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Patient-reported and medical outcomes in patients treated for diabetic macular edema: A real-world longitudinal study
Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala universitet, Institutionen för medicinska vetenskaper.ORCID iD: 0000-0001-7721-8794
2020 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background Diabetes mellitus can lead to complications, when the complication affects the eyes it is called retinopathy. This can affect the macula and lead to severe loss of vision, diabetic macular edema (DME). This condition has traditionally been treated with laser. However, in 2011, anti-vascular endothelial growth factor (anti-VEGF) injections in the eye were approved as a treatment for diabetic macular edema, and started to be used in eye clinics.

Aim The overall aim of this thesis was to describe patient-reported outcomes and medical outcomes (PRO) in people treated for diabetic macular edema in a real-world setting in a long-time follow-up study in Sweden.

Methods Participants were enrolled at two eye clinics at two county hospitals in Sweden between 2012 and 2014. Patient-reported outcomes were measured using a vision-specific questionnaire, the 25-question National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and a generic questionnaire, the Short Form-36 Health Survey (SF-36). Completed questionnaires, medical data such as visual acuity (EDRS), macula swelling (OCT) and social background characteristics were collected before treatment start, at one-year and four-year follow up points. The data was analyzed, descriptive statistics developed and comparative analyses were performed. Interviews were performed before treatment start and were analyzed using qualitative content analysis.

Results A total of 59 participants were included at baseline. The mean age was 69 years, with an equal gender distribution. At baseline, the participants scored a low general health with the vision-specific questionnaire. In total, 21 participants were interviewed, and a theme emerged of ‘being at a crossroads and a crucial phase in life with an uncertain outcome’. The participants expressed thoughts and concerns at different levels, including practical concerns about the treatment procedure and more existential thoughts about hope for improved visual acuity or fear of deterioration. The results at the one-year follow up showed that 30 patients had improved visual acuity and reported an improvement in several subscales in the NEI VFQ-25. The remaining 27 participants had no improvement in visual acuity or in the vision specific questionnaire. The four-year follow-up involved 37 people, and the result showed significant improvement in subjective near-vision activities and improved distance visual acuity.

Conclusion: Before treatment, the participants reported low general health and expressed concerns about the injection treatment and their vision. One year after treatment started, the results showed significant improvement in several NEI VFQ-25 subscales, decreased macula swelling and improved visual acuity. These positive results remained at the four-year follow-up point.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis , 2020. , p. 68
Keywords [en]
Diabetes mellitus, Patient-reported outcomes, Retinopathy, Macular edema, Anti-VEGF treatment
National Category
Endocrinology and Diabetes
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
URN: urn:nbn:se:du-32652ISBN: 978-91-513-0896-8 (print)OAI: oai:DiVA.org:du-32652DiVA, id: diva2:1429378
Public defence
2020-04-28, Aula Gunnesalen, Ingång 10, Psykiatrins hus. Akademiska sjukhuset Uppsala., 13:00 (Swedish)
Opponent
Supervisors
Available from: 2020-05-11 Created: 2020-05-11 Last updated: 2021-11-12Bibliographically approved
List of papers
1. Visual functioning and health-related quality of life in diabetic patients about to undergo anti-vascular endothelial growth factor treatment for sight-threatening macular edema
Open this publication in new window or tab >>Visual functioning and health-related quality of life in diabetic patients about to undergo anti-vascular endothelial growth factor treatment for sight-threatening macular edema
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2015 (English)In: Journal of diabetes and its complications, ISSN 1056-8727, E-ISSN 1873-460X, Vol. 29, no 8, p. 1183-1190Article in journal (Refereed) Published
Abstract [en]

Purpose

To examine patient-reported outcome (PRO) in a selected group of Swedish patients about to receive anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular edema (DME).

Material and methods

In this cross-sectional study, 59 patients with diabetes mellitus, who regularly visited the outpatient eye-clinics, were included. Sociodemographic and clinical data were collected and the patients completed PRO measures before starting anti-VEGF treatment. PRO measures assessed eye-specific outcomes (NEI-VFQ-25) and generic health-related quality of life (SF-36).

Results

The participants consisted of 30 men and 29 women (mean age, 68.5 years); 54 (92 %) patients had type 2 diabetes; Five (9%) patients had moderate or severe visual impairment; 28 (47 %) were classified as having mild visual impairment. Some of the patients reported overall problems in their daily lives, such as with social relationships, as well as problems with impaired sight as a result of reduced distance vision.

Conclusions

Further studies are needed to investigate PRO factors related to low perceived general health in this patient population. It is important to increase our understanding of such underlying mechanisms to promote improvements in the quality of patient care.

Keywords
Patient-reported measurements; health-related quality of life; visual function; diabetic macula edema; anti-VEGF treatment
National Category
Endocrinology and Diabetes
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
urn:nbn:se:du-19091 (URN)10.1016/j.jdiacomp.2015.07.026 (DOI)000366884900036 ()26318959 (PubMedID)2-s2.0-84947611604 (Scopus ID)
Available from: 2015-08-25 Created: 2015-08-25 Last updated: 2021-11-12Bibliographically approved
2. Patients’ experiences before starting anti-VEGF treatment for sight-threatening diabetic macular oedema: A qualitative interview study
Open this publication in new window or tab >>Patients’ experiences before starting anti-VEGF treatment for sight-threatening diabetic macular oedema: A qualitative interview study
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2018 (English)In: Nordic journal of nursing research, ISSN 2057-1585, E-ISSN 2057-1593, Vol. 38, no 1, p. 11-17Article in journal (Refereed) Published
Abstract [en]

The diabetic complication macular oedema (DME) is a growing problem worldwide because of the increasing number of patients suffering from diabetes mellitus (DM). DME is treated with injections of anti-vascular endothelial growth factor (anti-VEGF) in the eye. This real-world study aimed to describe patients’ experiences before they received their first injection in the eye. Twenty-one men and women aged 49 to 86 years were interviewed. The interviews were analysed using qualitative content analysis. Two categories and an overall theme ‘to be at a crossroads and a crucial phase in life with an uncertain outcome’ were found. The participants expressed thoughts and concerns at different levels, practical concerns about the treatment procedure, and other existential thoughts regarding hope for improved visual acuity or fear of deterioration. Cooperation between eye clinics and diabetes clinics should be strengthened to clarify who is responsible for providing the information and support required by patients.

Keywords
anti-VEGF treatment, diabetic macular oedema, qualitative research, visual impairment
National Category
Nursing
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
urn:nbn:se:du-25211 (URN)10.1177/2057158517709409 (DOI)2-s2.0-85084695262 (Scopus ID)
Available from: 2017-06-16 Created: 2017-06-16 Last updated: 2022-12-19Bibliographically approved
3. Patient-reported outcomes and visual acuity after 12 months of anti-VEGF-treatment for sight-threatening diabetic macular edema in a real world setting
Open this publication in new window or tab >>Patient-reported outcomes and visual acuity after 12 months of anti-VEGF-treatment for sight-threatening diabetic macular edema in a real world setting
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2016 (English)In: Diabetes Research and Clinical Practice, ISSN 0168-8227, E-ISSN 1872-8227, Vol. 121, p. 157-165Article in journal (Refereed) Published
Abstract [en]

Aims

To examine objective visual acuity measured with ETDRS, retinal thickness (OCT), patient reported outcome and describe levels of glycated hemoglobin and its association with the effects on visual acuity in patients treated with anti-VEGF for visual impairment due to diabetic macular edema (DME) during 12 months in a real world setting.

Methods

In this cross-sectional study, 58 patients (29 females and 29 males; mean age, 68 years) with type 1 and type 2 diabetes diagnosed with DME were included. Medical data and two questionnaires were collected; an eye-specific (NEI VFQ-25) and a generic health-related quality of life questionnaire (SF-36) were used.

Results

The total patient group had significantly improved visual acuity and reduced retinal thickness at 4 months and remains at 12 months follow up. Thirty patients had significantly improved visual acuity, and 27 patients had no improved visual acuity at 12 months. The patients with improved visual acuity had significantly improved scores for NEI VFQ-25 subscales including general health, general vision, near activities, distance activities, and composite score, but no significant changes in scores were found in the group without improvements in visual acuity.

Conclusions

Our study revealed that anti-VEGF treatment improved visual acuity and central retinal thickness as well as patient-reported outcome in real world 12 months after treatment start.

Place, publisher, year, edition, pages
Elsevier, 2016
Keywords
Patient-reported measurements; Diabetic macular edema; Anti-VEGF treatment; Visual function
National Category
Endocrinology and Diabetes
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
urn:nbn:se:du-23260 (URN)10.1016/j.diabres.2016.09.015 (DOI)000390460100020 ()27718374 (PubMedID)2-s2.0-84990196748 (Scopus ID)
Available from: 2016-10-14 Created: 2016-10-14 Last updated: 2021-11-12Bibliographically approved
4. Long-term follow-up of antivascular endothelial growth factor treatment for diabetic macular oedema: a four-year real-world study
Open this publication in new window or tab >>Long-term follow-up of antivascular endothelial growth factor treatment for diabetic macular oedema: a four-year real-world study
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2020 (English)In: Acta Ophthalmologica, ISSN 1755-375X, E-ISSN 1755-3768, Vol. 98, p. 360-367Article in journal (Refereed) Published
Abstract [en]

Purpose

To evaluate visual acuity (VA) and central retinal thickness (CRT) on optical coherence tomography during a 4‐year period in patients treated for sight‐threatening diabetic macular oedema (DMO) at two Swedish county hospitals. Additionally, to compare health‐related quality of life and subjective visual functioning before and after 4 years of treatment.

Methods

Fifty‐eight patients with DMO were evaluated after 4 years of antivascular endothelial growth factor (VEGF) treatment. VA, CRT and clinical data were retrospectively reviewed. Health‐related quality of life and subjective visual functioning were evaluated with Short Form Health Survey (SF‐36) and National Eye Institute Vision Functioning Questionnaire 25 (VFQ‐25). Comparisons between independent groups were performed using Pearson's χ2 test, Fisher's exact test or Mann–Whitney U test. Spearman's ρ was used for correlation analyses. Wilcoxon signed‐rank test was used for comparison between dependent groups. Logistic regression analysis was applied for analysis of VA and CRT over 4 years.

Results

Follow‐up data were obtained from 37 of 58 (63.8%) patients. Baseline characteristics were similar, regardless of follow‐up. VA improvement at 1 year (mean + 4.4, SD 7.5; ETDRS letter score) was maintained over 3 years, then declined. CRT was reduced throughout the study. In the first treatment year, eyes received 5.1 (1.4) anti‐VEGF injections, followed by approximately two injections yearly. Additional treatment included laser and dexamethasone implants. SF‐36 showed no change at 4 years, compared with baseline. VFQ‐25 demonstrated improvement in near vision activities (p = 0.036).

Conclusion

Significant long‐term improvement in visual function was present in patients with anti‐VEGF‐treated DMO.

Keywords
anti-VEGF treatment, diabetic macular oedema, long-term follow-up, longitudinal study, real-world study, visual acuity
National Category
Health Sciences
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
urn:nbn:se:du-31172 (URN)10.1111/aos.14290 (DOI)000492664100001 ()2-s2.0-85074598945 (Scopus ID)
Available from: 2019-12-06 Created: 2019-12-06 Last updated: 2021-11-12Bibliographically approved

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