학술논문
Cost-effectiveness of diagnosis and treatment of early gestational diabetes mellitus: economic evaluation of the TOBOGM study, an international multicenter randomized controlled trial.
Document Type
Academic Journal
Author
Haque MM; Translational Health Research Institute, Western Sydney University, Campbelltown, NSW, Australia.; Tannous WK; School of Business, Western Sydney University, Parramatta, NSW, Australia.; Herman WH; Schools of Medicine and Public Health, University of Michigan, Ann Arbor, MI, United States.; Immanuel J; School of Medicine, Western Sydney University, Campbelltown, NSW, Australia.; Hague WM; Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia.; Teede H; Monash University, Melbourne, VIC, Australia.; Enticott J; Monash University, Melbourne, VIC, Australia.; Cheung NW; Westmead Hospital and University of Sydney, Westmead, NSW, Australia.; Hibbert E; Nepean Clinical School, University of Sydney and Nepean Hospital, Nepean, NSW, Australia.; Nolan CJ; Canberra Hospital, Canberra, ACT, Australia.; Australian National University, Canberra, ACT, Australia.; Peek MJ; Australian National University, Canberra, ACT, Australia.; Wong VW; Liverpool Hospital, Liverpool and University of New South Wales, NSW, Australia.; Flack JR; Bankstown-Lidcombe Hospital, Bankstown, NSW, Australia.; Mclean M; Blacktown Hospital, Blacktown, NSW, Australia.; Sweeting A; Department of Endocrinology, Royal Prince Alfred Hospital, Sydney, NSW, Australia.; Gianatti E; Department of Endocrinology and Diabetes, Fiona Stanley and Fremantle Hospitals, Murdoch, WA, Australia.; Kautzky-Willer A; Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna, Austria.; Jürgen Harreiter; Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna, Austria.; Department of Medicine, Landesklinikum Scheibbs, Scheibbs, Austria.; Mohan V; Dr. Mohan's Diabetes Specialities Center and Madras Diabetes Research Foundation, Chennai, India.; Backman H; Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Orebro University, Orebro, Sweden.; Simmons D; School of Medicine, Western Sydney University, Campbelltown, NSW, Australia.
Source
Publisher: The Lancet Country of Publication: England NLM ID: 101733727 Publication Model: eCollection Cited Medium: Internet ISSN: 2589-5370 (Electronic) Linking ISSN: 25895370 NLM ISO Abbreviation: EClinicalMedicine Subsets: PubMed not MEDLINE
Subject
Language
English
Abstract
Background: A recently undertaken multicenter randomized controlled trial (RCT) " Treatment Of BOoking Gestational diabetes Mellitus" (TOBOGM: 2017-2022) found that the diagnosis and treatment of pregnant women with early gestational diabetes mellitus (GDM) improved pregnancy outcomes. Based on data from the trial, this study aimed to assess the cost-effectiveness of diagnosis and treatment of early GDM (from <20 weeks') among women with risk factors for hyperglycemia in pregnancy compared with usual care (no treatment until 24-28 weeks') from a healthcare perspective.
Methods: Participants' healthcare resource utilization data were collected from their self-reported questionnaires and hospital records, and valued using the unit costs obtained from standard Australian national sources. Costs were reported in US dollars ($) using the purchasing power parity (PPP) estimates to facilitate comparison of costs across countries. Intention-to-treat (ITT) principle was followed. Missing cost data were replaced using multiple imputations. Bootstrapping method was used to estimate the uncertainty around mean cost difference and cost-effectiveness results. Bootstrapped cost-effect pairs were used to plot the cost-effectiveness (CE) plane and cost-effectiveness acceptability curve (CEAC).
Findings: Diagnosis and treatment of early GDM was more effective and tended to be less costly, i.e., dominant (cost-saving) [-5.6% composite adverse pregnancy outcome (95% CI: -10.1%, -1.2%), -$1373 (95% CI: -$3,749, $642)] compared with usual care. Our findings were confirmed by both the CE plane (88% of the bootstrapped cost-effect pairs fall in the south-west quadrant), and CEAC (the probability of the intervention being cost-effective ranged from 84% at a willingness-to-pay (WTP) threshold value of $10,000-99% at a WTP threshold value of $100,000 per composite adverse pregnancy outcome prevented). Sub-group analyses demonstrated that diagnosis and treatment of early GDM among women in the higher glycemic range (fasting blood glucose 95-109 mg/dl [5.3-6.0 mmol/L], 1-h blood glucose ≥191 mg/dl [10.6 mmol/L] and/or 2-h blood glucose 162-199 mg/dl [9.0-11.0 mmol/L]) was more effective and less costly (dominant) [ - 7.8% composite adverse pregnancy outcome (95% CI: -14.6%, -0.9%), -$2795 (95% CI: -$6,638, -$533)]; the intervention was more effective and tended to be less costly [ - 8.9% composite adverse pregnancy outcome (95% CI: -15.1%, -2.6%), -$5548 (95% CI: -$16,740, $1547)] among women diagnosed before 14 weeks' gestation as well.
Interpretation: Our findings highlight the potential health and economic benefits from the diagnosis and treatment of early GDM among women with risk factors for hyperglycemia in pregnancy and supports its implementation. Long-term follow-up studies are recommended as a key future area of research to assess the potential long-term health benefits and economic consequences of the intervention.
Funding: National Health and Medical Research Council (grants 1104231 and 2009326), Region O¨rebro Research Committee (grants Dnr OLL-970566 and OLL-942177), Medical Scientific Fund of the Mayor of Vienna (project 15,205 and project 23,026), South Western Sydney Local Health District Academic Unit (grant 2016), and Western Sydney University Ainsworth Trust Grant (2019).
Competing Interests: WHH reports participation on Merck Sharp & Dohme Board and Rivus Pharmaceuticals Board. DS reports Presidency of the Australasian Diabetes in Pregnancy Society. All otherauthor(s) have no potential conflict of interests to report.
(© 2024 The Author(s).)
Methods: Participants' healthcare resource utilization data were collected from their self-reported questionnaires and hospital records, and valued using the unit costs obtained from standard Australian national sources. Costs were reported in US dollars ($) using the purchasing power parity (PPP) estimates to facilitate comparison of costs across countries. Intention-to-treat (ITT) principle was followed. Missing cost data were replaced using multiple imputations. Bootstrapping method was used to estimate the uncertainty around mean cost difference and cost-effectiveness results. Bootstrapped cost-effect pairs were used to plot the cost-effectiveness (CE) plane and cost-effectiveness acceptability curve (CEAC).
Findings: Diagnosis and treatment of early GDM was more effective and tended to be less costly, i.e., dominant (cost-saving) [-5.6% composite adverse pregnancy outcome (95% CI: -10.1%, -1.2%), -$1373 (95% CI: -$3,749, $642)] compared with usual care. Our findings were confirmed by both the CE plane (88% of the bootstrapped cost-effect pairs fall in the south-west quadrant), and CEAC (the probability of the intervention being cost-effective ranged from 84% at a willingness-to-pay (WTP) threshold value of $10,000-99% at a WTP threshold value of $100,000 per composite adverse pregnancy outcome prevented). Sub-group analyses demonstrated that diagnosis and treatment of early GDM among women in the higher glycemic range (fasting blood glucose 95-109 mg/dl [5.3-6.0 mmol/L], 1-h blood glucose ≥191 mg/dl [10.6 mmol/L] and/or 2-h blood glucose 162-199 mg/dl [9.0-11.0 mmol/L]) was more effective and less costly (dominant) [ - 7.8% composite adverse pregnancy outcome (95% CI: -14.6%, -0.9%), -$2795 (95% CI: -$6,638, -$533)]; the intervention was more effective and tended to be less costly [ - 8.9% composite adverse pregnancy outcome (95% CI: -15.1%, -2.6%), -$5548 (95% CI: -$16,740, $1547)] among women diagnosed before 14 weeks' gestation as well.
Interpretation: Our findings highlight the potential health and economic benefits from the diagnosis and treatment of early GDM among women with risk factors for hyperglycemia in pregnancy and supports its implementation. Long-term follow-up studies are recommended as a key future area of research to assess the potential long-term health benefits and economic consequences of the intervention.
Funding: National Health and Medical Research Council (grants 1104231 and 2009326), Region O¨rebro Research Committee (grants Dnr OLL-970566 and OLL-942177), Medical Scientific Fund of the Mayor of Vienna (project 15,205 and project 23,026), South Western Sydney Local Health District Academic Unit (grant 2016), and Western Sydney University Ainsworth Trust Grant (2019).
Competing Interests: WHH reports participation on Merck Sharp & Dohme Board and Rivus Pharmaceuticals Board. DS reports Presidency of the Australasian Diabetes in Pregnancy Society. All otherauthor(s) have no potential conflict of interests to report.
(© 2024 The Author(s).)