David Tabano

Eye care access for underserved patients with diabetes is limited and poorly understood. We identified barriers and innovative solutions to improve overall care and establish evidence-based practices.

Background/objectives: To assess geographically global clinical practice guidelines (CPGs) for diabetic macular oedema (DMO) management. Methods: A systematic literature review (SLR) of CPGs for DMO management was conducted using Embase and MEDLINE databases, Guideline Central, Health Technology Assessment bodies, professional ophthalmology associations, and backwards citation tracking. CPGs published between January 2010–October 2023 were included and independently assessed by four reviewers and one adjudicator using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. CPGs were qualitatively assessed for anatomical measurement (optical coherence tomography [OCT]) and visual acuity (VA) recommendations. PROSPERO identification: CRD42023473223. Results: 14/147 identified CPGs were included. Overall AGREE II scores were 49–91 (mean [SD] = 67 [11]). Strongest domains were Scope and Purpose (85 [10.9]), Clarity of Presentation (87 [18.7]), and Editorial Independence (91 [13.7]). Stakeholder Involvement (57 [8.3]), Applicability (54 [19.4]), and Rigor of Development (41 [19.0]) scored lowest. 13/14 CPGs were “Recommended” or “Recommended with Modifications”. All CPGs recommended OCT for initial diagnosis. 3/14 CPGs did not recommend VA or considered VA optional. For initial disease management, 11/14 CPGs recommended OCT. One considered OCT optional. VA was recommended by 9/14 CPGs for initial management. All CPGs recommended using VA and OCT for disease monitoring while on anti-vascular endothelial growth factor therapy. 12/14 CPGs recommended using OCT to measure anti-VEGF response to adjust treatment interval. Conclusion: CPGs were aligned regarding the importance of OCT in DMO management. More rigorous methods, applicability in resource-constrained systems, and patient perspectives will improve CPG trustworthiness and transparency.

Introduction Intravitreal (IVT) injections of anti-vascular endothelial growth factor (VEGF) agents are the standard of care for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). While demonstrated to be effective, these treatments potentially place a significant burden on patients owing to their cost and frequency of treatment visits required for administration. The objective of this study was to investigate the economic burden of treatment on patients with nAMD/DME and their informal caregivers in seven countries. Methods Data were collected from patients and caregivers in the USA, UK, Canada, Italy, Spain, Germany, and France using a survey between September and December 2022. Each survey collected data to facilitate calculating economic burden, combining the total financial costs (i.e., direct costs to receive treatment) and productivity losses associated with attending treatment appointments over a 6-month period. Quality of life data were collected using validated instruments. Results In total, 194 patients and 194 caregivers reported currently receiving (or caring for someone who receives) anti-VEGF treatment. Across all countries, the modal frequency of anti-VEGF treatment was every 4 weeks, except for patients with DME (every 8 weeks). The largest, mean 6-month economic burden on the pooled population of patients with nAMD/DME was reported in Italy (€1244) and on caregivers it was in the USA (€3069). Economic burden was lower for respondents receiving fewer anti-VEGF injections. Conclusions More durable therapies for nAMD/DME would reduce treatment burden and have a sizeable impact financially on patients with nAMD/DME and their caregivers.

Background/Objectives: To assess geographically global clinical practice guidelines (CPGs) for neovascular age-related macular degeneration (nAMD) management. Methods: A systematic literature review (SLR) of CPGs for nAMD management was conducted using Embase and MEDLINE databases, Guideline Central, Health Technology Assessment bodies, professional ophthalmology associations, and backwards citation tracking. CPGs published between January 2010–October 2023 were included and independently assessed by four reviewers using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). CPGs were qualitatively assessed for anatomical measurements (optical coherence tomography [OCT] and visual acuity [VA]). PROSPERO identification is CRD42023473223. Results: Nine of 147 identified global CPGs were included in the SLR for diagnosis, treatment, and disease monitoring for nAMD. Overall AGREE II scores were 62–95 (mean [standard deviation] score 75 [10.6]). Strongest domains were Scope and Purpose (86.6 [11.0]), Clarity of Presentation (84.3 [13.0]), and Editorial Independence (89.1 [15.4]); Stakeholder Involvement (63.4 [16.6]), Applicability (73.0 [12.6]), and Rigor of Development (55.4 [25.9]) were lowest. 4/9 CPGs were “Recommended” by reviewers, and 5/9 were “Recommended with Modifications”. All CPGs recommended OCT for initial diagnosis. 2/9 CPGs did not mention VA. For managing pharmacological interventions, 4/9 CPGs recommended using VA, and three recommended OCT. Eight CPGs recommended using either VA or OCT for disease monitoring while on anti-vascular endothelial growth factor (VEGF) treatment. 6/9 CPGs recommended screening for VA and 7/9 CPGs recommended using OCT to change anti-VEGF intervals. Conclusion: CPG methods, recommendations on applicability in resource-constrained systems, and patient advocacy/perspectives will improve CPG trustworthiness and transparency.

Background: Anti-vascular endothelial growth factor (anti-VEGF) agents are widely prescribed for the treatment of neovascular age-related macular degeneration (nAMD). Although studies have investigated patient choice of anti-VEGF agent, little is known regarding factors that influence physician preference of anti-VEGF agent for their patients. Objective: To describe physician rationale and challenges in prescribing anti-VEGF treatments for patients with nAMD. Methods: Data were drawn from the Adelphi Real World nAMD Disease Specific Programme™, a cross-sectional survey with retrospective data capture of physicians and their patients with nAMD in the United States between October 2021 and May 2022. Physicians (n = 56) reported data for up to 13 consecutively consulting patients (n = 451), including current anti-VEGF treatments used, factors affecting physicians’ choice of anti-VEGF agent and treatment strategy, and restrictions on specific agents. Results: Most physicians prefer employing a “treat-and-extend” treatment strategy, over “fixed interval” or “pro re nata” strategies. However, in routine clinical practice, “treat-and-extend” was reported for less than half of nAMD-diagnosed eyes. Top factors influencing physician choice of anti-VEGF agent and treatment strategy included maximizing clinical benefit (eg visual acuity gains and fluid control), patient convenience, and reducing out-of-pocket costs. However, physicians also reported facing substantial roadblocks in prescribing their choice of anti-VEGF agent, including restrictions on approved agents and gaps in insurance coverage. Persistent fluid was the most common physician-selected reason for switching a patient away from an anti-VEGF agent. Conclusion: Physicians face barriers to prescribing their preferred anti-VEGF agents in real-world healthcare settings. Overcoming these challenges may improve treatment outcomes for patients with nAMD. Plain Language Summary: People with wet age-related macular degeneration (wet AMD) have problems with their eyesight that can lead to blindness if left untreated. Eye doctors (ophthalmologists) use a class of medicine called anti-VEGF agents to treat people with wet AMD. However, eye doctors often face challenges in prescribing their anti-VEGF agent of choice. We surveyed eye doctors to determine the reasons why they preferred some anti-VEGF agents over others, as well as the barriers to prescribing these anti-VEGF agents. Eye doctors reported that they usually choose a specific anti-VEGF agent because it leads to better vision, has lower cost for people with wet AMD, or may reduce the number of appointments needed for people with wet AMD. Eye doctors also noted that they face challenges in treating people with wet AMD, including restrictions and limited insurance coverage for certain anti-VEGF agents. Solving these problems could help eye doctors use their medicine of choice and improve eyesight even more when they treat people with wet AMD.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: A distributed data network approach combined with distributed regression analysis (DRA) can reduce the risk of disclosing sensitive individual and institutional information in multi-center studies. However, software that facilitate large-scale and efficient implementation of DRA are limited. Objective: To assess the precision and operational performance of a DRA application comprised of a SAS-based DRA package and a file transfer workflow developed within the open-source distributed networking software PopMedNetTM in a horizontally partitioned distributed data network. Methods: We executed the SAS-based DRA package to perform distributed linear, logistic, and Cox proportional hazards regression analysis on a real-world test case with three data partners. We used PopMedNet to iteratively and automatically transfer highly summarized information between the data partners and the analysis center. We compared the DRA results to the results from standard SAS procedures executed on the pooled individual-level dataset to evaluate the precision of the SAS-based DRA package. We computed the execution time of each step in the workflow to evaluate the operational performance of the PopMedNet-driven file transfer workflow. Results: All DRA results were precise (< 10-12) and DRA model fit curves were identical or similar to those obtained from the corresponding pooled individual-level data analyses. All regression models required less than 20 minutes for full end-to-end execution. Conclusions: We integrated a SAS-based DRA package with PopMedNet and successfully tested the new capability within an active distributed data network. The study demonstrated the validity and feasibility of using DRA to enable more privacy-protecting analysis in multi-center studies.

BACKGROUND A distributed data network approach combined with distributed regression analysis (DRA) can reduce the risk of disclosing sensitive individual and institutional information in multicenter studies. However, software that facilitates large-scale and efficient implementation of DRA is limited. OBJECTIVE This study aimed to assess the precision and operational performance of a DRA application comprising a SAS-based DRA package and a file transfer workflow developed within the open-source distributed networking software PopMedNet in a horizontally partitioned distributed data network. METHODS We executed the SAS-based DRA package to perform distributed linear, logistic, and Cox proportional hazards regression analysis on a real-world test case with 3 data partners. We used PopMedNet to iteratively and automatically transfer highly summarized information between the data partners and the analysis center. We compared the DRA results with the results from standard SAS procedures executed on the pooled individual-level dataset to evaluate the precision of the SAS-based DRA package. We computed the execution time of each step in the workflow to evaluate the operational performance of the PopMedNet-driven file transfer workflow. RESULTS All DRA results were precise (<10−12), and DRA model fit curves were identical or similar to those obtained from the corresponding pooled individual-level data analyses. All regression models required less than 20 min for full end-to-end execution. CONCLUSIONS We integrated a SAS-based DRA package with PopMedNet and successfully tested the new capability within an active distributed data network. The study demonstrated the validity and feasibility of using DRA to enable more privacy-protecting analysis in multicenter studies.

Electronic health records (EHRs) provide an alternative to traditional public health surveillance surveys and administrative data for measuring the prevalence and impact of chronic health conditions in populations. As the infrastructure for secondary use of EHR data improves, many stakeholders are poised to benefit from data partnerships for regional access to information. Electronic health records can be transformed into a common data model that facilitates data sharing across multiple organizations and allows data to be used for surveillance. The Colorado Health Observation Regional Data Service, a regional distributed data network, has assembled diverse data partnerships, flexible infrastructure, and transparent governance practices to better understand the health of communities through EHR-based, public health surveillance. This article describes attributes of regional distributed data networks using EHR data and the history and design of Colorado Health Observation Regional Data Service as an emerging public health surveillance tool for chronic health conditions. Colorado Health Observation Regional Data Service and our experience may serve as a model for other regions interested in similar surveillance efforts. While benefits from EHR-based surveillance are described, a number of technology, partnership, and value proposition challenges remain.