Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of
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 evalu...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e067684.full |
| _version_ | 1797640316167127040 |
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| author | Sobha Sivaprasad Clare Bailey Augusto Azuara-Blanco Mike Clarke Danny Mcauley Louise Downey Noemi Lois Norman Waugh Hema Mistry Victor Chong Faruque Ghanchi Ahmed Saad David H Steel Geeta Menon Haralabos Eleftheriadis Nachiketa Acharya Samia Fatum Tariq M Aslam Paul Doherty Sheena George Robin Hamilton Catherine Adams Clíona McDowell Markus Groppe James Stephen Talks Mandy Maredza Marianne Shiew Christina Campbell Evie Gardener Aby Joseph Matthew Mills |
| author_facet | Sobha Sivaprasad Clare Bailey Augusto Azuara-Blanco Mike Clarke Danny Mcauley Louise Downey Noemi Lois Norman Waugh Hema Mistry Victor Chong Faruque Ghanchi Ahmed Saad David H Steel Geeta Menon Haralabos Eleftheriadis Nachiketa Acharya Samia Fatum Tariq M Aslam Paul Doherty Sheena George Robin Hamilton Catherine Adams Clíona McDowell Markus Groppe James Stephen Talks Mandy Maredza Marianne Shiew Christina Campbell Evie Gardener Aby Joseph Matthew Mills |
| author_sort | Sobha Sivaprasad |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T13:30:10Z |
| format | Article |
| id | doaj.art-2009bea9edd6469b9f83be65fc575c43 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T13:30:10Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-2009bea9edd6469b9f83be65fc575c432023-11-02T21:15:07ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2022-067684Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness ofSobha Sivaprasad0Clare Bailey1Augusto Azuara-Blanco2Mike Clarke3Danny McauleyLouise Downey4Noemi Lois5Norman Waugh6Hema Mistry7Victor Chong8Faruque Ghanchi9Ahmed SaadDavid H Steel10Geeta Menon11Haralabos Eleftheriadis12Nachiketa AcharyaSamia FatumTariq M AslamPaul Doherty13Sheena George14Robin Hamilton15Catherine Adams16Clíona McDowell17Markus Groppe18James Stephen Talks19Mandy Maredza20Marianne Shiew21Christina Campbell22Evie GardenerAby JosephMatthew Mills3 Clinical Research Facility, Moorfields Eye Hospital, London, UKconsultant ophthalmologist1 Centre for Public Health, Queen`s University Belfast, Belfast, UKNorthern Ireland Methodology Hub, Centre for Public Health, Queen`s University Belfast, Belfast, UK1 Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UKDepartment of Ophthalmology, Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, Belfast, UK1 Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medcial School, University of Warwick, Coventry, UK11NHS Ayrshire and ArranBradford Teaching Hospitals NHS Foundation Trust, Bradford, West Yorkshire, UKSunderland Eye Infirmary, Sunderland, UKHealth Education South LondonOphthalmology, King`s College Hospital NHS Foundation Trust, London, UK6 NICTU, Belfast Health and Social Care Trust, Belfast, UK12 NW London Clinical Research Network, London, UKThe Aurum Institute, Johannesburg, South Africa6 NICTU, Belfast Health and Social Care Trust, Belfast, UKNorthern Ireland Clinical Trials Unit, Belfast, UKVictoria Eye Unit, Hereford County Hospital, Hereford, UK27 The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UKWarwick Medical School, University of Warwick, Coventry, UKsenior house officerNorthern Ireland Clinical Trials Unit, Belfast, UKObjectives 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.https://bmjopen.bmj.com/content/13/10/e067684.full |
| spellingShingle | Sobha Sivaprasad Clare Bailey Augusto Azuara-Blanco Mike Clarke Danny Mcauley Louise Downey Noemi Lois Norman Waugh Hema Mistry Victor Chong Faruque Ghanchi Ahmed Saad David H Steel Geeta Menon Haralabos Eleftheriadis Nachiketa Acharya Samia Fatum Tariq M Aslam Paul Doherty Sheena George Robin Hamilton Catherine Adams Clíona McDowell Markus Groppe James Stephen Talks Mandy Maredza Marianne Shiew Christina Campbell Evie Gardener Aby Joseph Matthew Mills Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of BMJ Open |
| title | Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of |
| title_full | Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of |
| title_fullStr | Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of |
| title_full_unstemmed | Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of |
| title_short | Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of |
| title_sort | subthreshold micropulse laser versus standard laser for the treatment of central involving diabetic macular oedema with central retinal thickness of |
| url | https://bmjopen.bmj.com/content/13/10/e067684.full |
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