Inger Westborg

Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration

PURPOSE To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. DESIGN Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). METHODS Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. RESULTS Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. CONCLUSIONS The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.

Reduced occurrence of severe visual impairment after introduction of anti-Vascular Endothelial Growth Factor in wet age-related macular degeneration : a population- and register-based study from northern Sweden

To study the occurrence of severe visual impairment (SVI) and treatment outcome at 12 months in patients treated for wet age‐related macular degeneration (AMD) by use of data from the Swedish Macula Register (SMR) and referrals to the regional low vision clinics in five northern counties.

Intracameral anesthesia for cataract surgery: a population-based study on patient satisfaction and outcome

Purpose To evaluate if the standard anesthetic regimen – topical combined with intracameral anesthesia without sedation – in a population-based cohort of unselected cataract surgery cases is adequate, optimal, and good practice, or if improvements are necessary. Methods We conducted a prospective, observational study on all cases of cataract surgery during a 1-year period at one institution (n=1249). Data were collected from the patients’ records. Outcome measures were use of preoperative sedation, type of anesthesia, complications, and adverse events. In a subgroup of patients (n=124) satisfaction with the anesthetic regimen was evaluated using a short questionnaire. Results Most cases (90%, 1125/1249) had combined topical and intracameral anesthesia without sedation. Patients who chose preoperative sedation (midazolam hydrochloride sublingually) were significantly younger and more often female (P=0.0001 and P=0.011, respectively). In the questionnaire subgroup, the median pain score after surgery was 0.7 (visual analog scale, 0–10). A pain score of 1.9 or less was reported by 76% of the patients. Patients reporting a pain score of 2 or more had sedation and additional anesthetics more often. No significant difference was found regarding age, sex, pulse rate, oxygen saturation, first or second eye surgery, or adverse intraoperative events for patients with pain scores of 1.9 or less and 2 or more. Conclusion This large population-based series of small-incision phacoemulsification surgery shows that combined topical and intracameral anesthesia without sedatives is well tolerated for most phacoemulsification patients. It is also effective in cases when complications or adverse events occur. It is important to be responsive to the individual patient’s needs and adjust operating procedures if necessary, as there were a few patients who experienced insufficient anesthesia.

Treatment for neovascular age‐related macular degeneration in Sweden: outcomes at seven years in the Swedish Macula Register

To present Swedish Macula Register (SMR) data regarding treatment of neovascular age‐related macular degeneration (AMD) in clinical practice since 2008.

Risk Factors for Discontinuation of Treatment for Neovascular Age-Related Macular Degeneration

ABSTRACT Purpose: To investigate risk factors for treatment discontinuation for neovascular age-related macular degeneration (nAMD). Methods: Data from the Swedish Macula Register and the Skåne Healthcare Register are reported on the treatment received by 932 nAMD patients diagnosed 2013−2015. Treatment discontinuation is defined as having a termination visit or lacking a control or treatment visit during the period of 10−14 months after the diagnostic visit. The risk of treatment discontinuation during the first year is estimated using a Poisson model and a classification tree. Results: 503 eyes (50.9%) discontinued the treatment within the first year. Patients with visual acuity below 60 ETDRS letters (20/60 Snellen) at baseline, serious comorbidities, or treated at the university hospital have a 42% (95% CI 25−61%, P < 0.001), 27% (95% CI 13−43%, P = 0.001) and 30% (95% CI 15−46%, P < 0.001) increased risk to discontinue treatment compared with similar patients. Patients on ranibizumab therapy have a 45% (95% CI 28−63%, P < 0.001) increased risk for treatment discontinuation during year 1 compared with patients on aflibercept therapy. The classification tree also shows that patients on ranibizumab therapy and those with low VA at baseline are at a higher risk of terminating treatment. Conclusions: Almost half of the patients starting anti-VEGF therapy discontinue treatment during the first year. Patients with risk factors may require additional support to continue with the treatment. Aflibercept therapy could be an alternative to patients at risk of treatment discontinuation.