Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ : a cost-effectiveness analysis from the DIAMONDS trial
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ..
OBJECTIVES: To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ.
DESIGN: An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold.
SETTING: 18 UK Hospital Eye Services.
PARTICIPANTS: Adults with diabetes and centre involving DMO with CRT<400µ.
INTERVENTIONS: Participants (n=266) were randomised 1:1 to receive SML or SL.
METHODS: The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates.
RESULTS: One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%.
CONCLUSIONS: There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ.
TRIAL REGISTRATION NUMBERS: ISRCTN17742985; NCT03690050.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 10 vom: 18. Okt., Seite e067684 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mistry, Hema [VerfasserIn] |
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| Links: |
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| Themen: |
Diabetic retinopathy |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 29.10.2023 published: Electronic ClinicalTrials.gov: NCT03690050 ISRCTN: ISRCTN17742985 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2022-067684 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ |b a cost-effectiveness analysis from the DIAMONDS trial |
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| 500 | |a Date Completed 23.10.2023 | ||
| 500 | |a Date Revised 29.10.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03690050 | ||
| 500 | |a ISRCTN: ISRCTN17742985 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. | ||
| 520 | |a OBJECTIVES: To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ | ||
| 520 | |a DESIGN: An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold | ||
| 520 | |a SETTING: 18 UK Hospital Eye Services | ||
| 520 | |a PARTICIPANTS: Adults with diabetes and centre involving DMO with CRT<400µ | ||
| 520 | |a INTERVENTIONS: Participants (n=266) were randomised 1:1 to receive SML or SL | ||
| 520 | |a METHODS: The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates | ||
| 520 | |a RESULTS: One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76% | ||
| 520 | |a CONCLUSIONS: There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ | ||
| 520 | |a TRIAL REGISTRATION NUMBERS: ISRCTN17742985; NCT03690050 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Pragmatic Clinical Trial | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a diabetic retinopathy | |
| 650 | 4 | |a health economics | |
| 650 | 4 | |a ophthalmology | |
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| 700 | 1 | |a Campbell, Christina |e verfasserin |4 aut | |
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| 700 | 0 | |a DIAMONDS study group |e verfasserin |4 aut | |
| 700 | 1 | |a Lois, Noemi |e investigator |4 oth | |
| 700 | 1 | |a Azuara-Blanco, Augusto |e investigator |4 oth | |
| 700 | 1 | |a Campbell, Christina |e investigator |4 oth | |
| 700 | 1 | |a McAuley, Danny |e investigator |4 oth | |
| 700 | 1 | |a Maredza, Mandy |e investigator |4 oth | |
| 700 | 1 | |a Mistry, Hema |e investigator |4 oth | |
| 700 | 1 | |a Waugh, Norman |e investigator |4 oth | |
| 700 | 1 | |a Acharya, Nachiketa |e investigator |4 oth | |
| 700 | 1 | |a Aslam, Tariq M |e investigator |4 oth | |
| 700 | 1 | |a Bailey, Clare |e investigator |4 oth | |
| 700 | 1 | |a Chong, Victor |e investigator |4 oth | |
| 700 | 1 | |a Downey, Louise |e investigator |4 oth | |
| 700 | 1 | |a Eleftheriadis, Haralabos |e investigator |4 oth | |
| 700 | 1 | |a Fatum, Samia |e investigator |4 oth | |
| 700 | 1 | |a George, Sheena |e investigator |4 oth | |
| 700 | 1 | |a Ghanchi, Faruque |e investigator |4 oth | |
| 700 | 1 | |a Groppe, Markus |e investigator |4 oth | |
| 700 | 1 | |a Hamilton, Robin |e investigator |4 oth | |
| 700 | 1 | |a Menon, Geeta |e investigator |4 oth | |
| 700 | 1 | |a Saad, Ahmed |e investigator |4 oth | |
| 700 | 1 | |a Sivaprasad, Sobha |e investigator |4 oth | |
| 700 | 1 | |a Shiew, Marianne |e investigator |4 oth | |
| 700 | 1 | |a Steel, David H |e investigator |4 oth | |
| 700 | 1 | |a Talks, James Stephen |e investigator |4 oth | |
| 700 | 1 | |a Adams, Catherine |e investigator |4 oth | |
| 700 | 1 | |a Doherty, Paul |e investigator |4 oth | |
| 700 | 1 | |a Gardener, Evie |e investigator |4 oth | |
| 700 | 1 | |a Joseph, Aby |e investigator |4 oth | |
| 700 | 1 | |a McDowell, Cliona |e investigator |4 oth | |
| 700 | 1 | |a Mills, Matthew |e investigator |4 oth | |
| 700 | 1 | |a Clarke, Mike |e investigator |4 oth | |
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