lopes Assis Coelho RC, Campos D. Cost of microvascular complications in people with diabetes from a public healthcare perspective: a retrospective database study in Brazil. J Med Econ 2021; 24:1002-1010. [PMID: 34344240 DOI: 10.1080/13696998.2021.1963572] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
AIM To evaluate direct medical costs incurred by patients with diabetes in the periods before and after experiencing a microvascular complication from a Brazilian public healthcare system perspective. MATERIALS AND METHODS This was a retrospective, observational study using the Brazilian Unified Health System (DATASUS) database. Direct medical costs (hospitalization and outpatient) were extracted for patients with evidence of diabetes and a microvascular complication (January 2012-December 2018) and converted to 2019 US Dollars (USD). Length of hospital stays was also extracted. Mixed-effects logistic regression explored associations between demographic/clinical characteristics and incurrence of high direct medical costs (defined as the highest tertile of the annual costs ranked by median cost in the total population). RESULTS In total, 2,096 patients with diabetes experienced a microvascular complication and met study inclusion/exclusion criteria. Median [interquartile range] annual costs (USD/patient) were 176.3 [91.0; 481.2] at baseline, increasing to 1,678.5 [287.0; 6,908.4] and 5,172.4 [274.8; 7,395.9] in the first and second year after the complication, respectively. Median hospital stay was 2.0 and 3.0 days at baseline and in the first year, respectively. The odds of incurring high costs were substantially elevated in the first and second years (odds ratios of 69.9 and 84.7, respectively, vs. baseline, both p < .001). LIMITATIONS The DATASUS database covers secondary and tertiary care (not primary), adding selection bias to our sample. Additionally, our findings may not apply to the entire Brazilian population, as around 25% have some access to private healthcare. CONCLUSIONS This study demonstrates a large increase in costs, from the perspective of the Brazilian public healthcare system, in patients with diabetes after experiencing a microvascular complication compared with pre-complication costs. In addition to providing up-to-date cost estimates, our findings highlight the need to appraise the cost-effectiveness of evidence-based strategies that reduce the risk of diabetes-related microvascular complications in Brazilian patients.
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Bekele M, Norheim OF, Hailu A. Cost-Effectiveness of Saxagliptin Compared With Glibenclamide as a Second-Line Therapy Added to Metformin for Type 2 Diabetes Mellitus in Ethiopia. MDM Policy Pract 2021; 6:23814683211005771. [PMID: 34104781 PMCID: PMC8111283 DOI: 10.1177/23814683211005771] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2021] [Accepted: 03/04/2021] [Indexed: 11/30/2022] Open
Abstract
Background. Metformin is a widely accepted first-line pharmacotherapy for patients with type 2 diabetes mellitus (T2DM). Treatment of T2DM with glibenclamide, saxagliptin, or one of the other second-line treatment agents is recommended when the first-line treatment (metformin) cannot control the disease. However, there is little evidence on the additional cost and cost-effectiveness of adding second-line drugs. Therefore, this study aimed to estimate the cost-effectiveness of saxagliptin and glibenclamide as second-line therapies added to metformin compared with metformin only in T2DM in Ethiopia. Methods. This cost-effectiveness study was conducted in Ethiopia using a mix of primary data on cost and best available data from the literature on the effectiveness. We measured the interventions' cost from the providers' perspective in 2019 US dollars. We developed a Markov model for T2DM disease progression with five health states using TreeAge Pro 2020 software. Disability-adjusted life year (DALY) was the health outcome used in this study, and we calculated the incremental cost-effectiveness ratio (ICER) per DALY averted. Furthermore, one-way and probabilistic sensitivity analysis were performed. Results. The annual unit cost per patient was US$70 for metformin, US$75 for metformin + glibenclamide, and US$309 for metformin + saxagliptin. The ICER for saxagliptin + metformin was US$2259 per DALY averted. The ICER results were sensitive to various changes in cost, effectiveness, and transition probabilities. The ICER was driven primarily by the higher cost of saxagliptin relative to glibenclamide. Conclusion. Our study revealed that saxagliptin is not a cost-effective second-line therapy in patients with T2DM inadequately controlled by metformin monotherapy based on a gross domestic product per capita per DALY averted willingness-to-pay threshold in Ethiopia (US$953).
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Affiliation(s)
- Mengistu Bekele
- Bergen Center for Ethics and Priority Setting, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
- Oromia Regional Health Bureau, Addis Ababa, Ethiopia
| | - Ole Frithjof Norheim
- Bergen Center for Ethics and Priority Setting, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
- Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
| | - Alemayehu Hailu
- Bergen Center for Ethics and Priority Setting, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
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Miller R, Ambler GK, Ramirez J, Rees J, Hinchliffe R, Twine C, Rudd S, Blazeby J, Avery K. Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review. Eur J Vasc Endovasc Surg 2020; 61:491-501. [PMID: 33388237 DOI: 10.1016/j.ejvs.2020.11.043] [Citation(s) in RCA: 21] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2020] [Revised: 11/06/2020] [Accepted: 11/24/2020] [Indexed: 12/22/2022]
Abstract
OBJECTIVE Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes. METHODS A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs. RESULTS Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM. CONCLUSION A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.
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Affiliation(s)
- Rachael Miller
- Centre for Surgical Research, University of Bristol, UK; North Bristol NHS Trust, Bristol, UK.
| | - Graeme K Ambler
- Centre for Surgical Research, University of Bristol, UK; North Bristol NHS Trust, Bristol, UK
| | - Jozel Ramirez
- Centre for Surgical Research, University of Bristol, UK; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Jonathan Rees
- Centre for Surgical Research, University of Bristol, UK; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Robert Hinchliffe
- Centre for Surgical Research, University of Bristol, UK; North Bristol NHS Trust, Bristol, UK
| | | | | | - Jane Blazeby
- Centre for Surgical Research, University of Bristol, UK; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Kerry Avery
- Centre for Surgical Research, University of Bristol, UK
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Julian GS, Campos D, Broe Honore J, Sauer Tobaruella F, Hyun Yoon J, Hallén N. Cost of macrovascular complications in people with diabetes from a public healthcare perspective: a retrospective database study in Brazil. J Med Econ 2020; 23:985-993. [PMID: 32372710 DOI: 10.1080/13696998.2020.1764966] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
Aims: To evaluate costs in patients with diabetes who experienced a macrovascular complication from a Brazilian public healthcare system perspective.Materials and methods: A retrospective, observational study that utilized the database of the Brazilian Unified Health System (DATASUS). Data for direct medical costs (hospitalization and outpatient) were extracted for patients with diabetes and a macrovascular complication (1 January 2012-31 December 2018) and converted to US Dollars (2019 USD). Mixed-effects logistic regression explored associations between demographic and clinical characteristics with the incurrence of high direct medical costs.Results: In total, 1,668 (0.2%) patients with diabetes met study inclusion criteria and experienced a macrovascular complication, either alone (N = 1,193) or together with a microvascular complication (N = 475). Median [95% CI] annual costs (USD/patient) were 130.5 [90.7; 264.2] at baseline, increasing to 334.0 [182.2; 923.5] in the first year after the complication. The odds of incurring high costs were significantly elevated in the first and second year (vs. baseline), and in patients who experienced a macrovascular and microvascular complication (vs. macrovascular alone) (all p < 0.001).Limitations: The DATASUS database does not cover primary care (it covers secondary and tertiary care), adding a selection bias to the sample. Additionally, our findings may not be representative of the entire Brazilian population given that approximately 75% of the population of Brazil depend exclusively on the SUS, while the remaining 25% have some access to private healthcare.Conclusions: This study has demonstrated higher medical costs from the perspective of the Brazilian public healthcare system in patients with diabetes after experiencing a macrovascular complication, either alone or in conjunction with a microvascular complication, in comparison with costs before the complication(s). In addition to providing up-to-date cost estimates, our findings highlight the need to implement strategies to reduce the cardiovascular risk in Brazilian patients with diabetes and drive cost savings.
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Affiliation(s)
| | | | | | | | - Jung Hyun Yoon
- Novo Nordisk Farmacêutica Do Brasil Ltda, São Paulo, Brazil
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Hall JM, Fowler CF, Barrett F, Humphry RW, Van Drimmelen M, MacRury SM. HbA 1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. Diabet Med 2020; 37:1463-1470. [PMID: 31418916 PMCID: PMC7496699 DOI: 10.1111/dme.14110] [Citation(s) in RCA: 26] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/13/2019] [Indexed: 11/29/2022]
Abstract
AIM To assess the clinical performance and patient acceptance of HemaSpot™ blood collection devices as an alternative blood collection method. METHODS Adult men and women with any type of diabetes, routinely carrying out self-monitoring of blood glucose were recruited (n = 128). Participants provided a venous blood sample and prepared two HemaSpot dried blood spots, one at clinics and one at home. HbA1c analysis was by Tosoh G8 high-performance liquid chromatography. Participants also completed a questionnaire. RESULTS Strong linear relationships been HbA1c levels in dried blood spots and venous blood were observed and a linear model was fitted to the data. Time between dried blood spot preparation and testing did not impact the model. Participants were accepting of the approach: 69.2% would use this system if available and 60.7% would be more likely to use this system than going to their general practitioner. CONCLUSIONS The combination of a robust desiccating dried blood spot device, home sample preparation and return by post produces HbA1c data that support the use of a time-independent linear calibration of dried blood spot to venous blood HbA1c . A robust remote sample collection service would be valuable to people living with diabetes in urban areas who are working or house-bound as well as those living in remote or rural locations.
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Affiliation(s)
- J. M. Hall
- Division of Rural Health and WellbeingInstitute of Health Research and InnovationUniversity of the Highlands and IslandsCentre for Health ScienceInvernessUK
| | - C. F. Fowler
- Department of BiochemistryBlood Sciences, Raigmore HospitalInvernessUK
| | - F. Barrett
- Highland Clinical Research FacilityNHS HighlandCentre for Health ScienceOld Edinburgh RoadInvernessUK
| | - R. W. Humphry
- Epidemiology Research UnitScotland's Rural CollegeAn Lòchran, Inverness CampusInvernessUK
| | - M. Van Drimmelen
- Department of BiochemistryBlood Sciences, Raigmore HospitalInvernessUK
| | - S. M. MacRury
- Institute of Health Research and InnovationUniversity of the Highlands and IslandsCentre for Health ScienceInvernessUK
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Hua X, Lung TWC, Woodward M, Salomon JA, Hamet P, Harrap SB, Mancia G, Poulter N, Chalmers J, Clarke PM. Self-rated health scores predict mortality among people with type 2 diabetes differently across three different country groupings: findings from the ADVANCE and ADVANCE-ON trials. Diabet Med 2020; 37:1379-1385. [PMID: 31967344 PMCID: PMC7496988 DOI: 10.1111/dme.14237] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/16/2020] [Indexed: 01/19/2023]
Abstract
AIMS To explore whether there is a different strength of association between self-rated health and all-cause mortality in people with type 2 diabetes across three country groupings: nine countries grouped together as 'established market economies'; Asia; and Eastern Europe. METHODS The ADVANCE trial and its post-trial follow-up were used in this study, which included 11 140 people with type 2 diabetes from 20 countries, with a median follow-up of 9.9 years. Self-rated health was reported on a 0-100 visual analogue scale. Cox proportional hazard models were fitted to estimate the relationship between the visual analogue scale score and all-cause mortality, controlling for a range of demographic and clinical risk factors. Interaction terms were used to assess whether the association between the visual analogue scale score and mortality varied across country groupings. RESULTS The visual analogue scale score had different strengths of association with mortality in the three country groupings. A 10-point increase in visual analogue scale score was associated with a 15% (95% CI 12-18) lower mortality hazard in the established market economies, a 25% (95% CI 21-28) lower hazard in Asia, and an 8% (95% CI 3-13) lower hazard in Eastern Europe. CONCLUSIONS Self-rated health appears to predict 10-year all-cause mortality for people with type 2 diabetes worldwide, but this relationship varies across groups of countries.
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Affiliation(s)
- X. Hua
- School of Population and Global HealthUniversity of MelbourneMelbourneVICAustralia
- Nuffield Department of Population HealthUniversity of OxfordOxfordUK
| | - T. W. C. Lung
- George Institute for Global HealthUNSW SydneySydneyNSWAustralia
- School of Public HealthFaculty of Medicine and HealthUniversity of SydneySydneyNSWAustralia
| | - M. Woodward
- George Institute for Global HealthUNSW SydneySydneyNSWAustralia
- George Institute for Global HealthUniversity of OxfordOxfordUK
- Department of EpidemiologyJohns Hopkins UniversityBaltimoreMDUSA
| | - J. A. Salomon
- Department of MedicineStanford Medical SchoolStanfordCAUSA
| | - P. Hamet
- Centre de RechercheCentre Hospitalier de l'Université de MontréalMontréalQCCanada
- Department of MedicineUniversity of MontréalMontréalQCCanada
| | - S. B. Harrap
- Department of PhysiologyUniversity of MelbourneMelbourneVICAustralia
| | - G. Mancia
- University of Milano‐BicoccaMilanItaly
| | - N. Poulter
- Imperial Clinical Trials UnitSchool of Public HealthImperial College LondonLondonUK
| | - J. Chalmers
- George Institute for Global HealthUNSW SydneySydneyNSWAustralia
| | - P. M. Clarke
- School of Population and Global HealthUniversity of MelbourneMelbourneVICAustralia
- Nuffield Department of Population HealthUniversity of OxfordOxfordUK
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Torre E, Bruno GM, Di Matteo S, Martinotti C, Valentino MC, Bottaro LC, Colombo GL. Cost-Utility Analysis of Saxagliptin/Dapagliflozin Versus Gliclazide and Insulin Glargine: Economic Implications of the Outcomes of the CVD-Real Studies I and II. Health Serv Insights 2020; 13:1178632920929982. [PMID: 32595277 PMCID: PMC7298424 DOI: 10.1177/1178632920929982] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2020] [Accepted: 05/04/2020] [Indexed: 12/20/2022] Open
Abstract
Diabetes treatment cost represents an ever-growing problem. The adoption of new
drugs in therapy, although they can guarantee an improvement in patient’s
quality of life, can meet obstacles when it involves an increase in costs. We
decided to compare the costs and benefits of the new saxagliptin and
dapagliflozin combination versus traditional therapies. Bodyweight loss and the
sharp reduction in hypoglycemic episodes were the 2 main clinical outcomes that
emerged from registered studies of saxagliptin and dapagliflozin compared with
the sulfonylureas. These results, combined with the good cardiovascular risk
profile, led to develop a cost-utility analysis. We aimed to show the economic
value of this new association therapy. We carried out a cost-utility analysis
from the Italian National Healthcare System (NHS) perspective, focused on direct
costs related to the treatment and management of main diabetes complications.
Utility scores adopted have been measured based on the patient’s perception of
weight changes. In light of the better durability profile of
saxagliptin/dapagliflozin compared with gliclazide, we also considered a
simulation scenario to assess the impact on costs of switching to basal insulin,
starting from gliclazide and the fixed combination, respectively, and based on
the related probabilities to switch. To assess the robustness of the results, a
1-way sensitivity analysis was performed by changing the main parameters by
±20%. Furthermore, the sensitivity of the results was tested considering the
addition of a percent discount, because the purchase costs of drugs are usually
subject to hidden discounts. We calculated the total direct annual cost per
patient of saxagliptin/dapagliflozin versus gliclazide and insulin glargine for
patients with type 2 diabetes mellitus not achieving glycemic control on
metformin plus saxagliptin alone, dapagliflozin alone, or gliclazide at a lower
dosage. Total treatment costs have been obtained adding the direct cost of the
drug, needles, glycemic self-monitoring, hypoglycemic events, cardiovascular
complications, and effect on consumption of other drugs. The total direct cost
of saxagliptin/dapagliflozin fixed dose combination was €414.62 higher than
gliclazide (€1.067.72 vs €653.10), and greater than basal insulin, with a
difference of €166.99 (€1067.72 vs €900.72). Despite the higher annual direct
total cost, the additional cost per quality-adjusted life year (QALY) gained,
compared with gliclazide, has been €11 517, and €4639, when compared with
insulin glargine in the base-case scenario, and the robustness of the results
has been shown in the sensitivity analysis. The results of our cost-utility
analysis, expressed as incremental cost-effectiveness ratios, were fully
compliant with the threshold adopted for Italy. Then, saxagliptin/dapagliflozin
can be considered a cost-effective oral hypoglycemic agent. The positive effect
of this drug on the quality of life, induced by the bodyweight loss, has allowed
this outcome, despite the higher annual cost per patient, mainly determined by
the drug purchase cost.
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Affiliation(s)
- Enrico Torre
- Endocrinology Diabetology and Metabolic Diseases Unit-ASL3, Genoa, Italy
| | - Giacomo Matteo Bruno
- S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy
| | - Sergio Di Matteo
- S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy
| | - Chiara Martinotti
- S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy
| | - Maria Chiara Valentino
- S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy
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Guinan K, Beauchemin C, Tremblay J, Chalmers J, Woodward M, Tahir MR, Hamet P, Lachaine J. Economic Evaluation of a New Polygenic Risk Score to Predict Nephropathy in Adult Patients With Type 2 Diabetes. Can J Diabetes 2020; 45:129-136. [PMID: 33032912 DOI: 10.1016/j.jcjd.2020.06.010] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2019] [Revised: 05/31/2020] [Accepted: 06/09/2020] [Indexed: 10/24/2022]
Abstract
OBJECTIVES The current screening method for diabetic nephropathy (DN) is based on detection of albumin in the urine and decline of glomerular filtration rate. The latter usually occurs relatively late in the course of the disease. A polygenic risk score (PRS) was recently developed for early prediction of the risk for patients with type 2 diabetes (T2D) to develop DN. The aim of this study was to assess the economic impact of the implementation of the PRS for early prediction of DN in patients with T2D compared with usual screening methods in Canada. METHODS A cost-utility analysis was developed using a Markov model. Health states include pre-end-stage renal disease (ESRD), ESRD and death. Model efficacy parameters were based on prediction of outcome data by polygenic risk testing of the genotyped participants in the Action in Diabetes and Vascular Disease PreterAx and DiamicronN Controlled Evaluation trial. Analyses were conducted from Canadian health-care and societal perspectives. Deterministic and probabilistic sensitivity analyses were conducted to assess results robustness. RESULTS Over a lifetime horizon, the PRS was a dominant strategy, from both a health-care system and societal perspective. The PRS was less expensive and more efficacious in terms of quality-adjusted life-years compared with usual screening technics. Deterministic and probabilistic sensitivity analyses showed that results remained dominant in most simulations. CONCLUSIONS This economic evaluation demonstrates that the PRS is a dominant option compared with usual screening methods for the prevention of DN in patients with T2D. Adoption of the PRS would reduce costs saving but would also help prevent ESRD and improve patients' quality of life.
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Affiliation(s)
- Kimberly Guinan
- Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.
| | | | - Johanne Tremblay
- CHUM Research Center, University of Montreal, Montreal, Quebec, Canada
| | - John Chalmers
- The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
| | - Mark Woodward
- The George Institute for Global Health, University of Oxford, Oxford, United Kingdom
| | | | - Pavel Hamet
- CHUM Research Center, University of Montreal, Montreal, Quebec, Canada
| | - Jean Lachaine
- Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada
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50
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Omics research in diabetic kidney disease: new biomarker dimensions and new understandings? J Nephrol 2020; 33:931-948. [DOI: 10.1007/s40620-020-00759-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/05/2020] [Accepted: 05/23/2020] [Indexed: 12/14/2022]
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